Forest Service
Rural Utilities Service
National Oceanic and Atmospheric Administration
Federal Energy Regulatory Commission
Centers for Disease Control and Prevention
Centers for Medicare & Medicaid Services
Children and Families Administration
Food and Drug Administration
National Institutes of Health
Coast Guard
U.S. Citizenship and Immigration Services
Fish and Wildlife Service
Indian Affairs Bureau
National Park Service
Ocean Energy Management Bureau
Federal Aviation Administration
Federal Highway Administration
Federal Motor Carrier Safety Administration
Federal Railroad Administration
Maritime 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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Nuclear Regulatory Commission.
Final guide; issuance.
The U.S. Nuclear Regulatory Commission (NRC) is issuing Revision 4 to Regulatory Guide (RG), 4.7, “General Site Suitability for Nuclear Power Stations.” Revision 4 to RG 4.7 describes the major site characteristics related to public health and safety and environmental issues that the NRC staff considers in determining the suitability of sites for commercial nuclear power stations.
Revision 4 to RG 4.7 is available on February 29, 2024.
Please refer to Docket ID NRC-2023-0153 when contacting the NRC about the availability of information regarding this document. You may obtain publicly available information related to this document using any of the following methods:
•
•
•
Revision 4 to RG 4.7 and the regulatory analysis may be found in ADAMS under Accession Nos. ML23348A082 and ML23123A095, respectively.
Regulatory guides are not copyrighted, and NRC approval is not required to reproduce them.
Edward O'Donnell, Office of Nuclear Regulatory Research, telephone: 301-415-3317; email:
The NRC is issuing a revision in the NRC's “Regulatory Guide” series. This series was developed to describe methods that are acceptable to the NRC staff for implementing specific parts of the agency's regulations, to explain techniques that the staff uses in evaluating specific issues or postulated events, and to describe information that the staff needs in its review of applications for permits and licenses.
The proposed Revision 4 to RG 4.7 was issued with a temporary identification of Draft Regulatory Guide (DG)-4034. The NRC staff revised RG 4.7 to include alternative approaches to the population-density criterion and to expand the regulatory guidance developed for large light-water reactor (LWR) technology with appropriate modifications for advanced reactor designs (
The NRC published a notice of the availability of DG-4034 in the
As noted in the
This RG is a rule as defined in the Congressional Review Act (5 U.S.C. 801-808). However, the Office of Management and Budget has not found it to be a major rule as defined in the Congressional Review Act.
Issuance of this RG does not constitute backfitting as defined in 10 CFR 50.109, “Backfitting,” and as described in NRC Management Directive
A member of the public may, at any time, submit suggestions to the NRC for improvement of existing RGs or for the development of new RGs. Suggestions can be submitted on the NRC's public website at
For the Nuclear Regulatory Commission.
Coast Guard, Department of Homeland Security (DHS).
Correcting amendment.
The Coast Guard is correcting regulations that published in the
This correcting amendment is effective February 29, 2024.
If you have questions on this correcting amendment, call or email Mr. Lee D. Soule, Bridge Management Specialist, Ninth Coast Guard District; telephone 216-902-6085, email
In FR Doc. 2023-28645, appearing on page 89574 in the
Bridges.
For the reasons discussed in the preamble, the Coast Guard corrects 33 CFR part 117 by making the following correcting amendment:
33 U.S.C. 499; 33 CFR 1.05-1; and DHS Delegation No. 00170.1, Revision No. 01.3.
(h) The draw of the Dix Avenue Bridge, mile 2.73, is required to operate a radiotelephone, and shall open on signal except from January 1 through March 31 when the bridge shall open on signal if provided a 12-hour advance notice.
Coast Guard, Department of Homeland Security (DHS).
Final rule.
The Coast Guard is modifying the operating schedule that governs the Fifth Street Bridge, mile 0.15, and the Norfolk Southern Railroad Bridge, mile 1.5, both over the Ashtabula River. The Coast Guard is also changing signaling and signage requirements for the Norfolk Southern Railroad Bridge, mile 1.5. The Coast Guard is modifying these rules in response to complaints received concerning the operations of one or more bridges over the waterway and a desire to improve safety, remove barriers to interstate commerce, improve communications, and standardize winter operations associated with these bridges.
This rule is effective April 1, 2024.
To view documents mentioned in this preamble as being available in the docket, go to
If you have questions on this final rule, call or email Mr. Lee D. Soule, Bridge Management Specialist, Ninth Coast Guard District; telephone 216-902-6085, email
On May 8, 2023, the Coast Guard published an NPRM, with a request for comments, entitled “Drawbridge Operation Regulation; Ashtabula River, Ashtabula, OH” in the
The Ashtabula River flows into Lake Erie at the City of Ashtabula, Ohio. The Ashtabula River is 40 miles in length but only the first 2 miles of the river is navigable. Large commercial vessels, passenger vessels, and recreational vessels use the waterway. There are three bridges crossing the Ashtabula River. The Norfolk Southern Railroad, mile 0.5, is a fixed overhead conveyor with a horizontal clearance of over 50 feet and a vertical clearance of 100 feet above LWD. The Fifth Street Bridge, mile 1.4, is a single leaf bascule bridge with a reported horizontal clearance of 50 feet and a vertical clearance of 11 feet above LWD in the closed position and an unlimited clearance in the open position. The Norfolk Southern Railroad Bridge, mile 1.5, is a single leaf bascule bridge with a horizontal clearance of 112 feet and a vertical clearance of 11 feet above LWD in the closed position and an unlimited clearance in the open position. There is no alternative route for vessels traveling the Ashtabula River beyond mile 0.5 to prevent them from passing under or through one or all these bridges. Commercial vessels over 600 feet utilize moorings just outside of the river's mouth. Several of the vessels in the Ashtabula River are small passenger vessels and other small craft over 21-feet.
The two bascule bridges across the Ashtabula River are regulated by 33 CFR 117.847. The draw of the Fifth Street Bridge, mile 1.4, is required to open on signal for the passage of commercial and emergency vessels and on the hour and half for all other vessels. The Norfolk Southern Railroad Bridge, mile 1.5, is authorized to operate remotely, and is required to open on signal from April 1 through November 30 from 7 a.m. to 11 p.m. and requires a 24-hour advance notice outside of this time.
The Coast Guard is issuing this rule under authority 33 U.S.C. 499. The Coast Guard is also issuing new rules that will help mariners signal for and anticipate bridge openings.
On a typical summer weekend over thirty vessels can be seen waiting at the bridge for an opening while there is no train crossing the bridge. Mariners repeatedly expressed uncertainty regarding how to request an opening citing poor radio communications with the bridge and vague signage at the bridge which does not explain how to request a bridge opening. This new regulation will require the remote drawtender to monitor and answer a telephone in addition to the other signals required by regulation to help improve communications at the bridge, reducing unnecessary delays and the risks posed by poor communications.
The Coast Guard did not receive any comments from the NPRM.
We developed this rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive orders.
Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. This rule has not been designated a “significant regulatory action,” under section 3(f) of Executive Order 12866, as amended by Executive Order 14094 (Modernizing Regulatory Review). Accordingly, it has not been reviewed by the Office of Management and Budget (OMB).
This regulatory action determination is based on the ability that vessels can still transit the bridge given advanced notice and the requirement for signage has been in effect since April 24, 1984 (49 FR 17452), without any complaint to the burden of cost to the bridge owner.
The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard did not receive any comments from the Small Business Administration on this rule. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.
While some owners or operators of vessels intending to transit the bridge may be small entities, for the reasons stated in section V. A above, this rule will not have a significant economic impact on any vessel owner or operator.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the
Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.
This rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship
Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
We have analyzed this rule under Department of Homeland Security Management Directive 023-01, Rev.1, associated implementing instructions, and Environmental Planning Policy COMDTINST 5090.1 (series) which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f). The Coast Guard has determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule promulgates the operating regulations or procedures for drawbridges and is categorically excluded from further review, under paragraph L49, of Chapter 3, Table3-1 of the U.S. Coast Guard Environmental Planning Implementation Procedures.
Neither a Record of Environmental Consideration nor a Memorandum for the Record are required for this rule.
Bridges.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 117 as follows:
33 U.S.C. 499; 33 CFR 1.05-1; and DHS Delegation No. 00170.1, Revision No. 01.3.
(a) The draw of the Fifth Street Bridge, mile 1.4, over the Ashtabula River shall open on signal for the passage of vessels on the hour and half hour, except from October 10 through May 1 when no drawtender is required to be in attendance and the bridge will open on signal with a 12-hour advance notice from vessels.
(b) The draw of the Norfolk Southern Railroad Bridge, mile 1.5, over the Ashtabula River shall open on signal and may be remotely operated. The bridge owner shall maintain and monitor a 2-way public address system, VHF-FM Marine Radio, and telephone. From October 10 through May 1 the bridge will open on signal with a 12-hour advance notice from vessels. The bridge shall display a sign readable from vessels approaching the bridge from upriver or down river and readable for 500 feet that states: the name of the bridge; the river mile; that the bridge is remotely operated; and that mariners may signal the bridge to open by sounding one prolonged blast followed by one short blast of the horn, calling via VHF-FM Marine Radio Channel 16, or by calling the number posted by the owner. The sign shall also include language notifying mariners that from October 10 through May 1 the bridge requires a 12-hour advance notice for openings by calling the number posted by the owner.
Forest Service, Agriculture; Fish and Wildlife Service, Interior.
Final rule.
This final rule revises regulations for seasons, harvest limits, methods, and means related to taking of fish for subsistence uses in Alaska during the 2023-2024 and 2024-2025 regulatory years and the customary and traditional use determinations for fish and shellfish. This rule also revises the regulations for subsistence taking of wildlife, in response to deferred proposals from the 2022-2024 wildlife regulations cycle. The Federal Subsistence Management Program provides a preference for customary and traditional uses by rural Alaska residents of wild, renewable resources on Federal public lands and waters in Alaska.
This rule is effective February 29, 2024.
Federal Subsistence Board meeting transcripts are available for review at the Office of Subsistence Management, 1011 East Tudor Road, Mail Stop 121, Anchorage, AK 99503; on the Office of Subsistence Management website (
Chair, Federal Subsistence Board, c/o U.S. Fish and Wildlife Service, Attention: Amee Howard, Office of Subsistence Management; (907) 786-3888 or
Under title VIII of the Alaska National Interest Lands Conservation Act (ANILCA) (16 U.S.C. 3111-3126), the Secretary of the Interior and the Secretary of Agriculture (Secretaries) jointly implement the Federal Subsistence Management Program. The Program provides a preference for take of fish and wildlife resources for subsistence uses on Federal public lands and waters in Alaska. The term “subsistence uses” means the customary and traditional uses by rural Alaska residents of wild, renewable resources for direct personal or family consumption as food, shelter, fuel, clothing, tools, or transportation or for other specified purposes. The Secretaries published temporary regulations to carry out the Program in the
The Program managers have subsequently amended these regulations many times. Because this program is a joint effort between Interior and Agriculture, these regulations are located in two titles of the Code of Federal Regulations (CFR): title 36, “Parks, Forests, and Public Property,” and title 50, “Wildlife and Fisheries,” at 36 CFR 242.1-242.28 and 50 CFR 100.1-100.28, respectively. Consequently, to indicate that identical changes affect regulations in both titles 36 and 50, in this document we present references to specific sections of the CFR as shown in the following example: § __.24.
The Program regulations contain subparts as follows: Subpart A, General Provisions; Subpart B, Program Structure; Subpart C, Board Determinations; and Subpart D, Subsistence Taking of Fish and Wildlife. Consistent with subpart B of these regulations, the Secretaries established a Federal Subsistence Board to administer the Federal Subsistence Management Program. The Board comprises:
• A Chair appointed by the Secretary of the Interior with concurrence of the Secretary of Agriculture;
• The Alaska Regional Director, U.S. Fish and Wildlife Service (FWS);
• The Alaska Regional Director, National Park Service (NPS);
• The Alaska State Director, Bureau of Land Management (BLM);
• The Alaska Regional Director, Bureau of Indian Affairs (BIA);
• The Alaska Regional Forester, USDA Forest Service (USDA-FS); and
• Two public members appointed by the Secretary of the Interior with concurrence of the Secretary of Agriculture.
Through the Board, these agencies participate in the development of regulations for subparts C and D, which, among other things, set forth program eligibility, including determinations of which areas or communities in Alaska are nonrural, and specific harvest seasons and limits. The Board receives analytical and administrative assistance from the Interagency Staff Committee, which comprises senior technical experts from FWS, NPS, BLM, BIA, and USDA-FS (per § __.10(d)(7)).
In administering the Program, the Secretaries divided Alaska into 10 subsistence resource regions, each of which is represented by a Federal Subsistence Regional Advisory Council (Council). The Councils provide a forum for rural residents with personal knowledge of local conditions and resource requirements to have a meaningful role in the subsistence management of fish and wildlife on Federal public lands in Alaska. The Council members represent varied geographical, cultural, and user interests within each region.
The Board conducts rulemaking for the Program on a biennial schedule with the process of revising the fish and shellfish regulations and the process for revising the wildlife regulations occurring during opposite years. The Board addresses “customary and traditional use” determinations during the applicable biennial cycle. The regulations at § __.4 define “customary and traditional use” as “a long-established, consistent pattern of use, incorporating beliefs and customs which have been transmitted from generation to generation.” Since establishment of the Program regulations in 1992, the Board has made a number of customary and traditional use determinations at the request of affected subsistence users. These determinations have resulted in revisions to the regulations at § __.24. The modifications for fish and shellfish, along with some administrative corrections, were published in the
The Departments published a proposed rule, Subsistence Management Regulations for Public Lands in Alaska—2023-24 and 2024-25 Subsistence Taking of Fish Regulations, on March 17, 2022 (87 FR 15155), to amend the fish and shellfish sections of subparts C and D of 36 CFR part 242 and 50 CFR part 100. As stated in the proposed rule, during the rulemaking cycle for the fish and shellfish regulations, the Board also accepts proposals for nonrural determinations.
The proposed rule opened a comment period, which closed on May 16, 2022. The Departments advertised the proposed rule on the Program's web page and by mail, email, social media, radio, and newspaper. During that period, the Councils met and, in addition to other Council business, received suggestions for proposals from the public. The Board received a total of 10 proposals for changes to the subpart C regulations (which pertain to Board determinations for subsistence resource regions, rural determinations, and customary and traditional use determinations). Nine of those proposals were for changes to customary and traditional use determinations, and one was for a change to nonrural determinations. Nine proposals were submitted for changes to the subpart D regulations (which provide specific provisions regarding the taking of fish and wildlife). Two of those proposals were later withdrawn by their proponents. In addition, 19 fisheries closure reviews were presented for comment as required by Board policy that specifies a review of each closure at least every 4 years. Seven of the closure reviews were deferred from the previous fish and shellfish proposed rule (85 FR 9430, February 19, 2020).
The public submitted 20 comments, which are available for review at
After the comment period closed, the Board prepared a booklet describing the proposals and distributed it to the public. The proposals were also published on the Program's website. The public then had 30 days, until July 27, 2022, to comment on the proposed regulatory changes. The 10 Councils met again, received public comments, and formulated their recommendations to the Board on proposals for their respective regions. Therefore, the public received extensive opportunity to review and comment on all changes.
The Councils had a substantial role in reviewing the proposed rule and making recommendations for the final rule. Moreover, a Council Chair, or a designated representative, presented each Council's recommendations at the Board's public meeting of January 31-February 3, 2023.
The Board's actions on each fisheries proposal and closure review are listed in table 2 below. When making decisions, the Board may use, but is not limited to, the following guidelines for consideration of whether a proposal:
• provides a subsistence priority on public lands;
• is supported by substantial scientific and traditional ecological knowledge (TEK) evidence;
• recognizes principles of fish and wildlife conservation;
• provides opportunity; and
• would not be detrimental or place undue burden on rural Alaskan subsistence users.
Of the proposals on the consensus agenda, the Board adopted three, rejected two, and took no action on two. Of the closure reviews on the consensus agenda, the Board retained the status quo on four and rescinded one. Analysis and justification for the action taken on each proposal on the consensus agenda can be found in the Board meeting book and transcripts. Documents are available for review at the Office of Subsistence Management (OSM), 1011 East Tudor Road, Mail Stop 121, Anchorage, AK 99503; at
The final regulations in this document reflect Board review and consideration of Regional Advisory Council recommendations, Tribal and Alaska Native corporation consultations, and public and ADF&G comments. The proposals indicated above in table 2 as “adopted” are reflected in the rule portion of this document as revisions to the Program regulations. Because this rule concerns public lands managed by a bureau or bureaus in both the Departments of Agriculture and the Interior, identical text will be incorporated into 36 CFR part 242 and 50 CFR part 100.
The Board has provided extensive opportunity for public input and involvement in compliance with Administrative Procedure Act requirements, including publishing a proposed rule in the
In the more than 30 years that the Program has been operating, no benefit to the public has been demonstrated by delaying the effective date of the subsistence regulations. A lapse in regulatory control could affect the continued viability of fish or wildlife populations and future subsistence opportunities for rural Alaskans and would generally fail to serve the overall public interest. Therefore, the Board finds good cause pursuant to 5 U.S.C. 553(d)(3) to make this rule effective upon the date set forth in
A draft environmental impact statement that described four alternatives for developing a Federal Subsistence Management Program was distributed for public comment on October 7, 1991. The final environmental impact statement (FEIS) was published on February 28, 1992. The Record of Decision (ROD) on Subsistence Management for Federal Public Lands in Alaska was signed April 6, 1992. The selected alternative in the FEIS (alternative IV) defined the administrative framework of an annual regulatory cycle for subsistence regulations.
A 1997 environmental assessment dealt with the expansion of Federal jurisdiction over fisheries and is available at the office listed under
An ANILCA section 810 analysis was completed as part of the FEIS process on the Federal Subsistence Management Program. The intent of all Federal subsistence regulations is to accord subsistence uses of fish and wildlife on public lands a priority over the taking of fish and wildlife on such lands for other purposes, unless restriction is necessary to conserve healthy fish and wildlife populations. The final section
During the subsequent environmental assessment process for extending fisheries jurisdiction, an evaluation of the effects of this rule was conducted in accordance with section 810. That evaluation also supported the Secretaries' determination that the rule will not reach the “may significantly restrict” threshold that would require notice and hearings under ANILCA section 810(a).
This rule does not contain any new collections of information that require Office of Management and Budget (OMB) approval under the PRA (44 U.S.C. 3501
Executive Order 14094 reaffirms the principles of E.O. 12866 and E.O. 13563 and states that regulatory analysis should facilitate agency efforts to develop regulations that serve the public interest, advance statutory objectives, and are consistent with E.O. 12866, E.O. 13563, and the Presidential Memorandum of January 20, 2021 (Modernizing Regulatory Review). Regulatory analysis, as practicable and appropriate, shall recognize distributive impacts and equity, to the extent permitted by law. E.O. 13563 emphasizes further that regulations must be based on the best available science and that the rulemaking process must allow for public participation and an open exchange of ideas. We have developed this final rule in a manner consistent with these requirements.
E.O. 12866, as reaffirmed by E.O. 13563 and E.O. 14094, provides that the Office of Information and Regulatory Affairs (OIRA) in the Office of Management and Budget (OMB) will review all significant rules. OIRA has determined that this rule is not significant.
The Regulatory Flexibility Act of 1980 (5 U.S.C. 601
Under the Congressional Review Act (5 U.S.C. 804(2)), this rule is not a major rule. It does not have an effect on the economy of $100 million or more, will not cause a major increase in costs or prices for consumers, and does not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S.-based enterprises to compete with foreign-based enterprises.
Title VIII of ANILCA requires the Secretaries to administer a subsistence priority on public lands. The scope of the Program is limited by definition to certain public lands. Accordingly, these regulations have no potential takings of private property implications as defined by Executive Order 12630.
The Secretaries have determined and certify pursuant to the Unfunded Mandates Reform Act, 2 U.S.C. 1502
The Secretaries have determined that these regulations meet the applicable standards provided in sections 3(a) and 3(b)(2) of Executive Order 12988, regarding civil justice reform.
In accordance with Executive Order 13132, the rule does not have sufficient federalism implications to warrant the preparation of a federalism summary impact statement. Title VIII of ANILCA precludes the State from exercising subsistence management authority over fish and wildlife resources on Federal lands unless it meets certain requirements.
Title VIII of ANILCA, does not provide specific rights to Tribes for the subsistence taking of wildlife, fish, and shellfish. However, the Board provided Federally recognized Tribes and Alaska Native corporations opportunities to consult on this rule. Consultation with Alaska Native corporations are based on Public Law 108-199, div. H, Sec. 161, Jan. 23, 2004, 118 Stat. 452, as amended by Public Law 108-447, div. H, title V, Sec. 518, Dec. 8, 2004, 118 Stat. 3267, which provides that: “The Director of the Office of Management and Budget and all Federal agencies shall hereafter consult with Alaska Native corporations on the same basis as Indian Tribes under Executive Order No. 13175.”
The Secretaries, through the Board, provided a variety of opportunities for consultation: commenting on proposed changes to the existing rule; engaging in dialogue at the Council meetings; engaging in dialogue at the Board's meetings; and providing input in person, by mail, email, or phone at any time during the rulemaking process.
On January 31, 2023, the Board provided federally recognized Tribes and Alaska Native Corporations a specific opportunity to consult on this rule prior to the start of its public regulatory meeting. Federally recognized Tribes and Alaska Native Corporations were notified by mail and telephone and were given the opportunity to attend via teleconference.
This Executive order requires agencies to prepare statements of energy effects when undertaking certain actions. However, this rule is not a significant regulatory action under E.O. 13211, affecting energy supply, distribution, or use, and no statement of energy effects is required.
Justin Koller drafted these regulations under the guidance of Amee Howard of the Office of Subsistence Management, Alaska Regional Office, U.S. Fish and Wildlife Service, Anchorage, Alaska. Additional assistance was provided by
• Paul McKee, Alaska State Office, Bureau of Land Management;
• Eva Patton, Alaska Regional Office, National Park Service;
• Dr. Glenn Chen, Alaska Regional Office, Bureau of Indian Affairs;
• Jill Klein, Alaska Regional Office, U.S. Fish and Wildlife Service; and
• Gregory Risdahl, Alaska Regional Office, USDA Forest Service.
Administrative practice and procedure, Alaska, Fish, National forests, Public lands, Reporting and recordkeeping requirements, Wildlife.
Administrative practice and procedure, Alaska, Fish, National forests, Public lands, Reporting and recordkeeping requirements, Wildlife.
For the reasons set out in the preamble, the Federal Subsistence Board amends title 36, part 242, and title 50, part 100, of the Code of Federal Regulations, as set forth below.
16 U.S.C. 3, 472, 551, 668dd, 3101-3126; 18 U.S.C. 3551-3586; 43 U.S.C. 1733.
(a) * * *
(2) * * *
(3) * * *
(n) * * *
(9)
(i) Unit 9 consists of the Alaska Peninsula and adjacent islands, including drainages east of False Pass, Pacific Ocean drainages west of and excluding the Redoubt Creek drainage; drainages into the south side of Bristol Bay, drainages into the north side of Bristol Bay east of Etolin Point, and including the Sanak and Shumagin Islands:
(A) Unit 9A consists of that portion of Unit 9 draining into Shelikof Strait and Cook Inlet between the southern boundary of Unit 16 (Redoubt Creek) and the northern boundary of Katmai National Park and Preserve.
(B) Unit 9B consists of the Kvichak River drainage except those lands drained by the Kvichak River/Bay between the Alagnak River drainage and the Naknek River drainage.
(C) Unit 9C consists of the Alagnak (Branch) River drainage, the Naknek River drainage, lands drained by the Kvichak River/Bay between the Alagnak River drainage and the Naknek River drainage, and all land and water within Katmai National Park and Preserve.
(D) Unit 9D consists of all Alaska Peninsula drainages west of a line from the southernmost head of Port Moller to the head of American Bay, including the Shumagin Islands and other islands of Unit 9 west of the Shumagin Islands.
(E) Unit 9E consists of the remainder of Unit 9.
(ii) In the following areas, the taking of wildlife for subsistence uses is prohibited or restricted on public lands:
(A) You may not take wildlife for subsistence uses in Katmai National Park; and
(B) You may not use motorized vehicles, except aircraft, boats, or snowmobiles used for hunting and transporting a hunter or harvested animal parts from Aug. 1 through Nov. 30 in the Naknek Controlled Use Area, which includes all of Unit 9C within the Naknek River drainage upstream from and including the King Salmon Creek drainage; however, you may use a motorized vehicle on the Naknek-King Salmon, Lake Camp, and Rapids Camp roads and on the King Salmon Creek trail, and on frozen surfaces of the Naknek River and Big Creek.
(iii) Unit-specific regulations:
(A) If you have a trapping license, you may use a firearm to take beaver in Unit 9B from April 1 through May 31 and in the remainder of Unit 9 from April 1 through 30.
(B) You may hunt brown bear by State registration permit in lieu of a resident tag in Unit 9B, except that portion within the Lake Clark National Park and Preserve, if you have obtained a State registration permit prior to hunting.
(C) In Unit 9B, Lake Clark National Park and Preserve, residents of Iliamna, Newhalen, Nondalton, Pedro Bay, Port Alsworth, and that portion of the park resident zone in Unit 9B and 13.440 permit holders may hunt brown bear by Federal registration permit in lieu of a resident tag. The season will be closed when 4 females or 10 bears have been taken, whichever occurs first. The permits will be issued and closure announcements made by the Superintendent Lake Clark National Park and Preserve.
(D) Residents of Iliamna, Newhalen, Nondalton, Pedro Bay, and Port Alsworth may take up to a total of 10 bull moose in Unit 9B for ceremonial purposes, under the terms of a Federal registration permit from July 1 through June 30. Permits will be issued to individuals only at the request of a local organization. This 10-moose limit is not cumulative with that permitted for potlatches by the State.
(E) For Units 9C and 9E only, a federally qualified subsistence user (recipient) of Units 9C and 9E may designate another federally qualified subsistence user of Units 9C and 9E to take bull caribou on his or her behalf. The designated hunter must obtain a designated hunter permit and must return a completed harvest report and turn over all meat to the recipient. There is no restriction on the number of possession limits the designated hunter may have in his/her possession at any one time.
(F) For Unit 9D, a federally qualified subsistence user (recipient) may designate another federally qualified subsistence user to take caribou on his or her behalf. The designated hunter must obtain a designated hunter permit and must return a completed harvest report. The designated hunter may hunt for any number of recipients but may have no more than four harvest limits in his/her possession at any one time.
(G) The communities of False Pass, King Cove, Cold Bay, Sand Point, and Nelson Lagoon annually may each take, from October 1 through December 31 or May 10 through 25, one brown bear for ceremonial purposes, under the terms of a Federal registration permit. A permit will be issued to an individual only at the request of a local organization. The brown bear may be taken from either Unit 9D or Unit 10 (Unimak Island) only.
(H) You may hunt brown bear in Unit 9E with a Federal registration permit in lieu of a State locking tag if you have obtained a Federal registration permit prior to hunting.
(I) In Units 9B and 9C, a snowmachine may be used to approach and pursue a wolf or wolverine provided the snowmachine does not contact a live animal.
(17)
(i) Unit 17 consists of drainages into Bristol Bay and the Bering Sea between Etolin Point and Cape Newenham, and all islands between these points including Hagemeister Island and the Walrus Islands:
(A) Unit 17A consists of the drainages between Cape Newenham and Cape Constantine, and Hagemeister Island and the Walrus Islands;
(B) Unit 17B consists of the Nushagak River drainage upstream from, and including the Mulchatna River drainage and the Wood River drainage upstream from the outlet of Lake Beverley; and
(C) Unit 17C consists of the remainder of Unit 17.
(ii) In the following areas, the taking of wildlife for subsistence uses is prohibited or restricted on public lands:
(A) Except for aircraft and boats and in legal hunting camps, you may not use any motorized vehicle for hunting ungulates, bear, wolves, and wolverine, including transportation of hunters and parts of ungulates, bear, wolves, or wolverine in the Upper Mulchatna Controlled Use Area consisting of Unit 17B, from Aug. 1 through Nov. 1.
(B) [Reserved]
(iii) Unit-specific regulations:
(A) You may use bait to hunt black bear between April 15 and June 15.
(B) You may hunt brown bear by State registration permit in lieu of a resident tag if you have obtained a State registration permit prior to hunting.
(C) If you have a trapping license, you may use a firearm to take beaver in Unit 17 from April 15 through May 31. You may not take beaver with a firearm under a trapping license on National Park Service lands.
(D) In Unit 17, a snowmachine may be used to assist in the taking of a caribou, and caribou may be shot from a stationary snowmachine. “Assist in the taking of a caribou” means a snowmachine may be used to approach within 300 yards of a caribou at speeds under 15 miles per hour, in a manner that does not involve repeated approaches or that causes a caribou to run. A snowmachine may not be used to contact an animal or to pursue a fleeing caribou.
(E) In Unit 17, a snowmachine may be used to approach and pursue a wolf or wolverine provided the snowmachine does not contact a live animal.
(e) * * *
(3)
(i) Unless otherwise restricted in this section, you may take fish in the Yukon-Northern Area at any time. In those locations where subsistence fishing permits are required, only one subsistence fishing permit will be issued to each household per year. You may subsistence fish for salmon with rod and reel in the Yukon River drainage 24 hours per day, 7 days per week, unless rod and reel are specifically otherwise restricted in this paragraph (e)(3).
(ii) For the Yukon River drainage, Federal subsistence fishing schedules, openings, closings, and fishing methods are the same as those issued for the subsistence taking of fish under Alaska statutes (AS 16.05.060), unless superseded by a Federal special action.
(iii) In the following locations, you may take salmon during the open weekly fishing periods of the State commercial salmon fishing season and may not take them for 24 hours before the opening of the State commercial salmon fishing season:
(A) In District 4, excluding the Koyukuk River drainage;
(B) In Subdistricts 4B and 4C from June 15 through September 30, salmon may be taken from 6 p.m. Sunday until 6 p.m. Tuesday and from 6 p.m. Wednesday until 6 p.m. Friday;
(C) In District 6, excluding the Kantishna River drainage, salmon may be taken from 6 p.m. Friday until 6 p.m. Wednesday.
(iv) During any State commercial salmon fishing season closure of greater than 5 days in duration, you may not take salmon during the following periods in the following districts:
(A) In District 4, excluding the Koyukuk River drainage, salmon may not be taken from 6 p.m. Friday until 6 p.m. Sunday;
(B) In District 5, excluding the Tozitna River drainage and Subdistrict 5D, salmon may not be taken from 6 p.m. Sunday until 6 p.m. Tuesday.
(v) Except as provided in this section, and except as may be provided by the terms of a subsistence fishing permit, you may take fish other than salmon at any time.
(vi) In Districts 1, 2, 3, and Subdistrict 4A, excluding the Koyukuk and Innoko River drainages, you may not take salmon for subsistence purposes during the 24 hours immediately before the opening of the State commercial salmon fishing season.
(vii) In Districts 1, 2, and 3:
(A) After the opening of the State commercial salmon fishing season through July 15, you may not take salmon for subsistence for 18 hours immediately before, during, and for 12 hours after each State commercial salmon fishing period;
(B) After July 15, you may not take salmon for subsistence for 12 hours immediately before, during, and for 12 hours after each State commercial salmon fishing period.
(viii) In Subdistrict 4A after the opening of the State commercial salmon fishing season, you may not take salmon for subsistence for 12 hours immediately before, during, and for 12 hours after each State commercial salmon fishing period; however, you may take Chinook salmon during the State commercial fishing season, with drift gillnet gear only, from 6 p.m. Sunday until 6 p.m. Tuesday and from 6 p.m. Wednesday until 6 p.m. Friday.
(ix) You may not subsistence fish for salmon in the following drainages located north of the main Yukon River:
(A) Kanuti River upstream from a point 5 miles downstream of the State highway crossing;
(B) Bonanza Creek;
(C) Jim River including Prospect and Douglas Creeks.
(x) You may not subsistence fish in the Delta River.
(xi) In Beaver Creek downstream from the confluence of Moose Creek, a gillnet with mesh size not to exceed 3 inches stretch-measure may be used from June 15 through September 15. You may subsistence fish for all non-salmon species but may not target salmon during this time period (retention of salmon taken incidentally to non-salmon directed fisheries is allowed). From the mouth of Nome Creek downstream to the confluence of Moose Creek, only rod and reel may be used.
(xii) You may take salmon only by gillnet, beach seine, dip net, fish wheel, or rod and reel, subject to the restrictions set forth in this section.
(A) In the Yukon River drainage, you may not take salmon for subsistence fishing using gillnets with stretched mesh larger than 7.5 inches.
(B) In Subdistrict 5D, you may take salmon once the mid-range of the Canadian interim management escapement goal and the total allowable catch goal are projected to be achieved.
(C) Salmon may be harvested by dip net at any time, except during times of conservation when the Federal in-season manager may announce restrictions on time, areas, and species.
(xiii) In District 4, if you are a commercial fisherman, you may not take salmon for subsistence purposes during the State commercial salmon fishing season using gillnets with stretched-mesh larger than 6 inches after a date specified by ADF&G emergency order issued between July 10 and July 31.
(xiv) In Districts 5 and 6, you may not take salmon for subsistence purposes by drift gillnets.
(xv) In District 4, salmon may be taken by drift gillnet not more than 150 feet in length unless restricted by special action or as modified by regulations in this section.
(xvi) Unless otherwise specified in this section, you may take fish other than salmon by set gillnet, drift gillnet, beach seine, fish wheel, long line, fyke net, dip net, jigging gear, spear, lead, or rod and reel, subject to the following restrictions, which also apply to subsistence salmon fishing:
(A) During the open weekly fishing periods of the State commercial salmon fishing season, if you are a commercial fisherman, you may not operate more than one type of gear at a time, for commercial, personal use, and subsistence purposes.
(B) You may not use an aggregate length of set gillnet in excess of 150 fathoms, and each drift gillnet may not exceed 50 fathoms in length.
(C) In Districts 4, 5, and 6, you may not set subsistence fishing gear within 200 feet of other fishing gear operating for commercial, personal, or subsistence use except that, at the site approximately 1 mile upstream from Ruby on the south bank of the Yukon River between ADF&G regulatory markers containing the area known locally as the “Slide,” you may set subsistence fishing gear within 200 feet of other operating commercial or subsistence fishing gear, and in District 4, from Old Paradise Village upstream to a point 4 miles upstream from Anvik, there is no minimum distance requirement between fish wheels.
(D) During the State commercial salmon fishing season, within the Yukon River and the Tanana River below the confluence of the Wood River, you may use drift gillnets and fish wheels only during open subsistence salmon fishing periods.
(E) In Birch Creek, gillnet mesh size may not exceed 3 inches stretch-measure from June 15 through September 15.
(F) In Racetrack Slough on the Koyukuk River and in the sloughs of the Huslia River drainage, from when each river is free of ice through June 15, the offshore end of the set gillnet may not be closer than 20 feet from the opposite bank except that sloughs 40 feet or less in width may have 3/4-width coverage with set gillnet, unless closed by Federal special action.
(G) In the Jim River drainage, including Prospect and Douglas Creeks, you may harvest fish other than salmon with rod and reel only; the grayling harvest and possession limit is 10 per day.
(xvii) In District 4, from September 21 through May 15, you may use jigging gear from shore ice.
(xviii) You must possess a subsistence fishing permit for the following locations:
(A) For the Yukon River drainage from the mouth of Hess Creek to the mouth of the Dall River;
(B) For the Yukon River drainage from the upstream mouth of 22 Mile Slough to the U.S.-Canada border;
(C) Only for salmon in the Tanana River drainage above the mouth of the Wood River.
(xix) Only one subsistence fishing permit will be issued to each household per year.
(xx) In Districts 1, 2, and 3, from June 1 through July 15, if ADF&G has announced that Chinook salmon can be sold in the commercial fisheries, you may not possess Chinook salmon taken for subsistence purposes unless both tips (lobes) of the tail fin have been removed before the person conceals the salmon from plain view or transfers the salmon from the fishing site.
(xxi) In the Yukon River drainage, Chinook salmon must be used primarily for human consumption and may not be targeted for dog food. Dried Chinook salmon may not be used for dog food anywhere in the Yukon River drainage. Whole fish unfit for human consumption (due to disease, deterioration, and deformities), scraps, and small fish (16 inches or less) may be fed to dogs. Also, whole Chinook salmon caught incidentally during a subsistence chum salmon fishery in the following time periods and locations may be fed to dogs:
(A) After July 10 in the Koyukuk River drainage;
(B) After August 10, in Subdistrict 5D, upstream of Circle City.
(6)
(i) You may take fish other than salmon, rainbow/steelhead trout, or char at any time unless restricted under the terms of a subsistence fishing permit. If you take rainbow/steelhead trout incidentally in other subsistence net fisheries, you may retain them for subsistence purposes.
(ii) In the Unalaska District, you may take salmon for subsistence purposes from 6 a.m. until 9 p.m. from January 1 through December 31, except as may be specified on a subsistence fishing permit.
(iii) In the Adak, Akutan, Atka-Amlia, and Umnak Districts, you may take salmon at any time.
(iv) You may not subsistence fish for salmon in the following waters:
(A) The waters of Unalaska Lake, its tributaries and outlet stream;
(B) The waters of Summers and Morris Lakes and their tributaries and outlet streams;
(C) All streams supporting anadromous fish runs that flow into Unalaska Bay south of a line from the northern tip of Cape Cheerful to the northern tip of Kalekta Point; and
(D) Waters of McLees Lake and its tributaries and outlet stream.
(v) You may take salmon by seine and gillnet, or with gear specified on a subsistence fishing permit.
(vi) In the Unalaska District, if you fish with a net, you must be physically present at the net at all times when the net is being used.
(vii) You may take fish other than salmon by gear listed in this part unless restricted under the terms of a subsistence fishing permit.
(viii) You may take salmon, trout, and char only under the terms of a
(ix) You may take no more than 250 salmon for subsistence purposes unless otherwise specified on the subsistence fishing permit, except that in the Unalaska and Adak Districts, you may take no more than 25 salmon plus an additional 25 salmon for each member of your household listed on the permit. You may obtain an additional permit.
(x) You must keep a record on the reverse side of the permit of subsistence-caught fish. You must complete the record immediately upon taking subsistence-caught fish and must return it no later than October 31.
(7)
(i) You may take fish, other than salmon, rainbow/steelhead trout, or char, at any time unless restricted under the terms of a subsistence fishing permit. If you take rainbow/steelhead trout incidentally in other subsistence net fisheries or through the ice, you may retain them for subsistence purposes.
(ii) You may take salmon, trout, and char only under the authority of a subsistence fishing permit.
(iii) You must keep a record on the reverse side of the permit of subsistence-caught fish. You must complete the record immediately upon taking subsistence-caught fish and must return it no later than October 31.
(iv) You may take salmon at any time, except in those districts and sections open to commercial salmon fishing where salmon may not be taken during the 24 hours before and 12 hours following each State open weekly commercial salmon fishing period, or as may be specified on a subsistence fishing permit.
(v) You may take salmon by seine, gillnet, rod and reel, or with gear specified on a subsistence fishing permit. You may also take salmon without a permit by snagging (by handline or rod and reel), using a spear, bow and arrow, or capturing by bare hand.
(vi) You may take fish other than salmon by gear listed in this part unless restricted under the terms of a subsistence fishing permit.
(vii) You may not use a set gillnet exceeding 100 fathoms in length.
(viii) You may take no more than 250 salmon for subsistence purposes unless otherwise specified on your subsistence fishing permit.
(9)
(i) You may take fish other than salmon, rainbow/steelhead trout, char, bottomfish, or herring at any time unless restricted by the terms of a subsistence fishing permit. If you take rainbow/steelhead trout incidentally in other subsistence net fisheries, you may retain them for subsistence purposes.
(ii) You may take salmon for subsistence purposes 24 hours a day from January 1 through December 31, with the following exceptions:
(A) From June 1 through September 15, you may not use salmon seine vessels to take subsistence salmon for 24 hours before or during, and for 24 hours after, any State open commercial salmon fishing period. The use of skiffs from any type of vessel is allowed.
(B) From June 1 through September 15, you may use purse seine vessels to take salmon only with gillnets, and you may have no other type of salmon gear on board the vessel.
(iii) You may subsistence fish for salmon with rod and reel only in the following locations:
(A) Womens Bay—All waters inside a line from the tip of the Nyman Peninsula (57°43.23′ North latitude, 152°31.51′ West longitude), to the northeastern tip of Mary's Island (57°42.40′ North latitude, 152°32.00′ West longitude), to the southeastern shore of Womens Bay at 57°41.95′ North latitude, 152°31.50′ West longitude.
(B) Buskin River marine waters—All waters inside of a line running from a marker on the bluff north of the mouth of the Buskin River at approximately 57°45.80′ North latitude, 152°28.38′ West longitude, to a point offshore at 57°45.35′ North latitude, 152°28.15′ West longitude, to a marker located onshore south of the river mouth at approximately 57°45.15′ North latitude, 152°28.65′ West longitude.
(iv) You must have a subsistence fishing permit for taking salmon, trout, and char for subsistence purposes. You must have a subsistence fishing permit for taking herring and bottomfish for subsistence purposes during the State commercial herring sac roe season from April 15 through June 30.
(v) The annual limit for a subsistence salmon fishing permit holder is as follows:
(A) In the road-accessible Zone (Northeastern Kodiak Island), east of the line from Crag Point south to the westernmost point of Saltery Cove, including the inland waters of Spruce, Woody and Long Islands, and the Federal marine waters of and around Womens Bay, 25 salmon for the permit holder plus an additional 25 salmon for each member of the same household whose names are listed on the permit: an additional permit may be obtained upon request.
(B) In the remainder of the Kodiak Area not described in paragraphs (e)(9)(iii)(A) and (e)(9)(v)(A) of this section, there is no annual harvest limit for a subsistence salmon fishing permit holder.
(vi) You must record on your subsistence permit the number of subsistence fish taken. You must record all harvested fish prior to leaving the fishing site and must return the permit by the due date marked on the permit.
(vii) You may take fish other than salmon by gear listed in this part unless restricted under the terms of a subsistence fishing permit.
(viii) You may take salmon only by gillnet, rod and reel, or seine.
(ix) You must be physically present at the net when the net is being fished.
(13)
(i) Unless restricted in this section or under the terms of a subsistence fishing
(ii) You must possess a subsistence fishing permit to take salmon, trout, grayling, or char. You must possess a subsistence fishing permit to take eulachon from any freshwater stream flowing into fishing District 1.
(iii) In the Southeastern Alaska Area, a rainbow trout is defined as a fish of the species
(iv) In areas where use of rod and reel is allowed, you may use an artificial fly, lure, or bait when fishing with rod and reel, unless restricted by Federal permit. If you use bait, you must retain all federally regulated fish species caught, and they apply to your applicable daily, seasonal, and annual harvest limits for that species.
(A) For streams with steelhead, once your daily, seasonal, or annual limit of steelhead is harvested, you may no longer fish with bait for any species.
(B) Unless otherwise specified in this paragraph (e)(13), allowable gear for salmon or steelhead is restricted to gaffs, spears, gillnets, seines, dip nets, cast nets, handlines, or rod and reel.
(v) Unless otherwise specified in this paragraph (e)(13), you may use a handline for snagging salmon or steelhead.
(vi) You may fish with a rod and reel within 300 feet of a fish ladder unless the site is otherwise posted by the USDA Forest Service. You may not fish from, on, or in a fish ladder.
(vii) You may not accumulate Federal subsistence harvest limits authorized for the Southeastern Alaska Area with any harvest limits authorized under any State of Alaska fishery with the following exception: Annual or seasonal Federal subsistence harvest limits may be accumulated with State sport fishing harvest limits provided that accumulation of harvest limits does not occur during the same day.
(viii) If you take salmon, trout, or char incidentally with gear operated under terms of a subsistence permit for other salmon, they may be kept for subsistence purposes. You must report any salmon, trout, or char taken in this manner on your subsistence fishing permit.
(ix) Nets are prohibited in streams flowing across or adjacent to the roads on Wrangell and Mitkof Islands, and in streams flowing across or adjacent to the road systems connected to the community of Sitka.
(x) You may not possess subsistence-taken and sport-taken fish of a given species on the same day.
(xi) If a harvest limit is not otherwise listed for sockeye in this paragraph (e)(13), the harvest limit for sockeye salmon is the same as provided for in adjacent State subsistence or personal use fisheries. If a harvest limit is not established for the State subsistence or personal use fisheries, the possession limit is 10 sockeye and the annual harvest limit is 20 sockeye per household for that stream.
(xii) The Sarkar River system above the bridge is closed to the use of all nets by both federally qualified and non-federally qualified users.
(xiii) You may take Chinook, sockeye, and coho salmon in the mainstem of the Stikine River only under the authority of a Federal subsistence fishing permit. Each Stikine River permit will be issued to a household. Only dip nets, spears, gaffs, rod and reel, beach seine, or gillnets not exceeding 15 fathoms in length may be used. The maximum gillnet stretched mesh size is 8 inches during the Chinook salmon season and 5
(A) You may take Chinook salmon from May 15 through June 20. The annual limit is five Chinook salmon per household.
(B) You may take sockeye salmon from June 21 through July 31. The annual limit is 40 sockeye salmon per household.
(C) You may take coho salmon from August 1 through October 1. The annual limit is 20 coho salmon per household.
(D) You may retain other salmon taken incidentally by gear operated under terms of this permit. The incidentally taken salmon must be reported on your permit calendar.
(E) Fishing nets must be checked at least twice each day.
(xiv) You may take coho salmon with a Federal salmon fishing permit. There is no closed season. The daily harvest limit is 20 coho salmon per household. Only dip nets, spears, gaffs, handlines, and rod and reel may be used. There are specific rules to harvest any salmon on the Stikine River, and you must have a separate Stikine River subsistence salmon fishing permit to take salmon on the Stikine River.
(xv) Unless noted on a Federal subsistence harvest permit, there are no harvest limits for pink or chum salmon.
(xvi) Unless otherwise specified in this paragraph (e)(13), you may take steelhead under the terms of a subsistence fishing permit. The open season is January 1 through May 31. The daily household harvest and possession limit is one with an annual household limit of two. You may use only a dip net, gaff, handline, spear, or rod and reel. The permit conditions and systems to receive special protection will be determined by the local Federal fisheries manager in consultation with ADF&G.
(xvii) You may take steelhead trout on Prince of Wales and Kosciusko Islands under the terms of Federal subsistence fishing permits. You must obtain a separate permit for the winter and spring seasons.
(A) The winter season is December 1 through the last day of February, with a harvest limit of two fish per household; however, only one steelhead may be harvested by a household from a particular drainage. You may use only a dip net, handline, spear, or rod and reel. You must return your winter season permit within 15 days of the close of the season and before receiving another permit for a Prince of Wales/Kosciusko steelhead subsistence fishery. The permit conditions and systems to receive special protection will be determined by the local Federal fisheries manager in consultation with ADF&G.
(B) The spring season is March 1 through May 31, with a harvest limit of five fish per household; however, only two steelhead may be harvested by a household from a particular drainage. You may use only a dip net, handline, spear, or rod and reel. You must return your spring season permit within 15 days of the close of the season and before receiving another permit for a Prince of Wales/Kosciusko steelhead subsistence fishery. The permit conditions and systems to receive special protection will be determined by the local Federal fisheries manager in consultation with ADF&G.
(xviii) In addition to the requirement for a Federal subsistence fishing permit, the following restrictions for the harvest of Dolly Varden, brook trout, grayling, cutthroat trout, and rainbow trout apply:
(A) The daily household harvest and possession limit is 20 Dolly Varden; there is no closed season or size limit.
(B) The daily household harvest and possession limit is 20 brook trout; there is no closed season or size limit.
(C) The daily household harvest and possession limit is 20 grayling; there is no closed season or size limit.
(D) The daily household harvest limit is 6 and the household possession limit is 12 cutthroat or rainbow trout in combination; there is no closed season or size limit.
(E) You may use only a rod and reel.
(F) The permit conditions and systems to receive special protection will be determined by the local Federal fisheries manager in consultation with ADF&G.
(xix) The Klawock River drainage is closed to the use of seines and gillnets during July and August.
(xx) The Federal public waters in the Makhnati Island area, as defined in § __.3(b)(5) are closed to the harvest of herring and herring spawn, except by federally qualified users.
(xxi) Only federally qualified subsistence users may harvest sockeye salmon in Neva Lake, Neva Creek, and South Creek.
(xxii) The Federal public waters of Kah Sheets Creek are closed from July 1 to July 31, except by federally qualified users.
Environmental Protection Agency (EPA).
Final rule.
Pursuant to provisions specified by the Clean Air Act (CAA), the Governors of Illinois, Iowa, Minnesota, Missouri, Nebraska, Ohio, South Dakota, and Wisconsin submitted petitions requesting that EPA remove the 1-pound per square inch (psi) Reid vapor pressure (RVP) waiver for summer gasoline-ethanol blended fuels containing 10 percent ethanol (E10). EPA is acting on those petitions by removing the 1-psi waiver in those States effective April 28, 2025. This action also finalizes regulatory amendments to implement the removal of the 1-psi waiver for E10 in those States, as well as a regulatory process by which a State may request to reinstate the 1-psi waiver. Finally, consistent with a decision issued by the United States Court of Appeals for the D.C. Circuit on July 2, 2021, this action removes regulations that extended the 1-psi waiver to gasoline-ethanol blends between 10 and 15 percent ethanol (E15).
This rule is effective on April 29, 2024.
EPA has established a docket for this action under Docket ID No. EPA-HQ-OAR-2022-0513. All documents in the docket are listed on the
For questions regarding this action, contact Lauren Michaels, Office of Transportation and Air Quality, Compliance Division, Environmental Protection Agency, 2000 Traverwood Drive, Ann Arbor, MI 48105; telephone number: (734) 214-4640; email address:
Entities potentially affected by this final rule are those involved with the production, distribution, and sale of transportation fuels, including gasoline and diesel fuel. Potentially affected categories include:
This table is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. This table lists the types of entities that EPA is now aware could potentially be affected by this action. Other types of entities not listed in the table could also be affected. To determine whether your entity would be affected by this action, you should carefully examine the applicability criteria in 40 CFR part 1090. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed in the
In this action, EPA is responding to petitions from eight State Governors to remove the 1-psi (pound per square inch) waiver for gasoline-ethanol blends containing 10 percent ethanol (E10). The Governors made their requests pursuant to Clean Air Act (CAA) section 211(h)(5), which provides that EPA shall remove the 1-psi waiver by regulation upon a demonstration by a Governor that the 1-psi waiver increases emissions in their State.
After review of the modeling results presented by the Governors in their petitions, on March 6, 2023, EPA proposed to remove the 1-psi waiver with an effective date of April 28, 2024—and sought comment on delaying the effective date to April 28, 2025—in the following eight States: Illinois, Iowa, Nebraska, Minnesota, Missouri, Ohio, South Dakota, and Wisconsin.
Throughout this document we discuss key comments provided by stakeholders on the proposal and provide our response. Additional detail is provided in the Response to Comments (RTC) document and Technical Support Document (TSD)
EPA first took regulatory action to control the volatility of gasoline in 1987.
At the time the provision was enacted, the 1-psi waiver applied to a relatively small portion of the gasoline sold in the United States. Today, however, almost all gasoline sold is E10, and thus the 1-psi waiver increases the volatility of most gasoline.
On April 28, 2022, the Governors of Illinois, Iowa, Kansas, Minnesota, Nebraska, North Dakota, South Dakota, and Wisconsin submitted a petition for the removal of the 1-psi waiver for E10 in their States beginning in the summer of 2023, pursuant to CAA section 211(h)(5).
This rulemaking modifies EPA's fuel quality regulations in 40 CFR part 1090 to remove the 1-psi waiver that is applicable to fuel blends containing gasoline and 10 percent ethanol for the petitioning States. While we proposed to make such a change effective for the summer of 2024, after further careful consideration of comments and consultation with various agencies we are instead finalizing removal of the 1-psi waiver in these States beginning April 28, 2025.
CAA section 211(h)(1) requires EPA to “promulgate regulations making it unlawful . . . during the high ozone season . . . to sell . . . or introduce into commerce gasoline with a Reid Vapor Pressure in excess of 9.0 pounds per square inch (psi).” For nonattainment areas, CAA section 211(h)(1) also allows EPA to set a lower (
Prior to the April 28, 2022 petition, no Governor had ever submitted a petition under CAA section 211(h)(5) to EPA, and thus we are interpreting this statutory provision for the first time in this action. In this context, we find that the use of the prescriptive statutory language “shall” provides limited, if any, discretion for EPA to consider other issues such as economic impacts of removing the 1-psi waiver. Such impacts may instead be taken into consideration by a Governor when deciding whether to submit a petition to EPA.
In response to the proposal, we received comments suggesting that the Governors cannot meet the statutory criteria in CAA section 211(h)(5) because E10 is now the dominant fuel in the marketplace. Commenters suggested that the statutory language that the 1-psi waiver “will increase emissions” cannot be satisfied, because any emissions impacts from the 1-psi waiver have already occurred. We disagree with the comment. CAA section 211(h)(5)(A)—which was promulgated in 2005—requires EPA to remove the 1-psi waiver if it “will increase emissions that contribute to air pollution . . . during the high ozone season.” The term “will” connotes consideration of emissions that are expected in the future and as relevant here during the “high ozone season.”
Additionally, as we posited in the proposal, we do not interpret this provision as requiring a demonstration of a reduction in emissions of all pollutants that contribute to air pollution in the petitioning States, as advocated for by some commenters. Such a demonstration could not have been contemplated by Congress, as lowering the volatility of fuel was specifically the intent set out in CAA section 211(h)(1), which calls for EPA to set RVP standards to address “evaporative emissions.” As such, reducing the volatility of gasoline would be expected to have differing impacts on emissions of different pollutants.
Further, EPA views the Motor Vehicle Emissions Simulator (MOVES) as an appropriate tool for use in modeling the emission impacts required by CAA section 211(h)(5). The MOVES runs performed by the petitioning States compared emissions from motor vehicles and nonroad vehicles and equipment with and without the 1-psi waiver for E10 in each State in the summer. In the past, similar analyses have been used to support prior EPA actions for Federal and State fuel programs.
During the fall of 2021, EPA received several letters from States requesting that EPA engage in a dialogue about mechanisms to provide parity between E10 and E15 with respect to gasoline volatility standards.
On April 28, 2022, the Governors of Illinois, Iowa, Kansas, Minnesota, Nebraska, North Dakota, South Dakota, and Wisconsin submitted a joint petition to EPA for the removal of the 1-psi waiver for E10 in their respective States. The petition specifically requested the removal of the 1-psi waiver for E10 as a permanent solution for providing year-round E15 in those States beginning in the summer of 2023. As accompanying documentation, the petition provided quantified reductions in VOC, NO
On June 10, 2022, the Governor of Ohio also submitted a petition requesting the removal of the 1-psi waiver for E10 beginning in the summer of 2023. The petition provided quantified reductions in VOC, NO
On December 21, 2022, the Governor of Missouri also submitted a petition requesting the removal of the 1-psi waiver for E10 beginning in the summer of 2023. The petition provided quantified reductions in VOC, NO
Subsequent to submission of the petitions, all petitioning States except Missouri provided EPA with additional emissions modeling documentation, including for particulate matter (PM) and benzene.
All the petitioning States requested removal of the 1-psi waiver in all areas within their State where the limitation under CAA section 211(h)(4) applies. Therefore, the requests did not include areas within the States where RFG is required because the 1-psi waiver does not apply to RFG. The petitioning States also requested that the removal of the 1-psi waiver should take effect for the 2023 high ozone season, without further discussion. The States noted that rescinding the 1-psi waiver for E10 would support year-round sales of E15.
The petitioning States provided technical documentation with their petitions to demonstrate the reduction of emissions with the removal of the 1-psi waiver as required by CAA section 211(h)(5) in the form of MOVES modeling results.
As with the proposal, we have assessed the supporting documentation provided by the petitioning States and find that the MOVES modeling results submitted to EPA demonstrate a reduction in emissions of multiple pollutants (
Therefore, based on the Governors' petitions and the supporting documentation provided, we are removing the 1-psi waiver for E10 sold in the petitioning States and, as required by CAA section 211(h)(5), promulgating the 9.0 psi RVP standard contained in CAA section 211(h)(1) for the petitioning States. For the reasons discussed in Section VIII., such a change will be effective on April 28, 2025, given our determination of insufficient supply in 2023 and the renewal of that extension for one year based on a determination of insufficient supply in 2024.
In this section, we discuss the potential impacts of removing the 1-psi waiver in the petitioning States on the fuel production and distribution system, including impacts that would potentially affect gasoline refineries, pipelines, fuel terminals, retail outlets, and, ultimately, consumers.
In short, this action will require a lower-volatility conventional gasoline before oxygenate blending (CBOB)
We first note that volatility controls for gasoline differ across various States and regions within States. Summer gasoline for use in the continental U.S. must comply with either the Federal RVP standard of 9.0 psi or the more stringent RVP standard of 7.8 psi, unless the summer gasoline is either for use in an RFG covered area, is subject to California's gasoline regulations, or EPA has waived preemption and approved a State request to adopt a more stringent RVP standard into a State Implementation Plan (SIP). Most of the U.S. utilizes “conventional gasoline,” for which the Federal RVP standard is 9.0 psi, with a 1.0 psi waiver for gasoline blended with 10 percent ethanol. There are also areas that utilize conventional gasoline for which the Federal RVP standard is 7.8 psi, and in such regions, the 1.0 psi waiver also applies for gasoline blended with 10 percent ethanol.
Before discussing the various steps required to produce and distribute the new lower-volatility gasoline,
To minimize other impacts and enable production and distribution of low-RVP gasoline, refiners and fuel distributors will need time to make capital investments to optimize the fuel production and distribution system to replace the gasoline solely in the petitioning States with low-RVP gasoline. Without capital investments, which can take two years or more to complete, the limited availability of additional storage tanks for the new low-RVP gasoline grades—particularly at pipeline breakout tank locations, but also at refineries and downstream terminals—may result in low-RVP gasoline being sold within both the petitioning States and the immediately adjacent non-petitioning States. This would increase the volume of low-RVP gasoline needed to be produced and distributed to satisfy demand. Over time, we expect refiners and fuel distributors to invest in and optimize the fuel production and distribution system to more efficiently target low-RVP gasoline solely to the petitioning States.
Refiners will need to make modifications to their refinery operations to supply low-RVP gasoline. There are 11 petroleum refineries located within the petitioning States; that number increases to 40 when refineries located in States that border the petitioning States are included. Further, additional refineries outside of the immediate region may also modify their operations to provide low-RVP gasoline, as some of the gasoline supply for the petitioning States also historically comes from refineries located further west, east, and south, such as refineries in the Gulf Coast.
Throughout the year, refineries must adjust the volatility of their gasoline—typically lowering the volatility of the gasoline in the summer and increasing the volatility in the winter by adjusting the quantity of light hydrocarbons in their gasoline. Refineries typically control gasoline volatility by adjusting the amount of butane in gasoline, but sometimes they need to also modify the amount of pentane or natural gas liquids (NGLs). Refineries providing fuel to the petitioning States will have to modify their summer gasoline production operations and potentially add capital equipment to accommodate the 9.0 psi RVP standard. A refinery's ability to adapt to the 9.0 psi RVP standard and the time that it takes to do so depends on the refinery's structure, operations, and the mix of crude oil types that it processes.
In addition to contributing to gasoline's volatility, butane also contributes to gasoline's octane and volume. Thus, when removing butane, refineries must also make other changes to replace the lost octane to keep the gasoline consistent and in compliance with EPA regulations and industry specifications. Refineries could produce more alkylate or reformate, which are two high octane gasoline blendstocks, to make up the lost octane. We estimate that the amount of butane that would have to be removed to produce a gasoline 1-psi lower in RVP amounts to about two volume percent of the volume of gasoline. However, comments from the refining industry described how at least some refineries would need to not only remove butane, but some less-volatile hydrocarbons as well (
Regardless of how a refinery is modified to reduce the RVP of its gasoline, it will result in additional output of the removed butane or other light hydrocarbons. If excess onsite butane storage capacity is available, the refinery has the option of saving excess butane on-site for use in winter gasoline production, which would minimize the cost impact of producing low-RVP CBOB. However, if excess butane storage is not available, the refinery would then need to store it offsite (
Given the high demand for gasoline in the summer months, refineries often begin producing summer gasoline for storage well ahead of the upcoming high ozone season. This process can begin as early as December of the year prior to the applicable high ozone season, and thus storage of a differing volatility of fuel could impact the refinery's ability to utilize the fuel the next summer without further modification.
As discussed above, removal of the 1-psi waiver will require refineries that distribute gasoline to the petitioning States to produce low-RVP CBOB. There are three primary groups within the distribution chain that will be impacted: refineries, pipelines (with their breakout terminals), and downstream product terminals.
Most refineries have an onsite terminal with numerous product storage tanks wherein they accumulate and store the range of products that they produce prior to placing the products into the distribution system. Once a refinery accumulates a sufficient volume of a gasoline type and confirms that it meets the applicable gasoline specifications, the refinery then schedules the shipment of that batch of gasoline to downstream markets. Shipment can occur via an onsite product terminal analogous to that discussed in Section V.B.3 where trucks load product and deliver to retail outlets. However, most gasoline produced by refineries is loaded onto product pipelines for delivery to downstream product terminals. In some cases, refineries also distribute product by rail or barge. For those refineries that distribute most or all of their gasoline to the petitioning States, removal of the 1-psi waiver will have little impact on their distribution operations. They can switch over their existing product tanks to hold only low-RVP CBOB. Instead of transitioning from winter CBOB RVP levels (up to 15 psi) to a 9.0 psi RVP CBOB in the summer, they would instead transition to low-RVP CBOB. However, refineries that produce gasoline for both petitioning and non-petitioning States will likely need additional tanks, pipes, manifolds, and control systems to store the additional grades of gasoline. The time needed to plan, design, permit, and construct additional tankage is typically on the order of two or more years. Until this can be accomplished, a refinery that lacks the additional tankage will likely need to shift all its production to low-RVP CBOB. However, this can be avoided if unused systems already exist or other products are discontinued.
For those refineries that have excess tankage or invest in new tankage to allow the production of both 9.0 psi and low-RVP CBOB, they would also need to adjust their operations and schedules for loading gasoline blendstock onto pipelines, barges, or rail to split their production into separate product streams. These logistical changes would initially take some period of time in order to occur smoothly and safely, but should streamline over time.
Most fuel in the U.S. flows from refineries to consumer markets via pipeline systems. As described in the TSD, there are several pipeline systems serving the petitioning States, the vast majority of which serve both petitioning and non-petitioning States. Consequently, the addition of the low-RVP CBOB in the petitioning States will require significant changes in the operations of the pipeline systems. What is currently one large conventional fuel market distributing primarily 9.0 psi RVP CBOB will also need to distribute the new low-RVP CBOB. There will thus be a period where the pipeline systems go through a planning and optimization process to assess what gasoline type must be supplied to the pipeline to comply with the new fuel requirement. If a pipeline primarily serving the petitioning States is only equipped with breakout tanks compatible with a single gasoline type, the pipeline company will likely mandate that refiners solely provide that gasoline type. Decisions from refineries on whether they will supply low-RVP CBOB, and at what volumes, will be necessary to inform the planning and optimization process by pipeline systems. All of this can have impacts on gasoline supply not only to the petitioning States, but also to the surrounding States in the short term. Having the wrong fuel types in the wrong volume can result in an inability for the pipeline to move fuel in and out of tankage as needed, which, in turn, can result in significant supply disruption not only for the gasoline type in question, but also for all the fuels shipped on the pipeline. For the longer term, due to the market splitting into different types, some areas in the petitioning States may lose access to available markets of supply, which may then lead to more frequent shortfalls in supply during times of disruption (
Some pipeline companies operate a fungible distribution system. This allows them to collect a standard type of gasoline from refineries into their system, “transport” the barrels virtually, and draw out identical barrels at their destination. The barrels delivered are not actually the purchased barrels from the refinery, but rather the same product from a different refinery meeting the same product specifications. An additional type of gasoline would disrupt their ability to function as efficiently using the fungible system. This increases the complexity associated with ensuring products can be distributed to locations in the timeframe needed to ensure supply to the market.
The most significant impact on pipeline operations caused by the removal of the 1-psi waiver, however, will be on pipeline breakout tankage operations. Breakout tankage is required at junctions where pipelines connect with other pipelines that have differing schedules and flow rates. Thus, the pipelines typically need tankage to store every grade and type of product distributed on the pipeline, with the size and configuration of the tankage matched to the product and pipeline batch sizes. If new regular and premium grades of low-RVP CBOB need to be shipped on the pipeline, then it may require the addition of new tankage at these breakout tank facilities. The planning, permitting, and construction of such additional tankage would require two or more years and is likely to be an issue at many breakout tankage facilities both inside and outside the petitioning States. Until this additional breakout tankage can be brought into service, an impacted pipeline serving the petitioning States may be restricted to solely distributing either 9.0 psi or low-RVP CBOB, limiting gasoline supply to either the petitioning States or the surrounding States, and in turn restricting what the refineries shipping on the pipeline are able to produce if the pipeline restrictions do not allow for the distribution of a particular type of gasoline. Some pipelines may opt to carry one fuel type and some the other, limiting the product offerings at the various downstream product terminals. As with the refineries, it may be that due to tankage and logistical limitations, pipelines currently serving both petitioning and non-petitioning States will have to initially shift all the gasoline they carry to low-RVP CBOB, which is fungible in both markets. This will result in low-RVP CBOB being supplied in the surrounding States and additional reduction in supply of gasoline due to the necessary removal of butane and other light hydrocarbons. Pipelines would have the option to blend in butane during gasoline transport to the States with the 1-psi waiver that are located at the end of the pipeline systems (
The potential impact of the removal of the 1-psi waiver on product terminals varies depending on whether the terminals provide gasoline only to the petitioning States, or to non-petitioning States as well. Those terminals that only provide gasoline to the petitioning States will be little impacted, as they will simply take delivery of replacement grades of low-RVP CBOB beginning in the spring leading into the summer season. They will not have to contend with adding additional fuel grades and types and the tankage and logistics associated with them. This will most likely not be the case for terminals that serve areas both within and outside the petitioning States. If such terminals do not have sufficient onsite tankage capacity to handle the additional regular and premium grades of low-RVP CBOB, then they will need to either add the tankage or choose to serve one market or the other. The decision to serve a particular market or fuel type may also be dictated by a fuel marketer on the retail side. Both options could have gasoline supply, cost, and price impacts both within the petitioning States and in the surrounding areas the terminals serve. Approximately 75 such terminals are located close to the borders (
Regardless of whether a terminal serves only the petitioning States, or also non-petitioning States, all terminals will be impacted to some degree by a somewhat more challenging transition in the spring from winter to summer fuel due to the removal of the 1-psi waiver, particularly in the first year. While this transition occurs every year as the terminals blend down the volatility of the CBOB they have in storage from the higher RVP of winter CBOB to the lower RVP of summer CBOB, the change of having to blend down an additional 1.0 psi to accommodate low-RVP CBOB instead of 9.0 psi RVP CBOB will require some additional time and incur additional cost. In order to achieve the volatility of low-RVP CBOB, pipelines and terminals will likely need to blend down their winter CBOB with a summer CBOB that has an RVP as low as 6.0 psi during this transition period. Additionally, terminals will likely take steps to ensure their tanks are drained as low as possible prior to receiving a low-RVP CBOB to ensure the finished gasoline will comply with the 9.0 psi RVP standard, which could result in additional delays before the low-RVP CBOB begins moving to markets. This will likely occur more frequently at terminals located within and near the border of the petitioning States.
Moving gasoline to market also involves tank trucks that deliver the gasoline to retail outlets. For terminals located within the petitioning States, their operations should be little impacted by the removal of the 1-psi waiver; they will simply pick up a different type of gasoline from the product terminal than they did before and can transport it to market, even outside the petitioning States if the terminal normally covers the area. However, depending on the changes in product offering at the terminals, there may still be considerable stress on their operations. If some refineries, pipelines, or terminals limit their product offering to either 9.0 psi or low-RVP CBOB, especially in the near term, then the tank trucks would need to shift their operations accordingly. In some cases where there is a loss of fuel fungibility, this is expected to increase the distances traveled, which may in turn require the purchase of additional tank trucks and hiring of additional drivers. As with the rest of the fuel distribution system, this can all be accomplished, but will take some time for the market to respond and optimize around the new norms.
The removal of the 1-psi waiver and resulting transition from 10.0 psi RVP gasoline to 9.0 psi RVP gasoline received from the terminal should be minor for retail outlets—they will simply take delivery of the lower-volatility gasoline from the terminal. The most noticeable effects will be seen at retail outlets near the borders of States maintaining the 1-psi waiver, as the cost of 9.0 psi RVP gasoline within the petitioning States is likely to be higher than that of 10.0 psi RVP gasoline across the border in non-petitioning States. Retailers within the petitioning States may have to charge higher prices to recoup this cost, which could result in consumers preferentially choosing to refill at stations across the border when possible.
Under CAA section 211(h)(5)(C), the regulations removing the 1-psi waiver shall take effect on the later of: (1) The first day of the first high ozone season for the area that begins after the date of receipt of the notification; or (2) 1 year after the date of receipt of the notification. The high ozone season is defined in EPA's regulations as “June 1 through September 15 for retailers and [wholesale purchaser consumers (WPCs)], and May 1 through September 15 for all other persons,” which includes gasoline distribution terminals.
In applying this provision for the petition dated April 28, 2022, the later date is April 28, 2023. Therefore, the earliest date on which the removal of the 1-psi waiver for Illinois, Iowa, Nebraska, Minnesota, South Dakota, and Wisconsin could have been effective was April 28, 2023. This date would have been in advance of the high ozone season beginning May 1, 2023. For the petition from Ohio, dated June 10, 2022, the later date is June 10, 2023. This would have placed the effective date within the 2023 high ozone season (
Further, under CAA section 211(h)(5)(C), the effective date can be extended if EPA, on its own motion or on petition from any person, after consultation with the Secretary of Energy, determines there would be an insufficient supply of gasoline in a State that has requested the removal of the 1-psi waiver for E10.
As described above, EPA is allowed to extend the effective date of the removal of the 1-psi waiver upon a finding of “insufficient supply of gasoline in the [petitioning] state” that would result from “the promulgation of the regulations [to remove the 1-psi waiver].”
In considering the likelihood of supply disruptions, we look to the entire production and distribution chain, from the refineries where gasoline is produced, through distribution systems such as pipelines and trucking, and ultimately to the retail outlets. This reading is also similar to EPA's interpretation of other provisions in CAA section 211 that call for consideration of constraints on fuel supply when EPA is acting on petitions within the fuels program. For instance, CAA section 211(k)(6)(A)(ii) allows EPA, after consultation with the Department of Energy, to extend the effective date for a State that has petitioned to opt into the RFG program for a period that is up to one year from the date of receipt of the petition upon a finding of insufficient domestic capacity to produce RFG. A related provision in CAA section 211(k)(6)(B)(iii) allows EPA to extend the effective date for areas within the ozone transport region established under CAA section 184 that opt into RFG, upon a finding of insufficient capacity to supply RFG. Like the phrase “insufficient supply of gasoline” in CAA section 211(h)(5)(C), the statute does not define either “insufficient domestic capacity” or “insufficient capacity to supply RFG.” But in acting on petitions to opt into the RFG program, EPA has explained that setting the effective date allows EPA to consider any sudden and unexpected increases in the demand for RFG on the local supply and distribution system that is caused by an opt-in.
EPA's reading of “adequate supply” in CAA section 211(c)(4)(C)(ii) comports with our interpretation of CAA section 211(h)(5)(C) given that Congress intended for EPA to act in certain unique emergency circumstances to relieve supply disruptions within the “motor fuel distribution system.”
In contrast, the phrase “insufficient supply of gasoline” differs from other sub-provisions of CAA section 211 allowing for waivers of applicable requirements as well as implementation delays that use language such as “inadequate domestic supply.”
Finally, we note that consideration of the effective date for this action properly considers supply to the ultimate consumer given the statutory language “in the State.” Therefore, our analysis of “insufficient supply of gasoline” properly considers all stages of the gasoline production and distribution system, from the refinery to the retail outlet.
CAA section 211(h)(5)(C)(ii)(I) requires a determination of insufficient supply of gasoline in order to extend the effective date of the removal of the 1-psi waiver. We determined that a 2023 implementation date would result in insufficient supply of gasoline and proposed an effective date of April 28, 2024, for removal of the 1-psi waiver in all petitioning States.
Further, in response to and after the proposal, we received petitions from numerous stakeholders requesting a delay of the proposed effective date until either 2025 or 2026. These stakeholders posited that the extension of the effective date would be supported by the Administrator's finding of insufficient supply of gasoline pursuant to CAA section 211(h)(5)(C)(ii)(I).
At proposal, we provided the rationale for our determination of insufficient supply for 2023; we assessed the following three supply constraints: (1) Low gasoline inventories; (2) The limited time available for coordination between various parties to make the necessary physical changes to the gasoline production and distribution infrastructure; and (3) The physical loss of supply necessary to produce low-RVP CBOB. We determined that these constraints would likely have led to supply disruptions in the petitioning States in 2023.
We have now assessed gasoline supply impacts associated with an effective date in 2024 and updated our analyses of these supply constraints.
Since proposal, we have conducted an updated analysis to quantify the reduction in gasoline supply that would result from the removal of the 1-psi waiver. At proposal, we estimated the reduction in supply as 20 thousand barrels per day (kbpd) based on the removal of light hydrocarbons—mostly butane—to reduce the volatility of CBOB.
Further, at proposal we noted that while the gasoline inventories in PADD 2 (the affected region) was low, we believed that it would likely return closer to historic levels due to the previously shut-down Midwest refineries returning to operation. However, even though these refineries have since come back online—increasing gasoline production in the region—the gasoline inventories in PADD 2
As also described in Section V and the TSD, capital investments will be necessary for some refiners and fuel distributors to accommodate a transition to low-RVP CBOB in the petitioning States. This includes investments for the storage of additional gasoline types and grades, storage of excess butane and LSR, and associated measures for piping, pumping, and spill containment. We also anticipate that refineries would need to debottleneck debutanizers and octane-producing units to enable the production of low-RVP CBOB.
In addition, supplying the new low-RVP CBOB will require coordinated investments, planning, and actions between refineries, pipelines and other fuel distribution companies, terminals, and retail outlets. Typically, this coordination occurs before winter to provide the fuel production and distribution system a chance to make the proper preparations; we are now past the point in the calendar when such coordination typically occurs. We are also entering into the timeframe when most refineries have already started producing summer gasoline. As such, refineries will not have sufficient and appropriate notice to begin modifying their fuel supply for the summer of 2024.
Finally, we assumed at proposal that flexibility within the fuel production and distribution system could allow refiners and fuel distributors to mitigate the projected 2024 summer season supply reduction until such time as capital and physical changes could be completed. However, based on subsequent comment and analysis, we now believe that the existing flexibility would not be sufficient, particularly in light of the larger anticipated supply reduction and lingering low gasoline inventories in PADD 2.
For the above-mentioned reasons, supported by additional detail and analysis in the TSD, we are making a determination that there will be an insufficient supply of gasoline in the petitioning States in the 2024 summer season and, therefore, are renewing the extension of the effective date of the removal of the 1-psi waiver by an additional year to April 28, 2025.
There are associated costs with the changes to the refining and gasoline distribution systems described in Sections V and VI. Part of the costs will be incurred by the refining sector, while another portion will be incurred by the gasoline distribution system. Gasoline refining costs will increase due to several factors, the largest portion of which is the lost opportunity cost for refiners having to sell the removed light hydrocarbon material at lower market prices instead of blending this material into high value summer gasoline. To the extent that refiners and distributers install capital equipment, there are also additional capital and associated operating costs that will need to be recouped over time. These costs will be passed along to consumers in the petitioning and surrounding States in the form of higher gasoline prices.
With respect to consumer fuel prices, while fuel prices generally reflect fuel costs in the competitive gasoline market, this may not be the case when removal of the 1-psi waiver is first implemented, as gasoline supply will be reduced and not yet recovered. Due to the reduced supply, there will likely be a reduction in PADD 2 gasoline inventories, which could further increase gasoline prices. Due to the challenges that some refiners may have in producing low-RVP CBOB and the associated impacts on gasoline inventories, fuel prices will likely exceed fuel costs because the marginal cost producer will set the fuel price. This will likely affect gasoline prices in both petitioning and non-petitioning States and result in higher gasoline prices at the pump for consumers. The potential cost and price impacts due to the removal of the 1-psi waiver are discussed in more detail in the TSD.
As discussed above, under the relevant CAA provisions, upon receiving a petition from a State Governor that is accompanied by a successful demonstration of emissions increases as a result of the 1-psi waiver, EPA is required to remove the 1-psi waiver in the areas requested by the Governor. In deciding whether to grant the petition, the statute does not provide EPA with the authority to consider fuel cost or price impacts and we assume that any fuel cost or price impacts to consumers were taken into consideration by the Governors of the petitioning States in submitting their petitions. Therefore, regardless of the magnitude of the impact of this action on fuel costs or prices, EPA has not considered them in this action.
In the NPRM, we proposed changes to the fuel quality regulations at 40 CFR part 1090 to implement the removal of the 1-psi waiver in the petitioning States. Specifically, we proposed to include new designation and associated product transfer document (PTD) language requirements and a regulatory
We are finalizing as proposed a new designation and associated PTD language for summer CBOB in States where the 1-psi waiver for E10 has been removed under CAA section 211(h)(5).
In this action, we are requiring gasoline manufacturers to designate summer CBOB for use in States where we have removed the 1-psi waiver as “Low-RVP Summer CBOB.” We are also finalizing as proposed related changes to the PTD language requirements so that gasoline manufacturers that produce Low-RVP Summer CBOB can accurately and consistently describe the fuel designation. All other designation and PTD provisions will still apply (
We are finalizing as proposed a regulatory mechanism for States to request the reinstatement of the 1-psi waiver under CAA section 211(h)(5). This regulatory mechanism will be available for the petitioning States, as well as any other State for which EPA removes the 1-psi waiver under CAA section 211(h)(5) in the future. The regulations provide all States with criteria under which such a request could be made and granted. We modeled the regulatory mechanism for reinstatement of the 1-psi waiver on the regulations in 40 CFR 1090.295 that allow for the removal of 7.8 psi RVP standard.
This action also amends 40 CFR part 1090 to reflect the 2021 court decision in
In June 2019, EPA finalized a rule modifying volatility regulations for gasoline-ethanol blends containing more than 10 and up to 15 percent ethanol to provide a 1-psi RVP volatility “waiver.” The rule was challenged in the D.C. Circuit by AFPM and other groups in June 2019. The court issued its decision on July 2, 2021, vacating the volatility rule, and subsequently issued the mandate for its decision on September 17, 2021.
This action updates our regulations to reflect the court's vacatur of the volatility rule. Subsequent to the promulgation of the volatility rule and the corresponding regulations at 40 CFR 80.27, in December 2020, EPA finalized its fuels regulatory streamlining effort and transposed the regulations, with minor changes, to 40 CFR 1090.215.
We are also clarifying the status of the “substantially similar” determination for gasoline made in the same action. Because the 2019 interpretative rule
Finally, in the same rulemaking action, EPA promulgated regulations related to the RFS credit or “RIN” market.
This final rule amends the fuel quality regulations at 40 CFR part 1090, subparts C and R, to remove the 1-psi waiver for E15 contained in 40 CFR 1090.215(b)(2) and 1090.1720(e) by replacing the phrases “15 volume percent” and “15 percent” with “10 volume percent” and “10 percent,”
Additional information about these statutes and Executive Orders can be found at
This action is a “significant regulatory action,” as defined under section 3(f)(1) of Executive Order 12866, as amended by Executive Order 14094. Accordingly, EPA submitted this action to the Office of Management and Budget (OMB) for Executive Order 12866 review. Documentation of any changes made in response to the Executive Order 12866 review is available in the docket. EPA prepared an analysis of the potential costs and benefits associated with this action. This analysis is presented in the TSD, available in the docket for this action.
This action does not impose any new information collection burden under the PRA. OMB has previously approved the information collection activities contained in the existing regulations and has assigned OMB control number 2060-0731. This action removes the 1-psi waiver in eight States. It does not alter practices used by the existing recordkeeping and reporting requirements, nor does it change the number or type of respondents and the manner in which they satisfy the fuel designation and PTD requirements.
I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. The small entities subject to the requirements of this action are small refiners (which are defined at 13 CFR 121.201) that produce or distribute gasoline in Illinois, Iowa, Minnesota, Missouri, Nebraska, Ohio, South Dakota, or Wisconsin. This action removes the 1-psi waiver for E10 in these States. EPA is not aware of any small refiner that operates in these States. However, EPA is aware of at least one small refiner that distributes a portion of the gasoline it produces to some of the petitioning States, and thus will be affected this action. Therefore, to evaluate the impacts of this action on small entities, we have conducted a screening analysis to assess whether we should make a finding that this action will not have a significant economic impact on a substantial number of small entities.
This action does not contain an unfunded mandate of $100 million or more as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. This action implements mandates specifically and explicitly set forth in CAA section 211(h)(5) and we believe that this action represents the least costly, most cost-effective approach to achieve the statutory requirements.
This action does not have federalism implications. It will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.
This action does not have Tribal implications as specified in Executive Order 13175. This action will be implemented at the State level and would affect gasoline refiners, blenders, marketers, distributors, and importers. Tribal governments would be affected only to the extent they produce, purchase, and use gasoline. Thus, Executive Order 13175 does not apply to this action.
EPA interprets Executive Order 13045 as applying only to those regulatory actions that concern environmental health or safety risks that EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of the Executive Order. Therefore, this action is not subject to Executive Order 13045 because it implements specific standards established by Congress in statutes.
This action is not a “significant energy action” because it is not likely to have a significant adverse effect on the supply, distribution, or use of energy. This action removes the 1-psi waiver for eight States. As discussed in Section V, it will require changes to the production and distribution of gasoline, which is expected to have some short- and long-term impacts on gasoline supply and cost in the affected areas, but we believe the market will be able to accommodate the change without any significant disruption.
This action does not involve technical standards.
EPA believes that the human health and environmental conditions that exist prior to this action do not result in disproportionate and adverse effects on communities with environmental justice concerns. Numerous studies have found that environmental hazards such as air pollution are more prevalent in areas where people of color and low-income populations represent a higher fraction of the population compared to the general population. In addition, there is ample evidence that people who reside in close proximity to major roadways are disproportionately represented by
EPA believes that this action is not likely to result in new disproportionate and adverse effects on communities with environmental justice concerns. This is because any emissions impacts of this action are small. As described in Section IV.B, MOVES modeling performed by the States in support of their petitions demonstrated a reduction in VOCs, CO, and NO
EPA additionally identified and addressed EJ concerns by providing the relevant emissions information in this rulemaking action and providing an opportunity for public comment on this rule. We received no comments related to EJ concerns.
The information supporting this Executive Order review is contained in this preamble and the “Evaluation of MOVES Modeling and Results,” available in the docket for this action.
This action is subject to the CRA, and the EPA will submit a rule report to each House of the Congress and to the Comptroller General of the United States. This action meets the criteria set forth in 5 U.S.C. 804(2).
Environmental protection, Administrative practice and procedure, Air pollution control, Fuel additives, Gasoline, Petroleum, Renewable fuel.
For the reasons set forth in the preamble, EPA amends 40 CFR part 1090 as follows:
42 U.S.C. 7414, 7521, 7522-7525, 7541, 7542, 7543, 7545, 7547, 7550, and 7601.
The revision reads as follows:
(b) * * *
(3)(i) RFG and SIP-controlled gasoline that does not allow for the ethanol 1.0 psi waiver does not qualify for the special regulatory treatment specified in paragraph (b)(1) of this section.
(ii) Gasoline subject to the 9.0 psi maximum RVP per-gallon standard in paragraph (a)(1) of this section in the following areas is excluded from the special regulatory treatment specified in paragraph (b)(1) of this section:
(a) EPA may approve a request from a State asking to reinstate the ethanol 1.0 psi waiver specified in § 1090.215(b)(1) for any area (or portion of an area) specified in § 1090.215(b)(3)(ii) if it meets the requirements of paragraph (b) of this section. If EPA approves such a request, an effective date will be set as specified in paragraph (c) of this section. EPA will notify the State in writing of EPA's action on the request and the effective date of the reinstatement upon approval of the request.
(b) The request must be signed by the Governor of the State, or the Governor's authorized representative, and must include all the following:
(1) A geographic description of each area (or portion of such area) that is covered by the request.
(2) A description of all the means in which emissions reduction from the removal of the ethanol 1.0 psi waiver are relied upon in any approved SIP or in any submitted SIP that has not yet been approved by EPA, if applicable.
(3) For any area covered by the request where emissions reductions from the removal of the ethanol 1.0 psi waiver are relied upon as specified in paragraph (b)(2) of this section, the request must include the following information:
(i) Identify whether the State is withdrawing any submitted SIP that has not yet been approved.
(ii)(A) Identify whether the State intends to submit a SIP revision to any approved SIP or any submitted SIP that has not yet been approved, which relies on emissions reductions from the removal of the ethanol 1.0 psi waiver, and describe any control measures that the State plans to submit to EPA for approval to replace the emissions reductions from the removal of the ethanol 1.0 psi waiver.
(B) A description of the State's plans and schedule for adopting and submitting any revision to any approved SIP or any submitted SIP that has not yet been approved.
(iii) If the State is not withdrawing any submitted SIP that has not yet been approved and does not intend to submit a revision to any approved SIP or any submitted SIP that has not yet been approved, describe why no revision is necessary.
(4) A requested effective date of the reinstatement of the ethanol 1.0 psi waiver.
(5) The Governor of a State, or the Governor's authorized representative, must submit additional information needed to administer the reinstatement of the ethanol 1.0 psi waiver upon request by EPA.
(c)(1) Except as specified in paragraph (c)(2) of this section, EPA will set an effective date of the reinstatement of the ethanol 1.0 psi waiver as requested by the Governor, or the Governor's authorized representative, but no less than 90 days from EPA's written notification to the State approving the reinstatement request.
(2) Where emissions reductions from the removal of the ethanol 1.0 psi waiver are included in an approved SIP or any submitted SIP that has not yet been approved, EPA will set an effective date of the reinstatement of the ethanol 1.0 psi waiver as requested by the Governor, or the Governor's authorized representative, but no less than 90 days from the effective date of EPA approval of the SIP revision that removes the emissions reductions from the ethanol 1.0 psi waiver, and, if necessary, provides emissions reductions to make up for those from the ethanol 1.0 psi waiver reinstatement.
(d) EPA will publish a document in the
(e) Upon the effective date for the reinstatement of the ethanol 1.0 psi waiver in a subject area (or portion of a subject area) included in an approved
(a) * * *
(2) * * *
(iii) If the CBOB is excluded from the special regulatory treatment for ethanol under § 1090.215(b)(3)(ii), Low-RVP Summer CBOB.
(b) * * *
(2) * * *
(i) * * *
(C) “Low-RVP CBOB. This product does not meet the requirements for summer reformulated gasoline.”
Federal Communications Commission.
Final rule; announcement of effective date.
In this document, the Commission announces that the Office of Management and Budget (OMB) has approved the information collection requirements under OMB Control Numbers 3060-1121, 3060-1320, 3060-0009, 3060-0386, 3060-0175, 3060-0178, 3060-0182, 3060-0190, 3060-0320, 3060-0113, and 3060-1321 associated with the rules adopted in the
The amendments to 47 CFR 73.619; 73.625; 73.1250; 73.1350; 73.1560; 73.1615; 73.1620; 73.1635; 73.1675; 73.1690; 73.1740; 73.1750; 73.2080; 73.3540; 73.3544; 73.3549; 73.3550; 73.3598; 73.5006; 73.6024; 73.6025, published at 89 FR 7224 on February 1, 2024, are effective March 4, 2024.
Cathy Williams, Office of the Managing Director, Federal Communications Commission, at (202) 418-2918 or
This document announces that OMB approved the information collection requirements in 47 CFR 73.619; 73.625; 73.1250; 73.1350; 73.1560; 73.1615; 73.1620; 73.1635; 73.1675; 73.1690; 73.1740; 73.1750; 73.2080; 73.3540; 73.3544; 73.3549; 73.3550; 73.3598; 73.5006; 73.6024; 73.6025 on February 2, 2024, and February 14, 2024, respectively. These rule sections were adopted in the
As required by the Paperwork Reduction Act of 1995 (44 U.S.C. 3507), the Commission is notifying the public that it received final OMB approvals on February 2, 2024 and February 14, 2024, respectively, for the information collection requirements contained in 47 CFR 73.619; 73.625; 73.1250; 73.1350; 73.1560; 73.1615; 73.1620; 73.1635; 73.1675; 73.1690; 73.1740; 73.1750; 73.2080; 73.3540; 73.3544; 73.3549; 73.3550; 73.3598; 73.5006; 73.6024; 73.6025. Under 5 CFR part 1320, an agency may not conduct or sponsor a collection of information unless it displays a current, valid OMB Control Number.
No person shall be subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act that does not display a current, valid OMB Control Number. The OMB Control Numbers for the information collection requirements in 47 CFR 73.619; 73.625; 73.1250; 73.1350; 73.1560; 73.1615; 73.1620; 73.1635; 73.1675; 73.1690; 73.1740; 73.1750; 73.2080; 73.3540; 73.3544; 73.3549; 73.3550; 73.3598; 73.5006; 73.6024; 73.6025 are 3060-1121, 3060-1320, 3060-0009, 3060-0386, 3060-0175, 3060-0178, 3060-0182, 3060-0190, 3060-0320, 3060-0113, and 3060-1321.
The foregoing notice is required by the Paperwork Reduction Act of 1995, Public Law 104-13, October 1, 1995, and 44 U.S.C. 3507.
The total annual reporting burdens and costs for the respondents are as follows:
47 CFR 73.1750 requires that the licensee of each station provide a notification to the FCC in a Cancellation Application via the Commission's Licensing and Management System (LMS) of the permanent discontinuance of operation at least two days before operation is discontinued. Immediately after discontinuance of operation, the licensee must forward the station license and other instruments of authorization to the FCC, Attention: Audio Division (radio) or Video Division (television), Media Bureau, for cancellation.
47 CFR 73.3549 requires that requests for extension of authority to operate without required monitors, transmission system indicating instruments, or encoders and decoders for monitoring and generating the EAS codes and Attention Signal should be made to the FCC by electronically filing via LMS. Such requests must contain information as to when and what steps were taken to repair or replace the defective equipment and a brief description of the alternative procedures being used while the equipment is out of service.
47 CFR 73.3550(a) requires that all requests for new or modified call sign assignments for radio and television broadcast stations be made via LMS with the FCC. Paragraph 47 CFR 73.3550(j) provides that a change in call sign assignment will be made effective on the date specified in the Call Sign Request Authorization generated by LMS acknowledging the assignment of the requested new call sign and authorizing the change.
47 CFR 73.619(b)(5) requires that in determining coverage, the elevation or contour intervals must be taken from a high quality bald earth map or dataset such as the United States Geological Survey Topographic Quadrangle Maps or the National Elevation Dataset. We include these updates for informational purposes, but these changes do not impact an existing information collection or create a new collection.
47 CFR 73.625(c)(3)(v) requires that all azimuth plane patterns be plotted in a PDF attachment to an application in a size sufficient to be easily viewed; paragraph (vii) requires that if an elevation pattern is submitted in the application form, similar tabulations and PDF attachments must be provided for the elevation pattern; and paragraph (viii) requires that if a matrix pattern is submitted in the application form, similar tabulations must be provided as necessary in the form of a spreadsheet to accurately represent the pattern.
Similarly, 47 CFR 73.6025 requires that applications for modified Class A TV facilities proposing the use of directional antennas include the documentation in § 73.625(c)(3).
47 CFR 73.5006 requires that within ten days following the issuance of a public notice announcing that a long-form application for an AM, FM, or television construction permit has been accepted for filing, petitions to deny that application may be filed in the Commission's Licensing and Management (LMS) database. We include these updates for informational purposes, but these changes do not impact an existing information collection or create a new collection.
47 CFR 73.6024 requires that a Class A station within 275 kilometers of the U.S.-Mexico border must specify the full service emission mask in an application on FCC Form 2100. We include these updates for informational purposes, but these changes do not impact an existing information collection or create a new collection.
47 CFR 73.1675(c)(1) continues to state that where an FM, TV, or Class A
47 CFR 73.1690(c) continues to require FM, TV, or Class A TV station applicants to submit an exhibit demonstrating compliance with § 1.30003 or § 1.30002, as applicable, with a modification of license application, except for applications solely filed pursuant to paragraphs (c)(6) or (c)(9) of this section, where the installation is located on or near an AM tower, as defined in § 1.30002. The
On August 14, 2013, the Commission adopted the
47 CFR 1.30002(a) requires a proponent of construction or modification of a tower within a specified distance of a nondirectional AM station, and also exceeding a specified height, to notify the AM station at least 30 days in advance of the commencement of construction. If the tower construction or modification would distort the AM pattern, the proponent shall be responsible for the installation and maintenance of detuning equipment.
47 CFR 1.30002(b) requires a proponent of construction or modification of a tower within a specified distance of a directional AM station, and also exceeding a specified height, to notify the AM station at least 30 days in advance of the commencement of construction. If the tower construction or modification would distort the AM pattern, the proponent shall be responsible for the installation and maintenance of detuning equipment.
47 CFR 1.30002(c) states that proponents of tower construction or alteration near an AM station shall use moment method modeling, described in § 73.151(c), to determine the effect of the construction or alteration on an AM radiation pattern.
47 CFR 1.30002(f) states that, with respect to an AM station that was authorized pursuant to a directional proof of performance based on field strength measurements, the proponent of the tower construction or modification may, in lieu of the study described in § 1.30002 (c), demonstrate through measurements taken before and after construction that field strength values at the monitoring points do not exceed the licensed values. In the event that the pre-construction monitoring point values exceed the licensed values, the proponent may demonstrate that post-construction monitoring point values do not exceed the pre-construction values. Alternatively, the AM station may file for authority to increase the relevant monitoring point value after performing a partial proof of performance in accordance with § 73.154 to establish that the licensed radiation limit on the applicable radial is not exceeded.
47 CFR 1.30002(g) states that tower construction or modification that falls outside the criteria described in paragraphs § 1.30002(a) and (b) is presumed to have no significant effect on an AM station. In some instances, however, an AM station may be affected by tower construction notwithstanding the criteria set forth in paragraphs § 1.30002(a) and (b). In such cases, an AM station may submit a showing that its operation has been affected by tower construction or alteration. Such showing shall consist of either a moment method analysis or field strength measurements. The showing shall be provided to (i) the tower proponent if the showing relates to a tower that has not yet been constructed or modified and otherwise to the current tower owner, and (ii) to the Commission, within two years after the date of completion of the tower construction or modification. If necessary, the Commission shall direct the tower proponent to install and maintain any detuning apparatus necessary to restore proper operation of the AM antenna.
47 CFR 1.30002(h) states that an AM station may submit a showing that its operation has been affected by tower construction or modification commenced or completed prior to or on the effective date of the rules adopted in this Part pursuant to MM Docket No. 93-177. Such a showing shall consist of either a moment method analysis or of field strength measurements. The showing shall be provided to the current owner and the Commission within one year of the effective date of the rules adopted in this Part. If necessary, the Commission shall direct the tower owner, if the tower owner holds a Commission authorization, to install and maintain any detuning apparatus necessary to restore proper operation of the AM antenna.
47 CFR 1.30002(i) states that a Commission applicant may not propose, and a Commission licensee or permittee may not locate, an antenna on any tower or support structure, whether constructed before or after the effective date of these rules, that is causing a disturbance to the radiation pattern of the AM station, as defined in paragraphs § 1.30002(a) and (b), unless the
47 CFR 1.30003(a) states that when antennas are installed on a nondirectional AM tower the AM station shall determine operating power by the indirect method (see § 73.51). Upon the completion of the installation, antenna impedance measurements on the AM antenna shall be made. If the resistance of the AM antenna changes, an application on FCC Form 302-AM (including a tower sketch of the installation) shall be filed with the Commission for the AM station to return to direct power measurement. The Form 302-AM shall be filed before or simultaneously with any license application associated with the installation.
47 CFR 1.30003(b) requires that, before antennas are installed on a tower in a directional AM array, the proponent shall notify the AM station so that, if necessary, the AM station may determine operating power by the indirect method (see § 73.51) and request special temporary authority pursuant to § 73.1635 to operate with parameters at variance. For AM stations licensed via field strength measurements (see § 73.151(a)), a partial proof of performance (as defined by § 73.154) shall be conducted both before and after construction to establish that the AM array will not be and has not been adversely affected. For AM stations licensed via a moment method proof (see § 73.151(c)), the proof procedures set forth in § 73.151(c) shall be repeated. The results of either the partial proof of performance or the moment method proof shall be filed with the Commission on Form 302-AM before or simultaneously with any license application associated with the installation.
47 CFR 1.30004(a) requires proponents of proposed tower construction or modification to an existing tower near an AM station that are subject to the notification requirement in §§ 1.30002-1.30003 to provide notice of the proposed tower construction or modification to the AM station at least 30 days prior to commencement of the planned tower construction or modification. Notification to an AM station and any responses may be oral or written. If such notification and/or response is oral, the party providing such notification or response must supply written documentation of the communication and written documentation of the date of communication upon request of the other party to the communication or the Commission. Notification must include the relevant technical details of the proposed tower construction or modification, and, at a minimum, also include the following: proponent's name and address; coordinates of the tower to be constructed or modified; physical description of the planned structure; and results of the analysis showing the predicted effect on the AM pattern, if performed.
47 CFR 1.30004(b) requires that a response to a notification indicating a potential disturbance of the AM radiation pattern must specify the technical details and must be provided to the proponent within 30 days.
47 CFR 1.30004(d) states that if an expedited notification period (less than 30 days) is requested by the proponent, the notification shall be identified as “expedited,” and the requested response date shall be clearly indicated.
47 CFR 1.30004(e) states that in the event of an emergency situation, if the proponent erects a temporary new tower or makes a temporary significant modification to an existing tower without prior notice, the proponent must provide written notice to potentially affected AM stations within five days of the construction or modification of the tower and cooperate with such AM stations to remedy any pattern distortions that arise as a consequence of such construction.
47 CFR 73.875(c) requires an LPFM applicant to submit an exhibit demonstrating compliance with § 1.30003 or § 1.30002, as applicable, with any modification of license application filed solely pursuant to paragraphs (c)(1) and (c)(2) of this section, where the installation is on or near an AM tower, as defined in § 1.30002.
The Commission also revised 47 CFR 73.1740 such that Broadcast stations (AM, FM, TV or Class A TV licensees) may file this form in the Commission's LMS to notify the Commission of the station's suspension of broadcast operations. Broadcast stations may also use this form to request a silent STA or extension thereof. Types of Silent Notifications include Notification of Suspension and Resumption of Operations. Pursuant to Section 73.1740, broadcast station licensees must notify the Commission when
The Commission also revised 47 CFR 73.1615 such that broadcast stations (AM, FM, TV or Class A TV licensees) must file a notification under 47 CFR 73.1615(c) when such a station is in the process of modifying existing facilities as authorized by a construction permit and determines it is necessary to either discontinue operation or to operate with temporary facilities to continue program service for a period not more than 30 days (in which case it must file a Silent STA application or an Engineering STA application via LMS). Licensees or permittees of directional or nondirectional FM, TV or Class A TV or nondirectional AM must file a notification and comply with 47 CFR 73.1615(a). Licensees or permittees of a directional AM station whose modification does not involve a change in operating frequency must file a notification and comply with 47 CFR 73.1615(b). Licensees or permittees of a directional AM station whose modification does involve a change in frequency and determines it is necessary to discontinue operation for a period not more than 30 days must file a notification and comply with 47 CFR 73.1615(d)(2). The Commission does not have any program changes or adjustments to this collection as a result of the information collection requirements adopted in FCC 23-72 and there are no other adjustments to the other information collection requirements covered by this collection since last approved by OMB.
47 CFR 73.1350(h) requires licensees to submit a “letter of notification” to the FCC via a Change of Control Point Notice in the Commission's Licensing and Management System (LMS) database, whenever a transmission system control point is established at a location other than at the main studio or transmitter within three days of the initial use of that point. The letter should include a list of all control points in use, for clarity. This notification is not required if responsible station personnel can be contacted at the transmitter or studio site during hours of operation.
47 CFR 73.3544(b) permits that an informal electronic filing of an Administrative Update via the Commission's Licensing and Management System (LMS) may be filed to cover the following changes: (1) A correction of the routing instructions and description of an AM station directional antenna system field monitoring point, when the point itself is not changed; (2) A change in the type of AM station directional antenna monitor. See § 73.69; (3) The location of a remote control point of an AM or FM station when prior authority to operate by remote control is not required.
47 CFR 73.3544(c) requires a change in the name of the licensee where no change in ownership or control is involved may be accomplished by electronically filing an Administrative Update via LMS by the licensee to the Commission.
47 CFR 73.1620(a)(1) requires permittees of a nondirectional AM or FM station, or a nondirectional or directional TV station to notify the FCC upon beginning of program tests via a Program Test Authority filing in the Commission's Licensing and Management System (LMS) database. An application for license must be filed with the FCC within 10 days of this notification.
47 CFR 73.1620(a)(2) requires a permittee of an FM station with a directional antenna to file a request with the FCC for program test authority 10 days prior to date on which it desires to begin program tests on FCC Form 2100 Schedule 302-FM in LMS. This is filed in conjunction with an application for license.
47 CFR 73.1620(a)(3) requires a licensee of an FM station replacing a directional antenna without changes that would not require the submission of a construction permit application to file with the FCC a modification of license application on FCC Form 2100 Schedule 302-FM within 10 days after commencing operations with the replacement antenna. This is filed in conjunction with an application for license.
47 CFR 73.1620(a)(4) requires a permittee of an AM station with a directional antenna to file a request with the FCC for program test authority 10 days prior to date on which it desires to begin program tests. This is filed in conjunction with an application for license.
47 CFR 73.1620(a)(5) except for permits subject to successive license terms, the permittee of an Low Power TV (LPFM) station may begin program tests upon notification to the FCC in Washington, DC, provided that within 10 days thereafter, an application for license is filed. Program tests may be conducted by a licensee subject to mandatory license terms only during the term specified on such licensee's authorization.
47 CFR 73.1620(b) the Commission reserves the right to revoke, suspend, or modify program tests by any station without right of hearing for failure to comply adequately with all terms of the construction permit or the provisions of § 73.1690(c) for a modification of license application, or in order to resolve instances of interference. The Commission may, at its discretion, also require the filing of a construction permit application to bring the station into compliance the Commission's rules and policies.
47 CFR 73.1560(d) requires that licensees of AM, FM or TV stations file a notification with the FCC via the Commission's Licensing and Management System (LMS) when operation at reduced power will exceed ten consecutive days in a Reduced Power Notification and upon restoration of normal operations. If causes beyond the control of the licensee prevent restoration of authorized power within a 30-day period, an informal request for Special Temporary Authority must be made via LMS for any additional time as may be necessary to restore normal operations.
Emergency situations in which the broadcasting of information is considered as furthering the safety of life and property include, but are not limited to, tornadoes, hurricanes, floods, tidal waves, earthquakes, and school closings.
47 CFR 73.1250(e) requires that immediately upon cessation of an emergency during which broadcast facilities were used for the transmission of point-to-point messages or when daytime facilities were used during nighttime hours by an AM station, a report in letter form shall be forwarded to the FCC's main office in Washington, DC, as indicated in 47 CFR 0.401(a), setting forth the nature of the emergency, the dates and hours of the
Nuclear Regulatory Commission.
Draft guide; request for comment.
The U.S. Nuclear Regulatory Commission (NRC) is issuing for public comment a draft Regulatory Guide (DG), DG-1422, “Preparing Probabilistic Fracture Mechanics Submittals.” This DG is proposed Revision 1 to Regulatory Guide (RG) 1.245, “Preparing Probabilistic Fracture Mechanics Submittals.” DG-1422 describes an approach that is acceptable to the staff of the NRC for performing probabilistic fracture mechanics (PFM) analyses in support of regulatory applications.
Submit comments by April 1, 2024. Comments received after this date will be considered if it is practical to do so, but the NRC is able to ensure consideration only for comments received on or before this date.
You may submit comments by any of the following methods however, the NRC encourages electronic comment submission through the Federal rulemaking website:
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For additional direction on obtaining information and submitting comments, see “Obtaining Information and Submitting Comments” in the
Michael A. Eudy, telephone: 301-415-3104; email:
Please refer to Docket ID NRC-2024-0036 when contacting the NRC about the availability of information for this action. You may obtain publicly available information related to this action by any of the following methods:
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The NRC encourages electronic comment submission through the Federal rulemaking website (
The NRC cautions you not to include identifying or contact information that you do not want to be publicly disclosed in your comment submission. The NRC will post all comment submissions at
If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment into ADAMS.
The NRC is issuing for public comment a DG in the NRC's “Regulatory Guide” series. This series was developed to describe methods that are acceptable to the NRC staff for implementing specific parts of the agency's regulations, to explain techniques that the staff uses in evaluating specific issues or postulated events, and to describe information that the staff needs in its review of applications for permits and licenses.
The DG, entitled “Preparing Probabilistic Fracture Mechanics Submittals,” is temporarily identified by its task number, DG-1422 (ADAMS Accession No. ML23291A298).
This DG presents proposed guidance on justifying the acceptability of the methods used to generate and report PFM results. This DG does not describe how the results of PFM may be used to support a regulatory application. Regulatory applications typically contain information other than fracture mechanics analyses; this DG does not address the review of this other information. The proposed revisions made to RG 1.245, Revision 0 clarify guidance for applications that leverage risk insights, such as PFM. These changes are reflected in Regulatory Positions 2.1, “Regulatory Context,” and
The staff is also issuing for public comment a draft regulatory analysis (ADAMS Accession No. ML23291A299). The staff developed the regulatory analysis to assess the value of revising RG 1.245, Revision 0, as well as alternative courses of action.
As noted in the
Issuance of DG-1422, if finalized, would not constitute backfitting as defined in 10 CFR 50.109, “Backfitting,” and as described in NRC Management Directive (MD) 8.4, “Management of Backfitting, Forward Fitting, Issue Finality, and Information Requests”; affect issue finality of any approval issued under 10 CFR part 52, “Licenses, Certificates, and Approvals for Nuclear Power Plants”; or constitute forward fitting as defined in MD 8.4, because, as explained in this DG, licensees would not be required to comply with the positions set forth in this DG.
A member of the public may, at any time, submit suggestions to the NRC for improvement of existing RGs or for the development of new RGs. Suggestions can be submitted on the NRC's public website at
For the Nuclear Regulatory Commission.
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
The FAA proposes to adopt a new airworthiness directive (AD) for all airplanes with certain Pacific Scientific Company rotary buckle assemblies (buckles) installed. This AD was prompted by a report of a manufacturing defect in the screws used inside the buckle. This proposed AD would require inspecting the buckle screws, and depending on the results, reidentifying the buckle, replacing the screws and reidentifying the buckle, or replacing the buckle. This proposed AD would also prohibit installing certain buckles. The FAA is proposing this AD to address the unsafe condition on these products.
The FAA must receive comments on this proposed AD by April 15, 2024.
You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
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• For service information identified in this NPRM, contact Parker Meggitt Services, 1785 Voyager Avenue, Simi Valley, CA 93063; phone 877-666-0712; email
• You may view this service information at the FAA, Airworthiness Products Section, Operational Safety Branch, 2200 South 216th Street, Des Moines, WA. For information on the availability of this material at the FAA, call 206-231-3195. It is also available at
David Kim, Aviation Safety Engineer, FAA, 3960 Paramount Boulevard, Lakewood, CA 90712; phone 562-627-5274; email
The FAA invites you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under
Except for Confidential Business Information (CBI) as described in the following paragraph, and other information as described in 14 CFR 11.35, the FAA will post all comments received, without change, to regulations.gov, including any personal information you provide. The agency will also post a report summarizing each substantive verbal contact received about this NPRM.
CBI is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to this NPRM contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to this NPRM, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission containing CBI as “PROPIN.” The FAA will treat such marked submissions as confidential under the FOIA, and they will not be placed in the public docket of this
The FAA has received a report of a manufacturing defect in the screws used inside Pacific Scientific Company buckle part number (P/N) 1111475 (all dash numbers) and P/N 1111548-01. The screws used to fasten the load plate to the body of the buckle were found to be susceptible to hydrogen embrittlement due to improper baking during the electroplating process. This condition leads the screwhead to separate from the body of the screw when under load, which could result in the buckle failing to restrain the occupant to the seat. This issue was originally identified from a suspected lot of screws, Lot 348994-A. Since then, a buckle failed in an accident, calling into question Lot 348601-A. Lots 348601-A and 348994-A were the first two lots of screws received by Pacific Scientific Company from a new supplier and are the only suspected lots. The suspected buckles were manufactured between January 2012 and September 2012. The FAA is proposing this AD to address the unsafe condition on these products.
The rotary buckle may be included as a component of a different part-numbered restraint system assembly. Table 1 of Parker Meggitt Service Bulletin (SB) 1111475-25-001-2023, Revision 001, dated December 1, 2023, and Parker Meggitt SB 1111548-25-001-2023, Revision 001, dated December 1, 2023 (SB 1111475-25-001-2023 Rev 001 and SB 1111548-25-001-2023 Rev 001), includes a list of these restraint system assembly P/Ns.
This proposed AD would apply to all airplanes with a Pacific Scientific Company buckle P/N 1111475 (all dash numbers) or P/N 1111548-01 installed, if the buckle was manufactured between January 2012 and September 2012, or if the date of manufacture of the buckle is unknown. These same part-numbered buckles may also be installed in helicopters; however, the FAA determined that a shorter compliance time to accomplish the required actions is necessary for buckles installed in helicopters. Accordingly, the FAA issued AD 2024-01-11, Amendment 39-22662 (89 FR 6008, January 31, 2024), to address this unsafe condition on all helicopters with a Pacific Scientific Company buckle P/N 1111475 (all dash numbers) or P/N 1111548-01 installed.
The FAA is issuing this NPRM after determining that the unsafe condition described previously is likely to exist or develop on other airplanes with a restraint system with a buckle as part of their type design.
The FAA reviewed SB 1111475-25-001-2023 Rev 001 for buckle P/N 1111475 and SB 1111548-25-001-2023 Rev 001 for buckle P/N 1111548-01. This service information specifies procedures for inspecting the buckle for any missing or loose screw heads and, depending on the results, replacing the buckle and sending the removed buckle to Parker Meggitt for repair or replacement. If after that first inspection, all of the screw heads are intact, this service information specifies procedures for inspecting the buckle for any Torx head screws (alloy steel) and, depending on the results, allowing the buckle assembly to remain in-service temporarily, replacing any Torx head screws (alloy steel) with new hex head screws (stainless steel), and checking the functionality of the buckle. This service information also specifies procedures for removing a buckle from a restraint system, installing a buckle on a restraint system, and returning buckles to Parker Meggitt. If the buckle passes the specified inspections or is modified by replacing Torx head screws (alloy steel) with new hex head screws (stainless steel) screws, this service information specifies procedures for reidentifying the back of the buckle. This service information also identifies known affected restraint systems.
This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in
This proposed AD would require accomplishing the actions specified in the service information already described, except as discussed under “Differences Between this Proposed AD and the Service Information.”
The service information does not specify any compliance times, whereas this proposed AD would require accomplishing the required actions within twelve months. This proposed AD would also prohibit installing an affected buckle on any airplane.
The service information specifies sending any damaged buckles to Parker Meggitt for repair or replacement, and this proposed AD would not. Instead, this proposed AD would require replacing the buckle with an airworthy buckle.
The service information allows buckles with a Torx head (alloy steel) screw to remain in service temporarily and replaced at a time convenient to the operator, and this proposed AD would not. If a buckle has any number of Torx head (alloy steel) screws installed, this proposed AD would require replacing all four screws with hex head screws before further flight.
If a screw head breaks off during disassembly of a buckle or if reassembly of a buckle is not possible, the service information specifies returning the buckle to Parker Meggitt, whereas this proposed AD would not. If a screw head breaks off during disassembly, this proposed AD would require replacing the buckle with an airworthy buckle. If reassembly of a buckle is not possible, then the buckle is not airworthy.
The FAA estimates that this AD, if adopted as proposed, would affect 11,714 buckles installed on restraint systems in aircraft worldwide. The FAA has no way of knowing the number of airplanes of U.S. Registry that may have a restraint system with an affected buckle installed. The estimated costs on U.S. operators reflects the maximum possible costs based on affected buckles installed on restraint systems in aircraft worldwide. Labor rates are estimated at $85 per work-hour. Based on these numbers, the FAA estimates the following costs to comply with this proposed AD:
The FAA estimates the following costs to do any necessary repairs that would be required based on the results of the proposed inspection. The agency has no way of determining the number of buckles that might need this repair:
The FAA has included all known costs in its cost estimate. According to the manufacturer, however, some of the costs of this proposed AD may be covered under warranty, thereby reducing the cost impact on affected operators.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.
The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: General requirements. Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
The FAA determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify this proposed regulation:
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Would not affect intrastate aviation in Alaska, and
(3) Would not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
The FAA must receive comments on this airworthiness directive (AD) by April 15, 2024.
None.
This AD applies to all airplanes, certified in any category, with a restraint system with a Pacific Scientific Company rotary buckle assembly (buckle) part number (P/N) 1111475 (all dash numbers) or P/N 1111548-01 installed having a date of manufacture between January 2012 and September 2012 inclusive or an unknown date of manufacture. These buckles may be installed on, but not limited to, The Boeing Company model airplanes, certificated in any category.
Air Transport Association (ATA) of America Code: 25, Equipment/furnishings.
This AD was prompted by reports of a manufacturing defect in the screws used inside the buckle. The FAA is issuing this AD to prevent cracking and missing screw heads when under load. The unsafe condition, if not addressed, could result in a failure of the buckle to restrain the occupant.
Comply with this AD within the compliance times specified, unless already done.
(1) For airplanes with buckle P/N 1111475 (all dash numbers), within 12 months after the effective date of this AD, inspect each buckle screw for cracked, loose, and missing screw heads by following the Accomplishment Instructions, paragraphs B.(1) and (2), of Parker Meggitt Service Bulletin (SB) 1111475-25-001-2023, Revision 001, dated December 1, 2023 (SB 1111475-25-001-2023 Rev 001).
(i) If any screw has a cracked, loose, or missing screw head, before further flight, replace the buckle with an airworthy buckle.
(ii) If none of the four screw heads are cracked, loose, or missing, before further flight, inspect each screw to determine if any screw has a Torx head by using one of the following methods in the Accomplishment Instructions of SB 1111475-25-001-2023 Rev 001: paragraph B.(4)(a) (Magnet Test); paragraph B.(4)(b) (Inspection); or paragraphs C.(2) through (4) (removing the buckle from the restraint system) and paragraphs D.(1)(a) through (d) (disassembling the buckle).
(A) If none of the four screws have a Torx head, before further flight, reassemble the buckle (if necessary) by following the Accomplishment Instructions, paragraphs D.(1)(f) through (l), of SB 1111475-25-001-
(B) If at least one of the four screws has a Torx head, before further flight, with the buckle removed, replace each Torx head screw with a hex head screw, reassemble the buckle, and reidentify the buckle with “MOD. A” by following the Accomplishment Instructions, paragraphs D.(1)(e) through (m), of SB 1111475-25-001-2023 Rev 001, except you are not required to return any parts to Parker Meggitt. If a screw head breaks off during disassembly, before further flight, replace the buckle with an airworthy buckle.
(2) For airplanes with buckle P/N 1111548-01, within 12 months after the effective date of this AD, inspect each buckle screw for cracked, loose, and missing screw heads by following the Accomplishment Instructions, paragraph B.(1), of Parker Meggitt SB 1111548-25-001-2023, Revision 001, dated December 1, 2023 (SB 1111548-25-001-2023 Rev 001).
(i) If any screw has a cracked, loose, or missing screw head, before further flight, replace the buckle with an airworthy buckle.
(ii) If none of the four screw heads are cracked, loose, or missing, before further flight, inspect each screw to determine which screws have a Torx head by using one of the following methods in the Accomplishment Instructions of SB 1111548-25-001-2023 Rev 001: paragraph B.(3)(a) (except use Figure 6 for placement of the shim tool and use Figure 5 to distinguish the screw head types) (Inspection); or paragraph C. (removing the buckle from the restraint system) and paragraphs D.(1)(a) through (c) (disassembling the buckle). Before further flight, with the buckle removed, replace each Torx head screw with a hex head screw, reassemble the buckle, and reidentify the buckle with “MOD. A” by following the Accomplishment Instructions, paragraphs D.(1)(d) through (m), of SB 1111548-25-001-2023 Rev 001, except you are not required to return any parts to Parker Meggitt. If a screw head breaks off during disassembly, before further flight, replace the buckle with an airworthy buckle.
As of the effective date of this AD, do not install a buckle identified in paragraph (c) of this AD on any airplane unless the buckle is marked with “MOD. A” or “INS. A”.
(1) The Manager, West Certification Branch, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or responsible Flight Standards Office, as appropriate. If sending information directly to the manager of the West Certification Branch, send it to the attention of the person identified in paragraph (j) of this AD.
(2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the responsible Flight Standards Office.
For more information about this AD, contact David Kim, Aviation Safety Engineer, FAA, 3960 Paramount Boulevard, Lakewood, CA 90712; phone 562-627-5274; email
(1) The Director of the Federal Register approved the incorporation by reference of the service information listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
(2) You must use this service information as applicable to do the actions required by this AD, unless the AD specifies otherwise.
(i) Parker Meggitt Service Bulletin 1111475-25-001-2023, Revision 001, dated December 1, 2023.
(ii) Parker Meggitt Service Bulletin 1111548-25-001-2023, Revision 001, dated December 1, 2023.
(3) For service information identified in this AD, contact Parker Meggitt Services, 1785 Voyager Avenue, Simi Valley, CA 93063; phone 877-666-0712; email
(4) You may view this service information at the FAA, Airworthiness Products Section, Operational Safety Branch, 2200 South 216th Street, Des Moines, WA. For information on the availability of this material at the FAA, call 206-231-3195.
(5) You may view this material at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, visit
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
This action proposes to establish United States Area Navigation (RNAV) routes Q-147, Q-149, and T-484 in the eastern United States. This action supports FAA Next Generation Air Transportation System (NextGen) efforts to provide a modern RNAV route structure to improve the safety and efficiency of the National Airspace System (NAS).
Comments must be received on or before April 15, 2024.
Send comments identified by FAA Docket No. FAA-2024-0144 and Airspace Docket No. 23-ASO-34 using any of the following methods:
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FAA Order JO 7400.11H, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at
Brian Vidis, Rules and Regulations Group, Office of Policy, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-8783.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the
The FAA invites interested persons to participate in this rulemaking by submitting written comments, data, or views. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. The most helpful comments reference a specific portion of the proposal, explain the reason for any recommended change, and include supporting data. To ensure the docket does not contain duplicate comments, commenters should submit only one time if comments are filed electronically, or commenters should send only one copy of written comments if comments are filed in writing.
The FAA will file in the docket all comments it receives, as well as a report summarizing each substantive public contact with FAA personnel concerning this proposed rulemaking. Before acting on this proposal, the FAA will consider all comments it receives on or before the closing date for comments. The FAA will consider comments filed after the comment period has closed if it is possible to do so without incurring expense or delay. The FAA may change this proposal in light of the comments it receives.
An electronic copy of this document may be downloaded through the internet at
You may review the public docket containing the proposal, any comments received and any final disposition in person in the Dockets Operations office (see
United States Area Navigation routes are published in paragraph 2006 and 6011 of FAA Order JO 7400.11, Airspace Designations and Reporting Points, which is incorporated by reference in 14 CFR 71.1 on an annual basis. This document proposes to amend the current version of that order, FAA Order JO 7400.11H, dated August 11, 2023, and effective September 15, 2023. These updates would be published in the next update to FAA Order JO 7400.11. That order is publicly available as listed in the
FAA Order JO 7400.11H lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.
The FAA is proposing to amend 14 CFR part 71 by establishing RNAV routes Q-147, Q-149, and T-484 in the eastern United States. This action supports the FAA's NextGen efforts to provide a modern RNAV route structure to improve the safety and efficiency of the NAS. The proposed RNAV route actions are described below.
The FAA has determined that this proposed regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore: (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this proposed rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
This proposal will be subject to an environmental analysis in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures” prior to any FAA final regulatory action.
Airspace, Incorporation by reference, Navigation (air).
In consideration of the foregoing, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows:
49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
This action proposes to modify the Class D and Class E airspace designated as a surface area at McClellan-Palomar Airport, Carlsbad, CA. Additionally, this action proposes administrative amendments to update the airport's existing Class D and Class E airspace legal descriptions. These actions would support the safety and management of instrument flight rules (IFR) and visual flight rules (VFR) operations at the airport.
Comments must be received on or before April 15, 2024.
Send comments identified by FAA Docket No. FAA-2023-0786 and Airspace Docket No. 22-AWP-77 using any of the following methods:
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FAA Order JO 7400.11H, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at
Jeffery Drasin, Federal Aviation Administration, Western Service Center, Operations Support Group, 2200 S 216th Street, Des Moines, WA 98198; telephone (206) 231-2248.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would modify Class D and Class E airspace to support both IFR and VFR operations at McClellan-Palomar Airport, Carlsbad, CA.
The FAA invites interested persons to participate in this rulemaking by submitting written comments, data, or views. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. The most helpful comments reference a specific portion of the proposal, explain the reason for any recommended change, and include
The FAA will file in the docket all comments it receives, as well as a report summarizing each substantive public contact with FAA personnel concerning this proposed rulemaking. Before acting on this proposal, the FAA will consider all comments it receives on or before the closing date for comments. The FAA will consider comments filed after the comment period has closed if it is possible to do so without incurring expense or delay. The FAA may change this proposal in light of the comments it receives.
An electronic copy of this document may be downloaded through the internet at
You may review the public docket containing the proposal, any comments received and any final disposition in person in the Dockets Operations office (see
Class D and Class E4 airspace designations are published in paragraphs 5000 and 6004, respectively, of FAA Order JO 7400.11, Airspace Designations and Reporting Points, which is incorporated by reference in 14 CFR 71.1 on an annual basis. This document proposes to amend the current version of that order, FAA Order JO 7400.11H, dated August 11, 2023, and effective September 15, 2023. These updates would be published in the next update to FAA Order JO 7400.11. That order is publicly available as listed in the
FAA Order JO 7400.11H lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.
The FAA is proposing an amendment to 14 CFR part 71 that would modify the Class D and Class E airspace designated as a surface area at McClellan-Palomar Airport, Carlsbad, CA.
The existing Class D surface area is comprised of a 3-mile radius around the airport. This area should be modified to include a small extension centered on the airport's 259° bearing extending .3 miles beyond the existing radius to better contain arriving IFR operations below 1,000 feet above the surface on the Area Navigation (RNAV) (Global Positioning System [GPS]) Y Runway (RWY) 6 and RNAV (Required Navigation Performance [RNP]) Z RWY 6 approach procedures.
The existing Class E surface area extension east of the airport should be realigned from the Palomar RWY 24 localizer east course to the 079° bearing from the airport and lengthened .2 miles to better contain arriving IFR operations below 1,000 feet above the surface on the RNAV (GPS) Y RWY 24 approach. The existing Class E surface area extension to the northwest is excessive and should be realigned from the Oceanside (OCN) 134° radial to the 313° bearing from the airport and reduced in size from a width of 3.6 miles to 2.6 miles and from a length of 5.8 miles to 4.5 miles, as it only needs to contain the VOR-A procedure while between the surface and 1,000 feet above the surface.
Finally, the FAA proposes administrative modifications to the airport's legal descriptions. The airport name on line 2 of the text headers in both legal descriptions should be updated from “Carlsbad, McClellan-Palomar Airport, CA” to “McClellan-Palomar Airport, CA” to comply with FAA Order 7400.2. The geographic coordinates located on line 3 of the text headers should be updated to match the FAA's database, and both legal descriptions should be updated to replace the outdated use of the phrases “Notice to Airmen” and “Airport/Facility Directory.” These phrases should read “Notice to Air Missions” and “Chart Supplement,” respectively, to align with the FAA's current nomenclature.
The FAA has determined that this proposed regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore: (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this proposed rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
This proposal will be subject to an environmental analysis in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures” prior to any FAA final regulatory action.
Airspace, Incorporation by reference, Navigation (air).
In consideration of the foregoing, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows:
49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
That airspace extending upward from the surface to and including 2,800 feet MSL within a 3-mile radius of McClellan-Palomar Airport and 1 mile each side of a 259° bearing from the airport extending from the 3-mile radius of the airport to 3.3 miles west of the airport. This Class D airspace area is
That airspace extending upward from the surface within 1.8 miles each side of the airport's 079° bearing extending from the 3-mile radius of the airport to 6.7 miles east of the airport and within 1.3 miles each side of the airport's 313° bearing extending from the 3-mile radius of the airport to 4.5 miles northwest of the airport. This Class E airspace area is effective during the specific dates and times established in advance by a Notice to Air Missions. The effective date and time will thereafter be continuously published in the Chart Supplement.
Commodity Futures Trading Commission.
Reopening of comment period.
On December 28, 2023, the Commodity Futures Trading Commission (“Commission” or “CFTC”) published in the
The comment period for the proposed rule published December 28, 2023, at 88 FR 90046, is reopened. Comments must be received on or before April 11, 2024.
You may submit comments, identified by “Real-Time Public Reporting Requirements and Swap Data Recordkeeping and Reporting Requirements, RIN 3038-AF26,” by any of the following methods:
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Please submit your comments using only one of these methods. To avoid possible delays with mail or in-person deliveries, submissions through the CFTC Comments Portal are encouraged.
All comments must be submitted in English, or if not, accompanied by an English translation. Comments will be posted as received to
The Commission reserves the right, but shall have no obligation, to review, pre-screen, filter, redact, refuse, or remove any or all of your submission from
Owen J. Kopon, Associate Chief Counsel, at (202) 418-5360 or
On December 28, 2023, the Commission published proposed amendments
In a February 12, 2024, Request Letter,
The following appendix will not appear in the Code of Federal Regulations.
On this matter, Chairman Behnam and Commissioners Johnson, Goldsmith Romero, Mersinger, and Pham voted in the affirmative. No Commissioner voted in the negative.
Bureau of Indian Affairs, Interior.
Notice of public meetings.
In accordance with the Federal Advisory Committee Act, the Self-Governance PROGRESS Act Negotiated Rulemaking Committee (Committee), will hold public meetings to negotiate and advise the Secretary of the Interior (Secretary) on a proposed rule to implement the Practical Reforms and Other Goals To Reinforce the Effectiveness of Self-Governance and Self-Determination for Indian Tribes Act of 2019 (PROGRESS Act).
The meeting is open to the public and will be held on Thursday, March 14, 2024, from 1 to 5 p.m. ET. Interested persons are invited to submit comments on or before April 13, 2024.
The meeting will be held at the Department of the Interior Building, 1849 C Street NW, Washington, DC 20240 in the North Penthouse Conference Room. Members of the public may attend the meeting in person or participate virtually. Send your comments, within 30 days following the meeting, to the Designated Federal Officer, Vickie Hanvey, using the following methods:
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Vickie Hanvey, Designated Federal Officer,
Please make requests in advance for sign language interpreter services, assistive listening devices, or other reasonable accommodations. We ask that you contact the person listed in the
These meetings will be held under the authority of the PROGRESS Act (Pub. L. 116-180), the Negotiated Rulemaking Act (5 U.S.C. 561
The PROGRESS Act amends subchapter I of the Indian Self-Determination and Education Assistance Act (ISDEAA), 25 U.S.C. 5301
These meetings are open to the public. Detailed information about the Committee, including meeting agendas can be accessed at
For in-person meetings, members of the public are required to present a valid government-issued photo ID to enter the building; and are subject to security screening, including bag and parcel checks.
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Depending on the number of people who want to comment and the time available, the amount of time for individual oral comments may be limited. Requests to address the Committee during the meeting will be accommodated in the order the requests are received. Individuals who wish to expand upon their oral statements, or those who had wished to speak but could not be accommodated on the agenda, may submit written comments to the Designated Federal Officer up to 30 days following the meeting. Written comments may be sent to Vickie Hanvey listed in the
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.
Internal Revenue Service (IRS), Treasury.
Notice of proposed rulemaking; notice of hearing.
This document provides a notice of public hearing on proposed regulations regarding excise taxes on taxable distributions made by a sponsoring organization from a donor advised fund (DAF), and on the agreement of certain fund managers to the making of such distributions.
The public hearing on these proposed regulations has been scheduled for May 6, 2024, at 10 a.m. ET. The IRS must receive speakers' outlines of the topics to be discussed at the public hearing by April 5, 2024. If no outlines are received by April 5, 2024, the public hearing will be cancelled.
The public hearing is being held in the Auditorium, at the Internal Revenue Service Building, 1111 Constitution Avenue NW, Washington, DC. Due to security procedures, visitors must enter at the Constitution Avenue entrance. In addition, all visitors must present a valid photo identification to enter the building. Because of access restrictions, visitors will not be admitted beyond the immediate entrance area more than 30 minutes before the hearing starts. Participants may alternatively attend the public hearing by telephone.
Send Submissions to CC:PA:01:PR (REG-142338-07), Room 5205, Internal Revenue Service, P.O. Box 7604, Ben Franklin Station, Washington, DC 20044. Submissions may be hand delivered Monday through Friday to CC:PA:01:PR (REG-142338-07), Couriers Desk, Internal Revenue Service, 1111 Constitution Avenue NW, Washington, DC 20224 or sent electronically via the Federal eRulemaking Portal at
Concerning the proposed regulations, Christopher A. Hyde, (202) 317-5800 (not a toll-free number); concerning submissions of requests to testify, the hearing and/or to be placed on the building access list to attend the public hearing, call Vivian Hayes (202) 317-6901 (not a toll-free number) or by email to
The subject of the public hearing is the notice of proposed rulemaking (REG-142338-07) that was published in the
The rules of 26 CFR 601.601(a)(3) apply to the hearing. Persons who wish to present oral comments at the hearing must submit an outline of the topics to be discussed and the time to be devoted to each topic by April 5, 2024.
A period of 10 minutes will be allotted to each person for making comments. An agenda showing the scheduling of the speakers will be prepared after the deadline for receiving outlines has passed. Copies of the agenda will be available free of charge at the hearing and via the Federal eRulemaking Portal (
Individuals who want to testify in person at the public hearing must send an email to
Individuals who want to testify by telephone at the public hearing must send an email to
Individuals who want to attend the public hearing in person without testifying must also send an email to
Individuals who want to attend the public hearing by telephone without testifying must also send an email to
Hearings will be made accessible to people with disabilities. To request special assistance during a hearing please contact the Publications and Regulations Section of the Office of Associate Chief Counsel (Procedure and Administration) by sending an email to
Any questions regarding speaking at or attending a public hearing may also be emailed to
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) is proposing to approve a State Implementation Plan (SIP) revision submitted by the State of Connecticut addressing source monitoring in Connecticut. The principal proposed revision is replacement of Regulations of Connecticut State Agencies (RCSA) section 22a-174-4 (source monitoring, record keeping and reporting), which is currently in the Connecticut SIP, with a new regulation section 22a-174-4a, also
Written comments must be received on or before April 1, 2024.
Submit your comments, identified by Docket ID No. EPA-R01-OAR-2023-0377 at
Alison C. Simcox, Air Quality Branch (AQB), Air and Radiation Division (ARD) (Mail Code 5-MD), U.S. Environmental Protection Agency, Region 1, 5 Post Office Square, Suite 100, Boston, Massachusetts, 02109-3912, (617) 918-1684;
Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA.
RCSA section 22a-174-4, “Source monitoring, record keeping, and reporting” was adopted by the state of Connecticut in 1989. This regulation defined how certain sources of air pollution are required to conduct air emissions and opacity monitoring. In 2003, the Connecticut Department of Environmental Protection (CT DEEP) proposed revisions to section 22a-174-4, and, on July 16, 2014, EPA approved 22a-174-4 into the Connecticut SIP (previously codified as Section 19-508-4).
In October 2022, to address changes in federal regulatory requirements and source-monitoring technologies, CT DEEP replaced section 22a-174-4 with 22a-174-4a (also called source monitoring, record keeping, and reporting). This new regulation became effective in Connecticut on October 28, 2022.
On November 17, 2022, CT DEEP submitted section 22a-174-4a as a SIP revision for EPA approval. This submission included several citation updates to other SIP-approved regulations (sections 22a-174-3d(f)(1)(B), 22a-174-20(a)(12), 22a-174-22e(m)(1), 22a-174-22e(m)(4), 22a-174-38(j)(1), and 22a-2a-1(b)(3)).
On December 19, 2022, CT DEEP submitted a supplement to this SIP revision that withdrew portions of the submitted regulatory text from the November 17, 2022 submittal that are currently not part of the Connecticut SIP (sections 22a-174-3d(f)(1)(B), 22a-174-38(j)(1), and 22a-2a-1(b)(3)).
On February 27, 2023, the state submitted a letter withdrawing one additional provision (section 22a-174-4a (g)(6)) of the submitted regulatory text in section 22a-174-4a. This letter also provided additional information about CT DEEP's implementation of “out-of-control” periods.
As described below, CT DEEP's SIP submittal, as modified by the December 19, 2022 supplement and the February 27, 2023 letter, strengthens its source monitoring requirements and, thus, the state's ability to detect violations of emission limits. Therefore, we are proposing to approve section 22a-174-4a, except for section 22a-174-4a(g)(6) which CT DEEP excluded from inclusion in the SIP submission, and the citation updates to related EPA-approved regulations into the Connecticut SIP.
EPA-approved RCSA section 22a-174-4 requires certain stationary sources to install, operate, and maintain opacity and gaseous continuous emissions monitoring (CEM) equipment. Opacity CEMs are also known as continuous opacity monitoring systems (COMS). These stationary sources, with some exemptions, include equipment that combusts coal, liquid or solid fuel-burning equipment with a maximum rated heat input equal to or greater than 250,000,000 British thermal units per hour (Btu/hr), incinerators with a maximum rated input greater than 2,000 pounds per hour (lbs/hr), and process sources with particulate matter (PM) emissions greater than 25 lbs/hr after application of control equipment when operated at maximum rated capacity.
Connecticut's SIP submittal, as modified by the December 2022 supplement and the February 2023 letter (described in the background section above), proposes to repeal section 22a-174-4 from the Connecticut SIP and replace it with section 22a-174-4a. The new regulation (section 22a-174-4a) applies to the same group of stationary sources as section 22a-174-4 but is restructured to include provisions that were either missing from or not clearly set out in section 22a-174-4, such as the applicability of the regulation and a distinct separation of opacity monitoring from other pollutant monitoring. The new regulation also provides more detailed and clearer provisions regarding performance specifications and quality-assurance requirements that are consistent with current federal and state requirements.
Specifically, section 22a-174-4a adds a separate section on applicability and clarifies that the regulation is intended to ensure compliance with Connecticut General Statute Chapter 446c “Air Pollution Control,” and regulations thereunder, which include all of Section 22a-174 (formerly Sec. 19-508). The new regulation also clarifies that it applies to sources that are required to install, operate, and maintain CEMS or COMS.
EPA-approved section 22a-174-4 requires sources with CEMS or COMS to submit a monitoring plan to the state for
The new regulation section 22a-174-4a requires a similar monitoring plan, called an “initial monitoring plan,” to be submitted electronically to the state not less than 90 days before initiation of required performance specification testing. This initial monitoring plan must be approved by the state. Section 22a-174-4a adds a new provision (
EPA-approved RCSA section 22a-174-4 requires any source with CEM equipment to conduct QA audits during each calendar quarter in which the source operates. The new regulation (section 22a-174-4a) strengthens this requirement by requiring these sources to perform annual, quarterly, and daily QA audits. In addition, each new CEMS must undergo an initial certification for each monitored pollutant, including a Relative Accuracy Test Audit certification, and each modified CEMS must be recertified for each pollutant or diluent for which the monitor was modified. Section 22a-174-4a also requires audit reports and COMS or CEMS reports to be submitted to CT DEEP each calendar quarter. These quarterly reports must include a summary of excess emissions and the CEMS or COMS performance, including a list of all periods of malfunctions of the CEMS or COMS.
As described in the background section above, CT DEEP's source-monitoring SIP submittal includes the original November 17, 2022 submittal plus the December 19, 2022 supplement and the February 27, 2023 letter. The source-monitoring submittal includes all of section 22a-174-4a, except 22a-174-4a(g)(6)), which would have allowed CT DEEP to waive certain minimum data availability requirements. The submittal also includes several citation updates to other SIP-approved regulations. These citation updates are in RCSA sections 22a-174-20(a)(12), 22a-174-22e(m)(1), and 22a-174-22e(m)(4). In addition, the submittal provides additional information about CT DEEP's implementation of “out-of-control” periods. Specifically, the provisions of 40 CFR 75, Appendix B and 40 CFR 60, Appendix F describe when an out-of-control period begins and ends. Therefore, determination of these periods would not be a matter of discretionary judgment by CT DEEP.
EPA has determined that CT DEEP's source-monitoring SIP submittal strengthens its source monitoring requirements and, thus, the state's ability to detect violations of emission limits.
EPA is proposing to approve RCSA Section 22a-174-4a “Source monitoring, record keeping and reporting,” except for section 22a-174-4a(g)(6). We are also proposing to approve modifications to sections 22a-174-20(a)(12), 22a-174-22e(m)(1), and 22a-174-22e(m)(4) into the Connecticut SIP. In addition, we are proposing to replace RCSA section 22a-174-4, which is currently in the Connecticut SIP, with RCSA section 22a-174-4a.
As described above, CT DEEP has adequately demonstrated that its source-monitoring SIP revisions would strengthen Connecticut's monitoring requirements and, thus, the state's ability to detect violations of emission limits. Moreover, these revisions will not interfere with attainment or maintenance of air quality standards or other applicable CAA requirements as required by section 110(l) of the CAA.
EPA is soliciting public comments on the issues discussed in this notice or on other relevant matters. These comments will be considered before taking final action. Interested parties may participate in the Federal rulemaking procedure by submitting written comments to this proposed rule by following the instructions listed in the
In this rule, the EPA is proposing to include in a final EPA rule regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is proposing to incorporate by reference Connecticut's regulation section 22a-174-4a (source monitoring, record keeping and reporting), and modifications to sections 22a-174-20(a)(12), 22a-174-22e(m)(1), and 22a-174-22e(m)(4) as discussed in section II. The EPA has made, and will continue to make, these documents generally available through
EPA is also proposing to remove Connecticut's regulation section 22a-174-4 (source monitoring, record keeping and reporting), which was approved July 16, 2014 (79 FR 41427), from the Connecticut SIP.
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.
• 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 (Public Law 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.
In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where 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).
Executive Order 12898 (Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations, 59 FR 7629, Feb. 16, 1994) directs Federal agencies to identify and address “disproportionately high and adverse human health or environmental effects” of their actions on minority populations and low-income populations to the greatest extent practicable and permitted by law. EPA defines environmental justice (EJ) as “the fair treatment and meaningful involvement of all people regardless of race, color, national origin, or income with respect to the development, implementation, and enforcement of environmental laws, regulations, and policies.” EPA further defines the term fair treatment to mean that “no group of people should bear a disproportionate burden of environmental harms and risks, including those resulting from the negative environmental consequences of industrial, governmental, and commercial operations or programs and policies.”
The Connecticut DEEP did not evaluate environmental justice considerations as part of its SIP submittal; the CAA and applicable implementing regulations neither prohibit nor require such an evaluation. EPA did not perform an EJ analysis and did not consider EJ in this action. Due to the nature of the action being taken here, this action is expected to have a neutral to positive impact on the air quality of the affected area. Consideration of EJ is not required as part of this action, and there is no information in the record inconsistent with the stated goal of E.O. 12898 of achieving environmental justice for people of color, low-income populations, and Indigenous peoples.
Environmental protection, Air pollution control, Carbon monoxide, Incorporation by reference, Intergovernmental relations, Lead, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds.
Environmental Protection Agency (EPA).
Notice of filing of petition and request for comment.
This document announces the Agency's receipt of an initial filing of a pesticide petition requesting the establishment or modification of regulations for residues of pesticide chemicals in or on various commodities.
Comments must be received on or before April 1, 2024.
Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2024-0059, through the
Madison H. Le, Biopesticides and Pollution Prevention Division (BPPD) (7511M), main telephone number: (202) 566-1400, email address:
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).
• Pesticide manufacturing (NAICS code 32532).
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EPA is announcing receipt of a pesticide petition filed under section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, requesting the establishment or modification of regulations in 40 CFR part 180 for residues of pesticide chemicals in or on various food commodities. The Agency is taking public comment on the request before responding to the petitioner. EPA is not proposing any particular action at this time. EPA has determined that the pesticide petition described in this document contains data or information prescribed in FFDCA section 408(d)(2), 21 U.S.C. 346a(d)(2); however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting of the pesticide petition. After considering the public comments, EPA intends to evaluate whether and what action may be warranted. Additional data may be needed before EPA can make a final determination on this pesticide petition.
Pursuant to 40 CFR 180.7(f), a summary of the petition that is the subject of this document, prepared by the petitioner, is included in a docket EPA has created for this rulemaking. The docket for this petition is available at
As specified in FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), EPA is publishing notice of the petition so that the public has an opportunity to comment on this request for the establishment or modification of regulations for residues of pesticides in or on food commodities. Further information on the petition may be obtained through the petition summary referenced in this unit.
21 U.S.C. 346a.
Legal Services Corporation.
Request for Information.
The Legal Services Corporation (LSC) is requesting public input on proposed revisions to regulations related to client grievance procedures and prohibition of discrimination based on disability, respectively. LSC is considering expanding the regulations' scope to require grantees to establish grievance procedures for board members and ensure they are afforded disability protections. The main purpose of these proposals would be to give board members the same protections under the regulations as applicants for legal assistance, clients, and grantee employees.
Comments due May 29, 2024.
Listening sessions, all conducted via Zoom, all times Eastern:
1. Wednesday, March 13, 2024, 10:30 a.m.-12:30 p.m.
2. Friday, March 22, 2024, 2:00 p.m.-4:00 p.m.
3. Tuesday, April 3, 2024, 3:00 p.m.-5:00 p.m.
4. Monday, April 15,2024, 1:00 p.m.-3:00 p.m.
You may send comments by any of the following methods:
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Brittany Sims Nwankwoala, Assistant General Counsel, Legal Services Corporation, 3333 K Street NW, Washington, DC 20007; (202) 295-1599 (phone); or
Find your local number:
Part 1624 requires LSC funded legal services programs to remove any impediments that may exist to the provision of legal assistance to persons with disabilities eligible for such assistance in accordance with section 504 of the Rehabilitation Act of 1973. Currently, part 1624 explicitly applies only to applicants for legal assistance, clients, applicants for employment, and grantee employees. Because many client-eligible members are persons with disabilities, the commenters felt expanding part 1624 to include governing body members was necessary to ensure that client-eligible individuals are afforded the same opportunities to be selected for and participate in grantee governing body activities as persons who do not have disabilities.
Through this Notice, LSC is asking grantees, clients, other stakeholders, and interested members of the public to provide LSC with their views on the following questions:
• What policies and procedures do your organizations currently have in place to address board member grievances? Describe the process.
• Has your organization had positive or negative experiences with utilizing these procedures in the past?
• What effect or impact would revising parts 1621 and 1624 to apply to grantee governing body members have on your organization? Unexpected outcomes?
• Based on previous experience, how often would your organization use regulations like part 1621 and part 1624?
• Is there anything else LSC can do to help resolve conflicts on your organization's board?
Interested parties may submit their comments in writing to LSC via email, fax, or postal mail. Additionally, LSC will hold four listening sessions during which interested parties may join a Zoom call with LSC staff to provide their comments orally. The dates and access information for those listening sessions are contained in the
Federal Communications Commission.
Petition for Reconsideration of Action in a Rulemaking Proceeding in WC Docket No. 17-84, adopted by the Commission on December 13, 2023, by Thomas B. Magee on behalf of Coalition of Concerned Utilities.
Oppositions to the Petition must be filed on or before March 15, 2024. Replies to oppositions to the Petition must be filed on or before March 25, 2024.
Federal Communications Commission, 45 L Street NE, Washington, DC 20554.
For additional information on this proceeding, contact Michael Ray of the Wireline Competition Bureau, Competition Policy Division, at (202) 418-0357 or
This is a summary of the Commission's document, Report No. 3210, released February 16, 2024. The full text of the Petition can be accessed online via the Commission's Electronic Comment Filing System at:
Federal Communications Commission.
Proposed rule.
In this document, based on a Petition for Rulemaking Addendum—Request for Clarification filed by the National Association of Broadcasters and Xperi, Inc., the Commission seeks additional public comment in the pending rulemaking proposing to change the methodology to determine whether an FM digital broadcast station can increase its digital power, and to allow asymmetric sideband operation.
All filings must be submitted in MB Docket No. 22-405. Pursuant to sections 1.415 and 1.419 of the Commission's rules, 47 CFR 1.415, 1.419, interested parties may file comments and reply comments on or before the dates indicated in the
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• Paper Filers: Parties who choose to file by paper must file an original and one copy of each filing.
Filings can be sent by commercial overnight courier, or by first-class or overnight U.S. Postal Service mail. All filings must be addressed to the Commission's Secretary, Office of the Secretary, Federal Communications Commission.
• Commercial overnight mail (other than U.S. Postal Service Express Mail and Priority Mail) must be sent to 9050 Junction Drive, Annapolis Junction, MD 20701.
• U.S. Postal Service first-class, Express, and Priority mail must be addressed to 45 L Street NE, Washington, DC 20554.
• Effective March 19, 2020, and until further notice, the Commission no longer accepts any hand or messenger delivered filings. This is a temporary measure taken to help protect the health and safety of individuals, and to mitigate the transmission of COVID-19. See FCC Announces Closure of FCC Headquarters Open Window and Change in Hand-Delivery Policy, Public Notice, DA 20-304 (March 19, 2020).
Albert Shuldiner, Chief, Media Bureau, Audio Division, (202) 418-2700; Thomas Nessinger, Senior Counsel, Media Bureau, Audio Division, (202) 418-2700. Press inquiries should be directed to Nancy Murphy, (202) 418-1043.
This is a summary of the Media Bureau's Public Notice in MB Docket No. 22-405; DA 24-154, released on February 21, 2024. The full text of this document is available electronically for public inspection via the Commission's Electronic Comment Filing System (ECFS) at
1. The Commission initiated this proceeding on August 1, 2023, with the release of an Order and Notice of Proposed Rulemaking seeking comment on a proposal to change the methodology used by digital FM stations to determine whether they can increase FM digital power, and to allow asymmetric sideband operation. Modifying Rules for FM Terrestrial Digital Audio Broadcasting Systems, MB Docket No. 22-405, Order and Notice of Proposed Rulemaking, FCC 23-61 (rel. Aug. 1, 2023) (NPRM). A
2. On February 2, 2024, the National Association of Broadcasters (NAB) and Xperi Inc. (Xperi), two of the parties that filed Petitions for Rulemaking that led to release of the NPRM, filed with the Media Bureau (Bureau) a Petition for Rulemaking Addendum—Request for Clarification (Petition for Clarification), which is available in the Commission's Electronic Comment Filing System at
3. In light of this requested clarification, and to provide a complete record on this issue, the Bureau encourages public comment on NAB and Xperi's proposed clarifying language and changes to proposed § 73.404(e) of the rules. The Bureau notes that NAB and Xperi ask the Commission to incorporate a reference in the rules to the NRSC-5 standard, which is subject to modification, as an appropriate means to implement the proposed change. Because it is unusual for the Commission to incorporate outside standards into its rules, the Bureau states that commenters should offer alternative means to incorporate the proposed clarification directly into the Commission's rules. The Bureau further seeks comment on whether the additional digital power necessitated by use of extended digital modes would increase potential interference to first adjacent channel analog FM stations, to the host analog station, or to other users of the FM broadcast spectrum or adjacent to that spectrum. The Bureau notes that the Petition for Clarification does not reference any technical studies
Rural Utilities Service, USDA.
Notice.
President Joe Biden has pledged that every American will have access to affordable, reliable, high-speed internet. Digital equity devices, skills and affordability that brings the internet to life are a critical part of that mission. As part of that work, the Rural Utilities Service (RUS, Agency), a Rural Development (RD) agency of the United States Department of Agriculture (USDA), announces the acceptance of applications under the Distance Learning and Telemedicine (DLT) grant program for fiscal year (FY) 2024, subject to the availability of funding. This notice is being issued prior to passage of a FY 2024 Appropriations Act in order to allow applicants sufficient time to leverage financing, prepare and submit their applications, and give the Agency time to process applications within FY 2024. Based on FY 2023 appropriated funding, the Agency estimates that approximately $60 million will be available for FY 2024. Successful applications will be selected by the Agency for funding and subsequently awarded to the extent that funding may ultimately be made available through appropriations. All applicants are responsible for any expenses incurred in developing their applications.
Applications must be submitted through
All applications must be submitted electronically at
For inquiries regarding eligibility concerns, please contact program staff at
• Assisting rural communities recover economically through more and better market opportunities and through improved infrastructure.
• Ensuring all rural residents have equitable access to RD programs and benefits from RD funded projects; and
• Reducing climate pollution and increasing resilience to the impacts of climate change through economic support to rural communities.
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To combat a key threat to economic prosperity, rural workforce and quality of life, the Agency is directed to set aside 20% of the total available funds for FY 2024 for projects that seek to reduce the morbidity and mortality associated with substance use disorder (including opioid misuse) in rural communities by strengthening the capacity to address prevention, treatment and/or recovery at the community level.
The total appropriated amount minus the determined set aside amount will be available for all eligible projects. RUS may at its discretion, increase the total level of funding available in this funding round from any available source provided the awards meet the requirements of the statute which made the funding available to the Agency.
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(a) Applicants must have a Unique Entity Identifier (UEI) and an active registration that includes the Financial Assistance Representations and Certifications and has current information in the System for Award Management (SAM) at:
(b) Corporations that have been convicted of a federal felony within the past 24 months are not eligible. Any corporation that has been assessed to have any unpaid federal tax liability, for which all judicial and administrative remedies have been exhausted or have lapsed and is not being paid in a timely manner pursuant to an agreement with the authority responsible for collecting the tax liability, is not eligible for financial assistance.
(c) Applicants are required to provide evidence of their ability to contract with RUS to obtain the grant and comply with all applicable requirements, in accordance with 7 CFR 1734.4(a). It is incumbent on applicants to determine the appropriate entity to apply for the grant. Entities created by educational or medical institutions for the purpose of applying for and managing grants, such as university or hospital foundations, should not be applicants unless they can own and manage grant-funded equipment as required by the Grant Agreement and applicable regulations, including 2 CFR part 200. Accordingly, RUS will not transfer awards to another entity because the applicant has later determined that it cannot close the award, execute the standard Grant Agreement, which is publicly available, nor hold the grant assets in its name.
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(a) The Application Guide provides additional information regarding eligible and ineligible items for equipment and facilities.
(b) Grant applications that are written by vendors who are mentioned in the application as vendors to be used on the project to be funded by the DLT award are ineligible as a violation of the competition rules in 2 CFR 200.319. Such vendors are also prohibited from bidding on the project because of conflict of interest. Additionally, applicants must fully understand the procurement requirements of 2 CFR part 200, subpart D and 7 CFR part 1734 when compiling an application for submission and must avoid the use of predetermined equipment as a violation of the bidding requirements unless they have adequately demonstrated in the application that no other equipment is available for the intended purpose.
(c) Projects located in areas covered by the Coastal Barrier Resources Act (16 U.S.C. 3501
(d) If a DLT project proposes service on or over Tribal Lands and the applicant is non-Tribal, then a letter of consent is required from each Tribal
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(a) At the time of application, each applicant must have an active registration in the SAM before submitting its application in accordance with 2 CFR part 25. To register in the SAM, entities will be required to obtain a UEI. Instructions for obtaining the UEI are available at
(b) Applicants must maintain an active SAM registration, with current, accurate and complete information, at all times during which it has an active federal award or an application under consideration by a federal awarding agency.
(c) Applicants must ensure they complete the Financial Assistance General Certifications and Representations in the SAM.
(d) Applicants must provide a valid UEI in its application, unless determined exempt under 2 CFR 25.110.
(e) The Agency will not make an award until the applicant has complied with all the SAM requirements including providing the UEI. If an applicant has not fully complied with the requirements by the time the Agency is ready to make an award, the Agency may determine that the applicant is not qualified to receive a federal award and use that determination as a basis for making a federal award to another applicant.
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The Agency will not solicit or consider new scoring or eligibility information that is submitted after the application deadline. The Agency reserves the right to contact applicants to seek clarification on materials contained in the submitted application.
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(a) Ineligible grant purposes are outlined in 7 CFR 1734.23. Applicants should exclude ineligible items and ineligible matching contributions from the budget. If an ineligible item or matching contribution is included in the budget, the item will be removed and may result in an application being deemed ineligible. See the Application Guide for more details on funding restrictions, matching contributions, a recommended budget format, and detailed budget compilation instructions.
(1) If an application includes both eligible and ineligible grant purposes on a single line of the application budget, and the cost of the ineligible item can be determined, the ineligible item will be removed from the approved budget. However, the entire line item will be deemed ineligible if the cost of the ineligible item cannot be determined.
(b) Hub sites located in non-rural areas are not eligible for grant assistance unless they are necessary to provide DLT services to rural residents at end user sites. See 7 CFR 1734.2(h).
(c) For the purposes for this NOSA, the cost of video conferencing platform licenses is considered an eligible cost if:
(1) The video conferencing platform is an integral component in a project delivering distance learning or telemedicine services to an end user through the use of eligible equipment;
(2) The cost does not exceed ten percent of the requested grant amount;
(3) The application demonstrates that the predominant use (50 percent or more) of the video conferencing platform will be for the distance learning or telemedicine project;
(4) The license is new and not a renewal of an existing license; and
(5) The number of licenses requested does not exceed the number of end-user devices requested in the application.
The duration of funding for video conferencing platform licenses is limited to three years from the date funds are made available.
(d) If an application includes multiple costs on a single line of the application budget, one of which is subject to a cost limitation, as outlined in 7 CFR 1734.21, the items that are not subject to the cost limitation will be deducted when calculating the cost limitation percentage. However, the entire line item will be applied against the cost limitation if each cost cannot be determined.
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(a) Applications will not be accepted via paper, fax or electronic mail.
(b) Submit the electronic application through
(c) For duplicate applications submitted through
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(1) the population size of each community where an end-user site is located and
(2) whether an end-user site lies within an urbanized area contiguous and adjacent to a city or town having a population in excess of 50,000 inhabitants.
For non-fixed site projects and projects which contain non-fixed components, the rurality score will be based on the hub site.
Applicants should use 2020 census data from the census website (
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(i) Projects proposing to serve rural communities with a Social Vulnerability Index (SVI) with a score of 0.75 or higher are eligible. For the purposes of this NOSA, Puerto Rico, Guam, America Samoa, the Northern Mariana Islands, Palau, the Marshall Islands, the Federated States of Micronesia, the U.S. Virgin Islands, and Hawaiian Census Tribal areas are considered Socially Vulnerable Communities. A GIS layer identifying the Socially Vulnerable Communities can be found using the DLT mapping tool available at:
(ii) Projects that enable and improve distance learning and telemedicine services on Tribal Lands. Tribal Lands will be identified in GIS layers included in the DLT mapping tool available at:
(iii) Projects proposed by a federally recognized Tribe, including Tribal instrumentalities and entities that are wholly owned by Tribes.
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The Agency evaluates grant applications in accordance with 7 CFR 1734.27(c). The Agency reserves the right to offer the applicant less than the grant funding requested.
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The items listed in 7 CFR part 1734, this announcement, the Application Guide, and program resources implement the appropriate administrative and national policy requirements, which include but are not limited to:
(a) Executing a DLT Grant Agreement.
(b) Using Form SF 270, Request for Advance or Reimbursement, to request reimbursements (along with the submission of receipts for expenditures and any other documentation to support the request for reimbursement).
(c) Submitting an annual Project Performance Activity Report, no later than January 31st of the year following the year in which all or any portion of the grant is first advanced and continuing in subsequent years until completion of the project.
(d) Ensuring that records are maintained to document all activities and expenditures utilizing DLT grant funds and matching funds (receipts for expenditures are to be included in this documentation).
(e) Providing a final project performance report, no later than one hundred twenty (120) days after the expiration date, termination of the grant, the project completion, or the final disbursement of the grant by the grantee, whichever event occurs last.
(f) Complying with policies, guidance, and requirements as described in the following applicable Code of Federal Regulations, and any successor regulations:
(1) 2 CFR parts 200 and 400 (Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards).
(2) 2 CFR parts 417 and 180 (Government-wide Nonprocurement Debarment and Suspension).
(g) Complying with Executive Order 13166, Improving Access to Services for Persons with Limited English Proficiency. For information on limited English proficiency and agency-specific guidance, go to
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The policies contained in this subpart apply to recipients. As recipients of federal financial assistance, awardees are required to comply with the applicable federal, tribal, state and local laws. Title VI of the Civil Rights Act of 1964 and Section 504 of the Rehabilitation Act prohibits discrimination by recipients of federal financial assistance. Recipients are required to adhere to specific outreach activities. These outreach activities include contacting community organizations and leaders that include minority leaders; advertising in local newspapers and other media throughout the entire service area; and including the nondiscrimination slogan, “This is an Equal Opportunity Program. Discrimination is prohibited by Federal Law,” in methods that may include, but not be limited to, advertisements, electronic media, public broadcasts, and printed materials, such as brochures and pamphlets.
By completing the Financial Assistance Representations and Certifications in SAM, recipients affirm that they will operate the program free from discrimination. The recipient will maintain the race and ethnic data on the board members and beneficiaries of the program. The recipient will provide alternative forms of communication to persons with limited English proficiency. The Agency will conduct Civil Rights Compliance Reviews on recipients to identify the collection of racial and ethnic data on program beneficiaries. In addition, the compliance review will ensure that equal access to the program benefits and activities are provided for persons with disabilities and language barriers.
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(1) Non-Federal Entities, which include recipients that are states, local governments, Indian tribes, institutions of higher education, or nonprofit organizations, shall provide RUS with an audit pursuant to 2 CFR part 200, subpart F (Audit Requirements). The recipient must follow subsection 2 CFR 200.502 in determining federal awards expended. All RUS loans impose an ongoing compliance requirement for the purpose of determining federal awards expended during a fiscal year. In addition, the recipient must include the value of new federal loans made along with any grant expenditures from all federal sources during the recipient's fiscal year. Therefore, the audit submission requirement for this program begins in the recipient's fiscal year that the loan is made and thereafter, based on the balance of federal loan(s) at the beginning of the audit period. All required audits must be submitted within the earlier of: (i) 30 calendar days after receipt of the auditor's report; or (ii) nine months after the end of the recipient's audit period.
(2) For all other entities, recipients shall provide RUS with an audit within 120 days after the as of audit date in accordance with 7 CFR part 1773. With respect to grant funds, the audit is required until all grant funds have been expended or rescinded. While an audit is required, recipients must also submit the reports on internal control; compliance with provisions of laws, regulations, contracts and grant agreements; and instances of fraud.
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(1) First Tier Sub-Awards of $25,000 or more (unless they are exempt under 2 CFR part 170) must be reported by the recipient to
(2) The total compensation of the recipient's executives (the five most highly compensated executives) must be reported by the recipient (if the recipient meets the criteria under 2 CFR part 170) to
(3) The total compensation of the sub-recipient's executives (the five most highly compensated executives) must be reported by the sub-recipient (if the sub- recipient meets the criteria under 2 CFR part 170) to the recipient by the end of the month following the month in which the sub-award was made.
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For general questions about this announcement, please contact the point of contact provided in the
With respect to any construction under the DLT project, Awardees that are Non-Federal Entities, defined pursuant to 2 CFR 200.1 as any State, local government, Indian tribe, Institution of Higher Education, or nonprofit organization, shall be governed by the requirements of Section 70914 of the Build America, Buy America Act (BABAA) within the Infrastructure Investment and Jobs Act (Pub. L. 117-58), and its implementing regulations at 2 CFR part 184. Any requests for waiver of these requirements must be submitted pursuant to USDA's guidance available online at
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Program information may be made available in languages other than English. Persons with disabilities who require alternative means of communication to obtain program information (
To file a program discrimination complaint, a complainant should complete a Form AD-3027,
USDA is an equal opportunity provider, employer, and lender.
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 (FACA) that a meeting of the Tennessee Advisory Committee to the Commission will convene by Zoom on Wednesday, March 13, 2024, at 3:30 p.m. (CT). The purpose of the meeting is to discuss their draft report on Voting Rights in the state.
The meeting will take place on Wednesday, March 13, 2024, at 3:30 p.m. (CST).
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 call-in number found through registering at the web link provided above for the meeting.
Members of the public are entitled to make comments during the open period at the end of the meeting. Members of the public may also submit written comments; the comments must be received in the Regional Programs Unit within 30 days following the respective 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
Under Secretary of Economic Affairs, Department of Commerce.
Notice of information collection, request for comment.
The Department of Commerce, in accordance with the Paperwork Reduction Act of 1995 (PRA), invites the general public and other Federal agencies to comment on proposed, and continuing information collections, which helps us assess the impact of our information collection requirements and minimize the public's reporting burden. The purpose of this notice is to allow for 60 days of public comment preceding submission of the collection to OMB.
To ensure consideration, comments regarding this proposed information collection must be received on or before April 29, 2024.
Interested persons are invited to submit written comments to Kenneth White, Office of the Under Secretary of Economic Affairs, by email at
Requests for additional information or specific questions related to collection activities should be directed to Kenneth White, Senior Policy Analyst, Under Secretary of Economic Affairs, U.S. Department of Commerce; by phone at (202) 482-2406 or via email at
This is a request for an extension of an already approved collection of information. In 2021 the Secretary held a referendum among eligible manufacturers to determine whether they favored the implementation of an Order to establish an orderly program for developing, financing, and carrying out an effective, continuous, and coordinated program of research, education and promotion, to support the concrete masonry products industry. The referendum passed and the Order went into effect in December 2021. The law requires the Secretary to conduct an additional referendum in the event: the Board requests such action or if after five years (2026) at least 25 percent of those eligible request such action. Continuation of this approved collection will cover both of these potential occurrences.
In 2022, the Secretary appointed members to the Concrete Masonry Products Board (Board) to develop and implement programs of research, education, and promotion. In 2023, the Board began collecting assessments
There are two forms in this Information Collection Request (ICR) relating to the referendum. The first is the registration form for the concrete referendum. The registration form may be submitted by eligible concrete masonry unit manufacturers and is necessary to ensure that the referendum is accurate and complete. Manufacturers only may participate in the referendum if they register. The second form for this ICR relates to the ballot form for the concrete referendum. Eligible concrete masonry unit manufacturers may complete and submit the ballot to reflect their desire for or against implementing the order. Authorizing Statute: 15 U.S.C. chapter 13 (sections 8701-8717).
Registrants may download, complete, print, and submit via fax or mail from the DOC website.
We are soliciting public comments to permit the Department/Bureau to: (a) Evaluate whether the proposed information collection is necessary for the proper functions of the Department, including whether the information will have practical utility; (b) Evaluate the accuracy of our estimate of the time and cost burden for this proposed collection, including the validity of the methodology and assumptions used; (c) Evaluate ways to enhance the quality, utility, and clarity of the information to be collected; and (d) Minimize the reporting burden on those who are to respond, including the use of automated collection techniques or other forms of information technology.
Comments that you submit in response to this notice are a matter of public record. We will include or summarize each comment in our request to OMB to approve this ICR. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you may ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of public meeting.
NMFS will convene the Research Track Assessment Peer Review Meeting for the purpose of reviewing Golden Tilefish. The Research Track Assessment Peer Review is a formal scientific peer-review process for evaluating and presenting stock assessment results to managers for fish stocks in the offshore U.S. waters of the northwest Atlantic. Assessments are prepared by the research track working group and reviewed by an independent panel of stock assessment experts from the Center of Independent Experts (CIE). The public is invited to attend the presentations and discussions between the review panel and the scientists who have participated in the stock assessment process.
The public portion of the Research Track Assessment Peer Review Meeting will be held from March 11, 2024-March 14, 2024. The meeting will conclude on March 14, 2024 at 12 p.m. eastern standard time. Please see
The meeting will be held in person and virtually. The in person meeting will be held in the S.H. Clark Conference Room in the Aquarium Building of the National Marine Fisheries Service, Northeast Fisheries Science Center (NEFSC), 166 Water Street, Woods Hole, MA 02543 and virtually using this Google Meet link:
Michele Traver, 508-495-2195;
For further information, please visit the NEFSC website at
The agenda is subject to change; all times are approximate and may be changed at the discretion of the Peer Review Chair.
The meeting is open to the public; however, during the `Report Writing' sessions on Wednesday, March 13th and Thursday, March 14th, the public should not engage in discussion with the Peer Review Panel.
This meeting is physically accessible to people with disabilities. Special
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of web conference.
The North Pacific Fishery Management Council (Council) Pacific Northwest Crab Industry Advisory Committee (PNCIAC) will meet March 15, 2024.
The meeting will be held on Friday, March 15, 2024, from 12 p.m. to 2 p.m., Alaska Time.
The meeting will be a web conference. Join online through the link at
Sarah Marrinan, Council staff; phone; (907) 271-2809; email:
The Committee will discuss several topics including: (a) consider Board of Fisheries proposals (
You can attend the meeting online using a computer, tablet, or smart phone, or by phone only. Connection information will be posted online at:
Public comment letters will be accepted and should be submitted electronically to
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of SEDAR 95 Atlantic Migratory Cobia Data Scoping Webinar.
The SEDAR 95 assessment of the Atlantic stock of cobia will consist of a series of data and assessment webinars. A SEDAR 95 Data Scoping Webinar is scheduled for March 18, 2024. See
The SEDAR 95 Atlantic Migratory Cobia Data Scoping Webinar has been scheduled for March 18, 2024, from 1 p.m. to 3 p.m., Eastern. The established times may be adjusted as necessary to accommodate the timely completion of discussion relevant to the assessment process. Such adjustments may result in the meeting being extended from or completed prior to the time established by this notice.
Meisha Key, SEDAR Coordinator, 4055 Faber Place Drive, Suite 201, North Charleston, SC 29405; phone: (843) 571-4366; email:
The Gulf of Mexico, South Atlantic, and Caribbean Fishery Management Councils, in conjunction with NOAA Fisheries and the Atlantic and Gulf States Marine Fisheries Commissions, have implemented the Southeast Data, Assessment and Review (SEDAR) process, a multi-step method for determining the status of fish stocks in the Southeast Region. SEDAR is a three-step process including: (1) Data Workshop; (2) Assessment Process utilizing webinars; and (3) Review Workshop. The product of the Data Workshop is a data report which compiles and evaluates potential datasets and recommends which datasets are appropriate for assessment analyses. The product of the Assessment Process is a stock assessment report which describes the fisheries, evaluates the status of the stock, estimates biological benchmarks, projects future population conditions, and recommends research and monitoring needs. The assessment is independently peer reviewed at the Review Workshop. The product of the Review Workshop is a Summary documenting panel opinions regarding the strengths and weaknesses of the stock assessment and input data. Participants for SEDAR Workshops are appointed by the Gulf of Mexico, South Atlantic, and Caribbean Fishery Management Councils and NOAA Fisheries Southeast Regional Office, Highly Migratory Species Management Division, and Southeast Fisheries Science Center. Participants include: data collectors and database managers; stock assessment scientists, biologists, and researchers; constituency representatives including fishermen, environmentalists, and non-governmental organizations (NGOs); international experts; and staff of Councils, Commissions, and state and federal agencies.
The items of discussion at the SEDAR 95 Atlantic Migratory Cobia Data Scoping Webinar are as follows: Discuss available data resources, points of contact, data delivery deadlines, and any known data issues.
Although non-emergency issues not contained in this agenda may come before this group for discussion, those issues may not be the subject of formal action during this meeting. Action will be restricted to those issues specifically
This meeting is accessible to people with disabilities. Requests for auxiliary aids should be directed to the South Atlantic Fishery Management Council office (see
The times and sequence specified in this agenda are subject to change.
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
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of a public meeting.
The Gulf of Mexico Fishery Management Council will hold a two day in-person meeting of its Shrimp Advisory Panel (AP).
The meeting will convene Tuesday, March 19, 2024, from 8:30 a.m. to 5 p.m. and Wednesday, March 20, 2024, from 8:30 a.m. to 3 p.m., EDT. For agenda details, see
The meeting will take place at the Gulf Council office. Registration information will be available on the Council's website by visiting
Dr. Matt Freeman, Economist, Gulf of Mexico Fishery Management Council;
The following items are on the agenda, though agenda items may be addressed out of order (changes will be noted on the Council's website when possible.)
Meeting will begin with Adoption of Agenda, Approval of Summary from the October 19, 2023 meeting, and Scope of Work. The AP will review and discuss Council Actions in Response to Motions from the October 2023
The AP will receive updates on the following: Southeast Regional Office (SERO) Protected Resources,
The AP will review the 2022 Gulf
Lastly, the AP will receive any public testimony and discuss other business items: Remainder of
The in-person meeting will be broadcast via webinar. You may register by visiting
The Agenda is subject to change, and the latest version along with other meeting materials will be posted on
Although other non-emergency issues not on the agenda may come before the Advisory Panel for discussion, in accordance with the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act), those issues may not be the subject of formal action during this meeting. Actions will be restricted to those issues specifically identified in this notice and any issues arising after publication of this notice that require emergency action under Section 305(c) of the Magnuson-Stevens Act, provided the public has been notified of the Council's intent to take-action to address the emergency at least 5 working days prior to the meeting.
These meetings are physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aid or accommodations should be directed to Kathy Pereira,
Northern Border Regional Commission.
Notice of adoption of categorical exclusions.
The Northern Border Regional Commission (NBRC) is adopting categorical exclusions (CEs) established by the Denali Commission, which the NBRC will apply to similar NBRC categories of actions to comply with the National Environmental Policy Act. This notice identifies the Denali Commission CEs and NBRC's categories of proposed actions for which it intends to use the Denali Commission's CEs, and describes the consultation between the agencies.
The CEs identified below are available for the NBRC to use for its proposed actions effective upon publication.
Rich Grogan, NBRC Executive Director, telephone number: 603-369-3001, email:
Congress enacted the National Environmental Policy Act, 42 U.S.C. 4321-4347, (NEPA) in order to encourage productive and enjoyable harmony between humans and the environment, recognizing the profound impact of human activity and the critical importance of restoring and maintaining environmental quality to the overall welfare of humankind. 42 U.S.C. 4321, 4331. NEPA seeks to ensure that agencies consider the environmental effects of their proposed major actions in their decision-making processes and inform and involve the public in that process. NEPA created the Council on Environmental Quality (CEQ), which promulgated NEPA implementing regulations, 40 CFR parts 1500 through 1508 (CEQ regulations).
To comply with NEPA, agencies determine the appropriate level of review of any major Federal action—an environmental impact statement (EIS), environmental assessment (EA), or CE. 40 CFR 1501.3. If a proposed action is likely to have significant environmental effects, the agency must prepare an EIS and document its decision in a record of decision. 40 CFR part 1502, 1505.2. If the proposed action is not likely to have significant environmental effects or the effects are unknown, the agency may instead prepare an environmental assessment (EA), which involves a more concise analysis and process than an EIS. 40 CFR 1501.5. Following the EA, the agency may conclude that the action will have no significant effects and document that conclusion in a finding of no significant impact. 40 CFR 1501.6. If the analysis concludes that the action is likely to have significant effects, however, then an EIS is required.
Under NEPA and the CEQ regulations, a Federal agency also can establish CEs—categories of actions that the agency has determined normally do not significantly affect the quality of the human environment—in their agency NEPA procedures. 42 U.S.C. 4336e(1); 40 CFR 1501.4, 1507.3(e)(2)(ii), 1508.1(d). If an agency determines that a CE covers a proposed action, it then evaluates the proposed action for extraordinary circumstances in which a normally excluded action may have a significant effect. 40 CFR 1501.4(b). If no extraordinary circumstances are present or if further analysis determines that the extraordinary circumstances do not involve the potential for significant environmental effects, the agency may apply the CE to the proposed action without preparing an EA or EIS. 42 U.S.C. 4336(a)(2), 40 CFR 1501.4. If the extraordinary circumstances have the potential to result in significant effects, the agency is required to prepare an EA or EIS.
An agency may not segment an action to meet the definition of a CE. Agencies must evaluate, in a single review, proposals or parts of proposals that are related to each other closely enough to be, in effect, a single course of action, and must consider as part of the review any connected actions. Connected actions are ones that automatically trigger other actions, cannot or will not proceed unless other actions are taken, or are interdependent parts of a larger action and depend on the larger action for their justification.
Section 109 of NEPA, enacted as part of the Fiscal Responsibility Act of 2023, allows a Federal agency to “adopt” and use another Federal agency's CEs for proposed actions. 42 U.S.C. 4336c. To use another agency's CEs under section 109, the adopting agency must identify the relevant CEs listed in another agency's (“establishing agency”) NEPA procedures that covers the adopting agency's category of proposed actions or related actions; consult with the establishing agency to ensure that the proposed adoption of the CE for a category of actions is appropriate;
Created in 2008, the Northern Border Regional Commission (NBRC) is a Federal-State partnership whose mission is to help alleviate economic distress and encourage private sector job creation in Maine, New Hampshire, New York, and Vermont. In its fifteen-year history, the NBRC has awarded over 400 grants through its primary Catalyst Program, the Forest Economy Program (FEP), the Timber for Transit program, and other special initiatives.
Since 2008, the NBRC has grown each year, both in size and appropriations, and was included in the 2021 Bipartisan Infrastructure Law (BIL) passed by Congress, which appropriated $150 million to the Commission for deployment across its four-State footprint in support of a wide range of economic development projects. Eligible recipients for NBRC grant funds include State and local governments, Indian Tribes, and public and nonprofit organizations.
Through its grantmaking, the NBRC funds projects in the following categories, as prescribed in 40 U.S.C., subtitle V, section 15501:
(1) to develop the transportation infrastructure of its region;
(2) to develop the basic public infrastructure of its region;
(3) to develop the telecommunications infrastructure of its region;
(4) to assist its region in obtaining job skills training, skills development and employment-related education, entrepreneurship, technology, and business development;
(5) to provide assistance to severely economically distressed and underdeveloped areas of its region that lack financial resources for improving basic health care and other public services;
(6) to promote resource conservation, tourism, recreation, and preservation of open space in a manner consistent with economic development goals;
(7) to promote the development of renewable and alternative energy sources; and
(8) to otherwise achieve the purposes of this subtitle.
Created by Congress in 1998, the Denali Commission is essentially similar to the NBRC in its mission and function. The Denali Commission Act of 1998 established the Denali Commission (Commission), and as part of the act, the Commission's mission of providing job training and other economic development services in rural communities was established with a specific focus on promoting rural development, and providing power generation, transmission facilities, modern communication systems, water and sewer systems and other infrastructure needs in rural Alaska.
Since its inception, the Denali Commission Act of 1998 has been updated several times expanding its mission to include the planning and construction of health care facilities and the establishment of the Denali Access System Program for surface transportation infrastructure and waterfront transportation projects. The NBRC collaborates extensively with the Denali Commission on both administrative and programmatic matters.
NBRC is in the process of developing its own list of CEs and, in the interim, has identified the following CEs listed in appendices A and B to subtitle B of the Denali Commission's NEPA implementing procedures, 45 CFR part 900. The NBRC will require all grantees to complete a CATEX Checklist, which will closely resemble the CATEX Checklist completed by applicants to the Denali Commission's programs. The NBRC will review the CATEX Checklist and project details and, if it determines that application of the CATEX is appropriate, will post a Memorandum for Record (MFR) on NBRC's NEPA-dedicated web page, which may be accessed by the public.
Because the Denali Commission and the NBRC serve similar purposes with respect to economic development in their respective Congressionally prescribed regions, the list of categories in the Denali procedures aligns closely with the categories of actions for which NBRC contemplates using the CE at this time.
Actions consistent with any of the following categories are, in the absence of extraordinary circumstances, categorically excluded from further analysis in an EA or EIS:
Application of the CE will be limited to the following NBRC activities:
• Internal operations of the NBRC.
• Grants that support discrete administrative and management activities funded under the authority granted in 40 U.S.C. 15501(a) such as internal planning, budgeting, and procurement activities.
Application of the CE will be limited to the following NBRC activities:
• Participation in regional forums,
• Single or multiple-agency visits to projects and potential projects;
• Participation in strategic planning initiatives of stakeholders and regional partners;
• Participation on ad hoc committees designed to elucidate community needs and economic development objectives.
Application of the CE will be limited to the following NBRC activities:
• Grants for capacity building initiatives in the NBRC's region to address limited capacity among partners and stakeholders, grantees and potential grantees. These initiatives include: Adding staff and/or contractual capacity within regional economic development entities for the purpose of technical assistance to grantees; Providing support for administrative overhead costs for these economic development entities; Providing grants for contractual support for grantees and potential grantees to be deployed through regional economic development entities.
Application of the CE will be limited to the following NBRC activities:
• Grants for workforce development and training programs, planning initiatives, community visioning processes, and other community-based capacity-building initiatives.
Application of the CE will be limited to the following NBRC activities:
• Grants for discrete planning and design activities, such as climate resiliency planning, inventory assessments, and identifying local and regional sourcing of forest-based products, where such activities are independent of any actions taken to implement the resulting plans and designs.
Application of the CE will be limited to the following NBRC activities:
• Grants to support discrete nondestructive data collection, inventory, study, research, and monitoring activities funded under 40 U.S.C. 15501(a).
Application of the CE will be limited to the following NBRC activities:
• Grants to support data collection and research that furthers the NBRC's, and/or grantees', stakeholders', partners', etc. understanding of the region's needs, capacity, or funding gaps as it pertains to economic development as defined by the NBRC and expressly noted in 40 U.S.C. 15501(a).
• Approving and issuing grants to organization to provide technical advice and grant administration assistance to organizations (
Application of the CE will be limited to the following NBRC activities:
• Grants to support acquisition and installation of fiber optic cable upgrades and other communications equipment within the existing footprint of a building, vehicle, existing electrical or communications infrastructure to improve broadband access;
• Grants to support acquisition and installation of medical and emergency equipment for medical facilities within the existing footprint of a building or within a vehicle;
• Grants to support acquisition and installation of equipment within the existing footprint of a building or within a vehicle to support enhanced cellular access.
Actions consistent with any of the following categories are, in the absence of extraordinary circumstances, categorically excluded from further analysis and documentation in an EA or EIS upon completion of the Denali Commission CATEX checklist:
Application of the CE will be limited to the following NBRC activities, all of which would occur within the existing footprint of a building or on adjacent disturbed land:
• Grants to support renovation of rural health facilities to bring them up to modern use standards;
• Grants to support upgrades, maintenance and repair of existing transportation infrastructure (
• Grants to support connections to existing trails, for example, from a city street to a bike path, and renovating tourist destination hubs to ensure continued access to tourist centers in the region where potential impacts of connections are documented and do not substantially alter existing facilities, traffic patterns or other existing infrastructure;
• Grants to support additions to existing buildings, roads, harbors, and/or other maritime facilities to ensure continued access for purposes of economic development and/or community access, where the addition will not result in changes to the existing functional use, and where any additions occur on adjacent previously disturbed land.
Application of the CE will be limited to the following NBRC activities:
• Grants to support improvement plans, rehabilitation planning, climate resiliency planning and the like, for projects including new water and wastewater infrastructure, outdoor recreation trails, and transportation studies for airports and roadways, where such assistance is independent of any implementation actions with potential environmental effects and does not result in surface disturbance.
a. Is at the site of existing infrastructure and capacity is not substantially increased; or
b. Is for infrastructure of less than 12,000 square feet of useable space when less than two acres of surface land area are involved at a new site.
Application of the CE will be limited to the following NBRC activities, which would occur on previously disturbed land:
• Grants for new infrastructure at rural healthcare facilities;
• Grants for new infrastructure at childcare facilities;
• Grants for projects that upgrade or replace outdated power generation technology;
• Grants for water and wastewater infrastructure;
Application of the CE will be limited to the following NBRC activities, which would occur on previously disturbed land:
• Grants to support the construction or modification of new or existing power stations and associated infrastructure in the region;
Application of the CE will be limited to the following NBRC activities:
• Grants to support new powerlines to communities seeking new connections or upgrades to existing infrastructure.
Application of the CE will be limited to the following NBRC activities, which would not involve the demolition of structures that are listed on or eligible for listing on the National Register of Historic Properties, or improvement activities outside the footprint of the existing structure:
• Grants to support demolition or improvement of buildings or structures to support economic development activities as specified in 40 U.S.C. 15501(a).
The NBRC will document the use of the above CEs for each project to which they are applied and will maintain this documentation in the project's records in the NBRC's online file storage system. The CEs will be documented in a “Memorandum for Record” format to stay consistent across projects. NBRC annually provides required NEPA dedicated training to our State, regional and local partners, as well as our grantees. NBRC's NEPA process, including all templates, guidance documents, procedures, etc., are made available to the public on NBRC's NEPA-dedicated web page.
If an agency determines that a CE covers a proposed action, the agency must evaluate the proposed action for extraordinary circumstances in which a normally excluded action may have a significant effect. 40 CFR 1501.4(b). NBRC does not currently have its own NEPA implementing procedures to guide its application of extraordinary circumstances. Until NBRC establishes NEPA implementing procedures, for purposes of considering extraordinary circumstances in connection with the Denali Commission CEs discussed in this notice, NBRC will consider whether the proposed action has the potential to result in significant effects by considering the factors listed in the Denali Commission's definition of extraordinary circumstances, including, but not limited to, a reasonable likelihood of significant impacts on environmentally sensitive resources; threatening a violation of a Federal, Tribal, State, or local law or requirement imposed for the protection of the environment; or disproportionate and adverse effects on communities with environmental justice concerns. NBRC would analyze proposed actions for the extraordinary circumstances in the Denali Commission's NEPA implementing procedures and consistent with the CEQ NEPA regulations. 45 CFR 900.204 (c). NBRC will then assess whether an extraordinary circumstance is present and if so, whether the CE may nonetheless be applied, consistent with 40 CFR 1501.4(b) or any successor regulation. If NBRC cannot apply a CE to a particular proposed action due to extraordinary circumstances, NBRC will prepare an EA or EIS, consistent with 40 CFR 1501.4(b)(2), or determine if the action is covered under an existing NEPA document. NBRC will document its consideration of extraordinary circumstances as part of the Memorandum for Record discussed in Part III above.
NBRC worked with the Denali Commission to identify Denali Commission CEs that could apply to NBRC proposed actions and began consultation in September 2023. During this consultation, the agencies discussed whether the categories of NBRC proposed actions would be appropriately covered by the Denali Commission CEs; each Agency's process for review of projects with respect to CEs; and the extraordinary circumstances that NBRC should consider before applying these CEs to NBRC's proposed actions. The consultation continued through early November 2023, and consisted of detailed email exchanges and virtual meetings with the Denali Commission's lead reviewer of NEPA-related items.
At the conclusion of that process, the agencies determined that NBRC's proposed use of the CEs as described in this notice would be appropriate because the categories of actions for which NBRC plans to use the CEs are covered by the Denali Commission CEs.
This notice documents adoption of the Denali Commission CEs listed above in accordance with 42 U.S.C. 4336c(3), and they are available for use by NBRC effective immediately.
Office of Special Education and Rehabilitative Services (OSERS), Department of Education (ED).
Notice.
In accordance with the Paperwork Reduction Act (PRA) of 1995, the Department is proposing an extension without change of a currently approved information collection request (ICR).
Interested persons are invited to submit comments on or before April 29, 2024.
To access and review all the documents related to the information collection listed in this notice, please use
For specific questions related to collection activities, please contact Caneshia McAlister, 202-987-1927.
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
National Center for Education Statistics (NCES), Department of Education (ED).
Notice.
In accordance with the Paperwork Reduction Act (PRA) of 1995, the Department is proposing a revision of a currently approved information collection request (ICR).
Interested persons are invited to submit comments on or before APRIL 29, 2024.
To access and review all the documents related to the information collection listed in this notice, please use
For specific questions related to collection activities, please contact Carrie Clarady, 202-245-6347.
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. The Department is soliciting comments on the proposed information collection request (ICR) that is described below. The Department is especially interested in public comment 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 records.
The 2024-25 TFS and 2024-25 PFS, like earlier TFS and PFS collections, will measure the one year attrition rates of teachers and principals, respectively, who leave the profession and will permit comparisons of stayers, movers, and leavers to fulfill the legislative mandate for NCES to report on the “condition of education in the United States.” “Stayers” are teachers or principals who remain in the same school between the NTPS year of data collection and the follow-up year.
The 2024-25 TFS analysis file will include TFS data in addition to data collected in the 2023-24 NTPS on teacher characteristics, qualifications, perceptions of the school environment and the teaching profession, and a host of other topics. Prior TFS data have played an important role in improving the understanding of the conditions that affect the balance between teacher attrition and retention. The NTPS and TFS provide national data on turnover in the teacher workforce, including rates of attrition from teaching, sources and characteristics of newly hired teachers, and characteristics and destinations of leavers. These data help shift the debate from the issue of teacher quantity to teacher quality; that is, from a focus on teacher shortages measured only in terms of the number of teaching positions left vacant to the qualifications and years of experience of teachers who stay in the classroom versus those who leave the profession. The cross-sectional repeated design of the TFS allows the analysis of trends related to these topics.
The 2024-25 PFS analysis file will include PFS data in addition to data on principal characteristics, qualifications, and perceptions of the school environment from data collected in the 2023-24 NTPS. Together, the NTPS and PFS will provide national data on turnover in the principal workforce, including rates of attrition from principalship, sources and characteristics of newly hired principals, characteristics and destinations of leavers, and due to the cross-sectional repeated design of the PFS, analyses of trends related to these topics.
This clearance request is to conduct both 2024-25 NTPS follow-up surveys (TFS and PFS), including all recruitment and data collection activities. This request seeks authorization for the 2024-25 TFS and 2024-25 PFS under the TFS single OMB number (OMB# 1850-0617).
This submission will undergo a 60-day public comment period, followed by an additional 30-day public comment period. This submission includes Supporting Statement Part A (justification), Part B (collection of information employing statistical methods), and Part C (item justification); Appendix A (respondent contact materials) and Appendix B (questionnaires). All submitted documents are subject to revision before the 30-day public comment period, and we encourage interested parties to return to these documents in late spring 2024 to see final drafts that will be submitted to OMB for their final review.
National Center for Education Statistics (NCES), Department of Education (ED).
Notice.
In accordance with the Paperwork Reduction Act (PRA) of 1995, the Department is proposing a revision of a currently approved information collection request (ICR).
Interested persons are invited to submit comments on or before April 1, 2024.
Written comments and recommendations for proposed information collection requests should be submitted within 30 days of publication of this notice. Click on this link
For specific questions related to collection activities, please contact Carrie Clarady, 202-245-6347.
The Department is especially interested in public comment 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 records.
The NTPS serves as the base year for two follow-up collections: The Principal Follow-up Survey (PFS) contacts principals who responded to the previous year's NTPS collection to determine whether, one year later, they are working as a principal at the same school as the previous year (“stayers”), have moved to a different school (“movers”), or have left the profession (“leavers”). The Teacher Follow-up Survey (TFS) contacts a sample of
For the 2021-22 and earlier TFS collections, our primary source of information on whether a teacher was a stayer, mover, or leaver (before we sampled and directly contacted those teachers) came from the school at which they worked during the previous year. However, not all schools report that information and, among those that do, they may not know the job status of the prior year's teachers. In order to determine whether that information can be collected more accurate and efficiently, we plan to ask NTPS teachers, at the end of the 2023-24 school year, whether they believe they will return to the same school in the 2024-25 school year. If their responses align with the information we later collect from schools and/or teachers who complete the TFS, we may be able to use this information to sample teachers for future administrations of the TFS.
For NTPS teachers who complete the NTPS Teacher Questionnaire web survey, on or after April 15, 2024, we will ask this question as the final item in the survey. For NTPS teachers who complete the survey before April 15, 2024 or who complete a paper questionnaire, we will send them an email invitation asking them to answer this additional question and, if needed, update their contact information. Teachers will only be asked this question once, but we have provided sample questions that reflect the two different ways in which the question may be asked. We estimate that this question will add 1 additional minute of burden for teachers from whom it is part of NTPS Teacher Questionnaire web survey, and 3 minutes for teachers who answer this item through a standalone web survey.
As part of this change, we have updated the estimated burden for teachers to complete the NTPS with the addition of this question in Part A. We have added the text of this question, shown here and in Appendix B, and the accompanying email for teachers who are sent a separate email invitation here and in Appendix A.
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, to protest, or to answer a complaint in any of the above proceedings must file in accordance with Rules 211, 214, or 206 of the Commission's Regulations (18 CFR 385.211, 385.214, or 385.206) 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:
The Commission's Office of Public Participation (OPP) supports meaningful public engagement and participation in Commission proceedings. OPP can help members of the public, including landowners, environmental justice communities, Tribal members and others, access publicly available information and navigate Commission processes. For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, the public is encouraged to contact OPP at (202) 502-6595 or
This is a supplemental notice in the above-referenced proceeding of Washington County Solar, LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
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 March 13, 2024.
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
The Commission's Office of Public Participation (OPP) supports meaningful public engagement and participation in Commission proceedings. OPP can help members of the public, including landowners, environmental justice communities, Tribal members and others, access publicly available information and navigate Commission processes. For public inquiries and
Take notice that on February 15, 2024, Venture Global Calcasieu Pass, LLC (Venture Global) requested that the Federal Energy Regulatory Commission (Commission) grant an extension of time (2023 Extension of Time Request), until February 21, 2025, to construct and make available for service a new liquefied natural gas (LNG) export terminal and associated facilities along the Calcasieu Ship Channel in Cameron Parish, Louisiana, authorized by the Commission in Docket No. CP15-550-000.
This notice establishes a 15-calendar day intervention and comment period deadline. Any person wishing to comment on Venture Global's request for an extension of time may do so. No reply comments or answers will be considered. If you wish to obtain the rights afforded parties to the above captioned proceedings, you should, on or before the comment date stated below, file a motion to intervene in accordance with the requirements of the Commission's Rules of Practice and Procedure (18 CFR 385.214 or 385.211) and the Regulations under the Natural Gas Act (18 CFR 157.10).
As a matter of practice, the Commission itself generally acts on requests for extensions of time to complete construction for Natural Gas Act facilities when such requests are contested.
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 “eFiling” link at
The Commission's Office of Public Participation (OPP) supports meaningful public engagement and participation in Commission proceedings. OPP can help members of the public, including landowners, environmental justice communities, Tribal members and others, access publicly available information and navigate Commission processes. For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, the public is encouraged to contact OPP at (202) 502-6595 or
Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection.
a.
b.
c.
d.
e.
f.
g.
h.
i.
j.
The Commission strongly encourages electronic filing. Please file motions to intervene and protests, comments, recommendations, terms and conditions, and prescriptions using the Commission's eFiling system at
The Commission's Rules of Practice require all intervenors filing documents with the Commission to serve a copy of that document on each person 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.
k. This application has been accepted and is ready for environmental analysis at this time.
l.
Great River Hydro operates the project in a peaking mode in coordination with its downstream Bellows Falls Project No. 1855 and Vernon Project No. 1904. Average annual generation is approximately 156,303 MW-hours. Great River Hydro is proposing changes to project operation that would reduce impoundment fluctuations and increase the stability of downstream flow releases relative to current project operation, including targeted water surface elevation levels and flow ramping rates. Great River Hydro also proposes several protection, mitigation, and enhancement measures for aquatic, terrestrial, cultural, recreation resources, and threatened and endangered species. The specific proposed changes are described in the amended application and the settlement agreement filed on August 4, 2022.
m. A copy of the application can be viewed on the Commission's website at
n. Anyone may submit comments, a protest, or a motion to intervene in accordance with the requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211, and .214. In determining the appropriate action to take, the Commission will consider all protests or other comments filed, but only those who file a motion to intervene in accordance with the Commission's Rules may become a party to the proceeding. Any comments, protests, or motions to intervene must be received on or before the specified comment date for the particular application.
All filings must: (1) bear in all capital letters the title “PROTEST,” “MOTION TO INTERVENE,” “COMMENTS,” “REPLY COMMENTS,” “RECOMMENDATIONS,” “PRELIMINARY TERMS AND CONDITIONS,” or “PRELIMINARY FISHWAY PRESCRIPTIONS;” (2) set forth in the heading the name of the applicant and the project number of the application to which the filing responds; (3) furnish the name, address, and telephone number of the person submitting the filing; and (4) otherwise comply with the requirements of 18 CFR 385.2001 through 385.2005. All comments, recommendations, terms and conditions, or prescriptions must set forth their evidentiary basis and otherwise comply with the requirements of 18 CFR 4.34(b). Agencies may obtain copies of the application directly from the applicant. A copy of any protest or motion to intervene must be served upon each representative of the applicant specified in the particular application. A copy of all other filings in reference to this application must be accompanied by proof of service on all persons listed on the service list prepared by the Commission in this proceeding, in accordance with 18 CFR 4.34(b) and 385.2010.
The Commission's Office of Public Participation (OPP) supports meaningful public engagement and participation in Commission proceedings. OPP can help members of the public, including landowners, environmental justice communities, Tribal members and others, access publicly available information and navigate Commission processes. For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, the public is encouraged to contact OPP at (202) 502-6595 or
You may also register online at
o.
p.
q. Final amendments to the application must be filed with the Commission no later than 30 days from the issuance date of this notice.
Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection.
a.
b.
c.
d.
e.
f.
g.
h.
i.
j.
The Commission strongly encourages electronic filing. Please file motions to intervene and protests, comments, recommendations, terms and conditions, and prescriptions using the Commission's eFiling system at
The Commission's Rules of Practice require all intervenors filing documents with the Commission to serve a copy of that document on each person 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.
k. This application has been accepted and is ready for environmental analysis at this time.
l.
The Turners Falls Project operates in peaking and run-of-river modes, depending on inflows. Average annual generation from 2011-2019 was approximately 332,351 MW-hours.
FirstLight proposes three changes to the current project boundary: (1) remove 0.2 acre of land associated with residential property; (2) add 0.8 acre of land for recreational purposes; and (3) remove 20.1 acres of land associated with the U.S. Geological Survey's Silvio Conte Anadromous Fish Laboratory.
FirstLight proposes to construct new fish passage facilities and recreational access trails. FirstLight also proposes changes to project operation that would generally reduce impoundment fluctuations and increase flow releases to the portion of the Connecticut River that is bypassed by the project. The specific proposed changes are described
m. A copy of the application can be viewed on the Commission's website at
n. Anyone may submit comments, a protest, or a motion to intervene in accordance with the requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211, and .214. In determining the appropriate action to take, the Commission will consider all protests or other comments filed, but only those who file a motion to intervene in accordance with the Commission's Rules may become a party to the proceeding. Any comments, protests, or motions to intervene must be received on or before the specified comment date for the particular application.
All filings must: (1) bear in all capital letters the title “PROTEST,” “MOTION TO INTERVENE,” “COMMENTS,” “REPLY COMMENTS,” “RECOMMENDATIONS,” “PRELIMINARY TERMS AND CONDITIONS,” or “PRELIMINARY FISHWAY PRESCRIPTIONS;” (2) set forth in the heading the name of the applicant and the project number of the application to which the filing responds; (3) furnish the name, address, and telephone number of the person submitting the filing; and (4) otherwise comply with the requirements of 18 CFR 385.2001 through 385.2005. All comments, recommendations, terms and conditions, or prescriptions must set forth their evidentiary basis and otherwise comply with the requirements of 18 CFR 4.34(b). Agencies may obtain copies of the application directly from the applicant. A copy of any protest or motion to intervene must be served upon each representative of the applicant specified in the particular application. A copy of all other filings in reference to this application must be accompanied by proof of service on all persons listed on the service list prepared by the Commission in this proceeding, in accordance with 18 CFR 4.34(b) and 385.2010.
The Commission's Office of Public Participation (OPP) supports meaningful public engagement and participation in Commission proceedings. OPP can help members of the public, including landowners, environmental justice communities, Tribal members and others, access publicly available information and navigate Commission processes. For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, the public is encouraged to contact OPP at (202) 502-6595 or
You may also register online at
o.
p.
q. Final amendments to the application must be filed with the Commission no later than 30 days from the issuance date of this notice.
On February 23, 2024, the Commission issued an order in Docket No. EL24-69-000, pursuant to section 206 of the Federal Power Act (FPA), 16 U.S.C. 824e, instituting an investigation to determine whether Viridon Midcontinent LLC's Formula Rate
The refund effective date in Docket No. EL24-69-000, established pursuant to section 206(b) of the FPA, will be the date of publication of this notice in the
Any interested person desiring to be heard in Docket No. EL24-69-000 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 (2023), within 21 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
The Commission's Office of Public Participation (OPP) supports meaningful public engagement and participation in Commission proceedings. OPP can help
Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:
Any person desiring to intervene, to protest, or to answer a complaint in any of the above proceedings must file in accordance with Rules 211, 214, or 206 of the Commission's Regulations (18 CFR 385.211, 385.214, or 385.206) on or before 5 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:
The Commission's Office of Public Participation (OPP) supports meaningful public engagement and participation in Commission proceedings. OPP can help members of the public, including landowners, environmental justice communities, Tribal members and others, access publicly available information and navigate Commission processes. For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, the public is encouraged to contact OPP at (202) 502-6595 or
On February 16, 2024, the Commission issued an order in Docket No. EL24-63-000, pursuant to section 206 of the Federal Power Act (FPA), 16 U.S.C. 824e, instituting an investigation to determine whether Oak Trail Solar, LLC's proposed Rate Schedule is unjust, unreasonable, unduly discriminatory or preferential, or otherwise unlawful.
The refund effective date in Docket No. EL24-63-000, established pursuant to section 206(b) of the FPA, will be the date of publication of this notice in the
Any interested person desiring to be heard in Docket No. EL24-63-000 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 (2023), within 21 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
The Commission's Office of Public Participation (OPP) supports meaningful public engagement and participation in Commission proceedings. OPP can help members of the public, including landowners, environmental justice communities, Tribal members and others, access publicly available information and navigate Commission processes. For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, the public is encouraged to contact OPP at (202) 502-6595 or
Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection.
a.
c.
d.
e.
f.
g.
h.
i.
j.
The Commission strongly encourages electronic filing. Please file motions to intervene and protests, comments, recommendations, terms and conditions, and prescriptions using the Commission's eFiling system at
The Commission's Rules of Practice require all intervenors filing documents with the Commission to serve a copy of that document on each person 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.
k. This application has been accepted and is ready for environmental analysis at this time.
l.
Great River Hydro operates the project in a peaking mode in coordination with its upstream Wilder Project No. 1892 and Bellows Falls Project No. 1855. Average annual generation is approximately 158,028 MW-hours. Great River Hydro is proposing changes to project operation that would reduce impoundment fluctuations and increase the stability of downstream flow releases relative to current project operation, including targeted water surface elevation levels and flow ramping rates. Great River Hydro also proposes several protection, mitigation, and enhancement measures for aquatic, terrestrial, cultural, recreation resources, and threatened and endangered species. The specific proposed changes are described in the amended application and the settlement agreement filed on August 4, 2022.
m. A copy of the application can be viewed on the Commission's website at
n. Anyone may submit comments, a protest, or a motion to intervene in accordance with the requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211, and .214. In determining the appropriate action to take, the Commission will consider all protests or other comments filed, but only those who file a motion to intervene in accordance with the Commission's Rules may become a party to the proceeding. Any comments, protests, or motions to intervene must be received on or before the specified comment date for the particular application.
All filings must: (1) bear in all capital letters the title “PROTEST,” “MOTION TO INTERVENE,” “COMMENTS,” “REPLY COMMENTS,” “RECOMMENDATIONS,” “PRELIMINARY TERMS AND CONDITIONS,” or “PRELIMINARY FISHWAY PRESCRIPTIONS;” (2) set forth in the heading the name of the applicant and the project number of the application to which the filing responds; (3) furnish the name, address, and telephone number of the person submitting the filing; and (4) otherwise comply with the requirements of 18 CFR 385.2001 through 385.2005. All comments, recommendations, terms and conditions, or prescriptions must set forth their evidentiary basis and otherwise comply with the requirements of 18 CFR 4.34(b). Agencies may obtain copies of the application directly from the applicant. A copy of any protest or motion to intervene must be served upon each representative of the applicant specified in the particular application. A copy of all other filings in reference to this application must be accompanied by proof of service on all persons listed on the service list prepared by the Commission in this proceeding, in accordance with 18 CFR 4.34(b) and 385.2010.
The Commission's Office of Public Participation (OPP) supports meaningful public engagement and participation in Commission proceedings. OPP can help members of the public, including landowners, environmental justice communities, Tribal members and others, access publicly available information and navigate Commission processes. For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, the public is encouraged to contact OPP at (202) 502-6595 or
You may also register online at
o.
p.
q. Final amendments to the application must be filed with the Commission no later than 30 days from the issuance date of this notice.
Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection.
a.
b.
c.
d.
e.
f.
g.
h.
i.
j.
The Commission strongly encourages electronic filing. Please file motions to intervene and protests, comments, recommendations, terms and conditions, and prescriptions using the Commission's eFiling system at
The Commission's Rules of Practice require all intervenors filing documents with the Commission to serve a copy of that document on each person 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.
k. This application has been accepted and is ready for environmental analysis at this time.
l.
Great River Hydro operates the project in a peaking mode in coordination with its upstream Wilder Project No. 1892 and downstream Vernon Project No. 1904. Average annual generation is approximately 239,070 MW-hours. Great River Hydro is proposing several protection, mitigation, and enhancement measures for aquatic, terrestrial, cultural, recreation resources, and threatened and endangered species, as well as changes to project operation that would reduce impoundment fluctuations and increase the stability of downstream flow releases relative to current project operation, including targeted water surface elevation levels and flow ramping rates. Great River Hydro also proposes to install a new turbine on the downstream side of the spillway that would generate power using the 300-cubic feet per second proposed minimum flow to the bypassed reach. The specific proposed changes are described in the amended application, the settlement agreement filed on August 4, 2022, and the revised relicensing proposal filed on June 8, 2023.
m. A copy of the application can be viewed on the Commission's website at
n. Anyone may submit comments, a protest, or a motion to intervene in accordance with the requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211, and .214. In determining the appropriate action to take, the Commission will consider all protests or other comments filed, but only those who file a motion to intervene in accordance with the Commission's Rules may become a party to the proceeding. Any comments, protests, or motions to intervene must be received on or before the specified comment date for the particular application.
All filings must: (1) bear in all capital letters the title “PROTEST,” “MOTION TO INTERVENE,” “COMMENTS,” “REPLY COMMENTS,” “RECOMMENDATIONS,” “PRELIMINARY TERMS AND CONDITIONS,” or “PRELIMINARY FISHWAY PRESCRIPTIONS;” (2) set forth in the heading the name of the applicant and the project number of the application to which the filing responds; (3) furnish the name, address, and telephone number of the person submitting the filing; and (4) otherwise comply with the requirements of 18 CFR 385.2001 through 385.2005. All comments, recommendations, terms and conditions, or prescriptions must set forth their evidentiary basis and otherwise comply with the requirements of 18 CFR 4.34(b). Agencies may obtain copies of the application directly from the applicant. A copy of any protest or motion to intervene must be served upon each representative of the applicant specified in the particular application. A copy of all other filings in reference to this application must be accompanied by proof of service on all persons listed on the service list prepared by the Commission in this proceeding, in accordance with 18 CFR 4.34(b) and 385.2010.
The Commission's Office of Public Participation (OPP) supports meaningful public engagement and participation in Commission proceedings. OPP can help members of the public, including landowners, environmental justice communities, Tribal members and others, access publicly available information and navigate Commission processes. For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, the public is encouraged to contact OPP at (202) 502-6595 or
You may also register online at
o.
p.
q. Final amendments to the application must be filed with the Commission no later than 30 days from the issuance date of this notice.
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 application for license for the Rumford Falls Hydroelectric Project, located on the Androscoggin River in the Town of Rumford, Oxford County, Maine and has prepared a Draft Environmental Assessment (DEA) for the project. No federal land is occupied by project works or located within the project boundary.
The DEA contains staff's analysis of the potential environmental impacts of the project and concludes that licensing the project, with appropriate environmental protective 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 DEA via the internet through the Commission's Home Page (
You may also register online at
Any comments should be filed within 30 days from the date of this notice.
The Commission strongly encourages electronic filing. Please file comments using the Commission's eFiling system at
Any questions regarding this notice may be directed to Ryan Hansen at (202) 502-8074 or
Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection.
a.
b.
c.
d.
e.
f.
g.
h.
i.
j.
The Commission strongly encourages electronic filing. Please file motions to intervene and protests, comments, recommendations, terms and conditions, and prescriptions using the Commission's eFiling system at
The Commission's Rules of Practice require all intervenors filing documents with the Commission to serve a copy of that document on each person 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.
k. This application has been accepted and is ready for environmental analysis at this time.
l. Project
The Northfield Mountain Pumped Storage Project generally operates in pumping mode when electricity demand is low and generating mode when electricity demand is high. In the summer and winter, the project generally operates in a peaking mode in the morning and late afternoon. In the spring and fall, the project may operate in a peaking mode one or two times a day depending on electricity demand. The existing license requires maintaining the upper reservoir between elevations 938.0 feet and 1,000.5 feet NGVD 29 (
Northfield proposes three changes to the current project boundary: (1) remove 0.2 acre of land associated with residential property; (2) remove 8.1 acres of land referred to as “Fuller Farm” that include residential and agricultural structures; and (3) add 135.5 acres of land that include recreation trails.
Northfield proposes to increase the maximum water surface elevation of the upper reservoir to 1,004.5 feet NGVD 29 and decrease the minimum water surface elevation of the upper reservoir to 920.0 feet NGVD 29 (
m. A copy of the application can be viewed on the Commission's website at
n. Anyone may submit comments, a protest, or a motion to intervene in accordance with the requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211, and .214. In determining the appropriate action to take, the Commission will consider all protests or other comments filed, but only those who file a motion to intervene in accordance with the Commission's Rules may become a party to the proceeding. Any comments, protests, or motions to intervene must be received on or before the specified comment date for the particular application.
All filings must: (1) bear in all capital letters the title “PROTEST,” “MOTION TO INTERVENE,” “COMMENTS,” “REPLY COMMENTS,” “RECOMMENDATIONS,” “PRELIMINARY TERMS AND CONDITIONS,” or “PRELIMINARY FISHWAY PRESCRIPTIONS;” (2) set forth in the heading the name of the applicant and the project number of the application to which the filing responds; (3) furnish the name, address, and telephone number of the person submitting the filing; and (4) otherwise comply with the requirements of 18 CFR 385.2001 through 385.2005. All comments, recommendations, terms and conditions, or prescriptions must set forth their evidentiary basis and otherwise comply with the requirements of 18 CFR 4.34(b). Agencies may obtain copies of the application directly from the applicant. A copy of any protest or motion to intervene must be served upon each representative of the applicant specified in the particular application. A copy of all other filings in reference to this application must be accompanied by proof of service on all persons listed on the service list prepared by the Commission in this proceeding, in accordance with 18 CFR 4.34(b) and 385.2010.
The Commission's Office of Public Participation (OPP) supports meaningful public engagement and participation in Commission proceedings. OPP can help members of the public, including landowners, environmental justice communities, Tribal members and others, access publicly available information and navigate Commission processes. For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, the public is encouraged to contact OPP at (202) 502-6595 or
You may also register online at
o.
p.
q. Final amendments to the application must be filed with the Commission no later than 30 days from the issuance date of this notice.
Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:
Any person desiring to intervene, to protest, or to answer a complaint in any of the above proceedings must file in accordance with Rules 211, 214, or 206 of the Commission's Regulations (18 CFR 385.211, 385.214, or 385.206) 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:
The Commission's Office of Public Participation (OPP) supports meaningful public engagement and participation in Commission proceedings. OPP can help members of the public, including landowners, environmental justice communities, Tribal members and others, access publicly available information and navigate Commission processes. For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, the public is encouraged to contact OPP at (202) 502-6595 or
This is a supplemental notice in the above-referenced proceeding of Decatur Solar Energy Center, LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
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 March 13, 2024.
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
The Commission's Office of Public Participation (OPP) supports meaningful public engagement and participation in Commission proceedings. OPP can help members of the public, including landowners, environmental justice communities, Tribal members and others, access publicly available information and navigate Commission processes. For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, the public is encouraged to contact OPP at (202) 502-6595 or
Take notice that on February 16, 2024, WBI Energy Transmission, Inc. (WBI Energy), 1250 West Century Avenue, Bismarck, North Dakota 58503, filed in the above referenced docket, a prior notice request pursuant to sections 157.205 and 157.208(b) of the Commission's regulations under the Natural Gas Act (NGA), and WBI Energy's blanket certificate issued in Docket No. CP82-487-000, for authorization to replace approximately 5.6 miles of its 12-inch-diameter Line Section 22 mainline pipeline located in Yellowstone County, Montana (2024 Elk Basin—Billings Replacement Project). The project is necessary for WBI Energy to comply with the U.S. Department of Transportation's Pipeline and Hazardous Materials Safety Administration class location requirements. The estimated cost for the project is $18.2 million, all as more fully set forth in the request 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 request should be directed to Lori Myerchin, Director, Regulatory Affairs and Transportation Services, WBI Energy Transmission, Inc., 1250 West Century Avenue, Bismarck, North Dakota 58503, by phone at (701) 530-1563, or by email at
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 April 23, 2024. How to file protests, motions to intervene, and comments is explained below.
The Commission's Office of Public Participation (OPP) supports meaningful public engagement and participation in Commission proceedings. OPP can help members of the public, including landowners, environmental justice communities, Tribal members and others, access publicly available information and navigate Commission processes. For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, the public is encouraged to contact OPP at (202) 502-6595 or
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 April 23, 2024. 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 CP24-59-000 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 CP24-59-000.
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, 1250 West Century Avenue, Bismarck, North Dakota 58503, or by email at
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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n. 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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q. The Commission's Office of Public Participation (OPP) supports meaningful public engagement and participation in Commission proceedings. OPP can help members of the public, including landowners, environmental justice communities, Tribal members and others, access publicly available information and navigate Commission processes. For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, the public is encouraged to contact OPP at (202) 502-6595 or
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, to protest, or to answer a complaint in any of the above proceedings must file in accordance with Rules 211, 214, or 206 of the Commission's Regulations (18 CFR 385.211, 385.214, or 385.206) on or before 5 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:
The Commission's Office of Public Participation (OPP) supports meaningful public engagement and participation in Commission proceedings. OPP can help members of the public, including landowners, environmental justice communities, Tribal members and others, access publicly available information and navigate Commission processes. For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, the public is encouraged to contact OPP at (202) 502-6595 or
With respect to an order issued by the Commission on February 21, 2024, in the above-captioned docket, with the exceptions noted below, the staff of the Office of Enforcement are designated as non-decisional in deliberations by the Commission in this docket.
Exceptions to this designation as non-decisional are:
Take notice that on February 16, 2024, pursuant to Rule 206 of the Rules of Practice and Procedure of the Federal Energy Regulatory Commission, 18 CFR 385.206 (2023), Musket Corporation filed a complaint against Colonial Pipeline Company (“Colonial”) challenging the justness and reasonableness of the rates charged by Colonial for transportation service pursuant to certain tariffs on file with the Commission.
The Complainant certifies that copies of the complaint were served on the contacts listed for Respondents in the Commission's list of Corporate Officials.
Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211, 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. The Respondent's answer and all interventions, or protests must be filed on or before the comment date. The Respondent's answer, motions to intervene, and protests must be served on the Complainants.
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 “eFiling” link at
The Commission's Office of Public Participation (OPP) supports meaningful public engagement and participation in Commission proceedings. OPP can help members of the public, including landowners, environmental justice communities, Tribal members and others, access publicly available information and navigate Commission processes. For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, the public is encouraged to contact OPP at (202) 502-6595 or
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency (EPA) has submitted an information collection request (ICR), National Volatile Organic Compound Emission Standards for Automobile Refinish Coatings (EPA ICR Number 1765.10, OMB Control Number 2060-0353) 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 February 29, 2024. Public comments were previously requested via the
Additional comments may be submitted on or before April 1, 2024.
Submit your comments, referencing Docket ID Number EPA-HQ-OAR-2003-0120, to: EPA online using
Submit written comments and recommendations to OMB for the proposed information collection within 30 days of publication of this notice to
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:
This is a proposed extension of the ICR, which is currently approved through February 29, 2024. An agency may neither conduct nor sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.
Public comments were previously requested via the
The information collection includes initial and periodic reporting necessary for the EPA to ensure compliance with the promulgated federal rule for automobile refinish coatings. The rule will be enforced through random sampling of coatings to determine VOC content. Respondents are manufacturers and importers of automobile refinish coatings and coating components.
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency (EPA) has submitted an information collection request (ICR), “Lead Training, Certification, Accreditation and Authorization Activities,” (EPA ICR No. 2507.05 and OMB Control No. 2070-0195) 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 February 29, 2024. Public comments were previously requested via the
Comments may be submitted on or before April 1, 2024.
Submit your comments, referencing Docket ID Number EPA-HQ-OPPT-2017-0692, to EPA online using
Submit written comments and recommendations to OMB for the proposed information collection within 30 days of publication of this notice to
Katherine Sleasman, Office of Program Support (7602M), Office of Chemical Safety and Pollution Prevention, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460; telephone number: (202) 566-1204; email address:
This is a proposed extension of the ICR which is currently approved through February 29, 2024. An agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.
Public comments were previously requested via the
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency (EPA) has submitted an information collection request (ICR), Transportation Conformity Determinations for Federally Funded and Approved Transportation Plans, Programs, and Projects (EPA ICR Number 2130.07, OMB Control Number 2060-0561), 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 February 29, 2024. Public comments were previously requested via the
Additional comments may be submitted on or before April 1, 2024.
Submit your comments to EPA, referencing Docket ID No. EPA-HQ-OAR-2007-0269, to EPA online using
Submit written comments and recommendations to OMB for the proposed information collection within 30 days of publication of this notice to
Aaron Letterly, Office of Transportation and Air Quality, Environmental Protection Agency, 2000 Traverwood Drive, Ann Arbor, MI 48105; telephone number 734-214-4340, email address:
This is a proposed extension of the ICR, which is currently approved through February 29, 2024. An agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.
Public comments were previously requested via the
Transportation conformity applies under EPA's conformity regulations at 40 CFR part 93, subpart A, to areas that are designated nonattainment and maintenance areas for the following transportation-related criteria pollutants: ozone, particulate matter (PM
The Environmental Protection Agency (EPA) is seeking public nominations of scientific and technical experts that EPA can consider for service as
Submit your nominations on or before April 1, 2024.
Submit your nominations to the SACC at
The Designated Federal Official (DFO) for the SACC is Dr. Alaa Kamel, Mission Support Division (7602M), Office of Program Support, Office of Chemical Safety and Pollution Prevention, Environmental Protection Agency; telephone number: (202) 564-5336 or call the SACC main office at (202) 564-8450; email address:
The Agency is seeking public nominations of scientific and technical experts that EPA can consider for service as
To facilitate nominations, this document provides information about the SACC, the intended topic for the planned peer review, the expertise sought for this peer review, instructions for submitting nominations to EPA, and the Agency's plan for selecting the
The SACC was established by EPA in 2016 in accordance with TSCA section 26(o), 15 U.S.C. 2625(o), to provide independent advice and expert consultation with respect to the scientific and technical aspects of issues relating to the implementation of TSCA. The SACC operates in accordance with the Federal Advisory Committee Act (FACA), 5 U.S.C. 10, and supports activities under TSCA, 15 U.S.C. 2601
This action is directed to the public in general. This action may, however, be of particular interest to those involved in the manufacture, processing, distribution, and disposal of chemical substances and mixtures, and/or those interested in the assessment of risks involving chemical substances and mixtures regulated under TSCA. Members of at-risk communities, non-governmental organizations (NGOs) (particularly those with an interest in protecting health for at-risk communities), and Federal, State and local officials may also be interested. Since other entities may also be interested, the Agency has not attempted to describe all the specific entities to which this action may apply.
Do not submit confidential business information (CBI) or other sensitive information to EPA through email. If your nomination contains any information that you consider to be CBI or otherwise protected, please contact the DFO listed under
You may subscribe to the following listserv for alerts regarding this and other SACC-related activities:
The SACC provides independent advice and recommendations to the EPA on the scientific and technical aspects of risk assessments, methodologies, and pollution prevention measures and approaches for chemicals regulated under TSCA. The SACC is comprised of experts in toxicology; environmental risk assessment; exposure assessment; and related sciences (
TSCA requires EPA to conduct risk evaluations on prioritized chemical substances and identifies the minimum components EPA must include in all chemical substance risk evaluations. The purpose of conducting risk evaluations is to determine whether a chemical substance presents an unreasonable risk to human health or the environment under the Conditions of Use (COUs). These evaluations include assessing unreasonable risks to relevant potentially exposed or susceptible subpopulations. As part of this process EPA: (1) Integrates hazard and exposure assessments using the best available science that is reasonably available to assure decisions are based on the weight of the scientific evidence, and (2) Conducts peer review for risk evaluation approaches that have not been previously peer reviewed. For more information about the three stages of EPA's process for ensuring the safety of existing chemicals (
On May 24, 2019, EPA received requests to conduct risk evaluations for DIDP and DINP from ExxonMobil Chemical Company, Evonik Corporation, and Teknor Apex, through the American Chemistry Council's High Phthalates Panel (ACC HPP). In December 2019, EPA notified ACC HPP that the Agency had granted their manufacturer requested risk evaluations.
DIDP is a common chemical name for the category of chemical substances that includes the following substances: 1,2-benzenedicarboxylic acid, 1,2-diisodecyl ester (CASRN 26761-40-0) and 1,2-benzenedicarboxylic acid, di-C9-11-branched alkyl esters, C10-rich (CASRN 68515-49-1). Both CASRNs contain mainly C10 dialkyl phthalate esters.
DINP is a common chemical name for the category of chemical substances that includes the following substances: 1,2-benzenedicarboxylic acid, 1,2-isononyl ester (CASRN 28553-12-0) and 1,2-benzenedicarboxylic acid, di-C9-11-branched alkyl esters, C9-rich (CASRN 68515-48-0). Both CASRNs contain mainly C9 dialkyl phthalate esters. Both DIDP and DINP are primarily used as a plasticizer in polyvinyl chloride (PVC) in consumer, commercial, and industrial applications.
DIDP and DINP are both structurally phthalates, and therefore many aspects of physical-chemical (p-chem) properties and exposure (to humans and ecological species) are similar. Because of the similar exposure and physical chemical properties of DIDP and DINP, EPA is developing these individual risk evaluations in parallel, and similarly the SACC peer review of the draft risk evaluations will occur concurrently. Both have extremely low water solubility and will be preferentially sorbed into sediments, soils, and suspended solids in surface water and wastewater. Both are expected to be persistent in anaerobic environments. Therefore, ecological risk will be assessed primarily considering exposure via sediment and soil pathways. Under indoor settings, DIDP and DINP are expected to partition to airborne particles and are expected to have extended lifetime compared to outdoor settings.
For both DIDP and DINP, liver and developmental toxicity are indicated as the most sensitive and robust non-cancer hazards. However, these two phthalates differ in several important respects regarding their human health hazard profiles. For DIDP, the developmental toxicity is not characterized by androgen insufficiency, and data are insufficient to determine the carcinogenicity. For DINP, developmental toxicity results in androgen insufficiency (phthalate
EPA is planning this SACC peer review of the Agency's risk evaluations for DIDP and DINP. EPA expects to ask the SACC to consider and review the novel approaches, unique exposure analyses and other calculations, and selection of key hazard endpoints for the risk evaluations of DIDP and DINP. Feedback from this review will be considered in the development of the final risk evaluations of the two phthalates under TSCA.
EPA continues to work on risk evaluations of additional high-priority substance phthalates, in addition to the cumulative risk assessment (CRA) for the phthalates. The subsequent five individual risk evaluations and the CRA are not part of this peer review but will be brought to the SACC at a future date.
EPA intends to publish a separate document in the
As part of a broader process for developing a pool of candidates for SACC peer reviews, EPA is asking the public and stakeholders for nominations of scientific and technical experts that EPA can consider as prospective candidates for service as
Those who are selected from the pool of prospective candidates will be invited to attend the public meeting and to participate in the discussion of key issues and assumptions at the meeting. In addition, they will be asked to review and to help finalize the meeting minutes.
Individuals nominated for this SACC peer review should have expertise in one or more of the following areas: Risk assessment; ecological risk assessment, including terrestrial hazard/wildlife toxicology for feedback on Toxicity Reference Value (TRV) approach, bioaccumulation and fate/physical chemistry (p-chem) for trophic transfer, and analogue selection; General exposure, particularly, consumer products and indoor air; Ingestion exposure for mouthing/ingestion route and chemical migration to saliva, surface water concentrations, water solubility, and acute aquatic hazard (fate/P-chem and aquatic toxicology), and use of European Union (EU) percentages to assign production volumes for the Conditions of Use (engineering); Human health, including liver toxicity and developmental toxicology for DIDP (toxicology), cancer and peroxisome proliferator-activated receptor alpha (PPARa mode of action), and dose response assessment.
Nominees should be scientists who have sufficient professional qualifications, including training and experience, to be capable of providing expert comments on the scientific issues for this review.
Submit your nomination as directed under
SACC members and
The selection of scientists to serve as
Numerous qualified candidates are often identified for SACC reviews. Therefore, selection decisions involve carefully weighing several factors including the candidates' areas of expertise and professional qualifications and achieving an overall balance of different scientific perspectives across reviewers. The Agency will consider all nominations of prospective candidates for service as
EPA anticipates selecting 8-10
Federal Communications Commission.
Notice and request for comments.
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995, the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid Office of Management and Budget (OMB) control number.
Written PRA comments should be submitted on or before April 29, 2024. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible.
Direct all PRA comments to Nicole Ongele, FCC, via email
For additional information about the information collection, contact Nicole Ongele, (202) 418-2991.
The information collection authorize licensed low power auxiliary station operations (referenced herein as “wireless microphone” operations) on additional frequency bands. Specifically, under section 74.803(c), the Commission permitted licensed wireless microphone operations on the 941.5-944 MHz, the 952.85-956.25 MHz, the 956.45-959.85 MHz, the 6875-6900 MHz, and the 7100-7125 MHz bands, provided the particular coordination requirements were met; under section 74.803(d), the Commission authorized operations on the 1435-1525 MHz band provided that requisite conditions, including coordination, were met. The Commission promoted its goal by accommodating wireless microphone users' needs through access to spectrum resources following the incentive auction and reconfiguration of the TV bands.
Federal Trade Commission.
Proposed consent agreement; request for comment.
The consent agreement in this matter settles alleged violations of federal law prohibiting unfair or deceptive acts or practices. The attached Analysis of Proposed Consent Order to Aid Public Comment describes both the allegations in the complaint and the terms of the consent order—embodied in the consent agreement—that would settle these allegations.
Comments must be received on or before April 1, 2024.
Interested parties may file comments online or on paper by following the instructions in the Request for Comment part of the
Cathlin Tully (202-326-3644), Attorney, Division of Privacy and Identity Protection, Bureau of Consumer Protection, Federal Trade Commission, 600 Pennsylvania Avenue NW, Washington, DC 20580.
Pursuant to Section 6(f) of the Federal Trade Commission Act, 15 U.S.C. 46(f), and FTC Rule § 2.34, 16 CFR 2.34, notice is hereby given that the above-captioned consent agreement containing a consent order to cease and desist, having been filed with and accepted, subject to final approval, by the Commission, has been placed on the public record for a period of 30 days. The following Analysis to Aid Public Comment describes the terms of the consent agreement and the allegations in the complaint. An electronic copy of the full text of the consent agreement package can be obtained at
You can file a comment online or on paper. For the Commission to consider your comment, we must receive it on or
Because of heightened security screening, postal mail addressed to the Commission will be subject to delay. We strongly encourage you to submit your comments online through the
Because your comment will be placed on the publicly accessible website at
Comments containing material for which confidential treatment is requested must be filed in paper form, must be clearly labeled “Confidential,” and must comply with FTC Rule § 4.9(c). In particular, the written request for confidential treatment that accompanies the comment must include the factual and legal basis for the request and must identify the specific portions of the comment to be withheld from the public record.
Visit the FTC website at
The Federal Trade Commission (the “Commission” or “FTC”) has accepted, subject to final approval, an agreement containing consent order from Avast Limited, Avast Software s.r.o., and Jumpshot, Inc. (“Respondents”). The proposed consent order (“Proposed Order”) has been placed on the public record for 30 days for receipt of comments by interested persons. Comments received during this period will become part of the public record. After 30 days, the Commission will again review the agreement, along with any comments received, and will decide whether it should withdraw from the agreement and take appropriate action or make final the Proposed Order.
The FTC's proposed complaint (“Proposed Complaint”) alleges that Respondent Avast Limited, a United Kingdom limited liability company, together with Respondent Avast Software s.r.o. (collectively, “Avast”), a Czech Republic limited liability company, collected consumers' browsing information through browser extensions and antivirus software (“Avast Software”) installed on consumers' computers and mobile devices. Through Respondent Jumpshot, Inc. (“Jumpshot”), Respondents sold this browsing data to third parties in non-aggregate, re-identifiable form.
According to the Proposed Complaint, the Avast Software collected browsing information from consumers, including uniform resource locators (URLs) of web pages visited, the URLs of background resources, consumers' search queries, and cookie values placed by third parties on consumers' computers. Among other things, the Avast Software collected browsing information revealing consumers' religious beliefs, health concerns, political leanings, location, financial status, visits to child-directed content, and interest in prurient content. Respondents combined this information with persistent identifiers, including identifiers created by Respondents that identified each consumer device uniquely, increasing the likelihood that consumers could be reidentified. As alleged in the Proposed Complaint, in many instances Respondents failed to disclose any information about their collection or sale of browsing information, and affirmatively represented that the Avast Software would “[b]lock[ ] annoying tracking cookies that collect data on your browsing activities” and “[s]hield your privacy.”
The Proposed Complaint alleges that after Avast acquired Jumpshot in 2013, Avast rebranded Jumpshot in 2014 as an analytics company. From 2014 to 2020, the Proposed Complaint alleges, Jumpshot sold browsing information collected by the Avast Software to customers such as consulting firms, investment companies, advertising companies, marketing data analytics companies, individual brands, search engine optimization firms, and data brokers. The Proposed Complaint alleges that, while Respondents purported to remove consumers' identifying information before transferring browsing information to Jumpshot, the proprietary algorithm Avast developed and used to do so was not sufficient to anonymize the data, which Jumpshot then sold in non-aggregate form to its customers through a variety of products. In total, the Proposed Complaint alleges that Respondents sold consumers' browsing information, and insights derived from such data, to more than 100 customers, earning tens of millions in gross revenues. After receiving the FTC's civil investigative demand, Respondents shut down Jumpshot's operations “with immediate effect.”
The Commission's three-count Proposed Complaint alleges that Respondents violated section 5(a) of the FTC Act by: (1) unfairly collecting consumers' browsing information, storing that information in granular form indefinitely, and selling that information in granular form to third parties, without adequate notice and without consumer consent; (2) representing that the Avast Software
With respect to the first count, the Proposed Complaint alleges Respondents' practices caused, or are likely to cause, substantial injury to consumers that is not outweighed by countervailing benefits to consumers or competition and is not reasonably avoidable by consumers themselves. The vast majority of consumers would not know the Avast Software would surveil their every move on the internet or their browsing information might be sold to more than 100 third parties in granular, re-identifiable form. Such practices constitute unfair acts or practices under Section 5 of the FTC Act.
With respect to the second count, the Proposed Complaint alleges Respondents claimed the Avast Software would stop the collection and sale of consumers' browsing information. The Proposed Complaint alleges that, in reality, and as noted above, Respondents' software collected consumers' browsing information which Respondents then sold to third parties. Respondent's failure to disclosure that material information was deceptive under Section 5 of the FTC Act.
With respect to the third count, the Proposed Complaint alleges Respondents claimed consumers' browsing information would be transferred to Respondent Jumpshot and to third parties only in aggregate and anonymous form. The Proposed Complaint alleges that, in reality, and as noted above, consumers' browsing information was transferred to Respondent Jumpshot and sold to third parties in non-aggregate and non-anonymous form. Such representations were, therefore, deceptive under Section 5 of the FTC Act.
The Proposed Order contains injunctive relief designed to prevent Respondents from engaging in the same or similar acts or practices in the future. Part I prohibits Respondents from selling, licensing, transferring, sharing, or otherwise disclosing to third parties for advertising: (1) browsing information from Avast products; (2) products or services derived from such browsing information; or (3) models or algorithms derived from such data. This provision further requires Respondents to obtain affirmative express consent from consumers before Respondents use browsing data for third-party advertising, and to obtain affirmative express consent from consumers using non-Avast branded products before selling, licensing, transferring, sharing, or otherwise disclosing to third parties browsing information collected by such products for advertising.
Part II prohibits Respondents from misrepresenting: (1) the purpose of their collection, use, disclosure, or maintenance of Covered Information (
Part III requires Respondents to delete all browsing information that Respondent Jumpshot received from the Avast Respondents and related models, algorithms, and software. This provision further requires Respondents to instruct all third parties that received browsing information from Respondent Jumpshot, any models or algorithms derived from such data, and any software developed to analyze such data, to delete or destroy such data, models, algorithms, or software.
Part IV requires that Respondents provide notice about the FTC's complaint and settlement with Respondents to consumers on the Avast websites, within Avast products, and via email to consumers who purchased or downloaded Avast products between 2014 and 2020. Part V requires that Respondents establish and implement, and thereafter maintain, a comprehensive privacy program that protects the privacy of consumers' personal information.
Part VI requires Respondents to obtain initial and biennial privacy program assessments by an independent, third-party professional for 20 years. Part VII requires Respondents to disclose all material facts to the assessor required by Part VI and prohibits Respondents from misrepresenting any fact material to the assessments required by Part VI. Part VIII requires each Respondent to submit an annual certification from a senior officer responsible for compliance with Part V that the Respondent has implemented the requirements of the Proposed Order and is not aware of any material noncompliance that has not been corrected or disclosed to the Commission.
Part IX requires Respondents to pay to the Commission $16,500,000 in monetary relief. Part X describes the procedures and legal rights related to that payment.
Parts XI-XIV are reporting and compliance provisions, which include recordkeeping requirements and provisions requiring Respondents to provide information or documents necessary for the Commission to monitor compliance. Part XV states that the Proposed Order will remain in effect for 20 years, with certain exceptions.
The purpose of this analysis is to facilitate public comment on the Proposed Order, and it is not intended to constitute an official interpretation of the Proposed Complaint or Proposed Order, or to modify the Proposed Order's terms in any way.
By direction of the Commission.
A person's browsing history can reveal extraordinarily sensitive information. A record of the websites someone visits can divulge everything from someone's romantic interests, financial struggles, and unpopular political views to their weight-loss efforts, job rejections, and gambling addiction.
Aware that internet users may want to protect their browsing history from data brokers and other trackers, some firms now market services to provide privacy protections online. Avast is one such firm. Since at least 2014, Avast has distributed browser extensions that it promoted through promising users enhanced privacy. It claimed, for example, that its products would “block[ ] annoying tracking cookies that collect data on your browsing activities” and “[p]rotect your privacy by preventing . . . web services from tracking your online activity.” It also stated that any sharing of user information would be in “anonymous and aggregate” form.
The Commission's complaint charges that these statements by Avast were deceptive. The complaint details how Avast collected highly detailed browsing data from millions of users
The FTC charges that Avast's conduct here was not only deceptive, but also an unfair practice, violating Section 5 of the FTC Act. Exposing people's detailed browsing data in ways that can be traced back to them marks an invasion of privacy and is likely to cause substantial injury. Because it is intrinsically sensitive, browsing data warrants heightened protection. Businesses that sell or share browser history data without affirmatively obtaining people's permission may be in violation of the law.
Today's action against Avast further builds out the Commission's work establishing that sensitive data triggers heightened privacy obligations and a default presumption against its sharing or sale. Through a series of cases, the FTC has been expounding on how firms are legally required to safeguard sensitive data.
Across these cases, we have established that businesses by default cannot sell people's sensitive data or disclose it to third parties for advertising purposes. We have also pursued bright-line bans. In
I am very grateful to the Division of Privacy and Identity Protection for their terrific work to protect Americans from privacy invasions and commercial surveillance, especially as it concerns their most sensitive data.
Office of the Integrated Award Environment, General Services Administration (GSA).
Notice of request for public comments regarding an extension to an existing OMB clearance.
Under the provisions of the Paperwork Reduction Act of 1995, the Regulatory Secretariat Division will be submitting to the Office of Management and Budget (OMB) a request to review and approve a renewal of the currently approved information collection requirement regarding FSRS Registration Requirements for Prime Grant Awardees.
Submit comments on or before April 29, 2024.
Submit comments identified by Information Collection 3090-0291, FSRS Registration Requirements for Prime Grant Awardees to
Ms. Salomeh Ghorbani, Director, IAE Outreach and Stakeholder Engagement Division, at 703-605-3467 or
The Federal Funding Accountability and Transparency Act (Pub. L. 109-282, as amended by section 6202(a) of Pub. L. 110-252), known as FFATA or the Transparency Act, requires information disclosure of entities receiving Federal financial assistance through Federal awards such as Federal contracts, sub-contracts, grants and sub-grants, FFATA 2(a),(2),(i),(ii). The system that collects this information is called the FFATA Sub-award Reporting System (FSRS,
If a prime awardee has already registered in FSRS to report contracts-related Transparency Act financial data, a new log-in will not be required. In addition, if a prime awardee had a user account in the Electronic Subcontract Reporting System (eSRS), a new log-in will not be required.
Public comments are particularly invited on: Whether this collection of information is necessary, whether it will have practical utility; whether our estimate of the public burden of this collection of information is accurate, and based on valid assumptions and methodology; ways to enhance the quality, utility, and clarity of the information to be collected; and ways in which we can minimize the burden of the collection of information on those who are to respond, through the use of appropriate technological collection techniques or other forms of information technology.
Pursuant to 5 U.S.C. 1009(d), 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, and the Determination of the Director, Office of Strategic Business Initiatives, Office of the Chief Operating Officer, CDC, pursuant to Public Law 92-463. 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.
The Director, Office of Strategic Business Initiatives, Office of the Chief Operating Officer, Centers for Disease Control and Prevention, has been delegated the authority to sign
Pursuant to 5 U.S.C. 1009(d), 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, and the Determination of the Director, Office of Strategic Business Initiatives, Office of the Chief Operating Officer, CDC, pursuant to Public Law 92-463. 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
The Director, Office of Strategic Business Initiatives, Office of the Chief Operating Officer, Centers for Disease Control and Prevention, has been delegated the authority to sign
In accordance with 5 U.S.C. 1009(d), the Centers for Disease Control and Prevention (CDC) announces 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, and the Determination of the Director, Office of Strategic Business Initiatives, Office of the Chief Operating Officer, CDC, pursuant to Public Law 92-463.
The Director, Office of Strategic Business Initiatives, Office of the Chief Operating Officer, Centers for Disease Control and Prevention, has been delegated the authority to sign
Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).
Notice of meeting.
In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC) and the Health Resources and Services Administration (HRSA) announce the following meeting of the CDC/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment (CHAC). This meeting is open to the public, limited only by the number of audio and web conference lines (1,000 lines are available). Time will be available for public comment (registration is required to provide oral comment).
The meeting will be held on April 9 and 10, 2024, from 9 a.m. to 4:30 p.m., EDT.
Written comments must be submitted by April 19, 2024. Registration to make oral comments must be submitted by March 26, 2024.
The telephone access number is 1-669-254-5252, Webinar ID: 160 972 1316, and the Passcode is 08044152. The web conference access is
Marah Condit, M.S., Committee Management Lead, Office of Policy, Planning, and Partnerships, National Center for HIV, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, 1600 Clifton Road NE, Mailstop US8-6, Atlanta, Georgia 30329-4027. Telephone: (404) 639-3423; Email:
The Director, Office of Strategic Business Initiatives, Office of the Chief Operating Officer, Centers for Disease Control and Prevention, has been delegated the authority to sign
Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).
Notice of meeting.
In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC) announces the following meeting for the Subcommittee on Procedures Reviews (SPR) of the Advisory Board on Radiation and Worker Health (ABRWH or the Advisory Board). This meeting is open to the public, but without a public comment period. The public is also welcomed to listen to the meeting by joining the audio conference (information below). The audio conference line has 150 ports for callers.
The meeting will be held on March 14, 2024, from 11 a.m. to 4:30 p.m., EDT.
Written comments must be received on or before March 7, 2024.
You may submit comments by mail to: Rashaun Roberts, National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention, 1090 Tusculum Avenue, MS C-24, Cincinnati, Ohio 45226.
Rashaun Roberts, Ph.D., Designated Federal Officer, National Center for Occupational Safety and Health, Centers for Disease and Prevention, 1090 Tusculum Avenue, Mailstop C-24, Cincinnati, Ohio 45226, Telephone: (513) 533-6800; Email:
The charter was issued on August 3, 2001, renewed at appropriate intervals, and rechartered under Executive Order 14109 on March 22, 2022, and will terminate on March 22, 2024.
The Director, Office of Strategic Business Initiatives, Office of the Chief Operating Officer, Centers for Disease Control and Prevention, has been delegated the authority to sign
Notice is hereby given of a change in the closed meeting of the Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP)—RFA-IP-24-046, Nationwide Cohort to Estimate Burden of Respiratory Viruses and Immunologic Response (Blood Donor Cohort); April 11-12, 2024, 10 a.m.-5 p.m., EDT, videoconference, in the original
The notice is being amended to change the meeting dates to a one-day meeting and should read as follows:
The meeting is closed to the public.
The Director, Office of Strategic Business Initiatives, Office of the Chief Operating Officer, Centers for Disease Control and Prevention, has been delegated the authority to sign
Centers for Medicare & Medicaid Services, Health and Human Services (HHS).
Notice.
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the
Comments must be received by April 29, 2024.
When commenting, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be submitted in any one of the following ways:
1.
2.
To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, please access the CMS PRA website by copying and pasting the following web address into your web browser:
William N. Parham at (410) 786-4669.
This notice sets out a summary of the use and burden associated with the following information collections. More detailed information can be found in each collection's supporting statement and associated materials (see
Under the PRA (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of
1.
The systems that support CCSQ programs includes but is not limited to: End-Stage Renal Disease Quality Reporting System (EQRS), Enterprise Shared Services (ESS), HCQIS ServiceNow (SNOW), Hospital Quality Reporting (HQR), Quality Improvement and Evaluation System (iQIES), Quality Management and Reporting System (QMARS), and Quality Payment Program (QPP).
The generic clearance will allow CMS to gather information to improve information systems that serve CMS audiences. CMS will gather this information using a mixture of qualitative and quantitative consumer research strategies (including formative research studies and methodological tests). CMS implements human-centered methods and activities for the improvement of policies, services, and products. This collection of information is necessary to enable CMS to garner customer and stakeholder feedback in an efficient, timely manner, in accordance with our commitment to improving service delivery.
As information systems and technologies are developed or improved upon, they can be tested and evaluated for end-user feedback regarding utility, usability, and desirability. The overall goal is to apply a human-centered engagement model to maximize the extent to which CIPST can gather ongoing feedback from consumers. Feedback helps engineers and designers arrive at better solutions, therefore minimizing the burden on consumers and meeting their needs and goals.
The activities under this clearance involve voluntary engagement with target CCSQ users to receive design and research feedback. The respondents will be voluntary end-users from self-selected customers, as well as convenience samples. It is our intent that selected respondents will either cover a broad range of customers or include specific characteristics related to certain products or services. All collections of information will allow us to continually refine our processes, systems, and services for the benefit of internal and external stakeholders.
2.
Based upon CMS' experience in the CSR data collection and evaluation process, CMS is not making any substantive changes to this information collection. The only changes are to update the number of policies issuers will report data for, based on the most recent enrollment numbers in CSR plan variants as of June 15, 2023. There are no programmatic changes. The CSR Issuer Summary Report and Standard Methodology Template Plan and Policy Report remain the same.
Centers for Medicare & Medicaid Services, Health and Human Services (HHS).
Notice.
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), Federal agencies are required to publish notice in the
Comments must be received by April 29, 2024.
When commenting, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be submitted in any one of the following ways:
1.
2.
To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, please access the CMS PRA website by copying and pasting the following web address into your web browser:
William N. Parham at (410) 786-4669.
This notice sets out a summary of the use and burden associated with the following information collections. More detailed information can be found in each collection's supporting statement and associated materials (see
Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term “collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA requires Federal agencies to publish a 60-day notice in the
1.
CMS has developed the six materials in the attached package as model notices in order to provide standardized and consistent language for potential and active program participants, regardless of which Part D plan they may be enrolled in. CMS will require Part D plans to disseminate these notices, as appropriate, to Part D enrollees to fulfill the requirements of the Sections 1860D-2(b)(2)(E)(v)(II)-(IV) of the Act.
Children's Bureau, Administration for Children and Families, U.S. Department of Health and Human Services.
Request for public comments.
The Children's Bureau (CB), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS) is requesting a 3-year extension of the Generic Clearance for the Comprehensive Child Welfare Information System (CCWIS) Technical Assistance (TA) and Review Process, (OMB #0970-0568, expiration 4/30/2024) and all approved information collections under this generic. There are no changes requested to the terms of the umbrella generic or to the currently approved information collections.
Comments due within 60 days of publication. In compliance with the requirements of the Paperwork Reduction Act of 1995, ACF is soliciting public comment on the specific aspects of the information collection described above.
You can obtain copies of the proposed collection of information and submit comments by emailing
The CCWIS Assessment Review (CAR) Process.
TA tools for title IV-E agencies to self-assess their conformity to CCWIS project and design requirements at 45 CFR 1355.52-3; The CCWIS requirements at 45 CFR 1355.55 require the review, assessment, and inspection of the planning, design, development, installation, operation, and maintenance of each CCWIS project on a continuing basis. The Advance Planning Document (APD) regulations at 45 CFR 95.621 require periodic reviews of state and local agency methods and practices to ensure information systems, including CCWIS, are utilized for purposes
This request is for an extension with no changes to the umbrella generic and all currently approved information collections, which can be found here:
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for PREVNAR-20 and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.
Anyone with knowledge that any of the dates as published (see
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.”
• 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
Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.
The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug or biologic product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
A regulatory review period consists of two periods of time: a testing phase and an approval phase. For human biological products, the testing phase begins when the exemption to permit the clinical investigations of the biological product becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human biological product and continues until FDA grants permission to market the biological product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human biological product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the human biologic product PREVNAR-20 (Pneumococcal 20-valent Conjugate Vaccine). PREVNAR-20 is indicated for:
• Active immunization for the prevention of invasive disease caused by
• Active immunization for the prevention of otitis media caused by
• Active immunization for the prevention of pneumonia caused by
The indication for the prevention of pneumonia caused by
Subsequent to this approval, the USPTO received patent term restoration applications for PREVNAR-20 (U.S. Patent No. 7,935,787) from Wyeth LLC, and (U.S. Patent Nos. 9,517,274; and 9,950,054), filed by Pfizer Inc., and the USPTO requested FDA's assistance in determining the patents' eligibility for patent term restoration. In a letter dated January 18, 2023, FDA advised the USPTO that this human biological product had undergone a regulatory review period and that the approval of PREVNAR-20 represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.
FDA has determined that the applicable regulatory review period for PREVNAR-20 is 1,678 days. Of this time, 1,434 days occurred during the testing phase of the regulatory review period, while 244 days occurred during the approval phase. These periods of time were derived from the following dates:
1.
2.
3.
This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its applications for patent extension, these applicants seek 665 days or 961 days of patent term extension.
Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see
Submit petitions electronically to
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for NULIBRY and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Anyone with knowledge that any of the dates as published (see
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.”
• 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
Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.
The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug or biological product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
A regulatory review period consists of two periods of time: a testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the human drug product, NULIBRY (fosdenopterin). NULIBRY is indicated to reduce the risk of mortality in patients with molybdenum cofactor deficiency Type A. Subsequent to this approval, the USPTO received a patent term restoration application for NULIBRY (U.S. Patent No. 7,504,095) from Origin Biosciences, Inc., and the USPTO requested FDA's assistance in determining the patent's eligibility for patent term restoration. In a letter dated September 21, 2022, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of NULIBRY represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.
FDA has determined that the applicable regulatory review period for NULIBRY is 2,815 days. Of this time, 2,572 days occurred during the testing phase of the regulatory review period, while 243 days occurred during the approval phase. These periods of time were derived from the following dates:
This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 1,529 days of patent term extension.
Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see
Submit petitions electronically to
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ISTURISA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of patents which claims that human drug product.
Anyone with knowledge that any of the dates as published (see
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.”
• 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
Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.
The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug or biological product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
A regulatory review period consists of two periods of time: a testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the
FDA has approved for marketing the human drug product, ISTURISA (osilodrostat phosphate). ISTURISA is indicated for the treatment of adult patients with Cushing's disease for whom pituitary surgery is not an option or has not been curative. Subsequent to this approval, the USPTO received patent term restoration applications for ISTURISA (U.S. Patent Nos. 8,314,097; 8,609,862) from Recordati AG, and the USPTO requested FDA's assistance in determining the patents' eligibility for patent term restoration. In a letter dated September 28, 2022, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of ISTURISA represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.
FDA has determined that the applicable regulatory review period for ISTURISA is 4,393 days. Of this time, 4,026 days occurred during the testing phase of the regulatory review period, while 367 days occurred during the approval phase. These periods of time were derived from the following dates:
1.
2.
3.
This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its applications for patent extension, this applicant seeks 1,148 days of patent term extension.
Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see
Submit petitions electronically to
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for OPDUALAG and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.
Anyone with knowledge that any of the dates as published (see
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.”
• 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
Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.
The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug or biologic product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
A regulatory review period consists of two periods of time: a testing phase and an approval phase. For human biological products, the testing phase begins when the exemption to permit the clinical investigations of the biological product becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human biological product and continues until FDA grants permission to market the biological product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human biological product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the human biologic product, OPDUALAG (nivolumab and relatlimab-rmbw). OPDUALAG is indicated for treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma. Subsequent to this approval, the USPTO received patent term restoration applications for OPDUALAG (U.S. Patent Nos. 9,505,839 and 10,377,824) from Bristol-Myers Squibb Company, and the USPTO requested FDA's assistance in determining the patents' eligibility for patent term restoration. In a letter dated September 28, 2023, FDA advised the USPTO that this human biological product had undergone a regulatory review period and that the approval of OPDUALAG represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.
FDA has determined that the applicable regulatory review period for OPDUALAG is 3110 days. Of this time, 2867 days occurred during the testing phase of the regulatory review period, while 243 days occurred during the approval phase. These periods of time were derived from the following dates:
1.
2.
3.
This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 552 days or 596 days of patent term extension.
Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see
Submit petitions electronically to
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for MOUNJARO and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Anyone with knowledge that any of the dates as published (see
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.”
• 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
Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.
The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term
A regulatory review period consists of two periods of time: a testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the human drug product, MOUNJARO (tirzepatide). MOUNJARO is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Subsequent to this approval, the USPTO received a patent term restoration application for MOUNJARO (U.S. Patent No. 9,474,780) from Eli Lilly and Company, and the USPTO requested FDA's assistance in determining the patent's eligibility for patent term restoration. In a letter dated September 28, 2023, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of MOUNJARO represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.
FDA has determined that the applicable regulatory review period for MOUNJARO is 2,208 days. Of this time, 1,967 days occurred during the testing phase of the regulatory review period, while 241 days occurred during the approval phase. These periods of time were derived from the following dates:
1.
2.
3.
This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 129 days of patent term extension.
Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see
Submit petitions electronically to
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for SOGROYA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.
Anyone with knowledge that any of the dates as published (see
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.”
• 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
Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.
The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug or biologic product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
A regulatory review period consists of two periods of time: a testing phase and an approval phase. For human biological products, the testing phase begins when the exemption to permit the clinical investigations of the biological product becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human biological product and continues until FDA grants permission to market the biological product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human biological product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the human biologic product SOGROYA (somapacitan-beco). SOGROYA is indicated for replacement of endogenous growth hormone in adults with growth hormone deficiency. Subsequent to this approval, the USPTO received a patent term restoration application for SOGROYA (U.S. Patent No. 8,779,109) from Novo Nordisk Health Care AG, and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated August 24, 2022, FDA advised the USPTO that this human biological product had undergone a regulatory review period and that the approval of SOGROYA represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.
FDA has determined that the applicable regulatory review period for SOGROYA is 2,200 days. Of this time, 1,833 days occurred during the testing phase of the regulatory review period, while 367 days occurred during the approval phase. These periods of time were derived from the following dates:
1.
2.
3.
This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 1,284 days of patent term extension.
Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see
Submit petitions electronically to
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for KLISYRI and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Anyone with knowledge that any of the dates as published (see
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.”
• 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
Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.
The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug or biological product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
A regulatory review period consists of two periods of time: a testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the human drug product, KLISYRI (tirbanibulin). KLISYRI is indicated for the topical treatment of actinic keratosis of the face or scalp. Subsequent to this approval, the USPTO received patent term restoration applications for KLISYRI (U.S. Patent Nos. 7,300,931; 7,851,470) from Athenex Inc., and the USPTO requested FDA's assistance in determining the patents' eligibility for patent term restoration. In a letter dated January 10, 2023, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of KLISYRI represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.
FDA has determined that the applicable regulatory review period for KLISYRI is 4,899 days. Of this time, 4,548 days occurred during the testing phase of the regulatory review period, while 351 days occurred during the approval phase. These periods of time were derived from the following dates:
1.
2.
3.
This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its applications for patent extension, this applicant seeks 1,827 days of patent term extension.
Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see
Submit petitions electronically to
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) announcing that the debarment of Timothy Baxter will terminate on October 26, 2025.
This order is applicable February 29, 2024.
Submit comments electronically at
Jaime Espinosa, Division of Compliance and Enforcement, Office of Policy, Compliance, and Enforcement, Office of Regulatory Affairs, Food and Drug Administration, at 240-402-8743 or
In a
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for TEMBEXA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Anyone with knowledge that any of the dates as published (see
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.”
• 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
Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.
The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug or biological product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
A regulatory review period consists of two periods of time: a testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the human drug product, TEMBEXA (brincidofovir) indicated for the treatment of human smallpox disease in adult and pediatric patients, including neonates. Subsequent to this approval, the USPTO received a patent term restoration application for TEMBEXA (U.S. Patent No. 9,303,051) from Chimerix, Inc. and the USPTO requested FDA's assistance in determining the patent's eligibility for patent term restoration. In a letter dated September 13, 2022, FDA advised the USPTO that this human drug product had undergone a regulatory review period, but that the approval of TEMBEXA did not represent the first permitted commercial marketing or use of the product. The USPTO also requested that FDA determine the product's regulatory review period.
FDA has determined that the applicable regulatory review period for TEMBEXA is 5,463 days. Of this time, 5,222 days occurred during the testing phase of the regulatory review period, while 241 days occurred during the approval phase. These periods of time were derived from the following dates:
1.
2.
3.
This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 1,064 days of patent term extension.
Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see
Submit petitions electronically to
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for SAPHNELO and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department
Anyone with knowledge that any of the dates as published (see
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.”
• 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
Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.
The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug or biologic product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
A regulatory review period consists of two periods of time: a testing phase and an approval phase. For human biological products, the testing phase begins when the exemption to permit the clinical investigations of the biological product becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human biological product and continues until FDA grants permission to market the biological product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human biological product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the human biologic product SAPHNELO (anifrolumab-fnia). SAPHNELO is indicated for the treatment of adult patients with moderate to severe systemic lupus erythematosus who are receiving standard therapy. Subsequent to this approval, the USPTO received patent term restoration applications for SAPHNELO (U.S. Patent Nos. 7,662,381; 8,460,668; 9,493,570; and 9,988,459) from AstraZeneca AB (agent of E.R.
FDA has determined that the applicable regulatory review period for SAPHNELO is 4,578 days. Of this time, 4,213 days occurred during the testing phase of the regulatory review period, while 365 days occurred during the approval phase. These periods of time were derived from the following dates:
1.
2.
3.
This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its applications for patent extension, this applicant seeks 5 days, 763 days, 778 days, and 1,673 days of patent term extension.
Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see
Submit petitions electronically to
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for EVKEEZA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.
Anyone with knowledge that any of the dates as published (see
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.”
• 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
Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.
The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug or biologic product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
A regulatory review period consists of two periods of time: a testing phase and an approval phase. For human biological products, the testing phase begins when the exemption to permit the clinical investigations of the biological product becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human biological product and continues until FDA grants permission to market the biological product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human biological product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the human biologic product EVKEEZA (evinacumab-dgnb). EVKEEZA is indicated as an adjunct to other low-density lipoprotein-cholesterol lowering therapies for the treatment of adult and pediatric patients, aged 12 years and older, with homozygous familial hypercholesterolemia. Subsequent to this approval, the USPTO received a patent term restoration application for EVKEEZA (U.S. Patent No. 9,018,356) from Regeneron, and the USPTO requested FDA's assistance in determining this patent's eligibility for patent term restoration. In a letter dated September 8, 2022, FDA advised the USPTO that this human biological product had undergone a regulatory review period and that the approval of EVKEEZA represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.
FDA has determined that the applicable regulatory review period for EVKEEZA is 3,002 days. Of this time, 2,756 days occurred during the testing phase of the regulatory review period, while 246 days occurred during the approval phase. These periods of time were derived from the following dates:
1.
2.
3.
This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 972 days of patent term extension.
Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see
Submit petitions electronically to
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for VONJO and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Anyone with knowledge that any of the dates as published (see
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.”
• 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
Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.
The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug or biological product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
A regulatory review period consists of two periods of time: a testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the human drug product, VONJO (pacritinib citrate) indicated for treatment of adults with intermediate or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis with a platelet count below 50 x 10
FDA has determined that the applicable regulatory review period for VONJO is 5,138 days. Of this time, 4,802 days occurred during the testing phase of the regulatory review period, while 336 days occurred during the approval phase. These periods of time were derived from the following dates:
1.
2.
3.
This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its applications for patent extension, this applicant seeks 1,085 days or 5 years of patent term extension.
Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see
Submit petitions electronically to
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for LEQVIO and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Anyone with knowledge that any of the dates as published (see
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.”
• 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
Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.
The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug or biological product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
A regulatory review period consists of two periods of time: a testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the human drug product, LEQVIO (inclisiran sodium). LEQVIO is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease, who require additional lowering of low-density lipoprotein cholesterol. Subsequent to this approval, the USPTO received a patent term restoration application for LEQVIO (U.S. Patent Nos. 8,222,222; 8,809,292; 8,828,956; 9,370,582; 10,125,369) from Novartis Pharmaceuticals Corporation, and the USPTO requested FDA's assistance in determining the patent's eligibility for patent term restoration. In a letter dated January 10, 2023, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of LEQVIO represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.
FDA has determined that the applicable regulatory review period for LEQVIO is 2,134 days. Of this time, 1,403 days occurred during the testing phase of the regulatory review period, while 731 days occurred during the approval phase. These periods of time were derived from the following dates:
1.
2.
3.
This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its applications for patent extension, this applicant seeks 492 days, 1,371 days, or 1,432 days of patent term extension.
Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see
Submit petitions electronically to
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ADUHELM and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.
Anyone with knowledge that any of the dates as published (see
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.”
• 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
Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.
The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug or biological product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
A regulatory review period consists of two periods of time: a testing phase and an approval phase. For human biological products, the testing phase begins when the exemption to permit the clinical investigations of the biological product becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human biological product and continues until FDA grants permission to market the biological product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human biological product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the human biologic product ADUHELM (aducanumab-avwa). ADUHELM is indicated for the treatment of Alzheimer's disease. This indication is approved under accelerated approval based on reduction in amyloid beta plaques observed in patients treated with ADUHELM. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s). Subsequent to this approval, the USPTO received patent term restoration applications for ADUHELM (U.S. Patent Nos. 8,906,367 and 10,131,708) from University of Zurich, and the USPTO requested FDA's assistance in determining the patents' eligibility for patent term restoration. In a letter dated September 28, 2022, FDA advised the USPTO that this human biological product had undergone a regulatory review period and that the approval of ADUHELM represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.
FDA has determined that the applicable regulatory review period for ADUHELM is 3,689 days. Of this time, 3,353 days occurred during the testing phase of the regulatory review period, while 336 days occurred during the approval phase. These periods of time were derived from the following dates:
1.
2.
3.
This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 634 days and 1,197 days of patent term extension.
Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see
Submit petitions electronically to
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for RECORLEV and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Anyone with knowledge that any of the dates as published (see
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.”
• 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
Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.
The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug or biological product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
A regulatory review period consists of two periods of time: a testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the human drug product, RECORLEV (levoketoconazole) indicated for the treatment of endogenous hypercortisolemia in adult patients with Cushing's syndrome for whom surgery is not an option or has not been curative. Subsequent to this approval, the USPTO received a patent term restoration application for RECORLEV (U.S. Patent No. 9,918,984) from Xeris Pharmaceuticals, Inc. and the USPTO requested FDA's assistance in determining the patent's eligibility for patent term restoration. In a letter dated October 19, 2023, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of
FDA has determined that the applicable regulatory review period for RECORLEV is 5,812 days. Of this time, 5,507 days occurred during the testing phase of the regulatory review period, while 305 days occurred during the approval phase. These periods of time were derived from the following dates:
1.
2.
3.
This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 844 days of patent term extension.
Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see
Submit petitions electronically to
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ONGENTYS and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Anyone with knowledge that any of the dates as published (see
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.”
• 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
Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.
The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug or biological product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
A regulatory review period consists of two periods of time: a testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the human drug product, ONGENTYS (opicapone) indicated as adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing “off” episodes. Subsequent to this approval, the USPTO received patent term restoration applications for ONGENTYS (U.S. Patent Nos. 8,168,793; 8,524,746; 9,550,759; 9,630,955; and 10,071,085) from Bial-Portela & CA., S.A., and the USPTO requested FDA's assistance in determining the patents' eligibility for patent term restoration. In a letter dated September 28, 2022, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of ONGENTYS represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.
FDA has determined that the applicable regulatory review period for ONGENTYS is 3,306 days. Of this time, 2,940 days occurred during the testing phase of the regulatory review period, while 366 days occurred during the approval phase. These periods of time were derived from the following dates:
1.
2.
3.
This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its applications for patent extension, this applicant seeks 478 days, 498 days, 1,323 days, 1,395 days, or 1,640 days of patent term extension.
Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see
Submit petitions electronically to
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for VEKLURY and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Anyone with knowledge that any of the dates as published (see
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.”
• 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
Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.
The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug or biological product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
A regulatory review period consists of two periods of time: a testing phase and an approval phase. For human drug products, the testing phase begins when
FDA has approved for marketing the human drug product, VEKLURY (remdesivir) indicated for adults and pediatric patients (12 years of age and older and weighing at least 40 kilograms) for the treatment of coronavirus disease 2019 requiring hospitalization. Subsequent to this approval, the USPTO received patent term restoration applications for VEKLURY (U.S. Patent Nos. 8,008,264; 8,318,682; 9,724,360; 9,949,994; 10,065,958; and RE46762) from Gilead Sciences, Inc., and the USPTO requested FDA's assistance in determining the patents' eligibility for patent term restoration. In a letter dated September 21, 2022, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of VEKLURY represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.
FDA has determined that the applicable regulatory review period for VEKLURY is 1,904 days. Of this time, 1,827 days occurred during the testing phase of the regulatory review period, while 77 days occurred during the approval phase. These periods of time were derived from the following dates:
1.
2.
3.
This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its applications for patent extension, this applicant seeks 429 days, 625 days, or 991 days of patent term extension.
Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see
Submit petitions electronically to
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for EVRYSDI and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Anyone with knowledge that any of the dates as published (see
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.”
• 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
Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.
The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug or biological product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
A regulatory review period consists of two periods of time: a testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the human drug product, EVRYSDI (risdiplam) indicated for the treatment of spinal muscular atrophy in patients 2 months of age and older. Subsequent to this approval, the USPTO received a patent term restoration application for EVRYSDI (U.S. Patent No. 9,586,955) from Genentech, Inc. (agent for PtC Therapeutics Inc. and Hoffmann-La Roche Inc.), and the USPTO requested FDA's assistance in determining the patent's eligibility for patent term restoration. In a letter dated September 13, 2022, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of EVRYSDI represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.
FDA has determined that the applicable regulatory review period for EVRYSDI is 1,368 days. Of this time, 1,049 days occurred during the testing phase of the regulatory review period, while 319 days occurred during the approval phase. These periods of time were derived from the following dates:
1.
2.
3.
This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension,
Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see
Submit petitions electronically to
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for BREXAFEMME and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Anyone with knowledge that any of the dates as published (see
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.”
• 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
Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.
The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug or biological product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
A regulatory review period consists of two periods of time: a testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the human drug product, BREXAFEMME (ibrexafungerp tablets). BREXAFEMME is indicated for the treatment of adult and postmenarchal pediatric females with vulvovaginal candidiasis. Subsequent to this approval, the USPTO received a patent term restoration application for BREXAFEMME (U.S. Patent No. 8,188,085) from Scynexis, Inc., and the USPTO requested FDA's assistance in determining the patent's eligibility for patent term restoration. In a letter dated October 19, 2023, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of BREXAFEMME represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.
FDA has determined that the applicable regulatory review period for BREXAFEMME is 4,130 days. Of this time, 3,886 days occurred during the testing phase of the regulatory review period, while 244 days occurred during the approval phase. These periods of time were derived from the following dates:
1.
2.
3.
This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 1,768 days of patent term extension.
Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see
Submit petitions electronically to
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for EPI-SENSE GUIDED COAGULATION SYSTEM and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of patents which claim that medical device.
Anyone with knowledge that any of the dates as published (see
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.”
• 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
Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.
The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug or biological product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
A regulatory review period consists of two periods of time: a testing phase and an approval phase. For medical devices, the testing phase begins with a clinical investigation of the device and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the device and continues until permission to market the device is granted. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a medical device will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(3)(B).
FDA has approved for marketing the medical device EPI-SENSE GUIDED COAGULATION SYSTEM. EPI-SENSE GUIDED COAGULATION SYSTEM is indicated for the treatment of symptomatic long-standing persistent atrial fibrillation (continuous atrial fibrillation greater than 12 months duration) when augmented in a hybrid procedure with an endocardial catheter listed in the instructions for use, in patients who are refractory or intolerant to at least one Class I and/or III antiarrhythmic drug; and in whom the expected benefit from rhythm control outweighs the potential known risks associated with a hybrid procedure such as delayed post-procedure inflammatory pericardial effusions. Subsequent to this approval, the USPTO received patent term restoration applications for EPI-SENSE GUIDED COAGULATION SYSTEM (U.S. Patent Nos. 7,399,300 and 7,572,257) from AtriCure, Inc., and the USPTO requested FDA's assistance in determining the patents' eligibility for patent term restoration. In a letter dated September 21, 2022, FDA advised the USPTO that this medical device had undergone a regulatory review period and that the approval of EPI-SENSE GUIDED COAGULATION SYSTEM represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.
FDA has determined that the applicable regulatory review period for EPI-SENSE GUIDED COAGULATION SYSTEM is 2,919 days. Of this time, 2,436 days occurred during the testing phase of the regulatory review period, while 483 days occurred during the approval phase. These periods of time were derived from the following dates:
1.
2.
3.
This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its applications for patent extension, this applicant seeks 1,826 days or 1,827 days of patent term extension.
Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see
Submit petitions electronically to
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for CAMZYOS and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Anyone with knowledge that any of the dates as published (see
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.”
• 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
Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.
The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug or biological product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
A regulatory review period consists of two periods of time: a testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the human drug product, CAMZYOS (mavacamten). CAMZYOS is indicated for the treatment of adults with symptomatic New York Heart Association class II-III obstructive hypertrophic cardiomyopathy to improve functional capacity and symptoms. Subsequent to this approval, the USPTO received patent term restoration applications for CAMZYOS (U.S. Patent Nos. 9,181,200; 9,585,883) from Myokardia, Inc. and the USPTO requested FDA's assistance in determining the patents' eligibility for patent term restoration. In a letter dated September 28, 2023, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of CAMZYOS represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.
FDA has determined that the applicable regulatory review period for CAMZYOS is 2,723 days. Of this time, 2,266 days occurred during the testing phase of the regulatory review period, while 457 days occurred during the approval phase. These periods of time were derived from the following dates:
This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its applications for patent extension, this applicant seeks 679 days of patent term extension.
Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see
Submit petitions electronically to
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA, the Agency, or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Submit written comments (including recommendations) on the collection of information by April 1, 2024.
To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to
Rachel Showalter, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 240-994-7399,
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
This information collection supports the implementation of FDA statutory and regulatory provisions and related forms. Sections 801(e) and 802 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 381(e) and 382) pertain to the export of FDA-regulated products and are intended to ease restrictions on exportation. The provisions also require the Agency to issue written export certifications within 20 days of any request. To offset Agency resource expenditures for processing certifications requests, the statute provides that FDA may charge firms a fee not to exceed $175.
The information collection contains FDA forms (Form FDA 3613, 3613a, 3613b, 3613c, 3613f, and 3613g) related to exporting FDA-regulated products. A description of each form is provided in table 1.
To obtain a fillable PDF file of each form, visit
We are transitioning to a requirement for electronic submission of the forms related to medical device products. Therefore, we revised FDA Forms 3613, 3613a, 3613c, and 3613g to remove the paper submission instructions in the portions of the forms related to medical device products.
We developed the guidance document “FDA Export Certification” (August 2021) which is intended to provide a general description of FDA export certification to industry and foreign governments. The guidance document is available from our website at:
In the
FDA estimates the burden of this collection of information as follows:
Appropriate centers within FDA review product information submitted by firms in support of the firms' certificate requests. We rely on respondents to certify their compliance with all applicable requirements of the FD&C Act both at the time the certification request is submitted to FDA and at the time the certification is submitted to the respective foreign government. Further information regarding FDA's Export Certificates may be found on our website at
The estimated burden for the information collection reflects an overall adjustment increase of 5,102 hours and a corresponding increase of 5,102 responses. CDER has instituted electronic certificates of pharmaceutical product (eCPP) to streamline the application process and reduce the time from receipt to issuance of export certificates. The increase in CDER export application requests is attributable to the implementation of the eCPP and an increase in drug exports. The increase is offset by a decrease in CVM and CBER export applications attributable to consequences of the COVID-19 pandemic. In addition, revised form instructions related to medical device products are included in the information collection request.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for GEMTESA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Anyone with knowledge that any of the dates as published (see
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
• 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
Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.
The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug or biological product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
A regulatory review period consists of two periods of time: a testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the human drug product, GEMTESA (vibegron) indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urgency frequency in adults. Subsequent to this approval, the USPTO received patent term restoration applications for GEMTESA (U.S. Patent Nos. 8,247,415 and 8,653,260) from Urovant Sciences GmbH, and the USPTO requested FDA's assistance in determining the patents' eligibility for patent term restoration. In a letter dated January 19, 2023, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of GEMTESA represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.
FDA has determined that the applicable regulatory review period for GEMTESA is 3,953 days. Of this time, 3,589 days occurred during the testing phase of the regulatory review period, while 364 days occurred during the approval phase. These periods of time were derived from the following dates:
1.
2.
3.
This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its applications for patent extension, this applicant seeks 1,483 days and 1,433 days of patent term extension.
Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see
Submit petitions electronically to
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for AMPLATZER AMULET and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of patents which claims that medical device.
Anyone with knowledge that any of the dates as published (see
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.”
• 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
Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.
The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's
A regulatory review period consists of two periods of time: a testing phase and an approval phase. For medical devices, the testing phase begins with a clinical investigation of the device and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the device and continues until permission to market the device is granted. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a medical device will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(3)(B).
FDA has approved for marketing the medical device AMPLATZER AMULET. AMPLATZER AMULET is indicated to reduce the risk of thrombus embolization from the left atrial appendage in patients who have nonvalvular atrial fibrillation and who are at increased risk for stroke and systemic embolism based on CHADS2 or CHA2DS2-VASc scores, are suitable for short term anticoagulation therapy, and have appropriate rationale to seek a non-pharmacologic alternative to oral anticoagulation, taking into consideration the safety and effectiveness of the device. Subsequent to this approval, the USPTO received patent term restoration applications for AMPLATZER AMULET (U.S. Patent Nos. 8,034,061; 8,758,389; 8,961,556; and 10,201,337) from St. Jude Medical, Cardiology Division, Inc., and the USPTO requested FDA's assistance in determining the patents' eligibility for patent term restoration. In a letter dated September 13, 2022, FDA advised the USPTO that this medical device had undergone a regulatory review period and that the approval of AMPLATZER AMULET represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.
FDA has determined that the applicable regulatory review period for AMPLATZER AMULET is 1,846 days. Of this time, 1,619 days occurred during the testing phase of the regulatory review period, while 227 days occurred during the approval phase. These periods of time were derived from the following dates:
1.
2.
3.
This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its applications for patent extension, this applicant seeks 571 days, 1,085 days, 1,296 days, and 1,616 days of patent term extension.
Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see
Submit petitions electronically to
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for XERAVA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Anyone with knowledge that any of the dates as published (see
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.”
• 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
Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.
The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug or biological product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
A regulatory review period consists of two periods of time: a testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the human drug product, XERAVA (eravacycline dihydrochloride). XERAVA is indicated for the treatment of complicated intra-abdominal infections in patients 18 years of age and older. Subsequent to this approval, the USPTO received a patent term restoration application for XERAVA (U.S. Patent No. 8,906,887) from Tetraphase Pharmaceutical, Inc., and the USPTO requested FDA's assistance in determining the patent's eligibility for patent term restoration. In a letter dated November 29, 2019, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of XERAVA represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.
FDA has determined that the applicable regulatory review period for XERAVA is 3,265 days. Of this time, 3,022 days occurred during the testing phase of the regulatory review period, while 243 days occurred during the approval phase. These periods of time were derived from the following dates:
1.
2.
3.
This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 608 days of patent term extension.
Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see
Submit petitions electronically to
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for INQOVI and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Anyone with knowledge that any of the dates as published (see
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.”
• 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
Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.
The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug or biological product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
A regulatory review period consists of two periods of time: a testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the human drug product, INQOVI (decitabine and cedazuridine) indicated for the treatment of adult patients with myelodysplastic syndromes (MDS), including previously treated and untreated, de novo and secondary MDS with the following French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups. Subsequent to this approval, the USPTO received patent term restoration applications for INQOVI (U.S. Patent Nos. 8,268,800; 8,618,075; and 9,567,363) from Otsuka Pharmaceutical Co., Ltd., and the USPTO requested FDA's assistance in determining the patents' eligibility for patent term restoration. In a letter dated September 28, 2022, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of INQOVI represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.
FDA has determined that the applicable regulatory review period for INQOVI is 2,330 days. Of this time, 2,120 days occurred during the testing phase of the regulatory review period, while 210 days occurred during the approval phase. These periods of time were derived from the following dates:
1.
2.
3.
This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its applications for patent extension, this applicant seeks 726 days, 1,270 days, or 2,330 days of patent term extension.
Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see
Submit petitions electronically to
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the
Either electronic or written comments on the collection of information must be submitted by April 29, 2024.
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.”
• 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
Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867,
Under the PRA (44 U.S.C. 3501-3521), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the
With respect to the following collection of information, 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
This information collection supports the FDA medical device and device user fee programs. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) (Pub. L. 107-250), and the Medical Device User Fee Amendments of 2007 (Title II of the Food and Drug Administration Amendments Act of 2007 (FDAAA) (Pub. L. 110-85)), authorizes FDA to collect user fees for certain medical device applications. Under this authority, companies pay a fee for certain new medical device applications or supplements submitted to the Agency for review. Because the submission of user fees concurrently with applications and supplements is required, the review of an application cannot begin until the fee is submitted. Form FDA 3601, the “Medical Device User Fee Cover Sheet,” is designed to provide the minimum necessary information to determine whether a fee is required for review of an application, to determine the amount of the fee required, and to account for and track user fees. Form FDA 3601 and instructions are available online for registered users. The form provides a cross-reference between the fees submitted for an application with the actual submitted application by using a unique number tracking system. The information collected is used by FDA's Center for Devices and Radiological Health (CDRH) and FDA's Center for Biologics Evaluation and Research (CBER) to initiate the administrative screening of new medical device applications and supplemental applications.
Owners or operators of places of business (also called establishments or facilities) that are involved in the production and distribution of medical devices intended for use in the United States are required to register annually with FDA, a process known as establishment registration (21 CFR part 807, subparts A through D). (The information collection for medical device establishment registration and listing is approved under OMB control number 0910-0625.) All establishments required to register must pay a user fee. Form FDA 3601a, the “Device Facility User Fee Cover Sheet,” is designed to collect payments for the annual establishment registration fee for medical device establishments.
Under section 704(g) of the FD&C Act (21 U.S.C. 374(g)), FDA may accredit persons to inspect qualified manufacturers of class II and class III devices. An eligible establishment is permitted to select any FDA-accredited person to conduct an inspection in lieu of an FDA inspection, but the eligible establishment must submit notice to FDA for selection approval (see 21 U.S.C. 374(g)(1) and (g)(6)(B)). Referred to as the “Accredited Persons Inspection Program,” FDA publishes a complete list of accredited persons and the activities for which they are accredited on our website at Third Party Device Inspection,
The guidance document entitled “FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act” (December 2019)
FDA estimates the burden of this collection of information as follows:
According to FDA's database system, manufacturers of products subject to MDUFMA submit an average of 6,182 applications annually and submit an average of 24,086 Device Facility User Fee applications. However, not all manufacturers will have any cover sheet submissions in a given year and some may have multiple cover sheet submissions. The estimated hours per response are based on past FDA experience with the various cover sheet submissions and range from 5 to 30 minutes. The hours per response are based on the average of these estimates (18 minutes). The total hours are rounded to the nearest whole number.
Section 704(g) of the FD&C Act provides for accreditation of persons for the purpose of conducting inspections and provides the minimum requirements a person must meet to be accredited to conduct inspections (an Accredited Person). The burden estimate for requests for accreditation is based on the number of applications we've received. Once an organization is accredited, it will not be required to reapply.
The AP Program permits eligible manufacturers to use Accredited Persons to perform certain inspections. While all firms remain subject to inspection by FDA, eligible manufacturers have the option of requesting inspection by an Accredited Person. A device establishment is eligible for inspection by Accredited Persons if the establishment meets certain conditions of section 704(g)(6) of the FD&C Act, including that they provide notice of their intention to use an Accredited Person to conduct inspections of the establishment.
We estimate there are 4,000 domestic manufacturers and 4,000 foreign manufacturers that are eligible for inclusion under the AP program. Based on informal communications with industry, approximately 10 of these manufacturers may submit a request to use an Accredited Person in any given year.
Respondents may elect to prepare their 513(g) request for information using CDRH's electronic Submission Template and Resource (eSTAR) voluntary guided submission preparation tool, which was developed to improve submission consistency and enhance efficiency in the review process. The total number of annual responses is based on the average number of 513(g) requests received each year by CDRH and CBER respectively.
Based on a review of the information collection since our last request for OMB approval, we have made no adjustments to our burden estimate.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for CAMCEVI and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Anyone with knowledge that any of the dates as published (see
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.”
• 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
Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.
The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug or biologic product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
A regulatory review period consists of two periods of time: a testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the human drug product, CAMCEVI (leuprolide mesylate) indicated for the treatment of adult patients with advanced prostate cancer. Subsequent to this approval, the USPTO received patent term restoration applications for CAMCEVI (U.S. Patent Nos. 9,572,857; 9,744,207; 10,646,572) from Foresee Pharmaceutials Co., Ltd. and the USPTO requested FDA's assistance in determining the patents' eligibility for patent term restoration. In a letter dated September 21, 2022, FDA advised the USPTO that this human drug product had undergone a regulatory review period, but that the approval of CAMCEVI did not represent the first permitted commercial marketing or use of the product. The USPTO also requested that FDA determine the product's regulatory review period.
FDA has determined that the applicable regulatory review period for CAMCEVI is 2,569 days. Of this time, 2,266 days occurred during the testing phase of the regulatory review period, while 303 days occurred during the approval phase. These periods of time were derived from the following dates:
1.
2.
3.
This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its applications for patent extension, this applicant seeks 340 days, 834 days, or 928 days of patent term extension.
Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see
Submit petitions electronically to
Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following 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.
Cybersecurity and Infrastructure Security Agency (CISA), Department of Homeland Security (DHS).
Announcement of meeting.
CISA will facilitate a public event to build on existing community-led work around Software Bill of Materials (SBOM) on specific SBOM topics. The goal of this meeting is to help the broader software and security community understand the current state of SBOM and what efforts have been made by different parts of the SBOM community, including CISA-facilitated, community-led work and other activity from sectors and governments.
February 29, 2024, 12 p.m. to 4 p.m. EST.
The event will be virtual. Connection and dial-in information for this virtual event will be available one week before this event at
Allan Friedman, 202-961-4349,
An SBOM has been identified by the cybersecurity community as a key aspect of modern cybersecurity, including software security and supply chain security. Executive Order (E.O.) 14028 declares that “the trust we place in our digital infrastructure should be proportional to how trustworthy and transparent that infrastructure is, and to the consequences we will incur if that trust is misplaced.”
E.O. 14028 defines SBOM as “a formal record containing the details and supply chain relationships of various components used in building software.”
The idea of an SBOM is not novel.
Still, SBOM generation and sharing across the software supply chain was not seen as a commonly accepted practice in modern software. In 2018, the National Telecommunications and Information Administration (NTIA) convened the first multistakeholder process to promote software component transparency.
CISA believes that the concept of SBOM and its implementation would benefit from further refinement, and that a broad-based community effort can help scale and operationalize SBOM implementation. To support such a community effort to advance SBOM technologies, processes, and practices, CISA facilitated the 2023 CISA SBOM-a-Rama. The Winter 2024 SBOM-a-Rama will build on the 2023 event to offer updates as well as present new discussion topics for consideration by the community.
The goal of this meeting is to help the broader software and security community understand the current state of SBOM and what efforts have been made by different parts of the SBOM community, including CISA-facilitated, community-led work and other activity from sectors and governments. Attendees are invited to ask questions, share comments, and raise further issues that need attention. Specific presentations will be made on the community-led efforts around sharing SBOMs, cloud and online applications, tools and implementation, the Vulnerability Exploitability eXchange (VEX) model, and SBOM on-ramps and adoption. The event will also feature presentations and discussions on sector efforts around the world. CISA will also facilitate conversations on how the community can most efficiently make progress in addressing gaps in the SBOM ecosystem.
A full agenda will be posted in advance of the meeting at
This event is open to anyone. CISA welcomes participation from anyone interested in learning about the current state of SBOM practice and implementation including private sector practitioners, policy experts, academics, and representatives from non-U.S. organizations. Additional information, including the meeting link, will be available one week before the meeting date at
This notice is issued under the authority of 6 U.S.C. 652(c)(10)-(11) and 6 U.S.C. 659(c)(4).
Cybersecurity and Infrastructure Security Agency (CISA), Department of Homeland Security (DHS).
60-Day notice and request for comments; new collection request and OMB control number is 1670-NNEW.
The Vulnerability Management (VM) within Cybersecurity and Infrastructure Security Agency (CISA) will submit the following Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review.
Comments are encouraged and will be accepted until April 29, 2024.
You may submit comments, identified by docket number Docket # CISA-2024-0008, at:
○
Christopher Murray,
The Cybersecurity and Infrastructure Security Agency (CISA) operates the federal information security incident center. Through this center, CISA provides technical assistance and guidance on detecting and handling security Vulnerability Disclosures, compile and analyze incident information that threatens information security, inform agencies of current and potential threats and vulnerabilities, and provide intelligence or other information about cyber threats, vulnerabilities, and incidents to agencies. 44 U.S.C. 3556(a), see also 6 U.S.C. 659(c) (providing for cybersecurity services for both Federal Government and non-Federal Government entities).
CISA is responsible for performing coordinated Vulnerability Disclosure, which may originate outside the United States Government (USG) network/community and affect users within it, or originate within the USG community and affect users outside of it. Often, therefore, the effective handling of security incidents relies on information sharing among individual users, industry, and the USG, which may be facilitated by and through CISA. A dedicated form on the CISA website will allow for external reporting of vulnerabilities that the reporting entity believe to be Known Exploited Vulnerabilities (KEV) eligible. Upon submission, CISA will evaluate the information provided, and then will add to the KEV Catalog, if all KEV requirements are met.
For the developmental digital copy of this information collection for review, please contact the POC listed above in this notice request.
The Office of Management and Budget is particularly interested in comments which:
1. 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;
2. 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;
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 through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
U.S. Citizenship and Immigration Services, Department of Homeland Security.
60-Day notice.
The Department of Homeland Security (DHS), U.S. Citizenship and Immigration Services (USCIS) invites the general public and other Federal agencies to comment upon this proposed extension. In accordance with the Paperwork Reduction Act (PRA) of 1995, the information collection notice is published in the
Comments are encouraged and will be accepted for 60 days until April 29, 2024.
All submissions received must include the OMB Control Number 1615-0060 in the body of the letter, the agency name and Docket ID USCIS-2008-0021. Submit comments via the Federal eRulemaking Portal website at
USCIS, Office of Policy and Strategy, Regulatory Coordination Division, Samantha Deshommes, Chief, telephone number (240) 721-3000 (This is not a toll-free number. Comments are not accepted via telephone message). Please note contact information provided here is solely for questions regarding this notice. It is not for individual case status inquiries. Applicants seeking information about the status of their individual cases can check Case Status Online, available at the USCIS website at
You may access the information collection instrument with instructions or additional information by visiting the Federal eRulemaking Portal site at:
Written comments and suggestions from the public and affected agencies should address one or more of the following four points:
(1) 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;
(2) 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;
(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 through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
(1)
(2)
(3)
(4)
(5)
(6)
(7)
Bureau of Indian Affairs, Interior.
Notice of information collection; request for comment.
In accordance with the Paperwork Reduction Act of 1995, we, the Bureau of Indian Affairs (BIA) are proposing to renew an information collection.
Interested persons are invited to submit comments on or before April 1, 2024.
Written comments and recommendations for the proposed information collection request (ICR) should be sent within 30 days of publication of this notice to the Office of Information and Regulatory Affairs (OIRA) through
To request additional information about this ICR, contact Steven Mullen, Information Collection Clearance Officer, Office of Regulatory Affairs and Collaborative Action—Indian Affairs, U.S. Department of the Interior, 1001 Indian School Road NW, Suite 229, Albuquerque, New Mexico 87104;
In accordance with the Paperwork Reduction Act of 1995 (PRA, 44 U.S.C. 3501
A
As part of our continuing effort to reduce paperwork and respondent burdens, we are again soliciting comments from the public and other Federal agencies on the proposed ICR that is described below. We are especially interested in public comment addressing the following:
(1) Whether or not the collection of information is necessary for the proper performance of the functions of the agency, including whether or not the information will have practical utility;
(2) The accuracy of our estimate of the burden for this collection of information, including the validity of the methodology and assumptions used;
(3) Ways to enhance the quality, utility, and clarity of the information to be collected; and
(4) How might the agency minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
Comments that you submit in response to this notice are a matter of public record. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
An agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.
The authority for this action is the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
National Park Service, Interior.
Meeting notice.
In accordance with the Federal Advisory Committee Act of 1972, as amended, the National Park Service is hereby giving notice that the Cedar Creek and Belle Grove National Historical Park Advisory Commission (Commission) will meet as indicated below.
The Commission will meet on Thursday, March 21, 2024; Thursday, June 20, 2024; Thursday, September 19, 2024; and Thursday, December 19, 2024. All scheduled meetings will begin at 9 a.m. and will end by 11 a.m. (EASTERN).
The March 21, 2024, and December 19, 2024, meetings will be held via teleconference and in-person at Warren County Government Center, 220 North Commerce Avenue, Front Royal, VA 22630. The June 20, 2024, and September 19, 2024, meetings will be held via teleconference and in-person at the Middletown Town Hall Council Chambers, 7875 Church Street, Middletown, VA 22645. Information on joining the teleconference will be available on the Cedar Creek and Belle Grove National Park website at
Karen Beck-Herzog, Site Manager, Cedar Creek and Belle Grove National Historical Park, P.O. Box 700, Middletown, Virginia 22645, telephone (540) 868-9176, email
The Commission was established by Congress to provide advice to the Secretary of the Interior on the preparation and implementation of the park's general management plan and to advise on land protection (16 U.S.C. 410iii-7). The meeting is open to the public. Individuals who are interested in the park, the implementation of the plan, or the business of the Commission are encouraged to attend the meeting. Interested members of the public may present, either orally or through written comments, information for the Commission to consider during the public meeting. Attendees and those wishing to provide comment are strongly encouraged to preregister through the contact information provided. Written comments may be sent to Karen Beck-Herzog (see
Commission meetings consist of the following:
National Park Service, Interior.
Meeting notice.
In accordance with the Federal Advisory Committee Act, as amended, the National Park Service (NPS) is hereby giving notice that the meeting of the reestablished Cape Cod National Seashore Advisory Commission (Commission) will meet as indicated below.
The Commission will meet on Monday, April 8, 2024, at 1 p.m. and will end by 4 p.m. (eastern).
The meeting will be held at the Salt Pond Visitors Center, 50 Nauset Road, Eastham, Massachusetts 02642.
Jennifer Flynn, Superintendent and Designated Federal Officer, Cape Cod National Seashore, 99 Marconi Site Road, Wellfleet, Massachusetts 02667, telephone (508) 771-2144 or
The Commission was established by section 8 of Public Law 87-126, as amended, and expired on September 26, 2018. The Commission was reestablished by Div. DD, title VI, subtitle B, section 613 of Public Law 117-328, the Consolidated Appropriations Act, 2023. The Commission's new termination date is September 26, 2029. The purpose of the Commission is to consult with the Secretary of the Interior, or her designee, with respect to matters relating to the development of Cape Cod National Seashore, and with respect to carrying out the provisions of the Act establishing the Seashore. The meeting is open to the public. Interested persons may make oral presentations to the Commission. Such requests should be made to the Superintendent at the beginning of the meeting. Depending on the number of persons wishing to speak, and the time available, the time for individual comments may be limited. Written comments can be sent to Jennifer Flynn [see
The Commission meeting location may change based on inclement weather or exceptional circumstances. If a meeting location is changed, the Superintendent will issue a press release and use local newspapers to announce the change. Detailed minutes of the meeting will be available for public inspection within 90 days of the meeting.
National Park Service, Interior.
Notice.
The National Park Service is soliciting electronic comments on the significance of properties nominated before February 17, 2024, for listing or related actions in the National Register of Historic Places.
Comments should be submitted electronically by March 15, 2024.
Comments are encouraged to be submitted electronically to
Sherry A. Frear, Chief, National Register of Historic Places/National Historic Landmarks Program, 1849 C Street NW, MS 7228, Washington, DC 20240,
The properties listed in this notice are being considered for listing or related actions in the National Register of Historic Places. Nominations for their consideration were received by the National Park Service before February 17, 2024. Pursuant to Section 60.13 of 36 CFR part 60, comments are being accepted concerning the significance of the nominated properties under the National Register criteria for evaluation.
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.
Nominations submitted by State or Tribal Historic Preservation Officers.
A request for removal has been made for the following resource(s):
Additional documentation has been received for the following resource(s):
Nomination(s) submitted by Federal Preservation Officers:
The State Historic Preservation Officer reviewed the following nomination(s) and responded to the Federal Preservation Officer within 45 days of receipt of the nomination(s) and supports listing the properties in the National Register of Historic Places.
Bureau of Ocean Energy Management, Interior.
Draft programmatic environmental impact statement; extension of comment period.
On January 12, 2024, the Bureau of Ocean Energy Management (BOEM) published a notice of availability (NOA) in the
The comment period for the notice published January 12, 2024, at 89 FR 2249, is extended. Comments must be received no later than March 13, 2024.
The draft PEIS and detailed information about the project can be found on BOEM's website at:
• Delivered by mail or delivery service, enclosed in an envelope labeled, “NY BIGHT PEIS” and addressed to Chief, Division of Environmental Assessment, Office of Environmental Programs, Bureau of Ocean Energy Management, 45600 Woodland Road, VAM-OEP, Sterling, Virginia 20166; or
•
Jill Lewandowski, BOEM Office of Environmental Programs, 45600 Woodland Road, VAM-OEP, Sterling, Virginia 20166, (703) 787-1703 or
Please refer to the NOA published in the
Comments already submitted in response to the January 12, 2024, NOA do not need to be resubmitted. BOEM discourages the submittal of anonymous comments.
Please include your name and address as part of your comment. BOEM makes all comments in their entirety, including the names and addresses of respondents, available for public review online and during regular business hours. You may request that BOEM withhold your name, address, or any other personal identifiable information (PII) included in your comment from the public record. However, BOEM cannot guarantee that it will be able to do so. If you wish your name, address, or other PII to be withheld, you must state your request prominently in a cover letter and explain the harm that you fear from its disclosure such as unwarranted privacy invasion, embarrassment, or injury. All submissions from organizations or businesses and from individuals identifying themselves as representatives or officials of organizations or businesses will be made available for public inspection in their entirety.
Even if BOEM withholds your PII in the context of this notice, your comment is subject to the Freedom of Information Act (FOIA) (5 U.S.C. 552). Your information will only be withheld if a determination is made that one of the FOIA exemptions to disclosure applies. Such a determination will be made in accordance with the Department's FOIA implementing regulations (43 CFR part 2) and applicable law.
BOEM protects business confidential information in accordance with the Freedom of Information Act (5 U.S.C. 552) and the Department of the Interior's implementing regulations (43 CFR part 2 and 30 CFR part 585).
On the basis of the record
The Commission instituted these investigations effective January 18, 2023, following receipt of petitions filed with the Commission and Commerce by Cleveland-Cliffs Inc. (“Cleveland-Cliffs”), Cleveland, Ohio, and the United Steel, Paper and Forestry, Rubber, Manufacturing, Energy, Allied Industrial and Service Workers International Union (“USW”), Pittsburgh, Pennsylvania. The final phase of the investigations was scheduled by the Commission following notification of preliminary determinations by Commerce that imports of tin mill products from China were subsidized within the meaning of section 703(b) of the Act (19 U.S.C. 1671b(b)) and imports from Canada, China, and Germany, were sold at LTFV within the meaning of 733(b) of the Act (19 U.S.C. 1673b(b)).
The Commission made these determinations pursuant to §§ 705(b) and 735(b) of the Act (19 U.S.C. 1671d(b) and 19 U.S.C. 1673d(b)). It completed and filed its determinations in these investigations on February 26, 2024. The views of the Commission are contained in USITC Publication 5492 (February 2024), entitled
By order of the Commission.
United States International Trade Commission.
March 7, 2024 at 11 a.m.
Room 101, 500 E Street SW, Washington, DC 20436, Telephone: (202) 205-2000.
Open to the public.
1.
2. Minutes.
3. Ratification List.
4. Commission vote on Inv. Nos. 701-TA-590 and 731-TA-1397 (Review) (Sodium Gluconate, Gluconic Acid, and Derivative Products from China). The Commission currently is scheduled to complete and file its determinations and views of the Commission on March 15, 2024.
5.
Sharon Bellamy, Supervisory Hearings and Information Officer, 202-205-2000.
The Commission is holding the meeting under the Government in the Sunshine Act, 5 U.S.C. 552(b). In accordance with Commission policy, subject matter listed above, not disposed of at the scheduled meeting, may be carried over to the agenda of the following meeting.
By order of the Commission.
Notice; correction.
The Department of Justice published a document in the
Zhen Zheng, (202) 598-9955.
In the
Bureau of Alcohol, Tobacco, Firearms and Explosives, Department of Justice.
60-Day notice.
The Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF), Department of Justice (DOJ), will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995.
Comments are encouraged and will be accepted for 60 days until April 29, 2024.
If you have additional comments especially on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, contact: Jaclyn N. Wiltshire, Personnel Security Division, either by mail at U.S. Department of Justice, PSD—Room (1E-300), 99 New York Ave. NE, Washington, DC 20226, by email at
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:
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2.
3.
4.
The obligation to respond is voluntary.
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Notice of availability; request for comments.
The Department of Labor (DOL) is submitting this Office of the
The OMB will consider all written comments that the agency receives on or before April 1, 2024.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Wilson Vadukumcherry by telephone at 202-693-0110, or by email at
The information collections under OMB Control No. 1225-0013 provides for payment of fees and expenses to eligible parties who have prevailed against the Department in certain administrative proceedings. In order to obtain an award, the statute and associated regulations (29 CFR part 16) require the filing of an application. For additional substantive information about this ICR, see the related notice published in the
This information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless the OMB approves it and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information that does not display a valid OMB Control Number.
DOL seeks PRA authorization for this information collection for three (3) years. OMB authorization for an ICR cannot be for more than three (3) years without renewal. The DOL notes that information collection requirements submitted to the OMB for existing ICRs receive a month-to-month extension while they undergo review.
National Archives and Records Administration (NARA).
Notice of a request for comments regarding an information collection.
We are renewing a generic information collection request (generic ICR) entitled Generic Clearance for NARA Public and Education Program Registration. This notice announces that we plan to submit this generic ICR plan to OMB for approval under the Paperwork Reduction Act and solicits comments on specific aspects of the collection plan. We will use this to collect information from individuals registering for an education or other program at NARA.
We must receive written comments on or before April 29, 2024.
Send comments to Paperwork Reduction Act Comments (MP), Room 4100; National Archives and Records Administration; 8601 Adelphi Road; College Park, MD 20740-6001, or by email to
Contact Tamee Fechhelm by telephone at 301-837-1694 with requests for additional information or copies of the proposed information collection and supporting statement.
Pursuant to the Paperwork Reduction Act of 1995 (Pub. L. 104-13), we invite comments on: (a) whether collecting this information is necessary for proper performance of the agency's functions, including whether the information will have practical utility; (b) the accuracy of our estimate of the information collection's burden on respondents; (c) ways to enhance the quality, utility, and clarity of the information we propose to collect; (d) ways to minimize the burden on respondents of collecting the information, 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. Burden means the total time, effort, or financial resources people need to provide the information, including time to review instructions, process and maintain the information, search data sources, and respond.
A generic ICR is a request for OMB to approve a plan for conducting more than one information collection using very similar methods when (1) we can evaluate the need for and the overall practical utility of the data in advance, as part of the review of the proposed plan, but (2) we cannot determine the details of the specific individual collections until a later time. Most generic clearances cover collections that are voluntary, low burden (based on a consideration of total burden, total respondents, or burden per respondent), and uncontroversial. This notice, for example, describes a general plan to gather registration information from members of the public who wish to participate in programs at NARA, through a series of registration forms used for a variety of current and future education programs at different facilities. As part of this plan, we construct, distribute, and use the registration forms in a similar manner, but customize each one for the type and location of the program involved.
Because we seek public comment on the plan, we do not need to seek public comment on each specific information
• The collection is voluntary;
• The collection is low-burden for respondents (based on considerations of total burden hours, total number of respondents, or burden-hours per respondent) and is low-cost for both the respondents and the Federal Government;
• The collection is non-controversial and does not raise issues of concern to other Federal agencies;
• Personally identifiable information (PII) is collected only to the extent necessary and is retained only for the period of time required by NARA records schedules;
• Information gathered will be used only internally for program management purposes and is not intended for release outside of the agency;
• Information gathered will not be used for the purpose of substantially informing influential policy decisions; and
• Information gathered will yield qualitative information; the collections will not be designed or expected to yield statistically reliable results or used as though the results are generalizable to the population of study.
As a general matter, information collections under this generic collection request will not result in any new system of records containing privacy information and will not ask questions of a sensitive nature, such as sexual behavior and attitudes, religious beliefs, and other matters that are commonly considered private. In this notice, NARA solicits comments concerning the following information collection:
In accordance with the Federal Advisory Committee Act (Pub. L. 92-463, as amended), the National Science Foundation (NSF) announces the following meeting:
To attend the meeting in person, all visitors must contact the Directorate for Mathematical and Physical Sciences at least 48 hours prior to the meeting to arrange for a visitor's badge.
All visitors must access NSF via the Visitor Center entry adjacent to the south building entrance on Eisenhower Avenue on the day of the meeting to receive the visitor's badge. It is suggested that visitors allow time to pass through security screening.
To attend virtually, please use the link provided on the MPS AC website located at
A final/updated agenda will be available on the MPS AC website located at
Pursuant to Section 19(b)(1)
The Exchange proposes to modify Rule 6.91P-O (Electronic Complex Order Trading) to specify additional trading interest that would result in the early end of a Complex Order Auction (“COA”). 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 modify Rule 6.91P-O (Electronic Complex Order Trading) to specify additional trading interest that would result in the early end of a Complex Order Auction (“COA”). This proposed amendment to the Exchange's complex order trading rule would align with the recently modified complex order trading rule of the Exchange's affiliated options exchange, NYSE American LLC (“NYSE American”).
Rule 6.91P-O reflects how Electronic Complex Orders (“ECOs”) will trade on the Exchange
The Exchange proposes to modify Rule 6.91P-O(f)(3) to add new
As noted above, until a COA concludes, the Book is not updated to reflect any COA Order executions (with price-improving auction interest or with resting ECO or leg market interest) or any balance of the COA Order ranking in the Book. Thus, to allow the later-arriving Complex QCC Order to be evaluated based on the most up-to-date Book, the Exchange proposes to end a COA upon the arrival of a Complex QCC Order in the same complex strategy. This proposed early termination would allow the Exchange to incorporate executions from the COA, or any remaining balance of the COA Order, to conduct the requisite price validations per Rule 6.62P-O(g)(1)(D) for the Complex QCC Order (
The proposed rule change would be consistent with current Rule 6.91P-O(f)(3)(A)-(D), which describes four circumstances that cause the early end of a COA to ensure that later-arriving interest does not trade ahead of a COA Order and to ensure that the Book is updated to reflect executions resulting from the COA. The Exchange believes that the proposed rule change achieves this same objective. As with the existing early end scenarios, the proposed early end of a COA does not prevent the COA Order from trading with any interest, including price-improving interest, that arrived prior to the early termination (
In addition to NYSE American, the Exchange notes that at least two other (non-affiliated) options exchanges offer both Complex QCC Orders and COA functionality and each has opted for a different way to address the race condition posed by these two features. For example, per the technical specifications for complex orders executed on Cboe Exchange Inc. (“Cboe”), a Complex QCC Order is “immediately executed or canceled on entry” and is not “restricted by other auction types going on at the same time” and, as such, the price validations on the later-arriving Complex QCC are (apparently) done without consideration of the COA process and its potential impact on Cboe's Complex Order Book.
The Exchange believes that its proposal to codify by rule its distinct approach to resolving the same issue faced by Cboe and MIAX would provide the best protection to its market participants and would mirror the approach taken by NYSE American.
The proposed rule change is consistent with Section 6(b) of the Securities Exchange Act of 1934 (the “Act”),
The Exchange believes that the proposed amendment to Rule 6.91P-O(f)(3) regarding the additional circumstance that would cause a COA to end early would promote just and equitable principles of trade because it would ensure that the COA Order is executed to the extent possible and, if applicable, is ranked in the Consolidated Book before the Exchange evaluates the later-arriving Complex QCC Order. As noted above, until the COA concludes, the Book is not updated to reflect any COA Order executions (with price-improving auction interest or with resting ECO or leg market interest) or any balance of the COA Order ranking in the Book. This proposed early termination would then allow the Exchange to incorporate executions from the COA, or any remaining balance of the COA Order, to conduct the requisite price validations for the Complex QCC Order (per Rule 6.62P-O(g)(1)(D)) based on the most up-to-date Book (
As noted herein, current Rule 6.91P-O(f)(A)-(D) describes four circumstances under which a COA must end early to ensure that later-arriving interest does not trade ahead of a COA Order and to ensure that the Book is updated to reflect executions resulting from the COA. The Exchange believes that the proposed rule change achieves this same objective. As with the existing early end scenarios, the proposed early end of a COA does not prevent the COA Order from trading with any interest, including price-improving interest, that arrived prior to the early termination (
At least two other options exchanges have taken different approaches to address how to handle the arrival of a Complex QCC Order while a Complex Order Auction is in progress. As noted herein, the Exchange believes that its proposed approach would provide the best protection to investors because ending a COA upon receipt of a Complex QCC Order would ensure that the COA Order executes to the extent possible and that the Exchange relies on the most-up-to-date Book (following executions in the COA) to validate the price of the Complex QCC Order. Thus, the Exchange believes the proposed rule change would promote just and equitable principles of trade because it would help preserve—and maintain investor's confidence in—the integrity of the Exchange's local market.
Finally, the Exchange believes that modifying the rule as proposed would add clarity and transparency to Rule 6.91P-O regarding the handling of COA Orders.
The Exchange does not believe that the proposed rule change will impose any burden on intra-market competition that is not necessary or appropriate in furtherance of the purposes of the Act. The proposed rule change would apply in the same manner to all similarly-situated market participants that opt to utilize the COA process, the use of which is voluntary and, as such, market participants are not required to avail themselves of this process.
The Exchange does not believe that its proposed rule change will impose any burden on inter-market competition that is not necessary or appropriate in furtherance of the purposes of the Act because the proposed change is designed to ensure that both a COA Order and a Complex QCC Order receive timely executions based on current market conditions, which change is identical to NYSE American Rule 980NYP(f)(3)(E). To the extent that other options exchanges, like Cboe or MIAX, offer complex order auctions and Complex QCC Orders, such exchanges are free to adopt (if they have not already done so) the early termination provision proposed herein.
No written comments were solicited or received with respect to the proposed rule change.
The Exchange has filed the proposed rule change pursuant to Section 19(b)(3)(A)(iii) of the Act
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 under Section 19(b)(2)(B)
Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
On January 10, 2024, the Options Clearing Corporation (“OCC”) filed with the Securities and Exchange Commission (“Commission”) the proposed rule change SR-OCC-2024-001 (“Proposed Rule Change”) pursuant to Section 19(b) of the Securities Exchange Act of 1934 (“Exchange Act”)
Section 19(b)(2)(i) of the Exchange Act
The 45th day after publication of the Notice of Filing is March 10, 2024. In order to provide the Commission with sufficient time to consider the Proposed Rule Change, the Commission finds that it is appropriate to designate a longer period within which to take action on the Proposed Rule Change and therefore is extending this 45-day time period.
Accordingly, the Commission, pursuant to Section 19(b)(2) of the Exchange Act,
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1)
The Exchange proposes to amend its Price List to eliminate obsolete Crossing Session pricing. 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 purpose of this filing is to eliminate obsolete Crossing Session I (“CS I”) and Crossing Session II (“CS II”) pricing.
The Exchange proposes to implement these changes to its Price List effective February 12, 2024.
CS I permitted execution, at the Exchange's closing price, of single-stock, single-sided closing price orders and crosses of single-stock, closing price buy and sell orders. The Exchange did not charge for CS I executions. CS I was eliminated in 2009.
CS II ran on the Exchange from 4:00 p.m. to 6:30 p.m. Eastern Time and handled member organization crosses of baskets of securities of aggregate-priced buy and sell orders.
The Exchange proposes to delete CS I and II fee pricing in its entirety. Both crossing sessions are no longer operative. As noted above, CS I was eliminated in 2009 and CS II was decommissioned at the end of January 2024. Since the Exchange no longer offers after hours crossing sessions, the Exchange proposes to delete the section of the Price List titled “Crossing Sessions I and II” in its entirety as obsolete.
The proposed changes are not otherwise intended to address any other issues, and the Exchange is not aware of any problems that member organizations would have in complying with the proposed change.
The Exchange believes that the proposed rule change is consistent with Section 6(b) of the Act,
The Exchange believes that the proposed elimination of crossing session fees is reasonable because the fees are no longer being charged. The Exchange believes it is reasonable to delete obsolete fees from the Price List because it would streamline the Price List and reduce confusion as to which fees are applicable on the Exchange. The Exchange believes that amending the Price List to remove fees that are no longer charged would promote the protection of investors and the public interest because it would promote clarity and transparency in the Price List, thereby enabling market participants to navigate the Exchange's Price List more easily.
The Exchange believes the proposal equitably allocates fees among its market participants because the obsolete crossing session fees that the Exchange proposes to eliminate would be eliminated in their entirety, and would no longer be available to any member organization in any form. Similarly, the Exchange believes the proposal equitably allocates fees among its market participants because elimination of obsolete fees would apply to all similarly-situated member organizations on an equal basis. All such member organizations would continue to be subject to the same fee structure, and access to the Exchange's market would continue to be offered on fair and nondiscriminatory terms.
The Exchange believes that the proposal is not unfairly discriminatory because it neither targets nor will it have a disparate impact on any particular category of market participant. The Exchange believes that the proposal is not unfairly discriminatory because the proposed elimination of the obsolete fees would affect all similarly-situated market participants on an equal and non-discriminatory basis. The Exchange believes that eliminating obsolete fees would no longer be available to any member organization on an equal basis. The Exchange also believes that the proposed change would protect investors and the public interest because the deletion of obsolete fees would make the Price List more accessible and transparent and facilitate market participants' understanding of
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,
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 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 under Section 19(b)(2)(B)
Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1)
The Exchange proposes to amend Rule 915 to permit the listing and trading of options on the Bitwise Bitcoin ETF, the Grayscale Bitcoin Trust (BTC), and any trust that holds bitcoin. 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 Rule 915 (Criteria for Underlying Securities), Commentary .10, to allow the Exchange to list and trade options on the Bitwise Bitcoin ETF (“BITC”), the Grayscale Bitcoin Trust (BTC) (“GBTC”), and any trust that holds only bitcoin and cash (collectively, “Bitcoin ETPs”).
Commentary .06 to Rule 915 (hereinafter “Commentary .06”) provides that, subject to certain other criteria set forth in Rule 915, securities deemed appropriate for options trading include ETFs that represent certain types of interests,
Bitcoin ETPs, including the Bitwise Bitcoin ETF (“BITC”) and the Grayscale Bitcoin Trust (“GBTC”), are bitcoin-backed commodity ETPs structured as trusts.
Bitcoin ETPs provide investors with cost efficient alternatives that allow a level of participation in the bitcoin market through the securities market. The primary substantive difference between Bitcoin ETPs and ETFs currently deemed appropriate for options trading are that ETFs may hold securities, certain financial instruments, and specified precious metals (which are commodities), while Bitcoin ETPs hold bitcoin (which is also deemed a commodity).
Bitcoin ETPs will trade in the same manner as options on other ETFs (including commodities ETFs) on the Exchange.
The Exchange's initial listing standards for ETFs on which options may be listed and traded on the Exchange will apply to Bitcoin ETPs. The Exchange expects Bitcoin ETPs to satisfy the initial listing standards as set forth in Rule 915(a) (generally) and Commentary .06 (which applies to ETFs specifically). Pursuant to Rule 915(a), a security (which includes ETFs) on which options may be listed and traded on the Exchange must be duly registered (with the Commission) and be an NMS stock (as defined in Rule 600 of Regulation NMS under the Act,) and be characterized by a substantial number of outstanding shares that are widely held and actively traded. In addition, Commentary .06 requires that ETFs must either (1) meet the criteria and standards set forth in Commentary .01 to Rule 915,
Options on Bitcoin ETPs will also be subject to the Exchange's continued listing standards set forth in Commentary .07 to Rule 916 which provides that options on ETFs may be subject to the suspension of opening transactions as follows: (1) the ETFs no longer meets the terms of Commentary .01 to Rule 916; (2) following the initial twelve-month period beginning upon the commencement of trading of the ETFs, there are fewer than 50 record and/or beneficial holders of the ETFs for 30 or more consecutive trading days; (3) the value of the underlying commodity is no longer calculated or available; or (4) such other event occurs or condition exists that in the opinion of the Exchange makes further dealing on the Exchange inadvisable. Additionally, ETFs will be deemed to not meet the requirements for continued approval, and the Exchange will not open for trading any additional series of option contracts covering the ETF if such security ceases to be an “NMS stock” as provided for Commentary .01(5) to Rule 915 or the ETF is halted from trading on its primary market.
Options on Bitcoin ETPs listed pursuant to proposed Commentary .10 to Rule 915 would be physically
Specifically, consistent with Rule 903, which governs the opening of options series on a specific underlying security (including ETFs), the Exchange will open at least one expiration month for options on Bitcoin ETPs and may also list series of options on Bitcoin ETPs for trading on a weekly
Pursuant to Rule 903, Commentary .05(a), which governs strike prices of series of options on ETFs, the interval between strike prices of series of options on ETFs approved for options trading (per Commentary .06) will be fixed at a price per share which is reasonably close to the price per share at which the underlying security is traded in the primary market at or about the same time such series of options is first open for trading on the Exchange, or at such intervals as may have been established on another options exchange prior to the initiation of trading on the Exchange. With respect to the Short Term Options Series or Weekly Program, during the month prior to expiration of an option class that is selected for the Short Term Option Series Program, the strike price intervals for the related non-Short Term Option (“Related non-Short Term Option”) shall be the same as the strike price intervals for the Short Term Option.
Position and exercise limits for options on ETFs, including options on Bitcoin ETPs, are determined pursuant to Rules 904 and 905, respectively. Position and exercise limits for ETFs
The Exchange notes that options on Bitcoin ETPs would not be available for trading until The Options Clearing Corporation (“OCC”) represents to the Exchange that it is fully able to clear and settle such options. The Exchange has also analyzed its capacity and represents that it and The Options Price Reporting Authority (“OPRA”) have the necessary systems capacity to handle the additional traffic associated with the listing of options on Bitcoin ETPs. The Exchange believes any additional traffic that would be generated from the trading of options on Bitcoin ETPs would be manageable. The Exchange represents that Exchange members will not have a capacity issue as a result of this proposed rule change.
The Exchange represents that the same surveillance procedures applicable to all other options on other ETFs currently listed and traded on the Exchange will apply to options on Bitcoin ETPs. The Exchange's existing surveillance and reporting safeguards are designed to deter and detect possible manipulative behavior which might arise from listing and trading options on ETFs, including the options on Bitcoin ETPs. The Exchange believes that its surveillance procedures are adequate to properly monitor the trading of options on Bitcoin ETPs in all trading sessions and to deter and detect violations of Exchange rules. In addition, the Exchange will implement any new surveillance procedures it deems necessary to effectively monitor the trading of options on Bitcoin ETPs. Also, the Exchange may obtain trading information via the Intermarket Surveillance Group (“ISG”) from other exchanges who are members of the ISG, or from other exchanges with which the Exchange has entered into a comprehensive surveillance sharing agreement (“CSSA”). The Exchange will enter into new CSSAs with other exchanges as necessary to effectively monitor the trading of options on Bitcoin ETPs. The Exchange represents that these procedures will be adequate to properly monitor Exchange trading of options on Bitcoin ETPs and to deter and detect violations of Exchange rules.
Finally, quotation and last sale information for ETFs is available via the Consolidated Tape Association (“CTA”) high speed line. Quotation and last sale information for such securities is also available from the exchange on which such securities are listed. Quotation and last sale information for options on Bitcoin ETPs will be available via OPRA and major market data vendors.
The Exchange believes that its proposed rule change is consistent with Section 6(b) of the Act
In particular, the Exchange believes that the proposal to list and trade options on Bitcoin ETPs 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 offering options on Bitcoin ETPs will provide investors with a greater opportunity to realize the benefits of utilizing options on an ETF based on spot bitcoin, including cost efficiencies and increased hedging strategies. The Exchange believes that offering options on a competitively priced ETF based on spot bitcoin will benefit investors by providing them with an additional, relatively lower cost risk management tool allowing them to manage, more easily, their positions, and associated risks, in their portfolios in connection with exposure to spot bitcoin. Today, the Exchange lists options on other commodity ETFs structured as a trust, which essentially offer analogous objectives and benefits to investors, and for which the Exchange has not identified any issues with the continued listing and trading of options on those ETFs.
The Exchange also believes the proposal to permit options on Bitcoin ETPs will remove impediments to and perfect the mechanism of a free and open market and a national market system, because options on Bitcoin ETPs will comply with current Exchange rules as discussed herein. Specifically, options on Bitcoin ETPs must satisfy the initial listing standards and continued listing standards currently in the Exchange rules, applicable to options on all ETFs, including options on other commodity ETFs already deemed appropriate for options trading on the Exchange pursuant to Rule 915, Commentary .10. Further, Exchange rules that currently govern the listing and trading of options on ETFs, including permissible expirations, strike prices, minimum increments, position and exercise limits, and margin requirements, will govern the listing and trading of options on Bitcoin ETPs.
The Exchange represents that it has the necessary systems capacity to support any additional traffic that may be generated by the trading of options on Bitcoin ETPs. In addition, the Exchange represents that its existing surveillance procedures are adequate to properly monitor the trading of options on Bitcoin ETPs in all trading sessions and to deter and detect violations of Exchange rules. The Exchange further represents that it will implement new surveillance procedures, as necessary, to effectively monitor the trading of options on Bitcoin ETPs. Finally, the Commission has previously approved the listing and trading of options on other commodity ETFs structured as a trust, such as SPDR Gold Trust,
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.
No written comments were solicited or received with respect to the proposed rule change.
Within 45 days of the date of publication of this notice in the
(A) by order approve or disapprove the proposed rule change, or
(B) institute proceedings to determine whether the proposed rule change should be 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)
The Exchange proposes to amend the content of the NYSE Best Quote & Trades (“NYSE BQT”) data feed to identify the current day consolidated first price and last price of a security published by the securities information processors for all listed equity securities. 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 enhance the content of NYSE BQT to identify the current day consolidated first price and last price of a security published by the securities information processors (“SIPs”) for all listed equity securities.
The NYSE BQT
NYSE BBO, NYSE Arca BBO, NYSE American BBO, NYSE National BBO and NYSE Chicago BBO are existing data feeds that distribute on a real-time basis the same BBO information that NYSE, NYSE Arca, NYSE American, NYSE National and NYSE Chicago, respectively, report under the Consolidated Quotation (“CQ”) Plan for inclusion in the CQ Plan's consolidated quotation information data stream. NYSE Trades, NYSE Arca Trades, NYSE American Trades, NYSE National Trades and NYSE Chicago Trades are existing data feeds that distribute on a real-time basis the same last sale information that NYSE, NYSE Arca, NYSE American, NYSE National and NYSE Chicago, respectively, report under the Consolidated Tape Association (“CTA”) Plan for inclusion in the CTA Plan's consolidated data streams. Among other things, NYSE BQT also includes consolidated volume for all listed equity securities regardless of where a transaction is executed.
The Exchange also previously amended NYSE BQT to include the consolidated high and consolidated low price for all equity securities as obtained directly from the SIPs.
Now, in addition to the information currently provided in NYSE BQT, the Exchange proposes to include the current day consolidated first price
The NYSE BQT data feed is offered in a capacity similar to that of a vendor. The Exchange, NYSE Arca, NYSE American, NYSE National and NYSE Chicago are the exclusive distributors of the 10 BBO and Trades feeds
The Exchange will announce the implementation date of this proposed rule change by Trader Update, which, subject to the effectiveness of this proposed rule change, will be no later than the second quarter of 2024. The Exchange is not proposing any change to the fees for NYSE BQT as a result of this modification.
The Exchange believes that the proposed rule change is consistent with Section 6(b)
The Exchange also believes that the proposed rule change is consistent with Section 11(A) of the Act
Furthermore, the Exchange believes that the proposed rule change is consistent with Rule 603 of Regulation NMS,
The proposed rule change is designed to promote just and equitable principles of trade and remove impediments to and perfect the mechanism of a free and open market and a national market system by identifying the consolidated first price and consolidated last price of a security published by the SIPs for all listed equity securities as obtained directly from the SIPs. Such information would provide NYSE BQT users with a static benchmark against which to compare price movements shown on NYSE BQT using first and last prices in the consolidated market. Therefore, the consolidated first and consolidated last price for listed equity securities would provide meaningful information to investors.
The Exchange also believes this proposal is consistent with Section 6(b)(5) of the Act because it protects investors and the public interest and promotes just and equitable principles of trade by providing investors with new options for receiving such information. As noted above, another exchange currently provides similar price information in its market data product.
In addition, this proposal would not permit unfair discrimination because NYSE BQT will continue to be available to all of the Exchange's customers through SFTI and market data vendors on an equivalent basis. In addition, any customer that wished to continue to be able to purchase one or more of the individual underlying data feeds would be able to do so.
In accordance with Section 6(b)(8) of the Act,
The Exchange believes the proposal will have no impact on intramarket competition as the proposal is not targeted at, or expected to be limited in its applicability to, any particular segment of market participants and no segment of retail investors, the general investing public, or any other market participant is expected to benefit more than any other. Therefore, the Exchange believes the inclusion of the consolidated first and consolidated last price in NYSE BQT would not impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act.
No written comments were solicited or received with respect to the proposed rule change.
The Exchange has filed the proposed rule change pursuant to Section 19(b)(3)(A)(iii) of the Act
At any time within 60 days of the filing of such proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings under Section 19(b)(2)(B)
Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Selective Service System.
Notice.
The following forms have been submitted to the Office of Management and Budget (OMB) for extension of clearance in compliance with the Paperwork Reduction Act (44 U.S.C. chapter 35):
Copies of the above-identified forms can be obtained upon written request to the Selective Service System, Public & Intergovernmental Affairs Directorate, 1501 Wilson Boulevard, Arlington, Virginia 22209.
Written comments and recommendations for the proposed extension of clearance of the forms should be sent within 60 days of the publication of this notice to: Selective Service System, Public & Intergovernmental Affairs Directorate, 1501 Wilson Boulevard, Arlington, Virginia 22209.
A copy of the comments should be sent to the Office of Information and Regulatory Affairs, Attention: Desk Officer, Selective Service System, Office of Management and Budget, New Executive Office Building, Room 3235, Washington, DC 20503.
The Advisory Committee on Historical Diplomatic Documentation will meet in person in open and closed sessions to discuss matters concerning declassification and transfer of Department of State records to the National Archives and Records Administration and the status of the
June 10-11, 2024. RSVP and requests for reasonable accommodation for the meeting should be sent not later than June 3, 2024.
Open session for the meeting will take place from 10 a.m. until noon in SA-4D Conference Room 109, Department of State, 2300 E Street NW, Washington, DC 20372 (Potomac Navy Hill Annex), with a virtual option on June 10, 2024.
Questions concerning the meeting should be directed to Adam M. Howard, Executive Secretary, Advisory Committee on Historical Diplomatic Documentation, Department of State, Office of the Historian, Washington, DC 20372, telephone (202) 955-0214, (email:
Personal data is requested pursuant to Public Law 99-399 (Omnibus Diplomatic Security and Antiterrorism Act of 1986), as amended; Public Law 107-56 (USA PATRIOT Act); and Executive Order 13356. The purpose of the collection is to validate the identity of individuals who enter Department facilities. The data will be entered into the Visitor Access Control System (VACS-D) database. Please see the Security Records System of Records Notice (State-36) at
Note that requests for reasonable accommodation received after the dates indicated in this notice will be considered but might not be possible to fulfill.
Surface Transportation Board.
Decision No. 1 in Docket No. FD 36744; notice of acceptance of application; notice of acceptance of related filings for consideration; issuance of procedural schedule.
The Surface Transportation Board (Board) is accepting for consideration an application (Application) filed on January 30, 2024, by Canadian National Railway Company (CNR) and Grand Trunk Corporation (GTC), together with the Iowa Northern Railway Company (Iowa Northern or IANR) (collectively, Applicants). The Application seeks Board approval for CNR and GTC to acquire control of Iowa Northern, a Class III rail carrier that operates a total of approximately 218 route miles in the state of Iowa. This proposal is referred to as the “Proposed Transaction.” The Board is also accepting for consideration two related filings. Those filings are verified notices of exemption seeking Board approval of transactions involving mutual trackage rights between Iowa Northern and the Chicago, Central & Pacific Railroad Company (CCP), an indirect rail carrier subsidiary of GTC (Related Transactions).
The effective date of this decision is February 29, 2024. Any person who wishes to participate in this proceeding as a Party of Record must file, no later than March 15, 2024, a notice of intent to participate. All comments, protests, requests for conditions, and any other evidence and argument in opposition to the Application and related filings, including filings by the U.S. Department of Justice (DOJ) and the U.S. Department of Transportation (DOT), must be filed by April 1, 2024. Responses to comments, protests, requests for conditions, other opposition, and rebuttal in support of the Application or related filings must be filed by May 1, 2024.
Any filing submitted in this proceeding should be filed with the Board via e-filing on the Board's website. In addition, one copy of each filing must be sent (and may be sent by email only if service by email is acceptable to the recipient) to each of the following: (1) Secretary of Transportation, 1200 New Jersey Avenue SE, Washington, DC 20590; (2) Attorney General of the United States, c/o Assistant Attorney General, Antitrust Division, Room 3109, Department of Justice, Washington, DC 20530; (3) CNR's and GTC's representative, Matthew J. Warren, Sidley Austin LLP, 1501 K Street NW, Washington, DC 20005; (4) Iowa Northern's representative, Kevin M. Sheys, Law Office of Kevin M. Sheys LLC, 42 Brush Hill Road, Sherborn, MA 01770; and (5) any other person designated as a Party of Record on the service list.
Sarah Fancher at (202) 245-0355. If you require an accommodation under the Americans with Disabilities Act, please call (202) 245-0245.
Applicants seek the Board's prior review and authorization pursuant to 49 U.S.C. 11323-25 and 49 CFR part 1180 for CNR and GTC to acquire control of Iowa Northern. (Appl. 1.) Applicant GTC is a non-carrier holding company through which CNR controls its U.S. rail carrier subsidiaries.
Applicants state that Iowa Northern owns or leases approximately 175 route miles of rail line in Iowa and operates via trackage rights over an additional approximately 43 route miles of track, for a total distance of 218 route miles. (
According to Applicants, CN's current network spans approximately 18,600 route miles in 13 U.S. states and eight Canadian provinces. (
Applicants further note that CN will preserve existing access between Iowa Northern and other railroads—Iowa Northern currently interchanges with three Class I railroads (including CN) and one short line. (
Applicants claim that, through the Proposed Transaction, a combined CN-Iowa Northern would provide more efficient and economical service, providing customers with access to new market opportunities, while supporting reliable local service on Iowa Northern's lines. (
Notwithstanding the above, however, Applicants state that they agree to imposition of labor conditions in accordance with
When a transaction does not involve the merger or control of two or more Class I railroads, the Board's treatment differs depending upon whether the transaction would have “regional or national transportation significance.” 49 U.S.C. 11325. Under 49 CFR 1180.2, a transaction that does not involve two or more Class I railroads is to be classified as “minor”—and thus not having regional or national transportation significance—if a determination can be made that either: (1) the transaction clearly will not have any anticompetitive effects; or (2) any anticompetitive effects of the transaction will clearly be outweighed by the transaction's anticipated contribution to the public interest in meeting significant transportation needs. A transaction not involving the control or merger of two or more Class I railroads is to be classified as “significant” if neither of these determinations can be made.
The Board finds the Proposed Transaction to be a “minor transaction” because it appears from the face of the Application that the efficiency and other public interest benefits would clearly outweigh whatever anticompetitive effects may exist. As discussed in the Application, Iowa Northern shippers could benefit from operational efficiencies and access to markets through single-line service on the combined CN-Iowa Northern system. (
Further, the Proposed Transaction does not appear to pose any significant anticompetitive effects. The Application indicates that the Proposed Transaction would not result in any two-to-one customer stations (although, as Applicants acknowledge, there are three potential three-to-two customer stations). (
For these reasons, based on the information provided in the Application, the Board finds the Proposed Transaction to be a minor transaction under 49 CFR 1180.2(c). The Board emphasizes that this is not a final determination and may be rebutted by subsequent filings and evidence submitted into the record for this proceeding. Further, this determination should not be read to mean that the Proposed Transaction is insignificant or of little importance. Indeed, after the record is fully developed, the Board will conduct a careful review before making a final determination as to whether the Proposed Transaction would substantially lessen competition, create a monopoly, or restrain trade, and whether any anticompetitive effects would be outweighed by the public interest.
If a request is made in the notice of intent to participate to have more than one name added to the service list as a Party of Record representing a particular entity, the extra name(s) will be added to the service list as a “Non-Party.” Any person designated as a Non-Party will receive copies of Board decisions, orders, and notices but not copies of official filings. Persons seeking to change their status must accompany that request with a written certification that he or she has complied with the service requirements set forth at 49 CFR 1180.4 and any other requirements set forth in this decision.
This action will not significantly affect either the quality of the human environment or the conservation of energy resources.
1. The application filed in Docket No. FD 36744 is accepted for consideration and the related verified notices of exemption filed in Docket Nos. FD 36744 (Sub-No. 1) and FD 36744 (Sub-No. 2) are accepted for consideration.
2. The parties to this proceeding must comply with the procedural schedule shown in the Appendix to this decision and the procedural requirements described in this decision.
3. This decision is effective on February 29, 2024.
By the Board, Board Members Fuchs, Hedlund, Oberman, Primus, and Schultz.
Federal Highway Administration (FHWA), Department of Transportation (DOT).
Notice of intent to prepare an environmental impact statement.
The FHWA in coordination with the Massachusetts Department of Transportation Highway Division (MassDOT) is issuing this Notice of Intent (NOI) to solicit comments and advise the public, agencies, and stakeholders that an Environmental Impact Statement (EIS) will be prepared in accordance with the National Environmental Policy Act (NEPA) to study the potential environmental and related social and economic effects of proposed transportation improvements through the Cape Cod Bridges Program in the town of Bourne, Barnstable County, Massachusetts. The Cape Cod Bridges Program proposes critical transportation infrastructure improvements including replacement of the Bourne and Sagamore highway bridges spanning Cape Cod Canal; reconfiguration of the highway approach networks north and south of Cape Cod Canal to align with the replacement highway bridges; and provision of separated pedestrian and bicycle accommodations along the replacement bridges with connections to the local roadway network. This NOI contains a summary of the information required in the Council on Environmental Quality (CEQ) NEPA regulations. This NOI should be reviewed together with the Supplementary NOI Document, which includes important details about the Cape Cod Bridges Program and complements the information in this NOI. Persons and agencies who may be interested in or affected by the Cape Cod Bridges Program are encouraged to comment on the information in this NOI and the Supplementary NOI Document. All comments received in response to this NOI will be considered and any information presented herein may be revised in consideration of the comments.
Publication of this NOI initiates a 30-day public comment period. Comments on the NOI or the Supplementary NOI Document are to be received by FHWA through the methods below by April 1, 2024.
This NOI and the Supplementary NOI Document are also available in the docket referenced above at
All submissions should include the agency name and the docket number that appears in the heading of this Notice. All comments received will be posted without change to
The FHWA and MassDOT are committed to public involvement for this study. The FHWA, as the Lead Federal Agency, and MassDOT, as sponsor and joint lead agency, are preparing an EIS for the Cape Cod Bridges Program to identify, analyze, and disclose the potential environmental and related social and economic effects of the Build and No Build alternatives. The EIS will be prepared in accordance with the requirements of the National Environmental Policy Act (NEPA) of 1969, as amended (42 United States Code [U.S.C.] 4321,
The Supplementary NOI Document provides additional information on the Purpose and Need for the proposed action, alternatives considered, and expected impacts on the human, natural and built environments. The FHWA requests comments and suggestions on the Purpose and Need, study alternatives and impacts, and the identification of any relevant information, studies or analyses of any kind concerning impacts to the quality of the human and natural environment. All public comments received in response to this NOI will be considered, and changes may be made to the study as appropriate.
The Bourne and Sagamore Bridges, which were simultaneously built between 1933 and 1935, are two high level, fixed span highway bridges spanning Cape Cod Canal in the town of Bourne, Barnstable County, Massachusetts. The New England District of the U.S. Army Corps of Engineers (USACE) owns, operates, and maintains the Bourne and Sagamore Bridges (collectively referred to as the Cape Cod Canal highway bridges) as part of the Cape Cod Canal Federal Navigation Project. The Cape Cod Canal highway bridges provide the only roadway access for the more than 35 million vehicles that cross Cape Cod Canal each year and serve as the gateway to Cape Cod for more than 250,000 year-round residents of the Cape and Islands (Barnstable, Dukes, and Nantucket counties), and millions of annual visitors to the region during the height of the summer tourist season between Memorial Day and Labor Day. As the only roadway access points between mainland Massachusetts and Cape Cod, and by extension to the islands of Martha's Vineyard and Nantucket via Cape Cod based ferry services, the Cape Cod Canal highway bridges serve as essential routes for general transportation, commerce, tourism, and evacuations in case of emergency. The Cape Cod Canal highway bridges, particularly the Bourne Bridge, also provide the only vehicular access points from the
In accordance with 23 U.S.C. 139(f)(4)(E)(ii) and 40 CFR 1501.12, the Cape Cod Bridges Program builds upon and references prior, multi-year foundational studies, including:
(1) The USACE Cape Cod Canal Bridges Major Rehabilitation Evaluation (MRE), which was completed to evaluate the current condition of the bridges and determine whether standard operation and maintenance, major rehabilitation, or replacement of either or both bridges would provide the most reliable, fiscally responsible solution for providing long-term vehicular access across Cape Cod Canal (
(2) The MassDOT Office of Transportation Planning (OTP) Cape Cod Canal Transportation Study, which was completed to identify and evaluate existing and future multimodal transportation deficiencies and needs of the existing roadway network around the Cape Cod Canal area (
On December 19, 2022, MassDOT requested that FHWA serve as lead Federal Agency for the Cape Cod Bridges Program. On January 20, 2023, FHWA responded in agreement to MassDOT's request. On August 11, 2023, FHWA determined the Cape Cod Bridges Program would require the preparation of an EIS to ensure full and fair discussion of significant environmental impacts are disclosed to decision makers and the public. This NOI initiates the FHWA NEPA review process.
The following information provided in the NOI is supplemented with more detail in the Supplementary NOI Document.
The purpose of the Cape Cod Bridges Program is to improve cross-canal mobility and accessibility between Cape Cod and mainland Massachusetts for all road users and to address the increasing maintenance needs and functional obsolescence of the aging Cape Cod Canal highway bridges.
The needs for the Cape Cod Bridges Program are as follows: address the deteriorating structural condition and escalating maintenance demands of the Cape Cod Canal highway bridges; address the substandard design elements of the Cape Cod Canal highway bridges, the immediate mainline approaches, and their adjacent interchanges and intersections; improve vehicular traffic operations; and improve accommodations for pedestrians and bicyclists.
The Purpose and Need statement and supporting documentation, including data and public input summary, is included in the Supplementary NOI Document and will be available in the DEIS. The Purpose and Need may be revised based on consideration of public and agency comments received during the comment period for this NOI and during the Scoping process for the DEIS.
Pursuant to 23 U.S.C. 139(f)(4)(E)(ii) and 40 CFR 1501.2, the FHWA and MassDOT's Cape Cod Bridges Program EIS builds upon and references the analyses and findings of MassDOT's Cape Cod Canal Transportation Study and the USACE's Cape Cod Canal Highway Bridges MRER/EA. The Cape Cod Bridges Program EIS incorporates the USACE's proposed action to replace the Bourne and Sagamore Bridges with new adjacent highway bridges, with each structure providing four through-travel lanes and two auxiliary acceleration/deceleration lanes, updated to comply with current Federal and state highway design standards.
The alternatives may be revised based on the consideration of public and agency comments. The range of reasonable alternatives to be carried forward and documented in the DEIS will be finalized after consideration of comments received during the comment period on this NOI and after conclusion of the Scoping outreach process. Refer to the Supplementary NOI Document for details of the analysis of design parameters that FHWA and MassDOT conducted to identify the recommended Alternatives Retained for Detailed Study in the DEIS.
The FHWA and MassDOT have initiated data collection and agency coordination to identify the types of environmental, cultural, and socio-economic resources present in the Program Study Areas and those likely to be impacted. The following key resources and issues have been identified for evaluation in the EIS and supporting technical studies:
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The EIS will also evaluate potential impacts to the following: land use; social and community resources; local and regional economies; environmental justice; air quality and climate; transportation systems; threatened, endangered, and special status species; noise sensitive areas; wetlands and floodplains; coastal resources and navigation; stormwater and water quality; hazardous waste and contaminated materials; public utilities and services; and visual resources. The level of review of the identified resources for the EIS will be commensurate with the anticipated effects to each resource from the proposed action and will be governed by the statutory and regulatory requirements applicable to those resources.
The analyses and evaluations conducted for the EIS will identify the potential for construction-related (short-term) and operational (long-term) effects (direct, indirect, and cumulative); avoidance measures; whether anticipated effects would be adverse; and mitigation measures for any adverse effects. Additional information on the expected impacts is provided in the Supplementary NOI Document available for review in the docket established for this Program and on the Program website as noted in the
Anticipated Federal permits and authorizations for the Cape Cod Bridges Program include:
• USACE permits under Section 404 of the Clean Water Act (33 U.S.C. 1344) and Section 10 of the Rivers and Harbors Act (33 U.S.C. 403);
• U.S. Coast Guard (USCG) Bridge Permits under Section 9 of the Rivers and Harbors Act of 1899, as amended (33 U.S.C. 403);
• National Marine Fisheries Service (NMFS) consultation under Section 7 of the Endangered Species Act (16 U.S.C. 1536) and the Marine Mammal Protection Act of 1972 (16 U.S.C. 1371);
• U.S. Fish and Wildlife Service (USFWS) consultation under Section 7 of the Endangered Species Act (16 U.S.C. 1536), the Migratory Bird Treaty Act of 1918 (16 U.S.C. 703), the Bald and Golden Eagle Protection Act (16 U.S.C. 668), and the Fish and Wildlife Coordination Act (16 U.S.C. 661);
• NMFS Essential Fish Habitat Consultation/Assessment under the Magnuson-Stevens Fishery Conservation and Management Act (16 U.S.C. 1801-1891d);
• Evaluation under Section 4(f) of the U.S. Department of Transportation Act (49 U.S.C. 303(c));
• Evaluation under Section 106 of the National Historic Preservation Act (54 U.S.C. 306108);
• USACE Section 408 approval under Section 14 of the Rivers and Harbors Act of 1899 (33 U.S.C. 408);
• United States Environmental Protection Agency (USEPA) National Pollutant Discharge Elimination System (NPDES) Construction General Permit;
• Federal Aviation Administration (FAA) review under 29 U.S.C. 44718;
• Federal Archaeologist Permit under 43 CFR 7.
Anticipated state and local permits and approvals for the Cape Cod Bridges Program include:
• Massachusetts Executive Office of Energy and Environmental Affairs (MA EEA) Secretary Certification under the Massachusetts Environmental Policy Act (MEPA) Regulations (301 CMR 11.00);
• Bourne Conservation Commission Order of Conditions (OOC) under the Massachusetts Wetlands Protection Act (310 CMR 10.00);
• Massachusetts Department of Environmental Protection (MassDEP) 401 Water Quality Certification (WQC) under the 401 Water Quality Certification Regulations (314 CMR 9.00);
• MassDEP Chapter 91 Licenses under the Massachusetts Public Waterfront Act (310 CMR 9.00);
• Massachusetts Office of Coastal Zone Management (MA CZM) Federal Consistency Review under the Massachusetts Coastal Zone Management Act (301 CMR 20.00);
• Massachusetts Historical Commission (MHC) State Archaeologist Permit (950 CMR 70.00);
• Potential Massachusetts Division of Fisheries and Wildlife (MA DFW) Conservation and Management Permit (CMP) under the Massachusetts Endangered Species Act (MESA) Regulations (321 CMR 10.00).
The schedule for the Cape Cod Bridges Program will be established as part of the requirements of the environmental review process under 23 U.S.C. 139 and will comply with 40 CFR 1501.10(a) and (b)(2) and 23 U.S.C. 23, which requires that environmental reviews and authorization decisions for major projects occur within two years from the date of publication of the NOI to the date of issuance of the Record of Decision (ROD), and all necessary authorizations be issued in 90 days from the ROD.
Following the issuance of this NOI, FHWA and MassDOT will coordinate with the Participating and Cooperating Agencies to develop study documentation and the DEIS.
• Continued Scoping outreach is anticipated in spring of 2024 following publication of this NOI.
• The Draft EIS is anticipated to be issued in spring of 2025.
• The combined Final EIS and ROD is anticipated to be issued in winter of 2026.
• All Federal permits and authorizations are anticipated to be received by spring of 2026.
Refer to the Supplementary NOI Document for additional schedule details.
In accordance with 23 U.S.C. 139(f)(4)(E)(ii), FHWA and MassDOT have incorporated public and stakeholder comment obtained relative to the Cape Cod Bridges Program Environmental Notification Form (ENF) filing under the Massachusetts Environmental Policy Act (MEPA) (
The public and agency Scoping process is continuing with the publication of this NOI. Publication of this NOI initiates a 30-day Scoping period during which time the public, Tribal governments and other Federal, State, and local agencies are requested to review and comment on any element of the Cape Cod Bridges Program, including the Purpose and Need for the proposed action; the Alternatives Retained for Detailed Study; and identification of any potentially significant adverse environmental impacts to be evaluated in the EIS.
To ensure that the full range of issues related to the Cape Cod Bridges Program is addressed, and all significant issues are identified, comments and suggestions are invited from all interested parties during Scoping. The FHWA will hold at least one public Scoping meeting upon publication of this NOI as part of the Scoping process for the EIS. Advanced notice of the date, time and location of the public Scoping meeting will be provided to the public through the Program website, public notices, and press releases. Such comments or questions concerning this Notice and/or the scope of the EIS, including the Purpose and Need, Alternatives Retained for Detailed Study, and impacts to be evaluated, may be submitted via the Program website or in writing to FHWA or MassDOT at the addresses provided above. Public input received during the Scoping process will be considered in the development of the DEIS. Once complete, the DEIS will be available for agency review and comment prior to the DEIS Public Hearing and for public review at the DEIS Public Hearing. Advanced notice of the date, time and location of the Public Hearing will be provided to the public through the Program website, public notices, and press releases. All substantive public comments on the DEIS will be addressed in the Final EIS (FEIS).
The FHWA intends to issue a single document that consists of the FEIS and ROD pursuant to 49 U.S.C. 304a(b) [and 23 U.S.C. 139(n)(2)] unless FHWA determines that statutory criteria or practicability considerations preclude issuance of such a combined document.
To ensure that a full range of issues related to the Cape Cod Bridges Program is addressed and all potential issues are identified, FHWA invites comments and suggestions from all interested parties. The FHWA requests comments and suggestions on potential alternatives and impacts, and the identification of any relevant information, studies, or analyses of any kind concerning impacts affecting the quality of the human and natural environment. Any information presented herein, including the Purpose and Need, Alternatives Retained for Detailed Study, and identification of impacts, may be revised after consideration of the comments. The purpose of this request is to bring relevant comments, information, and analyses to the attention of FHWA, as early in the process as possible, to enable FHWA to make maximum use of this information in decision making. Comments may be submitted according to the instructions in the
Federal Highway Administration (FHWA), Department of Transportation (DOT).
Notice of limitation on claims for judicial review of actions by the California Department of Transportation (Caltrans).
The FHWA, on behalf of Caltrans, is issuing this notice to announce actions taken by Caltrans, that are final. The actions relate to a proposed highway project, State Route 49 and State Route 4, from post miles: 4-8.4-9.1, R20.8-21.4 within the City of Angels Camp in the County Calaveras County, State of California. Those actions grant licenses, permits, and approvals for the project.
By this notice, the FHWA, on behalf of Caltrans, is advising the public of final agency actions subject to 23 U.S.C. 139(l)(1). A claim seeking judicial review of the Federal agency actions on the highway project will be barred unless the claim is filed on or before July 29, 2024. If the Federal law that authorizes judicial review of a claim provides a time period of less than 150 days for filing such claim, then that shorter time period still applies.
For Caltrans: Jonathan Coley-Branch Chief, California Department of Transportation, Northern San Joaquin Environmental Management Branch 1, 1976 Doctor Martin Luther King Junior Boulevard, Stockton, CA 95205. Office Hours 8 a.m.-5 p.m., Pacific standard time, (209) 479-4083 or email at
Effective July 1, 2007, the Federal Highway Administration (FHWA) assigned, and the California Department of Transportation (Caltrans) assumed, environmental responsibilities for this project pursuant to 23 U.S.C. 327. Notice is hereby given that the Caltrans, have taken final agency actions subject to 23 U.S.C. 139(l)(1) by issuing licenses, permits, and approvals for the following highway project in the State of California: The Calaveras 49 Mobility Improvement Project will make intersection, roadway, pedestrian, and bicycle improvements along State Route 49 from post miles 8.4 to 9.1 and on State Route 4 from post miles R20.8 to R21.4 in the City of Angels Camp in Calaveras County. The actions by the Federal agencies, and the laws under which such actions were taken, are described in the Final Environmental Assessment (EA)/Finding of No Significant Impact (FONSI) for the project, approved on June 29, 2023, in the Notice of Decision (NOD) issued on July 5, 2023, and in other documents in the project records. The EA, NOD, and other project records are available by contacting Caltrans at the address provided above. The Caltrans EA and NOD can be viewed and downloaded from the project website at
This notice applies to all Federal agency decisions as of the issuance date of this notice and all laws under which such actions were taken, including but not limited to:
Federal Highway Administration (FHWA), Department of Transportation (DOT).
Notice of limitation on claims for judicial review of actions by the California Department of Transportation (Caltrans).
The FHWA, on behalf of Caltrans, is issuing this notice to announce actions taken by Caltrans that are final. The actions relate to a proposed highway project, the State Route 46 Corridor Improvement Project Antelope Grade Section, approximately 10 miles northeast of the community of Shandon in the County of San Luis Obispo and 32 miles northwest of the census-designated town of Lost Hills in the County of Kern, State of California. Those actions grant licenses, permits, and approvals for the project.
With this notice, the FHWA, on behalf of Caltrans, is advising the public of final agency actions subject to 23 U.S.C. 139(l)(1). A claim seeking judicial review of the federal agency's actions on the highway project will be barred unless the claim is filed on or before July 29, 2024. If the federal law that authorizes judicial review of a claim provides a time period of less than 150 days for filing such a claim, then that shorter time period still applies.
For Caltrans: Lucas Marsalek, Environmental Branch Chief, Caltrans District 5, 50 Higuera Street, San Luis Obispo, CA 93401, (805) 458-5408,
Effective July 1, 2007, the Federal Highway Administration (FHWA) assigned, and the California Department of Transportation (Caltrans) assumed, environmental responsibilities for this project pursuant to 23 U.S.C. 327. Notice is hereby given that Caltrans has taken final agency actions subject to 23 U.S.C. 139(l)(1) by issuing licenses, permits, and approvals for the following highway project in the State of California: The State Route 46 Corridor Improvement Project Antelope Grade Section will begin at post mile 57.3 in San Luis Obispo County and will continue to post mile 0.4 in Kern County. Caltrans proposes to convert a 3.6-mile portion of State Route 46 from a two-lane highway to a four-lane expressway with a 62-foot median on a new alignment that roughly parallels the existing highway corridor to the north (FHWA Project Number: 0518000075). The actions by the federal agencies and the laws under which such actions were taken are described in the Final Updated Environmental Assessment (FEA) with Finding of No Significant Impact (FONSI) for the project, approved on January 2, 2024, and in other documents in the project records. The FEA, FONSI, and other project records are available by contacting Caltrans at the address provided above. The Caltrans FEA and FONSI can be viewed and downloaded from the project website at
This notice applies to all federal agency decisions as of the issuance date of this notice and all laws under which such actions were taken, including but not limited to:
Federal Motor Carrier Safety Administration (FMCSA), Department of Transportation (DOT).
Notice and request for comments.
In accordance with the Paperwork Reduction Act of 1995, FMCSA announces its plan to submit the Information Collection Request (ICR) described below to the Office of Management and Budget (OMB) for review and approval. The information collected will be used to help ensure that motor carriers of passengers and property maintain the statutorily mandated levels of financial responsibility to operate on public highways. On October 3, 2023, FMCSA published a notice in the
Comments on this notice must be received on or before April 1, 2024.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Mr. Jeffrey Secrist, Office of Registration, Chief, Registration Division, DOT, FMCSA, West Building 6th Floor, 1200 New Jersey Avenue SE, Washington, DC 20590; (202) 385-2367;
The Secretary of Transportation is responsible for implementing regulations which establish minimum levels of financial responsibility for: (1) for-hire motor carriers of property to cover public liability, property damage, and environmental restoration, and (2) for-hire motor carriers of passengers to cover public liability and property damage. The Endorsement for Motor Carrier Policies of Insurance for Public Liability (Forms MCS-90/90B) and the Motor Carrier Public Liability Surety Bond (Forms MCS-82/82B) contain the minimum amount of information necessary to document that a motor carrier of property or passengers has obtained, and has in effect, the minimum levels of financial responsibility as set forth in applicable regulations (49 CFR 387.9 (motor carriers of property) and 49 CFR 387.33T (motor carriers of passengers)). FMCSA and the public can verify that a motor carrier of property or passengers has obtained, and has in effect, the required minimum levels of financial responsibility by reviewing the information enclosed within these documents.
Issued under the authority of 49 CFR 1.87.
Federal Motor Carrier Safety Administration (FMCSA), Department of Transportation (DOT).
Notice of application for exemption; request for comments.
FMCSA requests public comment on an application for exemption submitted by Convoy Technologies, Inc. (Convoy) to allow motor carriers to operate commercial motor vehicles (CMV) equipped with Convoy's Electronic Rear View System (ERVS) installed as an alternative to the two rear-vision mirrors required by the Federal Motor Carrier Safety Regulations (FMCSRs).
Comments must be received on or before April 1, 2024.
You may submit comments identified by docket number FMCSA-2024-0076 using any of the following methods:
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Mr. David Sutula, Vehicle and Roadside Operations Division, Office of Carrier, Driver, and Vehicle Safety, FMCSA, 1200 New Jersey Avenue SE, Washington, DC 20590-0001, (202) 366-5541,
If you submit a comment, please include the docket number for this notice (FMCSA-2024-0076), indicate the specific section of this document to which the comment applies, and provide a reason for suggestions or recommendations. You may submit your comments and material online or by fax, mail, or hand delivery, but please use only one of these means. FMCSA recommends that you include your name and a mailing address, an email address, or a phone number in the body of your document so the Agency can contact you if it has questions regarding your submission.
To submit your comment online, go to
If you submit your comments by mail or hand delivery, submit them in an unbound format, no larger than 8
FMCSA will consider all comments and material received during the comment period. Comments received after the comment closing date will be filed in the public docket and will be considered to the extent practicable.
CBI is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to the notice contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to the notice, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission that constitutes CBI as “PROPIN” to indicate it contains proprietary information. FMCSA will treat such marked submissions as confidential under the Freedom of Information Act, and they will not be placed in the public docket of the notice. Submissions containing CBI should be sent to Brian Dahlin, Chief, Regulatory Evaluation Division, Office of Policy, FMCSA, 1200 New Jersey Avenue SE, Washington, DC 20590-0001 or via email at
To view any documents mentioned as being available in the docket, go to
In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its regulatory process. DOT posts these comments, including any personal information the commenter provides, to
FMCSA has authority under 49 U.S.C. 31136(e) and 31315(b) to grant exemptions from the 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 maintain a level of safety equivalent to, or greater than, the level that would be achieved by the current regulation (§ 381.305(a)). The Agency must publish its decision in the
Section 393.80(a) of the FMCSRs requires that each bus, truck, and truck tractor be equipped with two rear-vision mirrors, one at each side. The mirrors must be positioned to reflect to the driver a view of the highway to the rear and the area along both sides of the CMV. Section 393.80(a) cross-references the National Highway Traffic Safety Administration's standard for mirrors on motor vehicles (
In accordance with 49 U.S.C. 31315(b)(6), FMCSA requests public comment from all interested persons on Convoy's application for an exemption to allow motor carriers to use its ERVS in lieu of the rear-vision mirrors required by 49 CFR 393.80(a). All comments received before the close of business on the comment closing date indicated at the beginning of this notice will be considered and will be available for examination in the docket at the location listed under the
Under part 211 of title 49 Code of Federal Regulations (CFR), this document provides the public notice that on January 4, 2024, Nevada Northern Railway (NNRX) petitioned the Federal Railroad Administration
Specifically, NNRX requests a special approval pursuant to 49 CFR 215.203,
A copy of the petition, as well as any written communications concerning the petition, is available for review online at
Interested parties are invited to participate in these proceedings by submitting written views, data, or comments. FRA does not anticipate scheduling a public hearing in connection with these proceedings since the facts do not appear to warrant a hearing. If any interested party desires an opportunity for oral comment and a public hearing, they should notify FRA, in writing, before the end of the comment period and specify the basis for their request.
All communications concerning these proceedings should identify the appropriate docket number and may be submitted at
Communications received by April 29, 2024 will be considered by FRA before final action is taken. Comments received after that date will be considered if practicable.
Anyone can search the electronic form of any written communications and comments received into any of our dockets by the name of the individual submitting the comment (or signing the document, if submitted on behalf of an association, business, labor union, etc.). Under 5 U.S.C. 553(c), the U.S. Department of Transportation (DOT) solicits comments from the public to better inform its processes. DOT posts these comments, without edit, including any personal information the commenter provides, to
Issued in Washington, DC.
Under part 211 of title 49 Code of Federal Regulations (CFR), this document provides the public notice that on January 15, 2024, Strasburg Rail Road Company (SRC) petitioned the Federal Railroad Administration (FRA) to extend a waiver of compliance from certain provisions of the Federal railroad safety regulations contained at 49 CFR part 215 (Railroad Freight Car Safety Standards). FRA assigned the petition Docket Number FRA-2004-17188.
Specifically, SRC requests to extend its existing special approval pursuant to 49 CFR 215.203,
A copy of the petition, as well as any written communications concerning the petition, is available for review online at
Interested parties are invited to participate in these proceedings by submitting written views, data, or comments. FRA does not anticipate scheduling a public hearing in connection with these proceedings since the facts do not appear to warrant a hearing. If any interested party desires an opportunity for oral comment and a public hearing, they should notify FRA, in writing, before the end of the comment period and specify the basis for their request.
All communications concerning these proceedings should identify the appropriate docket number and may be submitted at
Communications received by April 29, 2024 will be considered by FRA before final action is taken. Comments received after that date will be considered if practicable.
Anyone can search the electronic form of any written communications and comments received into any of our dockets by the name of the individual submitting the comment (or signing the document, if submitted on behalf of an association, business, labor union, etc.). Under 5 U.S.C. 553(c), the U.S. Department of Transportation (DOT) solicits comments from the public to better inform its processes. DOT posts these comments, without edit, including any personal information the commenter provides, to
Issued in Washington, DC.
Maritime Administration, Department of Transportation.
Notice.
The Maritime Administration (MARAD) announces a public meeting of the Peer Review Group (PRG). The PRG was established pursuant to the requirements of the National Historic Preservation Act (NHPA) and its implementing regulations to plan for the decommissioning and disposition of the Nuclear Ship Savannah (NSS). PRG membership is comprised of officials from the U.S. Department of Transportation, MARAD, the U.S. Nuclear Regulatory Commission (NRC), the Advisory Council on Historic Preservation (ACHP), and the Maryland State Historic Preservation Officer (SHPO) and other consulting parties. The public meeting affords the public
The meeting will be held on Tuesday, March 19, 2024, from 2:30 p.m. to 4:00 p.m. Eastern Daylight Time (EDT). Requests to attend the meeting must be received by 5:00 p.m. EDT one week before the meeting, Tuesday, March 12, 2024, to facilitate entry or to receive instructions to participate online. Requests for accommodations for a disability must also be received one week before the meeting, Tuesday, March 12, 2024.
The meeting will be held onboard the NSS, online, or by phone. The NSS is located at Pier 13 Canton Marine Terminal, 4601 Newgate Avenue, Baltimore, MD 21124.
Erhard W. Koehler, (202) 680-2066 or via email at
The decommissioning and disposition of the NSS is an Undertaking under section 106 of the NHPA. Section 106 requires that Federal agencies consider views of the public regarding their Undertakings; therefore, in 2020, MARAD established a Federal docket at
The NHPA Programmatic Agreement (PA) for the Decommissioning and Disposition of the NSS is available on the MARAD docket located at
The agenda will include (1) welcome and introductions; (2) program update; (3) status of PA stipulations; (4) other business; and (5) date of next meeting. The agenda topic titled PA stipulations involves deliverables identified in the PA. MARAD will provide status updates for the following items: the Disposition Alternatives Study; the Notice of Availability/Request for Information; and the License Termination Plan. The agenda will also be posted on MARAD's website at
The meeting will be open to the public. Members of the public who wish to attend in person or online must RSVP to the person listed in the
By Order of the Maritime Administrator.
Maritime Administration, Department of Transportation.
Notice.
The Maritime Administration (MARAD) announces a public meeting of the U.S. Maritime Transportation System National Advisory Committee (MTSNAC) to develop and discuss advice and recommendations for the U.S. Department of Transportation on issues related to the marine transportation system. In general, the meeting will cover ways to enhance the use of America's Marine Highways, the enhancement of U.S. port infrastructure and performance, how to strengthen U.S. Maritime capabilities essential to national security and economic prosperity, and finally, ways to enable maritime industry innovation in information, safety, environmental sustainability, and other areas.
The meeting will be held on Wednesday, March 20, 2024, from 9:00 a.m. to 4:30 p.m. and Thursday, March 21, 2024, from 9:00 a.m. to 4:30 p.m. Eastern Daylight Time (EDT). Requests to attend the meeting must be received by 5:00 p.m. EDT on the prior week, Friday, March 15, 2024, to facilitate entry. Requests for accommodations for a disability must be received by Monday, March 18, 2024. Those requesting to speak during the public comment period of the meeting must submit a written copy of their remarks to DOT no later than Friday, March 15, 2024. Requests to submit written materials for review during the meeting must be received by Friday, March 15, 2024.
The meeting will be held at the at the DOT Conference Center at 1200 New Jersey Ave. SE, Washington, DC 20590. Any Committee-related request should be sent to the person listed in the following section.
Capt. Jeffrey Flumignan, Designated Federal Officer, at
The MTSNAC is a Federal advisory committee that advises the U.S. Secretary of Transportation through the Maritime Administrator on issues related to the maritime transportation system. The MTSNAC was established in 1999 and mandated in 2007 by the Energy Independence and Security Act of 2007 (Pub. L. 110-140). The MTSNAC is codified at 46 U.S.C. 50402 and operates in accordance with the provisions of the Federal Advisory Committee Act.
The agenda will include (1) welcome, opening remarks, and introductions; (2) administrative items; (3) subcommittee break-out sessions; (4) updates to the Committee on the subcommittee work; (5) public comments; (6) discussions relevant to formulate recommendations; and (7) presentation of recommendations. A final agenda will be posted on the MTSNAC internet website at
The meeting will be open to the public. Members of the public who wish to attend in person must RSVP to the person listed in the
By Order of the Maritime Administrator.
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.
See
OFAC: Bradley T. Smith, 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 Assistant Director for Compliance, tel.: 202-622-2490.
The SDN List and additional information concerning OFAC sanctions programs are available on OFAC's website (
On February 14, 2024, OFAC determined that the property and interests in property subject to U.S. jurisdiction of the following persons are blocked under the relevant sanctions authority listed below.
Departmental Offices, U.S. Department of the Treasury.
Notice of information collection; request for comment.
The Department of the Treasury will submit the following information collection requests 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. The public is invited to submit comments on these requests.
Comments should be received on or before April 1, 2024 to be assured of consideration.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Copies of the submissions may be obtained from Spencer W. Clark by emailing
2.
Securities and Exchange Commission.
Final rule.
The Securities and Exchange Commission (“SEC” or “Commission”) is adopting new rules to further define the phrase “as a part of a regular business” as used in the statutory definitions of “dealer” and “government securities dealer” under sections 3(a)(5) and 3(a)(44), respectively, of the Securities Exchange Act of 1934 (“Exchange Act”).
Emily Westerberg Russell, Chief Counsel; John Fahey, Deputy Chief Counsel; Joanne Rutkowski, Assistant Chief Counsel; Bonnie Gauch, Senior Special Counsel; Shauna Sappington Vlosich, Senior Special Counsel; Geeta Dhingra, Branch Chief; Katherine Lesker, Special Counsel; and Carl Emigholz, Special Counsel at 202-551-5550 in the Office of Chief Counsel, Division of Trading and Markets, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-7010.
The Commission is adopting the following new rules under the Exchange Act: (1) 17 CFR 240.3a5-4 (“Rule 3a5-4”), and (2) 17 CFR 240.3a44-2 (“Rule 3a44-2”) (collectively, “final rules”).
The dealer regulatory regime is a cornerstone of the U.S. Federal securities laws and helps to promote the Commission's longstanding mission to protect investors, maintain fair, orderly, and efficient markets, and facilitate capital formation.
The Federal securities laws provide a comprehensive system of regulation of securities activity, and the definition of “dealer” is one of the Exchange Act's most important definitions, as it sets forth certain activities that cause persons to fall within the Commission's regulatory ambit.
Under the Exchange Act, the SEC has the authority to define the terms used in the statutory definitions of “dealer” and “government securities dealer,” and to oversee and regulate registered dealers.
Registration will enable more comprehensive regulatory oversight of securities markets and those participants that take on significant liquidity-providing roles. The final rules will support market stability and resiliency and protect investors by promoting the financial responsibility and operational integrity of significant liquidity providers that are acting as dealers in the securities markets.
The statutory definition of “dealer” in section 3(a)(5) and the accompanying registration requirements of the Exchange Act were drawn broadly by Congress in 1934 to encompass a wide range of activities involving the securities markets and their participants. Section 3(a)(5) of the Exchange Act defines the term “dealer” to mean “any person engaged in the business of buying and selling securities . . . for such person's own account through a broker or otherwise,” but excludes “a person that buys or sells securities . . . for such person's own account, either individually or in a fiduciary capacity, but not as a part of a regular business.”
The Commission has long identified factors that would be informative for determining whether a person is a dealer. For example, the Commission's 2002 Release states that “[a] person generally may satisfy the definition, and therefore, be acting as a dealer in the securities markets by conducting various activities: (1) underwriting; (2) acting as a market maker or specialist on an organized exchange or trading system; (3) acting as a
In recent years, market participants regularly engaging in significant liquidity provision have not registered, either as “dealers” under section 15 of the Exchange Act or “government securities dealers” under section 15C of the Exchange Act.
Courts have repeatedly recognized the requirement that dealers register as being “of the utmost importance in effecting the purposes of the Exchange Act.”
On March 28, 2022, the Commission proposed Rules 3a5-4 and 3a44-2 to identify certain activities that would constitute a “regular business” requiring a person engaged in certain liquidity-providing activities to register as a “dealer” or a “government securities dealer,” absent an exception or exemption.
The Commission received comment letters from a variety of commenters including investment advisers, PTFs, private fund advisers, crypto asset related entities and industry groups, insurance industry groups, industry associations, advisory groups, retail investors, and other market participants.
Commenters in support of the proposal shared the Commission's concerns regarding the significant role of unregistered entities that act as liquidity providers and emphasized the benefits of registration and regulation.
Some commenters stated that they supported the Commission's policy goals but expressed concerns regarding whether the proposed rules would achieve those goals.
Many commenters also questioned whether the quantitative standard exceeds the Commission's authority under the Exchange Act and is consistent with historical Commission interpretations and guidance and Federal case law.
In addition, commenters, many of which were in the asset management industry, stated that the proposed definition of “own account” would
Further, many commenters believed that the economic analysis did not adequately address economic implications of the proposed rules.
After careful review of comments received and upon further consideration, the Commission is adopting Rules 3a5-4 and 3a44-2 as revised. As discussed below, while the Commission is generally retaining the overall structure of the proposed rules, we are making certain modifications to the text of the rules and also are providing guidance to address concerns raised during the comment process. In particular, the modifications we have made to more appropriately tailor the scope of the final rules will address various concerns raised by commenters and appropriately require only entities engaging in
An overview of the changes from the proposal follows:
As a result of these modifications, the final rules establish two non-exclusive ways in which a person will be determined to be engaged in a regular pattern of providing liquidity to other market participants “as part of a regular business”:
• Regularly expressing trading interest that is at or near the best available prices on both sides of the market for the same security, and that is communicated and represented in a way that makes it accessible to other market participants (“expressing trading interest factor”);
• Earning revenue primarily from capturing bid-ask spreads, by buying at the bid and selling at the offer, or from capturing any incentives offered by trading venues to liquidity-supplying trading interest (“primary revenue factor”).
However, with a view to deterring the establishment of multiple legal entities or accounts to evade appropriate regulation, the final rules include an anti-evasion provision that prohibits persons from evading the registration requirements by: (1) engaging in activities indirectly that would satisfy the qualitative factors; or (2) disaggregating accounts. The changes from the proposed rules address concerns about the scope of the proposed rules as raised by commenters while enhancing the Commission's current ability to prevent and address potentially evasive behavior.
The Commission is not adopting certain commenters' suggestions for additional exclusions. Among other things, as discussed more fully below, the Commission is not excluding private funds or registered investment advisers from the final rules because an investment adviser or private fund could be acting as a dealer depending upon the particular activities in which it is engaged. The final rules do, however, include several modifications and clarifications to address many of the compliance and other concerns raised by certain commenters, including those raised by private funds and registered investment advisers.
In addition, as discussed in more detail below, the Commission is not excluding certain types of securities, specifically crypto asset securities, from the application of the final rules.
Further, the Commission disagrees with the argument that certain market participants, including PTFs, are not dealers because they do not have customers.
Further, a helpful analogy can be drawn to the Commission's rulemaking further defining who is a “security-based swap dealer”—a definition that closely parallels the statutory definition of “dealer,” particularly with respect to the exclusion of activities that are not part of a regular business.
As stated above, some commenters suggested that the final rules are unnecessary because the SEC has other tools to accomplish the goals of the rulemaking, including large trader reporting, TRACE, and CAT. Certain commenters urged the Commission to take additional or different regulatory actions for entities covered by the Investment Advisers Act of 1940 (“Advisers Act”) than the approach we have adopted, including leveraging existing data from Form PF filings or making amendments to the existing regulatory regime under the Advisers Act. However, as discussed below, dealer registration is tailored to provide specific protections to address potential risks associated with dealer activity, and the aforementioned tools do not provide sufficient regulatory oversight and transparency into the trading activity of entities that are not otherwise registered as dealers.
Commenters expressed the view that the proposed rules could have a negative impact on liquidity or may cause many market participants to cease, modify, or curtail their trading activity to avoid being required to register as a dealer.
The final rules are not the exclusive means of establishing that a person is a dealer or government securities dealer; otherwise applicable Commission interpretations and precedent will continue to apply.
The final rules, as modified, appropriately balance the concerns of the various commenters in a way that will best achieve the Commission's important goals to protect investors and support fair, orderly, and resilient markets through the complete and consistent application of dealer regulations. Further, the modifications we have made to tailor the scope of the final rules, including the persons scoped into the final rules, will address various concerns raised by commenters and appropriately require only entities engaging in dealing activity to register as dealers.
The qualitative standard in the proposed rules was intended to build on existing statements by the Commission and the courts regarding “dealer” activity to further define certain factors for determining when a person is engaged in buying and selling securities for its own account “as part of a regular business” as that phrase is used in sections 3(a)(5) and 3(a)(44) of the Exchange Act. Under paragraph (a)(1) of the proposed rules, a person would be engaged in buying and selling securities for its own account “as a part of a regular business” and so would be a dealer or a government securities dealer, if that person engages in a routine pattern of buying and selling securities (or government securities) that has the effect of providing liquidity to other market participants. Under this standard, as supplemented by the qualitative factors, when the frequency and nature of a person's securities trading is such that the person assumes a role—whether described as market-making,
Commenters stated that the terms “routine” and “routinely” in the proposed rules were unclear and would lead to inconsistent interpretations.
In addition, as discussed below, after further consideration, the Commission has revised the qualitative standard by eliminating the proposed first qualitative factor and modifying the remaining two qualitative factors. These changes are designed to more appropriately tailor the rule to the nature of dealing in today's securities markets.
• Regularly expressing trading interest that is at or near the best available prices on both sides of the market for the same security, and that is communicated and represented in a way that makes it accessible to other market participants; or
• Earning revenue primarily from capturing bid-ask spreads, by buying at the bid and selling at the offer, or from capturing any incentives offered by trading venues to liquidity-supplying trading interest.
As discussed in the Proposing Release, the proposed first qualitative factor was intended to capture a person's pattern of trading, the consistency and regularity of which indicate that its liquidity provision forms a part of a regular business.
Commenters raised a number of concerns about the proposed first qualitative factor.
After further consideration and in light of commenters' concerns, the Commission has decided to eliminate the proposed first qualitative factor. The Commission agrees with commenters that the proposed first qualitative factor could capture more than dealing activity intended to be captured by the rule. Accordingly, the Commission is not adopting the first factor.
The Commission emphasizes that the elimination of this factor does not mean that the conduct that would have been captured by the proposed factor is not dealing activity. This conduct may be
The Commission proposed a second qualitative factor to identify activity that “has the effect of providing liquidity to other market participants” focused on the expression of trading interests. Specifically, under proposed 17 CFR 240.3a5-4(a)(1)(ii) and 240.3a44-2(a)(1)(ii), a person that, trading for its own account, “routinely express[es] trading interests that are at or near the best available prices on both sides of the market and that are communicated and represented in a way that makes them
The Commission explained in the Proposing Release the meanings of certain key terms used in the proposed second qualitative factor.
The Commission received a range of comments on the proposed second qualitative factor. One commenter explicitly supported the proposed second qualitative factor, voicing support for the policy goal of requiring PTFs in the government securities market to register as government securities dealers.
Advancements in the securities markets have altered the way in which market participants interact with the markets. Certain market participants continue to perform important dealer functions as providers of liquidity to other market participants by expressing trading interest on both sides of the market for a security to other market participants. The expressing trading interest factor takes these changes into account, while also allowing for flexibility in its application in the markets for different securities, based on the wide variance in liquidity, depth, or other traits.
In adopting the proposed second qualitative factor as the expressing trading interest factor, the Commission is replacing the term “routinely” with “regularly.” The Commission is also revising the rule text to explicitly provide that the test applies with respect to the expression of trading interest in the “same” security. Other than these changes, and certain non-substantive changes, for the reasons set forth below, the Commission is adopting this factor as proposed. Accordingly, under the expressing trading interest factor, a person “regularly expressing trading interest that is at or near the best available prices on both sides of the market for the same security and that is communicated and represented in a way that makes it accessible to other market participants” is engaged in buying and selling securities for its own account “as a part of a regular business” as the phrase is used in sections 3(a)(5)(B) and 3(a)(44)(A) of the Exchange Act. The expressing trading interest factor will appropriately capture those market participants who are engaging in liquidity-providing activities similar to those traditionally performed by dealers or government securities dealers as defined under sections 3(a)(5) and 3(a)(44) of the Exchange Act.
The Proposing Release stated that the term “routinely” as used in the proposed second qualitative factor meant that a person must express trading interests more frequently than occasionally, but not necessarily continuously, both intraday and across time.
A number of commenters expressed concerns related to the use of the term “routinely.”
As an alternative to “routinely,” some commenters suggested using a different term, with most such commenters suggesting “continuous.”
After further consideration, the Commission has replaced the term “routinely” with “regularly.” As with the term “routinely” in the Proposing Release, the term “regularly” in the final rules will apply to a person's expression of trading interest both within a trading day and over time.
A market participant does not need to be continuously expressing trading interest to be engaging in a “regular” business. The Exchange Act's definitions of “dealer” and “government securities dealer” do not include a requirement of continuous participation. The ordinary meaning of “continuous” is “characterized by continuity; extending in space without interruption of substance; having not interstices or breaks; having its parts in immediate connection; connected, unbroken” and “marked by uninterrupted extension in space, time, or sequence,” as defined by the Oxford English and the Merriam-Webster dictionaries, respectively.
Whether a person's activity is “regular” will depend on the liquidity and depth of the relevant market for the security. For example, in markets that have significant liquidity and market depth, and have experienced advancements in technology and electronic trading, like the U.S. Treasury market,
The expressing trading interest factor captures the hallmark
The proposed second qualitative factor in the proposed rules would have applied to “trading interests.” The Proposing Release stated that the use of the broader term “trading interests” in the proposed second qualitative factor, rather than the term “quotations,” would reflect the prevalence of non-firm trading interest offered by marketplaces today, and account for the varied ways in which developing technologies permit market participants to hold themselves out as willing to buy or sell securities, or otherwise communicate their willingness to trade, and to effectively make markets.
A number of commenters objected to the use of the term “trading interests” on various grounds including, among others, the difficulty in applying the term and the breadth of the term purportedly causing non-dealing trading activity to be captured.
Two commenters stated that applying the proposed second qualitative factor to investment advisers would inappropriately subject them to potential dealer status simply for exercising their fiduciary duties.
Similarly, other commenters stated that the proposed second qualitative factor could require firms, including unregistered funds excluded from the Investment Company Act and registered investment advisers, to register as dealers for engaging in activity that has not historically been considered to be dealer activity.
After consideration of the comments, the Commission has determined to adopt the proposed second qualitative factor with minor, non-substantive modifications to the term “trading interest.” The term “trading interest” means: (i) an “order” as the term is defined under 17 CFR 240.3b-16(c) (“Rule 3b-16(c)”);
At the same time, expressing trading interest is not, standing alone, enough to demonstrate engaging in a “regular pattern of buying and selling securities that has the effect of providing liquidity to other market participants” under the final rules. Specifically, under the final rules, a person will be engaged in activity as part of a regular business if that person “[e]ngages in a regular pattern of
One commenter questioned how to apply the term “trading interest” to certain types of products, structures, or activities in the so-called decentralized finance (“DeFi”) market to provide crypto asset securities liquidity.
Under the proposed rules, in order to come within the proposed second qualitative factor, the expression of trading interests would need to be “at or near the best available prices on both sides of the market.”
Several commenters requested clarification as to how to apply the phrase “on both sides of the market,” particularly, with regard to what period of time to use when evaluating orders placed on both sides of the market, and as to whether the phrase applies to the market for a single security or related instruments.
Consistent with the Proposing Release which explained that the proposed second qualitative factor applies to persons expressing trading interests on both sides of the market in a given security, the Commission is modifying the rule text to add the phrase “for the same security” to the second qualitative factor.
The Commission is not adopting a requirement that the trading interest be expressed simultaneously on both sides of the market. Limiting the expressing trading interest factor to the simultaneous expression of trading interests could exclude other regular expressions of trading interest that constitute dealer activity by providing liquidity to other market participants. While simultaneously expressing trading interest on both sides of the market in the same security is indicative of dealer activity, market participants also can be acting as dealers by regularly providing liquidity even where the expressions of trading interest on both sides of the market for the same security are not simultaneous, particularly because the markets for different securities have varying structures, trading volume, and liquidity.
The Commission recognizes that non-firm trading interest (and firm quotations for that matter) need not be executed, even if matched. Nonetheless, it will be possible to assess whether a non-firm trading interest is actually “at or near the best available price,” using the similar information that market participants use to make bids and offers, including recently completed purchases and sales and the totality of indications of willingness to buy or sell at specified prices.
Finally, as discussed above in connection with the term “trading interest,” to come within this factor, a person expressing trading interest (including through a CLOB) must be buying and selling securities, and it must engage in such activity “regularly.”
Under the proposed rules, market participants would have had to routinely express trading interests accessible to other market participants to be considered to have engaged in a routine pattern of trading that has the effect of providing liquidity to other market participants.
One commenter objected to the proposed second qualitative factor's phrase “communicated and represented in a way that makes them accessible to other market participants,” stating that the Proposing Release does not make clear whether trading interests made available to a limited group of participants via a RFQ would trigger the factor, versus trading interests published on a broadly accessible order book. The commenter stated further that the vagueness of the standard would prevent market participants from applying it with confidence and might encourage market participants to choose execution venues and order types that are not transparent or accessible.
The phrase “accessible to other market participants” reflects the plain
The Commission is not adopting the suggestion to replace this factor with a test defining a dealer as a person engaging in
One commenter stated that the proposed second qualitative factor would impact the Commission's Order Competition Rule proposal.
In sum, the Commission has determined to replace the term “routinely” with “regularly,” add the phrase “for the same security,” and make non-substantive modifications to this factor, but otherwise is adopting this factor as proposed.
Finally, the Commission proposed a third qualitative factor encompassing activity that “has the effect of providing liquidity to other market participants.” Specifically, under proposed 17 CFR 240.3a5-4(a)(1)(iii) and 240.3a44-2(a)(1)(iii), a person that, trading for its own account, “earn[ed] revenue primarily from capturing bid-ask spreads, by buying at the bid and selling at the offer, or from capturing any incentives offered by trading venues to liquidity-supplying trading interests,” would have been engaging in a routine pattern of trading that has the effect of providing liquidity to other market participants, and as a result, would have been a dealer under the proposed rules.
The Commission explained in the Proposing Release that one fundamental characteristic typical of market makers and liquidity providers—and one that has historically been viewed as dealer activity—is trading in a manner designed to profit from bid-ask spreads or liquidity incentives rather than with a view toward appreciation in value.
The proposed third qualitative factor accounted for both forms of revenue. As to the first—capturing bid-ask spreads—the Commission stated that when a liquidity provider routinely buys and sells securities in a manner designed to capture a spread with such frequency and consistency that its revenue is made up primarily of this form of compensation, it would be considered to be engaged in a routine pattern of providing liquidity as a service and would fall within the scope of the rules.
In the Proposing Release, the Commission explained the meaning of certain key terms in the proposed third qualitative factor. The Commission stated that the factor used the phrase “earn revenue”—rather than, for example, “profit from”—to make clear that a person's trading strategies would not need to be profitable to bring them within the rule.
Finally, with respect to the term “trading venues,” the Commission stated that market evolution has given rise to a variety of venues in which liquidity providers can express trading interests, and the term “trading venues” is designed to capture the breadth of these different venues.
Of the three proposed qualitative factors, this factor received the fewest comments. Two commenters supported the third qualitative factor as proposed.
Another commenter stated the proposed third qualitative factor was “workable,” assuming two modifications.
Some commenters objected to the proposed third qualitative factor,
After consideration of the comments, the Commission has determined to adopt, as the primary revenue factor, the third qualitative factor as proposed, with a non-substantive change. The final rules continue to use the phrase “earn revenue” rather than “earn profit.” While the Commission acknowledges the possibility that persons whose liquidity provision fails to turn a profit may ultimately seek out more profitable lines of business, dealer status requires only that a person be “in the business,” not that that business be profitable.
The term “trading venues” is intended to accommodate the variety of venues in which market participants today engage in liquidity-providing dealer activity. In addition, the use of this term is intended to capture venues as they evolve, wherever that activity occurs, whether on a national securities exchange, an ATS, any other broker- or dealer-operated platform for executing trading interest internally by trading as principal or crossing orders as agent, or any other platform performing a similar function.
Regarding the term “primarily” as used in the primary revenue factor, the Proposing Release stated that if a person derives the majority of its revenue from the sources described in paragraph (a)(3)(iii), it would likely be in a regular business of buying and selling securities or government securities for its own account.
A commenter stated that the Proposing Release did not account for how the primary revenue factor would apply to market participants transacting in the crypto asset securities market; as commenters have pointed out, the crypto asset securities market has structures, products and activities that may implicate dealer registration.
With respect to portfolio management and trading strategies that for varying reasons may seek to take advantage of pricing differentials in bid-ask spreads, as stated above, persons who engage in a pattern of trading for their own account having the effect of providing liquidity to other market participants should be subject to the dealer regulatory regime, even if they are also registered investment advisers or private funds. As discussed below, the important protections provided by the dealer regulatory framework differ from those under the private fund and private fund advisers regulatory scheme established by the Advisers Act.
To summarize, one fundamental and historically recognized view of dealer activity is trading in a manner designed to profit from spreads or liquidity incentives.
The Commission proposed a quantitative standard that would establish a bright-line test under which persons engaging in certain specified levels of activity in the U.S. Treasury market would be defined to be buying and selling government securities “as a part of a regular business,” regardless of whether they meet any of the qualitative factors.
Some commenters generally supported inclusion of the quantitative standard.
Many commenters maintained that the quantitative standard was arbitrary and overly broad, and opined that a volume standard alone could not distinguish between a dealer and a trader.
After consideration of the comments, the Commission has decided to eliminate the quantitative standard from the final rules. While a trading volume threshold could provide a bright-line test under which persons engaging in certain specified levels of activity in the U.S. Treasury market would be defined to be buying and selling securities “as a part of a regular business,” the Commission has concluded such a bright-line test is unnecessary. The modified qualitative factors and otherwise applicable court precedent and Commission interpretations will appropriately address when market participants are acting as government securities dealers in the U.S. Treasury market by engaging in a “regular” pattern of buying and selling securities that has the effect of providing liquidity to other market participants. Therefore, the Commission has decided to delete the quantitative standard from the final rules.
In addition, as discussed in section II.A.5, no presumption shall arise that a person is not a government securities dealer as defined by the Exchange Act solely because that person does not satisfy Rule 3a44-2(a).
The proposed rules provided exclusions for certain market participants that the Commission determined do not provide liquidity to the markets in a manner requiring dealer registration or are subject to a comparable regulatory structure which addresses the types of concerns that the proposed rules were intended to address. The Commission is adopting these exclusions as proposed. In addition, the Commission is adding exclusions for central banks, sovereign entities, and international financial institutions, as defined in the final rules. Each of these exclusions is discussed in more detail below.
In the Proposing Release, the Commission proposed to exclude from the proposed rules “[a] person
Commenters that addressed this exclusion raised a number of concerns.
After consideration of comments, the Commission is adopting this exclusion as proposed. While we appreciate commenters' concerns, as indicated in the Proposing Release, the final rules are intended to capture market participants not registered as dealers that serve a critical dealer role in the securities and government securities markets through their liquidity provision or significant and regular trading activity in the market. These smaller market participants are unlikely to engage in the significant liquidity provision that is
The Commission also proposed to exclude registered investment companies registered under the Investment Company Act from the application of the rules.
Many commenters agreed with the proposed exclusion for registered investment companies.
In addition, many commenters stated that imposing dealer requirements—and in particular net capital requirements
Some commenters described potential practical difficulties with applying the dealer regulatory framework to private fund advisers and private funds
As support for such potential practical difficulties, some commenters stated that private funds are merely pools of assets that rely on fund managers for all functions and therefore do not have personnel or infrastructure to meet the dealer regulatory requirements.
After consideration of the comments and for the reasons stated here and in the Proposing Release,
The Commission, however, is not including an express exclusion for private funds or registered investment advisers. Depending on the totality of the facts, a private fund may be engaged in the business of buying and selling securities for its own account.
Entities engaging in dealing activity that meet the qualitative standard are required to register as dealers and comply with regulatory requirements that are applicable to dealer activity. Dealer regulatory requirements address related but distinct concerns from investment adviser regulation. In addition, dealer registration enhances regulatory oversight
However, the Commission is mindful of concerns raised by commenters regarding the application of the dealer regime to registered investment advisers and private funds and as such has made significant changes to the definition of “own account” to remove the
Further, there are material differences between the private fund and dealer regulatory frameworks, and dealer registration offers important benefits and regulatory protections to address the risks related to dealing activities.
Although, as commenters noted, the Commission collects some information about certain private funds through Form PF, this reporting alone is not a sufficient substitute for the comprehensive dealer requirements because the dealer requirements are specific to dealer activity. For example, Form PF only requires reporting related to a subset of the private fund industry and does not include individual trade reporting details, which would give regulators greater insight into securities trading patterns, including the ability to more efficiently match trades to market participants.
In response to commenters who stated that private funds are merely pools of assets that rely on fund managers for all functions and therefore do not have personnel or infrastructure to meet the dealer regulatory requirements, to the extent that a private fund engages in activities that trigger dealer registration under the final rules, such private funds would need similarly to establish means, whether by contract or otherwise, of complying with the obligations for registered dealers, just as the fund must do to comply with any other regulatory obligation.
In response to the commenter who suggested there were “only two differences” between the dealer and private fund regulatory regimes, the examples provided in the Proposing Release (
Finally, while not excluding registered investment advisers and private funds, the Commission is, however, modifying the definition of “own account” to mean an account held in the name of, or for the benefit of, that person and removing the proposed first qualitative factor. These changes will respond to concerns related to separately managed accounts and investment advisers trading on behalf of their clients, including those exercising discretion; these investment advisers generally will not be captured by the final rules because they would not be buying and selling for their “own account.” Private funds that are buying and selling for their “own account” in a way that meets the qualitative standard could be captured by the final rules. To the extent that private funds or investment advisers trigger application of the final rules, they would need to comply with the dealer registration requirements or cease engaging in dealer activity.
The Commission is adopting express exclusions for central banks, sovereign entities, and international financial institutions, as defined in the final rules. Together, these exclusions are referred to as the “Official Sector Exclusions.”
The Official Sector Exclusions are designed to permit central banks, sovereign entities, and international financial institutions to continue to pursue important policy goals, and to be consistent with principles of international comity and the privileges and immunities granted to foreign central banks, foreign sovereigns and sovereign entities, and certain international financial institutions under U.S. Federal law.
For purposes of the Official Sector Exclusion, the final rules define a “central bank” as a reserve bank or monetary authority of a central government (including the Board of Governors of the Federal Reserve System or any of the Federal Reserve Banks). This definition also includes the Bank for International Settlements (“BIS”). The BIS is owned by central banks,
The exclusion is appropriate for the Federal Reserve System—the central bank of the United States—both because excluding the Federal Reserve System will not contravene any of the Commission's goals in adopting the final rules and because of the Federal Reserve System's unique role in the U.S. Treasury market and the U.S. economy. Entities that constitute part of the Federal Reserve System should be excluded from dealer registration because requiring them to register as dealers would not address the primary concerns animating the final rules.
With respect to central banks generally, central banks are typically created by statute and are part of, or aligned with, a central government.
Finally, Congress has granted foreign central banks, other foreign sovereign entities, and certain international financial institutions special privileges and immunities under U.S. Federal law,
The Commission received a number of comments about how the proposed rules would apply to crypto assets. In the Proposing Release, the Commission explained that the definition of “dealer” and the accompanying registration requirements of the Exchange Act were drawn broadly by Congress to encompass a wide range of activities involving securities markets and participants in those markets.
The Commission received several comments concerning the application of the proposed rules to crypto assets that are securities that trade through centralized trading platforms or trade in the so-called DeFi market, and to persons who trade crypto asset securities. Many opposed applying the proposed rules to persons transacting in crypto asset securities.
One commenter supported applying the proposed rules to all securities, including crypto asset securities, and asked the Commission to resist suggestions from other commenters to carve out any types of assets that are securities from the “dealer” definition.
The Commission also received comments about the application of the proposed rules to so-called DeFi products, structures, and activities, and users and participants thereof.
As stated in the Proposing Release, as a threshold matter, the definitions of “dealer” and “government securities dealer” under sections 3(a)(5) and 3(a)(44) of the Exchange Act, and the requirement that dealers and government securities dealers register with the Commission pursuant to sections 15 and 15C of the Exchange Act, apply with respect to the buying and selling of all securities or government securities.
The dealer framework is a functional analysis based on the securities trading activities undertaken by a person, not the type of security being traded. The final rules apply to the buying and selling of all securities, including crypto assets that are securities or government securities within the meaning of the Exchange Act. While some commenters stated that the proposed rules should not apply to so called DeFi, whether there is a dealer involved in any particular transaction or structure (whether or not referred to as so-called DeFi) is a facts and circumstances analysis. There is nothing about the technology used, including distributed ledger technology-based protocols using smart contracts, that would preclude crypto asset securities activities from falling within the scope of dealer activity.
Rules 3a5-4 and 3a44-2 apply to persons transacting in crypto assets that meet the definition of “securities” or “government securities” under the Exchange Act. If a person's trading activities in crypto asset securities, including products, structures and activities involved in the so-called DeFi market, meet the definition of “as part of a regular business” as set forth in the final rules (
In addition to the commenters requesting additional exclusions for private funds and advisers and for market participants transacting in crypto asset securities, a commenter stated that the Commission should exclude from the scope of the proposed rules inter-affiliate transactions used by banking institutions to centrally manage cash or risk throughout their organizations.
The Commission is not adding an exclusion for inter-affiliate transactions because the Commission is removing the aggregation provision, and the final rules have been modified to focus on the trading activity of a person for an account in the name of, or for the benefit of, that person.
Further, some commenters requested clarification that the proposed rules would not apply to a governmental plan, including public pensions, nor to state administrators managing state funds or to city administrators managing the city pension funds through an exclusion from the proposed rules.
As noted in the Proposing Release, the Exchange Act defines a “dealer” or “government securities dealer” as a person engaged in the business of buying and selling securities for its “own account.”
The proposed rules would have broadly defined a person's “own account” to mean any account that is: “held in the name of that person,” or “held in the name of a person over whom that person exercises control or with whom that person is under common control,”
The proposed rules would have excluded from the definition of “own account”: (A) an account in the name of a registered broker, dealer, or government securities dealer, or an investment company registered under the Investment Company Act of 1940;
The Proposing Release explained that the proposed definitions were intended to avoid incentivizing market participants to change their corporate structures for the purpose of avoiding registration.
The Commission received extensive comment on the definitions included in the Proposing Release.
Many commenters stated that the Commission should maintain an entity approach to registration, focusing on activity on an entity-by-entity basis,
Regarding the proposed aggregation standard, many commenters raised concerns that trading activities of entities, including banks and bank holding companies, that may be excepted or exempted from dealer registration would nonetheless need to be aggregated with, and potentially trigger registration of, commonly controlled persons under the proposed rules, contrary to policy decisions Congress and the Commission has made to not require these entities to register as dealers.
One commenter stated that the Commission has not explained how dealer registration would work if unrelated client accounts needed to be aggregated.
As noted above, many commenters did not support the definitions, specifically the definition of “own account,” which they stated was overbroad.
Similarly, many commenters also did not support the definition of “control”
After careful review of these comments and upon further consideration, the Commission acknowledges the concerns raised by commenters and has determined that for the purpose of assessing dealer status under the final rules, an anti-evasion approach is appropriate. The Commission is revising the rule text to delete from the definition of “own account” any accounts held in the name of a person over whom that person exercises control or with whom that person is under common control and corresponding exclusions. Accordingly, under the rules as adopted, “own account” thus means any account: (a) held in the name of that person; or (b) held for the benefit of that person.
Each of these changes is discussed in more detail below.
The Commission is adopting the definition of “person” as proposed. Removal of the aggregation provision adequately addresses the comment mentioned above
As stated above, the Commission is adopting the definition of “own account” under paragraph (b)(2) to mean any account: (i) held in the name of that person; or (ii) held for the benefit of that person. Further, the Commission is removing the definitions of “control” and “parallel account structure” as the corresponding language in the aggregation provisions of the proposed rules has been removed, and the definitions are no longer relevant.
In response to concerns raised by commenters related to, among other things, the breadth of the proposed rule's aggregation approach, the Commission has determined to focus in the first instance on an analysis of activity on an entity-by-entity basis, rather than aggregating accounts across entities that are controlled by or are under common control with an entity.
Although the Commission has determined to eliminate the proposed rule's aggregation provision, the Commission nevertheless remains concerned that some persons may seek to structure their business for the purpose of evading dealer registration. Accordingly, the Commission is adopting an anti-evasion provision in the final rules, consistent with suggestions from commenters. This anti-evasion provision prohibits structuring activities or disaggregating accounts for the purpose of evading the dealer registration requirements.
The first anti-evasion prong prohibits a person from evading the registration requirements by engaging indirectly in activity that would meet the qualitative standard. This prong makes clear that persons are prohibited from evading the dealer registration requirements under the final rules by, among other things, using another person or entity to indirectly engage in activity that would meet the qualitative standard.
The final rules also include a second anti-evasion prong. This prong, which is modeled on Rule 13h-1(c)(2),
The anti-evasion provision is intended to capture persons dividing or structuring their activity to evade the application of the final rules. Potentially evasive activity would include but is not limited to, coordinating and integrating trading across commonly controlled groups of legal entities such that it would not meet the qualitative standard, including by switching which legal entity is engaged in trading to evade the “regular” requirement of the qualitative standard. Other specific examples of potentially evasive behavior include: (i) a person that uses two legal entities to separately purchase and sell securities;
In determining whether or not a person is evading the dealer registration requirements in violation of the anti-evasion provision, the Commission may consider, for example, whether there are: (i) information barriers to prevent sharing of information or sufficiently segregated trading,
While the Commission has identified a number of non-exhaustive examples of potentially evasive behavior and described factors that weigh against a conclusion that a person's intent is evasive, it is important to recognize that whether a person has violated the anti-evasion provision will depend on an evaluation of the totality of the facts and circumstances.
In the Proposing Release, the Commission proposed to include a “no presumption” clause to clarify that a person may be a dealer if it engages in a regular business of buying and selling securities for its own account, even if it does not meet the conditions set forth in the proposed rules. The Commission explained that the proposed rules did not seek to address all persons that may be acting as dealers under otherwise applicable interpretations and precedent (for example, by acting as an underwriter, regardless of whether such person has or controls assets of less than $50 million).
No commenters suggested changes to the proposed no presumption clause. For the reasons discussed in the Proposing Release, we are adopting this provision as proposed. We also reiterate, consistent with our adoption of the no presumption clause, that the final rules do not modify existing court precedent and Commission interpretations, which continue to apply to determine whether a person is a dealer, even if such person would not qualify as a dealer under the final rules.
In the Proposing Release, the Commission proposed and sought comment on a compliance date of one year from the effective date of the adoption of the final rules.
The Commission received a few comments relating to the compliance date.
After further consideration, the Commission is adopting a one-year
However, we emphasize that the one-year compliance period only applies to market participants who are engaging in activities covered by the final rules prior to the compliance date, and does not apply to persons whose activities otherwise satisfy the definition of dealer under applicable Commission interpretations and court precedent. It is incumbent here, as with questions of “dealer” status generally, for market participants to analyze and monitor their trading activities to understand their registration obligations.
The Commission is sensitive to the economic effects of its rules, including the costs and benefits and effects on efficiency, competition, and capital formation. Section 3(f) of the Exchange Act requires the Commission, whenever it engages in rulemaking pursuant to the Exchange Act and is required to consider or determine whether an action is necessary or appropriate in the public interest, to consider, in addition to the protection of investors, whether the action would promote efficiency, competition, and capital formation.
The final rules will promote competition among entities that regularly provide significant liquidity by applying consistent regulation to these entities, thus leveling the playing field between liquidity provision conducted by entities that are currently registered as dealers and government securities dealers and by entities that are not. The final rules will also promote the financial responsibility and operational integrity of significant liquidity providers that are acting as dealers in securities markets by subjecting them to the Net Capital Rule and to other Commission and SRO rules and oversight. The financial responsibility and operational integrity of these significant liquidity providers, in turn, will support the resilience of securities markets. In addition, the final rules will improve the Commission's ability to analyze market events and detect manipulation and fraud. Although the final rules may have small negative effects on market liquidity and efficiency, due to increases in costs for affected parties, the final rules may also promote liquidity and efficiency by limiting the probability that significant liquidity providers fail.
The baseline against which the costs, benefits, and the effects on efficiency, competition, and capital formation of the final rules are measured consists of the current state of the securities markets, current practice as it relates to dealers and other significant liquidity providers in securities markets, and the current regulatory framework. The economic analysis considers existing regulatory requirements, including recently adopted rules, as part of its economic baseline against which the costs and benefits of the final rules are measured.
Dealers perform important market functions, such as absorbing order imbalances and providing liquidity to buyers and sellers who may not arrive at the same time, and a regulatory regime exists to govern their activities.
Persons engaged in the business of buying and selling securities for such person's own account are generally dealers pursuant to section 3(a)(5) of the Exchange Act and are required to register as dealers with the Commission in accordance with section 15(b) of the Exchange Act, become members of an SRO, and adhere to a comprehensive regulatory regime, unless their activities fall within an exception,
Dealers that are also government securities dealers are further subject to rules issued by the Treasury that concern financial responsibility, capital requirements, recordkeeping, and
The regulatory regime for registered dealers includes provisions that limit risk (
The regulatory regime differs somewhat for entities that transact only in government securities, especially with respect to requirements on SIPC membership and capitalization.
The SEC's recently-adopted Treasury Clearing rule requires that any direct participant of a covered clearing agency submit all eligible secondary market transactions in U.S. Treasury securities for clearance and settlement, including transactions where the counterparty is another member of a covered clearing agency.
As explained in section I.A, courts have repeatedly recognized the requirement that dealers and government securities dealers register as being “of the utmost importance in effecting the purposes of the Exchange Act.”
The Commission believes that some entities who are not registered as dealers or government securities dealers perform a significant role in providing liquidity in markets, including entities
PTFs, who trade only for their own account without customers, have emerged as
Table 1 summarizes the number and type of identifiable market participants in TRACE, by average monthly trading volume in 2022.
PTFs that are engaged in dealing activities without registering with the Commission as dealers do not have the same regulatory responsibilities as registered dealers or government securities dealers. These responsibilities include compliance with regulations regarding capitalization, operational controls, book-keeping, and record-keeping.
PTFs that are not registered as dealers do face constraints on risk-taking, but they face fewer constraints than registered dealers or government securities dealers. When they trade through a bank or broker-dealer, 12 CFR parts 220, 221, and 224 (“Federal Reserve Regulations T, U, and X”) require the bank or broker-dealer to limit the PTFs' risk by imposing margin requirements on loans that use securities as collateral.
PTFs that are not registered as dealers do not have reporting obligations to CAT or to TRACE, though these data sources contain certain information on PTFs' trading.
Pursuant to the CAT NMS Plan, the CAT must capture and store Customer and Customer Account Information in a secure database physically separated from the transactional database. “CAIS” refers to the Customer and Account Information System within the CAT System that collects and links Customer-ID(s) to Customer and Account Attributes and other identifiers for queries by regulatory staff.
Additionally, broker-dealers and ATSs report transactions in U.S. Government securities to TRACE. However, TRACE data include the identities of unregistered entities only when the trades occur on an ATS covered by FINRA Rule 6730.07 (generally, the ATSs with higher volume).
PTFs with high volumes or large portfolios in equities markets may also have to report to the Commission on Form 13F
PTFs are subject to the anti-manipulation and antifraud provisions under Securities Act section 17(a) and Exchange Act section 10(b), but they are not subject to Exchange Act section 15(c). Exchange Act section 15(c) authorizes the Commission to issue, for registered entities, specific rules and regulations that “define, and prescribe means reasonably designed to prevent, such acts and practices as are fraudulent, deceptive, or manipulative and such quotations as are fictitious.”
Private funds
Table 2 shows the number of private funds as of the fourth quarter of 2022.
The business models of private equity funds
Investment advisers are subject to the Advisers Act and the Commission oversees private fund advisers, many of which are registered with the SEC or report to the SEC as exempt reporting advisers.
The Advisers Act establishes reporting and recordkeeping requirements for registered advisers to private funds. For example, section 204 requires registered investment advisers to keep certain books and records (records of the advised private funds are considered records of the adviser for these purposes). Registered investment advisers and exempt reporting advisers must also disclose information on Form ADV. Registered private fund advisers report certain information on the private funds they manage to the Commission annually (and, for certain large advisers of certain large hedge funds, quarterly) on Form PF. Specifically, large hedge fund advisers currently file quarterly periodic reports and—within 72 hours of the occurrence of certain events including extraordinary investment losses and large margin increases—current reports to the Commission on Form PF and are subject to books and records rules and examinations.
However, private funds and investment advisers do not have to comply with the Net Capital Rule or with any other direct regulatory constraint on leverage. They also are not required to report their transactions (though their broker-dealer may be required to report the transactions), and they are not subject to section 15(c) of the Exchange Act.
In this section, we provide estimates of the number of entities that may satisfy the qualitative standard, as adopted. These estimates are subject to significant caveats that we also describe below. We use TRACE data on U.S. Treasury transactions to provide an estimate of the number of identifiable Treasury-market participants that could be affected. We use data from Form PF
Using TRACE data for U.S. Treasury securities, we estimate the number of affected parties by identifying firms that appear to meet the primary revenue factor by earning revenue from capturing bid-ask spreads in the market for U.S. Treasury securities. We do not estimate the number of entities that appear to meet the expressing trading interest factor because the Commission does not have sufficient data on quoting activities. TRACE data identify specific parties in the Treasury market that are not registered broker-dealers who trade on certain ATSs.
The Commission does not necessarily observe all revenue sources for the most active participants in the U.S. Treasury market. Thus, for the purpose of estimating the number of affected entities, we consider that firms potentially meet the primary revenue factor if they trade at least 4 of the 10 highest-volume U.S. Government securities on at least 15 different trading days in a given month and if they realize, on average across the month, a positive intraday trading spread on each of those securities.
Figure 2 counts the number of identifiable non-broker-dealers that appear to meet the primary revenue factor for 1+, 2+, etc. months during 2022 in the market for U.S. Government securities. Figure 2, using the empirical measures described above, identifies as potential significant liquidity providers a total of 31 non-broker-dealers in TRACE that would have met the primary revenue factor for at least one month in 2022,
Several commenters
Table 3 describes the number of hedge funds that used at least some HFT strategies, as reported by their advisers in the advisers' most recent Form PF filing between 2021-Q4 and 2022-Q3. Using Form PF, advisers report their use of HFT strategies as a range of percentages of net asset value (“NAV”), such as “less than 10%” of NAV, “10%-25%,” etc. We calculate a range of dollar values for each fund by multiplying the high and low values of the reported range by the fund's NAV. For example, if an adviser reports that a fund engages in HFT using “Less than 10%” of the fund's NAV, and if the fund's NAV is $100, then we conclude that the fund uses HFT to manage between $0 and $10 (10% of $100). For reported HFT use of “100% or more” of NAV, we use 500% of NAV as the high end of the range. The third row of Table 3 shows the total range of HFT use that we obtain by summing the low and the high estimates across funds. The left column provides statistics for funds with reported HFT use that is less than 10% of NAV, and the right column provides statistics for funds with reported HFT use that is 10% or more of NAV.
The use of HFT strategies is, however, an imperfect proxy for whether these funds would qualify under the qualitative standard, as adopted. We are unable to determine whether the HFT activities that these funds report would satisfy the expressing trading interest factor or the primary revenue factor because we do not observe individual transactions in Form PF. The use of HFT strategies, to the extent it may be dealing, is more likely to be a primary source of revenue when it accounts for a larger percentage of a fund's NAV. Accordingly, the 12 hedge funds with HFT of at least 10% of NAV in Table 3 are the more likely to meet the final rules' primary revenue factor. However, since reported HFT may apply to a broader set of activities than the final rules' qualitative factors, the actual number of affected funds may be less than 12.
Our empirical analyses of likely affected parties face other limitations. In the current stage of implementation of CAT, we do not have comprehensive statistics on option or equity market activity stemming from entities engaging in dealing activity that are not registered as dealers, such as those known as PTFs in other markets.
Commenters said that the number of hedge funds affected by the Proposed Rules would be much higher than the Proposing Release suggested, potentially numbering into the hundreds.
One commenter stated that the Commission did not estimate the number of affected parties based on trading in other asset classes, such as corporate bonds, municipal securities, and asset- or mortgage-backed securities.
Because crypto asset platforms transacting in crypto assets for their own account may already be dealers under current law—
The previous sections highlight important differences in regulatory treatment among competing significant liquidity providers. Specifically, registered dealers and the unregistered market participants that perform similar functions operate under different regulations—
Our analysis of TRACE data suggests that liquidity provision in the interdealer market for U.S. Government securities is not concentrated.
The Commission also understands that many firms compete to provide liquidity in the markets for corporate bonds and for equities (not necessarily the same firms). Research has documented that, as of the first quarter of 2020, about 600 dealers intermediated in the market for corporate bonds, but that the top 10 broker-dealers controlled approximately 70% of the volume.
The current competitive landscape among significant liquidity providers is shaped by the difference in regulatory treatment between registered dealers and the unregistered market participants that perform a similar role in the markets. Competition among significant liquidity providers in U.S. capital markets, described above, puts pressure on firms' ability to profit from these activities, meaning that even small regulatory differences across significant liquidity providers can be important. The compliance costs of the additional requirements to which registered dealers are subject may currently allow less-regulated firms such as PTFs to increase (or continue to increase) their share of dealing activity at registered dealers' expense. These dynamics may especially apply to the electronic interdealer segment of the Treasury market, where PTFs now account for a majority of trading activity (as of 2019).
Externalities arise in a market when a market participant engages in activity that impacts participants not otherwise directly related to the activity and the market participant does not take this impact into account. In this analysis, externalities can arise with regard to activities, such as risk taking and abusive trading, that are taken by market participants who act as regular significant liquidity providers (
Market participants that act as regular significant liquidity providers, whether registered with the Commission as dealers or not, can not only harm their counterparties but also cause wider harm throughout securities markets if they fail financially.
Failed liquidity providers can become unable to meet short-term obligations to trading counterparties, repo lenders and other lenders, and clearing firms. Negative effects can be transmitted further through creditors or counterparties to other market entities who are not directly related. For instance, a lender that suffers a loss due to the bankruptcy of one of its borrowers may reduce its willingness to lend (
If the failed liquidity provider is a substantial market participant, then its disorderly exit from the market or from a securities position may push market prices away from fundamental value and harm traders across the markets. Because a significant liquidity provider can harm others to whom it is not directly related—and who may not be able to contract to bear those costs—its failure can impose negative externalities. These externalities may ensue whether the failed liquidity provider is registered as a dealer or not. However, the next paragraph explains how the dealer regime's limitations on financial risk, including the Net Capital Rule, reduce the risk for registered dealers.
Dealer regulations are designed to mitigate the magnitude of these externalities and to limit the probability that they occur at all. For example, the Net Capital Rule requires dealers to maintain sufficient liquid assets to meet all unsubordinated liabilities—including obligations to counterparties and other creditors—and to have adequate additional resources to wind down their business in an orderly manner if they fail financially. PTFs that are not registered as dealers currently face fewer regulations restricting their operational or financial risk,
Some commenters disagreed that traders without customers pose risks to investors, since they do not interact directly with the investing public.
Some commenters questioned the proposal's premise that market participants who are not registered dealers can have important externalities, or stated that any such externalities manifest themselves so infrequently that the proposed rules are unnecessary.
In addition, the 2021 IAWG Joint Staff Report showed that PTFs in particular (many of whom were not registered as dealers) appeared to pull back from providing liquidity in the Treasury markets relative to dealers during the market volatility in March 2020, possibly because “their lower capitalization relative to dealers may [have left] them with less capacity to absorb adverse shocks.”
Negative externalities can also derive from market misconduct by unregistered dealers. Several elements of the dealer regulatory regime address misconduct risks and regulators can examine regulated dealers. Under that regime, financial statement reporting, transaction reporting,
Some commenters said that requiring more Treasury security transactions to be centrally cleared would address the same externalities that are described above.
Accordingly, the Commission acknowledges that the Treasury Clearing Adopting Release addresses some of the externalities discussed above stemming from the failure of large firms, which the final rules are also intended to address. However, given that the Treasury Clearing Adopting Release and the final rules address these externalities through different mechanisms, the final rules would serve to further reduce the externalities in the market for U.S. Government securities. This, in turn, further reduces the probability that a significant liquidity provider fails and thus promotes the stability and resiliency of the government securities market. By limiting the risk of failure, the final rules limit the probability that such failure could harm creditors or lead to price volatility as a troubled firm rapidly deleverages. The final rules may also limit the probability of failure for all PTFs and hedge funds who are engaged in dealing activity. The Treasury Clearing Adopting Release, in contrast, would not require central clearing for hedge funds' cash trades or for any transaction between a PTF who is not a member of a clearing agency and another non-member counterparty. In addition, benefits of the final rules such as the consistent application of dealer regulations across significant liquidity providers, operational and financial requirements designed to mitigate risks, deterrence of abusive and deceptive trading practices, extension of SROs' examination authority to significant liquidity providers for U.S. financial markets, and increased transparency into the identities of significant liquidity providers in the Treasury market, are largely unaffected by the adoption of the Treasury Clearing Adopting Release.
As described in section II, the Commission believes that the final rules will promote the stability and transparency of U.S. Treasury and other securities markets by closing the regulatory gap that currently exists and ensuring consistent regulatory oversight of persons engaging in regular liquidity provision in securities markets. Specifically, the final rules will increase the share of liquidity provision that is undertaken by persons who are subject to the dealer regime's limits on financial risk-taking, reporting requirements, regulation against abusive practices, and examinations. The greatest benefits come from applying these dealer regulations to entities that are currently not registered at all—
Costs of the final rules include registration and membership fees, costs of recordkeeping and reporting, and costs associated with net capital requirements. Additionally, the final rules may influence patterns of market participation, which may in turn affect competition among significant liquidity providers, market liquidity and efficiency, and capital formation.
The final rules would subject all market participants that perform similar dealer functions to a common regulatory regime. This regime includes provisions that limit risk (
As previously discussed, PTFs and hedge funds would be the primary affected parties, and registering PTFs that are dealing would provide the
In response to a related initiative in 2010,
Currently, large market participants that are not registered as dealers (or government securities dealers) perform critical market functions, in particular liquidity provision, akin to those performed by dealers (or government securities dealers). For example, in the U.S. Treasury market, PTFs account for about half of the daily volume in the interdealer market and yet are not registered as dealers. The final rules will help ensure that all market participants that take on significant liquidity-providing roles are appropriately registered as dealers and government securities dealers. The final rules will thereby promote competition among entities that regularly provide significant liquidity by applying consistent regulation to these entities, thus leveling the competitive playing field between liquidity provision conducted by entities that are currently registered as dealers and government securities dealers and by entities that are not.
The regulatory consistency under the final rules is expected to benefit currently registered dealers by ensuring that all of their competitors, including currently unregistered market participants that perform the same function as dealers, are subject to common regulatory requirements.
Some commenters stated that the final rules would negatively impact competition by especially harming small PTFs and creating barriers to entry against small liquidity providers.
The final rules will mitigate externalities to liquidity and stability, discussed in section III.B.3, by applying the Net Capital Rule and SRO requirements to additional significant liquidity providers. These final rules will reduce the risk that a significant liquidity provider fails and harms its counterparties and the broader functioning of the markets, by promoting the financial stability of individual significant liquidity providers. SRO supervision may also reduce the risks that errors in algorithms lead to trading activities that violate Commission or SRO rules.
The Net Capital Rule will make risk-taking more costly for affected parties because the final rules will require them to maintain a greater supply of liquid assets when they are exposed to more risk. In the event that a significant liquidity provider fails, the Net Capital Rule will ensure that it has sufficient liquid assets to meet all its liabilities to unsubordinated creditors. In addition, qualifying hedge funds,
The benefit of the Net Capital Rule's constraints on risk-taking may be smaller for certain affected parties. Some persons may meet the final rules' definition of dealing but also keep their gross exposure small at any moment. Such persons would operate with very little leverage and would have few short-term obligations at any moment. The benefit of the Net Capital Rule may also be smaller when applied to persons whose creditors and counterparties have rigorous risk management practices and are capable of calculating and managing their exposure to that person. Such creditors and counterparties may not be seriously harmed by a dealer's failure. As noted above, registered government securities dealers are subject to minimum liquid capital requirements as set forth in 17 CFR 402.2. These requirements would generally serve the same risk-limiting purpose as the Net Capital Rule. Also, the Net Capital Rule would not necessarily make affected persons more willing to provide liquidity in times of market stress; solvent firms could still decide not to provide liquidity if it were not profitable to do so.
The final rules require affected persons to become FINRA members and comply with FINRA rules designed to
A few commenters agreed that the proposed rules would provide benefits of market stability, integrity, and resiliency.
Many commenters stated that market participants who are not registered as dealers are already subject to regulatory risk limits, because the market participants typically trade through registered entities (
Some commenters questioned the benefits of applying the Net Capital Rule to entities without customers—
The final rules may also increase the benefits associated with increased central clearing. Under the recent Treasury Clearing amendments,
Entities that register as dealers, other than registered government securities dealers, will be required to become members of SIPC. Some commenters questioned whether dealers registered under the final rules that do not have customers would benefit from SIPC membership.
The final rules would enhance regulators' oversight of significant liquidity providers and of individual securities trades. Entities that register as dealers under the final rules will have new reporting obligations to CAT (if they transact in CAT-reportable securities) and to TRACE (if they transact in TRACE-eligible securities). The additional reporting would give regulators greater insight into securities trading patterns, including the ability to more efficiently match trades to market participants.
Comment letters argued that dealer registration would not provide an information benefit because transactions are already reported to TRACE or CAT,
The final rules would help the Commission and the SROs to detect and deter abusive behaviors such as fraud or manipulation by subjecting significant liquidity providers to section 15(c) of the Exchange Act
Registered dealers and government securities dealers are subject to examinations by the Commission and by the relevant SRO, and they are also required to comply with certain books and records requirements.
Examinations also help regulators analyze market disruptions and inform subsequent regulatory changes. Since the final rules will give regulators the ability to conduct targeted examinations of entities that provide substantial market liquidity and price formation, regulators will be able to better determine the causes of market disruptions and implement regulatory reforms designed to mitigate and prevent future similar disruptions.
The final rules will impose compliance costs on certain market participants, including costs of registering with the Commission and with an SRO, recordkeeping and reporting costs, direct costs that may stem from meeting net capital requirements (
1. Costs related to registration as a dealer or government securities dealer.
2. Costs related to FINRA membership or membership with another SRO.
3. Costs related to TRACE reporting for firms that trade fixed income securities.
4. Costs related to CAT reporting for firms that trade NMS securities or OTC equities.
5. Costs related to SIPC membership for firms that register as dealers under section 15(b) of the Exchange Act.
The costs of registration as a dealer or government securities dealer will apply to all firms. Likewise, the cost of FINRA membership or membership with another SRO will apply to all firms. However, the costs of TRACE reporting will only apply to firms that trade fixed income securities. The costs of CAT reporting will only apply to firms that trade NMS securities, OTC equity securities, or options. The costs of SIPC membership will apply only to firms that register as dealers under section 15(b) of the Exchange Act and not firms that register as government securities dealers under section 15C of the Exchange Act.
The Commission has itemized and updated its cost estimates for affected parties in response to commenters.
The cost estimates in the following subsections are subject to several assumptions, uncertainties, and other factors. In particular, the cost estimates are for firms the Commission expects to register as dealers or government securities dealers because the firms meet either the expressing trading interest factor or the primary revenue factor in the final rule. Since estimates of the number of affected parties are subject to some uncertainty, the following cost estimates are subject to similar uncertainty and limitations.
This section discusses the Commission's estimates of the costs associated with dealer registration under section 15(b) of the Exchange Act and government securities dealer registration under section 15C of the Exchange Act with the Commission for the final rules' affected parties. The Commission expects the costs of registration to be similar for dealer registration under section 15(b) and government securities dealer registration under section 15C because
The Commission estimates the initial cost of the final rules for affected parties that register as dealers is approximately $700,000.
The Commission estimates the ongoing cost of registering with the Commission as a dealer is approximately $600,000.
A dealer registered under section 15(b) of the Exchange Act is subject to the compliance requirements of the customer protection rule, Rule 15c3-3, unless the dealer's operations satisfy certain criteria that exempt the dealer from the rule.
The initial and ongoing compliance costs include financial reporting, recording keeping, and net capital requirement compliance operations. The costs associated with the reporting, record keeping, and net capital requirements of dealer registration will depend on the scope of the firm's dealer activities, capital structure, existing compliance-related activity, and jurisdiction. If a firm trades securities belonging to several different asset classes, then the firm may incur greater dealer related compliance costs because different types of securities are subject to different reporting, record keeping, and net capital requirements.
An additional compliance cost of the rules is the cost of self-evaluation.
If a firm finds its trading operations might satisfy the criteria for the trading interest factor or primary revenue factor, then the firm will likely hire legal counsel to conduct an independent review of a firm's trading operations. The review will produce one of two outcomes. The first possible outcome is the preparation of an opinion letter stating that the legal counsel believes a firm's trading operations do not satisfy the trading interest or primary revenue factors and therefore the firm does not need to register as a dealer. The second possible outcome is that the external legal counsel finds that the firm should register as a dealer following the final rules' adoption, in which case the firm will not incur the costs associated with the preparation of an opinion letter.
The Commission is unable to provide quantitative estimates of the number of firms that would incur the cost of self-evaluation but determine they are not required to register. The Commission is unable to provide a quantitative estimate because of the same data limitations that constrain the Commission's ability to estimate the number of firms that will ultimately register as dealers.
Affected parties that register as dealers after the final rules' adoption must become members of FINRA or another appropriate SRO.
The initial costs for an affected party to become a member of FINRA are composed of FINRA membership application fees and any legal or consulting costs necessary for an affected party to complete the FINRA membership application and comply with FINRA rules.
The fees associated with a FINRA membership application can vary.
The other initial cost associated with FINRA membership is a consulting expense, which accounts for the legal and other advisory work necessary for an affected party to successfully complete a FINRA membership application. Some affected parties may decide to perform this work internally, while others may use outside counsel. When making this choice, an affected party will likely consider factors, such as the size and resources of the affected party, the complexity of the affected
Affected parties will incur ongoing annual costs to maintain FINRA membership after completing their initial application. The ongoing annual costs include the Gross Income Assessment (“GIA”), the Trading Activity Fee (“TAF”), the FINRA section 3 fee, FINRA-related compliance activities, and the personnel assessment. Table 6 summarizes these ongoing annual expenses for the final rules' affected parties. The Commission estimates that the ongoing annual cost of FINRA membership for an affected entity will range from approximately $61,000 for a relatively small firm to $1,130,000 for a relatively large firm. We will discuss each of these costs and our estimates below.
The Commission estimates the TAF cost for an affected party registering as a dealer following the final rules' adoption will range from approximately $7,000 for a small firm conducting few trades in securities subject to TAF to $120,000 for a large firm conducting many trades subject to TAF.
The TAF is a transaction-based fee that is usually assessed on member firm transactions in covered equity securities, options, security futures, TRACE-eligible bonds, and asset-backed securities.
The GIA is an annual expense determined by a firm's annual gross revenue, which is defined as a firm's total income as reported on FOCUS form Part II or Part IIA excluding commodities income.
A firm's GIA is the greater of the expense calculated per the schedule in Table 8 below or the firm's average GIA over the previous three years. Table 8 reports the schedule used to calculate a firm's GIA given its gross revenue. The table reports the assessment for the portion of a firm's gross revenue within a given range. For instance, suppose a firm's gross revenue is $100M. The firm's Gross Income Assessment is $172,293. This assessment is the sum of the following items: The firm owes $1,200 on its first million dollars of gross revenue. The firm owes an additional $41,568 = ($24M × 0.1732%) on its gross revenue between $1M and $25M. The firm also owes $92,625 = ($25M × 0.3705%) on its gross revenue between $25M and $50M. And the firm owes $36,900 = ($50M × 0.0738%) on its gross revenue between $50M and $100M.
FINRA charges an annual personnel assessment of $210 for each of the first five registered representatives at a firm, $200 for each of the sixth through 25th registered representatives at a firm, and $190 for each of the 26th and subsequent representatives at a firm.
FINRA also charges an annual branch office fee of $75 for each office, excluding one office, operated by a firm and registered by FINRA.
Finally, registered dealers are subject to an annual renewal fee that applies for each SRO or jurisdiction where the dealer is registered. Renewal fees vary by SRO and jurisdiction, as well as by the number of registered representatives and branch offices at a dealer. Given our estimate that entities that register as a result of the final rules will not have registered representatives or branch offices, we focus on the fee that applies at the level of the dealer. At the jurisdiction level, renewal fees range between $40 and $600, depending on the state, with most between $250 and $300. If the newly registered dealer chooses to also register with another SRO, renewal fees range between $0 and $10,000, depending on the SRO.
The discussion above may overstate the final rules' costs to affected firms to the extent that already registered broker-dealers pass regulatory costs through to the affected firms. For example, the Commission understands that FINRA member brokers and dealers can pass at least some of the burden of regulatory costs including the TAF to their customers, so that the parties who will be affected by the final rules may already bear these costs indirectly to the extent that they trade with FINRA members. If the affected party were to register as a dealer and become a FINRA member, some of the regulatory costs incurred by its trading partners may fall. For instance, when a PTF who is not a broker-dealer places a sell order on an ATS and matches with a FINRA member broker-dealer, the TAF is assessed on the FINRA member executing the cross.
Firms joining FINRA will also incur the costs of reporting their fixed-income transactions (other than municipal securities) to TRACE.
In this section, we estimate costs from CAT-related reporting, should an affected party trade CAT-eligible securities. However, the Commission believes few, if any, of the 43 potentially affected parties identified in section III.B.2.c will incur CAT-related reporting costs. If an affected party does
The Commission estimates the initial cost of CAT reporting for an affected party that trades CAT-reportable securities will range from a lower value of approximately $1,100,000 for a small firm with relatively few reportable trades to an upper value of approximately $4,900,000 for a large firm with many reportable trades. Our estimates for the initial costs of CAT compliance for an affected party registered as a dealer and trading CAT-reportable securities are based on inflation-adjusted cost estimates from the CAT NMS Plan Approval Order.
The Commission estimates the ongoing cost of CAT reporting for an affected party that trades CAT-reportable securities will range from a lower value of approximately $600,000 annually for a small firm with relatively few CAT-related trades to an upper value of approximately $4,000,000 annually for a relatively large firm reporting many trades to CAT. The Commission's estimates for the annual costs of CAT compliance of an affected party registered as a dealer and trading CAT-reportable securities are based on inflation-adjusted cost estimates from the CAT NMS Plan Approval Order.
CAT reporting costs also vary depending on security type, order size, and trading venue, among other factors.
In addition to the costs for reporting data to CAT, affected parties that register as dealers and trade NMS stocks, OTC equities, or listed options may be assessed CAT fees under the CAT Funding Plan.
Commenters said that the costs of joining SIPC should also be considered in addition to the costs discussed in the Proposing Release.
The Commission estimates the annual cost of SIPC membership for an affected party registered as a dealer is approximately $3,000 plus 0.15% of gross operating revenues generated by the affected party's securities business minus interest expense and dividends. This annual expense is the sum of two separate annual costs associated with SIPC membership. The first annual expense is approximately $3,000 and represents costs associated with preparing and filing annual reports with SIPC.
One commenter stated that the Commission should consider that “the sheer number and complexity of the Proposals, when considered in their totality, if adopted, would impose staggering aggregate costs, as well as unprecedented operational and other practical challenges.”
In this regard, some commenters mentioned the proposals which culminated in the recent adoptions of the May 2023 SEC Form PF Amending Release, the Private Fund Advisers Adopting Release, the Treasury Clearing Release, the Beneficial Ownership Amending Release, the Rule 10c-1a Adopting Release, the Short Position Reporting Adopting Release, and the Securitizations Conflicts Adopting Release.
However, we think these increased costs from overlapping compliance periods will be limited for several reasons. First, the number of newly registered dealers that will be subject to each of the recently adopted rules identified by commenters will be limited based on whether those newly registered dealers' activities fall within the scope of the other rules.
As discussed above, the final rules may result in certain transactions of newly registered dealers or government securities dealers being subject to central clearing requirements under the recent Treasury Clearing amendments.
Affected persons who are not currently in compliance with the Net Capital Rule would need to decrease the charges to their net capital or raise additional capital. This may particularly impact private funds, as their investors generally have withdrawal rights and the Net Capital Rule requires a broker-dealer to subtract from net worth when calculating net capital any contribution of capital to the broker-dealer: (1) under an agreement that provides the investor with the option to withdraw the capital; or (2) that is intended to be withdrawn within a period of one year of the contribution.
For market participants engaging in dealing activity, other than private funds, the Net Capital Rule may require additional capital. We anticipate the costs associated with the Net Capital Rule to vary according to the type of investment. For example, less liquid investments and derivatives positions are subject to greater haircuts (see below), and will thus require more capital.
One comment letter stated that the proposed rule would greatly increase the cost of certain trading strategies and provided numerical estimates.
In this context, in response to the commenter's letter, we undertake our own estimations of how much the final rules may increase affected parties' required capital for different position sizes under 17 of the 18 strategies listed in the comment letter.
In each strategy, the entity in question simultaneously (i) takes a long position of $P (in total) in one or more securities or futures and a short position of $P (in total) in one or more securities or futures; (ii) posts margin; and (iii) keeps no additional cash on its balance sheet, so that its equity equals the value of its margin account.
The net capital calculation begins with computing Tentative Net Capital (“TNC”), which is equal to book equity minus assets not readily convertible to cash (
NC must equal or exceed the greater of a fixed-dollar minimum requirement and a ratio-based minimum requirement. The aggregate indebtedness (AI) standard requires NC to exceed the greater of (i) one-fifteenth of AI (or one-eighth for 12 months after commencing business as a broker or dealer) and (ii) a fixed dollar amount that varies by broker-dealer type.
Certain dealers
OTC derivatives dealers must also maintain TNC of $100 million, and dealers that are approved to calculate haircuts using their own internal risk models must maintain TNC of $5 billion. Our calculations are for affected parties to which these TNC requirements do not apply, however.
Lastly, as described above, our calculations assume that the entity in question, whether registered as a dealer or not, faces a margin requirement of 2%, so that its book equity equals $0.02P.
To summarize, we estimate the increased capital requirement for affected parties under the following conditions: (i) TNC equals book equity; (ii) affected parties would use the standardized haircuts specified in the Net Capital Rule; (iii) the fixed amount under the AI standard is $100,000 and AI equals zero so that the AI standard requires $100,000 of NC; (iv) the alternative standard requires NC of $250,000, therefore it would not be adopted by affected parties in lieu of the $100,000 fixed dollar minimum required under the AI standard; (v) certain entities can claim a market maker exception that allows them to avoid calculating a haircut (so NC=TNC) if they maintain capital above a certain threshold; (vi) all futures positions are covered; and (vii) the entity in question must maintain capital of $0.02P even if it does not register with the Commission.
Under these conditions, the AI standard requires that book equity minus any haircut exceeds $100,000—
Eleven of the 17 strategies for which we provide estimates have no haircuts under the Net Capital Rule, because the securities and/or futures positions offset each other—the 11 strategies are strategy 1, 2, 3, 4, 5, 6, 9, 11, 13, 14, and 15—and six strategies do have haircuts—these strategies are 7, 8, 12, 16, 17, and 18. To illustrate the calculations involved, Box 1 describes the calculation details for a strategy with no haircut, and Box 2 describes the calculation details for a strategy with a haircut.
For strategies with no haircuts, such as in Box 1, the percentage change in capital is equal to ($100,000/0.02P)−1, which converges to zero as the position size P grows, since as P gets large the 2% margin requirement already requires more capital than would the Net Capital Rule.
For strategies with haircuts, such as in Box 2, the AI standard with the market maker exemption is the easiest to meet when the position size P is small enough because the market maker exemption allows the entity to avoid taking a haircut. As P grows, the market maker exemption becomes more binding, and the regular AI standard is the easiest to meet. As P grows arbitrarily large, the increase in equity converges to (haircut/0.02)−1.
Table 10 reports our findings. The first column shows the estimated increase in required capital that the commenter provided for each strategy included in the comment letter. Columns 2 shows our estimated increases in required minimum capital for a position size of $50 million (
The values shown in Table 10 may also overstate or understate the actual costs of the Net Capital Rule for the following reasons. For affected parties that pursue more than one trading strategy, we expect that the actual increase in minimum net capital would be lower than the values shown in column 2, and perhaps even lower than the values shown in column 3, because net capital applies to the entire portfolio and not just to a single strategy. The increases shown in Table 10 are therefore not additive—
The values shown in Table 10 may understate the actual costs of the Net Capital Rule because this analysis does not consider the “lock-up” requirement that capital be held for at least a period of one year.
We acknowledge that in instances where the Net Capital Rule may increase affected parties' minimum capital requirements, these parties may need to raise capital or reduce leverage. Several commenters suggested that affected parties could respond to the final rules by changing or curtailing their trading to avoid the revised dealer definition.
Commenters mentioned other potential conflicts between private funds' business and the dealer rules and regulations beyond the challenge of reconciling fund investors' withdrawal rights with dealers' capital requirements.
One potential conflict is that private funds that register as dealers may face restrictions against participating in the IPO market.
Several commenters stated that registering as dealers would cause funds to lose the benefit of various customer protection regulations that govern their relations with their broker-dealers.
One commenter suggested that the proposed rules' impact may be costly for private funds because funds and broker-dealers are treated differently for tax purposes.
One commenter said that “many investment funds (
A commenter suggested one scenario in the context of all-to-all trading in which a fund's best execution obligation as a dealer under FINRA Rule 5310 may conflict with the fund adviser's fiduciary duty to achieve best execution for its client, the fund.
Another commenter said that FINRA rules may restrict investment advisers who are also dealers from receiving carried interest from their private fund clients.
Studies on HFT are mixed on whether affected firms' activities may improve or worsen market liquidity.
We acknowledge that the final rules could have the effect of reducing liquidity. Affected parties may respond by curtailing their liquidity-providing activities. If the final rules reduce affected parties' profitability, then investors in those entities may reduce their market participation as well.
We conclude that any potential harm to market liquidity is likely to be smaller than commenters suggested because the final rules will likely affect fewer entities than the proposed rule, due to the elimination of the proposed first qualitative factor
The following analysis of Form PF data sheds light on how the final rules' effect on private funds might, in turn, reduce market liquidity.
As described in section III.B.2.c, the advisers in the left column may be less likely than those in the right column to have funds that meet the final rules' definition of dealing. To put the turnover numbers in context, total equity trading volume across all U.S. exchanges averaged about $12 trillion per month in 2022,
We also analyze entities' trading volumes in TRACE data to estimate how much liquidity affected parties may provide in the market for U.S. Government securities. For each government security CUSIP in TRACE in 2022, we calculate trading volume in the interdealer market
The values for “% interdealer volume” in Figure 3 may be biased downwards by any non-broker-dealers that trade on Treasury ATSs by submitting orders through broker-dealers, because TRACE would attribute such trades to the broker-dealer and the ultimate buyer or seller would remain anonymous. However, this bias will be
The TRACE analysis is limited by the large volume of trading where the counterparty to the reporting broker-dealer is anonymous.
Commenters said that the proposed rules would harm liquidity in markets for crypto assets.
The previous section explains why we believe the final rules could have a small negative effect on market liquidity. More liquid markets tend to be more efficient markets since they allow new information to influence securities prices more quickly. Therefore, we also expect that the final rules could have a small negative effect on market efficiency, especially in the market for U.S. Government securities.
Section III.C.1.a describes how the final rules will promote competition among entities that regularly provide significant liquidity by applying consistent regulation to these entities, thus leveling the competitive playing field between liquidity provision conducted by entities that are currently registered as dealers and government securities dealers and by entities that are not. The section also discusses how the final rules' costs may be proportionally greater for smaller affected parties, which may reduce the overall benefits to competition. Commenters also raised concerns that the final rules could harm competition. We respond to these concerns in the paragraphs below, but, in general, any negative effect on the competitiveness of liquidity provision in U.S. securities markets would likely be small because, as discussed in section III.B.3 (including Table 4 for the U.S. Treasury market), liquidity provision in securities markets is not concentrated, even among currently registered broker-dealers. The final rules may also affect some PTFs who conduct smaller trading volumes but nevertheless fit the final rules' qualitative factor, and such PTFs may choose to cease their liquidity-providing activities. Because such PTFs would be less significant liquidity providers on account of their smaller volumes, and because currently registered broker-dealers are not concentrated, we expect that any exit of theirs from the market would have a negligible effect on the competitiveness of liquidity provision in U.S. securities markets.
One commenter said that the final rules could put U.S. liquidity providers at a disadvantage versus foreign firms.
One commenter said that the final rules would harm competition by requiring some private funds to register but not others.
Another commenter said that the proposed rules would not have leveled the playing field because too many non-dealing entities would have been swept up by the proposed quantitative factor, by ambiguity in the proposed qualitative factors (
Two commenters said that the proposed rules would harm competition in crypto asset markets.
In addition, as stated above, some commenters requested that the Commission consider interactions between the economic effects of the proposed rules and other recent Commission rules, as well as practical realities such as implementation timelines.
We expect the final rules' effect on capital formation to be mixed. As described above in sections III.C.2.d and III.C.3.a, we agree with commenters
The final rules will also promote market stability, resiliency, and investor confidence by helping to ensure that dealing activity is adequately capitalized, subject to regulatory oversight, and accompanied by regulated internal controls and deterrents to deceptive behaviors. More stable markets and strengthened investor confidence in U.S. markets may promote capital formation by increasing demand for securities issued in U.S. markets, raising security prices, and lowering yields. One commenter agreed that the “overall effects [on market participation, market liquidity, price efficiency, competition among liquidity providers, and capital formation] are positive.”
The Commission considered several alternatives to the final rules: (1) retain the quantitative factor; (2) add a quantitative threshold to the proposed first qualitative factor; (3) remove the exclusion for registered investment companies; (4) exclude registered investment advisers and private funds; (5) require registered investment advisers and private funds to report to TRACE (rather than comply with the full set of dealer rules and regulations); and (6) revise the final rules to carve out or narrow the application to crypto asset securities.
Proposed Rule 3a44-2 would have required dealer registration of persons who purchased and/or sold a total of at least $25 billion in U.S. Government securities in each of 4 out of the last 6 months. The Commission proposed the particular threshold value because available data suggested that $25 billion would appear to strike a balance between low values, which may affect many small-volume traders who are not dealing, and high values, which may miss entities whose activities provide significant liquidity in the market.
Market participants who would meet the quantitative standard by regularly conducting large volumes of securities trading activity would likely also meet the expressing trading interest and primary revenue factors. The overlap may exist either because large trading volumes accompany expressions of trading interest in line with the expressing trading interest factor or because significant liquidity-providers that earn revenue from capturing bid-ask spreads or from capturing any incentives offered by trading venues (primary revenue factor) also tend to have large trading volumes.
Table 12 approximates the overlap between the proposed quantitative factor and the primary revenue factor by sorting identifiable firms based on their average monthly Treasury-trading volume in 2022 and then showing how many firms in each volume bucket appear to meet or not meet the primary revenue factor (
The quantitative factor could support the final rules in applying dealer registration to entities that provide significant liquidity, by specifically including the most active market participants (unless excluded). The bright-line test in the quantitative factor also could reduce self-evaluation costs for persons who regularly surpass the threshold, but it would not reduce the self-evaluation costs of persons who do not regularly surpass the threshold because such persons would still have to consider the expressing trading interest and primary revenue factors.
The quantitative factor would potentially increase the costs of the final rules because the quantitative standard may apply to a greater number of entities.
Given that the quantitative factor is unlikely to capture dealing activity that is not also captured by the expressing trading interest and primary revenue factors, and given the additional costs of requiring entities who are not dealing to register as dealers, the Commission has removed the quantitative standard from the final rules.
The Commission has long distinguished dealer activity from trader activity by focusing on, among other things, a dealer's frequent turnover of positions—stating, for example, that the dealer “sells securities . . . he has purchased or intends to purchase elsewhere or buys securities . . . with a view to disposing of them elsewhere”
Commenters raised concerns about the proposed first qualitative factor, saying that the factor's language was vague and that the factor could potentially capture significant non-dealing activities.
Retaining the proposed first qualitative factor may improve regulators' ability to analyze data on market activity,
The final rules exclude registered investment companies from the application of the rules, even if their activities meet the final rules' definition of dealing. The Commission could adopt the final rules without this exclusion, extending the rationale that all market participants engaged in activities that meet the final rules' definition of dealing, including registered investment companies, ought to register as dealers.
Including investment companies in the application of the rule would provide additional benefits by applying dealer regulation to more significant liquidity providers. First, we believe that standardizing the regulatory treatment of all significant liquidity providers would be beneficial because, as discussed previously, the uneven regulation potentially gives less-regulated entities an unfair advantage over registered dealers that engage in similar activities. Specifically, this alternative would further standardize regulatory treatment of significant liquidity providers in terms of capitalization, transaction reporting, books and records requirements, and anti-manipulation and anti-fraud provisions.
Removing the exclusion for registered investment companies would increase the costs of the final rules. Affected investment companies would bear the costs of registering with the Commission as dealers, joining FINRA or another SRO, reporting to TRACE and CAT, and becoming a member of SIPC.
Instead of registering as dealers, affected investment companies could respond by curtailing or ceasing certain trading activities.
Commenters generally agreed with the exclusion for registered investment companies,
Registered investment advisers and private funds may engage in activities that meet the final rules' definition of dealing. If so, the final rules would require them to register as dealers and comply with dealer regulations. Some commenters said that the Commission should exclude registered investment advisers, along with any private funds they may advise, from the final rules because the advisers are already subject to an extensive regulatory framework under the Advisers Act and because elements of the dealer regime—
Excluding registered investment advisers and their private fund clients could reduce many of the final rules' benefits by applying dealer regulation to fewer significant liquidity providers.
This alternative would also reduce the final rules' benefit to competition, by failing to level the playing field between significant liquidity providers who are registered as dealers and significant liquidity providers who may be investment advisers or private funds. However, if the final rules would have a net negative impact on competition by deterring private funds and advisers from providing liquidity,
Excluding registered investment advisers and private funds would reduce the final rules' costs. Advisers and private funds who would otherwise be affected would not be required to register with the Commission as dealers, join FINRA or another SRO, report to TRACE and CAT, and become a member of SIPC.
Excluding private funds would also limit the final rules' effects on market liquidity, efficiency, competition, and capital formation, since it would affect fewer parties who could respond by curtailing their trading activities. Section III.C.2.d describes how such a response could harm market liquidity and efficiency as well as how reductions in funds' profitability could reduce investor participation in the market. If advisers and private funds were excluded, then they would not respond in this way, and so any potential negative impact of such curtailing on market functioning or investor participation could be less than under the final rules.
Excluding advisers and private funds may allow current or future significant liquidity providers to avoid the dealer regime by registering as advisers. Commenters argued that principal
As described above, private funds and private fund advisers not registered as dealers are not subject to the requirement to report transactions to TRACE. Rather than requiring liquidity-providing investment advisers and private funds to register as dealers, the Commission could instead require them to report their transactions to TRACE as if they were members of FINRA, without submitting to the other requirements of the dealer regime.
As described in section II.A.3 above, the Commission received comments regarding the application of the proposed rules to crypto asset securities. Commenters requested that if the Commission were to move forward with adopting the proposed rules, the Commission revise the final rules to carve out or narrow the application to crypto asset securities.
As noted in section II.A.3, the definitions of “dealer” and “government securities dealer” under sections 3(a)(5) and 3(a)(44) of the Exchange Act, and the requirement that dealers and government securities dealers register with the Commission pursuant to sections 15 and 15C of the Exchange Act, apply to dealers in all securities or government securities, including crypto asset securities. Rules 3a5-4 and 3a44-2, as adopted, apply to any person transacting in securities or government securities, irrespective of where, or the technology through which, the security or government security trades.
The Commission is not changing this longstanding historical application of the Federal securities laws to securities, including crypto assets that are securities. After consideration of comments, the Commission continues to believe that Rules 3a5-4 and 3a44-2 apply to persons transacting in crypto assets that meet the definition of “securities” or “government securities” under the Exchange Act. As discussed above, certain persons engaging in crypto asset securities transactions may be operating as dealers as defined under the Exchange Act.
If the Commission were to revise the final rules to carve out or narrow the application to market participants who transact in crypto asset securities, that alternative would reduce costs for such market participants who are not dealers under current law and who, absent an exemption, would be required to register as dealers under the final rules. The alternative would also reduce the benefits of the final rules, discussed in section III.C.1, since it would not apply the dealer regime to market participants that provide liquidity in crypto asset securities markets.
The alternative could also have negative competitive effects, since certain market participants that deal in crypto asset securities would be exempted from registering as dealers, while market participants that deal in other types of securities would not enjoy such an exemption.
The new definitions adopted in this document do not, in and of themselves, contain “collection of information” requirements within the meaning of the Paperwork Reduction Act of 1995 (“PRA”).
As stated above, new definitions adopted in this document do not create any new collections of information, but we believe they will add respondents to the 14 existing collections of information noted above. The collections of information applicable to the additional respondents,
Section 15(a)(1) of the Exchange Act provides that it is unlawful for persons who meet the definition of the term “broker” or “dealer” to solicit or effect transactions in most securities unless they are registered as broker-dealers with the Commission pursuant to section 15(b) of the Exchange Act. Similarly, section 15C(a)(1) of the Exchange Act provides that it is unlawful for persons who meet the definition of the term government securities broker or government securities dealer, other than persons registered with the Commission as broker-dealers and certain financial institutions, to solicit or effect transactions in government securities unless they are registered with the Commission as government securities broker-dealers pursuant to section 15C(a)(2) of the Exchange Act. To implement these provisions, the Commission adopted Rules 15b1-1, 15Ca1-1, and 15Ca2-1 and Form BD. In addition, Rules 15b3-1 and 400.5 require that registered broker-dealers and government securities broker-dealers submit an amended Form BD when information originally reported on Form BD changes or becomes inaccurate.
The Commission uses the information disclosed by applicants in Form BD: (1) to determine whether the applicant meets the standards for registration set forth in the provisions of the Exchange Act; (2) to develop a central information resource where members of the public may obtain relevant, up-to-date information about broker-dealers and government securities broker-dealers, and where the Commission, other regulators, and SROs may obtain information for investigatory purposes in connection with securities litigation; and (3) to develop statistical information about broker-dealers and government securities broker-dealers. In addition, all information collected on Forms BD is public. The public may use this information to assist in determining whether to engage in business with a particular broker-dealer.
Section 15(b)(5) of the Exchange Act provides that any broker-dealer may, upon such terms and conditions as the Commission deems necessary or appropriate in the public interest or for the protection of investors, withdraw from registration by filing a written notice of withdrawal with the Commission. Similarly, section 15C(c)(1)(B) of the Exchange Act provides that any registered government securities broker or government securities dealer may, upon such terms and conditions as the Commission may deem necessary in the public interest or for the protection of investors, withdraw from registration by filing a written notice of withdrawal with the Commission. To implement these statutory provisions of the Exchange Act, the Commission promulgated Rules 15b6-1 and 15Cc1-1 and Form BDW (the uniform request for broker-dealer withdrawal).
The Commission uses the information disclosed by applicants in Form BDW, as required by Rules 15b6-1, 15Bc3-1, and 15Cc1-1 to: (1) determine whether it is in the public interest to permit broker-dealers and notice-registered broker-dealers to withdraw from registration; (2) develop central information resources where the Commission and other government agencies and SROs may obtain information for investigatory purposes in connection with securities litigation; and (3) develop statistical information about broker-dealers, notice-registered broker-dealers, municipal securities dealers, and government securities broker-dealers.
The Commission adopted Rule 15c2-7 in 1964 to improve the reliability and transparency of the quotations broker-dealers submit to inter-dealer quotation systems. To ensure that an inter-dealer quotation system clearly reveals where two or more quotations in different names for a particular security represent a single quotation or where one broker-dealer appears as a correspondent of another, Rule 15c2-7 sets forth certain criteria that must be met for broker-dealers to furnish, or submit directly or indirectly, any quotation for a security (other than a municipal security) to an inter-dealer quotation system. More specifically, to furnish or submit any such quotation Rule 15c2-7 requires that:
• Broker-dealers that are correspondents for other broker-dealers for a particular security and enter quotations inform the inter-dealer quotation system of both the existence of the arrangement and the identity of the correspondent;
• Where two or more broker-dealers place quotations pursuant to any other arrangement between or among other broker-dealers, the identity of each broker-dealer participating in any such arrangement(s), and the fact that an arrangement exists, must be disclosed;
• The inter-dealer quotation systems to which the quotation is furnished or submitted must make it a general practice to disclose, with each published quotation, these arrangements, along with the identities of all other broker-dealers that were disclosed to the inter-dealer quotation system; and
• When a broker-dealer enters into any correspondent or other arrangement in which two or more broker-dealers furnish or submit quotations for a particular security, the broker-dealer must inform all broker-dealers furnishing or submitting such quotations of the existence of such correspondent or other arrangement and the identity of the parties thereto.
The information required by Rule 15c2-7 is designed to help the Commission prevent fraud, manipulation, and deceptive acts and practices. When Rule 15c2-7 was adopted in 1964, the information it required was critical to the Commission's role in monitoring broker-dealers and protecting the integrity of over-the-counter markets. The disclosures required by Rule 15c2-7 help assure that inter-dealer quotation systems reflect the demand for, and market activity related to, the securities quoted on their systems.
Rule 15c3-1 is designed to ensure that broker-dealers registered with the Commission at all times have sufficient liquid capital to protect the assets of customers and to meet their responsibilities to other broker-dealers.
Various provisions of Rule 15c3-1 require that broker-dealers provide written notification to the Commission and/or their DEA under certain circumstances. For example, no equity capital of a broker-dealer may be withdrawn if the amount withdrawn exceeds specified levels unless notice is provided to the broker-dealer's DEA and the Commission within prescribed timeframes.
There are also certain recordkeeping requirements under Rule 15c3-1. For example, a broker-dealer must keep a record of who is acting as an agent in a securities loan transaction and records with respect to obtaining DEA approval prior to withdrawing capital within one year of a contribution.
These recordkeeping and reporting requirements are designed to inform the Commission and a broker-dealer's DEA of certain financial situations involving broker-dealers' financial situations.
Rule 15c3-5 requires that broker-dealers with access to trading directly on an exchange or ATS, including those providing sponsored or direct market access to customers or other persons, implement risk management controls and supervisory procedures reasonably designed to manage the financial, regulatory, and other risks of this business activity. More specifically, these broker-dealers must establish, document, and maintain certain risk management controls and supervisory procedures; regularly review those controls and procedures and document the review; and remediate issues discovered to assure overall effectiveness of such controls and procedures. These broker-dealers also must preserve a copy of their supervisory procedures and a written description of their risk management controls as part of their books and records. In addition, the Chief Executive Officer (or equivalent officer) is required to certify annually that the broker or dealer's risk management controls and supervisory procedures comply with Rule 15c3-5, and that the broker-dealer conducted the required review. These documents are required to be preserved by the broker-dealer as part of its books and records.
Rule 15c3-5 is generally designed to ensure that broker-dealers (which, under the current regulatory structure, are the only entities that may be members of exchanges or provide access to trading in securities on an ATS to non-broker-dealers) appropriately control the risks associated with market access, so as not to jeopardize their own financial condition, that of other market participants, the integrity of trading on the securities markets, and the stability of the financial system.
The Commission adopted Rules 17a-3 and 17a-4 (“Recordkeeping Rules”) in 1939 to standardize recordkeeping practices by establishing minimum standards with respect to business records that broker-dealers registered with the Commission must create and maintain. Rule 17a-3 requires broker-dealers to make and keep current certain records relating to their financial condition, communications, customer information, and employees. Rule 17a-4 requires broker-dealers to preserve, for prescribed periods of time, the records required to be created under Rule 17a-3 and certain other Commission rules. In addition, Rule 17a-4 requires broker-dealers to preserve other records that may be created or received by the broker-dealer in the ordinary course of its business for prescribed periods of time. Rule 17a-4 also specifies the manner in which these records should be maintained. The Commission has periodically modified these rules to include additional records and to
The records and the information created and maintained in accordance with Rules 17a-3 and 17a-4 are used by examiners and other representatives of the Commission, State securities regulatory authorities, and the self-regulatory organizations (
Rule 17a-5 requires that broker-dealers create, submit, and make available various reports. Paragraph (a)(1) of Rule 17a-5 requires broker-dealers to file quarterly or monthly (depending on a broker-dealer's business) reports on Form X-17A-5, the Financial and Operational Combined Uniform Single Report (“FOCUS Report”).
Reports required to be filed under Rule 17a-5 are used, among other things, to monitor the financial and operational condition of a broker-dealer by Commission staff and by the broker-dealer's DEA. The reports required under Rule 17a-5 are one of the primary means of ensuring compliance with the broker-dealer financial responsibility rules. In addition, FOCUS Report data are used in preparation for broker-dealer examinations. The completed forms also are used to determine which firms are engaged in various securities-related activities, the extent to which they are engaged in those activities, and how economic events and government policies might affect various segments of the securities industry.
Rule 17a-11 requires broker-dealers that are experiencing financial or operational difficulties to provide notice to the Commission, the broker-dealer's DEA, and the CFTC (if the broker-dealer is registered with the CFTC as a futures commission merchant). For example, if a registered broker-dealer determines that the net capital it has on hand has fallen below the amount it must maintain (as calculated under Rule 15c3-1), it must immediately notify the Commission and its DEA (and, if applicable, the CFTC).
Rule 613 requires FINRA and the national securities exchanges (“Participants”) to submit an NMS plan to create, implement, and maintain the CAT to capture order event information for orders in NMS securities, across all markets, from the time of order inception through routing, cancellation, modification, or execution in a single, consolidated data source.
This audit trail information is designed to allow regulators to efficiently and accurately monitor and surveil the securities markets and detect and investigate activity in NMS securities throughout the U.S. markets, whether on one market or across markets. The data collected and reported to the central repository can also be used by regulators to evaluate tips and complaints and for complex enforcement inquiries or investigations, as well as inspections and examinations. Further, regulators can use the data collected and reported to conduct more timely and accurate analysis of market activity for reconstruction of broad-based market events in support of regulatory policy decisions.
As discussed above, new Rules 3a5-4 and 3a44-2 would further define activities that would cause a person engaged in a regular business of buying and selling securities for its own account within the meaning of the Exchange Act. A person who satisfies the factors described in the amended definitions would be considered a “dealer” or “government securities dealer,” and thus would be required to register as such with the Commission, absent an exception or exemption. As detailed in section III.B.2.c, the TRACE analysis identifies as potential significant liquidity providers a total of 31 firms that are not currently registered as dealers; including 22 entities classified as PTFs, 4 entities classified as hedge funds, and another 5 entities.
As discussed above, section 15C of the Exchange Act requires that government securities dealers register with the Commission.
The time necessary to complete and file Form BDW will vary depending on the nature and complexity of the applicant's securities business. On average, the Commission estimates that it would take a broker-dealer approximately one hour
Any broker-dealer could be a potential respondent for Rule 15c2-7. Only quotations entered into through an inter-dealer quotation system, such as OTC Link and Global OTC, are covered by Rule 15c2-7. According to representatives of OTC Link and Global OTC, none of those entities has recently received, nor anticipates receiving, any Rule 15c2-7 notices.
The respondents that must register with the Commission as a result of the new final rules may incur a collection of information burden to comply with Rule 15c3-1. The Commission estimates the hour burdens of the requirements associated with Rule 15c3-1 as follows.
To comply with Rule 15c3-5, a respondent must maintain its risk management system by monitoring its effectiveness and updating its systems to address any issues detected.
As discussed above, the respondents that must register as dealers or government securities as a result of these new definitions will incur a burden associated with the collections of information necessary to comply with Rule 17a-3.
While recordkeeping requirements will vary based on the size and complexity of the broker-dealer, the Commission estimates that one hour a day
In addition to the hour burden estimate for Rule 17a-3 generally, the Commission also believes that paragraphs (a)(12) and (19) of Rule 17a-3 will impose specific burdens on respondents. Paragraphs (a)(12) and (19) of Rule 17a-3 require that a broker-dealer create certain records regarding its associated persons.
Paragraphs (a)(20) through (22) of Rule 17a-3 require broker-dealers to make, among other things, records documenting the broker-dealer's compliance, or that the broker-dealer has adopted policies and procedures reasonably designed to establish compliance, with applicable Federal regulations and SRO rules that require approval by a principal of the broker-dealer of any advertisements, sales literature, or other communications with the public.
The respondents that registered as dealers or government securities would incur a collection of information burden to comply with Rule 17a-4. Rule 17a-4 establishes the records that must be
This section summarizes the burdens associated with Rule 17a-5.
In 2019, the Commission received 343 Rule 17a-11 notices from broker-dealers.
Paragraph (c) of Rule 613 provides that certain requirements are placed upon broker-dealers to record and report CAT information to the central repository in accordance with specified
The Commission recognizes that broker-dealers may insource or outsource CAT data reporting obligations.
After a respondent establishes the appropriate systems and processes required for collection and transmission of the required information, the Commission estimates that Rule 613 imposes ongoing annual burdens associated with, among other things, personnel time to monitor each respondent's reporting of the required data, maintenance of the systems to report the required data, and implementing changes to trading systems that might result in additional reports.
In addition to the hour burdens associated with these rules, there may also be external costs associated with the paperwork burdens imposed by these rules.
Broker-dealers that file consolidated financial reports must obtain an opinion of counsel in accordance with appendix C to Rule 15c3-1.
The Commission estimates that the average ongoing external hardware and software expenses relating to the paperwork burden associated with Rule 15c3-5 would be approximately $20,500 per respondent,
The Commission estimates that the average broker-dealer spends approximately $5,000 each year to store documents required to be retained under Rule 17a-4.
The Commission estimates that Rule 17a-5 causes a broker-dealer to incur an annual dollar cost to meet its reporting obligations. Those requirements that are anticipated to impose an annual cost are discussed below.
The Commission estimates that each of the 12 respondents that may engage in effecting transactions in NMS securities will, on average, incur approximately $450,000 in initial costs for hardware and software to implement the systems changes needed to capture the required information and transmit it to the central repository, an additional $9,500 in initial third party costs, and an additional $250,000 in costs to implement the modified allocation timestamp requirement,
After each respondent has established the appropriate systems and processes, the Commission believes that Rule 613 imposes ongoing annual burdens associated with, among other things, personnel time to monitor each respondent's reporting of the required data, maintenance of the systems to report the required data, and implementing changes to trading systems that might result in additional reports to the central repository.
The Regulatory Flexibility Act (“RFA”) requires Federal agencies, in promulgating rules, to consider the impact of those rules on small entities. Section 603(a) of the Administrative Procedures Act (“APA”),
The Commission received one comment on this certification.
As stated in the Proposing Release, the RFA defines “small entity” to mean “small business,” “small organization,” or “small governmental jurisdiction.”
The final rules would not apply to persons that have or control total assets of less than $50 million.
For the foregoing reasons, the Commission certifies, pursuant to section 605(b), that the final rules will not have a significant economic impact on a substantial number of small entities for purposes of the RFA.
Pursuant to the Congressional Review Act,
If any of the provisions of these final rules, or the application thereof to any person or circumstance, is held to be invalid, such invalidity shall not affect other provisions or application of such provisions to other persons or circumstances that can be given effect without the invalid provision or application.
The Commission is adopting Rules 3a5-4 and 3a44-2 pursuant to authority set forth in sections 3 and 23 of the Exchange Act (15 U.S.C. 78c and 78w).
Securities dealers, Government securities dealers.
For the reasons set out in the preamble, the Commission is amending title 17, chapter II, of the Code of Federal Regulations as follows:
15 U.S.C. 77c, 77d, 77g, 77j, 77s, 77z-2, 77z-3, 77eee, 77ggg, 77nnn, 77sss, 77ttt, 78c, 78c-3, 78c-5, 78d, 78e, 78f, 78g, 78i, 78j, 78j-1, 78j-4, 78k, 78k-1, 78
(a) A person that is engaged in buying and selling securities for its own account is engaged in such activity “as a part of a regular business” as the phrase is used in section 3(a)(5)(B) of the Act (15 U.S.C. 78c(a)(5)(B)) if that person:
(1) Engages in a regular pattern of buying and selling securities that has the effect of providing liquidity to other market participants by:
(i) Regularly expressing trading interest that is at or near the best available prices on both sides of the market for the same security and that is communicated and represented in a way that makes it accessible to other market participants; or
(ii) Earning revenue primarily from capturing bid-ask spreads, by buying at the bid and selling at the offer, or from capturing any incentives offered by trading venues to liquidity-supplying trading interest; and
(2) Is not:
(i) A person that has or controls total assets of less than $50 million;
(ii) An investment company registered under the Investment Company Act of 1940; or
(iii) A central bank, sovereign entity, or international financial institution.
(b) For purposes of this section:
(1) The term
(2) A person's
(i) Held in the name of that person; or
(ii) Held for the benefit of that person.
(3) The term
(4) The term
(5) The term
(c) No person shall evade the registration requirements of this section by:
(1) Engaging in activities indirectly that would satisfy paragraph (a) of this section; or
(2) Disaggregating accounts.
(d) No presumption shall arise that a person is not a dealer within the meaning of section 3(a)(5) of the Act solely because that person does not satisfy paragraph (a) of this section.
(a) A person that is engaged in buying and selling government securities for its own account is engaged in such activity “as a part of a regular business” as the phrase is used in section 3(a)(44)(A) of the Act (15 U.S.C. 78c(a)(44)(A)) if that person:
(1) Engages in a regular pattern of buying and selling government securities that has the effect of providing liquidity to other market participants by:
(i) Regularly expressing trading interest that is at or near the best available prices on both sides of the market for the same security and that is communicated and represented in a way that makes it accessible to other market participants; or
(ii) Earning revenue primarily from capturing bid-ask spreads, by buying at the bid and selling at the offer, or from capturing any incentives offered by trading venues to liquidity-supplying trading interest; and
(2) Is not:
(i) A person that has or controls total assets of less than $50 million; or
(ii) An investment company registered under the Investment Company Act of 1940; or
(iii) A central bank, sovereign entity, or international financial institution.
(b) For purposes of this section:
(1) The term
(2) A person's
(i) Held in the name of that person; or
(ii) Held for the benefit of that person.
(3) The term
(4) The term
(5) The term
(c) No person shall evade the registration requirements of this section by:
(1) Engaging in activities indirectly that would satisfy paragraph (a) of this section; or
(2) Disaggregating accounts.
(d) No presumption shall arise that a person is not a government securities dealer within the meaning of section 3(a)(44) of the Act (15 U.S.C. 78c(a)(44)) solely because that person does not satisfy paragraph (a) of this section.
By the Commission.