Under the Federal Meat Inspection Act (FMIA) and the Poultry Products Inspection Act (PPIA), FSIS has the authority to designate states that do not maintain MPI programs “at least equal to” FSIS' Federal inspection programs (21 U.S.C. 645, 661(c), 454(c), 460(e)) and to recognize those that do (21 U.S.C. 661(a), 454(a)). FSIS has historically codified its list of states without MPI programs in 9 CFR 331.2, 331.6, 381.221, and 381.224.

FSIS is removing these lists from its regulations and will instead maintain up-to-date lists on the FSIS website at www.fsis.usda.gov. FSIS is also removing or revising related cross references to the lists of designated states without MPI programs. These changes will improve transparency, accuracy, and ease of access for stakeholders.

This rule is solely an administrative change to the format and location of the lists of designated states without MPI programs. This action will not change FSIS' criteria for approving state MPI programs. FSIS will continue to review state MPI programs to verify that they are “at least equal to” FSIS' Federal inspection. Because FSIS is not required to do so, it will not publish a notice in the Federal Register if it terminates a designation and approves a new state MPI program. Additionally, this action will not change FSIS' process for terminating state MPI programs. FSIS will publish a notice in the Federal Register if it designates or redesignates a state under 21 U.S.C. 661(c) or 454(c).

This rule is not subject to the Administrative Procedure Act (APA) requirement to publish a notice of proposed rulemaking and provide the public with the opportunity to comment before issuing a final rule because this action falls under the exceptions outlined in 5 U.S.C. 553 (A) and (B). Specifically, the APA exempts rules related to agency procedure or practice, or when the agency for good cause finds that notice and comment is impracticable, unnecessary, or contrary to the public interest. Since the removal of FSIS' lists of States without MPI programs and the decision to maintain them on the FSIS website is an administrative update that does not alter the substantive rights or duties of stakeholders, it qualifies for these exemptions. This rule will streamline information dissemination and improve accessibility without impacting FSIS' regulatory framework or regulated entities' responsibilities.

Executive Order (E.O.) 12866 provides that the Office of Information and Regulatory Affairs (OIRA) in the Office of Management and Budget will determine whether a regulatory action is significant as defined by E.O. 12866 and will review significant regulatory actions. OIRA has determined that this final rule is not significant as defined by E.O. 12866. E.O. 13563 reaffirms the principles of E.O. 12866 while calling for improvements in the Nation's regulatory system to promote predictability, to reduce uncertainty, and to use the best, most innovative, and least burdensome tools for achieving regulatory ends. E.O. 14215 amends E.O. 12866 to ensure Presidential supervision and control of the entire executive branch and to require that all executive departments and agencies submit for review all proposed and final significant regulatory actions to OIRA before publication in the Federal Register . The Department has developed the final rule consistent with E.O. 13563 and E.O. 14215.

This final rule is considered an E.O. 14192 deregulatory action.

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. ), OIRA has designated this final rule as not a major rule as defined by 5 U.S.C. 804(2).

Under the Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612) (as amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA) of 1996; 5 U.S.C. 601 et seq. ), agencies must prepare and make available for public comment a regulatory flexibility analysis that describes the effect of the rule on small entities ( i.e., small businesses, small organizations, and small government jurisdictions). No regulatory flexibility analysis is required, however, if the head of an agency or an appropriate designee certifies that the rule will not have a significant economic impact on a substantial number of small entities. Because this rule is an administrative change, FSIS has concluded and hereby certifies that this rule will not have a significant economic impact on a substantial number of small entities; therefore, an analysis is not included.

Executive Order 13175 requires Federal agencies to consult and coordinate with Tribes on a government-to-government basis on policies that have Tribal implications, including regulations, legislative comments or proposed legislation, and other policy statements or actions that have substantial direct effects on one or more Indian Tribes, on the relationship between the Federal Government and Indian Tribes, or on the distribution of power and responsibilities between the Federal Government and Indian Tribes. FSIS has assessed the impact of this rule on Indian tribes and determined that this rule would not have tribal implications that require consultation under Executive Order 13175.

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520), FSIS has reviewed the final rule. The Administrator has determined that this rulemaking would not impact information collection, paperwork, or recordkeeping activities.

The Department is committed to complying with the E-Government Act, 2002 to promote the use of the internet and other information technologies to provide increased opportunities for citizen access to Government information and services, and for other purposes.

The final rule is an administrative change that will have no effect on States and local governments, so FSIS anticipates that this rule will not have implications for federalism. FSIS will maintain lists of states with and without MPI programs on its website to ensure accurate and timely access to information about State and Federal inspection programs. Therefore, under Section 6(b) of the E.O., a federalism summary is not required.

This final rule will not have a reasonably foreseeable significant effect on the quality of the human environment. The rule is an administrative change that merely updates how FSIS communicates information about state and Federal inspection programs to the public. Accordingly, this action is appropriately subject to the categorical exclusion from the preparation of an Environmental Assessment or an Environmental Impact Statement as authorized under 7 CFR 1b.3(a)(1) of the USDA regulations.

For the reasons discussed in the preamble, FSIS is amending 9 CFR Chapter III as follows:

Upon request, FDA has classified the muscular dystrophy newborn screening 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 reducing regulatory burdens by placing the device into a lower device class than the automatic class III assignment.

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

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

FDA may also classify a device through “De Novo” classification, a common name for the process authorized under section 513(f)(2) of the FD&C Act (see also part 860, subpart D (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.

We believe this De Novo classification will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens. 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 November 4, 2019, FDA received PerkinElmer Inc.'s request for De Novo classification of the GSP Neonatal Creatine Kinase—MM kit. 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 513(a)(1)(B) of the FD&C Act). 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 December 12, 2019, FDA issued an order to the requester classifying the device into class II. In this final order, FDA is codifying the classification of the device by adding 21 CFR 862.1506. 1 We have named the generic type of device muscular dystrophy newborn screening test, and it is identified as an in vitro diagnostic device that is intended to measure creatine kinase levels obtained from dried blood spot specimens on filter paper from newborns as an aid in screening newborns for muscular dystrophy.

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 final 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 862 is amended as follows:

Upon request, FDA has classified the lysosomal storage disorder newborn screening test system 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 reducing regulatory burdens 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 part 860, subpart D (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.

We believe this De Novo classification will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens. 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 August 7, 2015, FDA received Baebies, Inc.'s request for De Novo classification of the SEEKER System. FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act.

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

Therefore, on February 3, 2017, FDA issued an order to the requestor classifying the device into class II. In this final order, FDA is codifying the classification of the device by adding 21 CFR 862.1488. 1 We have named the generic type of device lysosomal storage disorder newborn screening test system, and it is identified as a device intended to measure lysosomal enzyme levels obtained from dried blood spot specimens on filter paper from newborns as an aid in screening newborns for a lysosomal storage disorder.

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 final 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. 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 862 is amended as follows:

Upon request, FDA has classified the fluorescence in situ hybridization-based detection of chromosomal abnormalities from patients with hematologic malignancies 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 reducing regulatory burdens 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 to a predicate device that does not require premarket approval (21 U.S.C. 360c(i)). 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 part 860, subpart D (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.

We believe this De Novo classification will enhance patients’ access to beneficial innovation, in part by reducing regulatory burdens. 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 29, 2017, FDA received Cytocell, Ltd.'s request for De Novo classification of the following devices: MLL (KMT2A) Breakapart FISH Probe Kit; P53 (TP53) Deletion FISH Probe Kit; Del(20q) Deletion FISH Probe Kit; CBFβ (CBFB)/MYH11 Translocation, Dual Fusion FISH Probe Kit; Del(5q) Deletion FISH Probe Kit; Del(7q) Deletion FISH Probe Kit; AML1/ETO (RUNX1/RUNX1T1) Translocation, Dual Fusion FISH Probe Kit; and EVI1 (MECOM) Breakapart FISH Probe Kit. 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 513(a)(1)(B) of the FD&C Act). 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 December 21, 2018, 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 864.1880. 1 We have named the generic type of device “fluorescence in situ hybridization-based detection of chromosomal abnormalities from patients with hematologic malignancies,” and it is used to detect chromosomal abnormalities in human specimens from patients with hematologic malignancies. The test is indicated for the clinical management of patients consistent with internationally accepted guidelines ( e.g., World Health Organization guidelines for Classification of Tumours of Haematopoietic and Lymphoid Tissues) and in conjunction with other clinical and clinicopathological criteria. The results are to be interpreted by a pathologist or equivalent professional.

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 final 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 the 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 864 is amended as follows:

Upon request, FDA has classified the herpes simplex virus (HSV) nucleic acid-based assay for central nervous system (CNS) infections 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 reducing regulatory burdens 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 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 part 860, subpart D (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.

We believe this De Novo classification will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens. 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 December 4, 2013, FDA received Focus Diagnostics, Inc.'s request for De Novo classification of the Simplexa TM HSV 1 & 2 Direct. 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 general controls, will provide reasonable assurance of the safety and effectiveness of the device.

Therefore, on March 21, 2014, FDA issued an order to the requestor classifying the device into class II. In this final order, FDA is codifying the classification of the device by adding 21 CFR 866.3307. 1 We have named the generic type of device herpes simplex virus nucleic acid-based assay for central nervous system infections, and it is identified as a qualitative in vitro diagnostic device intended for the detection and differentiation of HSV-1 and HSV-2 in cerebrospinal fluid (CSF) samples from patients suspected of HSV infections of the CNS. This test is intended as an aid in the diagnosis of HSV-1 and HSV-2 infections of the CNS. Negative results do not preclude HSV-1 or HSV-2 infection and should not be used as the sole basis for treatment or other patient management decisions.

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 final 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 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 cream for x-ray attenuation 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 reducing regulatory burdens 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 part 860, subpart D (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.

We believe this De Novo classification will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens. 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 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 February 4, 2013, FDA received BloXR Corporation's request for De Novo classification of the X-ray Attenuating Cream. 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 general controls, will provide reasonable assurance of the safety and effectiveness of the device.

Therefore, on May 9, 2013, FDA issued an order to the requestor classifying the device into class II. In this final order, FDA is codifying the classification of the device by adding 21 CFR 892.6510. 1 We have named the generic type of device cream for x-ray attenuation, and it is a sterile cream intended for use as a radiation shield. It is intended to be applied to the user's hand before donning gloves, or it may be applied on a glove on the hand, followed by donning a second glove. Cream for x-ray attenuation is intended to be used during medical procedures in which hands are necessarily exposed to radiation to offer some degree of protection from radiation exposure in the diagnostic imaging range of up to 130 kVp. This may include surgical procedures that require the use of fluoroscopy or radiography or other procedures. Cream for x-ray attenuation is not intended to be used in or adjacent to the primary x-ray beam or the transmitted beam and should not be used in lieu of a Radiographic Procedure Glove, which is used in radiography for those studies requiring the physician's hand or forearm be in the direct path of the primary x-ray beam.

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 the 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 final 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. 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 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 892 is amended as follows:

The Coast Guard will enforce the special local regulation in 33 CFR 100.902 for the Annual Bayview Mackinac Race from 10 a.m. through 3 p.m. on July 12, 2025. This action is being taken to provide for the safe control vessel movements in the vicinity of the race and provide for the safety of the general boating public and commercial shipping. Our regulation for marine events within the Captain of the Port Detroit zone in § 100.902(a) specifies the location of the regulated area for the Annual Bayview Mackinac Race. During the enforcement period, no vessel may enter the regulated area without prior approval from the Coast Guard's designated Patrol Commander (PATCOM). The PATCOM may restrict vessel operation within the regulated area to vessels having particular operating characteristics. Vessels desiring to transit the regulated area may do so only with prior approval of the PATCOM and when so directed by that officer. The PATCOM may be contacted on Channel 16 (156.8 MHZ) by the call sign “Coast Guard Patrol Commander.” Vessels permitted to transit the regulated area will operate at no wake speed and in a manner which will not endanger participants in the event or any other craft.

If the District Commander, Captain of the Port, or PATCOM determines that the regulated area need not be enforced for the full duration stated in this notice, he or she may use a Broadcast Notice to Mariners to grant general permission to enter the regulated area.

The Milwaukee Air and Water Show is a long-standing event that has occurred for 14 years. During that time, there have been numerous requests to establish a safety zone for four days in duration, rather than the three days currently enforced. The Captain of the Port (COTP) Sector Lake Michigan determined that, due to the repetitive requests, it was pertinent to revise the current safety zone in 33 CFR 165.929, table 4 to § 165.929, line No. 29 for the Milwaukee Air and Water Show to add a fourth day for the event.

In response, on April, 8, 2025, the Coast Guard published a notice of proposed rulemaking (NPRM) titled Safety Zone; Milwaukee Air and Water Show, Milwaukee, WI. 1 There we stated why we issued the NPRM and invited comments on our proposed regulatory action related to this fireworks display. During the comment period that ended May 8, 2025, we received 4 comments, all in support of the additional day for enhanced safety.

The Coast Guard is issuing this rule under the authority in 46 U.S.C. 70034. The COTP Sector Lake Michigan determined that potential hazards were associated with the previously established safety zone in 33 CFR 165.929, table 4 to § 165.929, line No. 29 for the Milwaukee Air and Water Show that could be addressed through an additional day. The purpose of this rulemaking is to ensure the safety of vessels and the navigable waters within an area approximately 5,000-yards by 1,500-yards before, during, and after the scheduled event, which required expanding the enforcement period to include four days.

As noted above, we received 4 comments on our NPRM published April 8, 2025. All comments were in support of the proposed amendment. There are no changes in the regulatory text of this rule from the proposed rule in the NPRM.

This rule amended an established safety zone in 33 CFR 165.929, table 4 to § 165.929, line No. 29 for the Milwaukee Air and Water Show by adding a fourth day to the event. The Milwaukee Air and Water Show event is a recurring event held on the third weekend in July from 8:00 a.m. to 5 p.m. The safety zone covers all navigable waters of Lake Michigan in the vicinity of McKinley Park and Bradford Beach located within an area that is approximately 5,000 yards by 1,500 yards. The expanded duration of the zone ensures the safety of vessels and these navigable waters before, during, and after the scheduled Milwaukee Air and Water Show. No vessel or person is be permitted to enter the safety zone without obtaining permission from the COTP or a designated representative.

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

Executive Orders 12866 (Regulatory Planning and Review) and 13563 (Improving Regulation and Regulatory Review) direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. Executive Order 14192 (Unleashing Prosperity Through Deregulation) directs agencies to significantly reduce the private expenditures required to comply with Federal regulations and provides that “any new incremental costs associated with new regulations shall, to the extent permitted by law, be offset by the elimination of existing costs associated with at least 10 prior regulations.”

The Office of Management and Budget (OMB) has not designated this rule a “significant regulatory action,” under section 3(f) of Executive Order 12866. Accordingly, OMB has not reviewed it.

This rule is not an Executive Order 14192 regulatory action because this rule is not significant under Executive Order 12866. See OMB Memorandum M-25-20, “Guidance Implementing Section 3 of Executive Order 14192, titled ‘Unleashing Prosperity Through Deregulation’ ” (Mar. 26, 2025).

This regulatory action determination is based on the size, location, duration and time of day of the regulated area. This regulatory action determination is based on the previous rulemaking and the additional day not substantially altering the previous regulation. Additionally, prior events have included temporary final rules to encompass the four-day timeframe.

The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard received no comments from the Small Business Administration on this rulemaking. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.

This regulatory action determination is based on the size, location, and duration of the safety zone. The regulation will be in effect only during the event listed in this regulation for which the COTP has determined pose risks to the safety of life and property for the maritime public and event participants. The size, location, and duration of the regulation will be limited to the extent necessary to minimize these risks. Moreover, the COTP will make advance notice of the enforcement of the regulation through the Local Notice to Mariners and/or Broadcast Notice to Mariners. This regulation also provides a means for anyone needing to transit through or within the safety zone to seek permission from the COTP.

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

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

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

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

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

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

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

Purpose of Program: The Innovative Rehabilitation Training program is designed to develop: (a) new types of training programs for rehabilitation personnel and to demonstrate the effectiveness of these new types of training programs for rehabilitation personnel in providing rehabilitation services to individuals with disabilities; (b) new and improved methods of training rehabilitation personnel so that there may be a more effective delivery of rehabilitation services to individuals with disabilities by designated State rehabilitation agencies and designated State rehabilitation units or other public or non-profit rehabilitation service agencies or organizations; and (c) new innovative training programs for VR professionals and paraprofessionals to have a 21st-century understanding of the evolving labor force and the needs of individuals with disabilities so they can more effectively provide VR services to individuals with disabilities.

Assistance Listing Number: 84.263G

Program Authority: 29 U.S.C. 709(c) and 772.

Applicable Program Regulations: 34 CFR parts 385 and 387.

We published a notice of proposed priority and requirements (NPP) for this program in the Federal Register on December 18, 2024 (89 FR 102841). That notice contained background information and the Department's reasons for proposing the priority and requirements.

Public Comment: In response to our invitation in the NPP, 18 parties submitted comments on the proposed priority and requirements.

Generally, we do not address technical and other minor changes or suggested changes the law does not authorize us to make under the applicable statutory authority. In addition, we do not address general comments that raised concerns not directly related to the proposed priority or requirements.

Analysis of Comments and Changes: An analysis of the comments and of any changes in the priority and requirements since publication of the NPP follows.

Comment: Several commenters suggested that Topic Area 2 (Career Assessment Addressing Emerging Career and Employment Trends) should focus on improving the quality and availability of career assessment and vocational evaluation services through the development of formal, graduate-level training programs. A few commenters specifically noted that the discontinuation of formal, graduate-level training programs in recent years appears to have contributed to a shortage of qualified evaluators and VR professionals trained in using career assessment data. A few commenters also specified that, given these shortages, there are long waitlists for critical career assessment and vocational evaluation services. A few commenters specifically noted considerations for the ways that artificial intelligence (AI) can be part of career assessment.

Discussion: The Department acknowledges the value of career assessment and VR professionals with career assessment expertise. It is also clear that career assessment and VR professionals should be exposed to additional learning options (coursework, practicums, internships, etc.). As a general matter, the Department notes that Topic Area 2 already affords potential applicants flexibility in their proposed approaches, which may include AI.

Changes: Topic Area 2 has been revised to clarify that proposed projects under this topic area must focus on strengthening the capacity of career assessment and vocational evaluation professionals to serve VR participants under this priority. The topic area has also been revised to clarify that an applicant may propose various approaches to strengthen the capacity of career assessment and vocational evaluation professionals. Application Requirement C has also been revised to remove the specific reference to VR counselors in the training plan given that other VR professionals may also be part of such plan.

Comment: One commenter provided support for the importance of Topic Area 2 but noted that the other topic areas in the NPP were overly prescriptive, noting a general burden on data collection and entry requirements and caseload sizes.

Discussion: The Department contends that the commenter's concerns about prescriptiveness do not seem to pertain to other topic areas under this proposed priority and are rather general issues in the field of vocational rehabilitation. However, as a general matter, the Department notes that the priority already affords potential applicants flexibility in their proposed approaches, activities, and objectives in response to the topic area(s) within the priority.

Changes: None.

Comment: One commenter recommended adding language to Topic Area 2 requiring career development professionals working under this priority to hold one or more specified professional certifications and to maintain records showing that they have received 30 hours of continuing education every three years.

Discussion: We do not believe that the recommendation to require or verify specific standards or credentials is within the scope of purpose of the Innovative Rehabilitation Training Program, as defined in the program regulations at 34 CFR part 387. Moreover, we believe that this level of specificity is not necessary and that individual projects are best positioned to define these expectations for their participants.

Changes: None.

Comment: None.

Discussion: In proposed Topic Area 2 (Career Assessment Addressing Emerging Career and Employment Trends), among the list of potential activities that the Department proposed that applicants could address, the Department included “tracking emerging 21st century career trends in [. . .] green industries such as sustainable manufacturing and renewable energy[.]” Upon further review, we do not think it is necessary to prescribe that level of specificity, and that such activities would be subsumed under the broader heading of STEM and advanced technologies. The Department recognizes that applicants might choose to address emerging 21st century career trends in a number of ways that align to local context.

Changes: The reference to “green industries such as sustainable manufacturing and renewable energy” from Topic Area 2 has been removed.

Comment: One commenter recommended adding language in proposed Topic Area 5 (Engagement and Service Delivery Strategies for Underserved Populations) requiring the inclusion of cultural competence training components addressing the unique needs of various groups.

Discussion: Grantees are required to comply with the Federal civil rights laws, which prohibit discrimination on the basis of race, color, or national origin. Therefore, programs funded under this priority will provide the necessary training to all rehabilitation personnel, so that these personnel may effectively deliver rehabilitation services to individuals with disabilities.

Changes: Consistent with the Administration's priority that all recipients of services supported by Federal funding be treated equally, we have removed proposed Topic Area 5. We have also removed a reference to Topic Area 5 from requirement (a).

Comment: A few commenters recommended that the Department add a new topic area on services to transition-age youth and students with disabilities, including family engagement. The commenters indicated that this topic should be addressed distinctly from Topic Area 6 (Field Initiated), given the prioritized attention on collaboration among rehabilitation community providers, centers for independent living, rehabilitation counselors, and other transition professionals required by the new topic area.

Discussion: The Department concurs with the importance of transition services for youth and students with disabilities. An applicant may choose to address transition services through final Topic Area 5 (Field Initiated).

Changes: None.

Comment: One commenter recommended that the priority promote the study and implementation of “qualified service provider” definitions across State VR services.

Discussion: The focus of the Innovative Training Program is on innovative and improved methods of training to provide quality VR and supported employment services that lead to quality employment outcomes for individuals with disabilities. The Department believes that the study of qualified service provider definitions falls outside of the intended scope of the program (as defined in 34 CFR 387.1). We also believe that the program will have the most impact through a priority focused on specific training methods and strategies. As such, we decline to include this change in the priority.

Changes: None.

Innovative Rehabilitation Training on Emerging VR Counseling, Engagement, and Service Delivery Strategies Leading to Quality Employment in 21st Century Careers for Individuals With Disabilities.

Projects that propose a new innovative rehabilitation training program for rehabilitation personnel on emerging VR counseling, engagement, and service delivery best practices or strategies in any of five topic areas that provides a 21st century understanding of the evolving labor force and the needs of individuals with disabilities, resulting in more effective delivery of rehabilitation services to individuals with disabilities. The five topic areas under this priority are:

(1) VR Counselor Participant Engagement Practices, (2) Career Assessment Addressing Emerging Career and Employment Trends, (3) Preparing VR Participants for High-Quality Employment in Science, Technology, Engineering, and Math (STEM) and Advanced Technology Careers, including Artificial Intelligence (AI), (4) Dual Customer Employer Engagement and Service Delivery Strategies, and (5) Field Initiated.

(1) VR Counselor Participant Engagement Practices. Proposed projects under this topic area must focus on improving VR counselors' knowledge and skills to effectively engage with VR participants through the VR continuum from referral and application to the provision of VR services under a signed IPE, and through the achievement of an employment outcome. This may include, for example, VR counseling relationship-building skills training; early and ongoing engagement strategies, including pre-employment transition services; benefits counseling, financial planning, and VR participant self-advocacy skills training; and the development of internal and external partnerships with cross-disciplinary VR agency specialists, employers, workforce development partners, Client Assistance Programs, and community-based organizations, including community rehabilitation programs (CRPs) and Centers for Independent Living (CILs).

(2) Career Assessment Addressing Emerging Career and Employment Trends. Proposed projects under this topic area must focus on strengthening the capacity of career assessment and vocational rehabilitation professionals to identify and support VR participants' informed choice and optimal career and employment goals, postsecondary education and training, credentialing and measurable skills attainment pathways, and comprehensive support needs including assistive technology, consistent with participants' unique strengths, abilities, capabilities, and interests. This may include, for example, providing vocational evaluation and comprehensive assessments; facilitating AI-enabled individual supports and accommodations; conducting local and national labor market analyses; tracking emerging 21st century career trends in STEM and advanced technologies; exploring work options such as business ownership, self-employment, and telework; and identifying the most appropriate training and employment options including apprenticeships, customized employment, and career pathways. Projects under this priority may propose various approaches to strengthening the capacity of professionals through career assessment and vocational evaluation programs, courses, modules, practicums, and internships.

(3) Preparing VR Participants for High-quality Employment in STEM and Advanced Technology Careers, including AI. Proposed projects under this topic area must focus on maximizing the number of VR participants provided the opportunity to explore, consider, and pursue high quality careers in STEM and advanced technology careers, including AI, and other emerging high-quality fields. This may include, for example, early and meaningful exposure to such careers through quality pre-employment transition services; peer mentorship by persons with disabilities in such careers; identification of VR participants whose unique strengths, abilities, interests, and informed choice align with such careers; and partnerships with State and local educational agencies, Institutions of Higher Education (IHE), career and technical education programs, disability organizations, CRPs, and others to provide the appropriate training, education, and support services.

(4) Dual Customer Employer Engagement and Service Delivery Strategies. Proposed projects under this topic area must focus on helping VR agency personnel to engage effectively with employers through the provision of the services and training outlined in 34 CFR 361.32, meeting employers' needs for skilled workers while creating quality employment and training opportunities for VR participants. This may include, for example, strategies for identifying promising dual customer employer engagement opportunities; providing training and technical assistance to employers regarding the employment of individuals with disabilities, including disability awareness, and the requirements of the Americans with Disabilities Act and other employment-related laws; supporting VR agency capacity-building to provide quality dual customer services and training to employers; conducting outreach to employers, community-based organizations, and business associations highlighting VR agency capabilities and documented successes; and delivering dual customer services and training through the coordinated efforts of cross-disciplinary VR personnel, employers, and workforce development system partners.

(5) Field Initiated. Proposed projects under this topic area must address an area not specified in this priority, consistent with the stated purpose of the priority, or a combination of two or more topic areas specified in this priority.

Note: The numbering of the topic areas does not reflect an established hierarchy or preference among the topic areas.

When inviting applications for a competition using one or more priorities, we designate the type of each priority as absolute, competitive preference, or invitational through a notice in the Federal Register . The effect of each type of priority follows:

Absolute priority: Under an absolute priority, we consider only applications that meet the priority (34 CFR 75.105(c)(3)).

Competitive preference priority: Under a competitive preference priority, we give competitive preference to an application by (1) awarding additional points, depending on the extent to which the application meets the priority (34 CFR 75.105(c)(2)(i)); or (2) selecting an application that meets the priority over an application of comparable merit that does not meet the priority (34 CFR 75.105(c)(2)(ii)).

Invitational priority: Under an invitational priority, we are particularly interested in applications that meet the priority. However, we do not give an application that meets the priority a preference over other applications (34 CFR 75.105(c)(1)).

(a) Establish the empirical basis of the proposed project objectives and activities. The applicant must identify the particular focus area it intends to address within the selected topic area; the key knowledge and practice determinants of VR service effectiveness and employment outcome quality; and the empirical sources and rationale for the identified knowledge and practices, including available research, literature reviews, and relevant projects conducted by RSA or other Federal or non-government entities.

(b) Establish a process, including clear and actionable steps as well as specific timelines, to continue assessing innovative practices and training methods for possible incorporation, especially during the initial year of the grant, including stakeholder surveys to identify promising practices that the State VR agencies may already be implementing.

(c) Design an innovative, multifaceted training plan to convey the identified knowledge and practices. The training plan must specify the intended participants; proposed curricula, activities, and products, including training modules, communities of practice, research studies, published articles, or videos; instructional and communication technologies, including AI-based methods and tools, if applicable; and knowledge translation methods adapted to diverse learning styles or ethnic and linguistic backgrounds. The training plan must address a broad range of VR professionals—decision-makers, counselors, cross-disciplinary specialists—and pertinent partners and stakeholders, as appropriate.

(d) Establish an advisory panel of one or more VR agencies and other pertinent stakeholders to help develop, implement, and evaluate the project. The applicant must describe the panel membership, structure, and responsibilities. Panel member responsibilities may include identifying key knowledge requirements, best practices, and innovative approaches for the training curricula and methods; coordinating with other interested parties to disseminate curricula, recruit training participants, engaging additional VR agencies and stakeholders; and participating in the project's continuous feedback, evaluation, and improvement processes.

(e) Prioritize key stakeholder engagement, partnerships, and information-sharing in the innovative training activities, including with IHEs, and relevant professional associations. The applicant must identify the stakeholders to be involved within each of the project's particular focus areas; the purpose and expected benefits of stakeholder involvement; anticipated communities of practices to facilitate stakeholder involvement; and the innovative or advanced convening or communication technologies to be used, as applicable.

(f) Establish continuous feedback, evaluation, and improvement processes, including action steps and clear timelines, to ensure that the training curricula and resources are responsive to the needs of the current and aspiring VR professionals and stakeholders; meet the project scope and objectives; and reflect evolving research, promising practices, and innovative training methods during the life of the grant.

(g) Disseminate, replicate, and sustain the innovative training curricula and resources. The applicant must post completed training curricula and related resources on National Clearinghouse of Rehabilitation Training Materials (NCRTM) and other appropriate venues on an ongoing basis; facilitate replication of training curricula by interested VR agencies, IHEs, or other interested parties; sustain and maintain the training curriculum beyond the life of the grant; and present innovative training curricula, resources, outcomes, and lessons learned in at least one national forum during the final year of the grant.

This document does not preclude us from proposing additional eligibility criteria, priorities, requirements, definitions, and selection criteria subject to meeting applicable rulemaking requirements.

Note: This document does not solicit applications. In any year in which we choose to use this priority and these requirements, we invite applications through a notice in the Federal Register .

Under Executive Order 12866, it must be determined whether this regulatory action is “significant” and, therefore, subject to the requirements of the Executive order and subject to review by the Office of Management and Budget (OMB). Section 3(f) of Executive Order 12866 defines a “significant regulatory action” as an action likely to result in a rule that may—

(1) Have an annual effect on the economy of $100 million or more, or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or Tribal governments or communities;

(2) Create a serious inconsistency or otherwise interfere with an action taken or planned by another agency;

(3) Materially alter the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof; or

(4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive order.

This regulatory action is not a significant regulatory action subject to review by OMB under section 3(f) of Executive Order 12866.

Since this regulatory action is not a significant regulatory action under section 3(f) of Executive Order 12866, it is not considered an “Executive Order 14192 regulatory action.”

We have also reviewed this regulatory action under Executive Order 13563, which supplements and explicitly reaffirms the principles, structures, and definitions governing regulatory review established in Executive Order 12866. To the extent permitted by law, Executive Order 13563 requires that an agency—

(1) Propose or adopt regulations only upon a reasoned determination that their benefits justify their costs (recognizing that some benefits and costs are difficult to quantify);

(2) Tailor its regulations to impose the least burden on society, consistent with obtaining regulatory objectives and taking into account—among other things and to the extent practicable—the costs of cumulative regulations;

(3) In choosing among alternative regulatory approaches, select those approaches that maximize net benefits;

(4) To the extent feasible, specify performance objectives, rather than the behavior or manner of compliance a regulated entity must adopt; and

(5) Identify and assess available alternatives to direct regulation, including economic incentives—such as user fees or marketable permits—to encourage the desired behavior, or provide information that enables the public to make choices.

Executive Order 13563 also requires an agency “to use the best available techniques to quantify anticipated present and future benefits and costs as accurately as possible.” OIRA has emphasized that these techniques may include “identifying changing future compliance costs that might result from technological innovation or anticipated behavioral changes.”

We are issuing this final priority and requirements only on a reasoned determination that their benefits would justify their costs. In choosing among alternative regulatory approaches, we selected those approaches that would maximize net benefits. Based on the analysis that follows, the Department believes that this regulatory action is consistent with the principles in Executive Order 13563.

We also have determined that this regulatory action would not unduly interfere with State, local, and Tribal governments in the exercise of their governmental functions.

In accordance with these Executive Orders, the Department has assessed the potential costs and benefits, both quantitative and qualitative, of this regulatory action. The potential costs are those resulting from statutory requirements and those we have determined as necessary for administering the Department's programs and activities.

In addition, we have considered the potential benefits of this regulatory action and have noted these benefits in the background section of the NPP.

We are issuing this final priority and these requirements only on a reasoned determination that its benefits justify their costs. In choosing among alternative regulatory approaches, we selected those approaches that maximize net benefits. Based on the preceding analysis, the Department believes that this regulatory action is consistent with the principles in Executive Order 13563.

We also have determined that this final regulatory action does not unduly interfere with State, local, and tribal governments in the exercise of their governmental functions.

The final priorities, including requirements, contain information collection requirements that are approved by OMB under OMB control number 1820-0028; the final priorities, including requirements, do not affect the currently approved data collection.

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This document provides early notification of our specific plans and actions for this program.

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This rule establishes a framework under the authority of the MMPA (16 U.S.C. 1361 et seq. ) and authorizes, for a 5-year period (2025-2030), take of marine mammals incidental to the UCSC/MARINe's rocky intertidal research activities in Oregon and California.

NMFS received an incidental take authorization (ITA) application from the UCSC/MARINe requesting 5-year regulations and an LOA to take four species of marine mammals by Level B harassment (Application). Take of harbor seal ( Phoca vitulina richardii ), Steller sea lion ( Eumetopias jubatus ), northern elephant seal ( Mirounga angustirostris ), and California sea lion ( Zalophus californianus ) would occur by Level B harassment only, incidental to visual and auditory disturbance of pinnipeds occurring near research sites. No mortality or serious injury is anticipated or authorized. Please see the Estimated Take of Marine Mammals section below for definitions of harassment.

A previous incidental take authorization was issued in association with this ongoing, long-term project. That authorization was issued to the UCSC Partnership for Interdisciplinary Studies of Coastal Oceans (referred to as UCSC/PISCO). Additional information about that action can be found at: https://www.fisheries.noaa.gov/action/incidental-take-authorization-university-california-santa-cruz-rocky-intertidal-monitoring-0.

The MMPA prohibits the “take” of marine mammals, with certain exceptions. Sections 101(a)(5)(A) and (D) of the MMPA (16 U.S.C. 1361 et seq. ) direct the Secretary of Commerce (as delegated to NMFS) to allow, upon request, the incidental, but not intentional, taking of small numbers of marine mammals by U.S. citizens who engage in a specified activity (other than commercial fishing) within a specified geographical region if certain findings are made, regulations are promulgated, and public notice and an opportunity for public comment are provided.

Authorization for incidental takings shall be granted if NMFS finds that the taking will have a negligible impact on the species or stock(s) and will not have an unmitigable adverse impact on the availability of the species or stock(s) for taking for subsistence uses (where relevant). Further, NMFS must prescribe the permissible methods of taking and other “means of effecting the least practicable adverse impact” on the affected species or stocks and their habitat. NMFS will pay particular attention to (1) rookeries, mating grounds, and areas of similar significance, (2) the availability of the species or stocks for taking for certain subsistence uses (referred to as “mitigation”), and (3) the requirements pertaining to the mitigation, monitoring and reporting of the takings are set forth. The definitions of all applicable MMPA statutory terms cited above are included below.

Section 101(a)(5)(A) of the MMPA and the implementing regulations at 50 CFR part 216, subpart I, provide the legal basis for issuing 5-year regulations and an associated LOA. This rule establishes required mitigation, monitoring, and reporting requirements for the UCSC/MARINe's activities.

The following is a summary of the major provisions of this rule regarding UCSC/MARINe's research activities. These provisions include measures requiring:

• Mitigation to minimize impact to pinnipeds and avoid disruption to dependent pups including several measures to approach haulouts cautiously to minimize disturbance, especially when pups are present; and

• Monitoring of the research areas to detect the presence of marine mammals before initiating surveys.

On September 6, 2024, NMFS received a request from the UCSC/MARINe for an authorization to take marine mammals incidental to rocky intertidal monitoring surveys along the Oregon and California coasts. Following NMFS' review of the application, UCSC/MARINe submitted a revised version that was deemed adequate and complete on November 26, 2024. UCSC/MARINe's request is for incidental take of four pinniped species by Level B harassment only; harbor seal, Steller sea lion, northern elephant seal, and California sea lion. Neither UCSC/MARINe nor NMFS expect serious injury or mortality to result from this activity.

NMFS previously issued seven IHAs (77 FR 72327, December 5, 2012; 78 FR 79403, December 30, 2013; 79 FR 73048, December 9, 2014; 81 FR 7319, February 11, 2016; 82 FR 12568, March 6, 2017; 83 FR 11696, March 16, 2018; 84 FR 17784, April 26, 2019) to the UCSC Partnership for Interdisciplinary Studies of Coastal Oceans (UCSC/PISCO) for this work before issuing a final rule and associated LOA in 2020 (85 FR 18459, April 2, 2020). UCSC/PISCO complied with all the requirements ( e.g., mitigation, monitoring, and reporting) of the previous IHAs and LOA. UCSC/PISCO monitoring results from 2013 to 2024 may be found in the Application, which is available online at: https://www.fisheries.noaa.gov/action/incidental-take-authorization-university-california-santa-cruzs-rocky-intertidal-monitoring.

UCSC/MARINe has been authorized to conduct rocky intertidal monitoring work for over 20 years. This work focuses on understanding the nearshore ecosystems of the U.S. West Coast through a number of interdisciplinary collaborations. The program integrates long-term monitoring of ecological and oceanographic processes at dozens of sites with experimental work in the lab and field. Research is conducted throughout the year along the California and Oregon coasts and is expected to continue indefinitely. Researchers accessing and conducting research activities on the sites occasionally result in the incidental take of four pinniped species by incidental, Level B harassment. UCSC/MARINe expects, and NMFS concurs, that the disturbance to pinnipeds from the research activities will be limited to Level B harassment. Take by Level A harassment, serious injury, or mortality is not anticipated and will not be authorized through this action.

Some sampling may occur in all months of the calendar year. Over the course of this 5-year effective period for the rule, UCSC/MARINe expects approximately 300 days of survey effort. Exact locations of sampling sites can be found in table 1 of the Application, along with maps at: https://www.fisheries.noaa.gov/action/incidental-take-authorization-university-california-santa-cruzs-rocky-intertidal-monitoring.

A detailed description of the monitoring project, along with mitigation, monitoring, and reporting measures, are described in detail in the Federal Register notice for the proposed ITA (90 FR 13322, March 21, 2025). Since that time, the only change that has been added is a mitigation measure that was omitted in the proposed rule (see Summary of Request section above). Therefore, a detailed description is not provided here. Please refer to that Federal Register notice for the description of the specific activity.

A notice of NMFS' proposal to issue an ITA to the UCSC/MARINe was published in the Federal Register notice for the proposed ITA (90 FR 13322, March 21, 2025). That notice described, in detail, UCSC/MARINe's activity, the marine mammal species that may be affected by the activity, and the anticipated effects on marine mammals. In that notice, we requested public input on the request for authorization described therein, our analyses, the proposed authorization, and any other aspect of the notice of proposed ITA, and requested that interested persons submit relevant information, suggestions, and comments.

During the 30-day public comment period, NMFS received comments from two individuals. Both comments supported the project activities, and emphasized the continued timely posting of the annual reports for public transparency, and the continued refinement of mitigation measures to reduce disturbance. The comments and recommendations are available online at: https://www.regulations.gov/document/NOAA-NMFS-2024-0144-0003/comment. Please see the comment submissions for full details regarding the recommendations and supporting rationale. As comments suggested continued mitigation measures already employed by the applicant, no changes resulting from public comments were made from the proposed to the final rule.

There is one change from the proposed to the final rule. NMFS inadvertently omitted from the proposed rule a mitigation measure stating that any research occurring on the Channel Islands, Farallon Islands, or Año Nuevo Island would be coordinated with researchers who regularly work in these areas in order to both gain access and reduce the amount of disturbance to marine mammals. UCSC proposed this measure as part of its petition for regulations, which was made available for public review during the Notice of Receipt and proposed rule public comment periods. This mitigation measure has been added to this final rule in the preamble and the regulatory text.

Table 1 lists all species or stocks for which take is expected and authorized for this activity and summarizes information related to the population or stock, including regulatory status under the MMPA and Endangered Species Act (ESA) and potential biological removal (PBR), where known. Sections 3 and 4 of the application summarize available information regarding status and trends, distribution and habitat preferences, and behavior and life history of the potentially affected species (table 1). NMFS fully considered all of this information, and we refer the reader to these descriptions, instead of reprinting the information. Additional information regarding population trends and threats may be found in NMFS' Stock Assessment Reports (SARs; https://www.fisheries.noaa.gov/national/marine-mammal-protection/marine-mammal-stock-assessments ) and more general information about these species ( e.g., physical and behavioral descriptions) may be found on NMFS' website ( https://www.fisheries.noaa.gov/find-species ).

A detailed description of the species likely to be affected by the UCSC/MARINe project, including brief introductions to the species and relevant stocks as well as available information regarding population trends and threats, and information regarding local occurrence, were provided in the Federal Register notice for the proposed ITA (90 FR 13322, March 21, 2025); since that time, we are not aware of any changes in the status of these species and stocks; therefore, detailed descriptions are not provided here. Please refer to that Federal Register notice for these descriptions. Please also refer to NMFS' website ( https://www.fisheries.noaa.gov/find-species ) for generalized species accounts.

The effects of underwater noise from UCSC/MARINe monitoring activities have the potential to result in behavioral harassment of marine mammals in the vicinity of the survey area. The notice of proposed rulemaking (90 FR 13322, March 21, 2025) included a discussion of the effects of anthropogenic noise on marine mammals and the potential effects of underwater noise from UCSC/MARINe monitoring activities on marine mammals and their habitat. That information and analysis is referenced in this final ITA determination and is not repeated here; please refer to the notice of proposed rulemaking (90 FR 13322, March 21, 2025).

This section provides an estimate of the number of incidental takes of the four species of pinnipeds by Level B harassment that may be authorized under this rule, which informs both NMFS' consideration of “small numbers” and the negligible impact determination.

Harassment, defined previously in the Purpose and Need for Regulatory Action section, is the only type of take expected to result from these activities.

Authorized takes will be by Level B harassment only, in the form of potential disruption of behavioral patterns for individual marine mammals resulting from exposure to researchers and the operation of their equipment. Based on the nature of the activity, Level A harassment is neither anticipated nor authorized. As described previously, no mortality is anticipated or authorized for this activity. Researchers with extensive knowledge and experience at each survey site estimated the actual number of marine mammal takes likely to occur, using annual recorded observations. Take estimates are based on historical marine mammal observations from 2013-2024 at each site from previous UCSC/PISCO (MARINe) survey activities. Take estimates for each species were based on the following equation:

The species' estimated take totals for each survey site were summed to arrive at a total estimated take for the entire duration of the rule across all four impacted species of pinnipeds. We fully describe how the take numbers are estimated in detail in the proposed ITA (90 FR 13322, March 21, 2025), and summarize below in table 2.

Monitoring reports from the previously issued LOA (2020-2025), including Level B harassment take numbers, are available on our website: https://www.fisheries.noaa.gov/action/incidental-take-authorization-university-california-santa-cruz-rocky-intertidal-monitoring-0.

Under section 101(a)(5)(A) of the MMPA, NMFS must set forth the permissible methods of taking pursuant to the activity, and other means of effecting the least practicable impact on the species or stock and its habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance, and on the availability of the species or stock for taking for certain subsistence uses (the latter is not applicable for this action). NMFS regulations require applicants for incidental take authorizations to include information about the availability and feasibility (economic and technological) of equipment, methods, and manner of conducting the activity or other means of effecting the least practicable adverse impact upon the affected species or stocks, and their habitat (50 CFR 216.104(a)(11)).

In evaluating how mitigation may or may not be appropriate to ensure the least practicable adverse impact on species or stocks and their habitat, as well as subsistence uses where applicable, NMFS considers two primary factors:

(1) The manner in which, and the degree to which, the successful implementation of the measure(s) is expected to reduce impacts to marine mammals, marine mammal species or stocks, and their habitat. This considers the nature of the potential adverse impact being mitigated ( e.g., likelihood, scope, range). It further considers the likelihood that the measure will be effective if implemented ( i.e., probability of accomplishing the mitigating result if implemented as planned), the likelihood of effective implementation (probability of accomplishing the mitigating result if implemented as planned); and

(2) The practicability of the measures for applicant implementation, which may consider cost and impact on operations.

UCSC/MARINe will implement several mitigation measures to reduce potential take by Level B harassment. Measures are listed below.

• Researchers will observe a site from a distance for at least 5 minutes, using binoculars, if necessary, to detect any marine mammals prior to approach to determine if mitigation is required ( i.e., site surveys will not be conducted if other pinnipeds are present, researchers will approach with caution, walking slowly, quietly, and close to the ground to avoid surprising any hauled out individuals and to reduce flushing/stampeding of individuals).

• Researchers will avoid pinnipeds along access ways to sites by locating and taking a different access route. Researchers will keep a safe distance from, and not approach, any marine mammal while conducting research unless it is absolutely necessary to flush ( i.e., disturb from its position) a marine mammal in order to continue conducting research ( i.e. if a site cannot be accessed or sampled due to the presence of pinnipeds).

• Researchers will avoid making loud noises ( e.g., using hushed voices) and keep bodies low to the ground ( i.e., crouched) in the visual presence of pinnipeds.

• Researchers will monitor the offshore area for predators ( e.g., killer whales and great white sharks) and avoid flushing of pinnipeds when predators are observed in nearshore waters. Note that UCSC/MARINe has never observed an offshore predator while researchers were present at any of the survey sites.

• Intentional approach will not occur if dependent pups are present to avoid mother/pup separation and trampling of pups. Staff shall reschedule work at sites where pups are present unless other means of accomplishing the work can be done without causing disturbance to mothers and dependent pups.

• When operating UAVs around pinnipeds, altitude will not drop below 10 meters.

• Researchers will promptly vacate sites at the conclusion of sampling.

• Research occurring on the Channel Islands, Farallon Islands, or Año Nuevo Island will be coordinated with researchers who regularly work in these areas.

The primary methods of mitigating the risk of disturbance to pinnipeds is the selection of judicious routes of approach to study sites, avoiding close contact with pinnipeds hauled out on shore, and the use of extreme caution upon approach. Each visit to a given study site will last for approximately 4-6 hours, after which the site is vacated and can be re-occupied by any marine mammals that may have been disturbed by the presence of researchers. In addition, workers will be arriving before low tide; worker presence will tend to encourage pinnipeds to move to other areas for the day before they haul out and settle onto rocks at low tide.

In order to both gain access and further reduce the amount of disturbance to marine mammals, any research occurring on the Channel Islands, Farallon Islands, or Año Nuevo Island would be coordinated with researchers who regularly work in these areas. This mitigation measure, which was proposed by UCSC, was inadvertently omitted from the proposed rule, and has been added to this final rule in the preamble and the regulatory text.

Based on our evaluation of the applicant's proposed measures, NMFS has determined that the mitigation measures provide the means effecting the least practicable impact on the affected species or stocks and their habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance.

In order to issue an ITA for an activity, section 101(a)(5)(D) of the MMPA states that NMFS must set forth requirements pertaining to the monitoring and reporting of such taking. The MMPA implementing regulations at 50 CFR 216.104(a)(13) indicate that requests for authorizations must include the suggested means of accomplishing the necessary monitoring and reporting that will result in increased knowledge of the species and of the level of taking or impacts on populations of marine mammals that are expected to be present while conducting the activities. Effective reporting is critical to both compliance as well as ensuring that the most value is obtained from the required monitoring.

Monitoring and reporting requirements prescribed by NMFS should contribute to improved understanding of one or more of the following:

• Occurrence of marine mammal species or stocks in the area in which take is anticipated ( e.g., presence, abundance, distribution, density);

• Nature, scope, or context of likely marine mammal exposure to potential stressors/impacts (individual or cumulative, acute or chronic), through better understanding of: (1) action or environment ( e.g., source characterization, propagation, ambient noise); (2) affected species ( e.g., life history, dive patterns); (3) co-occurrence of marine mammal species with the activity; or (4) biological or behavioral context of exposure ( e.g., age, calving or feeding areas);

• Individual marine mammal responses (behavioral or physiological) to acoustic stressors (acute, chronic, or cumulative), other stressors, or cumulative impacts from multiple stressors;

• How anticipated responses to stressors impact either: (1) long-term fitness and survival of individual marine mammals; or (2) populations, species, or stocks;

• Effects on marine mammal habitat ( e.g., marine mammal prey species, acoustic habitat, or other important physical components of marine mammal habitat); and

• Mitigation and monitoring effectiveness.

UCSC/MARINe will contribute to the knowledge of pinnipeds in California and Oregon by noting observations of: (1) unusual behaviors, numbers, or distributions of pinnipeds, such that any potential follow-up research can be conducted by the appropriate personnel; (2) tag-bearing carcasses of pinnipeds, allowing transmittal of the information to appropriate agencies and personnel; and (3) rare or unusual species of marine mammals for agency follow-up.

Monitoring requirements in relation to UCSC/MARINe's rocky intertidal monitoring will include observations made by the applicant. Information recorded will include species counts (with numbers of pups/juveniles) of animals present before approaching, numbers of observed disturbances (based on the scale below), and descriptions of the disturbance behaviors during the monitoring surveys, including location, date, and time of the event. For consistency, any reactions by pinnipeds to researchers will be recorded according to a 3-point scale shown in table 3. Note that only observations of disturbance levels 2 and 3 should be recorded as takings.

In addition, observations regarding the number and species of any marine mammals observed (either in the water or hauled out at, or adjacent to, a research site) are recorded as part of field observations during research activities. Information regarding physical and biological conditions pertaining to a site, as well as the date and time that research was conducted, will also be recorded. This information will be incorporated into a monitoring report for NMFS and raw data will be provided.

If at any time the specified activity clearly causes the take of a marine mammal in a prohibited manner such as an injury (Level A harassment), serious injury, or mortality, UCSC/MARINe shall immediately cease the specified activities and report the incident to the Office of Protected Resources, NMFS, and the West Coast Regional Stranding Coordinator, NMFS. The report must include the following information:

(1) Time and date of the incident;

(2) Description of the incident;

(3) Environmental conditions ( e.g., wind speed and direction, Beaufort sea state, cloud cover, and visibility);

(4) Description of all marine mammal observations in the 24 hours preceding the incident;

(5) Species identification or description of the animal(s) involved;

(6) Fate of the animal(s); and

(7) Photographs or video footage of the animal(s) (if equipment is available).

Activities shall not resume until NMFS is able to review the circumstances of the prohibited take. NMFS will work with UCSC/MARINe to determine what measures are necessary to minimize the likelihood of further prohibited take and ensure MMPA compliance. UCSC/MARINe may not resume the activities until notified by NMFS.

In the event that UCSC/MARINe discovers an injured or dead marine mammal and determines that the cause of the injury or death is unknown and the death is relatively recent ( e.g., in less than a moderate state of decomposition), UCSC/MARINe shall immediately report the incident to the Office of Protected Resources, NMFS, and the West Coast Regional Stranding Coordinator, NMFS. The report must include the same information identified in the paragraph above. Activities may continue while NMFS reviews the circumstances of the incident. NMFS will work with UCSC/MARINe to determine whether additional mitigation measures or modifications to the activities are appropriate.

In the event that an injured or dead marine mammal is discovered and it is determined that the injury or death is not associated with or related to the activities authorized in the regulations and LOA ( e.g., previously wounded animal, carcass with moderate to advanced decomposition, or scavenger damage), UCSC/MARINe shall report the incident to the Office of Protected Resources, NMFS, and the West Coast Regional Stranding Coordinator, NMFS, within 24 hours of the discovery. UCSC/MARINe shall provide photographs, video footage (if available) or other documentation of the stranded animal sighting to NMFS and the Marine Mammal Stranding Network. Activities may continue while NMFS reviews the circumstances of the incident.

A draft annual report shall be submitted to NMFS Office of Protected Resources within 90 days after the conclusion of each annual field season (50 CFR 217.105(d)(1)). The report will include a summary of the information gathered pursuant to the monitoring requirements set forth above and in the LOA. A final annual report shall be submitted to the Director of the NMFS Office of Protected Resources within 30 days after receiving comments from NMFS on the draft annual report (50 CFR 217.105(d)(2)). If no comments are received from NMFS, the draft annual report will be considered the final report.

UCSC/MARINe complied with the mitigation and monitoring that were required under the prior IHAs issued from 2013 to 2019, and the LOA issued in 2020. In compliance with those IHAs, they submitted reports detailing the activities and marine mammal monitoring they conducted, the most recent report submitted in 2024 and accessible at: https://www.fisheries.noaa.gov/action/incidental-take-authorization-university-california-santa-cruz-rocky-intertidal-monitoring-0. The IHAs required UCSC/MARINe to conduct counts of pinnipeds present at study sites prior to approaching the sites and to record species counts and any observed reactions to the presence of the researchers. These monitoring results were summarized above in the Estimated Take of Marine Mammals section, with a detailed discussion in the proposed ITA (90 FR 13322, March 21, 2025).

Based on the results from the monitoring reports, we conclude that the mitigation measures set forth in the previous authorizations effected the least practicable impact on the species or stocks. There were no stampede events during these years and most disturbances were level 1 and 2 on the disturbance scale (see table 3), meaning the animal did not fully flush but observed or moved slightly in response to researchers. Those that did fully flush to the water did so slowly. Most of these animals tended to observe researchers from the water and then re-haul out farther up-coast or down-coast of the site within approximately 30 minutes of the disturbance.

The regulations governing the take of marine mammals incidental to the UCSC/MARINe's research activities would contain an adaptive management component. The reporting requirements associated with this rule are designed to provide NMFS with annual monitoring data to allow consideration of whether any changes are appropriate. The use of adaptive management allows NMFS to consider new information from different sources to determine on an annual basis if mitigation or monitoring measures should be modified (including additions or deletions). Mitigation measures could be modified if new data suggests that such modifications would have a reasonable likelihood of reducing adverse effects to marine mammals and if the measures are practicable.

The following are some of the possible sources of applicable data to be considered through the adaptive management process: (1) results from monitoring reports, as required by MMPA authorizations; (2) results from general marine mammal and sound research; and (3) any information which reveals that marine mammals may have been taken in a manner, extent, or number not authorized by these regulations or LOAs issues pursuant to these regulations.

NMFS has defined negligible impact as an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival (50 CFR 216.103). A negligible impact finding is based on the lack of likely adverse effects on annual rates of recruitment or survival ( i.e., population-level effects). An estimate of the number of takes alone is not enough information on which to base an impact determination. In addition to considering estimates of the number of marine mammals that might be “taken” through harassment, NMFS considers other factors, such as the likely nature of any impacts or responses ( e.g., intensity, duration), the context of any impacts or responses ( e.g., critical reproductive time or location, foraging impacts affecting energetics), as well as effects on habitat, and the likely effectiveness of the mitigation. We also assess the number, intensity, and context of estimated takes by evaluating this information relative to population status. Consistent with the 1989 preamble for NMFS' implementing regulations (54 FR 40338, September 29, 1989), the impacts from other past and ongoing anthropogenic activities are incorporated into this analysis via their impacts on the baseline ( e.g., as reflected in the regulatory status of the species, population size and growth rate where known, ongoing sources of human-caused mortality, or ambient noise levels).

To avoid repetition, the discussion of our analysis applies to all the species listed in table 1, given that the anticipated effects of this activity on these different marine mammal stocks are expected to be similar. There is little information about the nature or severity of the impacts, or the size, status, or structure of any of these species or stocks that would lead to a different analysis for this activity. Research activities have the potential to disturb or displace marine mammals. Specifically, the project activities may result in take, in the form of Level B harassment from researcher's movements and equipment handling. Potential takes could occur if individuals of these species are present nearby when these activities are underway. No injuries or mortalities are anticipated to occur as a result of UCSC/MARINe's rocky intertidal monitoring surveys and none are authorized.

Typically, even those reactions constituting Level B harassment would result, at most, in a temporary, short-term behavioral disturbance. In any given study season, researchers will visit select sites one to two times per year for four to six hours per visit. Therefore, disturbance of pinnipeds resulting from the presence of researchers lasts only for short periods. These short periods of disturbance lasting less than a day are separated by months or years. Community structure sites are visited at most twice per year and the visits occur in different seasons. Biodiversity surveys take place at a given location once every three to five years.

Of the marine mammal species anticipated to occur in the activity areas, none are listed under the ESA. Taking into account the planned mitigation measures, effects to marine mammals are generally expected to be restricted to short-term changes in behavior or temporary abandonment of haulout sites, pinnipeds are not expected to permanently abandon any area that is surveyed by researchers, as is evidenced by continued presence of pinnipeds at the sites during annual monitoring counts. No adverse effects to prey species are anticipated and habitat impacts are limited and highly localized, consisting of the placement of permanent bolts and temporary research equipment in the intertidal zone. Based on this analysis of the likely effects of the specified activity on marine mammals and their habitat, and considering the implementation of the proposed mitigation and monitoring measures, NMFS finds that the total marine mammal incidental take from UCSC/MARINe's rocky intertidal monitoring program will not adversely affect annual rates of recruitment or survival. Therefore, such incidental take will have a negligible impact on the affected species or stocks.

In summary and as described above, the following factors primarily support our determination that the impacts resulting from this activity are not expected to adversely affect any of the species or stocks through effects on annual rates of recruitment or survival:

• No serious injury or mortality is anticipated or authorized;

• Only a small number of pups are expected to be disturbed;

• Effects of the survey activities would be limited to short-term, localized behavioral changes;

• Nominal impacts to pinniped habitat are anticipated; and

• Mitigation measures are anticipated to be effective in minimizing the number and severity of takes by Level B harassment, which are expected to be of short duration.

Based on the analysis contained herein of the likely effects of the specified activity on marine mammals and their habitat, and taking into consideration the implementation of the monitoring and mitigation measures, NMFS finds that the total marine mammal take from the activity will have a negligible impact on all affected marine mammal species or stocks.

As noted previously, only take of small numbers of marine mammals may be authorized under sections 101(a)(5)(A) of the MMPA for specified activities other than military readiness activities. The MMPA does not define small numbers and so, in practice, where estimated numbers are available, NMFS compares the maximum number of individuals taken in any year to the most appropriate estimation of abundance of the relevant species or stock in our determination of whether an authorization is limited to small numbers of marine mammals. When the predicted number of individuals to be taken is fewer than one-third of the species or stock abundance, the take is considered to be of small numbers (see 86 FR 5322, January 19, 2021). Additionally, other qualitative factors may be considered in the analysis, such as the temporal or spatial scale of the activities.

The amount of take NMFS authorizes is 0.04 to 0.94 percent of any stock's best population estimate (see table 2). These are likely conservative estimates because they assume all encounters result in take, which has not historically been the case.

Based on the analysis contained herein of the activity (including the mitigation and monitoring measures) and the anticipated take of marine mammals, NMFS finds that small numbers of marine mammals would be taken relative to the population size of the affected species or stocks.

There are no relevant subsistence uses of the affected marine mammal stocks or species implicated by this action. Therefore, NMFS has determined that the total taking of affected species or stocks would not have an unmitigable adverse impact on the availability of such species or stocks for taking for subsistence purposes.

To comply with the National Environmental Policy Act of 1969 (NEPA; 42 U.S.C. 4321 et seq. ) and NOAA Administrative Order (NAO) 216-6A, NMFS must review our action ( i.e., promulgation of regulations and issuance of a 5-year LOA) and alternatives with respect to potential impacts on the human environment.

This action is consistent with categories of activities identified in Categorical Exclusion B4 (incidental take authorizations ITAs with no anticipated serious injury or mortality) of the Companion Manual for NAO 216-6A, which do not individually or cumulatively have the potential for significant impacts on the quality of the human environment and for which we have not identified any extraordinary circumstances that would preclude this categorical exclusion. Accordingly, NMFS has determined that the issuance of the ITA qualifies to be categorically excluded from further NEPA review.

Section 7(a)(2) of the ESA of 1973 (16 U.S.C. 1531 et seq. ) requires that each Federal agency ensure that any action it authorizes, funds, or carries out is not likely to jeopardize the continued existence of any endangered or threatened species or result in the destruction or adverse modification of designated critical habitat. To ensure ESA compliance for the issuance of IHAs, NMFS consults internally whenever we propose to authorize take for endangered or threatened species.

No incidental take of ESA-listed species is authorized or expected to result from this activity. Therefore, NMFS has determined that formal consultation under section 7 of the ESA is not required for this action.

The Office of Management and Budget has determined that this rule is not significant for purposes of Executive Order 12866. This rule is not an Executive Order regulatory action because this action is not significant under Executive Order 12866.

Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA), the Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration at the proposed rule stage that this rule would not have a significant economic impact on a substantial number of small entities. UCSC/MARINe is the sole entity that would be subject to the requirements in these regulations, and UCSC/MARINe is not a small governmental jurisdiction, organization, or business as defined by the RFA. No comments were received regarding this certification or on the economic impacts of the rule more generally. As a result, a regulatory flexibility analysis is not required and none has been prepared.

This rule does contain collection-of-information requirements subject to the provisions of the Paperwork Reduction Act (PRA) (44 U.S.C. 3501-3521). Notwithstanding any other provision of law, no person is required to respond to, nor shall a person be subject to, a penalty for failure to comply with a collection of information subject to the requirements of the PRA unless that collection of information displays a currently valid Office of Management and Budget (OMB) control number. These requirements have been approved by OMB under control number 0648-0151, Applications and Reporting Requirements for Incidental Taking of Marine Mammals by Specified Activities Under the Marine Mammal Protection Act, and include the applications for regulations, subsequent LOA, and reports.

NMFS has determined that there is good cause under the Administrative Procedure Act (5 U.S.C. 553(d)(3)) to waive the 30-day delay in the effective date of this final rule. No individual or entity other than UCSC is affected by the provisions of these regulations.

The waiver of the 30-day delay of the effective date of the final rule will ensure that the MMPA final rule and LOA are in place as soon as possible to ensure the UCSC's compliance with the MMPA. Any delay in finalizing the rule would result in either: (1) A suspension of planned research, which would disrupt the provision of vital data necessary for effective management of intertidal habitat; or (2) the UCSC's procedural non-compliance with the MMPA (should the UCSC conduct research without an LOA), thereby resulting in the potential for unauthorized takes of marine mammals. Moreover, UCSC is ready to implement the regulations immediately and requested the waiver. For these reasons, NMFS finds good cause to waive the 30-day delay in the effective date. In addition, the rule authorizes incidental take of marine mammals that would otherwise be prohibited under the statute. Therefore, by granting an exception to UCSC, the rule will relieve restrictions under the MMPA, which provides a separate basis for waiving the 30-day effective date for the rule.

For reasons set forth in the preamble, 50 CFR part 217 is amended as follows:

The Mid-Atlantic Fishery Management Council (Council) and the Atlantic States Marine Fisheries Commission (Commission) cooperatively manage the summer flounder, scup, and black sea bass commercial and recreational fisheries. The Council and the Commission's Summer Flounder, Scup, and Black Sea Bass Management Board (Board) meet together each year to recommend recreational management measures for all three species, generally set for two years, so that recreational harvest achieves, but does not exceed, the recreational harvest targets specified by the Percent Change Approach adopted in the Harvest Control Rule Framework (Framework 17) (88 FR 14499, March 9, 2023).

Pursuant to the regulations at 50 CFR 648.142(d), NOAA's National Marine Fisheries Service (NMFS) must implement coastwide measures or approve conservation-equivalent measures for black sea bass as soon as possible following the Council and Board's recommendation. This action approves conservation equivalency for black sea bass in 2025.

In this final rule, NMFS is implementing conservation equivalency to manage the 2025 black sea bass recreational fishery, as described in the proposed rule published on April 3, 2025 (90 FR 14595). Under conservation equivalency, Federal regulations that apply to the recreational black sea bass fishery are waived and federally permitted party/charter vessels and all recreational vessels fishing in Federal waters are subject to the recreational fishing measures implemented by the state in which they land. This approach allows for more customized measures at a state or regional level that are likely to better meet the needs of anglers in each area, compared to coastwide measures that may be advantageous to anglers in some areas and unnecessarily restrictive in others.

The combination of state/regional measures must be “equivalent,” in terms of conservation, to a set of “non-preferred coastwide measures” that are recommended by the Council and the Board each year. States, through the Commission, are collectively implementing measures designed to constrain landings to the recreational harvest targets. Additional information on the development of these measures is provided in the proposed rule (90 FR 14595; April 3, 2025) and not repeated here.

On April 23, 2025, the Commission notified NMFS that it had certified that the 2025 recreational fishing measures to be implemented in state waters for black sea bass are, collectively, the conservation equivalent of the season, fish size, and possession limit prescribed in §§ 648.145(a), 648.146, and 648.147(b). According to § 648.142(d)(2), if conservation equivalency is adopted, vessels subject to the recreational fishing measures are not subject to Federal measures and instead are subject to the recreational fishing measures implemented by the state in which they land. Section 648.151 is amended through this final rule to recognize state-implemented measures as the conservation equivalent of the Federal coastwide recreational management measures for 2025.

There are no changes from the proposed rule.

NMFS received 16 unique comments on the proposed rule (90 FR 14595, April 3, 2025). Comments were received from 12 individuals, the Huntington Angler's Club, the Montauk Boatmen and Captains Association, and two comments were submitted anonymously. Several comments included discussion on changes and recommendations for state management measures, which were not part of the proposed action, and therefore, are not addressed in the following responses. The majority of comments were in support of the proposed action. Comments are grouped and summarized by topic.

Comment 1: Five comments referenced the high biomass of black sea bass and commented on the need for higher catch limits. Three commenters noted that the stock is in good shape, increasing, and has been saved, and that no reductions were needed, but that higher catch limits were needed, with one adding an additional comment that many fish may die from post-release mortality because of the higher biomass. One comment also expressed these views and asked for better use of for-hire vessel trip report (VTR) data for the black sea bass fishery. Finally, one commenter asked for more favorable regulations for just black sea bass, and that there should not be a season for black sea bass.

Response: NMFS agrees that the biomass of black sea bass is high, with the 2024 management track assessment indicating that the stock is 2.19 times the biomass target. No additional reductions are being implemented. The 2025 black sea bass measures are the same as those implemented in 2024.

The overall catch limit (OFL) and corresponding catch limits are based on projections from the 2024 management track stock assessment. The Council and the Commission cooperatively manage summer flounder, scup, and black sea bass. The OFL, ABC, and commercial and recreational quotas for 2025 fishing year for black sea bass have been finalized already through a prior, separate action (89 FR 99138; December 10, 2024).

The Council and the Commission's Management Boards meet jointly each year to recommend recreational management measures. The Percent Change Approach, which was used to determine what, if any, changes to previously implemented measures may be necessary for 2025, was designed by the Council and Commission for managing Mid-Atlantic recreational fisheries. The Percent Change Approach uses two factors to determine if management measures could remain status quo, could be liberalized, or must be restricted. These two factors are: (1) a comparison of the confidence interval (CI) around an estimate of expected harvest under status quo measures with the average recreational harvest limit for the upcoming 2 years; and (2) biomass compared to the target level, as defined by the most recent stock assessment. These two factors also determine the appropriate degree of change ( i.e., a percentage change in expected harvest). This approach attempts to constrain harvest to prevent overfishing while also acknowledging that recreational catch estimates are uncertain and often highly variable (more so than commercial catch estimates). The Percent Change Approach makes incremental adjustments, thus reducing the tendency of management measures to chase after the highs and lows by either liberalizing or restricting measures too much in any given year in reaction to potentially large year-to-year variations in recreational catch estimates. This year, the process concluded that no changes were required for 2025.

This rule does not implement state-specific measures for black sea bass, but rather waives the Federal recreational measures for black sea bass through a process called conservation equivalency. Under conservation equivalency, Federal recreational measures are waived and federally permitted for-hire vessels and all recreational vessels fishing in Federal waters are subject to the recreational fishing measures implemented by the state in which they land. States and regions set their own management measures, which are approved through the Commission process. The combination of state or regional measures must achieve equivalent conservation as the non-preferred coastwide measures, which are intended to maintain a status quo recreational harvest.

A response on post-release mortality can be found in Comment 3.

Expanded use of recreational for-hire VTRs may be considered in the future. The Council has initiated an action to consider additional changes to recreational fisheries management, which may include the consideration of enhanced VTR requirements. Please see the following comment, Comment 2, for more information on future Council actions.

Comment 2: Two comments were supportive of the rule while also highlighting the need for future actions. Specifically, both requested additional review of catch data for setting the next cycle of recreational measures for 2026 and 2027 due to the concerns over accurate recreational data. Both comments also asked NMFS to consider the impacts of potential management approaches under development as part of the Recreational Sector Separation Amendment.

Response: The data used to inform the black sea bass recreational management measures are the best available data on recreational catch. In addition to the Marine Recreational Information Program (MRIP), a bioeconomic model developed by the Northeast Fisheries Science Center (the Recreational Demand Model (RDM)) was used to estimate harvest. The RDM uses trip attributes such as expected harvest and costs, as well as the availability of different sizes of fish, to estimate the likelihood that an angler will go fishing under a given set of regulations. The RDM is informed by a 2022 survey of anglers from Maine through Virginia as well as recent size distribution information from the stock assessment.

For 2026 and 2027 measures, the new Recreational Measures Framework—if approved by NMFS and implemented following further notice and comment rulemaking—would be used to set management measures. The new framework, which the Council voted to recommend to NMFS at its April 2025 meeting, incorporates revisions to the existing Percent Change Approach to determine if measures should remain status quo, be restricted, or be liberalized. Additionally, updated MRIP information and a new stock assessment are anticipated to be available for management use. The RDM will be rerun with the updated information to enable states to select appropriate management measures in the future.

In response to considerations in 2027 for mode management and sector separation, the Recreational Sector Separation Amendment is currently in development by the Council and Commission, and no formal alternatives have been prepared. Therefore, it is not possible to predict how future management measures may be impacted by changes that may be implemented under this action. As NMFS, the Council, and the Commission develop the amendment, there will be continued opportunities for public comment and engagement. NMFS encourages interested parties to continue to engage with the involved bodies as the action continues to be developed.

Comment 3: Two comments focused specifically on post-release mortality and expressed concerns over the practice of “upgrading” or “high-grading” and supported management measures to reduce mortality.

Response: The most recent stock assessment included information on recreational discards, including specific discard mortality rates for regions and for the commercial and recreational sectors. The assessment output was then used to set catch limits and, within the RDM, to enable states to select appropriate management measures with a greater understanding of the impact of those measures on total mortality. There is mortality associated with all types of fishing and the total mortality described in the assessment includes a percentage of dead fish that were released alive that do not survive, based on scientific research. Any specific change to a management measure to reduce black sea bass fishing mortality or disincentivize specific selective fishing practices would be up to the individual states when they set measures as a part of the conservation equivalency process approved by this action.

Comment 4: One comment supported the proposed rule but had concerns on its implementation and the impacts on recreational anglers, enforcement with sufficient monitoring and reporting systems, and accuracy of recreational data.

Response: This action is routine and expected by the recreational sector and waives Federal management measures in favor of state management measures, which reduces confusion among anglers. NMFS has approved conservationally equivalent recreational measures for black sea bass with similar actions in 2023 and 2024, and therefore, this action should not have large impacts on recreational anglers. As stated in Comment 1, the States set their own management measures and are responsible for enforcing these measures, in coordination with Federal law enforcement. As stated in Comment 2, MRIP and the application of the RDM, a bioeconomic model, are the best scientific tools available for the recreational fishery. Furthermore, the Council is considering revisions to recreational data collection through its Recreational Reform Initiative to improve recreational reporting systems and data accuracy.

Comment 5: Six commenters expressed support for the 2025 black sea bass recreational measures. Commenters cited that this action is a wise use of the resource, appreciated the flexibility given to States and regions to select their own measures, and were supportive of preventing overfishing on the stock.

Response: NMFS agrees. This action approves conservation equivalency for black sea bass for fishing year 2025. See Comment 1 for additional information on conservation equivalency.

Pursuant to section 305(d) of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) (16 U.S.C. 1855(d)), the Assistant Administrator for Fisheries, NOAA, has determined that this action is necessary to carry out the Summer Flounder, Scup, and Black Sea Bass Fishery Management Plan, and its implementing regulations, and that this final rule is consistent with the Summer Flounder, Scup, and Black Sea Bass Fishery Management Plan, other provisions of the Magnuson-Stevens Act, and other applicable law. In a previous action under section 304(b), the regulations at § 648.142 authorize NMFS to take this action under section 305(d).

The Assistant Administrator for Fisheries, NOAA, finds good cause under 5 U.S.C. 553(d)(3) to make the rule effective immediately upon filing with the Office of the Federal Register. Stakeholder and industry groups have been involved with the development of this action and have participated in public meetings throughout the past year. Generally, stakeholders are supportive of the use of conservation equivalency because it allows states, and regions, more flexibility to set measures, instead of one set of coastwide measures that apply to all. A further delay in implementation past the start of the recreational fishing season would be contrary to the public interest, as it could perpetuate confusion both in the recreational fisheries regarding the management measures, and with state agencies as they prepare and finalize their recreational management measures. Until this rule is effective, federally permitted for-hire vessels are subject to the Federal 2024 non-preferred coastwide measures ( i.e., 5 fish, 15 inches (38 centimeters) or greater, open season of May 15-September 8), which may be more restrictive than a given the state's measures. This puts federally permitted for-hire vessels in those states at a disadvantage relative to state-only permitted for-hire vessels.

NMFS could not publish this final rule at an earlier date. The recreational management measure setting process begins after the Council and Board provide recommended annual specifications in August of each year, followed by a NMFS notice and comment rulemaking. Throughout the fall, the Council's Monitoring Committee evaluates the needed changes in recreational harvest under the proposed specifications, and develops recommendations for coastwide management measures for the Council and Board to consider. At the December 2024 meeting, the Council and Board voted on recommended recreational management measures. Council staff then prepared and submitted those recommendations to NMFS and NMFS prepared a proposed rule that was published on April 3, 2024, with a public comment period that was open through April 18, 2024. After the comment period closes, NMFS must review, consider, and respond to all comments on the proposed rule and develop the final rule package, which is then subject to further review upon completion. In addition, during the proposed rule development and comment period, the states are developing management measures and submitting that information to the Commission to ensure that the suite of state measures are the conservation equivalent of coastwide Federal measures. The letter confirming conservation equivalent measures from the Commission was received by NMFS on April 23, 2025. Pursuant to §§ 648.102(d)(2)(ii) and 648.142(d)(2)(ii), NMFS cannot finalize conservation equivalency without this information from the Commission.

As noted above, the Federal, non-preferred coastwide measures for black sea bass that were codified last year (89 FR 32374, April 26, 2024) remain in effect until the decision to waive Federal measures for 2025 is made effective by this final rule. Many states have already implemented their conservationally equivalent 2025 measures and have opened their recreational seasons; any additional delay in implementing the measures of this rule will increase confusion on what measures are in place in Federal waters. Inconsistencies between the states' measures and the Federal measures could lead to misunderstanding of the applicable regulations and could increase the likelihood of noncompliant landings.

Unlike actions that require an adjustment period to comply with new rules, this action does not require recreational and charter/party operators to purchase new equipment or otherwise expend time or money to comply with this action's management measures. Rather, compliance with this final rule simply means adhering to the published state management measures for black sea bass while the recreational and charter/party operators are engaged in fishing activities. For these reasons, the Assistant Administrator finds good cause to waive the 30-day delay in the date of effectiveness and to implement this rule upon the date of filing in the Federal Register .

This final rule has been determined to be not significant for purposes of Executive Order (E.O.) 12866.

This final rule is not a regulatory action pursuant to E.O. 14192 because this action is not significant under E.O. 12866.

NMFS has determined that this action would not have a substantial direct effect on one or more Indian Tribes, on the relationship between the Federal Government and Indian Tribes, or on the distribution of power and responsibilities between the Federal Government and Indian Tribes; therefore, consultation with Tribal officials under E.O. 13175 is not required, and the requirements of sections (5)(b) and (5)(c) of E.O. 13175 also do not apply. A Tribal summary impact statement under section (5)(b)(2)(B) and section (5)(c)(2)(B) of E.O. 13175 is not required and has not been prepared.

The Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration during the proposed rule stage that this action would not have a significant economic impact on a substantial number of small entities. The factual basis for the certification was published in the proposed rule and is not repeated here. NMFS received no comments regarding this certification. Therefore, a final regulatory flexibility analysis was not required and none was prepared.

This final rule contains no information collection requirements under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501 et seq. ).

For the reasons set out in the preamble, NMFS amends 50 CFR part 648 as follows:

The golden tilefish fishery and the blueline tilefish fishery north of the North Carolina/Virginia border are managed under the Tilefish FMP, which outlines the process for establishing annual specifications. The Tilefish FMP requires the Mid-Atlantic Fishery Management Council (Council) to recommend acceptable biological catch (ABC), an annual catch limit (ACL), an annual catch target (ACT), total allowable landings (TAL), and other management measures for the commercial and recreational sectors of the fisheries. The Council's Scientific and Statistical Committee (SSC) provides ABC recommendations for both species to the Council to derive these catch limits. The Council makes recommendations to NMFS that cannot exceed the SSC's ABC recommendation. The Council's recommendations must include supporting documentation concerning the environmental, economic, and social impacts of the recommendations. NMFS reviews these recommendations and, if they are approved, publishes the specifications in the Federal Register . A proposed rule for these specifications was published on April 1, 2025 (90 FR 14350), and comments were accepted through April 16, 2025. Additional information on the process for setting these specifications is contained in the proposed rule and is not repeated here.

This action implements status quo recreational blueline tilefish management measures and specifications for 2025, with a lower commercial TAL reduced by the commercial overage in 2024. Preliminary analysis indicates commercial landings exceeded the 2024 ACL by 5,975 pounds (lb; 2.7 metric tons (mt)). The regulations require an overage to be deducted in the following year. The resulting specifications are summarized in table 1.

The directed golden tilefish fishery is managed under an individual fishing quota (IFQ) program, with a small amount of non-IFQ catch allowed under an incidental permit. This action implements 2025 and projects 2026 and 2027 specifications for golden tilefish. This action implements a constant-ABC approach, which members of the golden tilefish fishing industry have historically supported. The final specifications for golden tilefish are detailed in table 2.

This action does not change the landing limits for non-IFQ commercial fisheries. A vessel fishing under a non-IFQ Federal commercial tilefish vessel permit will continue to be prohibited from possessing gutted golden tilefish amounting to more than 500 lb (227 kilograms (kg)) or 50 percent by weight of the total of all species being landed, whichever is less. This landing limit does not apply to a vessel authorized to land golden tilefish under a Tilefish IFQ permit. A vessel fishing under a non-IFQ commercial tilefish permit will also continue to be prohibited from possessing more than 500 lb (227 kg) of gutted blueline tilefish per trip. If 70 percent of the blueline tilefish commercial TAL is landed, the Regional Administrator may reduce the blueline tilefish possession limit to 300 lb (136 kg).

This action does not change the recreational management measures for golden or blueline tilefish. Any vessel used to fish recreationally for golden or blueline tilefish must have the appropriate Federal vessel permit. Boats used to take anglers for hire must have the Charter/Party Tilefish Permit, while private recreational vessels need to have the Private Recreational Tilefish Permit. Both permit types require the submission of vessel trip reports. Additional information about permitting and reporting requirements is available from the Greater Atlantic Regional Fisheries Office's Permits Office at (978) 282-8438 or NMFS.GAR.Permits@noaa.gov.

The 2025 fishing year for golden tilefish and blueline tilefish began on January 1, 2025. The regulations include rollover provisions for both species that allow the fisheries to operate under status quo specifications until new specifications are approved.

We received three comments on the proposed rule. Two of the comments received were not relevant to this rule and are, therefore, not discussed further. No changes were made from the proposed action.

Comment: The commenter is an individual who is not directly involved in either the golden or the blueline tilefish fisheries. The commenter expressed general support for the action and the need for, and importance of, setting specifications for the tilefish fisheries to prevent overfishing from occurring. The comment notes that specification-setting is also economically important for the industry which utilizes the resource.

Response: NMFS agrees. This action approves 2025 specifications for blueline and golden tilefish and projects 2026 and 2027 golden tilefish specifications.

NMFS is issuing this rule pursuant to section 305(d) of the Magnuson Stevens Act (16 U.S.C. 1855(d)). In a previous action taken pursuant to section 304(b) of the Magnuson-Stevens Act (16 U.S.C. 1854(b)), the FMP and implementing regulations created the process by which specifications are developed through a NMFS rulemaking process distinct from that of 304(b). See 50 CFR 648.292. As such, NMFS is issuing this rule pursuant to section 305(d). The NMFS Assistant Administrator has determined that this final rule is consistent with the Tilefish FMP, other provisions of the Magnuson-Stevens Act, and other applicable law.

There is good cause under 5 U.S.C. 553(d)(3) to waive the 30-day delay in effective date. The 2025 fishing year began on January 1, 2025, operating under a rollover provision using specifications from the prior fishing year. This is a routine specifications action that occurs every year, and stakeholder and industry groups have been involved with the development of this action and have participated in public meetings throughout its development. Further delay in the date of effectiveness would be contrary to the public interest as it could increase confusion in the tilefish industry around current quotas. The 2025 fishing year quotas are slightly lower than the quotas from the prior year that are currently in effect, so continued delay in the effectiveness of this rule could increase the risk of overages that may result in overfishing. Furthermore, regulated parties do not require any additional time to come into compliance with this rule and a 30-day delay before the final rule becomes effective does not provide any benefit. Unlike actions that require an adjustment period, tilefish fishing vessels will not have to purchase new equipment or otherwise expend time or money to comply with these management measures. Rather, complying with this final rule simply means adhering to the new catch limits set for the 2025 fishing year. Finally, fishery stakeholders have also been involved in the development of this action and are anticipating this rule. For these reasons, there is good cause not to delay the effective date of this final rule, consistent with 5 U.S.C. 553(d)(3), and to implement this action upon publication in the Federal Register .

This final rule is exempt from review under Executive Orders 12866 and 14192.

NMFS has determined that this action would not have a substantial direct effect on one or more Indian Tribes, on the relationship between the Federal Government and Indian Tribes, or on the distribution of power and responsibilities between the Federal Government and Indian Tribes; therefore, consultation with Tribal officials under E.O. 13175 is not required, and the requirements of sections (5)(b) and (5)(c) of E.O. 13175 also do not apply. A Tribal summary impact statement under section (5)(b)(2)(B) and section (5)(c)(2)(B) of E.O. 13175 is not required and has not been prepared.

The Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration during the proposed rule stage that this action would not have a significant economic impact on a substantial number of small entities. The factual basis for the certification was published in the proposed rule and is not repeated here. No comments were received regarding this certification. As a result, a regulatory flexibility analysis was not required and none was prepared.

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

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

The New England Fishery Management Council (Council) manages the small-mesh multispecies fishery within the Northeast Multispecies FMP. The small-mesh multispecies fishery is made up of three species of hakes that are managed as five stocks: (1) Northern and southern silver hake; (2) northern and southern red hake; and (3) offshore hake. Southern silver hake and offshore hake are often grouped together for management purposes and collectively referred to as “southern whiting.” Amendment 19 to the FMP (April 4, 2013, 78 FR 20260) established a process for specifying catch limits for the small-mesh multispecies fishery stocks, including values for an overfishing limit (OFL), acceptable biological catch (ABC), ACL, and TAL. The FMP requires that this specifications process be implemented on an annual basis for up to 3 years at a time with each fishing year running from May 1 through April 30. Prior to the start of fishing year 2024, the Council recommended specifications for the 2024-2026 fishing years (table 1).

The Council's recommendations for the 2024-2026 small-mesh multispecies fishery specifications are based on the most recent assessments of the small-mesh multispecies stocks conducted in September 2023 and the recommendations from the Council's Scientific and Statistical Committee. The southern red hake stock remains under a rebuilding plan established in Framework Adjustment 62 to the Northeast Multispecies FMP (87 FR 3694, January 25, 2022), and we will continue to implement the 25-percent reduction on the Council-recommended ABC in accordance with the rebuilding plan. We continue to maintain the position that we do not anticipate the 25-percent reduction to have a meaningful impact on industry. The fishery has landed approximately 19 percent of the TAL for the 2024 fishing year as of the end of February 2025 and is not anticipated to have substantially higher landings for the remainder of the year based on fishing trends over the last three years.

On August 29, 2024, NMFS published a final rule implementing the Council-recommended specifications with the required reduction to southern red hake for the 2024 fishing year, effective through April 30, 2025, and projecting the fishery's specifications for 2025 through 2026 (89 FR 70124). At the end of each fishing year, we evaluate catch information and determine if any of the quotas have been exceeded. If a quota is exceeded, the regulations at 50 CFR 648.90(b)(5)(ii) require that in a subsequent year, the in-season adjustment trigger that reduces possession limits be reduced by the same percentage that the ACL was exceeded. In any given year when new specifications are not implemented by May 1, the start of the new fishing year, the previous year's specifications remain in effect until superseded by the final rule implementing the current year's specifications (50 CFR 648.90(b)(1)(iv)(D)).

We have reviewed available 2023 and 2024 fishery information against the projected 2025 specifications. At its September 2024 meeting, the Council received the 2023 year-end report and did not make any recommended changes to the 2025 proposed specifications. There have been no quota overages, nor is there any new biological information that would require altering the projected 2025 specifications published in 2024. Based on this information, we are finalizing specifications for fishing year 2025, as projected in the 2024 specifications rule, and outlined above in table 1. These specifications are not expected to result in overfishing and adequately account for scientific uncertainty. NMFS will provide notice of the final 2026 specifications, and any necessary reductions, prior to the start of the 2026 fishing year.

NMFS is issuing this rule pursuant to the authority at section 305(d) of the Magnuson-Stevens Act, which authorizes the Secretary of Commerce to implement management measures necessary to carry out an approved FMP. Small-mesh multispecies specifications are implemented pursuant to the regulations at 50 CFR 648.90 that were approved and implemented by NMFS in Amendment 19 to the FMP (78 FR 20260; April 4, 2013). The NMFS Assistant Administrator has determined that this final rule is consistent with the Northeast Multispecies FMP, the 2024-2026 small-mesh multispecies specifications, and other applicable law.

This final rule is exempt from review under Executive Order (E.O.) 12866 and from E.O. 14192.

Pursuant to the Administrative Procedure Act (APA) (5 U.S.C. 553(c)) and the process described in the small-mesh multispecies regulations (§ 648.90), NMFS provided the public with the opportunity to comment on the proposed rule to implement 2024-2026 small-mesh multispecies fishery specifications (89 FR 59034; July 22, 2024), which included the projected 2025 specifications that are being reaffirmed through this final rule. We received one comment on the proposed rule that requested we correct the northern red hake TAL to reflect the Council's recommendation and acknowledging our requirement to adjust the southern red hake ABC to meet the requirements of the rebuilding plan. We responded to that comment and made the requested correction in the final rule to implement 2024-2026 small-mesh multispecies specifications (89 FR 70124, August 29, 2024). This final rule contains no changes from the projected 2025 specifications that were included in the August 29, 2024, final rule (89 FR 70124). Through both the proposed rule for the 2024-2026 specifications and the final rule for the 2024 specifications, we alerted the public that we would conduct a review of the latest available catch information in each of the interim years of the multi-year specifications and announce the final quota prior to the May 1 start of the fishing year. Thus, the proposed and final rules that contained the projected 2025 specifications provided a full opportunity for the public to comment on the substance and process of this action. Furthermore, at the September 2024 Council meeting, there was an opportunity for additional public comment following the Whiting Committee report. No comment was received about the proposed 2025 specifications.

The Chief Counsel for Regulation, Department of Commerce, previously certified to the Chief Counsel for Advocacy of the Small Business Administration (SBA) that the 2024-2026 small-mesh multispecies specifications would not have a significant economic impact on a substantial number of small entities. Implementing the 2025 specifications will not change the conclusions drawn in that previous certification to the SBA. No comments were received regarding this prior certification. As a result, no new regulatory flexibility analysis is required and none has been prepared.

This action does not contain a collection of information requirement for purposes of the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq. ). NMFS has determined that this action would not have a substantial direct effect on one or more Indian Tribes, on the relationship between the Federal Government and Indian Tribes, or on the distribution of power and responsibilities between the Federal Government and Indian Tribes; therefore, consultation with Tribal officials under E.O. 13175 is not required, and the requirements of sections (5)(b) and (5)(c) of E.O. 13175 also do not apply. A Tribal summary impact statement under section (5)(b)(2)(B) and section (5)(c)(2)(B) of E.O. 13175 is not required and has not been prepared.

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

The final rule announces the U.S. total allowable catch (TAC) for Pacific whiting, which was determined under the terms of the Agreement Between the Government of the United States of America and the Government of Canada on Pacific Hake/Whiting of 2003 (Agreement). This final rule also establishes a Tribal Pacific whiting allocation based on a percentage of the recommended U.S. TAC of Pacific whiting, a 2025 set-aside for research and incidental mortality in non-groundfish fisheries, and the 2025 Harvest Guideline (HG) and sector allocations for the non-Tribal commercial Pacific whiting fishery. NMFS implements these actions under the authority of the Pacific Coast Groundfish Fishery Management Plan (FMP), sections 304(b) and 305(d) of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act), the Pacific Whiting Act of 2006 (Whiting Act), and other applicable laws.

The Tribal and non-Tribal commercial Pacific whiting fisheries open on May 1 of each year. The Tribal and non-Tribal commercial sector allocations for Pacific whiting, as well as set-asides, are effective until December 31, 2025.

The transboundary stock of Pacific whiting is managed through the Agreement. The Agreement establishes bilateral management bodies to implement the terms of the Agreement. The bilateral bodies include: the Joint Management Committee (JMC), which recommends the annual catch limit for Pacific whiting; the Joint Technical Committee (JTC), which conducts the Pacific whiting stock assessment; the Scientific Review Group (SRG), which reviews the stock assessment; and the Advisory Panel (AP), which provides stakeholder input to the JMC. NMFS issued a proposed rule on April 15, 2025 (90 FR 15675) that further describes the Agreement, the distribution of the Pacific whiting coastwide TAC between the United States (73.88 percent) and Canada (26.12 percent), the bilateral bodies to implement the terms of the Agreement, including the JMC, and the process used to determine the coastwide TAC under the Agreement.

The Treaty's AP and the JMC met in Victoria, British Columbia on March 11-13, 2025, to develop advice on a 2025 coastwide TAC. The AP provided its 2025 TAC recommendation to the JMC on March 12, 2025. The JMC reviewed the advice of the JTC, the SRG, and the AP, and agreed on a TAC recommendation for transmittal to the United States and Canadian Governments.

The Agreement directs the JMC to base the catch limit recommendation on the F-40 default harvest rate, unless scientific evidence demonstrates that a different harvest rate is necessary to sustain the offshore Pacific whiting resource. The F-40 default harvest rate is a fishing mortality rate that would reduce the spawning biomass of Pacific whiting to 40 percent of the estimated unfished level. After consideration of the 2025 stock assessment and other relevant scientific information, the JMC did not use the default harvest rate, and instead agreed on a more conservative approach. There were 4 primary reasons for choosing a TAC below the default harvest rate: (1) the last available survey biomass estimate (from 2023) was the third lowest in the time series; (2) the proportion of fish in Canadian waters was at an all-time low; (3) catch attainment for both countries declined in the last two years reaching all-time lows relative to their respective TAC levels in 2024; and (4) the biomass of whiting has shifted south in both 2023 and 2024 resulting in lower observed biomass off Washington and Oregon, and higher biomass off of California waters. Further, long-term trends in acoustic survey biomass show lower proportions of whiting migrating into Canadian waters. The JMC concluded that these factors warranted setting the coastwide TAC below the 2024 value of 555,000 metric tons (mt), and lower than the level that would result from application of the F-40 default harvest rate. This conservative approach was endorsed by the AP and is consistent with Article III.1. of the Agreement.

The Agreement allows an adjusted TAC when either country's catch exceeds or is less than its TAC in the prior year. If the catch is in excess of the country's TAC, the amount of the overage is deducted from that country's TAC in the following year. If catch falls short of the country's TAC, a portion of the shortfall is carried over and added to the country's TAC for the following year. Under the Agreement, carryover adjustments cannot not exceed 15 percent of a party country's unadjusted TAC for the year in which the shortfall occurred. In 2024, neither country fully attained their respective TACs. The percentage of the U.S. TAC attained for 2024 is detailed in the Final Regulatory Flexibility Analysis (FRFA) (see the ADDRESSES section), which is summarized in the Classification section below.

For the 2025 Pacific whiting fishery, the JMC recommended an unadjusted coastwide TAC of 328,973 mt. Based on Article III.2 of the Agreement, the Canadian share of the unadjusted coastwide TAC is 26.12 percent (85,928 mt) and the U.S. share is 73.88 percent (243,045 mt). Consistent with Article II.5(b) of the Agreement, an adjustment (carryover from 2024) of 18,552 mt is added to the Canadian share, for an adjusted Canadian TAC of 104,480 mt. In the same manner, an adjustment of 52,475 mt is added to the United States share, for an adjusted United States TAC of 295,520 mt. This results in a coastwide adjusted TAC of 400,000 mt for 2025.

This recommendation is consistent with the best available scientific information and provisions of the Agreement. The recommendation was transmitted via letter to the United States and Canadian Governments on March 13, 2025. NMFS, under delegation of authority from the Secretary of Commerce (Secretary), approved the TAC recommendation of 243,045 mt for U.S. fisheries on April 17, 2025.

This final rule announces the adjusted coastwide TAC of 400,000 mt and an adjusted U.S. TAC of 295,520 mt.

This final rule establishes the Tribal allocation of Pacific whiting for 2025. Four Washington coastal treaty Indian Tribes—the Makah Indian Tribe, the Quileute Indian Tribe, the Quinault Indian Nation, and the Hoh Indian Tribe (collectively, the Treaty Tribes)—can participate in the Tribal Pacific whiting fishery. The regulations at 50 CFR 660.50(d) identify the procedures for implementing the treaty rights that Pacific Coast Treaty Tribes have to harvest groundfish in their usual and accustomed fishing areas in U.S. waters, including the process by which Tribes with treaty fishing rights in the area covered by the FMP request allocations, set-asides, or regulations specific to the Treaty Tribes. 50 CFR 660.50(d) provides that the Secretary will develop Tribal allocations and regulations in consultation with the affected Treaty Tribes and, insofar as possible, with Tribal agreement.

NMFS allocates a portion of the U.S. TAC of Pacific whiting to the Tribal fishery following the process established in 50 CFR 660.50(d). The Tribal allocation is subtracted from the U.S. Pacific whiting TAC before allocation to the non-Tribal sectors.

In its proposed rule issued on April 15, 2025 (90 FR 15675), NMFS described the Tribal allocation as 17.5 percent of the U.S. TAC, and projected a range of potential Tribal allocations for 2025 based on a range of U.S. TACs over the last 10 years (plus or minus 15 percent to capture variability in stock abundance). The proposed rule used a range of U.S. TACs because the 2025 U.S. TAC was not approved before the proposed rule publication date. As described in the proposed rule, the resulting range of potential Tribal allocations was 48,354 mt and 92,927 mt. Applying the approach described in the proposed rule, NMFS is establishing the 2025 Tribal allocation of 51,716 mt in this final rule, which is 17.5 percent of the U.S. TAC of 295,520 mt.

As with prior Tribal allocations of Pacific whiting, this final rule is not intended to establish a precedent for future Pacific whiting seasons, or for the determination of the total amount of Pacific whiting to which the Tribes are entitled under their treaty right. In 2009, NMFS, the States of Washington and Oregon, and the coastal treaty Tribes started a process to determine the long-term Tribal allocation for Pacific whiting; however, no long-term allocation has been determined. The long-term Tribal treaty amount will be based on further development of scientific information and additional coordination and discussion with and among the coastal treaty Tribes and the States of Washington and Oregon.

The U.S. non-Tribal whiting fishery is managed under the FMP. Each year, the Council recommends a set-aside to accommodate research activities and incidental mortality in non-groundfish fisheries ( e.g., pink shrimp) based on estimates of scientific research catch and estimated bycatch mortality in non-groundfish fisheries (50 CFR 660.55(j)). At its November 2024 meeting, the Council recommended a research and incidental mortality set-aside of 750 mt for 2025, which would be unchanged from 2024. This final rule implements the Council's recommendation for a 750 mt set-aside for 2025.

This final rule implements the fishery HG ( i.e., the non-Tribal allocation) and non-Tribal commercial sector allocations for Pacific whiting for 2025. NMFS did not include the non-Tribal HG and sector allocations in the proposed rule due to the timing of the TAC recommendation and approval process under the Agreement and the Whiting Act. The non-Tribal HG and sector allocations could not be determined for the proposed rule because they are based on the U.S. TAC. NMFS, under delegation of authority from the Secretary of Commerce, approved the U.S. TAC for Pacific whiting on April 17, 2025, which was after the publication of the proposed ruled. The U.S. Agreement committees and interested parties were notified via direct email when the TAC was approved, and interim sector allocations were issued to open the fishery, on May 1.

Each year NMFS establishes the non-Tribal fishery HG for Pacific whiting and distributes it to the non-Tribal sectors according to the commercial allocation structure in the FMP section 6.3.2.2 and regulations at 50 CFR 660.55(i)(2). To determine the 2025 non-Tribal fishery HG, the 2025 Tribal allocation of 51,716 mt, and the 750 mt set-aside for research and incidental mortality are deducted from the total adjusted U.S. TAC of 295,520 mt, resulting in a fishery HG of 243,054 mt.

The HG is then allocated among the three non-Tribal sectors of the Pacific whiting fishery: The Catcher/Processor (C/P) Co-op Program, the Mothership (MS) Co-op Program and the Shorebased Individual Fishing Quota (IFQ) Program. The C/P Co-op Program is allocated 34 percent (82,638.36 mt for 2025), the MS Co-op Program is allocated 24 percent (58,332.96 mt for 2025), and the Shorebased IFQ Program is allocated 42 percent (102,082.68 mt for 2025). These commercial sector allocations are summarized in table 1 below. The fishery south of 42° N lat. may not take more than 7,088 mt (5 percent of the Shorebased IFQ Program allocation) prior to May 1, the start of the primary Pacific whiting season north of 42° N lat.

NMFS issued a proposed rule on April 15, 2025 (90 FR 15675). The comment period on the proposed rule closed April 30, 2025. NMFS received three comments from individuals during the comment period. Two of the comments received supported the action. Neither of those comments included further recommendations for changes to the proposed action. The third comment received was not relevant to this rulemaking.

No substantive changes from the proposed action were made to the final action based on the relevant comments received.

This final rule is implemented under the statutory and regulatory authority of sections 304(b) and 305(d) of the Magnuson-Stevens Act, the Whiting Act, the regulations governing the groundfish fishery at 50 CFR 660.5-660.360, and other applicable laws. NMFS is using section 305(d) of the Magnuson-Stevens Act for the Tribal allocation because in a previous action taken pursuant to section 304(b), the FMP and its implementing regulations authorize NMFS to take action pursuant to Magnuson-Stevens Act section 305(d).

The NMFS Assistant Administrator has determined that this final rule is consistent with sections 304(b)(1)(a) and 305(d) of the Magnuson-Stevens Act, the Whiting Act, the regulations governing the groundfish fishery at 50 CFR 660.5-660.360, and other applicable laws. Additionally, pursuant to Magnuson-Stevens Act section 305(d), this action is necessary to carry out Tribal allocations, set-asides, and regulations pursuant to FMP section 6.2.5 and 50 CFR 660.50(d)(1) because with this rule, NMFS will ensure that the fishery is managed in a manner consistent with treaty rights of the four Treaty Tribes to fish in their “usual and accustomed grounds and stations” in common with non-Tribal citizens ( United States v. Washington, 384 F. Supp. 313 (W.D. Wash. 1974)).

Pursuant to Executive Order 13175, this action was developed after meaningful and timely consultation with Tribal officials from the area covered by the FMP. NMFS consulted with the Treaty Tribes per requirements under the MSA at 16 U.S.C. 1852(b)(5), wherein one of the voting members of the Pacific Council must be a representative of an Indian Tribe with federally recognized fishing rights from the area of the Council's jurisdiction. In addition, NMFS invited consultation on this action through exchanged emails with Tribal officials leading up to the development of the rule and through this rule will implement the allocation requested by the Makah Indian Tribe. Regulations implementing the FMP establish a procedure by which the Tribes with treaty fishing rights in the area covered by the FMP request allocations or regulations specific to the Tribes, in writing, before the first of the two meetings at which the Council considers groundfish management measures. The regulations at 50 CFR 660.50(d)(2) further state that the Secretary will develop Tribal allocations and regulations under this paragraph in consultation with the affected Tribe(s) and, insofar as possible, with Tribal consensus.

Pursuant to 5 U.S.C. 553(d)(3), the NMFS Assistant Administrator finds good cause to waive the 30-day delay in the date of effectiveness for this final rule because such a delay would be contrary to the public interest. The Pacific whiting fishery season began on May 1, 2025 under interim allocations based on a proxy coastwide TAC analyzed in the 2025 Pacific whiting stock assessment (see ADDRESSES ). This proxy coastwide TAC was 350,000 mt, which is approximately 12.5 percent lower than the 2025 adjusted coastwide TAC of 400,000 mt recommended by the JMC and approved by the Secretary. If the non-Tribal commercial sectors fully harvest this partial interim allocation before the final TAC is implemented, NMFS will be required to close the Pacific whiting fishery until such time that the full 2025 season allocation is implemented. Timely implementation of the full TAC will avoid the need to close the Pacific whiting fishery if the current interim allocations are fully harvested.

As the Pacific whiting season is only open from May 1 to December 31, a 30-day delay in the implementation of the full 2025 season allocations represents a significant operational limitation to the commercial whiting sectors. If this final rule were delayed by 30 days, the Pacific whiting commercial sectors would not be able to fish under the final catch limits for Pacific whiting for that time period, be at risk of potential premature season closure, and would not be able to realize the full level of economic opportunity this rule provides. This rule increases catch limits for Pacific whiting compared to the restrictive partial interim allocation the fishery is currently operating under, and NMFS therefore finds good cause to waive the 30-day delay in the date of effectiveness requirement.

Additionally, many vessels in the Pacific whiting fishery also participate in the Alaskan pollock fishery. The Alaskan pollock fishery B-season typically runs from mid-June to mid-November of each year, overlapping with the May 1 to December 31 Pacific whiting season. Vessels that participate in both the West Coast Pacific whiting fishery, and the Alaskan pollock fishery must time operations and travel between these fisheries. Without having access to their full 2025 Pacific whiting season allocations, fishery participants are unable to plan the timing of their operations, and are restricted in their participation in these fisheries for the 2025 season. Issuing complete 2025 Pacific whiting allocations to quota owners in a timely fashion ensures they can plan their participation for the year in both the Pacific whiting and Alaskan pollock fisheries. Implementing this rule upon the date of publication relieves the limitation in planning vessel operations and provides the commercial whiting fleet more opportunity and greater flexibility to harvest the optimal yield. Waiving the 30-day delay in effectiveness will allow this final rule to more fully benefit the fishery through increased fishing opportunities as described in the preamble of this rule.

This rulemaking could not be completed prior to the May 1 start date of the 2025 Pacific Whiting primary fishing season due to the timeline required by the Agreement, which resulted in the short time frame between the approval of the TAC recommendation and the start of the fishing season. The AP and JMC met in Victoria, British Columbia on March 11- 13, 2025, to develop a recommendation for a 2025 coastwide TAC. At this meeting, the JMC agreed on a TAC recommendation, which was transmitted to the United States and Canadian Governments on March 13, 2025. In a written communication to the NMFS West Coast Region on April 1, 2025, the Department of State concurred with the 2025 TAC recommendation. The proposed rule was published on April 15, 2025 (90 FR 15675). The Department of Commerce consulted with the Department of State on the recommended TAC and concurred with the NMFS West Coast Region on April 17, 2025 to accept the JMC recommended adjusted TAC for 2025. The public comment period closed on April 30, 2025. The 2025 Pacific whiting primary fishing season began shortly thereafter on May 1, 2025. Therefore, NMFS could not issue full season allocations implemented under this final rule prior to the May 1 start date of the Pacific whiting fishery.

Waiving the 30-day delay in effectiveness will not have a negative impact on any entities, as there are no new compliance requirements or other burdens placed on the fishing community with this rule. Making this rule effective immediately would also serve the best interests of the public because it will allow for the longest possible fishing season for Pacific whiting and therefore the best possible economic outcome for those whose livelihoods depend on this fishery.

The Office of Management and Budget has determined that this final rule is not significant for purposes of Executive Order 12866.

This final rule is not an Executive Order 14192 regulatory action because this action is not significant under Executive Order 12866.

A range of potential total harvest levels for Pacific whiting has been considered in the Final Environmental Impact Statement (FEIS) for Harvest Specifications and Management Measures for 2015-2016 and Biennial Periods thereafter (2015/16 FEIS), and in the Environmental Assessment (EA) and the Regulatory Impact Review (RIR) included in the analytical document for Amendment 30 to the Pacific Coast Groundfish FMP and 2025-2026 Harvest Specifications and Management Measures. These documents are available from NMFS (see ADDRESSES ). The 2015/16 FEIS examined the harvest specifications and management measures for 2015-2016 and gave 10-year projections for routinely adjusted harvest specifications and management measures. The 10-year projections were produced to evaluate the impacts of the ongoing implementation of harvest specifications and management measures and to evaluate the impacts of the routine adjustments that are the main component of each biennial cycle. The EA for the 2025-2026 cycle builds on the 2015/16 FEIS and focuses on the harvest specifications and management measures that were not within the scope of the 10-year projections in the 2015/16 FEIS.

NMFS issued a proposed rule on April 15, 2025 (90 FR 15675) for the 2025 Pacific whiting Tribal allocation and 2025 incidental set-aside. An Initial Regulatory Flexibility Analysis (IRFA) was prepared and summarized in the Classification section of the preamble to the proposed rule. The comment period on the proposed rule closed April 30, 2025. NMFS received two public comments in support of the proposed rule, and one that was not relevant. The Chief Counsel for Advocacy of the Small Business Administration (SBA) did not file any comments on the IRFA or on the proposed rule. The description of this action, its purpose, and its legal basis are described in the preamble to the proposed rule and are not repeated here. A FRFA was prepared and incorporates the IRFA. There were no public comments received on the IRFA. A copy of the FRFA is available from NMFS (see ADDRESSES ). A summary of the FRFA, per the requirements of 5 U.S.C. 604, follows.

Under the RFA, the term “small entities” includes small businesses, small organizations, and small governmental jurisdictions. For purposes of complying with the RFA, NMFS has established size criteria for entities involved in the fishing industry that qualify as small businesses. A business involved in fish harvesting is a small business if it is independently owned and operated and not dominant in its field of operation (including its affiliates) and if it has combined annual receipts not in excess of $11 million for all its affiliated operations worldwide (80 FR 81194, December 29, 2015; 50 CFR part 200). In addition, the SBA has established size criteria for other entities that may be affected by this proposed rule. A wholesale business servicing the fishing industry is a small business if it employs 100 or fewer persons on a full time, part time, temporary, or other basis, at all its affiliated operations worldwide (NAICS code 424460; 13 CFR 121.201). A seafood processor is a small business if it is independently owned and operated, not dominant in its field of operation, and employs 750 or fewer persons on a full time, part time, temporary, or other basis, at all its affiliated operations worldwide (NAICS code 311710; 13 CFR 121.201). For purposes of this rulemaking, NMFS is also applying the seafood processor standard to C/Ps because whiting C/Ps earn the majority of the revenue from processed seafood product.

NMFS issued a proposed rule on April 15, 2025 (90 FR 15675). The comment period on the proposed rule closed on April 30, 2025, and NMFS received three comments. Two of the comments received supported the action. Neither of those comments provided further recommendations for changes to the proposed action. The third comment received was not relevant to this rulemaking.

This rule affects how Pacific whiting is allocated to the following sectors/programs: Tribal, Shorebased IFQ Program Trawl Fishery, MS Co-op Program Whiting At-sea Trawl Fishery, and C/P Co-op Program Whiting At-sea Trawl Fishery. The amount of Pacific whiting allocated to these sectors is based on the U.S. TAC, which is developed and approved through the process set out in the Agreement and the Whiting Act.

NMFS expects one Tribal entity, the Makah Tribe, to fish for Pacific whiting in 2025. Tribes are not considered small entities for the purposes of RFA. Impacts to Tribes are nevertheless considered in this analysis.

Although there are three non-Tribal sectors directly affected by this rule (the C/P Co-op Program, the Shorebased IFQ Program, and the MS Co-op Program), many companies participate in two sectors, and some participate in all three sectors, as well as other non-whiting groundfish fisheries. For example, some companies may own permits in both the C/P and MS sectors, and own vessels capable of operating as either a C/P or an MS. Depending on the operational needs of the parent company in a given year, a C/P vessel may be assigned a permit to alternatively act as an MS. As part of the permit application processes for the non-Tribal fisheries, NMFS asks permit applicants if they considered themselves a small business based on a review of the SBA size criteria and asks each permit applicant to provide detailed ownership information. Data on employment worldwide, including affiliates, are not available for these companies, which generally operate in Alaska as well as on the West Coast in non-whiting groundfish fisheries and may have operations in other countries, as well. NMFS requests that limited entry permit holders self-report their size status. There is substantial, but not complete, overlap between permit ownership and vessel ownership, so there may be a small number of additional small entity vessel owners who will be impacted by this rule.

The C/P Co-op Program is composed of 10 C/P endorsed permits owned by 3 companies that have formed a single co-op. This co-op is considered a large entity both because it has participants that are large entities and because it has in total more than 750 employees worldwide including affiliates. For 2025, all 3 owners of the 10 C/P permits reported that they are not small businesses.

As of January 2025, the Shorebased IFQ Program is composed of 158 Quota Share permits/accounts (120 of which were allocated whiting quota pounds (54 kilograms) and 39 licensed first receiver sites, of which 7 companies receive whiting. Of these companies that receive whiting, six are not considered small entities.

The MS Co-op Program is the limited access program that applies to eligible harvesters and processors in the MS sector of the Pacific whiting at-sea trawl fishery. In 2025 this program consists of 6 MS processor permits and a catcher vessel fleet currently composed of a single co-op with 33 Mothership/Catcher Vessel endorsed permits (with 3 permits each having two catch history assignments). For 2025, 8 permits in the MS Co-op reported that they are not small businesses.

After accounting for cross-fishery participation, multiple Quota Share account holders, and affiliation through ownership, NMFS estimates based on 2025 permit registration and quota share information that there are 100 non-Tribal entities directly affected by these regulations, 86 of which are considered small entities. This is considered a significant number of small entities. This rule is not expected to result in adverse impacts on small entities, as detailed in the following sections of this FRFA.

The final rule will allocate Pacific whiting between Tribal and non-Tribal commercial harvesters (a mixture of small and large businesses). Tribal fisheries consist of a mixture of fishing activities that are similar to the activities that non-Tribal fisheries undertake. Tribal harvests may be delivered to both shoreside plants and motherships for processing. These processing facilities also process fish harvested by non-Tribal fisheries. The effect of the Tribal allocation on non-Tribal fisheries will depend on the level of Tribal harvests relative to their allocation and the reapportionment process as described in regulations at 50 CFR 660.131(h). If the Tribes do not harvest their entire allocation, there are opportunities during the year to reapportion unharvested Tribal amounts to the non-Tribal commercial fleets.

The prices for Pacific whiting are largely determined by the world market because most of the Pacific whiting harvested in the United States is exported. The U.S. Pacific whiting TAC is highly variable, as is subsequent attainment of sector allocations, and ex-vessel revenues. For the years 2013 to 2023, the U.S. non-Tribal commercial fishery sectors averaged harvests of approximately 262,531 mt, and revenues of $52.7 million annually. The 2024 average ex-vessel price of Pacific whiting, which was $230.91 per mt. The 2024 U.S. non-Tribal commercial fishery sectors attained a Pacific whiting catch of approximately 165,061 mt out of a harvest guideline of 337,528 mt (48.9 percent attainment), resulting in a total revenue of $46.6 million.

Impacts to the U.S. non-Tribal fishery are measured with an estimate of ex-vessel revenue. The adjusted coastwide TAC of 400,000 mt results in an adjusted U.S. TAC of 295,520 mt and, after deduction of the Tribal allocation and the incidental catch set-aside, a U.S. non-tribal harvest guideline of 243,054 mt. Using the 2024 weighted-average non-Tribal price of $230.91 per mt, the 2025 adjusted U.S. TAC is estimated to result in an ex-vessel revenue of $56.12 million for the U.S. non-tribal fishing fleet if 100 percent harvested. Due to operational constraints in 2025, the U.S. commercial sectors estimate a 75 percent attainment of the U.S. HG which would result in an ex-vessel revenue of $42.09 million.

Impacts to Tribal catcher vessels who elect to participate in the Tribal fishery are measured with an estimate of ex-vessel revenue. In lieu of more complete information on Tribal deliveries, total ex-vessel revenue is estimated with the 2024 average ex-vessel price of Pacific whiting, which was $230.91 per mt. At that price, the 2025 Tribal allocation of 51,716 mt would potentially have an ex-vessel value of $11.94 million if fully harvested.

The effect of the Tribal allocation on non-Tribal fisheries will depend on the level of Tribal harvests relative to their allocation and the reapportionment process. For example, in 2024 NMFS reapportioned 40,000 mt of the original 71,755.95 mt Tribal allocation (89 FR 84302, October 22, 2024). The revised Pacific whiting allocations for 2024 following the reapportionment were: Tribal 26,755.95 mt; C/P Co-op 130,059.53 mt; MS Co-op 91,806.73 mt; and Shorebased IFQ Program 160,661.78 mt. Shoreside processors are unlikely to be impacted by allocating U.S, Pacific whiting TAC between Tribal and non-Tribal sectors because they can receive and process landings from both Tribal and non-Tribal catcher vessels.

NMFS has determined this final rule would not have a significant economic impact on small entities. This rule is similar to previous rulemakings concerning Pacific whiting. In the context of an internationally set TAC, this rule concerns the amount of the U.S. TAC that should be allocated to the Tribal fishery and to a set-aside for research and bycatch in non-groundfish fisheries, and announces Pacific whiting allocations for the non-Tribal fishery for 2025. With this final rule, NMFS, acting on behalf of the Secretary, determined that the Pacific Coast Groundfish FMP is implemented in a manner consistent with treaty rights of four Treaty Tribes to fish in their “usual and accustomed grounds and stations” in common with non-tribal citizens ( United States v. Washington, 384 F. Supp. 313 (W.D. Wash. 1974)). Pacific whiting allocations to the non-Tribal sectors provide additional economic opportunity to the entities considered in this analysis to prosecute a quota species within a multi-species groundfish catch share program. In addition, the reapportioning process allows unharvested Tribal allocations of Pacific whiting, fished by small entities, to be fished by the non-Tribal fleets, potentially providing economic benefits to both large and small entities. NMFS believes this rule will not adversely affect small entities. Thus, as discussed above, this action would not have a significant economic impact on small entities. The TAC recommendation and resulting non-Tribal commercial sector allocations are based on the Treaty-based JMC recommendation and are non-discretionary, therefore NMFS did not consider any other alternatives.

This final rule contains no information collection requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

No Federal rules have been identified that duplicate, overlap, or conflict with this action.

Section 212 of the Small Business Regulatory Enforcement Fairness Act of 1996 states that, for each rule or group of related rules for which an agency is required to prepare a FRFA, the agency shall publish one or more guides to assist small entities in complying with the rule and shall designate such publications as “small entity compliance guides.” The agency shall explain the actions a small entity is required to take to comply with a rule or group of rules. Stakeholders subscribed to the Groundfish and Whiting listservs will be sent a public notice providing links to the final rule and the small entity compliance guide available from NMFS at the following website: https://www.fisheries.noaa.gov/action/2025-pacific-whiting-us-total-allowable-catch-2025-tribal-allocation-2025-incidental-set. Stakeholders will receive the notice without any further action on their end.

For the reasons set out in the preamble, NMFS amends 50 CFR part 660 as follows: