On June 30, 2020 (85 FR 39049), the NRC published a direct final rule amending its regulations in part 72 of title 10 of the Code of Federal Regulations to revise the TN Americas LLC, Standardized NUHOMS® Horizontal Modular Storage System listing within the “List of approved spent fuel storage casks” to include Renewed Amendment No. 16 to Certificate of Compliance No. 1004. In the direct final rule, the NRC stated that if no significant adverse comments were received, the direct final rule would become effective on September 14, 2020. The NRC did not receive any comments on the direct final rule. Therefore, this direct final rule will become effective as scheduled.

The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain The Boeing Company Model 787-8 and 787-9 airplanes. The NPRM published in the Federal Register on January 10, 2020 (85 FR 1295). The NPRM was prompted by reports that the CAC outlet check valve failed due to fatigue of the aluminum flappers, and exposed the Y-duct to temperatures above its design limit. The NPRM proposed to require installing new inboard and outboard CAC outlet check valves on the left-side and right-side CACTCS packs.

The FAA is issuing this AD to address failed CAC outlet check valves, which could expose the flight deck and passenger cabin to smoke and fumes, and lead to reduced crew performance or produce passenger discomfort. Off-gassed compounds could cause respiratory distress and could cause serious injury for an individual with a compromised respiratory system.

The FAA gave the public the opportunity to participate in developing this final rule. The following presents the comments received on the NPRM and the FAA's response to each comment.

The Air Line Pilots Association, International, stated that it supports the NPRM.

All Nippon Airways (ANA) requested that the FAA reference CAC outlet check valve, part number (P/N) 7010105H01, directly in paragraph (i) of the proposed AD. ANA noted that paragraph (i) of the proposed AD stated that “no person may install a CAC outlet check valve, with a part number listed in paragraph 1.B, `Spares Affected' of Boeing Service Bulletin B787-81205-SB210108-00, Issue 002, dated October 15, 2019, on any airplane.” ANA pointed out that only CACTCS Pack P/Ns are listed in paragraph 1.B, “Spares Affected” of Boeing Service Bulletin B787-81205-SB210108-00, Issue 002, dated October 15, 2019 (“SB B787-81205-SB210108-00, Issue 002”), and the part number of the CAC outlet check valve that is of concern is not listed.

The FAA agrees with the request for the reasons provided. Although SB B787-81205-SB210108-00, Issue 002, does list CAC outlet check valves part numbers in paragraph 1.B of the service bulletin, the CAC outlet check valve part number that is of concern, P/N 7010105H01, is not listed in paragraph 1.B of the service bulletin. The CAC outlet check valve part number of concern, P/N 7010105H01, was intended to be a part prohibited from installation. The Accomplishment Instructions of SB B787-81205-SB210108-00, Issue 002, Note 9 of the General Information section states, among other things, that any CAC outlet check valve having P/N 7010105H01 cannot be installed again and must be made unserviceable. Additionally, supplier service information UTC Aerospace Systems Service Bulletin 7110097/098/188/189-21-4, dated May 3, 2018; and UTC Aerospace Systems Service Bulletin 7010097/098/188/189-21-9, dated May 3, 2018, which are referenced in SB B787-81205-SB210108-00, Issue 001; dated May 25, 2018 (“SB B787-81205-SB210108-00, Issue 001”), and SB B787-81205-SB210108-00, Issue 002, also state that all replaced CAC outlet check valves having P/N 7010105H01 cannot be installed again and must be made unserviceable. The FAA has revised paragraph (i) of this AD to specify that no person may install a CAC outlet check valve with a part number listed in paragraph 1.B of SB B787-81205-SB210108-00, Issue 002, or P/N 7010105H01 on any airplane as of the effective date of this AD.

American Airlines (AA) and United Airlines (UA) requested that the FAA clarify the requirements for marking the MOD DOT number on the CACTCS pack identification plate. Both commenters noted that paragraphs 2.A.(2), 2.A.(3), 2.B.(2), and 2.B.(3) of the Accomplishment Instructions of SB B787-81205-SB210108-00, Issue 002, are listed as “RC” (Required for Compliance) and specify to replace the CAC outlet check valve and mark the MOD DOT number on the CACTCS pack identification plate. The commenters pointed out that paragraph (j) of the proposed AD provides credit for actions accomplished in accordance with Boeing Service Bulletin B787-81205-SB210108-00, Issue 001, which does not have instructions for marking the MOD DOT number on the CACTCS pack identification plate. Because SB B787-81205-SB210108-00, Issue 002, specifies to mark the MOD DOT number on the CACTCS pack identification plate, but SB B787-81205-SB210108-00, Issue 001, does not, the commenters requested clarification on this requirement.

The FAA agrees to clarify. SB B787-81205-SB210108-00, Issue 001, specifies to do actions “in accordance with” the supplier service information, which included instructions for part marking. Therefore, operators that accomplished this issue of the service bulletin should have also marked the MOD DOT number on the CACTCS pack identification plate. However, the FAA acknowledges that SB B787-81205-SB210108-00, Issue 001 specified only replacing the parts, not marking them. If operators otherwise complied with SB B787-81205-SB210108-00, Issue 001, but did not mark the MOD DOT number on the CACTCS pack identification plate, they cannot claim credit for part marking and must mark the part as specified in SB B787-81205-SB210108-00, Issue 002. The FAA has not changed this AD in this regard.

UA requested that the FAA clarify the requirement to part mark an “X” on the CACTCS pack identification plate. UA pointed out that paragraphs 2.A.(2), 2.A.(3), 2.B.(2), and 2.B.(3) of the Work Instructions of SB B787-81205-SB210108-00, Issue 002, specify to mark the MOD DOT number on the CACTCS pack identification plate. In the associated tables, footnote [1] specifies to “also part mark an `X' on the applicable number in the MOD DOT area of the identification plate . . .” UA stated that the result is that MOD DOT markings are required in two places, which UA maintains is redundant and not consistent.

The FAA agrees to clarify. Footnote [1] of Tables 1 through 8 of the Work Instructions of SB B787-81205-SB210108-00, Issue 002, specifies to mark an “X” on the identification plate for the appropriate MOD DOT for CACTCS pack configuration H05 and H09 only, which is a separate action from marking the MOD DOT number on the CACTCS pack identification plate. The FAA has not changed this AD in this regard.

Boeing requested that the FAA update the Costs of Compliance section of the NPRM to reflect a name change for the supplier warranty information from UTC Aerospace Systems to Collins Aerospace. The FAA has revised the Costs of Compliance section of this AD accordingly.

Boeing requested that the FAA modify portions of the Discussion of the NPRM to clarify the cause of failing CAC outlet check valves and more clearly explain the sequence of events leading to the unsafe condition. Whereas the NPRM described the cause of the flapper fatigue as “increasing open/close cycles,” Boeing stated that the flapper fatigue was due to “open/close cycles exceeding design requirements.” Boeing also requested that the FAA modify the Discussion of the NPRM to clarify that “This [open/close cycles exceeding design requirements] can cause reverse flow through the broken check valve during times of single CAC operation. With repeated exposure to temperatures in excess of the Y-Duct design limit, the duct may degrade and this can lead to failure of the Y-Duct if not addressed. Dual CAC operation with a failed Y-Duct may lead to high temperatures that can result in off gassing from the duct material.”

The FAA agrees that the description in the NPRM was inaccurate and is clarified in the previous paragraph. Since that section of the preamble does not reappear in the final rule, no change to the final rule is necessary.

The FAA reviewed the relevant data, considered the comments received, and determined that air safety and the public interest require adopting this final rule with the changes described previously and minor editorial changes. The FAA has determined that these changes:

• Are consistent with the intent that was proposed in the NPRM for addressing the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM.

The FAA also determined that these changes will not increase the economic burden on any operator or increase the scope of this final rule.

The FAA reviewed Boeing Service Bulletin B787-81205-SB210108-00, Issue 002, dated October 15, 2019. The service information describes procedures for installing new inboard and outboard CAC outlet check valves on the left-side and right-side CACTCS packs. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

The FAA estimates that this AD affects 90 airplanes of U.S. registry. The FAA estimates the following costs to comply with this AD:

According to the manufacturer, some or all of the costs of this AD may be covered under warranty by Collins Aerospace, thereby reducing the cost impact on affected individuals. The FAA does not control warranty coverage for affected individuals. As a result, the FAA has included all known costs in the cost estimate.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.

The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: General requirements. Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

This AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify that this AD:

(1) Is not a “significant regulatory action” under Executive Order 12866,

(2) Will not affect intrastate aviation in Alaska, and

(3) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:

The EASA, which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2020-0072, dated March 26, 2020 (“EASA AD 2020-0072”) (also referred to as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for all Dassault Aviation Model Falcon 10 airplanes.

The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to all Dassault Aviation Model Falcon 10 airplanes. The NPRM published in the Federal Register on May 7, 2020 (85 FR 27170). The NPRM was prompted by a report of hydraulic fluid on the ground near the MLG brake assembly. The hydraulic leakage started in a cracked System #2 hydraulic pipe, with the crack likely due to chafing between two hydraulic pipes or between hydraulic pipes and structure. The NPRM proposed to require an inspection for chafing or interference of the hydraulic pipes and certain rib passage holes, and, depending on findings, modification or repair, as specified in an EASA AD.

The FAA is issuing this AD to address chafed or cracked hydraulic pipes, which could lead to hydraulic fluid leakage near an ignition source and possibly result in an uncontained fire. See the MCAI for additional background information.

The FAA gave the public the opportunity to participate in developing this final rule. The FAA has considered the comment received. Hailey Berk indicated support for the NPRM.

The FAA reviewed the relevant data, considered the comment received, and determined that air safety and the public interest require adopting this final rule as proposed, except for minor editorial changes. The FAA has determined that these minor changes:

• Are consistent with the intent that was proposed in the NPRM for addressing the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM.

EASA AD 2020-0072 describes procedures for an inspection for chafing or interference of the System #2 hydraulic pipes and rib 1 to rib 2a passage holes, and, depending on findings, modification to prevent interference or chafing at rib passage holes or repair. This material is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

The FAA estimates that this AD affects 85 airplanes of U.S. registry. The FAA estimates the following costs to comply with this AD:

The FAA estimates the following costs to do any necessary on-condition actions that would be required based on the results of any required actions. The FAA has no way of determining the number of aircraft that might need these on-condition actions:

The EASA, which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2020-0070, dated March 24, 2020 (“EASA AD 2020-0070”) (also referred to as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Airbus SAS Model A350-941 and -1041 airplanes.

The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain Airbus SAS Model A350-941 and -1041 airplanes. The NPRM published in the Federal Register on April 27, 2020 (85 FR 23262). The NPRM was prompted by the results of laboratory tests on non-rechargeable lithium batteries installed in certain ELTs, which highlighted a lack of protection against current injections of 28 volts DC or 115 volts AC that could lead to thermal runaway and a battery fire. The NPRM proposed to require modifying a certain ELT by installing a diode between the ELT and the terminal block, as specified in an EASA AD.

The FAA is issuing this AD to address local fires in non-rechargeable lithium batteries installed in ELTs, which could result in damage to the airplane and injury to occupants. See the MCAI for additional background information.

The FAA gave the public the opportunity to participate in developing this final rule. The following presents the comments received on the NPRM and the FAA's response to each comment.

Delta Air Lines (DAL) noted that the NPRM was based on the failure mode where a wire from the ELT is shorted to another wire carrying 28 volts DC or 115 volts AC causing voltage to be induced into the ELT's battery, resulting in a battery fire. The commenter explained that on Airbus Model A321 and A330 airplanes this failure mode could occur because the wiring is characterized by four discrete wires run in bundles with other discrete wires carrying 28 volts DC or 115 volts AC. The commenter questioned whether the NPRM should be applicable to Airbus Model A350 airplanes because these airplanes have a cable assembly with its four wires inside an outer jacket and shielding, which would therefore mitigate the unsafe condition addressed in the NPRM.

The FAA infers that the commenter is requesting that the NPRM be withdrawn because of the unique configuration of certain airplanes, including Airbus SAS Model A350-941 and -1041 airplanes. The FAA disagrees with the commenter's request. EASA, the State of Design Authority for these airplane models, conducted a risk assessment, and concluded that the type design of the applicable airplanes are susceptible to the current injection of 28 volts DC or 115 volts AC, that is not limited to just wire chafing. Therefore, the FAA is requiring the applicable corrective actions in this AD to mitigate the risk of the thermal runaway and battery fire. The FAA has determined that it is necessary to issue this final rule.

DAL also requested that operators be allowed to use any color and width of reinforced silicon tape instead of part number ASNA51072503, to protect the wiring in the area where the diode is secured to the harness. The commenter explained that part number ASNA51072503 is specified in Airbus Service Bulletin A350-25-P152, dated January 10, 2020 (“Airbus Service Bulletin A350-25-P152”), and is for the 1-inch orange tape under the ASNA5107 standard [which is an aerospace industry standard for a silicone rubber tape]. The commenter requested approval to use any color and width of tape meeting the specifications of the broader ASNA5107 standard.

The FAA partially agrees with the commenter's request. EASA AD 2020-0070 refers to Airbus Service Bulletin A350-25-P151, dated January 10, 2020 (“Airbus Service Bulletin A350-25-P151”), and Airbus Service Bulletin A350-25-P152, as the sources of service information for modifying the affected ELTs. Although the commenter mentioned only Airbus Service Bulletin A350-25-P152 in its comment, silicone tape having part number ASNA51072503 is specified in both service bulletins. The FAA agrees that operators can use any brightly colored tape because orange does not have a specific safety function. The FAA disagrees that operators can use any width of tape because the width could provide a safety function. The FAA has added paragraph (h)(3) to this AD to specify that operators may use any brightly colored 1-inch tape that meets the criteria specified in the ASNA5107 standard.

In addition, DAL requested and provided an option to replace Step 3.C.(g) specified in Airbus Service Bulletin A350-25-P152. The commenter explained that Step 3.C.(g) in Airbus Service Bulletin A350-25-P152 requires a continuity test of the modified wiring and provides no specific steps for this test other than referencing Electrical Standard Practices (ESP) section A350-A-20-52-21-00ZZZ-36AZ-A. The commenter noted that although this ESP section does provide basic continuity procedures, it fails to provide a procedure for a wire with a diode installed.

The FAA disagrees with the commenter's request. Based on the report from EASA, the State of Design Authority for these airplane models, the FAA has determined that the procedures described in Step 3.C.(g) of Airbus Service Bulletin A350-25-P152 do include a continuity test that considers an installed diode. Operators may, however, request alternative methods of compliance to replace Step 3.C.(g) specified in Airbus Service Bulletin A350-25-P152 by using the procedures described in paragraph (i)(1) of this AD and demonstrating how this alternative addresses the unsafe condition. The FAA has not changed this AD regarding this issue.

The FAA reviewed the relevant data, considered the comments received, and determined that air safety and the public interest require adopting this final rule with the changes described previously and minor editorial changes. The FAA has determined that these minor changes:

• Are consistent with the intent that was proposed in the NPRM for addressing the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM.

The FAA also determined that these changes will not increase the economic burden on any operator or increase the scope of this final rule.

EASA AD 2020-0070 describes procedures for modifying a certain ELT by installing a diode between the ELT and the terminal block. This material is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

The FAA estimates that this AD affects 7 airplanes of U.S. registry. The FAA estimates the following costs to comply with this AD:

According to the manufacturer, some or all of the costs of this AD may be covered under warranty, thereby reducing the cost impact on affected individuals. The FAA does not control warranty coverage for affected individuals. As a result, the FAA has included all known costs in the cost estimate.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.

The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: General requirements. Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

This AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify that this AD:

(1) Is not a “significant regulatory action” under Executive Order 12866,

(2) Will not affect intrastate aviation in Alaska, and

(3) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:

The EASA, which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2020-0037, dated February 27, 2020; corrected February 28, 2020 (“EASA AD 2020-0037”) (also referred to as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Airbus SAS Model A318 series airplanes; Model A319-111, -112, -113, -114, -115, -131, -132, and -133 airplanes; Model A320-211, -212, -214, -215, -216, -231, -232, and -233 airplanes; and Model A321-111, -112, -131, -211, -212, -213, -231, and -232 airplanes. Model A320-215 airplanes are not certificated by the FAA and are not included on the U.S. type certificate data sheet; this AD therefore does not include those airplanes in the applicability.

The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain Airbus SAS Model A318 series airplanes; Model A319-111, -112, -113, -114, -115, -131, -132, and -133 airplanes; Model A320-211, -212, -214, -216, -231, -232, and -233 airplanes; and Model A321-111, -112, -131, -211, -212, -213, -231, and -232 airplanes. The NPRM published in the Federal Register on April 17, 2020 (85 FR 21334). The NPRM was prompted by a report that cracks were detected on the LH and RH sides of the first rivet hole of the FR43 foot coupling during scheduled maintenance. The NPRM proposed to require a rotating probe test of the fastener holes at FR43 on the LH and RH sides for any cracking, and on-condition actions if necessary, as specified in an EASA AD.

The FAA is issuing this AD to address cracking in the foot coupling, which could affect the structural integrity of the airplane. See the MCAI for additional background information.

The FAA gave the public the opportunity to participate in developing this final rule. The following presents the comments received on the NPRM and the FAA's response to each comment.

Olivia Lawless stated support for the NPRM.

Olivia Lawless requested that training for operators should be implemented, or at least explored. The commenter stated concern about the implications that may result from requiring “on-condition actions including a high frequency eddy current (rototest) inspection for cracks of the affected fastener holes, modification, and repair.” The commenter noted that the NPRM suggests that the materials are available through the parties' normal course of business, however, it would be unlikely that employees would know how to perform these tests, or how to determine when on-condition actions occur without significant amounts of training.

The FAA agrees to clarify. The service information needed to comply with the required actions will be available in the AD docket. That service information contains detailed instructions for operators and their employees to follow. In addition, the FAA notes that it is the operators' responsibility to have adequate tools and provide adequate training for its employees to accomplish the required actions in an AD. The FAA has not changed this AD in this regard.

Delta Airlines (DAL) requested that the compliance time be limited to flight cycles and not flight hours. DAL stated that Airbus Service Bulletin A320-53-1269, Revision 02, dated February 7, 2019, specifies that the cracks which prompted the development of modification 153126 and modification 153742, were identified as a part of the full scale fatigue test campaign. DAL commented that because the failure mode is fatigue driven, there is no reason to include a compliance time requirement based upon flight hours.

The FAA disagrees with the commenter's request. The requirements in this AD align with the requirements specified in EASA AD 2020-0037, which include compliance times in both flight hours and flight cycles. In addition, the FAA notes that the commenter did not submit any substantiating data to support using only a flight cycle requirement. However, under the provisions of paragraph (j)(1) of this AD, the FAA will consider requests for approval of a revision to the compliance time if sufficient data are submitted to substantiate that the change would provide an acceptable level of safety. The FAA has not changed this AD in this regard.

DAL requested the use of CML 10ABE1 as a more appropriate choice of a chemical corrosion surface pretreatment. DAL stated that after the cold expansion is completed using Airbus Structural Repair Manual (SRM) 51-48-00, but prior to the installation of the new fastener, Airbus Service Bulletin A320-53-1270, Revision 02, dated April 11, 2014, specifies an application of chemical conversion surface pretreatment CML 10ABC1, which is intended for use in fuel tank applications.

The FAA disagrees with the commenter's request. The FAA has not received any information from either the state of design, EASA, or Airbus allowing alternate CML 10ABE1. CML 10ABC1 is a suitable pretreatment product that meets the requirements of this AD and addresses the identified unsafe condition. However, under the provisions of paragraph (j)(1) of this AD, the FAA will consider requests for approval of application of alternative chemical corrosion surface pretreatment products if sufficient data are submitted to substantiate that the change would provide an acceptable level of safety. The FAA has not changed this AD in this regard.

DAL requested that the application of corrosion inhibiting compounds (CICs) be added to paragraph (h) of the proposed AD, “Exceptions to EASA AD 2020-0037,” and not be a requirement for AD compliance. DAL stated that paragraph 3.C.(4)(c) of the Accomplishment Instructions of Airbus Service Bulletin A320-53-1270, Revision 02, dated April 11, 2014, requires that corrosion preventative compound CML 12ADB1 be applied to the cold worked area. DAL commented that each operator has a corrosion prevention and control program (CPCP) to control corrosion and may revise CIC products as necessary. DAL also commented that requiring the application of CML 12ADB1 within the required for compliance paragraph is problematic in maintaining perpetual compliance with the NPRM if a CPCP maintenance program task is applicable to the same area.

The FAA disagrees with the commenter's request. Since this AD affects multiple operators, and the FAA is not aware of the details of CIC compounds used as an inherent part of each operator's CPCP maintenance task, it is not practical for the FAA to revise this AD based on DAL's unique maintenance program. If DAL intends to use an approved substitution of the CIC that is not included in the SRM as an alternate to the CIC required by this AD, then DAL may request an alternative method of compliance (AMOC) under the provisions of paragraph (j)(1) of this AD. The FAA has not changed this AD regarding this issue.

The FAA reviewed the relevant data, considered the comments received, and determined that air safety and the public interest require adopting this final rule as proposed, except for minor editorial changes. The FAA has determined that these minor changes:

• Are consistent with the intent that was proposed in the NPRM for addressing the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM.

EASA AD 2020-0037 describes procedures for a rotating probe test (special detailed inspection) of the fastener holes at FR43 on the LH and RH sides for any cracking, and on-condition actions including a high frequency eddy current (rototest) inspection for cracks of the affected fastener holes, modification, and repair.

This material is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

The FAA estimates that this AD affects 867 airplanes of U.S. registry. The FAA estimates the following costs to comply with this AD:

The FAA estimates the following costs to do any necessary on-condition actions that would be required based on the results of any required actions. The FAA has no way of determining the number of aircraft that might need these on-condition actions:

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.

The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: General requirements. Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

This AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify that this AD:

(1) Is not a “significant regulatory action” under Executive Order 12866,

(2) Will not affect intrastate aviation in Alaska, and

(3) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:

The EASA, which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2020-0163R1, dated August 7, 2020 (“EASA AD 2020-0163R1”) (also referred to as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for all Airbus SAS Model A350-941 and -1041 airplanes.

This AD was prompted by a report of a slat system jam during landing. The FAA is issuing this AD to address a slat system jam during landing phase which could lead to a double shaft disconnection or rupture, potentially causing one or more slat surfaces to be no longer connected to either the slat wing tip brake or the slat PCU, possibly resulting in reduced control of the airplane. See the MCAI for additional background information.

EASA AD 2020-0163R1 describes procedures for a one-time health check of the slat PCU TSU for discrepancies ( i.e., for certain TSU values), and corrective actions (corrective actions include repairing discrepancies, and repeating the slat PCU TSU health check, and replacing the slat PCU); a detailed inspection of the LH and RH slat transmission systems for discrepancies ( e.g., wear, scratches, and abrasion), and corrective actions (corrective actions may include replacing parts); and LH and RH track 12 SGRA water drainage and vent plug cleaning (which includes an inspection for moisture). This material is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to the FAA's bilateral agreement with the State of Design Authority, the FAA has been notified of the unsafe condition described in the MCAI referenced above. The FAA is issuing this AD because the FAA evaluated all pertinent information and determined the unsafe condition exists and is likely to exist or develop on other products of the same type design.

This AD requires accomplishing the actions specified in EASA AD 2020-0163R1, described previously, as incorporated by reference, except for any differences identified as exceptions in the regulatory text of this AD.

In the FAA's ongoing efforts to improve the efficiency of the AD process, the FAA initially worked with Airbus and EASA to develop a process to use certain EASA ADs as the primary source of information for compliance with requirements for corresponding FAA ADs. The FAA has since coordinated with other manufacturers and civil aviation authorities (CAAs) to use this process. As a result, EASA AD 2020-0163R1 is incorporated by reference in this final rule. This AD, therefore, requires compliance with EASA AD 2020-0163R1 in its entirety, through that incorporation, except for any differences identified as exceptions in the regulatory text of this AD. Using common terms that are the same as the heading of a particular section in the EASA AD does not mean that operators need comply only with that section. For example, where the AD requirement refers to “all required actions and compliance times,” compliance with this AD requirement is not limited to the section titled “Required Action(s) and Compliance Time(s)” in the EASA AD. Service information specified in EASA AD 2020-0163R1 that is required for compliance with EASA AD 2020-0163R1 is available on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2020-0783.

Section 553(b)(3)(B) of the Administrative Procedure Act (APA) (5 U.S.C. 551 et seq. ) authorizes agencies to dispense with notice and comment procedures for rules when the agency, for “good cause,” finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under this section, an agency, upon finding good cause, may issue a final rule without providing notice and seeking comment prior to issuance. Further, section 553(d) of the APA authorizes agencies to make rules effective in less than thirty days, upon a finding of good cause.

An unsafe condition exists that requires the immediate adoption of this AD without providing an opportunity for public comments prior to adoption. The FAA has found that the risk to the flying public justifies waiving notice and comment prior to adoption of this rule because a slat system jam during landing could lead to a double shaft disconnection/rupture, potentially causing one or more slat surfaces to be no longer connected to either the slat wing tip brake or the slat PCU, possibly resulting in reduced control of the airplane. In addition, the compliance time for the required action is shorter than the time necessary for the public to comment and for publication of the final rule. Therefore this rule must be issued immediately, to ensure the safety of the flight crews conducting such flights. Accordingly, notice and opportunity for prior public comment are impracticable and contrary to the public interest pursuant to 5 U.S.C. 553(b)(3)(B).

In addition, the FAA finds that good cause exists pursuant to 5 U.S.C. 553(d) for making this amendment effective in less than 30 days, for the same reasons the FAA found good cause.

This AD is a final rule that involves requirements affecting flight safety, and the FAA did not precede it by notice and opportunity for public comment. The FAA invites you to send any written relevant data, views, or arguments about this AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2020-0783; Project Identifier MCAI-2020-01026-T” at the beginning of your comments. The most helpful comments reference a specific portion of the proposal, explain the reason for any recommended change, and include supporting data. Except for Confidential Business Information (CBI) as described in the following paragraph, and other information as described in 14 CFR 11.35, the FAA will consider all comments received by the closing date and may amend this AD based on those comments.

The FAA will post all comments the FAA receives, without change, to https://www.regulations.gov, including any personal information you provide. The FAA will also post a report summarizing each substantive verbal contact the FAA receives about this AD.

CBI is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to this AD contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to this AD, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission containing CBI as “PROPIN.” The FAA will treat such marked submissions as confidential under the FOIA, and they will not be placed in the public docket of this AD. Submissions containing CBI should be sent to the person identified in the FOR FURTHER INFORMATION CONTACT section. Any commentary that the FAA receives which is not specifically designated as CBI will be placed in the public docket for this rulemaking.

The FAA considers this AD interim action. The inspection reports that are required by this AD will enable the manufacturer to obtain better insight into the nature, cause, and extent of the issue, and eventually to develop final action to address the unsafe condition. Once final action has been identified, the FAA might consider further rulemaking.

The requirements of the RFA do not apply when an agency finds good cause pursuant to 5 U.S.C. 553 to adopt a rule without prior notice and comment. Because the FAA has determined that it has good cause to adopt this rule without notice and comment, RFA analysis is not required.

The FAA estimates that this AD affects 14 airplanes of U.S. registry. The FAA estimates the following costs to comply with this AD:

The FAA estimates that it takes about 1 work-hour per product to comply with the reporting requirement in this AD. The average labor rate is $85 per hour. Based on these figures, the FAA estimates the cost of reporting on U.S. operators to be $1,190, or $85 per product

The FAA has received no definitive data that would enable us to provide cost estimates for the on-condition actions specified in this AD.

A federal agency may not conduct or sponsor, and a person is not required to respond to, nor shall a person be subject to penalty for failure to comply with a collection of information subject to the requirements of the Paperwork Reduction Act unless that collection of information displays a current valid OMB control number. The control number for the collection of information required by this AD is 2120-0056. The paperwork cost associated with this AD has been detailed in the Costs of Compliance section of this document and includes time for reviewing instructions, as well as completing and reviewing the collection of information. Therefore, all reporting associated with this AD is mandatory. Comments concerning the accuracy of this burden and suggestions for reducing the burden should be directed to Information Collection Clearance Officer, Federal Aviation Administration, 10101 Hillwood Parkway, Fort Worth, TX 76177-1524.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.

The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: General requirements. Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

The FAA determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify that this AD:

(1) Is not a “significant regulatory action” under Executive Order 12866, and

(2) Will not affect intrastate aviation in Alaska.

Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:

The EASA, which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2020-0077, dated March 31, 2020 (“EASA AD 2020-0077”) (also referred to as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Airbus SAS Model A330-202, -203, -223, -243, -301, -321, -322, -323, -341, -342, and -343 airplanes; and Model A340-211, -212, -213, -311, -312, and -313 airplanes.

The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain Airbus SAS Model A330-202, -203, -223, -243, -301, -321, -322, -323, -341, -342, and -343 airplanes; and Model A340-211, -212, -213, -311, -312, and -313 airplanes. The NPRM published in the Federal Register on May 22, 2020 (85 FR 31083). The NPRM was prompted by a report indicating that the allowable load limits on the vertical tail plane could be reached and possibly exceeded in cases of multiple rudder doublet inputs. The NPRM proposed to require upgrading the FCDC, associated FCPC, and FWC, and activation of the SRIW device, as specified in EASA AD 2020-0077.

The FAA is issuing this AD to address cases of multiple rudder doublet inputs, which could lead to excessive load on the vertical tail plane and a subsequent loss of control of the airplane. See the MCAI for additional background information.

The FAA gave the public the opportunity to participate in developing this final rule. The following presents the comments received on the NPRM and the FAA's response to each comment.

Air Line Pilots Association, International (ALPA), indicated its support for the NPRM.

Delta Air Lines requested revising the Applicability paragraph (paragraphs (c)(1) through (4) of this AD) to add the phrase “except those that have embodied Airbus modification 49144.” Delta noted that the phrase is in EASA AD 2020-0077. Delta suggested that including the phrase in paragraph (c) of the NPRM would allow a definitive determination of whether an airplane is affected, without reading EASA AD 2020-0077.

The FAA disagrees with the commenter's request. Paragraph (c) of this AD states the airplane models as identified in EASA AD 2020-0077. EASA AD 2020-0077 states in their applicability statement that airplanes on which Airbus modification 49144 has been embodied are excluded from the requirements. In the interest of streamlining the process for this AD and to minimize the potential for errors, the FAA has used incorporation by reference, the process which allows the FAA to refer to material published elsewhere without republishing that material in this AD or the Federal Register . Because EASA AD 2020-0077 is incorporated by reference in this AD under 1 CFR part 51, referring to the document itself is the same as specifically stating the language used in the Applicability section of EASA AD 2020-0077 directly in this AD. Therefore it is not necessary to restate that language directly in this AD. This is similar to the FAA's process of referencing serial numbers of airplanes that are identified in service information that is incorporated by reference in an AD instead of listing those numbers directly in the AD. No change has been made to this AD.

The FAA reviewed the relevant data, considered the comments received, and determined that air safety and the public interest require adopting this final rule as proposed, except for minor editorial changes. The FAA has determined that these minor changes:

• Are consistent with the intent that was proposed in the NPRM for addressing the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM.

EASA AD 2020-0077 describes procedures for upgrading the FCDC, associated FCPC, and FWC, and activation of the SRIW device. This material is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

The FAA estimates that this AD affects 10 airplanes of U.S. registry. The FAA estimates the following costs to comply with this AD:

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.

The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: General requirements. Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

This AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify that this AD:

(1) Is not a “significant regulatory action” under Executive Order 12866,

(2) Will not affect intrastate aviation in Alaska, and

(3) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:

This rule amends Title 14, Code of Federal Regulations, Part 97 (14 CFR part 97) by amending the referenced SIAPs.

The complete regulatory description of each SIAP is listed on the appropriate FAA Form 8260, as modified by the National Flight Data Center (NFDC)/Permanent Notice to Airmen (P-NOTAM), and is incorporated by reference under 5 U.S.C. 552(a), 1 CFR part 51, and 14 CFR 97.20. The large number of SIAPs, their complex nature, and the need for a special format make their verbatim publication in the Federal Register expensive and impractical. Further, airmen do not use the regulatory text of the SIAPs, but refer to their graphic depiction on charts printed by publishers of aeronautical materials. Thus, the advantages of incorporation by reference are realized and publication of the complete description of each SIAP contained on FAA form documents is unnecessary.

This amendment provides the affected CFR sections, and specifies the SIAPs and Takeoff Minimums and ODPs with their applicable effective dates. This amendment also identifies the airport and its location, the procedure and the amendment number.

The material incorporated by reference is publicly available as listed in the ADDRESSES section.

The material incorporated by reference describes SIAPs, Takeoff Minimums and ODPs as identified in the amendatory language for part 97 of this final rule.

This amendment to 14 CFR part 97 is effective upon publication of each separate SIAP and Takeoff Minimums and ODP as amended in the transmittal. For safety and timeliness of change considerations, this amendment incorporates only specific changes contained for each SIAP and Takeoff Minimums and ODP as modified by FDC permanent NOTAMs.

The SIAPs and Takeoff Minimums and ODPs, as modified by FDC permanent NOTAM, and contained in this amendment are based on the criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these changes to SIAPs and Takeoff Minimums and ODPs, the TERPS criteria were applied only to specific conditions existing at the affected airports. All SIAP amendments in this rule have been previously issued by the FAA in a FDC NOTAM as an emergency action of immediate flight safety relating directly to published aeronautical charts.

The circumstances that created the need for these SIAP and Takeoff Minimums and ODP amendments require making them effective in less than 30 days.

Because of the close and immediate relationship between these SIAPs, Takeoff Minimums and ODPs, and safety in air commerce, I find that notice and public procedure under 5 U.S.C. 553(b) are impracticable and contrary to the public interest and, where applicable, under 5 U.S.C. 553(d), good cause exists for making these SIAPs effective in less than 30 days.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore—(1) Is not a “significant regulatory action” under Executive Order 12866;(2) is not a “significant rule” under DOT regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Accordingly, pursuant to the authority delegated to me, Title 14, Code of Federal Regulations, Part 97, (14 CFR part 97), is amended by amending Standard Instrument Approach Procedures and Takeoff Minimums and ODPs, effective at 0901 UTC on the dates specified, as follows:

This rule amends Title 14 of the Code of Federal Regulations, Part 97 (14 CFR part 97), by establishing, amending, suspending, or removes SIAPS, Takeoff Minimums and/or ODPS. The complete regulatory description of each SIAP and its associated Takeoff Minimums or ODP for an identified airport is listed on FAA form documents which are incorporated by reference in this amendment under 5 U.S.C. 552(a), 1 CFR part 51, and 14 CFR part 97.20. The applicable FAA forms are FAA Forms 8260-3, 8260-4, 8260-5, 8260-15A, and 8260-15B when required by an entry on 8260-15A.

The large number of SIAPs, Takeoff Minimums and ODPs, their complex nature, and the need for a special format make publication in the Federal Register expensive and impractical. Further, airmen do not use the regulatory text of the SIAPs, Takeoff Minimums or ODPs, but instead refer to their graphic depiction on charts printed by publishers of aeronautical materials. Thus, the advantages of incorporation by reference are realized and publication of the complete description of each SIAP, Takeoff Minimums and ODP listed on FAA form documents is unnecessary. This amendment provides the affected CFR sections and specifies the types of SIAPs, Takeoff Minimums and ODPs with their applicable effective dates. This amendment also identifies the airport and its location, the procedure, and the amendment number.

The material incorporated by reference is publicly available as listed in the ADDRESSES section.

The material incorporated by reference describes SIAPS, Takeoff Minimums and/or ODPS as identified in the amendatory language for part 97 of this final rule.

This amendment to 14 CFR part 97 is effective upon publication of each separate SIAP, Takeoff Minimums and ODP as Amended in the transmittal. Some SIAP and Takeoff Minimums and textual ODP amendments may have been issued previously by the FAA in a Flight Data Center (FDC) Notice to Airmen (NOTAM) as an emergency action of immediate flight safety relating directly to published aeronautical charts.

The circumstances that created the need for some SIAP and Takeoff Minimums and ODP amendments may require making them effective in less than 30 days. For the remaining SIAPs and Takeoff Minimums and ODPs, an effective date at least 30 days after publication is provided.

Further, the SIAPs and Takeoff Minimums and ODPs contained in this amendment are based on the criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these SIAPs and Takeoff Minimums and ODPs, the TERPS criteria were applied to the conditions existing or anticipated at the affected airports. Because of the close and immediate relationship between these SIAPs, Takeoff Minimums and ODPs, and safety in air commerce, I find that notice and public procedure under 5 U.S.C. 553(b) are impracticable and contrary to the public interest and, where applicable, under 5 U.S.C 553(d), good cause exists for making some SIAPs effective in less than 30 days.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore—(1) Is not a “significant regulatory action” under Executive Order 12866;(2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26,1979) ; and (3)does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal.

For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Accordingly, pursuant to the authority delegated to me, Title 14, Code of Federal Regulations, Part 97 (14 CFR part 97) is amended by establishing, amending, suspending, or removing Standard Instrument Approach Procedures and/or Takeoff Minimums and Obstacle Departure Procedures effective at 0901 UTC on the dates specified, as follows:

This document and additional information concerning OFAC are available from OFAC's website ( http://www.treasury.gov/ofac ).

Section 4 of the Federal Civil Penalties Inflation Adjustment Act (1990 Pub. L. 101-410, 104 Stat. 890; 28 U.S.C. 2461 note), as amended by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (Pub. L. 114-74, 129 Stat. 599, 28 U.S.C. 2461 note) (collectively, the FCPIA Act), requires each federal agency with statutory authority to assess civil monetary penalties (CMPs) to adjust CMPs for inflation according to a formula described in section 5 of the FCPIA Act. One purpose of the FCPIA Act is to ensure that CMPs continue to maintain their deterrent effect through periodic cost-of-living based adjustments.

The FCPIA Act directs agencies to adjust the level of CMPs for inflation with an initial “catch-up” adjustment to be effective no later than August 1, 2016, followed by annual adjustments. The FCPIA directs the Office of Management and Budget (OMB) to provide agencies with guidance and Consumer Price Index for all Urban Consumers (CPI-U)-related multipliers for the initial catch-up adjustment and subsequent annual adjustments.

OFAC currently is authorized to impose CMPs pursuant to five statutes: The Trading with the Enemy Act (50 U.S.C. 4315) (TWEA); the International Emergency Economic Powers Act (50 U.S.C. 1705) (IEEPA); the Antiterrorism and Effective Death Penalty Act of 1996 (18 U.S.C. 2339B) (AEDPA); the Foreign Narcotics Kingpin Designation Act (21 U.S.C. 1906) (FNKDA); and the Clean Diamond Trade Act (19 U.S.C. 3907) (CDTA).

OFAC issued an initial catch-up adjustment rule for CMPs pursuant to these statutes on August 1, 2016 (81 FR 43070, July 1, 2016), and issued annual CMP increases on February 10, 2017 (82 FR 10434, February 10, 2017), March 19, 2018 (83 FR 11876, March 19, 2018), June 14, 2019 (84 FR 27714, June 14, 2019), and April 9, 2020 (85 FR 19884, April 9, 2020).

OFAC inadvertently omitted from its initial catch-up regulation and subsequent annual increases its CMPs for failure to comply with a requirement to furnish information, the late filing of a required report, and failure to maintain records, which are located in its Economic Sanctions Enforcement Guidelines in appendix A to 31 CFR part 501. This interim final rule combines the catch-up adjustment that would have become effective August 1, 2016, plus the annual adjustments for 2017 through 2020 for these CMPs.

In addition, OFAC is making technical edits to the authority citation for part 501 to conform to Federal Register guidance.

In order to complete the catch-up adjustment for CMPs, the FCPIA Act directs agencies to identify when the CMP amount or range was established or last adjusted, other than adjustments pursuant to the FCPIA Act. Agencies are directed to use that amount or range as a starting point for performing calculations. The catch-up calculations therefore exclude prior inflationary adjustments under the FCPIA Act. The FCPIA Act directs agencies to calculate initial catch-up adjustments based on the percent change between the CPI-U for the month of October in the year of the last non-FCPIA-Act-based adjustment and the October 2015 CPI-U. In accordance with the FCPIA Act, the amount of the CMP catch-up adjustment shall not exceed 150 percent of the corresponding level in effect on November 2, 2015 (the “maximum adjustment”), and agencies must round all CMP levels to the nearest dollar after applying the multiplier.

On February 24, 2016, OMB issued written guidance providing agencies with CPI-U-related multipliers to use when adjusting the CMP level or range of CMP levels based on the year the CMP was established or last adjusted by statute or regulation. ( Memorandum for the Heads of Executive Departments and Agencies: Implementation of the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (OMB Catch-Up Guidance)).

OFAC's CMPs for failure to comply with a requirement to furnish information pursuant to 31 CFR 501.602 and the late filing of a report set forth in regulations or a specific license are contained in sections IV.A and B, respectively, of appendix A to 31 CFR part 501. OFAC established these CMPs on September 8, 2008 (73 FR 51933, September 8, 2008), and OFAC has not adjusted them since. Pursuant to the OMB Catch-Up Guidance, the inflation factor for catch-up adjustments for these CMPs is 1.09819, with a maximum allowable adjustment of 150 percent of the CMP that was in effect on November 2, 2015.

The CMP established in 2008 for failure to furnish information pursuant to 31 CFR 501.602 irrespective of whether any other violation is alleged is $20,000. Applying the multiplier of 1.09819 results in a catch-up CMP of $21,964. The CMP established in 2008 for failure to furnish information pursuant to 31 CFR 501.602 where OFAC has reason to believe that the apparent violation(s) involves a transaction(s) valued at greater than $500,000, irrespective of whether any other violation is alleged, is $50,000. Applying the multiplier of 1.09819 results in a catch-up CMP amount of $54,910. The CMP established in 2008 for the late filing of a required report, whether set forth in regulations or in a specific license, if filed within the first 30 days after the report is due, is $2,500. Applying the multiplier of 1.09819 results in a catch-up CMP amount of $2,745. The CMP established in 2008 for the late filing of a required report, whether set forth in regulations or in a specific license, if filed more than 30 days after the report is due, is $5,000. Applying the multiplier of 1.09819 results in a catch-up CMP amount of $5,491. The 2008 CMP for the late filing of a required report, whether set forth in regulations or in a specific license, if the report relates to blocked assets, is an additional $1,000 for every 30 days that the report is overdue, up to five years. Applying the multiplier of 1.09819 results in a catch-up CMP amount of $1,098. None of these catch-up increases exceeds the maximum adjustment amount. These catch-up increases are shown in Column 2 of Table 1.

OFAC last adjusted its CMP for failure to maintain records in conformance with the requirements of OFAC's regulations or of a specific license, which is located in section IV.C of appendix A to 31 CFR part 501, on November 9, 2009 (74 FR 57593, November 9, 2009). The 2009 adjustment of this CMP provides for a penalty in an amount up to $50,000. Pursuant to the OMB Catch-Up Guidance, the relevant inflation factor for the catch-up adjustment for this CMP is 1.10020, with a maximum allowable adjustment of 150 percent of the CMP that was in effect on November 2, 2015. Applying the multiplier of 1.10020 to this CMP results in the catch-up amount up to $55,010, which does not exceed the maximum adjustment. This catch-up figure is shown in Column 2 of Table 2.

The FCPIA Act requires agencies to adjust CMPs annually for inflation subsequent to the initial catch-up adjustment. These annual adjustments are to be based on the percent change between the CPI-U for the October preceding the date of the adjustment and the prior year's October CPI-U. Each December, OMB issues the adjustment multiplier for the upcoming year's calculations. In order to complete the annual adjustment, each CMP (as revised by the catch-up adjustment) is multiplied by the adjustment multiplier for that year. Under the FCPIA Act, any increases in CMPs must be rounded to the nearest multiple of $1.

The adjustment multiplier for the 2017 CMP increase was 1.01636, as set forth in OMB Memorandum M-17-11 of December 16, 2016 ( Memorandum for the Heads of Executive Departments and Agencies: Implementation of the 2017 Annual Adjustment pursuant to the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 ). For the 2018 CMP increase, OMB Memorandum M-18-03 of December 15, 2017 provided an adjustment multiplier of 1.02041 ( Memorandum for the Heads of Executive Departments and Agencies: Implementation of Penalty Inflation Adjustments for 2018, Pursuant to the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 ). For the 2019 CMP increase, OMB Memorandum M-19-04 of December 14, 2018 stated the adjustment multiplier was 1.02522 ( Memorandum for the Heads of Executive Departments and Agencies: Implementation of Penalty Inflation Adjustments for 2019, Pursuant to the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015, ). For the 2020 CMP increase, OMB Memorandum M-20-05 of December 16, 2019 provided an adjustment multiplier of 1.01764 ( Memorandum for the Heads of Executive Departments and Agencies: Implementation of Penalty Inflation Adjustments for 2020, Pursuant to the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 ).

If OFAC had calculated the 2017 annual adjustment for its CMPs for failure to comply with a requirement to furnish information and the late filing of a report, each of the catch-up CMP amounts would have been multiplied by the OMB-provided factor of 1.01636. The resulting amounts for the 2017 CMPs are shown in Column 3 of Table 1. If OFAC had calculated the 2018 annual adjustment, the 2017 CMPs would have been multiplied by the OMB-provided factor of 1.02041. The resulting amounts for the 2018 CMPs are shown in Column 4 of Table 1. If OFAC had calculated the 2019 CMP adjustment, the 2018 CMPs would have been multiplied by the OMB-provided factor of 1.02522. The resulting amounts for the 2019 CMPs are shown in Column 5 of Table 1.

For the 2020 CMP increases, OMB provided an adjustment factor of 1.01764. OFAC multiplied the 2019 CMP amounts by this factor, resulting in the 2020 CMP amounts as shown in Column 6 of Table 2. These 2020 CMP amounts will be effective October 5, 2020 for associated violations that occurred after November 2, 2015 for which penalties were assessed on or after October 5, 2020.

If OFAC had calculated the 2017 annual adjustment for its CMP for failure to maintain records in conformance with the requirements of OFAC's regulations or of a specific license, the catch-up CMP amount would have been multiplied by the OMB-provided factor of 1.01636. The resulting amount for the 2017 CMP is shown in Column 3 of Table 2. If OFAC had calculated the 2018 annual CMP adjustment, the 2017 CMP would have been multiplied by the OMB-provided factor of 1.02041. The resulting amount for the 2018 CMP is shown in Column 4 of Table 2. If OFAC had calculated the 2019 CMP adjustment, the 2018 CMP would have been multiplied by the OMB-provided factor of 1.02522. The resulting amount for the 2019 CMP is shown in Column 5 of Table 2.

For the 2020 CMP increase, OMB provided an adjustment factor of 1.01764. OFAC multiplied the 2019 CMP amount by this factor, resulting in the 2020 CMP amount as shown in Column 6 of Table 2. This 2020 CMP amount will be effective October 5, 2020 for associated violations that occurred after November 2, 2015 for which penalties were assessed on or after October 5, 2020.

The CMP for failure to comply with the requirement to furnish information pursuant to 31 CFR 501.602 irrespective of whether any other violation is alleged will increase from $20,000 to $23,765. The CMP for failure to comply with a requirement to furnish information, where OFAC has reason to believe that the apparent violation(s) that is the subject of the requirement to furnish information involves a transaction(s) valued at greater than $500,000, irrespective of whether any other violation is alleged, will increase from $50,000 to $59,413. The CMP for late filing of a required report, whether set forth in regulations or in a specific license, if filed within the first 30 days after the report is due will increase from $2,500 to $2,970. The CMP for late filing of a required report, whether set forth in regulations or in a specific license, if filed more than 30 days after the report is due, will increase from $5,000 to $5,942. The CMP for late filing of a required report, whether set forth in regulations or in a specific license, if the report relates to blocked assets, an additional CMP for every 30 days that the report is overdue, up to five years, will increase from $1,000 to $1,189. The CMP for failure to maintain records in conformance with the requirements of OFAC's regulations or of a specific license will increase from a maximum of $50,000 to $59,522.

The adjusted CMP amounts described in this rule are applicable only to CMPs assessed after October 5, 2020, whose associated violations occurred after November 2, 2015, the date of enactment of the FCPIA Act.

As required by the FCPIA Act, these amendments are being published as an interim final rule with an effective date of October 5, 2020. Although other notice and comment procedures are not required, OFAC invites comments on this rule related to the catch-up adjustment only. The FCPIA Act expressly exempts the inflation adjustments from the notice and comment requirements of the Administrative Procedure Act, by directing agencies to adjust CMPs for inflation “notwithstanding section 553 of title 5, United States Code” (Pub. L. 114-74, 129 Stat. 599; 28 U.S.C. 2461 note).

Because no notice of proposed rulemaking is required for this rule, the Regulatory Flexibility Act (5 U.S.C. 601-612) does not apply.

The Paperwork Reduction Act does not apply because this rule does not impose information collection requirements that would require the approval of the Office of Management and Budget under 44 U.S.C. 3501 et seq.

For the reasons set forth in the preamble, 31 CFR part 501 is amended as follows:

Expiration date: Unless extended after consideration of submitted comments, the medical benefit provisions in this IFR will cease to be in effect upon termination of the President's declared national emergency, in accordance with applicable law and regulation ( e.g., 50 U.S.C. 1622(a)), except the temporary waiver of certain acute care hospital requirements for temporary hospitals and freestanding ASCs, which will expire when Medicare's “Hospitals without Walls” provision expires. The temporary reimbursement waivers under this IFR will cease to be effective upon termination of the Secretary of Health and Human Services' (HHS) Public Health Emergency (PHE), or upon other guidance, regulations, or modifications made by Medicare, in accordance with the statutory requirement that TRICARE reimburse like Medicare (10 U.S.C. 1079(i)(2)). The adoption of NTAPs and HVBP are permanent and will not expire. Because TRICARE operates both in the United States and in overseas locations, the ASD(HA), or designee, may determine that it is appropriate to continue exemptions to permanent regulation provisions for some or all of TRICARE's overseas locations serviced by the TRICARE Overseas Program contractor under 32 CFR 199.1(b) beyond termination of the President's declared national emergency based on the status of COVID-19 community spread in those locations. Such continuation of these provisions for overseas locations will be published in TRICARE's implementing instructions (TRICARE manuals), available at http://manuals.health.mil.

If the ASD(HA) determines it would be appropriate to make these changes permanent, the ASD(HA) will follow-up with final rulemaking. The ASD(HA) will publish a document in the Federal Register announcing the expiration date.

A novel coronavirus (SARS-CoV-2), which causes COVID-19, was first detected in December 2019 and has spread rapidly throughout the world. On January 31, 2020, the Secretary of the HHS determined that a PHE had existed since January 27, 2020. 1 On March 13, 2020, the President declared a national emergency due to the COVID-19 outbreak, retroactive to March 1, 2020 (Proclamation 9994, 85 FR 15337). Following the declaration of the national emergency, the President signed into law multiple statutes to provide economic and health care relief for individuals and businesses, including health care providers. One such law was the Coronavirus Aid, Relief, and Economic Security (CARES) Act (Pub. L. 116-136), which in part provided for waivers of certain reimbursement provisions under Medicare.

According to World Health Organization data on May 3, 2020, there were 3,349,786 confirmed cases of COVID-19 worldwide (238,628 confirmed deaths), with 1,093,880 confirmed cases in the U.S. (62,406 confirmed deaths), with the number of cases rapidly expanding each day. Medical experts from the National Institute of Allergy and Infectious Disease anticipate more cases in the U.S. and overseas in the coming months. 2

In light of the rapid spread of COVID-19, the Centers for Disease Control and Prevention has urged Americans to work and engage in schooling from home whenever possible as well as to avoid congregating in groups. Many States ( e.g., Washington, New York) and cities ( e.g., Los Angeles) imposed stay-at-home orders during the early months of the pandemic, closing all but essential businesses such as medical care and grocery stores, all to prevent further spread of the disease.

While stay-at-home orders and recommendations for social distancing have slowed the spread of COVID-19, there is currently no cure, nor are there any FDA approved vaccines indicated for the prevention of COVID-19. It is likely that the health care system, in the U.S. and abroad, will need to contend with this threat for months, if not years. Many COVID-19 treatments are being tried, including convalescent plasma from patients recovered from COVID-19 and new potential antiviral drugs.

A TRICARE COVID-19-related IFR published on May 12, 2020 (85 FR 27921), provides a temporary exception to the regulatory exclusion prohibiting audio-only telehealth services, temporarily eliminates copayments and cost-shares for TRICARE Prime and Select beneficiaries utilizing authorized telehealth services provided by network providers as a necessary incentive to prevent further spread of COVID-19, and temporarily authorizes reimbursement of interstate practice by providers (both in-person and remotely) for care provided to TRICARE beneficiaries when such practice is permitted by federal or state law, even if the provider is not licensed in the state where practicing. That IFR was focused on temporary changes to the TRICARE program to aid in slowing community transmission of COVID-19. This second IFR continues efforts by the ASD(HA) to implement temporary regulation changes in response to COVID-19 by focusing on temporary benefit and reimbursement changes that will support treatment of TRICARE beneficiaries. It also implements two permanent regulation changes consistent with the statutory requirement that TRICARE reimburse like Medicare, to the extent practicable.

Pursuant to the President's national emergency declaration and as a result of the worldwide COVID-19 pandemic, the ASD(HA) hereby modifies the following regulations, but in each case, only to the extent determined necessary to ensure that TRICARE beneficiaries have access to the most up-to-date care required for the diagnosis and treatment of COVID-19, and that TRICARE continues to reimburse like Medicare, to the extent practicable, as required by statute. The following regulations are temporarily modified (except NTAPs and HVBP, which are permanently modified):

a. 32 CFR 199.4(b)(3)(xiv): As required by law, 10 U.S.C. 1074j(b)(1), the TRICARE skilled nursing facility (SNF) benefit is provided in the manner and under the conditions established for the Medicare SNF benefit. Consistent with Medicare, then, TRICARE's regulation adopted Medicare's requirement that an individual was an inpatient of a hospital for not less than 3 consecutive calendar days before his discharge from the hospital (three-day prior hospital stay), for coverage of a SNF admission. Medicare, under its authority granted by Sections 1812(f) of the Social Security Act, has waived this requirement during the COVID-19 pandemic. As required by the TRICARE statute for the SNF benefit to mirror that of Medicare, this provision of the IFR temporarily waives the regulatory requirement for a three-day prior hospital stay for TRICARE beneficiaries, providing temporary emergency coverage for those beneficiaries who need to be transferred during the period of the COVID-19 pandemic. This temporary waiver is in effect for the duration of the President's national emergency for the COVID-19 outbreak, retroactive to March 1, 2020.

b. 32 CFR 199.4(g)(15): This change temporarily adds coverage for the use of investigational drugs for the treatment of COVID-19 under FDA's expanded access provision at 21 CFR 312, subpart I. Under this provision, TRICARE coverage of investigational drugs provided under expanded access will include both costs associated with administration of the investigational drug, as well as the cost of the investigational drug itself when the investigational drug is for the treatment of COVID-19. This will include investigational drugs and associated costs provided for treatment of patients under expanded access INDs and protocols s authorized by the FDA, but will not include use of investigational drugs in clinical trials. The temporary modification under paragraph 199.4(g)(15)(i)(A) is effective for the period of the President's national emergency for the COVID-19 outbreak, and will only apply to treatments for COVID-19. However, we plan to re-evaluate our current exclusion preventing coverage of investigational drugs provided for treatment use under expanded access and may make permanent revisions to the regulation, if appropriate, after a thorough evaluation of the costs, benefits, risks, and other considerations. We invite comment on the temporary coverage of investigational drugs provided under expanded access for the treatment of COVID-19, as well as potential future coverage of investigational drugs for treatment use under expanded access for individuals with serious or life-threatening diseases (not including clinical trials not otherwise covered by TRICARE) for potential inclusion in a future final rule.

c. 32 CFR 199.6(b)(4)(i): This change will temporarily exempt certain temporary hospital facilities and locations, and freestanding ASCs that enroll as hospitals with Medicare from the institutional provider requirements for acute care hospitals in 32 CFR 199.6(b)(4)(i), but only to the extent that such exemptions are required to ensure adequate beneficiary access to acute care facilities during the COVID-19 national emergency. Under current regulatory requirements, temporary hospital facilities (to include hospitals that are already TRICARE-authorized providers operating in a temporary location, such as a parking lot, or at a temporary facility, such as a repurposed convention center or an erected tent) and freestanding ASCs which provide inpatient and outpatient hospital services are not TRICARE-authorized providers because they do not meet the institutional provider requirements for hospitals. This temporary waiver of institutional requirements is consistent with Medicare's “Hospitals without Walls” initiative. It also is consistent with the statutory requirement at 10 U.S.C. 1079(i)(2), which establishes that the amount paid to hospitals and other institutional providers is in accordance with the same reimbursement methodology as apply to payments to providers of services of the same type under Medicare, when practicable. This temporary change is in effect for the duration of Medicare's “Hospitals without Walls” initiative for COVID-19.

d. 32 CFR 199.14(a)(1)(iii)(E): Adjustments to the DRG-based reimbursement amounts. TRICARE shall reimburse acute care hospitals a 20 percent increase of the DRG for an individual diagnosed with COVID-19, confirmed through documentation of a positive COVID-19 laboratory test in the patient's medical record, discharged during the COVID-19 PHE period, retroactive to January 27, 2020. Further, TRICARE shall permanently adopt (1) Medicare's NTAP payment adjustment to DRGs, for new technologies approved by Medicare, and (2) Medicare's HVBP Program. These changes are in accordance with the statutory requirement that TRICARE inpatient care “payments shall be determined to the extent practicable in accordance with the same reimbursement rules as apply to payments to providers of services of the same type under Medicare.” The ASD(HA) has determined that it is practicable to adopt this Medicare adjustment to the TRICARE DRG-based reimbursement amounts.

e. 32 CFR 199.14(a)(9): Reimbursement for inpatient services provided by a LTCH. By statute, 10 U.S.C. 1079(i)(2), TRICARE shall, to the extent practicable, reimburse institutional providers in accordance with Medicare reimbursement rules. As such, TRICARE has generally adopted the Medicare inpatient prospective payment system for LTCHs (32 CFR 199.14(a)(9)), including Medicare's site neutral payment provisions (adopted December 29, 2017). Section 3711 of the CARES Act directs Medicare to waive the site neutral payment provisions for LTCHs during the COVID-19 PHE period. The ASD(HA) has determined that it is practicable to temporarily adopt this Medicare LTCH reimbursement waiver of the site neutral payment provisions for LTCHs for a discharge if the admission occurs during the COVID-19 PHE, retroactive to January 27, 2020, and is in response to the COVID-19 PHE. The effective and expiration dates are consistent with Medicare's dates for their temporary waiver of LTCH site neutral payment provisions in response to COVID-19, as required by the statutory mandate that TRICARE reimburse like Medicare, where practicable.

f. Dates. These modifications will become effective on September 3, 2020, and will cease to be in effect upon termination of the President's declared national emergency, except as otherwise noted in this paragraph. The NTAPs and HVBP provisions are applicable beginning January 1, 2020, and will not expire. The SNF three-day prior stay waiver is applicable beginning March 1, 2020. The temporary hospital and freestanding ASC acute care hospital requirements waiver expires upon expiration of Medicare's “Hospitals without Walls” initiative. The temporary reimbursement changes (20 percent increased DRG for COVID-19 patients and LTCH changes) are applicable beginning January 27, 2020, and will cease to be in effect upon termination of the HHS Secretary's PHE. The Secretary of HHS used his authority in the Public Health Service Act to declare a PHE in the entire United States on January 31, 2020, effective January 27, 2020. Since Medicare's applicable period for the PHE began on January 27, 2020, TRICARE will also begin the applicable period for the PHE on January 27, 2020, for the increase of the DRG by 20 percent for COVID-19 discharges and for waiver of site neutral payment provisions for LTCHs with admissions occurring during the COVID-19 PHE and in response to the PHE. With TRICARE beneficiaries located worldwide, the ASD(HA), or designee, may allow the provisions of this IFR to continue after termination of the President's national emergency for some or all of TRICARE's overseas locations based on the status of COVID-19 community transmission in those locations. Such continuation of these provisions for overseas locations will be published in TRICARE's implementing instructions (TRICARE manuals), available at http://manuals.health.mil.

Certain provisions of this IFR may be made permanent while others are anticipated to be removed when the COVID-19 pandemic has concluded. The DoD may issue a final rule to make permanent changes.

Agency rulemaking is governed by section 553 of the Administrative Procedure Act (APA), 5 U.S.C. 551 et seq. Section 553(b) requires that, unless the rule falls within one of the enumerated exemptions, the DoD must publish a notice of proposed rulemaking in the Federal Register that provides interested persons an opportunity to submit written data, views, or arguments, prior to finalization of regulatory requirements. Section 553(b)(B) of the APA authorizes a department or agency to dispense with the prior notice and opportunity for public comment requirement when the agency, for “good cause,” finds that notice and public comment thereon are impracticable, unnecessary, or contrary to the public interest. Section 553(d)(3) requires that an agency must include an explanation of such good cause with the publication of the new rule.

As noted in this preamble, the U.S., as well as numerous other countries, have taken unprecedented measures to try to contain or slow the spread of COVID-19. While studies of potential treatments of COVID-19 are in progress, these studies are expected to take time. Unfortunately, TRICARE beneficiaries infected with COVID-19 may not have time to wait for these treatments, given the rapidity with which the disease overtakes infected individuals who develop the most severe responses to the illness. Additionally, hospital resources being flexed to respond to COVID-19 cannot wait for the reimbursement relief offered in this IFR.

Given the national emergency caused by COVID-19, it would be impracticable and contrary to the public health—and, by extension, the public interest—to delay these implementing regulations until a full public notice-and-comment process is completed.

Additional good cause exists to publish as an IFR the permanent amendments to the TRICARE regulation regarding adoption of the Medicare DRG adjustments for NTAP and the HVBP Program. As previously noted, TRICARE is mandated by law, 10 U.S.C. 1079(i)(2), to reimburse institutional providers using the Medicare reimbursement methodologies, to the extent practicable. Also, TRICARE is required by section 705(a) of the National Defense Authorization Act (NDAA) to implement a value-based incentive program to encourage health care providers to improve the quality and delivery of services to TRICARE beneficiaries. The ASD(HA) is authorized by the Act to adopt value-based programs created by the CMS. As such, the ASD(HA) has determined that it is practicable to adopt as TRICARE DRG-based reimbursement adjustments, the Medicare NTAP and HVBP Program adjustments which Medicare has implemented through formal rule-making. In exercising his discretionary authority under statute, the ASD(HA) has determined that the purpose for prior notice and public comment has been satisfied by the Medicare rule-making and that good cause exists to avoid delay as further notice and public comment would be impracticable, unnecessary, or contrary to the public interest. Nonetheless, public comments on this IFR are invited and DoD is committed to considering all comments and issuing a final rule as soon as practicable.

Therefore, pursuant to 5 U.S.C. 553(b)(B), and for the reasons stated in this preamble, the ASD(HA), concludes that there is good cause to dispense with prior public notice and the opportunity to comment on this rule before finalizing this rule. For the same reasons, the ASD(HA) has determined, consistent with section 553(d) of the APA, that there is good cause to make this IFR effective immediately upon publication in the FR, with applicability of its provisions to coincide with the President's national emergency for the COVID-19 outbreak or the HHS Secretary's PHE, as stated in this rule.

This provision, 32 CFR 199.4(b)(3)(xiv), temporarily waives the requirement that an individual was an inpatient of a hospital for not less than 3 consecutive calendar days before his discharge from the hospital (three-day prior hospital stay), for coverage of a SNF admission, for those beneficiaries who need to be transferred as a result of the effect of the COVID-19 pandemic. This will align TRICARE's benefit with Medicare's for SNF admission as required by 10 U.S.C. 1074j(b), as Medicare has waived its three-day prior hospital stay requirement during the COVID-19 pandemic.

This provision, 32 CFR 199.4(g)(15)(i)(A), temporarily modifies TRICARE regulations for coverage of investigational drugs provided for treatment use under expanded access authorized by the FDA in a patient who is seriously ill or has a life threatening condition. Title 10 U.S.C. 1079(a)(12) mandates care provided to TRICARE beneficiaries to be medically or psychologically necessary, unless that care is provided by a Christian Science practitioner or in a National Institute of Health clinical trial when there is an agreement with HHS.

The existing regulations on treatment use of investigational drugs were first implemented in 1996 (62 FR 625), in a final rule that codified TRICARE procedures for determining when care provided to TRICARE beneficiaries is medically necessary under the statute. The regulations, minus minor revisions to the definition of off-label drugs and devices and removal of a list of unproven treatments, are unchanged from their establishment almost twenty-five years ago. The regulations currently allow for coverage of care associated with treatment investigational new drugs (INDs), but do not permit coverage of the treatment IND itself because a treatment IND is not labeled for commercial marketing in the U.S. Treatment INDs are one type of treatment use of investigational drugs under expanded access and are the only type mentioned in the regulation.

While we were considering potential temporary regulatory changes required in response to COVID-19, we found it appropriate to reconsider coverage of treatment INDs, and, in doing so, opted to expand our consideration to the larger universe of investigational drugs provided for treatment use under expanded access. FDA's regulations on expanded access of investigational drugs for treatment use are provided at 21 CFR, subpart I. Generally, drugs provided for treatment use under expanded access have not yet been approved for commercial marketing by the FDA. In these cases, a drug being studied in clinical trials might be used for treatment outside of such trials for patients for which there is no alternative. The FDA permits treatment use of an investigational drug under expanded access when the drug would treat a serious or life-threatening illness when there is no comparable or satisfactory alternative, the potential patient benefit justifies the potential risks of the treatment use, and providing the investigational drug will not compromise the potential development or interfere with the clinical investigations that could support marketing approval of the investigational drug for the expanded access use. Treatment use with an investigational drug under expanded access is subject to the requirements for informed consent and institutional review board review and approval.

Under this temporary provision, we will, for the first time, cover not just the care associated with administration of an investigational drug, but the investigational drug itself, when the investigational drug is for the treatment of COVID-19 or its associated sequelae. This use may be authorized in any setting for which the FDA allows treatment use of an investigational drug under expanded access to proceed. As an example, convalescent plasma, an investigational product, is the donated plasma from a person who has recovered from COVID-19, which is administered to a COVID-19 patient under the hypothesis that antibodies will aid the ill person in fighting the disease. Convalescent plasma has not yet been approved by the FDA for use in treating COVID-19, but is currently available for administering or studying through clinical trials or expanded access. Expanded access allows for treatment of patients with serious or life-threatening symptoms of COVID-19 but who are unable to participate in clinical trials. Treatment use of an investigational drug under expanded access is being offered on a case-by-case basis as an emergency individual treatment, and on a larger scale in participating acute care facilities where authorization has already been given to the facility prior to need by the individual patient, essentially speeding access to the treatment. Allowing TRICARE beneficiaries access to investigational drugs for serious and life-threatening COVID-19 conditions under expanded access is essential given the rapid progression of the disease and the lack of FDA-approved alternatives. We note, however, that if a manufacturer, provider, or supplier does not charge other payers, including other Federal payers, then billing TRICARE for an investigational drug may constitute inappropriate billing practices under § 199.9 of this regulation. In other words, if a drug manufacturer makes an investigational drug available for treatment use under expanded access at reduced or no cost to non-TRICARE patients, they are expected to provide the investigational drug to TRICARE patients at the same reduced or no-cost.

For beneficiaries overseas, TRICARE has long had a policy exemption for non-FDA-approved drugs due to differences in the way prescription drugs are managed outside of the United States. When implementing this temporary regulation change, the DHA intends to permit coverage of similar investigational drugs for treatment use overseas when the criteria are substantially similar to the use of investigational drugs for treatment use under expanded access in the U.S. That is, the drug is intended to treat a serious or life-threatening case of COVID-19 or its sequelae when there is no satisfactory or comparable alternative, the potential patient benefit justifies the potential risks of the treatment use, and providing the investigational drug will not compromise the potential development or interfere with the clinical investigations that could support marketing approval of the investigational drug for the expanded access use.

The change under this provision is temporary for the duration of the President's national emergency for the COVID-19 outbreak. An investigational drug provided for treatment use under expanded access under the requirements of this provision may continue to be covered beyond the national emergency if the course of treatment was started prior to the end of the national emergency. We intend to use this national emergency period to re-evaluate our current exclusion on coverage of treatment INDs and may revise the regulation to cover investigational drugs for treatment use under expanded access for all indications if appropriate after a thorough evaluation of the costs, benefits, risks, and other considerations. We invite public comment on this provision.

Due to the lack of hospital capacity and the strain on resources such as hospital beds as a result of the COVID-19 pandemic, state governments, existing hospitals, and other entities have begun constructing temporary hospital facilities (also known as temporary expansion sites and alternate care sites) to (1) treat patients recovering from COVID-19; and (2) treat patients with other conditions in order to mitigate their exposure to COVID-19. These temporary hospital facilities are typically operated by the U.S. Armed Forces, local or state governments, or existing hospital systems using HHS and the Army Corps of Engineers guidance on the establishment, operationalization, and management of alternate care sites. Additionally, ASCs have begun performing services typically provided in inpatient hospital settings to protect patients from exposure to COVID-19 and to reduce the strain on hospital resources.

As part of their IFR with Comment published April 6, 2020 (85 FR 19230), CMS announced their “Hospitals without Walls” initiative, through which CMS will permit Medicare coverage for services and supplies provided in temporary hospital locations and facilities, and allow freestanding ASCs to enroll as hospitals and provide inpatient and outpatient hospital services. Specifically, CMS is waiving requirements under the Medicare conditions of participation related to physical environment (42 CFR 482.41) and physical plant and environment (42 CFR 485.623), and the provider-based department requirements at 42 CFR 413.65. Under these waivers, Medicare is requiring that ASCs enroll as hospitals and that temporary hospital facilities meet the hospital conditions of participation in effect during the COVID-19 PHE. Temporary hospital facilities include (1) a hospital providing services at a location other than the hospital's physical structure ( e.g., the hospital parking lot) and (2) when a hospital is handling the majority of the operations of an alternate care site ( e.g., a hospital set up in a convention center).

While there are no direct corollaries in TRICARE regulation to those requirements being waived under Medicare, there do exist in TRICARE regulation certain requirements that would prevent similarly authorizing temporary hospitals and allowing freestanding ASCs to be considered as hospitals for the purposes of payment. 32 CFR 199.6(b)(4)(i) lists the requirements for providers to be considered TRICARE-authorized acute care hospital providers. It may not be possible for many temporary hospital facilities to meet all of these requirements, such as having Joint Commission (previously known as the Joint Commission on Accreditation of Hospitals) accreditation status or surveying of new facilities. Additionally, freestanding ASCs that are already TRICARE-authorized providers cannot register as hospitals because, at a minimum, they do not meet the requirement of primarily providing services to inpatients and they may not meet certain other requirements such as Joint Commission accreditation. While we assert that these institutional requirements continue to be necessary for acute care hospitals, we also recognize that during the national emergency for the COVID-19 outbreak, it may be necessary to relax some of these requirements so that beneficiaries can be assured of access to acute care settings. Unlike Medicare, TRICARE lacks the authority to waive individual regulatory requirements for any type of provider without rulemaking. Therefore, this provision will temporarily waive the acute care hospital institutional provider requirements in 32 CFR 199.6(b)(4)(i) for temporary hospital facilities and freestanding ASCs that enroll as hospitals with Medicare, but only to the extent necessary to ensure that TRICARE beneficiaries receive adequate access to acute inpatient care during the COVID-19 pandemic. The Director of the Defense Health Agency (DHA), may establish further requirements for such facilities in the implementing instructions (as found in the TRICARE manuals).

Our intent is to adopt certain requirements related to Medicare's “Hospitals without Walls” waiver to allow hospital services to be provided in temporary hospital facilities for the duration of the President's national emergency for the COVID-19 outbreak. Although there is no requirement to adopt Medicare's condition of participation requirements for hospitals, this provision does support the statutory directive in 10 U.S.C. 1079(i)(2) to pay like Medicare, when practicable. Title 10 U.S.C. 1079(i)(2) establishes that the amount paid to hospitals and other institutional providers is in accordance with the same reimbursement methodology, to the extent practicable, as apply to payments to providers of services of the same type under Medicare. Under this provision, hospitals that are already TRICARE-authorized providers and are operating in a manner consistent with their state's emergency plan in effect during the COVID-19 Presidential national emergency, will be reimbursed for covered inpatient and outpatient services using the same methodologies as if those services were provided at their permanent locations. Freestanding ASCs that enroll with Medicare as a hospital can also change their ASC status to a hospital under TRICARE. This means that, depending on the type of service provided, TRICARE's DRG System or Outpatient Prospective Payment System will be used for reimbursement. If a freestanding ASC initially enrolls as a hospital, but later changes their enrollment status back to an ASC, or if Medicare terminates the ASC's hospital status, then TRICARE will no longer recognize that ASC as being a hospital, effective the date of the enrollment status changes. If Medicare alters its requirements for coverage of temporary hospitals or freestanding ASCs acting as hospitals, the Director of DHA, or designee, will evaluate those changes and adopt, when practicable, in the implementing instructions.

These changes align with Medicare's “Hospitals without Walls” initiative. While we are waiving the institutional provider requirements under paragraph 199.6(b)(4)(i), we are still requiring that temporary hospital facilities and freestanding ASCs meet Medicare's conditions of participation established for this Presidential national emergency, which coincide with many of TRICARE's requirements for hospitals, such as operational, staffing, and supervisory requirements. This change will also improve the access of beneficiaries to medically necessary care provided in temporary hospital facilities and freestanding ASCs and may improve outcomes for beneficiaries by allowing them to receive treatment in facilities that are being used to prevent the spread of COVID-19 to COVID-19-negative patients and to mitigate hospitals' lack of capacity and shortages of resources. This change is temporary for the duration of Medicare's “Hospitals without Walls” initiative.

This IFR implements three changes to DRG-based payment amounts. By statute, 10 U.S.C. 1079(i)(2), TRICARE shall, to the extent practicable, reimburse institutional providers in accordance with Medicare reimbursement rules. As such, TRICARE has generally adopted the Medicare inpatient prospective payment system (DRG; e.g., see 32 CFR 199.14(a)(1)). The first DRG-based payment modification is a result of Section 3710 of the CARES Act, which directed Medicare to increase the weighting factor of the assigned DRG by 20 percent for an individual diagnosed with COVID-19 discharged during the COVID-19 PHE period. The ASD(HA) has determined that it is practicable to adopt this Medicare DRG adjustment and issues this IFR to adopt Medicare's increase of the DRG by 20 percent for an individual diagnosed with COVID-19 discharged during the COVID-19 PHE period, retroactive to January 27, 2020.

The second DRG-based payment modification in this IFR permanently adopts Medicare's NTAPs. The Benefits and Improvement Protection Act of 2000 mandated CMS to establish a process of identifying and ensuring adequate payment for new medical services and technologies under Medicare. In CMS' September 7, 2001, final rule (66 FR 46902), Medicare established a methodology to provide hospitals with a new type of outlier payment for new medical services and technologies furnished to Medicare beneficiaries. CMS implemented the NTAPs in Fiscal Year (FY) 2003.

While it may have been practicable for TRICARE to adopt CMS' NTAPs when enacted, there was no means to allow coverage for these emerging technologies. Coverage of a particular new technology under Medicare does not guarantee coverage under TRICARE. The TRICARE benefit is covered by a separate set of statutes and while benefits under the two programs are similar, they are not identical. Initially, these emerging technologies would not have met the coverage criteria under TRICARE's hierarchy of reliable evidence, so the NTAP was not adopted. Over time, though, Medicare's NTAP provision has added items permitted by TRICARE ( e.g., orphan drugs for rare diseases). Since all current NTAPs are permitted by TRICARE, and any future NTAPs are required to be a TRICARE benefit, we find it appropriate to adopt Medicare's NTAP provision now, in order to ensure this payment methodology is available for TRICARE beneficiaries.

When TRICARE covers emerging technology as a benefit under existing statute and regulation, the DHA will adopt the new technologies DRG add-on payment. DHA further adopts CMS' NTAP methodology as specified in 42 CFR 412.87 and 412.88. DHA will follow CMS' effective date for NTAPs ( i.e., currently the FY begin date), and will adopt any changes to the Medicare effective date in the future. Medicare typically provides NTAPs for two to three years (depending on when the technology receives FDA marketing authorization). This provision is effective from January 1, 2020, and we will issue a final rule to permanently allow NTAPs in the future.

We invite public comment on all parts of this provision of the IFR, including permanent adoption of NTAPs. We feel that since Medicare has already published a final rule for the NTAP and collected public comment, it is appropriate for TRICARE to adopt under this IFR. The ASD(HA) has determined that it is practicable to adopt this Medicare DRG adjustment and issues this IFR to adopt Medicare's NTAP for otherwise authorized TRICARE services and supplies.

The final DRG-based payment modification in this IFR permanently adopts Medicare's HVBP program. Section 705(a) of the NDAA for FY 2017 authorizes the development and implementation of value-based incentive programs to encourage health care providers to improve the quality and delivery of services to Medicare beneficiaries. The statute further allows the Secretary to adopt value-based incentive programs conducted by CMS or any other federal government, state government, or commercial health care program in fulfillment of the statutory authority granted under this section.

Congress authorized the Medicare Inpatient HVBP in Section 3001(a) of the Patient Protection and Affordable Care Act. The program uses the hospital quality data reporting infrastructure that was developed for the Hospital Inpatient Quality Reporting Program, authorized by Section 501(b) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003. The Medicare HVBP program provides incentives to hospitals that show improvement in areas of health care delivery, process improvement, and increased patient satisfaction. The program is budget-neutral with a two percent reduction in hospitals' base payments being redistributed by Medicare to hospitals in the form of incentive payments based on the hospital's Total Performance Score.

Per 10 U.S.C. 1079(i)(2), the amount to be paid to hospitals, SNFs, and other institutional providers under TRICARE shall, by statute, be established “to the extent practicable in accordance with the same reimbursement rules as apply to payments to providers of services of the same type under Medicare.” This IFR adopts Medicare's HBVP program for TRICARE, in accordance with this statutory requirement and encouragement by Congress to adopt value-based payment mechanisms.

TRICARE will continue to use its current method of calculating hospital DRG weights and rates. Medicare hospital payment adjustments would be obtained and applied from the CMS website by the Managed Care Support Contractors. The Medicare provider identification number will then be used to match the HVBP adjustments to the correct claim and apply the adjustment factor to each TRICARE discharge. Adopting Medicare's HVBP program approach would not require any additional reporting from TRICARE hospitals, as they are currently participating in the Medicare HVBP program. DHA will adopt the HVBP adjustment. DHA further adopts CMS' HVBP program and methodology. This provision is applicable from January 1, 2020, and we will issue a final rule to permanently allow Medicare's HVBP adjustments in the future.

We invite public comment on all parts of this provision of the IFR, including permanent adoption of HVBP. We feel that since Medicare has already published a final rule for the HVBP and collected public comment, it is appropriate for TRICARE to adopt under this IFR. The ASD(HA) has determined that it is practicable to adopt this Medicare DRG adjustment and issues this IFR to adopt Medicare's HVBP Program.

Title 32 CFR 199.14(a)(9) Reimbursement for inpatient services provided by an LTCH. TRICARE shall reimburse all LTCH cases with an admission date occurring on or after January 27, 2020, and admitted during the COVID-19 PHE period, the LTCH PPS standard Federal rate for claims. This is in accordance with the statutory requirement that TRICARE inpatient care “payments shall be determined to the extent practicable in accordance with the same reimbursement rules as apply to payments to providers of services of the same type under Medicare.”

This rule is issued under 10 U.S.C. 1073(a)(2) giving authority and responsibility to the Secretary of Defense to administer the TRICARE program. The text of 10 U.S.C. chapter 55 can be found at https://manuals.health.mil/.

Each of the sections being modified by this rule are revised every few years to ensure requirements continue to align with the evolving health care field. Title 32 CFR 199.4 was most recently updated on September 29, 2017, with an IFR (82 FR 45438) that implemented the Congressionally-mandated TRICARE Select benefit plan. Its revision to 32 CFR 199.4 included the addition of medically necessary foods as a benefit under the TRICARE Basic Program. Two paragraphs within § 199.4 are being modified by this IFR.

Paragraph 199.4(b)(3)(xiv) was originally created on June 13, 2002 (67 FR 40602), as part of an IFR partially implementing the TRICARE “sub-acute and long-term care program reform” enacted by Congress in the National Defense Authorization Act for Fiscal Year 2002, which created 10 U.S.C. 1074j, Sub-Acute Care Program. TRICARE covered SNF care prior to this change, but the NDAA required TRICARE to model its SNF program on Medicare's, with the exception of Medicare's day limits. The regulation adopted Medicare's prospective payment method and most of its benefit structure for SNF care, including Medicare's three-day prior stay rule. Prior to this change, TRICARE did not have a three-day prior stay rule. Paragraph 199.4(b)(3)(xiv) has not been revised since its enactment.

The provisions of paragraph 199.4(g)(15) were last revised on June 27, 2012 (77 FR 38177), with a clarification of the definition of off-label coverage of drugs and devices, and the removal a partial list of unproven drugs, devices, and medical treatments or procedures. The partial list of unproven treatments was eliminated due to rapid and extensive changes in medical technology that made it infeasible to maintain the list through updates to the regulation. The final rule stated unproven treatments would continue to be listed in the TRICARE manuals.

Title 32 CFR 199.6 was last revised on March 17, 2020 (85 FR 15061); the change added licensed or certified physical therapist assistants and occupational therapy assistants as TRICARE-authorized providers. Paragraph 199.6(b)(4)(i) with requirements for acute care hospitals is a long-standing component of the TRICARE program that has not been revised for over 20 years.

Title 32 CFR 199.14 was last revised on February 15, 2019 (84 FR 4333), as part of the final rule implementing the TRICARE Select benefit program. The revision to § 199.14 delayed the effective date for updates to the Civilian Health and Medical Program of the Uniformed Services (CHAMPUS) DRG-based payment system based on Medicare's Prospective Payment System to January 1 of each year, the start date for the program year under TRICARE Select. Two paragraphs within § 199.14 are modified by this IFR.

The first, paragraph 199.14(a)(1)(iii)(E), was last substantially revised with a final rule published on September 10, 1998 (63 FR 48446). Due to an error in the final rule, the changes were not formalized until a technical revision was published via a final rule correction issued on November 8, 1999 (64 FR 60671). This change updated numerous portions of § 199.14 to more closely align TRICARE reimbursement with Medicare's. This rule revised paragraph 199.14(a)(1)(iii)(E) regarding calculation of the indirect medical education adjustment factor, as well as the calculation of cost outlier payments for children's hospitals.

The second, paragraph 199.14(a)(9), was most recently modified on December 29, 2017 (82 FR 61692), as part of a final rule establishing reimbursement rates for LTCHs in accordance with the requirement that TRICARE reimburse like Medicare for services of the same type. Prior to that, TRICARE covered care in LTCHs but did not follow Medicare's DRG, instead reimbursing billed charges or network discount.

Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. Accordingly, the rule has been reviewed by the Office of Management and Budget under the requirements of these Executive Orders. This rule has been designated a “significant regulatory action” although, not determined to be economically significant, under section 3(f) of Executive Order 12866.

The modifications to paragraph 199.4(b)(3)(xiv) in this IFR will temporarily waive the requirement that an individual was an inpatient of a hospital for not less than 3 consecutive calendar days before his discharge from the hospital (three-day prior hospital stay), for coverage of a SNF admission for those beneficiaries who need to be transferred as a result of the effect of COVID-19.

The modification to paragraph 199.4(g)(15)(i)(A) in this IFR will temporarily allow changes to the TRICARE benefit by authorizing cost-sharing of investigational drugs for the treatment of COVID-19 and its sequelae under expanded access. This will expand existing coverage, which only permits coverage of care associated with administration of a treatment IND, but not the investigational drug itself. This coverage will be authorized for treatment use of an investigational drug under expanded access but not in clinical trials.

The modifications to paragraph 199.6(b)(4)(i) in this IFR will temporarily exempt temporary hospital facilities and freestanding ASCs that enroll as hospitals with Medicare from the institutional provider requirements for acute care hospitals described in paragraph 199.6(b)(4)(i). This will allow these facilities to provide inpatient and outpatient hospital services to improve the access of beneficiaries to medically necessary care. This change is also consistent with 10 U.S.C. 1079(i)(2) to reimburse hospitals and other institutional providers in accordance with the same reimbursement methodology as Medicare, when practicable.

The modifications to paragraph 199.14(a)(1)(iii)(E) in this IFR will temporarily adopt the Medicare Hospital Inpatient Prospective Payment Add-On Payment for COVID-19 patients during the COVID-19 PHE period, permanently adopt Medicare's NTAP payment and HVBP Program. The add-on payment for COVID-19 patients increases the weighting factor that would otherwise apply to the DRG to which the discharge is assigned, by 20 percent. The NTAP allows for an additional payment in addition to the DRG payment, for new and emerging technologies approved by Medicare. The HVBP Program provides incentives to hospitals that show improvement in areas of health care delivery, process improvement, and increased patient satisfaction.

The modifications to paragraph 199.14(a)(9)(i) in this IFR will adopt the Medicare waiver of site neutral payment provisions for LTCHs during the COVID-19 PHE period. This modification waives the site neutral payment provisions, and reimburses all LTCH cases at the LTCH PPS standard Federal rate for claims within the COVID-19 PHE period.

This change impacts all TRICARE beneficiaries who have a serious or life threatening case of COVID-19 and would benefit from treatment with an investigational drug under expanded access. TRICARE-authorized providers will be impacted by being able to treat those patients receiving an investigational drug for treatment use under expanded access. SNFs, LTCHs, and inpatient hospital care providers will be impacted by receiving reimbursement consistent with Medicare's reimbursement both for COVID-19 patients and under the NTAP and HVBP payment provisions. TRICARE's health care contractors will be impacted by being required to implement the provisions of this regulatory change. State, local, and tribal governments will not be impacted.

The cost estimates related to the changes discussed in this IFR include incremental health care cost increases as well as administrative costs to the government. The duration of the COVID-19 national emergency and HHS PHE are uncertain, resulting in a range of estimates for each provision in this IFR. Cost estimates are provided for an approximate nine-month (ending 12/31/2020) and eighteen-month scenario (ending 9/30/2021). The nine-month and 18-month periods would be longer for those provisions applicable beginning in January of this year, and shorter for those effective the date this IFR publishes. The terms nine-month and 18-month period are used throughout this estimate for the sake of simplicity.

The cost estimates consider whether the outbreak will have more than one active stage. The first active stage is considered to be March through August 2020, based on the Institutes for Health Metrics and Evaluation data as of May 27, 2020. 3 A two-wave scenario would have a second stage in winter/spring 2021, while a three-wave scenario would have additional waves from September 2020 to December 2020 and from January 2021 to June 2021.

Based on these factors, we estimate that the total cost estimate for this IFR will be between $43.6M and $59.4M for a nine-month period, and $66.3M to $82.1M for an 18-month period. This estimate includes just over $1M in administrative start-up costs and no ongoing administrative costs. The primary cost drivers in this analysis are the reimbursement changes being adopted under the statutory requirement that TRICARE reimburse like Medicare; that is, the 20 percent DRG increase for COVID-19 patients, the adoption of NTAPs and HVBP, and the waiver of LTCH site neutral payment reductions.

A breakdown of costs, by provision, is provided in the below table. A discussion of assumptions follows.

Assumptions specific to the estimates for each individual provision are explained below.

• SNF Three Day Prior Stay. A three-percent increase in SNF admissions directly from the community was assumed.

• Treatment use of Investigational Drugs for COVID-19 or Associated Sequelae under Expanded Access. The Expanded Access cost estimate assumes that investigational drugs for the treatment of COVID-19 under expanded access available during the period of the national emergency would include convalescent plasma (approximately $1,000 per patient), a new hospital-based infusion antiviral ($2,500 per patient), and two oral antivirals ($200 per 10-pack). The number of investigational drugs available to TRICARE beneficiaries, the extent to which the FDA authorizes expanded access to such investigational drugs for treatment use, and the length of time until marketing approval of the drug by FDA, or emergency use authorization, are highly uncertain.

• Temporary Hospitals and Freestanding ASCs Registering as Hospitals. This zero cost estimate assumes that inpatient care provided in these alternate sites is care that would have been reimbursed under TRICARE but for a lack of acute care hospital facility space ( i.e., we do not estimate that there would be any induced demand because of an increase in facilities). Additionally, it assumes that while reimbursement for outpatient procedures in freestanding ASCs would be higher than had those procedures been reimbursed under the traditional reimbursement rates for freestanding ASCs, the number of facilities choosing to register as hospitals is likely to be small enough to have a negligible impact on the budget.

• DRG Increase for COVID-19 Patients. Under a three-wave scenario, we assumed a total of 34,300 TRICARE beneficiaries under the age of 65 would be hospitalized with diagnoses related to COVID-19 during the 18-month period. Total cost for hospitalization of these patients would be $390M, with $51M as the incremental cost increase of implementing the 20 percent DRG increase. We did not include Medicare-eligible patients in our estimate, as TRICARE's cost-share would not change for these patients.

• NTAPs. We assumed TRICARE NTAPs would be a similar percentage of inpatient spending to Medicare's NTAP usage and that TRICARE would adopt all of Medicare's NTAPs. This amount will vary depending on the number of new NTAPs adopted by Medicare each year, the extent to which Medicare-identified emerging technologies are covered under TRICARE's statutory and regulatory requirements, and the extent to which TRICARE's population utilizes these technologies. The costs for this provision may overestimate the incremental costs of this regulatory change, because many of these claims are being approved on a case-by-case basis by the Director, DHA, under waiver authority. In those cases, adopting NTAPs is likely to reflect a cost savings, as waivers are typically paid at billed charges.

• HVBP Program. Due to our retroactive implementation of the HVBP Program, we anticipate that those hospitals qualifying for a positive adjustment for prior claims would do so, while those with negative adjustments or adjustments close to zero dollars would not. This would result in a cost in the first year, with claims in following years assumed to be budget neutral.

• LTCH Site Neutral Payments. TRICARE is in the process of phasing in Medicare's site-neutral payment rates. This cost estimate assumes that phase-in is halted and all TRICARE LTCH claims are paid at the full LTCH PPS rate.

Depending on the impact of certain provisions of this IFR, some cost savings could be achieved from a reduction in hospitalization rates ( i.e., use of investigational drugs for treatment use under expanded access), estimated from no savings to $40M over 18 months. The amount of cost-savings achieved will be determined by the therapies developed, how widespread their usage is, the extent to which the therapies are authorized for treatment use under expanded access, the effectiveness of the therapies in reducing hospitalizations and/or the use of mechanical ventilators, and how long the therapies remain investigational before transitioning to FDA-approval or emergency use authorization.

Any benefits achieved in reduced hospitalizations and/or mechanical ventilator use are also benefits to TRICARE beneficiaries, for whom avoidance of more serious COVID-19 illness is of paramount concern. While we cannot estimate the value of this avoidance in quantitative figures, the potential long-term consequences of a serious COVID-19 illness, including permanent cardiac or lung damage, are not insignificant. If beneficiaries are able to access emerging therapies that prevent long-term consequences (including death), this will be a benefit to the beneficiary.

The largest creators of costs under this IFR (reimbursement changes) are not anticipated or intended to create any cost savings. However, these changes will benefit TRICARE institutional providers and take stress off the entire health care system by ensuring adequate reimbursement during the PHE, at a time during which hospitals are losing revenue due to reduced elective procedures and patients who delay care due to fears of contracting COVID-19 during health care encounters. Ensuring a robust health care system is of benefit to our beneficiaries and the general public, particularly in rural or underserved areas, even though this benefit is not quantifiable.

The benefit changes in this IFR will positively impact TRICARE beneficiaries diagnosed with COVID-19 by ensuring that they have access to treatment with investigational drugs authorized by the FDA under expanded access (not in clinical trial settings). This change expands the therapies available to TRICARE beneficiaries while doing so in settings that ensure informed consent of the beneficiary, and that the benefits of treatment outweigh the potential risks. Providers will be positively impacted by being able to provide their patients with a broader range of treatment options. The expansion of providers who can provide inpatient and outpatient hospital services positively benefits beneficiaries, who will have increased access to acute care facilities, and providers, who will have increased options for providing their beneficiaries with said care. SNFs and acute care hospitals will be positively impacted by the ability to more quickly transition patients from acute care to skilled nursing care. LTCH and inpatients hospitals will be positively impacted by increased reimbursement when caring for patients with COVID-19.

The DoD considered several alternatives to this IFR. The first alternative involved taking no action. Although this alternative would be the most cost neutral for DHA, it was rejected as not addressing the urgent medical needs of the beneficiary population in response to the COVID-19 pandemic. Additionally, it would fail to fulfill the statutory mandate that TRICARE reimburse like Medicare.

The second alternative the DoD considered was implementing a more limited benefit change for COVID-19 patients by not covering investigational drugs for treatment use under expanded access. While this would have the benefit of reimbursing only care that has more established evidence in its favor, this alternative is not preferred because early access to treatments is critical for TRICARE beneficiaries given the rapid progression of the disease and the lack of available approved treatments.

The Secretary certifies that this IFR is not subject to the flexibility analysis requirements of the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ) because it would not, if promulgated, have a significant economic impact on a substantial number of small entities. The great majority of hospitals and most other health care providers and suppliers are small entities, either by being nonprofit organizations or by meeting the SBA definition of a small business (having revenues of less than $8.0 million to $41.5 million in any one year). Individuals and states are not included in the definition of a small entity. The provisions of this IFR that are most likely to have an economic impact on hospitals and other health care providers are the reimbursement provisions adopted to meet the statutory requirement that we reimburse like Medicare. As its measure of significant economic impact on a substantial number of small entities, HHS uses an adverse change in revenue of more than 3 to 5 percent. While TRICARE is not required to follow this guidance in the issuance of our rules, we provide this metric for context, given that these temporary changes align with similar changes made by Medicare.

Given that the temporary reimbursement provisions of this IFR increase reimbursement for hospitals and LTCHs, we find that these provisions would not have an adverse impact on revenue for hospitals and, therefore, would not have a significant impact on these hospitals and other providers meeting the definition of small business. We also find that NTAPs, given that they increase revenue under the DRG system, would not have an adverse impact on hospitals and providers. The HVBP program would not reduce revenue for a hospital being penalized under the system beyond the HHS threshold. Lastly, coverage of investigational drugs for treatment under expanded access and allowing temporary hospitals and freestanding ASCs to register as inpatient hospitals are not expected to result in any adverse economic impact on hospitals or other health care providers.

Therefore, the Regulatory Flexibility Act, as amended, does not require us to prepare a regulatory flexibility analysis.

Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq. ), the Office of Information and Regulatory Affairs designated this rule as not a major rule, as defined by 5 U.S.C. 804(2).

Section 202 of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1532) requires agencies to assess anticipated costs and benefits before issuing any rule whose mandates require spending in any one year of $100 million in 1995 dollars, updated annually for inflation. This IFR will not mandate any requirements for State, local, or tribal governments, nor will it affect private sector costs.

It has been determined that 32 CFR part 199 does not impose reporting or recordkeeping requirements under the Paperwork Reduction Act of 1995.

Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates an IFR (and subsequent final rule) that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has Federalism implications. This IFR does not preempt State law or impose substantial direct costs on State and local governments.

Accordingly, 32 CFR part 199 is amended as follows:

Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA.

On June 18, 2020 (85 FR 36823), EPA issued a notice of proposed rulemaking (NPRM) for the State of Rhode Island. In the NPRM, EPA proposed approval of a SIP revision submitted by Rhode Island on September 20, 2019. The SIP revision contains a certification that Rhode Island has met all RACT requirements for the 2008 and 2015 8-hour ozone NAAQSs and updates the SIP with the following changes to Title 250 Rhode Island Code of Regulations (RICR), Chapter 120 Air Resources, Subchapter 05 Air Pollution Control: Part 0 General Definitions Regulation; Part 11 Petroleum Liquids Marketing and Storage; Part 15 Control of Organic Solvent Emissions; Part 19 Control of Volatile Organic Compounds from Coating Operations; Part 21 Control of Volatile Organic Compound Emissions from Printing Operations; Part 25 Control of Volatile Organic Compound Emissions from Cutback and Emulsified Asphalt; Part 26 Control of Organic Solvent Emissions from Manufacturers of Synthesized Pharmaceutical Products; Part 27 Control of Nitrogen Oxide Emissions; Part 35 Control of Volatile Organic Compounds and Volatile Hazardous Air Pollutants from Wood Product Manufacturing Operations; Part 36 Control of Emissions from Organic Solvent Cleaning; Part 44 Control of Volatile Organic Compounds from Adhesives and Sealants; and Part 51 Control of Volatile Organic Compound Emissions from Fiberglass Boat Manufacturing.

The NPRM provides the rationale for EPA's proposed approval, which will not be restated here. EPA received no comments on the NPRM.

EPA is approving the Rhode Island SIP revision as meeting the State's RACT obligations for the 2008 and 2015 8-hour ozone NAAQSs as set forth in sections 182(b), 182(f) and 184(b)(2) of the CAA, and is adding to the SIP the State's submission entitled “Reasonably Available Control Technology State Implementation Plan Revision 2008 and 2015 Ozone National Ambient Air Quality Standards” dated September 20, 2019, which also includes twelve negative declarations for CTG source categories. EPA is also approving Subchapter 05 Air Pollution Control changes to the Rhode Island SIP. Specifically, revisions to Part 0 General Definitions Regulation, Part 11 Petroleum Liquids Marketing and Storage, Part 15 Control of Organic Solvent Emissions, Part 19 Control of Volatile Organic Compounds from Coating Operations, Part 21 Control of Volatile Organic Compound Emissions from Printing Operations, Part 25 Control of Volatile Organic Compound Emissions from Cutback and Emulsified Asphalt, Part 26 Control of Organic Solvent Emissions from Manufacturers of Synthesized Pharmaceutical Products, Part 27 Control of Nitrogen Oxide Emissions, Part 35 Control of Volatile Organic Compounds and Volatile Hazardous Air Pollutants from Wood Product Manufacturing Operations, Part 36 Control of Emissions from Organic Solvent Cleaning, Part 44 Control of Volatile Organic Compounds from Adhesives and Sealants, and addition of Part 51 Control of Volatile Organic Compound Emissions from Fiberglass Boat Manufacturing, with paragraphs 0.2, 11.2, 15.2, 19.2, 21.2, 25.2, 26.2, 27.2, 35.2, 36.2, 44.2, and 51.2 stricken from the regulations.

In this rule, the EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is finalizing the incorporation by reference of the Rhode Island regulations described in the amendments to 40 CFR part 52 set forth below. The EPA has made, and will continue to make, these documents generally available through https://www.regulations.gov and at the EPA Region 1 Office (please contact the person identified in the FOR FURTHER INFORMATION CONTACT section of this preamble for more information). Therefore, these materials have been approved by EPA for inclusion in the State implementation plan, have been incorporated by reference by EPA into that plan, are fully federally enforceable under sections 110 and 113 of the CAA as of the effective date of the final rulemaking of EPA's approval, and will be incorporated by reference in the next update to the SIP compilation. 1

Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:

• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);

• Is not an Executive Order 13771 regulatory action because this action is not significant under Executive Order 12866;

• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq. );

• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. );

• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);

• Does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);

• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);

• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act; and

• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).

In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this action and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by November 2, 2020. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

For the reasons stated in the preamble, the EPA amends part 52 of chapter I, title 40 of the Code of Federal Regulations as follows:

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

You may access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl .

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2017-0351 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing and must be received by the Hearing Clerk on or before November 2, 2020. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2017-0351, by one of the following methods:

• Federal eRulemaking Portal: http://www.regulations.gov . Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute.

• Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001.

• Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html .

For the latest status information on EPA/DC services and docket access, visit https://www.epa.gov/dockets .

In the Federal Register of September 15, 2017 (82 FR 43352) (FRL-9965-43), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the filing of a pesticide petition (PP IN-11062) by InvisiDex Inc., 1129 Maricopa Hwy. #217, Ojai, CA 93023. The petition requested that 40 CFR 180.910 be amended by establishing an exemption from the requirement of a tolerance for residues of deoxyribonucleic acid (CAS Reg. No. 9006-49-2) when used as an inert ingredient (product identifier) in pesticide formulations applied to growing crops and to raw agricultural commodities after harvest at a concentration not to exceed 1.0 parts per million (ppm). That document referenced a summary of the petition prepared by InvisiDex Inc., the petitioner, which is available in the docket, http://www.regulations.gov. One comment was received on the notice of filing. EPA's response to this comment is discussed in Unit V.B.

Inert ingredients are all ingredients that are not active ingredients as defined in 40 CFR 153.125 and include, but are not limited to, the following types of ingredients (except when they have a pesticidal efficacy of their own): Solvents such as alcohols and hydrocarbons; surfactants such as polyoxyethylene polymers and fatty acids; carriers such as clay and diatomaceous earth; thickeners such as carrageenan and modified cellulose; wetting, spreading, and dispersing agents; propellants in aerosol dispensers; microencapsulating agents; and emulsifiers. The term “inert” is not intended to imply nontoxicity; the ingredient may or may not be chemically active. Generally, EPA has exempted inert ingredients from the requirement of a tolerance based on the low toxicity of the individual inert ingredients.

Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(c)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue . . . .”

EPA establishes exemptions from the requirement of a tolerance only in those cases where it can be clearly demonstrated that the risks from aggregate exposure to pesticide chemical residues under reasonably foreseeable circumstances will pose no appreciable risks to human health. In order to determine the risks from aggregate exposure to pesticide inert ingredients, the Agency considers the toxicity of the inert in conjunction with possible exposure to residues of the inert ingredient through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. If EPA is able to determine that a finite tolerance is not necessary to ensure that there is a reasonable certainty that no harm will result from aggregate exposure to the inert ingredient, an exemption from the requirement of a tolerance may be established.

Consistent with FFDCA section 408(c)(2)(A), and the factors specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for deoxyribonucleic acid sequences including exposure resulting from the exemption established by this action. EPA's assessment of exposures and risks associated with deoxyribonucleic acid sequences follows.

EPA has evaluated the available toxicity data and considered their validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Specific information on the studies received and the nature of the adverse effects caused by deoxyribonucleic acid sequences as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies are discussed in this unit.

Deoxyribonucleic acid (DNA) is routinely synthesized and degraded by almost all living cells. DNA breakdown into constituent nucleic acids continuously occurs in living cells. Purine and pyrimidine nucleosides can either be degraded to waste products and excreted or can be salvaged as nucleotide components. Therefore, metabolites of DNA do not pose a toxicological risk.

DNA sequences used as product identifiers contain the same nucleic acids as DNA present in the environment, and humans routinely consume DNA as a component of food.

All humans are exposed to DNA throughout their lives as part of their diet, in which DNA is metabolized to its component nucleic acids, which are then further used by the body for essential metabolic processes. Consumption of nucleic acids in food has not been associated with any toxic effects. Thus, because the DNA sequences that are used as product identifier contain the same nucleic acids, (adenine, cytosine, guanine and thymine) as found in DNA, consumption of food containing residues of DNA sequences that are used as product identifiers are not expected to present a toxic effect.

There is a potential for extracellular or exogenous DNA to interact with microorganisms in the environment such as bacteria. This interaction could result in the formation of exogenous proteins or other materials that could potentially be harmful to humans. However, the DNA sequences proposed for use by the petitioner lack start codons or regulatory sequences necessary for the initiation of transcription or translation. They cannot encode a protein nor integrate with other genetic sequences and, as such, cannot lead to the formation of exogenous proteins or other materials. Moreover, the restriction of exempted DNA to be comprised of 300 base pairs or less will also limit the ability of DNA to replicate in the environment. Finally, the DNA sequence's ability to cause replication are further limited by lack of stability and integrity of extracellular DNA in the environment. Extracellular DNA routinely degrades in the environment when it is exposed to harsh environmental conditions such as mechanical shearing and UV degradation.

As no human health toxicity endpoints have been selected, a quantitative assessment is not being conducted.

All humans are exposed to DNA throughout their lives as part of diet. As an inert ingredient in pesticide products, DNA sequences may result in residues in or on food. DNA sequences may be used as an inert ingredient (product identifiers) in pesticide formulations that are used in residential setting, however because DNA sequences are unlikely to cross the skin barrier or be available via inhalation. Therefore, inhalation and dermal exposure are not of concern.

Due to the lack of toxicity, EPA does not expect these exposures to pose any risk of harm. DNA sequences used as product identifiers will also be limited to 1 ppm in pesticide formulations, with any resultant exposure to humans resulting from such use being negligible.

Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the FQPA Safety Factor (SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor.

Due to the lack of toxicity or any threshold effects, an FQPA SF is not needed to protect the safety of infants and children.

Taking into consideration all available information on deoxyribonucleic acid sequences consisting solely of adenine, cytosine, guanine and thymine, of 300 or fewer base pairs, and which do not contain start codons or regulatory sequences necessary for the initiation of transcription or translation when used as an inert ingredient (product identifier), EPA has determined that there is a reasonable certainty that no harm to any population subgroup will result from aggregate exposure to deoxyribonucleic acid sequences under reasonably foreseeable circumstances. Therefore, the establishment of an exemption from tolerance under 40 CFR 180.910 for residues of deoxyribonucleic acid sequences as described in the exemption when used as an inert ingredient in pesticide formulations applied to growing crops and to raw agricultural commodities after harvest at a concentration not to exceed 1.0 ppm, is safe under FFDCA section 408.

An analytical method is not required for enforcement purposes since the Agency is not establishing a numerical tolerance for residues of DNA sequences in or on any food commodities. EPA is establishing limitations on the amount of DNA sequences that may be used in pesticide formulations applied pre- and post-harvest. These limitations will be enforced through the pesticide registration process under the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”), 7 U.S.C. 136 et seq. EPA will not register any pesticide formulation for food use that exceeds 1 ppm by weight of DNA sequences in the final pesticide formulation.

One comment generally asserting that pesticides are toxic and should not be allowed on food was received in response to the notice of filing. Although the Agency recognizes that some individuals believe that pesticides should be banned on agricultural crops, the existing legal framework provided by section 408 of the Federal Food, Drug and Cosmetic Act (FFDCA) authorizes EPA to establish tolerances when it determines that the tolerance is safe. Upon consideration of the validity, completeness, and reliability of the available data as well as other factors the FFDCA requires EPA to consider, EPA has determined that this exemption is safe. The commenter has provided no information to indicate that the exemption would not be safe.

Based on clarification as to the composition of the DNA that would be utilized as a product identifier, the petitioner provided additional descriptive criteria that have been incorporated by the Agency into the tolerance exemption expression to ensure that the DNA sequences used as product identifiers would not be taken up by organisms in the environment and used for the production of proteins that could be harmful to human health.

Therefore, an exemption from the requirement of a tolerance is established under 40 CFR 180.910 for deoxyribonucleic acid sequences consisting solely of adenine, cytosine, guanine and thymine, of 300 or fewer base pairs, and which do not contain start codons or regulatory sequences necessary for the initiation of transcription or translation when used as an inert ingredient (product identifier) in pesticide formulations applied to growing crops and to raw agricultural commodities after harvest at a concentration not to exceed 1.0 ppm.

This action establishes an exemption from the requirement of a tolerance under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), nor is it considered a regulatory action under Executive Order 13771, entitled “Reducing Regulations and Controlling Regulatory Costs” (82 FR 9339, February 3, 2017). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq. ), nor does it require any special considerations under Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).

Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq. ), do not apply.

This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the National Government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq. ).

This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).

Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq. ), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Therefore, 40 CFR chapter I is amended as follows:

In 1980, Congress enacted the Comprehensive Environmental Response, Compensation, and Liability Act, 42 U.S.C. 9601-9675 (“CERCLA” or “the Act”), in response to the dangers of uncontrolled releases or threatened releases of hazardous substances, and releases or substantial threats of releases into the environment of any pollutant or contaminant that may present an imminent or substantial danger to the public health or welfare. CERCLA was amended on October 17, 1986, by the Superfund Amendments and Reauthorization Act (“SARA”), Public Law 99-499, 100 Stat. 1613 et seq.

To implement CERCLA, the EPA promulgated the revised National Oil and Hazardous Substances Pollution Contingency Plan (“NCP”), 40 CFR part 300, on July 16, 1982 (47 FR 31180), pursuant to CERCLA section 105 and Executive Order 12316 (46 FR 42237, August 20, 1981). The NCP sets guidelines and procedures for responding to releases and threatened releases of hazardous substances, or releases or substantial threats of releases into the environment of any pollutant or contaminant that may present an imminent or substantial danger to the public health or welfare. The EPA has revised the NCP on several occasions. The most recent comprehensive revision was on March 8, 1990 (55 FR 8666).

As required under section 105(a)(8)(A) of CERCLA, the NCP also includes “criteria for determining priorities among releases or threatened releases throughout the United States for the purpose of taking remedial action and, to the extent practicable, taking into account the potential urgency of such action, for the purpose of taking removal action.” “Removal” actions are defined broadly and include a wide range of actions taken to study, clean up, prevent or otherwise address releases and threatened releases of hazardous substances, pollutants or contaminants (42 U.S.C. 9601(23)).

The NPL is a list of national priorities among the known or threatened releases of hazardous substances, pollutants or contaminants throughout the United States. The list, which is appendix B of the NCP (40 CFR part 300), was required under section 105(a)(8)(B) of CERCLA, as amended. Section 105(a)(8)(B) defines the NPL as a list of “releases” and the highest priority “facilities” and requires that the NPL be revised at least annually. The NPL is intended primarily to guide the EPA in determining which sites warrant further investigation to assess the nature and extent of public health and environmental risks associated with a release of hazardous substances, pollutants or contaminants. The NPL is of only limited significance, however, as it does not assign liability to any party or to the owner of any specific property. Also, placing a site on the NPL does not mean that any remedial or removal action necessarily need be taken.

For purposes of listing, the NPL includes two sections, one of sites that are generally evaluated and cleaned up by the EPA (the “General Superfund section”) and one of sites that are owned or operated by other Federal agencies (the “Federal Facilities section”). With respect to sites in the Federal Facilities section, these sites are generally being addressed by other Federal agencies. Under Executive Order 12580 (52 FR 2923, January 29, 1987) and CERCLA section 120, each Federal agency is responsible for carrying out most response actions at facilities under its own jurisdiction, custody or control, although the EPA is responsible for preparing a Hazard Ranking System (“HRS”) score and determining whether the facility is placed on the NPL.

There are three mechanisms for placing sites on the NPL for possible remedial action (see 40 CFR 300.425(c) of the NCP): (1) A site may be included on the NPL if it scores sufficiently high on the HRS, which the EPA promulgated as appendix A of the NCP (40 CFR part 300). The HRS serves as a screening tool to evaluate the relative potential of uncontrolled hazardous substances, pollutants or contaminants to pose a threat to human health or the environment. On December 14, 1990 (55 FR 51532), the EPA promulgated revisions to the HRS partly in response to CERCLA section 105(c), added by SARA. On January 9, 2017 (82 FR 2760), a subsurface intrusion component was added to the HRS to enable the EPA to consider human exposure to hazardous substances or pollutants and contaminants that enter regularly occupied structures through subsurface intrusion when evaluating sites for the NPL. The current HRS evaluates four pathways: Ground water, surface water, soil exposure and subsurface intrusion, and air. As a matter of agency policy, those sites that score 28.50 or greater on the HRS are eligible for the NPL. (2) Each state may designate a single site as its top priority to be listed on the NPL, without any HRS score. This provision of CERCLA requires that, to the extent practicable, the NPL include one facility designated by each state as the greatest danger to public health, welfare or the environment among known facilities in the state. This mechanism for listing is set out in the NCP at 40 CFR 300.425(c)(2). (3) The third mechanism for listing, included in the NCP at 40 CFR 300.425(c)(3), allows certain sites to be listed without any HRS score, if all of the following conditions are met:

• The Agency for Toxic Substances and Disease Registry (ATSDR) of the U.S. Public Health Service has issued a health advisory that recommends dissociation of individuals from the release.

• The EPA determines that the release poses a significant threat to public health.

• The EPA anticipates that it will be more cost-effective to use its remedial authority than to use its removal authority to respond to the release.

The EPA promulgated an original NPL of 406 sites on September 8, 1983 (48 FR 40658) and generally has updated it at least annually.

A site may undergo remedial action financed by the Trust Fund established under CERCLA (commonly referred to as the “Superfund”) only after it is placed on the NPL, as provided in the NCP at 40 CFR 300.425(b)(1). (“Remedial actions” are those “consistent with a permanent remedy, taken instead of or in addition to removal actions” (40 CFR 300.5).) However, under 40 CFR 300.425(b)(2), placing a site on the NPL “does not imply that monies will be expended.” The EPA may pursue other appropriate authorities to respond to the releases, including enforcement action under CERCLA and other laws.

The NPL does not describe releases in precise geographical terms; it would be neither feasible nor consistent with the limited purpose of the NPL (to identify releases that are priorities for further evaluation), for it to do so. Indeed, the precise nature and extent of the site are typically not known at the time of listing.

Although a CERCLA “facility” is broadly defined to include any area where a hazardous substance has “come to be located” (CERCLA section 101(9)), the listing process itself is not intended to define or reflect the boundaries of such facilities or releases. Of course, HRS data (if the HRS is used to list a site) upon which the NPL placement was based will, to some extent, describe the release(s) at issue. That is, the NPL site would include all releases evaluated as part of that HRS analysis.

When a site is listed, the approach generally used to describe the relevant release(s) is to delineate a geographical area (usually the area within an installation or plant boundaries) and identify the site by reference to that area. However, the NPL site is not necessarily coextensive with the boundaries of the installation or plant, and the boundaries of the installation or plant are not necessarily the “boundaries” of the site. Rather, the site consists of all contaminated areas within the area used to identify the site, as well as any other location where that contamination has come to be located, or from where that contamination came.

In other words, while geographic terms are often used to designate the site ( e.g., the “Jones Co. Plant site”) in terms of the property owned by a particular party, the site, properly understood, is not limited to that property ( e.g., it may extend beyond the property due to contaminant migration), and conversely may not occupy the full extent of the property ( e.g., where there are uncontaminated parts of the identified property, they may not be, strictly speaking, part of the “site”). The “site” is thus neither equal to, nor confined by, the boundaries of any specific property that may give the site its name, and the name itself should not be read to imply that this site is coextensive with the entire area within the property boundary of the installation or plant. In addition, the site name is merely used to help identify the geographic location of the contamination; and is not meant to constitute any determination of liability at a site. For example, the name “Jones Co. plant site,” does not imply that the Jones Company is responsible for the contamination located on the plant site.

EPA regulations provide that the remedial investigation (“RI”) “is a process undertaken . . . to determine the nature and extent of the problem presented by the release” as more information is developed on site contamination, and which is generally performed in an interactive fashion with the feasibility study (“FS”) (40 CFR 300.5). During the RI/FS process, the release may be found to be larger or smaller than was originally thought, as more is learned about the source(s) and the migration of the contamination. However, the HRS inquiry focuses on an evaluation of the threat posed and therefore the boundaries of the release need not be exactly defined. Moreover, it generally is impossible to discover the full extent of where the contamination “has come to be located” before all necessary studies and remedial work are completed at a site. Indeed, the known boundaries of the contamination can be expected to change over time. Thus, in most cases, it may be impossible to describe the boundaries of a release with absolute certainty.

Further, as noted previously, NPL listing does not assign liability to any party or to the owner of any specific property. Thus, if a party does not believe it is liable for releases on discrete parcels of property, it can submit supporting information to the agency at any time after it receives notice it is a potentially responsible party.

For these reasons, the NPL need not be amended as further research reveals more information about the location of the contamination or release.

The EPA may delete sites from the NPL where no further response is appropriate under Superfund, as explained in the NCP at 40 CFR 300.425(e). This section also provides that the EPA shall consult with states on proposed deletions and shall consider whether any of the following criteria have been met:

(i) Responsible parties or other persons have implemented all appropriate response actions required;

(ii) All appropriate Superfund-financed response has been implemented and no further response action is required; or

(iii) The remedial investigation has shown the release poses no significant threat to public health or the environment and taking of remedial measures is not appropriate.

In November 1995, the EPA initiated a policy to delete portions of NPL sites where cleanup is complete (60 FR 55465, November 1, 1995). Total site cleanup may take many years, while portions of the site may have been cleaned up and made available for productive use.

The EPA also has developed an NPL construction completion list (“CCL”) to simplify its system of categorizing sites and to better communicate the successful completion of cleanup activities (58 FR 12142, March 2, 1993). Inclusion of a site on the CCL has no legal significance.

Sites qualify for the CCL when: (1) Any necessary physical construction is complete, whether or not final cleanup levels or other requirements have been achieved; (2) the EPA has determined that the response action should be limited to measures that do not involve construction ( e.g., institutional controls); or (3) the site qualifies for deletion from the NPL. For more information on the CCL, see the EPA's internet site at https://www.epa.gov/superfund/construction-completions-national-priorities-list-npl-sites-number.

The Sitewide Ready for Anticipated Use measure represents important Superfund accomplishments and the measure reflects the high priority the EPA places on considering anticipated future land use as part of the remedy selection process. See Guidance for Implementing the Sitewide Ready-for-Reuse Measure, May 24, 2006, OSWER 9365.0-36. This measure applies to final and deleted sites where construction is complete, all cleanup goals have been achieved, and all institutional or other controls are in place. The EPA has been successful on many occasions in carrying out remedial actions that ensure protectiveness of human health and the environment for current and future land uses, in a manner that allows contaminated properties to be restored to environmental and economic vitality. For further information, please go to https://www.epa.gov/superfund/about-superfund-cleanup-process#tab-9.

In order to maintain close coordination with states and tribes in the NPL listing decision process, the EPA's policy is to determine the position of the states and tribes regarding sites that the EPA is considering for listing. This consultation process is outlined in two memoranda that can be found at the following website: https://www.epa.gov/superfund/statetribal-correspondence-concerning-npl-site-listing.

The EPA has improved the transparency of the process by which state and tribal input is solicited. The EPA is using the Web and where appropriate more structured state and tribal correspondence that (1) explains the concerns at the site and the EPA's rationale for proceeding; (2) requests an explanation of how the state intends to address the site if placement on the NPL is not favored; and (3) emphasizes the transparent nature of the process by informing states that information on their responses will be publicly available.

A model letter and correspondence between the EPA and states and tribes where applicable, is available on the EPA's website at https://www.epa.gov/superfund/statetribal-correspondence-concerning-npl-site-listing.

Yes, documents relating to the evaluation and scoring of the sites in this final rule are contained in dockets located both at the EPA headquarters and in the EPA regional offices.

An electronic version of the public docket is available through https://www.regulations.gov (see table below for docket identification numbers). Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facilities identified in section II.D.

The headquarters docket for this rule contains the HRS score sheets, the documentation record describing the information used to compute the score, a list of documents referenced in the documentation record for each site and any other information used to support the NPL listing of the site.

The EPA regional dockets contain all the information in the headquarters docket, plus the actual reference documents containing the data principally relied upon by the EPA in calculating or evaluating the HRS score. These reference documents are available only in the regional dockets.

You may view the documents, by appointment only, after the publication of this rule. The hours of operation for the headquarters docket are from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding federal holidays. Please contact the regional dockets for hours. For addresses for the headquarters and regional dockets, see Addresses section in the beginning portion of this preamble.

You may obtain a current list of NPL sites via the internet at https://www.epa.gov/superfund/national-priorities-list-npl-sites-site-name or by contacting the Superfund docket (see contact information in the beginning portion of this document).

This final rule adds the following six sites to the General Superfund section of the NPL. These sites are being added to the NPL based on an HRS score of 28.50 or above.

The EPA reviewed all comments received on the sites in this rule and responded to all relevant comments. The EPA is adding six sites to the NPL in this final rule. The Orange County North Basin site in Orange County, CA was proposed for addition to the NPL on January 18, 2018 (83 FR 2576). The remaining five sites were proposed for addition to the NPL on November 8, 2019 (84 FR 60357).

Comments on the Orange County North Basin and Hwy 100 and County Road 3 Groundwater Plume sites are being addressed in a response to comment support document available in the public docket concurrently with this rule. To view public comments on this site, as well as EPA's response, please refer to the support document available at https://www.regulations.gov.

The EPA received no comments on the Henryetta Iron and Metal site.

The EPA received one comment supporting the listing of the Clearwater Finishing site, and two additional comments that are not site specific but that support the implementation of the Superfund statute.

For the Blades Groundwater site, in addition to comments in support of the listing, the EPA received one comment from a member of the public raising concerns about the impact on property values and another regarding health concerns of residents. The EPA notes that there are both costs and benefits that can be associated with listing a site. Among the benefits are increased health and environmental protection as a result of increased public awareness of potential hazards. In addition to the potential for federally financed remedial actions, the addition of a site to the NPL could accelerate privately financed, voluntary cleanup efforts. Listing sites as national priority targets also may give states increased support for funding responses at particular sites. As a result of the additional CERCLA remedies, there will be lower human exposure to high-risk chemicals, and higher quality surface water, ground water, soil, and air. Therefore, it is possible that any perceived or actual negative fluctuations in property values or development opportunities that may result from contamination may also be countered by positive fluctuations when a CERCLA investigation and any necessary cleanup are completed.

For the Caney Residential Yards site, the EPA received several comments which are unrelated to listing the site on the NPL.

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 is not an Executive Order 13771 regulatory action because this action is not significant under Executive Order 12866.

This action does not impose an information collection burden under the PRA. This rule does not contain any information collection requirements that require approval of the OMB.

I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. This action will not impose any requirements on small entities. This rule listing sites on the NPL does not impose any obligations on any group, including small entities. This rule also does not establish standards or requirements that any small entity must meet and imposes no direct costs on any small entity. Whether an entity, small or otherwise, is liable for response costs for a release of hazardous substances depends on whether that entity is liable under CERCLA 107(a). Any such liability exists regardless of whether the site is listed on the NPL through this rulemaking.

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. This action imposes no enforceable duty on any state, local or tribal governments or the private sector. Listing a site on the NPL does not itself impose any costs. Listing does not mean that the EPA necessarily will undertake remedial action. Nor does listing require any action by a private party, state, local or tribal governments or determine liability for response costs. Costs that arise out of site responses result from future site-specific decisions regarding what actions to take, not directly from the act of placing a site on the NPL.

This final rule 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. Listing a site on the NPL does not impose any costs on a tribe or require a tribe to take remedial action. Thus, Executive Order 13175 does not apply to this action.

The EPA interprets Executive Order 13045 as applying only to those regulatory actions that concern environmental health or safety risks that the EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of the Executive order. This action is not subject to Executive Order 13045 because this action itself is procedural in nature (adds sites to a list) and does not, in and of itself, provide protection from environmental health and safety risks. Separate future regulatory actions are required for mitigation of environmental health and safety risks.

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 the human health or environmental risk addressed by this action will not have potential disproportionately high and adverse human health or environmental effects on minority, low-income or indigenous populations because it does not affect the level of protection provided to human health or the environment. As discussed in Section I.C. of the preamble to this action, the NPL is a list of national priorities. The NPL is intended primarily to guide the EPA in determining which sites warrant further investigation to assess the nature and extent of public health and environmental risks associated with a release of hazardous substances, pollutants or contaminants. The NPL is of only limited significance as it does not assign liability to any party. Also, placing a site on the NPL does not mean that any remedial or removal action necessarily need be taken.

This action is subject to the CRA, and the EPA will submit a rule report to each House of the Congress and to the Comptroller General of the United States. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Provisions of the Congressional Review Act (CRA) or section 305 of CERCLA may alter the effective date of this regulation. Under 5 U.S.C. 801(b)(1), a rule shall not take effect, or continue in effect, if Congress enacts (and the President signs) a joint resolution of disapproval, described under section 802. Another statutory provision that may affect this rule is CERCLA section 305, which provides for a legislative veto of regulations promulgated under CERCLA. Although INS v. Chadha, 462 U.S. 919,103 S. Ct. 2764 (1983), and Bd. of Regents of the University of Washington v. EPA, 86 F.3d 1214,1222 (D.C. Cir. 1996), cast the validity of the legislative veto into question, the EPA has transmitted a copy of this regulation to the Secretary of the Senate and the Clerk of the House of Representatives.

If action by Congress under either the CRA or CERCLA section 305 calls the effective date of this regulation into question, the EPA will publish a document of clarification in the Federal Register .

For the reasons set out in the preamble, title 40, chapter I, part 300, of the Code of Federal Regulations is amended as follows:

A waybill is a “document or instrument prepared from the bill of lading contract or shipper's instructions as to the disposition of the freight, and [is] used by the railroad(s) involved as the authority to move the shipment and as the basis for determining the freight charges and interline settlements.” 49 CFR 1244.1(c). Among other things, a waybill contains the following data: (1) The originating and terminating freight stations; (2) the railroads participating in the movement; (3) the points of all railroad interchanges; (4) the number and type of cars; (5) the car initial and number; (6) the movement weight in hundredweight; (7) the commodity; and (8) the freight revenue.

A railroad is required to file with the Board a sample of its waybill data for all line-haul revenue waybills terminated on its lines in the United States, 1 if the railroad: (a) Terminated at least 4,500 revenue carloads in any of the three preceding years, or (b) terminated at least 5% of the revenue carloads terminating in any state in any of the three preceding years. 49 CFR 1244.2(a). The number of waybills that a railroad is required to file ( i.e., the sampling rate) is set forth at current 49 CFR 1244.4(b) and (c), and varies based on the number of carloads on the waybill, as shown in Table 1 below. 2

The Board creates an aggregate compilation of the sampled waybills of all reporting carriers, referred to as the Waybill Sample. First collected in 1946 by the Board's predecessor, 4 the Interstate Commerce Commission (ICC), the Waybill Sample is the Board's principal source of data about freight rail shipments. It has broad application in, among other things, rate cases, the development of costing systems, productivity studies, exemption decisions, and analyses of industry trends. The Waybill Sample is also used by other Federal agencies, state and local government agencies, the transportation industry, shippers, research organizations, universities, and others that have a need for rail shipment data. Because some of the submitted waybill data is commercially sensitive, the Board's regulations place limitations on the release and use of confidential Waybill Sample data. See 49 CFR 1244.9; see also 49 U.S.C. 11904. 5

As described more fully in the notice of proposed rulemaking in this proceeding, the Board's Rate Reform Task Force (RRTF) issued a report on April 25, 2019 (RRTF Report)  6 recommending, among other things, that the Board change the sampling rates for its Waybill Sample. RRTF Report 14, 47-49; Waybill Sample Reporting ( NPRM ), EP 385 (Sub-No. 8), slip op. at 2 (STB served Nov. 29, 2019). After considering the recommendations in the RRTF Report and the overall utility of the current Waybill Sample, in the NPRM issued on November 29, 2019, the Board proposed a simplified waybill sampling rate for non-intermodal carload shipments and separate waybill sampling strata and rates for intermodal shipments, as shown in Table 2 below. See NPRM, EP 385 (Sub-No. 8), slip op. at 6-8; 84 FR 65768, 65770-71 (Nov. 29, 2019).

As explained in the NPRM, EP 385 (Sub-No. 8), slip op. at 4, the Board reasoned that a net increase in sample size would provide more comprehensive information to the Board and other users of Waybill Sample data in a variety of contexts, such as exemption decisions, stratification reports, traffic volume and rate studies, Board-initiated investigations, certain rate cases, and any other waybill data-related analysis the Board currently performs or might seek to perform in the future. The Board also explained that the added number of observations in the Waybill Sample would likely allow it to avoid redacting, for confidentiality reasons, as many results from some of the Board's routine analysis published on its website ( e.g., the Standard Transportation Commodity Code 7 stratification report). Id. at 4-5. In addition, because it currently receives monthly and quarterly waybill data from reporting carriers, increasing the sampling rate would provide the Board with more observations in any given month or quarter from which it could draw meaningful insights throughout the year. Id. at 5. The Board also proposed that it should change the sampling requirements so that a greater portion of Waybill Sample data would represent regulated traffic instead of exempt traffic and stated that the proposed changes would help address the acknowledged shortcomings concerning the scarcity of data in some rate cases. Id. at 4-5, 8. The NPRM stated that the proposed waybill sampling rates would increase the percentage of movement categories containing at least 25 observations, 7 suggesting that the proposed changes would produce more movement categories that have sufficient representativeness. Id. at 5-6, 8-10, 8 n.18.

The Board received seven opening comments on the NPRM from the following organizations: American Fuel & Petrochemical Manufacturers (AFPM); Association of American Railroads (AAR); CSX Transportation, Inc. (CSXT); National Grain and Feed Association (NGFA); RSI Logistics, Inc. (RSI Logistics); U.S. Department of Agriculture (USDA); and Western Coal Traffic League (WCTL). The Board received one reply comment, from AAR.

After considering the comments, the Board will adopt the rule proposed in the NPRM, with certain modifications. Below, the Board addresses the comments and discusses the modifications being adopted in the final rule. The text of the final rule is below.

The comments received generally underscore the importance of the Waybill Sample as a critical source of information about the rail industry. For example, USDA notes that the Waybill Sample “is the most detailed and comprehensive data the federal government currently has on rail freight movements, making it instrumental in identifying trends and issues in the industry.” (USDA Comment 2.) RSI Logistics similarly states that the Waybill Sample “provides valuable insight into the rail marketplace.” (RSI Logistics Comment 1.) Due to the Waybill Sample's utility, most commenters support the Board's efforts to increase the quantity of waybill data collected through modified sampling rates. (AAR Comment 1; AFPM Comment 4; CSXT Comment 1; RSI Logistics Comment 1; USDA Comment 2, 4.) Although some commenters question the potential benefits of the proposed changes, suggest modifications to the proposed sampling rates, or urge the Board to be watchful for unintended effects, ( see AAR Comment 1; NGFA Comment 4-5; WCTL Comment 4-6), no commenter opposes the Board's effort to expand the quantity of waybill data collected.

Regarding suggested modifications to the proposed rule, AAR cautions against the Board's proposal to reduce the data collected for larger, non-intermodal shipments. In particular, AAR notes that “non-coal larger blocks of shipments are more likely to have greater variance in their characteristics, including in size, frequency, and origin-destination pairs” and claims that much of this detail could be lost as a result of the proposed reduction in the sampling rates for these strata. (AAR Comment 3.) AAR also states that “there is no reason to suspect that shipments in the larger carload strata would be any less relevant to the small rate case process[,]” which would make “the need for more observations [of larger shipments] . . . just as important as for the smaller carload strata.” ( Id. ) Based on these concerns, AAR argues that “[t]he Board's proposal to reduce the number of samples for the larger carload strata is at odds with the overarching goal of broadening access to relief and addressing the scarcity of data concerns expressed by the Board.” ( Id. ) AAR therefore asks the Board to maintain the current sampling rates for non-intermodal shipments with 16 or more carloads. (AAR Comment 1; AAR Reply 1.) CSXT likewise asks the Board to maintain the sampling rates for non- intermodal shipments with 16 or more carloads. (CSXT Comment 1 n.1.)

After considering the comments from AAR and CSXT, the Board concludes that the proposed decrease in the sampling rates for larger, non-intermodal shipments should not be adopted. The Board proposed reducing the sampling rates for non-intermodal shipments with 16 or more carloads per waybill to match the proposed sampling rates for non-intermodal shipments with 15 or fewer carloads as a way of simplifying the sampling rates while still achieving a net increase in the non-intermodal shipment data collected. The commenters' arguments concerning the variable characteristics of larger, non-coal shipments and the relevance of larger shipments to the small rate case process support the conclusion that the Waybill Sample would lose robustness for shipments of 16 or more carloads if the proposal were implemented. Although one of the goals of the Board's proposal was to simplify sampling rates, the Board also seeks to maintain a robust dataset that is of use to the agency and stakeholders. As noted in the NPRM, a greater number of observations would allow for additional or more granular factors to compare movements while maintaining representativeness. This applies to shipments of 16 or more carloads and justifies maintaining the current (more frequent) sampling rates for those carload shipments. Therefore, the Board will maintain the current sampling rates for non-intermodal shipments with 16 or more carloads, as suggested by AAR and CSXT.

USDA asks the Board to consider removing the stratification process altogether and collecting 100% of the waybill population data, “postulat[ing]” that if the ICC had possessed current technology at its disposal “it would not have needed to undertake the statistical design process that led to the creation of today's [Waybill Sample].” (USDA Comment 2.) USDA contends that collecting 100% of the waybill population should not be an additional burden for the railroads or the Board. ( Id. at 2-3.) USDA argues alternatively that if 100% of the population data cannot be collected, the Board should “significantly increase the sample size more than proposed.” ( Id. at 3.) Similarly, NGFA asks the Board to explore the feasibility of expanding to 100% data collection for non-intermodal carload traffic. (NGFA Comment 4.) In response, AAR raises various concerns about 100% data sampling, including regarding security-sensitive information and the risk of disclosure of confidential information. (AAR Reply 4-5.) AAR instead argues that the Board's proposal, as modified to maintain the non-intermodal sampling rates for larger shipments, “strikes a balanced approach to obtaining more information, while preserving customer anonymity.” ( Id. at 5).

The Board will not pursue 100% waybill data collection at this time, although it does not foreclose the possibility of doing so in the future. While the arguments in favor of 100% collection may have merit, the Board expects the increase in the sample adopted in this final rule will achieve the goals of the NPRM, and the Board has not identified any implementation or data management issues that could delay such improvements. As a result, the advantages of increased sampling will be captured in the 2021 reporting year with sufficient time for carriers to adjust to the new requirements. In contrast, pursuing a 100% waybill collection at this stage of the rulemaking proceeding would delay implementing the important, incremental improvements to the waybill collection that will be achieved here. Further, prior to removing the sampling framework altogether, the Board, through notice and comment, would need to fully assess the utility of the collection and weigh that against any identified implementation or data management issues.

As an alternative to 100% data sampling, some commenters asked the Board to further stratify the collected waybill data based on additional shipment variables, such as the railroad involved in the movement, the distance of the movement, the commodity transported, and the geographic region of the movement. (NGFA Comment 4; USDA Comment 3-4.) Beyond shipment data, some commenters suggest collecting waybill data based on performance variables related to service quality, demurrage, and accessorial charges. (AFPM Comment 4-5; USDA Comment 4.) In response, AAR argues that “these suggestions fail to recognize the nature and purpose of the waybill as a commercial document” and “[r]equiring additional, unrelated data to be included in waybills would require changes to industry practice and pose significant challenges.” (AAR Reply 2-3.)

The Board will not pursue the further stratification by additional shipment variables or the addition of performance variables to waybill data collection at this time. The Board already collects certain performance data, albeit not on a shipment basis, pursuant to 49 CFR part 1250. See, e.g., Pet. for Rulemaking to Amend 49 CFR part 1250, EP 724 (Sub-No. 5), slip op. at 3-5 (STB served May 21, 2020). Similarly, the Board recognizes the importance of monitoring the application of demurrage and accessorial rules and charges, which is why it initiated several related proceedings. See, e.g., Oversight Hearing on Demurrage & Accessorial Charges, Docket No. EP 754; Policy Statement on Demurrage & Accessorial Rules & Charges, Docket No. EP 757; Demurrage Billing Requirements, Docket No. EP 759. Because the Board has received public input on the proposals in the NPRM, it can implement these changes for the 2021 reporting year with sufficient time for carriers to adjust to the new regulations, whereas pursuing further stratification beyond what is proposed in the NPRM, or adding performance data that was not proposed in the NPRM, could delay improvements to the Waybill Sample until the 2022 reporting year. Prior to considering any possible further stratification or adding performance data, the Board, through notice and comment, would need to assess, among other things, the benefits of such changes against any potential technical challenges.

Some commenters ask the Board to monitor closely the effect of implemented changes for any unintended consequences, (NGFA Comment 5), or to maintain a parallel Waybill Sample based on the current methodology for at least two years (WCTL Comment 5-6). In response, AAR states that “[t]he Board can modify its processes to address anomalies or unintended consequences if they arise.” (AAR Reply 6.) The Board rejects WCTL's suggestion that the Board maintain a parallel Waybill Sample because, compared to current regulations, the final rule's waybill sampling rates, which have been modified from the NPRM, are either greater or the same for each stratified category of non-intermodal carload shipments and will have their expansion factors adjusted accordingly; as such, there is no longer any basis for concern that the Board's Waybill Sample would become less representative for certain non-intermodal carload shipments. 8 As a result, increasing the sampling rates would not affect any analyses that are based on a representation of the entire population of waybill shipments. The Board will continue to monitor the waybill dataset for anomalies or unintended effects, as it does in the ordinary course.

RSI Logistics suggests that the Board should require reporting by “holding companies” consisting “of multiple Class II or III railroads” if their traffic volume otherwise meets the reporting threshold. (RSI Logistics Comment 1.) The Board declines to make this change. A change to the applicability provisions of 49 CFR 1244.2 is beyond the scope of this proceeding, which focuses on adjustments to the sampling rates and strata. 9

The Board's standards and format guidance for the waybill collection is currently found in Statement No. 81-1, Procedure for Sampling Waybill Records by Computer (2009 edition), 10 and currently provides that submitted waybills may be listed in any order. USDA comments that “[u]nder systematic sampling, order is an important consideration to account for patterns in the frame that may correspond to the skip interval,” and suggests that the Board “either specify an order, use a random ordering, or even use a simple random sample rather than `any order,' in order to avoid potential sampling bias.” (USDA Comment 3 n.1.) The Board has no evidence suggesting that the Waybill Sample's unspecified sampling order has resulted in sampling bias. Moreover, the use of stratification is designed to reduce sampling bias. By sampling within certain strata, the sample is guaranteed to capture records of larger shipments that move less frequently. In addition, USDA's recommendation to use a random order is already addressed by using a different random start for each of the four subsamples within each stratum. Accordingly, the Board will not adopt USDA's recommendations.

In the NPRM, EP 385 (Sub-No. 8), slip op. at 3 n.5, the Board stated that “parties may provide comments on whether the manual system [for reporting waybill data] should be eliminated given its current lack of use.” In response, NGFA states that the Board “should deem manually submitted waybills to be obsolete and rule that they no longer are a permissible way for carriers to submit such data.” (NGFA Comment 5.) No other commenter addressed this issue, and the Board notes that no smaller carriers commented in this proceeding. Due to its current lack of use and the absence of support for its continuation, the Board sees no need to maintain the regulatory provision for manual reporting. Therefore, the Board will eliminate the manual system for reporting waybill data in the final rule and remove references to the manual system at sections 1244.4, 1244.5, 1244.6, and 1244.7.

CSXT asks the Board to provide a minimum of 90 days between the service date and the effective date of the final rule to give carriers sufficient time to make the programming changes necessary to comply with the revised reporting requirements. (CSXT Comment 3.) CSXT also requests that the Board limit, to the extent possible, revisions to Statement No. 81-1, and that if “extensive procedural changes” to Statement No. 81-1 are made, an additional 60 days be added to the 90 days it requested to implement the changes proposed in the NPRM. ( Id. at 2-3.) The Board is sensitive to the practicalities surrounding any revision of the waybill reporting requirements. As a result, the Board will require reporting under the final rule to begin on January 1, 2021, which will give reporting carriers sufficient time to prepare for the revised requirements. 11 Prior to that time ( i.e., for all 2020 waybill reportings), carriers should continue to report according to the current sampling requirements.

* * *

For the reasons discussed above, after consideration of all the comments received, the Board is adopting a final rule to amend its regulations to specify separate waybill sampling strata for intermodal and non-intermodal shipments and establish revised waybill sampling rates as shown in Table 3, below.

This rule is set out in full below and will be codified in the Code of Federal Regulations.

The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, generally requires a description and analysis of new rules that would have a significant economic impact on a substantial number of small entities. In drafting a rule, an agency is required to: (1) Assess the effect that its regulation will have on small entities; (2) analyze effective alternatives that may minimize a regulation's impact; and (3) make the analysis available for public comment. Section 601-604. In its final rule, the agency must either include a final regulatory flexibility analysis, section 604(a), or certify that the final rule would not have a “significant impact on a substantial number of small entities,” section 605(b). Because the goal of the RFA is to reduce the cost to small entities of complying with federal regulations, the RFA requires an agency to perform a regulatory flexibility analysis of small entity impacts only when a rule directly regulates those entities. In other words, the impact must be a direct impact on small entities “whose conduct is circumscribed or mandated” by the rule. White Eagle Coop. v. Conner, 553 F.3d 467, 480 (7th Cir. 2009).

The Board certifies under 5 U.S.C. 605(b) that the final rule would not have a significant economic impact upon a substantial number of small entities, within the meaning of the RFA. 12 Under the Board's existing regulations, a railroad is required to file Waybill Sample data for all line-haul revenue waybills terminated on its lines if: (a) It terminated at least 4,500 revenue carloads in any of the three preceding years; or (b) it terminated at least 5% of the revenue carloads terminating in any state in any of the three preceding years. 49 CFR 1244.2. Under this criteria, 53 railroads are currently required to report Waybill Sample data. Of these 53 railroads, the Board estimates that 36 are Class III rail carriers, and therefore small businesses within the meaning of the RFA. Of the 53 railroads required to report Waybill Sample data, 45 railroads currently use Railinc Corporation (Railinc)—a wholly-owned information technology subsidiary of the Association of American Railroads—to sample their waybills. 13 Eight railroads currently sample their own waybills.

For the railroads that submit their waybills to Railinc for sampling, there will be no additional burden or costs as result of the changes adopted in the final rule. These entities will continue to submit all their waybills to Railinc, which will then sample the data in accordance with the Board's revised sampling rates. Because the Board contracts with Railinc to sample railroads' waybills, the entities that use Railinc to sample their waybills will incur no additional costs from Railinc as a result of the Board's proposed changes. Of the approximately 36 Class III rail carriers, the Board estimates that 34 carriers fall into this category and therefore will not incur any additional burden or cost.

For the railroads that choose to sample their own waybills, the final rule will not result in a significant economic impact. The purpose of the changes adopted in the final rule is to create a more robust Waybill Sample and result in more comprehensive information critical to the Board's decision-making and analyses. The final rule will increase the rate at which the Board samples certain railroad shipments and appropriately differentiate based on industry waybill practices for intermodal shipments. These changes will result in additional observations for certain shipments but will not significantly alter small entities' current practices for sampling their shipments. Based on the total burden hours described in the Paperwork Reduction Act analysis below, the Board estimates that, for railroads conducting their own sampling, the change in reporting procedures will result in a one-time burden of approximately 150 hours per railroad. Moreover, this impact will not apply to a substantial number of small entities, as the Board estimates that only two of the approximately 36 Class III rail carriers will incur this burden.

Accordingly, the Board certifies under 5 U.S.C. 605(b) that the final rule will not have a significant economic impact on a substantial number of small entities within the meaning of the RFA. A copy of this decision will be served upon the Chief Counsel for Advocacy, Offices of Advocacy, U.S. Small Business Administration.

In this proceeding, the Board is modifying an existing collection of information that was approved by the Office of Management and Budget (OMB) under the collection of Waybill Sample data (OMB Control No. 2140-0015). In the NPRM, the Board sought comments pursuant to the Paperwork Reduction Act (PRA), 44 U.S.C. 3501-3521 and OMB regulations at 5 CFR 1320.8(d)(3) regarding: (1) Whether the collection of information, as proposed below to the NPRM, is necessary for the proper performance of the functions of the Board, including whether the collection has practical utility; (2) the accuracy of the Board's burden estimates; (3) ways to enhance the quality, utility, and clarity of the information collected; and (4) ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology, when appropriate.

In the NPRM, the Board estimated that the proposed requirements would add a total one-time hourly burden of 640 hours (or approximately 213.3 hours per year as amortized over three years) because the railroads, in most cases, will need to edit their software programs to implement these changes. The Board anticipated that, once the burden of the one-time programming changes is incurred, the annual burden would remain the same as before this modification. The Board received one comment from CSXT, offering its estimates for the one-time hourly burden of actual time and costs of collection of Waybill Sample data. 14 The Board received five other comments that generally pertained to the Board's burden analysis under the PRA.

In its comments, CSXT provides two estimates for its one-time hourly burden based on certain assumptions. CSXT estimates a base one-time hourly burden of 200 hours, assuming (i) the introduction of two new strata, (ii) no changes to the Kth interval and random starts for the existing strata, and (iii) the use of existing Kth interval and random start tables for the two new strata. CSXT estimates an additional one-time hourly burden of 50 hours if new Kth intervals and random start tables are necessary. It also suggests that other procedural changes are likely to have a similarly additive effect. (CSXT Comment 2.)

CSXT's estimates are helpful but CSXT's first assumption—that there will be two new intermodal strata—is not accurate because the final rule creates only one new stratum. The first intermodal stratum of “1 to 2” trailer/container units remains unchanged from the “1 to 2” carloads stratum currently applied to intermodal shipments. The second intermodal stratum of “3 and over” trailer/container units is the only new stratum. It combines the other four carload strata currently applied to intermodal shipments into one stratum ( i.e., “3 and over” trailer/container units). Given that the number of new strata assumed by CSXT is reduced by half, its base estimate of 200 one-time burden hours may also be reduced by half, to 100 one-time burden hours.

CSXT's second assumption is for an additional one-time burden of 50 hours if the Board intends to add new tables/intervals for the new sampling rates of the new strata. The new sampling rate of “1/5 waybills” will require a new Kth interval and random starts table, which will use the same interval and start table, even though it will be applied to three different strata, ( i.e., the first two carload strata and the second intermodal stratum). This will result in an additional one-time burden of 50 hours, which the Board will add to the adjusted base estimate of 100 hours, for a total of 150 one-time burden hours.

The other comments received, which generally pertain to the collection of this information, provided no data estimates or assumptions upon which to adjust the burdens under the PRA. These other comments pertain to those burdens in two ways. First, USDA and RSI Logistics propose general rule changes that would impact the burdens here. (USDA Comment 2-3; RSI Logistics Comment 1.) These comments are addressed above and are not adopted in this rulemaking. Second, AAR, AFPM, and NGFA point to the estimated total one-time hour burden (640 hours) under the PRA set forth in the NPRM as indicating the limited cost of the changes in the proposed rule. (AAR Comment 4 n.4; AFPM Comment 4; NGFA Comment 4-5.)

CSXT's estimates, as adjusted above, are reasonable. Therefore, the one-time burden for each of the eight railroads providing their own waybills will be increased from a total of 80 hours to 150 hours for each railroad providing its own waybills, as provided in the table below.

The Board's removal of the manual filing option does not impact the PRA analysis because the Board has not received a manual filing in 10 years.

This request to modify and extend an existing, approved collection will be submitted to OMB for review as required under the PRA, 44 U.S.C. 3507(d), and 5 CFR 1320.11. The request will address the comments discussed above as part of the PRA approval process.

Pursuant to the Congressional Review Act, 5 U.S.C. 801-808, the Office of Information and Regulatory Affairs has designated this rule as non-major, as defined by 5 U.S.C. 804(2).

It is ordered:

1. The Board adopts the final rule set forth in this decision. Notice of the final rule will be published in the Federal Register .

2. This decision is effective on January 1, 2021.

3. A copy of this decision will be served upon the Chief Counsel for Advocacy, Office of Advocacy, U.S. Small Business Administration.

For the reasons set forth in the preamble, the Surface Transportation Board amends part 1244 of title 49, chapter X, of the Code of Federal Regulations as follows:

The reef fish fishery of the Gulf is managed under the Fishery Management Plan (FMP) for Reef Fish Resources of the Gulf of Mexico, prepared by the Gulf of Mexico Fishery Management Council (Gulf Council). The CMP fishery is managed under the FMP for CMP Resources in the Gulf of Mexico and Atlantic Region, prepared by the Gulf Council and South Atlantic Fishery Management Council. Both FMPs are implemented through regulations at 50 CFR part 622 under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act).

The Generic Dealer Amendment established Federal dealer reporting requirements for federally permitted dealers in the Gulf and South Atlantic (79 FR 19490; April 9, 2014). Amendment 26 to the FMP established an IFQ program for the commercial red snapper component of the Gulf reef fish fishery (71 FR 67447; November 22, 2006). Amendment 29 to the FMP established an IFQ program for the commercial grouper and tilefish components of the Gulf reef fish fishery (74 FR 44732; August 31, 2009). Regulations implementing these IFQ programs (50 CFR 622.21 and 622.22) and the dealer reporting requirements (50 CFR 622.5(c)) require that Federal dealers and IFQ participants have access to a computer and internet and that they conduct administrative functions associated with dealer reporting and the IFQ program, e.g., landing transactions, online. However, these regulations also specify that during catastrophic conditions, as determined by the RA, the RA may waive or modify the reporting time requirements for dealers and authorize IFQ participants to use paper-based forms to complete administrative functions for the duration of the catastrophic conditions. The RA must determine that catastrophic conditions exist, specify the duration of the catastrophic conditions, and specify which participants or geographic areas are deemed affected.

Hurricane Laura made landfall in the U.S. near Cameron, Louisiana, in the Gulf as a Category 4 hurricane on August 27, 2020. Strong winds and flooding from this hurricane impacted communities throughout coastal Louisiana and Texas, resulting in power outages and damage to homes, businesses, and infrastructure. As a result, the RA has determined that catastrophic conditions exist in the Gulf for the Louisiana parishes of Saint Tammany, Orleans, Saint Bernard, Plaquemines, Jefferson, Saint Charles, Lafourche, Terrebonne, Saint Mary, Iberia, Vermilion, and Cameron; and for the Texas counties of Orange, Jefferson, Chambers, Harris, and Galveston.

Through this temporary rule, the RA is authorizing Federal dealers in these affected areas to delay reporting of trip tickets to NOAA Fisheries and IFQ dealers in this affected area to use paper-based forms, from August 31, 2020, through October 5, 2020. NMFS will provide additional notification to affected dealers via NOAA Weather Radio, Fishery Bulletins, and other appropriate means. NOAA Fisheries will continue to monitor and re-evaluate the areas and duration of the catastrophic conditions, as necessary.

Dealers may delay electronic reporting of trip tickets to NMFS during catastrophic conditions. Dealers are to report all landings to NMFS as soon as possible. Assistance for Federal dealers in effected area is available from the Fisheries Monitoring Branch at 1-305-361-4581. NMFS previously provided IFQ dealers with the necessary paper forms and instructions for submission in the event of catastrophic conditions. Paper forms are also available from the RA upon request. The electronic systems for submitting information to NMFS will continue to be available to all dealers, and dealers in the affected area are encouraged to continue using these systems, if accessible.

The administrative program functions available to IFQ dealers in the area affected by catastrophic conditions will be limited under the paper-based system. There will be no mechanism for transfers of IFQ shares or allocation under the paper-based system in effect during catastrophic conditions. Assistance in complying with the requirements of the paper-based system will be available via the Catch Share Support line, 1-866-425-7627 Monday through Friday, between 8 a.m. and 4:30 p.m., Eastern Time.

NMFS issues this action pursuant to section 305(d) of the Magnuson-Stevens Act. This action is consistent with the regulations in 50 CFR 622.5(c)(iii), 622.21(a)(3)(iii), and 622.22(a)(3)(iii) which were issued pursuant to section 304(b) of the Magnuson-Stevens Act, and are exempt from review under Executive Order 12866.

These measures are exempt from the procedures of the Regulatory Flexibility Act because this temporary rule is issued without opportunity for prior notice and comment.

Pursuant to 5 U.S.C. 553(b)(B), there is good cause to waive the requirements to provide prior notice and opportunity for public comment on this temporary rule. Such procedures are unnecessary because the final rules implementing the Gulf IFQ programs and the Gulf and Atlantic Federal dealer reporting have already been subject to notice and public comment. These rules authorize the RA to determine when catastrophic conditions exist, and which participants or geographic areas are deemed affected by catastrophic conditions. The final rules also authorize the RA to provide timely notice to affected participants via publication of notification in the Federal Register , NOAA Weather Radio, Fishery Bulletins, and other appropriate means. All that remains is to notify the public that catastrophic conditions exist and that paper forms may be utilized by IFQ dealers in the affected area and that Federal dealers may submit delayed reports. Additionally, delaying this temporary rule to provide prior notice and opportunity for public comment would be contrary to the public interest because affected dealers continue to receive these species in the affected area and need a means of completing their landing transactions. With the power outages and damages to infrastructure that have occurred in the affected area due to Hurricane Laura, numerous businesses are unable to complete landings transactions and dealer reports electronically. In order to continue with their businesses, IFQ dealers need to be aware they can still complete landing transactions and dealer reports using the paper forms.

For the aforementioned reasons, the AA also finds good cause to waive the 30-day delay in the effectiveness of this action under 5 U.S.C. 553(d)(3).

The snapper-grouper fishery of the South Atlantic includes red snapper and is managed under the Fishery Management Plan for the Snapper-Grouper Fishery of the South Atlantic Region (FMP). The FMP was prepared by the South Atlantic Fishery Management Council and is implemented by NMFS under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) by regulations at 50 CFR part 622.

The commercial ACL for red snapper in the South Atlantic is 124,815 lb (56,615 kg), round weight, as specified in 50 CFR 622.193(y)(1).

Under 50 CFR 622.193(y)(1), NMFS is required to close the commercial sector for red snapper when the commercial ACL is reached, or is projected to be reached, by filing a notification to that effect with the Office of the Federal Register. NMFS has determined that the commercial ACL for South Atlantic red snapper will be reached by September 5, 2020. Accordingly, the commercial sector for South Atlantic red snapper is closed effective at 12:01 a.m., eastern time, on September 5, 2020. For the 2021 fishing year, unless otherwise specified, the commercial season will begin on the second Monday in July (50 CFR 622.183(b)(5)(i)).

The operator of a vessel with a valid commercial vessel permit for South Atlantic snapper-grouper having red snapper on board must have landed and bartered, traded, or sold such red snapper prior to 12:01 a.m., eastern time, on September 5, 2020. Because the recreational sector closed on July 18, 2020 (85 FR 36165, June 15, 2020), after the commercial sector closure that is effective on September 5, 2020, all harvest and possession of red snapper in or from the South Atlantic EEZ is prohibited for the remainder of the 2020 fishing year.

On and after the effective date of the closure notification, all sale or purchase of red snapper is prohibited. This prohibition on the harvest, possession, sale or purchase apply in the South Atlantic on a vessel for which a valid Federal commercial or charter vessel/headboat permit for South Atlantic snapper-grouper has been issued, regardless if such species were harvested or possessed in state or Federal waters (50 CFR 622.193(y)(1) and 622.181(c)(2)).

NMFS issues this action pursuant to section 305(d) of the Magnuson-Stevens Act. This action is required by 50 CFR 622.193(y)(1), which was issued pursuant to section 304(b) of the Magnuson-Stevens Act, and is exempt from review under Executive Order 12866.

These measures are exempt from the procedures of the Regulatory Flexibility Act because the temporary rule is issued without opportunity for prior notice and comment.

This action responds to the best scientific information available. The Assistant Administrator for NOAA Fisheries (AA) finds that the need to immediately implement this action to close the commercial sector for red snapper constitutes good cause to waive the requirements to provide prior notice and opportunity for public comment pursuant to the authority set forth in 5 U.S.C. 553(b)(B), as such procedures are unnecessary and contrary to the public interest. Such procedures are unnecessary because the rule that established the commercial season, ACL, and accountability measure for red snapper has already been subject to notice and comment, and all that remains is to notify the public of the closure. Such procedures are contrary to the public interest because of the need to immediately implement this action to protect red snapper because the capacity of the fishing fleet allows for rapid harvest of the commercial ACL. Prior notice and opportunity for public comment would require time and could potentially result in a harvest well in excess of the established commercial ACL.

For the aforementioned reasons, the AA also finds good cause to waive the 30-day delay in the effectiveness of this action under 5 U.S.C. 553(d)(3).