In the Federal Register of May 7, 2024 (89 FR 38596-38644), we published a final rule entitled “User Fees for Agricultural Quarantine” that listed the designation for paragraph (h)(1) twice in 7 CFR 354.3. This document corrects that error.

In FR Doc. 2024-09348, appearing on pages 38596-38644 in the Federal Register of Tuesday, May 7, 2024, the following correction is made:

The substance of these special conditions has been published in the Federal Register for public comment in several prior instances with no substantive comments received. Therefore, the FAA finds, pursuant to 14 CFR 11.38(b), that new comments are unlikely, and notice and comment prior to this publication are unnecessary.

Except for Confidential Business Information (CBI) as described in the following paragraph, and other information as described in title 14, Code of Federal Regulations (14 CFR) 11.35, the FAA will post all comments received without change to www.regulations.gov, including any personal information you provide. The FAA will also post a report summarizing each substantive verbal contact received about these special conditions.

Confidential Business Information (CBI) is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to these special conditions contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to these special conditions, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission containing CBI as “PROPIN.” The FAA will treat such marked submissions as confidential under the FOIA, and the indicated comments will not be placed in the public docket of these proposed special conditions. Send submissions containing CBI to the individual listed in the For Further Information Contact section above. Comments the FAA receives, which are not specifically designated as CBI, will be placed in the public docket for these proposed special conditions.

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

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

On June 30, 2021, Textron applied for a change to Type Certificate No. A22CE for hydrophobic coatings in lieu of windshield wipers on the Model 560XL. The Textron Model 560XL airplane is a derivative of the Model 560XLS+ and is currently approved under Type Certificate No. A22CE. The Model 560XL is a twin-engine business jet, with a maximum seating capacity for 12 passengers, and a maximum take-off weight of 20,330 pounds.

Under the provisions of title 14, Code of Federal Regulations (14 CFR) 21.101, Textron must show that the Textron Aviation Inc. Model 560XL airplane, as changed, continues to meet the applicable provisions of the regulations listed in Type Certificate No. A22CE or the applicable regulations in effect on the date of application for the change, except for earlier amendments as agreed upon by the FAA.

If the Administrator finds that the applicable airworthiness regulations ( e.g., 14 CFR part 25) do not contain adequate or appropriate safety standards for the Textron Model 560XL airplane because of a novel or unusual design feature, special conditions are prescribed under the provisions of § 21.16.

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

In addition to the applicable airworthiness regulations and special conditions, the Textron Model 560XL airplane must comply with the exhaust-emission requirements of 14 CFR part 34, and the noise-certification requirements of 14 CFR part 36.

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

The modified Textron Model 560XL series airplane will incorporate the following novel or unusual design feature:

Hydrophobic windshield coatings to maintain a clear view. The airplane flightdeck design incorporates hydrophobic windshield coating that, during precipitation, provides an adequate outside view from the pilot compartment. Sole reliance on such coating, without windshield wipers, constitutes a novel or unusual design feature for which the applicable airworthiness regulations do not contain adequate or appropriate safety standards. Therefore, special conditions are required to provide a level of safety equivalent to that established by the regulations.

Title 14 CFR 25.773(b)(1) requires a means to maintain a clear portion of the windshield for both pilots to have a sufficiently extensive view along the flight path during precipitation conditions. The regulations require this means to maintain such an area during precipitation in heavy rain at speeds up to 1.5 V SR1 .

Effective December 26, 2002, amendment 25-108 changed the speed for effectiveness of the means to maintain an area of clear vision from up to 1.6 V S1 to 1.5 V SR1 to accommodate the redefinition of the reference stall speed from the minimum speed in the stall, V S1 , to greater than or equal to the 1g stall speed, V SR1 . As noted in the preamble to the final rule for that amendment, the reduced factor of 1.5 on V SR1 is to maintain approximately the same speed as the 1.6 factor on V S1 . Textron was granted an Equivalent Level of Safety (ELOS) to § 25.773(b)(1)(i) amendment 25-136 to use 1.6 Vs 1 instead of 1.5 V SR1 as documented in ELOS Memorandum No. TXTAV-18571-SM-03, dated December 6, 2023.

The requirement that the means to maintain a clear area of forward vision must function at high speeds and high precipitation rates is based on the use of windshield wipers as the means to maintain an adequate area of clear vision in precipitation conditions. The effectiveness of windshield wipers to maintain an area of clear vision normally degrades as airspeed and precipitation rates increase. It is assumed that because high speeds and high precipitation rates represent limiting conditions for windshield wipers, they will also be effective at lower speeds and precipitation levels. Accordingly, § 25.773(b)(1)(i) does not require maintenance of a clear area of forward vision at lower speeds or lower precipitation rates.

A forced airflow blown directly over the windshield has also been used to maintain an area of clear vision in precipitation. The limiting conditions for this technology are comparable to those for windshield wipers. Accordingly, introduction of this technology did not present a need for special conditions to maintain the level of safety embodied in the existing regulations.

Hydrophobic windshield coatings may depend to some degree on airflow to maintain a clear vision area. The heavy rain and high-speed conditions specified in the current rule do not necessarily represent the limiting condition for this new technology. For example, airflow over the windshield, which may be necessary to remove moisture from the windshield, may not be adequate to maintain a sufficiently clear area of the windshield in low- speed flight or during surface operations. Alternatively, airflow over the windshield may be disturbed during such critical times as the approach to land, where the airplane is at a higher-than-normal pitch attitude. In these cases, areas of airflow disturbance or separation on the windshield could cause failure to maintain a clear vision area on the windshield.

In addition to potentially depending on airflow to function effectively, hydrophobic coatings may also be dependent on water-droplet size for effective precipitation removal. For example, precipitation in the form of a light mist may not be sufficient for the coating's properties to result in maintaining a clear area of vision.

The current regulations identify speed and precipitation rate requirements that represent limiting conditions for windshield wipers and blowers, but not for hydrophobic coatings. Likewise, it is necessary to issue special conditions to maintain the level of safety represented by the current regulations.

These special conditions provide an appropriate safety standard for the hydrophobic-coating technology as the means to maintain a clear area of vision by requiring coating to be effective at low speeds and low precipitation rates, as well as at the higher speeds and precipitation rates identified in the current regulation.

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

As discussed above, these special conditions are applicable to the Textron Model 560XL airplane. Should Textron apply at a later date for a change to the type certificate to include another model incorporating the same novel or unusual design feature, these special conditions would apply to that model as well.

This action affects only a certain novel or unusual design feature on the Textron Model 560XL airplane. It is not a rule of general applicability.

The authority citation for these special conditions is as follows:

Accordingly, pursuant to the authority delegated to me by the Administrator, the following special conditions are issued as part of the type certification basis for Textron Model 560XL.

The airplane must have a means to maintain a clear portion of the windshield, during precipitation conditions, enough for both pilots to have a sufficiently extensive view along the ground or flight path in normal taxi and flight altitudes of the airplane. This means must be designed to function, without continuous attention on the part of the crew, in conditions from light misting precipitation to heavy rain, at speeds from fully stopped in still air, to 1.6 V S with lift and drag devices retracted.

The FAA published a final rule in the Federal Register on July 18, 2024 (89 FR 58262) for Docket No. FAA-2024-0383, updating the Class D airspace for Fort Liberty, NC, by excluding 1,400 feet MSL from the vertical limits (previously “including”), updating the airport's geographic coordinates, replacing “Notice to Airmen” with “Notice to Air Missions” in the description, and updating the reference to “Chart Supplement” (previously “Airport Facility Directory”). After publication, the FAA found updates to the FAA's database rendering the Airport Reference Point (ARP) data incorrect, which, as dependent upon the ARP, rendered other airspace description information incorrect. This action corrects these errors.

In FR Doc 2024-15483 at 58262, published in the Federal Register on July 18, 2024, the FAA makes the following corrections:

On page 58263, in the second column, correct the ASO NC D description for Fort Liberty, NC, to read as follows:

The IASA program is the means by which the FAA determines whether another country's oversight of its air carriers that (1) operate, or seek to operate, services to/from the United States using their own aircraft and crews, or (2) seek to display the code of a U.S. air carrier on any services, complies with safety standards established by the International Civil Aviation Organization (ICAO). The published IASA results of a country's placement in Category 1 or Category 2 is the notification to the U.S. traveling public as to whether a foreign air carrier's homeland civil aviation authority meets ICAO safety standards. A Category 1 rating indicates that the civil aviation authority meets ICAO safety standards for these operations, and a Category 2 rating indicates that the civil aviation authority does not meet ICAO safety standards. The IASA program was established by a document published in the Federal Register in 1992. Subsequent published documents in the Federal Register notified of the program's evolution. These Federal Register documents are as follows:

• August 24, 1992—Established the FAA Procedures for Examining and Monitoring Foreign Air Carriers (57 FR 38342).

• September 8, 1994—Established the Public Disclosure of the Results of Foreign Civil Aviation Authority Assessments, through a three-category numbered rating system (59 FR 46332).

• October 31, 1995—DOT Notice Clarification Concerning Examination of Foreign Carriers' Request for Expanded Economic Authority, clarified the Department's licensing policy regarding requests for expanded economic authority from foreign air carriers whose CAA's safety oversight capability has been assessed by the FAA as conditional (Category II) or unacceptable (Category III) (60 FR 55408).

• May 25, 2000—Changes to the International Aviation Safety Assessment program removed the Category 3 rating and combined it with Category 2 (65 FR 33751).

• March 8, 2013—Changes to the International Aviation Safety Assessment program removed inactive countries (countries with no air carrier operations to the United States or code-shares with U.S. air carrier for four years and no significant interaction between the country's CAA and the FAA) from the IASA Category list (78 FR 14912).

Through the IASA program, the FAA seeks continuous improvement to global aviation safety. As noted in the above-referenced policy statement of September 8, 1994, initial IASA assessments found that two-thirds of the assessed CAAs were deficient in meeting their safety oversight obligations under the Convention on International Civil Aviation.

The September 28, 2022, Policy Statement (87 FR 58725) (now suspended) announced certain changes to the IASA program and provided clarification to other aspects of the IASA policy. Since that publication, the FAA and DOT have received inquiries and questions that warrant reassessment of those changes and clarifications, and an opportunity for public comment before they are adopted permanently. As noted above, the FAA is suspending implementation of the September 28, 2022, Policy Statement while the agency reassesses the policy and considers public comments. Public comment is invited on the matters and issues described in the companion document published elsewhere in this issue of the Federal Register .

This document states the basis and purpose for the Commission's decision to adopt the Final Rule addressing the Commission's oversight of the Authority. The new oversight provisions were proposed and published for public comment in the Federal Register on February 8, 2024, in a notice of proposed rulemaking (“NPRM”). 1 After careful review and consideration of the entire record on the issues presented in this rulemaking proceeding, including 10 comments submitted by interested parties, the Commission has decided to adopt, with a few modifications, the proposed new oversight rule.

Upon request, FDA has classified the device to detect and identify nucleic acid targets in respiratory specimens from microbial agents that cause the SARS-CoV-2 respiratory infection and other microbial agents when in a multi-target test 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 (see 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 (Pub. L. 105-115) established the first procedure for De Novo classification. Section 607 of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144) modified the De Novo application process by adding a second procedure. 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) of the FD&C Act.

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 section 513(f)(2)(B)(i) of the FD&C Act). 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 section 513(i) of the FD&C Act, defining “substantial equivalence”). Instead, sponsors can use the less-burdensome 510(k) process, when necessary, to market their device.

On May 19, 2020, FDA received Biofire Diagnostics, LLC's request for De Novo classification of the BioFire Respiratory Panel 2.1 (RP2.1) device. 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 17, 2021, 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 866.3981. 1 We have named the generic type of device as device to detect and identify nucleic acid targets in respiratory specimens from microbial agents that cause the SARS-CoV-2 respiratory infection and other microbial agents when in a multi-target test, and it is identified as an in vitro diagnostic device intended for the detection and identification of SARS-CoV-2 and other microbial agents when in a multi-target test in human clinical respiratory specimens from patients suspected of respiratory infection who are at risk for exposure or who may have been exposed to these agents. The device is intended to aid in the diagnosis of respiratory infection in conjunction with other clinical, epidemiologic, and laboratory data or other risk factors.

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. 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 21 CFR part 860, subpart D, regarding De Novo classification 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 parts 801and 809, regarding labeling, have been approved under OMB control number 0910-0485.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 866 is amended as follows:

Upon request, FDA has classified the device to detect and identify selected microbial agents that cause acute febrile illness 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 (see 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 (see also 21 CFR part 860, subpart D). Section 207 of the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-115) established the first procedure for De Novo classification. Section 607 of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144) modified the De Novo application process by adding a second procedure. 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 section 513(f)(2)(B)(i) of the FD&C Act). 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 section 513(i) of the FD&C Act, defining “substantial equivalence”). Instead, sponsors can use the less-burdensome 510(k) process, when necessary, to market their device.

On June 26, 2020, FDA received BioFire Defense, LLC's request for De Novo classification of the FilmArray Global Fever Panel. 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 November 20, 2020, 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 866.3966. 1 We have named the generic type of device as a device to detect and identify selected microbial agents that cause acute febrile illness, and it is identified as an in vitro device intended for the detection and identification of microbial agents in human clinical specimens from patients with signs and symptoms of acute febrile illness who are at risk for exposure or who may have been exposed to these agents. It is intended to aid in the diagnosis of acute febrile illness in conjunction with other clinical, epidemiologic, and laboratory data, including patient travel, pathogen endemicity, or other risk factors.

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. 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 part 860, subpart D, regarding De Novo classification 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 parts 801 and 809, regarding labeling, have been approved under OMB control number 0910-0485.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 866 is amended as follows:

Upon request, FDA has classified the intravenous catheter force-activated separation device 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 (see 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 (Pub. L. 105-115) established the first procedure for De Novo classification. Section 607 of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144) modified the De Novo application process by adding a second procedure. 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 section 513(f)(2)(B)(i) of the FD&C Act). 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 section 513(i) of the FD&C Act, defining “substantial equivalence”). Instead, sponsors can use the less-burdensome 510(k) process, when necessary, to market their device.

On September 18, 2019, FDA received Site Saver, Inc. d/b/a Lineus Medical's request for De Novo classification of the SafeBreak Vascular. FDA reviewed the request 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 May 27, 2021, 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 880.5220. 1 We have named the generic type of device intravenous catheter force-activated separation device and it is identified as a device placed in-line with an intravenous (IV) catheter and an intravascular administration set, including any administration set accessories. It separates into two parts when a specified force is applied. The device is intended to reduce the risk of IV catheter failure(s) requiring IV catheter replacement.

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. 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. 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 21 CFR part 860, subpart D, regarding De Novo classification 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 and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 880 is amended as follows:

The final regulations (TD 9998) subject to these corrections are issued under sections 30C, 45, 45L, 45Q, 45U, 45V, 45Y, 45Z, 48C, and 179D of the Internal Revenue Code.

Accordingly, the final regulations (TD 9998) that are the subject of FR Doc. 2024-13331, published on Tuesday, June 25, 2024, at 89 FR 53184 are corrected as follows:

1. On page 53184, in the second column, in the third line of the second full paragraph, the language “credits” is corrected to read “credit”.

2. On page 53187, in the first column, under the heading “ IV. Prior Guidance ”, in the fifth line from the top of the paragraph, the language “credits” is corrected to read “credit”.

3. On page 53188, in the first column, in the second line from the bottom of the column, the language “grammatical or stylistic” is corrected to read “grammatical and stylistic”.

4. On page 53193, in the second column, in the eleventh line from the top of the column, the language “appliable” is corrected to read “applicable”.

5. On page 53196, in the first column, the sixth line from the top of the column is corrected to read “equivalent under the DBA, looks solely at”.

6. On page 53196, in the third column, the sixth line from the bottom of the column is corrected to read “definition of a qualified facility under”.

7. On page 53199, in the third column, the thirteenth line from the bottom of the column is corrected to read “laborer or mechanic”.

8. On page 53200, in the first column, the fourteenth line from the bottom of the column is corrected to read “but not all of the requests for qualified”.

9. On page 53204, in the first column, in the nineteenth line from the bottom of the column, the language “a” is removed.

10. On page 53204, in the first column, the third line from the bottom of the column is corrected to read “prevailing rates in accordance with”.

11. On page 53205, in the third column, the last line of the footnote is corrected to read “of section 179D(f); and in each case including any”.

12. On page 53209, in the first column, the tenth line from the top of the column is corrected to read “determinations is https://www.sam.gov. ”.

13. On page 53210, in the third column, the fifth line of the first full paragraph is corrected to read “the greatest number of laborers or”.

14. On page 53213, in the third column, in the fifth line of the first full paragraph, the language “apprenticeships” is corrected to read “apprentices”.

15. On page 53222, in the first column, in the fifth line from the top of the first full paragraph, the language “and amount” is removed.

16. On page 53225, in the first column, in the first line of the column, the language “applies” is corrected to read “apply”.

17. On page 53228, in the third column, the fourth line from the bottom of the second full paragraph is corrected to read “apprenticeship agency pursuant to 29 CFR”.

18. On page 53233, in the third column, in the second line of the footnote, the language “an NPRM” is corrected to read “a notice of proposed rulemaking”.

19. On page 53235, in the first column, the fourth line of last partial paragraph is corrected to read “programs. Under section 45(b)(8)(D)(ii), to”.

20. On page 53238, in the first column, the fourth line from the bottom of the partial paragraph is corrected to read “Under section 30C(c)(g)(3), rules similar”.

21. On page 53242, in the third column, in the sixth line of the second full paragraph, the language “48C(c)(2)” is corrected to read “section 48C(c)(2)”.

22. On page 53243, in the first column, in third line from the bottom of the first partial paragraph, the language “179D(b)” is corrected to read “section 179D(b)”.

23. On page 53244, in the second column, the fourth line of the last partial paragraph is corrected to read “suggested that the final regulations”.

24. On page 53246, in the third column, the fifth line from the second full paragraph is corrected to read “as it applies to facilities, property, projects,”.

25. On page 53247, in the third column, the sixth line of the second full paragraph is corrected to read “preamble to the notice of proposed rulemaking estimated these”.

26. On page 53248, in the second column, in the sixth line of the third paragraph, the language “paying” is removed.

27. On page 53248, in the second column, in the seventh line of the third paragraph, the language “qualified” is corrected to read “of qualified”.

28. On page 53248, in the third column, in the third line from the top of the column, the language “be” is removed.

29. On page 53249, in the second column, the nineth line of the second full paragraph is corrected to read “data includes approximately 18 million”.

30. On page 53249, in the second column, the eleventh line of the second full paragraph is corrected to read “the tax data includes more small”.

31. On page 53249, in the second column, the thirteenth line of the second full paragraph is corrected to read “one employee. Tax data provides a more”.

32. On page 53249, in the second column, the sixteenth line of the second full paragraph is corrected to read “tax data is an appropriate resource for”.

33. On page 53250, in the third column, the seventh line from the bottom of the first full paragraph is corrected to read “rates. Commenters suggested that the”.

34. On page 53251, in the first column, the fourth line from the bottom of the first full paragraph is corrected to read “processes for setting standards are”.

The final regulations (TD 9988) that are the subject of this correction are under section 6417 of the Code.

Accordingly, the final regulations (TD 9988) that are the subject of FR Doc. 2024-04604, published on March 11, 2024, are corrected to read:

1. On page 17550, in the first column, in the fourth line from the top of the first full paragraph, the language “designed” is corrected to read “designated”.

2. On page 17552, in the third column, in the eighth line from the bottom of the first full paragraph, the language “cert denied” is corrected to read “ cert. denied ”.

3. On page 17559, in the third column, in the twelfth line from the top of the first partial paragraph, the language “[ ]” is corrected to read “...”.

4. On page 17560, in the first column, in the tenth line from the top of the first partial paragraph, the language “book” is corrected to read “books”.

5. On page 17561, in the second column, in the eighth line from the bottom of the last partial paragraph, the language “tax-exempt” is corrected to read, “tax exempt”.

6. On page 17561, in the third column, in the fifteenth line from the top of the first partial paragraph, the language “tax-exempt” is corrected to read “tax exempt”.

7. On page 17562, in the second column, the third line from the bottom of the second full paragraph is corrected to read, “so as not to incur an addition to tax due”.

8. On page 17575, in the first column, in the tenth line from the top of the first partial paragraph, the language “tax-exempt” is corrected to read “tax exempt”.

9. On page 17577, in the second column, in the tenth line from the top of the first full paragraph, the language “Section” is corrected to read “part”.

10. On page 17581, in the third column, the second line from the bottom of the last partial paragraph the language “Section” is corrected to read “section”.

11. On page 17582, in the third column, the last sentence of the first full paragraph is corrected to read, “Although there is uncertainty as to the exact number of small businesses within this group, the current estimated number of respondents to these final rules is 20,000 taxpayers.”.

12. On page 17583, in the first column, in the fourth line the from the bottom of the second full paragraph, the column is corrected to read, “verified or have received registration”.

Accordingly, 26 CFR part 1 is corrected by making the following correcting amendments:

The final regulations (TD 10000) subject to these corrections are issued under sections 1001, 1012, 3406, 6045, 6045A, 6045B, 6050W, 6721, and 6722 of the Internal Revenue Code.

Accordingly, FR Doc. 2024-14004 (TD 10000), appearing on page 56480 in the Federal Register of Tuesday, July 9, 2024, is corrected as follows:

1. On page 56488, in the second column, the eighth line from the bottom of the column, is corrected to read “B) and not as a digital asset sale described”;

2. On page 56489, in the first column, the eighth line from the bottom of the first full paragraph is corrected to read “(and not by any customers or investors)”;

3. On page 56490, in the third column, the fourteenth line from the top is corrected to read “these final regulations, provides that”;

4. On page 56499, in the first column, in the eleventh line from the bottom, the word “consequence” is corrected to read “consequences”;

5. On page 56502, in the third column, the nineteenth line from the bottom, is corrected to read “returns under section 6045 is March 31 of the”;

6. On page 56502, in the third column, the tenth line from the bottom, is corrected to read “before the statute of limitations”;

7. On page 56504, in the third column, in the twenty-fourth line of the first full paragraph, the word “stablecoins” is corrected to read, “stablecoin”;

8. On page 56508, in the first column, the fourth line of the continuing paragraph is corrected to read, “According to comments, the average”;

9. On page 56508, in the first column, in the tenth line of the continuing paragraph the word “comment” is corrected to read “comments”;

10. On page 56508, in the first column, the first line of footnote 3 is corrected to read “One comment cited an article that referenced a report from”;

11. On page 56508, in the first column, the fourth and fifth sentences of footnote 3 are corrected to read “Another said: “The data sets underlying these estimates consist of public blockchain data regarding NFT volume, centralized exchange volume, and decentralized exchange volume. See Dune Analytics, https://dune.com/browse/dashboards (last visited October 30, 2023); Dune Analytics, https://github.com/duneanalytics/spellbook/tree/main (last visited October 30, 2023); The Block, https://www.theblock.co/data/cryptomarkets/spot/cryptocurrency-exchange-volumemonthly (last visited Oct. 30, 2023). ” “;

12. On page 56508, in the first column, the first line of footnote 4 is corrected to read “One comment referenced data”;

13. On page 56516, in the third column, the third line of the continuing paragraph, “non-U.S. digital asset broker, a”, is removed;

14. On page 56517, in the first column, the twelfth line from the bottom of the continuing paragraph is corrected to read “activities as an MSB was permitted”;

15. On page 56521, in the third column, in the fifth line of the first full paragraph the language “Am.” is corrected to read “Amend”;

16. On page 56536, in the third column, in the eighth line from the bottom of the first full paragraph, the word “stablecoins” is corrected to read “stablecoin”; and

17. On page 56542, in the first column, the sixth sentence of the second full paragraph is corrected to read, “Based on tax return data, only 200 of the 9,700 firms identified as impacted issuers in the upper bound estimate exceed the $41.5 million threshold.”.

The Abandoned Mine Land (AML) Reclamation Program was established by title IV of SMCRA (30 U.S.C. 1231-1245) in response to concerns over threats to the health and safety of the public and environmental damage caused by coal mining activities conducted before the enactment of the Act. The program is funded primarily by a reclamation fee collected on each ton of coal that is produced. The money collected is used to finance the reclamation of abandoned coal mines and other authorized activities. Section 405 of the Act allows States and Tribes to assume exclusive responsibility for reclamation activity within the State or on Indian lands if they develop and submit to the Secretary of the Interior (Secretary) for approval a program (often referred to as a plan) for the reclamation of abandoned coal mines within their jurisdiction.

On July 31, 1982, the Secretary approved the Pennsylvania Plan. You can find background information on the Plan, including the Secretary's findings, the disposition of comments, and the approval of the Plan in the July 30, 1982, Federal Register (47 FR 33081). You can find later actions concerning the Pennsylvania Plan and amendments to the Plan at 30 CFR 938.25.

By letter dated November 22, 2016 (Administrative Record No. PA 898.00), Pennsylvania sent us an amendment to its Plan under SMCRA at its own initiative. Within the proposed amendment, Pennsylvania requested to modify its Plan to allow PADEP to administer an Emergency AML Reclamation Program under title IV of SMCRA (30 U.S.C. 1231-1245).

We announced receipt of the proposed amendment in the May 16, 2018, Federal Register (83 FR 22607). In the same document, we opened the public comment period and provided an opportunity for a public hearing or meeting on the adequacy of the amendment. We did not receive any public comments and did not hold a public hearing or meeting because none was requested. The public comment period ended on June 11, 2018.

We have made the following findings concerning the amendment under SMCRA and the Federal regulations at 30 CFR 884.14 and 884.15. We are approving the amendment as described below. Any revisions that are not specifically discussed below concerning non-substantive wording or editorial changes can be found in the full text of the program amendment available at www.regulations.gov.

The proposed amendment consists of new Part G, The Pennsylvania Emergency Response Reclamation Program, to be added to the Pennsylvania Plan.

Section 410 of SMCRA (30 U.S.C. 1240) authorizes the Secretary to use funds under the AML Reclamation Program to abate or control emergency situations in which adverse effects of past coal mining pose an immediate danger to public health, safety, or general welfare. On September 29, 1982, OSMRE proposed delegating States and Tribes the authority to undertake emergency reclamation projects on behalf of the Secretary. States and Tribes were invited to amend their AML Reclamation Plans and demonstrate that they: (1) have the statutory authority to undertake emergencies; (2) the technical capability to design and supervise the emergency work; (3) the administrative mechanisms to quickly respond to emergencies either directly or through contractors; (4) have the staff qualified to make the findings of fact described in section 410 that emergency projects to be funded meet the definition of “emergency” under 30 CFR 700.5; and (5) that the scope of the work undertaken to reduce the emergency will be established by qualified staff, will not exceed the activities necessary to stabilize the life-threatening situation, and should allow remaining reclamation work to be undertaken later as a lower priority project. See 47 FR 42729 (Sept. 29, 1982). On May 28, 2010, OSMRE notified the States with approved AML Reclamation Plans that due to Federal budgetary constraints, as of Fiscal Year 2011, States would assume the responsibility for funding of the AML emergency programs from their title IV AML grants.

Part G of the Pennsylvania Plan includes a copy of the letter dated November 1, 1978, that Pennsylvania included in its original Plan submission, wherein the Governor of Pennsylvania designated the Pennsylvania Department of Environmental Resources (PADER) as the State agency responsible for the AML Program in Pennsylvania. According to additional information provided in Part G, on July 1, 1995, DER was split into the Department of Conservation and Natural Resources and PADEP, the latter of which administers Pennsylvania's Plan. The Pennsylvania Plan also includes: (1) the 1978 legal opinion of the Pennsylvania Attorney General that PADER (now PADEP) is authorized by Pennsylvania law to administer the Plan; and (2) a 2016 memorandum from PADEP's Office of Chief Counsel specifying PADEP's statutory authority to administer an Emergency AML Reclamation Program as part of its Plan.

OSMRE Findings: In addition to the general police power granted to PADEP to conduct reclamation work under the Clean Streams Law (35 P.S. 691.1 et seq. ) and the Administrative Code of 1929 (71 P.S. 510-15), section 16 of the Land and Water Conservation and Reclamation Act (32 P.S. 5116) and the Mine Fire and Subsidence Remedial Project Indemnification Law (52 P.S. 30.201-30.206) provide for the right of entry on any land where an emergency exists, and any other land to have access to the land where the emergency exists, with requirements to attempt to notify appropriate landowners and the option, at the agency's discretion, to recoup costs from the improved value of the land. Based on our review of Pennsylvania's relevant statutory provisions, and the inclusion of the 1978 legal opinion and the 2016 memorandum, we have determined that Pennsylvania has the statutory authority to undertake emergencies in compliance with SMCRA and all other applicable State and Federal laws and regulations.

On October 1, 2010, OSMRE ceased implementing the Emergency AML Reclamation Program in Pennsylvania and transferred emergency AML reclamation responsibilities to PADEP. Pennsylvania subsequently created an Accelerated Response Program (ARP) in 2010, which was administered by the PADEP's Bureau of Abandoned Mine Reclamation (BAMR), to address AML emergencies that have occurred throughout Pennsylvania's eligible coalfields.

As of the end of evaluation year 2022, Pennsylvania has reclaimed a total of 1,574,786 feet of dangerous highwalls, 2,016 acres of dangerous spoil piles and embankments, 47 dangerous impoundments, 153 hazardous water bodies, 1,601 vertical openings, and 771 miles of sediment-clogged streams. In its submission, Pennsylvania states that these are the same types of abandoned mine land features that the State will likely continue to encounter in emergency reclamation projects, and the technical capabilities used for emergency reclamation projects are generally the same as those used for normal, high priority reclamation projects, but with a potentially accelerated project schedule. In addition, Pennsylvania indicated that current staffing levels should be sufficient for the implementation of the emergency program, but PADEP may adjust the personnel structure as needed to accommodate the program in the future.

Pennsylvania states that BAMR maintains two field offices: one in eastern Pennsylvania (Anthracite Region) in Wilkes-Barre and one in western Pennsylvania (Bituminous Region) in Ebensburg, both of which have the capability to address emergency AML problems with both in-house staff and outside contractors. Pennsylvania indicates that both field offices maintain in-house construction crews with significant equipment available to respond to and address many small AML emergencies such as pothole (or cavehole) subsidences and mine drainage breakouts. Pennsylvania provides that emergency project development, design, realty, construction inspection, and administration are performed by BAMR staff or outside consultants. Pennsylvania indicates that approximately eighty percent of emergency projects have been constructed by PADEP's in-house crews between 2010 and 2020. In addition, Pennsylvania states that for larger AML emergencies, such as subsidence events causing structural damage to homes, businesses, and roads; mine fires; coal refuse fires; landslides; or other large-scale or complex AML problems, projects are completed by outside contractors awarded contracts using Pennsylvania's emergency contracting procedures.

OSMRE Findings: We have found that Pennsylvania has run ARP since 2010 in a cost efficient and professional manner. For example, having the in-house construction crews affords Pennsylvania a major time and cost saving advantage. We have found the in-house constructed projects require minimal design or construction management resources because the construction staff is proficient and experienced, and requires minimal, if any, construction inspection or oversight.

In addition, throughout the years, PADEP, through its partnership with OSMRE, has assembled the necessary funding, staff resources, expertise, and implementation measures to effectively address and mitigate suddenly occurring, dangerous abandoned mine land problems. OSMRE has recognized 18 Pennsylvania projects since 1993 with regional and national awards for going beyond standard reclamation requirements to achieve superior results in returning a site to productive use after completion of mining.

Based on Pennsylvania's demonstrated historical success in executing their Plan, the proficiency of ARP since 2010, and the description of its technical staff and processes described in section III of its submission, we have determined that Pennsylvania has the technical capability to design and supervise emergency work.

Pennsylvania explains in its submission that the organizational and management structure to be used for the proposed emergency program will be similar to that used for ARP. Pennsylvania states that key elements of the State's proposed program that provide essential flexibility to address emergency conditions include:

• access to accelerated contracting procedures provided within Pennsylvania's Procurement Code;

• use of multiple staff with the necessary technical skills working in parallel to advance reclamation quickly; and

• supplementary technical, legal, contracting, and administrative services from respective sections of PADEP as needed.

OSMRE Findings: PADEP has been operating ARP since OSMRE ceased implementing the Emergency AML Reclamation Program in 2010 in Pennsylvania. We find that Pennsylvania has run ARP in a cost efficient and professional manner. Many of the administrative processes required to implement the proposed emergency program are the same as those already in place for ARP and the Pennsylvania Plan, which has run successfully since approval in 1982. Based on Pennsylvania's description of its administrative and managerial structure in section IV of its submission, we have determined that Pennsylvania has the administrative mechanisms in place to manage and implement an emergency program.

In its submission, Pennsylvania provides that it will perform the investigations and eligibility findings for the proposed emergency projects under title IV of SMCRA. Pennsylvania indicates that it will then submit this information to the OSMRE official with delegated authority to make the requisite Finding of Fact and emergency declarations as required under section 410 of SMCRA. Moreover, Pennsylvania states that PADEP will follow the approved procedures contained in the OSMRE Federal Assistance Manual (FAM) chapter 4-120, which includes the Finding of Fact requirements.

OSMRE Findings: Given Pennsylvania's description of how PADEP will coordinate with OSMRE in establishing the Finding of Fact and emergency declaration, including the appropriate OSMRE official finding whether the problem meets the definition of “emergency” under 30 CFR 700.5, we have determined that Pennsylvania has the necessary procedures in place to make a Finding of Fact determination consistent with section 410 of SMCRA.

In its submission, Pennsylvania indicates that it will coordinate its emergency reclamation projects with OSMRE, including following the procedures found in FAM chapter 4-120. FAM 4-120 provides procedures for OSMRE to define the scope of work necessary to abate the emergency. In addition, FAM 4-120 provides information on how the State must determine the extent and scope of non-emergency work.

OSMRE Findings: Based on Pennsylvania's description of how it intends to coordinate with OSMRE on its emergency projects consistent with the FAM, we have determined that Pennsylvania has sufficient procedures, consistent with OSMRE guidelines, in place to ensure the scope of work for emergency projects will be established by qualified staff, is limited to that necessary to eliminate the life threatening situation, and will allow remaining reclamation work to be undertaken later as a lower priority project.

In accordance with section 405 of SMCRA and 30 CFR 884.14, Pennsylvania has submitted an amendment to its Plan, and we have determined that:

(1) The public has been given adequate notice and opportunity to comment, and the record does not reflect major unresolved controversies.

(2) Views of other Federal agencies have been solicited and considered.

(3) The State has the legal authority, policies, and administrative structure necessary to implement the amendment.

(4) The proposed plan amendment meets all requirements of the Federal AML Reclamation program regulations at 30 CFR chapter VII, subchapter R.

(5) The State has an approved State Regulatory Program.

(6) The amendment is in compliance with all applicable State and Federal laws and regulations.

Therefore, we find that the proposed Pennsylvania plan amendment allowing the State to assume responsibility for an Emergency AML Reclamation Program on behalf of OSMRE is in compliance with SMCRA and meets the requirements of Federal regulations. We are approving Pennsylvania's assumption of the Program.

In the May 16, 2018, Federal Register notice announcing our receipt of this amendment, OSMRE asked for public comments (Administrative Record No. PA-898.08). No requests for public meetings or hearings were received. OSMRE did not receive any comments.

On November 30, 2016, under 30 CFR 884.14(a)(2) and 884.15(a), OSMRE requested comments on the amendment from various Federal agencies with an actual or potential interest in the Pennsylvania program (Administrative Record No. PA 898.01). OSMRE did not receive any comments.

On November 30, 2016, under 30 CFR 884.14(a)(6), OSMRE requested comments from the EPA on the amendment (Administrative Record No. PA 898.01). The EPA responded with a letter dated January 6, 2017 (Administrative Record PA 898.03) that it has reviewed the proposed amendment and would not be providing comment.

Under 30 CFR 884.14(a)(6), OSMRE is required to request comments from the SHPO and ACHP on amendments that may have an effect on historic properties. On November 30, 2016, OSMRE requested comments on the Pennsylvania amendment (Administrative Record No. 898.01). OSMRE did not receive any comments.

Based on the above findings, OSMRE is approving the Pennsylvania amendment sent on November 22, 2016 (Administrative Record No. PA 898.00).

To implement this decision, we are amending the Federal regulations at 30 CFR part 938 that codify decisions concerning the Pennsylvania program. In accordance with the Administrative Procedure Act, this rule will take effect 30 days after the date of publication.

This rule would not affect a taking of private property or otherwise have taking implications that would result in private property being taken for government use without just compensation under the law. Therefore, a takings implication assessment is not required. This determination is based on an analysis of the corresponding Federal regulations.

Executive Order 12866, as amended by Executive Order 14094, provides that the Office of Information and Regulatory Affairs in the Office of Management and Budget (OMB) will review all significant rules. Pursuant to OMB guidance, dated October 12, 1993 (OMB Memo M-94-3), the approval of State program and/or plan amendments is exempted from OMB review under Executive Order 12866, as amended by Executive Order 14094. Executive Order 13563, which reaffirms and supplements Executive Order 12866, retains this exemption.

The Department of the Interior has reviewed this rule as required by section 3 of Executive Order 12988. The Department determined that this Federal Register document meets the criteria of section 3 of Executive Order 12988, which is intended to ensure that the agency review its legislation and proposed regulations to eliminate drafting errors and ambiguity; that the agency write its legislation and regulations to minimize litigation; and that the agency's legislation and regulations provide a clear legal standard for affected conduct rather than a general standard, and promote simplification and burden reduction. Because section 3 focuses on the quality of Federal legislation and regulations, the Department limited its review under this Executive order to the quality of this Federal Register document and to changes to the Federal regulations. The review under this Executive order did not extend to the language of the plan amendment that Pennsylvania drafted.

This rule has potential Federalism implications as defined under section 1(a) of Executive Order 13132. Executive Order 13132 directs agencies to “grant the States the maximum administrative discretion possible” with respect to Federal statutes and regulations administered by the States. Pennsylvania, through its approved reclamation program, implements and administers SMCRA and its implementing regulations at the State level. This rule approves an amendment to the Pennsylvania Plan submitted and drafted by the State and, thus, is consistent with the direction to provide maximum administrative discretion to States.

The Department of the Interior strives to strengthen its government-to-government relationship with Tribes through a commitment to consultation with Tribes and recognition of their right to self-governance and Tribal sovereignty. We have evaluated this rule under the Department's consultation policy and under the criteria in Executive Order 13175, and have determined that it has no substantial direct effects on the distribution of power and responsibilities between the Federal government and Tribes. The basis for this determination is that our decision is on the Pennsylvania program and plan that does not include Indian lands, as defined by SMCRA, or regulation of activities on Indian lands. Indian lands are regulated independently under the applicable, approved Federal program. The Department's consultation policy also acknowledges that our rules may have Tribal implications where the State proposing the amendment encompasses ancestral lands in areas with mineable coal. We are currently working to identify and engage appropriate Tribal stakeholders to devise a constructive approach for consulting on these amendments.

Executive Order 13211 requires agencies to prepare a Statement of Energy Effects for a rulemaking that is (1) considered significant under Executive Order 12866, and (2) likely to have a significant adverse effect on the supply, distribution, or use of energy. Because this rule is exempt from review under Executive Order 12866 and is not a significant energy action under the definition in Executive Order 13211, a Statement of Energy Effects is not required.

This rule does not constitute a major Federal action significantly affecting the quality of the human environment. We are not required to provide a detailed statement under the National Environmental Policy Act of 1969 because this rule qualifies for a categorical exclusion under the U.S. Department of the Interior Departmental Manual, part 516, section 13.5(B)(29).

Section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 3701 et seq. ) directs OSMRE to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. (OMB Circular A-119 at p. 14). This action is not subject to the requirements of section 12(d) of the NTTAA because application of those requirements would be inconsistent with SMCRA.

This rule does not include requests and requirements of an individual, partnership, or corporation to obtain information and report it to a Federal agency. As this rule does not contain information collection requirements, a submission to the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. 3501 et seq. ) is not required.

This rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). The State submittal, which is the subject of this rule, is based upon corresponding Federal regulations for which an economic analysis was prepared and certification made that such regulations would not have a significant economic effect upon a substantial number of small entities. In making the determination as to whether this rule would have a significant economic impact, the Department relied upon the data and assumptions for the corresponding Federal regulations.

This rule is not a major rule under 5 U.S.C. 804(2), the Small Business Regulatory Enforcement Fairness Act. This rule: (a) does not have an annual effect on the economy of $100 million; (b) will not cause a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions; and (c) does not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S.-based enterprises to compete with foreign-based enterprises. This determination is based on an analysis of the corresponding Federal regulations, which were determined not to constitute a major rule.

This rule does not impose an unfunded mandate on State, local, or Tribal governments or the private sector of more than $100 million per year. The rule does not have a significant or unique effect on State, local, or Tribal governments or the private sector. This determination is based on an analysis of the corresponding Federal regulations, which were determined not to impose an unfunded mandate. Therefore, a statement containing the information required by the Unfunded Mandates Reform Act (2 U.S.C. 1531 et seq. ) is not required.

For the reasons set out in the preamble, 30 CFR part 938 is amended as follows:

SSS published a proposed rule on February 6, 2024 (89 FR 8112). Public comments were received and were considered. Based on public comments, SSS is finalizing this rule with a few changes. Specifically, proposed subsection (a) and (b) were deleted from the proposed § 1662.23 (FOIA Exemption 6) and it now reads, “The FOIA exempts from disclosure records about individuals if disclosure would constitute a clearly unwarranted invasion of their personal privacy.” Additionally, minor edits were made to proposed § 1662.6 (c) (Requirements of a FOIA request) and it now reads, “The FOIA requires an Agency to provide the record in any form or format requested by the person if the record is readily reproducible by the Agency in that form or format. SSS will not search or produce records in response to a FOIA request that the FOIA Officer determines would be unduly burdensome ( as defined in case law ) to process. FOIA requests are unreasonably burdensome when it is a broad, sweeping request that lacks specificity. ”

The Housekeeping Statute, 5 U.S.C. 301, authorizes agency heads to promulgate regulations governing “the custody, use, and preservation of its records, papers, and property.” The FOIA is a Federal statute that allows the public to request records from the Federal government. The FOIA provides that any person has a right, enforceable in court, to obtain access to Federal agency records subject to the FOIA, except to the extent that any portions of such records are protected from public disclosure by one of nine exemptions or other law. Additionally, under the FOIA, agencies must make records specified in 5 U.S.C. 552(a)(2) ( e.g., instructional manuals issued to employees, general statements of policy, etc.) available for public inspection in an electronic format. The FOIA also statutorily requires Federal agencies to annually report on numerous and various metrics to the Department of Justice (DOJ).

Since the most recent update to 32 CFR part 1662, the E-FOIA, the OPEN Government Act, and the FOIA Improvement Act have been enacted. These laws provide guidance to agencies for the implementation of the FOIA requirements. This final rule updates and revises part 1662 consistent with these laws.

The final rule will better streamline the process for the Agency's FOIA policies and procedures. These updates are consistent with the Plain Writing Act of 2010 which requires Federal agencies to use clear communications that the public can understand and use. They underscore the FOIA guidelines issued by Attorney General Merrick Garland in his March 15, 2022, Memorandum for Heads of Executive Departments and Agencies. The Memorandum directs the heads of all executive branch departments and agencies to apply a presumption of openness in administering the FOIA, instructs agencies to remove barriers to access, and asks agencies to help requesters understand the FOIA process.

The E-FOIA requires agencies to make certain types of records, created by the Agency on or after November 1, 1996, available electronically. It requires agencies to make available for public inspection, via an electronic reading room, “copies of all records, regardless of form or format that have been released to any person [under the FOIA] and which, because of the nature of their subject matter, the Agency determines have become or are likely to become the subject of subsequent requests for substantially the same records.” The final rule complies with this requirement.

The OPEN Government Act amended the FOIA by providing new procedural and reporting requirements agencies must implement in their administration of the FOIA. It requires that (1) all FOIA requests that will take longer than ten days to process must be assigned an individualized tracking number and (2) agencies must provide requesters with a telephone line or internet service from which requesters can receive the status of their request(s).

The statute established the Office of Government Information Services (OGIS) within the National Archives and Records Administration that, among other duties, offers mediation services between FOIA requesters and Federal agencies as an alternative to litigation. It further directs agencies to designate a Chief FOIA Officer, who: (1) has responsibility for FOIA compliance; (2) monitors FOIA implementation; (3) makes recommendations to the Agency head concerning improvements to FOIA implementation; (4) reports to the Attorney General (through the Agency Head), as requested, on the Agency's FOIA implementation; (5) facilitates public understanding of the purposes of FOIA's statutory exemptions; and (6) designates one or more FOIA Public Liaisons. The FOIA Public Liaison serves as an official to whom a FOIA requester can raise concerns about service and is responsible for assisting in reducing delays in FOIA request processing, helping resolve disputes, and helping requesters understand the status of their requests.

The OPEN Government Act also revised annual reporting obligations, mandating reports on agency compliance with the FOIA to include information on: (1) FOIA denials based upon particular statutes; (2) response times; and (3) compliance by the agency and by each principal component thereof.

Regarding FOIA request processing, the OPEN Government Act: (1) modifies and specifies the time limits for an agency to determine whether to comply with a FOIA request; (2) establishes limitations on the circumstances under which the statutory time period may be “tolled”; and (3) prohibits an agency from assessing search or duplication fees under the FOIA if it fails to comply with time limits, provided that no unusual or exceptional circumstances apply.

Lastly, the OPEN Government Act provides for the definition of “representative of the news media” and amends the definition of “record” to include any information maintained by an agency contractor “for the purposes of record management.” This final rule conforms with the requirements of the OPEN Government Act.

The FOIA Improvement Act took effect on June 30, 2016, and applies to any FOIA request made after the date of enactment. Its intent is to improve Agency transparency and responsiveness in processing FOIA requests.

The statute codifies the “foreseeable harm” standard, establishing that agencies may only withhold information if the Agency reasonably foresees that disclosure would harm an interest protected by a statutory exemption, or if disclosure is prohibited by existing law. Unless the record is prohibited from disclosure by law, asserting a FOIA exemption alone is not sufficient; an agency must also determine that release of the record would cause foreseeable harm to others/interests protected under the exemption.

The FOIA Improvement Act also imposes numerous administrative and procedural requirements upon Federal agencies. It adds new elements to the annual reports that capture the number of record denials and the number of records of general interest or use to the public that are made available for public inspection. It also creates new duties for the Chief FOIA Officer, requiring the Chief FOIA Officer to (1) serve as the primary liaison between OGIS and the Office of Information Policy at DOJ and (2) offer training to staff regarding their FOIA responsibilities. It also creates a council of Chief FOIA Officers whose purpose is to improve an agency's administration of the FOIA. Within the Agency's final revisions to part 1662, it is not addressing the additional reporting requirements provided in the FOIA Improvement Act, as they do not affect its day-to-day administration of the FOIA.

This law also requires agencies to offer the services of the FOIA Public Liaison and OGIS in all decision letters. It further increases the time for appeals, now allowing requesters at least 90 days to file an administrative appeal of an adverse determination. Additionally, it codifies the “rule of three,” which requires agencies to make available for public inspection, in an electronic format, records that are of general interest or have been requested three or more times and released to any person.

Further, it prohibits an agency from charging search and/or duplication fees under the FOIA for providing records if the agency misses a deadline for complying with a FOIA request, unless unusual circumstances exist, and the agency takes certain action to notify the requester. Additionally, it amends one of the privileges recognized under the FOIA Exemption 5, the deliberative process privilege, by providing that this privilege cannot be applied to records that are 25 years or older at the time of the FOIA request.

Finally, the FOIA Improvement Act requires the head of each agency to (1) review agency regulations and issue regulations on procedures for disclosure of records in accordance with the amendments made by the bill and (2) include in such regulations procedures for engaging in dispute resolution through the FOIA Public Liaison and OGIS.

This final rule conforms with the requirements of the FOIA Improvement Act.

This final rule ensures the SSS FOIA program is easier for the public to navigate. Under this final rule, the Chief FOIA Officer conducts a thorough review to ensure proper disclosure. The Agency's Chief FOIA Officer makes the final determination on the release of records in response to initial requests and the Director of Selective Service is designated the final authority on appeal determinations. SSS also makes available for public inspection, in an electronic format, records that have been requested and released three or more times and other specified records described in revised § 1662.26, available at www.sss.gov/foia.

The Agency does not anticipate any additional costs associated with promulgations of the regulations contained herein.

The Agency anticipates qualitative benefits from the final rule which includes revisions to the FOIA regulations from streamlined and codified FOIA policies and procedures. SSS expects the codified regulations will benefit both the Agency and the public because the administration of the FOIA will be better organized and user friendly for requesters. The purpose of the FOIA is to provide the public with access to government records, and administrative transparency is paramount to a successful FOIA program. Clear policies generate efficient and effective processing of FOIA requests.

E.O.s 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. Following the requirements of these E.O.s, the Office of Management and Budget (OMB) has determined that this final rule is not a significant regulatory action under section 3(f) of E.O. 12866 nor a “major rule” as defined by 5 U.S.C. 804(2).

SSS certifies that this final rule is not subject to the Regulatory Flexibility Act, 5 U.S.C. 601, because it would not have a significant economic impact on a substantial number of small entities. Therefore, the Regulatory Flexibility Act, as amended, does not require SSS to prepare a regulatory flexibility analysis.

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

This final rule does not impose reporting or recordkeeping requirements under the Paperwork Reduction Act.

E.O. 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on state and local governments, preempts state law, or otherwise has federalism implications. This final rule will not have a substantial effect on state and local governments.

In E.O. 11623, the President delegated to the Director of Selective Service the authority to prescribe the necessary rules and regulations to carry out the provisions of the Military Selective Service Act. In carrying out the provisions of E.O. 11623, as amended by E.O. 13286, the Director shall request the views of the Secretary of Defense; the Attorney General; the Secretary of Labor; the Secretary of Health and Human Services; the Secretary of Homeland Security (when the Coast Guard is serving under the Department of Homeland Security); the Director of the Office of Emergency Preparedness; and the Chairman of the National Selective Service Appeal Board with regard to such proposed rule or regulation, and shall allow not less than 10 days for the submission of such views before publication of the proposed rule or regulation. On January 24, 2024, SSS completed its coordination requirements, and the Director certifies that he has requested the views of the officials required to be consulted pursuant to subsection (a) of E.O. 11623, considered those views and as appropriate incorporated those views in these regulations, and that none of these officials has requested that the matter be referred to the President for decision.

This final rule was reviewed and approved by Joel C. Spangenberg, Acting Director of Selective Service.

VA is amending 38 CFR 21.78(d) to authorize VREOs to delegate their concurrence authority to extend a Veteran's entitlement to a rehabilitation program. The lack of authority to delegate can delay the delivery of services if a VREO is out of the office for an extended period. A delegation of authority for entitlement extensions would follow other established procedures that allow for delegation of authority to a designee.

The total period a Veteran may participate in a Veteran Readiness and Employment rehabilitation program under chapter 31 alone may not exceed 48 months; however, there are situations when VA may extend a Veteran's entitlement to meet their individual needs. This is not automatically granted, and the Veteran must meet established criteria. Currently, only a VREO can provide the required concurrence for an extension that will exceed the 48-month limitation.

VA has general delegation authority under 38 U.S.C. 512(a). This amendment aligns with 38 U.S.C. 3105(b), will decrease approval times for entitlement extensions, and will allow for more timely services to Veterans.

The Secretary of Veterans Affairs finds that there is good cause under the Administrative Procedure Act (APA) to publish this rule without prior opportunity for public comment and with an immediate effective date. Pursuant to 5 U.S.C. 553(b)(B), general notice and opportunity for public comment are not required with respect to a rulemaking when an “agency for good cause finds (and incorporates the finding and a brief statement of reasons therefor in the rules issued) that notice and public procedure thereon are impracticable, unnecessary, or contrary to the public interest.” The Secretary finds that it is unnecessary to delay issuance of this rule for the purpose of soliciting prior public comment. This final rule will neither amend the substantive content of the regulation cited nor have a substantive impact on the public. Rather, the delegation of authority in 38 CFR 21.78(d) is procedural in nature and within VA's general delegation authority under 38 U.S.C. 512(a). Consequently, this rule is exempt from the notice-and-comment requirement as a rule of agency organization, procedure, or practice pursuant to 5 U.S.C. 553(b)(A).

The APA also requires a 30-day delayed effective date, except for “(1) a substantive rule which grants or recognizes an exemption or relieves a restriction; (2) interpretative rules and statements of policy; or (3) as otherwise provided by the agency for good cause found and published with the rule.” 5 U.S.C. 553(d). For the reasons stated above, the Secretary finds that there is also good cause for this rule to be effective immediately upon publication. Any delay in implementation would be unnecessary for purposes of 5 U.S.C. 553(d)(3).

Executive Order 12866 (Regulatory Planning and Review) directs agencies to assess the costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, and other advantages; distributive impacts; and equity). Executive Order 13563 (Improving Regulation and Regulatory Review) emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. Executive Order 14094 (Executive Order on Modernizing Regulatory Review) supplements and reaffirms the principles, structures, and definitions governing contemporary regulatory review established in Executive Order 12866 of September 30, 1993 (Regulatory Planning and Review), and Executive Order 13563 of January 18, 2011 (Improving Regulation and Regulatory Review). The Office of Information and Regulatory Affairs has determined that this rulemaking is not a significant regulatory action under Executive Order 12866, as amended by Executive Order 14094. The Regulatory Impact Analysis associated with this rulemaking can be found as a supporting document at www.regulations.gov.

The Regulatory Flexibility Act, 5 U.S.C. 601-612, is not applicable to this rulemaking because notice of proposed rulemaking is not required. 5 U.S.C. 601(2), 603(a), 604(a).

The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 1532, that agencies prepare an assessment of anticipated costs and benefits before issuing any rule that may result in the expenditure by state, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any one year. This final rule will have no such effect on state, local, and tribal governments, or on the private sector.

This final rule contains no provisions constituting a collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521).

Pursuant to subtitle E of the Small Business Regulatory Enforcement Fairness Act of 1996 (known as the Congressional Review Act) (5 U.S.C. 801 et seq. ), the Office of Information and Regulatory Affairs designated this rule as not satisfying the criteria under 5 U.S.C. 804(2).

Denis McDonough, Secretary of Veterans Affairs, approved this document on August 13, 2024, and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs.

For the reasons stated in the preamble, the Department of Veterans Affairs is amending 38 CFR part 21 as set forth below:

On June 28, 2024, the Postal Service published a notice of proposed rulemaking (89 FR 53914-53932) to simplify the parcel processing categories by making revisions to the physical standards of the machinable processing category, and consolidating the irregular and nonmachinable processing categories and renaming it “Nonstandard Parcels.” In response to the proposed rule, the Postal Service received three formal responses each containing several comments as follows:

Comment: One comment questioned whether the Postal Service intended to reduce the maximum height from 18 inches to 15 inches, and increase the maximum thickness/width from 15 inches to 18 inches?

Response: No, the Postal Service is just expressing the industry wide terms of length, width, and height for consistency within the DMM. The Postal Service will also revise the renumbered DMM Exhibit 201.7.5 and USPS Marketing Mail DMM subsection 201.8.4.2a to reflect width and height.

Comment: One comment provided that the proposal eliminates the minimum weight for Bound Printed Matter machinable parcels and given that change it appears there is very little Bound Printed Matter that would be nonstandard, except perhaps nonrectangular containers such as mailing tubes, which are rarely used for BPM. Any BPM that is nonstandard would be difficult and likely unproductive to bundle, due to its shape. As a result, it was requested that the Postal Service consider removing the bundling requirement for BPM nonstandard parcels weighing less than ten pounds, currently in DMM 245.8.2.

Response: The Postal Service agrees with the request and will remove DMM subsection 245.8.2 and will revise DMM 245.8.3 as the general requirement for mailing nonstandard parcels regardless of weight.

Comment: One comment provided that DMM subsection 255.4.4.3 currently requires DNDC nonmachinable parcels that each weigh 25 pounds or less must be sacked under DMM section 5.0, Preparing Machinable Parcels, and that line 2 of the sack labels be marked as MACH, rather than NONSTD.

Response: The issue is beyond the scope of this notice, however, the Postal Service will take this into consideration for a future revision.

Comment: One comment provided that DMM subsection 255.4.3.3f requires the use of PSCV PARCELS SCF for DSCF SCF sacks. However, there is no CIN code in 204 Exhibit 3.2.4 that matches the human readable line PSCV PARCELS SCF. We suggest that the human readable line should instead be PSVC MACH SCF (which does have a listed CIN code), since only machinable parcels are sacked at the SCF level. (Nonstandard parcels are required to be sacked at the 3D level, before reaching the SCF level.)

Response: While the comment is beyond the scope of this FRN, the Postal Service has reviewed the request and will revise the CIN code in DMM Exhibit 204.3.2.4 to read as PSVC MACH SCF.

Comment: Two comments stated the proposed November implementation date does not realistically reflect the effort required to execute necessary changes irrespective of whenever the Postal Service publishes a final rule.

Response: The Postal Service realized the needs of mailers and as a result the proposed rule provided that while the effective date was November 1, 2024, implementation was not expected until January 19, 2025.

Comment: One comment provided that parallel regulatory developments could affect the regulatory categorization of lightweight packages. For example, were the Postal Regulatory Commission to determine that Parcel Select—whole or in part—would be more properly categorized as a Market Dominant product, further development efforts would then be required.

Response: The revisions in the proposed rule address current products as they exist today.

Comment: One comment stated the DMM references included in the Notice are inconsistent regarding whether the term Nonstandard will be used for all retail parcels, all commercial parcels, or all parcels.

Response: Retail parcels are not categorized by processing categories. The proposed rule outlined what products would not be affected and the products that would be affected along with the applicable revisions.

Comment: One comment stated any package weighing less than 3.5 ounces, or in which contents may shift within a container, would be subject to an additional fee. Such a broad proposal could significantly impact certain categories such as clothing and pharmaceuticals. These categories often utilize standard fulfillment practices making use of poly bagging because it allows greater flexibility. Many users in these categories are price sensitive and imposition of a fee could put substantial volumes at risk by obviating the Postal Service's cost advantages with shipments that fit inside a mailbox.

Response: Nonstandard fees only to apply to packages that exceed set limits. Packages under 3.5 ounces would not be charged non-standard fees unless they exhibited a length over 22″, over 30″, or over 2 cubic feet in volume.

Comment: One comment provided the minimum size requirement warrants further clarification as the proposed rule implies that packages smaller than 4 inches x 6 inches may be non-mailable. Our concern is that this could force shippers into larger containers to avoid a fee and thereby increase postal handling costs.

Response: There is no dimensional requirement in the proposed rule for a package to be 4 inches x 6 inches. The only requirement is for a properly prepared label to be placed on a single optical plane without bending, folding, or overlapping. The “Parcel Labeling Guide” provides further information on label requirements.

The Postal Service is revising the “machinable” processing category by removing the minimum size dimensions requirement and, except for USPS Marketing Mail parcels, the minimum weight requirement. Except for cylindrical tubes and rolls or similar shaped pieces, and for labeling requirements in Publication 52, Hazardous, Restricted, and Perishable Mail, the minimum size of a machinable parcel will be determined by if it is large enough to hold the required delivery address, return address, mailing labels, postage, barcode, endorsements, and other mail markings on a single optical plane without bending, folding, or overlapping. All labels and markings must meet the applicable specifications ( e.g., DMM, Publication 199, Parcel Labeling Guide). A parcel that does not meet this requirement will be considered nonmailable. Except for USPS Marketing Mail parcels, which will continue to have the 3.5 ounce minimum to be a machinable parcel, the minimum weight requirement for other parcels will no longer be a factor in determining machinability.

The “Nonstandard Parcels” processing category will continue to have a size and weight component that will consist of parcels that exceed the maximum dimensions of a machinable parcel, parcels that weigh less than the 3.5 ounce minimum weight for USPS Marketing Mail parcels only, and parcels that exceed the 25 pound maximum weight for a machinable parcel. The “Nonstandard Parcels” processing category will also have a “Characteristics” component that will define the criteria that will be used to determine if a parcel is nonstandard ( e.g., cylindrical tubes and rolls, packaging). The “Characteristics” component of “Nonstandard Parcels” will be supported by DMM sections 601.3.0, Packaging, and 601.4.0, Acceptable Mailing Containers. The packaging criteria in DMM section 601.7.0, Packaging Standards for Mail Processed at Network Distribution Centers, will be consolidated into DMM section 601.3.0. The Postal Service is also revising the packaging standards under DMM section 601.3.0 to include that except for hazardous, restricted, and perishable items as provided in Publication 52, all other parcel priced pieces must be packaged in a box or other acceptable container that meets the applicable standards under DMM sections 601.3.0 and 601.4.0.

The revisions to parcel processing categories will not affect the Priority Mail Express®, Priority Mail®, USPS Ground Advantage®, or USPS Connect® Local, products. The revisions will result in no minimum size dimensions requirement, except for USPS Marketing Mail no minimum weight requirements, and a nomenclature change, for parcel preparation under the Parcel Select® Destination Entry, Library Mail, Media Mail®, Bound Printed Matter, Periodicals, and USPS Marketing Mail parcels (regular and nonprofit) products. Based on a request in the comments above, the Postal Service will revise the nonstandard Bound Printed Matter preparation standards.

In addition, the Postal Service is making minor revisions to the “Additional Physical Standards” subsections under DMM 101 and 201 to remove redundancy.

The Postal Service intends to notify the Postal Regulatory Commission (PRC) of these revisions for updates to the Mail Classification Schedule in a future filing. The Postal Service also intends to revise all collateral material ( e.g., Notice 123, Price List) in a future update.

While the effective date is November 4, 2024, sack, tray, and pallet, label compliance will not be required until January 19, 2025.

We believe these revisions will simplify the parcel processing categories providing mailers with a more efficient process for shipping.

The Postal Service adopts the described changes to Mailing Standards of the United States Postal Service, Domestic Mail Manual (DMM), incorporated by reference in the Code of Federal Regulations. We will publish an appropriate amendment to 39 CFR part 111 to reflect these changes.

Accordingly, 39 CFR part 111 is amended as follows:

The Judicial Officer Department recently issued a final rule revising its rules of practice with an updated internet address for its home page. This final rule is necessary to correct an error made in the previous filing.

Section 966.3(j) is amended to update the internet address for the Judicial Officer website and contact information for the Recorder.

Accordingly, the Postal Service amends 39 CFR part 966 as follows:

On August 13, 2018, PADEP submitted to EPA two SIP revisions to satisfy certain RACT requirements for sources of VOC emissions required by sections 182(b)(2) and 184(b)(l)(B) of the CAA and the implementing regulations for the 2008 8-hour ozone NAAQS (80 FR 12264, March 6, 2015; 40 Code of Federal Regulations (CFR) part 51, subpart AA).

On December 14, 2020 (85 FR 80616), EPA published a full approval of PADEP's two August 13, 2018 SIP submittals. The approval was challenged in the U.S. Court of Appeals for the Third Circuit, and on September 3, 2021, that court granted EPA's request for remand without vacatur of the Agency's final full approval. 1 Subsequently, a petitioner filed litigation in the Eastern District of Pennsylvania on May 16, 2023, arguing that EPA had unreasonably delayed in our reconsideration of the final approval of the August 13, 2018 SIP submittals. On December 15, 2023, the court filed a consent decree requiring that EPA complete our reconsideration of the December 14, 2020 final rule by November 15, 2024. 2

After reconsidering this full approval, EPA proposed to revise our prior action and in a notice of proposed rulemaking (NPRM) (May 17, 2024, 89 FR 43359), the Agency proposed to partially approve and partially disapprove parts of the August 13, 2018 SIP submittals. In the May 2024 NPRM, EPA proposed approval of certain clarifying amendments as well as a negative declaration submitted by PADEP. EPA proposed disapproval of the remainder of both SIP submittals related to CTGs and control of VOC emissions from industrial cleaning solvents.

PADEP submitted two SIP submittals to EPA on August 13, 2018. The first of these submittals is entitled “Certification of Reasonably Available Control Technology for Control Techniques Guidelines Under the 2008 Ozone National Ambient Air Quality Standards and Incorporation of 25 Pa Code Chapter 122 (Relating to National Standards of Performance for New Stationary Sources) into the Commonwealth's State Implementation Plan.” PADEP submitted this SIP revision for the purposes of meeting the RACT requirements under CAA sections 182(b)(2) and 184(b)(1)(B) and implementing the regulations for the 2008 8-hour ozone NAAQS. Specifically, this submittal: (1) certifies that PADEP's adoption and implementation of regulations to control VOC emissions is consistent with EPA's CTGs and represents RACT for these covered CTG sources for the 2008 ozone standard; (2) incorporates 25 Pa. Code Chapter 122 (relating to national standards of performance for new stationary sources) into the Pennsylvania SIP and certifies that those provisions continue to represent RACT for facilities subject to such standards of performance; and (3) incorporates specific permit conditions from certain facilities for the purpose of establishing source-specific RACT-level controls for those facilities.

The second August 13, 2018 SIP submittal, entitled “Control of Volatile Organic Compound Emissions from Industrial Cleaning Solvents; General Provisions; Aerospace Manufacturing and Rework; Additional RACT Requirements for Major Sources of NO X and VOCs,” includes: (1) the addition of 25 Pa. Code 129.63a (relating to the control of VOC from industrial cleaning solvents (ICS)); (2) amendments to 25 Pa. Code sections 121.1 and 129.51 (definitions and “general” provisions, respectively) in order to support the addition and implementation of 25 Pa. Code section 129.63a; (3) an administrative numbering correction a number correction to the VOC emission limit table in 25 Pa. Code section 129.73 (relating to aerospace manufacturing and re-work); and (4) amendments to 25 Pa. Code sections 129.96, 129.97, 129.99, and 129.100 to clarify certain requirements and to update the list of exemptions.

After reconsideration, EPA, in our 89 FR 43359, May 17, 2024 NPRM, proposed a partial disapproval and partial approval of the August 13, 2018 SIP submittals. In the NPRM associated with this action, EPA proposed to determine that the Agency erred in previously approving: the CTG portion of PADEP's RACT certification SIP, PADEP's determination that NSPS provisions meet CTG requirements and therefore are sufficient to implement RACT, 3 PADEP's determination that particular emission limitations in certain permits constitute RACT, and PADEP's determination that the 2006 ICS CTG is equal to RACT for the 2008 8-hour ozone NAAQs. 4 As explained in greater detail in our May 17, 2024 NPRM, PADEP failed in their August 13, 2018 SIP submittals to provide a sufficiently robust and well-developed record for their RACT determinations.

The May 2024 NPRM proposed to retain our approval of PADEP's negative declaration for one CTG source category, “Control of Volatile Organic Compound Emissions from Large Petroleum Dry Cleaners,”  5 as there are no sources in Pennsylvania (excluding Philadelphia County and Allegheny County). 6 In our May 17, 2024 NPRM, we also proposed to retain our approval of PADEP's amendments to 25 Pa. Code sections 122.1, 122.2, 122.3, 129.73, 129.96, 129.97, 129.99, and 129.100, as these amendments do not impact how PADEP determined that RACT was met by certain sources.

Comments: EPA received comments from one commenter, PADEP. In their comments, PADEP states that the Department “continues to certify that their current VOC CTG based rules continue to represent RACT in Pennsylvania.” PADEP asserts that the “control measures, rules, and regulations” that they have in place have been sufficient to reach “monitored attainment of the 2008 ozone NAAQS across the Commonwealth of Pennsylvania.” PADEP requests that EPA consider that the control measures in place in 2017 were sufficient for Pennsylvania to monitor compliance with the 2008 ozone NAAQS and therefore additional emissions reductions are unnecessary. To support its certification that Pennsylvania's existing CTG RACT rules meet RACT for the 2008 ozone NAAQS, PADEP also submitted, as part of their comments, additional documentation of their review of their CTG rules and regulations.

Response: PADEP argues that additional emissions reductions are not needed through RACT because the control measures, rules, and regulations in place in the Commonwealth have been sufficient to reach monitored attainment of the 2008 ozone NAAQS across Pennsylvania. However, this fact does not change the standard by which EPA must review these SIPs. As explained in our May 2024 NPRM, Pennsylvania's RACT requirements stem from CAA section 184(b), which provides that states in Ozone Transport Region (OTR) must follow moderate nonattainment area RACT requirements of section 182(b)(2), regardless of the attainment status in the state. Therefore, PADEP's RACT responsibilities do not change based on the attainment status or ozone monitor design values.

In both the OTR and nonattainment areas, EPA disagrees that monitored air quality alters a state's obligation to assess and adopt RACT for CTG-covered sources and major sources of VOC and nitrogen oxides (NO X ). EPA has defined RACT as the most stringent emission limitation that a particular source is capable of meeting by the application of control technology that is reasonably available considering technological and economic feasibility. EPA has long taken the position that the statutory requirement for states to assess and adopt RACT for sources exist independently from the attainment demonstration for such areas. 7

PADEP submitted its comments and additional supporting documentation to establish that Pennsylvania's CTG based rules and controls meet RACT for the 2008 ozone NAAQS and should not be disapproved. PADEP requests that EPA approve Pennsylvania CTG RACT certification. EPA disagrees that PADEP's submitted comments and accompanying documentation constitute a part of the rulemaking record upon which EPA can now approve Pennsylvania's CTG RACT certification. As stated in EPA's implementation rules for the ozone NAAQS, an air agency choosing to provide a written certification in lieu of submitting a new or revised regulation must provide the certification to EPA qualifying as a SIP revision in accordance with CAA section 110 and 40 CFR 51.102, 103 and part 51 appendix V. 8 EPA made clear in the 2015 ozone NAAQS implementation rule that “(t)hese written statements must be treated in the same manner as any other SIP submission and must be provided to EPA in accordance with applicable SIP submission requirements and deadlines.”  9 A fundamental requirement of the SIP revision process is providing for public notice and comment, and opportunity for public hearing at the state level. PADEP did not satisfy this requirement with its comment submittal and would need to submit this kind of supporting documentation as part of a SIP revision following state level notice and comment. For this reason alone, PADEP's submitted comments and accompanying documentation do not comprise any part of the record for this rulemaking and so as such were not considered by EPA, and do not alter our proposed disapproval of Pennsylvania's CTG RACT certification.

EPA is amending our prior full approval of PADEP's August 13, 2018 SIP submittals to a partial approval and partial disapproval. Specifically:

• For the August 13, 2018 SIP submittal titled “Certification of Reasonably Available Control Technology for Control Techniques Guidelines Under the 2008 Ozone National Ambient Air Quality Standards and Incorporation of 25 Pa Code Chapter 122 (Relating to National Standards of Performance for New Stationary Sources) into the Commonwealth's State Implementation Plan.”

EPA is disapproving the PADEP's certification that their adoption and implementation of regulations to control VOC emissions is consistent with EPA's CTGs and represents RACT for these covered CTG sources for the 2008 ozone standard;

EPA is approving the incorporation of 25 Pa. Code Chapter 122 (relating to national standards of performance for new stationary sources) into the Pennsylvania SIP;

EPA is disapproving PADEP's certification that 25 Pa. Code Chapter 122 continues to represent RACT for facilities subject to such standards of performance; and

EPA is disapproving PADEP's incorporation of specific permit conditions from certain facilities for the purpose of establishing source-specific RACT-level controls for those facilities.

• For the August 13, 2018 SIP submittal, titled “Control of Volatile Organic Compound Emissions from Industrial Cleaning Solvents; General Provisions; Aerospace Manufacturing and Rework; Additional RACT Requirements for Major Sources of NO X and VOCs.”

EPA is disapproving the addition of 25 Pa. Code 129.63a (relating to the control of VOC from industrial cleaning solvents (ICS)).

EPA is disapproving the amendments to 25 Pa. Code sections 121.1 and 129.51.

EPA is approving an administrative numbering correction to the VOC emission limit table in 25 Pa. Code section 129.73; and

EPA is approving the amendments to 25 Pa. Code sections 129.96, 129.97, 129.99, and 129.100.

In finalizing the disapproval, a sanctions clock under CAA section 179 begins. If EPA has not fully approved a revised plan within 18 months after this final disapproval, emission offset sanctions for new or modified sources will begin. If EPA has not approved a revised plan within six months thereafter, highway funding sanctions will apply in affected nonattainment areas. 10 The sanctions clock can be stopped only if the conditions of EPA's regulations at 40 CFR 52.31 are met. Pursuant to CAA section 110(c)(1)(B), this final disapproval also initiates an obligation for EPA to promulgate a Federal implementation plan (FIP) within 24 months unless PADEP has submitted, and EPA has approved, a plan addressing the applicable RACT requirements.

In this document, EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, and as discussed in sections II and IV of the preamble, EPA is reaffirming our prior final action for the incorporation by reference of 25 Pa. Code sections 122.1, 122.2, 122.3, 129.73, 129.96, 129.97, 129.99, and 129.100. These measures had been incorporated by reference into the SIP under a previous approval (85 FR 80625, December 14, 2020) and the Agency will retain them. EPA has made, and will continue to make, these materials generally available through www.regulations.gov and at EPA Region III Office (please contact the person identified in the FOR FURTHER INFORMATION CONTACT section of this preamble for more information).

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

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

Executive Order 12898 (59 FR 7629, February 16, 1994) directs Federal agencies to identify and address “disproportionately high and adverse human health or environmental effects” of their actions on minority populations and low-income populations to the greatest extent practicable and permitted by law. EPA defines environmental justice (EJ) as “the fair treatment and meaningful involvement of all people regardless of race, color, national origin, or income with respect to the development, implementation, and enforcement of environmental laws, regulations, and policies.” EPA further defines the term fair treatment to mean that “no group of people should bear a disproportionate burden of environmental harms and risks, including those resulting from the negative environmental consequences of industrial, governmental, and commercial operations or programs and policies.” PADEP did not evaluate environmental justice considerations as part of their SIP submittals; the CAA and applicable implementing regulations neither prohibit nor require such an evaluation. EPA did not perform an EJ analysis and did not consider EJ in this action. Consideration of EJ is not required as part of this action, and there is no information in the record inconsistent with the stated goals of E.O. 12898 of achieving environmental justice for people of color, low-income populations, and indigenous peoples.

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

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by October 15, 2024. 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 partial approval and partial disapproval may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

For the reasons stated in the preamble, EPA amends 40 CFR part 52 as follows:

The information presented in this preamble is organized as follows:

Section 553 of the APA, 5 U.S.C. 553(b)(4)(B), provides that, when an agency for good cause finds that notice and public procedures are impracticable, unnecessary, or contrary to the public interest, the agency may issue a rule without providing notice and an opportunity for public comment. The EPA has determined that there is good cause for making this final agency action without prior proposal and opportunity for comment because no significant EPA judgment is involved in making findings of failure to submit SIPs, or elements of SIPs, required by the CAA, where States have made no submissions to meet the requirement. Thus, notice and public procedures are unnecessary to take this action. The EPA finds that this constitutes good cause under 5 U.S.C. 553(b)(4)(B).

In addition to being available in the docket, an electronic copy of this Federal Register document will be posted at https://www.epa.gov/so2-pollution/2010-sulfur-dioxide-national-ambient-air-quality-standards-implementation-actions.

For questions related to specific States mentioned in this document, please contact the appropriate EPA Regional office:

In June 2010, the EPA (Environmental Protection Agency) promulgated a new 1-hour primary SO 2 NAAQS of 75 parts per billion (ppb), which is met when the 3-year average of the annual 99th percentile of daily maximum 1-hour average concentrations does not exceed 75 ppb. 1 Following promulgation of a new or revised NAAQS, the EPA is required to designate all areas of the country as either “attainment,” “nonattainment,” or “unclassifiable” (CAA section 107(d)(1)). In multiple separate rules, 2 the EPA cumulatively designated 51 areas within 23 States and territories as nonattainment for the 2010 1-hour primary SO 2 NAAQS.

The CAA directs States containing an area designated nonattainment for the 2010 SO 2 1-hour primary NAAQS to develop and submit a nonattainment area (NAA) SIP to the EPA within 18 months of the effective date of an area's designation as nonattainment. The nonattainment (NAA) SIP (also referred to as an attainment plan) must meet the requirements of subparts l and 5 of part D of Title I of the CAA, and provide for attainment of the NAAQS by the applicable statutory attainment date. All components of the SO 2 part D NAA SIP, including the emissions inventory, attainment demonstration, reasonably available control measures (RACM) including reasonably available control technology (RACT), enforceable emission limitations and control measures, reasonable further progress (RFP) plan, nonattainment new source review (NNSR), and contingency measures, are due under CAA section 191(a) to the EPA within 18 months of the effective date of designation of an area. Under CAA section 192(a), these NAA SIPs must provide for attainment of the NAAQS as expeditiously as practicable, but no later than 3 years from the effective date of the nonattainment designation. Responsible State air agencies were required to prepare and submit to the EPA a NAA SIP revision within 18 months of the effective date of the nonattainment designation to bring the NAAs into attainment by the relevant attainment date.

Pursuant to CAA section 110(k)(1)(B), the EPA must determine no later than 6 months after the date by which a State is required to submit a SIP whether a State has made a submission that meets the minimum completeness criteria established pursuant to CAA section 110(k)(1)(A). These criteria are set forth at 40 CFR part 51, appendix V. For those States that have not yet made a submittal that was complete with respect to the minimum completeness criteria for the 2010 1-hour primary SO 2 NAAQS, the EPA is making a finding of failure to submit a complete SIP.

On August 5, 2013, the EPA finalized its first-round designation of 29 areas as nonattainment for the 2010 SO 2 NAAQS, effective October 4, 2013. 3 This designation was based on air quality monitoring data from 2009-2011 and included the Miami, Arizona and St. Bernard Parish, Louisiana NAAs. Pursuant to CAA section 192(a), the Miami and St. Bernard Parish NAAs had until October 4, 2018—5 years after the effective date of the final action—to demonstrate attainment of the 2010 SO 2 NAAQS. Both NAAs failed to attain the standard by this statutory deadline and as such, under CAA section 179(c) the EPA issued findings of failure to attain (FFA) for Miami, Arizona on January 31, 2022  4 and for St. Bernard Parish, Louisiana on October 5, 2022. 5 These FFAs set a deadline for the responsible States to submit a revised SIP to the EPA within 1 year, under CAA section 179(d). The deadlines for the revised SIPs were January 31, 2023, for Miami, Arizona and October 5, 2023, for St. Bernard Parish, Louisiana. Neither Arizona nor Louisiana submitted a complete revised SIP addressing these areas by the appropriate deadline.

On March 26, 2021, the EPA finalized its fourth-round designation of 9 areas as nonattainment for the 2010 SO 2 NAAQS, effective April 30, 2021. 6 This Round 4 designation included St. Lawrence County (part), New York and Giles County (part), Virginia. Section 191 of the CAA directs States to submit SIPs for areas designated as nonattainment for the SO 2 NAAQS to the EPA within 18 months of the effective date of the nonattainment designation, i.e., by no later than October 30, 2022, in this case. New York and Virginia failed to submit complete revised SIPs by this deadline.

Based on a review of SIP submittals received and deemed complete as of the date of this final action, the EPA is finding that the States listed in Table 1 have failed to submit specific required SIP elements.

If the EPA finds that a State has failed to make the required SIP submittal or that a submitted SIP is incomplete, then CAA section 179(a) establishes specific consequences, after a period of time, including the imposition of mandatory sanctions for the affected area. Additionally, such a finding also triggers an obligation under CAA section 110(c) for the EPA to promulgate a FIP no later than 2 years after the finding of failure to submit if the affected State has not submitted, and the EPA has not approved, the required SIP submittal.

If the EPA has not affirmatively determined that a State has made the required complete SIP submittal for an area within 18 months of the effective date of this action, then, pursuant to CAA section 179(a) and (b) and 40 CFR 52.31, the offset sanction identified in CAA section 179(b)(2) will apply in the affected nonattainment area. If the EPA has not affirmatively determined that the State has made a complete submission within 6 months after the offset sanction is imposed, then the highway funding sanction will apply in the affected nonattainment area, in accordance with CAA section 179(b)(1) and 40 CFR 52.31. The sanctions will not take effect if, within 18 months after the date of these findings, the EPA affirmatively determines that the affected State has made a complete SIP submittal addressing the deficiency for which the finding was made. Additionally, if the State makes the required SIP submittal and the EPA takes final action to approve the submittal within 2 years of the effective date of these findings, the EPA is not required to promulgate a FIP for the affected nonattainment area.

Based on a review of SIP submittals received and deemed complete as of the date of signature of this action, the EPA finds that the States listed in Table 1 failed to submit the indicated SIP elements required under part D of Title I of the CAA within 18 months of their associated effective dates of designation. The EPA is, therefore, issuing a finding of failure to submit for the required SIP elements listed in Table 1 of this action. The effective date of this finding starts the 18-month emission offset sanctions clock, the 24-month highway funding sanctions clock, and a 24-month clock for the EPA to promulgate a FIP.

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

This action is not a significant regulatory action as defined in Executive Order 12866, as amended by Executive Order 14094, and was therefore not subject to a requirement for Executive Order 12866 review.

This action does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq. ). This final rule does not establish any new information collection requirement apart from what is already required by law. This action relates to the requirement in the CAA for States to submit SIPs under CAA sections 172, 191, and 192 that address the requirements that apply to areas designated as nonattainment for the SO 2 NAAQS.

I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. This action will not impose any requirements on small entities. This action is a finding that the named States have not made the necessary SIP submissions for certain nonattainment areas to meet the requirements of part D of Title I of the CAA.

This action does not contain an unfunded mandate of $100 million or more as described in UMRA (2 U.S.C. 1531-1538) and does not significantly or uniquely affect small governments. The action imposes no new enforceable duty on any State, local, or Tribal governments or the private sector.

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

This action does not have Tribal implications as specified in Executive Order 13175. This action finds that several States failed to submit SIP revisions that satisfy the nonattainment area planning requirements under sections 172, 191, and 192 of the CAA. No Tribe is subject to the requirement to submit an implementation plan under section 172, 191, and 192 of the CAA. Thus, Executive Order 13175 does not apply to this action.

The EPA interprets Executive Order 13045 as applying only to those regulatory actions that concern health or safety risks that the EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of the Executive order. This action is not subject to Executive Order 13045 because it is a finding that several States failed to submit required SIP revisions that satisfy the nonattainment area planning requirements under sections 172, 191, and 192 of the CAA and does not concern an environmental health risk or safety risk.

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

This action does not involve technical standards.

Executive Order 12898 (59 FR 7629, Feb. 16, 1994) directs Federal agencies to identify and address “disproportionately high and adverse human health or environmental effects” of their actions on minority populations and low-income populations to the greatest extent practicable and permitted by law. Executive Order 14096 (88 FR 25251, April 26, 2023) directs the Federal Government to build upon and strengthen its commitment to deliver environmental justice to all communities across the country through an approach that is informed by scientific research, high-quality data, and meaningful Federal engagement with communities experiencing environmental justice concerns.

The EPA believes that the human health or environmental conditions that exist prior to this action have the potential to result in disproportionate and adverse human health or environmental effects on communities with environmental justice concerns. The EPA believes that this action is not likely to change existing disproportionate and adverse effects on communities with environmental justice concerns. The areas impacted by this action are designated as nonattainment for the 2010 1-hour primary SO 2 NAAQS and this action is intended to comply with the CAA program to ensure attainment and maintenance of the NAAQS. From a programmatic perspective, this action is intended to ensure that affected air agencies comply with CAA obligations for the applicable nonattainment areas.

The EPA did not perform an EJ analysis and did not consider EJ in this action. In this action, the EPA is performing a nondiscretionary duty to find that required State submissions were not timely. There is not an alternative action that can be taken by the EPA to this action and thus, these determinations are not informed by additional EJ related analyses. Further, there is no information in the record inconsistent with the stated goals of Executive Orders 12898 or 14096 of achieving environmental justice for people of color, low-income populations, and indigenous peoples.

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

Section 307(b)(1) of the CAA governs judicial review of final actions by the EPA. This section provides, in part, that petitions for review must be filed in the United States Court of Appeals for the District of Columbia Circuit if (i) the agency action consists of “nationally applicable regulations promulgated, or final action taken, by the Administrator,” or (ii) such action is locally or regionally applicable, but “such action is based on a determination of nationwide scope or effect and if in taking such action the Administrator finds and publishes that such action is based on such a determination.”

This final action is “nationally applicable” within the meaning of CAA section 307(b)(1). This final action consists of findings of failure to submit required SIPs for four areas designated nonattainment for the 2010 primary 1-hour SO 2 NAAQS, which are located in four States in four of the 10 EPA Regions and in four different federal judicial circuits. This final action is also based on a common core of factual findings concerning the receipt and completeness of the relevant SIP submittals.

Accordingly, under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the District of Columbia Circuit by October 15, 2024.

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

Municipal solid waste landfills (MSWLFs) are discrete areas of land or excavation that receive household waste or other types of nonhazardous wastes such as commercial solid waste, nonhazardous sludge, and industrial nonhazardous solid waste. The original New Source Performance Standards (NSPS) (40 CFR part 60, subpart WWW) for MSWLFs and Emission Guidelines (40 CFR part 60, subpart Cc) for existing MSWLFs were promulgated by EPA on March 12, 1996 (61 FR 9905), based on the determination that MSWLFs cause or significantly contribute to air pollution that is considered to endanger public health and welfare.

326 IAC 8-8 implements the Federal 1996 Emission Guidelines and applies to landfills located in Lake, Porter, Clark, and Floyd counties. On January 17, 1997, EPA approved 326 IAC 8-8 into Indiana's SIP to address volatile organic compound (VOC) emission reductions for the nonattainment counties under the 1-hour ozone National Ambient Air Quality Standard (NAAQS). Specifically, 326 IAC 8-8 addresses Indiana's 15% Rate of Progress Plan to control VOC emissions in Clark and Floyd Counties and is included in the VOC contingency plans for Lake and Porter Counties (January 17, 1997, 62 FR 2591).

On August 29, 2016, EPA revised the MSWLF NSPS and Emission Guidelines in 40 CFR part 60, subparts XXX and Cf, respectively (81 FR 59332; 81 FR 59276). The 2016 Emission Guidelines revision updates the control requirements and monitoring, reporting, and recordkeeping provisions for existing MSWLF sources. In particular, the 2016 Emissions Guidelines implement changes to existing landfills that lower the emissions threshold of non-methane organic compounds (which include VOCs), at which an operator must install controls.

On May 21, 2021, EPA promulgated 40 CFR part 62, subpart OOO as the Federal plan for existing landfills (86 FR 27770). Indiana promulgated 326 IAC 8-8.2 to incorporate by reference the Federal plan to use as the underlying rule which implements and enforces the applicable provisions under the MSWLF 2016 Emission Guidelines in 40 CFR part 60, subpart Cf.

Consequently, MSWLFs in Indiana are subject to both 326 IAC 8-8 and the Federal plan for existing landfills if EPA does not repeal 326 IAC 8-8 and replace it with rule 326 IAC 8-8.2.

326 IAC 8-8.2 includes Federal updates to MSWLF rules with the incorporation by reference of the Federal plan for MSWLFs at 40 CFR part 62, subpart OOO. The Federal plan implements and enforces the 2016 MSWLF Emission Guidelines, codified in 40 CFR part 60, subpart Cf.

The updated 2016 Emission Guidelines apply to landfills constructed, modified, or reconstructed on or before July 17, 2014. These Emission Guidelines achieve additional emissions reductions of landfill gas and its components, including VOCs, by lowering the emissions threshold at which a landfill must install controls.

In particular, the 2016 Emission Guidelines are more stringent since they require affected landfills to install and operate gas collection control systems within 30 months after landfill gas emissions reach a new, lower threshold of 34 metric tons of non-methane organic compounds, which includes VOCs, or more per year. This threshold previously was higher at 50 metric tons per year in the 1996 Emission Guidelines, which is incorporated in 326 IAC 8-8.

In addition, the 2016 Emission Guidelines address other regulatory issues, including surface emissions monitoring, wellhead monitoring, and the definition of landfill gas treatment system.

Since 326 IAC 8-8.2 is more stringent than 326 IAC 8-8 and reflects EPA's most recent Federal rulemaking on MSWLFs, EPA approves this regulation to replace 326 IAC 8-8.

EPA is approving 326 IAC 8-8.2 for Lake, Porter, Clark, and Floyd Counties in Indiana and the repeal of 326 IAC 8-8 for those same counties. EPA is approving 326 IAC 8-8.2 as a VOC SIP strengthening measure.

We are publishing this action without prior proposal because we view this as a noncontroversial amendment and anticipate no adverse comments. However, in the proposed rules section of this Federal Register publication, we are publishing a separate document that will serve as the proposal to approve the State plan if relevant adverse written comments are filed. This rule will be effective October 15, 2024 without further notice unless we receive relevant adverse written comments by September 16, 2024. If we receive such comments, we will withdraw this action before the effective date by publishing a subsequent document that will withdraw the final action. All public comments received will then be addressed in a subsequent final rule based on the proposed action. EPA will not institute a second comment period. Any parties interested in commenting on this action should do so at this time. Please note that if EPA receives adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, EPA may adopt as final those provisions of the rule that are not the subject of an adverse comment. If we do not receive any comments, this action will be effective October 15, 2024.

In this rule, EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, EPA is finalizing the incorporation by reference of the Indiana Regulations 326 IAC 8-8.2 effective March 10, 2023, described in section II of this preamble and set forth in the amendments to 40 CFR part 52 below. EPA has made, and will continue to make, these documents generally available through www.regulations.gov and at the EPA Region 5 Office (please contact the person identified in the FOR FURTHER INFORMATION CONTACT section of this preamble for more information). Therefore, these materials have been approved by EPA for inclusion in the SIP, have been incorporated by reference by EPA into that plan, are fully federally enforceable under sections 110 and 113 of the CAA as of the effective date of the final rulemaking of EPA's approval, and will be incorporated by reference in the next update to the SIP compilation. 1

Also in this document, as described in Section II of this preamble and the amendments to 40 CFR part 52 set forth below, EPA is removing provisions of the EPA-Approved Indiana Regulations from the Indiana SIP, which is incorporated by reference in accordance with the requirements of 1 CFR part 51.

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

• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993), and 14094 (88 FR 21879, April 11, 2023);

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

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

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

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

• Is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997) because it approves a State program;

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

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

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).

Executive Order 12898 (Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations, 59 FR 7629, February 16, 1994) directs Federal agencies to identify and address “disproportionately high and adverse human health or environmental effects” of their actions on minority populations and low-income populations to the greatest extent practicable and permitted by law. EPA defines environmental justice (EJ) as “the fair treatment and meaningful involvement of all people regardless of race, color, national origin, or income with respect to the development, implementation, and enforcement of environmental laws, regulations, and policies.” EPA further defines the term fair treatment to mean that “no group of people should bear a disproportionate burden of environmental harms and risks, including those resulting from the negative environmental consequences of industrial, governmental, and commercial operations or programs and policies.”

IDEM did not evaluate EJ considerations as part of its SIP submittal; the CAA and applicable implementing regulations neither prohibit nor require such an evaluation. EPA did not perform an EJ analysis and did not consider EJ in this action. Due to the nature of the action being taken here, this action is expected to have a neutral to positive impact on the air quality of the affected area. Consideration of EJ is not required as part of this action, and there is no information in the record inconsistent with the stated goal of E.O. 12898 of achieving EJ for people of color, low-income populations, and Indigenous peoples.

For the reasons stated in the preamble, title 40 CFR part 52 is amended as follows:

Throughout this document “we,” “us,” and “our” refer to EPA.

The EPA is amending Nebraska's SIP and Operating Permits Program to include revisions to title 129 of the Nebraska Administrative Code and to add specific definitions from Nebraska Revised Statute 81-1502. The EPA is approving revisions to the Nebraska SIP received on December 2, 2022. The revisions are to Title 129—Nebraska Air Quality Regulations and include specific definitions from Nebraska Revised Statute 81-1502. These changes include new and renumbered rules, the consolidation of 43 chapters into 16 chapters, replacement of duplicative language with references to state statute and federal regulation, approval of specific definitions in state statute, revisions to reflect changes to state and federal law, and other changes to state regulations.

The State's submission has met the public notice requirements for SIP submissions in accordance with 40 CFR 51.102. The submission also satisfied the completeness criteria of 40 CFR part 51, appendix V. The State provided public notice on this SIP revision from February 23, 2022 to March 29, 2022, and held a public hearing on March 30, 2022 and received no comments. In addition, as explained above and in more detail in the TSD which is part of this docket, the revision meets the substantive SIP requirements of the CAA, including CAA section 110 and implementing regulations.

The public comment period on the EPA's proposed rule opened June 3, 2024, the date of its publication in the Federal Register , and closed on July 3, 2024 (89 FR 47504). During this period, EPA received one comment. The comment did not identify a specific issue that was germane to our proposed rule. The comment can be found in the docket for this action.

We are amending the Nebraska SIP and Operating Permit Program by approving the State's request to revise Title 129—Nebraska Air Quality Regulations and certain definitions in Nebraska Revised Statute 81-1502.

In this document, the EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is finalizing the incorporation by reference of the Nebraska rules:

• Chapter 1—General Provisions; Definitions, which provides general provisions and definitions for air quality regulations;

• Chapter 2—Nebraska Air Quality Standards, which lists the ambient air quality standards;

• Chapter 3—Construction Permits, which regulates air construction permitting in Nebraska;

• Chapter 4—Prevention Of Significant Deterioration of Air Quality (PSD) which regulates PSD permitting in Nebraska;

• Chapter 6—Operating Permits which regulates air operating permitting in Nebraska;

• Chapter 7—General Permits which regulates air general permitting in Nebraska;

• Chapter 8—Permits-By-Rule which regulates air permit-by-rule permitting in Nebraska;

• Chapter 9—Permit Revisions; Reopening For Cause which regulates air permit revisions in Nebraska;

• Chapter 10—Permits—Public Participation which regulates public notice requirements for air permitting in Nebraska;

• Chapter 11—Emissions Reporting, When Required which regulates air emissions inventory in Nebraska;

• Chapter 14—Incinerators, Emission Standards which regulates emissions from incinerators in Nebraska;

• Chapter 15—Compliance which regulates compliance with air regulations in Nebraska;

• Chapter 16—Sulfur Compound and Nitrogen Oxides Emissions Standards which regulates emissions of sulfur dioxide and nitrogen oxides in Nebraska;

• Appendix I—Hazardous Air Pollutants Sorted by CAS Number which lists the hazardous air pollutants;

• Appendix II—Air Pollution Emergency Episodes which explains Nebraska's emergency episode procedures; and

• Nebraska Revised Statute 81-1502—Terms, Defined which contains definitions for Nebraska's air quality regulations.

The state effective date of these rules is September 28, 2022. The state effective date of Nebraska Revised Statute 81-1502 is March 21, 2019. The EPA has made, and will continue to make, these materials generally available through https://www.regulations.gov and at the EPA Region 7 Office (please contact the person identified in the FOR FURTHER INFORMATION CONTACT section of this preamble for more information).

Also, in this document, as described in the amendments to 40 CFR part 52 set forth below, EPA is removing provisions of the EPA-Approved Nebraska Regulations and Statutes from the Nebraska State Implementation Plan, which is incorporated by reference in accordance with the requirements of 1 CFR part 51.

Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the CAA and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the 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 14094 (88 FR 21879, April 11, 2023);

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

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

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

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

• Is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997) because it approves a state program;

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

• 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.

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).

Executive Order 12898 (Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations, 59 FR 7629, February 16, 1994) directs Federal agencies to identify and address “disproportionately high and adverse human health or environmental effects” of their actions on minority populations and low-income populations to the greatest extent practicable and permitted by law. EPA defines environmental justice (EJ) as “the fair treatment and meaningful involvement of all people regardless of race, color, national origin, or income with respect to the development, implementation, and enforcement of environmental laws, regulations, and policies.” EPA further defines the term fair treatment to mean that “no group of people should bear a disproportionate burden of environmental harms and risks, including those resulting from the negative environmental consequences of industrial, governmental, and commercial operations or programs and policies.”

The Department of Environment and Energy did not evaluate environmental justice considerations as part of its SIP submittal; the CAA and applicable implementing regulations neither prohibit nor require such an evaluation. EPA did not perform an EJ analysis and did not consider EJ in this action. Consideration of EJ is not required as part of this action, and there is no information in the record inconsistent with the stated goal of E.O. 12898 of achieving environmental justice for people of color, low-income populations, and Indigenous peoples.

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

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by October 15, 2024. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements (see section 307(b)(2)).

For the reasons stated in the preamble, the EPA amends 40 CFR parts 52 and 70 as set forth below:

The NPL, created under section 105 of CERCLA, as amended, is an appendix of the NCP. The NCP establishes the criteria that EPA uses to delete sites from the NPL. In accordance with 40 CFR 300.425(e), sites may be deleted from the NPL where no further response is appropriate. Partial deletion of sites is in accordance with 40 CFR 300.425(e) and are consistent with the Notice of Policy Change: Partial Deletion of Sites Listed on the National Priorities List, 60 FR 55466, (November 1, 1995). The sites to be deleted are listed in table 1, including docket information containing reference documents with the rationale and data principally relied upon by the EPA to determine that the Superfund response is complete. The NCP permits activities to occur at a deleted site, or that media or parcel of a partially deleted site, including operation and maintenance of the remedy, monitoring, and five-year reviews. These activities for the site are entered in table 1 in this SUPPLEMENTARY INFORMATION section, if applicable, under Footnote such that; 1 = site has continued operation and maintenance of the remedy, 2 = site receives continued monitoring, and 3 = site five-year reviews are conducted. As described in 40 CFR 300.425(e)(3) of the NCP, a site or portion of a site deleted from the NPL remains eligible for Fund-financed remedial action if future conditions warrant such actions.

Information concerning the sites to be deleted and partially deleted from the NPL, and the proposed rule for the deletion and partial deletion of the sites, are included in table 2.

In FR Doc. 2024-11538 beginning on page 46024 in the Federal Register of Tuesday, May 28, 2024, the following corrections are made:

In the Federal Register of July 17, 2024, in FR Doc. 2024-15465, on page 58072, in the second column, correct the Dates caption to read:

The following are effective August 16, 2024:

(1) The amendments to 47 CFR 25.108(c)(5) and (c)(6), 25.114(a)(3), and 25.140(b)(6), published at 86 FR 49484 on September 3, 2021;

(2) The amendments to 47 CFR 25.114(d)(7), (15), and (18), 25.115(e), (g) and (k), 25.117(d)(2)(v), 25.140(a)(2) and (a)(3)(iii), (b)(3) through (7), and (d), 25.203 and 25.264, published at 87 FR 72388 on November 25, 2022;

(3) The corrections to 47 CFR 25.140 and 25.264; and

(4) The revisions to FCC Form 312 (including Schedules A, B, and C) and FCC Form 312R (used as required by part 25), published at 89 FR 32427 on April 26, 2024.

The DOLAR is part of the Federal Acquisition Regulations System, which consists of the Federal Acquisition Regulation (FAR), chapter 1 of title 48 of the CFR, and various agency acquisition regulations that implement or supplement the FAR. 48 CFR 1.101. The DOLAR is DOL's acquisition regulation implementing and supplementing the FAR, and addresses matters specific to DOL's procurement of goods and services.

This rulemaking is issued under the authority of the Office of Federal Procurement Policy (OFPP) Act and implementing regulations which authorize the heads of Federal executive agencies to issue agency acquisition regulations that implement or supplement the FAR. 41 U.S.C. 1707 and FAR 1.301(b), 1.303(b).

The DOLAR uses the regulatory structure and arrangement of the FAR, and headings and subject areas are consistent with FAR content. The DOLAR is divided into subchapters, parts (each of which covers a separate aspect of acquisition), subparts, and sections.

The FAR contains many provisions and clauses applicable to DOL procurements which need not be, and are not, repeated in the new DOLAR. If the DOLAR does not include provisions supplementing the FAR under the corresponding part or subpart, it is because the FAR language is considered sufficient. Where the DOLAR does not address a FAR subject, the FAR guidance is to be followed. The DOLAR is not by itself a complete document, as it must be read in conjunction with the FAR.

The DOLAR was last revised effective May 27, 2004, 69 FR 22990 (April 27, 2004). The final rule codifies internal departmental guidance to align with the FAR, removes outdated and duplicative requirements, streamlines sections, and removes information that applies only to DOL's internal operating procedures. With this final rule, DOL adopts a more efficient and straightforward approach to procurement regulations. The final DOLAR supersedes the prior regulation in its entirety.

On September 5, 2023, DOL published a notice of proposed rulemaking (NPRM), including the proposed text of the new DOLAR, in the Federal Register . 88 FR 60612. After reviewing and considering the comments received, DOL made no changes to the text of the rule as published in the NPRM, except to correct some typographical errors. This final rule is in substance the same as the proposed rule. As DOL explained in the NPRM, DOL is revising the DOLAR in its entirety to update and streamline agency procurement regulations consistent with the Federal Acquisition Reform Act and the Federal Acquisition Streamlining Act. The DOLAR final rule removes provisions that are redundant or obsolete and codifies provisions addressing a range of matters, including government property, continuity of operations, system requirements, records management, telework policy for contractor personnel, submission of invoices, mandatory training for contractors, organizational conflicts of interest, and changing the scope of a contract. The final rule also makes updates to existing language for clarity and streamlining purposes. Finally, the final rule removes provisions in the previous DOLAR that are DOL internal operating procedures, which need not be published in the CFR for them to take effect, per 41 U.S.C. 1707 and FAR 1.301(b), 1.303(b). Additionally, as noted in the NPRM, an appendix included in the NPRM (a table listing sections in the prior regulation and the corresponding section in the NPRM) will not appear in the CFR. Accordingly, that appendix has been removed and does not appear in the final rule.

In the NPRM, DOL explained all the revisions being made to the DOLAR from the prior regulation. To reiterate, the final rule removes parts that contain internal DOL policy and operating procedures, as well as parts that duplicate or adopt the FAR by reference; adds parts which codify clauses that are currently prescribed for incorporation in DOL contracts, when appropriate; and renames and renumbers sections to streamline the DOLAR.

Additionally, this final rule removes the following parts of the DOLAR because they relate to internal operating procedures of DOL and need not be published in the Federal Register (per 41 U.S.C. 1707 and FAR 1.301(b) and 1.303(b)): Parts 2906 (Competition Requirements); 2908 (Required Sources of Supplies and Services); 2922 (Application of Labor Laws to Government Acquisitions); 2923 (Environment, Energy and Water Efficiency, Renewable Energy Technologies, Occupational Safety, and Drug-Free Workplace); 2929 (Taxes); 2931 (Contract Cost Principles and Procedures); and 2953 (Forms).

Further, this final rule removes the following parts of the DOLAR because they are duplicative of the FAR, or merely adopt it by reference: Part 2910 (Market Research) is duplicative of FAR 6.302-1(c) and 10.002(b); part 2912 (Acquisition of Commercial Items) is duplicative of FAR 12.302(c); part 2913 (Simplified Acquisition Procedures) is duplicative of FAR 13.106-3(b) and 13.307; part 2914 (Sealed Bidding) is duplicative of FAR 14.404-1(c) and (f), 14.407-3(e) and (i), and 14.408-1; part 2916 (Contract Types) is duplicative of FAR 16.505(b)(5) and 16.603-2(c); part 2917 (Special Contracting Methods) duplicates and adopts by reference FAR 17.203(g)(2), 17.205(a), 17.207(f), and 17.503; part 2930 (Cost Accounting Standards Administration) adopts by reference FAR 30.201-5; part 2936 (Construction and Architect-Engineer Contracts) adopts by reference FAR 36.201, 36.209, 36.516, 36.602-1(b), 36.602-2, 36.602-3(d), 36.602-1, 36.602-5(b), 36.603, 36.604, and 36.702(c); part 2944 (Subcontracting Policies and Procedures) duplicates FAR 44.201-1(b) or 44.201-2 and adopts by reference FAR 44.202-2(a), 44.203, and 44.302(a).

This final rule codifies the following 15 standard contract clauses at part 2952, which are currently used in DOL contracts, when appropriate, but are new additions to the DOLAR: Clause 2952.201-70, Contracting Officer's Representative (COR) Clause; clause 2952.204-70, Records Management Requirements; clause 2952.207-70, Contractor Personnel Telework; clause 2952.209-70, Organizational Conflict of Interest Clause—OCI-1 Exclusion From Future Agency Contracts; clause at 2952.211-70, internet Protocol Version 6 (IPv6); clause 2952.224-70, Privacy Breach Notification Requirements; clause 2952.232-70, Limitation of Government's Obligation (LoGO); clause 2952.232-71 Submission of Invoices; clause 2952.237-70, Emergency Continuation of Essential Services; clause 2952.242-70, Access to Contractor Business Systems; clause 2952.242-71, DOL Mandatory Training Requirements; clause 2952.243-70, Contractor's Obligation to Notify the Contracting Officer of a Request to Change the Contract Scope (Contractor's Obligation Clause); clause 2952.245-70, Contractor Responsibility to Report Theft of Government Property; and clause 2952.245-71, Asset Reporting Requirements. In addition to being codified at section 2952.39-70, the clause covering Section 508 Requirements is being revised to avoid duplication with the FAR 508 provisions and to replace a generic “508” reference with the exact CFR reference. This final rule also adds the following two new parts to the DOLAR for the sole purpose of prescribing certain of the contractual clauses described above: parts 2924 (Protection of Privacy and Freedom of Information) and 2939 (Acquisition of Information Technology).

Finally, nonsubstantive changes have been made to the final regulatory text to correct numbering and for gender neutrality and plain language.

The NPRM invited the public to submit written comments concerning the proposed rule no later than November 6, 2023. No one requested an extension of the comment period.

The Department received four comments in response to the NPRM. The comments received may be viewed by entering docket number DOL-2023-0007 at https://www.regulations.gov. Of the four comments received, three were outside the scope of the rulemaking.

The single relevant comment received was supportive of DOL's approach to updating the DOLAR. The commenter noted that the revised DOLAR could foster increased competition and improve value for money in government procurement. The commenter cited elements outlined by the FAR and, where appropriate, the DOLAR, that are considered, in the commenter's view, best practices in government procurement. The commenter did not suggest any changes to the proposed rule.

The Department appreciates the commenter's positive view and supportive opinion of the proposed rulemaking. DOL does not believe that any change to the proposed rule was required in response to this comment and DOL has made no substantive change to the proposed rule in this final regulation.

This regulation has been drafted and reviewed in accordance with Executive Orders 12866 and 13563. This rule is primarily limited to agency organization, management, and personnel as described by E.O. 12866, section 3(d)(3) and, thus, is not a “regulation” as defined by that Executive order. Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives. DOL has examined the economic, budgetary, and policy implications of its regulatory action, and has determined that the impact on the public is minimal. The regulation mainly relates to internal DOL policies and procedures that do not impact the public, and otherwise addresses certain rules governing private entities doing business with DOL that likewise do not materially impact the public.

The Regulatory Flexibility Act (RFA), at 5 U.S.C. 603(a), requires agencies to prepare and make available for public comment an initial regulatory flexibility analysis, which describes the impact of the rule on small entities. Section 605 of the RFA allows an agency to certify a rule, in lieu of preparing an analysis, if the proposed rulemaking is not expected to have a significant economic impact on a substantial number of small entities. This rule streamlines DOL's procurement regulation by removing obsolete provisions, codifying currently in use clauses, removing provisions that are internal policy or in the FAR, and making edits that do not have a substantive impact on the regulation. Therefore, it will not have a significant economic impact on a substantial number of small entities. As a result, no regulatory flexibility analysis was required here.

The Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)) requires that DOL consider the impact of paperwork and other information collection burdens imposed on the public. DOL has determined that this rule does not alter any information collection burdens.

Section 6 of E.O. 13132 requires Federal agencies to consult with State entities when a regulation or policy may have a substantial direct effect on the States, the relationship between the National Government and the States, or the distribution of power and responsibilities among the various levels of government, within the meaning of the E.O. Section 3(b) of the E.O. further provides that Federal agencies must implement regulations that have a substantial direct effect only if statutory authority permits the regulation and it is of national significance.

This rulemaking revises the DOLAR which is DOL's regulation to implement the FAR and to supplement the FAR when coverage is needed for subject matter not covered in the FAR. Because the DOLAR primarily addresses internal operating procedure, it does not have sufficient federalism implications to warrant the preparation of a Federalism Assessment, as set forth in E.O. 13132.

This regulatory action has been reviewed in accordance with the Unfunded Mandates Reform Act of 1995 (the Reform Act). Under the Reform Act, a Federal agency must determine whether a regulation proposes a Federal mandate that would result in the increased expenditures by State, local, or tribal governments, in the aggregate, or by the private sector, of $100 million or more in any single year. This rule primarily makes administrative changes with respect to federal procurement administration. The requirements of title II of the Act, therefore, do not apply, and DOL did not prepare a statement under the Act.

DOL reviewed the NPRM under the terms of E.O. 13175 and DOL's Tribal Consultation Policy and concluded that the changes to regulatory text would not have tribal implications, as these changes do not have substantial direct effects on one or more Indian tribes, the relationship between the Federal Government and Indian tribes, nor the distribution of power and responsibilities between the Federal Government and Indian tribes. Therefore, no consultations with tribal governments, officials, or other tribal institutions were necessary.

The FAST Act was signed into law on December 4, 2015. Public Law 114-94. Section 24403 of the FAST Act directs the Secretary of Transportation to increase the amount of time manufacturers of motor vehicles, child restraint systems, and tires are required to maintain records that contain information concerning malfunctions that may be related to motor vehicle safety. In the final rule, the Secretary must lengthen the time that manufacturers must maintain these records to not less than 10 years from the date the records were generated or acquired. Public Law 114-94, sec. 24403(a).

In May 2019, NHTSA proposed amending its regulation to increase the retention period to 10 years and is now finalizing that proposal. Based on NHTSA's experience investigating potential defects, overseeing recalls, and our consideration of the comments, we have determined that finalizing the proposed 10-year records retention requirement would help address the agency's investigative needs while minimizing the burden to manufacturers of motor vehicles and equipment. Thus, this final rule extends the record retention requirement for records required to be maintained under 49 CFR 576.6 to 10 years. NHTSA may consider further extending the retention period in the future.

This final rule does not require manufacturers to retain any new information; it merely requires manufacturers to retain information they are already required to retain under 49 CFR part 576 for a longer period of time. This final rule also does not extend the time period that manufacturers of motor vehicles and motor equipment are required to retain records underlying information reported under 49 CFR part 579.

In accordance with the FAST Act, the extended time period applies to records in manufacturers' possession on the effective date of this rule and records generated or acquired in the future. Public Law 114-94, sec. 24403(b).

Part 576 requires manufacturers of motor vehicles, child restraint systems, and tires to retain “all documentary materials, films, tapes, and other information-storing media that contain information concerning malfunctions that may be related to motor vehicle safety.” 49 CFR 576.6; see 49 CFR 576.5(a). These records must be maintained for use in the investigation and disposition of possible defects related to motor vehicle safety or noncompliance with safety standards and associated regulations. 49 CFR 576.2. Manufacturers of motor vehicles, child restraint systems, and tires must currently keep the records required to be maintained by 49 CFR 576.6 for 5 years after they are generated or acquired. 49 CFR 576.5(a). Manufacturers of motor vehicles and all manufacturers of motor vehicle equipment must also keep documents underlying reporting required by 49 CFR part 579 for 5 years after they are generated or acquired. 49 CFR 576.5(b). However, according to 49 CFR 576.5(c), manufacturers of motor vehicles and motor vehicle equipment are not required to keep copies of documents reported to NHTSA as required by 49 CFR parts 573, 577, and 579. No manufacturer is required to keep duplicates according to 49 CFR 576.7.

In the notice of proposed rulemaking (NPRM), published May 15, 2019, 1 NHTSA proposed that manufacturers of motor vehicles, child restraint systems, and tires be required to retain records concerning malfunctions that may be related to motor vehicle safety for 10 years. The NPRM stated that the proposal was based on NHTSA's experience with the increasing age of motor vehicles and motor vehicle equipment and the importance of records from manufacturers, balanced against the agency's desire to avoid unnecessarily burdening manufacturers of motor vehicles and motor vehicle equipment. The NPRM stated that it was NHTSA's belief that a records retention period of 10 years would ensure that manufacturers would preserve records that NHTSA needs to conduct defect investigations without imposing an undue record retention burden on manufacturers.

The NPRM requested comment on manufacturers' current records retention practices; the burden of increasing the records retention period for records required to be maintained by 49 CFR 576.6 to 15, 20, or 25 years; costs that might be associated with storage of electronic records; and the total volume of records retained pursuant to part 576 by a manufacturer.

The NPRM noted that while the average age of the vehicle fleet was 11.6 years in 2016, 2 a 10-year long records retention period is of significant length when compared to records retention periods of similar scope of other operating administrations within the United States Department of Transportation and other federal agencies that regulate motor vehicles and child products. 3 The NPRM recognized that, as the length of time that vehicles remain on the road has increased in recent years, the amount of information generated and retained by vehicle manufacturers has also increased. Thus, extending the records retention requirement increases the total volume of information that must be stored.

The NPRM also noted that manufacturers of child restraint systems and tires would also be bound by a lengthened retention period in part 576 even though the free remedy period for tires is 5 years and the useful life of tires and child restraint systems is often less than 10 years.

The NPRM also discussed the several instances in which NHTSA has declined to extend the records retention period in part 576 to correspond to the free remedy period for recalls in 49 U.S.C. 30120. The NPRM stated that, based on NHTSA's experience investigating potential defects and overseeing recalls, many manufacturers of motor vehicles and equipment already retain some of the records subject to this rule for periods of time longer than the current 5-year minimum.

In response to the NPRM, NHTSA received comments from the U.S. Tire Manufacturers Association (USTMA), the Center for Auto Safety, and the Motor and Equipment Manufacturers Association (MEMA).

USTMA stated that it opposed any recordkeeping requirement applicable to tire manufacturers of a period longer than 10 years. USTMA stated that use cases for tires and the typical life span of tire models demonstrates that there is not sufficient justification to extend the records retention requirement longer than 10 years. USTMA further stated that an estimated 80 percent of tires are removed from service on a vehicle within 6 years of manufacture and more than 60 percent of tires are removed from service in fewer than 4 years after their manufacture. USTMA states that while the age of the U.S. vehicle fleet has increased, tire replacement rates have remained static despite improved tire technology because of increases in the total number of vehicle miles traveled per year in the U.S. USTMA pointed to prior instances in which NHTSA had found it was not cost beneficial to extend the records retention requirements in part 576 as evidence that it may not be cost beneficial in the current instance to extend the records retention requirements beyond 10 years.

The Center for Auto Safety stated that a 10-year period was insufficient to ensure that information relevant to safety defects is preserved for review by NHTSA investigators. The Center for Auto Safety further stated that by limiting the records retention requirements in part 576 to 10 years, NHTSA would be limiting the purview of NHTSA's Office of Defect Investigation (ODI) for vehicles older than 5 years to the post-design stage. The Center for Auto Safety maintained that this requirement would limit ODI's ability to investigate design defects. The Center for Auto Safety maintained that often NHTSA's ability to make a defect determination hinges on evidence of a design or manufacturing defect of which relevant documents may have been produced years before vehicles or equipment is manufactured and sold to the public. Thus, a shorter retention period could limit access to these types of records. The Center for Auto Safety noted that at the time of the NPRM, 44 percent of the 43 active Defect Petitions and Preliminary Evaluations and Engineering Analysis investigations involved vehicles or equipment that began production more than 10 years earlier. The Center for Auto Safety asserted that without knowing motor vehicle and equipment manufacturers' current records retention practices, NHTSA has no basis for asserting that extending the records retention period beyond 10 years will burden manufacturers because manufacturers are likely already retaining the records. The Center for Auto Safety specifically called on NHTSA to extend the record retention period to a minimum of 20 years to ensure the agency can effectively evaluate safety defects in both new and older vehicles and to support the agency's recall and enforcement authorities.

MEMA's comments applauded NHTSA for recognizing the differences in record retention burdens between manufacturers of vehicles and those of manufacturers of tires and child restraints. MEMA supported NHTSA's decision to propose only extending the records retention period in 49 CFR 576.6 as well as the decision not to propose extending retention requirements for manufacturers of motor vehicle equipment other than child restraints and tires. MEMA also supported the comments of USTMA.

The commenters did not provide information on vehicle or equipment manufacturers' current retention practices or the costs of electronic records storage.

After considering all available information, including the comments, NHTSA has decided to adopt the changes to the regulation proposed in the NPRM without modification. In the NPRM the agency stated, that based on its experience investigating potential defects and overseeing recalls, many manufacturers of motor vehicles and equipment currently retain records subject to this rule for periods of time longer than currently required. NHTSA also stated a belief that the cost of electronic storage is low and nothing contained in the comments has led NHTSA to change that view. Thus, this final rule will require manufacturers to maintain records for the minimum 10-year period specified in the FAST Act and NHTSA will consider further extending this requirement in the future.

NHTSA acknowledges, as mentioned by the Center for Auto Safety, that in many cases manufacturers of motor vehicles and equipment are currently retaining records for their own business purposes for a period of time longer than 10 years. In its investigations, ODI has been able to receive relevant records from the motor vehicle or equipment manufacturer, even in many instances in which the records are far older than those required to be retained. In response to the Center for Auto Safety's assertion that the age of the vehicles and equipment that are the subject of open investigations and Defect Petitions demonstrate that a 10-year records retention period is insufficient, NHTSA notes that the manufacturers' general practices of retaining records longer than the required period has enabled the agency to obtain relevant records when necessary.

While the burden of extending the records retention requirement in part 576 longer than 10 years may be minimal, the agency has decided that finalizing a 10-year requirement now is appropriate. That action will ensure that records are retained for that longer retention period immediately upon the effective date of this rule and will not foreclose the agency from further consideration of a longer retention period, which could serve as a backstop to ensure that manufacturers continue to retain older records that the agency often considers in its work. NHTSA must also consider the burden of extending the records retention requirements in 49 CFR 576.6 to manufacturers of tires and child restraints, which may not retain records for as long as motor vehicle manufacturers. Furthermore, ODI needs records older than 10 years old from child restraint system and tire manufacturers less often than from vehicle manufacturers. Thus, in the future, NHTSA may consider different retention periods tailored to its needs.

The Center for Auto Safety further asserted that a records retention period of 10 years will limit ODI's oversight of manufacturing and design defects. As noted above, it is ODI's experience that in most cases records are available past the period for which manufacturers are required to keep them. Furthermore, while design and manufacturing records can be helpful to demonstrating the existence of a defect, NHTSA can prove a defect based on performance alone. See 49 U.S.C. 30120(a)(3) (defining “defect” as including a defect in performance); U.S. v. Gen. Motors, 518 F.2d 420, 438 (D.C. Cir. 1975).

While we are declining at this time to extend the records retention requirement for records covered by 49 CFR 576.6 for a period longer than 10 years, we do note that the average age of the U.S. on-road vehicle fleet has increased since the NPRM. 4 Finalizing the proposed retention period now ensures that manufacturers retain records for the minimum 10-year period, in accordance with the FAST Act mandate. The agency will consider a further extension of the requirement in the future.

NHTSA has considered the impact of this rulemaking action under E.O. 12866, E.O. 13563, E.O. 14094, and DOT's regulatory policies and procedures. This final rule is nonsignificant under E.O. 12866 and E.O. 14094 and was not reviewed by the Office of Management and Budget (OMB). It is also not considered “of special note to the Department” under DOT Order 2100.6A, Rulemaking and Guidance Procedures.

This rule amends 49 CFR part 576 to require motor vehicle, child restraint system, and tire manufacturers to maintain records for a longer period than the currently required 5-year time period. This rule does not require manufacturers to maintain any records they are not already required to maintain, but instead is designed to lengthen the time manufacturers retain certain records. Extending the period of time to 10 years is expected to lead to various unquantifiable benefits such as formalizing manufacturers' records retention practices and ensuring that, in all instances, records that must be retained under section 576.6 are available in the case of a NHTSA investigation for a minimum of 10 years.

Based on NHTSA's experience conducting investigations and overseeing recalls, NHTSA believes that most manufacturers of motor vehicles subject to this rule already retain records for a longer period than currently specified in part 576. It is NHTSA's position that those manufacturers of motor vehicles or equipment who do currently retain records for longer than 10 years would be able to adjust their record retention systems in response to this rulemaking with minimal cost. Because we expect any costs, benefits, or savings associated with this rulemaking to be minimal, we have not prepared a separate economic analysis for this rulemaking.

In compliance with the Regulatory Flexibility Act, 5 U.S.C. 601, et seq., NHTSA has evaluated the effects of this action on small entities. I hereby certify that this final rule would not have a significant impact on a substantial number of small entities. The rule affects manufacturers of motor vehicles, child restraint systems, and tires, a few of which may qualify as small entities. Such manufacturers are expected to have fewer records, because they produce fewer motor vehicles, child restraint systems, and tires than larger manufacturers. Accordingly, the burden imposed on smaller manufacturers to retain these records should be small. Additionally, this rule will merely extend how long manufacturers keep records that they are already required to maintain under current regulations, amounting to a minimal impact on small businesses. Thus, NHTSA believes that the regulation does not impose a significant burden on small manufacturers.

NHTSA has examined today's rule pursuant to E.O. 13132 (64 FR 43255, Aug. 10, 1999) and concluded that no additional consultation with states, local governments, or their representatives is mandated beyond the rulemaking process. The agency has determined 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 would apply to manufacturers of motor vehicles and motor vehicle equipment and would 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. Thus, E.O. 13132 is not implicated and consultation with state and local officials is not required.

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

The Congressional Review Act, 5 U.S.C. 801 et seq., 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. NHTSA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . This rule does not meet the criteria in 5 U.S.C. 804(2) to be considered a major rule.

Under the procedures established by the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501, et seq. ), federal agencies must obtain approval from the OMB for each collection of information they conduct, sponsor, or require through regulations. A person is not required to respond to a collection of information by a federal agency unless the collection displays a valid OMB clearance number. In compliance with these requirements, NHTSA is submitting an information collection requestion (ICR) to OMB for modifications to a currently approved information collection titled “Record Retention—49 CFR part 576” (OMB Control No. 2127-0042, Current Expiration Date: 4/30/2026).

The final rule amends 49 CFR part 576 to extend the time manufacturers must retain certain information, which is considered to be an information collection requirement, as that term is defined by the OMB in 5 CFR part 1320. NHTSA sought comment on this change in the NPRM published on May 15, 2019. 5 NHTSA's responses to the comments are discussed in section III above. As discussed, NHTSA is adopting the proposal without modification.

In accordance with the requirements of the PRA, NHTSA is resubmitting the ICR for this final rule. While NHTSA has not made any substantial modifications to the ICR since publishing the NPRM, NHTSA has revised the estimates for the total burden of this collection due to changes in the number of respondents since the NPRM was issued. NHTSA estimates the total burden of this information collection to be 40,225 hours and $0, which is the same burden estimate provided for the currently approved information collection. NHTSA does not believe the modification will increase burden to manufacturers. However, this estimate is higher than what we estimated in the May 15, 2019 NPRM, in which we as estimated that the burden would be 40,020 hours and $0. The adjustment is a result of an increase in the estimated number of the manufacturers required to maintain the records (an increase of five manufacturers each incurring an estimated 40 burden hours each year and an additional five manufacturers incurring an estimated 1 burden hour each year). NHTSA continues to estimate that there are no additional costs associated with this information collection.

In compliance with the requirement at 5 CFR 1320.9(g), NHTSA is providing the following information to potential respondents to the information collections for part 576—Record Retention:

Under the National Technology Transfer and Advancement Act of 1995 (Pub. L. 104-113), “all Federal agencies and departments shall use technical standards that are developed or adopted by voluntary consensus standards bodies, using such technical standards as a means to carry out policy objectives or activities determined by the agencies and departments.” The amendment in today's final rule extends the time manufacturers retain records, and does not involve any voluntary consensus standards as it relates to NHTSA or this rulemaking.

With respect to the review of the promulgation of a new regulation, section 3(b) of E.O. 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 including all provisions repealed, circumscribed, displaced, impaired, or modified; (3) provides a clear legal standard for affected conduct rather than a general standard, 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 may 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 has considered these issues and determined that this rule does not have any retroactive or preemptive effect. The rule only applies to documents in manufacturers' possession at the time the rule goes into effect and documents generated or acquired by manufacturers in the future. NHTSA notes further that there is no requirement associated with this rule that individuals submit a petition for reconsideration or pursue other administrative proceeding before they may file suit in court.

The Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4) requires 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). This rule would not result in expenditures by state, local, or tribal governments, in the aggregate, or by the private sector in excess of $100 million annually (adjusted for inflation with base year of 1995).

E.O. 13211 (66 FR 28355, May 18, 2001) applies to any rulemaking that: (1) is determined to be economically significant as defined under E.O. 12866, and is likely to have a significantly adverse effect on the supply of, distribution of, or use of energy; or (2) that is designated by the Administrator of the Office of Information and Regulatory Affairs as a significant energy action. This rulemaking is not subject to E.O. 13211.

The DOT 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.

For the reasons discussed in the preamble, NHTSA amends 49 CFR part 576 as follows:

This final rule implements amendment 113 to the GOA FMP. A notice of availability (NOA) for amendment 113 was published by NMFS in the Federal Register on April 4, 2024 (89 FR 23535), with public comments invited through June 3, 2024. NMFS published a proposed rule to implement amendment 113 in the Federal Register on May 10, 2024 (89 FR 40449), with public comments invited through June 10, 2024. The Secretary of Commerce approved amendment 113 on June 27, 2024 after considering information from the public and determining that amendment 113 is consistent with the GOA FMP, the Magnuson-Stevens Act, and other applicable laws.

NMFS received 3 relevant written comments in response to requests for public comment, that were either directed to the NOA for the FMP amendments, the proposed rule, or both, in association with Secretarial approval of the amendment or the proposed rule. A summary of the comments and NMFS' responses are provided under the heading Comments and Responses section below.

The RP was developed to enhance resource conservation and improve economic efficiency in the CGOA rockfish fisheries. A detailed description of the RP and its development is provided in the preambles to the proposed and final rules implementing the RP (76 FR 52147, August 19, 2011; 76 FR 81248, December 27, 2011).

The RP, which includes the CGOA rockfish species of Pacific ocean perch, northern rockfish, and pelagic shelf rockfish, is based on the recognition of historical participation of fishing vessels and processors in the CGOA rockfish fisheries from 1996 to 2002. The rockfish primary species are northern rockfish, Pacific ocean perch, and dusky rockfish. The rockfish secondary species are Pacific cod, rougheye rockfish, shortraker rockfish, and sablefish. The RP provides catch limits for non-rockfish species and non-target rockfish species harvested with the CGOA rockfish species, based upon historical harvest levels of these incidentally caught species, and sets aside up to 5 percent of the TAC of the CGOA rockfish fisheries for CVs that are not eligible to participate in the program. The RP apportions TAC to cooperatives formed by individuals holding a License Limitation Program (LLP) license with rockfish quota share (QS). Fishing under cooperative management resulted in a slower-paced fishery that allowed harvesters to choose when to fish and provided greater stability for processors by spreading out production over a longer period of time.

Amendment 113 and this final rule address changes in, and potentially resolve associated commercial fish market impacts to, the RP fishery since the RP was reauthorized in 2021. A detailed description of this action and its development is provided in the preamble to the proposed rule and in the Analysis.

This final rule changes the regulations to improve the likelihood that the TACs for the rockfish species are fully harvested and landed in Kodiak. This final rule provides additional flexibility for trawl vessels to participate in the RP during April each year, and keep rockfish processors fully operational, thus mitigating impacts from changes in market conditions. This final rule also implements changes to three of the RP use caps to remove constraints on the amount of CQ that can be caught or processed by participants, while still maintaining RP's original intent to limit consolidation while allowing this fishery to be prosecuted in a sustainable and functional manner. The term “use cap” or “cap” is the limit on the quota that can be caught or processed by participants in the RP.

This final rule changes the start date for this fishery from May 1 to April 1, specified at 50 CFR 679.80(a)(3)(ii) for a rockfish cooperative, to enhance flexibility for processing plants and vessel operators participating in the RP. This change in season start date helps maintain processing capacity for other non-trawl fisheries through workforce stability.