The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain MHI RJ Aviation ULC Model CL-600-2C10 (Regional Jet Series 700, 701 & 702), CL-600-2D15 (Regional Jet Series 705), and CL-600-2D24 (Regional Jet Series 900) airplanes. The NPRM published in the Federal Register on May 29, 2024 (89 FR 46336). The NPRM was prompted by AD CF-2023-79, dated December 21, 2023, issued by Transport Canada, which is the aviation authority for Canada (Transport Canada AD CF-2023-79) (also referred to as the MCAI). The MCAI states that the electrical harnesses in the overhead bin above the class divider may have insufficient or no separation with the class divider mounting plate. This condition, if not corrected, could result in the electrical harnesses becoming chafed, which could affect the following aircraft systems: ordinance signs, emergency lights/signs, passenger oxygen, and passenger address and air conditioning systems.

In the NPRM, the FAA proposed to require inspecting the overhead bin electrical harnesses at the class dividers and modifying the class divider mounting plate assembly or accomplishing a temporary repair if necessary; and, eventually modifying the class divider mounting plate assembly if a modification was not done after accomplishing the inspection, as specified in Transport Canada AD CF-2023-79. The FAA is issuing this AD to address the unsafe condition on these products.

You may examine the MCAI in the AD docket at regulations.gov under Docket No. FAA-2024-1470.

The FAA received no comments on the NPRM or on the determination of the cost to the public.

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 this State of Design Authority, it has notified the FAA of the unsafe condition described in the MCAI referenced above. The FAA reviewed the relevant data and determined that air safety requires adopting this AD as proposed. Accordingly, the FAA is issuing this AD to address the unsafe condition on this product. Except for minor editorial changes, this AD is adopted as proposed in the NPRM. None of the changes will increase the economic burden on any operator.

Transport Canada AD CF-2023-79 specifies procedures for inspecting the left-hand and right-hand overhead bin electrical harnesses at the class divider for damage ( e.g., chafing), and if damage is found, modifying the class divider mounting plate assembly to improve the overhead bin harnesses protection or accomplishing a temporary repair. Transport Canada AD CF-2023-79 also specifies procedures for eventually modifying the class divider mounting plate assembly if a modification was not done after accomplishing the inspection ( i.e., if a temporary repair was done or if no damage was found after accomplishing the inspection). 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 246 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 FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply on all Dassault Aviation Model FALCON 7X airplanes. The NPRM published in the Federal Register on May 23, 2024 (89 FR 45612). The NPRM was prompted by AD 2024-0076, dated March 19, 2024, issued by EASA, which is the Technical Agent for the Member States of the European Union (EASA AD 2024-0076) (also referred to as the MCAI). The MCAI states that excessive thickness was found on the trailing edge of certain ailerons, which may affect the assembly of the rear spar with the lower and upper skins. The unsafe condition, if not addressed, could result in reduced structural integrity of the aileron.

In the NPRM, the FAA proposed to require a one-time ultrasonic or visual inspection of the aileron rear spar and trailing edge areas, and applicable corrective actions, as specified in EASA AD 2024-0076. The FAA is issuing this AD to address the unsafe condition on these products.

You may examine the MCAI in the AD docket at regulations.gov under Docket No. FAA-2024-1473.

The FAA received no comments on the NPRM or on the determination of the cost to the public.

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 this State of Design Authority, it has notified the FAA of the unsafe condition described in the MCAI referenced above. The FAA reviewed the relevant data and determined that air safety requires adopting this AD as proposed. Accordingly, the FAA is issuing this AD to address the unsafe condition on this product. Except for minor editorial changes, this AD is adopted as proposed in the NPRM. None of the changes will increase the economic burden on any operator.

EASA AD 2024-0076 specifies procedures for one-time ultrasonic and visual inspections for discrepancies (excessive paint thickness) of the aileron rear spar and trailing edge areas, and repair of discrepant parts. 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 160 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 action 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 this on-condition action:

The FAA has included all known costs in its cost estimate. According to the manufacturer, however, some or all of the costs of this AD may be covered under warranty, thereby reducing the cost impact on affected operators.

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

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

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 FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain Embraer S.A. Model EMB-545 and EMB-550 airplanes. The NPRM published in the Federal Register on March 7, 2024 (89 FR 16489). The NPRM was prompted by ANAC AD 2023-08-03R01, effective November 2, 2023 (ANAC AD 2023-08-03R01) (also referred to as the MCAI). The MCAI stated that premature cracks have occurred in the outer layer of left-hand and right-hand flight deck side windows with part number (P/N) NP-200402-7 or P/N NP-200402-8, caused by interference due to manufacturing tolerances.

In the NPRM, the FAA proposed to require initial and repetitive inspections of the flight deck side windows and applicable corrective actions, and to prohibit the installation of affected flight deck side windows, as specified in ANAC AD 2023-08-03R01. The FAA is issuing this AD to address cracks, delamination, scratches, erosion, and any other damage with the affected left-hand and right-hand flight deck side windows, which may subject the inner layer of the window to unpredicted loads for several flights, which could result in window failure and subsequent in-flight depressurization events.

You may examine the MCAI in the AD docket at regulations.gov under Docket No. FAA-2024-0455.

The FAA received one comment, from Embraer S.A. The following presents the comment received on the NPRM and the FAA's response to the comment.

Paragraph (b)(1)(i) of ANAC AD 2023-08-03R01 specified replacement of a window if “any crack in the outer layer” is detected. Paragraph (h)(2) of the proposed AD, however, specified replacement of a window if “any crack, delamination, or any other damage” is found. Embraer stated that delamination is commonly defined as a reduced adhesion or separation of the interlayer between the acrylic plies. Embraer claimed that delamination is found with some frequency in airplane windows and may be present during the inspection. Embraer added that delamination, as well as other typical damage (scratches, crazing, etc.) is not a structural concern, but would require the immediate window replacement according to the proposed AD. Embraer was concerned that the text of the proposed AD would require actions beyond the original intent of the ANAC AD, which is to provide instructions if a crack is identified. Embraer claimed that a crack in the window outer ply caused by the interference with its aluminum strap is the condition that may develop into the unsafe condition.

Since the commenter submitted the comment, ANAC has revised the MCAI. ANAC AD 2023-08-03R02, effective May 10, 2024 (ANAC AD 2023-08-03R02), clarifies the corrective actions for damages other than cracks, although it does not change the intent: If any crack in the outer layer is found, the revised MCAI requires replacing the window, and if delamination, scratches, erosion, or any damage other than a crack is found, the revised MCAI requires corrective actions that depend on the extent of the findings, as specified in Task 56-12-00-200-802-A, “Cockpit Side Window—Allowable limits,” Revision 50, dated May 12, 2023, as published in Aircraft Maintenance Manual AMM-5613, Part II (Maintenance Practices and Procedures-MPP), or further revisions of this task approved by ANAC.

The FAA affirms that maintenance procedures exist with limits defined by the window manufacturer in case of delamination, scratches, erosion, or any other damage. With the updated procedures, the FAA therefore agrees that the exception specified in paragraph (h)(2) of the proposed AD is unnecessary. The FAA has made the following changes to this AD:

• Paragraph (g) of this AD requires the actions specified in ANAC AD 2023-08-03R02 (instead of ANAC AD 2023-08-03R01).

• Paragraph (h)(2) of the proposed AD has been removed from this AD.

• Paragraph (i) has been added to this AD to provide credit if the actions in ANAC AD 2023-08-03R01 were accomplished before the effective date of this AD.

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 this State of Design Authority, it has notified the FAA of the unsafe condition described in the MCAI referenced above. The FAA reviewed the relevant data, considered the comments received, and determined that air safety requires adopting this AD as proposed. Accordingly, the FAA is issuing this AD to address the unsafe condition on this product. Except for minor editorial changes, and any other changes described previously, this AD is adopted as proposed in the NPRM. None of the changes will increase the economic burden on any operator.

The FAA reviewed ANAC AD 2023-08-03R02, effective May 10, 2024. This material specifies procedures for initial and repetitive general visual inspections of the left-hand and right-hand flight deck side windows with P/N NP-200402-7 or P/N NP-200402-8 to detect cracks, delamination, scratches, erosion, and any other damage (such as chipping and crazing). Corrective actions include window replacement and other maintenance procedures depending on the extent of the findings. ANAC AD 2023-08-03R02 also prohibits the installation of flight deck side windows with P/N NP-200402-7 or P/N NP-200402-8, on any airplane.

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 this AD affects 44 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 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 FAA has included all known costs in its cost estimate. According to the manufacturer, however, some or all of the costs of this AD may be covered under warranty, thereby reducing the cost impact on affected operators.

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

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

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 FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to supersede AD 2021-26-05, Amendment 39-21863 (87 FR 1335, January 11, 2022) (AD 2021-26-05). AD 2021-26-05 applied to all Saab AB, Support and Services Model SAAB 2000 airplanes. AD 2021-26-05 required revising the existing maintenance or inspection program, as applicable, to incorporate new or more restrictive airworthiness limitations. The FAA issued AD 2021-26-05 to address, among other things, fatigue cracking of principal structural elements (PSEs) and corrosion prevention and control. This unsafe condition, if not addressed, could result in reduced structural integrity of a PSE, and lead to loss of control of the airplane.

The NPRM published in the Federal Register on May 14, 2024 (89 FR 41903). The NPRM was prompted by AD 2023-0220, dated December 21, 2023 (EASA AD 2023-0220) (also referred to as the MCAI), issued by EASA, which is the Technical Agent for the Member States of the European Union. The MCAI states new or more restrictive airworthiness limitations have been developed.

In the NPRM, the FAA proposed to continue to require certain actions in AD 2021-26-05 and to require revising the existing maintenance or inspection program, as applicable, to incorporate new or more restrictive airworthiness limitations, as specified in EASA AD 2023-0220. The FAA is issuing this AD to address among other things, fatigue cracking of PSEs and corrosion prevention and control. The unsafe condition, if not addressed, could result in reduced structural integrity of a PSE, and lead to loss of control of the airplane.

You may examine the MCAI in the AD docket at regulations.gov under Docket No. FAA-2024-1293.

The FAA received no comments on the NPRM or on the determination of the cost to the public.

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 this State of Design Authority, it has notified the FAA of the unsafe condition described in the MCAI referenced above. The FAA reviewed the relevant data and determined that air safety requires adopting this AD as proposed. Accordingly, the FAA is issuing this AD to address the unsafe condition on this product. Except for minor editorial changes, this AD is adopted as proposed in the NPRM. None of the changes will increase the economic burden on any operator.

EASA AD 2023-0220 specifies new or more restrictive airworthiness limitations for airplane structures and safe life limits.

This AD also requires EASA AD 2021-0132, dated May 25, 2021, which the Director of the Federal Register approved for incorporation by reference as of February 15, 2022 (87 FR 1335, January 11, 2022).

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

The FAA estimates the total cost per operator for the retained actions from AD 2021-26-05 to be $7,650 (90 work-hours × $85 per work-hour).

The FAA has determined that revising the maintenance or inspection program takes an average of 90 work-hours per operator, although the agency recognizes that this number may vary from operator to operator. Since operators incorporate maintenance or inspection program changes for their affected fleet(s), the FAA has determined that a per-operator estimate is more accurate than a per-airplane estimate.

The FAA estimates the total cost per operator for the new actions to be $7,650 (90 work-hours × $85 per work-hour).

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 FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to supersede AD 2009-25-13, Amendment 39-16133 (74 FR 65401, December 10, 2009) (AD 2009-25-13). AD 2009-25-13 applied to certain Bombardier, Inc., Model BD-100-1A10 airplanes. AD 2009-25-13 required the deactivation of the LH baggage bay heater. The FAA issued AD 2009-25-13 to address the possibility of uncontrolled heating by the heater panel, and on the baggage bay compartment, that could result in a fire in the baggage bay.

The NPRM published in the Federal Register on May 22, 2024 (89 FR 44930). The NPRM was prompted by AD CF-2023-72, dated October 18, 2023, issued by Transport Canada, which is the aviation authority for Canada (Transport Canada AD CF-2023-72) (also referred to as the MCAI). The MCAI states that new procedures have been developed for modifications of the baggage bay sidewall interior panel, heater mat, and water tank heater installation that will address the unsafe condition.

In the NPRM, the FAA proposed to continue to require the actions in AD 2009-25-13, and further require modifying the baggage bay sidewall interior panel, heater mat, and water tank heater installation, and doing functional testing. In the NPRM, the FAA proposed that, upon the completion of the new actions, the retained requirements of AD 2009-25-13 would terminate. In the NPRM, the FAA also proposed to revise the applicability to clarify that the AD applies to airplanes having certain serial numbers (which equates to those equipped with sidewall heater having part number (P/N) 3436-06-1/0) instead of part numbers which could be misread. The FAA is issuing this AD to address the unsafe condition on these products.

You may examine the MCAI in the AD docket at regulations.gov under Docket No. FAA-2024-1469.

The FAA received no comments on the NPRM or on the determination of the cost to the public.

In the NPRM, the FAA inadvertently stated that the NPRM proposed to prohibit the installation of affected parts. This AD does not contain a parts installation prohibition, so the FAA deleted references to such a prohibition.

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 this State of Design Authority, it has notified the FAA of the unsafe condition described in the MCAI referenced above. The FAA reviewed the relevant data and determined that air safety requires adopting this AD as proposed. Accordingly, the FAA is issuing this AD to address the unsafe condition on this product. Except for minor editorial changes, this AD is adopted as proposed in the NPRM. None of the changes will increase the economic burden on any operator.

The FAA reviewed Bombardier Service Bulletin 100-25-35, Revision 02, dated January 11, 2016. This material specifies procedures for modifying the LH baggage bay sidewall interior panel and heater mat, installing a LH baggage bay sidewall interior panel blind insert for certain airplanes, modifying the wiring of the LH and right-hand (RH) baggage bay sidewall heater mats, re-identifying the LH heater mat as P/N 3436-07, installing LH and RH heater pictograms for certain airplanes, modifying the water tank heater installation, and performing a functional test.

This AD also requires Bombardier Service Bulletin A100-25-30, dated July 20, 2009, which the Director of the Federal Register approved for incorporation by reference as of December 28, 2009 (74 FR 65401, December 10, 2009).

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

The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to supersede AD 2021-17-02, Amendment 39-21685 (86 FR 48490, August 31, 2021) (AD 2021-17-02). AD 2021-17-02 applied to all ATR-GIE Avions de Transport Régional Model ATR42-200, -300, and -320 airplanes. AD 2021-17-02 required a one-time inspection for discrepancies of the wire bundles between the left- and right-hand AOA probes and the crew alerting computer, and, depending on findings, applicable corrective actions. AD 2021-17-02 also required for certain airplanes, modifying the captain stick shaker wiring, and for all airplanes, revising the existing AFM and applicable corresponding operational procedures to incorporate procedures for the stick pusher/shaker. The FAA issued AD 2021-17-02 to address false activation of the stall warning system due to wiring damage on the wire bundle between an AOA probe and the crew alerting computer, which could result in loss of control of the airplane during take-off and landing phases.

The NPRM published in the Federal Register on October 5, 2023 (88 FR 69102). The NPRM was prompted by AD 2023-0134, dated July 5, 2023 (EASA AD 2023-0134), issued by EASA, which is the Technical Agent for the Member States of the European Union. EASA AD 2023-0134 states final modification instructions of the affected wiring were developed.

In the NPRM, the FAA proposed to require installing a new AOA power supply unit and revising the existing AFM, as specified in EASA AD 2023-0134.

The FAA issued a supplemental notice of proposed rulemaking (SNPRM) to amend 14 CFR part 39 to supersede AD 2021-17-02. The SNPRM published in the Federal Register on May 21, 2024 (89 FR 44568). The SNPRM was prompted by additional modification of the affected wiring for certain airplanes, and by the issuance of EASA AD 2023-0191, dated November 2, 2023 (EASA AD 2023-0191) (also referred to as the MCAI). In the SNPRM, the FAA proposed to retain all of the requirements of AD 2021-17-02. The NPRM also proposed to require installing a new AOA power supply unit and removing the AFM amendment. The FAA is issuing this AD to address the unsafe condition on these products.

You may examine the MCAI in the AD docket at regulations.gov under Docket No. FAA-2023-1987.

The FAA received one comment, from Air Line Pilots Association, International (ALPA), who supported the SNPRM without change.

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 this State of Design Authority, it has notified the FAA of the unsafe condition described in the MCAI referenced above. The FAA reviewed the relevant data, considered the comment received, and determined that air safety requires adopting this AD as proposed. Accordingly, the FAA is issuing this AD to address the unsafe condition on this product. Except for minor editorial changes this AD is adopted as proposed in the SNPRM. None of the changes will increase the economic burden on any operator.

EASA AD 2023-0191 specifies procedures for a one-time inspection for discrepancies of the wire bundles between the left- and right-hand AOA probes and the crew alerting computer, and, depending on findings, applicable corrective actions (repair). EASA AD 2023-0191 also specifies procedures, for certain airplanes, for modifying the captain stick shaker wiring, and for all airplanes, revising the existing AFM to incorporate procedures for the stick pusher/shaker. Finally, EASA AD 2023-0191 specifies procedures for installing the AOA power supply unit, removing the AFM amendment, and accomplishing additional modification of the affected wiring.

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

The FAA has received no definitive data on which to base the cost estimates for the on-condition actions specified in 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:

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, 787-9, and 787-10 airplanes. The NPRM published in the Federal Register on November 24, 2023 (88 FR 82279).

The NPRM was prompted by incidents related to erroneous A/T behavior during a balked landing with the A/T engaged, potential erroneous readings from the LRRA, and possible deficiencies in low airspeed protections and crew alerting systems.

In the NPRM, the FAA proposed to require updating the TM and DCA OPS. The FAA is issuing this AD to address problems with the TM and DCA OPS, which could result in possible runway overrun or controlled flight into terrain.

The FAA received a comment from an individual who supported the NPRM without change.

The FAA also received comments from four commenters, including Air Canada, American Airlines, Boeing, and Qatar Airways. The following presents the comments received on the NPRM and the FAA's response to each comment.

Air Canada and Qatar Airways requested that paragraph (g)(1) of the proposed AD be revised to also allow compliance using Boeing Alert Requirements Bulletin B787-81205-SB310018-00 RB, Issue 001, dated August 3, 2020, for aircraft on which installation of the DCA software update has already been done using Boeing Alert RB B787-81205-SB310018-00 RB, Issue 001, dated August 3, 2020.

The FAA agrees with the commenters. There are no technical differences between Boeing Alert Requirements Bulletin B787-81205-SB310018-00 RB, Issue 002, dated July 15, 2021, and Boeing Alert Requirements Bulletin B787-81205-SB310018-00 RB, Issue 001, dated August 3, 2020. The FAA has changed paragraph (g)(1) to include Boeing Alert RB B787-81205-SB310018-00 RB, Issue 001, dated August 3, 2020, as acceptable for use before the effective date of this AD.

American Airlines and Qatar Airways requested that the proposed AD be revised to ensure that subsequent approved versions of DCA OPS and TM OPS software will still be compliant with the proposed AD. American Airlines requested that paragraph (g) of the proposed AD be revised to read as follows:

The FAA infers this request is to reduce the need for alternative methods of compliance (AMOCs) for subsequent (newer) approved versions of DCA OPS and TM OPS software.

The FAA partially agrees with the commenters. The FAA agrees that without the usage of the terminology “or later approved software” or some variation of the wording that allows the use of later-approved software, historically ADs related to software changes that did not have this wording have resulted in multiple AMOCs for software updates. The FAA disagrees with the need to add “or later approved software” language to paragraph (g) of this AD because this provision is found in Boeing Requirements Bulletins B787-81205-SB310018-00 RB, Issue 002, dated July 15, 2021, and Boeing Alert Requirements Bulletin B787-81205-SB340053-00 RB, Issue 001, dated November 16, 2022, which are required by paragraphs (g)(1) and (2) of this AD, respectively. The FAA has not changed this AD in regard to this comment.

Boeing requested that “throttle malfunction” be replaced with “erroneous autothrottle (A/T) behavior” in the Summary and Background of the NPRM, and paragraph (e) in the proposed AD, because the description incorrectly describes what occurred.

The FAA agrees that erroneous A/T behavior is a more accurate description of the occurrence. The full Background section is not restated in this final rule. The FAA has changed the Summary of the NPRM and paragraph (e) of this AD accordingly.

Boeing also requested that in the Background section, third paragraph, “flight management function (FMF)” be replaced with “Flight Management Function (FMF)/Thrust Management Function (TMF) Block Point (BP) 4.0” because the behavior was due to the design changes included in the thrust management operation software and flight management BP 4.0.

The FAA agrees that FMF/TMF BP 4.0 more accurately describes the associated change; however, the full text of the NPRM Background section is not repeated in the final rule, so no further change is necessary to this final rule.

Boeing further requested that the Background section, sixth paragraph, be revised to read “Airplanes with version TMF software BP 4 installed, the A/T system is engaged during a manual go-around or missed approach . . .” because the behavior seen during a balked landing was introduced with TMF BP 4.0.

The FAA agrees that the issue of erroneous A/T behavior was introduced by FMF/TMF BP 4; however, the full text of the NPRM Background section is not repeated in the final rule, so no further change is necessary to this final rule.

Boeing requested that the FAA revise the NPRM to delete any reference related to “possible deficiencies in low airspeed protections and crew alerting systems,” “crew alerting systems,” “displays and crew alerting (DCA),” “crew alerting (DCA) operational software (OPS),” “install and check DCA software,” and “The FAA reviewed Boeing Alert Requirements Bulletin B787-81205-SB310018-00 RB, Issue 002, dated July 15, 2021. This service information specifies procedures for installing updated DCA OPS software and doing a software configuration check” because the design change included in TMF 4.1 (TMF BP 4.1) to address 20-PAD-0048 (Erroneous A/T Behavior During Balked Landing) and 20-AD-0054 (Erroneous Low Range Radio Altimeter Readings) is not dependent on a DCA OPS update.

Boeing also requested that the FAA revise the NPRM to delete the following statements:

Boeing requested these deletions because the autothrottle low airspeed enhancements were implemented in FMF/TMF BP 4.0.

The FAA acknowledges that the changes associated with TMF BP 4.1 needed to address the issue of erroneous A/T behavior and erroneous LRRA readings are not dependent upon a DCA OPS update, but the FAA disagrees with removing any reference to the “deficiencies in low airspeed protections and crew alerting systems” or “crew alerting (DCA) OPS.” Some changes associated with TMF BP 4.1 are to fix an unsafe condition (A/T issue) introduced by the previous TMF update BP 4. The FAA had intended to mandate TMF BP 4 (in combination with a DCA OPS update) to address the unsafe condition of insufficient low airspeed protections and crew alerting systems but had to postpone AD action until TMF BP 4.1 was available over three years later. While TMF BP 4.1 includes the TMF BP 4 updates addressing low airspeed protections, this is the first time the FAA has mandated requirements to address this unsafe condition. The FAA has not changed this AD in regard to this comment.

The “Related Service Information Under 1 CFR part 51” section of the NPRM described the procedures specified in Boeing Alert Requirements Bulletin B787-81205-SB310018-00 RB, and then added that the FAA “also” reviewed Boeing Alert Requirements Bulletin B787-81205-SB340053-00 RB, Issue 001, dated November 16, 2022, which specifies procedures for installing updated TM OPS software. Boeing requested that the word “also” be deleted because there is only one Boeing Alert Requirement Bulletin associated with Thrust Management BP 4.1.

The FAA disagrees with the request. The documents cited in this section of the NPRM (and this final rule) are required sources of service information for the requirements of this AD. The two documents include different actions (one for installing updated DCA OPS software and the other for installing updated TM OPS software), but both are necessary to address the unsafe conditions identified in this final rule. The FAA has not changed this final rule as a result of this comment.

The FAA reviewed the relevant data, considered any comments received, and determined that air safety requires adopting this AD as proposed. Accordingly, the FAA is issuing this AD to address the unsafe condition on these products. Except for minor editorial changes, and any other changes described previously, this AD is adopted as proposed in the NPRM. None of the changes will increase the economic burden on any operator.

The FAA reviewed Boeing Alert Requirements Bulletin B787-81205-SB310018-00 RB, Issue 002, dated July 15, 2021. This material specifies procedures for installing updated DCA OPS software and doing a software configuration check.

The FAA also reviewed Boeing Alert Requirements Bulletin B787-81205-SB340053-00 RB, Issue 001, dated November 16, 2022. This material specifies procedures for installing updated TM OPS software and doing a software configuration check.

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

The FAA has included all known costs in its cost estimate. According to the manufacturer, however, some or all of the costs of this AD may be covered under warranty, thereby reducing the cost impact on affected operators.

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

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

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 Coast Guard will enforce the special local regulations in 33 CFR 100.703 for the Clearwater Offshore Nationals race regulated area identified in table 1 to § 100.703, item no. 6, from 8 a.m. until 4 p.m., on September 28-29, 2024. This action is being taken to provide for the safety of life on navigable waterways during this event. Our regulation for recurring marine events, Sector St. Petersburg, § 100.703, table 1 to § 100.703, item no. 6, specifies the location of the regulated area for the Clearwater Offshore Nationals race, which encompasses portions of the Gulf of Mexico near Clearwater, FL. During the enforcement periods, as reflected in § 100.703(c), if you are the operator of a vessel in the regulated area you must comply with directions from the Patrol Commander or any designated representative.

In addition to this notice of enforcement in the Federal Register , the Coast Guard plans to provide notification of this enforcement period via the Local Notice to Mariners, marine information broadcasts, or both.

A fuel oil discharge occurred at the oil transfer dock at Buckeye Terminal, in Wilmington, Delaware, on September 12, 2024, and prompt action is needed to respond to the potential safety hazards associated a fuel oil discharge into a navigable waterway. The Coast Guard is issuing this temporary rule under the authority in 5 U.S.C. 553(b)(B). This statutory provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” The Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because it would be contrary to the public interest to delay publication of a final rule to deal with this emergency situation.

Also, under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register . Delaying the effective date of this rule would be impracticable and contrary to the public interest because prompt action is needed to respond to the potential safety hazards associated a fuel oil discharge into a navigable waterway.

The Coast Guard is issuing this rule under authority in 46 U.S.C. 70034. The Captain of the Port Sector Delaware Bay (COTP) has determined that potential hazards associated with a fuel oil discharge into a navigable waterway will be a safety concern for anyone within a 1,000-yard radius of the oil transfer dock at Buckey Terminal Wilmington, in Wilmington, DE. This rule is needed to protect personnel, vessels, and the marine environment in the navigable waters within the safety zone while responding to a discharge of fuel oil.

This rule establishes a temporary safety zone from September 12, 2024, through September 19, 2024. The safety zone will cover all navigable waters of the Christina River and the Delaware River within 1,000 yards of the oil transfer dock at Buckeye Terminal Wilmington, in Wilmington, DE, in position latitude 39°42.96′ N, longitude 75°30.84′ W. The duration of the zone is intended to protect personnel, vessels, and the marine environment in these navigable waters while responding to a discharge of fuel oil. No vessel or person will be permitted to enter the safety zone without obtaining permission from the COTP or a designated representative.

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

Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. This rule has not been designated a “significant regulatory action,” under section 3(f) of Executive Order 12866, as amended by Executive Order 14094 (Modernizing Regulatory Review). Accordingly, this rule has not been reviewed by the Office of Management and Budget (OMB).

This regulatory action determination is based on size, duration, and location of the temporary safety zone. The safety zone is effective for 7 days but will only be enforced while personnel are responding to the fuel oil discharge. Vessel traffic may be able to transit through the safety zone if authorized by the COTP or a designated representative. Moreover, the Coast Guard will release the details of the zone via a Broadcast Notice to Mariners on VHF-FM radio channel 16.

The regulatory flexibility analysis provisions of the Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, do not apply this rule. They do not apply because this rule fits a 5 U.S.C. 553(b)(B) good-cause exception for notice-and-comment rulemaking. Therefore, we were not required to publish a notice of proposed rulemaking. Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please call or email the person listed in the FOR FURTHER INFORMATION CONTACT section.

Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

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

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

Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

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

We have analyzed this rule under Department of Homeland Security Directive 023-01, Rev. 1, associated implementing instructions, and Environmental Planning COMDTINST 5090.1 (series), which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a temporary safety zone lasting only 7 days that will prohibit entry within 1,000 yards of Buckeye Terminal Wilmington, in Wilmington, DE, to respond to the potential safety hazards associated a fuel oil discharge into a navigable waterway. It is categorically excluded from further review under paragraph L60(c) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1.

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

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:

The Coast Guard is issuing this temporary rule under authority in 5 U.S.C. 553(b)(B). This statutory provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” The Coast Guard finds that good cause exists for not publishing a Notice of Proposed Rulemaking (NPRM) with respect to this rule because doing so would be impracticable. The Coast Guard was not made aware of the fireworks event with sufficient time to publish an NPRM, take public comments, consider those comments, and issue a final rule by the scheduled date of the event. It is impracticable to publish an NPRM because we must establish this safety zone by September 21, 2024.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register . Delaying the effective date of this rule would be impracticable because prompt action is needed to respond to the potential safety hazards associated with a fireworks event taking place in a heavily trafficked harbor.

The Coast Guard is issuing this rule under authority in 46 U.S.C. 70034. The Captain of the Port Sector Boston (COTP) has determined that potential hazards exist with a fireworks event occurring in a heavily trafficked harbor in the vicinity of Admiral's Hill, Boston Inner Harbor, Mystic River, Chelsea, Massachusetts. This rule is needed to protect the maritime public and event participants from the hazards associated with the fireworks event.

This rule establishes a safety zone from 7:30 p.m. to 10 p.m. on September 21, 2024, with a rain date of September 22, 2024. The safety zone will cover all the navigable waters of a portion of Boston Inner Harbor in the vicinity of Admiral's Hill, Mystic River, Chelsea, specifically within a 300-yard radius of the fireworks barge in approximate position 42°23′08″ N, 071°3′03″ W. The duration of the zone is intended to protect event participants, support personnel, vessels, and the marine environment in these navigable waters during the fireworks event. No vessel or person will be permitted to enter the safety zone without obtaining permission from the COTP or a designated representative.

Requests to enter the zone will be considered and reviewed on a case-by-case basis. The COTP may be contacted by telephone at (856) 416-3015 or can be reached by VHF-FM channel 16. Persons and vessels permitted to enter this safety zone must transit at their slowest safe speed to minimize wake and comply with all lawful directions issued by the COTP or the designated representative.

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

Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. This rule has not been designated a “significant regulatory action,” under section 3(f) of Executive Order 12866, as amended by Executive Order 14094 (Modernizing Regulatory Review). Accordingly, this rule has not been reviewed by the Office of Management and Budget (OMB).

This regulatory action determination is based on the size, location, duration, and time-of-year of the safety zone. Vessel traffic will be able to safely transit around this safety zone which will impact a small, designated area of Boston Inner Harbor in the vicinity of Admiral's Hill, Mystic River, Chelsea, MA, in support of a fireworks event on September 21, 2024, with a rain date of September 22, 2024. Additionally, this safety zone will be of limited duration, two- and one-half hours, to minimize any adverse impacts to vessels who seek to transit the navigable waters. Moreover, the Coast Guard will issue a Local Notice to Mariners well in advance of the event and a Broadcast Notice to Mariners via VHF-FM marine channel 16 regarding the zone prior to commencement of the event, and the rule allows vessels to seek permission to enter the zone.

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

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

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 121), we want to assist small entities in understanding this rule. If the rule will affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please call or email the person listed in the FOR FURTHER INFORMATION CONTACT section.

Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

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

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

Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

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

We have analyzed this rule under Department of Homeland Security Directive 023-01, Rev. 1, associated implementing instructions, and Environmental Planning COMDTINST 5090.1 (series), which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a safety zone lasting for a period of 2.5 hours that will prohibit entry within the designated safety zone during a fireworks event. It is categorically excluded from further review under paragraph L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1. A Record of Environmental Consideration supporting this determination is available in the docket. For instructions on locating the docket, see the ADDRESSES section of this preamble.

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

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:

On September 16, 2011, the AIA was enacted into law (Pub. L. 112-29, 125 Stat. 284 (2011)), and in 2012, the Office implemented rules to govern Office trial practice for AIA trials, including IPR, PGR, covered business method (CBM), and derivation proceedings pursuant to 35 U.S.C. 135, 316, and 326 and AIA 18(d)(2). See 37 CFR part 42; Rules of Practice for Trials before the Patent Trial and Appeal Board and Judicial Review of Patent Trial and Appeal Board Decisions, 77 FR 48612 (August. 14, 2012); Changes to Implement Inter Partes Review Proceedings, Post-Grant Review Proceedings, and Transitional Program for Covered Business Method Patents, 77 FR 48680 (August 14, 2012); Transitional Program for Covered Business Method Patents—Definitions of Covered Business Method Patent and Technological Invention, 77 FR 48734 (August. 14, 2012). Additionally, the Office published a Patent Trial Practice Guide (Practice Guide) for the rules to advise the public on the general framework of the regulations, including the structure and times for taking action in each of the new proceedings. See 84 FR 64280 (November 21, 2019); https://www.uspto.gov/TrialPracticeGuideConsolidated. The Practice Guide provides a helpful overview of the Patent Trial and Appeal Board (PTAB or Board) process. See, e.g., Practice Guide at 5-8 (AIA trial process), 66-72 (motions to amend).

In 2019, the Office implemented a pilot program (MTA Pilot Program) for motions to amend filed in AIA proceedings before the PTAB. Notice Regarding a New Pilot Program Concerning MTA Practice and Procedures in Trial Proceedings Under the America Invents Act Before the Patent Trial and Appeal Board, 84 FR 9497 (March 15, 2019) (MTA pilot program notice). The MTA Pilot Program addressed public comments on a previously proposed procedure for MTAs, the Board's MTA practice generally, and the allocation of burdens of persuasion after Aqua Products, Inc. v. Matal, 872 F.3d 1290 (Fed. Cir. 2017) (en banc) ( Aqua Products )). See RFC on MTA Practice and Procedures in Trial Proceedings under the America Invents Act before the Patent Trial and Appeal Board, 83 FR 54319 (October 29, 2018) (2018 RFC). The MTA pilot program was extended through September 16, 2024. Extension of the Patent Trial and Appeal Board Motion to Amend Pilot Program, 87 FR 60134 (October 4, 2022).

In 2020, the Office, through notice and comment rulemaking, published a final rule that allocated burdens of persuasion in relation to motions to amend and the patentability of substitute claims. See 37 CFR 42.121(d), 42.221(d); Rules of Practice to Allocate the Burden of Persuasion on Motions to Amend in Trial Proceedings before the Patent Trial and Appeal Board, 85 FR 82936 (December 21, 2020) (“the burden-allocation rules”). These burden-allocation rules assign the burden of persuasion to the patent owner to show, by a preponderance of the evidence, that an MTA complies with certain statutory and regulatory requirements. 37 CFR 42.121(d)(1), 42.221(d)(1). The burden-allocation rules also assign the burden of persuasion to the petitioner to show, by a preponderance of the evidence, that any proposed substitute claims are unpatentable. 37 CFR 42.121(d)(2), 42.221(d)(2).

Finally, the burden-allocation rules further specify that irrespective of those burdens, the Board may, in the “interests of justice,” exercise its discretion to grant or deny an MTA, but “only for reasons supported by readily identifiable and persuasive evidence of record.” 37 CFR 42.121(d)(3), 42.221(d)(3); Hunting Titan, Inc. v. DynaEnergetics Europe GmbH, IPR2018-00600 (PTAB July 6, 2020) (Paper 67) ( Hunting Titan ). Situations meeting the interests of justice standard were stated to include, for example, those in which “the petitioner has ceased to participate in the proceeding or chooses not to oppose the motion to amend, or those in which certain evidence regarding unpatentability has not been raised by either party but is so readily identifiable and persuasive that the Board should take it up in the interest of supporting the integrity of the patent system, notwithstanding the adversarial nature of the proceedings.” 85 FR 82924, 82927 (citing Hunting Titan, Paper 67 at 12-13, 25-26). The burden-allocation rules further provide that in instances where the Board exercises its discretion in the interests of justice, the Board will provide the parties with an opportunity to respond before rendering a final decision on the MTA. Id. at 82927; see also 37 CFR 42.121(d)(3), 42.221(d)(3).

As noted in the final rule that allocated burdens of persuasion, “[i]n the vast majority of cases, the Board will consider only evidence a party introduces into the record of the proceeding.” 85 FR 82927. Thus, “[i]n most instances, in cases where the petitioner has participated fully and opposed the motion to amend, the Office expects that there will be no need for the Board to independently justify a determination of unpatentability.” Id. at 82927-28. That said, the Board may consider, for example “readily identifiable and persuasive evidence already before the Office in a related proceeding ( i.e., in the prosecution history of the challenged patent or a related patent or application, or in the record of another proceeding before the Office challenging the same patent or a related patent).” Id. at 82927. Likewise, “the Board may consider evidence that a district court can judicially notice under Federal Rule of Evidence 201.” Id.; see also 37 CFR 42.121(d)(3), 42.221(d)(3) (“[T]he Board may make of record only readily identifiable and persuasive evidence in a related proceeding before the Office or evidence that a district court can judicially notice.”).

Subsequent to the issuance of the burden-allocation rules, the United States Court of Appeals for the Federal Circuit issued a precedential decision in Hunting Titan, Inc., v. DynaEnergetics Europe GmbH, 28 F.4th 1371 (Fed. Cir. 2022). The court confirmed that no court precedent has “established that the Board maintains an affirmative duty, without limitation or exception, to sua sponte raise patentability challenges to a proposed substitute claim.” Id. at 1381 (citations omitted). The court also stated that “confining the circumstances in which the Board should sua sponte raise patentability issues was not itself erroneous.” Id. The court, however, found it “problematic” that the USPTO confined the Board's discretion to only rare circumstances. Id. It also noted that the USPTO's “substantial reliance on the adversarial system . . . overlooks the basic purpose of [inter partes review] proceedings: to reexamine an earlier agency decision and ensure that patent monopolies are kept within their legitimate scope.” Id. (citations omitted); see id. at 1385 (concurrence expressing concern that the burden-allocation rule's requirement for “readily identifiable and persuasive evidence” may prevent the Board from raising grounds “even when no one is around to oppose a new patent monopoly grant.”).

After four years of experience with the MTA pilot program and development of Federal Circuit case law concerning burden allocation in the MTA context, the Office issued a Request for Comments to seek feedback on the public's experience with the program and the burden-allocation rules that apply to MTAs. See Request for Comments Regarding MTA Pilot Program and Rules of Practice to Allocate the Burdens of Persuasion on Motions to Amend in Trial Proceedings Before the Patent Trial and Appeal Board, 88 FR 33063 (May 23, 2023) (2023 RFC). The Office also sought feedback on when reexamination or reissue proceedings, also referred to as post-grant options, are better alternatives for patent owners seeking to amend claims. Id. at 33065-66. Further, the Office sought comments on whether the MTA pilot program should be modified and what barriers the Office could address to increase the effectiveness of MTA procedures. Id. at 33066.

The 2023 RFC also sought comments on the burden-allocation rules. In light of the Federal Circuit court's commentary on the current rules, as well as the Board's Hunting Titan decision, and given the Office's desire to support the integrity of the patent system and to issue robust and reliable patent rights, the Office sought public comments on whether the Board should more broadly use its discretion to raise sua sponte grounds in the MTA process. Id. Additionally, the Office sought public comments on whether, and under what circumstances, the Office should solicit patent examiner assistance regarding an MTA or conduct a prior art search in relation to proposed substitute claims. Id.

Furthermore, the Office recognized that if the Board exercises its discretion and raises its own grounds of unpatentability under the current rule, 37 CFR 42.121(d)(3), the burden-allocation rules do not specifically state where the burden of persuasion lies for Board-raised grounds. The Office sought public comments on whether the burden-allocation rules should be revised to clarify who bears the burden of persuasion for grounds of unpatentability raised by the Board under 37 CFR 42.121(d)(3) or 42.221(d)(3). See 88 FR 33066; see also Nike, Inc. v. Adidas AG, No. 2021-1903, 2022 WL 4002668, at *4-10 (Fed. Cir. September 1, 2022) (leaving open the question “whether, in an inter partes review, the petitioner or Board bears the burden of persuasion for an unpatentability ground raised sua sponte by the Board against proposed substitute claims”).

On March 4, 2024, the Office published a notice of proposed rulemaking concerning Motion to Amend Practice and Procedures in Trial Proceedings Under the America Invents Act Before the Patent Trial and Appeal Board. 89 FR 15531 (“2024 NPRM”). The Office proposed to revise its rules of practice to provide for issuance of preliminary guidance in response to an MTA and to provide a patent owner with the option for filing one additional revised MTA. Further, the Office proposed to revise the rules to clarify that a preponderance of the evidence standard applies to any new ground of unpatentability raised by the Board and to clarify that when exercising the discretion to grant or deny an MTA or to raise a new ground of unpatentability, the Board may consider all evidence of record in the proceeding, including evidence identified through a prior art search conducted by the Office at the Board's request and added to the record. The comment period for the 2024 NPRM closed on May 3, 2024, and the Office received six public comments on the proposed rules.

The Office received six public comments to the 2024 NPRM none of which opposed the proposal to make permanent the MTA pilot program options. Some commenters, however, stated that the Office should consider additional proposals. These additional proposals include: (1) expressly allowing extensions of time for the final written decision and for filing MTA-related briefs, (2) revising the proposed rules to allow petitioner to file a sur-reply, and (3) clarifying the manner in which patent owner identifies written description support for the proposed substitute claims. Some commenters also recommended expanding the proposed rules on discretion to request examination assistance such that the Board would exercise this discretion in every case with a motion to amend. Finally, one commenter expressed concerns with the proposed rules that revise the Board's limits on the discretion to raise grounds of unpatentability sua sponte. These comments, along with other stated ideas and concerns, are addressed more specifically below.

A comment expressed support for an automatic extension of the deadline for issuing a final written decision in proceedings in which a motion to amend has been filed. A second comment raised the concern that any automatic extension of time might not be necessary in all cases and that there could be a potential for abuse of the motion to amend process if extensions were automatic. Another comment suggested that additional procedures, such as a Board-initiated conference call upon issuance of preliminary guidance, could provide an opportunity for a party to request an extension of time for the final written decision.

The Office appreciates the comments and the concern with scheduling when a motion to amend is filed. After careful review of the comments, the Office does not adopt any changes to the proposed rules. The proposed rules do not modify the current procedures by which an extension may be granted, as discussed above, and an extension of the final written decision deadline may be granted by the Chief Administrative Patent Judge for good cause, and the deadline may be extended by not more than six months. These procedures allow for a case-by-case determination of whether an extension should be granted. In the Board's experience, most cases do not require an extension. With respect to automatic scheduling of a conference call upon issuance of preliminary guidance, the rules provide for an initial conference call upon the filing of a motion to amend at which a discussion of the schedule can occur, and panels of the Board generally honor any request by a party for a further conference call. See 37 CFR 42.121(a), 42.221(a).

With respect to the limitations on timing for post grant review proceedings with motions to amend, we acknowledge a comment suggesting that reexamination or reissue proceedings may be better options for pursing claim amendments if substantial changes that may require additional time are contemplated. See Notice Regarding Options for Amendments by Patent Owner Through Reissue or Reexamination During a Pending AIA Trial Proceeding (April 2019), 84 FR 16654 (April 22, 2019).

A commenter expressed concern with the proposed rule as it relates to the preliminary guidance provided by the Board on an original motion to amend. In particular, the commenter noted that the proposed rule is silent as to whether the petitioner has an opportunity to file a sur-reply to address the Board's preliminary guidance or any new evidence that may accompany the patent owner's reply filed in response to the Board's preliminary guidance. The commenter noted that the proposed rule allows the petitioner to file a reply to the Board's guidance only if the patent owner does not file a reply or revised motion to amend. The commenter urged the Office that the petitioner should be provided, expressly, with a sur-reply in order to afford due process to the petitioner.

The Office appreciates the comment and agrees that the rule should expressly provide for a petitioner sur-reply. The final rule states that the petitioner may file a sur-reply that is limited to responding to the preliminary guidance and/or arguments made in the patent owner's reply brief. Further, although the sur-reply may not be accompanied by new evidence, it may comment on any new evidence filed with the reply and/or point to cross-examination testimony of a reply witness, if relevant to the arguments made in the reply brief.

Moreover, if a patent owner does not file either a reply or a revised MTA after receiving preliminary guidance from the Board, a petitioner may file a reply to the preliminary guidance, but such a reply may only respond to the preliminary guidance and may not be accompanied by new evidence. If a petitioner files a reply in this context, a patent owner may file a sur-reply, but that sur-reply may only respond to the petitioner's reply and may not be accompanied by new evidence.

A commenter raised a concern that proposed provisions in 37 CFR 42.121(b) and 42.221(b), which relate to the content of a motion to amend, contain a possible ambiguity regarding whether the required support in the original disclosure or earlier-filed disclosure must be set forth in the motion to amend or should be set forth as part of the claim listing.

The Office appreciates the comment. To improve clarity, this final rule amends those sections to state that the written description support for a proposed substitute claim must be set forth in the motion to amend, as opposed to the claim listing. This is consistent with current practice and the precedential decision in Lectrosonics: “[t]he written description support must be set forth in the motion to amend itself, not the claim listing.” Lectrosonics, Inc. v. Zaxcom, Inc., IPR2018-01129, 2019 WL 1118864, at *3 (precedential).

The majority of commenters support the proposed rule's provision permitting the Board to request examination assistance from patent examiners when considering claim amendments. A commenter noted, however, that opinions vary on whether, and to what extent, the Board should request assistance to conduct a prior art search. Two commenters suggested that such assistance not be limited to situations in which no petitioner opposes, or all petitioners cease to oppose a motion to amend. These commenters highlighted the expertise of examiners in identifying prior art as reasons to expand the situations for which assistance may be requested. These commenters also expressed concern that Board panels may hesitate to use the proposed rule's full extent, because identifying a petitioner's filing as “illusory opposition” appears to imply that the petitioner is not acting in good faith, and such a standard may be difficult to assess. These commenters suggested that the benefit of ensuring that substitute claims are patentable would justify the relatively few additional prior art searches per year. A third commenter also agreed that having an examiner's search report for each MTA would alleviate concerns with the Office issuing “unexamined” claims, finding such technical assistance to be of value to the panel in evaluating the parties' patentability arguments, although appreciating that such assistance may be perceived as a disincentive to filing motions to amend.

Another commenter suggested that amended claims undergo review prior to a decision being made by the Board only in circumstances where the adversarial system fails to provide the Board with arguments for the unpatentability of the proposed substitute claims, and that both parties be afforded the opportunity to respond. A further commenter disagreed that the Board should be pressured to come up with rejections even when the adversarial process has not failed. That further commenter suggested that encouraging the Board to dig deeply into the records of other proceedings would disadvantage patent owners seeking to save patentable claim scope. That further commenter suggested that language be added to make clear that intervention is neither needed nor expected in a typical proceeding.

The Office appreciates the robust discussion of the variety of viewpoints expressed in the comments. After careful consideration, the Office does not adopt the suggestions to rely solely on the adversarial nature of the proceeding to determine when to request examination assistance. Rather, the Office revises the proposed rule to take into account the comments expressing concern about the narrow circumstances under which examination assistance would be requested. The final rule now states that a lack of opposition would be considered one of the reasons sufficient for the Board to seek examination assistance. As such, the final rule also encompasses the situation in which the Board determines that a deficient prior art challenge in an opposition warrants a search for additional prior art. The ability of the Board to seek examination assistance when warranted, including a prior art search, for amended claims preserves the Office's goal of ensuring that it adequately evaluates the patentability of claims before issuance. The final rule's clarification of appropriate situations for seeking examination assistance is designed to help panels identify when such examination assistance would further the Office's goal. The final rule also accounts for the adversarial motion to amend process that suffices for the vast majority of cases filed to-date. The examination assistance typically would be appropriate in situations that are not duplicative of reasonable efforts expended by the petitioner, such as when an opposition lacks a prior art challenge or when there is no opposition, thus ensuring that the resources of the Office and the patent owner are not expended unnecessarily. Further because it relies on a determination that a deficient prior art challenge warrants a search for additional prior art, the Board would not need to address or inquire about the intent behind an opposition or bad faith efforts of a petitioner. As in the proposed rule, the final rule provides that when the Board requests examination assistance, that the request, as well as the results of the examination assistance will be made of record. The fact that the Board possesses, but has never used, its discretionary authority to request examination assistance reflects the Board's careful exercise of this authority to date. Based upon the comments and the Board's experience, the final rule fairly balances the interests of patent owners who desire to amend claims during an AIA proceeding and the Office's role in maintaining the integrity of the patent system by ensuring the issuance of robust and reliable patents.

A commenter expressed concerns with the proposed revisions to the rule on the Board's discretion to raise grounds of unpatentability sua sponte. In particular, the commenter stated that the proposed changes would broaden the Board's discretion to raise grounds to an uncertain degree, even in cases where zealous advocacy against an amendment is present. The commenter urged the Office to revise the proposed changes to the Board's exercise of discretion to restrain its frequency and clarify that the Board's actions in this regard would neither be needed nor expected in “run-of-the-mine proceedings.” This commenter also urged that the Board consider retaining the prior rule's limitation to considering “only readily identifiable and persuasive evidence in a related proceeding before the Office.” Other commenters expressed support for the proposed rules that give the Board the ability to more broadly exercise its discretion to raise sua sponte grounds of unpatentability and to ensure that the parties are given the opportunity to respond to those grounds. The commenters noted that the Office's current rules, which rely solely on the adversarial process, are at odds with current Federal Circuit case law and undermine the Office's role of ensuring that newly issued claims are patentable.

The Office appreciates the comments. After careful review of the comments made and in light of the careful balance of the various viewpoints on this issue and in alignment with the Office's goals of ensuring the issuance of robust and reliable patents, the Office does not adopt the suggestion to limit the exercise of discretion to raise grounds sua sponte, nor to retain the limit that only “readily identifiable and persuasive evidence” may be relied upon. The rule allows the Board to retain discretion to raise grounds of unpatentability with respect to proposed substitute claims in accordance with Federal Circuit precedent. See Nike, Inc. v. Adidas AG, 955 F.3d 45, 53 (2020); Hunting Titan, 28 F.4th at 1381. Additionally, the commenter's proposed limitations on the Board's exercise of discretion in this regard are similar to those criticized by the Federal Circuit in Hunting Titan. 28 F.4th at 1381, 1385. Consequently, as noted further below, the Board's Hunting Titan decision, which places limitations on the Board's exercise of discretion to raise grounds, is de-designated from precedential status as of the effective date of this final rule. See PTAB Standard Operating Procedure 2 (Revision 10), Publication of Decisions and Designation or De-Designation of Decisions as Precedential or Informative, Part IV (SOP2) available at https://www.uspto.gov/sites/default/files/documents/SOP2%20R10%20FINAL.pdf.

The Office notes that although the adversarial nature of the proceedings provides, in the majority of proceedings, the safeguards of a robust evaluation of proposed substitute claims, there may be situations in which, despite such advocacy, the Board will be able to identify or will be aware of additional reasons the proposed substitute claims may not be granted. It is better for the Office to maintain the integrity of the patent system by ensuring that where the Board determines sua sponte new reasons why a proposed substitute claim should not be granted, that in accordance with due process, the parties are notified of grounds of unpatentability not raised by the opposition and that the parties are given an opportunity to respond. The final rule provides that such notice may be included in the preliminary guidance if one is requested but does not place limitations on such a notice to be provided in other papers or at a different stage of the proceeding, such as after receiving a revised motion to amend. 37 CFR 42.121(e), 42.221(e).

Upon careful consideration of the public comments, the Office adopts the provisions in the proposed rule with minor changes for additional clarity and consistency.

The final rule, which implements the procedure set forth in the Motion to Amend Pilot Program, provides a patent owner with two options when proposing substitute claims for challenged patent claims during an AIA trial proceeding. First, if requested by a patent owner in its original MTA, the Board will issue preliminary, non-binding guidance. 37 CFR 42.121(e), 42.221(e). Second, a patent owner may file, without needing Board authorization, a revised MTA. 37 CFR 42.121(f), 42.221(f). These options are discussed further below.

The Board's preliminary guidance, if requested, typically will come in the form of a short paper issued after a petitioner has filed its opposition to the MTA (or after the due date for a petitioner's opposition, if none is filed). According to the MTA pilot program, the preliminary guidance provides, at a minimum, an initial discussion about whether there is a reasonable likelihood that the original MTA meets statutory and regulatory requirements for an MTA and whether the petitioner (or the record then before the Office, including any opposition to the MTA and accompanying evidence) establishes a reasonable likelihood that the substitute claims are unpatentable. See MTA pilot program notice, 84 FR 9500.

Under the amended rules, preliminary guidance will provide the Board's initial, preliminary views on the original MTA. The preliminary guidance will provide an initial discussion about whether the parties have shown a reasonable likelihood of meeting their respective burdens. See Rules of Practice To Allocate the Burden of Persuasion on Motions To Amend in Trial Proceedings Before the Patent Trial and Appeal Board. 85 FR 82923 (December 21, 2020); 37 CFR 42.121(d)(1) and (2), 42.221(d)(1) and (2). In particular, the preliminary guidance will address whether there is a reasonable likelihood that the patent owner has shown that the MTA meets the statutory and regulatory requirements for an MTA. See 37 CFR 42.121(d)(1), 42.221(d)(1); see also 35 U.S.C. 316(d), 326(d); Lectrosonics, Inc. v. Zaxcom, Inc., IPR2018-01129, 2019 WL 1118864, at *2 (precedential). The preliminary guidance will also provide an initial discussion about whether the petitioner (or the record then before the Office, including any opposition to the MTA and accompanying evidence) has established a reasonable likelihood that the proposed substitute claims are unpatentable. See 37 CFR 42.121(d)(2), 42.221(d)(2). The preliminary guidance may also address any new grounds of unpatentability discretionarily raised by the Board, together with citations to the evidence of record supporting those new grounds. See 37 CFR 42.121(d)(3) and (4), 42.221(d)(3) and (4). In general, the Board's preliminary guidance will address the proposed substitute claims in a patent owner's original MTA in light of the amendments presented in those claims and will not address the patentability of the originally challenged claims.

Preliminary guidance on an MTA during an AIA trial does not bind the Board. See Medytox, Inc. v. Galderma S.A., 71 F.4th 990, 1000 (Fed. Cir. 2023) (holding that the Board's decision to change its claim construction between its Preliminary Guidance and the final written decision was not arbitrary and capricious and did not violate the Administrative Procedure Act (APA)). The Board's preliminary guidance is not a “decision” under 37 CFR 42.71(d), and thus parties may not file a request for rehearing or a request for Director Review of the preliminary guidance.

The parties will have the opportunity to respond to the preliminary guidance. For example, a patent owner may file a reply to a petitioner's opposition to the MTA and/or the preliminary guidance or may file a revised MTA. If an opposition is filed and preliminary guidance was requested, the patent owner's reply may respond to the Board's preliminary guidance and/or to the petitioner's opposition to the MTA. If an opposition is not filed but preliminary guidance was requested, a patent owner's reply may only respond to the preliminary guidance. New evidence (including declarations) may be submitted with every paper in the MTA process, except with a sur-reply or in the special circumstance where a patent owner does not file either a reply or a revised MTA after receiving preliminary guidance from the Board as discussed below. Thus, a patent owner may file new evidence, including declarations, with its revised MTA or reply. See 84 FR 9500 (stating further that when filing new declarations, parties are expected to make their declarants available for depositions promptly and to make their attorneys available to take and defend such depositions; any unavailability will not be a reason to adjust the schedule for briefing on an MTA or revised MTA absent extraordinary circumstances). The petitioner may file a sur-reply that is limited to responding to the preliminary guidance and/or arguments made in the patent owner's reply brief. Although the sur-reply may not be accompanied by new evidence, it may comment on any new evidence filed with the reply and/or point to cross-examination testimony of a reply witness, if relevant to the arguments made in the reply brief.

In the special circumstance of a patent owner not filing either a reply or a revised MTA after receiving preliminary guidance from the Board, a petitioner may file a reply to the preliminary guidance, but such a reply may only respond to the preliminary guidance and may not be accompanied by new evidence. If a petitioner files a reply in this context, a patent owner may file a sur-reply limited to responding to the petitioner's reply, and the sur-reply may not be accompanied by new evidence.

A patent owner may choose to file a revised MTA after receiving a petitioner's opposition to the original MTA or after receiving the Board's preliminary guidance (if requested). As stated in the rule, a patent owner may file either a reply or a revised motion to amend, but not both. That is, if the patent owner did not elect to receive preliminary guidance, the patent owner can still choose to file a revised MTA to address the petitioner's opposition to the original MTA.

If a patent owner chooses to file a revised MTA, the revised MTA must include one or more new proposed substitute claims in place of previously presented substitute claims, where each new proposed substitute claim presents a new claim amendment. The new claim amendments, as well as arguments and evidence, must be responsive to issues raised in the preliminary guidance (if requested) or in petitioner's opposition. Particularly, the revised MTA may include new arguments and/or evidence as to why the revised MTA meets statutory and regulatory requirements for an MTA, as well as arguments and evidence relevant to the patentability of the new proposed substitute claims. 84 FR 9501. Because a revised MTA replaces the original MTA filed earlier in the proceeding, a patent owner may not incorporate by reference substitute claims or arguments presented in the original MTA into the revised MTA; all proposed substitute claims a patent owner wishes the Board to consider must be presented in the revised MTA.

A revised MTA is an additional MTA that is automatically authorized under 35 U.S.C. 316(d)(2) and 326(d)(2). The revisions therefore distinguish between additional MTAs under 37 CFR 42.121(c) and 42.221(c), which require pre-authorization upon a showing of “good cause,” and a revised MTA, which may be filed without prior authorization. Where the term “any motion to amend” is used, the final rule refers to an original, additional, or revised MTA.

A patent owner is not required to request preliminary guidance or file a revised motion to amend. Specifically, if a patent owner does not elect either to receive preliminary guidance on its original MTA or to file a revised MTA, the rules governing amendment of the patent are essentially unchanged from the practice prior to the MTA pilot program. See Lectrosonics, Inc. v. Zaxcom, Inc., IPR2018-01129, 2019 WL 1118864 (PTAB January 24, 2020) (precedential).

The MTA pilot program notice set forth typical timelines and due dates for the filing or issuance of MTA-related papers, depending on whether a patent owner takes advantage of one, both, or neither of the options under the program. See MTA pilot program notice, 84 FR 9506-9507, Appendices 1A (Patent Owner Reply Timeline) and 1B (Revised MTA Timeline). Where a revised MTA is filed, the Office issues a scheduling order that adjusts the deadline for oral hearing to accommodate additional briefing on the MTA.

To address the concerns raised as to the ability of parties to have sufficient time to fully take advantage of the MTA procedure, the Office amends the rules to clarify that the Board may determine whether to request the Chief Administrative Patent Judge extend the final written decision deadline. The rules have also been amended to clarify that the Board may determine whether to extend deadlines in the MTA timeline pursuant to 37 CFR 42.5(c)(2). Extensions are not anticipated to be needed in most cases because the Board's experience is that the default timelines have been sufficient to permit full and fair briefing in cases under the MTA pilot program. Thus, the Office will continue to apply the existing timelines by default as currently implemented under the MTA pilot program unless an extension is granted as discussed further below. See 84 FR 9506-9507 (setting forth MTA pilot program timelines).

The AIA provides the Director the discretion to extend the deadlines for issuing a final written decision for good cause and by not more than six months. 35 U.S.C. 316(a)(11), 326(a)(11). The Director's authority to extend the deadline of the final written decision has been delegated to the Chief Administrative Patent Judge. 37 CFR 42.100(c), 42.200(c). Thus, pursuant to 37 CFR 42.100(c) and 42.200(c), upon a showing of good cause, the Chief Administrative Patent Judge may extend the final written decision deadline beyond the statutory deadline ( i.e., one year from the date a trial is instituted) by up to six months. For example, good cause may be present if one or more circumstances are present in a proceeding, such as: (1) complex issues; (2) unavailability of the panel; or (3) need to accommodate additional papers (such as additional briefing or a requested examination assistance). See e.g., Eden Park Illumination, Inc., v. S. Edward Neister, IPR2022-00381, Paper 51 (August 4, 2023 PTAB) (determining as good cause the involvement of a revised MTA with new prior art, resulting in a substantially compressed schedule, multiple postponements of the oral hearing due to scheduling conflicts, and additional briefing); Hope Medical Enterprises, Inc. v. Fennec Pharmaceuticals Inc., IPR2022-00125, Paper 35 (April 18, 2023 PTAB) (determining as good cause the involvement of a revised MTA, resulting in a compressed schedule, with the revised claims subject to asserted grounds of unpatentability based on a combination of at least four references); Snap, Inc., v. Palo Alto Research Center Inc., IPR2021-00986, Paper 46 (November 7, 2022) (determining as good cause the substantial coordination of proceedings required by the Board due to multiple pending motions to amend).

As for deadlines that are not for a final written decision, typically, a panel of the Board determines whether to grant a good-cause extension under 37 CFR 42.5(c)(2) after request from, and conference with, the parties. In the context of the MTA timelines, the Board will continue to consider whether to grant extensions of those timelines as required by the Board's rules discussed above. In particular, the Board may determine at any time during the pendency of the case, but more specifically upon issuing the preliminary guidance or receiving a revised MTA, whether for good cause the particular circumstances raised by the parties to the proceeding warrant an extension of deadlines. When an extension is granted, the parties will be notified of the change in the due dates for the remainder of the deadlines and events in the proceeding.

Under the rules prior to this final rule and under Federal Circuit case law, the Board retains discretion to raise, or to not raise, grounds of unpatentability with respect to proposed substitute claims. See Nike, Inc. v. Adidas AG, 955 F.3d 45, 53 (2020); Hunting Titan, 28 F.4th at 1381.

In the final rule, the body of evidence that the Board may consider and make of record now includes the entire evidence of record in the proceeding, without limitation, in accordance with Nike, Inc. v. Adidas AG, 955 F.3d at 54 (“[T]he Board may rely on prior art of record in considering the patentability of amended claims.”). By removing limitations of the prior rules, such as the “interests of justice” standard and the requirement for “readily identifiable and persuasive” evidence, the final rule alleviates the Federal Circuit's concern that the Board confined its discretion to only rare circumstances. See Hunting Titan, 28 F.4th at 1381 (noting that the USPTO's “substantial reliance on the adversarial system . . . overlooks the basic purpose of [inter partes review] proceedings: to reexamine an earlier agency decision and ensure `that patent monopolies are kept within their legitimate scope.' ”); see also id. at 1385 (concurrence expressing concern that the burden-allocation rule's requirement for “readily identifiable and persuasive evidence” may prevent the Board from raising grounds “even when no one is around to oppose a new patent monopoly grant”). The final rule broadens the Board's authority to sua sponte raise grounds of unpatentability with respect to proposed substitute claims and provides for notification of those grounds to be given to the parties, typically in, but not limited to, preliminary guidance. 37 CFR 42.121(d)(3) and (4), 42.221(d)(3) and (4).

The final rule therefore departs from the Board's precedential Hunting Titan decision. Hunting Titan, Inc. v. DynaEnergetics Europe GmbH, IPR2018-00600 (PTAB July 6, 2020) (Paper 67). That decision, criticized by the Federal Circuit, is at odds with the proposed broader discretion of the Board to raise grounds sua sponte. Accordingly, the Hunting Titan decision is de-designated from precedential status as of the effective date of this final rule. See (SOP2).

Consistent with the Board's discretion to raise grounds of unpatentability, the MTA pilot program noted the Board's discretion to solicit patent examiner assistance regarding the MTA when “petitioner cease[d] to participate altogether in an AIA trial in which the patent owner file[d] an MTA, and the Board nevertheless exercise[d] its discretion to proceed with the trial.” 84 FR 9502. If solicited by the Board, the assistance could include the preparation of an advisory report that: (1) provides an initial discussion about whether an MTA meets certain statutory and regulatory requirements ( e.g., whether the amendment enlarges the scope of the claims of the patent or introduces new matter) and/or (2) provides an initial discussion about the patentability of proposed substitute claims, for example, in light of prior art that was identified by the parties in their submissions and/or obtained in prior art searches by the examiner. Id. As of issuance of this final rule, the Board has not exercised its discretion to solicit examination assistance.

The final rule provides that the Board may request such examination assistance consistent with current practice reflected in the MTA pilot program. 37 CFR 42.121(d)(3)(ii), 42.221(d)(3)(ii); 84 FR 9502. For example, the Board has discretion to solicit examination assistance if the petitioner ceases to participate altogether in an AIA trial in which the patent owner files an MTA and the Board nevertheless exercises its discretion to proceed with the trial thereafter. 84 FR 9502. The Board may also solicit examination assistance when a petitioner continues to participate in the AIA trial but either does not oppose or has ceased to oppose an MTA. Examination assistance could include the preparation of an advisory report as outlined above. Id.

The final rule thus confirms the Board's discretion to seek examination assistance at any time after any motion to amend has been filed if no petitioner opposes or all petitioners cease to oppose the MTA. The final rule also ensures that the Board retains the discretion to request examination assistance when the opposition is deficient such that a search for additional prior art is warranted. The final rule also clarifies that the Board may make of record information identified in response to the Board-initiated request for examination assistance. Additionally, the final rule provides that the Board's request for examination assistance and the results of that assistance will be made of record.

In light of the received comments, this final rule makes the revisions to the 2024 NPRM as follows.

Sections 42.121(b) and 42.221(b) have been revised further to clarify that the motion itself (not the claim listing) must set forth the support in the original disclosure of the patent for each proposed substitute claim and the support in an earlier-filed disclosure for each claim for which the benefit of the filing date of the earlier-filed disclosure is sought.

Sections 42.121(d)(3)(ii) and 42.221(d)(3)(ii) have been revised further to state that the Board also may consider and may make of record information identified in response to a Board-initiated request for examination assistance. These sections are revised further to expressly state that Board may request the examination assistance at any time after any motion to amend has been filed if no petitioner opposes or all petitioners cease to oppose the motion to amend, or if the Board determines that a deficient prior art challenge in an opposition to a motion to amend warrants a search for additional prior art. Further, the revised rules state that the Board's request for examination assistance and the results of such assistance will be made of record.

Sections 42.121(e)(3) and 42.221(e)(3) have been revised further to clarify that in response to the preliminary guidance, a patent owner may file a reply that responds to the petitioner's opposition to the motion to amend and/or the preliminary guidance. The patent owner may file a revised motion to amend instead of a reply, as discussed in §§ 42.121(f) and 42.221(f). These sections are also revised further to expressly provide for petitioner's filing of a sur-reply that is limited to responding to the preliminary guidance and/or arguments made in the patent owner's reply brief. Further, the revised rule specifies that the sur-reply may not be accompanied by new evidence, but may comment on any new evidence filed with the reply and/or point to cross-examination testimony of a reply witness, if relevant to the arguments made in the reply brief.

New §§ 42.121(e)(4) and 42.221(e)(4) are a renumbering of unchanged provisions previously included in §§ 42.121(e)(3) and 42.221(e)(3).

Sections 42.121(a) and 42.221(a) are amended to refer to original motions to amend and to allow for requests for preliminary guidance on an original motion to amend.

Sections 42.121(b) and 42.221(b) are amended to clarify that the regulation applies to any motion to amend and that support in the original disclosure or earlier-filed disclosure must be included in the motion for each proposed substitute claim.

Sections 42.121(d) and 42.221(d) are amended to provide that the Board may consider all evidence of record in the proceeding when exercising its discretion to grant or deny a motion to amend or raise a new ground of unpatentability in connection with a proposed substitute claim. These sections are further amended to provide that the Board may consider, and may make of record, any evidence in a related proceeding before the Office as well as evidence that a district court can judicially notice. These sections are also amended to provide that the Board may request examination assistance at any time after any motion to amend has been filed, if no petitioner opposes or all petitioners cease to oppose the motion to amend, or if the Board determines that a deficient prior art challenge in an opposition to a motion to amend warrants a search for additional prior art. These sections are further amended to state that information identified in response to the Board-initiated request for examination assistance may be considered and made of record, and that the request and the results of the examination assistance will also be made of record. The sections further state that when the Board exercises discretion to raise a new ground in connection with a motion to amend, the Board will determine patentability on the new ground by reference to the evidence of record or made of record and based on a preponderance of the evidence. These sections do not alter the current rules on burden of persuasions of parties to the proceeding.

Sections 42.121(e) and 42.221(e) are added to provide for an opportunity to request preliminary guidance, consistent with the MTA pilot program. Such guidance will not be binding on the Board, is not a “decision” under 37 CFR 42.71(d), and is not a final agency action. The added sections permit a patent owner to file a reply to the petitioner's opposition to the motion to amend and/or the preliminary guidance (if requested), or a revised MTA as discussed in §§ 42.121(f) and 42.221(f). The reply or revised MTA may be accompanied by new evidence. Further, the petitioner may file a sur-reply that is limited to responding to the preliminary guidance and/or arguments made in the patent owner's reply brief. The sur-reply may not be accompanied by new evidence but may comment on any new evidence filed with the reply and/or point to cross-examination testimony of a reply witness, if relevant to the arguments made in the reply brief. Moreover, the added sections provide that, if a patent owner does not file either a reply or a revised MTA after receiving preliminary guidance from the Board, the petitioner may file a reply to the preliminary guidance, but such a reply may only respond to the preliminary guidance and may not be accompanied by new evidence. If the petitioner files a reply in this context, a patent owner may file a sur-reply, but that sur-reply may only respond to the petitioner's reply and may not be accompanied by new evidence.

Further, the added sections provide that the Board may, upon issuing the preliminary guidance, for good cause and on a case-by-case basis, determine whether to request the Chief Administrative Patent Judge to extend the final written decision deadline more than one year from the date a trial is instituted in accordance with §§ 42.100(c) and 42.200(c) and whether to extend any remaining deadlines under § 42.5(c).

The final rule adds §§ 42.121(f) and 42.221(f) to provide an opportunity for a patent owner to file one revised motion to amend, consistent with the MTA pilot program. Such a revised motion to amend must be responsive to issues raised in the preliminary guidance, or the petitioner's opposition to the motion to amend, and must include one or more new proposed substitute claims in place of previously presented substitute claims, where each new proposed substitute claim presents a new claim amendment. Any revised motion to amend replaces the original motion to amend in the proceeding.

Further, the Board may, upon receiving the revised motion to amend, on a case-by-case basis, determine whether to request the Chief Administrative Patent Judge to extend the final written decision deadline more than one year from the date a trial is instituted in accordance with §§ 42.100(c) and 42.200(c) and whether to extend any remaining deadlines under § 42.5(c).

This rulemaking makes changes to the consolidated set of rules relating to Office trial practice for IPR, PGR, and derivation proceedings. The changes in this rulemaking do not alter the substantive criteria of patentability. These changes involve rules of agency practice. See, e.g., 35 U.S.C. 316(a)(5), as amended. The changes in this rulemaking involve rules of agency practice and procedure, and/or interpretive rules, and do not require notice-and-comment rulemaking. See Perez v. Mortg. Bankers Ass'n, 575 U.S. 92, 97, 101 (2015) (explaining that interpretive rules “advise the public of the agency's construction of the statutes and rules which it administers” and do not require notice and comment when issued or amended); Cooper Techs. Co. v. Dudas, 536 F.3d 1330, 1336-37 (Fed. Cir. 2008) (5 U.S.C. 553, and thus 35 U.S.C. 2(b)(2)(B), do not require notice-and-comment rulemaking for “interpretative rules, general statements of policy, or rules of agency organization, procedure, or practice”); and JEM Broadcasting Co. v. F.C.C., 22 F.3d 320, 328 (D.C. Cir. 1994) (explaining that rules are not legislative because they do not “foreclose effective opportunity to make one's case on the merits.”).

Nevertheless, the USPTO has chosen to seek public comment before implementing the rule to benefit from the public's input.

For the reasons set forth herein, the Senior Counsel for Legislative and Regulatory Affairs of the Office of General Law at the USPTO has certified to the Chief Counsel for Advocacy of the Small Business Administration that changes in this rule will not have a significant economic impact on a substantial number of small entities. See 5 U.S.C. 605(b).

This rule revises certain trial practice procedures before the Board. Specifically, the Office proposes to amend the rules of practice before the Board to reflect current Board practice, as set forth in various precedential and informative Board decisions, as well as the Office's Trial Practice Guide. Specifically, the Office amends the rules of practice to make permanent certain provisions of the Office's MTA pilot program. These changes are procedural in nature, and any requirements resulting from the proposed changes are of minimal or no additional burden to those practicing before the Board.

For the foregoing reasons, the changes in this rulemaking will not have a significant economic impact on a substantial number of small entities.

This rulemaking has been determined to be not significant for purposes of Executive Order 12866 (September 30, 1993), as amended by Executive Order 14094 (April 6, 2023).

The Office has complied with Executive Order 13563 (January 18, 2011). Specifically, and as discussed above, the Office has, to the extent feasible and applicable: (1) made a reasoned determination that the benefits justify the costs of the rule; (2) tailored the rule to impose the least burden on society consistent with obtaining the regulatory objectives; (3) selected a regulatory approach that maximizes net benefits; (4) specified performance objectives; (5) identified and assessed available alternatives; (6) involved the public in an open exchange of information and perspectives among experts in relevant disciplines, affected stakeholders in the private sector, and the public as a whole and provided online access to the rulemaking docket; (7) attempted to promote coordination, simplification, and harmonization across government agencies and identified goals designed to promote innovation; (8) considered approaches that reduce burdens and maintain flexibility and freedom of choice for the public; and (9) ensured the objectivity of scientific and technological information and processes.

This rulemaking pertains strictly to Federal agency procedures and does not contain policies with federalism implications sufficient to warrant preparation of a Federalism Assessment under Executive Order 13132 (August 4, 1999).

This rulemaking will not: (1) have substantial direct effects on one or more Indian tribes; (2) impose substantial direct compliance costs on Indian Tribal governments; or (3) preempt Tribal law. Therefore, a Tribal summary impact statement is not required under Executive Order 13175 (November 6, 2000).

This rulemaking is not a significant energy action under Executive Order 13211 because this rulemaking is not likely to have a significant adverse effect on the supply, distribution, or use of energy. Therefore, a Statement of Energy Effects is not required under Executive Order 13211 (May 18, 2001).

This rulemaking meets applicable standards to minimize litigation, eliminate ambiguity, and reduce burden as set forth in sections 3(a) and 3(b)(2) of Executive Order 12988 (February 5, 1996).

This rulemaking does not concern an environmental risk to health or safety that may disproportionately affect children under Executive Order 13045 (April 21, 1997).

This rulemaking will not affect a taking of private property or otherwise have taking implications under Executive Order 12630 (March 15, 1988).

Under the Congressional Review Act provisions of the Small Business Regulatory Enforcement Fairness Act of 1996 (5 U.S.C. 801 et seq. ), the USPTO will submit a report containing the final rule and other required information to the United States Senate, the United States House of Representatives, and the Comptroller General of the Government Accountability Office. The changes in this rulemaking are not expected to result in an annual effect on the economy of $100 million or more, a major increase in costs or prices, or significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of United States-based enterprises to compete with foreign-based enterprises in domestic and export markets. Therefore, this rulemaking is not a “major rule” as defined in 5 U.S.C. 804(2).

The changes set forth in this rulemaking do not involve a Federal intergovernmental mandate that will result in the expenditure by State, local, and Tribal governments, in the aggregate, of $100 million (as adjusted) or more in any one year, or a Federal private sector mandate that will result in the expenditure by the private sector of $100 million (as adjusted) or more in any one year, and will not significantly or uniquely affect small governments. Therefore, no actions are necessary under the provisions of the Unfunded Mandates Reform Act of 1995. See 2 U.S.C. 1501 et seq.

This rulemaking will not have any effect on the quality of the environment and is thus categorically excluded from review under the National Environmental Policy Act of 1969. See 42 U.S.C. 4321 et seq.

The requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) are not applicable because this rulemaking does not contain provisions that involve the use of technical standards.

The Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3549) requires that the Office consider the impact of paperwork and other information collection burdens imposed on the public.

In accordance with section 3507(d) of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ), the paperwork and other information collection burdens discussed in this rulemaking have already been approved under Office of Management and Budget (OMB) Control Number 0651-0069 (Patent Review and Derivations).

Notwithstanding any other provision of law, no person is required to respond to, nor shall any person be subject to, a penalty for failure to comply with a collection of information subject to the requirements of the Paperwork Reduction Act unless that collection of information has valid OMB control number.

For the reasons set forth in the preamble, the Office amends 37 CFR part 42 as follows:

The mission of MFCUs is to investigate and prosecute (or refer for prosecution): (1) fraud committed by Medicaid providers, (2) fraud in the administration of the Medicaid program, and (3) patient abuse or neglect of residents in health care facilities and board and care facilities and of Medicaid enrollees in noninstitutional or other settings. MFCUs receive most of their funding from the Federal Government, and each MFCU operates as “a single, identifiable entity of State government.” Each of the 50 States has a MFCU, as well as the District of Columbia, Puerto Rico, and the U.S. Virgin Islands. Except for four States, each MFCU is organized as part of the State Attorney General's office.

HHS-OIG has been delegated authority under sections 1903(q) and 1903(a)(6) of the Social Security Act (the Act) to certify and annually recertify Units as eligible for Federal financial participation (FFP), and to reimburse States for costs incurred in operating a MFCU. Through the certification and recertification process, OIG ensures that the Units meet the requirements for FFP set forth in section 1903(q) of the Act and in Federal regulations found at 42 CFR part 1007. As part of this process, OIG applies a series of performance standards, as required by section 1902(a)(61) of the Act, in determining the effectiveness of Units in carrying out required MFCU functions. The standards provide helpful guidance to MFCUs in their operations and assist OIG in its recertification process and periodic reviews of MFCUs. If OIG determines there are opportunities for a Unit to improve its adherence to the standards, OIG will work with the Unit to implement changes or may impose and monitor formal recommendations for improvement.

The standards reflect practices identified both by OIG and MFCUs that will improve MFCU effectiveness in fulfilling their oversight mission. OIG's goal, both with these standards and with OIG's other oversight activities, is to support each Unit in maximizing its effectiveness in fighting Medicaid fraud and protecting enrollees and other facility residents. We encourage Units to implement these standards in light of each State's organization and practices and to identify additional best practices that will improve their effectiveness.

OIG initially published the MFCU performance standards in 1994 (see 59 FR 49080, September 26, 1994) and revised the standards in 2012 (see 77 FR 32645, June 1, 2012). Based on its experience in overseeing MFCUs, OIG has updated the standards. The updated standards were developed in consultation with the National Association of Medicaid Fraud Control Units. OIG welcomes stakeholder feedback on the standards and may consider future revisions in response to feedback.

A Unit conforms with applicable statutes, regulations, and policy directives, including:

A. Section 1903(q) of the Social Security Act, containing the basic requirements for operation of a MFCU;

B. Regulations for operation of a MFCU contained in 42 CFR part 1007;

C. Federal administrative requirements, cost principles, and audit requirements referenced in the notice of grant award terms and conditions;

D. Applicable State and Federal requirements and standards pertaining to information security as described in Standard 7F;

E. OIG policy transmittals as maintained on the OIG website; and

F. Terms and conditions of the notice of the grant award as maintained on the OIG website.

A Unit maintains reasonable staff levels and office locations in relation to the State's Medicaid program expenditures and has a salary and benefit package that allows the Unit to recruit and retain qualified staff. To determine whether a Unit meets this standard, OIG will consider the following performance indicators:

A. The Unit seeks to employ a total number of professional staff that is commensurate with the State's total Medicaid program expenditures and that enables the Unit to effectively investigate and prosecute (or refer for prosecution) an appropriate volume of case referrals and workload for both Medicaid fraud and abuse or neglect of patients or residents.

B. The Unit employs an appropriate mix and number of attorneys, auditors, investigators, and other professional staff that is commensurate with the State's total Medicaid program expenditures and that allows the Unit to effectively investigate and prosecute (or refer for prosecution) an appropriate volume of case referrals and workload for both Medicaid fraud and abuse or neglect of patients or residents.

C. The Unit, when warranted for the number of employees, designates one or more supervisory staff, such as senior investigators, to supervise the activities of individual investigators or other employees.

D. The Unit employs a number of administrative staff in relation to its overall size that allows the Unit to operate effectively.

E. The Unit, consistent with State requirements, offers a competitive salary and benefits package that permits the Unit to recruit and retain qualified professional staff in the region where the Unit operates.

F. To the extent that a Unit maintains multiple office locations, such locations are distributed throughout the State and are adequately staffed, commensurate with the volume of case referrals and workload for each location.

A Unit establishes written policies and procedures for its operations and ensures that staff are familiar with, and adhere to, policies and procedures. To determine whether a Unit meets this standard, OIG will consider the following performance indicators:

A. The Unit has written guidelines or manuals that contain current policies and procedures, consistent with these performance standards and any applicable laws, regulations, and policy transmittals, for the investigation and (for those Units with prosecutorial authority) prosecution of Medicaid fraud and abuse and neglect of patients or residents.

B. The Unit adheres to current policies and procedures in its operations.

C. The Unit periodically reviews and updates its policies and procedures and creates and implements new policies and procedures as appropriate.

D. Policies and procedures also address, at a minimum, the following:

1. A timeframe for conducting periodic supervisory case reviews (see Standard 5C);

2. A process for referring cases, when appropriate, to Federal and State agencies;

3. Training standards for Unit employees;

4. A policy to ensure collaboration with Federal partners as required by 42 CFR 1007.11(e)(5); and

5. For those Units with sworn law enforcement agents, policies and procedures to address the exercise of the Unit's law enforcement authorities.

E. Written guidelines and manuals are readily available to all Unit staff, either electronically or in hard copy.

A Unit takes steps to maintain an adequate volume and quality of referrals from the State Medicaid agency and other sources. To determine whether a Unit meets this standard, OIG will consider the following performance indicators:

A. The Unit takes steps to ensure that the State Medicaid agency, managed care organizations, and other pertinent entities refer to the Unit suspected provider fraud. Steps to ensure referrals may include having consistent communication and meetings with referring entities, providing feedback on the quality and volume of referrals, and training on the characteristics of an effective referral.

B. The Unit, unless prohibited by law, provides timely information to the referring entity when the entity requests information on the status of MFCU investigations, including when the Medicaid agency requests quarterly certification pursuant to 42 CFR 455.23(d)(3)(ii).

C. The Unit takes steps to encourage pertinent entities to refer complaints of patient or resident abuse or neglect to the Unit. Pertinent entities may include licensing and certification agencies, the State Long-Term Care Ombudsman, and adult protective services offices.

D. The Unit takes steps through public outreach or other means to encourage the public to make referrals to the Unit.

A Unit takes steps to maintain reasonable case progression and to complete cases within an appropriate timeframe based on the complexity of the cases. To determine whether a Unit meets this standard, OIG will consider the following performance indicators:

A. Each stage of an investigation and prosecution is completed within an appropriate timeframe.

B. Supervisors document the approval to open and close all investigations in the case files or electronic case management system.

C. Supervisors conduct periodic case reviews, consistent with a specific timeframe established in the Unit's policies and procedures. Case reviews include a review of case progress and ensure that staff complete each stage of an investigation and prosecution within an appropriate timeframe. The Unit maintains a record of these reviews in the case files or electronic case management system.

D. Significant delays to cases are documented and explained in the case files or electronic case management system.

E. The Unit pursues, when warranted for the case, the availability and use of appropriate technology, such as digital forensics, surveillance technology, and data analytics.

F. Unit staff are issued, or have appropriate access to, electronic devices and other technology to effectively perform their duties.

A Unit's case mix, as practicable, covers all significant provider types and includes a balance of cases involving fraud and abuse or neglect of patients or residents. To determine whether a Unit meets this standard, OIG will consider the following performance indicators:

A. The Unit seeks to have a broad mix of cases among the significant provider types in the State and seeks to allocate resources among provider types based on levels of Medicaid expenditures or other objective measures of risk.

B. For those States that cover a significant number of Medicaid enrollees under managed care plans, the Unit investigates an appropriate number of cases arising in a managed care setting in its mix of cases.

C. The Unit investigates a balance of cases of fraud and cases of abuse or neglect of patients or residents, for those Units with the responsibility and jurisdiction to investigate or prosecute abuse or neglect of patients or residents.

A Unit maintains case files in an effective manner and uses an electronic case management system that allows efficient access to case information and other performance data. To determine whether a Unit meets this standard, OIG will consider the following performance indicators:

A. The Unit has an electronic case management system that manages and tracks case information from initiation to resolution.

B. Case file documentation is included within the Unit's electronic case management system unless particular circumstances ( e.g., space limitations or security concerns) require the selective use of another storage system.

C. Case files or the electronic case management system include all relevant information, including investigative reports and data analyses.

D. Significant litigation documents, such as charging documents, judgments, and settlement agreements, are included in the case files.

E. Investigative reports, consistent with the Unit's policies and procedures, address all relevant aspects of the investigation and are accurate, clear, complete, concise, logically organized, timely, and objective.

F. The Unit's electronic case management system ensures the protection of sensitive data, case information, and confidential sources.

1. The Unit's information system, including the electronic case management system, complies with applicable State requirements pertaining to information security and breach reporting and with current cybersecurity standards and guidelines as maintained in either: (a) the applicable version of the U.S. Department of Justice FBI Criminal Justice Information Services Division (CJISD) “Security Policy,” CJISD-ITS-DOC-08140-5.9, or (b) the applicable version of the National Institute of Standards and Technology (NIST), special publication, “Security and Privacy Controls for Information Systems and Organizations,” NIST SP 800-53.

2. The Unit maintains documentation of its compliance with policies identified in subsection F1.

3. Any audits, reviews, or risk assessments of the Unit's information system are shared with OIG as a part of the Unit's annual recertification submission.

4. Any known security breaches are reported within 30 days of discovering the incident to the OIG Information Systems Security Officer, isso@oig.hhs.gov.

G. The Unit's electronic case management system allows for monitoring cases and for monitoring and reporting case outcome data to OIG as specified in 42 CFR 1007.17(a)(2).

H. The Unit stores nondocumentary evidence securely and records the evidence in an effective and accessible system.

A Unit cooperates with OIG and other Federal and State agencies in the investigation and prosecution of Medicaid and other health care fraud. To determine whether a Unit meets this standard, OIG will consider the following performance indicators:

A. The Unit communicates on a regular basis with OIG and other Federal or State agencies investigating or prosecuting health care fraud in the State.

B. For criminal or civil cases that are regional or national in scope, the Unit collaborates with Federal agencies and other State MFCUs as appropriate.

C. The Unit cooperates and, as appropriate, coordinates with OIG's Office of Investigations and other Federal agencies on cases being pursued jointly, cases involving the same suspects or allegations, and cases that have been referred to the Unit by OIG or another Federal agency.

D. The Unit makes available, to the extent authorized by law and upon request by Federal investigators and prosecutors, all information in its possession concerning provider fraud or fraud in the administration of the Medicaid program.

E. For cases that require the granting of extended authority under 42 CFR 1007.11(a)(2) to investigate Medicare or other Federal health care fraud, the Unit seeks approval from the OIG regional Special Agent in Charge following procedures set by OIG or other relevant Federal Inspectors General under procedures set by those agencies.

F. For cases that have civil fraud potential, the Unit investigates and prosecutes such cases under State authority or refers such cases to OIG or the U.S. Department of Justice.

G. The Unit transmits to OIG, for purposes of program exclusions under section 1128 of the Social Security Act, all pertinent information on MFCU convictions, including joint cases. Pertinent information includes judgments of conviction, charging documents, plea agreements, and sentencing orders. Information will be provided within 30 days of sentencing, or as soon as practicable if the Unit encounters delays in receiving the necessary information from the court, as required by 42 CFR 1007.11(g)(3).

H. The Unit reports qualifying cases, as defined by 45 CFR 60.5, to the National Practitioner Data Bank, or successor data bases, within 30 days of sentencing or other reportable action.

A Unit makes statutory or programmatic recommendations, when warranted and appropriate, to the State government. To determine whether a Unit meets this standard, OIG will consider the following performance indicators:

A. The Unit, when warranted and appropriate, makes statutory recommendations to the State legislature to improve the operation or effectiveness of the Unit, including amendments to the enforcement provisions of the State code.

B. The Unit, when warranted and appropriate, makes other regulatory or administrative recommendations regarding program integrity issues to the State Medicaid agency and to other agencies responsible for Medicaid operations or funding.

C. The Unit monitors and maintains records regarding actions taken by the State legislature and the State Medicaid agency or other agencies in response to Unit recommendations.

A Unit periodically reviews its memorandum of understanding (MOU) with the State Medicaid agency to ensure that the MOU reflects current practice, policy, and legal requirements. To determine whether a Unit meets this standard, OIG will consider the following performance indicators:

A. The MOU complies with Federal regulations contained in 42 CFR 1007.9(d), “Relationship and agreement between Unit and Medicaid agency,” including: (1) an agreement for regularly scheduled meetings or communication with the Medicaid agency (and procedures for how the two agencies will coordinate their efforts), (2) procedures (as applicable) for managed care referrals as required by 42 CFR 438.608(a)(7), (3) a requirement that the Unit reviews the MOU at least every 5 years, and (4) an agreement that the Unit renegotiates the MOU as necessary to ensure that it addresses current law and practice.

B. The MOU meets other current Federal legal requirements as contained in law or regulation, including 42 CFR 455.21, “Cooperation with State Medicaid fraud control units,” and 42 CFR 455.23, “Suspension of payments in cases of fraud.”

C. The MOU is consistent with current Federal and State policy, including any policies issued by OIG or the Centers for Medicare & Medicaid Services (CMS).

D. Consistent with Performance Standard 4, the MOU establishes a process to encourage the receipt of an adequate volume and quality of referrals to the Unit from the State Medicaid agency and, as applicable, from managed care organizations.

E. The MOU incorporates by reference CMS's “Performance Standard for Referrals of Suspected Fraud from a Single State Agency to a Medicaid Fraud Control Unit.”

F. Consistent with 42 CFR 1007.11(c), the MOU specifies that overpayments will be referred to the State agency when the Unit is unable to recover such overpayments as a part of a fraud action.

A Unit exercises proper fiscal control over Unit resources. To determine whether a Unit meets this standard, OIG will consider the following performance indicators:

A. The Unit promptly submits to OIG its preliminary budget estimates, proposed budget application, and Federal financial expenditure reports.

B. The Unit limits its requests for grant funding, including its requested staffing levels, to operational amounts and staffing levels that it reasonably expects to fulfill in the upcoming fiscal period.

C. The Unit makes reasonable efforts to employ the number of staff that is included in the Unit's budget application request as approved by OIG.

D. The Unit maintains a property inventory that is updated regularly to reflect all equipment (as defined under 2 CFR 200.1) under the Unit's control and includes all property that may contain personally identifiable information or sensitive information or may be a potential security concern, such as computing devices, weapons, and investigative tools ( e.g., surveillance video or audio equipment).

E. The Unit maintains an effective time and attendance system and personnel activity records.

F. The Unit applies generally accepted accounting principles in its control of Unit funding.

G. The Unit employs a financial system in compliance with the standards for financial management systems contained in Federal grant administration requirements.

A Unit conducts training that aids the mission of the Unit. To determine whether a Unit meets this standard, OIG will consider the following performance indicators:

A. The Unit maintains a training plan for each professional discipline that includes an annual minimum number of training hours and that is at least as stringent as required for professional certification.

B. The Unit ensures that professional staff comply with their training plans and maintains records of completed training.

C. Professional certifications are maintained for all staff, including those that fulfill continuing education requirements.

D. The Unit participates in MFCU-related training, including training offered by OIG, other MFCUs, and other relevant organizations, as such training is available and as funding permits.

E. The Unit participates in cross-training with the fraud detection staff of the State Medicaid agency. As part of such training, Unit staff provide training on the elements of successful fraud referrals and receive training on the role and responsibilities of the State Medicaid agency. Unit training of Medicaid staff should be supplemented as appropriate with training for staff of managed care special investigations units.

The Board's regulations at 49 CFR 1002.3(a) provide for an annual update of the Board's entire user-fee schedule. Fees are generally revised based on the cost study formula set forth at 49 CFR 1002.3(d), which looks to changes in salary costs, publication costs, and Board overhead cost factors. Applying that formula, 95 of the Board's 136 fees will be increased and 41 will remain at their current levels.

Additional information is contained in the Board's decision. To obtain a free copy of the full decision, visit the Board's website at www.stb.gov or call (202) 245-0245. If you require an accommodation under the Americans with Disabilities Act, please call (202) 245-0245.

For the reasons set forth in the preamble, the Surface Transportation Board amends 49 CFR part 1002 as follows:

NMFS, with the advice of the Council, manages the Gulf reef fish fishery, which includes lane snapper, under the FMP. The FMP was prepared by the Council, approved by the Secretary of Commerce, and is implemented by NMFS through regulations at 50 CFR part 622 under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act).

The Magnuson-Stevens Act requires NMFS, with the advice from the regional fishery management councils, to prevent overfishing and achieve, on a continuing basis, the optimum yield (OY) from federally managed fish stocks. These mandates are intended to ensure fishery resources are managed for the greatest overall benefit to the Nation, particularly with respect to providing food production and recreational opportunities and protecting marine ecosystems.

On June 17, 2024, NMFS published a proposed rule for the abbreviated framework action and requested public comment (89 FR 51295). Comments received on the proposed rule are summarized and responded to in the Comments and Responses section of this final rule.

Unless otherwise noted, all weights in this final rule are in round weight.

Lane snapper occur in estuaries and shelf waters of the Gulf and are particularly abundant off south and southwest Florida. Lane snapper in the Gulf exclusive economic zone are managed as a single stock, with a combined annual catch limit (ACL) for the commercial and recreational sectors that is set equal to the acceptable biological catch (ABC). The fishing season is open year-round, January 1 through December 31 unless a closure is required to constrain landings to the ACL. Currently, the lane snapper overfishing limit (OFL) is 1,053,834 pounds (lb) (478,011 kilograms (kg)), and the ABC is 1,028,973 lb (466,734 kg). These catch limits are based on the results of an update to the Southeast Data, Assessment, and Review 49 (SEDAR 49) that was completed in 2019 and used recreational landings estimates generated by the Marine Recreational Information Program (MRIP) Fishing Effort Survey (FES) instead of the previous MRIP-Coastal Household Telephone Survey.

This final rule increases the lane snapper OFL, ABC, and ACL based on the results of the SEDAR 49 interim analysis (IA) and recommendations from the Council's Scientific and Statistical Committee (SSC). The SEDAR 49 IA included updated landings and dead discards information as well as an updated catch-per-unit-effort index for the headboat fleet.

The abbreviated framework action and final rule increase the lane snapper OFL from 1,053,834 lb (478,011 kg) to 1,116,331 lb (506,359 kg), increase the ABC from 1,028,973 lb (466,734 kg) to 1,088,873 lb (493,904 kg), and set the stock ACL equal to the ABC at 1,088,873 lb (493,904 kg). This results in an overall increase in the allowable harvest of 59,900 lb (27,170 kg).

For fishermen with a valid Federal commercial permit to harvest Gulf reef fish, NMFS is revising the process for requesting a power-down exemption to the VMS requirement. NMFS is also removing the requirement that the vessel owner or operator certify compliance with the proper installation and activation of a VMS unit. NMFS expects both of these changes to reduce the burden on individual fishermen and NMFS, and to increase enforceability.

Regulations at 50 CFR 622.28(a) require the owner or operator of a vessel that has been issued a commercial permit for Gulf reef fish to maintain an operational satellite-linked VMS unit on the vessel that transmits the location of the vessel on a regular and consistent basis. Regulations at 50 CFR 622.28(d) allow an owner or operator to power down the VMS unit if the vessel will be continuously out of the water or in port more than 72 consecutive hours. The regulations at 50 CFR 622.28(d) also specify the process for requesting this power-down exemption, which includes obtaining a letter of exemption from the NMFS Office of Law Enforcement (OLE), filing a report through the VMS terminal prior to each power down, and entering the power-down code in the VMS terminal prior to each power down.

When VMS was first required, the process to request a power-down exemption was not included in the regulations; instead, the regulations referred to the NOAA Enforcement Draft VMS Requirements that were included in Appendix E to Amendment 18A to the FMP (71 FR 45248, August 9, 2006). When NMFS revised the VMS regulations in 2007, NMFS added to the regulations the process for requesting a power-down exemption (72 FR 73270, December 27, 2007). Technology now allows for use of an online form and immediate authorization by NMFS.

Therefore, NMFS is modifying the process for submitting the power-down exemption, including how and what information is collected. The owner or operator of the permitted vessel will use an online form to request the VMS power-down exemption. The information requested on the online form is similar to the current form. The only change to the data collected is a field for an email address for the person making the request and their self-identification as the vessel owner or operator. NMFS expects the online form to allow for faster communication and approval for the requester, and to streamline the administrative process by eliminating the need for manual data entry. NMFS will use the self-identification to confirm that the submitter is authorized to submit the request as the vessel owner or operator.

If all of the required information is provided, the authorization for the power-down exemption will be provided automatically as a visible display soon after the time of submission, and will also be sent to the email address provided by the requester and, if different from the requester, to the permit holder's email address if NMFS was provided that information as part of the permit holder's previous permit application. Vessel owners and operators will no longer send an email from the VMS unit on the vessel to NMFS OLE or enter the power-down code using the VMS declaration form on the VMS terminal.

A power-down exemption will be valid until the expiration date requested, which NMFS will limit to not more than 1 year from the authorization date. A new request for a power-down exemption would be required after the completion of the previous authorization for any subsequent time period. There is no limit on the number of exemptions that can be requested.

If a vessel owner or operator wants to end a power-down exemption before the expiration date, the authorization would end automatically when the vessel owner or operator submits a commercial trip declaration. Alternatively, the vessel owner or operator may contact NMFS OLE to end the power-down exemption.

In addition to the changes to the power-down exemption regulations, NMFS is removing the current requirements at 50 CFR 622.28(f)(1) through (3) for a vessel owner or operator to submit a form certifying that a qualified marine electrician has installed and activated a NMFS-approved VMS unit on the vessel. The intent of the form, “Vessel Monitoring System (VMS) Installation and Activation Certification for the Reef Fish Fishery of the Gulf of Mexico,” was to provide NMFS with additional assurance that a vessel owner or operator is compliant with the requirements to install and activate an approved VMS unit. However, NMFS has determined that the compliance form is overly burdensome and has little utility. To accomplish the same purpose as the form, NMFS is adding a check-box certification to the permit application that is required when a commercial reef fish permit is renewed or transferred. In addition, NMFS can detect whether a unit is operational. The existing requirement for a qualified marine technician to install the VMS unit will remain in § 622.28(f).

NMFS received five comment submissions in response to the proposed rule that NMFS published for the abbreviated framework action. Three were in opposition to increasing the lane snapper catch limits and one expressed support for the proposed VMS changes. One comment was outside the scope of the abbreviated framework action and proposed rule, suggesting increased regulation of commercial shrimp boats to address lane snapper bycatch. The comments opposing the increase in the lane snapper catch limits are summarized below, followed by NMFS's response.

Comment 1: It is not appropriate to increase the lane snapper catch limits at this time, especially given recent red tide events that have resulted in fish kills. The population should be allowed to grow for 3-5 years before considering a small increase.

Response: NMFS disagrees that it is not appropriate to increase the lane snapper catch limits at this time. The most recent interim analysis (SEDAR 49 IA) included data through 2022 and indicated that an increase in the Gulf lane snapper stock ACL would not negatively impact the stock. Despite increased fishing pressure and red tide events in recent years, the SEDAR 49 IA found that the lane snapper population was steady and could support a small amount of additional harvest. The Council's SSC reviewed the results of the SEDAR 49 IA and recommended a 5.8 percent increase to the ABC of 59,900 lb (27,270 kg). The Council accepted the SSC's advice and recommended setting the stock ACL equal to the ABC. NMFS agrees that this increase, which is based on the best scientific information available, is appropriate at this time.

Pursuant to sections 304(b)(3) and 305(d) of the Magnuson-Stevens Act, NMFS issues this final rule, which provides the specific authority and procedure for implementing this action. Section 304(b)(3) authorizes NMFS to issue final regulations prepared and recommended by the Council under section 303(c). Section 305(d) authorizes NMFS to promulgate regulations necessary to carry out an FMP. The NMFS Assistant Administrator has determined that this final rule is consistent with the abbreviated framework action, the FMP, other provisions of the Magnuson-Stevens Act, and other applicable law.

This final rule has been determined to be not significant for purposes of Executive Order 12866. The Magnuson-Stevens Act provides the legal basis for this final rule. No duplicative, overlapping, or conflicting Federal rules have been identified. A description of this final rule, why it is being implemented, and the purposes of this final rule are contained in the SUMMARY and SUPPLEMENTARY INFORMATION sections of this preamble.

The first objective of this final rule is to update existing Gulf lane snapper catch limits based on the best scientific information available to achieve OY for Gulf lane snapper while preventing overfishing, consistent with the requirements of the Magnuson-Stevens Act. The second objective of this final rule is to revise VMS-related reporting requirements for commercial Gulf reef fish permit holders to be consistent with NMFS OLE's current practices and to remove the requirement to provide the certification of installation and activation.

The Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration during the proposed rule stage that this action would not have a significant economic impact on a substantial number of small entities. The factual basis for the certification was published in the proposed rule and is not repeated here. No public comments were received regarding this certification. NMFS did not receive any comments from the U.S. Small Business Administration's Office of Advocacy or the public regarding the economic analysis in the abbreviated framework action or the certification in the proposed rule. As a result, no changes to this final rule were made in response to public comments. Because this final rule is not expected to have a significant economic impact on a substantial number of small entities, a final regulatory flexibility analysis is not required and none has been prepared.

This final rule contains a collection-of-information requirement subject to review and approval by the OMB under the Paperwork Reduction Act (PRA). This final rule changes the existing requirements for the collection of information under OMB Control Number 0648-0544, Southeast Region Vessel Monitoring System and Related Requirements by revising the process for fishermen to request a VMS power-down exemption, including how and what information is collected, and the valid period of an exemption. This final rule also changes the existing requirements by removing an existing requirement for a vessel owner or operator to submit a form certifying that a qualified marine electrician has installed and activated a NMFS-approved VMS unit on the vessel, and that NMFS personnel have verified its operation.

The revised VMS power-down exemption would apply to all 814 actively permitted Gulf reef fish vessels, and NMFS expects the proposed VMS power-down exemption changes to decrease the number of respondents per year and decrease the number of annual responses. The annual fleet-wide time burden associated with this revision would be increased from 12.5 hours to 21.75 hours, or an increase of 9.25 total burden hours. Thus, the public reporting burden per vessel is expected to increase on average by approximately 0.01 hours per year and results in an increase in opportunity cost of approximately $0.32 per business per year. This includes the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.

The revised VMS Installation and Activation Certification requirement would also apply to all 814 actively permitted Gulf reef fish vessels, and NMFS expects the removal of the VMS Installation and Activation Certification for the Reef Fish Fishery of the Gulf of Mexico to decrease the number of respondents per year and decrease the number of annual responses. The annual fleet-wide time burden associated with this revision would be decreased from 593.3 hours to 2.67 hours, or a reduction of 590.63 total burden hours. Thus, the total decrease in time burden on average per vessel is approximately 0.73 hours per year and results in a reduction in opportunity cost of approximately $20.20 per business per year. This includes the time for reviewing instructions, searching existing data sources, gathering, and maintaining the data needed, and completing and reviewing the collection of information.

NMFS invites the general public and other Federal agencies to comment on proposed and continuing information collections, which helps NMFS assess the impact of our information collection requirements and minimize the public's reporting burden. Written comments and recommendations for this information collection should be submitted on the following website: www.reginfo.gov/public/do/PRAMain. Find this particular information collection by using the search function and entering the title of the collection or the OMB Control Number 0648-0544.

Notwithstanding any other provision of the law, no person is required to respond to, nor shall any person be subject to a penalty for failure to comply with, a collection of information subject to the requirements of the PRA, unless that collection of information displays a currently valid OMB Control Number.

For the reasons set out in the preamble, NMFS amends 50 CFR part 622 as follows: