Section 2.802 of title 10 of the Code of Federal Regulations (10 CFR), “Petition for rulemaking—requirements for filing,” provides an opportunity for any interested person to petition the NRC to issue, amend, or rescind any regulation. On February 22, 2019, the NRC received a petition for rulemaking (PRM) from Gerard P. Van Noordennen on behalf of EnergySolutions, LLC (ADAMS Accession No. ML19079A293). The petition requested the NRC revise the definition of Decommissioning in §  50.2, “Definitions,” and amend §  50.82, “Termination of license,” to allow access to the decommissioning trust fund to pay for the disposal of “major radioactive components” before the permanent cessation of operations at nuclear power plants. That term is currently defined in § 50.2: “ Major radioactive components means, for a nuclear power reactor facility, the reactor vessel and internals, steam generators, pressurizers, large bore reactor coolant system piping, and other large components that are radioactive to a comparable degree.”

The petition suggested that granting the petition would remove unnecessary burden from licensees who store major radioactive components on their sites during plant operations because they have limited operating funds and cannot use decommissioning funds for the disposal of these components.

The NRC published a notice of docketing and request for comment in the Federal Register on June 12, 2019 (84 FR 27209).

The public comment period closed on August 26, 2019. The NRC received a total of six public comment submissions, with six unique comments from the general public and industry. Five commenters supported the petition and one commenter opposed the petition.

Comment: One commenter suggested an approach to allow the use of excess decommissioning trust funds for disposal of major radioactive components. In this approach, the NRC could allow operators to reallocate excess decommissioning trust funds for operational expenses through a two-step process: (1) Excess funds are identified and returned from holder; and (2) operator uses returned funds to manage operational expenses, including disposal of large components.

NRC Response: The process described in the comment is available now, upon request by a licensee through the exemption process (§ 50.12, “Specific exemptions”), which requires a site-specific review and approval by the NRC. A projected excess in the decommissioning trust fund is one factor that the NRC would consider in reviewing an exemption request. Other potential factors include the size of the excess compared to the site-specific cost estimate (SSCE), whether the expense is included in a SSCE, evidence that funds have been collected or set aside for the activity in a comingled decommissioning trust fund, and availability of rate collection as a means to resolve a shortfall in radiological decommissioning funding. Any decision on an exemption request to use decommissioning funds to dispose of major radioactive components during operation would be based on a totality of the information in the request and any other information of which the NRC is aware. It should be noted that cost estimates for decommissioning are less accurate the further out in time the plant is from decommissioning. Thus, a release of funds without NRC approval whenever an excess is identified by the licensee would diminish decommissioning funding assurance, even if the excess is identified by comparison to a SSCE. The NRC has previously addressed this issue in the denial of PRM-50-88 (73 FR 62220; October 20, 2008).

Comment: One commenter stated that operators are making a business decision to store large components during a plant's operational period and dispose of the major radioactive components with decommissioning trust funds once the decommissioning period begins, despite storage and monitoring costs. The commenter states that this results in a potential for loss of control of radiological material, if improperly stored/monitored.

NRC Response: Existing NRC regulations ensure adequate control of radiological material, including major radioactive components that have been removed from service. Proper storage and monitoring of radiological material is addressed through the NRC's onsite inspection procedures.

Comment: One commenter stated that the NRC should consider early use of decommissioning trust funds by licensees if the disposal costs are specifically included in the cost estimate. The commenter stated that this could be achieved either by the licensee preparing a SSCE that included the items for which excess funds are to be used, or by the NRC revising the generic formula for trust fund calculation to require additional funds to account for these waste volumes, effectively increasing the estimated waste volume factor of the formula. The commenter noted that a change to the generic formula in this manner is problematic because some basis would be required to account for later reducing the waste volume based on operational disposal activities, which may be an ongoing or repeated activity during the operational life of a facility.

NRC Response: The NRC agrees with the commenter that a revision to the § 50.75 Table of Minimum Amounts would be problematic. The formulas provided in this table are generic and designed to provide a reasonable estimate of radiological decommissioning costs for the facility. Revising the table to account for the disposal of major radioactive components prior to decommissioning is difficult due to several factors, including site-specific variations in the generation and disposal of these components. As such, the Table of Minimum Amounts has not been updated for over 30 years. However, the NRC is considering updates to the generic decommissioning funding formula to make it more reflective of current cost considerations as part of the proposed rule, “Regulatory Improvements for Production and Utilization Facilities Transitioning to Decommissioning” (RIN 3150-AJ59), and will seek public comment on the matter. Nonetheless, currently licensees can use the existing formula, or an SSCE, as part of a demonstration that excess funds exist in the decommissioning trust fund to support either an exemption request or for other purposes, such as the reallocation of other funds. Projected excess funds would be one factor the NRC would consider when reviewing an exemption request. The staff notes the determination of excess funds relies on long-term projections that may prove inaccurate because unpredictable changes in economic conditions could result in future shortfalls in the decommissioning trust fund. Therefore, in reviewing an exemption request, the NRC would consider the totality of information provided in the request and any other information of which the NRC is aware.

Comment: One commenter stated that an “innovative financial approach” that could provide for early removal of large parts would be the establishment by the NRC of a process whereby a licensee can have access to excess decommissioning trust funds (where “excess” should consider spent fuel management funds, whether comingled or not) that can only be used for specific purposes by the licensee, such as management of large component/operational wastes or other items that will contribute to the ultimate decommissioning of the facility.

NRC Response: Under the NRC's existing regulatory framework, licensees can request access to excess decommissioning funds on such a basis through the exemption process.

Comment: Three commenters stated that nuclear utilities should have the flexibility to use decommissioning trust fundsduring operations to facilitate the timely disposal of these components in acost-effectivemanner to maximize the reduction in disposal cost and therefore aid in ensuringthat ample decommissioning trust funds remain available when fulldecommissioning takes place.

NRC Response: If excess decommissioning trust funds are available ( e.g., as determined by comparing decommissioning fund growth against an SSCE), then licensees may use existing procedures to access the available funds. If excess funds are not available, then licensees may use operating revenues or continue to store the components on site until such time as either excess funds are available (and then request an exemption to use those funds) or until decommissioning begins.

Comment: Two commenters stated that the industry and NRC have experience with thedecommissioning of nuclear power plants and the time has come to modernize the decommissioning regulatory process.

NRC Response: The NRC is currently pursuing decommissioning improvements in a separate rulemaking, “Regulatory Improvements for Production and Utilization Facilities Transitioning to Decommissioning” (82 FR 13778).

The NRC is denying the petition because a licensee may access the decommissioning trust fund to pay for the disposal of major radioactive components (1) by requesting reimbursement when submitting their decommissioning cost estimate per § 50.82 or (2) by requesting an exemption under § 50.12 to permit withdrawal from the decommissioning trust fund prior to decommissioning. Although the Commission has stated that trust fund withdrawals for disposal of major radioactive components would be granted only “in extraordinary circumstances” (73 FR 62222; October 20, 2008), the NRC reviews each exemption request based on the merit of the facts provided in the request.

While the petitioner noted that only “excess” funds would be used from the decommissioning trust fund to pay for the disposal of major radioactive components, the NRC notes that whether there is an excess would be based on economic projections. Economic projections are less accurate the further out in time they attempt to project, and, therefore, changes in economic conditions combined with withdrawals from the decommissioning trust fund could potentially result in future shortfalls in the fund. Nevertheless, a projected excess is one factor that the NRC would consider in reviewing an exemption request. Other potential factors include: The size of the excess compared to the SSCE, whether the expense is included in a SSCE, evidence that funds have been collected or set aside for the activity in a comingled decommissioning trust fund, and availability of rate collection as a means to resolve a shortfall in radiological decommissioning funding. Any decision on an exemption request to use decommissioning funds to dispose of major radioactive components during operation would be based on a totality of the information in the request and any other information of which the NRC is aware. These circumstances are site-specific and dependent on the unique financial status of each licensee.

The staff believes it would be difficult to develop generally applicable requirements to address the use of decommissioning trust funds for this purpose and therefore, more efficient to review such requests on a case-by-case basis. Therefore, the staff considers an exemption to be an adequate means for licensees to request a withdrawal from their decommissioning trust fund for the disposal of major radioactive components. If the staff sees an increase in exemption requests to withdraw decommissioning funds prior to decommissioning, then the NRC could reconsider whether addressing the issue through rulemaking would reduce the need for exemptions and be more efficient for the agency. Such reconsideration will include any experience and insights the staff has gained in evaluating exemption requests at that time.

Additionally, some licensees successfully pursued reallocating funding streams that would otherwise have been added to their decommissioning trust fund by establishing “sub-accounts” in their decommissioning trust funds. Such sub-accounts are not regulated by the NRC and, therefore, can be used at the discretion of the licensee at any time during operations or decommissioning. For rate-regulated licensees, these sub-accounts are typically funded with Public Utility Commission-authorized rate collections once it is established that the trust dedicated to radiologically decommissioning is sufficiently funded in accordance with NRC regulations. While non-rate-regulated ( i.e., merchant) licensees do not have access to rate collection, they may still fund such sub-accounts through alternate means or request a reallocation of funds across their decommissioning trust fund accounts using the 10 CFR 50.12 exemption process. The NRC is denying the petition because it does not raise a significant safety or security concern and the requested amendments are not necessary to enable licensees to access excess decommissioning funding prior to decommissioning for the purpose of disposal of major radioactive components under existing regulations in 10 CFR part 50.

For the reasons cited in this document, the NRC is denying PRM-50-119. The NRC reaffirms that its existing regulations continue to provide reasonable assurance of adequate protection of public health and safety.

On December 17, 2021, DOE published a NOPR proposing to amend the existing scope of the DOE test procedures for electric motors consistent with related industry changes for nomenclature and test procedure developments ( i.e., for air-over electric motors, submersible electric motors, electric motors greater than 500 horsepower, electric motors considered small, inverter-only electric motors, and synchronous electric motors); add test procedures, metric, and supporting definitions for additional electric motors covered under the proposed scope; and update references to industry standards to reference current versions. (86 FR 71710) Furthermore, DOE proposed to adopt industry provisions related to the prescribed test conditions to further ensure the comparability of testing. In addition, DOE proposed to update certain testing instructions to reduce manufacturer burden. Further, DOE proposed to amend the provisions pertaining to certification testing and determination of represented values for electric motors other than dedicated-purpose pool pump motors, apply these provisions to the additional electric motors proposed for inclusion in the scope of the test procedure, and to move both provisions consistent with the location of other certification requirements for other covered products and equipment. Finally, DOE proposed to add provisions pertaining to certification testing and determination of represented values for dedicated-purpose pool pump motors. DOE is seeking comment from interested parties on these proposals.

Interested parties in the matter, NEMA (on January 25, 2022) and the Hydraulic Institute (on January 26, 2022) requested an extension of the public comment period for 30 additional days (NEMA, No. 9 at p. 1; HI, No. 11 at p.1). 1 NEMA commented that the extension is necessary due to delays in developing their responses given the proposed scope of products along with the extent of information to be gathered. HI commented more time is needed for the pump industry to review and provide comment relating to the testing of submersible motors.

DOE has reviewed the requests and is extending the comment period to allow additional time for interested parties to submit comments. The proposed rule was published in the Federal Register on December 17, 2021, and a 60-day comment period was provided from the date of publication. In light of the submitted requests, DOE believes that additional time is warranted, and that extending the comment period until the end of the month of February is sufficient. Therefore, DOE is extending the comment period until February 28, 2022.

This document of the Department of Energy was signed on January 28, 2022, by Kelly J. Speakes-Backman, Principal Deputy Assistant Secretary for Energy Efficiency and Renewable Energy, pursuant to delegated authority from the Secretary of Energy. That document with the original signature and date is maintained by DOE. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DOE Federal Register Liaison Officer has been authorized to sign and submit the document in electronic format for publication, as an official document of the Department of Energy. This administrative process in no way alters the legal effect of this document upon publication in the Federal Register .

The FAA invites interested people to take part in this rulemaking by sending written comments, data, or views. The most helpful comments reference a specific portion of the special conditions, explain the reason for any recommended change, and include supporting data.

The FAA will consider all comments received by the closing date for comments. The FAA may change these special conditions based on the comments received.

On July 15, 2021, RHC applied for a change to Type Certificate No. R00015LA for the Model R66 helicopter. This change incorporated a pressure fueling system in the Model R66 helicopter. The RHC Model R66 helicopter, which is a derivative of the earlier models of the Model R66 helicopter currently approved under Type Certificate No. R00015LA, is a part 27 normal category helicopter. It is a single turbine engine helicopter with a four-passenger maximum passenger capacity and has a maximum gross weight, with no external load, of up to 2,700 pounds depending on the model configuration.

Under the provisions of 14 CFR 21.101, RHC must show that the Model R66 helicopter, as changed, continues to meet the applicable provisions of the regulations listed in Type Certificate No. R00015LA or the applicable regulations in effect on the date of application for the change, except for earlier amendments as agreed upon by the FAA.

If the Administrator finds that the applicable airworthiness regulations ( e.g., 14 CFR part 27) do not contain adequate or appropriate safety standards for the RHC Model R66 helicopter because of a novel or unusual design feature, special conditions are prescribed under the provisions of § 21.16.

Special conditions are initially applicable to the model for which they are issued. Should the type certificate for that model be amended later to include any other model that incorporates the same novel or unusual design feature, or should any other model already included on the same type certificate be modified to incorporate the same novel or unusual design feature, these special conditions would also apply to the other model under § 21.101.

In addition to the applicable airworthiness regulations and special conditions, the RHC Model R66 helicopter must comply with the noise certification requirements of 14 CFR part 36.

The FAA issues special conditions, as defined in 14 CFR 11.19, in accordance with § 11.38, and they become part of the type certification basis under § 21.101.

The RHC Model R66 helicopter will incorporate the following novel or unusual design feature:

A pressure refueling system, which will allow for optional pressure fueling.

RHC proposes to modify the Model R66 helicopter by incorporating a pressure refueling system that would allow for optional pressure fueling from a fueling port on the right side of the fuselage and the existing gravity system via the fuel filler cap on top of the main fuel tank. This modification would provide faster, easier, and safer refueling when the engines are running and rotors turning compared to the existing fueling system located on the top of the main fuel tank. The pressure refueling system cannot be used for defueling and would include a crash-resistant fuel hose that runs from the fueling port on the right side to an inlet at the top of the fuel tank on the left side of the helicopter.

Part 27 does not contain requirements for pressure refueling for normal category helicopters. However, 14 CFR 29.979, amendment 29-12, effective February 1, 1977, provides these requirements for transport category helicopters. Accordingly, these proposed special conditions are based on § 29.979 to provide requirements for the inclusion of the optional pressure refueling system on the Model R66 helicopters. 14 CFR 29.979 includes standards for pressure refueling and fueling provisions below fuel level on transport category rotorcraft.

This regulation is intended to prevent hazards to ground crew, flight crew, and occupants by reducing the probability of exposure to hazardous quantities of fuel due to spillage and ensuring the pressure refueling/defueling system is designed to prevent overfilling the fuel tank and to withstand an ultimate load overpressure event without failure.

Section 29.979(a) requires each fueling connection below the fuel level in each tank have a means to prevent the escape of hazardous quantities of fuel from that tank in case of malfunction of the fuel entry valve.

Section 29.979(b) requires systems intended for pressure refueling have a means in addition to the normal means for limiting the tank content to prevent damage to the tank in case of failure of the normal means.

Section 29.979(c) requires the rotorcraft pressure fueling system (not fuel tanks and fuel tank vents) to withstand an ultimate load that is 2.0 times the load arising from the maximum pressure, including surge, that is likely to occur during fueling. The maximum surge pressure must be established with any combination of tank valves being either intentionally or inadvertently closed.

Section 29.979(d) requires the rotorcraft defueling system (not including fuel tanks and fuel tank vents) to withstand an ultimate load that is 2.0 times the load arising from the maximum permissible defueling pressure (positive or negative) at the rotorcraft fueling connection. The design proposed by RHC does not include defueling capability.

The proposed special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.

These special conditions are applicable to the RHC Model R66 helicopter. Should RHC apply at a later date for a change to the type certificate to include another model incorporating the same novel or unusual design feature, these special conditions would apply to that model as well.

This action affects only a certain novel or unusual design feature on one model of helicopter. It is not a rule of general applicability.

The authority citation for these special conditions is as follows:

Accordingly, the Federal Aviation Administration (FAA) proposes the following special conditions as part of the type certification basis for Robinson Helicopter Company Model R66 helicopters.

The pressure refueling system must be designed and installed as follows:

(a) Each fueling connection below the fuel level in each tank must have the means to prevent the escape of hazardous quantities of fuel from that tank in case of malfunction of the fuel entry valve.

(b) For systems intended for pressure refueling, a means in addition to the normal means for limiting the tank content must be installed to prevent damage to the fuel tank in case of failure of the normal means.

(c) The rotorcraft pressure fueling system (not fuel tanks and fuel tank vents) must withstand an ultimate load that is 2.0 times the load arising from maximum pressure, including a surge, that is likely to occur during fueling. The maximum surge pressure must be established with any combination of tank valves being either intentionally or inadvertently closed.

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 airspace in Dyersburg, TN, to support IFR operations in the area.

Interested persons are invited to comment on 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 (Docket No. FAA-2021-0028 and Airspace Docket No. 21-ASO-41) and be submitted in triplicate to DOT Docket Operations (see ADDRESSES section for the address and phone number). You may also submit comments through the internet at https://www.regulations.gov.

Persons wishing the FAA to acknowledge receipt of their comments on this action must submit with those comments a self-addressed stamped postcard on which the following statement is made: “Comments to FAA Docket No. FAA-2021-0028; Airspace Docket No. 21-ASO-41.” 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 document may be changed in light of the comments received. All comments submitted will be available for examination in the public docket both before and after the comment closing date. 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 https://www.regulations.gov. Recently published rulemaking documents can also be accessed through the FAA's web page at https://www.faa.gov/air_traffic/publications/airspace_amendments/.

You may review the public docket containing the proposal, any comments received, and any final disposition in person in the Dockets Office (see the ADDRESSES section for address and phone number) between 9:00 a.m. and 5:00 p.m., Monday through Friday, except federal holidays. An informal docket may also be examined between 8:00 a.m. and 4:30 p.m., Monday through Friday, except federal holidays at the office of the Eastern Service Center, Federal Aviation Administration, Room 350, 1701 Columbia Avenue, College Park, GA 30337.

This document proposes to amend FAA Order JO 7400.11F, Airspace Designations and Reporting Points, dated August 10, 2021, and effective September 15, 2021. FAA Order JO 7400.11F is publicly available as listed in the ADDRESSES section of this document. FAA Order JO 7400.11F lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

The FAA proposes an amendment to 14 CFR part 71 to amend Class E surface airspace at Dyersburg Regional Airport, Dyersburg, TN, due the decommissioning of the Nally Dunston NDB and cancellation of associated approaches. This action would also update the airport name (formerly Dyersburg Municipal Airport) and geographic coordinates to coincide with the FAA's database.

This action would also replace the outdated term Airport/Facility Directory with the term Chart Supplement in the airport description.

Controlled airspace is necessary for the safety and management of instrument flight rules (IFR) operations in the area.

Class E airspace designations are published in Paragraph 6002 of FAA Order JO 7400.11F, dated August 10, 2021, and effective September 15, 2021, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document would be published subsequently in FAA Order JO 7400.11.

FAA Order JO 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.

The FAA has determined that this proposed regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a Regulatory Evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this proposed rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

This proposal will be subject to an environmental analysis in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures,” prior to any FAA final regulatory action.

In consideration of the foregoing, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows:

The Census Bureau is responsible for collecting, compiling, and publishing export trade statistics for the United States under the provisions of Title 13, United States Code (U.S.C.), Chapter 9, Section 301. Collecting and compiling trade statistics between the United States, Puerto Rico, and other territories is part of the U.S. Census Bureau's monthly processing of EEI. Ultimately, these statistics are sourced from the EEI filings in the Automated Export System (AES) and published in the FT-895 Publication Series. This FT-895 monthly program presents total quantity and value of detailed commodities shipped between the United States, Puerto Rico, and U.S. territories, including the U.S. Virgin Islands (USVI).

The ANPRM published in the Federal Register on September 17, 2020, (85 FR 58016) received 93 comments on the overall impact of the removal of the EEI filing requirements for shipments between the United States, Puerto Rico and the USVI. The Census Bureau received 50 comments in support of maintaining the current EEI filing requirement and 43 comments supporting the removal of the EEI filing requirement. A summary of the comments is provided below.

Comments provided in support of removing the EEI filing requirement to Puerto Rico and the USVI fell under the following themes:

1. Inequality: Several commenters support removing the EEI filing requirement were concerned about unfair treatment of U.S. territories. While Puerto Rico and the USVI are not states, they are territories of the United States and exports to and from these territories are considered domestic, not international shipments. Several commenters believe federal agencies should employ consistent treatment of Puerto Rico and the USVI for statistical data. Another commenter indicated, other agencies under the Department of Commerce (DOC), such as the Bureau of Industry and Security (BIS) and the International Trade Administration do not treat shipments to and from Puerto Rico and the USVI as exports. Another commenter stated that the requirement of EEI is the reason many businesses deny service to the trade community located in U.S. Caribbean territories. Another commenter indicated the EEI filing requirement hinders trade competitiveness and negatively impacts job creation.

2. Increased cost and burden: Several commenters were concerned that requiring EEI filing to U.S. territories has increased the cost and time of the shipping process for U.S. exporters and freight forwarders. Some commenters indicate the need to dedicate staff and/or hire additional personnel to manage EEI filings has increased labor cost for businesses. Commenters were also concerned that the requirement to file EEI between the mainland U.S., Puerto Rico and the USVI imposes substantial regulatory and economic burden on exporters. Several commenters stated that the Department of Commerce should minimize any governmental paperwork burden (electronic or otherwise) on U.S. citizens engaged in lawful commercial transactions within the U.S. Several commenters also indicated the EEI filing process imposes unnecessary burden on commerce by impeding the flow of trade and economic development in these territories due to the additional paperwork and administrative costs imposed by the EEI filing requirement. Several commenters stated that the costs are significant in terms of time lost, human resources required; many shippers and manufacturers in the U.S. have decided not to ship to these territories due to these additional steps in the shipping process and restrictions on trade. Additionally, some commenters pointed out that the cost of the EEI filing limits sourcing of U.S. products and increases the cost of goods in Puerto Rico and the USVI.

3. Possible alternative data sets: Several commenters identified the possibility of alternative methods for collecting export statistics data. One commenter stated that Puerto Rico is a part of the same U.S. Customs system and should use the same data collection methods as the other 50 states. Other commenters suggested that EEI is viable through data that already exists from multiple sources. One commenter suggested that EEI filing is repetitive and duplicative to manifest requirements of other agencies. Several commenters suggested specific alternative data sets such as the DOC's Bureau of Economic Analysis (BEA) data, which collects trade data that is used to calculate U.S. Gross Domestic Product (GDP) activity, state-to-state activity, and U.S. international transactions. Several commenters also proposed the use of Customs and Border Protection (CBP) manifest data, Puerto Rico's Sistema Unificado de Rentas Internas (SURI), Puerto Rico Port Authority data, monthly reporting similar to the current pipeline reporting, and the FT-895 report as alternative data sources.

Comments provided for maintaining the EEI filing requirement to Puerto Rico and USVI fell under the following themes:

1. Statistical purposes: The EEI reporting requirement yields high quality data for Puerto Rico and the USVI that serve several specific statistical objectives. Eliminating the mandatory requirement would remove an additional step in the shipping process. However, there would be several statistical implications associated with this change. Statistical data provides insight on policy decisions, GDP estimates, business development and marketing, economic recovery, research and academia as well as historical data and methodology, critical in measuring economic growth for Puerto Rico and the USVI.

A. Public Policy Decisions: Several commenters noted, EEI is utilized by the Government of Puerto Rico to produce statistical reports, gauge economic activity, and assist in sound policy making. A federal agency commented that it uses the data in its initiative to estimate Puerto Rico GDP statistics. Specifically, the agency commented that reliable GDP statistics for U.S. territories contribute to a better understanding of economic development, such as the impact of federal disaster relief spending in these areas. For example, to date, Congress has appropriated more than $60 billion for Puerto Rico recovery efforts following hurricanes in 2017 and earthquakes in 2020. Without high-quality GDP statistics, it is difficult for policy makers to gauge the impact of such funding on the Puerto Rican economy. Additionally, another federal agency has concerns about the loss of data, specifically, petroleum trade between the United States and Puerto Rico. This federal agency uses the data for calculation of the total shipped volumes of petroleum and other fuels. There is currently no other source of information or method for tracking trade flows of oil and other energy-related commodities between the United States and Puerto Rico. There is no alternative data source to collect this information because Puerto Rico does not locally collect the data and these data are not included in any other U.S. Census Bureau economic surveys. Commenters are concerned because this information can aid federal agencies in developing strategic plans to ensure Puerto Rico has resilient power generation systems for the future, as the current Administration starts to steer away from oil and towards sustainable energy and information.

B. Business Development and Marketing: One commenter stated that accurate and precise data is critical for the development of small businesses in Puerto Rico and to develop and update business and marketing plans to move Puerto Rico's economy forward. Another commenter noted that businesses in these territories and the U.S. mainland use this detailed data to inform choices and services around new and existing markets, which allows for more competition and better consumer options.

C. Economic Recovery: Several commenters noted, keeping the EEI filing requirement for Puerto Rico and the USVI allows these territories to rebuild their economies and accurately measure, project, and plan economic development. One commenter noted, the lack of reliable statistics is the worst scenario for a country in economic crisis as they work towards restructuring their debt and attaining a sustainable economy. Several other commenters noted that without a viable and tested alternative data source, the proposal to remove the requirements will make it impossible to measure and analyze Puerto Rico's economy. Other commenters noted that an economic development plan is urgent, and it cannot be attained without having complete, accurate and confident data that includes the information for shipments between the United States and Puerto Rico and USVI.

D. Research and Academic Importance: Several commenters were concerned that the proposed rule to eliminate the EEI filing requirement to Puerto Rico and the USVI will have a significant impact on research and academia. Commenters noted that without the filing requirement, economic students, scholars, entrepreneurs and citizens will not be able to access updated Census Bureau data for research policy purposes. One scholar specifically noted that the Census Bureau's statistical information for economic and agricultural economic courses is useful to students completing projects and thesis papers within their master's program. Another commenter was also concerned that the loss of this data will directly impact the agricultural industry with current global economic and climatic change.

2. Enforcement Purposes: We received several comments against removing the EEI filing requirement for export control and enforcement purposes. One commenter noted that without the collection of data from the U.S. mainland to Puerto Rico and USVI, enforcement agencies lose visibility on potential criminal activity. The Census Bureau consulted with one federal agency on this comment. This agency noted that the removal of the EEI filing requirements for shipments from the U.S. to those territories would adversely impact the agency's ability to ensure the effective enforcement of items subject to the Export Administration Regulations, potentially diverted to foreign countries.

3. No valid alternative data set: Though commenters presented potential alternative data sets, one commenter noted that the level of detail would not be similar to that obtained through the EEI requirement, and the data would not be compiled with the rigorousness as that by the Census Bureau. One federal agency also noted that the EEI is high-quality economic data which is not typical for the U.S. territories because the U.S. territories are not included in most federal surveys. Territory-level surveys and administrative data are limited. Several commenters noted, there is currently no substitute for EEI that is routinely available, continuous, current, high frequency and published with documentation and technical support. Without an alternative data source that meets the same statistical objectives, it is not possible to continue to produce GDP estimates for Puerto Rico or the USVI. Should the broader FT-895 report be eliminated as a result of the discontinuation of the EEI-sourced data, GDP estimates for the territory of American Samoa will also be at risk.

4. Cost Benefit: Several commenters noted that the Automated Export System (AES) is a mature system the trade industry understands and knows how to operate. There is concern that creating an entirely new system to capture the same data in today's current environment is an unnecessary burden. Additionally, creating a new system would come at a significant cost to the U.S. Government during a time of increased strain on Government funding, as well as costs to the industry. One commenter noted that many EEI filers for Puerto Rico's data also use the AES for international shipments to foreign countries and adding an alternative system would add a burden to their current operations and workflow. Several economists commented that the requirement to file EEI does not add significant burden on business and the cost and value of the EEI data is greater than the inconvenience to the trade compared to the potential sales acquired, the current information technologies and the fact that the bulk of the shipments to the U.S. are done by large U.S. corporations.

5. GDP Estimates: Several commenters noted that the Census Bureau's FT-895 reports and other statistical trade documents provide routine, consistent, and continuous monthly and annual data that is necessary and relevant for statistical and time-series compatibility. These commenters also added that consistent definitions are critical to ensure GDP estimates and the loss of the FT-895 and EEI reporting will adversely affect the computations of GDP estimates. One commenter specifically stated that the methodology should include a monthly total of the value of goods between the U.S., Puerto Rico and the USVI rather than presenting it on an annual frequency. Another commenter who has used the data for many years is concerned that interruptions or inconsistencies with the current dissemination of the Census Bureau data would create problems. Additionally, one federal agency noted that they significantly rely on trade data from the FT-895 in constructing reliable and consistent economic statistics, including GDP for U.S. territories. Such statistics provide key insight into the territorial economies, and meaningful information to businesses and decision makers alike. Territorial GDP are highly reliant on export and import data provided from the Census Bureau's FT-895. The direct concern is that an elimination of EEI reporting requirements could directly impact the availability of import data used in the USVI GDP statistics. To illustrate the significance of this information loss, in 2018 exports reported in the FT-895 accounted for 59-percent and 9-percent of American Samoa and the USVI GDP, respectively. The direct and indirect impact associated to the elimination of the EEI reporting requirements could severely affect the usefulness of American Samoa, Northern Mariana Islands, Guam and USVI GDP as time series statistics. Should the reporting requirement be eliminated, it remains unclear if the Census Bureau will continue to make non-EEI-sourced trade data available for these territories. Other commenters stated that the lack of data with no other avenue for gathering the information would be harmful and unfortunate if such a longtime source of information were to disappear. Similarly, a commenter noted that the FT-895 constitutes an excellent and unique tool benefitting individuals, businesses, academia, etc. and for which there is no viable substitute available.

Robert L. Santos, Director, Census Bureau, approved the publication of this notice of proposed rulemaking in the Federal Register .

FDA is proposing to amend part 203 (21 CFR part 203) to reflect changes to affected provisions of the FD&C Act following enactment of the DSCSA, Title II of the DQSA (Pub. L. 113-54). In this proposed rulemaking, we are proposing to amend certain provisions of part 203 to avoid potential confusion with the new standards and requirements for wholesale distributors applicable under the FD&C Act (as amended by the DSCSA), and to make certain related, conforming changes.

The proposed rule would: (1) Modify the “scope” and “purpose” sections of the regulations in part 203 to eliminate references to wholesale distribution, (2) delete Subpart E—Wholesale Distribution in its entirety, (3) delete from § 203.3 the definitions for terms that only appeared in subpart E, and (4) modify other provisions of part 203 to eliminate references to wholesale distribution to conform to the changes described above.

We are issuing this proposed rule under sections 503(c), 503(e), 582, 583 and 701(a) of the FD&C Act (21 U.S.C. 353(c), 353(e), 360eee-1, 360eee-2, and 371(a)).

This proposed rule is a companion to the proposed rule “National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers” (licensing standards proposed rule) which implements the national licensing standards requirements of DSCSA. The licensing standards proposed rule, which would amend part 205, is published elsewhere in this issue of the Federal Register . We analyze the effects of the two rules together; thus, we include the benefits and costs of this proposed rule in the regulatory impact analysis of the licensing standards proposed rule.

The DQSA was enacted on November 27, 2013. The DQSA contains two titles: Title I, the Compounding Quality Act and Title II, the DSCSA. The DSCSA amended Chapter V of the FD&C Act by adding Subchapter H (Pharmaceutical Distribution Supply Chain), which includes new sections 581 through 585 (21 U.S.C. 360eee through 360eee-4), and by amending section 503(e) of the FD&C Act. As amended, section 503(e) of the FD&C Act, together with new section 583 of the FD&C Act, require the Secretary of Health and Human Services (Secretary)  1 to establish national prescription drug wholesale distributor licensure standards. In addition, section 582 of the FD&C Act establishes prescription drug product tracing requirements for wholesale distributors and their trading partners. FDA is proposing to revise the regulations in part 203 by removing or amending those sections of the regulations that have been affected by the changes to the FD&C Act through the enactment of the DSCSA.

This rulemaking, when finalized, would: (1) Remove existing regulations regarding wholesale distribution of prescription drugs that conflict with or were superseded by new requirements established under the DSCSA; (2) modify other existing regulations for consistency with the regulations on standards for licensure of wholesale distributors that FDA is proposing pursuant to section 583 of the FD&C Act; and (3) make certain related, conforming changes. This rulemaking is needed to remove outdated regulations and to prevent confusion about requirements for wholesale distributors under the FD&C Act.

The Agency is proposing this rule under the authority to impose requirements regarding prescription drug marketing and wholesale drug distribution granted to it under various sections of the FD&C Act, including sections 503(c), 503(e), 582, 583, and 701(a). Section 503(c) describes certain restrictions on prescription drug marketing, including relating to the sale of drug samples and of drugs that have been purchased by hospitals or other healthcare entities. Section 503(e), together with section 583 of the FD&C Act, require the Secretary to establish national prescription drug wholesale distributor licensure standards, while section 582 describes requirements applicable to wholesale distributors and other entities related to product tracing. Section 701(a) provides general authority to issue regulations for the efficient enforcement of the FD&C Act. By clarifying provisions related to prescription drug marketing and by removing provisions relating to wholesale distribution, this rule, when finalized, is expected to aid in the efficient enforcement of the FD&C Act.

This proposed rule would make the deletions and changes to the existing regulations in part 203 discussed below as well as technical changes for clarity.

Existing §§ 203.1 and 203.2 describe the scope and purpose of the regulations in part 203, respectively. The proposed revisions would narrow the scope and purpose descriptions in light of the proposed elimination of requirements relating to wholesale distributors from part 203. We plan to address the standards and requirements related to wholesale distributor licensing elsewhere in our regulations, in accordance with the applicable provisions of the FD&C Act (as amended by the DSCSA).

Certain definitions that currently appear in this section would be modified or eliminated.

a. Authorized distributor of record. The amendments to section 503(e) effectuated by the DSCSA eliminated the definition of “authorized distributors of record” from section 503(e) of the FD&C Act, which previously provided that the definition applied for the purposes of section 503(d) and 503(e). However, the DSCSA added a definition of the same term in section 503(d) of the FD&C Act, which relates to drug sample distribution, in section 503(d)(4). The “authorized distributor of record” definition in § 203.3 would be revised to reflect the fact that, as used in the amended part 203, the phrase would relate solely to distribution of drug samples. The revised “authorized distributor of record” definition would be found in the new § 203.3(a). In addition, as further discussed below, references to distribution of products by authorized distributors of record would be amended throughout the text of part 203, where appropriate, to clarify that these references relate only to distribution of drug samples.

b. Emergency medical reasons. The proposed rule would amend the definition of “emergency medical reasons” in the new § 203.3(l). Section 203.22, which sets forth exemptions from the sales restrictions described in § 203.20, generally provides an exemption from those restrictions for sales, purchases, or trades of a drug for emergency medical reasons (§ 203.22(d)). Section 203.3(m) currently states, in part, that “emergency medical reasons” include, but are not limited to, transfers of a prescription drug between healthcare entities or from a healthcare entity to a retail pharmacy to alleviate a temporary shortage of a prescription drug arising from delays in or interruption of regular distribution schedules, as well as transfers of prescription drugs by a retail pharmacy to another retail pharmacy to alleviate a temporary shortage. As a result, under § 203.22(d) such transfers to alleviate temporary shortages are exempt from the sales restrictions set forth in § 203.20. Certain of those transfers may, however, constitute “wholesale distribution” as defined in the DSCSA (section 503(e)(4) of the FD&C Act) because, while the “wholesale distribution” definition generally excludes distributions for “emergency medical reasons,” it states that a drug shortage not caused by a public health emergency shall not constitute an emergency medical reason. With certain exceptions, a person cannot simultaneously be a healthcare entity and a wholesale distributor (see § 203.3(p)). Because of this, FDA proposes to amend relevant language in the “emergency medical reasons” definition to clarify the relationship between it and the definition of “wholesale distribution” in section 503(e)(4) of the FD&C Act. In particular, we would add text to § 203.3(l) to make clear that a transfer made to alleviate a temporary shortage would generally be considered to be for “emergency medical reasons” for purposes of part 203 only where the transfer was either to fulfill a specific patient need or where the shortage was caused by a public health emergency (that is, where such transfers would not constitute “wholesale distribution” as defined in section 503(e)(4) of the FD&C Act). As explained in our companion proposed rulemaking for part 205 (21 CFR part 205), the Agency considers the transfer or sale of a drug from one dispenser to another dispenser made to fulfill a specific patient need to be outside the scope of the “wholesale distribution” definition in section 503(e)(4) of the FD&C Act.

c. Unauthorized distributor and wholesale distribution. The definitions of “unauthorized distributor” and “wholesale distribution,” currently codified in § 203.3(bb) and (cc), respectively, would be eliminated from part 203, because these terms would no longer appear in part 203, as amended. The definition of the term “wholesale distributor” would be modified to indicate that the term would have the meaning set forth in section 581(29) of the FD&C Act.

Paragraphs (h) and (i) of § 203.22, which set forth exemptions from the sales restrictions in § 203.20, would be modified to eliminate the phrase indicating that the applicable requirements for a wholesale distributor or retail pharmacy are contained in part 203, because FDA is proposing to remove § 203.50, as discussed in section V.5.

FDA would replace the term “distributor” where it appears in subpart D with the phrase “authorized distributor of record” where that phrase is not already used (§§ 203.30, 203.31, 203.34, 203.36, and 203.37). As noted above, the DSCSA added a definition of “authorized distributors of record” in section 503(d) of the FD&C Act, which relates to drug sample distribution.

FDA proposes to remove § 203.50 (Subpart E—Wholesale Distribution) in its entirety. On July 14, 2011, FDA proposed to remove § 203.50(a) (76 FR 41434). Before that rulemaking was finalized, the DSCSA was enacted. The DSCSA replaced section 503(e)(1)-(3) of the FD&C Act and added additional and different requirements for wholesale distributors. The DSCSA also added new requirements for wholesale distributors, including phased-in prescription drug tracing requirements in section 582(c) of the FD&C Act. FDA is withdrawing the above referenced July 14, 2011, proposed rule in a document published elsewhere in this issue of the Federal Register . In accordance with the changes in statutory authorities, FDA proposes to remove § 203.50 in its entirety. FDA is proposing new requirements for wholesale distributors and wholesale distribution consistent with the relevant provisions of the DSCSA in a separate proposed rulemaking for part 205, also published in this issue of the Federal Register .

This regulation, if finalized as proposed, will be effective 30 calendar days after the date the final rule publishes in the Federal Register .

We have examined the impacts of the proposed rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct us to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). We believe that this proposed rule is not a significant regulatory action as defined by Executive Order 12866.

The Regulatory Flexibility Act requires us to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because the proposed rule imposes only minimal one-time costs of less than $100 per entity to read and understand the rule on small entities, we propose to certify that the proposed rule will not have a significant economic impact on a substantial number of small entities.

The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires us to prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $158 million, using the most current (2020) Implicit Price Deflator for the Gross Domestic Product. This proposed rule would not result in an expenditure in any year that meets or exceeds this amount.

We include the costs to read and understand this proposed rule in the regulatory impact analysis of the companion licensing standards proposed rule. The full preliminary analysis of economic impacts of both rules is available at https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm under “National Standards for Licensing of Prescription Drug Wholesale Distributor and Third Party Logistics Providers” (Ref. 1).

We have determined under 21 CFR 25.30 that this action is of the type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

FDA tentatively concludes that this proposed rule contains no collection of information. Therefore clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.

We have analyzed this proposed rule in accordance with the principles set forth in Executive Order 13132. We have determined that this proposed rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, we conclude that the rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement is not required.

We have analyzed this proposed rule in accordance with the principles set forth in Executive Order 13175. We have tentatively determined that the rule does not contain policies that would have a substantial direct effect on one or more Indian Tribes, on the relationship between the Federal Government and Indian Tribes, or on the distribution of power and responsibilities between the Federal Government and Indian Tribes. The Agency solicits comments from tribal officials on any potential impact on Indian Tribes from this proposed action.

The following reference is on display in the Dockets Management Staff (see ADDRESSES ) 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 https://www.regulations.gov. FDA has verified the website address, as of the date this document publishes in the Federal Register , but websites are subject to change over time.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, we propose that 21 CFR part 203 be amended as follows:

The Drug Quality and Security Act (DQSA) was enacted on November 27, 2013. The DQSA contains two titles: Title I, the Compounding Quality Act, and Title II, the DSCSA (Pub. L. 113-54). The DSCSA amended Chapter V of the Federal Food, Drug, and Cosmetic Act (FD&C Act) by adding Subchapter H (Pharmaceutical Distribution Supply Chain), sections 581 through 585 (21 U.S.C. 360eee through 360eee-4), and by amending section 503(e) of the FD&C Act (21 U.S.C. 353(e)). As amended, sections 503(e) and 583 of the FD&C Act require the Secretary to establish national prescription drug wholesale distributor licensure standards. In addition, section 582 of the FD&C Act establishes prescription drug product tracing requirements for wholesale distributors and their trading partners.

On July 14, 2011, FDA proposed to remove § 203.50(a) (21 CFR 203.50(a)). Before that rulemaking was finalized, the DSCSA was enacted. Section 204 of the DSCSA amended section 503(e)(1) through (3) of the FD&C Act with additional and different requirements for wholesale distributors. The DSCSA also added new requirements for wholesale distributors, including phased-in prescription drug tracing requirements in section 582(c) of the FD&C Act. Because of the changes to requirements for wholesale distributors under the DSCSA, the Agency's proposed rule published on July 14, 2011, to remove § 203.50(a), was never finalized.

In its proposed rulemaking entitled “Certain Requirements Regarding Prescription Drug Marketing,” published elsewhere in this issue of the Federal Register , FDA will propose a rule that will seek to amend part 203 (21 CFR part 203) to remove provisions no longer in effect and incorporate conforming changes following enactment of the DSCSA. In the proposed rulemaking, the Agency will clarify provisions to avoid potential confusion with the new standards for wholesale distribution established by the DSCSA. The amendments to part 203 in the proposed rule will include the removal of § 203.50 in its entirety, rendering the proposed rule published July 14, 2011, removing § 203.50(a), obsolete.

As result of these efforts, FDA is withdrawing the proposed rule “Removal of Certain Requirements Related to the Prescription Drug Marketing Act; Opportunity for Public Comment,” published in the Federal Register of July 14, 2011.

The withdrawal of this proposed rule does not preclude the Agency from reinstituting rulemaking concerning the issues addressed in the proposal. Should we decide to undertake such rulemakings in the future, we will re-propose the actions and provide new opportunities for comment. Furthermore, this proposed rule is only intended to address the withdrawal of the proposed rule on “Removal of Certain Requirements Related to the Prescription Drug Marketing Act; Opportunity for Public Comment,” published in the Federal Register of July 14, 2011, and not any other pending proposals that the Agency has issued or is considering. If you need additional information about the subject matter of the withdrawn proposed rule, visit the Agency's website at https://www.fda.gov for any current information on the matter.

The Depatment of Navy has notified the Coast Guard that it will be conducting a diving exercise from 6 a.m. to 6 p.m., each day from March 6, 2022, through March 17, 2022, along the entire length of the Gastineau Channel. Hazards associated with the exercise include collision and damage to remotely operated vehicles (ROVs) and collision and injury to divers in the water. The Captain of the Port Southeast Alaska (COTP) has determined that potential hazards associated with the exercise would be a security concern for anyone within a 200-yard radius of the Navy vessel displaying the Alpha (“Dive”) flag.

The purpose of this rulemaking is to ensure safety of the public as well as the Navy personnel and assets in the navigable waters before, during, and after the scheduled diving exercise. The Coast Guard is proposing this rulemaking under authority in 46 U.S.C. 70034 (previously 33 U.S.C. 1231).

The COTP is proposing to establish a security zone from March 6, 2022, through March 17, 2022. The security zone would be enforced daily from 6 a.m. to 6 p.m. and would cover all navigable waters within 200-yard radius of the Navy vessel displaying the Alpha (“Dive”) flag in the Gastineau Channel. The duration of the zone is intended to protect Navy personnel and assets on these navigable waters before, during, and after the scheduled 6 a.m. to 6 p.m. diving exercise. No vessel or person would be permitted to enter the security zone without obtaining permission from the COTP or a designated representative. The regulatory text we are proposing appears at the end of this document.

We developed this proposed rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive orders, and we discuss First Amendment rights of protestors.

Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. This NPRM has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, the NPRM has not been reviewed by the Office of Management and Budget (OMB).

This regulatory action determination is based on the size, location, and time of day of the security zone. Traffic is limited during the time of year when the security zone would be in effect. As a moving security zone assigned to a Navy vessel rather than a defined area of water, the impact to the waterway would be minimized. Moreover, the Coast Guard would issue a Broadcast Notice to Mariners via VHF-FM marine channel 16 about the zone, and the rule would allow vessels to seek permission to enter the zone.

The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this proposed rule would not have a significant economic impact on a substantial number of small entities.

While some owners or operators of vessels intending to transit the security zone may be small entities, for the reasons stated in section IV.A above, this proposed rule would not have a significant economic impact on any vessel owner or operator.

If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this proposed rule would have a significant economic impact on it, please submit a comment (see ADDRESSES ) explaining why you think it qualifies and how and to what degree this rule would economically affect it.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this proposed rule. If the proposed rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please call or email the person listed in the FOR FURTHER INFORMATION CONTACT section. The Coast Guard will not retaliate against small entities that question or complain about this proposed rule or any policy or action of the Coast Guard.

This proposed rule would not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

A rule has implications for federalism under Executive Order 13132 (Federalism), if it has a substantial direct effect on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this proposed rule under that order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.

Also, this proposed rule does not have tribal implications under Executive Order 13175 (Consultation and Coordination with Indian Tribal Governments) because it would not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this proposed rule has implications for federalism or Indian tribes, please call or email the person listed in the FOR FURTHER INFORMATION CONTACT section.

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this proposed rule would not result in such an expenditure, we do discuss the potential effects of this proposed rule elsewhere in this preamble.

We have analyzed this proposed rule under Department of Homeland Security Directive 023-01, Rev. 1, associated implementing instructions, and Environmental Planning COMDTINST 5090.1 (series), which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have made a preliminary determination that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This proposed rule involves a security zone lasting 12 hours for twelve days that would prohibit entry within 200-yard radius of the Navy vessel displaying the Alpha (“Dive”) flag. Normally such actions are categorically excluded from further review under paragraph L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1. A preliminary Record of Environmental Consideration supporting this determination is available in the docket. For instructions on locating the docket, see the ADDRESSES section of this preamble. We seek any comments or information that may lead to the discovery of a significant environmental impact from this proposed rule.

The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to call or email the person listed in the FOR FURTHER INFORMATION CONTACT section to coordinate protest activities so that your message can be received without jeopardizing the safety or security of people, places, or vessels.

We view public participation as essential to effective rulemaking, and will consider all comments and material received during the comment period. Your comment can help shape the outcome of this rulemaking. If you submit a comment, please include the docket number for this rulemaking, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation.

Submitting comments. We encourage you to submit comments through the Federal Decision Making Portal at https://www.regulations.gov. To do so, go to https://www.regulations.gov, type USCG-2021-0893 in the search box and click “Search.” Next, look for this document in the Search Results column, and click on it. Then click on the Comment option. If you cannot submit your material by using https://www.regulations.gov, call or email the person in the FOR FURTHER INFORMATION CONTACT section of this proposed rule for alternate instructions.

Viewing material in docket. To view documents mentioned in this proposed rule as being available in the docket, find the docket as described in the previous paragraph, and then select “Supporting & Related Material” in the Document Type column. Public comments will also be placed in our online docket and can be viewed by following instructions on the https://www.regulations.gov Frequently Asked Questions web page. We review all comments received, but we will only post comments that address the topic of the proposed rule. We may choose not to post off-topic, inappropriate, or duplicate comments that we receive.

Personal information. We accept anonymous comments. Comments we post to https://www.regulations.gov will include any personal information you have provided. For more about privacy and submissions to the docket in response to this document, see DHS's eRulemaking System of Records notice (85 FR 14226, March 11, 2020).

For the reasons discussed in the preamble, the Coast Guard is proposing to amend 33 CFR part 165 as follows:

The Copyright Act provides the Copyright Office with the authority to collect fees for its services, such as registration of a copyright claim and recordation of a transfer of copyright ownership. 1 General fee-setting authority is provided in 17 U.S.C. 708(a), which enumerates ten services for which fees shall be required, along with providing authority “to fix fees for other services.”  2 Several sections of the Copyright Act provide the Copyright Office with explicit authority to collect fees for services not listed in section 708(a), such as designating an agent to receive notifications of claimed infringement  3 and filing a notice of intent to enforce a restored copyright. 4 A number of other fees are set pursuant to the Copyright Office's general regulatory authority, such as the fee for providing notice to libraries and archives of normal commercial exploitation or availability of a copyrighted work at a reasonable price under 17 U.S.C. 108(h)(2)(B).

The majority of regulations addressing payment methods accepted by the Copyright Office for the fees it charges appear in 37 CFR 201.6; a number of other provisions address payment methods for specific services. Some of the payment options vary depending on the service—for example, the Office accepts payment by “electronic funds transfer, credit or debit card, or deposit account” for online applications for registration, 5 while it accepts payment by “money order, check, bank draft, deposit account,” and most major credit cards for registration of foreign works restored under 17 U.S.C. 104A. 6 Some services may be paid for with cash (only in person); others may not. 7 The different payment methods across provisions can lead to confusion if not spelled out in regulations.

As part of broader modernization efforts, the Office is reviewing its regulations and updating them where necessary to reflect current and anticipated practices. 8 The Office is undertaking this rulemaking as part of those efforts, which the Office anticipates will result in an integrated, unified IT system for its services, including payment processing.

The Office issued a notification of inquiry (“NOI”) on Registration Modernization on October 17, 2018, 9 that invited public comment on a number of issues concerning regulations and practices related to the registration of copyright claims. Among the questions, the Office asked whether it should eliminate “payment options via check or money order” for copyright registration applications. 10 This proposed rule, in part, reflects feedback that the Office received from commenters regarding payment methods. As this notice of proposed rulemaking does not address every issue raised in that notification of inquiry or by commenters, the Office reserves judgment on any matters not expressly discussed herein; no inference should be drawn from the Office's silence on any particular point. The comments received in response to the notification of inquiry that were not addressed by this proposed rule will continue to be evaluated by the Office as system development progresses.

The Copyright Office maintains a system of deposit accounts for frequent users of Office services. An individual or entity may establish a deposit account, make contributions to that account, and charge copyright fees against the balance instead of sending separate payments with applications and other requests for services. This process has been valued by deposit account holders, who have found it to be more efficient and less expensive than alternatives, and also to facilitate good recordkeeping and accounting practices—for example, by allowing companies to track and attribute specific payments to specific projects and business units.

Although the Copyright Act does not require the Copyright Office to offer and maintain deposit accounts, 11 the Office has done so as a convenience to high-volume users of its services since 1910. 12 Under current regulations, deposit account holders are required to engage in a minimum of 12 transactions per year and maintain a minimum balance (no less than $450) to hold a deposit account. 13 In addition, the regulations direct the Office to close a deposit account if it is overdrawn twice within any 12-month period and offer deposit account holders the option of automatic replenishment of their account via bank account or credit card. 14

These existing administrative requirements were created through a final rule that went into effect May 1, 2011. 15 The rule arose from a proceeding that the Copyright Office began on July 14, 2009, to solve problems associated with the suspension of paper registration applications for lack of deposit account funds. 16 The Office had initially proposed to eliminate the ability to pay for paper applications using deposit accounts and to require deposit account holders to file their applications electronically. 17 After considering public comments on the proposal, the Office “was persuaded that mandatory electronic application was not the most appropriate solution to its problem of underfunded paper applications.”  18 The Office explored other options for addressing this problem and subsequently proposed the above account-maintenance requirements. 19 Following favorable public comments, the Office promulgated the current regulations. 20

The Copyright Office more recently has been reviewing its deposit account regulations as part of its broader modernization efforts. 21 In May 2017, as part of those efforts, the Office sought comments on recordation modernization and solicited public comments on “whether or not to continue allowing remitters to pay through deposit accounts . . . including whether potential users of deposit accounts would be willing to pay a surcharge for the development and maintenance of an automated deposit account system.”  22 All respondents opposed the elimination of deposit accounts. 23

In October 2018, the Copyright Office sought public comment on issues related to modernization of the registration system. 24 Although the October 17, 2018, NOI did not expressly mention deposit accounts, it sought comment on whether the Office should eliminate “payment options via check or money order.”  25 In answering that question, several respondents reiterated support for deposit accounts. 26

Through its review, the Office has identified several areas where the current regulations could be improved. As a threshold matter, the Office recognizes that many stakeholders benefit from the ability to maintain deposit accounts, and the Office continues to support their availability. 27 The intent of this proceeding is to ensure that the Office is able to continue to provide deposit accounts in an efficient and cost-effective manner that aligns with user expectations, the overall operations of the Office, and the broader goals of the copyright system.

First, although the regulations prescribe minimum transaction and balance requirements, they do not prescribe any procedure for addressing noncompliant deposit accounts. The Copyright Office has periodically reviewed existing deposit accounts for noncompliance and has an internal procedure for closing noncompliant deposit accounts. The process is designed to provide clear notice to noncompliant deposit account holders and an opportunity to cure within a reasonable time period. Communicating a process through regulations would increase transparency, clarity, and certainty.

Second, the establishment and maintenance of deposit accounts create costs to the Copyright Office above other payment methods. These costs include staff time to establish, maintain, and reconcile accounts and invest excess balances, as well as developing and sustaining internal controls necessary to manage unused deposit account balances (which the Office must hold as a fiduciary for deposit account holders until they use the funds or the Office refunds them).

The Copyright Office previously proposed establishing fees in connection with the creation and maintenance of deposit accounts, 28 though it ultimately decided against doing so. In 1994, the Office, after noting that “the Copyright Office deposit account system involves substantial benefits to the depositors and substantial costs to the Copyright Office,” proposed a fee of $50 to open a deposit account and an annual maintenance fee of $50 (the average cost of providing the service at the time). 29 Along with the fees, the Office proposed eliminating the minimum 12 transactions per year requirement. 30 The Office subsequently abandoned implementing any fees following public comment. 31 The Office maintained that position again in 1998, as part of a general fee rulemaking, explaining that “the use of deposit accounts is beneficial both to the holder and the Office.”  32

Third, the current deposit account regulations allow for automatic replenishment of funds and state that a deposit account that was closed due to a second overdraft within a 12-month period “can be re-opened only if the holder elects to fund it through automatic replenishment.”  33 But the Copyright Office does not have the practical ability to accept automatic replenishment, either as a convenience for replenishment or as a means for re-opening a closed account, via the most-commonly used payment methods. Pay.gov —a U.S. Treasury Department system for secure processing of payments to federal government agencies that the Office uses to administer payment for electronic services—currently only allows automatic payments via ACH; it does not permit automatic payments to be made by other payment methods, such as credit cards. Accordingly, the regulations need to be revised to reflect current Office capabilities.

Having carefully considered the above issues, including relevant public comments in prior proceedings, the Copyright Office now issues a proposed rule amending its regulations regarding remitter payments and deposit accounts and invites further public comment on any aspects of the amended rules.

The Copyright Office proposes amending its regulations governing remitter payments as follows. First, the Office proposes to consolidate all regulations related to the types of payment methods it will accept for services into a single set of provisions. This will ensure accuracy and consistency in payment methods across the Office's services, particularly as the Office moves to an integrated enterprise IT system. 34 The rule enumerates the payment methods accepted for three different avenues: Electronic payments, mailed payments, and payments provided in person at the Office's Public Information Office. Electronic payments must be made through Pay.gov, which accepts most common types of electronic payment methods. For mailed payments, the Office will only accept checks or money orders. The Office will accept checks, money orders, credit card, debit card, and currency for services requested in person, along with electronic payments made via Pay.gov if done by appointment at the Public Information Office kiosk.

Although cash transactions are the costliest transactions to process, the Copyright Office notes that, prior to the pandemic-related suspension of in-person services, 35 the Public Information Office received a not insignificant volume of cash payments, 36 and that eliminating the acceptance of cash might limit access to Office services for some individuals. The Office will continue to explore ways to ensure the widest accessibility of its services while exercising fiscal responsibility, including the possibility of adding a surcharge to cash payments to offset their processing costs and incentivizing payment through less expensive methods. 37

The Copyright Office proposes simplifying requirements to maintain a deposit account and identifying in regulations the deposit account closure procedures. First, the Office proposes that a deposit account holder no longer be required to engage in a minimum number of transactions per year. The Office proposes to eliminate this requirement for several reasons. For one, as noted above, the rationale that led to the creation of the minimum-transactions requirement—that without a minimum-transaction requirement deposit account holders would neglect account balances and leave “insufficient funds to process a paper application”  38 —has lessened. The percentage of service requests the Office receives by paper, as opposed to electronically, has declined significantly since the requirement was created and is expected to continue to drop;  39 a lower proportion of paper applications reduces the likelihood of deposit account holders overdrawing because the Office's electronic system will not process a request if a deposit account lacks sufficient funds. Additionally, the imposition of a service charge for a deposit account that falls below the minimum balance, as discussed below, will create additional incentives for deposit account holders to maintain sufficient funds for service requests. Finally, the costs associated with monitoring transaction numbers outweigh any benefit the minimum-transaction requirement provides in reducing overdrafts. For deposit account holders, the elimination of the minimum-transaction requirement should ease their own regulatory burdens.

Second, the Copyright Office proposes imposing a service charge of $25 for each month a deposit account balance is below $450. 40 As pointed out above, this will incentivize deposit account holders to maintain sufficient funds in deposit accounts to avoid overdrafts. The Office notes that the U.S. Patent and Trademark Office currently imposes a similar service charge in connection with its deposit accounts. 41 The Copyright Office will not assess the service charge until the last day of the first full calendar month in which the account balance remains below the minimum balance in order to provide deposit account holders with sufficient opportunity to replenish the account before incurring the charge, and an account with less than $25 at the end of a month will be inactivated by the Office rather than incur the service charge.

Third, the proposed rules provide for the inactivation of accounts in two circumstances. One is when an account has had no activity for 24 months. Though the Office proposes to eliminate the minimum-transactions requirement, providing for inactivation when an account goes unused for such a prolonged period will reduce the costs associated with maintaining unused accounts. The other circumstance is after several unsuccessful attempts to contact the deposit account holder. Undeliverable accounts create burdens for the Copyright Office, and these procedures will alleviate them.

Fourth, the rules spell out the Copyright Office's procedures for closing noncompliant deposit accounts, including the circumstances for closure and the process for returning any remaining funds to the deposit account holder. Currently, the Office's closure procedures are not explicitly set out in regulations. Adding them will provide additional transparency, clarity, and certainty regarding Office deposit account policies.

Finally, the Copyright Office is eliminating references to automatic replenishment of deposit accounts. At this time, Pay.gov lacks the ability to provide such automatic replenishment.

For reasons stated in the preamble, the Copyright Office proposes to amend 37 CFR parts 201 and 202 as follows:

The addition reads as follows:

Section 403 of the John S. McCain III, Daniel K. Akaka, and Samuel R. Johnson VA Maintaining Internal Systems and Strengthening Integrated Outside Network Act of 2018 (Pub. L. 115-182, hereafter referred to as the MISSION Act) mandated the Department of Veterans Affairs (VA) create a pilot program to establish additional medical residency positions authorized under section 7302 of title 38 United States Code (U.S.C.) (note to 38 U.S.C. 7302) at certain covered facilities. This proposed rule would establish substantive and procedural requirements to allow VA to administer this pilot program in a manner consistent with section 403 of the MISSION Act.

Section 7302(e)(1) of title 38 United States Code (U.S.C.) permits VA to both establish medical residency programs in VA facilities and ensure that such established programs have a sufficient number of residents. Section 403 of the MISSION Act created a note to section 7302 to expand VA's authority to establish medical residency positions in covered facilities to include non-VA facilities such as health care facilities of the Department of Defense and Indian Health Service. Section 403 of the MISSION Act further provides parameters for VA to determine those covered facilities in which residents will be placed. For instance, section 403 requires VA to consider certain factors to determine whether there is a clinical need for providers in areas where residents would be placed. Section 403 also requires prioritized placement of residents under the pilot program in Indian Health Service facilities, Indian tribal or tribal organization facilities, certain underserved VA facilities, or other covered facilities. Section 403 additionally authorizes VA to pay resident stipends and benefits regardless of whether such residents are assigned to a VA facility, and requires VA to pay certain startup costs of new residency programs (such as curriculum development and faculty salaries) if residents are placed in such programs under the pilot program. The authority for the pilot was initially scheduled to expire on August 7, 2024; however, it was subsequently extended to August 7, 2031, under section 5107 of Public Law 116-169.

Before detailing the regulations we propose to implement this mandated pilot program, we provide a brief summary of VA's administration of its Graduate Medical Education (GME) programming under 38 U.S.C. 7302(e), to establish a basic understanding of VA's understand of the conduct of GME programming in general. Under section 7302(e)(1), VA establishes new medical residency programs in VA facilities and ensures that such programs have a sufficient number of residents; VA also ensures that existing medical residency programs have a sufficient number of residents. Criteria under sections 7302(e)(1)(A)-(B) and (e)(2)(A)-(B) further guide VA's selection of its facilities in which residency programs will be established or residents will be placed, where such criteria relate to VA staffing levels, location of VA facilities in certain areas deemed as health professional shortage areas, and priority for residents to be placed for the provision of specific types of health care. Through a request for proposal (RFP) mechanism, VA Central Office notifies VA facilities of these selection criteria as well as other parameters. This RFP details, among other things: Consideration factors to be assessed by VA Central Office (as well as the relative importance or weight of such factors); information required from VA facilities to be in any response to the RFP submitted back to VA Central Office; and the process to submit a response to the RFP, to include submission instructions and timelines for completion. Upon receipt of those RFP responses submitted by VA health care facilities, VA Central Office evaluates the responses submitted against the criteria in the RFP to determine those facilities in which residents will be placed or whether funding will be made available for certain costs of establishing new medical residency programs. In administering GME programming under section 7302(e), VA forms relationships with non-VA institutions that sponsor graduate medical educational programs (most often medical schools or teaching hospitals), and it is those sponsoring institutions that provide the residents that would be available for placement in VA facilities. VA, therefore, does not control the pool of participating educational programs or available residents, although VA does assess the requirements under section 7302(e) to determine the best placement for such residents in VA facilities. VA in effect then does not place residents but does provide for resident positions to be filled in VA facilities. Under section 7302(d), VA forms academic affiliations with sponsoring institutions to delineate the responsibilities regarding the training of the residents, and VA enters into other separate agreements to control funding of both certain residency program educational costs (such as accreditation fees and National Resident Match Program fees) and the costs of paying resident stipends and benefits. VA envisions that the pilot program authorized under section 403 would be conducted under the same basic tenets of GME programming as presented above, such that there would be agreements formed with academic affiliations with sponsoring institutions and the covered facilities recognized in section 403 and in which residents would be placed under the pilot. We will note throughout these proposed regulations where we expect there to be administrative and substantive similarities and differences between VA's statutory GME programming under 38 U.S.C. 7302 and the pilot program required by section 403.

We propose to establish several new regulation sections in part 17 of title 38 Code of Federal regulation (CFR) in §§ 17.243 through 17.248 to implement this mandated pilot program, as further discussed below.

Proposed § 17.243(a) would establish that proposed §§ 17.243 through 17.248 would implement the VA Pilot Program on Graduate Medical Education and Residency (PPGMER) to place residents in existing or new residency programs in covered facilities and to reimburse certain costs associated with establishing new residency programs in covered facilities, as authorized by section 403 of Public Law 115-182. Proposed § 17.243(b) would establish the scope of the PPGMER by stating that §§ 17.243 through 17.248 would apply only to the PPGMER as authorized under section 403 of Public Law 115-182, and not to VA's more general administration of GME programs in VA facilities as authorized under 38 U.S.C. 7302(e). Establishing the scope of the PPGMER as separate from VA's more general GME programming under 38 U.S.C. 7302(e) would be necessary because the PPGMER is a time-limited pilot program that will sunset on August 7, 2031 (unless statutorily reauthorized or made permanent), and because section 403 of the MISSION Act establishes PPGMER-specific criteria that do not otherwise apply to VA's administration of GME programs under 38 U.S.C. 7302(e). Additionally, although the PPGMER would be a separately administered program under these proposed regulations, the PPGMER would utilize some of the same administrative concepts or procedures as VA uses to administer programs under 38 U.S.C. 7302(e). For instance, some definitions as proposed in these regulations may be the same as established in certain VA policy used to administer GME programming under section 7302(e), as will be explained in discussion of proposed § 17.244. Proposed § 17.243 would not state the 2031 sunset date of the PPGMER, as the authority for PPGMER may be extended or made permanent in the future. If the authority for PPGMER were not extended or made permanent, VA would cease to implement the PPGMER and would issue a publication in the Federal Register to remove and reserve the regulation.

Proposed § 17.244 would establish definitions to apply to the PPGMER under proposed §§ 17.243 through 17.249.

The term benefit would be defined to mean a benefit provided by VA to a resident that has monetary value in addition to a resident's stipend, which may include but not be limited to health insurance, life insurance, worker's compensation, disability insurance, Federal Insurance Contributions Act (FICA) taxes, and retirement contributions. We believe this would be a commonly understood definition of this term as it is consistent with the characterization of benefits in VA policy that is used to administer programs under the authority of 38 U.S.C. 7302(e). This definition would be relevant as VA would pay benefits to residents as applicable, as explained later in the discussion of proposed § 17.248.

The term covered facility would be defined to mean any facility identified in § 17.245, as that section is proposed and discussed later in this rulemaking. We would define covered facility in relation to proposed § 17.245, to avoid having to reference § 17.245 in every instance in which the term covered facility would be used in the proposed regulation text.

The term educational activities would be defined to mean all activities in which residents participate to meet educational goals or curriculum requirements of a residency program, to include but not be limited to: Clinical duties; attendance in didactic sessions; research; attendance at VA facility committee meetings; scholarly activities that are part of an accredited training program; and approved educational details. We believe this would be a commonly understood definition of this term as it is consistent with the characterization of existing educational activities in VA policy (see, e.g., Veterans Health Administration (VHA) Directive 1400.09, Education of Physicians and Dentists) that is used to administer programs under the authority of 38 U.S.C. 7302(e). This term would be relevant as it would be used to qualify those stipend and benefits payments VA may make for residents under the PPGMER, as explained later in the discussion of proposed § 17.248.

The term resident would be defined to mean physician trainees engaged in post-graduate specialty or subspecialty residency programs that are either accredited by the Accreditation Council for Graduate Medical Education or in the application process for accreditation. The term resident would further be defined to include individuals in their first post-graduate year (PGY-1) of training (often referred to as Interns), and individuals who have completed training in their primary specialty and continue training in a subspecialty graduate medical education program and (generally referred to as Fellows). These Fellows would often be PGY-4 and above, depending upon the specialty. This term is relevant as it would be used throughout these proposed regulations, and we believe this proposed definition would be commonly understood as it is consistent with the characterization of a resident in VA policy that is used to administer programs under the authority of 38 U.S.C. 7302(e). Because this definition would require the residency programs to be accredited or in the process for such accreditation by the Accreditation Council of Graduate Medical Education, VA would not consider individuals in non-accreditable programs, including VA Advanced Fellows or post-training chief residents, as residents under this pilot. While section 7302(e) uses the term residency position, for purposes of this proposed rule, we propose to use the term resident because that was the term used in sections 403(a)(4) through (6) and (b) of the MISSION Act. Additionally, the proposed definition of resident would permit VA to consider more than one resident as occupying a single resident position (such as a split assignment, which VA would track according to the percentage of VA assigned educational activities).

The term stipend would be defined to mean the annual salary paid by VA for a resident. We believe this proposed definition would be commonly understood as it is consistent with the characterization of a stipend in VA policy that is used to administer programs under the authority of 38 U.S.C. 7302(e). This definition would be relevant as VA would pay stipends to residents as applicable, as explained later in the discussion of proposed § 17.248.

The term VA health care facility would be defined to mean any VA-owned or VA-operated location where VA physicians provide care to Veterans, to include but not be limited to a VA medical center, independent outpatient clinic, domiciliary, nursing home (community living center), residential treatment program, and community-based clinic. This definition would be relevant to characterize one type of covered facility under proposed § 17.245, and relevant to characterize one assessment criterion under proposed § 17.246(a)(7). We believe this definition is reasonable because it would capture the VA settings in which a VA physician provides care to Veterans, as it would be physicians who are teaching residents to be placed under the PPGMER.

Proposed § 17.245 would list the covered facilities in which residents may be placed under the PPGMER, consistent with section 403(a)(2) of the MISSION Act. We would restate the list of covered facilities from section 403(a)(2), versus merely cross-referencing section 403 or the statutory note to 38 U.S.C. 7302, for clarity and to provide regulatory citations that characterize or define certain terms related to covered facilities as applicable. Listing the facility types versus cross referencing section 403 would also allow proposed § 17.245 to include applicable regulatory citations. For instance, section 403(a)(2)(B) establishes that one type of covered facility are those health care facilities operated by an Indian tribe or tribal organization as those terms are defined in 25 U.S.C. 5304; proposed § 17.245(b) would restate this language from section 403 and would add the relevant regulatory citations for the definitions of Indian tribe and tribal organization.

Proposed § 17.245 would establish the following types of facilities as covered facilities under the PPGMER, consistent with section 403(a)(2) of the MISSION Act: (1) A VA health care facility as defined in § 17.244; (2) a health care facility operated by an Indian tribe or tribal organization, as those terms are defined in 25 U.S.C. 5304 and at 25 CFR 273.106; (3) a health care facility operated by the Indian Health Service; (4) a federally-qualified health center as defined in 42 U.S.C. 1396d(l)(2)(B); (5) a health care facility operated by the Department of Defense; or (6) other health care facilities deemed appropriate by VA. We note that although a VA health care facility is listed as a covered facility under section 403(a)(2)(A) and would also be listed as a covered facility in proposed § 17.245(a), we do not anticipate the PPGMER being a vehicle for the placement of residents in VA facilities, as VA intends to continue operating its GME programming to place residents in VA facilities as authorized under 38 U.S.C. 7302 and 7406, separate from the PPGMER for the duration in which the PPGMER is implemented. We believe the authority under section 7302 is sufficient to place residents in VA facilities. However, we would not want to exclude from this proposed rule an express type of covered facility as listed in section 403(a)(2) of the MISSION Act. Similarly, proposed § 17.245(f) would provide, consistent with section 403(a)(2)(F), that a covered facility could be any other health care facility as VA considers appropriate, giving VA the ability to place residents in a variety of facilities, such as those recognized by the Department of Health and Human Services as Rural Health Clinics, without curtailing the discretion provided to VA by section 403(a)(2)(F) in the administration of the PPGMER.

Proposed § 17.246 would establish factors that VA would consider when determining in which covered facilities residents would be placed under the pilot. Consistent with section 403(a)(4)(A)-(G) of the MISSION Act, proposed § 17.246(a)(1) through (7) would generally provide that VA would evaluate these factors in the context of whether there is a clinical need for providers in the area in which a covered facility is located. Proposed paragraphs (a)(1) through (7) would then restate from section 403(a)(4)(A)-(G) the specific factors VA must consider when determining whether there is a clinical need for providers in an area (those specific factors are discussed in detail further in this section of the preamble). We note that these proposed factors, consistent with section 403(a)(4), would not be weighted in any particular manner in the regulation text under proposed § 17.246(a), to allow flexibility for VA to consider the relative import of factors throughout the duration of the pilot. Although these factors would not be weighted in regulatory text, it may be the case that VA would assign levels of relative importance to these factors as part of its selection process, as discussed in the section of this preamble related to proposed § 17.247. Additionally, only one factor in proposed paragraphs (a)(1) through (7) would be required to be met for VA to determine that a covered facility would be in an area with a clinical need for providers. As discussed below, it may be the case that some covered facilities could be considered to meet the same factor under paragraphs (a)(1) through (7) of proposed § 17.246, and that additional factors would need to be considered.

Before discussing the specific factors that VA would consider in proposed § 17.246(a)(1) through (7) to determine the clinical need for providers in an area, we clarify that VA would not be soliciting the interest of covered facilities to participate in the PPGMER through a public funding announcement, a public request for proposal, or by establishing an public application process, because section 403 of the MISSION Act is not an express grant or cooperative agreement authority through which VA may offer a public funding opportunity. Further, section 403 does not authorize any amount of money to be appropriated to implement the PPGMER, separate from VA's administration of its existing GME programing authorized under 38 U.S.C. 7302 and 7406. Because VA does not interpret that section 403 of the MISSION Act to authorize a public funding opportunity for which covered facilities may apply or submit a proposal to be considered, VA would not conduct a public solicitation. Rather, the parameters of VA's selection process for covered facilities would be established in proposed § 17.247, as discussed later in this proposed rule.

Consistent with section 403(a)(4)(A) of the MISSION Act, proposed § 17.246(a)(1) would establish that VA would evaluate the ratio of veterans to VA providers for a standardized geographic area surrounding a covered facility, including a separate ratio for general practitioners and specialists. Proposed § 17.246(a)(1)(i) would establish that VA considers a standardized geographic area to mean the county in which a covered facility is located. We believe this is a reasonable interpretation of a standardized geographic area by which to compare ratios of veterans to VA providers, as most covered facilities as well as VA should be able to access such data. We understand that proposing to use a county as the standardized geographic area would mean that covered facilities in the same county would have the same ratios of veterans to VA providers, making such facilities incomparable in terms of this consideration factor. We reiterate, therefore, that this is only one of multiple factors that VA would consider when determining the need for clinical providers in an area, and we do not anticipate that this factor would prevent covered facilities in the same county from being considered, provided other factors that indicate clinical need are met. Proposed § 17.246(a)(1)(ii) would clarify that when deciding the clinical need for providers in an area, VA may consider either or both of the ratio(s) for general practitioners and specialists, where a higher ratio of veterans to VA providers would indicate a higher need for health care providers in an area. We believe these clarifications would be consistent with section 403(a)(4)(A).

Consistent with section 403(a)(4)(B) of the MISSION Act, proposed § 17.246(a)(2) would establish that VA would evaluate the range of clinical specialties of VA and non-VA providers for a standardized geographic area surrounding a covered facility, where the presence of fewer clinical specialties indicates a higher need for health care providers in an area, which we believe is a reasonable interpretation of section 403(a)(4)(B) to reflect a commonplace understanding that fewer types of providers in an area can indicate a greater clinical need. Proposed § 17.246(a)(2) would consider the range of specialties of both VA and non-VA providers in an area because section 403(a)(4)(B) is not specific to only VA providers. We note that the term standardized geographic area as used in proposed § 17.246(a)(2) would mean the county in which a covered facility is located, consistent with how that term is defined in proposed § 17.246(a)(1)(i).

Consistent with section 403(a)(4)(C) of the MISSION Act, proposed § 17.246(a)(3) would establish that VA would evaluate whether the specialty of a provider is included in the most recent staffing shortage determination by VA under 38 U.S.C. 7412. Under section 7412(a), not later than September 30 of each year, the Inspector General of VA shall determine, certain clinical and nonclinical occupations for which there are the largest staffing shortages with respect to each VA medical center of the Department. The type of providers considered under proposed § 17.246(a)(3) would be based on the list developed pursuant to 38 U.S.C. 7412(a). We note that the list developed pursuant to 38 U.S.C. 7412(a) is a national list (based on data from all VA medical centers in the country related to shortages of providers), and that this factor would not be evaluated in relation to provider types or numbers at any one VA facility. We also note that a covered facility would not similarly have to have a shortage of the type of provider on the list developed pursuant to 38 U.S.C. 7412, as it may be that a sufficient number of such providers at a covered facility could indicate the best conditions in which VA should place residents (as these would be the very types of providers VA needs more of). We would not regulate this factor more specifically, however, to provide VA the flexibility in assessing the list developed pursuant to 38 U.S.C. 7412.

Consistent with section 403(a)(4)(D) of the MISSION Act, proposed § 17.246(a)(4) would establish that VA would evaluate whether a covered facility is located in the local community of a VA facility that has been designated by VA as an underserved facility pursuant to criteria developed under section 401 of Public Law 115-182. We note that section 403(a)(4)(D) of the MISSION Act would require VA to consider whether the local community is designated as underserved pursuant to criteria developed under section 401 of Public Law 115-182. Section 401 of Public Law 115-182 relates to VA's criteria to designate its facilities as underserved, rather than communities at large. To clarify any potential inconsistency between the reference to underserved VA facilities in section 401 and underserved communities in section 403, we believe a reasonable reading of section 403(a)(4)(D) provides for VA to consider whether covered facilities are located in a local community in which a VA facility has been designated as underserved under section 401. In developing the criteria to identify underserved VA facilities under section 401, VA must consider various factors, including the ratio of veterans to VA health care providers in an area, the range of clinical specialties offered, whether the local community is medically underserved, data on open consults, whether the facility is meeting the wait-time goals of the Department, and such other factors that VA considers important in determining which facilities are not adequately serving area veterans. For purposes of this factor, if a covered facility is located in the same Veterans Integrated Service Network (VISN) as a VA facility designated as underserved pursuant to section 401, then VA would consider that covered facility to be located in the same local community as the VA facility. We believe the service area of a VISN would allow VA to consider a broad range of covered facilities, but we would not regulate that requirement more specifically in the event that VA facility service area names change in the future. Using the phrase local community in proposed § 17.246(a)(4) would also be consistent with section 403(a)(4)(D) of the MISSION Act, and would allow VA the flexibility to consider a service area that is different from a VISN in the future, in which case VA would clearly indicate a different standard in the request for proposal that is sent to VA health care facilities for consideration. Lastly, we note that under section 401, a VA facility is characterized as a medical center, ambulatory care facility, and a community-based outpatient clinic. Proposed § 17.246(a)(4) would reference VA facility to be consistent with section 401.

Consistent with section 403(a)(4)(E) of the MISSION Act, proposed § 17.246(a)(5) would establish that VA would evaluate whether the covered facility is located in a community designated by the Secretary of Health and Human Services (HHS) as a health professional shortage area under 42 U.S.C. 254e. Under 42 U.S.C. 254e(a)(1), a health professional shortage is an area in an urban or rural area that has been determined to have a provider shortage and which is not reasonably accessible to an adequately served area, a population group that has been determined to have such a shortage, or a public or nonprofit private medical facility or other public facility that has been determined to have such a shortage.

Consistent with section 403(a)(4)(F) of the MISSION Act, proposed § 17.246(a)(6) would establish that VA would evaluate whether the covered facility is in a rural or remote area. Proposed paragraph (a)(6)(i) would further interpret a rural area to mean those areas identified by the U.S. Census Bureau as rural. Section 403 does not specifically define or characterize the meaning of the term rural, and therefore, we believe it is rational to use the definition provided by the U.S. Census Bureau. The Census Bureau's classification of rural consists of all territory, population, and housing units located outside of urbanized areas and urban clusters. Interested parties are referred to the Census Bureau's website ( https://www.census.gov/programs-surveys/geography/guidance/geo-areas/urban-rural.html ) for additional information. Proposed paragraph (a)(6)(ii) would further interpret a remote area to mean an area within a zip-code designated as a frontier and remote area (FAR) code by the Economic Research Service within the United States Department of Agriculture, based on the most recent decennial census and to include all identified FAR code levels. VA would adopt this characterization of a remote area because it does not have a similarly comprehensive characterization of remote areas in statute or regulation. As we are unsure of the level of familiarity with this standard related to a frontier or remote area, as opposed to the characterization of a rural area as proposed above, we provide the following background. The Economic Research Service within the United States Department of Agriculture has developed ZIP-code-level FAR designations, where the phrase frontier and remote is used to describe territory characterized by some combination of low population size and high geographic remoteness. The most updated set of FAR codes is based on urban-rural data from the 2010 decennial census and provides four FAR definition levels, ranging from one that is relatively inclusive (12.2 million FAR level one residents) to one that is more restrictive (2.3 million FAR level four residents). FAR areas are defined in relation to the time it takes to travel by car to the edges of nearby urban areas, and four FAR levels are necessary because rural areas experience degrees of remoteness at higher or lower population levels that affect access to different types of goods and services. For instance, a larger number of people live significant distances from cities providing high order goods and services, such as advanced medical procedures, stores selling major household appliances, regional airport hubs, or professional sports franchises, and level one FAR codes are meant to approximate this degree of remoteness. A smaller number of people have difficulty accessing low order goods and services, such as grocery stores, gas stations, and basic health-care services, and level-four FAR codes more closely coincide with this higher degree of remoteness. Other types of goods and services—clothing stores, car dealerships, movie theaters—fall somewhere in between. We would use all four levels of FAR codes to characterize remote areas for purposes of these proposed rules.

Consistent with 403(a)(4)(G) of the MISSION Act, proposed § 17.246(a)(7) would implement VA's permissive authority, for purposes of resident placements under PPGMER, to evaluate other criteria that VA considers important in determining those covered facilities that are not adequately serving area veterans. Proposed paragraph (a)(7) would include a non-exhaustive list of criteria VA would consider. Proposed § 17.246(a)(7)(i) would establish that VA may evaluate the proximity of a non-VA covered facility to a VA health care facility, such that residents placed in non-VA covered facilities may also receive training in VA health care facilities. This criterion would be useful in assessing to what extent residents placed in non-VA covered facilities could reasonably be expected to travel to also receive resident training in VA health care facilities, consistent with the requirement that the discretionary criteria in section 403(a)(4)(G) of the MISSION Act relate to identifying those covered facilities that may not be adequately serving area veterans. For purposes of assessing the criterion in proposed § 17.246(a)(7)(i), VA would define a VA health care facility to mean any VA location where VA physicians provide care to Veterans, such as a VA medical center, independent outpatient clinic, domiciliary, nursing home (community living center), residential treatment program, and any of a variety of community-based clinics. We note that this definition is broader than the term “VA facility” under proposed § 17.246(a)(4), as proposed § 17.246 would relate to an independent characterization of the term VA facility under section 401 of Public Law 115-182. We also note that proposed § 17.246(a)(7)(i) does not create any requirement for residents placed under the PPGMER to necessarily rotate to VA facilities to receive training, it is merely one additional criterion that VA may assess in accordance with section 403(a)(4)(G) of the MISSION Act. Any requirement for rotation to VA facilities for residents placed under the PPGMER, like other training requirements for such residents, would be controlled by the agreements formed as will be discussed in the section of this rule that addresses proposed § 17.248. Proposed § 17.246(a)(7)(ii) would establish that VA may evaluate programmatic considerations related to establishing or maintaining a sustainable residency program when determining facilities are not adequately serving area veterans, for purposes of placing residents in covered facilities. These programmatic considerations would include but not be limited to whether the stated objectives of a residency program align with VA's workforce needs; the likely or known available educational infrastructure of a new residency program or existing residency program (including the ability to attract and retain qualified teaching faculty); and the ability of the residency program to remain financially sustainable after the cessation of any financial support from VA that may be furnished under proposed § 17.248. These considerations would allow VA to assess the likelihood of a residency program to be successful and sustainable, thus ensuring VA's resources in funding residents would be well placed to support the PPGMER.

Proposed § 17.246(b) would establish that there would be a prioritized placement of residents under the PPGMER to no fewer than 100 residents for the duration in which the PPGMER is administered in covered facilities operated by either the Indian Health Service, an Indian tribe, a tribal organization, or covered facilities located in the same areas as VA facilities designated by VA as underserved pursuant to criteria developed under section 401 of Public Law 115-182. This minimum number of residents to be placed in these specific covered facilities is consistent with the requirement in section 403(a)(5) of the MISSION Act. Proposed § 17.246(b) would further clarify that the placement of these 100 residents would be for the duration in which the PPGMER is administered, because we do not read anything in section 403(a)(5) to require these 100 residents to be the first residents placed under this pilot program. We also interpret section 403(a)(5) of the MISSION Act to require VA to consider priority placement of at least 100 residents and not 100 resident positions, which is consistent with a plain reading of section 403(a)(5). We clarify this point because we would define the term resident to permit multiple residents to occupy a single resident position as appropriate. We note that, generally, residents placed through the PPGMER could be at any point in their residency, and that any such placement at any point in a residency would qualify amongst the 100 priority placements in proposed § 17.246.

We reiterate from earlier in this proposed rule that VA does not interpret that section 403 authorizes a public funding opportunity through which covered facilities or any other entity may apply or submit a proposal to VA, for VA to then consider having residents placed in covered facilities and paying their stipends or benefits, or to reimburse certain costs of new residency programs. The introductory text to proposed § 17.247 would therefore state that section 403 of Public Law 115-182 does not authorize a grant program or cooperative agreement program through which covered facilities or any other entity may apply for residents to be placed in covered facilities or to apply for VA to pay or reimburse costs under § 17.248 (where proposed § 17.248, as discussed later in this rulemaking, would establish VA's payment of resident stipends and benefits, and VA's reimbursement of certain costs of new residency programs). The introductory text to proposed § 17.247 would further establish that VA will therefore not conduct a public solicitation to determine those covered facilities in which residents may be places or to determine costs that may be paid or reimbursed under § 17.248, but that VA would instead make such determinations based on the parameters further established in proposed § 17.247(a) through (c).

Proposed § 17.247(a) would state that VA Central Office will issue a request for proposal (RFP) to VA health care facilities to announce opportunities for residents to be placed in covered facilities and to have costs paid or reimbursed under § 17.248 (as explained later in this rulemaking, proposed § 17.248 will outline the types of costs available to be paid or reimbursed by VA under the PPGMER.) Proposed § 17.247(a) would further state that the RFP issued by VA Central Office would describe, at a minimum: (1) Consideration factors, to include the criteria in § 17.246, that will be used to evaluate any responses to the RFP, as well as the relative importance of such consideration factors; (2) information required to be in any responses to the RFP; and (3) the process to submit a response to the RFP. Under proposed § 17.247(a), the RFP issued by VA Central Office would provide education to VA health care facilities in the evaluation of the factors in proposed § 17.246(a)(1) through (7) to determine clinical need for providers in an area, and the VA health care facilities would then assess covered facilities that may be located in such areas to weigh the factors and determine those covered facilities that meet the criteria under the RFP. We reiterate from earlier in this rulemaking that VA Central Office conducts an RFP process to administer its more general GME programming under section 7302(e), and VA envisions a similar process to be followed under the PPGMER, where VA Central Office notifies VA facilities (directly, or through channels via Veterans Integrated Service Networks) of a forthcoming RFP cycle for the funding of residents or certain resident program costs. The RFP in turn would provide VA health care facilities with all required information to complete a response, including a clear statement of the consideration factors and submission instructions to include any submission dates as applicable and points of contact for questions. The RFP will additionally provide a general timeline in which VA health care facilities will conduct the process of assessing the consideration factors and reaching out to covered facilities regarding the RFP. The consideration factors in the RFP for the PPGMER would include those consideration factors expressly stated in section 403(a)(4) and in proposed § 17.246, and the relative importance of such factors ( e.g., whether they may be weighted differently). We reiterate from earlier in the preamble that the consideration factors in proposed § 17.246 would not be weighted in the regulatory text itself to allow VA the flexibility to consider the relative importance of factors over the duration of the pilot, as the relative importance of those factors may change. For instance, an RFP issued by VA Central Office for the PPGMER could indicate that there would be more weight assigned to areas that issued responses with covered facilities operated by Indian Health Service, an Indian tribe, a tribal organization, or covered facilities located in the same areas as VA facilities designated by VA as underserved, as these are deemed priority placement factors for the PPGMER in section 403(a)(5). Alternatively, an RFP issued by VA Central Office for the PPGMER could indicate that there would be more weight assigned depending on the specialty of a provider included in the most recent staffing shortage determination by VA under 38 U.S.C. 7412.

Proposed § 17.247(b) would then establish that VA health care facilities, in collaboration with covered facilities, will submit responses to the RFP to VA Central Office. This language would permit only VA health care facilities to submit responses to the RFP issued by VA Central Office, to further reinforce VA's interpretation that section 403 does not authorize a public funding opportunity for which covered facilities may apply directly or submit a proposal to be considered. VA health care facilities would assess covered facilities in their areas that participate with institutions that sponsor medical educational programs (most often a medical school or teaching hospital), where typically VA already has academic partnerships with such sponsoring institutions and the RFP details the involvement of any particular sponsoring institution. However, VA would not be prevented in these proposed regulations from assessing covered facilities that did not have educational relationships with sponsoring institutions, and covered facilities would not be prevented from initiating contact with a VA facility to determine if such covered facilities may meet the requirements to participate in the PPGMER as detailed in the RFP. We reiterate that the RFP will provide a general timeline in which VA health care facilities will conduct the process of assessing the consideration factors and reaching out to covered facilities regarding the RFP.

Proposed § 17.247(c) would then state that VA Central Office will evaluate responses to the RFP from VA health care facilities and will determine those covered facilities where residents may be placed and costs under § 17.248 are paid or reimbursed. In its evaluation, VA Central Office will assess the consideration factors established in the RFP to include the criteria in § 17.246, and will weigh those factors as their relative importance would be established in the RFP.

Proposed § 17.248 would establish the types of costs that VA may fund under the PPGMER to place residents in covered facilities or to reimburse certain costs incurred by new residency programs in accordance with sections 403(a)(6) and (b)(1)-(b)(5) of the MISSION Act. Section 403(a)(6) authorizes VA to pay stipends and provide benefits for residents in positions created under section 403(a)(1), and section 403(b) authorizes VA to reimburse certain new residency program costs if VA places a resident in such a program.

To address a few preliminary matters, we note that section 403(a)(6) is a discretionary authority to pay stipends and benefits of residents, regardless of whether they have been assigned to a VA facility, and that VA would retain this discretion in proposed § 17.248 to include establishing any general restrictions or conditions for such payments. We further interpret the discretionary nature of section 403(a)(6) to authorize VA's funding of resident stipends and benefits either through a direct payment or reimbursement mechanism, in accordance with any contract, agreement, or other arrangement VA has legal authority to form (possibly, to include payment mechanisms as applicable that VA currently uses to administer its more general GME programming under 38 U.S.C. 7302(e)). Conversely, we interpret section 403(b) as a mandatory authority to reimburse certain new resident program costs if VA places a resident in such programs, and further that subsections (b)(1)-(b)(5) establish the mandatory costs that must be reimbursed. However, we do not interpret that section 403(b) limits VA's authority to determine restrictions or criteria for such reimbursement. Lastly, consistent with section 403(a)(3), and other authorities under which VA may legally enter into contracts, agreements, or other arrangements, VA would enter into such contracts, agreements, or other arrangements to administer the PPGMER. It would be those contracts, agreements, or other arrangements that would establish the terms to control costs that could be funded.

The introductory text of proposed § 17.248 would establish that once VA determines in which covered facilities residents will be placed, in accordance with §§ 17.246 through 17.247, payment or reimbursement of certain costs would be authorized. Proposed § 17.248(a) would establish the first category of funding available under the PPGMER, related to resident stipends and benefits, consistent with section 403(a)(6). Proposed § 17.248(a) would establish that, for residents placed in covered facilities by VA, VA may pay only the proportionate cost of resident stipends and benefits that are associated with residents participating in educational activities directly related to the PPGMER. This language is intended to limit payments of stipend and benefits to only those educational activities that support the PPGMER, to prevent VA's payment for educational activities a resident may complete when they may engage in duties or responsibilities associated with portions of their training not associated with the PPGMER (such as when a resident may have portions of their training paid for by other entities not engaged with the PPGMER). We clarify that educational activities directly related to the PPGMER could be associated with the treatment of non-veteran patients, as section 403(a)(6) of the MISSION Act clearly permits VA to pay stipends and benefits for residents outside of VA facilities, and section 403(b) permits VA to reimburse certain costs associated with new residency programs established in covered facilities, which includes non-VA facilities. More generally, a primary purpose of VA's administration of GME programming under 38 U.S.C. 7302(e), and under section 403 of the MISSION Act by extension, is to fulfill one of VA's missions under 38 U.S.C. 7302 to assist in providing an adequate supply of health personnel to the United States. We reiterate from the discussion of proposed § 17.246(a)(7)(i) that this rule would not create any requirement for residents placed under the PPGMER to necessarily rotate to VA health care facilities to receive training, and any such requirement (as with other training requirements for PPGMER residents) would be controlled by the agreements formed as discussed further in this section of the rule related to proposed § 17.248. Proposed § 17.248(a) would further state that VA's payment of stipends and benefits would be in accordance with any contract, agreement, or other arrangement VA has legal authority to form. In addition, such stipends and benefits will not exceed VA's established maximum amounts for payments under any existing GME agreements. This language intends to establish that any criteria or restrictions related to VA's payment of stipends and benefits would be clearly indicated in contracts, agreements, or other arrangements outside of the proposed rule. This language would allow VA the flexibility to establish payment parameters as would be relevant to a covered facility, within the appropriate purchasing or other mechanisms that VA may legally use, to include an agreement permitted under section 403(a)(3) of Public Law 115-182. We note that VA would be bound by any legal requirements as they exist outside of this proposed rule with regards to these other authorities to enter into contracts, agreements, or other arrangements. Proposed § 17.248(a) would not state or reference these other authorities, or the resulting payment instruments, however, to provide VA and covered facilities the flexibility that would be needed to properly implement the payment of resident stipends and benefits.

Proposed § 17.248(b) would establish that VA may reimburse certain costs associated with new residency programs, consistent with section 403(b)(1)-(5) of the MISSION Act. Consistent with section 403(b), proposed § 17.248(b)(1) would establish that if a covered facility establishes a new residency program in which VA places a resident, VA will reimburse certain costs as further detailed in proposed § 17.248(b)(1)(i) through (v), where the following costs in proposed paragraphs (b)(1)(i) through (v) mirror the types of costs established in sections 403(b)(1)-(5), which are: Curriculum development costs; recruitment and retention of faculty costs; accreditation costs; faculty salary costs; and resident education expense costs. Each of the types of costs established in proposed § 17.248(b)(1)(i) through (v) would be further characterized by the following non-exhaustive examples: (1) Curriculum development costs would include but not be limited to costs associated with needs analysis, didactic activities, materials, equipment, consultant fees, and instructional design; (2) recruitment and retention of faculty costs would include but not be limited to costs associated with advertising available faculty positions, and monetary incentives to fill such positions such as relocation costs and educational loan repayment; (3) accreditation costs would include but not be limited to the administrative fees incurred by a covered facility in association with applying for only initial accreditation of the program by the Accreditation Council for Graduate Medical Education; (4) faculty salary costs would include only the proportionate cost of faculty performing duties directly related to the PPGMER; and (5) resident education expense costs, to include but not be limited to costs associated with the required purchase of medical equipment and required training, national resident match program participation fees, and residency program management software fees. We further note that faculty salary costs in proposed § 17.248(b)(1)(iv) would have a similar qualifying restriction as with resident stipends and benefits in proposed § 17.248(a), where faculty salary costs would be limited to only the proportionate cost of faculty performing duties directly related to the PPGMER. This restriction would provide an express notice that VA would not, for instance, reimburse costs for any portion of salary of an attending physician that correlates with supervising residents that were not participating in the PPGMER, as it may be the case that a group of residents being supervised by an attending physician is not fully comprised of PPGMER participants. Similar to proposed § 17.248(a), proposed § 17.248(b) would further state that VA's reimbursement of certain costs associated with a new residency program would be in accordance with any contract, agreement, or other arrangement VA has legal authority to form, and that reimbursements for authorized costs may not exceed VA's established maximum amounts for payment under any existing GME agreements. This language intends to establish that any criteria or restrictions related to VA's reimbursement of these costs would be clearly indicated in contracts, agreements, or other arrangements outside of the proposed rule, again to allow the flexibility to establish parameters as would be relevant and within the appropriate purchasing or reimbursement mechanisms that VA may legally use. We note that VA would be bound by any legal requirements as exist outside of this proposed rule with regards to these other authorities to enter into contracts, agreements, or other arrangements, but that proposed § 17.248(b) would not state or reference these other authorities, again to provide VA and covered facilities the flexibility that would be needed to properly implement the reimbursement of these costs.

Although proposed § 17.248(a) and (b) would not state any express criteria or restrictions that might exist in contracts, agreements, or other arrangements that would control the payment of resident stipends or benefits or reimbursement of certain new residency program costs, some examples of such criteria or restrictions could include: Establishing a discontinuation date for payments or reimbursements; establishing limitations on payments proportionate to the number of residents placed by VA; establishing any fixed dollar amount limits as found relevant or appropriate; or establishing a restricted look-back period, whereby VA would not reimburse the costs of, for instance, certain curriculum development costs that might occur prior to a specified timeframe before VA places a resident. Similarly, proposed § 17.248(a) and (b) would not expressly list the legal authorities or types of contracts, agreements, or other arrangements under which VA may pay resident stipends or benefits, or reimburse certain costs of new residency programs, or more generally to administer other typical aspects of GME programming through the PPGMER. Again, this lack of specificity with regards to identifying specific legal instruments in regulation would allow VA maximum flexibility to administer the PPGMER. However, we reiterate from earlier in this rulemaking that VA would otherwise be bound by any legal requirements as exist outside of this proposed rule with regards to these other authorities to enter into contracts, agreements, or other arrangements. We also reiterate from earlier in this rulemaking that VA would seek to administer the PPGMER in much the same manner as VA's more general GME programming is administered under 38 U.S.C. 7302(e), as would be applicable and permissible, which would likely include the forming of certain agreements between VA and sponsoring institutions to establish responsibilities for educating residents and to control VA's funding of residents and certain costs of new residency programs, or the evidence that such agreements were formed between sponsoring institutions and non-VA covered facilities. We therefore provide the following examples of types of agreements VA uses to administer its more general GME programming under section 7302(e), to provide some idea of whether the same or similar instruments might also be used to administer the PPGMER. Under VA's more general GME programming pursuant to 38 U.S.C. 7302(e), VA uses an affiliation agreement to delineate the duties and responsibilities regarding the training of residents, where an affiliation agreement is a central part of the relationship between VA and the affiliated institution and may involve specific provisions related to patient care, education, or research. Affiliated institutions can include academic institutions and other sponsoring institutions such as community hospitals, clinics, state agencies military treatment facilities, or Federal Health Education Consortia. VA would look to an affiliation agreement or similar instrument to form similar relationships with entities to administer the PPGMER. We note that VA policy currently recognizes sponsoring institutions and other entities as able to enter into an affiliation agreement prior to a subject residency program receiving comprehensive or full accreditation, such as an institution whose residency program may have some stage of Accreditation Council for Graduate Medical Education (ACGME) initial or provisional accreditation. See VHA Handbook 1400.03, Veterans Health Administration Educational Relationships. Under the PPGMER, we would retain VA's ability to enter into affiliation agreements or similar instruments or look to the formation of such instruments between sponsoring institutions and non-VA covered facilities, where the subject residency programs may have some form of initial or provisional ACGME accreditation.

Under VA's more general GME programming pursuant to 38 U.S.C. 7302(e), a disbursement agreement is used to administer stipend and benefits payments to residents in VA facilities. A disbursement agreement is an agreement through which VA allows a disbursing agent to administer salary payments and fringe benefits for medical residents assigned to a VA facility, where the disbursing agent may be the sponsoring institution for the residency training program itself or an entity delegated by the sponsoring institution(s) to handle stipend and benefit disbursements ( e.g., a graduate medical education consortium). VA may look to a similar instrument to administer stipend and benefits payments for residents it places in non-VA facilities under the PPGMER, or any other contract, agreement, or other arrangement VA may enter into as permissible and applicable.

Under VA's more general GME programming pursuant to 38 U.S.C. 7302(e), VA uses educational cost contracts to pay pro-rated educational costs of the affiliated institutions sponsoring residency programs. These educational cost contracts are entered into pursuant to 38 U.S.C. 8153, where the relevant health care resource being purchased includes health care support resources and administrative resources to include the operation of a residency program. The pro-rated educational costs to be covered are set forth in an educational cost contract in proportion to the number of residents that actually rotate to a VA facility. VA may look to a similar instrument to administer payments of costs associated with the PPGMER, or any other contract, agreement, or other arrangement VA may enter into as permissible and applicable.

VA also generally uses memoranda of agreement or understanding (MOA or MOU) as legally permissible to enter into agreements with entities and may look to such instruments to administer payments of costs associated with the PPGMER or to administer other aspects of the PPGMER. For instance, a MOA or MOU might be used to clearly indicate to a covered facility the extent of reimbursable costs allowable under proposed § 17.248(b), and could also include instructions for submitting to VA invoices of such costs and timeframes and modes of reimbursement.

Proposed § 17.248(b)(2) would lastly establish that VA considers new residency programs as only those residency programs that have initial ACGME accreditation or have continued ACGME accreditation without outcomes, and have not graduated an inaugural class, at the time VA has determined those covered facilities where residents will be placed under § 17.247(c). We believe the ACGME status of initial accreditation or continued ACGME accreditation without outcomes captures those residency programs still in development and that would benefit from VA's reimbursement of certain start-up costs in establishing a residency program. The additional criterion that such programs must not have graduated an inaugural class further supports that VA funding will not go to residency programs that otherwise have fully functioning curriculums and infrastructure to produce graduates. The ACGME status of initial accreditation is considered a developmental stage where residency programs can accept residents, and this status allows for site visits to determine compliance with relevant ACGME standards. As background, when a status of initial accreditation is conferred on a sponsoring institution or program, that institution or program will have a full site visit within two years of the effective date of initial accreditation, where the effective date is the date of the decision by the ACGME review committee (or, any effective date such committee may apply retroactively to the beginning of the academic year). If a residency program does not matriculate residents in the first academic year after receiving a status of initial accreditation, a site visit is conducted within three years from the effective date of such accreditation. If a sponsoring institution or program demonstrates substantial compliance at the subsequent review, the ACGME review committee may confer a status of continued accreditation or continued accreditation without outcomes. Proposed § 17.248(b)(2) would only include the ACGME status of continued accreditation without outcomes, beyond the initial accreditation stage, because continued accreditation without outcomes indicates that no residents have graduated, which in turn may indicate that the residency program still requires VA funding of certain costs to fully develop its curriculum and infrastructure.

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. The Office of Information and Regulatory Affairs has determined that this rule is a significant regulatory action under Executive Order 12866. The Regulatory Impact Analysis associated with this rulemaking can be found as a supporting document at www.regulations.gov.

We have analyzed this proposed rule in accordance with the principles set forth in Executive Order 13175. We have tentatively determined that the rule does not contain policies that would have a substantial direct effect on one or more Indian Tribes, on the relationship between the Federal Government and Indian Tribes, or on the distribution of power and responsibilities between the Federal Government and Indian Tribes. The Agency solicits comments from tribal officials on any potential impact on Indian Tribes from this proposed action.

The Secretary hereby certifies that this rulemaking would 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. The residents to be placed for training in covered facilities and to have certain stipend and benefits costs paid for by VA are individuals and not small entities. To the extent that any covered facilities are small entities, there is no significant economic impact because the rulemaking would only permit VA's reimbursement and not payment of certain costs associated with certain start up costs associated with new residency programs, there is no funding opportunity for which covered facilities may apply to be considered and otherwise no economic gain or loss for covered facilities associated with this rule. 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.

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 proposed rule would have no such effect on State, local, and tribal governments, or on the private sector.

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 Office of Management and Budget (OMB) control number. This proposed rule contains no provisions constituting a collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521).

The Assistance Listing program numbers and titles for the programs affected by this document are 64.011—Veterans Dental Care; 64.026—Veterans State Adult Day Health Care; 64.040—VHA Inpatient Medicine; 64.041—VHA Outpatient Specialty Care; 64.042—VHA Inpatient Surgery; 64.043—VHA Mental Health Residential; 64.045—VHA Outpatient Ancillary Services; 64.046—VHA Inpatient Psychiatry; 64.047—VHA Primary Care; 64.048—VHA Mental Health clinics; 64.050—VHA Diagnostic Care; 64.054—Research and Development.

Denis McDonough, Secretary of Veterans Affairs, approved this document on October 8, 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.

For the reasons stated in the preamble, the Department of Veterans Affairs proposes to amend 38 CFR part 17 as follows:

Participation in virtual public hearing. Please note that because of the current Centers for Disease Control and Prevention (CDC) recommendations, as well as state and local orders for social distancing to limit the spread of COVID-19, the EPA cannot hold in-person public meetings at this time.

If requested, the virtual hearing will be held on February 22, 2022. The hearing will convene at 11:00 a.m. Eastern Time (ET) and will conclude at 7:00 p.m. ET. The EPA may close a session 15 minutes after the last pre-registered speaker has testified if there are no additional speakers. The EPA will announce further details at https://www.epa.gov/stationary-sources-air-pollution/miscellaneous-organic-chemical-manufacturing-national-emission.

The EPA will begin pre-registering speakers for the hearing upon publication of this document in the Federal Register . To register to speak at the virtual hearing, please use the online registration form available at https://www.epa.gov/stationary-sources-air-pollution/miscellaneous-organic-chemical-manufacturing-national-emission or contact the public hearing team at (888) 372-8699 or by email at SPPDpublichearing@epa.gov. The last day to pre-register to speak at the hearing will be February 16, 2022. Prior to the hearing, the EPA will post a general agenda that will list pre-registered speakers in approximate order at: https://www.epa.gov/stationary-sources-air-pollution/miscellaneous-organic-chemical-manufacturing-national-emission.

The EPA will make every effort to follow the schedule as closely as possible on the day of the hearing, if requested, however, please plan for the hearings to run either ahead of schedule or behind schedule.

If a hearing is requested, each commenter will have 5 minutes to provide oral testimony. The EPA encourages commenters to provide the EPA with a copy of their oral testimony electronically (via email) by emailing it to lavoie.tegan@epa.gov. The EPA also recommends submitting the text of your oral testimony as written comments to the rulemaking docket.

The EPA may ask clarifying questions during the oral presentations but will not respond to the presentations at that time. Written statements and supporting information submitted during the comment period will be considered with the same weight as oral testimony and supporting information presented at the public hearing.

Please note that any updates made to any aspect of the hearing, if requested, will be posted online at https://www.epa.gov/stationary-sources-air-pollution/miscellaneous-organic-chemical-manufacturing-national-emission. While the EPA expects the hearing, if requested, to go forward as set forth above, please monitor our website to determine if there are any updates. The EPA does not intend to publish a document in the Federal Register announcing updates.

If you require the services of a translator or special accommodation such as audio description, please pre-register for the hearing with the public hearing team and describe your needs by February 11, 2022. The EPA may not be able to arrange accommodations without advanced notice.

Docket. The EPA has established a docket for this rulemaking under Docket ID No. EPA-HQ-OAR-2018-0746. All documents in the docket are listed in https://www.regulations.gov/. Although listed, some information is not publicly available, e.g., Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the internet and will be publicly available only in hard copy. With the exception of such material, publicly available docket materials are available electronically in Regulations.gov.

Instructions. Direct your comments to Docket ID No. EPA-HQ-OAR-2018- 0746. The EPA's policy is that all comments received will be included in the public docket without change and may be made available online at https://www.regulations.gov/, including any personal information provided, unless the comment includes information claimed to be CBI or other information whose disclosure is restricted by statute. Do not submit electronically any information that you consider to be CBI or other information whose disclosure is restricted by statute. This type of information should be submitted by mail as discussed below.

The EPA may publish any comment received to its public docket. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. The EPA will generally not consider comments or comment contents located outside of the primary submission ( i.e., on the Web, cloud, or other file sharing system). For additional submission methods, the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets.

The https://www.regulations.gov/ website allows you to submit your comment anonymously, which means the EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an email comment directly to the EPA without going through https://www.regulations.gov/, 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. If you submit an electronic comment, the EPA recommends that you include your name and other contact information in the body of your comment and with any digital storage media you submit. If the EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, the EPA may not be able to consider your comment. Electronic files should not include special characters or any form of encryption and be free of any defects or viruses. For additional information about the EPA's public docket, visit the EPA Docket Center homepage at https://www.epa.gov/dockets.

Due to public health concerns related to COVID-19, the Docket Center and Reading Room are open to the public by appointment only. Our Docket Center staff also continues to provide remote customer service via email, phone, and webform. Hand deliveries or couriers will be received by scheduled appointment only. For further information and updates on EPA Docket Center services, please visit us online at https://www.epa.gov/dockets.

The EPA continues to carefully and continuously monitor information from the CDC, local area health departments, and our Federal partners so that we can respond rapidly as conditions change regarding COVID-19.

Submitting CBI. Do not submit information containing CBI to the EPA through https://www.regulations.gov/ or email. Clearly mark the part or all of the information that you claim to be CBI. For CBI information on any digital storage media that you mail to the EPA, mark the outside of the digital storage media as CBI and then identify electronically within the digital storage media the specific information that is claimed as CBI. In addition to one complete version of the comments that includes information claimed as CBI, you must submit a copy of the comments that does not contain the information claimed as CBI directly to the public docket through the procedures outlined in Instructions above. If you submit any digital storage media that does not contain CBI, mark the outside of the digital storage media clearly that it does not contain CBI. Information not marked as CBI will be included in the public docket and the EPA's electronic public docket without prior notice. Information marked as CBI will not be disclosed except in accordance with procedures set forth in 40 Code of Federal Regulations (CFR) part 2. Send or deliver information identified as CBI only to the following address: OAQPS Document Control Officer (C404-02), OAQPS, U.S. Environmental Protection Agency, Research Triangle Park, North Carolina 27711, Attention Docket ID No. EPA-HQ-OAR-2018-0746. Note that written comments containing CBI and submitted by mail may be delayed and no hand deliveries will be accepted.

Preamble acronyms and abbreviations. Throughout this document wherever “we,” “us,” or “our” is used, it is intended to refer to the EPA. We use multiple acronyms and terms in this preamble. While this list may not be exhaustive, to ease the reading of this preamble and for reference purposes, the EPA defines the following terms and acronyms here:

Organization of this document. The information in this preamble is organized as follows:

The statutory authority for this action is provided by sections 112 and 307(d)(7)(B) of the Clean Air Act (CAA) (42 U.S.C. 7412 and 7607(d)(7)(B)).

Regulated entities. Categories and entities potentially regulated by this action are shown in Table 1 of this preamble.

Table 1 of this preamble is not intended to be exhaustive, but rather provides a guide for readers regarding the entities that this proposed action is likely to affect. To determine whether your facility is affected, you should examine the applicability criteria in the appropriate NESHAP. If you have any questions regarding the applicability of any aspect of these NESHAP, please contact the person listed in the preceding FOR FURTHER INFORMATION CONTACT section of this preamble.

In addition to being available in the docket, an electronic copy of this action is available on the internet. Following signature by the EPA Administrator, the EPA will post a copy of this proposed action at https://www.epa.gov/stationary-sources-air-pollution/miscellaneous-organic-chemical-manufacturing-national-emission. Following publication in the Federal Register , the EPA will post the Federal Register version of the proposal at this same website.

On December 17, 2019, the EPA published a proposed rule in the Federal Register addressing the risk and technology review (RTR) for the Miscellaneous Organic Chemical Manufacturing NESHAP (MON), 40 CFR part 63, subpart FFFF (84 FR 69182). On August 12, 2020, after receiving and addressing public comments, the EPA finalized determinations pursuant to CAA sections 112(d)(6) and (f)(2) for the Miscellaneous Organic Chemical Manufacturing source category and amended the rule based on those determinations (85 FR 49084). The August 2020 final action, herein referred to as the “2020 MON final rule,” included amendments pursuant to the technology review for equipment leaks and heat exchange systems, and also amendments pursuant to the risk review to specifically address ethylene oxide emissions from storage tanks, process vents, and equipment leaks. In addition, the 2020 MON final rule corrected and clarified regulatory provisions related to emissions during periods of startup, shutdown, and malfunction (SSM), including removing general exemptions for periods of SSM, adding work practice standards for periods of SSM where appropriate, and clarifying regulatory provisions for certain vent control bypasses. The final action also added monitoring and operational requirements for flares that control ethylene oxide emissions and flares used to control emissions from processes that produce olefins and polyolefins, added provisions for electronic reporting of performance test results and other reports, and included other technical corrections to improve consistency and clarity.

In the 2020 MON final rule's risk assessment, 1 we calculated cancer risks using the EPA's IRIS inhalation unit risk estimate (URE) for ethylene oxide, 2 and the risk review included a determination that the risks for this source category under the current Maximum Achievable Control Technology (MACT) provisions were unacceptable due to ethylene oxide emissions. When risks are unacceptable, the EPA must determine the emissions standards necessary to reduce risk to an acceptable level. As such, the EPA promulgated final amendments to the MON pursuant to CAA section 112(f)(2) that require control of ethylene oxide emissions for process vents, storage tanks, and equipment in ethylene oxide service. The 2020 MON final rule reduced risks to an acceptable level that also provides an ample margin of safety to protect public health. The final rule preamble stated that “the EPA remains open to new and updated scientific information,” and new dose-response values, such as those then being developed by the TCEQ (85 FR 49098). However, by the close of the public comment period for the proposed rulemaking (March 19, 2020), the TCEQ dose-response value had not yet been finalized and could not be considered in the final action.

Following promulgation of the 2020 MON final rule, the EPA received five separate petitions for reconsideration from four petitioners. The EPA received two petitions from the American Chemistry Council (ACC) (one petition dated October 2020, one dated December 2020), one from the TCEQ (dated October 2020), one from Squire Patton Boggs (US) LLP (submitted on behalf of Huntsman Petrochemical, LLC) (dated October 2020), and one from Earthjustice (submitted on behalf of RISE St. James, Louisiana Bucket Brigade, Louisiana Environmental Action Network, Texas Environmental Justice Advocacy Services (t.e.j.a.s.), Air Alliance Houston, Ohio Valley Environmental Coalition, Blue Ridge Environmental Defense League, Inc., Environmental Justice Health Alliance for Chemical Policy Reform, Sierra Club, Environmental Integrity Project, and Union of Concerned Scientists) (dated October 2020). Copies of the petitions are available in the docket for this rulemaking (see Docket ID No. EPA-HQ-OAR-2018-0746).

Three petitioners (ACC, TCEQ, Huntsman Petrochemical, LLC) requested the EPA reconsider the rule to reassess the risk assessment for the 2020 MON final rule using the TCEQ's alternative risk value for ethylene oxide instead of the EPA's 2016 IRIS value for ethylene oxide. These three petitioners further argued that the EPA's 2016 IRIS value for ethylene oxide is flawed, citing disagreement with the 2016 IRIS assessment's model selection and inclusion of breast cancer data. In their October 2020 petition, ACC argued that “CAA Section 307(d)(7)(B) requires EPA to convene a reconsideration proceeding where (1) it was either impractical to raise an objection during the comment period or new information becomes available after the close of the comment period; and (2) such information is of central relevance to the outcome of the rule.” Earthjustice did not raise a similar issue in their petition. Two petitioners (ACC and Earthjustice) raised other issues unrelated to the use of the IRIS value or TCEQ value for assessing risk from ethylene oxide emissions (see Docket ID No. EPA-HQ-OAR-2018-0746).

On June 22, 2021, the EPA sent letters to all the petitioners informing them that: (1) The EPA was granting reconsideration requests on two specific issues (described later in this section), (2) the EPA intended to issue a Federal Register document initiating a notice and comment rulemaking on the issues for which the Agency granted reconsideration, and (3) the EPA was continuing to review the other issues in the petitions for reconsideration and may choose to initiate reconsideration of additional issues in the future. Copies of the letters to petitioners are available in the docket for this rulemaking (see Docket ID No. EPA-HQ-OAR-2018-0746).

Pursuant to CAA section 307(d)(7)(B), the Agency granted reconsideration of the following aspects of the 2020 MON final rule: (1) The use of the EPA's IRIS value for ethylene oxide in assessing cancer risk for the source category, and (2) the use of the TCEQ risk value for ethylene oxide as an alternative risk value to the EPA's IRIS value for purposes of evaluating risk under CAA section 112(f)(2). Reconsideration was granted on these two topics on the following bases: The TCEQ risk value for ethylene oxide was finalized after the comment period for the proposed MON rulemaking closed, and the 2020 MON final rule preamble stated that the EPA remains open to new and updated scientific information, such as the TCEQ value; and because the risk posed by ethylene oxide is of central relevance to the EPA's determination that the risks from sources in the Miscellaneous Organic Chemical Manufacturing source category remaining after imposition of the then-current CAA section 112(d)(2) MACT standards were unacceptable and that more stringent standards are required. Because the criteria for mandatory reconsideration under CAA section 307(d)(7)(B) have been satisfied, the Agency is publishing this proposed reconsideration action in the Federal Register and requesting public comment on the issues discussed in this action. The EPA is seeking comment only on the issues subject to mandatory reconsideration and discussed in this proposed rule. The Agency will not respond to any comments addressing other issues raised by petitioners related to the 2020 MON final rule, or the EPA's December 13, 2021 response  3 to the Request for Correction (RFC)  4 of the IRIS value for ethylene oxide that was submitted to the EPA by petitioner ACC under the Information Quality Act, Public Law 106-554 (IQA). As discussed in section III.B of this preamble, the ACC requested correction of the ethylene oxide information in the EPA's most recent update to the National Air Toxics Assessment (NATA) released on August 22, 2018. In the EPA's response to the RFC, the EPA found that the RFC did not identify a need for correction in the 2016 ethylene oxide IRIS Assessment and determined that the inhalation URE derived in the 2016 ethylene oxide IRIS Assessment was the appropriate human health value to use for ethylene oxide in the 2014 NATA. The EPA's response to the RFC noted that the EPA's use of the IRIS value in CAA rulemakings would be addressed in the reconsideration of the 2020 MON final rule, and that the review would include consideration of additional information presented in comments on the 2020 MON rule that were not included in the 2018 RFC and addressed in the EPA's response to the RFC. As such, we are not reconsidering comments on the EPA's reliance upon the National Institute for Occupational Safety and Health (NIOSH) worker exposure studies, selection of dose-response models, and consideration of endogenous sources ( i.e., what the body produces) of ethylene oxide that were previously addressed in the response to ACC's RFC.

The EPA is proposing to take comment on the two selected issues raised in the petitions for reconsideration as described in sections III.A. and III.B. below.

The EPA's IRIS program was created to provide an internal Agency database of human health effects that may result from chronic exposure to chemicals found in the environment to which the public might be exposed. The IRIS database is intended to be used by the EPA's program and regional offices in risk assessments to inform decision making. 5 The development of IRIS values includes a robust peer-review, beginning with internal reviews to reach consensus within the Agency on the scientific positions, followed by external federal agency review, an opportunity for public review and comment, and an independent, external peer-review by the EPA's Science Advisory Board (SAB). 6 During this process, the EPA considers and responds to comments received from the public and the SAB, and revises the assessment to ensure that the best available science is represented.

During development of the 2020 MON final rule, the EPA used the 2016 IRIS cancer risk value for ethylene oxide  7 in the risk review. The EPA received and responded to numerous public comments on the use of the IRIS value in the 2020 MON final rule. A summary of these comments and responses is available in the preamble of the 2020 MON final rule (85 FR 49084; August 12, 2020) and also in the “Summary of Public Comments and Responses for the Risk and Technology Review for Miscellaneous Organic Chemical Manufacturing” document in the docket for this rulemaking. 8

For CAA section 112(f)(2) risk reviews, the EPA performs health risk assessments for the hazardous air pollutants (HAP) that are emitted from the source category after imposition of MACT standards under CAA section 112(d)(2). Consistent with the purpose of the IRIS database for use by the EPA's program and regional offices in risk assessments and the advice from the SAB, the “Residual Risk Assessment for the Miscellaneous Organic Chemical Manufacturing Source Category in Support of the 2020 Risk and Technology Review: Final Rule” in the docket for this rulemaking  9 described that the preferred source of chronic dose-response data is the IRIS database. If the EPA's IRIS program does not have an up-to-date hazard and/or dose-response assessment for a HAP, the EPA considers publicly available assessments that have been developed by other government agencies in a manner that is conceptually similar to the EPA's approach. This includes consistency with the EPA's risk assessment guidelines, incorporation of an independent external peer review, inclusion of a public review period, and use of the best available science with respect to dose-response information.

Application of this approach generally results in the following priority order for sources of risk values such as an inhalation URE: (1) U.S. EPA IRIS, (2) Agency for Toxic Substances and Disease Registry (ATSDR), (3) California EPA, and (4) other sources. Documentation of this approach, as applied in the CAA section 112(f)(2) reviews, is in the EPA report titled “Risk and Technology (RTR) Risk Assessment Methodologies: For Review by the EPA's Science Advisory Board: Case Studies—MACT I Petroleum Refining Sources and Portland Cement Manufacturing”. 10 This approach is also documented in the risk assessment technical support document for each RTR NESHAP rulemaking and is included in the rulemaking docket for this action. 11 12

This approach was presented to the SAB in 2009. In a May 7, 2010, memo  13 to the EPA Administrator regarding review of the EPA's RTR assessment methodologies, the SAB panel supported the EPA's approach to selecting dose-response chronic toxicity values. In the same memo, they also noted that: “The preferred database for chronic dose-response data is and should be the IRIS database. However, some chemicals of interest do not have IRIS values, and values for other chemicals have not been reviewed recently. The Panel urges the Agency to address these gaps and provide the resources necessary to maintain the updating process. Additional sources of data may also be considered if they have undergone adequate and rigorous scientific peer review.” Id. at 5.

In the 2020 MON final rule, the EPA followed this documented approach in selecting the 2016 EPA IRIS value for ethylene oxide for use in the risk review. We have carefully reviewed the three petitioners' comments that the 2016 IRIS value for ethylene oxide should not have been used, but after careful consideration of the issues raised, we have determined that these petitioners have not identified a basis for changing our approach to the risk assessment in the 2020 MON final rule. The substantive arguments raised by these petitioners regarding the 2016 IRIS value have been addressed in the EPA's response to the RFC, in the 2020 MON final rule's preamble (85 FR 49084; August 12, 2020), and in the response to comment document  14 for the 2020 MON final rule; beyond these alleged flaws in the 2016 IRIS value, these petitioners have presented no new arguments for why the EPA should not follow the documented approach for selecting risk values. The EPA proposes to not change its decision to use the IRIS inhalation URE for ethylene oxide in the 2020 MON final rule. Consequently, the EPA is proposing no changes to our risk assessment for the 2020 MON final rule.

During development of the 2020 MON final rule, the EPA received and responded to numerous public comments related to the use of the TCEQ's risk value for ethylene oxide as an alternative to the EPA's IRIS value in the 2020 MON risk assessment. TCEQ submitted its draft Development Support Document (DSD), which included the dose-response analysis underlying TCEQ's draft cancer risk value, as a comment during the 2020 MON rulemaking's comment period. Because the TCEQ risk value was not final until after the close of the comment period, the EPA did not directly assess the draft DSD from TCEQ in our final rule; however, the EPA received and addressed public comments from other groups ( e.g., ACC) that included the same analytical approaches utilized by TCEQ. A summary of these comments and responses is available in the 2020 MON final rule's preamble (85 FR 49084; August 12, 2020) and in the response to comment document  15 for the 2020 MON final rule. In this action, the EPA reaffirms those responses in support of its decision to use the IRIS inhalation URE in the 2020 MON final rule.

As part of this proposed reconsideration of the 2020 MON final rule, the EPA reviewed the final TCEQ ethylene oxide DSD, which TCEQ referenced in its petition for reconsideration, including the assertion that the final DSD contained “additional scientific analyses”. Based on this review, we have determined that TCEQ did not submit new data for the EPA's consideration that would cause us to use the final TCEQ cancer risk value instead of the IRIS cancer risk value for the MON risk review. Rather, TCEQ has pursued a different approach to analyzing the same NIOSH occupational exposure dataset that is the basis of the 2016 IRIS cancer risk value.

By using this approach, TCEQ estimated a risk value for ethylene oxide that is 2000-fold lower than that of the IRIS risk value. 16 TCEQ's analytical approach ( i.e., modeling mortality using a Cox proportional hazards model) closely mirrors the approach by Valdez-Flores (2010)  17 previously presented by other public commenters in the 2020 MON final rule, and which the EPA addressed in both its response to comments document  18 and its December 13, 2021 response  19 to the ACC's 2018 RFC regarding the EPA's use of the IRIS value for ethylene oxide. In addition to pursuing an analytical approach similar to that used by Valdez-Flores (2010), TCEQ went a step further and excluded women from their analysis. This exclusion included all lymphoid cancers in women, as well as the exclusion of breast cancer as an endpoint. Although modeling cancer mortality (instead of cancer incidence, which the EPA modeled) and excluding women from the lymphoid cancer analysis impacted the final URE value, the 2000-fold difference in the IRIS versus TCEQ risk values is driven primarily by two major differences: (1) TCEQ selected a different statistical model to represent the occupational exposure data; and (2) TCEQ excluded breast cancer from the derivation of a cancer risk value based on the claim that there is insufficient weight of evidence that ethylene oxide exposure causes breast cancer.

The questions of the appropriate dose-response model to use to evaluate the risk of ethylene oxide and the strength of the evidence linking ethylene oxide exposure to breast cancer were addressed in the 2016 ethylene oxide IRIS assessment. These questions were raised again in comments on the 2020 MON final rule and responded to in both the preamble (85 FR 49084; August 12, 2020) and associated response to comments document  18 for the 2020 MON final rule. Briefly, these responses note that the EPA's 2016 IRIS risk value for ethylene oxide is based on a statistical model selected to best represent the available data on cancers in workers exposed to ethylene oxide. This model, a two-piece linear spline model, was selected after extensive review by the EPA and the SAB. The Agency and the SAB  20 21 carefully considered and evaluated multiple alternative models, including a Cox proportional hazards regression model similar to that used by TCEQ. In its response to the SAB's recommendations, the EPA noted: “The EPA has followed the SAB's recommendations for model selection. Model selection for both the breast cancer incidence (see section 4.1.2.3) and lymphoid cancer (see section 4.1.1.2) data prioritizes functional forms that allow more local fits in the low-exposure range ( e.g., spline models), relies less on AIC, 22 and includes consideration of biological plausibility . . .” (IRIS, 2016, Appendix I, p. I-3). As such, in the 2016 ethylene oxide IRIS assessment, the EPA selected a model that best represented potential general population exposures, making it align well with the purpose of the risk assessment in the 2020 MON final rule, which sought to assess general risk exposure to the public.

Additionally, the EPA considered the weight of evidence regarding the risk of breast cancer from exposure to ethylene oxide in the IRIS process. In the 2016 IRIS ethylene oxide assessment, the EPA determined that the available epidemiological evidence for a causal relationship between ethylene oxide exposure and breast cancer was strong, and there were sufficient data to include breast cancer in the derivation of the URE. The SAB supported this determination. Comments on the evidence for breast cancer as an endpoint following ethylene oxide exposure were also addressed during the review process for the IRIS ethylene oxide assessment. For example, in response to a public comment on the IRIS 2013 draft claiming that the evidence for breast cancer is too weak to rely on in setting the URE, the EPA responded:

“Although the epidemiological database for breast cancer is more limited ( i.e., few studies with sufficient numbers of female breast cancer cases) than that for lymphohematopoietic cancers, the EPA determined that the available evidence is sufficient to consider breast cancer a potential hazard from ethylene oxide exposure . . .The 2007 SAB panel did not object to the derivation of unit risk estimates based on the available breast cancer evidence.” (IRIS, 2016, Appendix K, p. K-3). 23 The IRIS cancer risk value is representative of potential health risks to the general population because it reflects the combined cancer risk of developing lymphoid cancers in all people, and breast cancer in women.

After careful consideration of the TCEQ DSD and material provided in the petitions for reconsideration that requested the EPA use TCEQ's final cancer risk value, the EPA is proposing to determine that the TCEQ assessment and the petitions for reconsideration do not provide a scientifically supportable basis for relying on the URE developed by TCEQ to assess the residual risk for sources in the 2020 MON final rule. No new studies or other information have been identified by TCEQ or the petitioners requesting reconsideration that would call into question the conclusions in the 2016 IRIS ethylene oxide assessment or suggest that TCEQ's URE provides a better estimate of the risk of exposure from ethylene oxide. The 2016 ethylene oxide IRIS assessment remains the best available science, and the EPA proposes to reaffirm its decision to use the IRIS inhalation URE in the 2020 MON final rule.

We estimate that, as of November 6, 2018, there were 201 MON facilities, nine of which reported ethylene oxide emissions to the 2014 National Emissions Inventory. However, as the EPA is not proposing any changes to the regulatory text or regulatory requirements in this action, we do not anticipate that any sources will be affected by this reconsideration. A complete list of known MON facilities is available in Appendix 1 of the document, Residual Risk Assessment for the Miscellaneous Organic Chemical Manufacturing Source Category in Support of the 2019 Risk and Technology Review Proposed Rule, which is available in the docket for this rulemaking (see Docket Item No. EPA-HQ-OAR-2018-0746-0011).

The EPA does not project any air quality impacts associated with this action because this action does not propose any changes to the standards or other requirements on affected sources.

The EPA does not project any incremental costs associated with this action because it does not propose any changes to the standards or other requirements on affected sources.

The EPA does not project any economic impacts because there are no incremental costs associated with this action.

The EPA does not project any incremental benefits associated with this action because it does not propose any changes to the standards or other requirements on affected sources.

Additional information about these statutes and Executive Orders can be found at https://www.epa.gov/laws-regulations/laws-and-executive-orders.

This action is not a significant regulatory action and was therefore not submitted to the Office of Management and Budget (OMB) for review.

This action does not impose an information collection burden under the PRA.

I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. In making this determination, the EPA concludes that the impact of concern for this rule is any significant adverse economic impact on small entities and that the Agency is certifying that this rule will not have a significant economic impact on a substantial number of small entities if the rule has no net burden on the small entities subject to the rule. As we are not proposing any changes to the regulatory text or regulatory requirements, we do not anticipate any economic impacts resulting from this action. We have therefore concluded that this action will have no net regulatory burden for all directly regulated small entities.

This action does not contain any unfunded mandate as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. The action proposes no enforceable duty on any state, local or tribal governments or the private sector.

This action does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government.

This action does not have tribal implications as specified in Executive Order 13175. None of the MON facilities that have been identified as being affected by this action are owned or operated by tribal governments or located within tribal lands within a 10 mile radius. Thus, Executive Order 13175 does not apply to this action.

This action is not subject to Executive Order 13045 because it is not economically significant as defined in Executive Order 12866, and because this action does not present any changes to the rule that would affect environmental health or safety risks, including those that would present a disproportionate risk to children.

This action is not subject to Executive Order 13211, because it is not a significant regulatory action under Executive Order 12866.

This rulemaking does not involve technical standards.

The EPA believes that this action is not subject to Executive Order 12898 (59 FR 7629, February 16, 1994) because it does not establish an environmental health or safety standard. This regulatory action acts to clarify the language in the preamble of a previously promulgated regulatory action and does not have any impact on human health or the environment.

In support of its channel substitution request, the Petitioner states that the Commission has recognized that very high frequency (VHF) channels have certain characteristics that pose challenges for their use in providing digital television service and the station has received many complaints from viewers unable to receive a reliable signal on channel 10. An analysis using the Commission's TVStudy software tool indicates that KTVQ's move from channel 10 to channel 20 is predicted to create a small area where approximately 3,624 persons are predicted to lose service, but that the loss area, is partially overlapped by the noise limited contours of Scripps' owned TV translator stations K15LB-D, Red Lodge, Montana, and K28ON-D, Castle Rock, Montana, both of which carry the CBS network programming aired by KTVQ. Accordingly, only 483 persons would lose CBS service if KTVQ moves to channel 20, which Petitioner argues is de minimis. In addition, the Engineering Statement shows that the loss area is also partially overlapped by the noise limited contours of KSVI (ABC) and KULR (NBC), Billings, Montana; KHMT (FOX), Hardin, Montana; and KSGW (ABC/FOX), Sheridan, Wyoming. Thus, viewers in the loss area will continue to have access to major network programming.

This is a synopsis of the Commission's Notice of Proposed Rulemaking, MB Docket No. 22-39; RM-11917; DA 22—87, adopted January 26, 2022, and released January 26, 2022. The full text of this document is available for download at https://www.fcc.gov/edocs. To request materials in accessible formats (braille, large print, computer diskettes, or audio recordings), please send an email to FCC504@fcc.gov or call the Consumer & Government Affairs Bureau at (202) 418-0530 (VOICE), (202) 418-0432 (TTY).

This document does not contain information collection requirements subject to the Paperwork Reduction Act of 1995, Public Law 104-13. In addition, therefore, it does not contain any proposed information collection burden “for small business concerns with fewer than 25 employees,” pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, see 44 U.S.C. 3506(c)(4). Provisions of the Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, do not apply to this proceeding.

Members of the public should note that all ex parte contacts are prohibited from the time a notice of proposed rulemaking is issued to the time the matter is no longer subject to Commission consideration or court review, see 47 CFR 1.1208. There are, however, exceptions to this prohibition, which can be found in § 1.1204(a) of the Commission's rules, 47 CFR 1.1204(a).

See §§ 1.415 and 1.420 of the Commission's rules for information regarding the proper filing procedures for comments, 47 CFR 1.415 and 1.420.

For the reasons discussed in the preamble, the Federal Communications Commission proposes to amend 47 CFR part 73 as follows:

The AIDCP has been ratified or acceded by 14 countries, including the United States, and is applied provisionally by another two. Among the objectives of the AIDCP are to reduce dolphin mortalities and ensure the long-term sustainability of the tuna stocks within the AIDCP Agreement Area. 1 The full text of the AIDCP is available online at: https://www.iattc.org/PDFFiles/AIDCP/_English/AIDCP.pdf.

The United States is a member of the IATTC, which was established under the 1949 Convention for the Establishment of an Inter-American Tropical Tuna Commission (1949 Convention). The 1949 Convention was updated by the Convention for the Strengthening of the IATTC Established by the 1949 Convention between the United States of America and the Republic of Costa Rica (Antigua Convention). The full text of the Antigua Convention is available online at: https://www.iattc.org/PDFFiles/IATTC-Instruments/_English/IATTC_Antigua_Convention%20vJun%202003.vpdf.

The IATTC consists of 21 member nations and five cooperating non-member nations. The IATTC facilitates scientific research, as well as the conservation and management, of tuna and tuna-like species in the IATTC Convention Area. 2 The IATTC maintains a scientific research and fishery monitoring program and regularly assesses the status of tuna, sharks, and billfish stocks in the IATTC Convention Area to determine appropriate catch limits and other measures deemed necessary to promote sustainable fisheries and prevent the overexploitation of these stocks.

As a Party to the Antigua Convention and AIDCP and a Member of the IATTC, the United States is legally bound to implement decisions of the IATTC under the Tuna Conventions Act (16 U.S.C. 951 et seq. ) and decisions of the Parties to the AIDCP under the Marine Mammal Protection Act (16 U.S.C. 1361 et seq. ). The Tuna Conventions Act directs the Secretary of Commerce, in consultation with the Secretary of State and, with respect to enforcement measures, the U.S. Coast Guard, to promulgate such regulations as may be necessary to carry out the United States' obligations under the Antigua Convention, including recommendations and decisions adopted by the IATTC. The authority of the Secretary of Commerce to promulgate such regulations has been delegated to NMFS. The MMPA directs the Secretary of Commerce to issue regulations, and revise those regulations as may be appropriate, to implement the International Dolphin Conservation Program. As with the TCA, the authority of the Secretary of Commerce to promulgate such regulations has been delegated to NMFS.

U.S. large purse seine vessels ( i.e., those greater than 400 short ton carrying capacity) fishing for tuna in the EPO are subject to 100 percent observer coverage obligations under Annex II, paragraph 2 of the AIDCP and IATTC Resolution C-09-04, Resolution on the International Dolphin Conservation Program. The United States implemented this requirement for 100 percent observer coverage into domestic regulation at 50 CFR 216.24(e)(1), which requires vessel permit holders to allow an authorized observer to accompany the vessel on all fishing trips in the Eastern Tropical Pacific (ETP) for the purpose of collecting information pertaining to research and observing operations and prohibits vessels that fail to carry an observer in accordance with these requirements from engaging in fishing operations. The United States does not have its own national observer program for the large tuna purse seine fishery and relies solely on the AIDCP/IATTC program to place observers on U.S. large purse seine vessels. The observers are typically foreign nationals that board U.S. vessels at ports throughout Central and South America, as well as American Samoa.

On April 16, 2020, the IATTC issued a memorandum (Ref.: 0173-420)  3 indicating that the AIDCP Parties and the IATTC Members adopted procedures to provide for the temporary exemption, on a case-by-case basis, from purse seine observer requirements in the EPO for each vessel and trip where it is not possible to place an observer due to operational and logistical constraints arising from actions taken by governments or organizations to safeguard health in response to the COVID-19 Pandemic. Under these exemption procedures, owners and operators of vessels must continue requesting the placement of observers in accordance with pre-existing procedures. An AIDCP/IATTC exemption is considered granted when the IATTC Director, or the head of the field office and the national observer program office of AIDCP Parties, certify the unavailability of an observer for the vessel. These procedures were set to expire June 1, 2020, but the AIDCP/IATTC issued several subsequent memoranda extending the procedures, most recently until March 31, 2022 (0564-420; December 16, 2021), and they are expected to be extended further. The current AIDCP/IATTC exemption procedures are discussed in greater detail in the next section of this preamble.

In addition to the AIDCP/IATTC procedures, NMFS needed authority to provide exemptions from domestic regulations requiring observer coverage. On March 27, 2020, NMFS published a temporary rule for an emergency action in response to the COVID-19 Pandemic (85 FR 17285) that provides the authority to waive observer coverage requirements implemented under certain statutes, including the MMPA and TCA (“NMFS Emergency Rule”). That NMFS Emergency Rule permits NMFS to waive observer coverage requirements if:

(1) Placing an observer conflicts with travel restrictions or other requirements addressing COVID-19 related concerns issued by local, state, or national governments, or the private companies that deploy observers pursuant to NMFS regulations; or

(2) No qualified observer(s) are available for placement due to health, safety, or training issues related to COVID-19.

That temporary NMFS Emergency Rule was extended and is currently in effect until March 26, 2022, or until the Secretary of Health and Human Services determines that the COVID-19 Pandemic is no longer a public health emergency, whichever is earlier (March 29, 2021; 86 FR 16307). Pursuant to the NMFS Emergency Rule, and in accordance with exemption procedures adopted by the AIDCP/IATTC, NMFS West Coast Region (WCR) established a process, subject to revocation or extension as circumstances warrant, for issuing temporary exemptions on an individual basis to the U.S. regulatory requirements for observer requirements for large U.S. tuna purse seine vessels in the EPO. This process, which NMFS is proposing to maintain under the proposed rule, is discussed in greater detail in the next section of this preamble.

Though difficult to predict, NMFS expects travel restrictions will likely continue in American Samoa and other port States where observers are placed on purse seine vessels beyond March 26, 2022. As noted, the AIDCP/IATTC exemptions procedures have been extended until March 31, 2022, and are expected to be extended further. However, the temporary NMFS Emergency Rule that provides the United States domestic authority to waive observer coverage for large EPO purse seine vessels will expire on March 26, 2022. After this time, NMFS will no longer have the authority to issue exemptions from observer requirements to large purse seine vessels fishing in the EPO. Without the authority to issue observer exemptions, the United States would likely be the only AIDCP Party and IATTC Member unable to issue these exemptions to its purse seine vessels. This proposed rule is therefore necessary to allow NMFS to continue issuing temporary exemptions from the observer requirements beyond the NMFS Emergency Rule expiration date in March 2022 in accordance with continuing AIDCP/IATTC exemption procedures and, potentially, in accordance with exemption procedures adopted in the future. Because the AIDCP contains an unqualified requirement for 100 percent observer coverage, NMFS anticipates that the AIDCP/IATTC will only adopt exemption procedures in the future under emergency circumstances similar to the COVID-19 pandemic and that those procedures would be similarly limited to single fishing trips for which it would be impossible to place an observer on a vessel.

This rule is proposed under the authorities of the MMPA and TCA. This rule would amend § 216.24(e)(1) to add a provision that will allow NMFS to issue temporary exemptions from purse seine observer requirements, on a case-by-case basis, in accordance with procedures adopted by the Parties to the AIDCP and Members of the IATTC. These temporary exemptions would apply to U.S. large purse seine vessels that are used to catch tropical tuna in the IATTC Convention Area and would exempt a single vessel from the requirement to carry an observer during a single fishing trip, provided the vessel complies with AIDCP/IATTC exemption procedures and with other applicable regulations and requirements. Although the proposed provision would not expire, it would only be applicable for the duration that AIDCP and IATTC observer exemption procedures are effective. In other words, the proposed provision would only give NMFS the authority to grant an exemption: (1) If the Parties to the AIDCP and Members of the IATTC have collectively agreed to adopt procedures for exempting observer coverage requirements under certain emergency circumstances; and (2) in accordance with the specific procedures adopted by AIDCP/IATTC for granting those exemptions.

NMFS will notify the affected fleet via email when the current AIDCP/IATTC emergency exemption procedures are no longer in effect. NMFS will also notify the affected fleet via email and the public by publication of a notice in the Federal Register if new exemption procedures are adopted by the Parties to the AIDCP and Members of the IATTC. New exemptions would not be issued by NMFS when AIDCP/IATTC exemption procedures are not in effect and exemptions issued by NMFS while AIDCP/IATTC exemption procedures are in effect would only be effective for as long as the AIDCP/IATTC procedures remain in effect.

As previously noted, the AIDCP Parties and the IATTC Members adopted procedures for the temporary exemption, on a case-by-case basis, of the requirement to carry an observer for trips where it is not possible to place an observer on a vessel. The process for a vessel to be granted an exemption from the IATTC is outlined below:

• Vessel owners/operators planning a fishing trip in the EPO are to contact the IATTC Director and Observer Coordinator to request an observer.

• If the IATTC Director, or the head of the field office and the national program office, certifies, in coordination with Flag State Authorities, that it is not possible to place an observer on the vessel, then an exemption from AIDCP observer requirements will be considered granted for the fishing trip.

In addition, U.S. large purse seine vessels must also obtain from NMFS WCR an individual exemption from regulatory observer coverage requirements. As discussed previously, NMFS has been issuing those exemptions under the authority of the NMFS Emergency Rule; however, if finalized, this proposed rule would provide NMFS the authority to continue issuing such exemptions while AIDCP/IATTC exemption procedures are in effect. NMFS would continue using the existing process for a U.S. vessel to obtain an exemption from domestic regulations, as outlined below:

• Once NMFS West Coast Region receives certification from the IATTC or the vessel owner/operator that an exemption has been granted, NMFS will confirm that the vessel owner/operator meets the criteria set forth in the AIDCP/IATTC exemption procedures.

• If the criteria are met, NMFS will issue the permit holder a letter documenting that the requirement to carry an observer has been exempted for that vessel trip.

• A NMFS observer exemption may be requested from the NMFS West Coast Region, Sustainable Fisheries Division, Highly Migratory Species (HMS) Branch, via WCR.HMS@noaa.gov.

NMFS anticipates working in coordination with the IATTC and being able to provide individual vessel exemptions without significant delay to U.S. large purse seine vessels. Any changes to these procedures will be notified by email directly and/or via relevant email distribution lists to vessel owners, operators, and permit holders.

It should be noted that although these proposed regulations will allow NMFS to waive the regulatory requirements in § 216.24(e)(1) to carry an observer, tuna caught in the ETP on a trip without an AIDCP-approved observer will be ineligible for a United States dolphin-safe label or an AIDCP Dolphin-Safe Tuna Certificate. With respect to the U.S. dolphin-safe label, any tuna harvested by large purse seine vessels fishing in the ETP is subject to U.S. dolphin-safe labeling requirements at 50 CFR part 216, subpart H, and also subject to the authority of the International Dolphin Conservation Program Act (ICDPA; 16 U.S.C. 1417). Without an AIDCP-approved observer on a fishing trip (even with an observer exemption), the Tuna Tracking Forms (TTFs) cannot be completed by an observer for that trip and, thus, the tuna would be ineligible for a dolphin-safe label. TTFs are necessary for the issuance of the U.S.-required IDCP-member nation certification to accompany the NOAA Form 370 for tuna harvested by large purse seine vessels in the ETP. However, such tuna harvested in the ETP without an observer may still be legally sold in the United States as non-dolphin-safe, provided it was harvested in accordance with other relevant requirements.

With respect to the AIDCP Dolphin-Safe Tuna Certificate, it should also be noted that the AIDCP Parties did not waive the requirement for the observer's role in verifying the dolphin-safe status of the catches under the AIDCP Dolphin-Safe Tuna Certification Program. Therefore, any trip by a vessel of an AIDCP Party that is made without an observer would not have valid TTFs and, thus, no valid AIDCP Dolphin-Safe Tuna Certificate can be issued by a Party for any catches made on that particular fishing trip.

As noted earlier, the regulatory requirement for large purse seine vessels to carry observers during fishing operations in the EPO are found in 50 CFR part 216, which contains regulations governing the taking and importing of marine mammals. This proposed rule would incorporate that requirement into 50 CFR part 300, subpart C, which contains regulations governing eastern Pacific tuna fisheries. Specifically, NMFS proposes to add to § 300.25, Fisheries Management, a provision that re-states, and cross-references to, the existing observer coverage requirement in § 216.24(e)(1). This provision would clarify that the requirements in § 216.24(e)(1) apply within the IATTC Convention Area. NMFS also proposes to add to § 300.24(n) a prohibition against operating a large purse seine vessel in the IATTC Convention Area in contravention of applicable observer requirements.

The NMFS Assistant Administrator has determined that this proposed rule is consistent with the Marine Mammal Protection Act, Tuna Conventions Act of 1950, and other applicable laws.

This proposed rule has been determined to be not significant for purposes of Executive Order 12866.

There are no new collection-of-information requirements associated with this action that are subject to the Paperwork Reduction Act (PRA), and the existing collection-of-information requirements still apply under Office of Management and Budget (OMB) Control Numbers 0648-0148 (West Coast Region Pacific Tuna Fisheries Logbook, Fish Aggregating Device Form, and Observer Safety Reporting) and 0648-0335 (Fisheries Certificate of Origin). Notwithstanding any other provision of the law, no person is required to respond to, and no person shall be subject to penalty for failure to comply with, a collection of information subject to the requirements of the PRA, unless that collection of information displays a currently valid OMB control number. All currently approved NOAA collections of information may be viewed at: https://www.reginfo.gov/public/do/PRAMain.

Pursuant to the Regulatory Flexibility Act, 5 U.S.C. 605(b), the Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration that this proposed rule, if adopted, would not have a significant economic impact on a substantial number of small entities. The rationale for the certification is provided in the following paragraphs.

As previously mentioned, NMFS expects that travel restrictions due to the COVID-19 pandemic will likely continue in American Samoa and foreign ports where observers are placed on purse seine vessels into the foreseeable future. NMFS also expects that the AIDCP/IATTC will extend their observer exemptions procedures beyond the current March 31, 2022, expiration date. With the NMFS Emergency Rule that provides the United States domestic authority to waive observer coverage for large EPO purse seine vessels expiring on March 26, 2022, NMFS will no longer have the authority to issue exemptions from observer requirements to large purse seine vessels fishing in the or EPO after that date. This proposed rule will allow NMFS to continue issuing temporary exemptions from the observer requirements. The absence of this proposed rule would result in NMFS being unable to issue exemptions in cases where no observer is available, preventing U.S. large purse seine vessels from legally fishing, thereby decreasing fishing opportunities and putting the U.S. fleet at a competitive disadvantage.

The United States Small Business Administration (SBA) defines a “small business” (or “small entities”) as one with annual revenue that meets or is below an established size standard. NMFS has established that the small business size standard for all businesses primarily engaged in the commercial fishing industry (NAICS 11411) for Regulatory Flexibility Act (RFA) compliance purposes (80 FR 81194, December 29, 2015), is $11 million in annual gross receipts. The standard is to be used in place of the U.S. SBA standards of $20.5 million, $5.5 million, and $7.5 million for the finfish (NAICS 114111), shellfish (NAICS 114112), and other marine fishing (NAICS 114119) sectors, respectively, of the U.S. commercial fishing industry.

The entities directly affected by the actions of this proposed action are U.S. large ( i.e., well volume greater than 425 cubic meters) tuna purse seine vessels that are required to carry fisheries observers, pursuant to the AIDCP and U.S. regulations at § 216.24(e). Per the $11 million size standard, these purse seine vessels are both large and small businesses.

Estimates of ex-vessel revenues for large U.S. purse seine vessels fishing in the IATTC Convention Area before 2015 have been confidential and may not be publicly disclosed because of the small number of vessels in the fishery. However, beginning in 2015, more than three large purse seine vessels fished either exclusively in the EPO, or fished in both the EPO and WCPO. Thus, information from 2015 to 2020 is not confidential.

Ex-vessel price information specific to individual large U.S. purse seine vessels are not available to NMFS because these vessels did not land on the U.S. West Coast and the cannery receipts are not available through the IATTC. However, Regional Purse Seine Logbook (RPL) data from NMFS Pacific Islands Fisheries Science Center (PIFSC), and observer data from the IATTC may be used as a proxy for fish landings by large U.S. purse seiners, in lieu of cannery receipts. Since neither gross receipts nor ex-vessel price information specific to individual fishing vessels are available to NMFS, NMFS applied indicative regional cannery prices—as approximations of ex-vessel prices—to annual catches of individual vessels obtained from RPLs and IATTC observer data, to estimate the vessels' annual receipts. Indicative regional cannery prices are available through 2020 (developed by the Pacific Islands Forum Fisheries Agency; available at ( https://www.ffa.int/node/425 ). NMFS estimated vessels' annual receipts during 2019-2020. Using this approach, NMFS estimates that among the affected vessels, the range in annual average receipts in 2019-2020 was $400,000 to $15 million with an average of approximately $8 million. U.S. EPO purse seine vessels that carry observers in the IATTC Convention Area are both large and small entities. While vessels often fluctuate from year to year as being classified as a large or small entity, the majority of large U.S. purse seine vessels typically fall under the small entity category.

As of December 2021, there are 17 U.S. purse seine vessels on the IATTC active purse seine register that are expected to be impacted by this action. These vessels are large, size class 6 purse seine vessels, registered to fish in the IATTC Convention Area, and primarily based in the western and central Pacific Ocean (WCPO). They are subject to the 100 percent observer coverage requirement pursuant to the AIDCP and U.S. domestic regulations at § 216.24(e)(1).

As described in the previous section, even though NMFS would exempt the regulatory requirements in § 216.24(e) to carry an observer, if there are any tuna caught on a trip in the ETP, it would be ineligible for a U.S. dolphin-safe label or an AIDCP Dolphin-Safe Tuna Certificate if no observer was on board. However, such tuna harvested in the ETP without an observer may still be legally sold in the United States, provided it was harvested in accordance with other relevant requirements.

Despite these restrictions for use of the U.S. dolphin-safe label or an AIDCP Dolphin-Safe Tuna Certificate, some U.S. purse seine vessels have made determinations that there is still a market for tuna caught without an observer. Out of the 87 trips by U.S. vessels that occurred since the observer exemptions were approved in March 2020, the United States has issued 17 observer exemptions under the authority of the NMFS Emergency Rule. Of those exemptions, approximately one third were not utilized, i.e., no fishing occurred in the IATTC Convention Area during the trip for which the exemption was issued. For trips where no observer was deployed, vessels are required to submit directly to the IATTC an IATTC bridge log and a fish aggregating device (FAD) form that contains fields that would have otherwise been collected by the observer. The compliance rate with these requirements is 100 percent as of December 2021.

Lastly, beyond the aforementioned IATTC bridge log, FAD form, and NOAA Form 370 that are already collected for large purse seine trips, there are no new recordkeeping or reporting requirements associated with this action. There are also no relevant Federal rules that may duplicate, overlap, or conflict with this action.

This proposed action is not expected to substantially change the typical fishing practices of affected vessels or have a significant impact on the profitability of the affected U.S. vessels, as a relatively small number of U.S. vessels have been issued observer exemptions for trips under the NMFS Emergency Rule since March 2020. Though observer exemptions make catch of tuna in the EPO ineligible for U.S. dolphin safe label and AIDCP dolphin safe certificate, U.S. vessels and other IATTC members have found markets for catch without these labels/certificates and continue to request exemptions. The proposed action would allow U.S. large purse seine vessels to continue fishing activities in cases where it is not possible to place an observer. As such, this action is not expected to have a significant economic impact on a substantial number of small entities and will not have a disproportionate economic impact on small business entities relative to the large entities. Therefore, an Initial Regulatory Flexibility Analysis is not required and none has been prepared.

For the reasons set out in the preamble, the National Marine Fisheries Service proposes to amend 50 CFR parts 216 and 300 as follows:

NMFS and the Council manage the American Samoa bottomfish fishery under the FEP and implementing regulations. The fishery primarily targets and harvests a complex of 11 bottomfish management unit species (BMUS), which includes emperors, snappers, groupers, and jacks. Bottomfish are typically harvested in deep waters, though some species are caught over reefs at shallower depths. Most (85 percent) bottomfish habitat is in territorial waters (generally from the shoreline to 3 nautical miles (5.6 km) offshore), with the rest in Federal waters ( i.e., the U.S Exclusive Economic Zone) around offshore banks. Fishing for bottomfish in American Samoa primarily occurs within 20 mi (32.2 km) from shore using aluminum catamarans less than 32 ft (9.7 m) long, known locally as alia.

The Council and NMFS only have the authority to develop and implement fishery management regulations in Federal waters, and the American Samoa Government has the authority to implement fishery management measures in territorial waters. Bottomfish fishermen in American Samoa are not required to obtain a Federal permit to fish for BMUS or to report their BMUS catch to NMFS. The American Samoa Department of Marine and Wildlife Resources collects fishery catch information from fishermen through voluntary creel surveys, and commercial sales data from the mandatory commercial receipt book program. There are no territorial permitting requirements to fish for bottomfish in territorial waters.

The fishery is relatively small, with fewer than 20 participants in the fishery (86 FR 3028, January 14, 2021), and primarily non-commercial, but it is still of importance to the local economy, and from social, cultural, and food security standpoints. In the past 20 years, the estimated total catch has varied from a high of 42,301 lb (19,187 kg) in 2001 to a low of 7,688 lb (3,487 kg) in 2012. The average catch from 2018-2020 was 12,687 lb (5,755 kg), with 965 lb (438 kg) attributed to the commercial fishery and the 11,722 lb (5,317 kg) attributed to the non-commercial sector. In 2020, the commercial price was $3.48/lb ($7.67/kg) and the estimated fishery revenue was $4,018.

On February 10, 2020, NMFS notified the Council that the American Samoa bottomfish stock complex was overfished and subject to overfishing (85 FR 26940, May 6, 2020). Consistent with section 304(e) of the Magnuson-Stevens Act and implementing regulations at 50 CFR 600.310(j), the Council must prepare, and NMFS must implement, a rebuilding plan within two years of the notification. The rebuilding plan must specify the timeframe for rebuilding the stock complex's biomass to a level that is capable of producing maximum sustainable yield (B MSY ). The rebuilding timeframe must be as short as possible, taking into account the status and biology of the overfished stock, the needs of fishing communities, and the interaction of the overfished stock of fish within the marine ecosystem and cannot exceed 10 years, except in cases where the biology of the stock of fish, other environmental conditions, or management measures under an international agreement in which the United States participates dictate otherwise. The rebuilding must also have at least a 50 percent probability of attaining the B MSY, where such probabilities can be calculated.

If approved, Amendment 5 would implement a rebuilding plan for the American Samoa bottomfish stock complex that consists of an ACL and two AMs. We would set the ACL 5,000 lb (2,268 kg) starting in 2022. Because NMFS is obligated to manage the stock throughout its range, and the complex exists in both territorial and Federal waters, we would count harvests from territorial and Federal waters toward the ACL. Note, however, that existing data collection programs do not differentiate catch from territorial versus Federal waters. The fishing year is the calendar year.

As an in-season AM, if NMFS projects that the fishery will reach the ACL in any year, then we would close the fishery in Federal waters for the remainder of that year. At this time, the American Samoan Government does not have regulations in place to implement a complementary closure in territorial waters at the same time as a Federal closure. Therefore, NMFS expects there could continue to be fishing in territorial waters even after a closure of the bottomfish fishery in Federal waters, and this could offset the potential conservation benefits of restricting bottomfish harvest in Federal waters. As an additional AM, if the total annual catch (which includes catch from both Federal and territorial waters) exceeds the ACL during a year, we would close the fishery in Federal waters until NMFS and the Territory of American Samoa implement a coordinated management regime to ensure that the catch in both Federal and territorial waters is maintained at levels that allow the stock to rebuild. The rebuilding plan would remain in place until NMFS determines that the stock complex is rebuilt, which is expected to take 10 years if catches are maintained at the specified level. This rebuilding plan was selected because it allows for the least disruption to the fishing community and minimizes negative socio-economic impacts while still rebuilding the stock complex within the 10-year period required by the Magnuson-Stevens Act. NMFS and the Council would review the rebuilding plan routinely every two years and modify it, as necessary, per section 304(e)(7) of the Magnuson-Stevens Act.

NMFS must receive comments on this proposed rule by the date provided in the DATES section. NMFS is also soliciting comments on proposed Amendment 5; see the Notice of Availability (NOA) published on Date (FR citation). NMFS must receive comments on the NOA by Date. NMFS may not consider any comments not postmarked or otherwise transmitted by that date. NMFS will consider comments on both the NOA and this proposed rule in our decision to approve, disapprove, or partially approve Amendment 5. NMFS specifically invites public comments that address the impact of the proposed rule and Amendment 5 on cultural fishing in American Samoa.

Pursuant to section 304(b)(1)(A) of the Magnuson-Stevens Act, the NMFS Assistant Administrator has determined that this proposed action is consistent with the FEP, other provisions of the Magnuson-Stevens Act, and other applicable laws, subject to further consideration after public comment.

This proposed rule has been determined to be not significant for purposes of Executive Order 12866.

The Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration that this proposed rule, if adopted, would not have a significant economic impact on a substantial number of small entities. A description of the proposed action, why it is being considered, and the legal basis for it are contained in the preamble to this proposed rule.

The American Samoa bottomfish fishery is primarily a non-commercial fishery and is relatively small, with fewer than 20 participants, many of whom also participate in other fisheries such as troll and small-scale longline. Since 2011, percent of catch sold ranged from 2.9 percent in 2011 to 15.4 percent in 2014. In 2020, fishermen sold 3.2 percent of bottomfish catch. Fishing for bottomfish primarily occurs using aluminum alia catamarans less than 32 ft (9.7 m) in length that are outfitted with outboard engines and wooden hand reels that fishermen use for both trolling and bottomfish fishing. The demand for bottomfish on American Samoa varies depending on the need for fish at community events, and alia fishermen may switch to bottomfish fishing during periods when target longline catches or prices are low. Between 2018 and 2020, the bottomfish catch averaged 12,587 lb (5,709 kg) with 7.2 percent sold, with remaining catch likely to be non-commercial catch, kept for personal consumption or shared within the community. In 2020, the most recent year for which catch data are available, the total estimated annual catch of American Samoa BMUS was 9,592 lb (4,350 kg), with commercial catch an estimated 307 lb (139 kg). Using the average bottomfish price in 2020 of $3.48/lb ($7.67/kg), 2020 bottomfish revenue is estimated to be $1,067. However, the 2020 price for bottomfish was lower than the average prices for 2017 ($5.11), 2018 ($4.25), 2019 ($4.24). Using the most recent 3-year average catch of bottomfish (12,587 lb or 5,709 kg) and the 2020 bottomfish price per pound ($3.48/lb or $7.67/kg), NMFS estimates the expected annual total revenue of the fishery to be $3,179. Under this scenario, the expected annual revenue for each of the 20 participants of this fishery from commercial bottomfish catch is $159. If NMFS were to apply a higher price to the analyses, estimated revenues and revenue losses would be higher.

Under the proposed action, with an ACL of 5,000 lb (2,269 kg) and an in-season AM to close Federal waters upon reaching the ACL for the bottomfish fishery in American Samoa, NMFS expects the fishery to exceed the ACL within the first half of the year. The reduction in catch because of this action could be offset if fishing effort in Federal waters relocates to territorial waters (assuming that the American Samoa government does not implement complementary measures in territorial waters). Without complementary management in place, NMFS expects the fishery to land 11,534 lb (5,231 kg) or more in 2022, which would exceed the ACL. As a result, Federal waters would close. However, even after a closure of Federal waters, NMFS expects the fishery to land 10,784 lb (4,891 kg) or more from territorial waters. The expected catch would depend on the level of fishing activity transferring to territorial waters, once the in-season closure occurs. If all fishing effort that would have been conducted in Federal waters moves to territorial waters, catch could be closer to levels when the fishery had not been constrained by a limit. However, if post-closure fishing effort in Federal waters does not move to territorial waters, then implementing the proposed action would result in a potential reduction of 1,153 lb (523 kg) in catch in 2022 and 1,903 lb (863 kg) for every subsequent years of the rebuilding plan compared to the status quo. The estimated fleetwide bottomfish revenue during the first year of implementing the rebuilding plan could be as low as $2,888. Under this scenario, the 20 participants would earn approximately $144 each. For subsequent years, fleetwide revenue could be as low as $2,702 ($135 per participant). These would represent reduction in bottomfish revenue of $15 in 2022 and $24 for subsequent years, compared to the status quo. Fishermen could offset loss in revenue by selling some of their catch that had been intended to be retained or shared (non-commercial catch) or by relocating fishing effort to territorial waters which are likely to remain open.

The fishery is not expected to substantially change the way it fishes with respect to fishing gear, fishing effort, participation, or intensity, but may change slightly with respect to total catch and areas fished, with the fishermen who would normally choose to fish in Federal waters being affected more adversely. Larger impacts would occur if the American Samoa government implemented a complementary closure in territorial waters with expected fleetwide catch of 5,000 lb the first year (2,269 kg) and no bottomfish catch during subsequent years until a coordinated management approach is developed that ensures catch in both Federal and territorial waters can be maintained at levels that allow the stock to rebuild. While limiting total bottomfish catches annually may result in short-term economic impacts to fishery participants, rebuilding stock biomass to B MSY is expected to increase the exploitable biomass which, in turn, is expected to provide for long-term sustainability of fishery resources while allowing fishery participants to continue to benefit from their use.

NMFS has established a small business size standard for businesses, including their affiliates, whose primary industry is commercial fishing (see 50 CFR 200.2). A business primarily engaged in commercial fishing (NAICS code 11411) is classified as a small business if it is independently owned and operated, is not dominant in its field of operation (including its affiliates), and has combined annual receipts not in excess of $11 million for all its affiliated operations worldwide. Based on available information, NMFS has determined that all vessels subject to the proposed action are small entities, i.e., they are engaged in the business of finfish harvesting (NAICS code 114111), are independently owned or operated, are not dominant in their field of operation, and have annual gross receipts not in excess of $11 million. Even though this proposed action would apply to a substantial number of vessels, the implementation of this action would not result in significant adverse economic impact to individual vessels.

The proposed action does not duplicate, overlap, or conflict with other Federal rules and is not expected to have significant impact on small entities (as discussed above), organizations or government jurisdictions. There does not appear to be disproportionate adverse economic impacts from the proposed rule based on home port, gear type, or relative vessel size. The proposed rule will not place a substantial number of small entities, or any segment of small entities, at a significant competitive disadvantage to large entities. As a result, an initial regulatory flexibility analysis is not required and none has been prepared.

This proposed rule contains no information collection requirements under the Paperwork Reduction Act of 1995.

For the reasons set out in the preamble, NMFS proposes to amend 50 CFR part 665 as follows: