The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to all British Aerospace (Operations) Limited Model Jetstream Model 3101 and British Aerospace Regional Aircraft Model Jetstream Model 3201 airplanes. The NPRM published in the Federal Register on March 22, 2022 (87 FR 16118). The NPRM was prompted by MCAI originated by the Civil Aviation Authority (CAA), which is the aviation authority for the United Kingdom. CAA has issued AD G-2021-0017, dated December 21, 2021 (referred to after this as “the MCAI”), to correct an unsafe condition on all BAE Systems (Operations) Limited Model Jetstream Series 3100 and Series 3200 airplanes. The MCAI states:

You may examine the MCAI in the AD docket at https://www.regulations.gov by searching for and locating Docket No. FAA-2022-0285.

In the NPRM, the FAA proposed to require repetitively inspecting the turnbuckle type control cable terminals in the rudder and elevator primary flight control circuits for corrosion, pitting, and cracking and, depending on the inspection results, replacing an affected cable assembly. The FAA is issuing this AD to address the unsafe condition on these products.

The FAA received no comments on the NPRM or on the determination of the costs.

These products have been approved by the aviation authority of another country and are 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 and the public interest require adopting this AD as proposed. Accordingly, the FAA is issuing this AD to address the unsafe condition on these products. This AD is adopted as proposed in the NPRM.

The FAA reviewed British Aerospace Jetstream Series 3100 & 3200 Service Bulletin 27-JA181040, Original Issue, dated January 17, 2019. This service information specifies procedures for repetitively inspecting all threaded turnbuckle type control cable end terminals on certain part-numbered rudder and elevator primary flight control circuits for signs of corrosion, pitting, and cracking on the terminal fitting, and specifies replacing an affected cable assembly when the inspection results require it. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

The MCAI and service information apply to Model Jetstream Series 3100 and Jetstream Series 3200 airplanes, which are identified on the FAA type certificates as Jetstream Model 3101 airplanes and Jetstream Model 3201 airplanes, respectively.

Although the service information specifies reporting inspection results to the manufacturer, this AD does not require that action.

The FAA estimates that this AD affects 18 airplanes of U.S. registry.

The FAA estimates the following costs to comply with this AD:

The FAA estimates the following costs to replace a cable assembly based on the results of the inspection. The FAA has no way of determining the number of airplanes that might need this action:

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:

EASA, which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2021-0169, dated July 19, 2021 (EASA AD 2021-0169), to address an unsafe condition for all RRD Trent 7000-72 and Trent 7000-72C model turbofan engines.

The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to RRD Trent 7000-72 and Trent 7000-72C model turbofan engines. The NPRM published in the Federal Register on March 1, 2022 (87 FR 11355). The NPRM was prompted by in-service experience showing that certain HPT blades may prematurely deteriorate to an unacceptable condition when managed in accordance with the inspection intervals in the TLM. The manufacturer published Rolls-Royce (RR) Alert Non-Modification Service Bulletin (NMSB) Trent 1000 72-AK449, Revision 2, dated July 5, 2021 (the Alert NMSB) specifying procedures for performing initial and repetitive on-wing BSIs of the HPT blades to detect axial cracking. The Alert NMSB also specifies procedures for removing the engine from service to replace the HPT blade set before exceeding a specified number of flight cycles. The compliance time for the initial and repetitive BSIs of the HPT blades required by this AD meet the TLM inspection intervals for HPT blade, part number KH64485. In the NPRM, the FAA proposed to require accomplishing the actions specified in EASA AD 2021-0169, described previously, as incorporated by reference, except for any differences identified as exceptions in the regulatory text of this AD. The FAA is issuing this AD to address the unsafe condition on these products. See EASA AD 2021-0169 for additional background information.

The FAA received comments from three commenters. The commenters were Air Line Pilots Association, International (ALPA), Delta Air Lines, Inc. (DAL), and an individual commenter. The following presents the comments received on the NPRM and the FAA's response to each comment.

DAL requested that the FAA add a reference to AD 2021-25-03, Amendment 39-21846 (86 FR 71135, December 15, 2021), (AD 2021-25-03), to paragraph (b), Affected ADs. DAL commented that AD 2021-25-03 requires the operator's maintenance program be updated to incorporate Revision 7 of the RR TLM. DAL noted that Revision 7 of the RR TLM, Chapter 05-20, defines the interval for the piece-part inspection of the HPT blade. DAL also commented that Note 2 in paragraph (5) of EASA AD 2021-0169 specifically states that the life limitation cancelled the inspection intervals currently defined in the TLM. DAL stated that this AD would partially supersede the requirements of AD 2021-25-03.

The FAA disagrees with adding reference to AD 2021-25-03 in paragraph (b) of this AD. Paragraph (b) of this AD identifies superseded or revised ADs, or other ADs if the requirements of those ADs are affected. The compliance times for the initial and repetitive on-wing BSIs of the HPT blades required by this AD are more restrictive than the inspection intervals specified in the TLM. This AD does not affect the requirements of AD 2021-25-03 and, as a result, AD 2021-25-03 is not an affected AD. The FAA did not change this AD as a result of this comment.

DAL requested the FAA update paragraph (d), Subject, of this AD from JASC Code 7230 to JASC Code 7250. DAL commented that the required inspections and unsafe condition for the HPT fall under JASC Code 7250, not JASC Code 7230 as proposed in the NPRM.

The FAA agrees and has updated paragraph (d) of this AD.

ALPA and an individual commenter supported the NPRM without change.

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 EASA AD 2021-0169. EASA AD 2021-0169 specifies instructions for performing initial and repetitive on-wing BSIs of the HPT blades to detect axial cracking and, depending on the results of the inspections, removal from service of the engine for in-shop replacement of the HPT blade set. EASA AD 2021-0169 also specifies instructions for replacing HPT blades with a new HPT blade set before exceeding a specified number of flight cycles.

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 ADDRESSES .

The FAA reviewed RR Alert NMSB Trent 1000 72-AK449, Revision 2, dated July 5, 2021. This Alert NMSB describes procedures for performing initial and repetitive on-wing BSIs of the HPT blades to detect axial cracking. This Alert NMSB also specifies procedures for removing the engine to replace the HPT blade set before exceeding a specified number of flight cycles.

The FAA considers this AD to be an interim action. If final action is later identified, the FAA might consider additional rulemaking.

The FAA estimates that this AD affects 16 engines installed on 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 replacements that would be required based on the results of the inspection. The agency has no way of determining the number of aircraft that might need this replacement:

The FAA has included all known costs in its cost estimate. According to the manufacturer, however, some 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 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:

EASA, which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2021-0265, dated November 23, 2021 (EASA AD 2021-0265), to correct an unsafe condition for Airbus Helicopters (AH), formerly Eurocopter, Eurocopter France, Aerospatiale, Sud Aviation, Model SA 365 N, SA 365 N1, AS 365 N2, AS 365 N3, EC 155 B, EC 155 B1, AS 355 E, AS 355 F, AS 355F 1 and AS 355 F2 helicopters, all serial numbers.

The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to all Airbus Helicopters Model AS355E, AS355F, AS355F1, AS355F2, AS-365N2, AS 365 N3, SA-365N, SA-365N1, EC 155B, and EC155B1 helicopters. The NPRM published in the Federal Register on March 29, 2022 (87 FR 17955). The NPRM was prompted by investigation results from an engine compartment fire, which determined some of the internal parts of the engine cowling were painted with finish paint on top of the primer layer. The NPRM proposed to require a one-time inspection of certain part-numbered engine cowlings, and corrective actions if necessary, as specified in EASA AD 2021-0265.

The FAA is issuing this AD to detect finish paint inside the duct of the engine cowling. The unsafe condition, if not addressed, could result in fire propagation in case of exposure to high temperature, damage to the helicopter, and injury to the occupants. See EASA AD 2021-0265 for additional background information.

The FAA received no comments on the NPRM or on the determination of the costs.

These helicopters have been approved by EASA and are approved for operation in the United States. Pursuant to the FAA's bilateral agreement with the European Union, EASA has notified the FAA about the unsafe condition described in its AD. The FAA reviewed the relevant data and determined that air safety requires adopting this AD as proposed, except for minor editorial changes. Accordingly, the FAA is issuing this AD to address the unsafe condition on these helicopters.

EASA AD 2021-0265 requires a one-time inspection of certain part-numbered engine cowlings ( e.g., an affected part as defined in EASA AD 2021-0265) for finish paint and depending on the inspection results, accomplishment of applicable corrective actions. EASA AD 2021-0265 also allows an affected part to be installed on any helicopter, provided it is a serviceable part as defined in EASA AD 2021-0265. Corrective actions include repainting the affected part and replacing the affected part.

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 reviewed Airbus Helicopters Alert Service Bulletin (ASB) No. AS355-53.00.38, ASB No. AS365-53.00.65, and ASB No. EC155-53A040, all Revision 0, and all dated October 27, 2021, which specify procedures for inspecting the inside of the duct of the engine cowling for finish paint and corrective actions.

Service information referenced in EASA AD 2021-0265 specifies recording compliance with the applicable ASBs, whereas this AD does not.

The FAA estimates that this AD affects 93 helicopters of U.S. Registry. Labor rates are estimated at $85 per work-hour. Based on these numbers, the FAA estimates the following costs to comply with this AD.

Inspecting each engine cowling takes about 1 work-hour for an estimated cost of $85 per helicopter and $7,905 for the U.S. fleet.

Repainting each engine cowling with primer takes about 8 work-hours for an estimated cost of $680 per helicopter.

Replacing an engine cowling with a “serviceable part” as defined in EASA AD 2021-0265 takes about 4 work-hours and parts cost up to $7,800 for an estimated cost of up to $8,140 per replacement.

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 serial-numbered Viking Air Limited Model DHC-6-1, DHC-6-100, DHC-6-200, DHC-6-300, and DHC-6-400 airplanes. The NPRM published in the Federal Register on March 22, 2022 (87 FR 16123). The NPRM was prompted by MCAI originated by Transport Canada, which is the aviation authority for Canada. Transport Canada has issued AD CF-2021-42, dated November 26, 2021 (referred to after this as “the MCAI”), to correct an unsafe condition on Viking Air Limited Model DHC-6 series 1, DHC-6 series 100, DHC-6 series 110, DHC-6 series 200, DHC-6 series 210, DHC-6 series 300, DHC-6 series 310, DHC-6 series 320, and DHC-6 series 400 airplanes with certain part-numbered FCU push rod assemblies installed. The MCAI states:

You may examine the MCAI in the AD docket at https://www.regulations.gov by searching for and locating Docket No. FAA-2022-0284.

In the NPRM, the FAA proposed to require performing tests, inspections, and lubrication of the FCU push rod assemblies, and replacing them with improved parts as necessary. The FAA is issuing this AD to address the unsafe condition on these products.

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

These products have 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 and service information referenced above. The FAA reviewed the relevant data and determined that air safety and the public interest require adopting this AD as proposed. Accordingly, the FAA is issuing this AD to address the unsafe condition on these products. This AD is adopted as proposed in the NPRM.

The FAA reviewed the following:

• Viking DHC-6 Twin Otter Service Bulletin (SB) No. V6/0063, Revision A, dated February 1, 2021, which specifies procedures for performing tests, inspections, and lubrication of the FCU push rod assemblies; and

• Viking DHC-6 Twin Otter Technical Bulletin No. V6/00155, Revision NC, dated September 14, 2020, which specifies procedures for replacing the FCU push rod assemblies with improved parts.

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

The FAA also reviewed Viking DHC-6 Twin Otter SB No. V6/0063, Revision NC, dated June 7, 2019, which specifies procedures for performing tests, inspections, and lubrication of the FCU push rod assemblies. Viking revised this service information and issued Viking SB V6/0063, Revision A, to extend the lubrication requirement of Mod 6/2347 rod ends to all operating environments, add repeat inspections, and introduce a test and lubrication for airplanes that have not been in operation after a period of time before re-entry into service.

The MCAI applies to Viking Air Limited Model DHC-6 series 110, DHC-6 series 210, DHC-6 series 310, and DHC-6 series 320, and this AD would not because these models do not have an FAA type certificate. Model DHC-6 series 1, DHC-6 series 100, DHC-6 series 200, DHC-6 series 300, and DHC-6 series 400 airplanes specified in the MCAI correspond to Model DHC-6-1, DHC-6-100, DHC-6-200, DHC-6-300, and DHC-6-400 airplanes specified in this AD, respectively.

The MCAI requires reporting information to the manufacturer, and this AD does not.

The FAA estimates that this AD affects 34 airplanes of U.S. registry. The FAA estimates the following costs to comply with this AD:

The FAA estimates the following costs to replace the FCU push rod assemblies. The agency has no way of determining the number of airplanes that might need these replacements:

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:

Pursuant to the Convention on Cultural Property Implementation Act, Public Law 97-446, 19 U.S.C. 2601 et seq., which implements the 1970 United Nations Educational, Scientific and Cultural Organization (UNESCO) Convention on the Means of Prohibiting and Preventing the Illicit Import, Export and Transfer of Ownership of Cultural Property (823 U.N.T.S. 231 (1972)), the United States entered into a bilateral agreement with the Republic of Peru (Peru) on June 9, 1997, concerning the imposition of import restrictions on archaeological material from the Pre-Hispanic cultures and certain ethnological material from the Colonial period of Peru (the Memorandum of Understanding (MOU) between the United States of America and the Republic of Peru).

On June 11, 1997, the U.S. Customs Service (U.S. Customs and Border Protection's predecessor agency) published Treasury Decision (T.D.) 97-50 in the Federal Register (62 FR 31713), which amended § 12.104g(a) of title 19 of the Code of Federal Regulations (19 CFR 12.104g(a)) to reflect the imposition of these restrictions and included a list designating the types of archaeological and ethnological material covered by the restrictions. These restrictions continued the protection of archaeological material from the Sipán Archaeological Region forming part of the remains of the Moche culture that were first subject to emergency import restrictions on May 7, 1990 (T.D. 90-37), which were extended on June 27, 1994 (T.D. 94-54).

Import restrictions listed at 19 CFR 12.104g(a) are effective for no more than five years beginning on the date on which the agreement enters into force with respect to the United States. This period may be extended for additional periods of no more than five years if it is determined that the factors which justified the agreement still pertain and no cause for suspension of the agreement exists. See 19 CFR 12.104g(a).

Since the initial final rule was published on June 11, 1997, the import restrictions were subsequently extended four (4) times. First, on June 6, 2002, following the exchange of diplomatic notes, the former U.S. Customs Service published a final rule (T.D. 02-30) in the Federal Register (67 FR 38877) to extend the import restrictions for a period of five years. Second, on June 6, 2007, following the exchange of diplomatic notes, CBP published a final rule (CBP Dec. 07-27) in the Federal Register (72 FR 31176) to extend the import restrictions for an additional five-year period. Third, on June 7, 2012, following the exchange of diplomatic notes, CBP published a final rule (CBP Dec. 12-11) in the Federal Register (77 FR 33624) to extend the import restrictions for an additional five-year period. Fourth and lastly, on June 7, 2017, following the exchange of diplomatic notes, CBP published a final rule (CBP Dec. 17-03) in the Federal Register (82 FR 26340) to extend the import restrictions for an additional five-year period through June 8, 2022.

On September 13, 2021, the United States Department of State proposed in the Federal Register (86 FR 50931) to extend the MOU between the United States and Peru concerning the import restrictions on certain categories of archaeological and ethnological material from Peru. On March 15, 2022, after consultation with and recommendations by the Cultural Property Advisory Committee, the Assistant Secretary for Educational and Cultural Affairs, United States Department of State, determined that the cultural heritage of Peru continues to be in jeopardy from pillage of certain archeological and ethnological material, and that the import restrictions should be extended for an additional five years. Pursuant to the exchange of diplomatic notes to extend the agreement, the import restrictions will remain in effect for an additional five years, and the CBP regulations are being amended to reflect this further extension through June 8, 2027.

Accordingly, CBP is amending 19 CFR 12.104g(a) to reflect the extension of the import restrictions. The restrictions on the importation of archaeological artifacts and ethnological material are to continue to be in effect through June 8, 2027. Importation of such material from Peru continues to be restricted through that date unless the conditions set forth in 19 U.S.C. 2606 and 19 CFR 12.104c are met.

The Designated List and additional information may also be found at the following website address: https://eca.state.gov/cultural-heritage-center/cultural-property-advisory-committee/current-import-restrictions by selecting the material for “Peru.”

This amendment involves a foreign affairs function of the United States and is, therefore, being made without notice or public procedure under 5 U.S.C. 553(a)(1). For the same reason, a delayed effective date is not required under 5 U.S.C. 553(d)(3).

Because no notice of proposed rulemaking is required, the provisions of the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ) do not apply.

CBP has determined that this document is not a regulation or rule subject to the provisions of Executive Order 12866 because it pertains to a foreign affairs function of the United States, as described above, and therefore is specifically exempted by section 3(d)(2) of Executive Order 12866.

This regulation is being issued in accordance with 19 CFR 0.1(a)(1), pertaining to the Secretary of the Treasury's authority (or that of his/her delegate) to approve regulations related to customs revenue functions.

Chris Magnus, the Commissioner of CBP, having reviewed and approved this document, has delegated the authority to electronically sign this document to Robert F. Altneu, who is the Director of the Regulations and Disclosure Law Division for CBP, for purposes of publication in the Federal Register .

For the reasons set forth above, part 12 of title 19 of the Code of Federal Regulations (19 CFR part 12), is amended as set forth below:

I. Background

Upon request, FDA has classified the intravascular bleed monitor as class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness. In addition, we believe this action will enhance patients' access to beneficial innovation, in part by placing the device into a lower device class than the automatic class III assignment.

The automatic assignment of class III occurs by operation of law and without any action by FDA, regardless of the level of risk posed by the new device. Any device that was not in commercial distribution before May 28, 1976, is automatically classified as, and remains within, class III and requires premarket approval unless and until FDA takes an action to classify or reclassify the device (see 21 U.S.C. 360c(f)(1)). We refer to these devices as “postamendments devices” because they were not in commercial distribution prior to the date of enactment of the Medical Device Amendments of 1976, which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act).

FDA may take a variety of actions in appropriate circumstances to classify or reclassify a device into class I or II. We may issue an order finding a new device to be substantially equivalent under section 513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a predicate device that does not require premarket approval. We determine whether a new device is substantially equivalent to a predicate device by means of the procedures for premarket notification under section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).

FDA may also classify a device through “De Novo” classification, a common name for the process authorized under section 513(f)(2) of the FD&C Act. Section 207 of the Food and Drug Administration Modernization Act of 1997 established the first procedure for De Novo classification (Pub. L. 105-115). Section 607 of the Food and Drug Administration Safety and Innovation Act modified the De Novo application process by adding a second procedure (Pub. L. 112-144). A device sponsor may utilize either procedure for De Novo classification.

Under the first procedure, the person submits a 510(k) for a device that has not previously been classified. After receiving an order from FDA classifying the device into class III under section 513(f)(1) of the FD&C Act, the person then requests a classification under section 513(f)(2).

Under the second procedure, rather than first submitting a 510(k) and then a request for classification, if the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence, that person requests a classification under section 513(f)(2) of the FD&C Act.

Under either procedure for De Novo classification, FDA is required to classify the device by written order within 120 days. The classification will be according to the criteria under section 513(a)(1) of the FD&C Act. Although the device was automatically placed within class III, the De Novo classification is considered to be the initial classification of the device.

When FDA classifies a device into class I or II via the De Novo process, the device can serve as a predicate for future devices of that type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a result, other device sponsors do not have to submit a De Novo request or premarket approval application to market a substantially equivalent device (see 21 U.S.C. 360c(i), defining “substantial equivalence”). Instead, sponsors can use the less-burdensome 510(k) process, when necessary, to market their device.

On April 23, 2018, Saranas, Inc. submitted a request for De Novo classification of the Early Bird Bleed Monitoring System. FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act.

We classify devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls that, in combination with the general controls, provide reasonable assurance of the safety and effectiveness of the device for its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the information submitted in the request, we determined that the device can be classified into class II with the establishment of special controls. FDA has determined that these special controls, in addition to the general controls, will provide reasonable assurance of the safety and effectiveness of the device.

Therefore, on March 1, 2019, FDA issued an order to the requester classifying the device into class II. In this final order, FDA is codifying the classification of the device by adding 21 CFR 870.1345. 1 We have named the generic type of device intravascular bleed monitor, and it is identified as a probe, catheter, or catheter introducer that measures changes in bioimpedance and uses an algorithm to detect or monitor progression of potential internal bleeding complications.

FDA has identified the following risks to health associated specifically with this type of device and the measures required to mitigate these risks in table 1.

FDA has determined that special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness. In order for a device to fall within this classification, and thus avoid automatic classification in class III, it would have to comply with the special controls named in this final order. The necessary special controls appear in the regulation codified by this order. We encourage sponsors to consult with us if they wish to use a non-animal testing method they believe is suitable, adequate, validated, and feasible. We will consider if such an alternative method could be assessed for equivalency to an animal test method. This device is subject to premarket notification requirements under section 510(k) of the FD&C Act.

The Agency has determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

This final order establishes special controls that refer to previously approved collections of information found in other FDA regulations and guidance. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections of information in the guidance document “De Novo Classification Process (Evaluation of Automatic Class III Designation)” have been approved under OMB control number 0910-0844; the collections of information in 21 CFR part 814, subparts A through E, regarding premarket approval, have been approved under OMB control number 0910-0231; the collections of information in part 807, subpart E, regarding premarket notification submissions, have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 820, regarding quality system regulation, have been approved under OMB control number 0910-0073; and the collections of information in 21 CFR part 801, regarding labeling, have been approved under OMB control number 0910-0485.

Therefore, under the Federal Food, Drug, and Cosmetic Act, 21 CFR part 870 is amended as follows:

In FR Doc. 2022-10545 appearing at 87 FR 33001-33015 in the Federal Register of Wednesday, June 1, 2022, the following corrections are made: On page 33007, in the third column, in section III.B.a.1, correct the first paragraph to read: “The IFR temporarily waived the regulatory requirement that an individual be an inpatient of a hospital for not less than three consecutive calendar days before discharge from the hospital (three-day prior hospital stay) for coverage of a SNF admission for the duration of the COVID-19 national emergency, consistent with a similar waiver under Medicare and TRICARE's statutory requirement to have a SNF benefit like Medicare's. The waiver will terminate when the President's national emergency for COVID-19 is terminated.”

The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This 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.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because it is impracticable. Sector Upper Mississippi River received the marine event application on May 25, 2022, prompting the creation of this rule due to the nature of the event. We must establish this special local regulation immediately and lack sufficient time to provide a reasonable comment period and then consider those comments before issuing the rule. 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 this rule would be contrary to public safety due to potential hazards for participants of the event and those transiting in the area around it.

The Coast Guard is issuing this rule under authority in 46 U.S.C. 70034 (previously 33 U.S.C. 1231). The Captain of the Port Sector Upper Mississippi River (COTP) has determined that potential hazards associated with this marine parade will be a safety concern for anyone operating or transiting within the lake of the Ozarks from MM 6 through MM 1. This rule is needed to protect personnel, vessels, and the marine environment in the navigable waters within the special local regulation while the parade is occurring.

The World's Largest Boat Parade is a gathering of over 1000 boats in an attempt to break a world record for the largest parade. It will occur on June 10, 2022 from 10:30 a.m. until 1 p.m. on the Lake of the Ozarks from MM 6 through MM 1. This special local regulation is a moving limited access area that follows the participants of the parade as they transit the parade route between MM 6 through MM 1. All spectator vessels and vessels not participating in this parade will not be allowed to transit within a 50 yard radius surrounding the area that includes vessels at the front of the parade extending to the vessels transiting at the end of the parade. Vessels other than those directly involved in the event will only be allowed to safely transit the regulated area when the Coast Guard Patrol Commander has deemed it safe to do so.

No vessel or person will be permitted to enter the area without obtaining permission from the COTP or a designated representative. A designated representative is a commissioned, warrant, or petty officer of the U.S. Coast Guard (USCG) assigned to units under the operational control of USCG Sector Upper Mississippi River. To seek permission to enter, contact the COTP or a designated representative via VHF-FM channel 16, or through USCG Sector Upper Mississippi River at 314-269-2332. Persons and vessels permitted to enter the area must comply with all lawful orders or directions issued by the COTP or designated representative. The COTP or a designated representative will inform the public of the effective period for the special local regulation as well as any changes in the dates and times of enforcement, as well as reductions in size of the safety zone as conditions improve, through Local Notice to Mariners (LNMs), Broadcast Notices to Mariners (BNMs), and/or Safety Marine Information Broadcast (SMIB), as appropriate.

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

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

This regulatory action determination is based on a special local regulation located on the Lake of the Ozarks at MM 6 through MM 1. The regulation is expected to be active only during the hours of 10:30 a.m. to 1:00 p.m. on June 10, 2022.

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 special local regulation area may be small entities, for the reasons stated in section V.A above, this rule will not have a significant economic impact on any vessel owner or operator.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please 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 special local regulation is a moving limited access area that follows the participants of the parade as they transit the parade route between MM 6 through MM 1. All spectator vessels and vessels not participating in this parade will not be allowed to transit within a 50 yard radius surrounding the area that includes vessels at the front of the parade extending to the vessels transiting at the end of the parade. It is categorically excluded from further review under paragraph L61 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 100 as follows:

On May 11, 2022, the Coast Guard issued a final rule establishing a temporary safety zone on certain navigable waters of the Potomac River to protect persons and vessels during critical operations requiring a large crane within the federal navigation channel to lift and set 250-ton pier protection fender ring precast segments adjacent to the federal navigation channel at the new Governor Harry W. Nice/Senator Thomas “Mac” Middleton Memorial (US-301) Bridge (87 FR 28776). The original rule runs through 8 p.m. on June 18, 2022. However, additional time is needed to conduct the critical heavy lift operations, and, as a result, the Coast Guard needs to extend the safety zone through 8 p.m. on July 1, 2022. The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This 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.” Under 5 U.S.C. 553(b)(B), 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 and contrary to the public interest. The Coast Guard was unable to publish an NPRM and hold a reasonable comment period for this rulemaking due to the emergent nature of the continuing critical bridge construction operations and required publication of this extension. Immediate action is needed to continue to protect persons and vessels from the hazards associated with carrying out large crane heavy lifts at the new Governor Harry W. Nice/Senator Thomas “Mac” Middleton Memorial (US-301) Bridge that must occur within the federal navigation channel. It is impracticable and contrary to the public interest to publish an NPRM, because the extension needs to be in place by June 18, 2022. However, the Coast Guard is providing an opportunity to comment while the rule is in effect and may amend the rule after it becomes effective, if necessary.

We are issuing this rule under 5 U.S.C. 553(d)(3), and in accordance with 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 immediate action is needed to continue to respond to the potential safety hazards associated with construction operations at the new Governor Harry W. Nice/Senator Thomas “Mac” Middleton Memorial (US-301) Bridge to be conducted within the federal navigation channel.

The Coast Guard is issuing this rule under authority in 46 U.S.C. 70034 (previously 33 U.S.C. 1231). The COTP has determined there are potential hazards associated with critical bridge construction operations. The work is a safety concern for anyone within the federal navigation channel at the new Governor Harry W. Nice/Senator Thomas “Mac” Middleton Memorial (US-301) Bridge construction site. This rule is needed to protect personnel, vessels, and the marine environment in the navigable waters within the safety zone while the bridge is being constructed.

This rule extends the effective dates of an established safety zone, originally effective May 16, 2022 through 8 p.m. on June 18, 2022, through 8 p.m. on July 1, 2022. This extension makes no other changes to the original rule other than the end effective date. The safety zone includes all navigable waters of the Potomac River encompassed by a line connecting the following points beginning at 38°21′50.96″ N, 076°59′22.04″ W, thence south to 38°21′43.08″ N, 076°59′20.55″ W, thence west to 38°21′41.00″ N, 076°59′34.90″ W, thence north to 38°21′48.90″ N, 076°59′36.80″ W, and east back to the beginning point located between Charles County, MD and King George County, VA. The zone is approximately 450 yards in width and 270 yards in length. The extended duration of the zone is intended to protect personnel and the marine environment in these navigable waters while pier protection fender ring precast segments are lifted and set at the new Governor Harry W. Nice/Senator Thomas “Mac” Middleton Memorial (US-301) Bridge. Except for marine equipment and vessels operated by Skanska-Corman-McLean, Joint Venture, or its subcontractors, no vessel or person will be permitted to enter the safety zone without obtaining permission from the COTP Maryland-National Capital Region or a designated representative.

The COTP will notify the public that the safety zone will be enforced by all appropriate means to the affected segments of the public, as practicable, in accordance with 33 CFR 165.7(a). Such means of notification will also include, but are not limited to, Broadcast Notice to Mariners. Vessels or persons violating this rule are subject to the penalties set forth in 46 U.S.C. 70036 (previously codified in 33 U.S.C. 1232) and 46 U.S.C. 70052 (previously codified in 50 U.S.C. 192).

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 Executive Order 12866. Accordingly, this rule has not been reviewed by the Office of Management and Budget (OMB).

This regulatory action determination is based on size of the safety zone. The temporary safety zone is approximately 450 yards in width and 270 yards in length. This safety zone will impact a small designated area of the Potomac River for 13 days, but we anticipate that there will be no vessels that are unable to conduct business. Excursion vessels and commercial fishing vessels are not impacted by this rulemaking. Excursion vessels do not operate in this area, and commercial fishing vessels are not impacted because of their draft. Some towing vessels may be impacted, but bridge project personnel have been conducting outreach throughout the project in order to coordinate with those vessels. Vessel traffic, including recreational vessels, not required to use the navigation channel will be able to safely transit around the safety zone. Such vessels may be able to transit to the east or the west of the federal navigation channel, as similar vertical clearance and water depth exist under the next bridge span to the east and west. Moreover, the Coast Guard will issue Local Notices to Mariners and a Broadcast Notice to Mariners via VHF-FM marine channel 16 about 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 received no comments from the Small Business Administration on this rulemaking. 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 temporary 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. 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 13 total days that will prohibit entry within a portion of the Potomac River. 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.

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

Submitting comments. We encourage you to submit comments through the Federal Decision Making Portal at https://www.regulations.gov. To do so, go to https://www.regulations.gov, type USCG-2022-0330 in the search box and click “Search.” Next, look for this document in the Search Results column, and click on it. Then click on the Comment option. If you cannot submit your material by using https://www.regulations.gov, call or email the person in the FOR FURTHER INFORMATION CONTACT section of this proposed rule for alternate instructions.

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

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

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

I. Table of Abbreviations CFR Code of Federal Regulations DHS Department of Homeland Security FR Federal Register NPRM Notice of proposed rulemaking § Section U.S.C. United States Code II. Background Information and Regulatory History

The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This 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.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because the event sponsor did not submit notice of the fireworks display to the Coast Guard with sufficient time remaining before the event to publish an NPRM and immediate action is necessary to protect personnel, vessels, and the marine environment in the Oswego River. It is impracticable to public a NPRM because we must establish this safety zone by July 03, 2022.

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 . For the same reasons discussed in the preceding paragraph, waiting for a 30-day notice period to run would be impracticable because immediate action is necessary to protect personnel, vessels, and the marine environment during the fireworks display.

The Coast Guard is issuing this rule under authority in 46 U.S.C. 70034 (previously 33 U.S.C. 1231). The Captain of the Port (COTP) Buffalo has determined that fireworks over the water presents significant risks to public safety and property within a 300-foot radius of the launch point. This rule is needed to protect personnel, vessels, and the marine environment in the navigable waters within the safety zone while the fireworks display is taking place.

This rule establishes a safety zone from 9:15 p.m. through 10:45 p.m. on July 03, 2022. The safety zone will cover all navigable waters within a 300-foot radius of bridge launched fireworks over Oswego River in Oswego, NY. The zone is intended to protect spectators, vessels, and the marine environment in these navigable waters during the fireworks display. No vessel or person will be permitted to enter the safety zone without obtaining permission from the COTP Buffalo 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 Executive Order 12866. Accordingly, this rule has not been reviewed by the Office of Management and Budget (OMB).

This regulatory action determination is based on the characteristics of the safety zone. The safety zone will encompass a 300-foot radius from the bridge-launched fireworks in the Oswego River in Oswego, NY, with the event lasting approxiamately 1.5 hours during the evening when vessel traffic is normally low. Moreover, the Coast Guard would issue a Broadcast Notice to Mariners via VHF-FM Marine Channel 16 about the zone, and the rule would allow vessels to seek permission to enter the zone.

The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this 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. 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. If you believe this rule has implications for federalism or Indian tribes, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section above.

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 approximately 1.5 hours that will prohibit entry within a 300-foot radius in Oswego River in Oswego, NY for a fireworks display. 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:

The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This 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.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because the event sponsor notified the Coast Guard with insufficient time to publish an NPRM and immediate action is necessary to protect personnel, vessels, and the marine environment in Sandusky Bay. It is impracticable and contrary to the public interest to publish a NPRM because we must establish this safety zone by June 19, 2022.

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 . For the same reasons discussed in the preceding paragraph, delaying the effective date of this rule would be impracticable because immediate action is needed to respond to the potential safety hazards associated with a fireworks display.

The Coast Guard is issuing this rule under authority in 46 U.S.C. 70034 (previously 33 U.S.C. 1231). The Captain of the Port Detroit (COTP) has determined that potential hazards associated with fireworks displays will be a safety concern for anyone within a 300-yard radius of the launch site. The likely combination of recreational vessels, darkness punctuated by bright flashes of light, and fireworks debris falling into the water presents risks of collisions which could result in serious injuries or fatalities. This rule is necessary to protect personnel, vessels, and the marine environment in the navigable waters within the safety zone during the fireworks display.

This rule establishes a safety zone that will be enforced from 8 p.m. through 10:30 p.m. on June 19, 2022. The safety zone will encompass all U.S. navigable waters of Lake Erie within a 300-yard radius of the fireworks launch site located near Jackson Street Pier, Sandusky, OH. The duration of the zone is intended to protect personnel, vessels, and the marine environment in these navigable waters during the fireworks display. Entry into, transiting, or anchoring within the safety zone is prohibited unless authorized by the Captain of the Port Detroit or his designated representative. The Captain of the Port Detroit or his designated representative may be contacted via VHF Channel 16.

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 Executive Order 12866. 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, and duration of the safety zone. Vessel traffic will be able to safely transit around this safety zone which would impact a small designated area of Sandusky Bay 2.5 hours during the evening when vessel traffic is normally low. Moreover, the Coast Guard would issue a Broadcast Notice to Mariners via VHF-FM Marine Channel 16 about the zone, and the rule would allow vessels to seek permission to enter the zone.

The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this 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. 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. If you believe this rule has implications for federalism or Indian tribes, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section above.

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 only 2.5 hours that will prohibit entry within 300-yard radius of where the fireworks display will be conducted. It is categorically excluded from further review under paragraph L[60] 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 November 3, 2021, Northwest Powerboat Association notified the Coast Guard that it will be conducting a high-speed boat race from 8 a.m. to 7 p.m. on June 24, 2022 through June 26, 2022. These boats will be traveling at a rate of speed greater than usual boat traffic, and will be utilizing all of the waterway in the vicinity of Howard Amon Park, between mile markers 337 and 338. The Captain of the Port Columbia River (COTP) has determined that potential hazards associated with the high speed boat race would be a safety concern for anyone in the regulated area.

In response, on 30 March, 2022, the Coast Guard published a notice of proposed rulemaking (NPRM) titled Safety Zone; Columbia River, Richland, WA (87 FR 18755). There we stated why we issued the NPRM, and invited comments on our proposed regulatory action related to this high-speed boat race. During the comment period that ended May 2, 2022, we received no comments.

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 immediate action is needed to respond to the potential safety hazards associated with the high speed boat race.

The Coast Guard is issuing this rule under authority in 46 U.S.C. 70034 (previously 33 U.S.C. 1231). The COTP has determined that potential hazards from high speed boats associated with the event starting June 24, 2022, will be a safety concern for anyone within the safety zone. The purpose of this rule is to ensure safety of personnel, vessels, and the navigable waters within the safety zone before, during, and after the scheduled event.

As noted above, we received no comments on our NPRM published March 30, 2022. There are no changes in the regulatory text of this rule from the proposed rule in the NPRM.

This rule establishes a safety zone that will be subject to enforcement from 7:30 a.m. to 7:30 p.m. on June 24, 2022 through June 26, 2022. The safety zone will cover all navigable waters of the Columbia River from surface to bottom, in the vicinity of Howard Amon Park, between mile markers 337 and 338. The duration of the zone is intended to ensure the safety of personnel, vessels, and these navigable waters before, during, and after the scheduled 8 a.m. to 7 p.m. 3-day event. No vessel or person will be permitted to enter the regulated area 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 Executive Order 12866. 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 regulated area. This regulatory action will only impact a small 1-mile section of the Columbia River. The Coast Guard will issue Broadcast Notice to Mariners via VHF-FM marine channel 16 about the zone 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 received no comments from the Small Business Administration on this rulemaking. 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. 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 safety zone lasting only 60 hours that will prohibit entry within a 1 mile length of the Columbia River om Richland, WA for the duration of a high-speed boat race. 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:

Throughout this document “we,” “us,” and “our” means the EPA.

The background for this action is discussed in detail in our March 8, 2022 proposal (87 FR 12912). In that document, we proposed to approve the LMP for the Whitefish NAA and the State's request to redesignate the Whitefish NAA from nonattainment to attainment for the 1987 24-hour PM 10 NAAQS. Additionally, we proposed to determine that the Whitefish NAA has attained the NAAQS for PM 10 . That determination was based upon monitored air quality data for the PM 10 NAAQS during the years 2015 through 2020. Finally, in our March 8, 2022 proposal, EPA proposed to approve the Whitefish LMP as meeting the appropriate transportation conformity requirements found in 40 CFR part 93, subpart A.

The public comment period on the EPA's proposed rule opened on March 8, 2022, the date of its publication in the Federal Register (87 FR 12912) and closed on April 7, 2022. During this comment period we received no comments on our proposal.

As discussed on the proposed rule, to identify environmental burdens and susceptible populations in underserved communities in the Whitefish area, we performed a screening-level analysis using the EPA's environmental justice (EJ) screening and mapping tool (“EJSCREEN”). 1 The results of this screening level analysis are described in our proposed rule (87 FR 12912). This action addresses a plan for continued attainment of the 1987 PM 10 NAAQS for the Whitefish area. Approval of this plan does not impose any additional regulatory requirements on sources beyond those imposed by state law. As discussed in our proposed rule, Montana has demonstrated that the Whitefish area is attaining the 1987 PM 10 NAAQS and the Whitefish Maintenance Plan provides for the maintenance of the NAAQS for 10 years beyond redesignation. For these reasons, this action will not result in disproportionately high and adverse human health or environmental effects on communities with environmental justice concerns.

For the reasons explained in our proposed action, we are approving the LMP for the Whitefish NAA and the State's request to redesignate the Whitefish NAA from nonattainment to attainment for the 1987 24-hour PM 10 NAAQS. Additionally, the EPA is determining that the Whitefish NAA has attained the NAAQS for PM 10 . This determination is based upon monitored air quality data for the PM 10 NAAQS during the years 2015 through 2020. The EPA is approving that the Whitefish LMP as meeting the appropriate transportation conformity requirements found in 40 CFR part 93, subpart A.

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

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

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

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

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

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

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

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

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

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

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

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

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by August 8, 2022. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements (see section 307(b)(2)).

40 CFR parts 52 and 81 are amended as follows:

Throughout this document “we,” “us,” and “our” means the EPA.

The background for this action is discussed in detail in our March 8, 2022 proposal (87 FR 12905). In that document, we proposed to approve the LMP for the Thompson Falls NAA and the State's request to redesignate the Thompson Falls NAA from nonattainment to attainment for the 1987 24-hour PM 10 NAAQS. Additionally, we proposed to determine that the Thompson Falls NAA has attained the NAAQS for PM 10 . That determination was based upon monitored air quality data for the PM 10 NAAQS during the years 2015 through 2020. Finally, in our March 8, 2022 proposal, EPA proposed to approve the Thompson Falls LMP as meeting the appropriate transportation conformity requirements found in 40 CFR part 93, subpart A.

The public comment period on the EPA's proposed rule opened on March 8, 2022, the date of its publication in the Federal Register (87 FR 12905) and closed on April 7, 2022. During this comment period we received no comments on our proposal.

As discussed on the proposed rule, to identify environmental burdens and susceptible populations in underserved communities in the Thompson Falls area, we performed a screening-level analysis using the EPA's environmental justice (EJ) screening and mapping tool (“EJSCREEN”). 1 The results of this screening level analysis are described in our proposed rule (87 FR 12905). This action addresses a plan for continued attainment of the 1987 PM 10 NAAQS for the Thompson Falls area. Approval of this plan does not impose any additional regulatory requirements on sources beyond those imposed by state law. As discussed in our proposed rule, Montana has demonstrated that the Thompson Falls area is attaining the 1987 PM 10 NAAQS and the Thompson Falls Maintenance Plan provides for the maintenance of the NAAQS for 10 years beyond redesignation. For these reasons, this action will not result in disproportionately high and adverse human health or environmental effects on communities with environmental justice concerns.

For the reasons explained in our proposed action, we are approving the LMP for the Thompson Falls NAA and the State's request to redesignate the Thompson Falls NAA from nonattainment to attainment for the 1987 24-hour PM 10 NAAQS. Additionally, the EPA is determining that the Thompson Falls NAA has attained the NAAQS for PM 10 . This determination is based upon monitored air quality data for the PM 10 NAAQS during the years 2015 through 2020. The EPA is approving that the Thompson Falls LMP as meeting the appropriate transportation conformity requirements found in 40 CFR part 93, subpart A.

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

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

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

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

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

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

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

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

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

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

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

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

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by August 8, 2022. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements (see section 307(b)(2)).

40 CFR parts 52 and 81 are amended as follows:

This is a synopsis of the Commission's Report and Order, MB Docket No. 21-483; RM-11913; DA 22-584 adopted on May 25, 2022 and released on May 26, 2022. The full text of this Commission decision is available online at https://apps.fcc.gov/ecfs/. This document does not contain information collection requirements subject to the Paperwork Reduction Act of 1995, Public Law 104-13. The Commission will send a copy of the Report and Order in a report to be sent to Congress and the Government Accountability Office pursuant to the Congressional Review Act, see U.S.C. 801(a)(1)(A).

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

The purpose of this final rule is to replace references to the 14-inch Standard Reference Test Tire (SRTT) with references to a new 16-inch SRTT. As the name suggests, the SRTT is a test tire that is not manufactured for general use. The 14-inch SRTT is used by NHTSA in three ways. First, as part of the Federal Motor Vehicle Safety Standards (FMVSS) (49 CFR part 571), it is used to verify the surface friction of test surfaces for braking and electronic stability control standards. Second, it is used as a traction reference for the determination of whether a tire may be considered a “snow tire” under FMVSS No. 139 (49 CFR 571.139). Third, the SRTT is used in NHTSA's Uniform Tire Quality Grading Standards (UTQGS) consumer information program as the course reference tire as part of NHTSA's base course wear rating (BCWR) determination for the treadwear course.

Because Michelin, the only manufacturer of the 14-inch SRTT, has ceased production of the tire in 2020, NHTSA must find a suitable replacement tire. After substantial testing by NHTSA and several test partners, NHTSA has determined that the 16-inch SRTT is a suitable replacement. The testing program has determined equivalent values for test surface friction, the snow tire determination, and the BCWR determination that do not change the severity of any requirements and ensure that tire consumer ratings tested using either SRTT are comparable.

This rulemaking addresses the standard reference test tire (SRTT) manufactured according to specifications set forth in an ASTM International (ASTM) standard, E1136, “Standard Specification for P195/75R14 Radial Standard Reference Test Tire” (14-inch SRTT). The 14-inch SRTT is a size P195/75R14 all-season steel-belted radial tire. The dimensions, weight, materials, and other physical properties of the tire are specified in E1136. The tire is not intended for general use, but as the name indicates, is used for testing.

NHTSA uses the 14-inch SRTT to evaluate test surface friction  1 for safety standards relating to braking because the narrow specifications for the tire (size, component materials, etc.) ensure consistent, repeatable performance. The 14-inch SRTT is also incorporated in the definition of a “snow tire” in FMVSS No. 139, 2 which is defined as a tire that attains a traction index greater than or equal to 110 compared to the 14-inch SRTT when using the ASTM F1805 snow traction test. The SRTT is also used as part of the Uniform Tire Quality Grading Standards (UTQGS), 3 an information program to assist consumers in making informed decisions when purchasing tires. The UTQGS apply to passenger car tires and require motor vehicle and tire manufacturers and tire brand name owners to provide consumers with information about their tires' relative performance regarding treadwear, traction, and temperature resistance. The SRTT is used as the course monitoring tire (CMT) for the treadwear course. 4 Because tire performance over the test course can change daily due to variability in road surface, temperature, humidity, and precipitation, the CMTs are run alongside candidate tires being tested. The performance of the CMT is used to determine the base course wear rate (BCWR), which is published four times per year by NHTSA and is used to determine a course severity adjustment factor that is applied during tire treadwear testing.

In an August 5, 2021 notice of proposed rulemaking (NPRM), 5 NHTSA proposed amendments to the FMVSSs and tire regulations to replace references to the 14-inch SRTT with references to a newer 16-inch SRTT. The 14-inch SRTT was first introduced in the 1980s. The 14-inch SRTT was manufactured by one company, Michelin North America, Inc (Michelin) and was sold under its Uniroyal brand. Michelin has ceased production of the 14-inch SRTT because it has become difficult for Michelin to obtain the materials necessary to manufacture the SRTT. 6 ASTM has developed an updated specification for an SRTT designated F2493 (16-inch SRTT). The 16-inch SRTT is a size P225/60R16 97S radial standard reference test tire. The 16-inch SRTT is considered to be more representative of current tires because of its larger size and new material and design features that lead to traction that is more typical of modern passenger car tires. 7 To the best of NHTSA's knowledge, the 16-inch SRTT is manufactured only by Michelin and sold under its Uniroyal brand. NHTSA determined that the 16-inch SRTT was the only suitable replacement that had been suggested.

However, because the 16-inch SRTT is a larger size and uses more modern design and materials, it is likely that the 16-inch SRTT will not perform identically to the 14-inch SRTT. Therefore, NHTSA, in cooperation with Transport Canada, Natural Resources Canada, representatives of ASTM committees F09 on tires and E17 on vehicle-pavement systems, the U.S. Tire Manufacturers Association (including Michelin, currently the sole manufacturer of SRTTs), and the Rubber Association of Canada, conducted testing to determine the consequences of replacing the 14-inch SRTT with the 16-inch SRTT. The results of the testing by these entities, in addition to NHTSA's own testing, substantially contributed to the August 2021 proposal to replace the 14-inch SRTT with the 16-inch SRTT. 8

NHTSA first incorporated the 14-inch SRTT into the Federal Motor Vehicle Safety Standards (FMVSSs) in a 1995 rule adopting FMVSS No. 135, the light vehicle braking standard. The SRTT is used to determine the friction of the test surface using the 1990 version of the ASTM E1337 test method. The ASTM E1337 test method involves mounting the SRTT to a test trailer, bringing the trailer to a test speed of 40 mph (64 km/h), and applying the brake to produce the maximum braking force prior to wheel lockup.

When NHTSA was informed that production of the 14-inch SRTT was to be discontinued, NHTSA evaluated the 16-inch SRTT to determine whether it would be a suitable replacement. NHTSA carefully considered the effect of the 16-inch SRTT on the determination of peak friction coefficient (PFC). 9 NHTSA was concerned, and subsequent testing verified, that the use of the 16-inch SRTT without further changes to the FMVSSs would increase the stringency of the braking and ESC FMVSSs. The reason for this was that the different materials used in the 16-inch SRTT and the increased size of the tire would result in the 16-inch SRTT having better traction performance than the 14-inch SRTT. If the 16-inch SRTT has improved traction performance relative to the 14-inch SRTT, then the same surface would have a higher PFC when tested with the 16-inch SRTT. Alternatively stated, obtaining an identical PFC value using the 16-inch SRTT would require a road surface with lower friction. Testing braking systems using stopping distance on road surfaces with lower friction would require improved braking performance to stop in the same distance, which is not an outcome intended by this rulemaking. Consequently, NHTSA sought a conversion factor to evaluate PFC of a test surface using the 16-inch SRTT without altering the severity of any braking or ESC FMVSSs.

ASTM developed a formula to correlate PFC determinations using the 14-inch and 16-inch SRTTs. NHTSA also commissioned confirmatory testing with its contactor, Transportation Test Center Inc. (TRC), which further verified the conversion formula used in the 2019 version of ASTM E1337. 10 This formula was included in a 2019 update to ASTM E1337. In the NPRM, NHTSA proposed to replace the 1990 version of ASTM E1337 currently incorporated by reference with the 2019 version. Furthermore, NHTSA used the formula in the 2019 version of E1337 to derive new PFC values for all FMVSSs when evaluated using the 16-inch SRTT. Those values are listed in Table 1 below. 11

Presently, for a manufacturer to designate a tire as a “snow tire,” the tire must attain a traction index equal to or greater than 110 compared to the 14-inch SRTT when tested using the snow traction test in the 2000 version of ASTM F1805. The ASTM F09 committee on tires commissioned a study to determine the feasibility of replacing the 14-inch SRTT with the 16-inch SRTT in the determination of whether a tire meets the definition of “snow tire.” This study was funded by the United States Tire Manufacturers Association (USTMA). ASTM has published a technical report documenting this work. 14 ASTM determined that a correlation factor of 0.9876 was appropriate, meaning that a tire that attained a rating of 110 when tested using the 14-inch SRTT correlated to a rating of 111.4 or 111.5 when tested using the 16-inch SRTT, depending on the number of significant digits considered. Recent guidance issued by the USTMA, a trade association consisting of companies that manufacture tires in the United States, recommends a minimum traction index of 112 using the 16-inch SRTT. 15 Accordingly, NHTSA proposed to amend the definition of “snow tire” in FMVSS No. 139 to specify that a snow tire is a tire that attains a traction index of 112 when tested using the updated F1895 test method using the 16-inch SRTT, consistent with USTMA's guidance.

Furthermore, after reviewing this information from the USTMA, NHTSA determined that additional clarification was necessary to the definition of a “snow tire” in FMVSS No. 139. The 2020 version of ASTM F1805 defines the standard test procedure for measuring traction on “snow” and “ice” surfaces. However, there are multiple surface types in both the “snow” and “ice” categories. They include soft pack (new) snow, medium pack snow, medium hard pack snow, hard pack snow, ice—wet, and ice—dry. 16 The definition of “snow tire” in FMVSS No. 139 does not specify the surface type specified within ASTM F1805 for testing.

NHTSA stated that the “medium pack snow” condition was intended for use by manufacturers for marketing tires as “snow tires.” Accordingly, NHTSA proposed to specify that the traction index is obtained using the “medium pack snow ” surface and further proposed updating the incorporation by reference of ASTM F1805 to the 2020 version.

In anticipation of Michelin's decision to cease production of the 14-inch SRTT, NHTSA began including testing of the 16-inch SRTT as part of its BCWR determination. Since the second quarter of 2016, NHTSA has been duplicating BCWR testing using both the 14-inch SRTT and the 16-inch SRTT. NHTSA considered several options for updating the UTQGS regulations to account for the 16-inch SRTT. As of publication of the NPRM, NHTSA had acquired 17 consecutive quarters of side-by-side testing of the 14-inch and 16-inch SRTTs on the treadwear course and published BCWR data for that period. 17 NHTSA requested comments on how the new conversion factor should be selected from among the available quarters of data. For the NPRM, NHTSA used the average of all 17 quarters of data to adjust the formula for severity adjustment factor using the BCWR.

NHTSA also proposed a modification to language in the treadwear test procedure in § 575.104 to reference the total distance and schedule of events in terms of circuits completed rather than mileage. This proposed change was intended to allow testing to be more flexible in the event of route changes or other unforeseen circumstances.

Finally, NHTSA proposed changes lengthening the amount of time a CMT may be used after removal from storage. Currently, a CMT must be no more than one year old at the commencement of testing and that it must be used within two months after removal from storage. Because NHTSA lacks facilities to store tires in a climate-controlled environment at its testing facility in San Angelo, Texas, NHTSA only purchases CMTs on a quarterly basis depending on funding availability and conducts BCWR testing as soon as feasible after receiving a shipment of CMTs. Lack of funding sometimes requires NHTSA to delay CMT purchases, and sometimes when NHTSA purchases CMTs, supplies may be limited. NHTSA proposed lengthening the amount of time a tire may be removed from storage to four months. Further, NHTSA also requested comment on whether the word “storage” was sufficiently well defined and, if not, how NHTSA could define “storage” more clearly to ensure tires are stored in such a way that would minimize testing variability without providing inflexible limitations on NHTSA's use of the SRTT.

For the changes to the UTQGS, NHTSA stated that it expected to make any changes effective at the next BCWR determination at least 30 days after the date of publication of a final rule. NHTSA did not believe any further lead time is necessary for the following reasons. First, because NHTSA is using a conversion factor to keep the rating scale used with the 14-inch SRTT and 16-inch SRTT similar, ratings of a particular line of tires should not be affected by the proposed rule. Second, tire lines rated prior to the effective date of the changes would not be required to be rerated. Third, limited availability of the 14-inch SRTT could make it difficult for NHTSA to continue to obtain 14-inch SRTTs in its BCWR determinations.

For FMVSS changes, NHTSA proposed a lead time of six months. NHTSA determined that six months was sufficient to give compliance test facilities sufficient time to obtain and validate test surfaces using the 16-inch SRTT. Although NHTSA has determined an equivalent level of surface friction when evaluating PFC with the 16-inch SRTT in place of the 14-inch SRTT, NHTSA anticipates requiring test facilities conducting NHTSA's compliance tests to revalidate test surfaces using the 16-inch SRTT, to ensure that testing is being done in accordance with the procedures in the FMVSS. However, NHTSA observed that potential unavailability of the 14-inch SRTT may constitute good cause for NHTSA to impose a shorter lead time in a final rule resulting from the proposal.

NHTSA received five comments on the August 2021 NPRM from, the Japan Automobile Tyre Manufacturers Association (JATMA), Michelin North America, Inc. (Michelin), the U.S. Tire Manufacturers Association (USTMA), 18 Phillip Donovan, and the Alliance for Automotive Innovation (Alliance). 19 Both JATMA and Michelin supported the comments filed by USTMA. JATMA had no further comment other than to encourage NHTSA to expedite publication of a final rule because no 14-inch SRTTs were available for tire manufacturers to purchase. USTMA and Michelin also encouraged NHTSA to expedite publication of the final rule.

USTMA and Michelin recommended that all references to ASTM F2493 (the specifications for the 16-inch SRTT) refer to the standard without a revision date. As an example, USTMA cites a recent amendment to the Canadian Motor Vehicle Tire Safety Regulations, in which the snow tire definition references an SRTT that “meets the requirements of any version of ASTM F2493.”  20 Similarly, UNECE Regulation No. 117 and Global Technical Regulation No. 20 reference ASTM F2493 without regard to version.

The incorporation by reference of ASTM F2493 without regard to date in Canadian and UNECE regulations makes it easier for governments to update their rules in the event future changes to ASTM F2493 are warranted. In light of the comments and the benefit to NHTSA of not having to conduct rulemaking to keep references to the ASTM F2493 up-to-date, NHTSA has considered whether the incorporation by reference of the specifications for the SRTT is necessary.

As required by 5 U.S.C. 552(a)(1), NHTSA must publish the text of its rules and any amendment, revision, or repeal thereto in the Federal Register . The only exception to this requirement is that matter reasonably available that cannot be published in the Federal Register may be deemed published when incorporated by reference therein with the approval of the Director of the Federal Register. In 1 CFR 51.1(f), the regulations setting forth the policy followed by the Director of the Federal Register in approving incorporations by reference, an incorporation by reference of a publication is limited to the edition of the publication that is approved. Further, that regulation provides that future amendments or revisions to a publication are not included in an incorporation by reference. Therefore, while NHTSA may incorporate the most current and prior versions of ASTM F2493 into the CFR, the Director of the Federal Register will not approve incorporation by reference of ASTM F2493 without reference to version or in any other way that would include future versions.

NHTSA, with assistance from the Office of the Federal Register, has considered these provisions and the manner in which ASTM F2493 is referenced in the proposed rule and in this final rule. Because no requirements, procedures, or anything else within the text of ASTM F2493 are referenced in this final rule, incorporation by reference is unnecessary. In order to obtain a tire manufactured to the specifications of ASTM F2493, an entity would not need reference to the specific requirements of the standard. The entity would only need to contact the manufacturer of the tire.

Having determined that incorporation by reference is not necessary, NHTSA agrees with the commenters that it would be preferable to refer to ASTM F2493 without regard to version number. Because the SRTT is a reference tire that is designed to have a specific level of performance, NHTSA would not expect that any subsequent revision of ASTM F2493 to have a consequential effect on the performance of the SRTT. Further, regardless of any particular version of ASTM F2493 that might be referenced in NHTSA's regulations, it is likely that any tire available for purchase and used by NHTSA will be manufactured according to the most recent or immediate prior version of ASTM F2493, given that the tire is manufactured in small batches.

Accordingly, NHTSA is not incorporating ASTM F2493-19 by reference as proposed in the NRPM, and is instead referring to ASTM F2493 without reference to version number.

In the August 2021 NPRM, NHTSA proposed lengthening, from two months to four months, the maximum time an SRTT may be removed from storage prior to use as part of a BCWR determination. USTMA and Michelin opposed lengthening the amount of time tires may be removed from storage prior to use in UTQGS testing from two to four months. Michelin stated that environmental exposure affects tire properties and could impact the published BCWR compared to what has been done in the past. USTMA suggested it was open to further discussions on this issue and that it be severed from the proposal to be addressed in a potential separate rulemaking. Both USTMA and Michelin referenced a 2000 rulemaking where NHTSA noted that tires removed from storage degrade at the rate of approximately 10 percent per year, while tires stored outside of prescribed storage conditions degrade at a rate of no more than 5 percent per year.

This final rule contains no changes in response to these comments. While NHTSA appreciates Michelin's commitment to managing supply of the 16-inch SRTT, there are factors outside of Michelin's management of tire supply that affect when NHTSA can test a tire. After a tire is removed from storage, it must be shipped to NHTSA. NHTSA must then prepare the tires for testing and negotiate with the treadwear testing contractor the start date for the vehicle convoys that run the 16 circuits of the UTQGS treadwear course as part of the BCWR determination. Any of the steps between the shipment of tires and the initiation of the convoy may be impacted by weather conditions, scheduling conflicts, and operational limitations. USTMA and Michelin both referenced a 2000 rulemaking in which the requirement that NHTSA use tires within two months after removal from storage was first adopted. 21 In that rulemaking, Uniroyal cited a NHTSA study  22 that found an aging effect of approximately 5 percent per year for tires in storage and about 10 percent per year for tires not in storage. NHTSA found that one year of aging could result in tire degradation of up to 5 percent, which NHTSA deemed to be acceptable as the best available compromise within the economic constraints of the supply of SRTTs, given that SRTTs had limited production runs.

Although NHTSA's storage facilities do not meet the exact storage specifications in F2493, the facilities are kept climate controlled at all times, tires are not stored near ozone-generating equipment or sources of ultraviolet radiation, and tires are stored on racks rather than stacked. NHTSA believes that its efforts reduce any potential test variability that might result from environmental exposure. NHTSA is also committed to using SRTTs as soon as reasonably practicable. NHTSA believes that these factors mitigate any additional tire degradation resulting from lengthening the amount of time a tire may be used after removal from storage from two months to four months. NHTSA believes that Michelin's commitment to a timely supply of tires and the storage conditions at NHTSA's facility will ensure that the total tire degradation will not be significantly more than the 5 percent that NHTSA deemed acceptable in the 2000 rulemaking.

USTMA and Michelin also recommended that NHTSA define the term “storage” in its regulations according to the guidelines in ASTM F2493. These specifications include constant relative humidity, temperature greater than freezing but that does not exceed 70 °F (21 °C), ozone levels that do not exceed 5 parts/10. 8 The requirements further specify that tires not be stored within 30 ft (9.1 m) of electrical motors or other ozone-generating equipment, be stored in subdued light, and that tires be stacked unbundled no more than eight tires high on a pallet.

Upon consideration of the comments, NHTSA has determined that it is not necessary to include a definition of the term “storage” in its regulations. NHTSA assumes, based on Michelin's comment favoring the use of a definition of “storage” from ASTM F2493, that Michelin is storing SRTTs that it manufactures in accordance with the guidelines in ASTM F2493 prior to sale. Because F2493 contains specifications for storage, NHTSA has determined that there is no need to further define the term “storage” in its regulations.

Phillip Donovan's comments also addressed the age requirements used for testing. The commenter noted that, while the restriction that an SRTT be less than one year old and be used within two (or four as proposed) months of removal from storage was workable for an agency conducting year-round testing, for entities using tires sporadically, those restrictions could result in disposal of tires prematurely leading to excess waste and expense. The commenter suggested that NHTSA could use a hardness test to determine if the tire rubber was still within the specification for testing, such as one referenced in ASTM E1136.

In response, NHTSA first observes that the existing requirement that an SRTT be less than one year old and that it be used within two months of removal of storage applies only to NHTSA's use of SRTT as CMTs as part of a test convoy in determining BCWR ratings for testing tires to verify a tire's treadwear ratings are compliant with the UTQG regulations. That requirement does not apply to PFC determinations for test surfaces used for testing compliance with braking and ESC FMVSSs. The commenter appeared to be focusing on those PFC determinations. However, even if the comment is intended to address use of the SRTT as the CMT as part of the UTQG treadwear testing, NHTSA observes that the restriction applies only to NHTSA's compliance testing. Tire manufacturers may determine their tires' treadwear ratings using any method they deem appropriate if those tires attain their ratings when tested by NHTSA on the San Angelo, Texas course using the procedures specified in 49 CFR 575.104.

As for the suggestion that NHTSA adopt a hardness specification for determining whether tires are appropriate for testing, although the commenter references E1136 for a hardness testing, the F2493 specification for the 16-inch SRTT also contains hardness specification. NHTSA understands that those hardness specifications are part of determining whether a tire is compliant with the F2493 specification. NHTSA does not believe that the tire needs to be retested prior to use to ensure that it remains within the F2493 specification. Rather (and as discussed in more detail in response to Michelin's and USTMA's comments regarding the lengthening of time a tire may be removed from storage prior to use), NHTSA believes that the variability associated with the degradation of tires resulting from the specified maximum period of time to use a tire since the tire after its manufacture and removal from storage and the conditions in which they were stored. Accordingly, NHTSA has not made any changes to the proposal based on this comment.

Several of USTMA and Michelin's comments agreed with NHTSA's approach to issues raised in the NPRM. For example, USTMA and Michelin agreed that ASTM F1805-20 should be used for the snow tire definition and agreed with the requirement that a tire attain a traction index of equal to or greater than 112 to be considered a snow tire. USTMA and Michelin also agreed with the use of the “medium pack snow” surface condition in ASTM F1805. Michelin agreed with using all 17 quarters of available UTQGS test data. Michelin also agreed with the proposed UTQGS conversion factor of 1.324. USTMA and Michelin further agreed with referencing the total distance in terms of circuits rather than the estimated 400 miles per circuit.

USTMA and Michelin agreed that ASTM E1337-19 should be used for surface friction measurement, including its correlation equations between 14-inch and 16-inch SRTTs. Further, Michelin also agreed with the PFC values derived from the equation in ASTM E1337-19 in the NPRM.

NHTSA has considered these comments and is including these aspects of the proposal in this final rule as they were proposed.

Commenters also pointed out typographical errors in the NPRM. For example, regarding the UTQGS, USTMA and Michelin requested that NHTSA confirm that 17 quarters of data were used for comparison as referenced in Table 1 of the NPRM, rather than 14 quarters of data as stated in the preamble text. NHTSA can confirm this was an error in the preamble text and that 17 consecutive quarters of data were used in determination of the conversion factor. Furthermore, an example calculation in the text referred only to the first 14 quarters of data. The actual conversion factor was calculated using all 17 quarters of data, as Michelin states. In addition, as noted by USTMA, NHTSA inadvertently referred to the ASTM F1805 as “F1895.”

Due to the unavailability of the 14-inch SRTT, USTMA and Michelin agreed with the NPRM to make the changes to UTQGS effective at the next BCWR determination 30 days after publication of a final rule. Therefore, in light of the current unavailability of the 14-inch SRTT, NHTSA is making the UTQGS amendments effective 30 days after publication of this final rule as proposed. The effect of this is that the next BCWR determination made 30 days after publication of this final rule will use the 16-inch SRTT and will be calculated based on NHTSA's BCWR determinations using the 16-inch SRTT.

With respect to the FMVSS amendments, USTMA deferred to vehicle manufacturers on the appropriateness of lead time. Michelin recommended that NHTSA shorten the lead time to substantially less than 180 days. In contrast, the Alliance requested one year of lead time to prepare for the FMVSS amendments rather than the 180 days proposed in the August 2021 NPRM, with optional early compliance allowed. The Alliance reasoned that this would ensure that manufacturers have sufficient time to transition to the 16-inch SRTT and minimize any unnecessary waste of existing 14-inch SRTT stock. The Alliance also stated that NHTSA would not be prohibited from stockpiling 14-inch SRTTs to provide this additional lead time. The Alliance also requested that “NHTSA not require additional certification testing for carryover vehicle models that may have been certified using the 14-inch SRTT.”

NHTSA has considered these comments carefully and has concluded that a shorter lead time than proposed in the NPRM is necessary for the amendments to the FMVSS. This conclusion is primarily based on the unavailability of the 14-inch SRTT for purchase, as stated by Michelin. While NHTSA has considered the issues with a shorter lead time raised by the Alliance, NHTSA does not believe any of those issues would make a shorter lead time impracticable or difficult.

As discussed in the NPRM, the intention of this amendment is not to change the severity of any FMVSS. Accordingly, the new PFC values in the FMVSSs associated with the use of the 16-inch SRTT are based on an equivalence formula in ASTM E1337-19. Because the severity of the FMVSSs is not being changed, NHTSA does not believe that any vehicle certifications would be affected by the use of the 16-inch SRTT.

Relevant to the Alliance's request that NHTSA not require additional certification testing for vehicle models that may have been certified using the 14-inch SRTT, NHTSA does not specify how manufacturers certify their vehicles as compliant, nor does NHTSA opine on whether and what testing is sufficient for certification outside of a specific enforcement action. However, as stated in both the August 2021 NPRM and in this final rule, NHTSA believes that the PFC values specified for the 14-inch SRTT currently in the FMVSSs are equivalent to those in this final rule using the 16-inch SRTT. Therefore, NHTSA does not anticipate that manufacturers would incur any burden associated with certifying vehicle models that may have been certified based on the use of the 14-inch SRTT.

Finally, as for the suggestion that NHTSA allow optional early compliance rather than a shorter lead time, optional early compliance is not suitable for this rulemaking. The 14-inch SRTT is no longer manufactured and no entity, including NHTSA or vehicle manufacturers, are able to purchase new tires to validate its test surfaces using a 14-inch SRTT. Thus, NHTSA cannot continue validating test surfaces with a 14-inch SRTT and must begin using the 16-inch SRTT. However, this final rule does not require manufacturers to use the 16-inch SRTT in their testing and certification programs. They may continue to use the 14-inch SRTT in their own testing if they have tires available to them. However, they must ensure that the tires will meet all applicable requirements when tested by NHTSA in a compliance test program that uses the 16-inch SRTT.

Therefore, with respect to the FMVSS amendments, NHTSA finds that the present unavailability of the 14-inch SRTT requires that the 180-day lead time proposed in the NPRM be shortened. NHTSA has determined that a 30-day lead time is appropriate for changes to the FMVSS to enable the agency's use of the 16-inch SRTT. NHTSA emphasizes, however, that its data and analyses indicate that the change to the new SRTT will have no substantive effect on compliance with the present FMVSS and UTQGS requirements, so the shortened lead time is anticipated to be inconsequential.

For the reasons discussed in the August 2021 NPRM and in this final rule, NHTSA is updating references to the SRTT from the 14-inch SRTT to the 16-inch SRTT as proposed in the August 2021 NPRM except that NHTSA is incorporating by reference the 2020 version of the 16-inch SRTT specification rather than the 2019 version referenced in the NPRM. This final rule will be effective 30 days after the date of publication in the Federal Register .

NHTSA has considered the impact of this rulemaking action under Executive Order 12866, Executive Order 13563, and the Department of Transportation's administrative rulemaking procedures. This rulemaking is not considered significant and was not reviewed by the Office of Management and Budget under E.O. 12866, “Regulatory Planning and Review.”

This final rule updates the standard reference test tire used as a baseline tire for consumer information testing, in the determination of what is a snow tire, and to evaluate testing surface friction for evaluating braking and electronic stability control performance. This final rule will not have a direct effect on safety because the changes proposed in this rule are designed to maintain the present level of stringency of NHTSA's braking and electronic stability control FMVSSs. However, if the 14-inch SRTT is discontinued without a replacement, NHTSA would be unable to verify test surface friction coefficient prior to compliance testing for braking and electronic stability control system FMVSSs. Thus, this rulemaking indirectly affects safety by ensuring that NHTSA would be able to perform compliance tests of those FMVSSs. Also, if this rule were not adopted, it would be impossible for NHTSA to continue maintaining the BCWR for treadwear testing. This unavailability of an SRTT would lead to tire manufacturers being unable to rate their tires for treadwear under the UTQGS and mold those ratings onto the side of the tire as required by 49 CFR part 575.

This rule is expected to result in additional costs to NHTSA because the 16-inch SRTT has a retail price that is $35 per tire more than the 14-inch SRTT ($335 vs. $300). 23 NHTSA purchases 64 SRTTs for its own use annually in determining BCWR. Therefore, based on the cost difference of $35 per tire, NHTSA expects that this rule could result in up to $2,240 additional annual costs to the government. However, NHTSA has been using the 14-inch SRTT and 16-inch SRTT side-by-side since 2016 for its quarterly BCWR determination. With side-by-side testing no longer necessary, NHTSA would likely purchase fewer SRTTs than it has in the past several years.

As to potential costs to the public, based upon information provided to NHTSA by Michelin from 2017 and 2018, annual U.S. sales of 14-inch SRTTs is fewer than 2,000 units. If NHTSA assumes that U.S. sales of 16-inch SRTTs is comparable to sales of 14-inch SRTTs, the annual cost of this rule would be less than $70,000. However, NHTSA does not know how many sales are a consequence of the SRTT being used as part of NHTSA's compliance test procedures, versus those sold for other purposes ( e.g., SRTTs sold to assess the performance of tires to some other country's regulations or to voluntary industry standards). Any SRTT sales that are not related to compliance with NHTSA's regulations would not be affected by this rule and the existence of such sales would mean this rule would be less costly than the maximum estimate of $70,000 per year. Moreover, NHTSA does not have any direct knowledge of whether regulated entities have been conducting side-by-side testing using both the 14-inch SRTT and 16-inch SRTTs like NHTSA has and whether side-by-side testing has artificially increased sales in 2017 and 2018.

Pursuant to the Regulatory Flexibility Act (5 U.S.C. 601 et seq., as amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA) of 1996), whenever an agency is required to publish a notice of rulemaking for any proposed or final rule, it must prepare and make available for public comment a regulatory flexibility analysis that describes the effect of the rule on small entities ( i.e., small businesses, small organizations, and small governmental jurisdictions). The Small Business Administration's regulations at 13 CFR part 121 define a small business, in part, as a business entity “which operates primarily within the United States.” (13 CFR 121.105(a)). However, no regulatory flexibility analysis is required if the head of an agency certifies the rule would not have a significant economic impact on a substantial number of small entities. SBREFA amended the Regulatory Flexibility Act to require Federal agencies to provide a statement of the factual basis for certifying that a rule would not have a significant economic impact on a substantial number of small entities.

NHTSA has considered the effects of this rule under the Regulatory Flexibility Act. I certify that this rule will not have a significant economic impact on a substantial number of small entities. This rule will directly impact the government, as it affects the test procedures NHTSA uses in its FMVSSs and regulations that reference tire performance. It affects manufacturers of tires and of motor vehicles only to the extent those manufacturers choose to test their products in the manner NHTSA would test them. They are not required to use the test procedures NHTSA uses.

Although some entities producing tires or vehicles that would be tested by NHTSA are considered small businesses, this rule will not have a significant economic impact on those manufacturers. First, the small manufacturers are not required to use the SRTT in certifying their products. Second, for manufacturers choosing to use the 16-inch SRTT to test their products, this rule would result in a cost increase of only $35 per tire to entities currently purchasing the 14-inch SRTT to assess their products. NHTSA does not believe that this cost increase is significant. Finally, for the changes to the UTQGS, because NHTSA is using a conversion factor to keep the rating scale used with the 14-inch SRTT and 16-inch SRTT identical, ratings of a particular line of tires should not be affected by this rule. For FMVSS changes, NHTSA has determined an equivalent level of surface friction when evaluating PFC with the 16-inch SRTT in place of the 14-inch SRTT, so the change to the standard reference test tire should not change the performance of current tires or vehicles.

NHTSA has examined this rule pursuant to Executive Order 13132 (64 FR 43255, August 10, 1999) and concluded that no additional consultation with States, local governments or their representatives is mandated beyond the rulemaking process. The agency has concluded that the rulemaking would not have sufficient federalism implications to warrant consultation with State and local officials or the preparation of a federalism summary impact statement. The rule will not have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.”

NHTSA rules can preempt in two ways. First, the National Traffic and Motor Vehicle Safety Act contains an express preemption provision: When a motor vehicle safety standard is in effect under this chapter, a State or a political subdivision of a State may prescribe or continue in effect a standard applicable to the same aspect of performance of a motor vehicle or motor vehicle equipment only if the standard is identical to the standard prescribed under this chapter. 49 U.S.C. 30103(b)(1). It is this statutory command by Congress that preempts any non-identical State legislative and administrative law addressing the same aspect of performance.

The express preemption provision described above is subject to a savings clause under which “[c]ompliance with a motor vehicle safety standard prescribed under this chapter does not exempt a person from liability at common law.” 49 U.S.C. 30103(e). Pursuant to this provision, State common law tort causes of action against motor vehicle manufacturers that might otherwise be preempted by the express preemption provision are generally preserved. However, the Supreme Court has recognized the possibility, in some instances, of implied preemption of such State common law tort causes of action by virtue of NHTSA's rules, even if not expressly preempted. This second way that NHTSA rules can preempt is dependent upon there being an actual conflict between an FMVSS and the higher standard that would effectively be imposed on motor vehicle manufacturers if someone obtained a State common law tort judgment against the manufacturer, notwithstanding the manufacturer's compliance with the NHTSA standard. Because most NHTSA standards established by an FMVSS are minimum standards, a State common law tort cause of action that seeks to impose a higher standard on motor vehicle manufacturers will generally not be preempted. However, if and when such a conflict does exist—for example, when the standard at issue is both a minimum and a maximum standard—the State common law tort cause of action is impliedly preempted. See Geier v. American Honda Motor Co., 529 U.S. 861 (2000).

Pursuant to Executive Orders 13132 and 12988, NHTSA has considered whether this rule could or should preempt State common law causes of action. The agency's ability to announce its conclusion regarding the preemptive effect of one of its rules reduces the likelihood that preemption will be an issue in any subsequent tort litigation.

To this end, the agency has examined the nature ( e.g., the language and structure of the regulatory text) and objectives of this rule and finds that the rule affects only minimum safety standards (and only insofar as how NHTSA would conduct compliance testing under those standards). As such, NHTSA does not intend that this rule preempt State tort law that would effectively impose a higher standard on motor vehicle manufacturers than that established by the affected FMVSSs. Establishment of a higher standard by means of State tort law would not conflict with the minimum standards affected by this rule. Without any conflict, there could not be any implied preemption of a State common law tort cause of action. Aspects of this rule will amend 49 CFR part 575, which is not a safety standard but an information program to assist consumers in making informed decisions when purchasing tires. The 14-inch SRTT is used as part of the determination of a tire's treadwear rating. This rule will not impose any requirements on anyone.

With respect to the review of the promulgation of a new regulation, section 3(b) of Executive Order 12988, “Civil Justice Reform” (61 FR 4729; Feb. 7, 1996), requires that Executive agencies make every reasonable effort to ensure that the regulation: (1) Clearly specifies the preemptive effect; (2) clearly specifies the effect on existing Federal law or regulation; (3) provides a clear legal standard for affected conduct, while promoting simplification and burden reduction; (4) clearly specifies the retroactive effect, if any; (5) specifies whether administrative proceedings are to be required before parties file suit in court; (6) adequately defines key terms; and (7) addresses other important issues affecting clarity and general draftsmanship under any guidelines issued by the Attorney General. This document is consistent with that requirement.

Pursuant to this order, NHTSA notes as follows. The issue of preemption is discussed above. NHTSA notes further that there is no requirement that individuals submit a petition for reconsideration or pursue other administrative proceedings before they may file suit in court.

Executive Order 13045, “Protection of Children from Environmental Health and Safety Risks” (62 FR 19855, April 23, 1997), applies to any rule that: (1) Is determined to be “economically significant” as defined under Executive Order 12866, and (2) concerns an environmental, health, or safety risk that the agency has reason to believe may have a disproportionate effect on children. If the regulatory action meets both criteria, the agency must evaluate the environmental health or safety effects of the planned rule on children, and explain why the planned regulation is preferable to other potentially effective and reasonably feasible alternatives considered by the agency.

This rule is not economically significant under E.O. 12866. Further, it is part of a rulemaking that is not expected to have a disproportionate health or safety impact on children. Consequently, no further analysis is required under Executive Order 13045.

Under the Paperwork Reduction Act of 1995 (PRA), a person is not required to respond to a collection of information by a Federal agency unless the collection displays a valid Office of Management and Budget (OMB) control number. There is not any information collection requirement associated with this rule.

Under regulations issued by the Office of the Federal Register (1 CFR 51.5), an agency, as part of a rule that includes material incorporated by reference, must summarize material that is incorporated by reference and must discuss the ways the material incorporated by reference is reasonably available to interested parties or how the agency worked to make materials available to interested parties.

As discussed earlier in this document, the ASTM F2493-specified tire is a standard reference test tire that is not used for general use, but, as its name suggests, is used for testing. The ASTM F2493 standard reference test tire is primarily used for evaluating surface friction (traction). The standard reference test tire specifications include, among other things, size, design, construction, and materials requirements. Although NHTSA proposed incorporating ASTM F2493-19 by reference in the proposed rule, after consideration of public comments, NHTSA has decided it is permissible and preferable not to incorporate by reference ASTM F2493, and to refer to it without regard to version number.

This rule updates an existing incorporation by reference of ASTM E1337, “Standard Test Method for Determining Longitudinal Peak Braking Coefficient (PBC) of Paved Surfaces Using Standard Reference Test Tire.” ASTM E1337 is a standard test method for evaluating peak braking coefficient of a test surface using a standard reference test tire using a trailer towed by a vehicle. NHTSA uses this method to evaluate test surfaces for conducting compliance test procedures for its braking and electronic stability control standards. The 2019 version of ASTM E1337 specifies that the test may be conducted using the 16-inch SRTT and includes correlation data for converting testing using the 14-inch SRTT to the 16-inch SRTT and vice versa.

This rule also updates an existing incorporation by reference of ASTM F1805, “Standard Test Method for Single Wheel Driving Traction in a Straight Line on Snow- and Ice-Covered Surfaces.” ASTM F1805 is a test method for measuring the traction of tires on snow- or ice-covered surfaces using an instrumented four-wheel drive vehicle with a single test wheel capable of measure tire performance. NHTSA uses ASTM F1805 as part of its criteria for determining whether a tire may be considered a “snow tire” under its light vehicle tire standards. The 2020 version of F1805 specifies that the test may be conducted using the 16-inch SRTT and includes correlation data for converting testing using the 14-inch SRTT to the 16-inch SRTT and vice versa.

The ASTM standards incorporated by reference in this final rule are available for review at NHTSA's headquarters in Washington, DC, and for purchase from ASTM International. The ASTM standards that are replaced by this final rule are presently available for review at NHTSA or at ASTM's online reading room. 24 Once this final rule becomes effective, NHTSA anticipates that ASTM will update its reading room to include these standards.

Section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) requires NHTSA to evaluate and use existing voluntary consensus standards in its regulatory activities unless doing so would be inconsistent with applicable law ( e.g., the statutory provisions regarding NHTSA's vehicle safety authority) or otherwise impractical. Voluntary consensus standards are technical standards developed or adopted by voluntary consensus standards bodies. Technical standards are defined by the NTTAA as “performance-based or design-specific technical specification and related management systems practices.” They pertain to “products and processes, such as size, strength, or technical performance of a product, process or material.”

Examples of organizations generally regarded as voluntary consensus standards bodies include ASTM International, the Society of Automotive Engineers (SAE), and the American National Standards Institute (ANSI). If NHTSA does not use available and potentially applicable voluntary consensus standards, we are required by the Act to provide Congress, through OMB, an explanation of the reasons for not using such standards.

As discussed above, the standard reference test tire, the test method for determining surface friction, and the test method for determining whether a tire is a snow tire are based on specifications published by ASTM. Thus, this rulemaking accords with the requirements of the NTTAA.

Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) requires Federal agencies to prepare a written assessment of the costs, benefits, and other effects of proposed or final rules that include a Federal mandate likely to result in the expenditure by State, local, or tribal governments, in the aggregate, or by the private sector, of more than $100 million annually (adjusted for inflation with base year of 1995). Before promulgating a NHTSA rule for which a written statement is needed, section 205 of the UMRA generally requires the agency to identify and consider a reasonable number of regulatory alternatives and adopt the least costly, most cost-effective, or least burdensome alternative that achieves the objectives of the rule. The provisions of section 205 do not apply when they are inconsistent with applicable law. Moreover, section 205 allows the agency to adopt an alternative other than the least costly, most cost-effective, or least burdensome alternative if the agency publishes with the final rule an explanation of why that alternative was not adopted.

This rule will not result in any expenditure by State, local, or tribal governments or the private sector of more than $100 million, adjusted for inflation.

NHTSA has analyzed this rulemaking action for the purposes of the National Environmental Policy Act. The agency has determined that implementation of this action will not have any significant impact on the quality of the human environment.

The Department of Transportation assigns a regulation identifier number (RIN) to each regulatory action listed in the Unified Agenda of Federal Regulations. The Regulatory Information Service Center publishes the Unified Agenda in April and October of each year. You may use the RIN contained in the heading at the beginning of this document to find this action in the Unified Agenda.

In consideration of the foregoing, NHTSA amends 49 CFR parts 571 and 575 as follows:

NMFS and the Gulf Council manage the Gulf reef fish fishery and the red drum fishery under the respective FMPs. The Gulf Council prepared the FMPs and NMFS implements the FMPs through regulations at 50 CFR part 622 under the authority of the Magnuson-Stevens Act. Amendments 48/5 were prepared by the Gulf Council and will be incorporated into the management of Gulf reef fish and red drum through the respective FMPs.

On March 9, 2022, NMFS published a notice of availability (NOA) for Amendments 48/5 and requested public comment (87 FR 13274). NMFS did not receive any public comments on the NOA.

The Magnuson-Stevens Act and the National Standard 1 Guidelines require that FMPs specify a number of reference points for managed fish stocks, including maximum sustainable yield (MSY) or MSY proxy, and optimum yield, as well as status determination criteria (SDC), including an MFMT or an overfishing limit (OFL), and an MSST. These SDC represent the point at which a stock is determined to be overfished ( i.e., below MSST) or experiencing overfishing ( i.e., above MFMT or OFL). In 1999, the Gulf Council submitted the Generic Sustainable Fisheries Act (SFA) Amendment, which proposed definitions of MSY, OY, MFMT, and MSST for all reef fish stocks. NMFS approved most of the MFMT criteria, but disapproved all of the definitions for MSY, OY, and MSST because they were not based on biomass.

While NMFS refers to the document as “Amendments 48/5” in this notice of Agency decision, each amendment applies separately to the stocks in the respective FMPs. Amendment 5 applies to the red drum stock. Amendment 48 applies to several reef fish stocks and stock complexes that either have not been assessed or were assessed but still require stock status determinations.

These include: cubera snapper, lane snapper, goliath grouper, the shallow-water grouper complex (scamp, black grouper, yellowmouth grouper, and yellowfin grouper), the deep-water grouper complex (yellowedge grouper, warsaw grouper, snowy grouper, and speckled hind), the tilefish complex (golden tilefish, blueline tilefish, and goldface tilefish), the jacks complex (lesser amberjack, almaco jack, and banded rudderfish), and the mid-water snapper complex (wenchman, silk snapper, blackfin snapper, and queen snapper). Amendments 48/5 also addresses four reef fish stocks that have been assessed and have known stock status determinations: hogfish, mutton snapper, yellowtail snapper, and black grouper. Amendment 43 to the Reef Fish FMP established references points and SDC for hogfish. However, OY for hogfish was not defined there and is addressed in Amendments 48/5. Mutton snapper, yellowtail snapper, and black grouper, which occur in both the Gulf Council and South Atlantic Fishery Management Council areas of jurisdiction but are managed separately under each Council's FMPs, have reference points and SDC specified in the South Atlantic Snapper-Grouper FMP, but not in the Gulf Reef Fish FMP. With respect to black grouper, that species is managed by the South Atlantic Council as a single stock but is managed by the Gulf Council as part of the shallow-water grouper complex.

The NOA includes a detailed description of the biological references points and status determination criteria established in Amendments 48/5. A summary is provided below.

The MSY is the largest long-term average catch or yield that can be taken from a stock or stock complex under prevailing ecological, environmental conditions and fishery technological characteristics ( e.g., gear selectivity), and the distribution of catch among fleets. However, the actual MSY can rarely be estimated with certainty because of the difficulty in accurately estimating the relationship between the size of the spawning stock and the subsequent annual recruitment. As a result, proxies for MSY are typically used because they are easier to measure. Generally, MSY proxies used for fish species in the Gulf are based on some percentage of spawning potential ratio (SPR) and are expressed as the yield when fishing at F PROXY (where F is fishing mortality rate). In using SPR, NMFS assumes that a certain amount of fish must survive and spawn in order to replenish the stock, thus SPR represents the average number of eggs per fish over its lifetime when the stock is fished, compared to the average number of eggs per fish over its lifetime when the stock is not fished.

For reef fish stocks and stock complexes with the exception of goliath grouper, the MSY proxy selected by the Gulf Council is the yield when fishing at F 30 % SPR . For goliath grouper, the Gulf Council selected a more conservative MSY proxy because this species is more vulnerable to overfishing because of its long life-span and slow growth rate. The goliath grouper MSY proxy is the yield when fishing at F 40 % SPR .

The harvest of red drum is prohibited in Federal waters, but fishing is allowed in state waters under management measures developed by the respective Gulf state marine fisheries agencies. These agencies manage the stock to achieve a 30 percent escapement rate from state to Federal waters. Thus, Amendment 5 defines the red drum MSY proxy as the yield that provides for an escapement rate of juvenile fish to the spawning stock biomass (SSB) equivalent to 30 percent of those that would have escaped had there been no inshore state-waters fishery.

Amendments 48/5 also adopt a streamlined procedure for future specification of the MSY proxies for reef fish stocks and red drum that will allow the Gulf Council to adopt an MSY proxy recommended by the SSC by including a discussion of the change in a plan amendment. If the Gulf Council chooses to use this procedure, which would not include the consideration of alternatives to the MSY proxy recommended by the SSC, NMFS expects the Gulf Council to document its rationale for that decision. If more than one MSY proxy is supported by the best scientific information available, NMFS expects the Gulf Council to provide an appropriate analysis of these alternatives.

MFMT is the rate of fishing mortality above which a stock is experiencing overfishing. To keep MFMT consistent with the proposed MSY proxies, Amendments 48/5 set this threshold for the relevant stocks equal to the F at the MSY proxy for each stock or stock complex as discussed above.

The MSST is a biomass reference point that measures how many fish are left in the water rather than how many fish are caught, and determines at what biomass level a stock or stock complex is overfished. The MSST can be specified in terms of pounds of fish, numbers of fish, or the expected egg production from the SSB of the adult stock. The long-term average size of a stock that results from harvesting at MSY is called the biomass at MSY (B MSY ). The MSST is generally set at some level below B MSY , but cannot be set lower than 50 percent of B MSY . The greater the difference between B MSY and MSST, the less likely a stock is to be declared overfished, but the more difficult it may be to rebuild the stock back to B MSY should the stock size fall below MSST.

In Amendments 48/5 the Gulf Council set MSST at 0.75*B MSY (or proxy) for all of the stocks and stock complexes for which the Council also established an MSY and MFMT. The Gulf Council also considered and selected an additional alternative that would apply only to those individual stocks that span both the South Atlantic and Gulf Councils' areas of jurisdiction and would set MSST consistent with the MSST specified by the South Atlantic Council. These stocks are goliath grouper, black grouper, mutton snapper, and yellowtail snapper. The MSST specified by the South Atlantic Council is 0.75*B MSY (or proxy) for black grouper, mutton snapper, and yellowtail snapper, and (1-M)*B MSY (or proxy) for goliath grouper.

As discussed previously, and unlike the South Atlantic Council, the Gulf Council manages black grouper as part of the shallow water grouper complex, not as a single stock. Therefore, although black grouper was included in preferred alternative 5 that addressed the other three stocks that span both the South Atlantic and Gulf Councils' areas of jurisdiction, Amendment 48 does not consider specifying an MSY for black grouper as a single stock. Instead, consistent with the Gulf Council's current management of this stock, Amendment 48 specifies an MSY for the entire shallow-water grouper complex, which includes black grouper.

NMFS is approving the MSST for the shallow-water grouper complex as well as the MSST for black grouper, both of which are specified in Amendment 48 as 0.75*B MSY (or proxy). However, because Amendment 48 did not establish an MSY or MFMT for black grouper, NMFS encourages the Gulf Council to do so. Having the complete suite of biological reference points and SDC for black grouper in both the South Atlantic and Gulf FMPs would help inform the next stock assessment, which is scheduled to be complete in 2025.

Amendment 48 sets set OY at 90 percent of the MSY or MSY proxy for all reef fish stocks addressed in the amendment with the exception of goliath grouper. For goliath grouper, the Council set OY at zero, which reflects that harvest is prohibited.

For red drum, the Gulf Council decided to keep the existing OY definition, which is based on a 1987 SEFSC stock assessment that concluded under certain escapement rates of juveniles, the stock could rebuild. This OY definition is: (1) all red drum commercially and recreationally harvested from Gulf state waters landed consistent with state laws and regulations under a goal of allowing 30 percent escapement of the juvenile population; and (2) all red drum commercially or recreationally harvested from the Primary Area (Louisiana, Mississippi, and Alabama) of the exclusive economic zone (EEZ) under the total allowable catch (TAC) level and allocations specified under the provisions of the Red Drum FMP, and a zero-retention level from the Secondary Areas (Florida and Texas) of the EEZ. The red drum TAC for the Gulf EEZ has been zero since 1988 with the implementation of Amendment 2 to the Red Drum FMP and harvest in the EEZ is prohibited (53 FR 34662; June 29, 1988). Therefore, to achieve the OY, the Gulf states have independently and cooperatively implemented red drum regulations to achieve a 30 percent or greater escapement rate to the spawning stocks for each year class.

Because none of the measures included in the amendments involve regulatory changes, no proposed or final rule was prepared. The provisions of Amendments 48/5 are not specified in Federal regulations but are considered an amendment to the respective FMPs.

NMFS did not receive any public comments on the NOA, either in favor of, or in opposition to approving Amendments 48/5. There have been no changes to Amendments 48/5 based on NOA public comment.

Authority: 16 U.S.C. 1801 et seq.