Agricultural Marketing Service
Foreign Agricultural Service
Forest Service
Census Bureau
Industry and Security Bureau
National Oceanic and Atmospheric Administration
Federal Energy Regulatory Commission
National Nuclear Security Administration
Centers for Medicare & Medicaid Services
Food and Drug Administration
Health Resources and Services Administration
National Institutes of Health
Coast Guard
Land Management Bureau
National Park Service
Drug Enforcement Administration
Workers Compensation Programs Office
Copyright Royalty Board
Federal Aviation Administration
Maritime Administration
National Highway Traffic Safety Administration
Foreign Assets Control Office
Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, and notice of recently enacted public laws.
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Agricultural Marketing Service, USDA.
Final rule.
This final rule revises size requirements for Irish potatoes grown in certain designated counties of Idaho, and Malheur County, Oregon. The Idaho-Eastern Oregon Potato Committee (Committee) recommended this action to improve the handling and marketing of Idaho-Eastern Oregon potatoes and increase returns to producers.
Effective October 13, 2021.
Gregory A. Breasher, Marketing Specialist, or Gary D. Olson, Regional Manager, Northwest Marketing Field Office, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA; Telephone: (503) 326-2054, Fax: (503) 326-7440, or Email:
Small businesses may request information on complying with this regulation by contacting Richard Lower, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA, 1400 Independence Avenue SW, STOP 0237, Washington, DC 20250-0237; Telephone: (202) 720-2491, or Email:
This action, pursuant to 5 U.S.C. 553, amends regulations issued to carry out a marketing order as defined in 7 CFR 900.2(j). This final rule is issued under Marketing Agreement and Marketing Order No. 945, both as amended (7 CFR part 945), regulating the handling of Irish potatoes grown in certain designated counties in Idaho, and Malheur County, Oregon. Part 945 (referred to as the “Order”) is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.” The Committee locally administers the Order and is comprised of potato producers and handlers operating within the production area.
The Department of Agriculture (USDA) is issuing this final rule in conformance with Executive Orders 12866 and 13563. Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. This action falls within a category of regulatory actions that the Office of Management and Budget (OMB) exempted from Executive Order 12866 review.
This final rule has been reviewed under Executive Order 13175—Consultation and Coordination with Indian Tribal Governments, which requires agencies to consider whether their rulemaking actions would have tribal implications. The Agricultural Marketing Service (AMS) has determined that this final rule is unlikely to have substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.
This final rule has been reviewed under Executive Order 12988, Civil Justice Reform. This final rule is not intended to have retroactive effect.
The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 608c(15)(A) of the Act, any handler subject to an order may file with USDA a petition stating that the order, any provision of the order, or any obligation imposed in connection with the order is not in accordance with law and request a modification of the order or to be exempted therefrom. A handler is afforded the opportunity for a hearing on the petition. After the hearing, USDA would rule on the petition. The Act provides that the district court of the United States in any district in which the handler is an inhabitant, or has his or her principal place of business, has jurisdiction to review USDA's ruling on the petition, provided an action is filed not later than 20 days after the date of the entry of the ruling.
Under terms of the Order, fresh market shipments of Idaho-Eastern Oregon potatoes are required to be inspected and are subject to minimum grade, size, quality, maturity, pack, and container requirements. This rule revises provisions of previously established size requirements for potatoes handled under the Order.
At its meeting on August 6, 2020, the Committee unanimously recommended revising the Order's size requirements to allow shipment of Size B, U.S. No. 2 or better grade, non-Russet type potatoes. Sections 945.51 and 945.52 of the Order provide authority for the establishment and modification of grade, size, quality, and maturity regulations applicable to the handling of potatoes.
Section 945.341 of the Order establishes minimum grade, size, quality, maturity, pack, and container requirements for potatoes handled subject to the Order. The Order's handling regulations currently require that U.S. No. 2 or better grade, non-Russet type potatoes meet a minimum size of 1
This rule relaxes size requirements to allow handlers to ship Size B (1
Committee members reported that the Idaho-Eastern Oregon potato industry has been producing and shipping an increasing number of non-Russet potato varieties—yellow and red skinned, round types, in particular. Institutional customers have indicated that they
The Committee believes that potato size is a significant consideration for potato buyers. Providing potato buyers with the size and grade of potato desired by their customers is important to promoting potato sales. The Committee believes that size requirements intended to facilitate orderly marketing should not unintentionally inhibit a market segment, even if that segment is a minor one. Modifying size requirements to meet needs of potato buyers will facilitate the growth of the emerging market for small profile, non-Russet potato varieties. This change is expected to improve the marketing of Idaho-Eastern Oregon potatoes and enhance overall returns to handlers and producers.
Pursuant to requirements set forth in the Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612), AMS has considered the economic impact of this final rule on small entities. Accordingly, AMS has prepared this final regulatory flexibility analysis.
The purpose of the RFA is to fit regulatory actions to the scale of businesses subject to such actions in order that small businesses will not be unduly or disproportionately burdened. Marketing orders issued pursuant to the Act, and rules issued thereunder, are unique in that they are brought about through group action of essentially small entities acting on their own behalf. Import regulations issued under the Act are based on those established under Federal marketing orders.
There are approximately 32 handlers of Idaho-Eastern Oregon potatoes who are subject to regulation under the Order and about 450 potato producers in the regulated area. Small agricultural service firms, which include potato handlers, are defined by the Small Business Administration (SBA) as those having annual receipts of less than $30,000,000, and small agricultural producers are defined as those whose annual receipts are less than $1,000,000 (13 CFR 121.201).
During the 2019-2020 fiscal period, the most recent full year of statistics available, 34,306,700 hundredweight of Idaho-Eastern Oregon potatoes were inspected as required by the Order and sold into the fresh market. Based on information provided by the National Agricultural Statistics Service (NASS), the average producer price for the 2019 Idaho potato crop (the most recent full marketing year recorded) was $8.41 per hundredweight. Multiplying $8.41 by the shipment quantity of 34,306,700 hundredweight yields an annual crop revenue estimate of $288,519,347. The average annual fresh potato revenue for each of the 450 producers is therefore calculated to be $641,154 ($288,519,347 divided by 450), which is less than the SBA threshold of $1,000,000. Consequently, on average and assuming a normal distribution, most Idaho-Eastern Oregon potato producers may be classified as small entities.
In addition, based on information reported by USDA's Market News Service (Market News), the average Free-On-Board shipping point price for the 2019-2020 Idaho potato crop was $11.90 per hundredweight. Multiplying $11.90 by the shipment quantity of 34,306,700 hundredweight yields an annual crop revenue estimate of $408,249,730. The average annual fresh potato revenue for each of the 32 handlers is therefore calculated to be $12,757,804 ($408,249,730 divided by 32), which is below the SBA threshold of $30,000,000 for agricultural service firms. Therefore, assuming a normal distribution, it has been concluded that most Idaho-Eastern Oregon potato handlers may be classified as small entities.
This final rule revises size requirements for non-Russet type potatoes handled under the Order. Specifically, this action relaxes size requirements to allow shipment of non-Russet type, U.S. No. 2 or better grade, Size B potatoes. All other provisions of handling regulations will remain the same.
This action was recommended by the Committee to ensure that consumers are able to purchase the size and grade of potatoes that they prefer and are familiar with. This change is expected to improve the marketability of Idaho-Eastern Oregon potatoes and increase returns to handlers and producers. Authority for this rule is provided in §§ 945.51 and 945.52 of the Order.
At the August 6, 2020, meeting, the Committee discussed the impact of this change on handlers and producers. The change to size requirements is a relaxation in regulation. The regulatory change is expected to have a neutral to positive economic impact on industry participants.
The Committee relied on opinions of producers and handlers familiar with the industry to draw its conclusions regarding the recommended change in handling regulations. The Committee received anecdotal evidence from industry members at the August 6, 2020, meeting that customers were already familiar with the Size B potato profile and the U.S. No. 2 grade standards. Allowing industry members to pack and ship such potatoes will help them to move what has traditionally been a difficult size profile to market.
The Committee believes that this change will increase the quantity of potatoes in the Size B profile that are available to the fresh market, potentially increasing producer and handler revenues. Benefits derived from this rule change are not expected to be disproportionately more or less for small handlers or producers than for larger entities.
The Committee discussed alternatives to this change. One consideration was making no change at all to the current requirements. Another alternative was to further differentiate between various varieties and types of potatoes in handling regulations. The Committee also discussed further relaxing handling regulations to allow shipment of U.S. No. 2 or better grade, Creamer size, non-Russet type potatoes in addition to its recommendation for Size B potatoes. After consideration of all alternatives, the Committee believed that changes contained herein provide the greatest benefit to producers and handlers while maintaining the integrity of the Order.
The Committee's meeting was widely publicized throughout the potato industry, and all interested persons were invited to attend the meeting and participate in Committee deliberations. Like all Committee meetings, the August 6, 2020, meeting was a public meeting and all entities, both large and small, were able to express their views on this issue. Finally, interested persons were invited to submit comments on the proposed rule, including regulatory and information-collection impacts of this action on small businesses.
In accordance with the Paperwork Reduction Act of 1995, (44 U.S.C. Chapter 35), the Order's information collection requirements have been previously approved by OMB and assigned OMB No. 0581-0178, Vegetable and Specialty Crops. No changes are necessary in these requirements as a result of this action. Should any changes become necessary, they would be submitted to OMB for approval.
This final rule does not impose any additional reporting or recordkeeping requirements on either small or large potato handlers. As with all Federal
AMS is committed to complying with the E-Government Act, to promote the use of the internet and other information technologies to provide increased opportunities for citizen access to Government information and services.
A proposed rule concerning this action was published in the
A small business guide on complying with fruit, vegetable, and specialty crop marketing agreements and orders may be viewed at:
After consideration of all relevant material presented, including the information and recommendation submitted by the Committee and other available information, it was found that this rule effectuates the declared policy of the Act.
Marketing agreements, Potatoes, Reporting and recordkeeping requirements.
For reasons set forth above, 7 CFR part 945 is amended as follows:
7 U.S.C. 601-674.
(a) * * *
(2) * * *
(i)
(B) Size B (1
(ii)
(B) Size B (1
(iii)
U.S. Citizenship and Immigration Services (USCIS), Department of Homeland Security (DHS).
Final rule; technical amendment.
On January 17, 2017, DHS published a final rule with new regulatory provisions guiding the use of parole on a case-by-case basis with respect to entrepreneurs of start-up entities who can demonstrate through evidence of substantial and demonstrated potential for rapid business growth and job creation that they would provide a significant public benefit to the United States. The 2017 regulation provided that the investment and revenue amount requirements would automatically adjust every three years by the Consumer Price Index for All Urban Consumers (CPI-U). DHS is issuing this rule to inform the public of the increased amounts that will take effect at the start of Fiscal Year 2022 and to revise the regulations to accurately reflect the updated investment amounts.
This final rule is effective on October 1, 2021.
For technical questions only: Charles L. Nimick, Chief, Business and Foreign Workers Division, Office of Policy and Strategy, U.S. Citizenship and Immigration Services, Department of Homeland Security, 5900 Capital Gateway Drive, Camp Springs, MD 20588-0009, telephone (240) 721-3000 (this is not a toll-free number). Individuals with hearing or speech impairments may access the telephone number above via TTY by calling the toll-free Federal Information Relay Service at 1-877-889-5627 (TTY/TDD).
On January 17, 2017, the Department of Homeland Security (DHS) published a final rule with new regulatory provisions guiding the use of parole on a case-by-case basis with respect to entrepreneurs of start-up entities. These entrepreneurs would be eligible for consideration of parole if they could demonstrate a significant public benefit to the United States through substantial and demonstrated potential for rapid business growth and job creation.
On July 11, 2017, DHS published a rule delaying the effective date to March 14, 2018.
The regulatory provisions established by the January 17, 2017 rule, which were implemented after the delay rule was vacated on December 1, 2017,
The automatic adjustment required by 8 CFR 212.19(l) affects the amounts stated in 8 CFR 212.19(a)(5) (no less than $600,000 in aggregate investments by the qualifying investor and at least $500,000 in revenue by at least two entities), (b)(2)(ii)(B) (at least $250,000 in investments or at least $100,000 in government awards or grants), and (c)(2)(ii)(B) (at least $500,000 in additional investment or revenue). DHS has calculated the new investment and revenue amounts and revised the applicable provisions in this final rule.
• Received at least $528,293 in qualifying investments, qualified government grants or awards, or a combination of such funding, during the initial parole period;
• Created at least 5 qualified jobs with the start-up entity during the initial parole period; or
• Reached at least $528,293 in annual revenue in the United States and averaged 20 percent in annual revenue growth during the initial parole period.
In the alternative, an applicant who partially meets one or more of the criteria in paragraph (c)(2)(ii)(B) of this section may still qualify for consideration by providing other reliable and compelling evidence of the start-up entity's substantial potential for rapid growth and job creation. Finally, revised 8 CFR 212.19(a)(5) defines a qualified investor as an individual or investor who, among other requirements, has made investments in start-up entities comprising a total of no less than $633,952 in a 5-year period and at least two of those entities created at least 5 jobs or generated at least $528,293 in revenue with an average annualized revenue growth of at least 20 percent.
The revised amounts in this final rule are also posted on the USCIS website
Under the Administrative Procedure Act (5 U.S.C. 553(b)), an agency may waive the normal notice and comment requirements if it finds, for good cause, that they are impracticable, unnecessary, or contrary to the public interest. The final rule merely updates the investment and revenue amounts to account for inflation consistent with the regulatory requirement at 8 CFR 212.19(l) providing that these amounts will automatically adjust every three years by the Consumer Price Index. This amendment is a technical change to ensure that the regulation accurately reflects these updated investment amounts, automatically adjusted for inflation, and avoids potential confusion for applicants and other interested parties regarding the applicable investment amounts under 8 CFR 212.19. Therefore, notice and comment for this rule is unnecessary and contrary to the public interest because the rule has no substantive impact and is simply a ministerial update to the regulations. For the same reasons, pursuant to 5 U.S.C. 553(d)(3), a delayed effective date is not required.
The Regulatory Flexibility Act (RFA) (5 U.S.C. 603(b)), as amended by the Small Business Regulatory Enforcement and Fairness Act of 1996 (SBREFA), requires an agency to prepare and make available to the public a regulatory flexibility analysis that describes the effect of a proposed rule on small entities (
The Unfunded Mandates Reform Act of 1995 (UMRA) is intended, among other things, to curb the practice of imposing unfunded Federal mandates on State, local, and tribal governments. Title II of UMRA requires each Federal agency to prepare a written statement assessing the effects of any Federal mandate in a proposed or final agency rule that may directly result in a $100 million or more expenditure (adjusted annually for inflation) in any one year by State, local, and tribal governments, in the aggregate, or by the private sector. The inflation-adjusted value of $100 million in 1995 is approximately $170 million in 2020 based on the Consumer Price Index for All Urban Consumers (CPI-U).
This action does not require review by the Office of Management and Budget (OMB) under Executive Orders 12866 and 13563. As previously discussed, DHS has the authority to adjust the investment and revenue amount requirements according to the CPI-U.
The population that may be affected by this rule are the applicants that file for Form I-941, Application for Entrepreneur Parole, after this rule becomes effective. Table A presents the historical annual receipts for Form I-941 received for Fiscal Years 2018 through 2021. During this period, 41 total Form I-941 applications have been filed with USCIS, and DHS estimates that an annual average of 11 Form I-941 applications were received by USCIS.
The rule 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. Therefore, in accordance with section 6 of Executive Order 13132, DHS has determined that this final rule does not have sufficient federalism implications to warrant the preparation of a federalism summary impact statement.
This rule meets the applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 12988.
Under the Paperwork Reduction Act of 1995 (PRA), 44 U.S.C. 3501-3512, DHS must submit to the Office of Management and Budget (OMB) for review and approval, any reporting requirements inherent in a rule, unless they are exempt. This final rule will revise USCIS Form I-941. The information collected through the I-941 is used by USCIS to assist in determining if an applicant is eligible for discretionary grant of parole under 8 CFR 212.19. As provided under 5 CFR 1320.13, USCIS is requesting emergency processing for this collection of information as specified in the Paperwork Reduction Act and its implementing regulations. USCIS certifies that the requirements of 5 CFR 1320.13(a) are met and that:
• The collection of information is needed immediately and is essential to the mission of the agency.
• The use of normal clearance procedures is reasonably likely to prevent or disrupt the collection of information.
(1)
(2)
(3)
(4)
(5)
(6)
(7)
Administrative practice and procedure, Aliens, Immigration, Passports and visas, Reporting and recordkeeping requirements.
For the reasons stated in the preamble, DHS amends part 212 of title 8 of the Code of Federal Regulations (8 CFR part 212) as set forth below.
6 U.S.C. 111, 202(4) and 271; 8 U.S.C. 1101 and note, 1102, 1103, 1182 and note, 1184, 1187, 1223, 1225, 1226, 1227, 1255, 1359; section 7209 of Pub. L. 108-458 (8 U.S.C. 1185 note); Title VII of Pub. L. 110-229 (8 U.S.C. 1185 note); 8 CFR part 2; Pub. L. 115-218.
(a) * * *
(5) * * *
(i) The individual or organization made investments in start-up entities in exchange for equity, convertible debt, or other security convertible into equity
(ii) Subsequent to such investment by such individual or organization, at least 2 such entities each created at least 5 qualified jobs or generated at least $528,293 in revenue with average annualized revenue growth of at least 20 percent.
(b) * * *
(2) * * *
(ii) * * *
(B) * * *
(
(
(c) * * *
(2) * * *
(ii) * * *
(B) * * *
(
(
Federal Aviation Administration (FAA), DOT.
Final rule.
This action revokes the Class E extending upward from 700 feet above the surface at Peebles, OH; and amends the Class E airspace extending upward from 700 feet above the surface at Alexander Salamon Airport, West Union, OH. This action is the result of airspace reviews caused by the decommissioning of the West Union non-federal non-directional beacon (NDB). The geographic coordinates of the Alexander Salamon Airport are also being updated to coincide with the FAA's aeronautical database.
Effective 0901 UTC, December 2, 2021. The Director of the Federal Register approves this incorporation by reference action under 1 CFR part 51, subject to the annual revision of FAA Order 7400.11 and publication of conforming amendments.
FAA Order 7400.11E, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at
Jeffrey Claypool, Federal Aviation Administration, Operations Support Group, Central Service Center, 10101 Hillwood Parkway, Fort Worth, TX 76177; telephone (817) 222-5711.
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 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 revokes the Class E extending upward from 700 feet above the surface at Peebles, OH; and amends the Class E airspace extending upward from 700 feet above the surface at Alexander Salamon Airport, West Union, OH, to support instrument flight rule operations at these airports.
The FAA published a notice of proposed rulemaking (NPRM) in the
Class E airspace designations are published in paragraph 6005 of FAA Order 7400.11E, dated July 21, 2020, and effective September 15, 2020, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in the order.
This document amends FAA Order 7400.11E, Airspace Designations and Reporting Points, dated July 21, 2020, and effective September 15, 2020. FAA Order 7400.11E is publicly available as listed in the
This amendment to 14 CFR part 71:
Revokes the Class E airspace extending upward from 700 feet above the surface at Peebles, OH;
And amends the Class E airspace extending upward from 700 feet above the surface to within a 6.4-mile (decreased from a 7.7-mile) radius of Alexander Salamon Airport, West Union, OH; removes the name associated with the airport to comply with changes to FAA Order 7400.2N, Procedures for Handling Airspace Matters; and updates the geographic coordinates of the airport to coincide with the FAA's aeronautical database.
This action is due to airspace reviews caused by the decommissioning of the West Union non-federal NDB, and the closure of the airport and cancellation of the instrument procedures at Peebles, OH.
FAA Order 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current, is non-controversial and unlikely to result in adverse or negative comments. It, therefore: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures,” paragraph 5-6.5.a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.
Airspace, Incorporation by reference, Navigation (air).
In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:
49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
That airspace extending upward from 700 feet above the surface within a 6.4-mile radius of the Alexander Salamon Airport.
Federal Aviation Administration (FAA), DOT.
Final rule.
This action amends Class E airspace extending upward from 700 feet above the surface for Courtland Airport, Courtland, AL, by amending the name and geographical coordinates of Courtland Airport (formerly Industrial Airpark Airport).
Effective 0901 UTC, December 2, 2021. The Director of the Federal Register approves this incorporation by reference action under 1 CFR part 51, subject to the annual revision of FAA Order 7400.11 and publication of conforming amendments.
FAA Order 7400.11E, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at
John Fornito, Operations Support Group, Eastern Service Center, Federal Aviation Administration, 1701 Columbia Ave., College Park, GA 30337; Telephone (404) 305-6364.
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 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 amends the Class E airspace extending upward from 700 feet above the surface in Courtland, AL, to support IFR operations in the area.
The FAA published a notice of proposed rulemaking in the
Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.
Class E airspace designations are published in Paragraph 6005 of FAA Order 7400.11E, dated July 21, 2020, and effective September 15, 2020, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.
This document amends FAA Order 7400.11E, Airspace Designations and Reporting Points, dated July 21, 2020, and effective September 15, 2020. FAA Order 7400.11E is publicly available as listed in the
The FAA is amending 14 CFR part 71 by amending the Class E airspace extending upward from 700 feet above the surface at Courtland Airport, Courtland, AL, by updating the airport's name and geographical coordinates. In addition, the reference to Muscle Shoals Airport would be removed from the description, in compliance with (FAA Order 7400.2M).
FAA Order 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures,” paragraph 5-6.5a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.
Airspace, Incorporation by reference, Navigation (air)
In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:
49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
That airspace extending upward from 700 feet above the surface within a 6.5-mile radius of Courtland Airport.
Federal Aviation Administration (FAA), DOT.
Final rule.
This rule amends, suspends, or removes Standard Instrument Approach Procedures (SIAPs) and associated Takeoff Minimums and Obstacle Departure Procedures for operations at certain airports. These regulatory actions are needed because of the adoption of new or revised criteria, or because of changes occurring in the National Airspace System, such as the commissioning of new navigational facilities, adding new obstacles, or changing air traffic requirements. These changes are designed to provide for the safe and efficient use of the navigable airspace and to promote safe flight operations under instrument flight rules at the affected airports.
This rule is effective September 13, 2021. The compliance date for each SIAP, associated Takeoff Minimums, and ODP is specified in the amendatory provisions.
The incorporation by reference of certain publications listed in the regulations is approved by the Director of the Federal Register as of September 13, 2021.
Availability of matter incorporated by reference in the amendment is as follows:
1. U.S. Department of Transportation, Docket Ops-M30, 1200 New Jersey Avenue SE, West Bldg., Ground Floor, Washington, DC 20590-0001;
2. The FAA Air Traffic Organization Service Area in which the affected airport is located;
3. The office of Aeronautical Information Services, 6500 South MacArthur Blvd., Oklahoma City, OK 73169 or,
4. The National Archives and Records Administration (NARA).
For information on the availability of this material at NARA, email
All SIAPs and Takeoff Minimums and ODPs are available online free of charge. Visit the National Flight Data Center online at
Thomas J. Nichols, Flight Procedures and Airspace Group, Flight Technologies and Procedures Division, Flight Standards Service, Federal Aviation Administration. Mailing Address: FAA Mike Monroney Aeronautical Center, Flight Procedures and Airspace Group, 6500 South MacArthur Blvd., Registry Bldg. 29, Room 104, Oklahoma City, OK 73169. Telephone: (405) 954-4164.
This rule amends 14 CFR part 97 by amending the referenced SIAPs. The complete regulatory description of each SIAP is listed on the appropriate FAA Form 8260, as modified by the National Flight Data Center (NFDC)/Permanent Notice to Airmen (P-NOTAM), and is incorporated by reference under 5 U.S.C. 552(a), 1 CFR part 51, and 14 CFR 97.20. The large number of SIAPs, their complex nature, and the need for a special format make their verbatim publication in the
The material incorporated by reference is publicly available as listed in the
The material incorporated by reference describes SIAPs, Takeoff Minimums and ODPs as identified in the amendatory language for part 97 of this final rule.
This amendment to 14 CFR part 97 is effective upon publication of each separate SIAP and Takeoff Minimums and ODP as amended in the transmittal. For safety and timeliness of change considerations, this amendment incorporates only specific changes contained for each SIAP and Takeoff Minimums and ODP as modified by FDC permanent NOTAMs.
The SIAPs and Takeoff Minimums and ODPs, as modified by FDC permanent NOTAM, and contained in this amendment are based on criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these changes to SIAPs and Takeoff Minimums and ODPs, the TERPS criteria were applied only to specific conditions existing at the affected airports. All SIAP amendments in this rule have been previously issued by the FAA in a FDC NOTAM as an emergency action of immediate flight safety relating directly to published aeronautical charts.
The circumstances that created the need for these SIAP and Takeoff Minimums and ODP amendments require making them effective in less than 30 days.
Because of the close and immediate relationship between these SIAPs, Takeoff Minimums and ODPs, and safety in air commerce, I find that notice and public procedure under 5 U.S.C. 553(b) are impracticable and contrary to the public interest and, where applicable, under 5 U.S.C. 553(d), good cause exists for making these SIAPs effective in less than 30 days.
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore—(1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air Traffic Control, Airports, Incorporation by reference, Navigation (Air).
Accordingly, pursuant to the authority delegated to me, Title 14, CFR part 97, (is amended by amending Standard Instrument Approach Procedures and Takeoff Minimums and ODPs, effective at 0901 UTC on the dates specified, as follows:
49 U.S.C. 106(f), 106(g), 40103, 40106, 40113, 40114, 40120, 44502, 44514, 44701, 44719, 44721-44722.
By amending: § 97.23 VOR, VOR/DME, VOR or TACAN, and VOR/DME or TACAN; § 97.25 LOC, LOC/DME, LDA, LDA/DME, SDF, SDF/DME; § 97.27 NDB, NDB/DME; § 97.29 ILS, ILS/DME, MLS, MLS/DME, MLS/RNAV; § 97.31 RADAR SIAPs; § 97.33 RNAV SIAPs; and § 97.35 COPTER SIAPs, Identified as follows:
Federal Aviation Administration (FAA), DOT.
Final rule.
This rule establishes, amends, suspends, or removes Standard Instrument Approach Procedures (SIAPS) and associated Takeoff Minimums and Obstacle Departure procedures (ODPs) for operations at certain airports. These regulatory actions are needed because of the adoption of new or revised criteria, or because of changes occurring in the National Airspace System, such as the commissioning of new navigational facilities, adding new obstacles, or changing air traffic requirements. These changes are designed to provide safe and efficient use of the navigable airspace and to promote safe flight operations under instrument flight rules at the affected airports.
This rule is effective September 13, 2021. The compliance date for each SIAP, associated Takeoff Minimums, and ODP is specified in the amendatory provisions. The incorporation by reference of certain publications listed in the regulations is approved by the Director of the Federal Register as of September 13, 2021.
Availability of matters incorporated by reference in the amendment is as follows:
1. U.S. Department of Transportation, Docket Ops-M30. 1200 New Jersey Avenue SE, West Bldg., Ground Floor, Washington, DC 20590-0001;
2. The FAA Air Traffic Organization Service Area in which the affected airport is located;
3. The office of Aeronautical Information Services, 6500 South MacArthur Blvd., Oklahoma City, OK 73169; or
4. The National Archives and Records Administration (NARA). For information on the availability of this material at NARA, email
All SIAPs and Takeoff Minimums and ODPs are available online free of charge. Visit the National Flight Data Center at
Thomas J. Nichols, Flight Procedures and Airspace Group, Flight Technologies and Procedures Division, Flight Standards Service, Federal Aviation Administration. Mailing Address: FAA Mike Monroney Aeronautical Center, Flight Procedures and Airspace Group, 6500 South MacArthur Blvd., Registry Bldg. 29, Room 104, Oklahoma City, OK 73169. Telephone (405) 954-4164.
This rule amends 14 CFR part 97 by establishing, amending, suspending, or removes SIAPS, Takeoff Minimums and/or ODPS. The complete regulatory description of each SIAP and its associated Takeoff Minimums or ODP for an identified airport is listed on FAA form documents which are incorporated by reference in this amendment under 5 U.S.C. 552(a), 1 CFR part 51, and 14 CFR part 97.20. The applicable FAA Forms 8260-3, 8260-4, 8260-5, 8260-15A, 8260-15B, when required by an entry on 8260-15A, and 8260-15C.
The large number of SIAPs, Takeoff Minimums and ODPs, their complex nature, and the need for a special format make publication in the
The material incorporated by reference is publicly available as listed in the
The material incorporated by reference describes SIAPS, Takeoff Minimums and/or ODPs as identified in the amendatory language for part 97 of this final rule.
This amendment to 14 CFR part 97 is effective upon publication of each separate SIAP, Takeoff Minimums and ODP as amended in the transmittal. Some SIAP and Takeoff Minimums and textual ODP amendments may have been issued previously by the FAA in a Flight Data Center (FDC) Notice to Airmen (NOTAM) as an emergency action of immediate flights safety relating directly to published aeronautical charts.
The circumstances that created the need for some SIAP and Takeoff Minimums and ODP amendments may require making them effective in less than 30 days. For the remaining SIAPs and Takeoff Minimums and ODPs, an effective date at least 30 days after publication is provided.
Further, the SIAPs and Takeoff Minimums and ODPs contained in this amendment are based on the criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these SIAPs and Takeoff Minimums and ODPs, the TERPS criteria were applied to the conditions existing or anticipated at the affected airports. Because of the close and immediate relationship between these SIAPs, Takeoff Minimums and ODPs, and safety in air commerce, I find that notice and public procedure under 5 U.S.C. 553(b) are impracticable and contrary to the public interest and, where applicable, under 5 U.S.C. 553(d), good cause exists for making some SIAPs effective in less than 30 days.
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore—(1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air Traffic Control, Airports, Incorporation by reference, Navigation (Air).
Accordingly, pursuant to the authority delegated to me, Title 14, Code of Federal Regulations, Part 97 (14 CFR part 97) is amended by establishing, amending, suspending, or removing Standard Instrument Approach Procedures and/or Takeoff Minimums and Obstacle Departure Procedures effective at 0901 UTC on the dates specified, as follows:
49 U.S.C. 106(f), 106(g), 40103, 40106, 40113, 40114, 40120, 44502, 44514, 44701, 44719, 44721-44722.
Federal Trade Commission.
Final rule.
The Federal Trade Commission (“FTC” or “Commission”) is issuing a final rule (“Final Rule”) to amend its Prescreen Opt-Out Notice Rule to correspond to changes made to the Fair Credit Reporting Act (“FCRA”) by the Dodd-Frank Act and to reinstate and amend a model prescreen opt-out notice.
This rule is effective October 13, 2021.
David Lincicum (202-326-2773), Division of Privacy and Identity Protection, Bureau of Consumer Protection, Federal Trade Commission, 600 Pennsylvania Avenue NW, Washington, DC 20580.
Section 615(d) of the FCRA
The Fair and Accurate Credit Transactions Act of 2003 (“FACT Act”) was signed into law on December 4, 2003. Public Law 108-159, 117 Stat. 1952. Section 213(a) of the FACT Act amended FCRA section 615(d) to require that the statement mandated by section 615(d) “be presented in such format and in such type size and manner as to be simple and easy to understand, as established by the Commission, by rule, in consultation with the Federal banking agencies and the National Credit Union Administration.” On August 1, 2005, the FTC issued its Prescreen Opt-Out Notice Rule.
The Dodd-Frank Wall Street Reform and Consumer Protection Act (“Dodd-Frank Act”) was signed into law in 2010.
On May 22, 2019, the FTC rescinded several FCRA model notices and forms that were no longer necessary due to the Dodd-Frank Act's change to its rulemaking authority.
On September 21, 2020, the Commission solicited comments on the Prescreen Opt-Out Notice Rule. The Commission sought information about the costs and benefits of the Rule, and its regulatory and economic impact. In addition, the Commission proposed amending sections 642.1 and 642.2 to narrow the scope of the Rule to motor vehicle dealers excluded from CFPB jurisdiction as described in the Dodd-Frank Act and reinstating the Prescreen Opt-Out Notice Rule model notice. The Commission received two comments concerning the Rule.
The Commission promulgated the Prescreen Opt-Out Notice Rule at a time when it had rulemaking authority for a broader group of consumer report users. While the Dodd-Frank Act did not change the Commission's enforcement authority for the Prescreen Opt-Out Notice Rule, it did narrow the Commission's rulemaking authority with respect to the Rule. It now covers only motor vehicle dealers.
The amendment to section 642.1 narrows the scope of the Prescreen Opt-Out Notice Rule to those entities set forth in the Dodd-Frank Act that are predominantly engaged in the sale and servicing of motor vehicles, excluding those dealers that directly extend credit to consumers and do not routinely assign the extensions of credit to an unaffiliated third party.
The amendment to section 642.2 adds a definition of “motor vehicle dealer” that defines motor vehicle dealers as entities excluded from CFPB jurisdiction as described in the Dodd-Frank Act.
The amendments also reinstate the model prescreen opt-out notice that was rescinded in 2019 on the basis that motor vehicle dealers could use the CFPB-provided model form.
The South Carolina Department of Consumer Affairs (the “Department”) stated that there is a continuing need for the Prescreen Opt-Out Notice Rule and it benefits consumers by informing them their information has been shared for a prescreen offer and educating them of their rights to opt out of such offers.
Under the Paperwork Reduction Act of 1995 (PRA),
The Final Rule amends 16 CFR part 642 and 698. The Rule does not contain information collection requirements as defined by the PRA. The rule requires certain motor vehicle dealers using consumer report to provide consumers with opt-out notices and the amendments include a model notice that motor vehicle dealers may use. The public disclosure of information originally supplied by the Federal Government for the purpose of disclosure to the public is not included within the definition of the collection of information.
The Regulatory Flexibility Act (“RFA”), as amended by the Small Business Regulatory Enforcement Fairness Act of 1996, requires an agency to either provide an Initial Regulatory Flexibility Analysis (“IRFA”) with a proposed rule, or certify that the proposed rule will not have a significant impact on a substantial number of small entities.
The Commission does not believe that these amendments have the threshold impact on small entities. The amendments effectuate changes to the Dodd-Frank Act and will not impose costs on small motor vehicle dealers because the amendments are for clarification purposes and will not result in any increased burden on any motor vehicle dealer. Thus, a small entity that complies with current law need not take any different or additional action under the Final Rule. Although the Final Rule adopts a slightly revised model notice, motor vehicle dealers are not obligated to use the model notice. Therefore, the Commission certifies that amending the Prescreen Opt-Out Notice Rule will not have a significant economic impact on a substantial number of small businesses.
Although the Commission certifies under the RFA that the Final Rule will not have a significant impact on a substantial number of small entities, and hereby provides notice of that certification to the Small Business Administration, the Commission nonetheless has determined that publishing a final regulatory flexibility analysis (“FRFA”) is appropriate to ensure that the impact of the rule is fully addressed. Therefore, the Commission has prepared the following analysis:
To address the Dodd-Frank Act's changes to the Commission's rulemaking authority, the amendments clarify that the Rule applies only to motor vehicle dealers and reinstate a model form.
The Commission did not receive any comments that addressed the burden on small entities. In addition, the Commission did not receive any comments filed by the Chief Counsel for Advocacy of the Small Business Administration (“SBA”).
The Commission anticipates that many covered motor vehicle dealers may qualify as small businesses according to the applicable SBA size standards. As explained in the IRFA, however, determining a precise estimate of the number of small entities is not readily feasible. No commenters addressed this issue. Nonetheless, as discussed above, these amendments do not add any additional burdens on any covered small businesses.
The amendments impose no new reporting, recordkeeping, or other compliance requirements.
The Commission did not propose any specific small entity exemption or other significant alternatives because the amendments will not increase reporting requirements and will not impose any new requirements or compliance costs.
Pursuant to the Congressional Review Act (5 U.S.C. 801
Consumer protection, Credit, Trade practices.
For the reasons stated above, the Federal Trade Commission amends title 16 of the Code of Federal Regulations as follows:
Pub. L. 108-159, sec. 311; 15 U.S.C. 1681m(d); 12 U.S.C. 5519(d).
(b)
(b)
Any motor vehicle dealer that uses a consumer report on any consumer in connection with any credit or insurance transaction that is not initiated by the consumer, and that is provided to that person under section 604(c)(1)(B) of the FCRA (15 U.S.C. 1681b(c)(1)(B)), shall, with each written solicitation made to the consumer about the transaction, provide the consumer with the following statement, consisting of a short portion and a long portion, which shall be in the same language as the offer of credit or insurance:
12 U.S.C. 5519; 15 U.S.C. 1681m(h); 15 U.S.C. 1681s-3; Sec. 214(b), Pub. L. 108-159.
The model forms and disclosures prescribed by the FTC in this part do not constitute a trade regulation rule. The issuance of the model forms and disclosures set forth in appendices A, B, and C of this part carry out the directive in the statute that the FTC prescribe these forms and disclosures. Use or distribution of the model forms and disclosures in this part will constitute compliance with any section or subsection of the FCRA requiring that such forms and disclosures be used by any motor vehicle dealer subject to the FTC's rulemaking authority.
In order to comply with 16 CFR part 642, the following model notices may be used:
(a)
(2)
(b)
(2)
By direction of the Commission.
Food and Drug Administration, HHS.
Final rule; delay of effective date.
As required by an order issued by the U.S. District Court for the Eastern District of Texas, this action delays the effective date of the final rule (“Tobacco Products; Required Warnings for Cigarette Packages and Advertisements”), which published on March 18, 2020. The new effective date is October 11, 2022.
The effective date of the rule amending 21 CFR part 1141 published March 18, 2020, at 85 FR 15638, and delayed at 85 FR 32293, May 29, 2020; 86 FR 3793, January 15, 2021; and 86 FR 36509, July 12, 2021, is further delayed until October 11, 2022.
Courtney Smith, Office of Regulations, Center for Tobacco Products, Food and Drug Administration, Document Control
In the
On April 3, 2020, the final rule was challenged in the U.S. District Court for the Eastern District of Texas.
To the extent that 5 U.S.C. 553 applies to this action, the Agency's implementation of this action without opportunity for public comment, effective immediately upon publication today in the
Federal Mediation and Conciliation Service (FMCS).
Final rule.
The Federal Mediation and Conciliation Service (FMCS), issues a final rule amending its existing regulations to modify the submission method of information collection request, Notice to Mediation Agency, (Agency Form F-7) and remove the form titled “Notice to Mediation Agencies.”
This final rule is effective September 13, 2021.
Please contact the person identified in the
Arthur Pearlstein, Director, Arbitration, Notice Processing, Shared Neutrals,
Parties to private-sector collective bargaining agreements must file certain notices with the Federal Mediation Conciliation Service pursuant to 29 U.S.C. 158(d)(3). This modification changes the submission process of information collection request, Notice to Mediation Agency (Agency Form F-7), from mail-in to electronic submission. This revision is necessary to increase efficiency of FMCS both by allowing FMCS to receive Agency Form F-7's more quickly, but also to reduce processing time. This will allow the Service to provide its services to the parties more quickly. This modification removes the language which includes the verbiage of the Form-F7, to allow for FMCS to modify the form, if necessary, without necessitating additional rule change.
FMCS' authority to issue rules is found in 29 U.S.C. 172 of Taft Harley Act of 1947. This regulation is within the scope of that authority.
The public comment period on the proposed rule opened on July 22, 2021, the date of its publication in the
Administrative practice and procedure, Information collection requests, Labor management relations.
For the reasons discussed in the preamble, and under the authority 29 U.S.C. 172 of the Taft Hartley Act of 1947, FMCS amends 29 CFR part 1402 as follows:
Sec. 202, 61 Stat. 153, sec. 3, 80 Stat. 250, sec. 203, 61 Stat. 153; 5 U.S.C. 552, 29 U.S.C. 172, 173.
The notice of dispute filed with the Federal Mediation and Conciliation Service pursuant to the provisions of section 8(d)(3), of the Labor-Management Relations Act, 1947, as amended, shall be submitted electronically via a platform provided by FMCS. If electronic submission creates an undue hardship, the filer may contact the FMCS Notice Processing office to explain the circumstances and receive assistance. The Form F-7, for use by the parties in filing a notice of
Coast Guard, DHS.
Notice of enforcement of regulation.
The Coast Guard will enforce special local regulations for the Clearwater Offshore Nationals on September 26, 2021, to provide for the safety of life on navigable waterways during this event. Our regulation for recurring marine events within Sector St. Petersburg identifies the regulated area for this event in Clearwater, FL. During the enforcement periods, the operator of any vessel in the regulated area must comply with directions from the Patrol Commander or any designated representative.
The regulations in 33 CFR 100.703, Table 1 to § 100.703, item 7, will be enforced from 11:30 a.m. until 4 p.m., on September 26, 2021.
If you have questions about this notice of enforcement, call or email Marine Science Technician First Class Michael Shackleford, Sector St. Petersburg Prevention Department, Coast Guard; telephone (813) 228-2191, email
The Coast Guard will enforce the special local regulations in 33 CFR 100.703, Table 1 to § 100.703, item 7, for the Clearwater Offshore Nationals regulated area from 11:30 a.m. to 4 p.m., on September 26, 2021. This action is being taken to provide for the safety of life on navigable waterways during this event. Our regulation for recurring marine events, Sector St. Petersburg, § 100.703, Table 1 to § 100.703, item 7, specifies the location of the regulated area for the Clearwater Offshore Nationals which encompasses portions of the Gulf of Mexico near Clearwater beach. During the enforcement periods, as reflected in § 100.703(c), if you are the operator of a vessel in the regulated area you must comply with directions from the Patrol Commander or any designated representative.
In addition to this notice of enforcement in the
Department of Veterans Affairs.
Final rule.
The Department of Veterans Affairs (VA) adopts as final, with no substantive changes, an interim final rule revising its medical regulations to implement VA's authority under section 102 of the John S. McCain III, Daniel K. Akaka, and Samuel R. Johnson VA Maintaining Internal Systems and Strengthening Integrated Outside Networks Act of 2018 (MISSION Act), which authorizes VA to enter into agreements to furnish required hospital care, medical services, and extended care services in the community when such care and services are not feasibly available to certain individuals through a VA facility, a contract, or a sharing agreement. As specified in section 1703A and this implementing rule, these agreements are called Veterans Care Agreements (VCA).
This rule is effective on October 13, 2021.
Joseph Duran, Office of Community Care (10D), Veterans Health Administration, Department of Veterans Affairs, Ptarmigan at Cherry Creek, Denver, CO 80209; (303) 372-4629. (This is not a toll-free number.)
On June 6, 2018, the President signed into law the John S. McCain III, Daniel K. Akaka, and Samuel R. Johnson VA Maintaining Internal Systems and Strengthening Integrated Outside Networks Act of 2018, Public Law 115-182, 132 Stat. 1393 (2018) (codified as amended in scattered sections of 38 U.S.C.) (MISSION Act). This rule adopts as final, with no substantive changes, an interim final rule revising VA medical regulations to implement section 102 of the MISSION Act (codified as amended at 38 U.S.C. 1703A), which authorizes VA to enter into agreements to furnish required hospital care, medical services, and extended care services in the community when such care and services are not feasibly available to certain individuals through a VA facility, a contract, or a sharing agreement. As specified in section 1703A and this implementing rule, these agreements are called Veterans Care Agreements (VCA).
On May 14, 2019, VA published an interim final rule to establish the parameters of VCAs authorized under section 1703A, to include: Establishing a certification process for entities and providers that will seek to enter into a VCA and furnish care or services pursuant to that agreement; establishing certain parameters governing the payment rates that will be set forth in the terms of each VCA; and establishing an administrative process for adjudicating disputes arising under or related to VCAs, including those pertaining to claims for payment for care or services provided under a VCA. 84 FR 21668. VA received input from eight commenters in response to this interim final rule, only three of which raised issues relevant to the rule. VA's responses to those three commenters are summarized below.
One commenter that represents a membership consisting of long term and post-acute care providers offered four comments that relate to VA's implementation and use of VCAs. The comments do not expressly or impliedly request any changes to the interim final rule, nor do they raise any issues that would necessitate or merit any such changes.
First, the commenter noted that it wants to ensure its members obtain access to information “available at both the regional and national levels” within VA regarding VA's implementation and use of VCAs. Relatedly, the commenter also indicated that it has heard from some of its members that they would like VA to establish one or more points of contact at the “national” level that providers could communicate with directly when they have questions that “regional” VA offices are unable to answer regarding VA's implementation and use of VCAs. We interpret the commenter's references to information made available and points of contact established at the “national” and “regional” levels to constitute references to when such information
In its second comment, the same commenter noted that it wants to ensure that the Centers for Medicare & Medicaid Services (CMS) and VA communicate how CMS' Patient Driven Payment Model (PDPM), which became effective on October 1, 2019, and the VCA reimbursement structures will work together. As it pertains to VA, we interpret this comment as requesting that VA communicate whether and to what extent the rates that VA pays for care and services furnished by nursing facilities pursuant to VCAs are based upon or influenced by CMS' PDPM case-mix classification methodology for calculating Part A payments under Medicare's skilled nursing facility prospective payment system (SNF PPS). As established in § 17.4120 of the interim final rule, that information (
In its third comment, the same commenter indicated that providers might be hesitant to enter into VCAs until the U.S. Department of Labor's Office of Federal Contract Compliance Programs (OFCCP) issues a Notice of Proposed Rulemaking (NPRM) that would revise certain portions of 41 CFR subtitle B, chapter 60 that concern the obligations of TRICARE and certain other health care providers, as federal contractors and/or subcontractors, under the nondiscrimination and affirmative action provisions of Executive Order (E.O.) 11246 (as amended), section 503 of the Rehabilitation Act of 1973 (as amended), and the Vietnam Era Veterans' Readjustment Assistance Act of 1974 (as amended). We interpret this comment as referring to the NPRM subsequently published by OFCCP at 84 FR 59746 (Nov. 6, 2019). That NPRM culminated in a final rule, published by OFCCP at 85 FR 39834 (Jul. 2, 2020), that revised certain definitions set forth in 41 CFR 60-1.3, 60-300.2, and 60-741.2. Given that the rulemaking
In its fourth and final comment, the same commenter stated that it wants to ensure that “services covered under VA contracts will continue to be covered under VCAs.” While the intended meaning of this comment is unclear to us, we note that, in accordance with the statutory authority for VCAs and the interim final rule, VA can use VCAs to obtain “hospital care” (as defined in 38 U.S.C. 1701(5)), “medical services” (as defined 38 U.S.C. 1701(6)), and “extended care services” (defined as the services described in 38 U.S.C. 1710B(a)).
One commenter that represents a membership consisting of hearing health care professionals, including licensed hearing aid specialists, offered several comments in response to the interim final rule. Some of those comments pertain to matters that are outside the scope of this rulemaking and which do not implicate any considerations that would necessitate or merit any changes to the interim final rule. For example, the commenter urged VA to develop and implement the qualifications, which VA is authorized to prescribe pursuant to 38 U.S.C. 7402(b)(14), for hearing aid specialists appointed to positions in VHA in accordance with 38 U.S.C. 7401. The commenter also urged VA to include hearing aid specialists appointed pursuant to 38 U.S.C. 7401 in the audiology teams that operate in VHA facilities. The government personnel matters raised in these comments, including whether and when VA develops qualifications for hearing aid specialists appointed to positions in VHA, and how VA utilizes any such specialists in VHA facilities, are outside the scope of this rulemaking and implicate no issues bearing on the contents of the interim final rule.
The same commenter also urged VA to prioritize delivery of hearing-related health care services to veterans, both in VHA facilities and through “the Community Care Program,” a phrase that we interpret to be a reference to the Veterans Community Care Program (VCCP) established by section 101 of the MISSION Act (codified as amended at 38 U.S.C. 1703). The matters raised in this comment, including whether and to what extent VA can and does prioritize the provision of certain types of hospital care, medical services, and extended care services in VHA facilities or through the VCCP, are matters outside the scope of this rulemaking. Moreover, to the extent the commenter is concerned about VA electing to adopt regulatory parameters that restrict VA's ability to provide hearing-related health care services through VCAs, we note that the interim final rule contains no such elective restrictions. The interim final rule authorizes VA to use VCAs to obtain any of the types of hospital care, medical services, and extended care services permitted by the underlying statutory authority, 38 U.S.C. 1703A.
The commenter also recommended that VA use licensed hearing aid specialists and audiologists to provide hearing aid evaluations, hearing aid fittings, and related services when veterans are receiving such services through “the Community Care Program,” a phrase that, as previously noted, we interpret to be a reference to the VCCP. The matters raised in this comment, including whether and to what extent certain specific types of providers furnish the care and services that VA obtains for covered veterans through the VCCP, are matters outside the scope of this rulemaking. Moreover, to the extent the commenter is concerned about VA electing to adopt regulatory parameters that restrict VA's ability to use VCAs to obtain care and services furnished by licensed hearing aid specialists and audiologists, we note that the interim final rule contains no such elective restrictions. For example, the certification process set forth in § 17.4110 of the interim final rule contains no requirements or approval criteria that would fundamentally preclude VA from granting certification to licensed hearing aid specialists and audiologists or that are any more restrictive with regard to those types of providers than they are for any other type of provider or entity seeking certification.
In addition to providing the general comments described above, the same commenter also suggested two changes to the text of the interim final rule. First, the commenter suggested that VA replace the term “medical” in § 17.4110(b)(1)(i) with the term “health care” so that the licensure documentation requirement in that subparagraph encompasses health care professionals other than physicians. In response, we clarify that the requirement in that subparagraph to provide documentation of “applicable medical licenses” does not preclude health care professionals other than physicians from applying for and receiving certification under § 17.4110. If the applicant does not possess a medical license, then there are no “applicable medical licenses” of which the applicant must submit documentation under that subparagraph. Moreover, we also note that under § 17.4110(b)(1)(ii), VA can require applicants to submit documentation of relevant licenses other than medical licenses. Consequently, because the result apparently sought by the commenter—VA's certification process accommodating the submission of documentation of licenses from health care professionals other than physicians—is already provided for in the existing language of the interim final rule, VA does not adopt the change recommended in this comment. The commenter also indicated that the payment rate parameters set forth in § 17.4120(a)-(b) of the interim final rule, which are expressly tied to Medicare payment models, should be revised to allow for the establishment of fee schedules for services that are not within the scope of those Medicare-related parameters, such as hearing tests for the provision of hearing aids and related hearing aid services. In response, VA notes that the payment rate parameters set forth in § 17.4120 of the interim final rule already permit the very result that the commenter is seeking. Under § 17.4120, the rates paid by VA for hospital care, medical services, or extended care services furnished pursuant to a VCA are the rates set forth in the price terms of that specific VCA, and, when the Medicare-related parameters set forth in § 17.4120(a)-(b) do not apply to the care or services at issue, VA is permitted to establish the payment rates for such care or services based on a fee schedule or some other formulation that is unrelated to Medicare payment rates and methodologies. Given that the result sought by the commenter is already permitted under the existing language of the interim final rule, VA makes no changes based on this comment.
A commenter that operates a psychiatric facility raised multiple issues. First, the commenter noted that veterans often face specialized mental health needs, including “combat related” needs such as those resulting from post-traumatic stress disorder (PTSD) or traumatic brain injury (TBI). In light of VA's specialized experience in those clinical areas, the commenter urged VA to share its knowledge of “combat related illnesses” with mental health providers and indicated that VA should require mental health providers furnishing care pursuant to VCAs to be adequately trained to handle mental health needs that are unique to or more frequently experienced by veterans. In this regard, the commenter specifically recommended that the certification process in § 17.4110 of the interim final rule should require special training in the area of mental health. We interpret this recommendation to mean that such training should be required solely for mental health providers and should pertain to those clinical areas for which VA has special expertise, including PTSD and TBI. In response, we note that VA agrees that it is critical for veterans to receive competent care from qualified non-VA providers and that VA can contribute to that result in certain instances by providing training and/or education to non-VA providers in clinical areas for which VA has special expertise, including PTSD and TBI. In this regard, we note that VA will take a number of actions that will result in the provision of relevant training and education to non-VA providers furnishing care and services authorized pursuant to VCAs. For example, in accordance with section 133 of the MISSION Act (codified at 38 U.S.C. 1701 note), VA established competency standards and requirements, including training requirements, for the provision of care by non-VA providers in clinical areas for which VA has special expertise, including PTSD and TBI. Such requirements apply to providers furnishing care and services pursuant to VCAs. Also, in accordance with section 123 of the MISSION Act (codified at 38 U.S.C. 1701 note), VA established a program to provide continuing medical education to non-VA medical professionals furnishing care to VA beneficiaries, including pursuant to VCAs. Moreover, VA provides appropriate oversight of care and services furnished pursuant to VCAs as VA administers those agreements. For example, VA established and imposed quality standards in accordance with 38 U.S.C. 1703C and monitors and assess the quality of the care and services provided pursuant to VCAs in accordance with 38 U.S.C. 1703A(g). However, adding specific training requirements to the certification process in § 17.4110 through the regulation process, as opposed through the VCA agreements themselves, would not be an appropriate means of establishing such training requirements and ensuring that non-VA providers fulfill the appropriate training requirements prior to furnishing mental health care that VA obtains through VCAs in clinical areas for which VA has special expertise, including PTSD and TBI. Training requirements for mental health providers furnishing care and services pursuant to VCAs may need to be changed over time, potentially quickly in certain instances, for reasons including developments in clinical practice or new legal requirements with which VA must comply. So, establishing training requirements in the terms of VCAs, rather than in the certification process set forth in the final rule resulting from this rulemaking, will ensure VA retains the flexibility to more quickly and efficiently adjust those training requirements as appropriate based on evolving circumstances and requirements. For the foregoing reasons, we do not adopt the commenter's recommendation to add a training requirement to the certification process set forth in § 17.4110 of the interim final rule.
The same commenter also provided recommendations regarding the authority set forth in § 17.4020(d) of the interim final rule, which authorizes VA to establish payment rates exceeding the applicable Medicare-based limitations in § 17.4120(a)-(b) when VA determines that it is not practicable to limit payment to those rates. Specifically, the commenter recommended that the authority to make the determinations referenced in § 17.4120(d) should be delegated to officials at individual VHA medical facilities and should not be subject to an overly burdensome justification and approval process. In response, VA notes that although the authority to generate determinations referenced in § 17.4120(d) of the interim final rule is delegated to officials at individual VHA medical facilities, that authority is circumscribed by a requirement that each such determination must be approved by VHA's national Office of Community Care. This centralized oversight by the Office of Community Care is intended to enhance the effectiveness and integrity of VA's use of VCAs, as well as the entire VCCP, by bringing that office's resources, data, and enterprise-wide view of VCAs and the VCCP to bear in a manner that will promote consistency and quality in how VA interprets and applies the impracticability standard in § 17.4120(d) of the interim final rule and that will ensure VA is appropriately assessing and accounting for the potential impacts, if any, of such determinations on the VCCP more broadly. Consequently, VA does not make any changes to the interim final rule based on these comments.
The same commenter also indicated that the non-VA entities and providers furnishing care pursuant to VCAs need to be adequately compensated on a timely basis for their services. In response, we note that VA agrees with this comment and will work to ensure timely payments for care and services obtained pursuant to VCAs, as required by 38 U.S.C. 1703D. All VCAs contain payment terms that require VA to make payment in accordance with the timeframes required by statute, so it would serve no relevant purpose to add those same payment timeliness requirements to this final rule. Consequently, we do not make any changes to the interim final rule based on this comment.
The same commenter also asserted that VA must develop and partner with a network of dedicated providers and that service-disabled veteran owned small businesses (SDVOSB), veteran owned small businesses (VOSB), and prior VA clinicians should be given priority. The comment indicated that the reasons for recommending that VA prioritize utilization of SDVOSBs and VOSBs include that veterans (which we presume refers to the veteran owners of those businesses) have shared military experience that improves the efficacy of counseling services provided to fellow veterans and that such veteran owners are highly motivated, dedicated, and willing to make sacrifices to help their fellow veterans. As it pertains to the subject matter of this rulemaking, VCAs, we interpret this comment recommending that VA give “priority” to SDVOSBs, VOSBs, and prior VA clinicians to mean that when VA is obtaining needed hospital care, medical services, or extended care services for a veteran through a VCA, in accordance with the legal criteria for doing so,
VA has considered all relevant input and information contained in the comments submitted in response to the interim final rule (84 FR 21668) and, for the reasons set forth in the foregoing responses to those comments, has concluded that no changes to the interim final rule are warranted. Accordingly, based upon the authorities and reasons set forth in the interim final rule (84 FR 21668), as supplemented by the additional reasons provided in this document in response to comments received, VA is adopting the provisions of the interim final rule as a final rule with no substantive changes.
The Paperwork Reduction Act of 1995 (44 U.S.C. 3507) requires that VA consider the impact of paperwork and other information collection burdens imposed on the public. Except for emergency approvals under 44 U.S.C. 3507(j), VA 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 interim final rule included provisions constituting new collections of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521) that require approval by the Office of Management and Budget (OMB) (the provisions in the interim final rule are §§ 17.4110, 17.4130, and 17.4135). Accordingly, under 44 U.S.C. 3507(d), VA submitted a copy of the interim final rule to OMB for review, and VA requested that OMB approve the collections of information on an emergency basis. VA did not receive any comments on the collections of information contained in the interim final rule. OMB approved the collections of information under control number 2900-0872.
The Secretary hereby certifies that this rule will not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act, 5 U.S.C. 601-612. Therefore, pursuant to 5 U.S.C. 605(b), the initial and final regulatory flexibility analysis requirements of 5 U.S.C. 603 and 604 do not apply.
Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, and other advantages; distributive impacts; and equity). Executive Order 13563 (Improving Regulation and Regulatory Review) emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. OMB's Office of Information and Regulatory Affairs (OIRA) has determined that this rule is not a significant regulatory action under Executive Order 12866. The Regulatory Impact Analysis associated with this rulemaking can be found as a supporting document at
The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 1532, that agencies prepare an assessment of anticipated costs and benefits before issuing any rule that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any one year. This final rule will have no such effect on State, local, and tribal governments, or on the private sector.
Pursuant to the Congressional Review Act (5 U.S.C. 801
The Catalog of Federal Domestic Assistance numbers and titles for the programs affected by this document are as follows: 64.009, Veterans Medical Care Benefits; and 64.018, Sharing Specialized Medical Resources.
Administrative practice and procedure, Alcohol abuse, Alcoholism, Claims, Day care, Dental health, Drug abuse, Foreign relations, Government contracts, Grant programs—health, Grant programs—veterans, Health care, Health facilities, Health professions, Health records, Homeless, Medical and dental schools, Medical devices, Medical research, Mental health programs, Nursing homes, Philippines, Reporting and recordkeeping requirements, Scholarships and fellowships, Travel and transportation expenses, Veterans.
Denis McDonough, Secretary of Veterans Affairs, approved this document on July 27, 2021, and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication
Accordingly, the interim final rule amending 38 CFR part 17, which was published at 84 FR 21668 on May 14, 2019, is adopted as final with the following technical amendments:
38 U.S.C. 501, and as noted in specific sections
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Temporary rule; closure.
NMFS implements an accountability measure for red snapper in the exclusive economic zone (EEZ) of the South Atlantic. NMFS projects commercial landings of red snapper have reached the commercial annual catch limit (ACL) for the 2021 fishing year. Therefore, NMFS is closing the commercial sector for red snapper in the South Atlantic EEZ. This closure is necessary to protect the red snapper resource.
This temporary rule is effective from 12:01 a.m., eastern time, on September 14, 2021, through December 31, 2021.
Mary Vara, NMFS Southeast Regional Office, telephone: 727-824-5305, email:
The snapper-grouper fishery of the South Atlantic includes red snapper and is managed under the Fishery Management Plan for the Snapper-Grouper Fishery of the South Atlantic Region (FMP). The FMP was prepared by the South Atlantic Fishery Management Council and is implemented by NMFS under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) by regulations at 50 CFR part 622.
The commercial ACL for red snapper in the South Atlantic is 124,815 lb (56,615 kg), round weight, as specified in 50 CFR 622.193(y)(1).
Under 50 CFR 622.193(y)(1), NMFS is required to close the commercial sector for red snapper when the commercial ACL is reached, or is projected to be reached, by filing a notification to that effect with the Office of the Federal Register. NMFS has determined that the commercial ACL for South Atlantic red snapper will be reached by September 14, 2021. Accordingly, the commercial sector for South Atlantic red snapper is closed effective at 12:01 a.m., eastern time, on September 14, 2021. For the 2022 fishing year, unless otherwise specified, the commercial season will begin on the second Monday in July (50 CFR 622.183(b)(5)(i)).
The operator of a vessel with a valid commercial vessel permit for South Atlantic snapper-grouper having red snapper on board must have landed and bartered, traded, or sold such red snapper prior to 12:01 a.m., eastern time, on September 14, 2021. Because the recreational sector closed on July 12, 2021 (86 FR 30393, June 8, 2021), after the commercial sector closure that is effective on September 14, 2021, all harvest and possession of red snapper in or from the South Atlantic EEZ is prohibited for the remainder of the 2021 fishing year.
On and after the effective date of the closure notification, all sale or purchase of red snapper is prohibited. This prohibition on the harvest, possession, sale or purchase applies in the South Atlantic on a vessel for which a valid Federal commercial or charter vessel/headboat permit for South Atlantic snapper-grouper has been issued, regardless if such species were harvested or possessed in state or Federal waters (50 CFR 622.193(y)(1) and 622.181(c)(2)).
NMFS issues this action pursuant to section 305(d) of the Magnuson-Stevens Act. This action is required by 50 CFR 622.193(y)(1), which was issued pursuant to section 304(b) of the Magnuson-Stevens Act, and is exempt from review under Executive Order 12866.
Pursuant to 5 U.S.C. 553(b)(B), the NMFS Assistant Administrator (AA) finds good cause to waive prior notice and an opportunity for public comment on this action, as notice and comment are unnecessary and contrary to the public interest. Such procedures are unnecessary because the rule that established the commercial season, ACL, and accountability measure for red snapper has already been subject to notice and comment, and all that remains is to notify the public of the closure. Such procedures are contrary to the public interest because of the need to immediately implement this action to protect red snapper because the capacity of the fishing fleet allows for rapid harvest of the commercial ACL. Prior notice and opportunity for public comment would require time and could potentially result in a harvest well in excess of the established commercial ACL.
For the aforementioned reasons, the AA also finds good cause to waive the 30-day delay in the effectiveness of this action under 5 U.S.C. 553(d)(3).
16 U.S.C. 1801
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
This action proposes to amend the Class E airspace at Greenville, TX, and establish Class E airspace at Terrell, TX. The FAA is proposing this action as the result of airspace reviews due to the decommissioning of the Caddo Mills non-directional beacon (NDB). The geographic coordinates of Caddo Mills Municipal Airport, Caddo Mill, TX, would also be updated to coincide with the FAA's aeronautical database.
Comments must be received on or before October 28, 2021.
Send comments on this proposal to the U.S. Department of Transportation, Docket Operations, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590; telephone (202) 366-9826, or (800) 647-5527. You must identify FAA Docket No. FAA-2021-0740/Airspace Docket No. 21-ASW-15, at the beginning of your comments. You may also submit comments through the internet at
FAA Order 7400.11E, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at
Jeffrey Claypool, Federal Aviation Administration, Operations Support Group, Central Service Center, 10101 Hillwood Parkway, Fort Worth, TX 76177; telephone (817) 222-5711.
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 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 amend the Class E airspace extending upward from 700 feet above the surface at Caddo Mills Municipal Airport, Caddo Mills, TX, contained within the Greenville, TX, airspace legal description, and establish Class E airspace extending upward from 700 feet above the surface at Terrell Municipal Airport, Terrell, TX, to support instrument flight rule operations at these airports.
Interested parties are invited to participate in this proposed rulemaking by submitting such written data, views, or arguments, as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. Communications should identify both docket numbers and be submitted in triplicate to the address listed above. Commenters wishing the FAA to acknowledge receipt of their comments on this notice must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2021-0740/Airspace Docket No. 21-ASW-15.” The postcard will be date/time stamped and returned to the commenter.
All communications received before the specified closing date for comments will be considered before taking action on the proposed rule. The proposal contained in this notice may be changed in light of the comments received. A report summarizing each substantive public contact with FAA personnel concerned with this rulemaking will be filed in the docket.
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 Office (see the
This document proposes to amend FAA Order 7400.11E, Airspace Designations and Reporting Points, dated July 21, 2020, and effective September 15, 2020. FAA Order 7400.11E is publicly available as listed in the
The FAA is proposing an amendment to 14 CFR part 71 by:
Amending the Class E airspace extending upward from 700 feet above the surface to within a 6.4-mile (decreased from a 6.5-mile) radius of Caddo Mills Municipal Airport, Caddo Mills, TX, contained within the Greenville, TX, airspace legal description; removing the Caddo Mills RBN and associated extension from the Greenville, TX, airspace legal description; removing Terrell Municipal Airport and the associate airspace from the Greenville, TX, airspace legal description as the airspace no longer adjoins and separate airspace is being established for Terrell, TX; removing the city associated with Majors Airport, Greenville, TX, to comply with updates to FAA Order 7400.2N, Procedures for Handling Airspace Matters; updating the geographic coordinates of the Caddo Mills Municipal Airport to coincide with the FAA's aeronautical database; and removing the exclusionary language as it is no longer required;
And establishing the Class E airspace extending upward from 700 feet above the surface within a 6.5-mile radius of Terrell Municipal Airport, Terrell, TX.
These actions are the result of airspace reviews caused by the decommissioning of the Caddo Mills NDB which provided guidance to instrument procedures at these airports.
Class E airspace designations are published in paragraph 6005 of FAA Order 7400.11E, dated July 21, 2020, and effective September 15, 2020, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.
FAA Order 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current, is non-controversial and unlikely to result in adverse or negative comments. 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 rule, when promulgated, would 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).
Accordingly, pursuant to the authority delegated to me, 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 700 feet above the surface within a 7.8-mile radius of Majors Airport; and within a 6.4-mile radius of the Caddo Mills Municipal Airport.
That airspace extending upward from 700 feet above the surface within a 6.5-mile radius of Terrell Municipal.
Office of Government-wide Policy (OGP), General Services Administration (GSA).
Proposed rule.
This proposed rule would clarify that agencies can reimburse rental car fees (up to a certain number of days) for Outside the Continental United States (OCONUS) relocations as a miscellaneous expense allowance to account for privately owned vehicle (POV) shipping delays at the employee's new official station. The proposed rule also updates rental car insurance policy to state that the Government will pay for both collision damage waiver(s) and theft insurance on rental car used OCONUS and also clarifies that rental cars may be used for the same purposes as a Government vehicle (other than a Government aircraft). Finally, the proposed rule substitutes the terms “gas” and “gasoline” with the term “fuel” where appropriate. The term “fuel” is broader as it still includes gasoline as a fuel source and also encompasses alternate vehicle energy sources, like electricity. A definition of the term “Fuel” is added to the FTR.
Interested parties should submit written comments to the Regulatory Secretariat Division at the address shown below on or before November 12, 2021 to be considered in the formation of the final rule.
Submit comments in response to FTR case 2020-301-1 to:
For clarification of content, contact Mr. Ed Davis, Program Analyst, Office of Government-wide Policy, at 202-208-7638. Contact the Regulatory Secretariat Division (MVCB), 1800 F Street NW, 2nd Floor, Washington, DC 20405, 202-501-4755, for information pertaining to status or publication schedules. Please cite FTR Case 2020-301-1, Definition for “Fuel”, Rental Car Policy Updates and Clarifications.
Federal Travel Regulation (FTR) part 302-16 authorizes agencies to provide eligible employees a miscellaneous expenses allowance (MEA) to defray some of the costs incurred while relocating. A non-exhaustive list of examples of allowable miscellaneous expenses can be found at FTR 302-16.2.
While not specifically mentioned as an example of a reimbursable miscellaneous expense, the FTR allows for employees serving OCONUS to be reimbursed for rental car use while awaiting arrival of their POV due to shipment delay. The lack of specific mention of this type of miscellaneous expense in the FTR has caused agency confusion surrounding its authorization for reimbursement. Accordingly, this proposed rule would update the list of miscellaneous expenses examples in FTR 302-16.2 to explicitly include discretionary rental car reimbursement OCONUS, and add the caveat that such expense may only be authorized for up to 10 days, or until delivery of the POV, whichever occurs first.
To clarify a position that is in current practice, but not specifically stated in the FTR, a new paragraph (f) under FTR § 301-10.450 will be added stating that a rental car may be used for the same purposes as a Government vehicle (other than a Government aircraft) under FTR § 301-10.201.
As a general rule, employees authorized to rent a vehicle for official travel are not reimbursed the cost of collision damage waiver (CDW) or theft insurance. However, employees who are required to travel OCONUS may be reimbursed CDW or theft insurance, but not both, based on the current regulatory language (FTR § 301-10.451(b)). This proposed rule updates the FTR to reflect that both types of insurance can be paid when necessary.
Finally, the proposed rule removes the terms “gas” and “gasoline”, where appropriate, and replaces it with the term “fuel”, and further defines fuel to account for not only gasoline, but also other types of vehicle power sources, such as hydrogen, propane, and electricity.
Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is not anticipated to be a significant regulatory action and, therefore, was not subject to review under Section 6(b) of E.O. 12866, Regulatory Planning and Review, dated September 30, 1993. As this proposed rule is not anticipated to be a “significant regulatory action,” GSA is not required to provide an economic analysis under Section 6(a) of E.O. 12866.
This rule is not a major rule under 5 U.S.C. 804(2). Subtitle E of the Small Business Regulatory Enforcement Fairness Act of 1996 (codified at 5 U.S.C. 801-808), also known as the Congressional Review Act or CRA, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. OIRA has determined that this proposed rule is not a “major rule” as defined by 5 U.S.C. 804(2).
GSA does not expect this proposed rule to have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601,
Therefore, an Initial Regulatory Flexibility Analysis has not been performed. GSA invites comments from small business concerns and other interested parties on the expected impact of this rule on small entities.
GSA will also consider comments from small entities concerning the existing regulations in subparts affected by the rule in accordance with 5 U.S.C. 610. Interested parties must submit such comments separately and should cite 5 U.S.C 610 (FTR Case 2020-301-1), in correspondence.
The Paperwork Reduction Act does not apply because the changes to the FTR do not impose recordkeeping or information collection requirements, or the collection of information from offerors, contractors, or members of the public that require the approval of the Office of Management and Budget (OMB) under 44 U.S.C. 3501,
Government employees, Travel and transportation expenses.
For the reasons set forth in the preamble, GSA proposes to amend 41 CFR parts 300-3, 301-10, 301-51, and 302-16 as set forth below:
5 U.S.C. 5707; 40 U.S.C. 121(c); 49 U.S.C. 40118; 5 U.S.C. 5738; 5 U.S.C. 5741-5742; 20 U.S.C. 905(a); 31 U.S.C. 1353; E.O. 11609, as amended; 3 CFR 1971-1975 Comp., p. 586, Office of Management and Budget Circular No. A-126, revised May 22, 1992.
5 U.S.C. 5707, 40 U.S.C. 121(c); 49 U.S.C. 40118; Office of Management and Budget Circular No. A-126, “Improving the Management and Use of Government Aircraft.” Revised May 22, 1992.
Following is a chart listing the reimbursable and non-reimbursable expenses:
(f) A rental car may be used for the same purposes as a Government vehicle. See § 301-10.201.
(b)
5 U.S.C. 5707. Subpart A is issued under the authority of Sec. 2, Pub. L. 105-264, 112 Stat 2350 (5 U.S.C. 5701 note); 40 U.S.C. 121(c).
5 U.S.C. 5738; 20 U.S.C. 905(a); E.O. 11609, as amended, 3 CFR 1971-1975 Comp., p. 586.
(a) Costs associated with relocating that are not covered by other relocation benefits detailed in chapter 302, but are covered by the MEA.
(b) * * *
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Proposed rule; request for comments.
NMFS proposes to approve and implement measures included in Amendment 7 to the Atlantic Bluefish Fishery Management Plan, as submitted by the Mid-Atlantic Fishery Management Council. This amendment would revise the goals and objectives of the fishery management plan, reallocate quota between the commercial and recreational fisheries, reallocate commercial quota among the states, implement a rebuilding plan using a constant fishing mortality strategy, revise the sector quota transfer, and revise how management uncertainty is applied during the specifications process. Amendment 7 is intended to use the best information available to update the Bluefish Fishery Management Plan, by responding to changes in stock health and distribution, while recognizing economic need and reliance throughout the management area.
Comments must be received by October 13, 2021.
You may submit comments on this document, identified by NOAA-NMFS-2021-0071, by the following method:
1. Go to
2. Click the “Comment” icon, complete the required fields; and
3. Enter or attach your comments.
The Mid-Atlantic Fishery Management Council prepared an environmental assessment (EA) for this action that describes the proposed measures and other considered alternatives. The EA also provides a thorough analysis of the biological, economic, and social impacts of the proposed measures and other considered alternatives. Copies of Amendment 7, including the EA, the Regulatory Impact Review, and the Regulatory Flexibility Act analysis prepared in support of this action, are available upon request from: Dr. Christopher M. Moore, Executive Director, Mid-Atlantic Fishery Management Council, Suite 201, 800 North State Street, Dover, DE 19901. These documents are also accessible via the internet at
Cynthia Ferrio, Fishery Policy Analyst, (978) 281-9180.
The Mid-Atlantic Fishery Management Council (Council) and the Atlantic States Marine Fisheries Commission (Commission) cooperatively manage bluefish from Maine to Florida under the Atlantic Bluefish Fishery Management Plan (FMP). This joint Bluefish FMP was adopted over 30 years ago in 1990. Since that time, the only substantial changes to management measures were made through Amendment 1 to the FMP in 2000, which established most measures and regulations still managing the fishery today, based on fishery data from 1981-1989. The Council and Commission initiated Amendment 7 to the FMP as a joint action in December 2017 to respond to changes in the bluefish fishery that have occurred over the past 30-40 years, while the FMP has remained largely unaltered. When first initiated, Amendment 7 was intended to address a comprehensive range of management issues, from the goals and objectives of the FMP to the allocation and transfer of quota between the commercial and recreational sectors.
In August 2019, an operational stock assessment determined that bluefish is overfished but not subject to overfishing. Following this determination, the Council and Commission's Bluefish Management Board added development of a rebuilding plan to Amendment 7. The Council was notified of the overfished stock status determination in November 2019; therefore, this amendment must be implemented by the end of November 2021 to ensure that the rebuilding plan is compliant with the timing requirements of section 304(e)(3) of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act). This timing will also allow the other changes proposed in Amendment 7 to be effective for the 2022 fishing year, beginning on January 1, 2022. Final alternatives for Amendment 7 set forth in a Public Hearing Document were approved at the joint meeting of the Council and Commission's Bluefish Management Board in February 2021, and public hearings on those alternatives were held throughout the spring. On June 8, 2021, the Council and Board took final action to approve Amendment 7, with the intent that the measures would be effective for the 2022 fishing year in January.
A Notification of Availability (NOA) for Amendment 7 was published in the
This action proposes to implement Amendment 7 to the Bluefish FMP, as approved by the Council and Commission. The purpose of this action
The FMP's existing goals and objectives were adopted in 1991 with the original FMP, and have remained unchanged since that time. Amendment 7 would revise these goals and objectives to better reflect the current fishery. While the FMP currently only has one overarching goal and a few general objectives, the proposed revisions contain multiple goals linked to more specific objectives to better guide management. The following proposed revisions were developed with extensive input from the public.
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The existing FMP allocated quota between the commercial and recreational fishery sectors based on landings data from 1981-1989. This action proposes to re-allocate quota between the sectors to better represent recent trends in the fishery. Amendment 7 would allocate 14 percent of the annual catch limit (ACL) to the commercial fishery, and 86 percent to the recreational fishery, representing a 3-percentage point shift from the existing 17/83 split. These revised sector allocations are based on updated catch data from 1981-2018, and landings data from 2014-2018 and 2009-2018, as all three time series resulted in the same allocation.
The coastwide commercial quota for bluefish is allocated annually to each state within the management unit from Maine to Florida based on a percentage determined in the FMP. As with the sector allocation percentages, the existing state-by-state commercial quota allocations have not been updated since their implementation as a part of Amendment 1 (65 FR 45844; July 26, 2000), and are based on landings data from 1981-1989. Amendment 7 would revise the state-by-state quota allocations based on a recent, representative 10 years of landings data (2009-2018) for the commercial fishery to better capture how the stock and fishing activity have shifted over the years. The proposed allocations also include a 0.1-percent minimum default allocation to ensure that no state in the management unit is excluded from the commercial fishery entirely. To allow industry and state managers to adjust more easily to these changes in commercial quota allocation, this action proposes to phase in the changes over a period of seven years. The percent shift in allocation for each state would be divided evenly over the phase-in period, so each state would only experience 1/7th of the change in allocation each year through 2028.
The 2019 operational stock assessment determined that bluefish is overfished but not subject to overfishing. Amendment 7 would implement a rebuilding plan that uses a constant fishing mortality model (F = 0.154) to rebuild the stock in seven years. This rebuilding plan was selected because it allows for least disruption to industry and minimizes negative socio-economic impacts while still rebuilding within the 10-year period required by the Magnuson-Stevens Act. However, because this model projects acceptable biological catch (ABC) values during rebuilding that are higher than those generated by the Council's risk policy (5-year rebuilding alternative), an exemption to the FMP's “most restrictive ABC” requirement needs to be included with this amendment. This would allow the Council's Scientific and Statistical Committee to recommend higher ABCs than the risk policy would typically generate during a rebuilding plan as long as they are consistent with the rebuilding plan, and the plan is projected to rebuild within the necessary time period. This proposed rebuilding plan has been developed to begin in 2022, and would be reviewed and revised as necessary every two years, as required by section 304(e)(7) of the Magnuson-Stevens Act.
Currently, the FMP allows a quota transfer from the recreational sector to the commercial sector up to a maximum final commercial quota of 10.5 million lb (4,763 mt) per year if the recreational fishery is not expected to attain the full recreational harvest limit in that given year. This action proposes to revise the measures regarding this sector transfer to allow quota to be transferred in either direction (from commercial to recreational or vice versa). This amendment would also revise the maximum transfer to be up to 10 percent of the acceptable biological catch, allowing the size of the transfer to scale with the current biomass of the stock. A restriction would also be added to disallow sector transfers when the bluefish stock is overfished or subject to overfishing.
This amendment would revise how management uncertainty can be accounted for during the specifications process. In the current FMP, the fishery-level ACL may be reduced by a buffer to account for sources of management uncertainty before quota is allocated to the commercial and recreational fishery sectors. This action proposes to revise the specifications process so that the management uncertainty buffer is applied separately within each sector. This targeted approach would provide more management flexibility, and allow for the identification of sources of management uncertainty that are specific to one sector and are not present in the other.
Pursuant to section 304(b)(1)(A) of the Magnuson-Stevens Act, the NMFS Assistant Administrator has determined that this proposed rule is consistent with the Atlantic Bluefish FMP, other provisions of the Magnuson-Stevens Act, and other applicable law, subject to further consideration after public comment.
The Council reviewed the proposed regulations for this action and deemed them necessary and appropriate to implement consistent with section 303(c) of the Magnuson-Stevens Act.
This proposed rule has been determined to be not significant for purposes of Executive Order 12866.
This proposed rule contains no information collection requirements under the Paperwork Reduction Act of 1995.
The Mid-Atlantic Council prepared an EA for this action that analyzes the impacts of the measures contained in this proposed rule. This EA includes an initial regulatory flexibility analysis (IRFA), as required by section 603 of the Regulatory Flexibility Act (RFA), which is supplemented by information contained in the preamble of this proposed rule. The IRFA describes the economic impact that this proposed rule, if adopted, would have on small business entities, as well as the comparative possible impacts of the other alternatives considered. A copy of the detailed RFA analysis is available from the Council (see
This action is taken under the authority of the Magnuson-Stevens Act and regulations at 50 CFR part 648. This action proposes a range of management measures for the Atlantic bluefish fishery. A complete description of the action, why it is being considered, and its legal basis, are contained in the EA (see
This proposed rule affects those small entities engaged in commercial fishing operations in the Atlantic bluefish fishery (those with commercial bluefish permits), and those with Federal party/charter recreational permits for bluefish. Private recreational anglers are not considered “entities” under the RFA, thus economic impacts on private anglers are not considered here. For the purposes of the RFA analysis, the ownership entities (or firms), not the individual vessels, are considered to be the regulated entities. Ownership entities are defined as those entities or firms with common ownership personnel as listed on the permit application. Because of this, some vessels with bluefish permits may be considered to be part of the same firm because they may have the same owners. To identify these small and large firms, vessel ownership data from the permit database were grouped according to common owners and sorted by size. In terms of RFA, a business primarily engaged in commercial fishing is classified as a small business if it has combined annual receipts not in excess of $11 million, for all its affiliated operations worldwide. A business primarily engaged in for-hire (party/charter) fishing is classified as small business if it has combined annual receipts not in excess of $8 million.
The current ownership data set used in this analysis is based on calendar years 2018-2020 (the most recent and complete data available). According to the vessel ownership database, 526 commercial fishing affiliate firms landed bluefish during the 2018-2020 period, with 521 of those entities categorized as small businesses, and 5 categorized as large businesses. The three-year average (2018-2020) combined gross receipts (all species combined) for all small entities only was $197,251,017 and the average bluefish receipts was $899,490; this indicates that bluefish revenues contributed approximately 0.46 percent of the total gross receipts for these small entities.
For the recreational for-hire (party/charter) fishery, 361 for-hire affiliate firms reported revenue from recreational fishing for various species from 2018-2020. All 361 of those firms are categorized as small businesses. It is not possible to derive what proportion of the overall revenues for these for-hire firms came from fishing activities for an individual species. Nevertheless, given the popularity of bluefish as a recreational species in the Mid-Atlantic and New England, it is likely that revenues generated from bluefish may be somewhat important for many of these firms at certain times of the year. The 3-year average (2018-2020) combined gross receipts (all for-hire fishing activity combined) for these small entities was $49,916,903, ranging from less than $10,000 for 105 entities (lowest value $46) to over $1,000,000 for 8 entities (highest value $3.6 million).
There are no new reporting, recordkeeping, or other compliance requirements contained in this proposed rule, or any of the alternatives considered for this action.
NMFS is not aware of any relevant Federal rules that may duplicate, overlap, or conflict with this proposed rule.
The proposed amendment would implement several measures that could potentially impact small businesses in both the commercial and recreational sectors of the bluefish fishery; most notably the reallocation of quota among the sectors and states, the rebuilding plan, and the revision of sector transfer of quota. While the revised FMP goals and objectives and the sector-specific accounting of management uncertainty during the specifications process could have an indirect economic impact on businesses, these alternatives are largely administrative and not discussed here. On average, bluefish revenues contributed approximately 0.46 percent to the total gross receipts for the small businesses and 0.02 percent for the large businesses. Due to the slightly higher dependence on bluefish for the small businesses compared to the large businesses, the small businesses may feel the effects of this action to a greater extent than the large businesses. Even so, the small businesses did not rely on bluefish for a substantial amount of their annual income either; although when considered individually, some businesses may be more dependent on this species than others.
Several alternatives were considered for the sector quota allocations based on different time series of catch and landings data; however, all of these alternatives resulted in quota shifting from the commercial sector to the recreational sector by varying degrees. The No Action alternative would continue to allocate 83-percent of the fishery-level ACL to the recreational fishery, and 17 percent to the commercial fishery, while the alternatives considered shift this distribution by 1, 3, 4, and 6 percentage
Some potential negative impact sector allocation from the prior proposed measure may be mitigated further by the proposed alternative to revise the sector transfer. The proposed sector transfer provisions would allow quota (in an amount up to 10-percent of the ABC) to be transferred from either sector to the other (from commercial to recreational or vice versa). This management tool would allow for supplementation of quota to either sector in a year when the assigned allocations may not support the business needs of the sector.
Similar to the sector reallocations, several alternatives were considered for the reallocation of commercial quota to the states, based on different time series of landings data. Because these alternatives do not affect the total amount of quota available in the fishery, but rather how it is distributed geographically, it is unlikely that they would have a direct economic impact on commercial businesses as a whole; however, they may have a disproportionate, indirect impact on some businesses more than others. To mitigate potential negative effects on entities in states that would experience the largest degree of change in commercial allocation, the Council and Board proposed to phase in the allocation changes equally over seven years. This would make the difference in quota allocation that each state would experience each year much smaller, and thus minimize the magnitude of any potential negative effects as a result.
There were three main rebuilding plan strategies considered in this amendment: (1) A plan using constant harvest model to rebuild the stock in four years; (2) a plan based on the Council's risk policy to rebuild the stock in five years; and (3) a plan using a constant fishing mortality model to rebuild the stock in seven years. A “No Action” alternative was not possible because of the Magnuson-Stevens Act requirement to rebuild an overfished stock. Even though the constant harvest and risk policy plans would rebuild the stock more quickly, the constant fishing mortality rebuilding plan was preferred because the more gradual changes it proposes provides the most economic stability and least disruption of business operations while still rebuilding the stock within 10 years.
All alternatives have the potential to impact businesses in the commercial sector; whereas all alternatives except the commercial quota allocation to the states may affect recreational businesses, which comprise the majority of the fishery overall. However, most of the alternatives in this action affect small businesses indirectly and have minimal direct economic impacts. For example, they dictate the process for developing future landings limits, or shift the distribution of quota/effort, but do not change the overall annual amount. That being said, public input was solicited and considered throughout the development of this amendment, and the economic impact on small businesses was minimized wherever possible. Section 7.4 of the EA contains a more detailed discussion on the economic impacts of each of the alternatives considered in this amendment, and the full RFA analysis can be found in section 8.10.
Fisheries, Fishing, Reporting and recordkeeping requirements.
For the reasons set out in the preamble, 50 CFR part 648 is proposed to be amended as follows:
16 U.S.C. 1801
(c) * * *
(1) Unless otherwise allowed in paragraph (c)(2) or (3) of this section, for instances in which the application of the risk policy approaches in paragraph (b) of this section using OFL distribution results in a more restrictive ABC recommendation than the calculation of ABC derived from the use of F
(3) The SSC may specify higher ABCs for bluefish based on F
(a)
(1)
(2)
(3)
(b)
(1)
(2)
(d)
(2) The allocation percentages in paragraph (d)(1) of this section will be phased in over a 7-year period beginning in 2022. The percent change in allocation from those prior to 2022 for each state is divided equally by seven, and will be applied incrementally each year until the final allocations listed in paragraph (d)(1) are in full effect for fishing year 2028.
(f)
(g)
Foreign Agricultural Service, USDA.
Notice; correction.
The Foreign Agricultural Service (FAS) published a notice in the
Abdelsalam El-Farra, (202) 720-9439;
In the
(1) On page 49289, in the third column, in numbered paragraph 3, insert “inserting” after “(d)”, and
(2) On page 49290, in the first column, in numbered paragraph 5, delete “1,31,000” and insert “1,313,000” in lieu thereof.
Foreign Agricultural Service, U.S. Department of Agriculture.
Notice.
The Foreign Agricultural Service announces the establishment of the Fiscal Year (FY) 2022 (October 1, 2021-September 30, 2022) in-quota aggregate quantity of raw cane sugar at 1,117,195 metric tons raw value (MTRV), and the establishment of the FY 2022 in-quota aggregate quantity of certain sugars, syrups, and molasses (also referred to as refined sugar) at 222,000 MTRV.
This notice is applicable on September 13, 2021.
Souleymane Diaby, Multilateral Affairs Division, Trade Policy and Geographic Affairs, Foreign Agricultural Service, U.S. Department of Agriculture, Stop 1070, 1400 Independence Avenue SW, Washington, DC 20250-1070; by telephone (202) 720-2916; or by email
The provisions of paragraph (a)(i) of the Additional U.S. Note 5, Chapter 17 in the U.S. Harmonized Tariff Schedule (HTS) authorize the Secretary to establish the in-quota tariff-rate quota (TRQ) amounts (expressed in terms of raw value) for imports of raw cane sugar and certain sugars, syrups, and molasses that may be entered under the subheadings of the HTS subject to the lower tier of duties during each fiscal year. The Office of the U.S. Trade Representative (USTR) is responsible for the allocation of these quantities among supplying countries and areas.
Section 359(k) of the Agricultural Adjustment Act of 1938, as amended, requires that at the beginning of the quota year the Secretary of Agriculture establish the TRQs for raw cane sugar and refined sugars at the minimum levels necessary to comply with obligations under international trade agreements, with the exception of specialty sugar.
The Secretary's authority under paragraph (a)(i) of the Additional U.S. Note 5, Chapter 17 in the HTS and Section 359(k) of the Agricultural Adjustment Act of 1938, as amended, has been delegated to the Under Secretary for Trade and Foreign Agricultural Affairs (7 CFR 2.26). The Under Secretary has subsequently delegated this authority to the Administrator, Foreign Agricultural Service (7 CFR 2.601).
Notice is hereby given that I have determined, in accordance with paragraph (a)(i) of the Additional U.S. Note 5, Chapter 17 in the HTS and section 359(k) of the 1938 Act, that an aggregate quantity of up to 1,117,195 MTRV of raw cane sugar may be entered or withdrawn from warehouse for consumption during FY 2022. This is the minimum amount to which the United States is committed under the WTO Uruguay Round Agreements. The conversion factor is 1 metric ton raw value equals 1.10231125 short tons raw value. I have further determined that an aggregate quantity of 222,000 MTRV of sugars, syrups, and molasses (refined sugar) may be entered or withdrawn from warehouse for consumption during FY 2022. This quantity includes the minimum amount to which the United States is committed under the WTO Uruguay Round Agreements, 22,000 MTRV, of which 20,344 MTRV is established for any sugars, syrups and molasses, and 1,656 MTRV is reserved for specialty sugar. An additional amount of 200,000 MTRV is added to the specialty sugar TRQ for a total of 201,656 MTRV.
Because the specialty sugar TRQ is first-come, first-served, tranches are needed to allow for orderly marketing throughout the year. The FY 2022 specialty sugar TRQ will be opened in five tranches. The first tranche, totaling 1,656 MTRV, will open October 1, 2021. All specialty sugars are eligible for entry under this tranche. The second tranche of 60,000 MTRV will open on October 8, 2021. The third tranche of 60,000 MTRV will open on January 21, 2022. The fourth tranche of 40,000 MTRV will open on April 15, 2022. The fifth tranche of 40,000 MTRV will open on July 15, 2022. The second, third, fourth, and fifth tranches will be reserved for organic sugar and other specialty sugars not currently produced commercially in the United States or reasonably available from domestic sources.
Forest Service, Agriculture (USDA).
Notice; request for comment.
In accordance with the Paperwork Reduction Act of 1995, the Forest Service, U.S. Department of Agriculture, is seeking comments from all interested individuals and organizations on the renewal of a currently approved information collection, Appeal of Decisions Relating to Occupancy or Use of National Forest System Lands and Resources.
Comments must be received in writing on or before November 12, 2021 to be assured of consideration. Comments received after that date will be considered to the extent practicable.
Commenters are encouraged to submit comments by email, if possible. You may submit comments by any of the following methods:
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Comments submitted in response to this notice may be made available to the public through relevant websites and upon request. For this reason, please do not include in your comments information of a confidential nature, such as sensitive personal information or proprietary information. If you send an email comment, your email address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the internet. Please note that responses to this public comment request containing any routine notice about the confidentiality of the communication will be treated as public comments that may be made available to the public notwithstanding the inclusion of the routine notice.
The public may request an electronic copy of the draft supporting statement that further explains the 36 CFR 214 appeals process and/or any comments received be sent via return email. Requests should be emailed to Jody Sutton Spalding, Administrative Review Specialist, Ecosystem Management Coordination at
James Smalls, Assistant Director, Ecosystem Management Coordination staff, 571-289-1605.
All comments received in response to this notice, including names and addresses when provided, will be a matter of public record. Comments will be summarized and included in the request for Office of Management and Budget approval of the information collection.
Forest Service, Agriculture (USDA).
Notice of meeting.
The Northern Utah Resource Advisory Committee (RAC) will hold a virtual meeting by phone and/or video conference. The committee is authorized under the Secure Rural Schools and Community Self-Determination Act (the Act) and operates in compliance with the Federal Advisory Committee Act. The purpose of the committee is to improve collaborative relationships and to provide advice and recommendations to the Forest Service concerning projects and funding consistent with Title II of the Act as well as make recommendations on recreation fee proposals for sites on the Ashley and Uinta-Wasatch-Cache National Forests, consistent with the Federal Lands Recreation Enhancement Act. RAC information and meeting information can be found at the following websites:
The meeting will be held on September 29, 2021, at 6:00 p,m., Mountain Daylight Time.
All RAC meetings are subject to cancellation. For status of the meeting prior to attendance, please contact the person listed under
The meeting will be held virtually via Microsoft Teams. Participants may
Written comments may be submitted as described under
Dave Whittekiend, Designated Federal Officer (DFO), by email at
Individuals who use telecommunication devices for the hearing-impaired (TDD) may call the Federal Relay Service (FRS) at 1-800-877-8339, 24 hours a day, every day of the year, including holidays.
The purpose of the meeting is to:
The meeting is open to the public. The agenda will include time for people to make oral statements of three minutes or less. Individuals wishing to make an oral statement should request in writing by September 17, 2021, to be scheduled on the agenda. Anyone who would like to bring related matters to the attention of the committee may file written statements with the committee staff before or after the meeting. Written comments and requests for time for oral comments must be sent to Ms. Loyal Clark, Uinta-Wasatch-Cache National Forest, 857 West South Jordan Parkway, South Jordan, UT 84095; or by email to
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
Currently, we are requesting approval to conduct the 2022, 2023 and 2024 Quarterly Survey of Public Pensions.
This survey was initiated in 1968 at the request of both the Council of Economic Advisers and the Federal Reserve Board. The most important information this survey provides is the quarterly change in composition of the securities holdings of the defined benefit public employee retirement systems component of the economy. The Federal Reserve Board uses these data to track the public sector portion of the Flow of Funds Accounts. Additionally, the data are used by a variety of government officials, academics, students, and non-profit organizations to analyze trends in public employee retirement and the impact of retirement obligations on the fiscal well-being of state and local governments.
The survey provides a focus on the asset composition of the largest systems. These data are already produced for existing internal and external needs, and most closely align with the needs of the Federal Reserve Board. Additionally, the related Annual Survey of Public Pensions (0607-0585) will continue to provide a robust collection of revenue and benefit data on a fiscal year basis. These data items are in demand on an annual basis and are already created for internal and external purposes by most systems as they are required items in Comprehensive Annual Financial Reports (CAFRs).
Summary tables of the information collected are released quarterly on the internet. Documentation and explanatory materials are also available on the internet site here:
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
On February 6, 2020 in the U.S. District Court of Southern District of Texas, Anastacio San Miguel-Padron (“San Miguel-Padron”), was convicted of violating 18 U.S.C. 554. Specifically, San Miguel-Padron was convicted of fraudulently and knowingly exporting and sending or attempting to export or send from the United States to Mexico, approximately 850 rounds of .38 super caliber ammunition, 200 rounds of .40 caliber ammunition, 50 rounds of 9mm caliber ammunition and one 7.62 x 39 mm drum magazine. San Miguel-Padron was sentenced to 30 months in prison, and a $100 assessment.
Pursuant to Section 1760(e) of the Export Control Reform Act (“ECRA”),
BIS received notice of San Miguel-Padron's conviction for violating 18 U.S.C. 554, and has provided notice and opportunity for San Miguel-Padron to make a written submission to BIS, as provided in Section 766.25 of the Export Administration Regulations (“EAR” or the “Regulations”). 15 CFR 766.25.
Based upon my review of the record and consultations with BIS's Office of Exporter Services, including its Director, and the facts available to BIS, I have decided to deny San Miguel-Padron's export privileges under the Regulations for a period of seven years from the date of San Miguel-Padron's conviction. The Office of Exporter Services has also decided to revoke any BIS-issued licenses in which San Miguel-Padron had an interest at the time of his conviction.
Accordingly, it is hereby
A. Applying for, obtaining, or using any license, license exception, or export control document;
B. Carrying on negotiations concerning, or ordering, buying, receiving, using, selling, delivering, storing, disposing of, forwarding, transporting, financing, or otherwise servicing in any way, any transaction involving any item exported or to be exported from the United States that is subject to the Regulations, or engaging in any other activity subject to the Regulations; or
C. Benefitting in any way from any transaction involving any item exported or to be exported from the United States that is subject to the Regulations, or from any other activity subject to the Regulations.
A. Export, reexport, or transfer (in-country) to or on behalf of the Denied Person any item subject to the Regulations;
B. Take any action that facilitates the acquisition or attempted acquisition by the Denied Person of the ownership, possession, or control of any item subject to the Regulations that has been or will be exported from the United States, including financing or other support activities related to a transaction whereby the Denied Person acquires or attempts to acquire such ownership, possession or control;
C. Take any action to acquire from or to facilitate the acquisition or attempted acquisition from the Denied Person of any item subject to the Regulations that has been exported from the United States;
D. Obtain from the Denied Person in the United States any item subject to the Regulations with knowledge or reason to know that the item will be, or is intended to be, exported from the United States; or
E. Engage in any transaction to service any item subject to the Regulations that has been or will be exported from the United States and which is owned, possessed or controlled by the Denied Person, or service any item, of whatever origin, that is owned, possessed or controlled by the Denied Person if such service involves the use of any item subject to the Regulations that has been or will be exported from the United States. For purposes of this paragraph, servicing means installation, maintenance, repair, modification or testing.
On February 1, 2019, in the U.S. District Court for the Southern District of Florida, Samy Jecrois (“Jecrois”), was convicted of violating 18 U.S.C. 554. Specifically, Jecrois was convicted of knowingly attempting to export and send from the United States to Haiti a firearm, in violation of 18 U.S.C. 554. Jecrois was sentenced to 5 months in prison, two years supervised release and a $100 assessment.
Pursuant to Section 1760(e) of the Export Control Reform Act (“ECRA”),
BIS received notice of Jecrois's conviction for violating 18 U.S.C. 554, and has provided notice and opportunity for Jecrois to make a written submission to BIS, as provided in Section 766.25 of the Export Administration Regulations (“EAR” or the “Regulations”). 15 CFR 766.25.
Based upon my review of the record and consultations with BIS's Office of Exporter Services, including its Director, and the facts available to BIS, I have decided to deny Jecrois's export privileges under the Regulations for a period of five years from the date of Jecrois's conviction. The Office of Exporter Services has also decided to revoke any BIS-issued licenses in which Jecrois had an interest at the time of his conviction.
Accordingly, it is hereby
A. Applying for, obtaining, or using any license, license exception, or export control document;
B. Carrying on negotiations concerning, or ordering, buying, receiving, using, selling, delivering, storing, disposing of, forwarding, transporting, financing, or otherwise servicing in any way, any transaction involving any item exported or to be exported from the United States that is subject to the Regulations, or engaging in any other activity subject to the Regulations; or
C. Benefitting in any way from any transaction involving any item exported or to be exported from the United States that is subject to the Regulations, or from any other activity subject to the Regulations.
A. Export, reexport, or transfer (in-country) to or on behalf of the Denied Person any item subject to the Regulations;
B. Take any action that facilitates the acquisition or attempted acquisition by the Denied Person of the ownership, possession, or control of any item subject to the Regulations that has been or will be exported from the United States, including financing or other support activities related to a transaction whereby the Denied Person acquires or attempts to acquire such ownership, possession or control;
C. Take any action to acquire from or to facilitate the acquisition or attempted acquisition from the Denied Person of any item subject to the Regulations that has been exported from the United States;
D. Obtain from the Denied Person in the United States any item subject to the Regulations with knowledge or reason to know that the item will be, or is intended to be, exported from the United States; or
E. Engage in any transaction to service any item subject to the Regulations that has been or will be exported from the United States and which is owned, possessed or controlled by the Denied Person, or service any item, of whatever origin, that is owned, possessed or controlled by the Denied Person if such service involves the use of any item subject to the Regulations that has been or will be exported from the United States. For purposes of this paragraph, servicing means installation, maintenance, repair, modification or testing.
On February 14, 2020, in the U.S. District Court for the Southern District of Florida, Akeem Shonari Awer (“Awer”) was convicted of violating
Pursuant to Section 1760(e) of the Export Control Reform Act of 2018 (“ECRA”),
BIS received notice of Awer's conviction for violating Section 38 of the AECA, and has provided notice and opportunity for Awer to make a written submission to BIS, as provided in Section 766.25 of the Export Administration Regulations (“EAR” or the “Regulations”). 15 CFR 766.25.
Based upon my review of the record and consultations with BIS's Office of Exporter Services, including its Director, and the facts available to BIS, I have decided to deny Awer's export privileges under the Regulations for a period of 10 years from the date of Awer's conviction. The Office of Exporter Services has also decided to revoke any BIS-issued licenses in which Awer had an interest at the time of his conviction.
Accordingly, it is hereby
A. Applying for, obtaining, or using any license, license exception, or export control document;
B. Carrying on negotiations concerning, or ordering, buying, receiving, using, selling, delivering, storing, disposing of, forwarding, transporting, financing, or otherwise servicing in any way, any transaction involving any item exported or to be exported from the United States that is subject to the Regulations, or engaging in any other activity subject to the Regulations; or
C. Benefitting in any way from any transaction involving any item exported or to be exported from the United States that is subject to the Regulations, or from any other activity subject to the Regulations.
A. Export, reexport, or transfer (in-country) to or on behalf of the Denied Person any item subject to the Regulations;
B. Take any action that facilitates the acquisition or attempted acquisition by the Denied Person of the ownership, possession, or control of any item subject to the Regulations that has been or will be exported from the United States, including financing or other support activities related to a transaction whereby the Denied Person acquires or attempts to acquire such ownership, possession or control;
C. Take any action to acquire from or to facilitate the acquisition or attempted acquisition from the Denied Person of any item subject to the Regulations that has been exported from the United States;
D. Obtain from the Denied Person in the United States any item subject to the Regulations with knowledge or reason to know that the item will be, or is intended to be, exported from the United States; or
E. Engage in any transaction to service any item subject to the Regulations that has been or will be exported from the United States and which is owned, possessed or controlled by the Denied Person, or service any item, of whatever origin, that is owned, possessed or controlled by the Denied Person if such service involves the use of any item subject to the Regulations that has been or will be exported from the United States. For purposes of this paragraph, servicing means installation, maintenance, repair, modification or testing.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of public meetings.
The Mid-Atlantic Fishery Management Council (Council) will hold public meetings of the Council and its Executive Committee.
The meetings will be held Tuesday, October 5, 2021 through Wednesday, October 6, 2021. For agenda details, see
This meeting will be conducted entirely by webinar. Webinar registration details will be available on the Council's website at
Christopher M. Moore, Ph.D. Executive Director, Mid-Atlantic Fishery Management Council; telephone: (302) 526-5255. The Council's website,
The following items are on the agenda, although agenda items may be addressed out of order (changes will be noted on the Council's website when possible.)
Recommend Spiny Dogfish Advisory Panel Vacancy Appointments.
Review progress on 2021 Implementation Plan.
Review staff recommendations for 2022 actions and deliverables.
Public comment opportunity.
Approve draft actions and deliverables for further development in 2022 Implementation Plan.
Walt Golet, University of Maine/Gulf of Maine Research Institute.
Review recommendations from the Advisory Panel, SSC, and Monitoring Committee.
Review previously set 2022 chub mackerel specifications and recommend any changes if necessary.
Review SSC's September 2021 meeting results regarding rebuilding.
Provide additional guidance regarding rebuilding plan modifications, if appropriate.
Review SSC, Advisory Panel, Monitoring Committee, staff, and Committee recommendations for 2022 fishing year specifications.
Review staff trip limit analysis.
Review previously implemented 2022 specifications (including trip limit) and recommend changes if necessary.
Report from GARFO on Tilefish permitting and reporting numbers.
Atlantic Large Whale Take Reduction Team scoping for risk reduction measures for Atlantic trap/pot and gillnet fisheries.
New Incidental Take Statement, RPMs and Terms and Conditions, and Sea Turtle Monitoring Plan.
Committee Reports (SSC, Executive Committee); Executive Director's Report; Organization Reports; and Liaison Reports.
Although non-emergency issues not contained in this agenda may come before this group 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 these meetings. 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).
These meetings are physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aid should be directed to Shelley Spedden, (302) 526-5251, at least 5 days prior to the meeting date.
Office of Environmental Management, Department of Energy.
Notice of in-person/virtual hybrid meeting.
This notice announces an in-person/virtual hybrid meeting of the Environmental Management Site-Specific Advisory Board (EM SSAB), Portsmouth. The Federal Advisory Committee Act requires that public notice of this in-person/virtual hybrid meeting be announced in the
Thursday, October 7, 2021; 6:00 p.m.-7:30 p.m.
This hybrid meeting will be conducted in person for Board members, Department of Energy (DOE) representatives and support staff, and virtually for all other participants. Members of the public will observe the meeting via YouTube at this link:
Board members, DOE representatives and support staff will participate in-person at: The Ohio State University, Endeavor Center, 1862 Shyville Road, Piketon, OH 45661.
Board liaisons and supporting contractors will participate via virtual platforms.
Eric Roberts, SSAB Board Support Manager, by Phone: (270) 554-3004 or Email:
National Nuclear Security Administration, Department of Energy.
Reopening of the public comment period.
The Department of Energy (DOE) published the Request for information (RFI) to invite public comment on topics related to the Establishment of the DOE's Uranium Reserve program on August 11, 2021. Through this notice, DOE announces the reopening of the Uranium Reserve RFI comment period for an additional 30 days. The August 11, 2021
The comment period for the RFI published on August 11, 2021 (86 FR 44007), which closed on September 10, 2021, is hereby reopened. DOE will accept written comments, data, information in response no later than October 13, 2021.
Interested persons may submit comments by any of the following methods:
The Government has posted a parallel RFI to
Requests for further information should be sent to:
The U.S. Department of Energy (DOE or the Department) issued this RFI to invite public comment on topics related to establishment of the DOE's Uranium Reserve program. DOE is re-opening the comment period on this RFI to provide ample time for interested parties to respond.
In the United States (U.S.), nuclear energy provides more than 55 percent of our clean energy and supports about half a million American jobs. However, the U.S. nuclear industry and the nuclear fuel supply chain face significant challenges that have left domestic nuclear fuel suppliers in a weakened position on the domestic and global stage. Revitalizing the U.S. nuclear fuel supply infrastructure would support the Administration's goals described in the American Jobs Plan,
In December 2020, Congress passed the
In considering options, the Department will focus on reinvigorating domestic nuclear fuel supply chain capabilities, utilizing existing facilities, and minimizing negative disruption of market mechanisms. The Department expects the acquisition of natural uranium to result in new uranium production at existing domestic sites. The Department does not intend such new production to initiate or expand mining on Tribal lands, expand the Office of Legacy Management's (LM) Uranium Leasing Program, or expand access to additional uranium deposits located on other Federal lands. Additionally, the Department does not intend to acquire uranium or uranium hexafluoride produced from enricher underfeeding, the re-enrichment of tails, or other sources that do not support the reinvigoration of uranium production and conversion capabilities. Likewise, the Department expects to use existing domestic commercial conversion capabilities and store the uranium hexafluoride at a domestic facility.
The Department will comply with all applicable laws, including the
The Department is publishing this RFI to gain a better understanding of Tribal and other disadvantaged communities and stakeholder views on topics related to the establishment of a uranium reserve. Responses to the RFI will inform the Department's establishment of a uranium reserve, as well as the development of a procurement strategy for acquisition of uranium, conversion services, and storage.
This document of the Department of Energy was signed on September 7, 2021, by Dr. Charles Verdon, Deputy Administrator for Defense Programs for the National Nuclear Security Administration, pursuant to delegated authority from the Secretary of Energy. That document with the original signature and date is maintained by DOE. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DOE Federal Register Liaison Officer has been authorized to sign and submit the document in electronic format for publication, as an official document of the Department of
On August 26, 2021, Pacific Gas and Electric Company submitted to the Federal Energy Regulatory Commission (Commission) a copy of their application for a Clean Water Act section 401(a)(1) water quality certification filed with the California State Water Resources Control Board (California Water Board), in conjunction with the above captioned project. Pursuant to 40 CFR 121.6, we hereby notify the California Water Board of the following:
If the California Water Board fails or refuses to act on the water quality certification request by the above waiver date, then the agency's certifying authority is deemed waived pursuant to section 401(a)(1) of the Clean Water Act, 33 U.S.C. 1341(a)(1).
Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection.
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k. Pursuant to section 4.32(b)(7) of 18 CFR of the Commission's regulations, if any resource agency, Indian Tribe, or person believes that an additional scientific study should be conducted in order to form an adequate factual basis for a complete analysis of the application on its merit, the resource agency, Indian Tribe, or person must file a request for a study with the Commission not later than 60 days from the date of filing of the application, and serve a copy of the request on the applicant.
l.
The Commission strongly encourages electronic filing. Please file additional study requests and requests for cooperating agency status using the Commission's eFiling system at
m. The application is not ready for environmental analysis at this time.
n.
o. The current license requires Green Mountain Power Corporation to: (1) Operate the project in run-of-river mode; (2) release a continuous bypassed reach minimum flow of 50 cubic feet per second (cfs) from April 15 to June 10 and 25 cfs during the remainder of the year; and (3) release a year-round,
p. Green Mountain Power Corporation proposes to: (1) Continue operating the project in run-of-river mode; (2) release new bypassed reach minimum flows of 35 cfs from May 15 to October 15 and 30 cfs from October 16 to May 14; and (3) release a new aesthetic flow of 10 cfs over the dam from May 15 to October 15 during daytime hours and no aesthetic flow the remainder of the year.
q. In addition to publishing the full text of this notice in the
You may also register online at
r.
s. Final amendments to the application must be filed with the Commission no later than 30 days from the issuance date of the notice of ready for environmental analysis.
Take notice that on August 27, 2021, ANR Pipeline Company (ANR), 700 Louisiana Street, Suite 1300, Houston, Texas 77002-2700, filed an application pursuant to section 7(c) of the Natural Gas Act (NGA), in Docket No. CP21-488-000, for authorization to implement working gas capacity-to base gas capacity conversions (“Storage Conversion Plan”) at the Goodwell Storage Field, located in Newaygo County, Michigan, and at the Lincoln-Freeman Storage Field, located in Clare County, Michigan. ANR states that the Storage Conversion Plan is needed to allow ANR to access and utilize stranded working storage capacity and improve late season deliverability and reliability at the Goodwell and Lincoln-Freeman fields.
In addition to publishing the full text of this document in the
Any questions concerning this application should be directed to Alexander Kass, Legal Counsel, ANR Pipeline Company, 700 Louisiana Street, Suite 1300, Houston, Texas, by phone at 832.320.5226, or by email at
Pursuant to Section 157.9 of the Commission's Rules of Practice and Procedure,
There are three ways to become involved in the Commission's review of this project: You can file a protest to the project, you can file a motion to intervene in the proceeding, and you can file comments on the project. There is no fee or cost for filing protests, motions to intervene, or comments. The deadline for filing protests, motions to intervene, and comments is 5:00 p.m. Eastern Time on September 28, 2021. How to file comments and motions to intervene is explained below.
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 September 28, 2021. However, 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.
Persons who comment on the environmental review of this project will be placed on the Commission's environmental mailing list, and will receive notification when the
Any person, which includes individuals, organizations, businesses, municipalities, and other entities,
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.
There are two ways to submit your comments and motions to intervene to the Commission. In all instances, please reference the Project docket number CP21-488-000 in your submission. The Commission encourages electronic filing of submissions.
(1) You may file your comments or motions to intervene electronically by using the eFiling feature, which is located on the Commission's website (
(2) You can file a paper copy of your comments by mailing them to the following address below. Your written comments must reference the Project docket number (CP21-488-000).
To mail via USPS, use the following address:
To mail via any other courier, use the following address:
Motions to intervene must be served on the applicants either by mail or email (with a link to the document) at: ANR Pipeline Company (ANR), 700 Louisiana Street, Suite 1300, Houston, Texas 77002-2700 or at
All timely, unopposed
Throughout the proceeding, additional information about the projects 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
Environmental Protection Agency (EPA).
Notice of public meeting.
The Environmental Protection Agency (EPA), Office of Research and Development (ORD), gives notice of a series of virtual meetings of the Board of Scientific Counselors (BOSC) Air, Climate and Energy (ACE) Subcommittee to discuss emerging pollutants and sources and the changing environment.
1. The meeting will be held over three days via videoconference:
a. Tuesday, October 12, 2021, from 12 p.m. to 5 p.m. (EDT);
b. Wednesday, October 13, 2021, from 12 p.m. to 5 p.m. (EDT); and
c. Thursday, October 14, 2021, from 12 p.m. to 5 p.m. (EDT).
Attendees must register by October 8, 2021.
2. A BOSC deliberation videoconference will be held on October 27, 2021, from 2 p.m. to 5 p.m. (EDT).
Attendees must register by October 26, 2021.
3. A final BOSC deliberation videoconference will be held on November 12, 2021, from 2 p.m. to 5 p.m. (EDT). Attendees must register by November 10, 2021.
Meeting times are subject to change. This series of meetings is open to the public. Comments must be received by October 8, 2021, to be considered by the subcommittee. Requests for the draft agenda or making a presentation at the meeting will be accepted until October 8, 2021.
Instructions on how to connect to the videoconference will be provided upon registration at:
Submit your comments to Docket ID No. EPA-HQ-ORD-2015-0365 by one of the following methods:
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Copyrighted materials in the docket are only available via hard copy. The telephone number for the ORD Docket Center is (202) 566-1752.
The Designated Federal Officer (DFO), Tom Tracy, via phone/voicemail at: 919-541-4334; or via email at:
Any member of the public interested in receiving a draft agenda, attending the meeting, or making a presentation at the meeting should contact Tom Tracy no later than October 8, 2021.
The Board of Scientific Counselors (BOSC) is a federal advisory committee that provides advice and recommendations to EPA's Office of Research and Development on technical and management issues of its research programs. The meeting agenda and materials will be posted to
Proposed agenda items for the meeting include, but are not limited to, the following: Emerging pollutants and sources and the changing environment.
Environmental Protection Agency (EPA).
Notice.
As provided under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), State-designated lead agencies may register pesticides, within their respective States, to meet special local needs. EPA's regulations require the State lead agencies to notify EPA of such special local need registrations. EPA may disapprove any such State registration. EPA's regulations require that notice of disapproval actions be published in the
September 13, 2021.
Marietta Echeverria, Acting Director, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone number: (703) 305-7090; 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).
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2021-0224, is available at
Due to the public health concerns related to COVID-19, the EPA Docket Center (EPA/DC) and Reading Room is closed to visitors with limited exceptions. The staff continues to provide remote customer service via email, phone, and webform. For the latest status information on EPA/DC services and docket access, visit
Section 24(c) of FIFRA (7 U.S.C. 136v(c)) authorizes States to register “additional uses of federally registered pesticides to meet special local needs.” Pursuant to FIFRA section 24(c), EPA's regulations at 40 CFR 162.154(h) require States to notify EPA of such special local needs registrations. EPA's regulations pertaining to such special local need registrations state that “the Administrator may disapprove, on any reasonable grounds, any state [special local needs] registration . . . Grounds for disapproval . . . include . . . [p]robable creation of unreasonable adverse effects on man or the environment by the registered use[and f]ailure of information submitted by the State to support the State's decision to issue the registration under the standards established by § 162.153.” 40 CFR 162.154(a)(1). In addition, FIFRA Section 24(c)(1) precludes state SLN registrations “if registration for such use has . . . previously been denied, disapproved, or canceled by the Administrator, or voluntarily canceled by the registrant subsequent to issuance of a notice of intent to cancel because of health or environmental concerns about an ingredient contained in the pesticide product.” 40 CFR 162.152(a)(3).
On March 15, 2021, EPA disapproved special local need registrations from the North Carolina Department of Agriculture and Consumer Services to extend the application cut-off dates to July 31 for over-the-top (OTT) use of the following dicamba products on dicamba-tolerant soybean and dicamba-tolerant cotton:
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On April 9, 2021, EPA disapproved special local need registrations from the Tennessee Department of Agriculture to extend the application cut-off date to July 30 for OTT use of the following dicamba products on dicamba-tolerant soybean:
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On April 23, 2021, EPA disapproved special local need registrations from the Georgia Department of Agriculture to reduce the annual application training requirement to every other year, remove application cut-off dates and reduce buffer requirements for OTT use of the following dicamba product on dicamba-tolerant soybean and dicamba-tolerant cotton:
Additional information may be found in the docket for this action, docket ID number EPA-HQ-OPP-2021-0224, available at
Environmental Protection Agency (EPA).
Notice—final determination; correction.
The Environmental Protection Agency (EPA) is correcting a notice of final determination published on May 11, 2021. EPA determined that adequate facilities for the safe and sanitary removal and treatment of sewage from all vessels were reasonably available to support the State's prohibition of vessel sewage discharges in thirteen waterbodies in Anne Arundel County, Maryland, but has since identified errors in the geographic coordinates that correspond to the boundaries of the no-discharge zones as described in the earlier notice. This notice simply corrects those geographic coordinate errors; it does not otherwise change EPA's May 11, 2021 final determination.
This correction is effective on September 13, 2021.
Ferry Akbar Buchanan, U.S. Environmental Protection Agency—Region III. Telephone: (215) 814-2570; email address:
On May 11, 2021 (86 FR 25856), EPA published a notice of final determination, “Clean Water Act: No-Discharge Zones for Vessel Sewage in Maryland and Virginia.” The notice explained EPA's determination that adequate facilities for the safe and sanitary removal and treatment of sewage from all vessels are reasonably available for the thirteen waterbodies located in Anne Arundel County for which Maryland sought to establish a no-discharge zone for vessel sewage under Clean Water Act section 312(f)(3). The document also provided one of the geographic coordinates from an existing no-discharge zone for Perrin River, Virginia, published at 85 FR 59796 on September 23, 2020.
As published, the notice of the final determination misidentified the geographic coordinates of the no-discharge zone boundaries for Bodkin Creek, Magothy and Little Magothy Rivers, Podickory Creek, Sandy Point/Mezick Pond, Severn River, Fishing Creek, and South River waterbodies. The notice explained these boundaries in narrative terms; the earlier-published geographic coordinates did not correspond to the narrative descriptions of the boundaries for which EPA made the determination. Upon identifying the errors, EPA confirmed the correct geographic coordinates with Maryland. EPA finds that there is good cause to make this correction without prior notice and opportunity to comment on the basis that notice and comment is unnecessary and would not be in the public interest. The change merely conforms numeric geographic coordinates to the clear narrative descriptions and detailed maps of the no-discharge zone boundaries that were included in Maryland's application and upon which EPA's approval was based. As such, this correction does not alter EPA's earlier determination. EPA further determines that good cause exists to make the change effective upon publication, rather than delay the effective date, because the narrative boundary descriptions are clear, rendering a delayed effective date unnecessary. In addition, public interest requires prompt confirmation of the correct numeric geographic coordinates further describing the no-discharge zone boundaries.
In the
Export-Import Bank of the United States.
Submission for OMB review and comments request.
The Export-Import Bank of the United States (EXIM), as a part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal Agencies to comment on the proposed information collection, as required by the Paperwork Reduction Act of 1995.
Comments must be received on or before October 13, 2021 to be assured of consideration.
Comments may be submitted electronically on
The form can be viewed at:
To request additional information, please Edward Coppola
Form can be viewed at
Our customers will be able to submit this form on paper or electronically. This form is used by insurance brokers to register with Export-Import Bank. It provides EXIM staff with the information necessary to make a determination of the eligibility of the broker to receive commission payments under Export-Import Bank's credit insurance programs.
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 on the collection(s) of information must be received by the OMB desk officer by
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following:
1. Access CMS' website address at website address at:
William Parham at (410) 786-4669.
Under the Paperwork Reduction Act of 1995 (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 (44 U.S.C. 3506(c)(2)(A)) requires federal agencies to publish a 30-day notice in the
1.
This iteration proposes to: Remove certain reporting requirements, revise the information collection instrument, and revise reporting instructions. We are also proposing to change the respondent's occupation and hourly wage, adjust the number of respondents, and adjust the number of enrollees by using more recent data.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or Agency) announces a forthcoming public advisory committee meeting of the Blood Products Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. Members will participate via teleconference. At least one portion of the meeting will be closed to the public.
The meeting will be held on November 4, 2021, from 9:30 a.m. to 5:20 p.m. Eastern Time.
Please note that due to the impact of the COVID-19 pandemic, all meeting participants will be joining this advisory committee meeting via an online teleconferencing platform. The online web conference meeting will be available at the following link on the day of the meeting:
Christina Vert or Joanne Lipkind, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 6268, Silver Spring, MD 20993-0002, 240-402-8054,
FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's website after the meeting. Background material is
For press inquiries, please contact the Office of Media Affairs at
FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Christina Vert (
FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our website at
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is withdrawing approval of three new drug applications (NDAs) from multiple holders of those NDAs. The basis for the withdrawal is that these NDA holders have repeatedly failed to file required annual reports for those NDAs.
Approval is withdrawn as of September 13, 2021.
Kimberly S. Lehrfeld, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6226, Silver Spring, MD 20993-0002, 301-796-3137,
The holder of an approved application to market a new drug for human use is required to submit annual reports to FDA concerning its approved application in accordance with § 314.81 (21 CFR 314.81).
In the
FDA finds that the holders of the NDAs listed in table 1 have repeatedly failed to submit reports required by § 314.81. In addition, under § 314.200, FDA finds that the holders of the NDAs have waived any contentions concerning the legal status of the drug products. Therefore, under these findings, approval of the NDAs listed in table 1 and all amendments and supplements thereto is hereby withdrawn as of September 13, 2021.
Food and Drug Administration, Health and Human Services (HHS).
Notice.
The Food and Drug Administration (FDA or Agency) is consolidating regulatory oversight responsibilities in the Center for Biologics Evaluation and Research (CBER) for certain devices that process autologous human cells, tissues, and cellular and tissue-based products (HCT/Ps) at the point of care where the device output is intended to mediate the intended therapeutic effect. To support this consolidation effort, fat transfer devices (described further below) with the product code MUU that are currently regulated by the Center for Devices and Radiological Health (CDRH) will be transferred to CBER for regulation. This action affects only center assignment.
John Barlow Weiner, Office of Combination Products, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5130, Silver Spring, MD 20993, 301-796-8941,
FDA is consolidating regulatory oversight responsibilities in CBER for devices that process autologous human cells, tissues, and cellular and tissue-based products (HCT/Ps) at the point of care to produce a therapeutic article. To support this consolidation effort, fat transfer devices (described further below) with the product code MUU that are currently regulated by CDRH will be transferred to CBER for regulation. This action affects only center assignment.
FDA has the authority to regulate devices as defined under section 201(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(h)). Devices may be regulated by CDRH or CBER (see,
In July 2007, the Agency published the final guidance “Devices Used to Process Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)” to assist sponsors in determining which center at FDA would have regulatory oversight for devices used at the point of care to process HCT/Ps (Ref. 2). Assignment of these devices is determined by whether the point-of-care device creates an HCT/P that is intended to mediate the intended therapeutic effect. Point-of-care devices that process autologous materials are assigned to CBER when the intended therapeutic effect is mediated by the biological output of the device. For example, a cell sorter that is used to isolate CD34+ cells from bone marrow for use in hematopoietic reconstitution is assigned to CBER for review and regulation because the cellular output of the device is intended to provide the intended therapeutic effect.
Since the publication of the 2007 guidance, assignment of point-of-care devices intended to process HCT/Ps has generally been consistent with that guidance, with a few exceptions. Under 21 CFR 878.5040, a suction lipoplasty system is a Class II device that is intended for aesthetic body contouring and consists of a powered suction pump (containing a microbial filter on the exhaust and a microbial in-line filter in the connecting tubing between the collection bottle and the safety trap), collection bottle, cannula, and connecting tube. These devices act by removal of unwanted fat from areas of the body.
However, fat transfer devices, that is, devices that process adipose tissue for return to the body, have also been regulated at CDRH and assigned the same product code, MUU, as suction lipoplasty systems. While suction lipoplasty devices for fat removal do not produce an article for return to the body in order to mediate an intended therapeutic effect, the output of fat transfer devices is returned to the body in order to mediate the intended therapeutic effect (
This transfer does not include the suction lipoplasty devices previously in product code MUU that are solely intended to remove fat for discard for the purpose of body contouring. These devices have been assigned a new product code, QPB, and will continue to be regulated by CDRH. For the transferred MUU products, submissions, communications, and required reports should be directed to CBER. Submissions, communications, and required reports for the QPB products should continue to be directed to CDRH. Additionally, CDRH will continue to handle submissions under review or on hold (
The following references are on display in the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500 and is available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; it is also available electronically at
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) 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 October 13, 2021.
To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to
Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10 a.m.-12 p.m., 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726,
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
Section 1701(a)(4) of the Public Health Service Act (42 U.S.C. 300u(a)(4)) authorizes FDA to conduct research relating to health information. Section 1003(d)(2)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 393(d)(2)(C)) authorizes FDA to conduct research relating to drugs and other FDA regulated products in carrying out the provisions of the FD&C Act.
The Office of Prescription Drug Promotion's (OPDP) mission is to protect the public health by helping to ensure that prescription drug promotion is truthful, balanced, and accurately communicated. OPDP's research program provides scientific evidence to help ensure that our policies related to prescription drug promotion will have the greatest benefit to public health. Toward that end, we have consistently conducted research to evaluate the aspects of prescription drug promotion that are most central to our mission. Our research focuses in particular on three main topic areas: Advertising features, including content and format; target populations; and research quality. Through the evaluation of advertising features, we assess how elements such as graphics, format, and disease and product characteristics impact the communication and understanding of prescription drug risks and benefits. Focusing on target populations allows us to evaluate how understanding of prescription drug risks and benefits may vary as a function of audience, and our focus on research quality aims at maximizing the quality of research data through analytical methodology development and investigation of sampling and response issues. This study will inform the first two areas: Advertising features and target populations.
Because we recognize that the strength of data and the confidence in the robust nature of the findings is improved by utilizing the results of multiple converging studies, we continue to develop evidence to inform our thinking. We evaluate the results from our studies within the broader context of research and findings from other sources, and this larger body of knowledge collectively informs our policies as well as our research program. Our research is documented on our homepage, which can be found at:
The purpose of this research is to build on prior FDA research on the topic of disclosures by examining the impact of disclosures of two different types of information, detailed later in this notice. The literature on disclosures suggests their effectiveness is subject to format, design, and audience factors, among other things (Ref. 1). For example, research on consumer attitudes has found some people believe that FDA evaluates certain dietary supplement claims despite the presence and consumer awareness of language required by the Dietary Supplement Health and Education Act, which clearly states that FDA has not evaluated those claims (Refs. 2 and 3). In the context of prescription drug promotion, there is initial evidence that—when noticed—disclosures may effectively convey important information (Refs. 4 to 6); however, what role disclosures may play in educating or correcting misunderstanding warrants further investigation.
In the new study proposed here, the first type of disclosed information we will examine is clinical benefit information based on a secondary endpoint reported in a product's approved labeling (a secondary claim). In some cases, truthful and non-misleading presentations about secondary endpoints in well-designed clinical studies can provide reliable information about treatment effects that may be distinct from the treatment effects described in the product's indication statement. For example, a product may be indicated to treat a specific type of cancer based on a primary endpoint of survival. However, a secondary endpoint in the study of that product may provide data about an additional distinct benefit, such as functional status.
Phase 1 of the proposed research will examine the impact of adding a disclosure about a secondary claim in DTC and healthcare provider (HCP)-directed promotion in the context of a prescription drug website. We will also examine the effect of the presence of a comparative claim about the secondary claim. Our proposed main outcome measures are perceptions of and attitudes toward the product, the secondary claim, and the disclosure. The pretest and main studies for Phase 1 will have the same design, will be conducted online, and will follow the same procedure. We will examine four levels of secondary claim disclosure to explore the effects of disclosing that the secondary benefit is not one of the indicated uses of the product (
The second, independent phase of the proposed research will examine disclosures about a biosimilar product. In both consumer and HCP audiences, we will assess the impact of a disclosure designating the product as a biosimilar as well as varying basic factual statements about biosimilars. Phase 2 will examine the impact of: (1) Adding a disclosure designating the product as a biosimilar; (2) adding general informational statements about biosimilars; and (3) naming a reference product. This approach allows us to examine the effect of disclosing biosimilar status; examines the additive effect of including one, two, or three additional basic statements of information about biosimilars; and measures the effect of naming the reference product. Our proposed main outcome measures are perceptions of and attitudes toward the biosimilar product and the disclosure.
We propose to examine seven different disclosure conditions plus a control with no disclosure for a total of eight test conditions. As a baseline, each of the seven disclosure conditions will include a statement that the drug is a biosimilar. Six of the seven disclosure conditions will include this baseline statement and will vary the amount of additional basic factual information about biosimilar products in the following way: (1) Two of the six conditions have the baseline + statement A; (2), two of the six conditions have the baseline + statement A + statement B; and (3) two of the six conditions have the baseline + statement A + statement B + statement C. Moreover, three of the six disclosure conditions will name the specific reference product while the other three will refer to a reference product generally (for example, “This biosimilar is a biological product that is highly similar to and has no clinically meaningful differences from an existing FDA-approved reference product”). The wording of the disclosure will be tailored to the audience; for example, the disclosures for the consumer audience will avoid technical terms. A control condition will also be included in which no biosimilar statement or additional information disclosure is presented.
The pretest and main studies for Phase 2 will have the same design, will be conducted online, and will follow the same procedure. Both phases will be conducted concurrently. Sample sizes were determined on the basis of power analysis that will allow us to detect medium effect sizes.
In the
(Comment 1) Two comments were supportive of the study, and one comment was supportive of the study's inclusion of both HCP and consumer samples.
(Response 1) We thank the commenters for their support of the research.
(Comment 2) One comment asserted that FDA has not made the stimuli available for public comment.
(Response 2) Our full stimuli are under development during the PRA process. We do not make draft stimuli public during this time because of concerns that this may contaminate our participant pool and compromise our research. In our research proposals, we describe the purpose of the study, the design, the population of interest, and the estimated burden.
(Comment 3) Two comments recommended FDA ensure the wording of the stimuli in both phases is appropriate to each audience (HCP and consumer), and one comment suggested FDA partner with a health literacy organization.
(Response 3) We assessed understanding of both the consumer and provider versions of statements through in-depth cognitive interviews and will also do so in our survey. Findings from our cognitive interviews suggest that most consumers understood the gist of this information, although they were not always familiar with some terminology.
(Comment 4) One comment suggested we measure diabetes and obesity comorbidities of the Phase 1 consumer sample. One comment suggested we restrict the Phase 2 sample to consumers who have rheumatoid arthritis (RA), half of whom are being treated with a biologic for that condition, and one comment suggested we only sample rheumatologists.
(Response 4) In Phase 1 we are measuring participants' self-reported diagnosis of type 2 diabetes, knowledge about the disease and treatments for type 2 diabetes and weight loss, and prior experience with type 2 diabetes and weight loss treatment. These will be used as covariates in the analyses, where appropriate.
With respect to the suggestion to limit the sample to diagnosed consumers and rheumatologists in Phase 2, there are several factors to consider. Diagnosed sample participants are likely to be more motivated to read the ad because it is relevant to their medical condition. On the other hand, participants in that sample are also more likely to be familiar with treatments for their condition and bring with them prior knowledge that may influence their responses. As in Phase 1, we will assess treatment familiarity and diagnosis amongst our general population sample and control for those variables. While we understand that the Phase 2 topic may be relevant for specialists, and we do often include specialists in our research, we chose not to limit our HCP sample. Recruiting from a wider HCP sample is more reflective of the reality of the healthcare environment where patients interact with HCPs across multiple specialties and expertise. Further, specialists make up a small proportion of HCPs, which makes them harder to recruit. In 2020, for example, the proportion of specialists representing each specialty area ranged from 3 percent (endocrinologists) to 17 percent (emergency medicine specialists) (Ref. 7). These data demonstrate that the pool of potentially eligible specialists is limited.
(Comment 5) One comment suggested we focus the study on patients rather than HCPs, as the knowledge levels of patients is low, or perhaps conduct separate but parallel studies of both HCPs and patients.
(Response 5) The study will be conducted among two separate populations, consumers from the general population and HCPs. As shown in table 1, the study design incorporates parallel arms for consumers and HCPs.
(Comment 6) One comment suggested FDA ensure a sufficient sample size to conduct rigorous statistical analysis.
(Response 6) We conducted a power analyses to determine the sample size per study arm and will have a sufficient sample to rigorously test our research questions.
(Comment 7) Two comments suggested studying comparative claims in a separate study to reduce participant burden and confusion.
(Response 7) Our proposed design examines the impact of adding comparative and quantitative information to the disclosure of interest (see table 1). Each participant will see only one claim. Because these variables are fully crossed in the design, we will be able to examine the impact of comparative information and quantitative information separately.
(Comment 8) One comment asked FDA to explain the added value and appropriateness of including disclosures in biosimilar product promotional materials. The comment cautioned that disclosures must not be couched in cautionary or negative terms or include statements that are ambiguous or of minimal relevance to patients.
(Response 8) Currently, FDA neither requires nor prohibits biosimilar-related disclosures in biosimilar product promotion, and this research does not presuppose or reflect any established FDA position on their value. FDA is using this research to gather information to assess how certain biosimilar product disclosures, if they are used in promotion, could impact perceptions. Our study seeks to test several variations of biosimilar statements. We specifically examined potential negative reactions during in-depth cognitive interviews. Participants in our interviews expressed that the language was neutrally worded, and participants did not perceive the statements to be negative or cautionary.
(Comment 9) One comment questioned whether there was a control group in the Phase 2 questionnaire and suggested a control group that will not identify the product as a biosimilar be included.
(Response 9) The Phase 2 study includes a control condition where the promotional material does not identify the product as biosimilar.
(Comment 10) One comment noted that the prescribing information for a biosimilar does not include a named reference product and questioned why FDA is mandating inclusion of a named reference product in biosimilar promotional materials.
(Response 10) Sponsors may choose to disseminate promotion in which a comparator product is named. These comparative promotions exist in the marketplace. One purpose of Phase 2 is to examine the difference between a disclosure statement that includes a named comparator and one that refers to a comparator generally. The fact that FDA is conducting research that includes specific disclosures does not create a requirement that sponsors use any of those disclosures or any other requirement.
(Comment 11) Two comments suggested concepts that should be conveyed in the biosimilar disclosures. One comment stressed the importance of the tone of the disclosure statement about biosimilars. The following key messages were proposed for inclusion in the study:
1. Patients can expect that biosimilars will provide the same safety and effectiveness as the reference product.
2. FDA has a rigorous review and approval process, applying the same high-quality standards to both biosimilars and reference products.
3. Patients have been benefitting from the use of biosimilars for many years.
The second comment suggested the study should also include an examination of the impact of adding additional information about the list of extrapolated indications, and the rationale for extrapolation of indications to a biosimilar product to assess impact on HCP perceptions.
(Response 11) This study seeks to test several variations on potential biosimilar statements but does not attempt to test all possible statements. We decline to expand this study to test additional content like that suggested by the comments, but other content may be considered in future research. With regard to the comment about tone, for the disclosure variations that we will test, we examined potential negative reactions during in-depth cognitive interviews. Participants in our interviews expressed that the language was neutrally worded, and participants did not perceive the statements to be negative or cautionary. An examination of how HCPs perceive a biosimilar based on extrapolated indications is beyond the scope of this research. It may be considered in future research.
(Comment 12) One comment suggested Phase 1 and Phase 2 be converted to separate studies.
(Response 12) Phase 1 and Phase 2 are intended to be two separate studies that are being examined concurrently for efficiency. We will make this distinction clear in any discussion of results.
(Comment 13) One comment recommended FDA narrow the scope of the research to questions within its jurisdiction and eliminate overlap with other ongoing research.
(Response 13) As explained earlier, the Public Health Service Act authorizes FDA to conduct research relating to health information, and the FD&C Act authorizes FDA to conduct research relating to drugs and other FDA regulated products in carrying out the provisions of the FD&C Act. The study is within FDA's authority, and it will help to inform OPDP's work to help ensure that prescription drug information is truthful, balanced, and accurately communicated, so that HCPs and consumers can make informed decisions. While the comment did not identify any specific ongoing research as overlapping, we note that in general, OPDP may conduct concurrent or overlapping studies on similar topics to serve these goals.
(Comment 14) One comment suggested participants be permitted to refer back to the stimuli while answering questions.
(Response 14) For this study we will instruct participants to read the material carefully and alert them that they will be answering several questions about the content that they just saw. The goal of this study is not to assess participants' comprehension of detailed, verbatim information in the stimuli, for which repeated exposures to study stimuli may be more appropriate. Rather, our study will determine if experimental manipulation of the disclosure language influences “gist” understanding of the information, attitudes, and perceptions (Ref. 8). Allowing for multiple exposures to the stimuli could potentially influence these outcomes. A large body of literature supports presence of a “mere exposure effects” in social science research, where more exposure enhances processing and increases positive affect towards stimuli (Refs. 9 and 10).
(Comment 15) One comment stated the research lacks practical utility because it treats the secondary benefit claim as not related to the product's indicated uses, and the comment recommends that FDA revise Phase 1 of the study to reflect that secondary endpoints are not inherently unapproved uses and to focus instead on comprehension of what is a primary versus secondary endpoint in the data supporting a drug's approval.
(Response 15) In this study, we are not making a generalization about the approval status of secondary endpoints. We are examining the specific case of a disclosure about a secondary endpoint that, while it may be related to the product's primary indication, is not in itself an indication for the product and was not evaluated in such a way to support the drawing of conclusions about the product's effect on that endpoint. In this scenario, a disclosure about the secondary claim may help the audience interpret the secondary claim and provide context. The purpose of this study is to evaluate such disclosures about this specific type of secondary claim and measure the impact on perceptions of and attitudes toward the product, the secondary claim, and the disclosure. For instance, we will vary such elements as the presence of quantitative information about the secondary claim and the presence of comparative information (see table 1 for full design). We note that there are examples of prescription drug ads currently in use that contain language similar to what we are evaluating in order to qualify secondary endpoints, thus highlighting the practical utility of this research.
(Comment 16) One comment suggested changes to the instructions for Phase 2 to state that the study is intended to “assess your understanding of and reactions to biosimilar biologic drug disclosures.”
(Response 16) The control condition does not identify the product as biosimilar. To maintain the internal validity of the study and avoid potentially biasing participants' responses, we will keep the instructions as they are.
(Comment 17) One comment suggested changing the dosage route and strength of the reference product to be consistent with currently marketed biologics.
(Response 17) We have made this change.
(Comment 18) Two comments asked that the name of the reference product be changed to one that is fictitious.
(Response 18) We have made this change and will use a fictitious reference product name.
(Comment 19) One comment suggested stratifying the sample on several variables. The comment suggested that obesity and diabetes diagnosis be considered specifically for Phase 1, as well as variables like disease severity, treatment history (
(Response 19) Typically, stratified randomization is used if there are prognostic variables that correlate with outcome measures and researchers are concerned about such factors not being evenly distributed across groups (Ref. 11). We have no reason to believe that we will not achieve adequate balance of prognostic variables given the large sample size proposed for this study (Ref. 11). Random assignment will help to produce groups that are, on average, probabilistically similar to each other. Because randomization eliminates most other sources of systematic variation, we can be reasonably confident that any effect that is found is the result of the intervention and not some preexisting differences between the groups (Ref. 12). Our survey includes several questions about health and medical demographics that will enable us to assess their association with our outcomes and statistically control for them if necessary.
(Comment 20) One comment suggested using consistent scales throughout the study and adding “based on the ad you just saw” to many of the questions.
(Response 20) As suggested, we have added statements in the instructions for respondents to answer based on the promotion they “just saw” for clarification. Where possible, we have used validated measures and have retained the scale endpoints of those measures. We do not believe that these varied types of questions will pose difficulties for respondents as we did not find evidence of difficulties in cognitive testing.
(Comment 21) One comment suggested deleting or revising Phase 1 Questions 4 to 7 to focus on whether the participant understands that the secondary use is linked to the approved primary indication.
(Response 21) Our collection of constructs and measures, grounded in behavioral theory (Refs. 1 to 3), assesses perceptions, attitudes, understanding, and intentions around prescription drug disclosures. Based on cognitive testing, we have removed these questions.
(Comment 22) One comment suggested deleting Phase 1 Questions 9, 15, and 16 because they deal with the practice of medicine.
(Response 22) The intent of Question 9 is to assess understanding of the secondary claim disclosure, which explains that even though the drug is not indicated for weight loss, that it can help some people lose weight. Based on
(Comment 23) One comment suggested deleting or clarifying Phase 1 Question 11 to refer to “type 1 or type 2 diabetes” rather than “other health conditions.” This comment also suggested revising Phase 1 Questions 12 to 16 to indicate they are focused on diabetic patients.
(Response 23) We have deleted Question 11 and have revised the other items to refer specifically to type 2 diabetes to improve question clarity.
(Comment 24) One comment suggested deleting or revising Phase 1 Question 10 to read “[Drug X] is approved for helping people without diabetes lose weight.”
(Response 24) We have deleted this question.
(Comment 25) One comment recommended deleting Phase 1 Questions 17 to 23 and Questions 35 to 38 because responses could be influenced by many reasons and it is unclear how these questions relate to the study objectives.
(Response 25) These items measure perceived efficacy and attitude toward the drug. Attitude toward the drug and perceived efficacy can influence other outcomes such as the intention to take the drug or mention it to the doctor. Thus, we believe it is important to assess these variables. Given that we are randomizing participants to experimental conditions, we suspect that differences between experimental conditions are due to the experimental manipulations rather than participants' background and experiences. Additionally, we also included several variables to measure participants' experience with diabetes and weight loss, as well as medications for these conditions. If these variables are related to perceived efficacy and attitude toward the drug, we plan to include them as covariates in analyses.
(Comment 26) One comment suggested deleting Phase 1 Questions 32 to 34 because these questions ask about perceived risks and side effects that are not within the stated study objectives.
(Response 26) The goal of the study is to examine the impact of the presence of the comparative claim and type of disclosures; it is possible for participants to form different (and potentially distorted) risk perceptions based on the presence or absence of the comparative claim or type of disclosure. Assessing this outcome will allow us to determine whether risk perceptions vary based on exposure to study manipulations.
(Comment 27) One comment suggested deleting or revising Phase 2 Questions 4 to 11 and Questions 14 to 18 because participants will not be able to evaluate the safety and efficacy of, or make decisions about, their intended course of action related to the fictitious drug.
(Response 27) The promotional material will include information on primary and secondary endpoints as well as an important safety information section. We acknowledge that in a clinical setting patients and HCPs may use additional information. However, the intent of these items is to understand whether exposure to different types of information related to the comparative claim and disclosure results in different comprehension or behavioral intention. All participants will have the same level of information regarding the fictitious drug with the only difference being the manipulated content. So, we would expect that all participants will be equally informed about the fictitious drug and differences between conditions could be attributed to the manipulations. Items 4 to 11 assess participant comprehension of promotional material.
(Comment 28) One comment suggested deleting all Phase 2 questions about the advertising statement, questions assessing participants' understanding of how prescription drugs and biologic products work, familiarity with similar treatments, and attitudes about pharmaceutical companies; in particular, Questions 3, 27 to 30, and 36.
(Response 28) The answers to these questions may help contextualize differences between the experimental conditions. There is some evidence that prior attitudes toward prescription drugs and pharmaceutical companies have an impact on attitudes and perceptions of particular prescription drugs and DTC ads (Ref. 13). Question 3 assesses attitudes toward the disclosure. For instance, it is possible that participants exposed to a certain disclosure may have more favorable attitudes towards the drug because they viewed the disclosure as trustworthy. Questions 27 to 30 and 36 will also help us contextualize the findings by understanding participants' prior beliefs about prescription drugs, biosimilars, and pharmaceutical companies that may influence their responses and how they process the disclosure, in which case we would include them as controls in our analyses.
(Comment 29) One comment suggested moving Phase 2 Questions 27 to 38 to the beginning of the questionnaire, before the participant views the stimuli.
(Response 29) These questions are included to contextualize the findings and obtain an understanding of participants' prior beliefs and perceptions about biosimilars and more broadly prescription drug promotion. We ask these questions after the main study outcomes are assessed so that we do not contaminate participants' thoughts and perceptions of the promotional material. In addition, we do not want to prime the participants in the control condition (who are not told the drug is a biosimilar) to think the drug is a biosimilar, which would be equivalent to one of the other study conditions.
(Comment 30) One comment suggested adding a response option to capture a neutral or “no reaction” response to questions.
(Response 30) There are benefits and drawbacks to including a neutral or “no reaction” response in survey research, and the decision to use a neutral mid-point depends on the goal of the measures. For items assessing comprehension of disclosure language, we include a “do not know” option as this response would indicate some level of uncertainty about the meaning of the disclosure, which is meaningful and actionable information. However, when assessing perceptions and attitudes towards disclosures, our objective is to force a selection and have participants choose a leaning towards agreement or disagreement with the statement. Inclusion of a neutral response option in these instances could potentially encourage “satisficing”—cuing participants to select a neutral response under uncertainty because it is offered (Ref. 14).
(Comment 31) One comment suggested clarifying Phase 2 Question 28 to make clear it refers to the
(Response 31) We have removed this item from our survey.
(Comment 32) One comment suggested revising Phase 2 Question 18 to ask about safety and efficacy separately because they may introduce bias if located in the same items.
(Response 32) We acknowledge safety and efficacy are separate issues, and we assess beliefs about safety and efficacy separately in Questions 5 to 8. However, because biosimilars have no clinically meaningful differences in safety, purity, or potency (safety and effectiveness) from their reference product, we are also interested in the impact of the disclosure statement on participants' perceptions of safety and efficacy as a whole. Given this, we do not believe this question will introduce bias.
(Comment 33) One comment suggested either deleting or revising questions about the biosimilar disclosure to make clear what “same types of sources” means.
(Response 33) The wording of the biosimilar disclosure statement was crafted using terminology from FDA's Biosimilar Basics Patient Materials (
(Comment 34) One comment suggested only asking Phase 2 Question 17 of participants who are currently receiving a biologic.
(Response 34) The intent of the question is to understand whether participants would ask their doctor to switch their medication after viewing the ad. We provided a hypothetical scenario and asked participants to answer this question as if they were taking the reference medication or another prescription medication to treat RA. This question would not be feasible among only those with RA who are receiving a biologic, given the prevalence of RA in the population (
FDA estimates the burden of this collection of information as follows:
The following references marked with an asterisk (*) are on display with the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500 and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; these also are available electronically at
Health Resources and Services Administration (HRSA), Department of Health and Human Services.
Notice.
This notice seeks public comment on several proposed updates to The Periodicity Schedule of the Bright Futures Recommendations for Pediatric Preventive Health Care (“Bright Futures Periodicity Schedule”), as part of the HRSA-supported preventive service guidelines for infants, children, and adolescents. Please see
Members of the public are invited to provide written comments no later than October 13, 2021. All comments received on or before this date will be reviewed and considered by the Bright Futures Periodicity Schedule Workgroup and provided for further consideration by HRSA in determining the recommended updates that it will support.
Members of the public who wish to provide comments can do so by accessing the public comment web page at:
Savannah Kidd, HRSA, Maternal and Child Health Bureau, email:
The Periodicity Schedule of the Bright Futures Recommendations for Pediatric Preventive Health Care (“Bright Futures Periodicity Schedule”), as part of the HRSA-supported preventive service guidelines for infants, children, and adolescents, is maintained in part through a national cooperative agreement, the Bright Futures Pediatric Implementation Program. Under Section 2713 of the Public Health Service Act, non-grandfathered group health plans and health insurance issuers must include coverage, without cost sharing, for certain preventive services for plan years (in the individual market, policy years) that begin on or after the date that is 1-year after the date the recommendation or guideline is issued. These include preventive health services provided for in the Bright Futures Periodicity Schedule as part of the HRSA-supported preventive services guidelines for infants, children, and adolescents. A panel of pediatric primary care experts convened to review the latest evidence has identified proposed updates to the Bright Futures Periodicity Schedule in several areas in response to new evidence impacting children. The proposed updates to the Bright Futures Periodicity Schedule are: (1) A new category for sudden cardiac arrest and sudden cardiac death risk assessment, (2) a new category for hepatitis B virus infection risk assessment, (3) add suicide risk as an element of universal screening for children ages 12-21, and (4) update of Psychosocial/Behavioral Assessment to Behavioral/Social/Emotional Screening. The updated category title will be “Behavioral/Social/Emotional Screening” with no revision to the ages in which the screening occurs (newborn to 21 years). Finally, two references related to dental fluoride varnish and fluoride supplementation are proposed to be added with no recommended changes to clinical practice.
The American Academy of Pediatrics, which has been the HRSA cooperative agreement recipient for this program since 2007, maintains the Periodicity Schedule. Under HRSA's cooperative agreement with the American Academy of Pediatrics, the Bright Futures Program is required to administer a process for developing and regularly recommending, as needed, updates to the Bright Futures Periodicity Schedule. As described in the Notice of Funding Opportunity for the Bright Futures Program (HRSA-18-078), the consideration of potential updates is expected to be “a comprehensive, objective, and transparent review of available evidence that incorporates opportunity for public comment. Accordingly, the award recipient will review the evidence on an annual basis to determine whether updates are needed, using a deliberative review process by experts qualified to conduct such a review; administer the receipt and consideration of public comments for a minimum of 30 calendar days following publication of the
Office of the Secretary, Health and Human Services (HHS).
Notice.
In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.
Comments on the ICR must be received on or before November 12, 2021.
Submit your comments to
When submitting comments or requesting information, please include the document identifier 0990-0475-60D and project title for reference, to Sherrette A. Funn, email:
Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
OMB No. 0990-0475.
The CABS is a longitudinal survey that will be fielded tri-annually to 4,000 U.S. adults for the duration of the Campaign via NORC at the University of Chicago's AmeriSpeak Panel. The survey will be fielded online, and each fielding period will last between 3 and 6 weeks. Those that respond to wave 1 of the survey will be recontacted in each wave, facilitating a comparison of COVID-19 behavior change over time for a representative sample and evaluation of U.S. adults. Panel members selected to participate in the study will receive one pre-invitation postcard in the mail, one email invitation, and three email reminders to complete the survey in each wave.
The MOS is a shorter, cross-sectional survey that will be fielded monthly to 5,000 U.S. adults for the duration of the Campaign via the Ipsos KnowledgePanel 5K Omnibus Survey. The survey will be fielded online, and each fielding period will last between 7 and 10 days.
National Institutes of Health, HHS.
Notice.
The National Cancer Institute, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the Supplementary Information section of this Notice to Sana Biotechnology Inc. Life Sciences Inc., (“Sana”), located in Seattle, Washington.
Only written comments and/or complete applications for a license which are received by the National Cancer Institute's Technology Transfer Center on or before September 28, 2021 will be considered.
Requests for copies of the patent applications, inquiries, and comments relating to the contemplated Exclusive Patent License should be directed to: Jim Knabb, Senior Technology Transfer Manager, at Telephone: (240)-276-7856; or at Email:
1. US Provisional Patent Application 61/042,329, filed April 4, 2008 (E-080-2008-0-US-01);
2. International Patent Application PCT/US2009/039,080, Filed April 1, 2009 (E-080-2008/0-PCT-02);
3. US Patent Application: 12/934,214, filed September 23, 2010 (E-080-2008-0-US-03);
4. US Patent Application 13/959,061, filed August 5, 2015 (E-080-2008-0-US-04);
5. US Patent Application 15/012,023, filed February 1, 2016 (E-080-2008-0-US-05);
6. US Patent Application 15/424,238, filed February 3, 2017 (E-080-2008-0-US-06).
1. US Provisional Patent Application 61/717,960, filed October 24, 2012 (E-291-2012-0-US-01);
2. International Patent Application PCT/US2013/060332, filed September 18, 2013 (E-291-2012-0-PCT-02);
3. Australia Patent Application No: 2019235926, filed September 2, 2020 (E-291-2012-0-AU-03);
4. Brazil Patent Application BR112015009003-6, filed April 22, 2015 (E-291-2012-0-BR-04);
5. Canada Application No: 2889055, filed September 18, 2013 (E-291-2012-0-CA-05);
6. China Application No: 201380061387.5, filed May 25, 2015 (E-291-2012-0-CN-06);
7. European Patent Application No: 13773468.7, filed September 18, 2013 (E-291-2012-0-EP-07);
8. India Patent Application No: 2344/CHENP/2015, filed September 18, 2013 (E-291-2012-0-IN-08);
9. Japan Application No: 539602/2015, filed April 24, 2015 (E-291-2012-0-JP-09);
10. Russia Patent Application: 2015117237, filed May 7, 2015 (E-291-2012-0-RU-10);
11. US Patent Application: 14/437,889, filed April 23, 2015 (E-291-2012-0-US-11);
12. Hong Kong Patent Application: 16101891.0, filed February 19, 2016 (E-291-2012-0-HK-12);
13. Russia Patent Application: 2018116582, filed May 4, 2018 (E-291-2012-0-RU-13);
14. Japan Patent Application: 2018-088908, filed May 2, 2018, (E-291-2012-0-JP-14);
15. Australia Patent Application: 2018204257, filed June 14, 2018 (E-291-2012-0-AU-16);
16. US Patent Application: 16/107,271, filed August 21, 2018 (E-291-2012-0-US-17);
17. Germany Patent Application: 13773468.7, filed April 22, 2015 (E-291-2012-0-DE-18);
18. Spain Patent Application: 13773468.7, filed April 22, 2015 (E-291-2012-0-ES-19);
19. France Patent Application: 13773468.7, filed April 22, 2015 (E-291-2012-0-FR-20);
20. Great Britain Patent Application: 13773468.7, filed April 22, 2015 (E-291-2012-0-GB-21);
21. Italy Patent Application: 13773468.7, filed April 22, 2015 (E-291-2012-0-IT-22);
22. China Patent Application: 201910500128.7, filed June 11, 2019 (E-291-2012-0-CN-23);
23. US Patent Application: 16/869,792, filed May 8, 2020 (E-291-2012-0-US-24).
1. US Provisional Patent Application No.: 62/135,442, filed March 19, 2015 (E-106-2015-0-US-01);
2. International Patent Application PCTUS2016/023055, Filed March 18, 2016 (E-106-2015-0-PCT-02);
3. US Patent Application: 15/559,485. Filed September 19, 2017 (E-106-2015-0-US-03).
1. US Provisional Patent Application No.: 62/135,442, filed May 15, 2017 (E-017-2017-0-US-01);
2. International Patent Application PCT/US2018/032,809, filed May 15, 2018 (E-017-2017-0-PCT-02);
3. Australia Patent Application No.: 2018269194, filed October 28, 2019 (E-017-2017-0-AU-03;
4. Canada Patent Application No: 3062433, filed May 15, 2018 (E-017-2017-0-CA-04);
5. China Patent Application No.: 201880032676.5, filed
6. European Patent Application No.: 18733012.1, filed May 15, 2018 (E-017-2017-0-EP-06);
7. Japan Patent Application No.: 2019-563082, filed November 13, 2019 (E-017-2017-0-JP-07);
8. Korea Patent Application No.: 2019-7017289, filed December 13, 2019, (E-017-2017-0-KR-08);
9. Singapore Patent Application No.: 11201910499V, filed November 11, 2019 (E-017-2017-0-SG-09);
10. United States Patent Application No.: 16/613,187, filed November 13, 2019 (E-017-2017-0-US-10).
The patent rights in these inventions have been assigned and/or exclusively licensed to the government of the United States of America.
The prospective exclusive license territory may be worldwide, and the fields of use may be limited to the following:
“Field 1: “Ex vivo allogeneic CAR-T”
The development, manufacture and commercialization of chimeric antigen receptor T cells (CAR-T cells) for the treatment of B cell malignancies, wherein the CAR-T cells are engineered to express a CAR that comprises the m971 binder and is mono-specific for CD22, or is specific to both CD22 and CD19 (but are not engineered to bind to any other B cell antigen), and the engineered CAR-T cells are generated
Field 2: “In vivo gene therapy vector”
The development, manufacture and commercialization of gene therapy vectors encoding a chimeric antigen receptor construct (CAR construct), wherein the CAR construct comprises either (i) a CD22 binder m971 or (ii) the CD22 binder m971 and a CD19 binder, but, in each case (i) and (ii), comprises no other binder against a B cell antigen. For the avoidance of doubt, the field of use excludes development, manufacture and commercialization of genetically modified autologous T cells made by obtaining a patient's T cells via a standard leukapheresis procedure, genetically modifying the T cells
This technology discloses CAR therapies that target CD22 alone or in combination with CD19 by utilizing the anti-CD22 binder known as m971. CD22 and CD19 are expressed on the surface of B cells in B cell malignancies and CAR-T utilizing binders targeting CD 19 and CD22 have shown early promise in clinical trials for B cell malignancies.
This Notice is made in accordance with 35 U.S.C. 209 and 37 CFR part 404. The prospective exclusive license will be royalty bearing, and the prospective exclusive license may be granted unless within fifteen (15) days from the date of this published Notice, the National Cancer Institute receives written
In response to this Notice, the public may file comments or objections. Comments and objections, other than those in the form of a license application, will not be treated confidentially, and may be made publicly available.
License applications submitted in response to this Notice will be presumed to contain business confidential information and any release of information from these license applications will be made only as required and upon a request under the Freedom of Information Act, 5 U.S.C. 552.
National Institutes of Health, Health and Human Services (HHS).
Notice.
In compliance with the requirement of the Paperwork Reduction Act of 1995, to provide opportunity for public comment on proposed data collection projects, the National Institute of Environmental Health Sciences (NIEHS), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication.
To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Dr. Kristianna Pettibone, Evaluator, Program Analysis Branch, NIEHS, NIH, 530 Davis Dr., Room 3055, Morrisville, NC 20560, or call non-toll-free number (984) 287-3303 or Email your request, including your address to:
Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 requires: Written comments and/or suggestions from the public and affected agencies are invited to address one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
Information gained from this primary data collection will be used in conjunction with data from grantee progress reports and presentations at grantee meetings to inform internal programs and new funding initiatives. Outcome information to be collected includes measures of agency-funded research resulting in dissemination of findings, investigator career development, grant-funded knowledge and products, commercial products and drugs, laws, regulations and standards, guidelines and recommendations, information on patents and new drug applications and community outreach and public awareness relevant to extramural research funding and emerging areas of research.
OMB approval is requested for 3 years. There are no costs to respondents, other than their time. The total estimated annualized burden hours are 700.
National Institutes of Health, HHS.
Notice.
The National Cancer Institute, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the Supplementary Information section of this notice to Athenex, Inc. (“Athenex”) headquartered in Buffalo, NY.
Only written comments and/or applications for a license which are received by the National Cancer Institute's Technology Transfer Center on or before September 28, 2021 will be considered.
Requests for copies of the patent application, inquiries, and comments relating to the contemplated an Exclusive Patent License should be directed to: Suna Gulay French, Ph.D., Technology Transfer Manager, NCI Technology Transfer Center, Telephone: (240)-276-5530; Email:
1. US Provisional Patent Application 62/565,383, filed September 29, 2017 (E-237-2017-0-US-01);
2. International Patent Application PCT/US2018/051285, filed September 17, 2018 (E-237-2017-2-PCT-01);
3. Australian Patent Application 2018342246, filed September 17, 2018 (E-237-2017-2-AU-02);
4. Brazilian Patent Application BR112020006012-7, filed September 17, 2018 (E-237-2017-2-BR-03);
5. Canadian Patent Application 3977024, filed September 17, 2018 (E-237-2017-2-CA-04);
6. Chinese Patent Application 201880074539.8, filed September 17, 2018 (E-237-2017-2-CN-05);
7. Costa Rica Patent Application 2020-0170, filed September 17, 2018 (E-237-2017-2-CR-06);
8. Eurasian Patent Application 202090757, filed September 17, 2018 (E-237-2017-2-EA-07);
9. European Patent Application 18780006.5, filed September 17, 2018 (E-237-2017-2-EP-08);
10. Israeli Patent Application 273515, filed September 17, 2018 (E-237-2017-2-IL-09);
11. India Patent Application 202047013911, filed September 17, 2018 (E-237-2017-2-IN-10);
12. Japanese Patent Application 2020-517556, filed September 17, 2018 (E-237-2017-2-JP-11);
13. Korean Patent Application 2020-7012344, filed September 17, 2018 (E-237-2017-2-KR-12);
14. Mexico Patent Application MX/a/2020/003504, filed September 17, 2018 (E-237-2017-2-MX-13);
15. New Zealand Patent Application 763023, filed September 17, 2018 (E-237-2017-2-NZ-14);
16. Singapore Patent Application 11202002636P, filed September 17, 2018 (E-237-2017-2-SG-15);
17. United States Utility Patent Application 16/651,242, filed September 17, 2018 (E-237-2017-2-US-16); and
18. Hong Kong Patent Application 62020021272.3, filed November 30, 2020 (E-237-2017-2-HK-17).
1. US Provisional Patent Application 62/867,619, filed June 27, 2019 (E-135-2019-0-US-01);
2. International Patent Application PCT/US2020/039785, filed June 26, 2020 (E-135-2019-0-PCT-02); and
3. Taiwanese Patent Application 109121744, filed June 26, 2020 (E-135-2019-0-TW-03).
1. US Provisional Patent Application 63/074,747, filed September 4, 2020 (E-173-2020-0-US-01).
1. US Provisional Patent Application 62/665,234, filed May 1, 2018 (E-098-2018-0-US-01);
2. International Patent Application PCT/US2019/030108, filed May 1, 2019 (E-098-2018-0-PCT-02);
3. Australian Patent Application 2019263233, filed May 1, 2019 (E-098-2018-0-AU-03);
4. Canadian Patent Application 3,099,106, filed May 1, 2019 (E-098-2018-0-CA-04);
5. European Patent Application 19723615.1, filed May 1, 2019 (E-098-2018-0-EP-05); and
6. United States Utility Patent Application 17/051,860, filed May 1, 2019 (E-098-2018-0-US-06).
1. US Provisional Application 63/050,9131, filed July 13, 2020 (E-165-2020-0-US-01); and
2. International Patent Application PCT/US2021/041375, filed July 13, 2021 (E-165-2020-0-PCT-02).
1. US Provisional Application 63/052,502, filed July 16, 2020 (E-172-2020-0-US-01); and
2. International Patent Application PCT/US2021/041737, filed July 15, 2021 (E-172-2020-0-PCT-02).
1. US Provisional Application 63/086,674, filed October 2, 2020 (E-189-2020-0-US-01).
1. US Provisional Application 63/060,340, filed August 3, 2020 (E-190-2020-0-US-01) and U.S., PCT and foreign patent applications claiming priority to the aforementioned application.
1. US Provisional Patent Application 62/565,464, filed September 29, 2017 (E-237-2017-1-US-01);
2. International Patent Application PCT/US2018/051280, filed September 17, 2018 (E-237-2017-1-PCT-02);
3. Australian Patent Application 2018342245, filed September 17, 2018 (E-237-2017-1-AU-03);
4. Canadian Patent Application 3080274, filed September 17, 2018 (E-237-2017-1-CA-04);
5. Chinese Patent Application 201880063656.4, filed September 17, 2018 (E-237-2017-1-CN-05);
6. European Patent Application 18782605.2, filed September 17, 2018 (E-237-2017-1-EP-06);
7. Israeli Patent Application 273516, filed September 17, 2018 (E-237-2017-1-IL-07);
8. Japanese Patent Application 2020-517553, filed September 17, 2018 (E-237-2017-1-JP-08);
9. Korean Patent Application 2020-7012343, filed September 17, 2018 (E-237-2017-1-KR-09);
10. Singapore Patent Application 11202002635R, filed September 17, 2018 (E-237-2017-1-SG-10);
11. United States Utility Patent Application 16/650,696, filed September 17, 2018 (E-237-2017-1-US-11); and
12. Hong Kong Patent Application 62020021274.9, filed November 30, 2020 (E-237-2017-1-HK-12).
The patent rights in these inventions have been assigned and/or exclusively licensed to the government of the United States of America.
The prospective exclusive license territory may be worldwide and the fields of use may be limited to the following:
“Development, manufacture, and commercialization of allogeneic Natural Killer T (NKT) cell therapy products engineered via viral and non-viral means, including CRISPR modification, to express T cell receptors reactive to mutated P53, KRAS, and EGFR within the context of multiple HLAs, as claimed in the Licensed Patent Rights, for the treatment of human cancers. For the purposes of this license, NKT cells are a subset of peripheral blood lymphocytes specifically and intentionally isolated based on unique characteristics of NKT cells resulting in a manufactured clinical product containing at least 50% NKT cells.”
“Development, manufacture, and commercialization of allogeneic Natural Killer T (NKT) cell therapy products engineered via viral and non-viral means, including CRISPR modification, to express T cell receptors reactive to mutated P53, isolated as claimed in the Licensed Patent Rights, for the treatment of human cancers. For the purposes of this license, NKT cells are a subset of peripheral blood lymphocytes specifically and intentionally isolated based on unique characteristics of NKT cells resulting in a manufactured clinical product containing at least 50% NKT cells.”
Intellectual Property Group A description is as follows:
E-237-2017-0, E-135-2019 and E-173-2020 patent rights are primarily directed to isolated TCRs reactive to mutated tumor protein 53 (TP53 or P53), within the context of several HLAs.
E-165-2020, E-172-2020, E-189-2020 and E-190-2020 patent rights are primarily directed to isolated TCRs reactive to mutated Kirsten rat sarcoma viral oncogene homolog (KRAS), within the context of several human leukocyte antigens (HLAs). Mutated KRAS, which plays a well-defined driver role in oncogenesis, is expressed by a variety of human cancers, including: Pancreatic, lung, endometrial, ovarian and prostate. Due to its restricted expression in precancerous and cancerous cells, this antigen may be targeted on mutant KRAS-expressing tumors with minimal normal tissue toxicity.
E-098-2018 patent rights are primarily directed to isolated TCRs reactive to mutated epidermal growth factor receptor (EGFR), within the context of HLA DPA1*02:01 DPB1*01:01. EGFR is a transmembrane protein involved in cell growth and proliferation signaling. Mutations in the gene encoding EGFR can lead to its overexpression, causing several types of cancer (
Intellectual Property Group B description is as follows:
E-237-2017-1 patent rights are primarily directed to methods of rapidly isolating T cells which are reactive to mutated P53 antigens. Briefly, pools of 25-mer peptides covering all known P53 “hotspot” mutations have been generated. These peptides may be pulsed into antigen presenting cells which are subsequently co-cultured with isolated T cells. Reactive T cells are then purified and may be used as source material for the further isolation of mutant P53-targeting TCRs.
This notice is made in accordance with 35 U.S.C. 209 and 37 CFR part 404. The prospective exclusive license will be royalty bearing, and the prospective exclusive license may be granted unless within fifteen (15) days from the date of this published notice, the National Cancer Institute receives written evidence and argument that establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR part 404.
In response to this Notice, the public may file comments or objections. Comments and objections, other than those in the form of a license application, will not be treated confidentially, and may be made publicly available.
License applications submitted in response to this Notice will be presumed to contain business confidential information and any release of information in these license applications will be made only as required and upon a request under the Freedom of Information Act, 5 U.S.C. 552.
Bureau of Land Management, Interior.
Notice of information collection; request for comment.
In accordance with the Paperwork Reduction Act of 1995 (PRA), the Bureau of Land Management (BLM) proposes to renew an information collection.
Interested persons are invited to submit comments on or before October 13, 2021.
Written comments and recommendations for this information collection request (ICR) should be sent within 30 days of publication of this notice to
To request additional information about this ICR, contact Susie Greenhalgh by email at
In accordance with the PRA and 5 CFR 1320.8(d)(1), we provide the general public and other Federal agencies with an opportunity to comment on new,
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, notwithstanding any other provision of law, 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.
Notice.
The Illinois State Museum has completed an inventory of human remains and associated funerary objects, in consultation with the appropriate Indian Tribes or Native Hawaiian organizations, and has determined that there is a cultural affiliation between the human remains and associated funerary objects and present-day Indian Tribes or Native Hawaiian organizations. Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains and associated funerary objects should submit a written request to the Illinois State Museum. If no additional requestors come forward, transfer of control of the human remains and associated funerary objects to the lineal descendants, Indian Tribes, or Native Hawaiian organizations stated in this notice may proceed.
Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains and associated funerary objects should submit a written request with information in support of the request to the Illinois State Museum at the address in this notice by October 13, 2021.
Dr. Brooke Morgan, Illinois State Museum Research & Collections Center, 1011 East Ash Street, Springfield, IL 62703, telephone (217) 785-8930, email
Notice is here given in accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), 25 U.S.C. 3003, of the completion of an inventory of human remains and associated funerary objects under the control of the Illinois State Museum, Springfield, IL. The human remains and associated funerary objects were removed from Grundy County, IL.
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA, 25 U.S.C. 3003(d)(3). The determinations in this notice are the sole responsibility of the museum, institution, or Federal agency that has control of the Native American human remains and associated funerary objects. The National Park Service is not responsible for the determinations in this notice.
A detailed assessment of the human remains was made by the Illinois State Museum professional staff in consultation with representatives of the Forest County Potawatomi Community, Wisconsin; Nottawaseppi Huron Band of the Potawatomi, Michigan [previously listed as Huron Potawatomi, Inc.]; Peoria Tribe of Indians of Oklahoma; and the Winnebago Tribe of Nebraska. In addition, the Citizen Potawatomi Nation, Oklahoma; Hannahville Indian Community, Michigan; Ho-Chunk Nation of Wisconsin; Kickapoo Traditional Tribe of Texas; Kickapoo Tribe of Indians of the Kickapoo Reservation in Kansas; Kickapoo Tribe of Oklahoma; Match-e-be-nash-she-wish Band of Pottawatomi
On an unknown date, human remains representing, at minimum, one individual were removed from a burial in Grundy County, IL. The human remains were previously at the Grundy County Historical Society. The Society's records indicate the human remains may have been donated in the 1920s. In 1998, the human remains were transferred to the Illinois State Museum. The human remains belong to a child 3-12 years old and of indeterminate sex. No known individual was identified. The four associated funerary objects are three round metal brooches attached to a braid of hair and one lot of fabric.
The metal trade artifacts and fabric suggest a Late Historic date (ca. 1760-1820) for the burial. Based on these artifacts, historical records, and oral traditional information, these human remains are connected to the Potawatomi, Ho-Chunk/Winnebago, and Kickapoo, all of whom were in the Grundy County area during this time.
Officials of the Illinois State Museum have determined that:
• Pursuant to 25 U.S.C. 3001(9), the human remains described in this notice represent the physical remains of one individual of Native American ancestry.
• Pursuant to 25 U.S.C. 3001(3)(A), the four objects described in this notice are reasonably believed to have been placed with or near individual human remains at the time of death or later as part of the death rite or ceremony.
• Pursuant to 25 U.S.C. 3001(2), there is a relationship of shared group identity that can be reasonably traced between the Native American human remains and associated funerary objects and the Citizen Potawatomi Nation, Oklahoma; Forest County Potawatomi Community, Wisconsin; Hannahville Indian Community, Michigan; Ho-Chunk Nation of Wisconsin; Kickapoo Traditional Tribe of Texas; Kickapoo Tribe of Indians of the Kickapoo Reservation in Kansas; Kickapoo Tribe of Oklahoma; Match-e-be-nash-she-wish Band of Pottawatomi Indians of Michigan; Nottawaseppi Huron Band of the Potawatomi, Michigan [previously listed as Huron Potawatomi, Inc.]; Pokagon Band of Potawatomi Indians, Michigan and Indiana; Prairie Band Potawatomi Nation [previously listed as Prairie Band of Potawatomi Nation, Kansas]; and the Winnebago Tribe of Nebraska (hereafter referred to as “The Tribes”).
Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains and associated funerary objects should submit a written request with information in support of the request to Dr. Brooke Morgan, Illinois State Museum Research & Collections Center, 1011 East Ash Street, Springfield, IL 62703, telephone (217) 785-8930, email
The Illinois State Museum is responsible for notifying The Consulted and Invited Tribes that this notice has been published.
National Park Service, Interior.
Notice.
The Sam Noble Oklahoma Museum of Natural History (Museum) at the University of Oklahoma has completed an inventory of human remains and associated funerary objects, in consultation with the appropriate Indian Tribes or Native Hawaiian organizations, and has determined that there is a cultural affiliation between the human remains and associated funerary objects and present-day Indian Tribes or Native Hawaiian organizations. Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains and associated funerary objects should submit a written request to the Museum. If no additional requestors come forward, transfer of control of the human remains and associated funerary objects to the lineal descendants, Indian Tribes, or Native Hawaiian organizations stated in this notice may proceed.
Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains and associated funerary objects should submit a written request with information in support of the request to the Museum at the address in this notice by October 13, 2021.
Dr. Marc Levine, Associate Curator of Archaeology, Sam Noble Oklahoma Museum of Natural History, University of Oklahoma, 2401 Chautauqua Avenue, Norman, OK 73072-7029, telephone (405) 325-1994, email
Notice is here given in accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), 25 U.S.C. 3003, of the completion of an inventory of human remains and associated funerary objects under the control of the Sam Noble Oklahoma Museum of Natural History, University of Oklahoma, Norman, OK. The human remains and associated funerary objects were removed from McCurtain County, OK.
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA, 25 U.S.C. 3003(d)(3). The determinations in this notice are the sole responsibility of the museum, institution, or Federal agency that has control of the Native American human remains and associated funerary objects. The National Park Service is not responsible for the determinations in this notice.
A detailed assessment of the human remains was made by the Sam Noble Oklahoma Museum of Natural History professional staff in consultation with representatives of the Caddo Nation of Oklahoma and The Choctaw Nation of Oklahoma.
In 1941, human remains representing, at minimum, 10 individuals were removed from the Clement 1 site (34Mc8) in McCurtain County, OK. This mound and midden site was excavated in 1941 by the Works Progress Administration, and the excavated
The 1,103 associated funerary objects are: Four Avery Engraved type ceramic bowls, one Avery Engraved type ceramic bottle, 162 Avery Engraved type potsherds, two Emory Punctate type ceramic jars with castellated rims, one Simms Engraved type ceramic carinated bowl, 61 Simms Engraved type ceramic potsherds, six decorated ceramic bowls, one decorated ceramic jar, one decorated ceramic bottle, one decorated ceramic vessel with four applique nodes with rattles, one decorated ceramic vessel with four animal effigies on the rim, four undecorated ceramic bowls, one undecorated ceramic jar, one undecorated ceramic red olla vessel, two ceramic rattle fragments, 390 decorated potsherds, 352 undecorated potsherds, three ceramic pipe fragments, 31 small corner-notched projectile points, two Gary type projectile points, one chipped stone flake, one fragment of fire cracked rock, one stone celt, four pigment stones, one unmodified stone, two copper covered shell earspools, four faunal bone fragments, 17 shell beads, one engraved shell gorget, four engraved shell fragments, 26 shell fragments, four wood fragments, five charred corn cob fragments, one seed bead with sediment, two soil samples with possible textile matting, one charcoal sample from a vessel, and one daub fragment.
While the Clement 1 site (34Mc8) includes both historic and prehistoric components, all the human remains and associated funerary objects listed in this notice belong to the prehistoric component. Based on an analysis of the diagnostic cultural materials from the site (chipped and ground stone, ceramics, bone tools, and ornaments), as well as radiocarbon dates obtained from more recent investigations there, the prehistoric component of the site dates to A.D. 1200-1500. Archeological, oral traditional, and post-contact European historical information reasonably show that a cultural affiliation exists between the earlier group connected to the human remains and associated funerary objects at the Clement I site and the present-day Caddo Nation of Oklahoma.
Officials of the Sam Noble Oklahoma Museum of Natural History have determined that:
• Pursuant to 25 U.S.C. 3001(9), the human remains described in this notice represent the physical remains of 10 individuals of Native American ancestry.
• Pursuant to 25 U.S.C. 3001(3)(A), the 1,103 objects described in this notice are reasonably believed to have been placed with or near individual human remains at the time of death or later as part of the death rite or ceremony.
• Pursuant to 25 U.S.C. 3001(2), there is a relationship of shared group identity that can be reasonably traced between the Native American human remains and associated funerary objects and the Caddo Nation of Oklahoma.
Lineal descendants or representatives of any Indian Tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains and associated funerary objects should submit a written request with information in support of the request to Dr. Marc Levine, Associate Curator of Archaeology, Sam Noble Oklahoma Museum of Natural History, University of Oklahoma, 2401 Chautauqua Avenue, Norman, OK 73072-7029, telephone (405) 325-1994, email
The Sam Noble Oklahoma Museum of Natural History is responsible for notifying the Caddo Nation of Oklahoma and The Choctaw Nation of Oklahoma that this notice has been published.
Drug Enforcement Administration, Justice.
Notice of application.
The Drug Enforcement Administration (DEA) is providing notice of an application it has received from an entity applying to be registered to manufacture in bulk basic class(es) of controlled substances listed in schedule I. DEA intends to evaluate this and other pending applications according to its regulations governing the program of growing marihuana for scientific and medical research under DEA registration.
Registered bulk manufacturers of the affected basic class(es), and applicants therefor, may file written comments on or objections to the issuance of the proposed registration on or before November 12, 2021.
Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW 8701 Morrissette Drive, Springfield, Virginia 22152. To ensure proper handling of comments, please reference Docket No—DEA-XXX in all correspondence, including attachments.
The Controlled Substances Act (CSA) prohibits the cultivation and distribution of marihuana except by persons who are registered under the CSA to do so for lawful purposes. In accordance with the purposes specified in 21 CFR 1301.33(a), DEA is providing notice that the entity identified below has applied for registration as a bulk manufacturer of schedule I controlled substances. In response, registered bulk manufacturers of the affected basic class(es), and applicants therefor, may file written comments on or objections of the requested registration, as provided in this notice. This notice does not constitute any evaluation or determination of the merits of the application submitted.
The applicant plans to manufacture bulk active pharmaceutical ingredients (APIs) for product development and distribution to DEA registered researchers. If the application for registration is granted, the registrant would not be authorized to conduct
As this applicant has applied to become registered as a bulk manufacturer of marihuana, the application will be evaluated under the criteria of 21 U.S.C. 823(a). DEA will conduct this evaluation in the manner described in the rule published at 85 FR 82333 on December 18, 2020, and reflected in DEA regulations at 21 CFR part 1318.
In accordance with 21 CFR 1301.33(a), DEA is providing notice that on July 1, 2021, Amethyst Exploration, LLC., 4210 Jewell Road, Sparta, Georgia 31087, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substances:
Drug Enforcement Administration, Justice.
Notice of application.
Eli-Elsohly Laboratories has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
Registered bulk manufacturers of the affected basic class(es), and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before November 12, 2021. Such persons may also file a written request for a hearing on the application on or before November 12, 2021.
Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152.
In accordance with 21 CFR 1301.33(a), this is notice that on August 5, 2021, Eli-Elsohly Laboratories, 5 Industrial Park Drive, Oxford, Mississippi 38655, applied to be registered as an bulk manufacturer of the following basic class(es) of controlled substance(s):
The company plans to manufacture the listed controlled substances for product development and reference standards. In reference to drug codes 7360 (Marihuana) and 7370 (Tetrahydrocannabinols), the company plans to isolate these controlled substances from procured 7350 (Marihuana Extract). In reference to drug code 7360, no cultivation activities are authorized for this registration. In reference to drug code 9333 (Thebaine), the company plans to manufacture a Thebaine derivative. No other activities for these drug codes are authorized for this registration.
Drug Enforcement Administration, Justice.
Notice of application.
Aurobindo Pharma USA, Inc. has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
Registered bulk manufacturers of the affected basic class(es), and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before October 13, 2021. Such persons may also file a written request for a hearing on the application on or before October 13, 2021.
Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for a hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for a hearing should also be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/OALJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152.
In accordance with 21 CFR 1301.34(a), this is notice that on July 20, 2021, Aurobindo Pharma USA, Inc., 6 Wheeling Road, Dayton, New Jersey 08810-1526, applied to be registered as an importer of the following basic class(es) of controlled substance(s):
Approval of permit applications will occur only when the registrant's business activity is consistent with what is authorized under 21 U.S.C. 952(a)(2). Authorization will not extend to the import of Food and Drug Administration-approved or non-approved finished dosage forms for commercial sale.
Drug Enforcement Administration, Justice.
Notice of application.
Cayman Chemical Company, has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to
Registered bulk manufacturers of the affected basic class(es), and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before November 12, 2021. Such persons may also file a written request for a hearing on the application on or before November 12, 2021.
Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152.
In accordance with 21 CFR 1301.33(a), this is notice that on July 15, 2021, Cayman Chemical Company, 1180 East Ellsworth Road, Ann Arbor, Michigan 48108-2419, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s):
The company plans to bulk manufacture the listed controlled substances for internal use or for sale to its customers. In reference to dug codes 7360 (Marihuana), and 7370 (Tetrahydrocannabinols), the company plans to bulk manufacture these drugs as synthetic. No other activities for these drug codes are authorized for this registration.
On August 30, 2021, the Department of Justice lodged a proposed Consent Decree with the United States District Court for the Western District of Oklahoma in
The United States filed this lawsuit under Section 107 of the Comprehensive Environmental Response, Compensation, and Liability Act (“CERCLA”), 42 U.S.C. 9607, to recover its past response costs incurred at the Hudson Refinery Superfund Site in Cushing, Oklahoma (“Site”). The Consent Decree requires that Defendants pay the United States $5.7 million to reimburse those past response costs. The Consent Decree also resolves alleged violations by Defendant Land O'Lakes, Inc. of a U.S. Environmental Protection Agency CERCLA Unilateral Administrative Order at the Site.
The publication of this notice opens a period for public comment on the proposed Consent Decree. Comments should be addressed to the Assistant Attorney General, Environment and Natural Resources Division, and should refer to
During the public comment period, the proposed Consent Decree may be examined and downloaded at this Justice Department website:
Please enclose a check or money order for $6.25 (25 cents per page reproduction cost) payable to the United States Treasury.
Notice of availability; request for comments.
The Department of Labor (DOL) is submitting this Bureau of Labor Statistics (BLS)-sponsored information collection request (ICR) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995 (PRA). Public comments on the ICR are invited.
The OMB will consider all written comments that agency receives on or before October 13, 2021.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Comments are invited on: (1) Whether the collection of information is necessary for the proper performance of the functions of the Department, including whether the information will have practical utility; (2) if the information will be processed and used in a timely manner; (3) the accuracy of the agency's estimates of the burden and cost of the collection of information, including the validity of the methodology and assumptions used; (4) ways to enhance the quality, utility and clarity of the information collection; and (5) ways to minimize the burden of the collection of information on those who are to respond, including the use of automated collection techniques or other forms of information technology.
Mara Blumenthal by telephone at 202-693-8538, or by email at
The American Time Use Survey (ATUS) is the Nation's first federally administered, continuous survey on time use in the United States. It measures, for example, time spent with children, working, sleeping, or doing leisure activities. In the United States, several existing Federal surveys collect income and wage data for individuals and families, and analysts often use such measures of material prosperity as proxies for quality of life. Time-use data substantially augment these quality-of life measures. The data also can be used in conjunction with wage data to evaluate the contribution of non-market work to national economies. This enables comparisons of production between nations that have different mixes of market and non-market activities. 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.
Notice of availability; request for comments.
The Department of Labor (DOL) is submitting this Employee Benefits Security Administration (EBSA)-sponsored information collection request (ICR) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995 (PRA). Public comments on the ICR are invited.
The OMB will consider all written comments that agency receives on or before October 13, 2021.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Comments are invited on: (1) Whether the collection of information is necessary for the proper performance of the functions of the Department, including whether the information will have practical utility; (2) if the information will be processed and used in a timely manner; (3) the accuracy of the agency's estimates of the burden and cost of the collection of information, including the validity of the methodology and assumptions used; (4) ways to enhance the quality, utility and clarity of the information collection; and (5) ways to minimize the burden of the collection of information on those who are to respond, including the use of automated collection techniques or other forms of information technology.
Mara Blumenthal by telephone at 202-693-8538, or by email at
The Departments of Labor, Health and Human Services, and the Treasury share interpretive jurisdiction of the Mental Health Parity and Addiction Equity Act (MHPAEA) and have split enforcement jurisdictions. The Department of Labor is responsible for enforcing MHPAEA with respect to private employer-sponsored group health plans. The Consolidated Appropriations Act, enacted on December 27, 2020, amended MHPAEA, in part, by expressly requiring group health plans to perform and document a comparative analysis of the design and application of any non-quantitative treatment limitations (NQTLs) that apply to medical/surgical and mental health and substance use disorder benefits. 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.
Notice.
The Department of Labor, as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA95). This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. Currently, the Office of Workers' Compensation Programs is soliciting comments concerning the proposed collection: Authorization for Release of Medical Information (CM-936). A copy of the proposed information collection request can be obtained by contacting the office listed below in the addresses section of this Notice.
Written comments must be submitted to the office listed in the addresses section below on or before November 12, 2021.
You may submit comments by mail, delivery service, or by hand to Ms. Anjanette Suggs, U.S. Department of Labor, 200 Constitution Ave. NW, Room S-3323, Washington, DC 20210; by fax (202) 354-9660; or by Email to
The Black Lung Benefits Act, as amended, 30 U.S.C. 901
The Department of Labor is particularly interested in comments which:
* Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
* evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
* enhance the quality, utility and clarity of the information to be collected; and
* minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
The Department of Labor seeks approval for the extension of this currently-approved information collection in order to obtain claimant consent for the release of medical information for consideration by the Office of Workers' Compensation Programs in their claim for benefits. Failure to gather this information would inhibit the adjudication of black lung claims because pertinent medical data would not be available for consideration during the processing of the claim.
Comments submitted in response to this notice will be summarized and/or included in the request for Office of Management and Budget approval of the information collection request; they will also become a matter of public record.
Copyright Royalty Board, Library of Congress.
Notice requesting comments.
The Copyright Royalty Judges solicit comments on a motion of Multigroup Claimants for partial distribution of 2015-2017 cable royalty funds.
Comments are due on or before October 13, 2021.
Interested claimants must submit timely comments using eCRB, the Copyright Royalty Board's online electronic filing application, at
Anita Blaine, Program Specialist, 202-707-7658,
Each year cable systems must submit royalty payments to the Register of Copyrights as required by the statutory license set forth in sec. 111 of the Copyright Act for the retransmission to cable subscribers of over-the-air television and radio broadcast signals.
Allocation of the royalties collected occurs in one of two ways. In the first instance, the Judges may authorize distribution in accordance with a negotiated settlement among all claiming parties. 17 U.S.C. 111(d)(4)(A). If all claimants do not reach agreement with respect to the royalties, the Judges must conduct a proceeding to determine the distribution of any royalties that remain in controversy. 17 U.S.C. 111(d)(4)(B). Alternatively, the Judges may, on motion of claimants and on notice to all interested parties, authorize a partial distribution of royalties, reserving on deposit sufficient funds to resolve identified disputes. 17 U.S.C. 111(d)(4)(C), 801(b)(3)(C).
On July 23, 2021, Worldwide Subsidy Group LLC dba Multigroup Claimants (MGC) filed with the Judges a motion requesting partial distributions in the amount of $893,086 from the 2015 cable royalty fund, $842,586 from the 2016 cable royalty fund, and $839,111 from the 2017 cable royalty fund, pursuant to sec. 801(b)(3)(C) of the Copyright Act. 17 U.S.C. 801(b)(3)(C). Motion at 5.
The Settling Devotional Claimants (SDC) opposed the Motion as well as a separate motion that MGC filed in the companion satellite docket. Settling Devotional Claimants' Opposition to Multigroup Claimants' Motion for Partial Distribution of 2015-2017 Cable and Satellite Royalty Funds (Opposition).
Prior to ruling on a motion for partial distribution filed under § 801(b)(3)(C) of the Copyright Act, the Judges must publish a notice in the
Copyright Royalty Board, Library of Congress.
Notice requesting comments.
The Copyright Royalty Judges solicit comments on a motion of Multigroup Claimants for partial distribution of 2015-2017 satellite royalty funds.
Comments are due on or before October 13, 2021.
Interested claimants must submit timely comments using eCRB, the Copyright Royalty Board's online electronic filing application, at
Anita Blaine, Program Specialist, 202-707-7658,
Each year satellite systems must submit royalty payments to the Register of Copyrights as required by the statutory license set forth in section 119 of the Copyright Act for the retransmission to satellite subscribers of over-the-air television broadcast signals.
Allocation of the royalties collected occurs in one of two ways. In the first instance, the Judges may authorize distribution in accordance with a negotiated settlement among all claiming parties. 17 U.S.C. 119(b)(5)(A), 801(b)(3)(A). If all claimants do not reach an agreement with respect to the royalties, the Judges must conduct a proceeding to determine the distribution of any royalties that remain in controversy. 17 U.S.C. 119(b)(5)(B), 801(b)(3)(B). Alternatively, the Judges may, on motion of claimants and on notice to all interested parties, authorize a partial distribution of royalties, reserving on deposit sufficient funds to resolve identified disputes. 17 U.S.C. 119(b)(5)(C), 801(b)(3)(C).
On July 23, 2021, Worldwide Subsidy Group LLC dba Multigroup Claimants (MGC) filed with the Judges a motion
The Settling Devotional Claimants (SDC) opposed the Motion as well as a separate motion that MGC filed in the companion cable docket.
Prior to ruling on a motion for partial distribution filed under § 801(b)(3)(C) of the Copyright Act, the Judges must publish a notice in the
Millennium Challenge Corporation.
Notice.
The Millennium Challenge Act of 2003 requires the Millennium Challenge Corporation to publish a report that identifies countries that are “candidate countries” for Millennium Challenge Account assistance during fiscal year 2022. The report is set forth in full below.
This report to Congress is provided in accordance with section 608(a) of the Millennium Challenge Act of 2003, as amended, 22 U.S.C. 7701, 7707(a) (the Act).
The Act authorizes the provision of assistance for global development through the Millennium Challenge Corporation (MCC) for countries that enter into a Millennium Challenge Compact with the United States to support policies and programs that advance the progress of such countries to achieve lasting economic growth and poverty reduction. The Act requires MCC to take a number of steps in selecting countries with which MCC will seek to enter into a compact, including determining the countries that will be eligible countries for fiscal year (FY) 2022 based on (a) a country's demonstrated commitment to (i) just and democratic governance, (ii) economic freedom, and (iii) investments in its people, (b) the opportunity to reduce poverty and generate economic growth in the country, and (c) the availability of funds to MCC. These steps include the submission to the congressional committees specified in the Act and publication in the
• The countries that are “candidate countries” for FY 2022 based on their per capita income levels and their eligibility to receive assistance under U.S. law and countries that would be candidate countries but for specified legal prohibitions on assistance (section 608(a) of the Act);
• The criteria and methodology that the MCC Board of Directors (the Board) will use to measure and evaluate the relative policy performance of the “candidate countries” consistent with the requirements of subsections (a) and (b) of section 607 of the Act in order to determine “eligible countries” from among the “candidate countries” (section 608(b) of the Act); and
• The list of countries determined by the Board to be “eligible countries” for FY 2022, identification of such countries with which the Board will seek to enter into compacts, and a justification for such eligibility determination and selection for compact negotiation (section 608(d) of the Act).
This report is the first of three required reports listed above.
The Act requires the identification of all countries that are candidate countries for FY 2022 and the identification of all countries that would be candidate countries but for specified legal prohibitions on assistance. Under sections 606(a) and (b) of the Act, candidate countries must qualify as low income or lower middle income countries as defined in the Act.
Specifically, a country will be a candidate country in the low income category for FY 2022 if it
• has a per capita income that is not greater than the World Bank's lower middle income country threshold for such fiscal year ($4,095 gross national income per capita for FY 2022);
• is among the 75 countries identified by the World Bank as having the lowest per capita income; and
• is not ineligible to receive United States economic assistance under part I of the Foreign Assistance Act of 1961, as amended (the Foreign Assistance Act), by reason of the application of the Foreign Assistance Act or any other provision of law.
A country will be a candidate country in the lower middle income category for FY 2022 if it
• has a per capita income that is not greater than the World Bank's lower middle income country threshold for such fiscal year ($4,095 gross national income per capita for FY 2022);
• is not among the 75 countries identified by the World Bank as having the lowest per capita income; and
• is not ineligible to receive United States economic assistance under part I of the Foreign Assistance Act by reason of the application of the Foreign Assistance Act or any other provision of law.
Under section 606(c) of the Act as applied for FY 2022, a country with per capita income changes from FY 2021 to FY 2022 such that the country would be reclassified from the low income category to the lower middle income category or vice versa will retain its income status in its former category for FY 2022 and two subsequent fiscal years (FY 2023 and FY 2024). A country that has transitioned to the upper middle income category does not qualify as a candidate country.
Pursuant to section 606(d) of the Act, the Board identified the following countries as candidate countries under the Act for FY 2022. In so doing, the Board referred to the prohibitions on assistance to countries for FY 2021 under the Department of State, Foreign Operations, and Related Programs Appropriations Act, 2021 (Div. J., Pub. L. 116-94) (FY 2021 SFOAA).
Countries that would be considered candidate countries for FY 2022 but are ineligible to receive United States economic assistance under part I of the Foreign Assistance Act by reason of the application of any provision of the Foreign Assistance Act or any other provision of law are listed below. This list is based on legal prohibitions against economic assistance that apply as of July 27, 2021.
• Burma is ineligible to receive foreign assistance, including due to concerns relative to its record on human rights and pursuant to the military coup restriction in section 7008 of the FY 2021 SFOAA.
• Cambodia is ineligible to receive foreign assistance pursuant to section 7043(b)(2) of the FY 2021 SFOAA, which restricts (with limited exceptions) assistance to the Government of Cambodia unless the Secretary of State certifies that the Government of Cambodia is taking effective steps to strengthen regional security and stability and respect the rights and responsibilities enshrined in the Constitution of the Kingdom of Cambodia.
• Comoros is ineligible to receive foreign assistance due to its status as a Tier 3 country under the Trafficking Victims Protection Act of 2000 (22 U.S.C. 7101
• Eritrea is ineligible to receive foreign assistance due to its human rights record and its status as a Tier 3 country under the Trafficking Victims Protection Act of 2000 (22 U.S.C. 7101
• Ethiopia is ineligible to receive foreign assistance due to its human rights record.
• Guinea-Bissau is ineligible to receive foreign assistance due to its status as a Tier 3 country under the Trafficking Victims Protection Act of 2000 (22 U.S.C. 7101
• Iran is ineligible to receive foreign assistance, including due to its status as a Tier 3 country under the Trafficking Victims Protection Act of 2000 (22 U.S.C. 7101
• Korea, North is ineligible to receive foreign assistance, including due to its status as a Tier 3 country under the Trafficking Victims Protection Act of 2000 (22 U.S.C. 7101
• Mali is ineligible to receive foreign assistance pursuant to the military coup restriction in section 7008 of the FY 2021 SFOAA.
• Nicaragua is ineligible to receive foreign assistance, including due to its status as a Tier 3 country under the Trafficking Victims Protection Act of 2000 (22 U.S.C. 7101
• South Sudan is ineligible to receive foreign assistance pursuant to section 7042(i)(2) of the FY 2021 SFOAA due to its human rights record.
• Sudan is ineligible to receive foreign assistance including due to the military coup restriction in section 7008 of the FY 2021 SFOAA.
• Syria is ineligible to receive foreign assistance due to its status as a Tier 3 country under the Trafficking Victims Protection Act of 2000 (22 U.S.C. 7101
• Zimbabwe is ineligible to receive foreign assistance, including pursuant to section 7042(k)(2) of the FY 2021 SFOAA, which prohibits (with limited exceptions) assistance for the central government of Zimbabwe unless the Secretary of State certifies and reports to Congress that the rule of law has been restored, including respect for ownership and title to property, and freedoms of expression, association, and assembly.
• Sri Lanka is ineligible to receive foreign assistance pursuant to section 7044(e)(2) of the FY 2021 SFOAA,
Countries identified above as candidate countries, as well as countries that would be considered candidate countries but for the applicability of legal provisions that prohibit U.S. economic assistance, may be the subject of future statutory restrictions or determinations, or changed country circumstances, that affect their legal eligibility for assistance under part I of the Foreign Assistance Act by reason of application of the Foreign Assistance Act or any other provision of law for FY 2022.
Nuclear Regulatory Commission.
NUREG; issuance.
The U.S. Nuclear Regulatory Commission (NRC) is issuing a knowledge management NUREG, NUREG/KM-0015, “Considerations for Estimating Site-Specific Probable Maximum Precipitation at Nuclear Power Plants in the United States of America.” The NRC staff and Oak Ridge National Laboratory have prepared a reference document summarizing recent lessons-learned in connection with a review of the site-specific probable maximum precipitation (SSPMP) estimates used by some nuclear power plant owners and operators in connection with a recent re-evaluation of external flooding at their respective project sites.
NUREG/KM-0015 is available on September 13, 2021.
Please refer to Docket ID NRC-2020-0237 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:
•
•
•
Kevin Quinlan, Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-6809, email:
By letter dated March 12, 2012, the NRC issued a request for information to all power reactor licensees and holders of construction permits in active or deferred status licensees to reevaluate seismic and external flooding for their sites against current Commission requirements and guidance. This request was made consistent with paragraph 50.54(f) of title of the
In response to the staff's 2012 § 50.54(f) information request, owners and licensees submitted about 60 external flood hazard re-evaluation reports (FHRRs) corresponding to the operating fleet of power reactors. In the matter of the probable maximum precipitation (PMP) value used for some of the flood-hazard re-evaluations (primarily the estimation of local intense precipitation and riverine-based floods), current NRC guidance documents recommend the use of the PMP estimation methods described in a series of Hydrometeorological Reports (HMRs) developed by the National Oceanographic and Atmospheric Administration (NOAA). The PMP event itself is generally defined as the greatest depth of precipitation for a given duration meteorologically possible for a design watershed or a given storm area at a particular time of year. The estimated PMP over a particular watershed or basin results in a flood magnitude for which there is virtually no risk of exceeding. The challenge, however, is that HMR-derived PMP estimates are based on methodologies and data which have not been updated with rainfall and storm events which have occurred in the decades since the HMRs were last published.
Upon review of the FHRRs, the staff found that about 26 project sites responding to the § 50.54(f) information request submitted PMP estimates that were not based on NOAA HMRs but were developed by a commercial interest. As part of the FHRR process, the staff conducted an audit of the commercial vendor who developed the site-specific PMP estimates to better-understand the technical basis underlying the approach. In all cases, these SSPMP estimates were less than those obtained from the applicable HMR. Although the development and estimation of the SSPMP studies reviewed by the staff generally followed processes similar to those described in the existing guidance, several different methods, data sources, assumptions, and procedures were used to obtain site specific results other than those found using the HMR methodology.
Based on the staff's § 50.54(f) review experience and in anticipation of its continued use, this NUREG summarizes the lessons-learned concerning the review and application of a SSPMP. To that end, this NUREG addresses the following topics:
This reference document describes the technical theory, data sources, and analysis methodology that could be used to derive a SSPMP estimate. Certain new terms are also introduced and defined. This reference document also identifies key technical (meteorological) considerations when reviewing a SSPMP estimate.
To date, there is no clear NRC guidance on this topic or a commonly agreed-to approach on the estimation of SSPMP. As the staff may be reviewing additional SSPMP estimates in the future in connection with its regulatory responsibilities, it was decided to elicit stakeholder views on the matters and approaches discussed in this draft document.
This document contains no regulatory guidance or regulatory positions.
A request for comments on draft NUREG/KM-0015, (ADAMS Accession No. ML20356A293) was published in the
Since its inception, the Atomic Energy Commission and its successor, the NRC, have focused on preserving the (explicit) documentary record of its decision-making in the form of NUREGs, SECY Papers, Regulatory Guides, and other documents. However, in 2006, the agency recognized that there was a need to engage in a more-formal program of knowledge management that also reflects the less-tangible (implicit) human capital aspect of the agencies' knowledge base. This feature was particularly important as the agency enters its fifth decade of operation—a period characterized by an increasing number of retirements among long-serving staff involved in many of the agencies' early regulatory programs and associated licensing actions. Staff efforts thus far in preserving this legacy of experience that describe important historical events, facts, and research that were instrumental in shaping NRC's regulatory programs, can be found at
The purpose of this knowledge management NUREG (or NUREG/KM) is intended to satisfy an NRC goal of maintaining and preserving knowledge concerning the lessons-learned from the recent flood hazard re-evaluations at current and planned nuclear power plant sites performed most recently in connection with the staff 2012 § 50.54(f) reviews.
For the Nuclear Regulatory Commission.
Nuclear Regulatory Commission.
Regulatory guide; issuance; correction.
The U.S. Nuclear Regulatory Commission (NRC) is correcting a notice that was published in the
The correction takes effect on September 13, 2021.
Please refer to Docket ID NRC-2021-0038 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:
•
•
• Attention: The PDR, where you may examine and order copies of public documents, is currently closed. You may submit your request to the PDR via email at
RG 1.243 and the regulatory analysis may be found in ADAMS under Accession Nos. ML21089A032 and ML20339A559, respectively.
Regulatory guides are not copyrighted, and NRC approval is not required to reproduce them.
Edward O'Donnell, telephone: 301-415-3317, email:
In the FR on September 7, 2021, in FR Doc. 2021-19178, on page 50190, in the notice title after agency name correct “NRC-2020-0038” to read “NRC-2021-0038.” In the
For the Nuclear Regulatory Commission.
Pursuant to Section 19(b)(1)
The Exchange proposes to modify the Arca Options Deep market data product. 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 the Arca Options Deep market data product.
The Exchange currently offers the following real-time options market data feeds: “Arca Options Top,” “Arca Options Deep,” and “Arca Options Complex” (the “Arca Options Products”). “Arca Options Top” is a single market data product that combines last sale data, best bids and offers (“BBO”), order imbalance information and series status and underlying status messages. “Arca Options Complex,” also a single market data product, provides subscribers NYSE Arca Options quote and trade information (including orders/quotes, requests for responses, and trades) for the complex order book on a real-time basis. “Arca Options Deep” is also a single market data product that provides subscribers NYSE Arca Options quotes and orders at the first three price levels in each series on a real-time basis.
The Exchange charges a single fee for Arca Options Products and subscribers of Arca Options Products receive all three data feeds described above.
The Exchange proposes to modify the Arca Options Deep market data product so that quotes and orders would be available for the full order book in each series on a real-time basis rather than at the first three price levels. As modified, Arca Options Deep would provide vendors and subscribers with a unified view of events, in sequence, as they appear on the Exchange's matching engine. The modified Arca Options Deep would include depth of book order data, last sale data, opening imbalance data, series status updates (
The Exchange believes that Arca Options Deep, as modified, addresses requests received from vendors and subscribers that would like to receive the data described above in an integrated fashion. An integrated data feed would provide greater efficiencies and reduce errors for vendors and subscribers that currently choose to integrate the data after receiving it from the Exchange. The Exchange believes that providing vendors and subscribers with the option of a market data product that both integrates existing products and includes additional market data would allow vendors and subscribers to choose the best solution for their specific businesses while also enhancing the functionality of the product.
The proposed modification to the Arca Options Deep data feed will allow subscribers who currently obtain depth of market data at three price levels to receive the full order book market data in a single data feed. Offering a data product that provides the full order book in one market data product would provide greater efficiencies and better sequencing for vendors and subscribers. As it does currently, Arca Options Deep would continue to provide last sale and BBO information on a real-time basis as reported to the Options Price Reporting Authority (“OPRA”) and disseminated on a consolidated basis under the OPRA Plan.
The Exchange does not propose to make any change to the fees for Arca Options Deep. The single fee charged for the Arca Options Products that comprise the Arca Options Top, Arca
Arca Options Deep would continue to be offered through the Exchange's Liquidity Center Network (“LCN”), a local area network in the Exchange's Mahwah, New Jersey data center that is available to users of the Exchange's co-location services. The Exchange would also continue to offer the Arca Options Deep through the Exchange's Secure Financial Transaction Infrastructure (“SFTI”) network, through which all other users and members access the Exchange's trading and execution systems and other proprietary market data products.
The Exchange plans to introduce the modified Arca Options Deep market data product when the Exchange transitions to the Pillar trading platform, anticipated for the fourth quarter of 2021.
The proposed rule change is consistent with Section 6(b)
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 improved options for receiving market data. The proposed rule change would benefit investors by facilitating their prompt access to the additional real-time information contained in a modified Arca Options Deep market data product.
The Exchange believes the proposed change is reasonable because it would provide vendors and subscribers with a higher quality market data product.
In adopting Regulation NMS, the Commission granted self-regulatory organizations and broker-dealers increased authority and flexibility to offer new and unique market data to consumers of such data. It was believed that this authority would expand the amount of data available to users and consumers of such data and also spur innovation and competition for the provision of market data. The Exchange believes that the options data product changes proposed herein are precisely the sort of market data product evolutions that the Commission envisioned when it adopted Regulation NMS. The Commission concluded that Regulation NMS—by lessening regulation of the market in proprietary data—would itself further the Act's goals of facilitating efficiency and competition:
By removing “unnecessary regulatory restrictions” on the ability of exchanges to sell their own data, Regulation NMS advanced the goals of the Act and the principles reflected in its legislative history.
The proposed modified Arca Options Deep market data feed will help to protect a free and open market by providing additional data to the marketplace and give investors greater choices. In addition, the proposal would not permit unfair discrimination because the products will be available to all of the Exchange's customers and broker-dealers through both the LCN and SFTI.
In accordance with Section 6(b)(8) of the Act,
No written comments were solicited or received with respect to the proposed rule change.
Because the foregoing proposed rule change does not: (i) Significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A) of the Act
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule change should be approved or disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The principal purpose of the proposed amendments is for ICE Clear Europe to make certain amendments to Part EE of its Delivery Procedures to add provisions relating to delivery of an additional contract, the ICE Endex Austrian Central European Gas Hub AG (“CEGH”) Virtual Trading Point (“VTP”) Natural Gas Daily Futures (“ICE Endex VTP Natural Gas Daily Futures”), that will be traded on the ICE Endex exchange and cleared at ICE Clear Europe. The amendments also propose to correct the name of the ICE Endex CEGH Austrian VTP Natural Gas Futures to ICE Endex Austrian CEGH VTP Natural Gas Futures (“ICE Endex VTP Natural Gas Futures”) and make certain corresponding updates throughout Part EE.
In its filing with the Commission, ICE Clear Europe included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. ICE Clear Europe has prepared summaries, set forth in sections (A), (B), and (C) below, of the most significant aspects of such statements.
ICE Clear Europe is proposing to amend Part EE of its Delivery Procedures to add provisions relating to delivery of an additional contract, the ICE Endex Austrian CEGH VTP Natural Gas Daily Futures (“ICE Endex VTP Natural Gas Daily Futures”), that will be traded on the ICE Endex exchange and cleared at ICE Clear Europe. The proposed amendments also correct the name of the ICE Endex CEGH Austrian VTP Natural Gas Futures to ICE Endex Austrian CEGH VTP Natural Gas Futures (“ICE Endex VTP Natural Gas Futures”) and make certain corresponding updates throughout Part EE.
Proposed amendments to Part EE would set out the delivery specifications and procedures for deliveries under the Contract. Delivery would be effected by the transfer of rights to natural gas at the VTP from a Transferor (nominated by the Seller and which may be the Seller) to the Clearing House and from the Clearing House (via its nomination
Proposed amendments to Part EE would address certain the responsibilities of the Clearing House and relevant parties for delivery under the Contracts, supplementing the existing provisions of the Rules. Specifically, the Clearing House would not be responsible for the performance of CEGH. Further, neither the Buyer nor the Seller, nor their Transferees or Transferors, would have any claim against the Clearing House for any loss incurred as a result of the condition or operation of the Transmission Network unless provided in the ICE Endex Rules.
A definition of “ICE Endex VTP Natural Gas Daily Futures” is being proposed. Where applicable, amendments will be made throughout Part EE to apply to the ICE Endex VTP Natural Gas Daily Futures in addition to ICE Endex VTP Natural Gas Futures. The existing defined term “ICE Endex VTP Natural Gas” is being proposed to be changed to “ICE Endex VTP Natural Gas Futures” for clarity and to distinguish that contract from the new daily futures contract. Various other corrections to the use of defined terms and other typographical and similar corrections are also being proposed.
Section 3.4 (which describes the price of the Contracts) is being proposed to be amended to provide that the price at which the Contract is delivered is the Exchange Delivery Settlement Price for the Delivery Day of each of the ICE Endex VTP Natural Gas Futures or ICE Endex Natural Gas Daily Futures in accordance with the ICE Endex Rules (instead of the Business Day immediately prior to the calendar day on which the Delivery Month for the ICE Endex VTP Natural Gas Futures commences). This change is intended to update the Delivery Procedures to reflect current practice with respect to the ICE Endex VTP Natural Gas Futures.
Section 3.6 (which describes cessation of trading) is being proposed to be revised so that such procedures apply to ICE Endex VTP Natural Gas Daily Futures in addition to ICE Endex VTP Natural Gas Futures. The description of the cessation of trading is also being proposed to be revised to clarify that it is consistent with the ICE Endex Rules. The ICE Endex VTP Natural Gas Daily Futures ceases trading one business day prior to the Delivery Day.
Section 3.7 (which describes the Exchange for Physicals (EFPs) and Exchange for Swaps (EFSs)) is being proposed to be amended to specify that ICE Endex VTP Natural Gas Daily Futures, EFPs and EFSs may be posted up to thirty minutes following the cessation of trading in accordance with ICE Endex Rules.
In Section 6 Delivery Timetable, an outdated reference to ICE Endex Austrian VTP Natural Cas Futures is being proposed to be updated to ICE Endex VTP Natural Gas Futures.
A new Section 8 is being proposed to be added which includes a routine delivery timetable, from the last trading day of the Contract through final settlement, for ICE Endex VTP Natural Gas Daily Futures. The timetable specifies procedures, deadlines and requirements submissions of delivery intentions, nominations of Transferors or Transferees, Conversion and Confirmation Reports, notification files to the nomination agent, provision of Buyer's and Seller's security, final confirmation of the delivery report, release of Seller's security and Buyer's top-up following completion of delivery, payment and invoicing.
A new Section 9 is being proposed to be added which includes a delivery timetable for failed delivery for ICE Endex VTP Natural Gas Daily Futures. The timetable specifies the procedures and timing with respect to calling and releasing additional Seller's Security and/or Buyer's Security and invoicing, payment and receipt of failed deliveries. A note is also added that, in the event of a failed delivery, the Clearing House may retain Buyer's Security and/or Seller's Security.
A new Section 11.2 is being proposed to be added that provides a delivery documentation summary with respect to ICE Endex VTP Natural Gas Daily Futures. The timetable specifies the reports produced by the Clearing House and made available to Buyers and Sellers electronically, an explanation of each such report, and when each such report is made available. A note is also added that provides that such timetable may be altered at the discretion of the Clearing House.
Section 17A(b)(3)(F) of the Act
In addition, Rule 17Ad-22(e)(10)
ICE Clear Europe does not believe the proposed rule changes would have any impact, or impose any burden, on
Written comments relating to the proposed amendments have not been solicited or received by ICE Clear Europe. ICE Clear Europe will notify the Commission of any comments received with respect to the proposed rule change.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A) of the Act and paragraph (f) of Rule 19b-4 thereunder. 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.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
All comments received will be posted without change. Persons submitting comments are cautioned that we do not redact or edit personal identifying information from comment submissions. You should submit only information that you wish to make available publicly. All submissions should refer to File Number SR-ICEEU-2021-016 and should be submitted on or before October 4, 2021.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”),
Cboe EDGX Exchange, Inc. (the “Exchange” or “EDGX” or “EDGX Equities”) proposes to amend its Fee Schedule. The text of the proposed rule change is provided in Exhibit 5.
The text of the proposed rule change is also available on the Exchange's website (
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The Exchange proposes to amend its Fee Schedule applicable to its equities trading platform (“EDGX Equities”) to modify Growth Tier, effective September 1, 2021.
The Exchange first notes that it operates in a highly competitive market in which market participants can readily direct order flow to competing venues if they deem fee levels at a particular venue to be excessive or incentives to be insufficient. More specifically, the Exchange is only one of 16 registered equities exchanges, as well as a number of alternative trading systems and other off-exchange venues that do not have similar self-regulatory responsibilities under the Exchange Act, to which market participants may direct their order flow. Based on publicly available information,
Under footnote 1 of the Fee Schedule the Exchange currently offers various Add/Remove Volume Tiers. In particular, the Exchange offers three Growth Tiers that each provide an enhanced rebate for Members' qualifying orders yielding fee codes B, V, Y, 3 and 4,
The Exchange believes that the proposed rule change is consistent with the objectives of Section 6 of the Act,
As described above, the Exchange operates in a highly competitive market in which market participants can readily direct order flow to competing venues if they deem fee levels at a particular venue to be excessive or incentives to be insufficient. The proposed rule changes reflect a competitive pricing structure designed to incentivize market participants to direct their order flow to the Exchange, which the Exchange believes would enhance market quality to the benefit of all Members. Additionally, the Exchange notes that relative volume-based incentives and discounts have been widely adopted by exchanges,
In particular, the Exchange believes the proposed changes to Growth Tier 1 is reasonable because the Tier will continue to be available to all Members and provide all Members with an additional opportunity to receive an enhanced rebate, albeit using slightly modified criteria and providing an alternative criteria Members may satisfy. The Exchange further believes the Growth Tier 1, even as amended, continues to provide a reasonable means to encourage overall growth in Members' order flow to the Exchange and to incentivize Members to continue to provide liquidity adding volume to the Exchange by offering them an additional opportunity to receive an enhanced rebate on qualifying orders. An overall increase in activity would deepen the Exchange's liquidity pool, offers additional cost savings, support the quality of price discovery, promote market transparency and improve market quality, for all investors.
Further, the Exchange believes that the proposed changes are reasonable as it does not represent a significant departure from the criteria currently offered in the Fee Schedule. For example, the Exchange notes similar criteria is offered under the first prong of Growth Tier 2 which provides an enhanced rebate where a Member adds a Step-Up ADAV from June 2021 of greater than or equal to 0.10% of the TCV or adds a Step-Up ADAV from June 2021 greater than or equal to 8,000,000.
The Exchange also believes that the proposal represents an equitable allocation of fees and rebates and is not unfairly discriminatory because all Members continue to be eligible for Growth Tier 1 and have the opportunity to meet the Tier's criteria and receive the corresponding enhanced rebate if such criteria is met. Without having a view of activity on other markets and off-exchange venues, the Exchange has no way of knowing whether this proposed rule change would definitely result in any Members qualifying for Growth Tier 1, as amended. While the Exchange has no way of predicting with certainty how the proposed changes will impact Member activity, the Exchange anticipates that at least one Member will be able to satisfy the criteria proposed under the Tier (currently, two Members satisfy Growth Tier 1). The Exchange also notes that proposed changes will not adversely impact any Member's ability to qualify for reduced fees or enhanced rebates offered under other tiers. Should a Member not meet the proposed new criteria, the Member will merely not receive that corresponding enhanced rebate.
The Exchange does not believe that the proposed rule changes will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act. Rather, as discussed above, the Exchange believes that the proposed change would encourage the submission of additional order flow to a public exchange, thereby promoting market depth, execution incentives and enhanced execution opportunities, as well as price discovery and transparency for all Members. As a result, the Exchange believes that the proposed change furthers the Commission's goal in adopting Regulation NMS of fostering competition among orders, which promotes “more efficient pricing of individual stocks for all types of orders, large and small.”
The Exchange believes the proposed rule change does not impose any burden on intramarket competition that is not necessary or appropriate in furtherance of the purposes of the Act. Particularly, the proposed changes to Growth Tier 1 applies to all Members equally in that all Members are eligible for the Tier, have a reasonable opportunity to meet the Tier's criteria and will receive the enhanced rebate on their qualifying orders if such criteria is met. The Exchange does not believe the proposed changes burdens competition, but rather, enhances competition as it is intended to increase the competitiveness of EDGX by amending an existing pricing incentive in order to attract order flow and incentivize participants to increase their participation on the Exchange, providing for additional execution opportunities for market participants and improved price transparency. Greater overall order flow, trading opportunities, and pricing transparency benefits all market participants on the Exchange by enhancing market quality and continuing to encourage Members to send orders, thereby contributing towards a robust and well-balanced market ecosystem.
Next, the Exchange believes the proposed rule change does not impose any burden on intermarket competition that is not necessary or appropriate in furtherance of the purposes of the Act. As previously discussed, the Exchange operates in a highly competitive market. Members have numerous alternative venues that they may participate on and direct their order flow, including other equities exchanges, off-exchange venues, and alternative trading systems. Additionally, the Exchange represents a small percentage of the overall market. Based on publicly available information, no single equities exchange has more than 16% of the market share.
The Exchange neither solicited nor received comments on the proposed rule change.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A) of the Act
Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
Persons submitting comments are cautioned that we do not redact or edit personal identifying information from comment submissions. You should submit only information that you wish to make available publicly. All submissions should refer to File Number SR-CboeEDGX-2021-038 and should be submitted on or before October
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 NYSE Arca Equities Fees and Charges (“Fee Schedule”) to eliminate the per share credit associated with certain Retail Orders that add and remove liquidity. The Exchange proposes to implement the fee change effective August 23, 2021. The proposed rule change is available on the Exchange's website at
In its filing with the Commission, the self-regulatory organization included statements concerning the purpose of, and basis for, the proposed rule change and discussed any comments it received on the proposed rule change. The text of those statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant parts of such statements.
The Exchange proposes to amend the Fee Schedule to eliminate the per share credit associated with certain Retail Orders
The Exchange operates in a highly competitive market. The Commission has repeatedly expressed its preference for competition over regulatory intervention in determining prices, products, and services in the securities markets. In Regulation NMS, the Commission highlighted the importance of market forces in determining prices and SRO revenues and, also, recognized that current regulation of the market system “has been remarkably successful in promoting market competition in its broader forms that are most important to investors and listed companies.”
While Regulation NMS has enhanced competition, it has also fostered a “fragmented” market structure where trading in a single stock can occur across multiple trading centers. When multiple trading centers compete for order flow in the same stock, the Commission has recognized that “such competition can lead to the fragmentation of order flow in that stock.”
The Exchange believes that the ever-shifting market share among the exchanges from month to month demonstrates that market participants can move order flow, or discontinue or reduce use of certain categories of products. While it is not possible to know a firm's reason for shifting order flow, the Exchange believes that one such reason is because of fee changes at any of the registered exchanges or non-exchange venues to which a firm routes order flow. The competition for Retail Orders is even more stark, particularly as it relates to exchange versus off-exchange venues.
The Exchange thus needs to compete in the first instance with non-exchange venues for Retail Order flow, and with the 15 other exchange venues for that Retail Order flow that is not directed off-exchange. Accordingly, competitive forces compel the Exchange to use exchange transaction fees and credits, particularly as they relate to competing for Retail Order flow, because market participants can readily trade on competing venues if they deem pricing levels at those other venues to be more favorable.
To respond to this competitive environment, the Exchange has established Retail Order Step-Up tiers,
The Exchange proposes to eliminate the per share credit associated with the execution of orders that are internalized.
Under the Retail Order Step-Up Tier 1 pricing tier, such orders currently receive a credit of $0.0038 per share for adding liquidity and do not pay a fee for removing liquidity. Under the Retail Order Step-Up Tier 2 pricing tier, such orders currently receive a credit of $0.0035 per share for adding liquidity and do not pay a fee for removing liquidity. Lastly, under the Retail Order Step-Up Tier 3 pricing tier, such orders currently receive a credit of $0.0036 per share for adding liquidity and do not pay a fee for removing liquidity. When both sides of an execution are not Retail Orders or do not share the same MPID, the Exchange will continue to not charge a fee for removing liquidity and will continue to provide the credits noted above. The proposed rule change would not impact orders that qualify for the Retail Order pricing tier that are internalized. Such orders would continue to receive a credit of $0.0033 per share for providing liquidity and would continue to pay a fee of $0.0030 per share for removing liquidity.
The proposed changes are not otherwise intended to address any other issues, and the Exchange is not aware of any significant problems that market participants would have in complying with the proposed changes.
The Exchange believes that the proposed rule change is consistent with Section 6(b) of the Act,
As discussed above, the Exchange operates in a highly fragmented and competitive market. The Commission has repeatedly expressed its preference for competition over regulatory intervention in determining prices, products, and services in the securities markets. Specifically, in Regulation NMS, the Commission highlighted the importance of market forces in determining prices and SRO revenues and, also, recognized that current regulation of the market system “has been remarkably successful in promoting market competition in its broader forms that are most important to investors and listed companies.”
The Exchange believes that the ever-shifting market share among the exchanges from month to month demonstrates that market participants can shift order flow, or discontinue to reduce use of certain categories of products, in response to fee changes. With respect to Retail Orders, ETP Holders can choose from any one of the 16 currently operating registered exchanges, and numerous off-exchange venues, to route such order flow. Accordingly, competitive forces reasonably constrain exchange transaction fees that relate to Retail Orders on an exchange. Stated otherwise, changes to exchange transaction fees can have a direct effect on the ability of an exchange to compete for order flow.
In particular, the Exchange believes that the proposed elimination of credits is reasonable because the Exchange has determined to no longer provide credits for Retail Orders that are internalized. With this proposed rule change, the Exchange is eliminating credits only for a subset of Retail Orders,
The Exchange believes it is reasonable to no longer provide credits for certain types of orders transacted on the Exchange because the Exchange is not required to provide such credits. As noted above, the Exchange believes that it is reasonable to eliminate credits for Retail Orders that are internalized because the pricing incentive currently in place is intended to attract liquidity that other market participants can interact with. The Exchange is not required to provide credits for activity that it believes does not accrue liquidity on the Exchange for the benefit of other market participants. The Exchange notes that other markets have utilized a similar basis for eliminating rebates. In particular, Cboe BZX Exchange, Inc. (“BZX”) recently eliminated the rebate applied to orders in securities priced below $1.00 because, as BZX noted, it “no longer wishes to, nor is it required to, provide such a rebate.”
The Exchange believes that, despite the removal of the credits, ETP Holders may continue to direct orders to the Exchange that may otherwise be internalized off-exchange, which would contribute to a deeper, more liquid market and provide even more execution opportunities for market participants.
The Exchange believes the proposal is an equitable allocation of fees among its market participants because all ETP Holders that participate on the Exchange will be able to internalize their Retail Orders on the Exchange at no cost,
The Exchange further notes that the market for attracting Retail Orders remains competitive. For example, until recently, CBOE EDGX Equities, Inc. (“EDGX”) charged its members an internalization fee of $0.00050 per share for orders, including Retail Orders, that add liquidity and a fee of $0.00050 per share for orders, including Retail Orders, that remove liquidity if such members did not have an adding ADV of 10,000,000 shares.
The Exchange believes the proposed change is equitable and not unfairly discriminatory because ETP Holders would continue to not pay any fees for Retail Orders that are internalized. Further, the Exchange believes the proposed change is equitable and not unfairly discriminatory because it would apply equally to all ETP Holders. Notwithstanding the elimination of credits for Retail Orders that are internalized under the Retail Order Step-Up Tiers 1-3, the Exchange believes that its current fee structure,
The Exchange believes that the proposed rule change is equitable because maintaining the proportion of Retail Orders in exchange-listed securities that are executed on a registered national securities exchange (rather than relying on certain available off-exchange execution methods) would contribute to investors' confidence in the fairness of their transactions and would benefit all investors by deepening the Exchange's liquidity pool, supporting the quality of price discovery, promoting market transparency and improving investor protection.
The Exchange believes that the proposal is not unfairly discriminatory. The Exchange also believes that nothing about its proposed pricing model for Retail Orders that are internalized is inherently unfair; instead, it is a rational pricing model that was employed by one of the Exchange's competitors for many years.
The Exchange believes that the proposed change is not unfairly discriminatory because it would apply to all ETP Holders on an equal and non-discriminatory basis. All ETP Holders on the Exchange that qualify for the Retail Order Step Up Tiers 1-3 whose Retail Orders are internalized would no longer receive credits and would continue to not pay a fee. The Exchange also notes that the proposed rule change will not adversely impact any ETP Holder's ability to qualify for other reduced fee or enhanced rebate tiers. Lastly, the submission of Retail Orders is optional for ETP Holders in that they could choose whether to submit Retail Orders and, if they do, the extent of its activity in this regard. 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 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.
U.S. Small Business Administration.
Notice.
This is a Notice of the Presidential declaration of a major disaster for Public Assistance Only for the State of North Dakota (FEMA-4613-DR), dated 09/01/2021.
Issued on 09/01/2021.
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW, Suite 6050, Washington, DC 20416, (202) 205-6734.
Notice is hereby given that as a result of the President's major disaster declaration on 09/01/2021, Private Non-Profit organizations that provide essential services of a governmental nature may file disaster loan applications at the address listed above or other locally announced locations.
The following areas have been determined to be adversely affected by the disaster:
The Interest Rates are:
The number assigned to this disaster for physical damage is 17129 B and for economic injury is 17130 0.
Small Business Administration.
Notice.
This is a Notice of the Presidential declaration of a major disaster for Public Assistance Only for the State of Tennessee (FEMA-4609-DR), dated 09/01/2021.
Issued on 09/01/2021.
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW, Suite 6050, Washington, DC 20416, (202) 205-6734.
Notice is hereby given that as a result of the President's major disaster declaration on 09/01/2021, Private Non-Profit organizations that provide essential services of a governmental nature may file disaster loan applications at the address listed above or other locally announced locations.
The following areas have been determined to be adversely affected by the disaster:
The Interest Rates are:
The number assigned to this disaster for physical damage is 17125 6 and for economic injury is 17126 0.
U.S. Small Business Administration.
Notice.
This is a Notice of the Presidential declaration of a major disaster for Public Assistance Only for the State of Missouri (FEMA-4612-DR), dated 09/01/2021.
Issued on 09/01/2021.
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW, Suite 6050, Washington, DC 20416, (202) 205-6734.
Notice is hereby given that as a result of the President's major disaster declaration on 09/01/2021, Private Non-Profit organizations that provide essential services of a governmental nature may file disaster loan applications at the address listed above or other locally announced locations.
The following areas have been determined to be adversely affected by the disaster:
The Interest Rates are:
The number assigned to this disaster for physical damage is 17127 B and for economic injury is 17128 0.
U.S. Small Business Administration.
Notice.
This is a Notice of the Presidential declaration of a major disaster for Public Assistance Only for the State of New York (FEMA-4615-DR), dated 09/05/2021.
Issued on 09/05/2021.
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW, Suite 6050, Washington, DC 20416, (202) 205-6734.
Notice is hereby given that as a result of the President's major disaster declaration on 09/05/2021, Private Non-Profit organizations that provide essential services of a governmental nature may file disaster loan applications at the address listed above or other locally announced locations.
The following areas have been determined to be adversely affected by the disaster:
The Interest Rates are:
The number assigned to this disaster for physical damage is 17149 8 and for economic injury is 17150 0.
U.S. Small Business Administration.
Notice.
This is a Notice of the Presidential declaration of a major disaster for Public Assistance Only for the State of New Jersey (FEMA-4614-DR), dated 09/05/2021.
Issued on 09/05/2021.
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW, Suite 6050, Washington, DC 20416, (202) 205-6734.
Notice is hereby given that as a result of the President's major disaster declaration on 09/05/2021, Private Non-Profit organizations that provide essential services of a governmental nature may file disaster loan applications at the address listed above or other locally announced locations.
The following areas have been determined to be adversely affected by the disaster:
The Interest Rates are:
The number assigned to this disaster for physical damage is 17145 8 and for economic injury is 17146 0.
U.S. Small Business Administration.
Notice.
This is a Notice of the Presidential declaration of a major disaster for the State of New York. (FEMA-4615-DR), dated 09/05/2021.
Issued on 09/05/2021.
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW, Suite 6050, Washington, DC 20416, (202) 205-6734.
Notice is hereby given that as a result of the President's major disaster declaration on 09/05/2021, applications for disaster loans may be filed at the address listed above or other locally announced locations.
The following areas have been determined to be adversely affected by the disaster:
The Interest Rates are:
The number assigned to this disaster for physical damage is 17147 8 and for economic injury is 17148 0.
Small Business Administration.
Notice.
This is a notice of an Administrative declaration of a disaster for the State of California dated 09/02/2021.
Issued on 09/02/2021.
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW, Suite 6050, Washington, DC 20416, (202) 205-6734.
Notice is hereby given that as a result of the Administrator's disaster declaration, applications for disaster loans may be filed at the address listed above or other locally announced locations.
The following areas have been determined to be adversely affected by the disaster:
The Interest Rates are:
The number assigned to this disaster for physical damage is 17131 5 and for economic injury is 17132 0.
The States which received an EIDL Declaration # are California, Nevada.
U.S. Small Business Administration.
Notice.
This is a Notice of the Presidential declaration of a major disaster for the State of New Jersey (FEMA-4614-DR), dated 09/05/2021.
Issued on 09/05/2021.
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW, Suite 6050, Washington, DC 20416, (202) 205-6734.
Notice is hereby given that as a result of the President's major disaster declaration on 09/05/2021, applications for disaster loans may be filed at the address listed above or other locally announced locations.
The following areas have been determined to be adversely affected by the disaster:
The Interest Rates are:
The number assigned to this disaster for physical damage is 17143 8 and for economic injury is 17144 0.
U.S. Small Business Administration.
Notice.
This is a Notice of the Presidential declaration of a major disaster for Public Assistance Only for the State of Nebraska (FEMA-4616-DR), dated 09/06/2021.
Issued on 09/06/2021.
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW, Suite 6050, Washington, DC 20416, (202) 205-6734.
Notice is hereby given that as a result of the President's major disaster declaration on 09/06/2021, Private Non-Profit organizations that provide essential services of a governmental nature may file disaster loan applications at the address listed above or other locally announced locations.
The following areas have been determined to be adversely affected by the disaster:
The Interest Rates are:
The number assigned to this disaster for physical damage is 17151 B and for economic injury is 17152 0.
Notice is hereby given of the following determinations: I hereby determine that certain objects being imported from abroad pursuant to agreements with their foreign owners or custodians for temporary display in the exhibition “Van Gogh and the Olive Groves” at the Dallas Museum of Art, Dallas, Texas; in the exhibition “Van Gogh and Landscapes” at the Dayton Art Institute, Dayton, Ohio; in the exhibition “Van Gogh in America” at the Detroit Institute of Art, Detroit, Michigan; and at possible additional exhibitions or venues yet to be determined, are of cultural significance, and, further, that their temporary exhibition or display within the United States as aforementioned is in the national interest. I have ordered that Public Notice of these determinations be published in the
Chi D. Tran, Program Administrator, Office of the Legal Adviser, U.S. Department of State (telephone: 202-632-6471; email:
The foregoing determinations were made pursuant to the authority vested in me by the Act of October 19, 1965 (79 Stat. 985; 22 U.S.C. 2459), Executive Order 12047 of March 27, 1978, the Foreign Affairs Reform and Restructuring Act of 1998 (112 Stat. 2681,
Department of State.
Notice of meeting.
The Department of State announces the location, date, time, and agenda for the next meeting of the Cultural Property Advisory Committee. The Cultural Property Advisory Committee (“the Committee”) will meet October 5, 6, and 8, 2021, from 9:00 a.m. to 5:00 p.m. (EDT) via videoconference. The Committee will hold an open session on October 5, 2021, at 2:00 p.m. (EDT), which will last approximately one hour.
For general questions concerning the meeting, contact Allison Davis, Bureau of Educational and Cultural Affairs—Cultural Heritage Center, by phone (202-702-1166) or email (
In accordance with the Convention on Cultural Property Implementation Act (19 U.S.C. 2601
You do not need to register to observe the open session. You do not have to submit written comments to make an oral comment in the open session. If you do wish to speak, however, you must request to be scheduled by September 28, 2021, via email (
Department of State.
Public notice.
Proposal to extend the
Allison Davis, Cultural Heritage Center, Bureau of Educational and Cultural Affairs: 202-632-6301;
Pursuant to the authority vested in the Assistant Secretary of State for Educational and Cultural Affairs, and pursuant to 19 U.S.C. 2602(f)(1), an extension of the
A copy of the Memorandum of Understanding, the Designated List of categories of material restricted from import into the United States, and related information can be found at the Cultural Heritage Center website:
Department of State.
Public notice.
Proposal to extend and amend the
Chelsea Freeland, Cultural Heritage Center, Bureau of Educational and Cultural Affairs: 202-632-6301;
Pursuant to the authority vested in the Assistant Secretary of State for Educational and Cultural Affairs, and pursuant to 19 U.S.C. 2602(f)(1), an extension and amendment of the
The Government of the Republic of Cyprus has requested that the agreement be amended to include additional categories of archaeological and ethnological material.
A copy of the Memorandum of Understanding, the Designated List of categories of material restricted from import into the United States, and related information can be found at the Cultural Heritage Center website:
Notice is hereby given of the following determinations: I hereby determine that certain objects being imported from abroad pursuant to agreements with their foreign owners or custodians for temporary display in the exhibition “Sophie Taeuber-Arp: Living Abstraction” at The Museum of Modern Art, New York, New York, and at possible additional exhibitions or venues yet to be determined, are of cultural significance, and, further, that their temporary exhibition or display within the United States as aforementioned is in the national interest. I have ordered that Public Notice of these determinations be published in the
Chi D. Tran, Program Administrator, Office of the Legal Adviser, U.S. Department of State (telephone: 202-632-6471; email:
The foregoing determinations were made pursuant to the authority vested in me by the Act of October 19, 1965 (79 Stat. 985; 22 U.S.C. 2459), Executive Order 12047 of March 27, 1978, the Foreign Affairs Reform and Restructuring Act of 1998 (112 Stat. 2681,
Notice is hereby given of the following determinations: I hereby determine that certain objects being imported from abroad pursuant to agreements with their foreign owners or custodians for temporary display in the exhibition “City of Cinema: Paris 1850-1907” at the Los Angeles County Museum of Art, Los Angeles, California, and at possible additional exhibitions or venues yet to be determined, are of cultural significance, and, further, that their temporary exhibition or display within the United States as aforementioned is in the national interest. I have ordered that Public Notice of these determinations be published in the
Chi D. Tran, Program Administrator, Office of the Legal Adviser, U.S. Department of State (telephone: 202-632-6471; email:
The foregoing determinations were made pursuant to the authority vested in me by the Act of October 19, 1965 (79 Stat. 985; 22 U.S.C. 2459), Executive Order 12047 of March 27, 1978, the Foreign Affairs Reform and Restructuring Act of 1998 (112 Stat. 2681,
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Notice.
This notice contains a summary of a petition seeking relief from specified requirements of Federal Aviation Regulations. The purpose of this notice is to improve the public's awareness of, and participation in, FAA's exemption process. Neither publication of this notice nor the inclusion nor omission of information in the summary is intended to affect the legal status of the petition or its final disposition.
Comments on this petition must identify the petition docket number and must be received on or before October 4, 2021.
Send comments identified by docket number FAA-2021-0327 using any of the following methods:
•
•
•
•
Jake Troutman, (202) 683-7788, Office of Rulemaking, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591.
This notice is published pursuant to 14 CFR 11.85.
Issued in Washington, DC.
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Notice.
This notice contains a summary of a petition seeking relief from specified requirements of Federal Aviation Regulations. The purpose of this notice is to improve the public's awareness of, and participation in, the FAA's exemption process. Neither publication of this notice nor the inclusion nor omission of information in the summary is intended to affect the legal status of the petition or its final disposition.
Comments on this petition must identify the petition docket number and must be received on or before October 4, 2021.
Send comments identified by docket number FAA-2021-0643 using any of the following methods:
•
•
•
•
Jake Troutman, (202) 683-7788, Office of Rulemaking, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591.
This notice is published pursuant to 14 CFR 11.85.
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Notice.
This notice contains a summary of a petition seeking relief from specified requirements of Federal Aviation Regulations. The purpose of this notice is to improve the public's awareness of, and participation in, the FAA's exemption process. Neither publication of this notice nor the inclusion nor omission of information in the summary is intended to affect the legal status of the petition or its final disposition.
Comments on this petition must identify the petition docket number and must be received on or before October 4, 2021.
Send comments identified by docket number FAA-2014-0275 using any of the following methods:
•
•
•
•
Heidi L. Hunt, 202-267-7806, Office of Rulemaking, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591.
This notice is published pursuant to 14 CFR 11.85.
Issued in Washington, DC.
Maritime Administration, Transportation (DOT).
Notice.
The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to issue coastwise endorsement eligibility determinations for foreign-built vessels which will carry no more than twelve passengers for hire. A request for such a determination has been received by MARAD. By this notice, MARAD seeks comments from interested parties as to any effect this action may have on U.S. vessel builders or businesses in the U.S. that use U.S.-flag vessels. Information about the requestor's vessel, including a brief description of the proposed service, is listed below.
Submit comments on or before October 13, 2021.
You may submit comments identified by DOT Docket Number MARAD-2021-0202 by any one of the following methods:
•
•
James Mead, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE, Room W23-459, Washington, DC 20590. Telephone 202-366-5723, Email
As described in the application, the intended service of the vessel TAHINA is:
The complete application is available for review identified in the DOT docket as MARAD 2021-0202 at
Please submit your comments, including the attachments, following the instructions provided under the above heading entitled
Go to the docket online at
Yes. Be aware that your entire comment, including your personal identifying information, will be made publicly available.
If you wish to submit comments under a claim of confidentiality, you should submit the information you claim to be confidential commercial information by email to
In the event MARAD receives a Freedom of Information Act (FOIA) request for the information, procedures described in the Department's FOIA regulation at 49 CFR 7.29 will be followed. Only information that is ultimately determined to be confidential under those procedures will be exempt from disclosure under FOIA.
In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its rulemaking process. DOT posts these comments, without edit, to
By Order of the Acting Maritime Administrator.
Maritime Administration, DOT.
Notice.
The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to issue coastwise endorsement eligibility determinations for foreign-built vessels which will carry no more than twelve passengers for hire.
Submit comments on or before October 13, 2021.
You may submit comments identified by DOT Docket Number MARAD-2021-0203 by any one of the following methods:
•
•
James Mead, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE, Room W23-459, Washington, DC 20590. Telephone: 202-366-5723, Email:
As described in the application, the intended service of the vessel LA DOLCE VITA is:
The complete application is available for review identified in the DOT docket as MARAD 2021-0203 at
Please submit your comments, including the attachments, following the instructions provided under the above heading entitled
Go to the docket online at
Yes. Be aware that your entire comment, including your personal identifying information, will be made publicly available.
If you wish to submit comments under a claim of confidentiality, you should submit the information you claim to be confidential commercial information by email to
In the event MARAD receives a Freedom of Information Act (FOIA) request for the information, procedures described in the Department's FOIA regulation at 49 CFR 7.29 will be followed. Only information that is ultimately determined to be confidential under those procedures will be exempt from disclosure under FOIA.
In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its rulemaking process. DOT posts these comments, without edit, to
By Order of the Acting Maritime Administrator.
Maritime Administration, DOT.
Notice.
The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to issue coastwise endorsement eligibility determinations for foreign-built vessels which will carry no more than twelve passengers for hire. A request for such a determination has been received by MARAD. By this notice, MARAD seeks comments from
Submit comments on or before October 13, 2021.
You may submit comments identified by DOT Docket Number MARAD-2021-0193 by any one of the following methods:
•
•
James Mead, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE, Room W23-459, Washington, DC 20590. Telephone: 202-366-5723, Email:
As described in the application, the intended service of the vessel CRAZY TOO is:
The complete application is available for review identified in the DOT docket as MARAD 2021-0193 at
Please submit your comments, including the attachments, following the instructions provided under the above heading entitled
Go to the docket online at
Yes. Be aware that your entire comment, including your personal identifying information, will be made publicly available.
If you wish to submit comments under a claim of confidentiality, you should submit the information you claim to be confidential commercial information by email to
In the event MARAD receives a Freedom of Information Act (FOIA) request for the information, procedures described in the Department's FOIA regulation at 49 CFR 7.29 will be followed. Only information that is ultimately determined to be confidential under those procedures will be exempt from disclosure under FOIA.
In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its rulemaking process. DOT posts these comments, without edit, to
Maritime Administration, DOT.
Notice.
The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to issue coastwise endorsement eligibility determinations for foreign-built vessels which will carry no more than twelve passengers for hire. A request for such a determination has been received by MARAD. By this notice, MARAD seeks comments from
Submit comments on or before October 13, 2021.
You may submit comments identified by DOT Docket Number MARAD-2021-0195 by any one of the following methods:
•
•
James Mead, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE, Room W23-459, Washington, DC 20590. Telephone: 202-366-5723, Email:
As described in the application, the intended service of the vessel LAUNDRA is:
The complete application is available for review identified in the DOT docket as MARAD 2021-0195 at
Please submit your comments, including the attachments, following the instructions provided under the above heading entitled
Go to the docket online at
Yes. Be aware that your entire comment, including your personal identifying information, will be made publicly available.
If you wish to submit comments under a claim of confidentiality, you should submit the information you claim to be confidential commercial information by email to
In the event MARAD receives a Freedom of Information Act (FOIA) request for the information, procedures described in the Department's FOIA regulation at 49 CFR 7.29 will be followed. Only information that is ultimately determined to be confidential under those procedures will be exempt from disclosure under FOIA.
In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its rulemaking process. DOT posts these comments, without edit, to
By Order of the Acting Maritime Administrator.
Maritime Administration, Transportation (DOT).
Notice.
The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to issue coastwise endorsement eligibility determinations for foreign-built vessels which will carry no more than twelve passengers for hire. A request for such a determination has been received by MARAD. By this notice, MARAD seeks comments from interested parties as to any effect this action may have on U.S. vessel builders or businesses in the U.S. that use U.S.-
Submit comments on or before October 13, 2021.
You may submit comments identified by DOT Docket Number MARAD-2021-0194 by any one of the following methods:
•
•
James Mead, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE, Room W23-459, Washington, DC 20590. Telephone 202-366-5723, Email
As described in the application, the intended service of the vessel KON TIKI is:
Please submit your comments, including the attachments, following the instructions provided under the above heading entitled
Go to the docket online at
Yes. Be aware that your entire comment, including your personal identifying information, will be made publicly available.
If you wish to submit comments under a claim of confidentiality, you should submit the information you claim to be confidential commercial information by email to
In the event MARAD receives a Freedom of Information Act (FOIA) request for the information, procedures described in the Department's FOIA regulation at 49 CFR 7.29 will be followed. Only information that is ultimately determined to be confidential under those procedures will be exempt from disclosure under FOIA.
In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its rulemaking process. DOT posts these comments, without edit, to
By Order of the Acting Maritime Administrator.
Maritime Administration, Transportation (DOT).
Notice.
The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to issue coastwise endorsement eligibility determinations for foreign-built vessels which will carry no more than twelve passengers for hire. A request for such a determination has been received by MARAD. By this notice, MARAD seeks comments from interested parties as to any effect this action may have on U.S. vessel builders or businesses in the U.S. that use U.S.-flag vessels. Information about the
Submit comments on or before October 13, 2021.
You may submit comments identified by DOT Docket Number MARAD-2021-0204 by any one of the following methods:
•
•
James Mead, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE, Room W23-459, Washington, DC 20590. Telephone 202-366-5723, Email
As described in the application, the intended service of the vessel DRAGONFLY is:
The complete application is available for review identified in the DOT docket as MARAD 2021-0204 at
Please submit your comments, including the attachments, following the instructions provided under the above heading entitled
Go to the docket online at
Yes. Be aware that your entire comment, including your personal identifying information, will be made publicly available.
If you wish to submit comments under a claim of confidentiality, you should submit the information you claim to be confidential commercial information by email to
In the event MARAD receives a Freedom of Information Act (FOIA) request for the information, procedures described in the Department's FOIA regulation at 49 CFR 7.29 will be followed. Only information that is ultimately determined to be confidential under those procedures will be exempt from disclosure under FOIA.
In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its rulemaking process. DOT posts these comments, without edit, to
By Order of the Acting Maritime Administrator.
Maritime Administration, DOT.
Notice.
The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to issue coastwise endorsement eligibility determinations for foreign-built vessels which will carry no more than twelve passengers for hire. A request for such a determination has been received by MARAD. By this notice, MARAD seeks comments from interested parties as to any effect this action may have on U.S. vessel builders or businesses in the U.S. that use U.S.-flag vessels. Information about the requestor's vessel, including a brief description of the proposed service, is listed below.
Submit comments on or before October 13, 2021.
You may submit comments identified by DOT Docket Number MARAD-2021-0207 by any one of the following methods:
•
•
James Mead, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE, Room W23-459, Washington, DC 20590. Telephone 202-366-5723, Email James.Mead
As described in the application, the intended service of the vessel TRANQUILITY is:
The complete application is available for review identified in the DOT docket as MARAD 2021-0207 at
Please submit your comments, including the attachments, following the instructions provided under the above heading entitled
Go to the docket online at
Yes. Be aware that your entire comment, including your personal identifying information, will be made publicly available.
If you wish to submit comments under a claim of confidentiality, you should submit the information you claim to be confidential commercial information by email to
In the event MARAD receives a Freedom of Information Act (FOIA) request for the information, procedures described in the Department's FOIA regulation at 49 CFR 7.29 will be followed. Only information that is ultimately determined to be confidential under those procedures will be exempt from disclosure under FOIA.
In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its rulemaking process. DOT posts these comments, without edit, to
By Order of the Acting Maritime Administrator.
Maritime Administration, Transportation (DOT).
Notice.
The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to issue coastwise endorsement eligibility determinations for foreign-built vessels which will carry no more than twelve passengers for hire. A request for such a determination has been received by MARAD. By this notice, MARAD seeks comments from interested parties as to any effect this action may have on U.S. vessel builders or businesses in the U.S. that use U.S.-flag vessels. Information about the requestor's vessel, including a brief
Submit comments on or before October 13, 2021.
You may submit comments identified by DOT Docket Number MARAD-2021-0206 by any one of the following methods:
•
•
James Mead, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE, Room W23-459, Washington, DC 20590. Telephone 202-366-5723, Email
As described in the application, the intended service of the vessel PLEIADES is:
The complete application is available for review identified in the DOT docket as MARAD 2021-0206 at
Please submit your comments, including the attachments, following the instructions provided under the above heading entitled
Go to the docket online at
Yes. Be aware that your entire comment, including your personal identifying information, will be made publicly available.
If you wish to submit comments under a claim of confidentiality, you should submit the information you claim to be confidential commercial information by email to
In the event MARAD receives a Freedom of Information Act (FOIA) request for the information, procedures described in the Department's FOIA regulation at 49 CFR 7.29 will be followed. Only information that is ultimately determined to be confidential under those procedures will be exempt from disclosure under FOIA.
In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its rulemaking process. DOT posts these comments, without edit, to
By Order of the Acting Maritime Administrator.
Maritime Administration, DOT.
Notice.
The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to issue coastwise endorsement eligibility determinations for foreign-built vessels which will carry no more than twelve passengers for hire. A request for such a determination has been received by MARAD. By this notice, MARAD seeks comments from interested parties as to any effect this action may have on U.S. vessel builders or businesses in the U.S. that use U.S.-flag vessels. Information about the
Submit comments on or before October 13, 2021.
You may submit comments identified by DOT Docket Number MARAD-2021-0196 by any one of the following methods:
•
•
James Mead, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE, Room W23-459, Washington, DC 20590. Telephone: 202-366-5723, Email:
As described in the application, the intended service of the vessel SHARKNADO is:
The complete application is available for review identified in the DOT docket as MARAD 2021-0196 at
Please submit your comments, including the attachments, following the instructions provided under the above heading entitled
Go to the docket online at
Yes. Be aware that your entire comment, including your personal identifying information, will be made publicly available.
If you wish to submit comments under a claim of confidentiality, you should submit the information you claim to be confidential commercial information by email to
In the event MARAD receives a Freedom of Information Act (FOIA) request for the information, procedures described in the Department's FOIA regulation at 49 CFR 7.29 will be followed. Only information that is ultimately determined to be confidential under those procedures will be exempt from disclosure under FOIA.
In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its rulemaking process. DOT posts these comments, without edit, to
By Order of the Acting Maritime Administrator.
Maritime Administration, DOT.
Notice.
The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to issue coastwise endorsement eligibility determinations for foreign-built vessels which will carry no more than twelve passengers for hire. A request for such a determination has been received by MARAD. By this notice, MARAD seeks comments from interested parties as to any effect this action may have on U.S. vessel builders or businesses in the U.S. that use U.S.-flag vessels. Information about the
Submit comments on or before October 13, 2021.
You may submit comments identified by DOT Docket Number MARAD-2021-0201 by any one of the following methods:
•
•
James Mead, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE, Room W23-459, Washington, DC 20590. Telephone: 202-366-5723, Email: James.Mead
As described in the application, the intended service of the vessel ROLLING ROCK is:
The complete application is available for review identified in the DOT docket as MARAD 2021-0201 at
Please submit your comments, including the attachments, following the instructions provided under the above heading entitled
Go to the docket online at
Yes. Be aware that your entire comment, including your personal identifying information, will be made publicly available.
If you wish to submit comments under a claim of confidentiality, you should submit the information you claim to be confidential commercial information by email to
In the event MARAD receives a Freedom of Information Act (FOIA) request for the information, procedures described in the Department's FOIA regulation at 49 CFR 7.29 will be followed. Only information that is ultimately determined to be confidential under those procedures will be exempt from disclosure under FOIA.
In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its rulemaking process. DOT posts these comments, without edit, to
By Order of the Acting Maritime Administrator.
Maritime Administration, Transportation (DOT).
Notice.
The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to issue coastwise endorsement eligibility determinations for foreign-built vessels which will carry no more than twelve passengers for hire. A request for such a determination has been received by MARAD. By this notice, MARAD seeks comments from interested parties as to any effect this action may have on U.S. vessel builders or businesses in the U.S. that use U.S.-
Submit comments on or before October 13, 2021.
You may submit comments identified by DOT Docket Number MARAD-2021-0205 by any one of the following methods:
•
•
James Mead, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE, Room W23-459, Washington, DC 20590. Telephone 202-366-5723, Email
As described in the application, the intended service of the vessel SABAI is:
The complete application is available for review identified in the DOT docket as MARAD 2021-0205 at
Please submit your comments, including the attachments, following the instructions provided under the above heading entitled
Go to the docket online at
Yes. Be aware that your entire comment, including your personal identifying information, will be made publicly available.
If you wish to submit comments under a claim of confidentiality, you should submit the information you claim to be confidential commercial information by email to
In the event MARAD receives a Freedom of Information Act (FOIA) request for the information, procedures described in the Department's FOIA regulation at 49 CFR 7.29 will be followed. Only information that is ultimately determined to be confidential under those procedures will be exempt from disclosure under FOIA.
In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its rulemaking process. DOT posts these comments, without edit, to
By Order of the Acting Maritime Administrator.
Maritime Administration, DOT.
Notice.
The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to issue coastwise endorsement eligibility determinations for foreign-built vessels which will carry no more than twelve passengers for hire. A request for such a determination has been received by MARAD. By this notice, MARAD seeks comments from interested parties as to any effect this action may have on U.S. vessel builders or businesses in the U.S. that use U.S.-flag vessels. Information about the requestor's vessel, including a brief
Submit comments on or before October 13, 2021.
You may submit comments identified by DOT Docket Number MARAD-2021-0198 by any one of the following methods:
•
•
James Mead, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE, Room W23-459, Washington, DC 20590. Telephone: 202-366-5723, Email:
As described in the application, the intended service of the vessel DISCOVER E is:
The complete application is available for review identified in the DOT docket as MARAD 2021-0198 at
Please submit your comments, including the attachments, following the instructions provided under the above heading entitled
Go to the docket online at
Yes. Be aware that your entire comment, including your personal identifying information, will be made publicly available.
If you wish to submit comments under a claim of confidentiality, you should submit the information you claim to be confidential commercial information by email to
In the event MARAD receives a Freedom of Information Act (FOIA) request for the information, procedures described in the Department's FOIA regulation at 49 CFR 7.29 will be followed. Only information that is ultimately determined to be confidential under those procedures will be exempt from disclosure under FOIA.
In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its rulemaking process. DOT posts these comments, without edit, to
By Order of the Acting Maritime Administrator.
Maritime Administration, DOT.
Notice.
The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to issue coastwise endorsement eligibility determinations for foreign-built vessels which will carry no more than twelve passengers for hire. A request for such a determination has been received by MARAD. By this notice, MARAD seeks comments from interested parties as to any effect this action may have on U.S. vessel builders or businesses in the U.S. that use U.S.-flag vessels. Information about the requestor's vessel, including a brief description of the proposed service, is listed below.
Submit comments on or before October 13, 2021.
You may submit comments identified by DOT Docket Number MARAD-2021-0200 by any one of the following methods:
•
•
James Mead, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE, Room W23-459, Washington, DC 20590. Telephone: 202-366-5723, Email:
As described in the application, the intended service of the vessel ALWAYS GO is:
The complete application is available for review identified in the DOT docket as MARAD 2021-0200 at
Please submit your comments, including the attachments, following the instructions provided under the above heading entitled
Go to the docket online at
Yes. Be aware that your entire comment, including your personal identifying information, will be made publicly available.
If you wish to submit comments under a claim of confidentiality, you should submit the information you claim to be confidential commercial information by email to
In the event MARAD receives a Freedom of Information Act (FOIA) request for the information, procedures described in the Department's FOIA regulation at 49 CFR 7.29 will be followed. Only information that is ultimately determined to be confidential under those procedures will be exempt from disclosure under FOIA.
In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its rulemaking process. DOT posts these comments, without edit, to
By Order of the Acting Maritime Administrator.
Maritime Administration, Transportation (DOT).
Notice.
The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to issue coastwise endorsement eligibility determinations for foreign-built vessels which will carry no more than twelve passengers for hire. A request for such a determination has been received by MARAD. By this notice, MARAD seeks comments from interested parties as to any effect this action may have on U.S. vessel builders or businesses in the U.S. that use U.S.-flag vessels. Information about the requestor's vessel, including a brief
Submit comments on or before October 13, 2021.
You may submit comments identified by DOT Docket Number MARAD-2021-0197 by any one of the following methods:
•
•
James Mead, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE, Room W23-459, Washington, DC 20590. Telephone 202-366-5723, Email
As described in the application, the intended service of the vessel YCM 105 is:
The complete application is available for review identified in the DOT docket as MARAD 2021-0197 at
Please submit your comments, including the attachments, following the instructions provided under the above heading entitled
Go to the docket online at
Yes. Be aware that your entire comment, including your personal identifying information, will be made publicly available.
If you wish to submit comments under a claim of confidentiality, you should submit the information you claim to be confidential commercial information by email to
In the event MARAD receives a Freedom of Information Act (FOIA) request for the information, procedures described in the Department's FOIA regulation at 49 CFR 7.29 will be followed. Only information that is ultimately determined to be confidential under those procedures will be exempt from disclosure under FOIA.
In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its rulemaking process. DOT posts these comments, without edit, to
By Order of the Acting Maritime Administrator.
Maritime Administration, Transportation (DOT).
Notice.
The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to issue coastwise endorsement eligibility determinations for foreign-built vessels which will carry no more than twelve passengers for hire. A request for such a determination has been received by MARAD. By this notice, MARAD seeks comments from interested parties as to any effect this action may have on U.S. vessel builders or businesses in the U.S. that use U.S.-flag vessels. Information about the requestor's vessel, including a brief
Submit comments on or before October 13, 2021.
You may submit comments identified by DOT Docket Number MARAD-2021-0208 by any one of the following methods:
•
•
James Mead, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE, Room W23-459, Washington, DC 20590. Telephone 202-366-5723, Email
As described in the application, the intended service of the vessel PHOENIX is:
The complete application is available for review identified in the DOT docket as MARAD 2021-0208 at
Please submit your comments, including the attachments, following the instructions provided under the above heading entitled
Go to the docket online at
Yes. Be aware that your entire comment, including your personal identifying information, will be made publicly available.
If you wish to submit comments under a claim of confidentiality, you should submit the information you claim to be confidential commercial information by email to
In the event MARAD receives a Freedom of Information Act (FOIA) request for the information, procedures described in the Department's FOIA regulation at 49 CFR 7.29 will be followed. Only information that is ultimately determined to be confidential under those procedures will be exempt from disclosure under FOIA.
In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its rulemaking process. DOT posts these comments, without edit, to
By Order of the Acting Maritime Administrator.
Maritime Administration, DOT.
Notice.
The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to issue coastwise endorsement eligibility determinations for foreign-built vessels which will carry
Submit comments on or before October 13, 2021.
You may submit comments identified by DOT Docket Number MARAD-2021-0199 any one of the following methods:
•
•
James Mead, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE, Room W23-459, Washington, DC 20590. Telephone: 202-366-5723, Email:
As described in the application, the intended service of the vessel LA LA LAND is:
The complete application is available for review identified in the DOT docket as MARAD 2021-0199 at
Please submit your comments, including the attachments, following the instructions provided under the above heading entitled
Go to the docket online at
Yes. Be aware that your entire comment, including your personal identifying information, will be made publicly available.
If you wish to submit comments under a claim of confidentiality, you should submit the information you claim to be confidential commercial information by email to
In the event MARAD receives a Freedom of Information Act (FOIA) request for the information, procedures described in the Department's FOIA regulation at 49 CFR 7.29 will be followed. Only information that is ultimately determined to be confidential under those procedures will be exempt from disclosure under FOIA.
In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its rulemaking process. DOT posts these comments, without edit, to
By Order of the Acting Maritime Administrator.
National Highway Traffic Safety Administration (NHTSA), Department of Transportation (DOT).
Receipt of petition.
Michelin North America, Inc. (MNA) has determined that certain Michelin CrossClimate SUV
Send comments on or before October 13, 2021.
Interested persons are invited to submit written data, views, and arguments on this petition. Comments must refer to the docket and notice number cited in the title of this notice and submitted by any of the following methods:
•
•
•
• Comments may also be faxed to (202) 493-2251.
Comments must be written in the English language, and be no greater than 15 pages in length, although there is no limit to the length of necessary attachments to the comments. If comments are submitted in hard copy form, please ensure that two copies are provided. If you wish to receive confirmation that comments you have submitted by mail were received, please enclose a stamped, self-addressed postcard with the comments. Note that all comments received will be posted without change to
All comments and supporting materials received before the close of business on the closing date indicated above will be filed in the docket and will be considered. All comments and supporting materials received after the closing date will also be filed and will be considered to the fullest extent possible.
When the petition is granted or denied, notice of the decision will also be published in the
All comments, background documentation, and supporting materials submitted to the docket may be viewed by anyone at the address and times given above. The documents may also be viewed on the internet at
DOT's complete Privacy Act Statement is available for review in a
MNA has determined that certain Michelin CrossClimate SUV replacement tires do not fully comply with the requirements of paragraphs S5.5(e) and (f) of FMVSS No. 139,
This notice of receipt of MNA's petition is published under 49 U.S.C. 30118 and 30120 and does not represent any Agency decision or other exercise of judgment concerning the merits of the petition.
Approximately 884 Michelin CrossClimate SUV replacement tires, size 235/55R17 99V, manufactured between October 20, 2019, and November 30, 2019, are potentially involved.
MNA explains that the noncompliance is due to a mold error and that as a result, the number of tread plies indicated on the sidewall of the subject tires does not match the actual number of plies in the tire construction as required by paragraphs S5.5(e) and (f) of FMVSS No. 139. Specifically, the tires were marked “Tread Plies: 2 Polyester + 2 Steel + 1 Polyamide; Sidewall: 2 Polyester” when they should have been marked “Tread Plies: 1 Polyester + 2 Steel + 1 Polyamide; Sidewall: 1 Polyester.”
Paragraphs S5.5(e) and (f) of FMVSS No. 139 include the requirements relevant to this petition. Each tire must be marked on each sidewall with the information specified in paragraphs S5.5(a) through (d) and on one sidewall with the information specified in paragraphs S5.5(e) through (i) according to the phase-in schedule specified in paragraph S7 of FMVSS No. 139. Specifically, each tire should be marked with the generic name of each cord material used in the plies (both sidewall and tread area) of the tire and the actual number of plies in the sidewall, and the actual number of plies in the tread area, if different.
The following views and arguments presented in this section, “V. Summary of MNA's Petition,” are the views and arguments provided by MNA. They have not been evaluated by the Agency and do not reflect the views of the Agency. MNA describes the subject noncompliance and contends that the noncompliance is inconsequential as it relates to motor vehicle safety.
In support of its petition, MNA submitted the following reasoning:
a. Tire performance—MNA says that the subject tires have been designed as a single ply construction. The mismarked tires have been manufactured according to the design specification. These tires fully comply with MNA performance requirements as well as with all applicable FMVSS tire safety performance standards and related requirements.
b. Tire application—MNA claims that the mismarked ply information has no direct impact on tire application. The tires are properly marked with all other FMVSS required information including the tire size designation, maximum load, and maximum inflation pressure. These markings provide both dealers and consumers with the necessary information to ensure proper selection and application of the tires.
c. Tire repair and retread—MNA also says that concerns related to the safety of tire repair and retread personnel have been previously raised for filings involving steel carcass ply tires. The CrossClimate SUV is a passenger car, sport utility, and light truck tire line with a polyester carcass. The tire is not
a. Upon identification of the mismarking, MNA instituted a block on the affected sku. A total of 782 tires were captured and retained in MNA inventory. These tires will be repaired to display the correct single ply marking, or they will be scrapped.
b. The tire specification drawing has been corrected and the mold plate has been updated to show the correct single ply marking. All tires currently being produced have the correct marking.
MNA states that NHTSA has concluded in other petitions related to the number of plies marking that this type of noncompliance is inconsequential to safety. Examples of prior decisions include:
MNA concludes by again contending that the subject noncompliance is inconsequential as it relates to motor vehicle safety, and that its petition to be exempted from providing notification of the noncompliance, as required by 49 U.S.C. 30118, and a remedy for the noncompliance, as required by 49 U.S.C. 30120, be granted.
NHTSA notes that the statutory provisions (49 U.S.C. 30118(d) and 30120(h)) that permit manufacturers to file petitions for a determination of inconsequentiality allow NHTSA to exempt manufacturers only from the duties found in sections 30118 and 30120, respectively, to notify owners, purchasers, and dealers of a defect or noncompliance and to remedy the defect or noncompliance. Therefore, any decision on this petition only applies to the subject tires that MNA no longer controlled at the time it determined that the noncompliance existed. However, any decision on this petition does not relieve equipment distributors and dealers of the prohibitions on the sale, offer for sale, or introduction or delivery for introduction into interstate commerce of the noncompliant tires under their control after MNA notified them that the subject noncompliance existed.
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: Andrea M. Gacki, Director, tel.: 202-622-2480; Associate Director for Global Targeting, tel.: 202-622-2420; Assistant Director for Licensing, tel.: 202-622-2480; Assistant Director for Regulatory Affairs, tel.: 202-622-4855; or the Assistant Director for Sanctions Compliance & Evaluation, tel.: 202-622-2490.
The Specially Designated Nationals and Blocked Persons List and additional information concerning OFAC sanctions programs are available on OFAC's website (
On September 3, 2021, OFAC determined that the property and interests in property subject to U.S. jurisdiction of the following persons are blocked under the relevant sanctions authorities listed below.
Department of Veterans Affairs (VA).
Notice.
This document updates the acute inpatient and Skilled Nursing Facility (SNF)/sub-acute inpatient facility charges. The updated charges are based on Medical Severity-Diagnosis Related Groups (MS-DRG) for fiscal year (FY) 2022.
Debra Vatthauer, Office of Community Care, Revenue Operations, Payer Relations and Services, Rates and Charges (13RO1), Veterans Health Administration, Department of Veterans Affairs, 128 Bingham Road, Suite 1000, Asheville, NC 28806; email:
38 CFR 17.101(a)(1) sets forth VA's collection or recovery regulations for medical care or services provided or furnished by VA to a Veteran for a nonservice-connected disability for which the Veteran is entitled to care (or the payment of expenses of care) under a health plan contract; for a nonservice-connected disability incurred incident to the Veteran's employment and covered under a worker's compensation law or plan that provides reimbursement or indemnification for such care and services; or for a nonservice-connected disability incurred as a result of a motor vehicle accident in a state that requires automobile accident reparations insurance. The methodologies for establishing billed amounts for several types of charges are found in 38 CFR 17.101; however, this notice will only address the acute inpatient and the SNF/sub-acute inpatient facility charges.
Based on the methodologies set forth in 38 CFR 17.101(b), this notice updates the acute inpatient facility charges that were based on the FY 2021 MS-DRGs. Acute inpatient facility charges by MS-DRGs are posted on the Veterans Health Administration (VHA) Office of Community Care (OCC) website, at the following link:
Also, this notice updates the SNF/sub-acute inpatient facility all-inclusive per diem charge using the methodologies set forth in 38 CFR 17.101(c). This charge is adjusted by a geographic area factor that is based on the location where the care is provided. For the geographic area factors, see Table N, title “Acute Inpatient,” and Table O, title “SNF,” on the VHA OCC website under the v4.215 link in the “Reasonable Charges Data Tables” section. Tables N and O are not being updated by this notice. The SNF/sub-acute inpatient facility per diem charge is posted on the VHA OCC website under the “Reasonable Charges Data Tables” section, Table B (v4.21). This Table B corresponds to the Table B referenced in a notice published in the
The charges in this notice for acute inpatient and SNF/sub-acute inpatient facility services are effective October 1, 2021.
This notice is retaining the table designations used for acute inpatient facility charges by MS-DRGs, which are posted on the VHA OCC website under “Reasonable Charges Data Tables.” This notice also is retaining the table designation used for SNF/sub-acute inpatient facility charges, which also are posted on the VHA OCC website. Accordingly, the tables identified as being updated by this notice correspond to the applicable tables referenced in a notice published in the
The list of data sources presented in Supplementary Table 1 (v4.22) reflects the updated data sources used to establish the updated charges described in this notice and will be posted on the VHA OCC website under the “Reasonable Charges Data Sources” section.
The list of VA medical facility locations is also updated. In Supplement Table 3, posted on the VHA OCC website under the VA Medical Facility Locations section, VA set forth the list of VA medical facility locations, which includes the first three digits of their zip codes and provider-based/non-provider-based designations.
Consistent with VA's regulations, the updated tables described in this notice will be posted on the VHA OCC website, under the “Payer Rates and Charges” information section.
Denis McDonough, Secretary of Veterans Affairs, approved this document on August 16, 2021, and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs.
Farm Credit Administration.
Final rule.
The Farm Credit Administration (FCA, we, or our) is amending the its regulations governing standards of conduct (SOC) of directors and employees of Farm Credit System (System) institutions, excluding the Federal Agricultural Mortgage Corporation (Farmer Mac). The final rule requires each System institution to have or develop a Standards of Conduct Program based on core principles to put into effect ethical values as part of its corporate culture.
This regulation will be effective 30 days after publication in the
The objectives of this final rule are to:
• Establish principles for ethical conduct at System institutions;
• Enhance Standards of Conduct Programs using core principles;
• Require each System institution to adopt a Code of Ethics; and
• Encourage and enhance ethical behavior within the Farm Credit System.
The Farm Credit Act of 1971, as amended, (Act)
We published a proposed rule on June 15, 2018, to update FCA's standards of conduct regulations.
The comment period for the 2018 proposed rule closed September 13, 2018.
We received 151 comment letters, all of which came from System institutions or persons affiliated with the System. Of the comment letters received, one came from the Farm Credit Council (Council) acting on behalf of its membership. Each of the four Farm Credit banks submitted a letter, with 15 directors or officers from AgFirst FCB also submitting letters (herein after collectively referred to as “FC banks”). Additionally, 121 letters came from associations, or directors and officers of an association, which represents 34 associations, and another 10 letters were submitted on behalf of one service corporation and two unincorporated business entities. A total of 139 comment letters expressed support for the Council's letter, with eighty-two stating specific support, among which were the four FC banks. Of the comments received from associations and persons or entities affiliated with associations, a total of 44 letters stated support for the comments coming from the FC banks: 32 expressed support for comments made by AgFirst FCB, nine supported comments made by the Farm Credit Bank of Texas (FCB of Texas) and three expressed support for comments made by CoBank ACB. All 151 comment letters contained constructive comments, some supporting portions of the proposed rule, but most asking for changes. A few commenters requested we withdraw the proposed rule and keep the existing regulations in place. Several commenters expressed support for the proposed rule's principles-based approach, explaining it allows for greater flexibility.
In our response to comments we have made some changes on certain proposed provisions, including not finalizing some proposed items, and have provided explanations to further clarify the final rule, all of which are discussed below.
The Council and several other commenters complained that the proposed changes would be administratively burdensome, require revisions of existing policies and procedures, amounting to a needless overhaul of existing System institution standards of conduct processes. Comments were also made questioning our Regulatory Flexibility Act (RFA) analysis and adherence to section 212 of the Farm Credit System Reform Act of 1996 (1996 Act).
We received general comments that the preamble to the proposed rule discussed things that the regulatory text did not say. We have addressed a few of those comments by moving preamble discussions into the relevant provisions in the final rule as clarifying changes, but, for the most part, because the intent of this rule is to present general parameters for compliance and allow the System institution the flexibility to develop a Standards of Conduct Program that best suits its own needs, we provide guidance within the preamble without putting forth accompanying regulatory requirements.
Comments were made that the proposed rule presented items that were unnecessary, burdensome, or inconsistent with the 1996 Act. Section 212(b) of the 1996 Act requires us to continuously review our regulations to eliminate rules that are unnecessary,
The Council and a couple of others commented that the rule should not be exempt from the RFA as our analysis should focus on the individual impact of this rulemaking to each System institution and not consider financial affiliations between the FC banks and associations. Under the RFA, an agency must certify that a rulemaking will not have a significant economic impact on a substantial number of small entities. If the rulemaking will have such an impact, then the agency must conduct a regulatory flexibility analysis. The RFA definition of a “small entity” incorporates the Small Business Administration (SBA) definition of a “small business concern,” including its size standards. A small business concern is one independently owned and operated, and not dominant in its field of operation. The SBA explains that “independently owned and operated” is determined, in part, by the entity's affiliation with other businesses. Generally, an affiliate is one that is controlled by, or has control over, the entity. Businesses with ownership, management, and contractual relationships that make them economically dependent may also be affiliates.
For purposes of the RFA, the interrelated ownership, control, and contractual relationship between associations and their funding banks are sufficient to permit them to be treated as a single entity. Further, System institutions fall under the SBA “Credit Intermediation and Related Activities” size category for small business concerns and the “All Other Non-Depository Credit Intermediation” subcategory. This subcategory defines a small entity as one with average annual assets less than $6 million. As affiliates, the combined average annual assets of each Farm Credit bank and its affiliated associations exceed $6 million. Therefore, System institutions do not satisfy the RFA definition of “small entities.” Because System institutions are not small entities and the FCA regulations apply only to System operations, FCA regulations generally do not and will not have a substantial economic impact on small entities.
We proposed consolidating, renaming and assigning new regulatory section numbers to most existing provisions as well as removing other sections altogether. The Council and its supporters objected to the proposed reorganization of subpart A of part 612, asking us to retain existing rule numbering wherever possible. Fourteen commenters found the consolidation of director and employee provisions problematic, stating the existing separation in the rules makes them well-structured and easy to follow. In response to these concerns, we are finalizing some, but not all, of our proposed reorganization. Specifically, we are finalizing the proposed changes to section headings and the consolidation of provisions to remove separate sections on director and employee conduct matters. However, we are keeping most existing sections numbers for matters covering the same subject matter as what was proposed. We are also keeping the separate section for standards of conduct for agents but renumbering it as § 612.2180. We discuss later in this preamble content changes to the existing provisions on agents resulting from our proposals on the issue and comments received.
We proposed adding new terms, as well as either removing or modifying the meaning of some existing terms used in subpart A of part 612. Specifically, we proposed as new terms:
We received 129 comment letters on proposed changes to § 612.2130, including a letter each from the Council and three FC banks. Comments were directed at thirteen of the twenty terms contained in this section of the proposed rule, plus the removal of the term “officer.” Over half of the commenters objected to the proposed changes to the meaning of “agent” and “family.” One-third of the commenters sought changes to the terms “conflict of interest”, “employee”, and “standards of conduct official.” Less than a quarter of comments were on the term “reportable business entity”. The remaining comments were on the terms: “entity”, “ordinary course of business”, “resolved”, “Code of Ethics”, “material”, “preferential”, and “standards of conduct program.” In addition, twenty-two commenters, including the Council, CoBank, and FCB of Texas, objected to removing the term “officer.” Two commenters expressed specific support for removing the term “relative.”
What follows is a discussion of the comments on the definitions and our responses. If a term is not discussed, it is finalized as proposed.
As proposed, changes to the definition of agent would have explained that an agent is someone who currently represents the System institution as a fiduciary in contacts with third parties, including cyber-security and internet technology providers. We received 78 comments objecting to our proposed changes to this term. The Council and many other commenters remarked that the changes expand the reporting burden, with some commenters stating that those covered by the proposed definition may be prevented by other laws from filing conflict reports. Letters from the Council, FCB of Texas and several other commenters asked that the definition be confined to the legal meaning of “agent” where a fiduciary duty is included. Some commenters stated that an agent is more than someone with fiduciary duties, but also one with power to act for the institution. Some commenters remarked that the change was too broad and the term should exclude those already bound by a code of professional conduct. One commenter said it would be better to ensure those with fiduciary duties act in accordance with a Code of Ethics then extend the SOC program by changing definition of “agent.” Another commenter expressed concern with
The Council, CoBank, FCB of Texas, and several other commenters specifically objected to identifying cyber security and information technology professionals as agents of a System institution. The Council, FCB of Texas and one other commenter stated these persons are not members of a profession having a generally recognized code of conduct as the other professions listed in the definition (
We note that after issuance of the proposed rule and closure of the comment period, the Act was further amended by the Agricultural Improvement Act of 2018 (2018 Farm Bill).
We considered all the comments made on the meaning of “agent” and the new authorities granted FCA in the 2018 Farm Bill. In general, the comments offered three suggestions:
A Code of Ethics was proposed to mean a written statement of the principles and values the System institution follows to establish a culture of ethical conduct for directors and employees. The FCB of Texas and a few others asked that Code of Ethics be referred to as “code of conduct” to avoid confusion with the existing financial disclosure code of ethics. FCB of Texas also suggested adding “including, at a minimum, the core principles set forth in § 612.2136” to the definition. We decline to change the name from a Code of Ethics and finalize its meaning as proposed, with one change. We agree that the Code of Ethics should have a connection to the core principles and have included the statement recommended by FCB of Texas.
We proposed to define a conflict of interest to mean a set of circumstances creating a risk that a secondary or non-work-related interest could unduly influence or materially impact a director's or employee's decision-making with respect to a primary interest. The Council, two FC banks and 32 others commented on this proposed definition. The Council, CoBank and some others commented that changes to this term are not customary, remarking on the ambiguity of using primary and secondary interests in the definition of a conflict of interest, with one commenter asking for more specificity. FCB of Texas and CoBank asked for explanation of what are primary and secondary interests. The Council and some other commenters objected to expanding the definition to cover activities which “could” materially impact someone's objectivity, stating the current scope of actual impact and appearance of impact are sufficient. The Council, CoBank and several others asked that proposed changes not be made, allowing the existing definition to remain. FCB of Texas stated no change to the existing definition was needed but offered a new definition it believed clarified what interests are primary in nature. FCB of Texas also asked that if the term was going to be expanded as proposed, that the companion term “material” be adjusted as well, and that guidance be given on when a set of circumstances would rise to a conflict. FCB of Texas also commented that the proposed definition implied that a financial interest was not the only circumstance that could give rise to a conflict.
In response to comments, we have made changes to the proposed definition of conflict of interest. The final rule keeps the existing definition of “conflicts of interest.” In regards to the commenters who objected to expanding the definition to cover activities which “could” materially impact someone's objectivity, we believe that potential conflicts of interest should remain in the definition because they can affect or give the appearance of affecting the impartiality of the director or employee and as such, need to be reported under § 612.2145. The final definition provides that a conflict of interest includes known circumstances or circumstances that appear to affect a person's ability to perform official duties and responsibilities in a totally impartial manner due to a financial interest in a transaction, relationship, or activity. System institutions should understand that the definition's use of a reasonable person's perspective is applied in a manner that gives full consideration to the cooperative structure of the System.
Changes to the definition of “employee” were proposed to ensure that everyone working at the System institution, including temporary employees, would be part of the ethical corporate culture, regardless of length of employment. The Council, two FC banks and twenty-two other commenters remarked upon this
In the final rule, we adopt the suggestion to replace “employed” with “working” within the definition of “employee.” We have also modified our proposed definition of “employee” in response to comments received to clarify the term does not include those persons not maintained on the institution's payroll, which we believe would include those for whom the institution withholds payroll taxes. In the final rule text, we specifically identify that independent contractors are not “employees” for purposes of the standards of conduct rules. Generally, an independent contractor can be identified: (1) By how he or she is paid, which distinguishes them from those on the payroll (
We are not exempting seasonal employees as suggested by commenters. We believe that temporary employees, including interns, regardless of how long employed, may have positions in the institution that put them in contact with sensitive information that could be used in misconduct. Therefore, we believe temporary and other short-term employees who are being paid by the institution should be held to the same standards of conduct as full- and part-time employees.
The proposed rule would have eliminated the definition of “officer” because officers are a type of employee. Commenters asked that we retain the part 612 definition of “officer” as the term is useful in differentiating prohibited actions and reporting requirements amongst general employees and those specific to officers. In response to this request, we are not removing the definition of “officer” as was proposed.
The term `sole proprietorship' was proposed as an addition to the definition of “entity”. FCB of Texas and one other commenter asked that we remove `sole proprietorships' from the definition as those businesses are normally understood to be other than an entity. FCB of Texas suggested that we include businesses owned by one or more individual in the definition, such as unincorporated business entities, limited liability companies, or limited partnerships. The final rule addresses these comments by adding explanatory parentheticals for `partnerships' and `trusts' and by removing `sole proprietorships' from the definition. The explanatory parentheticals address comments on capturing unincorporated businesses by explaining a partnership can be general or limited and a trust can be formed for business or otherwise. Also, the term `sole proprietorships' is moved to the definition of “person” to ensure that type of operation is captured.
As proposed, the phrase “significant other” would have been added to the definition of family. The Council, three FC banks, and 83 other commenters remarked on this proposal. The Council, FCB of Texas, three commenters from AgFirst FCB, and many other commenters objected to the proposed use of “significant other” in the definition, with some asking for its removal or replacing it with “civil union partner”. Many commenters stated the expanded definition was burdensome for reporting purposes and unreasonable because it created the expectation that institutions make the determination as to the seriousness of an individual's relationship status. CoBank and some other commenters asked that the use of “significant other” in the definition be removed as it is a vague term and several commenters explained that there is no common understanding of the phrase. Some commenters specifically remarked that “significant other” needed to be defined. One commenter supported adding “significant other” to the definition.
The Council, CoBank and FCB of Texas suggested that instead of quantifying relationships under the definition of “family” by using specific titles, we should use the description applied in the Standards of Conduct regulations for Farmer Mac regarding households and financial dependence.
Additionally, the individual commenters from the FC banks and several commenters expressed concern with expanding the definition to include cousins, as was discussed in the proposed rule preamble. Some commenters said that would create a broad burden as there was no accompanying limit on if only first cousins were contemplated or more lineal remote cousins. These commenters asked that the term not include cousins, but if it does, then it should be put in the regulatory text. These commenters also asked that if cousins were included, it be limited to first cousins and to only those first
The final meaning of “family” has been revised from what was proposed to incorporate most of the comments received. First, reference to significant others has been replaced with a reference to civil union partners. Second, cousins have not been added to the definition. Next, highly specific relationships are replaced with more gender-neutral terms and accompanying language that those terms apply whether the relationship arises from biological, adoptive, martial, or other legal means. This action also brings the definition closer to that of “immediate family” used in 12 CFR part 620 as requested by some commenters. Finally, persons residing in the household or who are legal/financial dependents, regardless of familial relationships, have been added as requested. This change makes the definition similar to the existing Farmer Mac guidance found at § 651.22(a) and harmonizes it with other areas of the law.
No substantive changes to this definition were proposed. However, the FCB of Texas asked that the current definition be retained without change. The commenter then suggested that if the intent was to expand the definition to include personal interests that the rule clearly state that, adding that a parallel change should be made to the definition of conflict of interest. The term is finalized as proposed. We have not made the suggested changes to the definition as we do not believe they are necessary.
In the preamble to the proposed rule, we discussed that something that is material in one context or geographic area may not be material in a different context or geographical area. We also discussed our expectation that each System institution would develop its own guidelines on that which is material, possibly including a dollar threshold for what would not be material. We continue to believe the System institution board should be accountable for, and involved in approving, these guidelines as required in § 612.2137.
Changes proposed to the definition of “ordinary course of business” would separate out the existing definition for “preferential” and define “ordinary course of business” as:
• A transaction that is usual and customary in the business in question on terms that are not preferential, or
• A transaction with a person who is in the business of offering the goods or services that are the subject of the transaction on terms that are not preferential.
This term is being finalized as proposed. We do not find the proposed definition confusing or subjective. The current definition applies to transactions that are usual and customary, as does our proposed definition. The current definition also applies to transactions with a person who is in the business of offering the goods or services that are the subject of the transaction, as does our proposed definition. Additionally, we do not agree with the commenters' concerns regarding the first and second paragraphs. The first paragraph applies to a transaction that is usual and customary in a business but is not necessarily with a person in that business. The second applies to a transaction with a person in the business that is the subject of the transaction. In either case, the rule does not allow a director or employee to trade on their position within the System institution to get a special deal or preferential treatment for goods and services.
In the proposed rule, the definition of “preferential” currently contained within the definition for “ordinary course of business” would be a separate term. Only the FCB of Texas commented on the proposed change, suggesting we include a reference to the institution's policies and procedures in the regulatory definition of preferential. This term is being finalized as proposed. Although we decline the suggestion to add a reference to institution policies and procedures because we believe the addition would be overly prescriptive, a System institution can include a discussion of preferential in its SOC program policies and procedures for business transactions.
We proposed changing the term “controlled entity” to “reportable business entity”, defining it as an entity in which a person owns, controls, or has power to vote a material percentage of the equity. The intent behind this proposed change was to avoid confusion with the term `control' in the corporate context, and to allow the System institution discretion to determine when an interest in a business entity may present a conflict and therefore should be reported to the institution.
The Council, two FC banks and 15 other commenters remarked on this proposal. The Council, CoBank and one other commenter stated the revisions to this definition do not align clearly with how “affiliated organizations” is used in 12 CFR part 620. The Council pointed out that the part 620 disclosures for some directors and senior officers are taken directly from standards of conduct reports and it is difficult to understand how the two sets of regulations will work together with the new term “reportable entity” only used in one of the rules. The Council asked for the two rules to be reconciled or that FCA otherwise state if the proposed change in part 612 means a separate process for part 620 disclosures is now expected. FCB of Texas said the proposed definition is an improvement over “controlled entity” but disagrees with replacing the 5% ownership threshold with the less specific “material percentage” language. The FCB of Texas also remarked that it was unreasonable to ask an institution's board to set a dollar threshold for materiality in different situations, instead suggesting we keep the specific ownership threshold but raise it 25%. The same commenter also suggested changing language on the power to exercise “material influence” to “controlling influence.” In the alternative, the commenter recommended replacing the definition entirely with that used to define “affiliated organization” in § 620.1. CoBank supported removing the 5% ownership language. Fourteen commenters stated support for the term “reportable business entity” but would like it used with the existing definition of “controlling entity” because it reflects numerical ownership of an entity, which does not always mean control of that entity.
We appreciate that it would be easier to comply with this provision if we simply used a bright line percentage
Commenters also asked that we use the definition of affiliated organization in § 620.1(a).
The final rule modifies the proposed definition of “reportable business entity” by adding to the third and last listed item, the phrase “. . . from his or her status as a partner, director, officer, or majority shareholder in the entity.” This addition comes from 12 CFR 620.1 and is made in response to comments asking us to reconcile the term with that of “affiliated organization” in part 620. We also point out that if a System institution is concerned about picking up all § 620.1(a) affiliated organizations in its standards of conduct disclosures, it can provide, through its own policies and procedures, that all § 620.1(a) affiliated organizations be treated as reportable business entities when making conflicts of interest reports.
We proposed adding a new term “resolved.” One commenter remarked on this proposal, asking that we remove the term since not all conflicts are resolved. The commenter instead suggested leaving it to each institution to identify how conflicts are addressed. This term is being finalized as proposed as we believe it is important that there be a common understanding and application of the term. We agree that each institution should identify how conflicts are to be addressed and allow the institution that opportunity in its policies and procedures. The rule requires the institution to address the process by which real and apparent conflicts will be resolved and explain action(s) to be taken when a conflict cannot be resolved to the satisfaction of the institution in its policies and procedures as part of its standards of conduct program.
Changes proposed to the definition of a Standards of Conduct Official (SOCO) would have required the SOCO to be an employee of the System institution and have the authority to report to the institution board of directors or designated board committee on standards of conduct matters. The Council, one FC bank, and 37 individuals from several associations commented upon this proposal. The Council and several other commenters specifically disagreed with limiting the SOCO to an employee of the institution while supporting the SOCO having direct access to the institution's board of directors. The Council asked that if the proposed limitation is finalized, FCA make clear the SOCO's employment reporting relationship is within the organizational structure, not a direct supervisory relationship with the board. One commenter suggested defining the SOCO as either an employee or agent of the institution with direct access to the institution's board of directors.
FCB of Texas and some other commenters strongly disagreed with limiting the SOCO to employees of an institution explaining there is validity in using someone from the outside, especially for smaller associations. One commenter stated it saw the benefit of limiting the position to employees and another saw value in multiple SOCOs. Both said there should be flexibility to outsource. Other commenters expressed strong belief in allowing each institution to decide who should serve as the SOCO. These same commenters explained the value of outside sources for the SOCO, stating there is greater confidentiality and file protection.
In response to commenters, the final rule incorporates commenter suggestions but in a manner that preserves the policy objectives behind the proposed rule. Some of the suggested changes are reflected in the definition of SOCO and others are captured in the rule sections on SOC program elements and the SOCO duties and responsibilities, both discussed later in this preamble. In the definition section of the final rule, and in response to comments, the SOCO is defined as a person appointed by the institution's board of directors to administer and report on the standards of conduct program, as well as investigate allegations of misconduct. We clarify in this preamble that the Standards of Conduct Official must be in a position to be independent and impartial in order to discharge his or her duties but does not have to be an employee. We also agree with comments that the institution is in the best position to know its needs and resources, including the person who would best satisfy the SOCO role in light of those needs and the program in place, whether such person is employed by the institution or is an outside resource.
As proposed, the Standards of Conduct Program would be defined to mean the policies and procedures, internal controls, and other actions a System institution must put into practice to meet the requirements of this rule. Only the FCB of Texas commented on this term, suggesting that the definition include “specific guidelines and comprehensive rules.” The definition explains that the Standards of Conduct Program includes the policies and procedures, internal controls, audit, training, and other activities that promote ethical behavior. Therefore, we are not making the suggested change, preferring to keep the principals-based approach of the rule. Further, as was explained in the proposed rule, we reiterate that the Standards of Conduct Program is the totality of the policies, procedures, internal controls, audit, training, and other activities used to promote ethical behavior at a System institution.
We proposed substantially revising current rule § 612.2135 to set forth the core principles we believe are essential to fostering an ethical culture within the System. We also proposed certain basic minimum requirements for compliance as well as requiring cooperation between employees, directors, and the SOCO. We received 23 comment letters on this section, including one from the Council and two FC banks. Most of these same commenters asked us to retain the existing rule instead of what was proposed, stating the proposed
We finalize this section substantially as proposed but make some changes in response to comments that we discuss in the subsections below. We also make small changes to improve readability and align the format of the rule, such as adding headings to main paragraphs and clarifying language on fulfilling the core principles. At the request of commenters, we are retaining the numbering of this section as § 612.2135.
In paragraph (a) we proposed increasing the ethical standard to “the highest ethical standards of the financial banking industry, including standards of care, honesty, integrity, and fairness.” The Council and most other commenters to this section objected to raising the standard from “high” to “highest” and using the financial banking industry as the guide. The Council and six others said the highest standard is ambiguous, leading to uncertainty, and recommended keeping the existing high standard. The Council, FCB of Texas, and twenty other commenters stated the current high standard does not need to be replaced, with FCB of Texas suggesting use of a more focused approach directed at the System's reputation and mission. CoBank and one other commenter expressed support for maintaining the highest ethical standards but characterized it as an aspirational goal rather than a requirement. The Council, CoBank, and seven other commenters remarked that the financial banking industry is an inappropriate guide because commercial banks are not subject to the same conduct rules as the System. Commenters asked that reference to financial banking industry be removed. CoBank suggested keeping the current language of § 612.2135(a) and one other commenter suggested replacing proposed financial banking industry with “financial services industry”.
In response to comments, we retain the current rule's language requiring “high” ethical standards and remove the proposed reference to the financial banking industry. We also replace proposed language asking employees and directors to “vet” conflicts of interest with the SOCO to clarify that the provision requires identification and reporting conflicts of interest as well as resolving those conflicts. We make this change in direct response to FCB of Texas and fourteen other commenters stating the verbiage “vet” was confusing. To further clarify this provision, the final rule lists reporting to the SOCO conflicts of interest involving a director or employee (or family and reportable business entities thereof) separately from the requirement to work with the SOCO to identify conflicts and resolve any conflict reported.
FCB of Texas suggested that we add to proposed paragraph (a)(5) the words “between an individual's personal interests and official duties” before the words “in System business relationships and activities” to make clear where conflicts of interest actually arise. We are not making the changes suggested by FCB of Texas. The suggested language by FCB of Texas was designed to clarify the provision. We believe we have achieved the requested clarity through other changes made to this provision.
We proposed requiring directors and employees to fulfill fiduciary duties, as applicable. FCB of Texas asked that we insert “as a director or employee” when talking about fiduciary duties instead of the phrase “as applicable.” Five commenters remarked that the proposal would extend fiduciary duties beyond those currently in law, causing a significant burden for all concerned. One of these commenters also remarked that the proposal would change director and senior officer disclosures made under 12 CFR 620.6, significantly expanding them beyond directors and senior officers and adding no benefit. The commenters asked that the provision only apply to directors and senior officers or be removed entirely. Commenters expressed that not all employees have fiduciary duties and that the phrase “as applicable” is confusing and should be clarified or eliminated.
FCA expects System institution directors to acknowledge their fiduciary duties. Additionally, most officers have fiduciary duties, whether they are senior officers or not. To distinguish established fiduciary duties from other conduct requirements, the final rule moves the provision on fulfilling fiduciary duties to § 612.2135(c) and adds clarifying language that these responsibilities apply to officers and directors of the institution. We continue to believe there are fiduciary responsibilities held by non-officer employees in the financial sector. However, we are not currently regulating it for all employees as a System institution is in the best position to determine which employees have fiduciary duties based on job responsibilities. We expect each institution to address these responsibilities within the Standards of Conduct policies and procedures.
As proposed, directors and employees would be required to comply with all applicable laws and regulations. One commenter expressed that this provision should also include violations of state or local laws in determining a standards of conduct violation. The final rule at § 612.2135(b) does not add the distinction requested by the commenter but does contain clarification that compliance with an institution's standards of conduct means following the SOC policies and procedures as well as law and regulation. We believe that “all applicable laws” would include state and local laws and therefore, it is unnecessary to make it a condition in this final rule. However, a System institution may specifically address state and local laws in its policies and procedures if it wishes. We also clarify in § 612.2135(b) that the provision on reporting known or suspected activities refers to anonymous reporting procedures.
We proposed to require directors and employees to certify participation in the institution's annual standards of conduct training. The FCB of Texas suggested that this provision belongs in the section that would establish the standards of conduct training as part of the Standards of Conduct Program. We agree with this comment and have relocated the provision to the section on standards of conduct training. We renumber the remaining subparagraphs of this section in conformance with this change.
Six commenters expressed that directors and employees should be able to certify participation in standards of conduct training using methods other than in writing. We did not intend to limit the manner in which conflicts of interest reports are filed or how training participation is certified as long as records are created. Therefore, we have added language to the definition section at § 612.2130 to explain that for purposes of this subpart, words like report, certify, file, and sign are to be treated as permitting their electronic equivalent.
Proposed § 612.2137 would set forth a System institution's responsibility to establish a Standards of Conduct Program that includes policies and procedures and a Code of Ethics, among other things, to implement the objectives of this rule. We received 118 comment letters on this section of the proposed rule, including letters from the Council and three FC banks. A significant number of the commenters asked that we retain current rule provisions in certain areas, including the treatment of agents, family and reportable business entities under the Standards of Conduct Program. Commenters also asked for clarifications and exceptions to what was proposed, with a few asking us to relocate reporting information to the section on disclosures and training information to the section on SOCO duties.
We finalize the rule with changes based on comments received and we discuss those changes in the subsections below. We also make small changes to improve readability and align the format of the rule, such as adding headings to main paragraphs and clarifying language on designing a standards of conduct program.
Proposed § 612.2137(a) would establish that the Standards of Conduct Program set forth the core principles in § 612.2135 and provide resources for its implementation. FCB of Texas suggested that language be inserted after the reference to § 612.2135 to make explicit that the Standards of Conduct Program comply with more than just the core principles of the regulation. We agree and have revised the regulatory text in final rule § 612.2137(a) accordingly. This commenter also suggested that the preamble language “including but not limited to, additional staffing or access to outside counsel where necessary,” be added to the end of § 612.2137(a). We are making this change but not using specific language provided. Instead, we have added language to require resources for both implementation and operation of the SOC program. We leave specificity on the type of resources to each institution. For example, reference to adequate resources could include staffing and access to outside counsel if the institution deems it necessary. It is up to each institution's board of directors to provide the necessary resources to implement an effective SOC program.
Proposed § 612.2137 would require a System institution to maintain records of conflicts of interest reports, investigations, and other documents for at least 6 years. As proposed, institutions would be required to protect these records and other confidential information obtained as part of the standards of conduct program from unauthorized release. Each institution would also have to periodically review and update the SOC program. One commenter expressed general agreement with the recordkeeping requirements but asked for wording changes. Another commenter suggested that these records be maintained by outside counsel for confidentiality reasons. FCB of Texas suggested naming the person responsible for the reviews and updates.
In response to the comment asking us to clarify record retention and consolidate like provisions, we move language from proposed paragraph (d) to this paragraph, which requires maintaining conflict of interest reports a minimum of six years. Language from proposed paragraph (e)(1) on maintaining SOC program records of investigations for six years is also moved into paragraph (a). No significant wording was revised but the suggested language of the commenter was considered. Although not in rule text, we clarify that a System institution may choose to place records with outside counsel, but we decline to make it a requirement. We also apply to this section the comment from FCB of Texas on naming responsible parties in the section addressing SOC program administration.
In § 612.2137(b), we finalize the requirement to appoint a SOCO and add language in response to comments on who may serve as a SOCO. When offering comments on proposed duties of the SOCO, thirty-two commenters also remarked on the proposed limit of who may be SOCO in two regards: The limitation of the SOCO being an employee and the supervisory implications of the SOCO reporting directly to the board. These commenters generally expressed that the board should retain full discretion in selecting the SOCO and espoused the belief that using a person outside the institution as SOCO provides greater independence and security in monitoring and reporting conflicts. Six commenters from one association explained that at smaller associations only the Chief Executive Officer (CEO) reports directly to the board and the CEO may not be the best person to serve as the SOCO. These same commenters expressed a preference for continuing the existing practice of contracting with an outside law firm, where the SOCO is free from undue pressures by management and offers an independence desirable to employees for discussing conflict issues. Twenty commenters from two associations stated that the board should retain the discretion to select the SOCO whether inside or outside the institution. One other commenter stated that FCA's reasons for proposing the SOCO be an employee can be satisfied to a greater extent by outsourcing the position, as the independence from internal operations gives greater objectivity in standards of conduct issues and makes reporting directly to the board more manageable. Another commenter expressed significant concern with having a SOCO report to its board for standards of conduct issues but report to management on other job tasks. This commenter asks if FCA is insisting institutions create a stand-alone, full time SOCO position. If so, the commenter said that would be a real burden for smaller associations. Another commenter stated the proposed SOCO limitation threatens critical independence and objectivity. This commenter also remarked that the proposed change removes clarity, makes the SOCO role more difficult for employees to hold as the proposed SOCO duties appear to require legal expertise. This commenter also remarked upon the day-to-day work environment for employees serving as SOCO, especially once the employee takes actions against co-workers or
The final rule removes the proposed restriction on using only employees as the SOCO. To offer flexibility in response to comments, the rule specifically authorizes institutions to appoint a SOCO from several sources including using: One if its officers, the resources of a 4.25 service corporation, another institution's SOCO, or contracting with a third-party to serve as SOCO (including under a contract shared with another System institution). In situations where institutions share a SOCO, the rule requires the existence of a separate confidential relationship. Whether the SOCO serves in a full-time capacity, as a collateral duty, or in an as needed capacity is a decision of the institution.
Proposed § 612.2137(c) would require each System institution to adopt a Code of Ethics that establishes principles and values for the ethical conduct of its directors and employees, including standards for appropriate professional conduct at the workplace and in matters related to employment. It was proposed that System institutions also be required to post the Code of Ethics on the external website for public access. The Council, CoBank, and most other commenters remarked that the Code should not include matters normally associated with employment conduct. Seventeen commenters specifically said much of the provision was redundant of work done by the human resources staff, making it inefficient to have the SOCO duplicate those efforts, and asking that language be removed. CoBank supported requiring a Code of Ethics but objected to publishing it for fear of litigation. Two commenters also objected to public posting of the Code, with one stating the whistleblower information is already on the website providing the public a venue for reporting issues. Eighteen commenters supported the suggestion of posting a general statement of the institution's professional integrity and conduct but saw no benefit in posting the entire Code of Ethics. Instead, most of these commenters said they viewed posting the Code as an invitation for borrowers to contest credit decisions on other than the merits. FCB of Texas supported requiring a Code of Ethics and publishing it, if the Code is limited to general ethical statements and does not include matters related to employment. This commenter also offered specific wording to soften the regulation in this area. Comments asking to rename this Code as a “code of conduct” were made when remarking on the definition for “Code of Ethics” and are addressed in that section.
The proposed requirement to adopt and maintain a written Code of Ethics is finalized with the following changes made in response to comments received:
• Adding clarifying language explaining the Code must be kept up-to-date;
• Replacing language regarding employment matters with language explaining the Code is directed at business transactions; and
• Revising the proposed requirement of posting the Code on an institution's website with a requirement for posting a statement that the Code has been adopted. The statement must summarize the Code and advise the public that a copy of the Code of Ethics is available on request and at no cost.
As proposed, a System institution would have responsibility to establish policies and procedures that further the objectives of this rule. We noted that some commenters confused the proposed responsibilities of the System institution to develop policies and procedures on reporting of conflicts of interest in real time with the proposal for the periodic reporting of other matters. The institution, its directors, its employees and the SOCO all have a role in implementing the Standards of Conduct Program. The periodic reporting of other matters is a responsibility of each director and employee. Developing policies and procedures for those reporting responsibilities is a duty of the institution. We offer further clarifications in the respective discussions that follow.
In the process of addressing comments to specific provisions within this section, the organization and numbering of paragraphs has changed, including:
• Proposed paragraph (d)(1) on contents of a conflicts of interest report is renumbered paragraph (d)(2).
• Proposed paragraph (d)(2) on resolving conflicts is renumbered paragraph (d)(3).
• Provisions on third party relationships in proposed paragraph (d)(3) is renumbered paragraph (d)(4).
• Proposed paragraphs (d)(4) and (5) on enforcing the SOC program are consolidated into renumbered paragraph (d)(6) and now follow renumbered paragraph (d)(5) discussing receipt of gifts.
• Proposed paragraph (e)(3) on anonymous reporting is moved and renumbered as paragraph (d)(7). As finalized, § 612.2137(d)(1) contains the requirement to file a conflict of interest report, including the timing of the report, and providing disclosure information required under § 620.6(a), (e), and (f). The part 620 items were moved to this section in partial response to comments asking us to reconcile the conflicts of interest disclosure requirements of parts 612 and 620.
Commenters were concerned that the proposed rule preamble discussion on requirements for reporting of material interests was not adequately reflected in the rule. To address commenters' concerns, we include a requirement in final rule § 612.2137(d)(2) that the System institution must establish criteria to help directors, employees, agents and the SOCO identify conflicts and those that are material.
As proposed, each System institution would have the flexibility to develop a Standards of Conduct Program most suited to its unique needs, and to use its existing Standards of Conduct Program if it is adequate to satisfy the purposes of this regulation. The Council and several other commenters objected to the rule requiring reports outside the ordinary course of business, stating it was too broad. The Council, FCB of Texas and some other commenters asked that this provision give the SOCO authority to exclude non-material activities and that transactions be limited to fiscal year interactions with institution directors, employees, and agents. Fourteen commenters stated the provision conflicted with other provisions as it is not limited to transactions with the institution but could be read to include all business transactions. FCB of Texas observed the rule does not require reporting ordinary business transactions as is done in 12 CFR 620.6(e) and (f). Similarly, one commenter stated the requirement to annually report all business transactions was too broad and inconsistent with 12 CFR 620.6 disclosures. This commenter asked that current reporting language be kept instead of the proposed provision. The commenter also asked that the reporting expectations be reconciled with 12 CFR 620.6(e) and (f) as well as the term “affiliated organization” used in part 620. One commenter asked for general clarifications and to relax the requirements to allow institutions to tailor their policies to their needs.
We discussed in the preamble to the proposed rule our expectation that each System institution should set its own
FCB of Texas asked that we move all reporting details to the proposed disclosure section. We believe the final rule achieves this by consolidating all reporting requirements in § 612.2145, which correspond with the policy requirements in § 612.2137(d). However, discussion of reporting content and how reports are made is still a part of § 612.2137 as each institution's board of director must address these issues in their SOC program policies and procedures.
Proposed § 612.2137(d)(1)(iii) and (iv) would require System institutions to establish policies and procedures for disclosing conflicts arising from family and business entities. We received several comments on this proposal and address them in III.B.4 of this preamble discussion of provisions on the reporting of conflicts.
We proposed that an institution's policies and procedures address how reported conflicts of interest will be resolved. We received no substantive comments on this area, but there were related comments asking us to clarify the role of the SOCO in the resolution process. We finalize the rule in this area substantially as proposed but make some changes to improve readability and clarity. We also add language clarifying that the policies and procedures must explain the process for how conflicts will be resolved and the role of the SOCO in resolving conflicts. This clarification is made in response to comments on the issue and is in keeping with our principals-based approach to the rule.
As proposed, System institutions would establish policies and procedures to address third-party relationships, including disclosing known conflicts. Several commenters questioned the ability to get agents to cooperate in reporting the required information and whether all System personnel know all the institution's agents. Some specifically suggested keeping the current requirements of § 612.2260 saying it is clear and understandable. The Council asked how the phrase “third-party relationships” differed from the proposed definition of “agent”. The Council, CoBank and several others suggested that those parties not covered as “agents” be handled by the institution's vendor management policies. The Council and nineteen other commenters also asked that service providers covered by professional conduct and ethics standards be exempted from compliance with an institution's standards of conduct or be treated as satisfying those requirements if in compliance with their own professional and ethical standards. CoBank and some others asked that existing agent contracts be grandfathered in to avoid costly renegotiations. A few commenters asked that we allow institutions to follow reasonable policies on agents. Four commenters remarked on preamble language discussing conditioning an agent's appointment on the misconduct rules, stating that is an overreach and inconsistent with rule text. Another comment stated vendors cannot be expected to know the institution's SOC program and asked us to remove the requirement. Still others asked that we add a knowledge element to the reporting requirement for agents. One commenter pointed out that most agents do not have direct knowledge of the institution's borrowers so would be unable to accurately report any potential conflicts of interest. Seventeen commenters said the requirement was unnecessary as contract language to engage an agent already has behavior clauses.
In response to comments asking to keep the current rules on agents in 12 CFR 612.2260, the final rule does not implement the proposed removal of that section. However, the existing provision is renumbered as § 612.2180. A full discussion of this retained section is contained later in this preamble at III.B.7. In connection with making this requested change, the final rule replaces proposed language with language requiring an institution's board of directors to adopt conflict of interest polices for third party relationships (including agents). And, following the comments regarding use of contracts, the final rule requires each board to apply ethical safeguards in contracts with third parties, including agents. The final rule also implements commenter suggestions by adding a knowledge requirement of conflicts disclosed by agents and other third-parties. At a minimum, board policies address its expectations for agents and other third-party service providers to disclose known conflicts to the institution. By definition, an agent is someone who has the power to act for the institution either by contract or apparent authority; therefore, it is important that agents and other third-parties maintain the same high ethical standards as directors and employees. We consider not finalizing the proposed third-party reporting provision, along with keeping existing rule text on conflict of interest reporting by agents, as satisfying all other comments asking for changes to that requirement.
Some commenters objected to the suggestion in the proposed rule preamble that a System institution should require agents to acknowledge a System institution's Code of Ethics by signing it. This is not a requirement in the rule, although a System institution could consider imposing this requirement on their own in future agency relationships.
As proposed, System institutions would be required to establish policies and procedures prohibiting gifts but could have rules in place to allow directors and employees to accept
The final rule clarifies that the required policies and procedures on gifts address those gifts not otherwise prohibited by FCA regulation. As requested by commenters, the final rule alters proposed language on the contents of these policies and procedures to provide that institutions may make appropriate exceptions for gift giving related to non-business events as long as gift exchanges would not be viewed as an attempt to influence official institution activities. While commenters suggested various changes and specific exceptions on gifts, in keeping with the principals-based approach of this rulemaking the final rule does not adopt those detailed suggestions nor do we include a de minimis level. Instead, the rule leaves it to the institution to set specific gift parameters. The final rule also clarifies that authorized gift exchanges must have de minimis thresholds at both the individual gift level and in the annual aggregate, per recipient.
We do not believe the restrictions on gifts are more restrictive. The principles-based approach to the regulations allows the institutions to set criteria for accepting gifts and includes an exception for non-business events where the gift is not viewed by the institution as attempting to influence official institution business. We encourage institutions to have internal controls or policies to ensure adequate de minimis levels are set and followed. The final rule retains the proposed requirement that the policies and procedures establish disclosure requirements for gifts received as well as any disposed of because they were impermissible. In response to other changes, this provision is renumbered as § 612.2137(d)(5).
Proposed paragraphs (d)(4) and (5) would require SOC program policies and procedures to discuss how the SOC program is monitored and enforced. We received no substantive comments on this area, but there were related comments asking us to clarify the role of the SOCO in enforcement actions. We finalize the rule in this area substantially as proposed but make some changes to improve readability and clarity, including consolidating the provisions into renumbered paragraph (d)(6). As requested by commenters, we also specifically require the policies and procedures identify who is authorized to take enforcement actions and discuss the SOCO role in investigating certain conduct issues.
The proposed rule would require internal controls for anonymous reporting of suspected standards of conduct and Code of Ethics violations through a hotline or other reporting procedure. FCB of Texas suggested adding language to clarify that reporting is for any individual action. CoBank stated that this provision appears to codify the Whistleblower Program that is already in place for reporting financial improprieties and used for other types of anonymous reporting and thus the new provision should be eliminated. We finalize the rule substantially as proposed but add reference to individuals making a report and make small changes to improve readability. We feel that providing an avenue to anonymously report both known and suspected violations is an important part of a Standards of Conduct Program and believe it should be included within SOC program policies and procedures even when there is Whistleblower Program in place. We also add that nothing in the rule prevents institutions from adapting existing Whistleblower or Hotline programs for SOC program purposes. In response to other changes, this provision is renumbered as § 612.2137(d)(7).
Proposed § 612.2137(e) would require each System institution to arrange periodic internal audits of the Standards of Conduct Program to identity weaknesses, measure effectiveness, and conduct reviews to prescribe necessary corrective actions. Two commenters said the program as written would be costly to implement especially for those associations who do not have an internal audit department. The commenters asked that the word “internal” be removed to allow for outsourcing the service. One commenter also asked if FCA was requiring each institution to establish a new department of internal SOC audits. Another commenter asked us to explain how the provision would be applied at unincorporated business entities (UBE) of a System institution.
We finalize the rule in this area substantially as proposed but, as discussed earlier, moved some provisions to other paragraphs. We also add a heading to the paragraph in keeping with the overall format of the rule. We make some clarifying changes considered necessary based on comments received and to improve readability. The final rule clarifies that the institution's board of directors establishes the internal controls program but does so with the assistance of the SOCO and other officers of the institution. However, the board ultimately decides the scope of the internal review and identifies who will conduct the audit. Also, the final rule clarifies that all audit results of the SOC program go directly to the board. A commenter asked about the proposed rule's reference to UBEs so the final rule adds reference to FCA regulations in § 611.1150(b).
The final rule's requirement for an “internal” audit of the SOC program refers to an audit of the internal operations of the program. It does not limit the persons who perform the audit. System institutions are not required to establish an internal audit department. While we recognize there could be some additional costs involved, the audit could be a component of the institution's risk assessment process as established by the Audit Committee and conducted by a person or entity independent of the Standards of Conduct Program. The board is responsible for identifying who will conduct the internal audit, which is important to ensure the program is being managed effectively. We believe that to ensure a strong ethical culture, ethical conduct must be encouraged
Proposed § 612.2137(f) would require each System institution to establish within its policies and procedures SOC program training, setting the timeframes for conducting such training. FCB of Texas remarked that this could be duplicative of the training requirements proposed elsewhere and suggested consolidating them all into this section. As discussed earlier in this preamble at III.B.2-d, the final rule relocates most provisions on standards of conduct training into this paragraph. The final rule makes some clarifying changes to § 612.2137(f) considered necessary based on consolidating like provisions and adds a heading to the paragraph in keeping with the overall format of the rule. Changes made in response to other comments are discussed below.
As proposed, new directors would receive standards of conduct training 60 calendar days before or after the director's election or beginning of his or her term. The Council, CoBank, and 16 others separately commented on the proposed timeframes, questioning if there was an error in asking for training before a director begins his or her term of service. The commenters explained the unworkability of trying to administer training
We agree with commenters that it is impractical as well as generally impossible to provide training to directors who have not yet begun serving their terms of office. Directors are not employees of the institution so providing individuals access to the institution's resources for training or other reasons before board service would be impermissible due to confidentiality laws and regulations, especially as there is no basis under which to obtain confidentiality agreements from these individuals until board service begins. It is an established corporate governance principle that once elected to the board a director owes his or her fiduciary duties, including a duty of confidentiality, to the institution and shareholders as a whole. As such, an institution may take measures to ensure each director abides by policies defining and specifying the treatment of the institution's confidential information, including restricting directors from disclosing confidential information to the shareholders electing them to serve on the institution's board. However, this authority does not arise until board service begins. We appreciate commenters identifying our inadvertent mistake. In this final rule we correct the error on director training by changing “before” to “after” and, for further clarity and consistency, use the language of § 611.210(b) on when to start the 60 days. New director training must occur within 60 calendar days of a director assuming his or her position on the board. We decline requests to extend the timeframe to one year as directors should be made aware of their standards of conduct responsibilities as soon as possible. We clarify that this new director standards of conduct training can be considered part of the overall § 611.210(b) orientation training as nothing in § 611.210(b) requires all components of orientation training to occur at one time; rather, it all must just be completed within 1 year.
We proposed that newly hired employees receive training within five business days of starting employment. One commenter asked that we provide a longer timeframe, suggesting 10 business days. FCB of Texas also remarked five days was too short. In response to the commenters' request for a longer period of time, we are changing the time period in the final rule from five days to the suggested ten days. We believe the requested timeframe of 10 days is reasonable and meets policy objectives.
Over 30 commenters supported the requirement for annual SOC training, with fourteen of them asking to incorporate it into existing training requirements rather than treat it as a separate training event. Six commenters asked that periodic training be every other year (
We believe it is important for all employees, not just directors, to receive SOC training to ensure knowledge of prohibited conduct and any changes to the SOC program. We do not agree that training every 2 years is sufficient and final the requirement for annual training. We think it is important for training to reinforce the SOC requirements. The institution can decide if that can be accomplished effectively by incorporating the SOC training into existing training. Additional comments on SOC program training are addressed in III.B.6-c of this preamble.
We proposed consolidating and revising existing standards of conduct reporting requirements to enhance the quality of information captured in a standards of conduct report as well as implement a principles-based approach. As proposed, the rule would establish requirements for directors and employees to identify and report conflicts of interest. We received 132 comments on the proposed changes to the standards of conduct reporting requirements, including comments from the Council and three FC banks, as well as individual letters representing 27 associations. The majority of comments were directed at the proposed paragraph regarding the contents of conflict of interest reports.
We finalize the provisions on reporting conflicts of interest with changes based on comments received. We discuss those changes in the subsections below. We also make small changes to improve readability and align the format of the rule, such as adding headings to main paragraphs and clarifying language.
FCB of Texas asked that the heading for this section read as only “reporting requirements” to avoid confusion. In response to the suggestion on the heading for this section, the final rule changes the heading for this provision to “Disclosing and reporting conflicts of interest.” Additionally, in response to requests that we keep existing section numbering, we do not final the proposal to move reporting requirements to a new § 612.2138. Section 612.2145, which currently addresses SOC program reporting for directors, will now encompass reporting for directors and employees. The § 612.2155 employee reporting section is removed and reserved.
As proposed, directors and employees would be required to take affirmative action to identify, report and resolve conflicts or potential conflicts of interest of which they are aware. It is intended to compel each director and employee to take ownership of and invest in ethical responsibilities. We also proposed that a director or employee with a conflict in a matter subject to official action refrain from participating in the official action (
The final rule consolidates into paragraph (a) the proposed paragraphs discussing identification and reporting conflicts of interest. To further group the responsibilities into paragraph (a), the proposed contents of paragraph (b) are consolidated and renumbered as (a)(1). As suggested by a commenter, language on recusals is now in new paragraph (a)(1). In the process of consolidating these provisions, some language was revised for readability and to remove redundancy. Also, a new paragraph (a)(2) is added as a conforming change with retaining existing language regarding reporting illegal or unethical behavior, which is further discussed in this preamble at III.B.6-d. The contents of paragraph (a)(2) resemble the core principles in § 612.2135(b)(3).
CoBank and several others asked that the requirement to report “any matter” be limited to transactions outside the ordinary course of business. The commenters also asked to limit entity reporting to material business transactions with the System. Commenters explained that normal business interactions should not trigger a report as operating as a cooperative, many System directors are farmers and conduct farm business in the same communities as their institution's borrowers. The final rule replaces the proposed language on reporting “any matter, transactions or activities pending at the System institution” with language explaining that identification, disclosure and reporting on conflicts means “any interest or circumstance that does or could constitute” a conflict or potential conflict. The final rule has a related requirement for directors and employees to disclose actual conflicts with “a matter, transaction or activity subject to official action” by the institution. We think that it is more important to both disclose the conflict of interest and refrain from participating in any action or board discussion of the matter rather than prescribe what must be in the disclosure. As was proposed, the final rule at § 612.2145(a)(1) requires directors and employees to refrain from participating in official actions at the institution that are related to the matter disclosed. In keeping with the principals-based approach, we have not finalized the proposed language detailing what the disclosure must contain. Additionally, System institutions should understand that identifying conflicts uses a reasonable person's perspective in a manner that gives full consideration to the cooperative structure of the System, and institutions may build their SOC program policies and procedures accordingly.
As proposed, directors and employees would identify, report, and cooperate with the SOCO to resolve conflicts of interest. Commenters asked that a director or employee not be required to identify conflicts of interest when functionally it is the SOCO who has the obligation to determine whether there is a conflict. We view the process of reporting conflicts of interest as a collaborative one between the director or employee making the report and the SOCO. We have made clarifying changes to better reflect that process. We have revised the wording in final rule § 612.2145(a) to provide that the director or employee must identify, disclose, and report any interest or circumstance that does or could be a conflict of interest. The rule at § 612.2170(b)(1) lists helping institution personnel identify conflicts as a SOCO responsibility. Next, the rule at § 612.2145(a) requires directors and employees to cooperate with the SOCO in identifying if a conflict is material or not. The rule elaborates in § 612.2145(b) that this includes providing enough information to the SOCO for a “reasonable person” to make a materiality determination. Elsewhere we explain that the SOCO will use the institution's SOC program policies and procedures to determine materiality. Further guidance on any interest or circumstance that might give rise to a conflict of interest must be provided in the System institutions' policies and procedures as discussed earlier in III.B.3-c of this preamble.
The Council and a few other commenters specifically asked that directors be excused from detailed reporting as they are no longer involved in loan approvals. We decline the request. Directors of System institutions have ultimate responsibility for all that occurs at the institution and are directly involved in hiring the CEO. Directors also play a role in credit decisions when setting institution lending policies and through service on the institution's credit review committee.
As proposed, annual reporting of interests in business matters, names of family members, material financial interests, reportable business entities, and persons residing in the home would be required. The Council and most associations (or persons and entities affiliated with associations) objected to the language on reporting the names of family and reportable business entities, stating it is too broad and inconsistent with 12 CFR 620.6(e) and (f). The Council and 20 other commenters recommended keeping existing regulations in this area and explaining how these reports interact with the part 620 annual reporting requirements on conflicts of interest for directors and senior officers. CoBank and a few other commenters likewise objected to reporting requirements on entities, asking to limit it to those with current year transactions. Eleven of these also asked that the provision be reconciled with how affiliated organizations are reported in part 620.
The reporting requirements of § 612.2145(b) were revised in response to comments received. Some changes were made to general areas of § 612.2145, but most were specific to certain subject matters and we discuss those in the subsections below.
Additionally, existing language from current §§ 612.2145(b) and 612.2155(b) was inadvertently omitted from the proposed rule. The final rule restores:
• The language requiring directors and employees to file conflicts of interest reports with the SOCO that contain the disclosures required by this section and the institution's SOC program policies and procedures;
• The current provisions of §§ 612.2145(b)(2) and 612.2155(b)(2) regarding the scope of reporting for reportable business entities; and
• The current provisions of §§ 612.2145(b)(1) and 612.2155(b)(1) regarding the scope of reporting for family.
In response to comments, the final rule also modifies the proposed list of minimum report contents as follows:
• Clarifies that “business matters” includes loans and loan applications.
• Clarifies that “business matters” reported must include those before the institution, a supervised institution, and a supervising institution.
• Limits reported material transactions to those with any director, employee, agent or borrower of the institution, or a supervised or supervising institution; and
• Clarifies that the report must include gifts received or disposed of that are reportable under the institution's SOC program policies and procedures.
As a conforming change to the consolidation of proposed paragraphs (a) and (b), this provision is now numbered as § 612.2145(b).
The Council, CoBank, FCB of Texas, three commenters from AgFirst, and most of those associations commenting expressed concern with being required to report all past transactions. These commenters asked that only current and new transactions be subject to reporting. We agree that the obligation to report should be limited to current and new transactions and think that limiting transactions to the current year should be sufficient to capture any known or potential conflicts of interest. The final rule clarifies that transactional timeframes are those occurring in the current year, as that term is defined in the institution's SOC program policies and procedures.
The Council and FCB of Texas remarked that the requirement to report “any” interest in “any” business matter is too broad. The Council recommended moving into the rule text the preamble explanation that this provision captures direct and indirect business matters pertaining to the System institution, including those occurring through an entity. FCB of Texas recommended limiting the requirement to interests with System personnel. This commenter added that if we keep the provision as proposed, the phrase “any business matter” should create a link with the initial conflict of interest report. One association questioned the need for disclosure of personal relationships. In response to the request of some commenters, the final rule specifies that only those transactions with the institution or the supervising or supervised institution must be reported under paragraph (b)(1).
The Council, three commenters from AgFirst FCB, and several others objected to the requirement to report “all” material financial interests regardless of any System connection, asking the reporting expectation to be limited to transactions with System institutions and System borrowers. The Council and CoBank asked that this element be further limited to reporting only those transactions that are outside the ordinary course of business. The Council remarked that without these constraints, the reporting requirement would be overly broad and burdensome. FCB of Texas said this reporting requirement overlaps with those in proposed § 612.2138, asking us to clarify if the intent is for both ordinary transactions and those outside the ordinary course of business be reported, or just those outside the ordinary course of business.
In § 612.2145(b)(2), a material interest with any director, employee, agent, or borrower must be reported, regardless of the nature of the interest. We understand this may result in an ordinary course of business transaction being reported because the transaction presents a conflict or is material in nature. The policies and procedures of the System institution should provide further clarification and explain how materiality of a conflict is identified.
FCB of Texas asked that “business affiliates” be removed from the provision to avoid confusion, while twenty other commenters asked that it be defined. The final rule in this area does not contain the phrase “business affiliates” as requested by commenters.
The Council asked that reporting on “reportable business entities” be limited to only where the person holds a material interest in an entity that poses a conflict. The Council, FCB of Texas and several other commenters suggested following the existing rule under § 612.2145(b)(1), which only requires reporting those entities doing business with the System. The final rule does not make the requested change to only limit entity reporting on a materiality standard. We do not think it is necessary to limit reporting on “reportable business entities” to where the person holds a material interest in the entity because the term “reportable business entity” is based on ownership and control. However, the final rule does make the requested change to follow existing rules on with whom transactions occur that will make them reportable. The final rule limits the listing of reportable business entities to those transacting business in the current year with the institution, a supervised or supervising institution, or a borrower who has business with your System institution, or a supervised or supervising institution.
AgFirst FCB remarked that the proposed definition of “family” would make the reporting requirement unduly burdensome, especially as the “family” definition does not require a legal relationship. This commenter and a few others said the requirement substantially increases the workload of the SOCO, who reviews all submissions. AgFirst FCB and many others suggested the requirement be limited to reporting family members when there is actual knowledge of business transactions with the institution. CoBank and several other commenters stated the rule was unclear on if extended family needed to be reported and expressed support for keeping the current requirement to report only immediate family having business with the institution during the reporting year. One commenter suggested restricting the scope of family to immediate family to reduce the reporting burden and place focus on those family members who are most likely to present a risk of undue influence risk to the institution director or employee.
The Council, FCB of Texas and several other commenters objected to expanding existing requirements on naming family and placing no time constraints on activities to be reported. The Council and several others suggested limiting the requirement to transactions occurring in the reporting year, including those that ended in the reporting year. In the alternative, the Council suggested following the proposed rule preamble explanation by leaving the reporting of past business transactions to each institution's discretion. FCB of Texas also said the transactions being reported should be tied to System transactions as is done in existing § 612.2155(b). Three others said reporting on family transactions should be limited to when it occurs rather than a set time annual timeframe. These commenters suggested keeping the existing rule provision requiring positive reporting on family when there is actual knowledge.
We have changed the definition of family, which was discussed above in III.B.1-f of the preamble. In response to comments, we have also changed the reporting requirements for family and reportable business entities to those “you know or have reason to know” and included a timeframe of the current year. In response to other comments, the final rule modifies the reporting requirements for family to resemble that of the current rules in §§ 612.2145(b) and 612.2155(b). Reportable transactions by family are those occurring in the current year with the director's or employee's System institution or any supervised or supervising institution. We have chosen not to limit the requirement to immediate family, preferring to use the definition of family found in § 612.2130. We believe the changes to that definition provide sufficient limits while still addressing potentials for conflict to arise.
The proposed standard for what to disclose as a real or potential conflict of interest was “to the best of your knowledge and belief.” When reporting for family, the proposed standard was supplemented to require reporting the name of those family members “you know or have reason to know” have business with the System. The Council, CoBank and some others asked for clarification of whether the proposed reporting requirement for family was intended to be more or less restrictive and if this same requirement poses a duty to inquire. The Council, FCB of Texas and some commenters remarked that combining a knowledge standard with a “reason to know” standard is contradictory and suggested using an actual knowledge standard for this provision or at least clarifying the same standard used for all reporting areas. The Council and a few others also asked if the “reason to know” standard was restricted to family reporting. FCB of Texas, CoBank and some other commenters recommended we use the existing rule's actual knowledge standard. A couple of commenters suggested using “to the best of knowledge” as not all directors and employees know the financial activities of family. The majority of commenters expressed a preference for the same standard to be used in all of the proposed reporting items.
As a director or employee, you should know what interests you have in business matters or loan applications that are being considered by your institution or supervising institution. However, you may not be directly involved in transactions with family members or reportable business entities. Therefore, the final rule applies a “know or have reason to know” standard for reporting on family and reportable business entities transactions with the System. The other reportable items do not have a similar qualifier.
FCB of Texas asked that gift reporting requirements from the SOC program elements be moved to this section. We are not moving the gift requirements as suggested but have modified the rule to explain the report must include reportable gifts received or disposed of that are reportable under the institution's SOC program policies and procedures.
The proposed rule would have required all directors and employees to make the disclosures required under 12 CFR 620.6(f). The part 620 provision currently only applies to directors and senior officers. The proposal also inadvertently omitted paragraphs (a) and (e) of 12 CFR 620.6 from this requirement. A few commenters asked that we keep the term “senior officer” to clarify that reporting on part 620 disclosures is not being extended to all employees. A few asked if institutions have the authority to limit reporting under this provision to senior officers and directors and if so, asked that the rule text reflect that.
We agree with comments that the part 620 disclosures only apply to directors and officers and make appropriate changes in the final rule. The final rule also moves references to reports made under 12 CFR 620.6 to a new paragraph (c) since those disclosures are only required of directors and officers. In conformance with final provisions on the SOCO duties discussed in this preamble at III.B.6-b, § 612.2145(c) requires directors and officers give the SOCO disclosures required under § 620.6(a), (e), and (f). We note that the § 612.2130 definition of “officer” is substantially similar to that of “senior officer” as used in part 620 and defined in § 619.9310. The final rule leaves it to the institution to determine the timing of these disclosures, but specifies they must at least occur annually (in connection with filing the institution's annual report) and when the institution issues an Annual Meeting Information Statement under FCA regulations § 620.21(a)(3).
We proposed consolidating the current prohibited activities for directors, employees and joint employees into one section. We also proposed incorporating the existing prohibitions on purchasing System obligations into this same section. In the process, we proposed clarifications and elaborations to existing rule text. We received 45 comments on the proposed changes to prohibited conduct and the related consolidation, including comments from the Council and two FC banks. Outside of general comments to keep the existing rule, all the comments for this section were directed at a few specific provisions. We make some changes to the proposed provisions on prohibited conduct in response to comments and to reconcile provisions with changes elsewhere, which we discuss in the subsections that follow. We also make small changes to improve readability and align the format of the rule, such as adding headings to main paragraphs and clarifying language. Those changes include:
• Consolidating proposed paragraph (a)(1) into the main portion of paragraph (a), renumbering the remaining subordinate paragraphs, and adding a new lead to paragraph (a) for the list of prohibited activities.
• Adding clarifying language that “you” refers to both directors and employees.
• Clarifying that the subordinate paragraph on gifts refers to prohibited gifts.
• Using consistent language to identify supervising and supervised institutions.
• Numbering provisions containing exceptions for ease of reference; and
• Only using the term “family” since the additional language on persons residing in the home is now captured in the definition of “family.”
In response to general requests that we keep existing section numbering where possible, we do not final the proposal to number these provisions as § 612.2139. Instead, we have consolidated and moved prohibited conduct provisions to the existing section on employee prohibited conduct in § 612.2150. The current § 612.2140 director prohibited conduct numbering is removed and reserved.
As proposed, the current director and employee prohibitions on participation in matters affecting certain financial interests would be retained. The final rule clarifies this prohibition includes
The proposed language on gifts would prohibit directors and employees from soliciting, obtaining or accepting, directly or indirectly, any gift, fee or other compensation that could be viewed as offered to influence decision-making, or official action or to obtain information. The final rule makes minor changes to reconcile the provision with the final language on the elements of a SOC program, located in § 612.2137, discussing an institution's role in setting SOC program policies and procedures for gifts, including limiting the blanket gift prohibition to gifts offered because a person serves as a director or employee of a System institution.
We proposed keeping the current prohibitions against directors and employees knowingly purchasing or otherwise acquiring any interest in real or personal property owned by his or her System institution within the past 12 months. FCB of Texas asked for an exception to the 12-month provision when a third party purchases the property from the institution and then sells it by competitive bid within 1 year. The Council and CoBank asked if the provision applied to inventory property held by a UBE, as was mentioned in the proposed rule preamble but not regulatory text. Many commenters offered the general observation that items were put in the proposed preamble that should be contained in rule text. In some instances, we have agreed with commenter requests and in others we have not.
We stated in the preamble to the proposed rule that the prohibition on acquired property would apply to collateral acquired by a System institution, including collateral acquired directly or through an acquired property UBE. As requested by commenters, the final rule text specifically references property held or sold by a UBE or a 4.25 service corporation. In one of our preamble explanations for this section, we said that the acquired property prohibition does not affect a director's right of first refusal to inventory property under 12 U.S.C. 2219a. Commenters asked that this be included in the rule text and the final rule adds that exception. As finalized, this paragraph sets forth all the exceptions on acquiring institution property in subparagraph form: (i) By inheritance, (ii) through the right of first refusal, and (iii) when property is sold by public auction. We caution that although we do not directly include agents in the acquired property prohibition, System institutions should be aware of agent conflicts and not allow an agent to purchase acquired property if he or she has non-public information (
One commenter questioned why employees were included in the prohibition. The current rule does not exempt employees from this prohibition and we did not propose to change that. Unlike directors, institution employees are heavily involved in the acquisition and sale of acquired properties and thus present real possibility for actual conflicts of interest. To minimize the potential for misconduct and the burden of institutions augmenting their internal controls and monitoring systems, we believe that it is in the best interest of the System to keep employees covered by the prohibition.
We proposed keeping the current limitations on directors and employees entering into lending relationships with individuals who may have a financial relationship with a System institution, with certain exceptions. The FCB of Texas and one other commenter expressed concern that the proposed rule does not keep the existing exception for transactions with any person residing in the director's or employee's household. The final rule retains the existing exemption for family and given the final rule also changes the definition of “family” to now include persons residing in the household, we believe the final rule addresses this comment. These same two commenters questioned the absence of the existing exception for non-material transactions. These comments are directed at the current provision allowing the SOCO to determine an otherwise prohibited transaction as permissible because it does not involve a material amount of money and the director or employee does not participate in the other party's business with the institution. We did not propose to keep this exemption based on other changes to the subpart and are not otherwise persuaded by the comments to now do so. We point out that the final rule retains the prohibited transaction exception for ordinary course of business transactions. However, the extent to which these transactions will be allowed is for each institution to address as part of the SOC program policies and procedures.
The final rule makes minor changes to improve the readability of the provision, including breaking the main sentence into two. This action separates the language prohibiting financial transactions with the institution from those with a borrower of the institution. No change in the meaning is intended by this. Also, as mentioned earlier, the exceptions to this prohibition are set forth in subparagraph form. In making this modification, we identified that an existing exception to the prohibition on financial transactions was inadvertently omitted. The final rule restores the exception for official transactions connected with the institution's relationships with Other Financing Institutions.
We proposed keeping the current limitations on directors and employees purchasing System obligations. The Council, CoBank, and one other commenter asked that the prohibition exclude those obligations held in a mutual fund or other account where an individual investor is not involved in selecting the securities comprising the mutual fund. The commenters do not elaborate on if the mutual funds would be publicly available or private funds.
We understand the concern surrounding mutual funds. At this time, we are not making the requested change. Because of the complicated nature of this request, we will review this issue and possibly include it in another rule making action. We remind the commenters that the rule does not prevent most System directors and employees
We proposed retaining most existing joint employment prohibitions for employees, but also proposed establishing additional ones. We received comments on some of the proposals for this issue and discuss them below.
We received sixteen comments on limiting service on the board of directors of a non-System entity. Four commenters expressed concern with limiting service on other rural boards. Eleven comments discussed service on a family-owned company, explaining the current rule allows employees to work on family-owned entities but the proposed rule would change that to “reportable business entities”, eliminating many family-owned businesses because of the proposed definition of “reportable business entity.” These commenters state the proposed change will reduce the employment pool in rural areas and asked FCA to keep the exception for family-owned businesses that may not satisfy the new meaning of “reportable business entity.”
The final rule prohibits serving as a director or employee of any commercial bank, savings and loan, or other non-System financial institution in all situations. The final rule retains the exception for service at an employee credit union. However, the proposed limits on serving at an entity transacting business with the institution or serving at another System institution in the district are not being finalized as proposed. Instead, the prohibition on serving at an entity transacting business with the institution or with any institution in the district now applies the exceptions for `transacts business with' as provided in the rule. Additionally, the final rule further limits application of the provision to non-System entities. We believe this change provides some of the requested relief but remind commenters that the provision is in our current Standards of Conduct rules, so it is not a new prohibition.
In response to comments regarding family businesses that may not satisfy the definition of “reportable business entities”, the final rule includes those family businesses as one of the named exceptions to the `transacts business with' provision. We recognize that employees may work on family-owned entities that do not necessarily meet the definition of a “reportable business entity.” Without this broader exception, employees who assist in family farming operations without having a material influence might be prohibited from serving as a director or employee of a family operation, which was not our intent. Therefore, we have added family-owned entities into the exception. The final rule provides that the phrase “transacts business”, as used in this provision, does not include loans by a System institution to a family-owned entity or a reportable business entity; service on the board of directors of the Federal Agricultural Mortgage Corporation; transactions with non-profit entities; or transactions with entities in which the System institution has an ownership interest. As a conforming change, the final rule removes the sentence cross-referencing the joint employment provision of paragraph (b)(4) since it is redundant with the final rule language regarding non-System entities.
As proposed, the current exception allowing an employee of a Farm Credit Bank or association to serve as a director of a cooperative that borrows from a bank for cooperatives (BCs) would be removed. One commenter remarked that the offered reason of mergers for removing this exception was not clear, stating there was a need for board members to serve cooperatives in small rural areas. The commenter suggested limiting prohibitions on board service to System institutions. We agree with the commenter that service on a cooperative board would not be a conflict in all situations. As such, we do not final the proposed removal of the current provision giving an exception for serving as a director of a cooperative borrowing from the System under Title III authorities. However, the rule updates the current language of this provision to recognize that the former BCs merged and now exist within CoBank. As a result of a subsequent merger with a Farm Credit Bank, CoBank is currently the only institution possessing Title III lending authority under the Act. The final rule recognizes there is an obvious conflict with employees of CoBank also serving as directors of cooperatives borrowing from CoBank. As existed in the current rule, this final rule allows System employees—except those employed at CoBank—to serve as a director of a cooperative borrowing from the System under Title III authorities. This authorization is dependent upon the current employing institution approving service on that cooperative's board of directors. We expect each institution to consider the potential for conflict when approving or disapproving an employee request to serve on a cooperative's board, particularly if the employee involved works at a System association for which CoBank is the funding bank.
We proposed keeping the current joint employee prohibition but with an exception to allow certain joint employee relationships. The proposed exception would require both boards to authorize the service and that the duties and compensation at each institution be delineated in the board's approval. The institutions would also provide reasonable notice to the FCA beforehand. CoBank expressed support for the changes, adding that joint employment between banks and associations does not often occur. The Council and CoBank commented that proposed language regarding service on the board of other System institutions differs from the existing rule. The Council contended that under the existing rule an employee may serve on the board of another System institution, particularly service corporations, regardless of ownership. Both commenters expressed concern that the proposal limits service to only those institutions where the employing institution has an ownership interest. We also received eight comments from persons affiliated with the Foundations service corporation, two from persons associated with Farm Start, and 34 letters from association personnel or directors. All commented that paragraph (b)(4), as proposed, could be interpreted to preclude System institution employees from serving as officers or managers of a service corporation or other entity in which a System institution has an ownership interest. One commenter specifically stated the provision would preclude alliances among System institutions.
The final rule does not contain language requiring or prohibiting ownership interest in both institutions when sharing an employee. The relevant measure is the relationship between a supervised and supervising institution. To prevent potential conflicts, the rule prohibits officers from serving simultaneously at both the supervising and supervised institutions: Other employees are not similarly prevented from this activity. This reflects the current prohibitions for banks and association officers, excepting use of the terms “supervising” and “supervised” institutions. The definitions of these terms as proposed and as contained in this final rule do not include service corporations. We believe commenters
FCB of Texas commented on proposed language regarding notice to FCA of the joint employees, asking that it be clarified regarding the terms “extraordinary situations” and “reasonable prior notice”. FCB of Texas suggested removing the latter term, replacing it with a requirement for FCA approval. CoBank also commented that “reasonable prior notice” was vague, asking for clarification or, in the alternative, removal of all restrictions on joint employment. FCB of Texas also observed this section of the proposed rule used the word “officer” when the word had been proposed for replacement with “employee.” The commenter suggested keeping the term and related definition of “officer.”
The final rule implements the suggestions of commenters regarding FCA involvement in joint employee arrangements. The rule explains that in extraordinary circumstances, FCA may approve a non-officer Farm Credit bank employee serving as an officer at a supervised institution when both institutions have board approval of the joint service and the division of the shared employee's duties and compensation are identified in the board approval documents. To address the concern over the term “reasonable prior notice”, the final rule changes the requirement to send the approval documents to FCA at least 10 business days in advance of the joint employment beginning. Comments regarding use of the term “officer” have been addressed by the final rule retaining the definition of “officer.”
To incorporate changes made at the suggestion of commenters, the layout of paragraph (b)(4) was revised. Now the opening sentence of the provision contains the blanket prohibition on serving at a supervised or supervising institution. Thereafter, subordinate paragraphs are used to identify the two exceptions:
• Serving as a non-officer employee at a Farm Credit bank and association when expenses are appropriately divided; or
• Serving as an officer at a supervised association in extraordinary circumstances.
We proposed enhancing the role of the Standards of Conduct Official (or SOCO) by identifying the SOCO as the point of contact for advice, guidance, and reporting on matters related to conflicts of interests. We also proposed charging the SOCO with responsibility for training in this area and requiring the SOCO to have direct access to an institution's board of directors. We received 59 comment letters on the role of the SOCO, including comments from the Council and two FC banks. Most expressed support, some asked for modifications and ten commenters from one association remarked that the listed SOCO responsibilities were unreasonable and will make finding a SOCO difficult. Two other commenters asked us to keep the existing language of § 612.2170, stating the current rule works well and the proposed rule does not improve on existing provisions. Some commenters, including FCB of Texas, noted that this section is duplicative of other sections, asking us to consolidate like provisions.
In conformance with changes made elsewhere in the rule on defining and appointing a SOCO, the final rule adds a new paragraph (a) on the authority of the SOCO to administer the program. In response to commenters' requests, the final rule also consolidates provisions on the SOCO authority to carry out assigned responsibilities, clarifying that the SOCO must have access to directors, employees and agents to fulfill these duties as well as possess the resources and legal authority to do his or her job. This preamble adds the clarification that legal authority is directed at the ability to receive confidential SOC program communications. This was added because of FCA regulations in 12 CFR part 618, subpart G, regarding an institution's responsibilities to safeguard its files and records from unauthorized disclosure. Under the final rule, the institution board authorizes the SOCO to handle these confidential documents as a means of recognizing it is necessary for performing official duties of the institution as SOCO and therefore permitted under FCA regulation § 618.8300.
We had proposed as part of the SOCO definition a requirement for access to the institution's board of directors. Further, the proposed duties of the SOCO included reporting to the institution's board of directors or designated board committee any instance of non-compliance with the System institution's standards of conduct rules or Code of Ethics. Based on comments made elsewhere, we consolidated that language to this section.
Three commenters, including one FC bank, asked that only significant or material instances of non-compliance be reported by the SOCO to the board. Another commenter asked for clarification that the board access did not replace supervisory reporting lines or other institution organizational structures. The final rule clarifies that the SOCO must have direct access to the board for purposes of discussing and reporting on matters related to standards of conduct or the Code of Ethics. Information reported by the SOCO is determined by each institution's SOC program policies and procedures.
As proposed, the SOCO would provide guidance and information to directors and employees on conflicts, resolve reported conflicts, maintain appropriate documentation and report to the institution's board noncompliance with the SOC program. A few commenters stated that the SOCO should not be responsible for giving advice, especially not to agents, and eighteen commenters objected to language in the proposed rule preamble naming the SOCO the authority for giving advice. These commenters remarked that the SOCO can provide guidance and information, but not advice. Two commenters suggested consolidating the proposed language on the SOCO providing guidance with the paragraph on helping identify conflicts. One remarked that nothing in this section requires the SOCO to identify conflicts of interest, only help others to do so. This commenter suggested the SOCO have responsibility for identifying and reporting conflicts.
In conformance with changes made elsewhere in the rule on SOC program elements and comments on how a SOCO duties are characterized, the final rule consolidates into paragraph (b) various provisions in proposed § 612.2170 regarding SOC program administration, making some language modifications in response to comments. The consolidation results in a list of key duties for the SOCO:
• Providing guidance and aiding in the identification of conflicts required to be reported (from proposed paragraph (b));
• Receiving conflicts of interest reports (from proposed paragraph (d));
• Receiving the disclosures required under 12 CFR 620.6(a), (e), and (f) as a supplement to any conflicts-of-interest report filed under part 612 (from proposed § 612.2138(c)(4) and existing standards of conduct reporting requirements at §§ 612.2145(a), 612.2155(a), and 612.2165(b)(12));
• Reviewing and acting upon filed reports, including documenting resolution efforts for material conflicts (from proposed paragraphs (d), (e), and (f));
• Maintaining SOC program records (from proposed paragraph (f));
• Conducting investigations authorized under FCA regulations or the institution's SOC program policies and procedures (from existing rule text inadvertently omitted); and
• Promptly reporting to the institution's board of directors those matters as required under FCA regulations or the institution's SOC program policies and procedures (from proposed paragraph (g)). We believe the consolidation and clarifications address the general comments made on this provision. Below we address more specific comments on certain SOCO duties.
As proposed, the Standards of Conduct Official would make written determinations on how conflicts of interest will be resolved, consistent with the System institution's policies and procedures. The SOCO would also document resolved and unresolved material or significant conflicts of interest. One commenter observed the word “significant” is redundant and confusing. Another commenter questioned how the Standards of Conduct Official can resolve a conflict when the resolution is to fire the employee or director. One commenter remarked that conflict situations are fluid so one set process for reporting and addressing the conflicts as proposed is unrealistic. This commenter asked to keep resolution processes in the hands of the association through the SOC program policies and procedure. The commenter also remarked that documenting conflicts is given too much importance when focus should be on reporting transactions and financial obligations as well as avoiding conflicts.
The final rule requires the SOCO to review and act upon reports and disclosures. In response to comments, we are not finalizing the requirement to document “significant” conflicts of interest but have retained a requirement on making determinations on how conflicts of interest will be resolved and documenting material conflicts, whether resolved or unresolved. The process of deciding the appropriate resolution to a conflict does not always empower the SOCO to enforce the resolution, that is dependent upon the institution's SOC program policies and procedures as is the resolution process.
Two commenters observed we had not proposed a record retention schedule on reported conflicts within § 617.2170. We talk about maintaining SOC program documentation in § 612.2137(a) so do not believe it is necessary to repeat it in this section.
In proposed paragraphs (c)(1) through (6), the SOCO would give training for the following:
• Procedures for the review of the institution's standards of conduct rules and the Code of Ethics, and recommendations of any updates;
• Procedures for anonymously reporting known or suspected violations of standards of conduct and Code of Ethics and unethical conduct;
• Rules for prohibited conduct;
• Fiduciary duties;
• Conflicts of interest and apparent conflicts of interest;
• Reporting requirements; and
• New director and new employee training.
Commenters' concerns with the specificity of the training requirements proposed in this section are reasonable. Therefore, the final rule does not include the proposed list. We believe this allows each System institution the requested flexibility to develop the training that meets its needs and improve its ethical culture. We clarify that SOC program training could include separate training for directors, officers and other employees. We consider our removal of the training list as satisfying all other comments asking for changes to that list, including comments asking us to change terminology used and asking us to restrict training requirements for fiduciary duties to directors. We continue to see a need for targeted training for those employees with fiduciary duties and strongly encourage each institution to devote time to providing that training. The final rule continues to require that the SOC program training include updates to the institution's Code of Ethics and standards of conduct policies and procedures.
The rule finalizes the proposal to require the SOCO to obtain certification of participation from every director and employee taking the SOC program training. Comments regarding the format of training certifications are addressed in III.B.2-d of this preamble. Also, as discussed earlier at III.B.3-e, the final rule relocates most provisions on standards of conduct training, including timelines, into § 612.2137(f).
We did not propose keeping the SOCO's existing responsibilities regarding criminal referrals. We received no comments on this change but are not finalizing it. At the time of the proposed rulemaking, discussions were underway to modify the criminal referral process of subpart B of part 612. However, FCA issued Bookletter-073 instead of making a rule change,
We proposed removing the current separate provision on standards of conduct for agents at § 612.2260. At the request of commenters, we are not finalizing that change. The final rule retains this section but renumbers it as § 612.2180. Additionally, the final rule makes small changes to improve readability and align the format of the section with the rest of the rule, such as
The final rule also adds a new paragraph (d) to capture a legal change in FCA's authority over “institution-affiliated parties.” As is discussed earlier in this preamble at III.B.1-a, FCA's enforcement authorities were enhanced to give FCA enforcement jurisdiction over “institution-affiliated parties”, which definition includes both agents and independent contractors of System institutions as well as “any other person, as determined by the Farm Credit Administration (by regulation or on a case-by-case basis) who participates in the conduct of the affairs of a System institution.” The final rule adds this statutory language to the regulations without elaboration or interpretation.
Pursuant to section 605(b) of the Regulatory Flexibility Act (5 U.S.C. 601
Under the provisions of the Congressional Review Act (5 U.S.C. 801
Agriculture, Banks, banking, Conflict of interests, Crime, Investigations, Rural areas.
For the reasons stated in the preamble, part 612 of chapter VI, title 12 of the Code of Federal Regulations is amended as follows:
Secs. 5.9, 5.17, 5.19, 5.31A of the Farm Credit Act of 1971, as amended, (Act) (12 U.S.C. 2243, 2252, 2254, 2267a); Sec. 514 of Pub. L. 102-552, 106 Stat. 4102.
For purposes of this subpart, the following terms and definitions apply excepting that words like document, record, certify, report, sign, and write generally should be interpreted to permit their electronic equivalents:
(1) A transaction that is usual and customary in the business in question on terms that are not preferential; or
(2) A transaction with a person who is in the business of offering the goods or services that are the subject of the transaction on terms that are not preferential.
(1) Owns a material percentage of the equity;
(2) Owns, controls, or has the power to vote a material percentage of any class of voting securities; or
(3) Has the power to exercise a material influence over the management of policies of such entity from his or her status as a partner, director, officer, or majority shareholder in the entity.
(a)
(1) Maintain high ethical standards, including high standards of care, honesty, integrity, and fairness.
(2) Act in the best interest of the institution.
(3) Preserve the reputation of the institution and the public's confidence in the Farm Credit System.
(4) Exercise diligence and good business judgment in carrying out official duties and responsibilities.
(5) Report to the Standards of Conduct Official conflicts of interest and circumstances or transactions that have the appearance of creating a conflict of interest involving yourself, your family, or your reportable business entity.
(6) Work with the Standards of Conduct Official to identify conflicts and resolve reported conflicts of interest and appearances of conflicts of interest.
(7) Avoid self-dealing and acceptance of gifts or favors that may be deemed as offered, or have the appearance of being offered, to influence official actions or decisions.
(b)
(1) Comply with the standards of conduct and Code of Ethics policies and procedures maintained at his or her institution.
(2) Comply with all applicable laws and regulations.
(3) Timely report to the Standards of Conduct Official, or use the institution's anonymous reporting procedures, any known or suspected:
(i) Illegal or unethical activity; or
(ii) Violation of the institution's standards of conduct and Code of Ethics.
(c)
Each System institution board of directors is ultimately responsible for the implementation, oversight of, and compliance with, the Standards of Conduct Program. In fulfilling these responsibilities, each System institution board of directors must do the following:
(a)
(b)
(c)
(d)
(1) Requiring conflict of interest reporting from all directors and employees pursuant to § 612.2145. The frequency of conflicts of interest reporting and other disclosures must be addressed in SOC program policies and procedures using the institution's fiscal year calendar. At a minimum, each person must annually report to the SOCO known conflicts occurring in the current year. Pursuant to § 612.2145(c), the board must also require directors and officers to give the SOCO the disclosures required under § 620.6(a), (e), and (f) of this chapter, regardless of
(2) Explaining what constitutes SOC program compliance, including setting criteria for documentation submitted with conflicts of interest reports and providing instructions to help directors and employees identify and report on interests or circumstances that could give rise to an actual or apparent conflict of interest.
(i) The board must explain within the policies and procedures what transactions are likely to present real or potential conflicts, setting benchmarks and thresholds for both single and aggregate activities. The policies and procedures must also explain how transactions in the ordinary course of business are identified.
(ii) The board must explain within the policies and procedures, setting benchmarks and thresholds, how materiality of a conflict is identified. The materiality guidelines must be used when evaluating conflicts of interest reports filed by employees and directors. An exception for those matters affecting all shareholders or borrowers may be used in making the determination of materiality.
(3) Addressing the process by which real and apparent conflicts will be resolved. The procedures must also explain action(s) to be taken when a conflict cannot be resolved to the satisfaction of the institution. The procedures must explain the role and authorities of the SOCO in resolving conflicts.
(4) Addressing the conduct of third-party relationships. The board of directors at each institution must adopt conflict-of-interest policies for third-party relationships and develop safeguards for use in contractual obligations that require third-party service providers to perform services on behalf of the institution in an ethical manner. At a minimum, the policies for third-party relationships must set forth expectations for disclosing known conflicts of interest to the institution. The policies must also implement the requirements of § 612.2180 for agents of the institution.
(5) Setting criteria for accepting gifts that are not otherwise prohibited by this subpart. The criteria must explain the scope of application and may make appropriate exceptions for non-business events where the gift is not viewed by the institution as attempting to influence official institution business. The gift criteria must include de minimis dollar thresholds for all permissible gifts, regardless of the gift giving reason. The thresholds must apply both per gift and in the aggregate per recipient, per year. The institution must also establish disclosure requirements for gifts received as well as procedures for disposing of impermissible gifts.
(6) Identifying the appropriate actions that may be taken against any director or employee who violates the standards of conduct policies and procedures, Code of Ethics, or regulations under this subpart. The board must also identify who is authorized to take which action and when. The board must address how the SOCO exercises his or her authority under § 612.2170 to investigate certain conduct issues.
(7) Providing for anonymous reporting by individuals of known or suspected violations of the institution's Standards of Conduct Program and Code of Ethics, through a hotline or other venue.
(e)
(1) Protect against unauthorized disclosure of confidential information maintained by the institution.
(2) Conduct scheduled periodic reviews of the Standards of Conduct Program that determine the continued adequacy of the program. Each review must look for consistency with institution practices, financial services industry best practices, and Farm Credit Administration (FCA) regulations in this chapter, identifying any required updates.
(3) Perform internal audits of the Standards of Conduct Program. The board of directors, with the assistances of the SOCO and appropriate officers of the institution, must determine the scope and depth of the audit. The board is responsible for identifying who will conduct the internal audit. The audit findings must be given directly to the institution's board or designated board committee. The audit itself must be designed to:
(i) Review the effectiveness of advancing the core principles;
(ii) Identify weaknesses;
(iii) Recommend and report necessary corrective actions; and
(iv) Cover the entire Standards of Conduct Program across the institution, including all activities conducted through a System institution unincorporated business entity (UBE) formed under § 611.1150(b) of this chapter, including UBEs organized for the express purpose of investing in a Rural Business Investment Company.
(f)
(1) Newly elected or appointed directors must receive Standards of Conduct training within 60 calendar days of the director assuming his or her position.
(2) New employees must receive Standards of Conduct training within 10 business days of beginning work.
(3) Periodic training for all directors and employees must occur at least annually but may be more frequent.
(a)
(1) If you have a conflict of interest in a matter, transaction, or activity subject to official action by the institution or before the board of directors then you must disclose it and refrain from participating in official action or board discussion of the matter, transaction, or activity. You must also avoid voting on or influencing any decision directed at the matter, transaction, or activity.
(2) You must report, either to the SOCO or by using the institution's anonymous reporting procedures, any known or suspected activity by a person affiliated with the institution that you suspect is illegal, unethical, or a violation of the institution's standards of conduct and Code of Ethics.
(b)
(1) Any interest you have in any business matter, including any loan or loan application, to be considered by the System institution, or supervised or supervising institution in the current year;
(2) All material financial interests, including those arising in the ordinary course of business, you have with any director, employee, agent, or borrower of your System institution, or a supervised or supervising institution;
(3) The name(s) of your reportable business entities that you know or have reason to know in the current year transacted business with:
(i) Your System institution;
(ii) Any supervised or supervising institution; or
(iii) A borrower that transacts business with your System institution, or any supervised or supervising institution.
(4) The name(s) of your family members you know or have reason to know transacted business with your System institution or any supervised or supervising institution in the current year.
(5) Reportable gifts received or disposed of under the institution's SOC program policies and procedures.
(c)
(a)
(1)
(2)
(3)
(4)
(i) You acquire the property by inheritance.
(ii) You are exercising your rights of first refusal under section 4.36 of the Act.
(iii) If you are a director of the institution, you may purchase property from a System institution when the property is sold through public auction or similar open, competitive bidding process. The exception in this paragraph (a)(4)(iii) only applies if you did not participate in the decision to foreclose upon the property nor did you participate in deciding how the institution would dispose of the property. Participating in these decisions includes setting the sale terms or receiving information as a result of your position with the institution that could give you an advantage over other potential bidders or purchasers of the property.
(5)
(i) Transactions with family members.
(ii) Transactions that occur in the ordinary course of business as determined and documented by the written policies and procedures of your institution.
(iii) Transactions undertaken in an official capacity and in connection with the institution's discounting, lending, or participation relationships with other financing institutions (OFIs) and other lenders.
(6)
(i) Do not purchase or retire any stock in advance of the release of material, non-public, information concerning the institution to other stockholders.
(ii) If you are a director or employee of the Funding Corporation, do not purchase or otherwise acquire, directly or indirectly, except by inheritance, any obligation or equity of a System institution, including any joint, consolidated or System-wide obligations, unless it is a common cooperative equity as defined in § 628.2 of this chapter.
(b)
(1)
(i) You may serve as a director or employee of an employee credit union.
(ii) You may serve as a director of a cooperative that borrows from the System under the Act's Title III authorities if you are not employed at an institution with Title III lending authority and your employing institution approves your service on the cooperative's board.
(2)
(3)
(4)
(i) You may be both a non-officer employee at a Farm Credit bank and a supervised association if the employment expenses are appropriately reflected in each institution's financial statements.
(ii) If you are currently employed with a Farm Credit bank as other than an officer, in extraordinary circumstances, FCA may approve your serving as an officer of a supervised association. This requires the boards at both institutions to agree to the joint service and for the duties and compensation at each institution to be delineated in the board approval documents. The board documents, along with the request, must be sent at least 10 business days before the effective date to the Director of Regulatory Policy, Farm Credit Administration.
(a)
(1) Direct access to the board (or designated board committee) for the purpose of discussing and reporting on matters related to the institution's Standards of Conduct Program and Code of Ethics;
(2) Authority to carry out the responsibilities set forth in this section;
(3) Accessibility to all directors, employees, and agents of the institution;
(4) Legal authority to receive confidential SOC program communications from all directors, employees, and agents of the institution; and
(5) Resources adequate for implementing a successful Standards of Conduct Program.
(b)
(1) Providing guidance and information to directors and employees on conflicts of interest, including aiding in the identification of reportable conflicts of interest and reportable financial interests in accordance with this subpart;
(2) Receiving reports required under this subpart from directors, employees, and agents;
(3) Receiving from directors and officers the disclosures required under § 620.6(a), (e), and (f) of this chapter for treatment as a supplement to an individual's conflicts of interest report;
(4) Reviewing and acting upon all SOC program reports and disclosures, including documenting resolved and unresolved conflicts of interest that are material, and making written determinations on how conflicts of interest will be resolved;
(5) Maintaining all SOC program records for the required period of time, including documentation that explains how conflicts are being handled;
(6) Conducting investigations as either authorized under this subpart or by the institution's SOC program policies and procedures;
(7) Reporting promptly to the institution's board of directors (or designated board committee) those SOC program or Code of Ethics matters required by the institution's SOC program policies and procedures or FCA regulations in this chapter; and
(8) Reporting to the institution's board of directors those activities investigated pursuant to paragraph (d) of this section.
(c)
(d)
(1) At a minimum, the Standards of Conduct Official must investigate, or cause to be investigated, all cases involving:
(i) Possible violations of criminal statutes;
(ii) Possible violations of director or employee prohibited conduct regulations in § 612.2150, and the applicable institution policies and procedures;
(iii) Complaints of misconduct received against directors and employees of the institution;
(iv) Possible violations of other provisions of this part; and
(v) Suspected activities of a sensitive nature which could affect continued public confidence in the Farm Credit System.
(2) The SOCO serves as the reporting official for all cases investigated under subpart B of this part (criminal referrals). In this capacity, the SOCO must report to both the institution's board and the Farm Credit Administration's Office of General Counsel all cases where:
(i) A preliminary investigation indicates that a Federal criminal statute may have been violated;
(ii) An investigation results in the removal of a director or discharge of an employee; or
(iii) A violation may have an adverse impact on continued public confidence in the System or any of its institutions.
(a)
(b)
(c)
(1) The employment of agents who are related to directors or employees of the institutions;
(2) The solicitation and acceptance of gifts, contributions, or special considerations by agents; and
(3) The use of System and borrower information obtained in the course of the agent's work with the institution.
(d)
(1) A director, officer, employee, shareholder, or agent of a System institution;
(2) An independent contractor (including an attorney, appraiser, or accountant) who knowingly or recklessly participates in:
(i) A violation of law (including regulations) that is associated with the operations and activities of one or more System institutions;
(ii) A breach of fiduciary duty; or
(iii) An unsafe practice that causes or is likely to cause more than a minimum financial loss to, or a significant adverse effect on, a System institution; or
(3) Any other person, as determined by the Farm Credit Administration (by regulation or on a case-by-case basis) who participates in the conduct of the affairs of a System institution.