On September 28, 2023, the Office of Personnel Management (OPM) published an interim final rule in the Federal Register at 88 FR 66677 to implement changes authorized by the National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2023 on the noncompetitive appointment authority for certain military spouses. OPM made these changes to implement provisions in the FY 2023 NDAA, Public Law 117-263. Section 573(d) of Public Law 115-232 (“FY 2019 NDAA”) provided for a temporary amendment to 5 U.S.C. 3330d to expand the eligibility for noncompetitive appointment of spouses currently married to a member of the armed forces on active duty. Under the FY 2019 NDAA, this authority would have sunset on August 13, 2023, which was reflected in OPM's regulations. Section 1111 of the FY 2023 NDAA extended the temporary amendment until December 31, 2028.

Section 573(d) of the FY 2019 NDAA required agencies to report annually to OPM on the number of relocating and non-relocating spouses of current military members appointed; the types of positions filled (by title, series, and grade level); and the effectiveness of this hiring authority. Section 573(d) also required a report to Congress 18 months after enactment that had become obsolete. The FY 2023 NDAA removed these temporary agency reporting requirements established under the FY 2019 NDAA. Although the reporting requirements have been removed from statute, section 3(f) of Executive Order 13832, of May 9, 2018, Enhancing Noncompetitive Civil Service Appointments of Military Spouses, imposed similar agency reporting requirements that are still in effect. The changes in the FY 2023 NDAA became effective upon the President's signature. OPM amended its regulations through the interim final rule to reflect the provisions of the FY 2023 NDAA.

Although the interim final rule was effective immediately upon publication, OPM provided a 60-day comment period, which ended November 27, 2023. OPM received nine comments on the interim rule: one comment from a federal agency and four individual comments. Four other individual comments were not responsive to the subject matter discussed in the rule and contained privacy protected information.

One Federal agency (comment OPM-2023-0026-006) recommended OPM remove the reference to “. . . January 1, 2029, or later . . .” in 5 CFR 315.612(e)(1)(ii). The interim final rule allows spouses married to members of the armed forces on active duty to remain eligible for non-competitive appointment until December 31, 2028. In accordance with the FY 2023 NDAA, on January 1, 2029, eligibility for spouses married to members of the armed forces on active duty will require the spouse to be indicated on the service member's permanent change of station (PCS) orders. The agency suggested that a military spouse should be eligible for appointment after January 1, 2029, regardless of the date of the PCS orders. OPM cannot adopt this suggestion. Section 573 of the FY 2019 NDAA amended 5 U.S.C. 3330d by, among other things, authorizing the head of an agency to appoint noncompetitively the spouse of a member of the armed forces on active duty. This amendment was originally to sunset in August 2023, but has since been extended until December 31, 2028, by the FY 2023 NDAA. After December 31, 2028, the statutory provisions will require a military spouse to have PCS orders dated January 1, 2029, or later to be eligible for noncompetitive appointment. The statute did not give OPM the authority to waive or modify this date.

Another individual (OPM-2023-0026-0004) did not support OPM's interim final rule. This commenter stated that special considerations for military spouses negatively impacts recruitment of the best and brightest individuals for Federal jobs. OPM does not share this view and does not have discretion in implementing this provision, which was mandated by statute. Furthermore, OPM notes that several noncompetitive and excepted service hiring authorities have been codified to groups of applicants in obtaining Federal employment.

Another individual (OPM-2023-0026-0005) suggested OPM apply these rules to spouses of the Department of State's Foreign Service. This commenter stated Foreign Service spouses face strains similar to those of military families, such as frequent moves overseas, without receiving the same level of support that military spouses receive. OPM cannot adopt this suggestion because the implementing statute does not provide for noncompetitive appointment of spouses of Foreign Service personnel unless otherwise eligible under these provisions.

Another commenter (OPM-2023-0026-0002) provided positive feedback and fully supported the swift implementation and expedited effective date, saying that the interim final rule ensured that the regulations accurately reflect the current statute. OPM appreciates this comment.

A different commenter (OPM-2023-0026-0003) generally supported the interim final rule. This individual stated that, although spouses of active-duty members face the hardship challenges of finding employment, the change to the recruitment date would give them a positive advantage. This commenter suggested that if the intent of the rule is to enhance the recruitment and hiring of military spouses for permanent Federal positions in the competitive service then OPM should remove the January 1, 2029 date. OPM appreciates this comment but notes the January 1, 2029 recruitment date is specified in statute and that OPM cannot alter it via regulation.

OPM is adopting the interim final rule with no changes.

This final rule adopts, without change, the interim final rule implementing statutory changes codified at 5 U.S.C. 3330d, which extended the eligibility date for noncompetitive appointment of military spouses married to a member of the armed forces on active duty until December 31, 2028, and removed the temporary agency reporting requirements established under section 573(d) of Public Law 115-232. OPM did not receive any comments on the costs identified in the interim final rule. The final rule will benefit military spouses married to military members on active duty and hiring agencies by reflecting the statutorily revised sunset date for the noncompetitive appointment hiring authority in the FY 2023 NDAA. This rule also benefits agencies by removing duplicative reporting requirements originally established under the FY 2019 NDAA provisions.

On September 28, 2023, OPM published an interim final rule (88 FR 66677) and determined that there was a basis under the Administrative Procedure Act for issuing the interim final rule with immediate effect. OPM has considered all relevant input and information contained in the comments submitted in response to the interim final rule and has concluded that no changes to the interim final rule are warranted. OPM is adopting the provisions of the interim final rule as a final rule with no changes.

Executive Orders 13563, 12866, and 14094 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). The Office of Management and Budget has determined that this final rule is not a “significant regulatory action” under Section (3)(f) Executive Order 12866, as amended by Executive Order 14094.

The Director of OPM certifies that this final rule will not have a significant economic impact on a substantial number of small entities because it applies only to Federal agencies and employees.

This final rule will not have substantial direct effects on the States, on the relationship between the National Government and the States, or on distribution of power and responsibilities among the various levels of government. Therefore, in accordance with Executive Order 13132, OPM has determined that this final rule does not have federalism implications that require preparation of a federalism summary impact statement.

OPM has determined this final rule meets the relevant standards of Executive Order 12988.

This final rule will not result in the expenditure by State, local or tribal governments, in the aggregate, or by the private sector of more than $100 million annually. Thus, no written assessment of unfunded mandates is required.

OMB's Office of Information and Regulatory Affairs has determined this final rule does not satisfy the criteria listed in 5 U.S.C. 804(2).

This final regulatory action will not impose any additional reporting or recordkeeping requirements under the Paperwork Reduction Act.

Over the past three years, the CFPB has extensively analyzed lenders marketing their loans as “Buy Now, Pay Later.” This includes a major study published in 2022, insights from supervisory examinations, and other market monitoring and investigation. Although market participants' loan offerings vary in this lending sector, the CFPB is publishing this interpretive rule to clarify existing obligations for market participants with specific business practices.

This interpretive rule's legal analysis states that lenders that issue digital user accounts that consumers use from time to time to access credit products to purchase goods and services are “card issuers” under Regulation Z, including when those products are marketed as Buy Now, Pay Later (BNPL). Such lenders are “card issuers” because such digital user accounts are “credit cards” under Regulation Z. Traditional BNPL products are closed-end loans payable in four or fewer installments without a finance charge, used to make purchases on credit. Consequently, BNPL loans are subject to some, but not all, of Regulation Z's credit card regulations.

Digital user accounts that consumers use to access BNPL credit mimic conventional credit cards. They meet the regulatory definition of “credit cards” as defined at 12 CFR 1026.2(a)(15)(i). Lenders that issue such digital user accounts are “card issuers” as defined at 12 CFR 1026.2(a)(7) and “creditors” for purposes of subpart B of Regulation Z, as defined at 12 CFR 1026.2(a)(17)(iii). However, traditional BNPL products do not meet the definition of “open-end credit” as defined at 12 CFR 1026.2(a)(20) or of a “credit card account under an open-end (not home-secured) consumer credit plan” as defined at 12 CFR 1026.2(a)(15)(ii).

Accordingly, lenders that issue digital user account to access BNPL credit are subject to the regulations appearing in subpart B of Regulation Z, including, most importantly, provisions governing credit card dispute and refund rights. Although subpart B is labeled “Open-End Credit,” 12 CFR 1026.2(a)(17)(iii) specifically states that subpart B also applies to credit that is not open end if, as with BNPL, the credit is not subject to a finance charge and is not payable by written agreement in more than four installments. This is the case because Congress expressly instructed the Bureau to apply open-end credit regulations to this form of credit that is not open end. The Truth in Lending Act (TILA) says that “the Bureau shall, by regulation, apply [open-end credit] requirements to [card issuers that extend credit with no finance charge that is payable in four or fewer installments], to the extent appropriate, even though the requirements [of the open-end credit provisions] are by their terms applicable only to creditors offering open-end credit plans.”  1

Lenders that issue digital user accounts to access BNPL credit are generally not subject to the credit card regulations appearing in subpart G of Regulation Z ( e.g., penalty fee limits and ability-to-repay requirements). 2

Since the mid-2010s, a financing method marketed as “Buy Now, Pay Later” (BNPL) has rapidly gained popularity as an alternative to conventional credit cards in the United States and abroad. 3 While variations of the product exist, for this interpretive rule, BNPL refers to a consumer loan for a retail transaction that is repaid in four (or fewer) interest-free installments and does not otherwise impose a finance charge. 4 The loan generally requires an initial down payment of 25 percent, followed by three additional installments due every two weeks.

BNPL lenders currently acquire customers primarily through two channels: the merchant partner acquisition model and the app-driven acquisition model. In the merchant partner acquisition model, BNPL lenders typically establish contracts with online merchants to offer their BNPL product as a payment option on the merchant's website or mobile app checkout page. 5 The BNPL lenders provide merchants with the necessary digital code to integrate or embed access to the BNPL product into the merchant websites or mobile apps. Such digital code or other integrations are referred to in this interpretive rule as “integrations.”

In the app-driven acquisition model, which is less common but rapidly expanding, consumers use the BNPL lender's own website or mobile app directly to create a digital user account to access the BNPL product. 6 Once activated by the provider, the consumer can use their digital user account through the BNPL website or mobile app to access credit and make purchases directly with partner merchants. For non-partner merchants, the BNPL lender enables the payment part of the credit process by issuing a single-use virtual card to the consumer, normally through an issuer processor and a bank partner. The consumer then typically has 24 hours to complete their purchase directly with the merchant, using the virtual card. 7

In addition, BNPL lenders may issue credit through other methods, such as in-store or through browser extensions. 8 These methods generally operate the same as the acquisition methods described above, allowing the consumer to access credit with their BNPL digital user account to make purchases either through the merchant's website or through the issuance of a single-use virtual card.

Regardless of how consumers access BNPL, a BNPL digital user account is activated when a consumer first accesses BNPL credit, similar to how a virtual credit card number for a traditional credit card account is issued at the same time a consumer opens the credit card account online and makes their first purchase on the card. These digital user accounts are secure, personal profiles that the BNPL provider activates for a consumer, enabling the consumer to access and utilize BNPL credit. 9 Once a digital user account is activated, the consumer can then immediately use their BNPL digital user account on an ongoing basis to access credit to make additional purchases. BNPL providers typically inform consumers of their “amount available to spend,” similar to a credit limit for conventional credit cards, and offer a frictionless borrowing process allowing consumers to rapidly access the BNPL credit. 10

A significant and increasing number of Americans who purchase goods and services on credit do so with BNPL credit instead of conventional credit cards. According to a recent CFPB Making Ends Meet survey, 17 percent of consumers with a credit record made at least one purchase using BNPL between February 2021 and February 2022. 11 And data from five leading BNPL lenders reflect that originations have increased from $2 billion in 2019 to over $24 billion in 2021. 12 BNPL borrowers also increased their repeat usage during this timeframe. The data reveal that the average number of BNPL loans taken out by BNPL consumers from a single lender each quarter rose from 1.9 to 2.8. 13 The percentage of BNPL borrowers with more than five loans per quarter also increased, from 6.3 percent to 15.5 percent. 14

BNPL is popular among a broad range of consumers, but certain groups have shown a significantly higher likelihood of using BNPL. These groups include Black, Hispanic, and female consumers, as well as consumers with an annual household income between $20,001-$50,000 and consumers under the age of 35. 15 In comparison to non-BNPL borrowers, BNPL borrowers tend to have higher levels of debt, carry balances on their conventional credit cards, have delinquencies on traditional credit products, and make use of higher-cost financial services like payday loans, pawn, and overdraft. 16 BNPL borrowers are also more likely to use other credit products like conventional credit cards, personal loans, and student loans, but have less liquidity and savings compared to non-BNPL borrowers. 17

Consumers often use BNPL offerings as an alternative to conventional credit cards, and the two share many similarities. Both combine payment processing and credit services. Both charge transaction fees to merchants and are extensively used for retail transactions. 18 And consumers often use these two payment methods in a similar manner. In fact, often when a consumer is making purchases online from a merchant's website, the only options for paying on credit consist of conventional credit cards and BNPL, which are presented next to each other as alternatives.

The CFPB has been closely monitoring the BNPL market by issuing reports based on collected BNPL data and supervising certain BNPL lenders. In December 2021, the CFPB issued mandatory data collection orders to five large BNPL lenders to understand market trends and practices. These responses formed the basis of the September 2022 report “Buy Now Pay Later: Market Trends and Consumer Impacts,” which highlighted industry growth, as well as consumer benefits and risks associated with BNPL loans. 19 The report noted, among other findings, a lack of standardized disclosures and challenges in resolving disputes. 20 In March 2023, the CFPB published “Consumer Use of Buy Now, Pay Later,” which used data from the annual Making Ends Meet survey and credit bureaus to identify demographic and other characteristics of BNPL borrowers. 21 In March 2024, the CFPB released its “Consumer Response Annual Report” for 2023, which noted issues consumers faced with merchants regarding BNPL, such as non-receipt of items and challenges in canceling loans. 22 Through monitoring consumer complaints, the CFPB has further refined its understanding of the BNPL market. The CFPB continues to observe the industry and monitor new market and product trends.

Recognizing the importance of adequate consumer protections for BNPL loans, the CFPB is issuing this interpretive rule so that BNPL providers understand their obligations. As this interpretive rule explains, lenders that issue BNPL digital user accounts are “card issuers” under Regulation Z because the digital user accounts they issue constitute “credit cards” under Regulation Z. The term “credit card”—which, as defined by TILA and Regulation Z, includes the term “other credit device” or “other single credit device” used for the purpose of obtaining credit—encompasses digital user accounts that consumers can use through websites, mobile apps, browser extensions, or integrations with merchant websites or mobile apps to access BNPL credit for the purchase of goods and services. The CFPB also affirms through this interpretive rule that BNPL lenders that extend credit—even though that credit is not subject to a finance charge and is not payable by written agreement in more than four installments—are creditors subject to subpart B of Regulation Z, including those provisions governing cost of credit disclosures and billing disputes.

This interpretive rule discusses the application of subpart B of Regulation Z to lenders that issue digital user accounts that consumers use from time to time to access credit, which includes those lenders that market their loans as “Buy Now, Pay Later.” Regulation Z  23 implements the Truth in Lending Act (TILA). 24 The purpose of TILA is to “assure a meaningful disclosure of credit terms so that the consumer will be able to compare more readily the various credit terms available to him and avoid the uninformed use of credit, and to protect the consumer against inaccurate and unfair credit billing and credit card practices.”  25 Accordingly, TILA and its implementing regulation generally establish uniform methods for calculating the cost of credit, require meaningful disclosure of those costs to consumers, and provide standardized mechanisms for resolving credit billing disputes. 26

Although subpart B primarily covers open-end credit, many of its provisions apply more broadly, including to closed-end credit, under certain circumstances. 27 Certain subpart B provisions, such as those governing cardholder liability, apply to any “card issuer,” regardless of the type of credit offered. 28 Regulation Z defines “card issuer” as “a person that issues a credit card or that person's agent with respect to the card.”  29 Additionally, “card issuers” are considered “creditors” for purposes of subpart B if they also extend “either open-end credit or credit that is not subject to a finance charge and is not payable by written agreement in more than four installments.”  30 Such “creditors” are broadly subject to the provisions of subpart B, including those governing disclosures and billing dispute resolution. 31 Thus, BNPL lenders that issue a credit card as defined by Regulation Z are card issuers for purposes of the regulation. And as they also extend credit, even though that credit is not subject to a finance charge and not payable by written agreement in more than four installments, those BNPL lenders are creditors subject to the provisions of subpart B.

The definition of “credit card” in TILA and Regulation Z is not limited to a plastic or metal embossed physical card. While the term certainly includes those, it also includes archaic forms of credit devices like plates and coupon books, and non-physical credit devices like account numbers, including virtual credit cards where the account number itself is the “credit card.” In creating these definitions, Congress understood the need for flexibility to cover evolving types of credit devices, reflecting the rapid advancement of credit mechanisms at the time of enactment. TILA defines “credit card” as “any card, plate, coupon book or other credit device existing for the purpose of obtaining money, property, labor, or services on credit.”  32 Regulation Z similarly defines “credit card” as “any card, plate, or other single credit device that may be used from time to time to obtain credit.”  33

The CFPB interprets the terms “other credit device” and “other single credit device” found within the TILA and Regulation Z definitions of credit card to include a BNPL digital user account that a consumer can use through websites, mobile apps, browser extensions, or integrations with merchant websites or mobile apps to access BNPL credit, to the extent the user account is used to draw, transfer, or authorize the draw or transfer of credit in the course of authorizing, settling, or otherwise completing transactions to obtain goods or services. 34 The broad catch-all terms “other credit device” and “other single credit device” are not defined by TILA and Regulation Z. 35 However, this interpretation is consistent with the ordinary meaning and historical context of the words.

The CFPB's interpretation flows from the ordinary meaning of the word “device.” Merriam-Webster Dictionary contains several definitions for the word “device,” including “something devised or contrived: such as . . . [a] plan, procedure, [or] technique . . . [or] a piece of equipment or a mechanism designed to serve a special purpose or perform a special function.”  36 Similarly, Oxford English Dictionary defines “device” in part to mean “[t]he result of contriving; something devised or framed by art or inventive power; an invention, contrivance; esp. a mechanical contrivance (usually of a simple character) for some particular purpose.”  37 These definitions indicate that the ordinary meaning of “device” is broad and incorporates a wide range of mechanisms, tools, or procedures specifically designed or contrived to achieve a particular purpose.

The CFPB's interpretation is also consistent with use of the word “device” broadly in other contexts. For example, both the CFPB, and the Federal Reserve Board (Board) before it, have interpreted “access device” in Regulation E to include such non-physical devices as personal identification numbers (PINs), telephone transfer and bill payment codes, and other means that may be used by a consumer to initiate an electronic fund transfer. 38

The CFPB's interpretation is also consistent with Congress' intent to define the terms “other credit device” and “credit card” broadly. As a preliminary matter, courts have routinely held that, as a remedial statute, TILA should be interpreted expansively in favor of the consumer. 39 More specifically, as courts have recognized, the inclusion of the phrase “other credit device” in the statutory definition of “credit card” indicates that Congress intended the term “credit card” to encompass a wider scope than its customary usage. 40 Congress initially enacted the definitions in 1970 at the height of a rapid evolution of credit devices, which first included now-archaic credit devices such as coins and plates before the use of conventional credit cards became widespread. 41 In this context, Congress appears to have intended a flexible and comprehensive definition of “credit card” that could encompass both the entire range of existing credit devices and also those “other credit devices” that might not yet exist.

Indeed, the Board, which previously had jurisdiction over Regulation Z, adopted a similarly broad interpretation of “other single credit device” in 2010. The Board clarified in Official Staff Interpretations of Regulation Z that non-physical devices—in that case, account numbers—could be considered “credit cards” under the definition. 42 The Board explained in the rulemaking preamble that while Congress did not generally intend to treat all account numbers as credit cards—for example, where credit is transferred into a consumer's asset account—it would be inconsistent with Congressional intent not to do so when the account number could be used to access credit for the purchase of goods and services. 43 As an example, the Board provided a hypothetical scenario in which an open-end credit account was designed for online purchases, functioning like a conventional credit card account, but only accessible with an account number. 44 In such circumstances, the Board stated, it believed that TILA's credit card protections should apply. 45

This analysis applies equally in the BNPL context. BNPL is a product primarily designed for the online purchase of goods and services and a digital BNPL user account functions like a conventional credit card. Consumers can use their BNPL digital user accounts through BNPL websites, mobile apps, browser extensions, or integrations with merchant websites or mobile apps to access credit for purchases. Given its similarities to conventional credit cards, a consumer's BNPL digital user account is among the types of “credit devices” that Congress would have had in mind in enacting TILA.

In order for a device to constitute a credit card under Regulation Z, it must be usable from time to time to obtain credit. 46 The commentary to Regulation Z interprets the term “time to time” to “involve[ ] the possibility of repeated use of a single device.”  47 The CFPB interprets the phrase “usable from time to time” to cover a consumer's BNPL digital user account that is issued as part of a business model designed for repeat use that can be used through websites, mobile apps, browser extensions, or integrations with merchant websites or mobile apps, to access credit for the purchase of goods and services. 48 Like conventional credit cards, the BNPL business model is designed around the repeat use of a digital user account to make real-time purchases on credit. 49 The CFPB therefore interprets the term “credit cards” to include such digital credit devices for purposes of TILA and Regulation Z.

Of course, not all digital user accounts are credit cards. However, digital user accounts with the purpose of giving consumers access to credit from time to time in the course of completing transactions to purchase goods or services, including those marketed as BNPL, meet the regulatory definition of “credit card.” When consumers use them through websites, mobile apps, browser extensions, and integrations, they get credit in the course of completing transactions to pay for a product at check-out or even in physical stores. 50 And these digital user accounts “exist for [that] purpose.”  51 They are, effectively, digital replacements for conventional credit cards, and consumers use them in the same way as conventional credit cards. The statutory and regulatory definitions of “credit card” are broad enough to capture new, technologically advanced “devices” designed to mimic the core features of conventional credit cards.

Consequently, BNPL providers issuing the credit cards (and their agents with respect to the credit card) are “card issuers” for purposes of Regulation Z. Additionally, as noted above, a “card issuer” is a “creditor” for purposes of subpart B if it extends credit, even though that credit is not subject to a finance charge and not payable by written agreement in more than four installments. Thus, BNPL lenders that issue credit cards are “creditors” for purposes of subpart B and must comply with its requirements, including the provisions related to disclosures and billing dispute resolution.

This is an interpretive rule issued under the Bureau's authority to interpret TILA and Regulation Z, including under section 1022(b)(1) of the Consumer Financial Protection Act of 2010, which authorizes guidance as may be necessary or appropriate to enable the CFPB to administer and carry out the purposes and objectives of Federal consumer financial laws. 52 While not required under the APA, the CFPB is collecting comments and may make revisions to the interpretive rule at a later time as appropriate in light of feedback received. The CFPB may take no further action if no revisions are warranted.

By operation of TILA section 130(f), no provision of TILA sections 130, 108(b), 108(c), 108(e), or section 112 imposing any liability applies to any act done or omitted in good faith in conformity with this interpretive rule, notwithstanding that after such act or omission has occurred, the interpretive rule is amended, rescinded, or determined by judicial or other authority to be invalid for any reason. 53

The CFPB has determined that this interpretive rule does not impose any new or revise any existing recordkeeping, reporting, or disclosure requirements on covered entities or members of the public that would be collections of information requiring approval by the Office of Management and Budget under the Paperwork Reduction Act. 54

Pursuant to the Congressional Review Act, 55 the Bureau will submit a report containing this interpretive rule and other required information to the United States Senate, the United States House of Representatives, and the Comptroller General of the United States prior to the rule's published effective date. The Office of Information and Regulatory Affairs has designated this interpretive rule as a “major rule” as defined by 5 U.S.C. 804(2).

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it modifies and removes Class E airspace to support IFR operations at Mammoth Yosemite Airport, Mammoth Lakes, CA.

The FAA published a notice of proposed rulemaking for Docket No. FAA-2023-1758 in the Federal Register (88 FR 88546; December 22, 2023) for the removal and modification of Class E airspace at Mammoth Yosemite Airport, Mammoth Lakes, CA. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

The legal description of the Class E airspace designated as a surface area within the NPRM included the following language: “This Class E airspace area is effective during the specific dates and times established in advance by a Notice to Air Missions. The effective date and time will thereafter be continuously published in the Chart Supplement.” The FAA subsequently determined that the Class E airspace at Mammoth Yosemite Airport is effective 24 hours a day. Accordingly, the final rule does not include this language.

Class E2 and E5 airspace area designations are published in paragraphs 6002 and 6005, respectively, of FAA Order JO 7400.11, Airspace Designations and Reporting Points, which is incorporated by reference in 14 CFR 71.1 on an annual basis. This document amends the current version of that order, FAA Order JO 7400.11H, dated August 11, 2023, and effective September 15, 2023. FAA Order JO 7400.11H is publicly available as listed in the ADDRESSES section of this document. These amendments will be published in the next update to FAA Order JO 7400.11.

FAA Order JO 7400.11H lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

This action amends 14 CFR part 71 by modifying the Class E airspace designated as surface area, modifying the Class E airspace extending upward from 700 feet above the surface, and removing the Class E airspace extending upward from 1,200 feet above the surface at Mammoth Yosemite Airport, Mammoth Lakes, CA.

The Class E surface area extension east of the airport centered on the 099° bearing is recentered to the airport's 096° bearing. Additionally, the width is reduced from 1.8 miles to 1 mile either side of the bearing, and the extension length is reduced from 5.6 miles to 4.6 miles east of the airport. This will better contain arriving IFR operations between the surface and 1,000 feet above the surface while executing the Area Navigation (RNAV) (Global Positioning System [GPS]) Runway (RWY) 27 approach.

The Class E airspace extending upward from 700 feet above the surface at the airport is extended eastward to include that airspace within 2.6 miles either side of the airport's 091° bearing extending from the 6.6-mile radius to 13.1 miles east of the airport. This will contain arriving IFR operations below 1,500 feet above the surface while executing the RNAV (GPS) RWY 27 approach.

In addition, the existing Class E airspace extending upward from 1,200 feet above the surface is removed, as the area is already within the Coaldale Class E en route domestic airspace area.

Finally, the FAA is modifying the airport's legal descriptions. The airport name within the text headers of both airspace legal descriptions, and any reference within the bodies, are changed to match the new airport name, Mammoth Yosemite Airport (formerly Mammoth Lakes Airport). The geographic coordinates located in the text header of both airspace legal descriptions are updated to match the FAA's database.

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

The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures,” paragraph 5-6.5.a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.

In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:

The final rule provides to an owner or consignee notice and an opportunity to present testimony when the Agency intends to administratively destroy a device valued at $2,500 or less (or such higher amount as the Secretary of the Treasury may set by regulation) that has been refused admission into the United States. The Safeguarding Therapeutics Act (STA) (Pub. L. 116-304), signed into law on January 5, 2021, amended section 801(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 381(a)) to provide FDA with the authority to administratively destroy certain refused devices without providing the owner or consignee with the opportunity for export. FDA is amending § 1.94 (21 CFR 1.94) to provide to the owner or consignee of a refused device valued at $2,500 or less (or such higher amount as the Secretary of the Treasury may set by regulation) notice and an opportunity to present testimony to the Agency prior to destruction of the device.

The final rule provides to an owner or consignee notice and an opportunity to present testimony when the Agency intends to administratively destroy a device valued at $2,500 or less (or such higher amount as the Secretary of the Treasury may set by regulation) that has been refused admission into the United States under section 801(a) of the FD&C Act.

FDA is amending part 1 (21 CFR part 1) by expanding the scope of § 1.94, which provides to the owner or consignee notice and opportunity to present testimony prior to the refusal and destruction of certain refused drugs, to also include notice and opportunity to present testimony prior to the refusal and destruction of certain refused devices.

We are issuing this final rule under sections 701 and 801 of the FD&C Act (21 U.S.C. 371 and 381, respectively).

The primary public health benefit of the final rule will be the value of preventing additional illnesses or deaths by destroying, rather than returning, refused devices valued at $2,500 or less, which may pose a public health risk. This benefit will accrue whenever FDA's existing enforcement tools would not have prevented the violative device from entering the U.S. market. The estimated primary costs of the final rule include the additional costs to destroy, rather than return, refused devices valued at $2,500 or less, and the additional costs to store these devices at International Mail Facilities (IMFs) prior to destruction. There will also be one-time costs to FDA to update its electronic Operational and Administrative System for Import Support (OASIS) and System for Entry Review and Import Operations (SERIO); revise its Regulatory Procedures Manual (RPM), Investigations Operations Manual (IOM), and additional FDA and inter-Agency procedures; and train employees on the new procedures. Express couriers will incur one-time costs to read and understand the rule. We estimate that the annualized benefits over 10 years will range from $148,000 to $750,000 at a 7 percent discount rate and a 3 percent discount rate, with a primary estimate of $317,000. The annualized costs will range from $68,000 to $1.59 million at a 7 percent discount rate, with a primary estimate of $475,000, and from $63,000 to $1.58 million at a 3 percent discount rate, with a primary estimate of $470,000.

Section 708 in the Food and Drug Administration Safety and Innovation Act (FDASIA) (Pub. L. 112-144), enacted in 2012, gave FDA the authority in section 801(a) of the FD&C Act to destroy, without providing an opportunity for export, any refused drug valued at $2,500 or less (or such higher amount as the Secretary of the Treasury may set by regulation). Section 801(a) of the FD&C Act, as amended by FDASIA, allows the Agency to combine the notice and opportunity to introduce testimony on the admissibility of the drug under section 801(a) of the FD&C Act with the notice and opportunity to introduce testimony on the destruction of the drug, as long as appropriate notice is provided to the owner or consignee.

To implement that authority, FDA published a final rule in the Federal Register on September 15, 2015 (80 FR 55237) that revised § 1.94 to provide notice and an opportunity for the owner or consignee to appear before the Agency and introduce testimony prior to the destruction of a drug.

The STA expanded FDA's administrative destruction authority to include any refused device valued at $2,500 or less (or such higher amount as the Secretary of the Treasury may set by regulation). To implement this authority, we issued a proposed rule to amend § 1.94 to provide to the owner or consignee of any refused device valued at $2,500 or less (or such higher amount as the Secretary of the Treasury may set by regulation) notice and an opportunity to appear and introduce testimony prior to the destruction. An NPRM was published in the Federal Register on October 7, 2022 (87 FR 60947).

As discussed in the preamble to the proposed rule, FDA has refused devices, including those valued at $2,500 or less, sent to the United States via international mail or express couriers, including illegal devices that are being imported to diagnose, prevent, or treat COVID-19 such as test kits, respirators, and face masks. Examples of other devices that pose significant public health concerns if counterfeit, unapproved, or unauthorized, or otherwise misbranded or adulterated, include contact lenses and blood glucose test strips.

There is currently little deterrence against sellers shipping illegal devices or re-sending previously refused devices to the United States via international mail or an express courier. Devices that have been refused admission into the United States might be subsequently offered for re-importation by unscrupulous sellers who attempt to circumvent U.S. import regulatory systems. Under the final rule, FDA will be better able to deter such shipments by having an administrative mechanism for destroying a device valued at $2,500 or less (or such higher amount as the Secretary of the Treasury may set by regulation) that has been refused admission into the United States.

For further information on the need for this regulation, see section III.B. (Need for the Regulation) of the NPRM (87 FR 60947 at 60949-60951). The need for this regulation as discussed in the preamble to the proposed rule applies to the final rule.

We received approximately 10 comment letters on the proposed rule by the close of the 60-day public comment period, each containing 1 or more comments on 1 or more issues. We received comments from individuals, an association, a business, medical personnel, and a foreign government. Some comments were submitted anonymously. The majority of the comments supported the proposed rule.

FDA has the legal authority under section 801(a) of the FD&C Act, as amended by the STA, to administratively destroy, without providing opportunity for export, any device valued at $2,500 or less (or such higher amount as the Secretary of the Treasury may set by regulation) that has been refused admission into the United States. A device that is imported or offered for import is subject to refusal of admission under section 801(a) of the FD&C Act if, among other reasons, it appears to be adulterated or misbranded in violation of section 501 or 502 of the FD&C Act (21 U.S.C. 351 or 352).

Section 801(a) of the FD&C Act directs FDA to issue regulations that provide the owner or consignee of a device designated by the Agency for administrative destruction with notice and an opportunity to introduce testimony to us prior to the destruction of the device. Section 801(a) of the FD&C Act further states that this process may be combined with the notice and opportunity to appear before FDA and introduce testimony on the admissibility of the device under section 801(a) of the FD&C Act, as long as appropriate notice is provided to the owner or consignee.

Additionally, section 701(a) of the FD&C Act authorizes the Agency to issue regulations for the efficient enforcement of the FD&C Act.

As used throughout, the term “device” means those articles meeting the definition of device in section 201(h) of the FD&C Act (21 U.S.C. 321(h)), which includes devices intended for human or animal use. Section 201(h) of the FD&C Act defines the term “device,” in part, as an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, intended for use in the diagnosis of a disease or other condition or in the cure, mitigation, treatment, or prevention of a disease or intended to affect the structure or any function of the body, and that does not achieve its primary intended purposes through chemical action within or on the body of man or other animals or by being metabolized.

We describe and respond to the comments received in the public docket in sections V.B., V.C., and VI of this document. We have numbered each comment to help distinguish between different comments. We have grouped similar comments together under the same number, and, in some cases, we have separated different issues discussed in the same comment and designated them as distinct comments for purposes of our responses. The number assigned to each comment or comment topic is purely for organizational purposes and does not signify the comment's importance or the order in which comments were received.

The Agency also received a number of comments that were not responsive to the content of the proposed rule and therefore were not considered in its final development.

After considering the comments responsive to the proposed rule, the Agency is not making any changes to the text of the regulation included in the proposed rule.

Several commenters made general remarks supporting or opposing the proposed rule without focusing on a particular proposed provision. In the following paragraphs, we discuss and respond to such general comments.

(Comment 1) Some commenters recommended that FDA consider granting greater reciprocity for foreign manufactured diagnostic devices rather than expand administrative destruction because the Agency had not documented those products' adverse effects and suggested that the Agency should assume that the product is suitable for the U.S. market if cleared by a foreign regulatory agency. One commenter recommended that FDA should return products cleared by a foreign regulatory agency so that they can be used in that foreign country.

(Response 1) We decline to follow the suggestion that FDA rely on the findings of a foreign regulatory agency rather than effectuate the authority granted to FDA by Congress in the STA. Section 801(a) of the FD&C Act, as amended by the STA, authorizes FDA to administratively destroy certain devices that are refused admission into the United States, and directs FDA to issue regulations that provide the owner or consignee of a device designated by the Agency for administrative destruction with notice and an opportunity to introduce testimony to us prior to the destruction of the device. The devices subject to administrative destruction are governed by the FD&C Act and its implementing regulations to protect public health. FDA generally plans to take risk and other factors into account in determining whether to seek destruction of a particular device. In addition, we disagree with the suggestion to return devices that meet the criteria for administrative destruction to the country where they have been “cleared” as this may be difficult due to an exporter not being located in that country and any such return could result in those products being reimported to the United States.

(Comment 2) Some commenters asserted that device manufacturers are more compliant than drug manufacturers so there is no need to expand administrative destruction to devices. Other commenters noted the influx of “faulty” and “fake” devices such as COVID-19 tests, respirators, face masks, and other personal protective equipment during the COVID-19 pandemic.

(Response 2) By passing the STA, Congress determined that expanding administrative destruction to devices was appropriate. Additionally, in the preamble to the proposed rule, we discussed numerous examples of illegal devices that were imported or offered for import, the public health risk associated with such illegal devices, and the lack of deterrence without administrative destruction (87 FR 60947 at 60949-60951). As discussed above and in the preamble to the proposed rule, we believe administrative destruction of illegal devices that are imported or offered for import is appropriate.

(Comment 3) One commenter expressed concern that the proposed rule states that section 801(a) of the FD&C Act would apply to “certain devices” without clarification as to the identity of those devices and another commenter asked what the selection process is for administrative destruction of devices under the rule.

(Response 3) As stated in the preamble to the proposed rule, the term “device” means those articles meeting the definition of device in section 201(h) of the FD&C Act, which includes devices intended for human or animal use (87 FR 60947 at 60951). When we use the term “certain devices”, we mean those devices that meet the criteria for administrative destruction as provided in section 801(a) of the FD&C Act: a device that is valued at $2,500 or less (or such higher amount as the Secretary of the Treasury may set by regulation) that is refused admission into the United States ( e.g., because it appears to be adulterated or misbranded) and is not brought into compliance as described under section 801(b) of the FD&C Act.

Any device that is reviewed by FDA for admissibility and meets the criteria for administrative destruction may initially be selected for destruction. FDA staff will then determine, taking into account any applicable policies and the circumstances regarding the device and importation, whether to seek destruction. If the decision is made to select the device for destruction, FDA will give notice to the owner or consignee of FDA's intent to refuse and destroy the device.

(Comment 4) One comment asked whether the owner or consignee would have the option of having the shipment returned to its origin rather than destroyed as part of the notice and opportunity to offer testimony process.

(Response 4) An owner or consignee has an opportunity to contest the destruction of a device by providing testimony at an informal hearing before the Agency. FDA, not the owner or consignee, makes the determination whether a refused device will be returned or destroyed.

(Comment 5) One comment suggested that the Agency should include “the testimony opportunity for the company providing product subject to this policy” in the final rule.

(Response 5) We decline to require that the notice and opportunity for a hearing under § 1.94 be given to the company that provided the device. Section 801(a) requires that FDA provide to the owner or consignee of a device notice and an opportunity to provide testimony prior to the administrative destruction. Owner or consignee is defined in 21 CFR 1.83. As discussed in the preamble to the proposed rule, if the article was sent by international mail, FDA generally considers the addressee of that package to be the owner or consignee (87 FR 60947 at 60951). Consistent with section 801(a) of the FD&C Act and the process for administrative destruction of certain drugs under § 1.94, FDA believes that providing the owner or consignee of a device notice and an opportunity to provide testimony prior to administrative destruction is sufficient. The owner or consignee can choose to present testimony from the company providing the product (assuming the owner or consignee is not the company providing the product) if the owner or consignee decides to contest the destruction at an informal hearing before the Agency.

(Comment 6) One comment asked if there is a way for the public to be informed of the devices that are destroyed by FDA so that consumers can get rid of the item if it's in their possession.

(Response 6) We decline to provide such notice in this rule. As discussed in our response to comment 5, the notice required in section 801(a) of the FD&C Act and § 1.94 is for the purpose of allowing the owner or consignee of the device to contest the administrative destruction.

FDA currently provides on its website public notice of safety issues associated with devices through various means, e.g., information about device recalls, consumer alerts or updates, news releases, and safety communications. We referenced some of these public notices for coronavirus tests, vaccines, and treatments, and contact lenses and glucose test strips in the preamble to the proposed rule (87 FR 60947 at 60954-60955). FDA also provides information about import alerts on its website to inform the Agency's field staff and the public that the Agency has enough evidence to allow for detention without physical examination of FDA-regulated products that appear to be in violation of FDA's laws and regulations.

To provide the necessary information for consumers to take action on destroyed devices, FDA would have to expend a significant amount of our limited resources to identify and publish the name of each destroyed device, its manufacturer, batch and lot number, and expiration date. We do not believe that such a large expenditure of FDA resources to provide that additional information to the public is warranted.

(Comment 7) A foreign government submitted a comment requesting that FDA clarify whether “a device” is regarded as a single item or a whole batch of devices of the same device category for the purpose of applying the $2,500 or less valuation for administrative destruction. The commenter also requested that the Agency provide a transition period for their device industry in accordance with Article 2.12 of the World Trade Organization Technical Barriers to Trade Agreement (TBT Agreement), stating that the rule will have a profound impact on the manufacturers or owners in their country.

(Response 7) Section 801(a) of the FD&C Act states that FDA may destroy “any drug or device refused admission under [section 801 of the FD&C Act], if such drug or device is valued at an amount that is $2,500 or less (or such higher amount as the Secretary of the Treasury may set by regulation . . .)” and requires the Agency to issue regulations providing notice and an opportunity to present testimony “on destruction of a drug or device.” FDA interprets this administrative destruction provision to apply the $2,500 or less valuation to a singular device rather than to an entire entry or shipment containing multiple devices of the same type or product code.

We decline to provide an additional transition period beyond that required by the Administrative Procedure Act. Because this rule does not meet the definition of a “technical regulation” of the TBT Agreement, as defined in Annex 1 of the Agreement, Article 2.12 of the TBT Agreement does not apply.

Additionally, we do not think an additional transition period is necessary, particularly since there is nothing for manufacturers to implement under this rule. This rule addresses certain illegal devices that are imported or being offered for import to the United States and implements the authority under the FD&C Act, as amended by the STA, for FDA to administratively destroy these devices rather than returning them.

As noted earlier, the STA was signed into law on January 5, 2021, over 3 years ago. The proposed rule was published well over a year ago, on October 7, 2022, and a 60-day period for submission of public comment followed. The final rule will be effective 30 days from publication in the Federal Register .

In the NPRM preamble, FDA explained that the Agency intends to make a change to the procedures for destroying a refused drug and intends to use the same procedures for devices that are subject to administrative destruction. Under our revised procedures for destruction, FDA might not make a determination that a drug or device subject to administrative destruction is, in fact, in violation of the FD&C Act if the owner or consignee has not requested a hearing to contest the administrative destruction (including the basis for refusal of admission). We will continue to make a determination that a drug or device is, in fact, in violation of the FD&C Act when an owner or consignee timely requests a hearing to contest the administrative destruction (including the basis for refusal of admission) (87 FR 60947 at 60951-60952).

The majority of the comments on the notice regarding the change to our internal administrative destruction procedures were supportive. FDA is finalizing the procedures described in the preamble in the NPRM published on October 7, 2022 (87 FR 60947 at 60951-60952) and will implement the procedures at the same time the final rule takes effect.

(Comment 8) One comment stated that there should be data made available for the counterfeit devices that are the subject of this rule rather than using the 99 percent rate for drugs that are designated for destruction and found to be adulterated or misbranded. Another commenter suggested that we sunset the program to evaluate, sometime after implementation, to see whether the 99 percent rate is substantially the same for devices that are subject to destruction. A different commenter requested that we make a report on the effectiveness of the program publicly available.

(Response 8) We used the data we have from the administrative destruction of drugs program that was implemented in April 2016 because we do not have data on the devices subject to administrative destruction given that the program for devices has not yet been implemented. FDA intends to periodically evaluate the effectiveness of its program and does not see a need to sunset the program while we perform an evaluation. Finally, at this time, we do not agree that public reports on the effectiveness of the program are warranted or would be an optimal use of FDA's limited resources.

The rule is effective 30 days after publication of a final rule in the Federal Register .

We have examined the impacts of the final rule under Executive Order 12866, Executive Order 13563, Executive Order 14094, the Regulatory Flexibility Act (5 U.S.C. 601-612), the Congressional Review Act/Small Business Regulatory Enforcement Fairness Act (5 U.S.C. 801, Pub. L. 104-121), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4).

Executive Orders 12866, 13563, and 14094 direct us to assess all benefits, costs, and transfers of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). Rules are “significant” under Executive Order 12866 Section 3(f)(1) (as amended by Executive Order 14094) if they “have an annual effect on the economy of $200 million or more (adjusted every 3 years by the Administrator of [the Office of Information and Regulatory Affairs (OIRA)] for changes in gross domestic product); 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, territorial, or tribal governments or communities.” OIRA has determined that this final rule is not a significant regulatory action under Executive Order 12866 section 3(f)(1).

Because this rule is not likely to result in an annual effect on the economy of $100 million or more or meets other criteria specified in the Congressional Review Act/Small Business Regulatory Enforcement Fairness Act, OIRA has determined that this rule does not fall within the scope of 5 U.S.C. 804(2).

The Regulatory Flexibility Act requires us to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because of the number of expected device destructions per year and the very small value per event, we certify that the final rule will not have a significant economic impact on a substantial number of small entities.

The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires us to prepare a written statement, which includes an assessment of anticipated costs and benefits, before issuing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The 2022 threshold after adjustment for inflation is $177 million, using the 2022 Implicit Price Deflator for the Gross Domestic Product. This final rule will not result in an expenditure in any year that meets or exceeds this amount.

The final rule will implement the authority of FDA to destroy a device valued at $2,500 or less (or such higher amount as the Secretary of the Treasury may set by regulation) that has been offered for import and refused admission into the United States under the FD&C Act by providing notice and opportunity to the owner or consignee to appear and introduce testimony to FDA prior to the destruction. Because the majority of devices offered for import that are valued at $2,500 or less are shipped via international mail and express couriers, FDA currently intends to implement the final rule at the IMFs and express couriers. We do not, therefore, consider impacts related to shipments via commercial air, land, and seaports. 1

The costs and benefits of the final rule will depend on the number of administrative destructions that FDA orders each year for refused devices valued at $2,500 or less. For our primary estimates, we assume that FDA will order the destruction of 65 percent of refused devices valued at $2,500 or less. We additionally assume that FDA will contract out the act of destruction to a private firm and combine the notice and hearing process for destruction with the notice and hearing process for refusal. We summarize the costs and benefits of the final rule in table 1.

We estimate that the annualized benefits over 10 years will range from $148,000 to $750,000 at a 7 percent discount rate and a 3 percent discount rate, with a primary estimate of $317,000. The annualized costs will range from $68,000 to $1.59 million at a 7 percent discount rate, with a primary estimate of $475,000, and from $63,000 to $1.58 million at a 3 percent discount rate, with a primary estimate of $470,000.

Over 10 years, the present value of total benefits will range from $1.04 million to $5.27 million at a 7 percent discount rate, with a primary estimate of $2.22 million, and from $1.27 million to $6.39 million at a 3 percent discount rate, with a primary estimate of $2.70 million. The present value of total costs will range from $474,000 to $11.14 million at a 7 percent discount rate, with a primary estimate of $3.33 million, and from $539,000 to $13.49 million at a 3 percent discount rate, with a primary estimate of $4.01 million.

Notwithstanding the quantified estimated benefits described above, the primary benefit of the final rule will be the unquantified value of additional illnesses or deaths averted from destroying, rather than returning, refused devices valued at $2,500 or less (or such higher amount as the Secretary of the Treasury may set by regulation). Additionally, if a destroyed device is a counterfeit or an otherwise falsified version of an approved or cleared device, the owner of the approved or cleared device may benefit through increased sales, brand value, or research and development funding. The threat of destruction additionally may have a deterrent effect, reducing the amount of adulterated or misbranded (violative) devices that are offered for import into the United States. These benefits will accrue whenever FDA's existing enforcement tools would not have prevented the violative device from entering the U.S. market; the current policy for returning refused devices does not preclude the re-importation of the device into the United States in the future. We do not have enough information to quantify these benefits.

The destruction of refused devices will lessen the costs incurred to export and return refused devices to the country of origin (the current procedure for refused devices valued at $2,500 or less). Express couriers and the U.S. Postal Service (USPS) will incur quantified cost savings from exporting and returning fewer refused devices, respectively.

Quantified costs of the final rule will include the costs to FDA to destroy, rather than return, refused devices valued at $2,500 or less, and the additional costs to store these devices at IMFs prior to destruction. FDA will additionally incur one-time costs to update its electronic OASIS and SERIO; revise its RPM, IOM, and additional FDA and inter-Agency procedures; and train employees on the new procedures. Express couriers will incur one-time costs to read and understand the rule.

If our assumptions do not hold, FDA may incur additional costs, including costs to purchase equipment to destroy refused devices, costs to train employees administering the destruction of refused devices, costs to notify separately the owners or consignees of refused devices, and costs to prepare for hearings on destruction that the owners or consignees of refused devices request. We have developed a comprehensive Economic Analysis of Impacts that assesses the impacts of the final rule. The full analysis of economic impacts is available in the docket for this rule (Ref. 1) and at https://www.fda.gov/about-fda/economics-staff/regulatory-impact-analyses-ria .

We have determined under 21 CFR 25.30(h) 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 rule contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.

We have analyzed this final rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, we conclude that the rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement is not required.

We have analyzed this rule in accordance with the principles set forth in Executive Order 13175. We have determined that the rule does not contain policies 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. Accordingly, we conclude that the rule does not contain policies that have Tribal implications as defined in the Executive order and, consequently, a Tribal summary impact statement is not required.

The following reference is on display with the Dockets Management Staff (see ADDRESSES ) and is available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; it also available electronically at https://www.regulations.gov . Although FDA verified the website addresses in this document, please note that websites are subject to change over time.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, the Food and Drug Administration amends 21 CFR part 1 as follows:

The final rule published April 24, 2024, at 89 FR 31544, contained an incorrect effective date. It stated the effective date is June 24, 2024. This document corrects the effective date to June 29, 2024. This document also makes a correction to § 556.901(h).

In FR Doc. 2024-08309 appearing on page 31544 in the Federal Register of Wednesday, April 24, 2024, the following corrections are made:

1. On page 31544, in the first column, in the DATES section, the first sentence is corrected to read “This final rule is effective on June 29, 2024.”

On September 19, 2023, the Coast Guard issued a general deviation to NYSDOT allowing the bridge owner, NYSDOT, to deviate from the current operating schedule in 33 CFR 117.799(h) for the Meadowbrook State Parkway Bridge. This deviation allowed the bridge to operate under single leaf operations from September 20, 2023, to March 17, 2024, in order to perform bridge deck replacement.

Since the actual scope of the work would take longer than the allowable time limit of the General Deviation, the Coast Guard published a notice of proposed rulemaking (NPRM) on October 3, 2023, entitled “Drawbridge Operation Regulation; Sloop Channel, Nassau County, NY,” in the Federal Register (88 FR 68033). There we stated why we issued the NPRM and invited comments on our proposed regulatory action related to the rehabilitation of the Meadowbrook State Parkway Bridge. During the comment period that ended November 2, 2023, we received no comments.

On February 23, 2024, the Coast Guard published a Temporary Final Rule (TFR) entitled “Drawbridge Operation Regulation; Sloop Channel, Nassau County, NY,” in the Federal Register (89 FR 13911). There we stated why we issued the TFR and implemented the change to the operating schedule for maintenance of the bridge.

The Coast Guard is issuing this Temporary Interim Rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because it is impracticable. The bridge is currently operating under single leaf openings to conduct a bridge rehabilitation until May 15, 2024, and the bridge cannot be brought back to normal operation. Also, on February 29, 2024, the Meadowbrook State Parkway Bridge experienced electrical failure in the submarine cables which has now added substantial time needed for repair and will further restrict the operation of the bridge. Due to the extensive damage to the submarine cables and delay in material procurement, NYSDOT predicts the repairs will take an estimate of 8 months to complete.

However, we will be soliciting comments on this rulemaking during the first 30 days while this rule is in effect. If the Coast Guard determines that changes to the temporary interim rule are necessary, we will publish a secondary temporary interim rule or other appropriate document. Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making it effective in less than 30 days after publication in the Federal Register because it is impracticable. Due to the damage the bridge suffered on February 29, 2024; the bridge cannot comply with the current operating regulation in 33 CFR 117.799(h) which states the bridge shall open on signal if at least a one-half hour notice is given to the New York State Department of Transportation.

The Coast Guard is issuing this rule under authority in 33 U.S.C. 499. Meadowbrook State Parkway Bridge across Sloop Channel is a bascule bridge with a vertical clearance of 21 feet mean high water in the closed position and unlimited clearance in the open position. The Meadowbrook State Parkway Bridge normally operates under 33 CFR 117.799(h); however, paragraph (h) has been stayed and a temporary paragraph (k) was issued to conduct the rehabilitation of the bridge under the TFR.

The bridge is currently operating under single leaf openings to conduct bridge rehabilitation operations until May 15, 2024. On February 29, 2024, NYSDOT notified USCG of a bridge failure that occurred at the Meadowbrook State Parkway. The Meadowbrook State Parkway Bridge suffered damage to the submarine cables disabling the bridge from operating under the current regulation which states the bridge must open on signal if at least a one-half hour notice is given. NYSDOT is requesting a 3-hour notice be required for bridge openings during set times.

NYSDOT is proposing single leaf openings with a 3-hour advance notice for the following times: 5 a.m., 8 a.m., 11 a.m., 2 p.m., 5 p.m., 8 p.m., and 11 p.m., from May 31, 2024 through May 15, 2024. From May 16, 2024, until January 2, 2025, the bridge will perform double leaf openings with a 3-hour advance notice for the following times: 5 a.m., 8 a.m., 11 a.m., 2 p.m., 5 p.m., 8 p.m., and 11 p.m. No bridge openings will be performed outside of these time frames except for emergency vessels. This temporary interim rule is required while NYSDOT performs bridge repairs. 33 CFR 117.799(h) will remain stayed until January 2, 2025, and the current temporary paragraph (k) will be revised to reflect the new temporary operating schedule.

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

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

This regulatory action determination is based on the ability that vessels can still transit the bridge given 3 hours advanced notice.

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

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

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section.

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

This rule calls for no 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 Management Directive 023-01, Rev.1, associated implementing instructions, and Environmental Planning Policy COMDTINST 5090.1 (series) which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f). The Coast Guard has 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 promulgates the operating regulations or procedures for drawbridges and is categorically excluded from further review, under paragraph L49, of Chapter 3, Table 3-1 of the U.S. Coast Guard Environmental Planning Implementation Procedures.

Neither a Record of Environmental Consideration nor a Memorandum for the Record are required for this rule.

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 117 as follows:

The Coast Guard is issuing this temporary rule under authority in 5 U.S.C. 553(b)(B). This statutory provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” The Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because the Coast Guard was given short notice of a lighted drone show, and a safety zone is needed to protect persons and vessels within the area from hazards associated with overhead drones. It is impracticable to publish an NPRM, provide a comment period, consider any comments submitted, and publish a final regulation by July 4, 2024, when the rule must be in effect to ensure the safety of life on the navigable waters during the drone show scheduled to take place then.

The Coast Guard is issuing this rule under authority in 46 U.S.C. 70034. The Captain of the Port Sector Virginia (COTP) has determined that potential hazards associated with a lighted drone show on July 4, 2024, will be a safety concern for anyone beneath the drones as they are flown over the Hampton River. This rule is needed to protect personnel and vessels in the navigable waters within the safety zone during the lighted drone show.

This rule establishes a safety zone from 9 p.m. until 9:30 p.m. on July 4, 2024. The safety zone will encompass all navigable waters from the shoreline of the Hampton River contained within the following points: 37°01′31.9″ N 76°20′25.5″ W; 37°01′32.9″ N 76°20′20.8″ W; 37°01′36.0″ N 76°20′21.4″ W. The duration of the safety zone is intended to protect personnel and vessels in these navigable waters during the lighted drone show. No vessel or person will be permitted to enter the safety zone without obtaining permission from the COTP or a designated representative.

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

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

This regulatory action determination is based on the size, location, duration, and time-of-day of the safety zone. Vessel traffic will be able to safely transit around this safety zone which would impact a small, designated area of the Hampton River for less than 1 hour during the evening when vessel traffic is normally low. Moreover, the Coast Guard would issue a Broadcast Notice to Mariners via VHF-FM marine channel 16 about the zone, and the rule would allow vessels to seek permission to enter the zone.

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

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

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please call or email the person listed in the FOR FURTHER INFORMATION CONTACT section.

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

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

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

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

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

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

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

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

The Coast Guard will enforce the security zone for the Portland Rose Festival in 33 CFR 165.1312 for the Willamette River regulated area from noon on June 5, 2024 through noon on June 10, 2024. This action is necessary to ensure the security of vessels participating in the 2024 Portland Rose Festival on the Willamette River during the event. Under the provisions of 33 CFR 165.1312 and subpart D of Part 165, no person or vessel may enter or remain in the security zone, consisting of all waters of the Willamette River, from surface to bottom, encompassed by the Hawthorne and Steel Bridges, without permission from the Captain of the Port Columbia River. Persons or vessels wishing to enter the security zone may request permission to do so from the on-scene Captain of the Port representative via VHF Channel 16 or 13. The Coast Guard may be assisted by other Federal, State, or local enforcement agencies in enforcing this regulation.

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

The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to 5 U.S.C. 553(b). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because it is impracticable. This safety zone must be in place by June 1st to protect personnel, vessels, and the marine environment from potential hazards associated with removal of the pipelines and there is insufficient time between now and June 1st to provide notice of a proposal to create these safety zones, consider comments received, and publish a final rule.

In addition, the Coast Guard finds that good cause also exists under 5 U.S.C. 553(d)(3) for making this rule effective less than 30 days after publication in the Federal Register because the safety zone must be in effect less than 30 days from now to serve their purpose and it would be contrary to the public interest to delay its effective date until after the hazardous activities begin.

The Coast Guard is issuing this rule under authority in 46 U.S.C. 70034. The Captain of the Port, Sector Corpus Christi (COTP) has determined that hazards inherent in blocking the channel for pipeline removal activities necessitate provisions to protect personnel, vessels, and the marine environment while those activities are taking place. The activities giving rise to these hazards include the deployment of heavy equipment which will obstruct vessel traffic, continuous diving operations, and various other activities which create underwater hazards while people are working.

This rule is subject to overnight enforcement, starting from 8 p.m. of the first day, to 6 a.m., of the next day, each and every day, from June 1st, 2024 through June 30, 2024. No vessel or person will be permitted to enter the temporary safety zones during the period in which the rule is subject to enforcement without obtaining permission from the COTP or a designated representative, who may be contacted on Channel 16 VHF-FM (156.8 MHz) or by telephone at 1-800-874-2143. The Coast Guard will issue Broadcast Notices to Mariners, Local Notices to Mariners, and/or Safety Marine Information Broadcasts as appropriate.

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

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

This regulatory action determination is based on the size, location, and duration of the safety zones. The safety zones cover less than 0.5 square mile area of the Corpus Christi Ship Channel in Texas. The temporary safety zones will be subject to enforcement for a period of 9 consecutive hours, each day, from June 1st, 2024 through June 30, 2024. The rule does not completely prohibit vessel traffic within the waterway and it allows mariners to request permission to enter the zones.

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

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

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section.

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

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

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

Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this rule has implications for federalism or Indian tribes, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section above.

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

We have analyzed this rule under Department of Homeland Security Directive 023-01 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 establishment of a temporary safety zone for navigable waters in the Corpus Christi Bay. The safety zone is needed to protect personnel, vessels, and the marine environment from potential hazards created by pipeline removal activities that may include deployment of heavy equipment which will obstruct vessel traffic, continuous diver's operations, and various other activities which create underwater hazards while people are working. It is categorically excluded from further review under paragraph L60(a), in Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1. A Record of Environmental Consideration supporting this determination is available in the docket. For instructions on locating the docket, see the ADDRESSES section of this preamble.

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

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

In the Federal Register of March 25, 2024, 89 FR 20548, WTB/OET attempted to make a non-substantive, editorial revision to § 2.106(c)(431), table 22, deleting the Norfolk CPA from the list of CPAs and PUAs and renaming the Newport News CPA/PUA as the “Newport News-Norfolk CPA/PUA.” The document contained an incorrect instruction regarding the revision to table 22, and the amendments couldn't be incorporated. In the Federal Register of April 4, 2024, 89 FR 23527, the instruction was corrected, and the amendments incorporated into the CFR. This document removes as redundant the entry “Newport News *”.

For the reasons discussed in the preamble, the Federal Communications Commission corrects 47 CFR part 2 by making the following correcting amendment:

This document announces that, on May 7, 2024, OMB approved the information collection requirements contained in §§ 73.6030(c) and (d) of the Commission's rules. The OMB Control Number is 3060-1326. In addition, on May 7, 2024, OMB approved the information collection requirements associated with a revision to FCC Form 2100, Application for Media Bureau Audio and Video Service Authorization, Schedule F (formerly FCC 302-CA). The OMB Control Number is 3060-0928. The Commission publishes this document as an announcement of the operational date of these rules. If you have any comments on the burden estimates listed below, or how the Commission can improve the collections and reduce any burdens caused thereby, please contact Cathy Williams, Federal Communications Commission, Room 3-317, 45 L Street NE, Washington, DC 20554. Please include the OMB Control Number, 3060-1326 and/or 3060-0928, in your correspondence. The Commission will also accept your comments via email at PRA@fcc.gov.

To request materials in accessible formats for people with disabilities (Braille, large print, electronic files, audio format), send an email to fcc504@fcc.gov or call the Consumer and Governmental Affairs Bureau at (202) 418-0530 (voice), (202) 418-0432 (TTY).

As required by the Paperwork Reduction Act of 1995 (44 U.S.C. 3507), the FCC is notifying the public that it received final OMB approval on May 7, 2024, for the information collection requirements contained in new § 73.6030(c) and (d) of the Commission's rules and the information collection requirements contained in revisions to FCC Form 2100, Schedule F.

Under 5 CFR 1320, an agency may not conduct or sponsor a collection of information unless it displays a current, valid OMB Control Number.

No person shall be subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act that does not display a current, valid OMB Control Number.

The foregoing notice is required by the Paperwork Reduction Act of 1995, Public Law 104-13, October 1, 1995, and 44 U.S.C. 3507.

The total annual reporting burdens and costs for the respondents are as follows:

OMB Control Number: 3060-1326.

OMB Approval Date: May 7, 2024.

OMB Expiration Date: May 31, 2027.

Title: Class A Television Stations—Low Power Protection Act.

Respondents: Business or other for-profit entities, not-for-profit institutions, and state, local, or tribal governments.

Number of Respondents and Responses: 50 respondents; 250 responses.

Estimated Time per Response: 1 hour.

Frequency of Response: One-time reporting requirement.

Obligation to Respond: Required to obtain or retain benefits. Statutory authority for this collection of information is contained in 47 U.S.C. 151, 152, 154(i), 154(j), 303, 307, 309, 311, 336(f), and the Low Power Protection Act, Public Law 117-344, 136 Stat. 6193 (2023).

Total Annual Burden: 250 hours.

Total Annual Cost: No cost.

Needs and Uses: The Commission will use the information collected under this information collection to determine whether applicants can convert to Class A status pursuant to the Low Power Protection Act.

On December 11, 2023, the Commission adopted a Report and Order to implement the Low Power Protection Act (LPPA or Act), which was enacted on January 5, 2023. The LPPA provides certain low power television (LPTV) stations with a limited window of opportunity to apply for primary spectrum use status as Class A television stations. The Report and Order establishes the period during which eligible stations may file applications for Class A status, eligibility and interference requirements, and the process for submitting applications.

The Report and Order adopts new rules 47 CFR 73.6030(c) and (d) which contain information collections. Section 73.6030(c) provides that applications for conversion to Class A status must be submitted using FCC Form 2100, Schedule F within one year beginning on the date on which the Commission issues notice that the rules implementing the Low Power Protection Act take effect. The licensee will be required to submit, as part of its application, a statement concerning the station's operating schedule during the 90 days preceding January 5, 2023 and a list of locally produced programs aired during that time period. The applicant may also submit other documentation, or may be requested by Commission staff to submit other documentation, to support its certification that the licensee meets the eligibility requirements for a Class A license under the Low Power Protection Act. Section 73.6030(d) provides that A Class A television broadcast license will only be issued under the Low Power Protection Act to a low power television licensee that files an application for a Class A Television license (FCC Form 2100, Schedule F), which is granted by the Commission.

Under this new information collection, the Commission will collect the information, disclosures, and certifications required by § 73.6030(c) and (d) of the Commission's rules from each applicant seeking to convert to Class A status and will use the information, disclosures, and certifications to determine whether an applicant is qualified to convert to a Class A station. Without the information collected, the Commission will not be able to determine if an applicant is qualified to become a Class A station under the LPPA.

OMB Control Number: 3060-0928.

OMB Approval Date: May 7, 2024.

OMB Expiration Date: May 31, 2027.

Title: FCC Form 2100, Application for Media Bureau Audio and Video Service Authorization, Schedule F (Formerly FCC 302-CA); 47 CFR 73.6028; Section 73.3700(b)(3); Section 73.3700(h)(2) and Section 73.3572(h).

Form Number: FCC Form 2100, Schedule F.

Respondents: Business or other for-profit entities, not-for-profit institutions; State, local, or Tribal Government.

Number of Respondents and Responses: 115 respondents; 165 responses.

Estimated Time per Response: 2 hours.

Frequency of Response: On occasion reporting requirement and One-time reporting requirement.

Obligation to Respond: Required to obtain or retain benefits. Statutory authority for the collection of information associated with the LPPA is contained in 47 U.S.C. 151, 152, 154(i), 154(j), 303, 307, 309, 311, 336(f), and the Low Power Protection Act, Public Law 117-344, 136 Stat. 6193 (2023).

Statutory authority for the collection of information associated with the CBPA is contained in 47 U.S.C. 154(i), 307, 308, 309, and 319, and the Community Broadcasters Protection Act of 1999, and the Middle Class Tax Relief and Job Creation Act of 2012.

Total Annual Burden: 460 hours.

Total Annual Cost: $41,725.

Needs and Uses: The FCC Form 2100, Schedule F is used by Low Power TV (LPTV) stations that seek to convert to Class A status; existing Class A stations seeking a license to cover their authorized construction permit facilities; and Class A stations entering into a channel sharing agreement. The FCC Form 2100, Schedule F requires a series of certifications by the Class A applicant as prescribed by the Community Broadcasters Protection Act of 1999 (CBPA). Licensees will be required to provide weekly announcements to their listeners: (1) informing them that the applicant has applied for a Class A license and (2) announcing the public's opportunity to comment on the application prior to Commission action.

On December 11, 2023, the Commission adopted a Report and Order, FCC 23-112, to implement the Low Power Protection Act (LPPA or Act), which was enacted on January 5, 2023. The LPPA provides certain low power television (LPTV) stations with a limited window of opportunity to apply for primary spectrum use status as Class A television stations. The Report and Order establishes the period during which eligible stations may file applications for Class A status, eligibility and interference requirements, and the process for submitting applications. The Report and Order provides that applications to convert to Class A status under the Low Power Protection Act must be filed using FCC Form 2100, Schedule F. The application form requires certifications by the applicant as prescribed by the LPPA. This submission was made to OMB for approval of the modified FCC Form 2100, Schedule F. In addition, LPTV stations that file an application to convert to Class A status must provide local public notice of the filing of the application pursuant to 47 CFR 73.3580(c). Specifically, the station must both broadcast on-air announcements and give online notice. This submission also reflects the burden associated with that information collection and was made to request Office of Management and Budget (OMB) approval of that collection.

A “species” is defined in section 3 of the ESA to include “any subspecies of fish or wildlife or plants, and any distinct population segment of any species of vertebrate fish or wildlife which interbreeds when mature” (16 U.S.C. 1532(16)). On July 19, 2023, we received a petition from the Delaware Riverkeeper Network (DRN) to list the Delaware River Atlantic sturgeon ( Acipenser oxyrinchus oxyrinchus ) population as a DPS, to list that DPS as endangered under the ESA, and to designate critical habitat for that DPS concurrent with the listing. The Delaware River Atlantic sturgeon population is currently protected under the ESA as part of the New York Bight DPS of Atlantic sturgeon, and 137 kilometers (85 miles) of the lower Delaware River are included as part of the designated critical habitat for the DPS.

We listed the New York Bight DPS as endangered after two separate status reviews. The first status review, which was completed in 1998, was conducted by NMFS and the U.S. Fish and Wildlife Service (collectively the “Services”) in response to a petition to list Atlantic sturgeon in the United States under the ESA. We concluded that listing Atlantic sturgeon as a subspecies  1 was not warranted (63 FR 50187, September 21, 1998). The second status review was completed in 2007. It concluded that there was new information to support listing Atlantic sturgeon in the United States as five DPSs (Atlantic Sturgeon Status Review Team (ASSRT), 2007).

On October 6, 2009, NMFS received a petition to list Atlantic sturgeon throughout its range as endangered or, alternatively, to list the five DPSs described in the 2007 status review. We reviewed the available information, including the 2007 Atlantic sturgeon status review report, and determined, in accordance with the Services' joint DPS Policy (61 FR 4722, February 7, 1996), that the U.S. populations of Atlantic sturgeon comprised five DPSs because they met both criteria of the policy— i.e., that the populations are both “discrete” and “significant” (77 FR 5880, February 6, 2012; 77 FR 5914, February 6, 2012). Evidence to support the existence of discrete Atlantic sturgeon populations included temporal and spatial separation during spawning and the results from genetic analyses. The significance criterion was met because each identified DPS persists in an ecological setting that is unique relative to the taxon as a whole, and the loss of any of the five DPSs would result in a significant gap in the range of the taxon. After reviewing the best available information regarding each DPSs' current status and extinction risk, we listed four DPSs as endangered (including the New York Bight DPS) and one as threatened (77 FR 5880, February 6, 2012; 77 FR 5914, February 6, 2012).

The New York Bight DPS is defined in the regulations as all Atlantic sturgeon spawned in the watersheds that drain into coastal waters from Chatham, Massachusetts, to the Delaware-Maryland border on Fenwick Island (50 CFR 224.101). The Delaware River and the Hudson River populations of Atlantic sturgeon were the only known extant populations for the DPS when it was listed. We subsequently identified the areas of the Delaware River and the Hudson River where the physical and biological features essential for successful reproduction and recruitment of the respective Atlantic sturgeon populations are found. We designated these areas as critical habitat for the New York Bight DPS on August 17, 2017 (82 FR 39160).

We completed a 5-year review of the New York Bight DPS on February 17, 2022. In that review, we described new information available since the listing, including information that further supports our understanding of when spawning occurs in the Delaware River, the genetic assignment of Delaware River Atlantic sturgeon to the New York Bight DPS and the river-of-origin, and where the Delaware River Atlantic sturgeon occur in the marine environment (NMFS, 2022). We also described new information suggesting a possible spawning population in the Connecticut River for which research is on-going. As summarized in the 5-year review, the information available since the listing continues to support our determination in the 2012 listing rule that the New York Bight DPS is both discrete and significant relative to the taxon as a whole. We found no new information that would change our determinations regarding the application of the DPS Policy, the status of the DPS, or its designated critical habitat (NMFS, 2022).

Section 4(b)(3)(A) of the ESA of 1973, as amended (16 U.S.C. 1531 et seq. ), requires, to the maximum extent practicable, that within 90 days of receipt of a petition to list a species as threatened or endangered, the Secretary of Commerce shall make a finding on whether that petition presents substantial scientific or commercial information indicating that the petitioned action may be warranted, and promptly publish such finding in the Federal Register (16 U.S.C. 1533(b)(3)(A)). If NMFS finds that substantial scientific or commercial information in a petition indicates the petitioned action may be warranted (a “positive 90-day finding”), we are required to promptly commence a review of the status of the species concerned, during which we will conduct a comprehensive review of the best available scientific and commercial data. In such cases, within 12 months of receipt of the petition, we conclude the review with a finding as to whether, in fact, the petitioned action is warranted. Because the finding at the 12-month stage is based on a more thorough review of the best available information, as compared to the narrow scope of review at the 90-day stage, a “positive 90-day finding” does not prejudge the outcome of the status review.

Under the ESA, a listing determination may address a species, which is defined to also include subspecies and, for any vertebrate species, any DPS that interbreeds when mature (16 U.S.C. 1532(16)). The Services joint DPS Policy clarifies the agencies' interpretation of the phrase “distinct population segment” for the purposes of listing, delisting, and reclassifying a species under the ESA (61 FR 4722, February 7, 1996). A species, subspecies, or DPS is “endangered” if it is in danger of extinction throughout all or a significant portion of its range, and “threatened” if it is likely to become endangered within the foreseeable future throughout all or a significant portion of its range (ESA sections 3(6) and 3(20), respectively, 16 U.S.C. 1532(6) and (20)). Pursuant to the ESA and our implementing regulations, we determine whether species are threatened or endangered based on any one or a combination of the following section 4(a)(1) factors: (1) The present or threatened destruction, modification, or curtailment of habitat or range; (2) overutilization for commercial, recreational, scientific, or educational purposes; (3) disease or predation; (4) inadequacy of existing regulatory mechanisms to address identified threats; (5) or any other natural or manmade factors affecting the species' existence (16 U.S.C. 1533(a)(1), 50 CFR 424.11(c)).

ESA-implementing regulations issued jointly by the Services (50 CFR 424.14(h)(1)(i)) define “substantial scientific or commercial information” in the context of reviewing a petition to list, delist, or reclassify a species as credible scientific or commercial information in support of the petition's claims such that a reasonable person conducting an impartial scientific review would conclude that the action proposed in the petition may be warranted. Conclusions drawn in the petition without the support of credible scientific or commercial information will not be considered substantial information. In reaching the initial (90-day) finding on the petition, we consider the information described in sections 50 CFR 424.14(c), (d), and (g) (if applicable) and may also consider information readily available at the time the determination is made (50 CFR 424.19(h)(1)(ii)).

Our determination as to whether the petition provides substantial scientific or commercial information indicating that the petitioned action may be warranted depends in part on the degree to which the petition includes the following types of information: (1) information on current population status and trends and estimates of current population sizes and distributions, both in captivity and the wild, if available; (2) identification of the factors under section 4(a)(1) of the ESA that may affect the species and where these factors are acting upon the species; (3) whether, and to what extent, any or all of the factors alone or in combination identified in section 4(a)(1) of the ESA may cause the species to be an endangered species or threatened species ( i.e., the species is currently in danger of extinction or is likely to become so within the foreseeable future), and, if so, how high in magnitude and how imminent the threats to the species and its habitat are; (4) information on adequacy of regulatory protections and effectiveness of conservation activities by States, as well as other parties, that have been initiated or that are ongoing, that may protect the species or its habitat; and (5) a complete, balanced representation of the relevant facts, including information that may contradict claims in the petition. See 50 CFR 424.14(d).

We may also consider information readily available at the time the determination is made (50 CFR 424.14(h)(1)(ii)). We are not required to consider any supporting materials cited by the petitioner if the petitioner does not provide electronic or hard copies, to the extent permitted by U.S. copyright law, or appropriate excerpts or quotations from those materials ( e.g., publications, maps, reports, and letters from authorities). See 50 CFR 424.14(c)(6) and (h)(1)(ii).

The “substantial scientific or commercial information” standard must be applied in light of any prior reviews or findings we have made on the listing status of the species that is the subject of the petition (50 CFR 424.14(h)(1)(iii)). Where we have already conducted a finding on, or review of, the listing status of that species (whether in response to a petition or on our own initiative), we will evaluate any petition received thereafter seeking to list, delist, or reclassify that species to determine whether a reasonable person conducting an impartial scientific review would conclude that the action proposed in the petition may be warranted despite the previous review or finding. Where the prior review resulted in a final agency action—such as a final listing determination, a 90-day not-substantial finding ( i.e., negative 90-day finding), or a 12-month not-warranted finding—a petition will generally not be considered to present substantial scientific and commercial information indicating that the petitioned action may be warranted unless the petition provides new information or analysis not previously considered. See 50 CFR 424.14(h)(1)(iii).

At the 90-day finding stage, we do not conduct additional research, and we do not solicit information from parties outside the agency to help us in evaluating the petition. We accept the petitioner's sources and characterizations of the information presented if they appear to be based on accepted scientific principles, unless we have specific information in our files that indicates the petition's information is incorrect, unreliable, obsolete, or otherwise irrelevant to the requested action. Information that is susceptible to more than one interpretation, or that is contradicted by other available information, will not be dismissed at the 90-day finding stage, so long as it is reliable and a reasonable person conducting an impartial scientific review could conclude it supports the petitioner's assertions. In other words, conclusive information indicating the species may meet the ESA's requirements for listing is not required to make a positive 90-day finding.

To make a 90-day finding on a petition to list a species, we first evaluate whether the information presented in the petition, in light of the information readily available in our files, indicates that the petitioned entity constitutes a species eligible for listing under the ESA. Next, we evaluate whether the petition presents substantial scientific or commercial information indicating the subject species may be either a threatened or endangered species, as defined by the ESA. This may be indicated in information expressly discussing the species' status and trends, or in information describing impacts and threats to the species. We evaluate whether the petition presents any information on specific demographic factors pertinent to evaluating extinction risk for the species ( e.g., population abundance and trends, productivity, spatial structure, age structure, sex ratio, diversity, current and historical range, habitat integrity, or fragmentation), and the potential contribution of identified demographic risks to extinction risk for the species. We then evaluate whether the petition presents information suggesting potential links between these demographic risks and the causative impacts and threats identified in section 4(a)(1) of the ESA.

Information presented on impacts or threats should be specific to the species and should reasonably suggest that one or more of these factors may be operative threats that act, or have acted, on the species to the point that it may warrant protection under the ESA. Broad statements about generalized threats to the species, or identification of factors that could negatively impact a species, do not constitute substantial information indicating that listing may be warranted. We look for information indicating that not only is the particular species exposed to a factor, but that the species may be responding in a negative fashion. We then assess the potential significance of that negative response.

Many petitions identify risk classifications made by nongovernmental organizations, such as the International Union for Conservation of Nature (IUCN), the American Fisheries Society, or NatureServe, as evidence of extinction risk for a species. Risk classifications by other organizations or made under other Federal or State statutes may be informative, but such classification alone may not provide the rationale for a positive 90-day finding under the ESA. For example, as explained by NatureServe, their assessments of a species' conservation status do not constitute a recommendation by NatureServe for listing under the ESA because NatureServe assessments have different criteria, evidence requirements, purposes, and taxonomic coverage than government lists of endangered and threatened species, and therefore these two types of lists should not be expected to coincide ( https://explorer.natureserve.org/AboutTheData/DataTypes/ConservationStatusCategories ). Additionally, species classifications under IUCN and the ESA are not equivalent; data standards, criteria used to evaluate species, and treatment of uncertainty are also not necessarily the same. Thus, when a petition cites such classifications, we will evaluate the source of information that the classification is based upon in light of the standards on extinction risk and impacts or threats in accordance with the ESA and our implementing regulations as discussed above.

The petitioner requests that we list the Delaware River population of Atlantic sturgeon as a separate DPS under the ESA, list that DPS as endangered, and designate critical habitat for the DPS. As noted above, the Delaware River population of Atlantic sturgeon is currently afforded the protections of an endangered species because it is part of the ESA-listed, endangered New York Bight DPS of Atlantic sturgeon. The petitioner did not request any other changes to the New York Bight DPS that may be necessary if the Delaware population was listed as its own DPS ( e.g., changes to the regulatory definition of the New York Bight DPS without the Delaware River population or changes to the status of the New York Bight DPS).

As noted above, where we have already conducted a finding or review of the listing status of a species (whether in response to a petition or on our own initiative), we will evaluate any petition received thereafter seeking to list, delist, or reclassify that species to determine whether a reasonable person conducting an impartial scientific review would conclude that the action proposed in the petition may be warranted despite the previous review of finding. Therefore, despite our previous determination that the Delaware River population of Atlantic sturgeon is part of the New York Bight DPS, we evaluated whether this petition provides new information or a new analysis not previously considered to determine whether the petitioned action may be warranted.

The petitioner asserts that there has been significant research following the 2007 status review (ASSRT, 2007) and the 2012 listing determinations for the Atlantic sturgeon DPSs, and that the information, scientific studies, and expert analyses are available in the “relevant literature” section provided at the end of the petition. The petitioner did not, however, cite to specific references for the assertions that they made in the petition. We reviewed the literature provided by the petitioner to identify whether that literature provides any relevant new information that became available after the listing of the New York Bight DPS under the ESA (77 FR 5880, February 6, 2012) and after we completed the literature review for the 5-year review of the New York Bight DPS (NMFS, 2022), and to identify any other information that we had not previously considered.

We found that we have already considered most of the literature that was provided by the petitioner, and we have cited it either in the 2007 status review (ASSRT, 2007), the listing determinations (77 FR 5880, February 6, 2012; 77 FR 5914, February 6, 2012), or in our recent 5-year review for the New York Bight DPS (NMFS, 2022). The studies that focused on genetics related to the Delaware River population ( e.g., King et al., 2001; Waldman et al., 1996a, 1996b, 1998, 2002; Wirgin et al., 2000) provided some of the earliest results that documented genetic differentiation among Atlantic sturgeon populations. These results were described and used by the ASSRT to inform the 2007 status review (ASSRT, 2007). Additional genetic analyses were conducted for the 2007 status review to inform whether there were discrete populations of Atlantic sturgeon (ASSRT, 2007). We considered all of this information as well as the results of Wirgin et al. (2007) and Grunwald et al. (2008), which became available after completion of the 2007 status review, in reaching our listing determinations (77 FR 5880, February 6, 2012; 77 FR 5914, February 6, 2012). There was no new information regarding the differentiation of the Atlantic sturgeon populations, in general, or for the New York Bight DPS, specifically, when we completed the 5-year review for the DPS (NMFS, 2022). We did, however, review and describe new life history information for the New York Bight DPS ( e.g., distribution in their marine range, occurrence in certain coastal estuaries) that became available as a result of studies that used genetic analysis to identify the origin of the individual sturgeon captured (NMFS, 2022). The genetic studies reviewed and cited for the 5-year review were Dunton et al. (2012), Kazyak et al. (2021), O'Leary et al. (2014), Waldman et al. (2013, 2019), and Wirgin et al. (2015a, 2015b); all of which the petitioner also lists in the “relevant literature.”

Some of the sturgeon studies provided by the petitioner can be found in NMFS' files on Atlantic sturgeon but do not provide information relevant to considering whether the Delaware River population of Atlantic sturgeon may meet the discreteness and significance criteria of the Service's joint DPS Policy. These include Balazik et al. (2017), which described the James River populations of Atlantic sturgeon; Farrae et al. (2017), which described the Edisto River populations of Atlantic sturgeon; and Panagiotopoulou et al. (2014a and 2014b), which described methodology for analyzing genetic information of North American and European stocks of Atlantic sturgeon. We could not make any connection between these studies and the petitioner's statements that the Delaware River population of Atlantic sturgeon is discrete and warrants listing as its own, endangered DPS.

We identified eight reports or publications in the “relevant literature” section at the end of the petition that became available after we completed our literature search for the 5-year review of the New York Bight DPS. Four of these references relate to Atlantic sturgeon genetics ( i.e., White et al., 2021a, 2021b, 2022; Wirgin et al., 2023), and four relate to impacts to the Delaware River population of Atlantic sturgeon or its habitat ( i.e., Delaware River Basin Commission (DRBC), 2022a, 2022b; Environmental Research and Consulting (ERC) and Verdantas, 2022; Hagy, 2023).

Accordingly, we reviewed these eight references to determine whether they provide new information to show that the Delaware River population of Atlantic sturgeon may meet the criterion of the Service's joint DPS Policy (61 FR 4722, February 7, 1996). First, and as discussed below, we focused on the assertions made by the petitioner regarding discreetness, the first prong in the DPS analysis. We considered information in our files, and the four new references pertaining to genetics, to determine if the petition presents new information not previously considered with regard to whether the Delaware River population may be discrete. We also reviewed the information provided from the other four references (DRBC, 2022a, 2022b; ERC and Verdantas, 2022; Hagy, 2023), but found they did not contain new information that informed whether the Delaware River population may be discrete.

The petitioner claims that the Delaware River population of Atlantic sturgeon is discrete because it is genetically unique with characteristics found only in the Delaware River population. The petitioner's conclusion presents only part of the information available in the literature with regard to unique characteristics found in sturgeon populations. Some mitochondrial haplotypes and some microsatellite alleles are unique to some individuals of the Delaware River population. However, that does not mean that the population is discrete. The results of analyses conducted for the 2007 status review revealed that some mitochondrial DNA haplotypes were unique to specific Atlantic sturgeon river populations, such as the A5 haplotype for the Delaware River population (ASSRT, 2007). However, only a minority of the Delaware River sturgeon that were tested had the unique haplotype. The results of Wirgin et al. (2007) and Grunwald et al. (2008) provided additional information that the A5 haplotype is found in only a minority of the fish belonging to the Delaware River population. Wirgin et al. (2007) and Grunwald et al. (2008) also found that haplotypes B and B1 are found only in the Delaware River and the Hudson River populations. Overall, the results of studies that we reviewed and considered as part of the 5-year review of the New York Bight DPS support the conclusion that: the Delaware River population as well as many of the other Atlantic sturgeon river populations have a unique haplotype; only a minority of the individual sturgeon sampled in each population carry the unique haplotype; the Hudson River and Delaware River populations of Atlantic sturgeon share unique haplotypes that are not found in any of the other Atlantic sturgeon populations; and the majority of individuals in each Atlantic sturgeon population carry haplotypes that are common to all or many of the sturgeon populations (Savoy et al., 2017; Waldman et al., 2013; Wirgin et al., 2015b). Therefore, the unique A5 haplotype carried by some individuals in the Delaware River population does not support that the population is discrete.

The four new studies cited by the petitioner in the “relevant literature” use microsatellite DNA rather than mitochondrial DNA. In the case of microsatellite DNA, similar to the available information on mitochondrial DNA haplotypes, private alleles ( i.e., a version of a gene sequence that is found only in a single population) occur in Atlantic sturgeon populations and most Atlantic sturgeon populations have at least one private allele that is carried by at least one individual of that population. White et al. (2021a) found that the majority of the sturgeon groups tested contained at least one private allele across all loci. However, not all individuals of a population carry the unique allele. In addition, sampling bias can influence whether and where a private allele is discovered. For example, an allele may be detected by chance in one population and may be misidentified as a private allele because the same allele also occurs in other populations but has not yet been detected in samples from another population. The scientific literature for the genetics information available to us for the 2007 status review, the listing determinations, and the 5-year review of the New York Bight DPS all describe the methods used to analyze Atlantic sturgeon genetics data which include screening for multiple, specific, microsatellite loci, use of reference collections, and various analytical tools described in each scientific publication. The new genetic studies included in the petitioner's “relevant literature” also used these methods to further inform Atlantic sturgeon population structuring (White et al., 2021a), the origin of sturgeon captured in the New York Bight directed fishery in the 1990s (White et al., 2021b), the estimated spawning abundance for the Delaware River population (White et al., 2022), and population structuring ( i.e., genetic differentiation between population segments) for the South Atlantic DPS (Wirgin et al., 2023). None of the studies relied on identification of individuals from the Delaware River population based solely on the presence of unique haplotypes or alleles, and none provided new information for the Delaware River population's marked separation from the other populations such that it may be considered discrete as contemplated in the Services' DPS Policy. The information available in White et al. (2021a, 2021b, 2022) and Wirgin et al. (2023) does not include new information on the genetic uniqueness of the Delaware River population of Atlantic sturgeon. In fact, all of these studies are consistent with the existing information, that only some individuals carry the unique A5 haplotype or unique allele, which we presented in our listing determination and 5-year review for the New York Bight DPS. The information available in these new studies corroborates our listing determination that the Delaware River population of Atlantic sturgeon and the Hudson River population of Atlantic sturgeon are part of the same DPS.

The petitioner asserted that the Delaware River population of Atlantic sturgeon is clearly recognizable from both mitochondrial and nuclear DNA markers such that individuals are correctly assigned to the Delaware River genetic group at very high rates, among the highest rates for any river population. The petitioner is correct that individuals are assigned to the Delaware River population at relatively high rates; however, as described above, individual Atlantic sturgeon are not assigned to the Delaware River population based on the A5 haplotype or a private allele, as asserted by the petitioner, because those are only present in some individuals of the population. A much more rigorous methodology is used by the geneticists in the above-referenced studies to assign individual Atlantic sturgeon to the river and DPS of origin and a number of factors can influence assignment certainty. Those factors include the quality of the extracted DNA from the sample ( e.g., as a result of sample preservation) and the genetic baseline. The genetic baseline is a reference collection of samples from individual Atlantic sturgeon captured in a river and assumed to be natal to that river because the fish was captured either as a river resident juvenile ( i.e., too physiologically immature to leave the natal estuary) or as an adult in spawning condition on the known or presumed spawning grounds of that river's spawning population. The methods used to establish the genetic baseline and the expansion of the baseline are described in the literature provided by the petitioner (ASSRT, 2007; Waldman et al., 2013; Wirgin et al., 2015b; Kazyak et al., 2021; White et al., 2021a). The Delaware River reference collection is based solely on samples from river resident juveniles (Kazyak et al., 2021), which makes for a very strong reference collection, and, in turn, imparts a high level of certainty when making individual assignments to the Delaware River population. White et al. (2021a) and Wirgin et al. (2023)—both new publications provided by the petitioner—include discussions of assignment certainty with respect to the southern DPSs and their reference collections that demonstrate the connection between the strength of the genetics baseline and assignment certainty. As noted in our listing determination (77 FR 5880, February 6, 2012), assignment certainty reflects several factors, including sampling methods used and samples available to develop the genetics baseline, but assignment certainty is not a stand-alone factor for determining that a population is discrete.

The petitioner also claims that fidelity to the natal spawning river is so high that the Delaware River population is reproductively isolated from all other river populations including the Hudson River population, and, effectively, zero cross-river migration occurs. It is unclear from the petitioner's statement whether they contend that the Delaware population is reproductively isolated such that only natal Delaware River fish spawn together, or whether, given the petitioner's use of the term “effectively,” the petitioner is stating that some low level of spawning occurs between the Delaware River population and the Hudson River population. As described in the listing determination, based on extensive research, including genetic analyses and tagging and tracking data, the vast majority of Atlantic sturgeon return to their natal rivers to spawn, with some studies showing only one or two individuals per generation spawning outside their natal river system (77 FR 5880, February 6, 2012). Our statements in the listing determination were based on the scientific research described in Wirgin et al. (2000), King et al. (2001), and Waldman et al. (2002); all of which are also included by the petitioner in the “relevant literature.” The publications and reports available for the 5-year review of the New York Bight DPS did not change our conclusions regarding fidelity of the Delaware River or the Hudson River populations of Atlantic sturgeon to their natal river. Those publications and reports are also included in the petitioner's “relevant literature.” Of the four new genetic studies provided by the petitioner, White et al. (2021a) further investigates population structure by using an expanded baseline of more than 2,500 sampled Atlantic sturgeon and multiple analytical techniques to describe the coastwide population structure for Atlantic sturgeon. Their results further demonstrate that the Atlantic sturgeon populations exhibit high fidelity to their natal river at spawning.

The three other genetic publications provided by the petitioner do not provide new information that is relevant to the petitioner's statement that the Delaware River population is reproductively isolated or to the overall discreteness of this population. White et al. (2021b) describes new information based on genetic analysis of Atlantic sturgeon fin spines to identify the origins of Atlantic sturgeon captured in the New York fishery in the 1990s. White et al. (2022) describes the feasibility of a new method for estimating the number of spawning adults for the Delaware River population of Atlantic sturgeon. It is based on the knowledge that there is high spawning fidelity for the Delaware River population, but the purpose of the research was not to investigate spawning fidelity and it does not provide any new information that would support the petitioner's statement. Wirgin et al. (2023), while noting that their results for population structuring of all but the South Atlantic DPS will be reported elsewhere, states that the certainty of genetic assignments was high for both Atlantic sturgeon belonging to the Delaware River population and for Atlantic sturgeon belonging to the Hudson River population, and that the assignment certainty was even higher at the DPS-level. Other studies ( e.g., Kazyak et al., 2021) have also found a higher level of certainty for DPS-level assignments compared to the river specific assignments within the DPS, which suggests that there is some limited genetic exchange between river populations within a DPS.

We described in the proposed listing rule why we proposed to list Atlantic sturgeon as five DPSs (75 FR 61872, October 6, 2010). In summary, we identified five discrete Atlantic sturgeon population segments based on the evidence that each discrete population is temporally and spatially separated during spawning. The results of genetic analyses further supported that there is strong fidelity to the natal river at spawning time. We concluded that the five discrete Atlantic sturgeon population segments meet the significance criterion of the DPS Policy because each reproduces in a unique ecological setting, and the loss of any of these discrete population segments would result in a significant gap in the range of the taxon. We responded to public comment, including comments from the petitioner (DRN Comment, November 9, 2010), to further explain why we were listing the Delaware River and the Hudson River populations of Atlantic sturgeon as a single DPS (see Response to Comments 13 and 16; 77 FR 5890 and 5892, February 6, 2012). In their comments, as in this petition, the petitioner claimed that the Delaware River population of Atlantic sturgeon is genetically unique as evidenced by the presence of the A5 haplotype, and that including the Delaware River population and the Hudson River population into a single DPS affords less ESA protection to the Delaware River population. We acknowledged in our responses to their comments that genetics could be used to distinguish Atlantic sturgeon that originate from the Delaware River population from those that originate from the Hudson River population. However, we also stated that even though the Delaware River population was genetically distinguishable from the Hudson River population, based upon our evaluation of whether Atlantic sturgeon population segments met the DPS Policy criteria, we could delineate five Atlantic sturgeon DPSs (as described in detail in the proposed rule). Based on application of the DPS Policy criteria, we determined that the Delaware River population did not meet the criteria of a DPS on its own because its spawning time was not temporally separated from that of the Hudson River population, the spawning habitat of both the Delaware River and the Hudson River populations occur within the same unique ecological setting, and analyses of the genetic data for population structuring indicated that the two rivers grouped together (see 75 FR 61876, October 6, 2010). We considered our decision during the 5-year review of the New York Bight DPS in light of new information that had become available since the listing, and we concluded that no changes to the listing of the New York Bight DPS were warranted. We have reviewed and considered the four new genetic studies provided by the petitioner and listed in their “relevant literature.” As described above, none of these provide new information regarding the discreteness of the Delaware River population of Atlantic sturgeon. On the contrary, one new study, White et al. (2021a), provides additional information that corroborates our listing determination for the New York Bight DPS. As described above, the three other genetic publications provided by the petitioner do not provide new information that is relevant to the petitioner's assertion that the Delaware River population is reproductively isolated or to the overall discreteness of this population.

A DPS must be both discrete and significant to the taxon as a whole. If a population is found to be discrete in accordance with the Service's joint DPS Policy, we next consider whether that discrete population is also significant in the context of the joint DPS Policy. In this case, the petitioner has not provided new information to show that the Delaware River population of Atlantic sturgeon may be discrete. We also note that the petitioner appears to be confusing the meaning of the term “significance” in the context of the joint DPS Policy with the word “significance” as it is used in everyday language. The joint DPS Policy directs the Services to consider available scientific evidence of the discrete population segment's importance to the taxon to which it belongs (61 FR 4722, February 7, 1996). However, the petitioner's “relevant literature” provides no scientific evidence that speaks to the significance of the Delaware River population of Atlantic sturgeon to the taxon as a whole. Instead, the petitioner claims that the Delaware population of Atlantic sturgeon is significant because of the population's historical abundance. This reference to the historical abundance of the Delaware River population does not provide any new information. In the proposed and final listing rules we described the significant range-wide declines in Atlantic sturgeon from historical abundance levels due to overfishing, and we stated that the best available data indicated that current numbers of spawning adults for each DPS are one to two orders of magnitude smaller than historical levels. We also described the Delaware River population as presumably very small and extremely vulnerable to any sources of anthropogenic mortality. In addition, the petitioner claims that the Delaware River population of Atlantic sturgeon has “unique adaptive characteristics that will help the species adapt to a changing environment.” However, we could not find any information in the “relevant literature” that supported this statement nor any such information in our files.

We also do not consider here the petitioner's request to list a Delaware River DPS as endangered and to designate critical habitat for the DPS since both of these are dependent on a determination that the Delaware River population may warrant listing as a DPS. However, as described above, the “relevant literature” includes four new reports relative to impacts to the Delaware River population of Atlantic sturgeon or its habitat ( i.e., DRBC, 2022a, 2022b; ERC and Verdantas, 2022; Hagy, 2023), and each report speaks to an impact that we previously identified for the Delaware River population ( i.e., vessel strikes of the fish and low dissolved oxygen levels within its habitat). The petitioner did not include other information as required at 50 CFR 424.14(d). The petitioner did not include in the “relevant literature” section any new reports or publications relative to a need for a new critical habitat designation for the Delaware River population. Those reports or publications that were included ( e.g., Allen et al., 2014; Breece et al., 2013; Brundage et al., 2009; Campbell and Goodman, 2004; and Lazzari et al., 1986) were also considered and used by us when we designated critical habitat in the Delaware River for the New York Bight DPS (82 FR 39160, February 17, 2017; NMFS, 2017).

We thoroughly reviewed the petition, the list of references provided by the petitioner, and other literature and information readily available to us, and find that the petition does not provide any new information regarding the discreteness of the Delaware River population of Atlantic sturgeon or otherwise offer substantial information not already considered in our status review report (ASSRT, 2007), the listing decision (77 FR 5880, February 6, 2012), or our 5-year review (NMFS, 2022). As such, we find that the petition does not present substantial scientific or commercial information indicating that the petitioned action to identify the Delaware River population of Atlantic sturgeon as a DPS may be warranted. We note that the population will continue to be listed as endangered as part of the New York Bight DPS of Atlantic sturgeon and that critical habitat in the Delaware River will continue to be designated as part of the critical habitat for the New York Bight DPS.

A complete list of all references cited herein is available upon request (see FOR FURTHER INFORMATION CONTACT section).

BFT fisheries are managed under the 2006 Consolidated HMS Fishery Management Plan (FMP) and its amendments pursuant to the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act; 16 U.S.C. 1801 et seq. ) and consistent with the Atlantic Tunas Convention Act (ATCA; 16 U.S.C. 971 et seq. ). HMS implementing regulations are at 50 CFR part 635. Section 635.23 describes the daily retention limits for BFT including retention limits on RFDs. Section 635.27 divides the U.S. BFT quota, established by the United States and other members of the International Commission for the Conservation of Atlantic Tunas (ICCAT), among the various domestic fishing categories per the allocations established in the FMP and its amendments. Section 635.27(a)(1) defines and describes the General category quota for BFT. NMFS is required under the Magnuson-Stevens Act at 16 U.S.C. 1854(g)(1)(D) to provide U.S. fishing vessels with a reasonable opportunity to harvest quotas under relevant international fishery agreements such as the ICCAT Convention, which is implemented domestically pursuant to ATCA.

On February 23, 2024, NMFS published a proposed rule and released a Draft Environmental Assessment (EA) (89 FR 13667, February 23, 2024). The proposed rule and Draft EA contain background information on the potential changes to the General category fishery and are not repeated here. The comment period for the proposed rule closed on March 25, 2024. NMFS received 34 written comments as well as oral comments during the public hearing held by webinar on March 18, 2024. The comments received, and the responses to those comments, are summarized in the Response to Comments section.

In developing the final measures, NMFS considered the objectives of this rulemaking along with public comments on the proposed rule and Draft EA. After reviewing this information, NMFS has concluded that the codification of a three-day default RFD schedule from July 1 through November 30 on Tuesdays, Fridays, and Saturdays is warranted to accomplish the objective of extending fishing opportunities through a greater portion of the General category time periods, and this final rule implements such codification. Additionally, NMFS believes that the addition of a fourth RFD per week on Sundays is appropriate in 2024 in order to further this objective and gather additional information about how the fishery operates with 4 RFDs and determine whether it would be appropriate for the future. As such, this final action implements 4 RFDs each week in 2024: Sunday, Tuesday, Friday, and Saturday from July 1 through November 30. At this time, Sunday will be an RFD only in 2024. After November 30, 2024, NMFS will consider whether a fourth RFD per week is needed in future years and whether Sunday should be that day. More information regarding this modification to the proposed rule can be found in both the “Response to Comments” and “Changes from the Proposed Rule” sections.

In brief, the final management measures implemented in this rule are: (1) the codification of a default regulatory RFD schedule consisting of every Tuesday, Friday, and Saturday from July 1 through November 30 of each year; (2) the setting of an additional non-codified RFD specifically in 2024 on every Sunday from July 1 through November 30, 2024; (3) the establishment of a General category default daily retention limit of three large medium or giant BFT per vessel on open days in June and one large medium or giant BFT per vessel on open days for all other months in time periods where the fishery is open ( i.e., January through March and July through December, noting that the General category BFT fishery is not open during the months of April and May); and (4) the clarification of BFT regulations regarding dealer activities on RFDs and the definition of a BSD tag. On an RFD, Atlantic Tunas General category permitted vessels may not fish for (including catch-and-release or tag-and-release fishing), possess, retain, land, or sell BFT. However, on an RFD, Atlantic Tunas General category permitted vessels may fish for, possess, retain, land, or sell other Atlantic HMS tunas ( e.g., bigeye, albacore, yellowfin, and skipjack). Furthermore, on an RFD, HMS Charter/Headboat permitted vessels with a commercial sale endorsement also are subject to these restrictions and may not fish commercially for BFT under the General category restrictions and retention limits. However, such vessels may still fish for, possess, retain, or land BFT when fishing recreationally under applicable HMS Angling category rules.

As described in the Responses to Comments below, NMFS made one change to the preferred alternatives between the proposed and final rule, based in part on public comments. The specific change is described below in the section titled “Changes from the Proposed Rule.”

NMFS has prepared a final EA, Regulatory Impact Review (RIR), and Final Regulatory Flexibility Analysis (FRFA), which analyze the anticipated environmental, social, and economic impacts of several alternatives considered for this final rule. The full list of alternatives and their analyses are provided in the final EA/RIR/FRFA and are not repeated here. A summary of the FRFA is provided below. A copy of the final EA/RIR/FRFA prepared for this final rule is available from NMFS (see ADDRESSES ).

NMFS received 34 written comments from individual members of the public. All written comments can be found at www.regulations.gov; type “NOAA-NMFS-2024-0021” in the Search box ( note : copying and pasting the FDMS Docket Number directly from this document may not yield search results). Below, NMFS summarizes and responds to the comments made on the proposed rule during the comment period.

Comment 1: NMFS received multiple comments expressing concerns with codifying specific days as RFDs. Commenters felt that codifying RFDs would not provide NMFS the flexibility to respond to changes in BFT stock status, the environment, the regulations, and market conditions.

Response: NMFS disagrees that codifying specific days as RFDs would reduce the flexibility needed to respond to such changes. As stated in the proposed rule, NMFS may waive previously scheduled RFDs under certain circumstances, consistent with § 635.23(a)(7). Specifically, NMFS may waive an RFD(s) by adjusting the daily BFT retention limit from zero up to five on specified RFDs, after considering the inseason adjustment determination criteria at § 635.27(a)(7). These considerations include, among other things, review of dealer reports, daily landing trends, and the availability of BFT on fishing grounds. We would announce any such waiver by filing a retention limit adjustment with the Office of the Federal Register for publication. NMFS also may waive previously designated RFDs effective upon closure of the General category fishery so that persons aboard vessels permitted in the General category may conduct tag-and-release fishing for BFT. Similarly, if NMFS is conducting a rulemaking as a result of changes in the BFT stock status, BFT quotas, or other related situations, NMFS could consider the combined impacts of RFDs and those changes on the fishery, and, if needed and appropriate, propose changes to the codified RFD schedule.

Comment 2: NMFS received several comments suggesting that the preferred 3-day RFD schedule has not been effective in extending the length of the season. Some commenters noted that data pre- and post-establishment of RFDs indicate that NMFS should take other measures to control effort better. Many commenters stated that NMFS should set additional RFDs per week as the preferred 3-day RFD schedule has not accomplished the primary goal to allow fishing opportunities later into the applicable time periods.

Response: NMFS disagrees that RFDs have not been effective in meeting its primary goal of extending the fishing season. NMFS acknowledges that in the past few years, with the 3-day RFD schedule of Tuesday, Friday, and Saturday from July 1 through November 30, the subquotas have still been harvested before the end of each time period, necessitating an early closure. However, this is because landings rates continue to be very high compared to past landings rates. This increase in landings rates may be due to various factors including increased availability of BFT and favorable weather conditions. The use of RFDs has extended the applicable time periods and has provided for additional fishing opportunities throughout each time period. Without RFDs, because of those high landings rates, the time period subquotas would likely have been met within days of each time period opening. Such a quick closure would not provide fishing opportunities through much of the fishing season.

Thus, after considering public comment and reviewing daily catch landings data in recent and past years, NMFS is finalizing the codification of a 3-day RFD schedule. NMFS is further setting a fourth, non-codified RFD for the 2024 fishing year (see Responses 3 and 4 for more information). NMFS believes the addition of a fourth day will further the objective of extending the fishing season and continuing to provide equitable fishing opportunities throughout the year and intends to evaluate after the 2024 fishing year whether a permanent codification of a fourth RFD is warranted.

Comment 3: NMFS received a variety of comments regarding a specific RFD schedule. Some commenters supported the preferred 3-day RFD schedule. One commenter supported a 3-day RFD schedule, but suggested that NMFS modify the days to Sunday, Monday, and Friday. The majority of commenters suggested that NMFS set 4 RFDs per week from July 1 through November 30, with Sunday being added as the additional RFD. These commenters felt that the past years' schedule of 3 RFDs per week was not effective in extending the fishing season and stated that a 4-day RFD schedule would extend the quota later into the season, while also reducing market saturation and improving BFT prices. Other commenters felt having 4 RFDs a week would have a negative economic impact on local coastal communities, would eliminate fishing opportunities for participants who can only fish during the weekend, and could result in safety-at-sea issues. Without specifying which specific days, some commenters supported 4 or more RFDs. A few of these commenters suggested 6 RFDs a week as long as NMFS had the flexibility to increase or decrease fishing days by waiving RFDs when needed, while one comment supported as many RFDs per week as would be needed to stabilize the BFT market. One commenter supported 4 RFDs per week from August through December.

Response: A primary objective of this action is to slow the harvest rate of BFT in order to provide General category fishing opportunities through a greater portion of the General category time periods. As stated in the response to Comment 2, the RFD schedule in recent years ( e.g., 3 RFDs per week on Tuesdays, Fridays, and Saturdays) has been effective at allowing extra fishing opportunities. However, the time period subquotas have still been reached quickly resulting in early closures of the General category. After reviewing public comments and catch rate data, NMFS has determined that it is appropriate to set a fourth RFD per week from July 1 through November 30 in 2024 to further slow the rate of catches in the General category and provide for additional fishing opportunities later into the applicable time periods. NMFS will evaluate/review the data from the 2024 fishing season to determine how well a fourth RFD achieves that objective. NMFS recognizes that a 4-day RFD schedule in 2024, specifically a Sunday, Tuesday, Friday, and Saturday schedule, would eliminate BFT commercial fishing opportunities on the weekend and may negatively affect commercial fishermen that currently only fish for BFT on the weekend. However, all General category and HMS Charter/Headboat permit holders that fish commercially for BFT are affected when the subquota is harvested quickly and the season is closed after only a few days. In those cases, commercial fishing opportunities for all General category and HMS Charter/Headboat permit holders fishing commercially for BFT are negatively affected. By setting a 4-day RFD schedule in 2024, we believe more fishing opportunities will be available for all General category participants later into each time period. Furthermore, NMFS has the ability to waive RFDs, if necessary. We believe this added flexibility provides NMFS effective tools to manage the General category fishery.

Regarding safety-at-sea, NMFS recognizes that fishing can be dangerous in the best of circumstances. NMFS does not believe that a 4-day RFD schedule inherently causes more safety issues than a 3-day RFD schedule. Under either schedule, fishermen are not required to go fishing and must make their own determination about whether to fish given the weather or other safety-at-sea conditions. If a schedule of 4 RFDs per week in 2024 is successful at extending fishing opportunities throughout the fishing season, fewer fishermen may feel the need to go fishing on a non-RFD if the weather or other conditions are hazardous.

Comment 4: NMFS received many comments in support of adding Sunday as a fourth RFD per week. The commenters who supported adding Sunday as an RFD noted the highest commercial landings and effort occur on Sunday. Some recreational commenters who supported Sunday as a fourth RFD felt the high commercial fishing effort on Sundays is detrimental to any recreational vessels trying to fish. One commenter noted fishing tournaments in New England do not operate on Sundays, and therefore a Sunday RFD would not cause any impacts to any General category participants in such tournaments. Some commenters opposed the addition of a Sunday RFD, noting that the addition of Sunday would eliminate commercial BFT fishing on weekends.

Response: After considering public comment and further reviewing daily catch landings data in recent and past years, NMFS has determined that Sunday should be added as an additional non-codified RFD in 2024 because Sundays have recently been high landings days in the General category. From 2021 through 2023 for the months with RFDs in place, the rate of landings on Sundays was relatively high (~14 metric tons (mt) per day). Recognizing the concerns from stakeholders regarding the addition of Sunday, at this time we are adding Sunday as an additional non-codified RFD per week only for the 2024 fishing year. This limited time should allow the opportunity to collect data and determine if it would be appropriate to include Sunday as a codified fourth RFD in future years. We recognize that the use of RFDs may allow for an increase in recreational catches of BFT on RFDs, including on weekends. However, the purpose of this action is not to increase recreational landings, but to extend the General category BFT fishery for 2024 year and during subsequent years. Although recreational landings may increase on RFDs, we note that the recreational quota has not been reached in recent years. Additionally, we emphasize that Charter/Headboat permitted vessels must abide by established retention limits when fishing recreationally on RFDs. Thus, NMFS anticipates that recreational landings would remain within the current annual Angling category quota as specified at 635.27(a)(2).

Furthermore, NMFS acknowledges that some HMS tournaments in the New England region may not include fishing on Sundays. However, NMFS is aware of some fishing tournaments that take place on Sundays in other regions during time periods when catch rates are high. RFDs that occur on a tournament date may negatively affect BFT fishing at those tournaments since some tournament participants are General category permit holders and are prohibited from fishing for BFT on RFDs. However, on an RFD, General category permit holders may still participate in non-BFT fishing during the tournament and may land sharks (if they also hold a shark endorsement), swordfish, billfish, and/or bigeye, albacore, yellowfin (YFT), and skipjack tunas recreationally as otherwise allowed. Additionally, on an RFD, Charter/Headboat-permitted vessels may participate recreationally in HMS fishing tournaments, including for BFT, under the applicable Angling category restrictions and size class limits.

Comment 5: NMFS received multiple comments that did not support establishing a default three-fish daily retention limit in the month of June and a default one-fish daily retention limit for all other months in time periods when the fishery is open ( i.e., January through March and July through December. Commenters expressed concerns that a three-fish daily retention limit for the month of June results in too many landings in June for the June through August time period, which is contrary to the goal of this action. These commenters were also concerned that the default retention limit would not provide NMFS the flexibility to modify the retention limit if needed. Other commenters stated that a one-fish daily retention limit would preserve resources and ensure better market prices for BFT.

Response: NMFS disagrees that having a default three-fish daily retention limit in June is contrary to the objectives of this action or would reduce the flexibility needed to modify the retention limit. In recent years, the rate of landings and overall fishing effort in the General category is typically slow in early June. For example, in 2023, the average amount of BFT harvested per day in June ( i.e., 30 open days), with the three-fish daily limit, was 1.5 mt. From July 1 through August 17 ( i.e., 28 open days), with the one-fish daily limit, the average amount harvested per day was 11.8 mt. In recent years, after consideration of the relevant criteria provided under § 635.27(a)(7), which includes consideration of catch rates, NMFS has regularly set the daily retention limit for the beginning of the June through August time period at three fish ( e.g., 86 FR 27814, May 24, 2021; 87 FR 32094, May 27, 2022; 88 FR 34454, May 30, 2023). During the month of June, NMFS monitors the landings closely, and, as appropriate, NMFS can reduce the limit to a one-fish daily retention limit to ensure fishing opportunities in all respective General category time periods and to ensure that the available quota is not exceeded. Any change in the retention limit considers the relevant criteria and includes consideration of the catch rates associated with the various authorized gear types ( i.e., harpoon, rod and reel). Throughout the season, NMFS monitors landings and catch rates and will close the fishery or modify retention limits as appropriate to ensure the quotas are not exceeded. NMFS will continue to monitor and evaluate the effectiveness of all these management measures in the context of current conditions to determine whether other actions are necessary.

Comment 6: NMFS received multiple comments suggesting that NMFS negotiate for more BFT quota at ICCAT citing increases in BFT biomass and shifts in BFT fishing grounds, resulting in high landings. Several commenters noted that the BFT stock has rebounded and is healthy. Some commenters noted that more quota is needed to address recreational trophy and tournament landings, both of which potentially affect General category participation and landings. One commenter expressed that NMFS should consider a special allocation for giant BFT caught in tournaments with no commercial sale.

Response: The most recent western Atlantic BFT stock assessment, conducted in 2021, determined that the overfished status remains unknown and that the stock is not subject to overfishing. This stock status remains in effect. In 2022, NMFS increased the baseline U.S. BFT quota to 1,316.14 mt (not including the 25-mt ICCAT allocated to the United States to account for bycatch of BFT in pelagic longline fisheries in the Northeast Distant Gear Restricted Area), as codified at § 635.27(a), consistent with Recommendation 21-07 adopted by ICCAT at the November 2021 annual meeting (87 FR 33049, June 1, 2022). ICCAT Recommendation 22-10 maintained the U.S. BFT quota as specified above. Further information on the BFT stock assessment and stock status can be found in the 2022 rule referenced above and associated EA.

Regarding more quota for recreational trophy and tournament landings this would require modifications to the BFT quota for the Angling category quota and subquotas and NMFS is not considering modifications of the Angling category in this action. Additionally, regarding a special allocation for giant BFT caught in tournaments with no commercial sale, NMFS is not considering this modification, as it would require modifications to the BFT quota for the General category quota and subquotas. Amendment 13 to the 2006 Consolidated HMS FMP and its final rule (87 FR 59966, October 3, 2022) considered modifications to the BFT category subquotas. As described in Amendment 13, NMFS determined that the current structure of the BFT fishery provides equitable fishing opportunities. As such, Amendment 13 did not modify the General category subquota percentages. However, Amendment 13 eliminated the Purse Seine category and proportionally reallocated Purse Seine category quota to all of the other BFT quota categories, including the General and Angling categories, resulting in an increase to the General category and Angling category quota and subquotas.

Comment 7: One commenter referenced National Standard 4, which requires that conservation and management measures shall not discriminate between residents of different states, and expressed concerns that RFDs are set only for when BFT arrive off Maine versus year-round. Another commenter stated that NMFS has a responsibility to protect the economic value of the BFT fishery under the Magnuson-Stevens Act and codifying effort controls will not provide the flexibility to do so.

Response: The preferred alternatives are designed to extend fishing opportunities through a greater portion of the General category time period subquotas, prevent the overharvest of quota in any period, and improve distribution of fishing opportunities without increasing BFT mortality. This action also provides flexibility to waive codified RFDs (see response to comment 1). Consistent with National Standard 4, the preferred alternatives do not discriminate between residents of different States, as the measures considered in this action apply the same rules to all General category and HMS Charter/Headboat permit holders with a commercial sale endorsement fishing commercially for BFT regardless of their state of residence. The preferred RFD schedule does not apply only to certain regions. Instead, it applies to all regions, during time periods in which landings have been the highest, shortening the time it takes to meet relevant subquotas, resulting in inseason closures earlier than desired, and contributing to market gluts. In the final rule establishing the 2023 RFD schedule, NMFS considered, among other things, RFDs for the December, and the January through March time periods (88 FR 33839, May 25, 2023). Based on public comment, at that time, NMFS did not finalize RFDs for those time periods, in part because the weather during those periods already limits participation. NMFS did not reconsider RFDs during those time periods in this rule, as the reasons for not finalizing them in 2023 still apply.

NMFS emphasizes that the Magnuson-Stevens Act requires the consideration and application of numerous factors when developing fishery conservation and management measures, including the ten National Standards at 16 U.S.C. 1851(a)(1)-(10). The proposed rule and EA did discuss past market conditions and recognized that this action should also help prevent large numbers of BFT from entering the market at the same time, which may indirectly affect price. While NMFS considered economic factors in the development of this action, the primary purpose of RFDs is not economic in nature. Rather, RFDs are an effort control used to extend General category fishing opportunities through a greater portion of the General category time period subquotas, prevent overharvest of quota in any period, and improve distribution of fishing opportunities without increasing BFT mortality.

Comment 8: NMFS received multiple comments expressing concerns with General category permit holders' participation in HMS tournaments. These commenters stated that tournaments contribute significantly to landings of General category BFT in the summer. Some commenters noted that BFT landed by General category vessels participating in tournaments that include BFT should not count toward the General category quota. Some commenters suggested that NMFS should require tournaments to be catch and release only for BFT. Some commenters suggested that NMFS should require all commercially-sized BFT that are landed during tournaments be weighed in dressed form rather than whole form. One commenter expressed that HMS Charter/Headboat vessels should be able to continue to fish in and sell BFT landed in tournaments.

Response: NMFS disagrees that tournament landings contribute significantly to BFT General category landings in the summer. While NMFS acknowledges that tournament landings do affect landings in the General category, non-tournament landings constitute the majority of landings in the General category fishery in the summer. Furthermore, under the current regulations General category and HMS Charter/Headboat permitted vessels with a commercial sale endorsement may participate in BFT fishing tournaments (on non-RFDs) and must comply with the Atlantic Tunas General category regulations to land and sell commercial sized BFT (see § 635.4(c)(3)). In recent years both fishermen and dealers have expressed concerns regarding General category participation in HMS fishing tournaments. At this time, NMFS is not considering action to modify existing regulations regarding General category participation in HMS tournaments. NMFS may consider potential changes to these regulations in the future, if warranted.

Comment 9: NMFS received multiple comments suggesting alternative options to RFDs for the purpose of controlling fishing effort. One commenter suggested that NMFS take action regarding dealer and fishermen communication to reduce unsold fish. Some commenters noted that NMFS should not issue permits unless General category or HMS Charter/Headboat permit holders show proof of meeting safety regulations. These commenters cited that non-compliance of commercial safety gear, stickers, and handling restrictions by Charter/Headboat permit holders leads to an increase in General category fishing by inexperienced or unsafe fishermen resulting in BFT that are not handled properly for sale or landed and unsold.

Response: NMFS believes that RFDs and retention limits offer the best options to pace General category landings to extend fishing opportunities through a greater portion of the time periods. Furthermore, as part of this action, NMFS is clarifying existing regulations to improve the understanding of vessel and dealer restrictions and requirements for participants in the General category BFT fishery. Through these measures, NMFS believes the number of unsold fish should be reduced. Additionally, in recent years (most recently in 2023), NMFS has actively encouraged operators of vessels authorized to sell bluefin tuna to contact their local Atlantic tuna dealers before departing on a trip to determine if dealers are willing to purchase BFT.

Regarding the commercial fishing vessel safety requirements, these requirements are promulgated and enforced by the U.S. Coast Guard, not by NMFS. Such provisions can be found in 46 CFR part 28. Modifying the prerequisites to obtain an HMS permit is outside the scope of this action, however NMFS takes the suggestion under advisement.

Comment 10: NMFS received one comment requesting that NMFS ban imports of BFT or YFT when the fishery is open and ban imported farm/pen raised tunas.

Response: This comment is outside of the scope of this action. Information regarding import restrictions can be found on the NMFS Office of International Affairs, Trade, and Commerce web page at https://www.fisheries.noaa.gov/about/office-international-affairs-trade-and-commerce.

Changes from the proposed rule were made in response to public comment and refined analyses for this final rule. Therefore, where relevant, the description of measures implemented by this final rule includes any changes from the measures in the proposed rule and EA. All changes in this final rule fall within the scope of, or are a logical outgrowth of, the alternatives in the proposed rule and Draft EA. The only changes from the proposed measures are to add Sunday as a temporary fourth RFD each week from July 1 through November 30, 2024, and some minor changes to the regulatory text as described below.

NMFS proposed to set and codify a 3-day RFD schedule for every Tuesday, Friday, and Saturday from July 1 through November 30. As stated in the proposed rule, NMFS has used this RFD schedule since 2022 (in 2021, NMFS used the same 3-day schedule from September 3 through November 30) to correspond with the time periods when catch rates have been historically high in the General category often resulting in premature closures of the fishery. In this final rule, NMFS is codifying the preferred RFD schedule of every Tuesday, Friday, and Saturday from July 1 through November 30, as proposed.

However, as described in the responses to Comments 3 and 4, NMFS received many public comments suggesting that NMFS set a 4-day RFD schedule by adding Sunday as an additional RFD. Based on those public comments and refined analyses, NMFS decided to add Sunday as a fourth RFD each week for the 2024 fishing year. This change applies only to 2024, and NMFS is not codifying by regulation a Sunday RFD through this action. Instead, NMFS may consider codifying Sunday as an additional RFD in the future if deemed appropriate.

Thus, as part of this rule, NMFS is setting 4 RFDs per week for the 2024 fishing year: every Sunday, Tuesday, Friday, and Saturday from July 1 through November 30. As stated in the Response to Comments section, NMFS maintains the ability to waive previously scheduled RFDs and would announce such waivers by filing a retention limit adjustment with the Office of the Federal Register for publication.

NMFS has made a few minor changes to the regulatory text, which includes adding the word “fishing” to tag-and-release activities to § 635.23(a)(7)(i), adding the words “local time” to § 635.31(a)(1), and technical editorial corrections to meet the Office of Federal Register guidelines.

Pursuant to section 304(g) of the Magnuson-Stevens Act, the NMFS Assistant Administrator has determined that this final rule is consistent with the 2006 Consolidated HMS FMP and its amendments, other provisions of the Magnuson-Stevens Act, ATCA, and other applicable law.

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

A FRFA was prepared for this final rule. The FRFA incorporates the initial regulatory flexibility analysis (IRFA), a summary of the significant issues raised by the public comments in response to the IRFA, NMFS' responses to those comments, and a summary of the analyses updated in response to the comments and completed to support the action. A copy of this analysis is available from NMFS (see ADDRESSES ). A summary is provided below.

Section 604(a)(1) of the Regulatory Flexibility Act (RFA) requires agencies to state the need for, and objective of, the final action. This action is consistent with the objectives of the 2006 Consolidated HMS FMP and its amendments, the Magnuson-Stevens Act, ATCA, and other applicable law. The need for this action is to simplify and clarify the regulatory process regarding RFDs. RFDs increase the likelihood of pacing General category landings to extend fishing opportunities through a greater portion of the General category time period subquotas. Additionally, this action would reestablish a General category retention limit on open days for better understanding by General category quota participants and clarify the existing HMS dealer regulations to improve the understanding of vessel and dealer restrictions and requirements for participants in the General category BFT fishery to ensure better compliance by dealers and dealers' agents when operating on an RFD. In short, the objective of this action is to modify the process of scheduling RFDs and reestablish a General category default daily retention limit for large medium or giant BFT on open days. As effort controls, both RFDs and daily retention limits are meant to extend General category fishing opportunities through a greater portion of the General category time period subquotas, prevent overharvest of quota in any period, and improve distribution of fishing opportunities without increasing BFT mortality. Lastly, this action would clarify existing HMS dealer regulations and the definition of a BSD tag to improve the understanding of vessel and dealer restrictions and requirements for participants in the General category BFT fishery.

Section 604(a)(2) of the RFA requires a summary of significant issues raised by the public in response to the IRFA, a summary of the agency's assessment of such issues, and a statement of any changes made in the rule as a result of the comments. NMFS received 34 written comments on the proposed rule and Draft EA during the public comment period. A summary of those comments and the agency's responses are described above. No comments specifically referenced the IRFA, although some comments raised a variety of economic concerns including viability of the General category fishery with RFDs (see comment 3), retention limit impacts on ensuring higher market prices (see comment 5) and NMFS responsibility to protect the economic value of the BFT fishery (see comment 7). NMFS' responses to those comments are summarized above. After careful consideration of all the comments received, NMFS is: (1) codifying an RFD schedule every Tuesday, Friday, and Saturday from July 1 through November 30 that will apply in 2024 and future years; (2) adding Sunday as an additional RFD for the 2024 fishing year; (3) establishing a General category default daily retention limit of three large medium or giant BFT per vessel on open days in June and one large medium or giant BFT per vessel on open days for all other months in time periods where the fishery is open; and (4) clarifying the regulations regarding BFT dealer activities on RFDs and the definition of a BSD tag.

Section 604(a)(3) of the RFA requires the agency to respond to any comments filed by the Chief Counsel for Advocacy of the Small Business Administration (SBA) in response to the proposed rule, and a detailed statement of any change made in the rule as a result of such comments. NMFS did not receive any comments from the Chief Counsel for Advocacy of the SBA in response to the proposed rule. As noted above, no comments specifically referenced the IRFA, although some comments raised a variety of economic concerns including viability of the General category fishery with RFDs (see comment 3), retention limit impacts on ensuring higher market prices (see comment 5) and NMFS responsibility to protect the economic value of the BFT fishery (see comment 7).

Section 604(a)(4) of the RFA requires agencies to provide descriptions of, and where feasible, an estimate of the number of small entities to which the rule would apply. NMFS established a small business size standard of $11 million in annual gross receipts for all businesses in the commercial fishing industry (North American Industry Classification System (NAICS) 11411) for RFA compliance purposes. The SBA has established size standards for all other major industry sectors in the United States, including the scenic and sightseeing transportation (water) sector (NAICS code 487210), which includes for-hire ( e.g., charter/party boat) fishing entities. The SBA has defined a small entity under the scenic and sightseeing transportation ( i.e., water) sector as one with average annual receipts ( i.e., revenue) of less than $14 million. NMFS considers all HMS permit holders, both commercial and for-hire, to be small entities because they had average annual receipts of less than their respective sector's standard of $11 million and $14 million. As of October 2022, there are 2,630 General category permit holders and 4,175 HMS Charter/Headboat permit holders, of which 1,873 hold HMS Charter/Headboat permits with a commercial sale endorsement.

Section 604(a)(5) of the RFA requires agencies to describe any new reporting, record-keeping, and other compliance requirements. This final rule does not contain any new collection of information, reporting, or record-keeping requirements.

Section 604(a)(6) of the RFA requires agencies to describe the steps taken to minimize the significant economic impact on small entities consistent with the stated objectives of applicable statutes, including a statement of the factual, policy, and legal reasons for selecting the alternative adopted in the final rule and why each one of the other significant alternatives to the rule considered by the agency which affect the impact on small entities was rejected.

As described below, NMFS analyzed several different alternatives in this final rulemaking, including by incorporating updates as a result of public comments and additional data reviewed. NMFS also provides rationales for identifying the preferred alternatives to achieve the desired objectives. For purposes of the FRFA, NMFS assumes that each vessel will have similar catch and gross revenues to show the relative impact of the final action on vessels.

Under Alternative A, the status-quo alternative, NMFS would maintain the status quo, and as needed, would continue the recent practice of conducting an annual rulemaking to set the schedule of RFDs for upcoming fishing years. The average annual revenue for BFT landed in the General category is approximately $9.9 million based on the average ex-vessel price from 2018 through 2022 and adjusted for inflation using the GDP Deflator. Overall, RFDs do not modify the General category quota and are designed to extend fishing opportunities through a greater proportion of the time periods in which they apply by spreading fishing effort out over time. To the extent that the ex-vessel revenue for a BFT sold by a General or HMS Charter/Headboat permitted vessel (with a commercial endorsement) may be higher when a lower volume of domestically caught BFT is on the market at one time, the use of RFDs may result in some short-term increase in BFT prices, and the value of BFT for the applicable General category time periods could increase. These increases in price are unlikely to impact the overall average annual revenue. Under this alternative, General category participants would continue to have the same opportunity to land the annual General category quota and subquotas as they have in the past few years. As such, NMFS expects this status quo alternative would have neutral economic impacts as it does not expect this alternative to have new economic impacts on small entities participating in the fishery beyond those currently occurring.

Under Alternative B (Preferred Alternative), which NMFS is considering as four sub-alternatives (B1 is the preferred sub-alternative), NMFS would modify the process for setting an RFD schedule. Under this alternative, NMFS would no longer need to conduct an annual rulemaking to set an RFD schedule. Instead, NMFS would codify the General category time periods and days in which RFDs would be applied as a default. NMFS could, if needed and as appropriate, conduct rulemaking to change the codified RFD schedule ( e.g., remove an RFD or add an RFD). NMFS clarifies that this rulemaking could be for a change to the schedule on either a temporary or permanent basis. NMFS may waive these scheduled RFDs for the specific time periods and days on which they apply by adjusting the daily BFT retention limit from zero up to five after considering the criteria at § 635.27(a)(7). NMFS also may waive previously designated RFDs effective upon closure of the General category fishery so that persons aboard vessels permitted in the General category may conduct only tag-and-release fishing for BFT under § 635.26(a). Codification of default RFDs would provide greater certainty and predictability than annual rulemaking to schedule all RFDs for a certain year, providing some positive economic impacts to General category participants and dealers in terms of business planning. As stated above, the average annual revenue for BFT landed in the General category is approximately $9.9 million based on the average ex-vessel price from 2018 through 2022 and adjusted for inflation using the GDP Deflator. To the extent that the ex-vessel revenue for a BFT sold by a General or HMS Charter/Headboat permitted vessel with a commercial endorsement may be higher when a lower volume of domestically caught BFT is on the market at one time, the use of RFDs may result in some short-term increase in BFT prices, and the value of BFT for the applicable General category time periods could increase.

As part of Alternative B, NMFS is considering four sub-alternatives specifying different days of the week when RFDs would take place to the RFD schedule for 2024 and subsequent years. In general, three of the sub-alternatives (B1, B2, B3) have similar economic impacts because they establish the same number of RFDs and RFDs do not modify the General category quota. Instead, RFDs are designed to extend fishing opportunities through a greater proportion of the time periods in which they apply by spreading fishing effort out over time. To the extent that the ex-vessel revenue for a BFT sold by a General or HMS Charter/Headboat permitted vessel with a commercial endorsement may be higher when a lower volume of domestically caught BFT is on the market at one time, the use of RFDs may result in some short-term increase in BFT prices, and the value of the General category time period subquotas could increase.

Under Sub-Alternative B1, the preferred sub-alternative for the RFD schedule, NMFS will codify a 3-day-per-week RFD schedule for every Tuesday, Friday, and Saturday from July 1 through November 30. This sub-alternative could have neutral to minor beneficial economic impacts on small entities participating in the fishery beyond those currently occurring because this schedule could extend fishing opportunities through a greater portion of the General category time periods in the fishing year while also reducing the influx of BFT products into the market, resulting in short-term increases in ex-vessel prices and revenues for General category participants. However, these short-term increases in price are unlikely to impact the overall average annual revenue.

Under Sub-Alternative B2, NMFS would codify a 3-day-per-week RFD schedule for every Thursday, Friday, and Saturday from July 1 through November 30. This sub alternative could have neutral to minor adverse economic impacts on small entities participating in the fishery as four consecutive landings days could increase the influx of BFT products into the market resulting in a short-term decrease in ex-vessel prices and revenues for General category participants. This short-term decrease in BFT prices would be unlikely to impact the overall average annual revenue.

Under Sub-Alternative B3, NMFS would codify a 3-day-per-week RFD schedule for every Friday, Saturday, and Sunday from July 1 through November 30. This sub-alternative could have neutral to minor adverse economic impacts on small entities participating in the fishery as RFDs for an entire weekend could negatively impact General category participants who can only commercially fish for BFT on the weekends. At this time, because current reporting requirements only track when a BFT is landed and not how often or when vessels fish, NMFS does not have estimates on how many General category permit holders follow this approach. However, under this sub-alternative, as with the other sub-alternatives, all permit holders would have the opportunity to fish for BFT on non-RFDs. Based in part on public comments and upon reviewing fishing activities in past years, NMFS anticipates that General category participants would adjust their schedules, similar to fishermen behavior during past years' RFD schedules. As such, allowing 4 consecutive landing days (even with the weekend restricted) could increase the influx of BFT products into the market resulting in a short-term decrease in ex-vessel prices and revenues for General category participants. This short-term decrease in BFT prices is unlikely to impact the overall average annual revenue.

Under Sub-Alternative B4, NMFS would codify a 4-day (or more)-per-week RFD schedule. Based on public comment and further reviewing of catch data, NMFS now believes that this sub-alternative could have minor beneficial to adverse economic impacts on small entities participating in the General category fishery as 4 or more RFDs could, rather than extending fishing opportunities, actually limit opportunities for General category participants to land the BFT quota and subquotas possibly resulting in underharvest and derby-like conditions. NMFS believes that a greater derby-like effect is expected with a greater number of RFDs per week. This derby-like effect, if large enough, could lead to an influx of BFT products into the market, which, depending on the schedule, could result in a decrease in ex-vessel prices and revenues for General category participants, which may negatively impact overall average revenue. For instance, based on public comment, NMFS now believes that a 4 non-consecutive-day RFD schedule could reduce the influx of BFT products into the market which could result in short-term increases in ex-vessel prices and revenues and thus minor beneficial impacts for some General category participants who are able to participate on all open days. Overall, for the fleet, such a schedule would result in 3 days per week for commercial BFT fishing opportunities. Under this scenario, NMFS would anticipate that some General category participants may be unable to take advantage of the limited open days; however, NMFS would anticipate the General category quota being fully utilized as effort would likely shift to the 3 open days. This would likely have neutral economic impacts because all participants will have the same opportunities to fish commercially on open days. However, an RFD schedule of 5 or more days per week would result in 2 or fewer days per week for commercial BFT fishing opportunities. Under this scenario, NMFS would anticipate greater numbers of General category participants being unable to take advantage of more limited open days. If fishing effort is reduced enough, this may lead to an underharvest of the General category quota and subquotas, and the underutilization of the available fishery resource. In this scenario, NMFS would anticipate more adverse economic impacts.

As stated above in Sub-Alternative B1, NMFS is codifying a three-day RFD schedule on Tuesdays, Fridays, and Saturdays from July 1 through November 30. However, based on public comment on the proposed rule and Draft EA, NMFS is adding Sunday as an additional non-codified fourth RFD for the 2024 fishing year. Additionally, as noted above in the comments and responses, in further reviewing recent catch data, NMFS notes that from 2021 through 2023 for the months with RFDs in place, the rate of landings on Sundays was relatively high ( i.e., ~14 mt per day). The Sunday RFD will not be codified into the regulations at this time to allow for NMFS to gather additional data and observe how the fishery functions. Thus, for the 2024 fishing year, NMFS is setting an RFD schedule of 4 days ( i.e., Sunday, Tuesday, Friday, and Saturday) every week from July 1 through November 30. When the July through November time period is open to fishing, all General category participants could fish on Monday, Wednesday, and Thursday. At this time, NMFS believes that this schedule in 2024 would likely have neutral to adverse economic impacts on individual General category participants who could only commercially fish for BFT on the weekends. However, these individuals would have the opportunity to fish commercially for other tunas ( e.g., bigeye, albacore, yellowfin, skipjack) and non-HMS managed species on the weekends. Overall, for the fleet, such a schedule would likely have neutral to minor beneficial economic impacts because all participants will have the same opportunities to fish commercially on open days, and there is no change to the overall BFT General category quota and subquotas which NMFS anticipates would be fully landed with a possible increase in ex-vessel price due to landings being spread out over time.

Under Alternative C, NMFS would remove RFDs from the existing HMS regulations and no longer set RFDs for the General category. As stated earlier in this document, the goal of RFDs is to extend General category fishing opportunities through a greater portion of the General category time periods. Without RFDs, high catch rates early in each time period would prompt NMFS to prematurely close the General category because the quota has been reached, even though fish may still be available on fishing grounds. Premature closure would mean commercial fishermen operating under the General category could not fish for, possess, retain, or sell commercial sized fish. To the extent that the ex-vessel revenue for a BFT sold by a General or HMS Charter/Headboat permitted vessel (with a commercial endorsement) may be higher when a lower volume of domestically caught BFT is on the market at one time, the use of RFDs may result in some short-term increase in BFT prices, and the value of the General category time period subquotas could increase. This alternative could have neutral to minor adverse economic impacts on small entities participating in the fishery. General category participants would likely land the subquotas over an extremely short time period increasing the influx of BFT products into the market, potentially resulting not only in an earlier closure of the fishery but also a slight decrease in ex-vessel prices and revenues for General category participants which may negatively impact overall average revenue.

As part of Alternative D, NMFS is considering three alternatives specifying the General category retention limits for BFT. In general, the three Sub-Alternatives (D1, D2, and D3) have similar economic impacts as retention limits overall are designed to extend the length of the General category time periods when BFT can be landed, providing additional fishing opportunities while also reducing the influx of BFT products into the market, which could result in a short-term increase in ex-vessel prices for General category participants.

Under Sub-Alternative D1, the status-quo alternative for retention limits, NMFS would maintain the current regulations at § 635.23(a)(3) which do not establish a default retention limit on open days ( i.e., non-RFDs) when the General category is open. Under this alterative NMFS may set the General category default daily retention limit for large medium or giant BFT over a range of zero (on RFDs) to five BFT per vessel for each time period in an action published in the Federal Register . The daily retention limit would apply to General category permitted vessels and HMS Charter/Headboat permitted vessels with a commercial sale endorsement when fishing commercially for BFT. Overall, the use of retention limits would likely have neutral to minor beneficial economic impacts on small entities participating in the General category fishery as they could extend the length of the General category time periods when BFT can be landed, providing additional fishing opportunities while also reducing the influx of BFT products into the market which could result in a short-term increase in ex-vessel prices for General category participants. This short-term increase in BFT prices are unlikely to impact the overall average annual revenue. NMFS expects the status-quo alternative to have neutral economic impacts as it does not change existing management.

Under Sub-Alternative D2, NMFS would establish a General category default daily retention limit of one large medium or giant BFT per vessel on days when the General category is open. The daily retention limit would apply to General category permitted vessels and HMS Charter/Headboat permitted vessels with a commercial sale endorsement when fishing commercially for BFT. Retention limits would likely have neutral to minor beneficial economic impacts on small entities participating in the General category fishery as they could extend the length of the General category time periods when BFT can be landed, providing additional fishing opportunities while also reducing the influx of BFT products into the market which could result in a short-term increase in ex-vessel prices for General category participants. However, since the current practice in recent years is to set a daily retention limit of three large medium or giant BFT per vessel on days when the General category is open, starting June 1 through June 30, a default of one BFT could potentially constrain the revenue of vessels that might have been able to land two or three BFT on open days from June 1 through June 30. Although this alternative may have a short-term minor adverse impact on a limited number of individuals and their revenues (likely resulting in a short-term decrease in ex-vessel prices), NMFS expects that the overall average annual revenue would unlikely be impacted.

Under Sub-Alternative D3, the preferred sub-alternative for retention limits, NMFS is establishing a General category daily retention limit of three large medium or giant BFT per vessel on open days in June and one large medium or giant BFT on days during all other months when the fishery is open ( i.e., January through March and July through December; the General category BFT fishery is not open during the months of April and May) unless adjusted with an inseason action. The daily retention limit would apply to General category permitted vessels and HMS Charter/Headboat permitted vessels with a commercial sale endorsement when fishing commercially for BFT. Retention limits would likely have neutral to minor beneficial economic impacts on small entities participating in the General category fishery as retention limits could extend the length of the General category time periods when BFT can be landed, providing additional fishing opportunities while also reducing the influx of BFT products into the market which could result in a short-term increase ex-vessel prices for General category participants. Implementation of these default retention limits would align with current management practices and provide additional fishing opportunities in all respective time periods. Codifying the current retention limits and management practices would potentially reduce some uncertainty regarding future retention limits for General category participants and dealers and thus lead to some positive economic impacts associated with their improved business planning. NMFS expects that the overall average annual revenue would be unlikely to be impacted.

Therefore in this final action, NMFS will finalize Alternative B, specifically the RFD schedule of Sub-Alternative B1, which would modify the process for setting an RFD schedule and codify a three-day-per-week schedule of RFDs for every Tuesday, Friday, and Saturday from July 1 through November 30 for 2024 and subsequent years. Additionally, based on public comments, NMFS is also adding Sunday as an additional non-codified RFD for the 2024 fishing year. This change occurred as a logical outgrowth of public comments and refined analyses of recent catch rates. Based on this change we are setting a four-day-per-week RFD schedule of every Sunday, Tuesday, Friday, and Saturday from July 1 through November 30, 2024. NMFS may waive these scheduled RFDs for the specific time periods and days on which they apply by adjusting the daily BFT retention limit from zero up to five, after considering the criteria at 50 CFR 635.27(a)(7). NMFS also may waive previously designated RFDs effective upon closure of the General category fishery so that persons aboard vessels permitted in the General category may conduct only tag-and-release fishing for BFT under 50 CFR 635.26(a). NMFS may also remove or establish additional RFDs, either temporary ones ( i.e., effective only for one fishing year) or permanent ones, as appropriate, through further rulemaking.

NMFS also will finalize Sub-Alternative D3, which would establish a retention limit of three large medium or giant BFT ( i.e., one fish measuring 73 inches or greater) per vessel on open days when the General category is open, for June 1 through June 30 unless adjusted with an inseason action, if warranted. For all other months in time periods where the fishery is open ( i.e., January through March and July through December; note that the General category BFT fishery is not open during the months of April and May), the default retention limit of one large medium or giant BFT would go into effect on open days when the General category is open.

In this final rule, NMFS is clarifying the regulations to specify explicitly when Atlantic Tunas General category and HMS Charter/Headboat permit holders can sell BFT and permitted dealers can buy BFT related to RFDs as discussed in the proposed rule. These clarifications to the existing regulations are intended to aid in the enforcement of RFDs and address questions from fishing participants and dealers. As described in the proposed rule, these changes are administrative in nature and are therefore not expected to have any economic impact.

Section 212 of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. No. 104-121) 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” (see 5 U.S.C. 601). The agency shall explain the actions a small entity is required to take to comply with a rule or group of rules. As part of this rulemaking process, NMFS has prepared a small entity compliance booklet summarizing fishery information and regulations for Atlantic BFT General category RFDs, retention limits, and dealer requirements for 2024 and subsequent years. That booklet serves as the small entity compliance guide for this rule. Copies of this final rule and compliance guide are available on the HMS Management Division website.

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

For the reasons set out in the preamble, NMFS amends 50 CFR part 635 as follows:

BFT fisheries are managed under the 2006 Consolidated Atlantic HMS Fishery Management Plan (FMP) and its amendments, pursuant to the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act; 16 U.S.C. 1801 et seq. ) and consistent with the Atlantic Tunas Convention Act (ATCA; 16 U.S.C. 971 et seq. ). HMS implementing regulations are at 50 CFR part 635. Section 635.27 divides the U.S. BFT quota recommended by the International Commission for the Conservation of Atlantic Tunas (ICCAT) and as implemented by the United States among the various domestic fishing categories, per the allocations established in the 2006 Consolidated HMS FMP and its amendments. NMFS is required under the Magnuson-Stevens Act at 16 U.S.C. 1854(g)(1)(D) to provide U.S. fishing vessels with a reasonable opportunity to harvest quotas under relevant international fishery agreements, such as the ICCAT Convention, which is implemented domestically pursuant to ATCA.

Under § 635.28(a)(1), NMFS files a closure action with the Office of the Federal Register for publication when a BFT quota (or subquota) is reached or is projected to be reached. Retaining, possessing, or landing BFT under that quota category is prohibited on and after the effective date and time of a closure action for that category, for the remainder of the fishing year, until the opening of the subsequent quota period or until such date as specified.

The 2024 BFT fishing year, which is managed on a calendar-year basis and subject to an annual calendar-year quota, began January 1, 2024. The Angling category season opened January 1, 2024, and continues through December 31, 2024. As described in § 635.27(a), the current baseline U.S. BFT quota is 1,316.14 metric tons (mt) (not including the 25 mt ICCAT allocated to the United States to account for bycatch of BFT in pelagic longline fisheries in the Northeast Distant Gear Restricted Area per § 635.27(a)(3)). The Angling category baseline quota is 297.4 mt, of which 9.2 mt (3.1 percent of the annual Angling category quota) is suballocated for the harvest of large medium and giant (trophy) BFT by vessels fishing under the Angling category quota, with 2.3 mt (25 percent of the annual large medium and giant BFT Angling category quota) allocated for each of the following areas: north of lat. 42° N (the Gulf of Maine area); south of lat. 42° N and north of lat. 39°18′ N (the southern New England area); south of lat. 39°18′ N, and outside of the Gulf of Mexico (the southern area); and the Gulf of Mexico region. Trophy BFT measure 73 inches (185 centimeters) curved fork length or greater. We note, when the Gulf of Mexico area trophy fishery is open, no large medium or giant BFT may be retained, possessed, landed, or sold in the Gulf of Mexico, except one per vessel per year may be landed if caught incidentally to fishing for other species as specified at § 635.23(b)(1)(i) while the fishery is open. This closure action applies to the Gulf of Mexico area.

Based on landings data from the NMFS Automated Catch Reporting System, as well as average catch rates and anticipated fishing conditions, the Angling category Gulf of Mexico area trophy BFT subquota of 2.3 mt has been reached and exceeded. Therefore, retaining, possessing, or landing large medium or giant ( i.e., measuring 73 inches (185 centimeters) curved fork length or greater) BFT in the Gulf of Mexico by persons aboard HMS Angling and HMS Charter/Headboat permitted vessels (when fishing recreationally) must cease at 11:30 p.m. local time on May 29, 2024. This closure will remain effective through December 31, 2024. This action applies to HMS Angling and HMS Charter/Headboat permitted vessels when fishing recreationally for BFT, and is taken consistent with the regulations at § 635.28(a)(1). This action is intended to prevent further overharvest of the Angling category Gulf of Mexico area trophy BFT subquota.

If needed to ensure available quotas or subquotas are not exceeded or to enhance fishing opportunities, subsequent Angling category adjustments or closures will be published in the Federal Register per § 635.27(a)(7) and § 635.28(a)(1). Information regarding the Angling category fishery for Atlantic tunas, including daily retention limits for BFT measuring 27 inches (68.5 centimeters) to less than 73 inches (185 centimeters), and any further Angling category adjustments, is available at https://hmspermits.noaa.gov. During a closure, fishermen aboard HMS Angling and HMS Charter/Headboat permitted vessels when fishing recreationally may continue to catch and release (or tag and release) BFT of all sizes, subject to the requirements of the catch-and-release and tag-and-release programs at § 635.26. All BFT that are released must be handled in a manner that will maximize survival, and without removing the fish from the water, consistent with requirements at § 635.21(a)(1). For additional information on safe handling, see the “Careful Catch and Release” brochure available at https://www.fisheries.noaa.gov/resource/outreach-and-education/careful-catch-and-release-brochure.

NMFS will continue to monitor the BFT fisheries closely. Per § 635.5(c)(1), HMS Angling and HMS Charter/Headboat permitted vessel owners are required to report the catch of all BFT retained or discarded dead, within 24 hours of the landing(s) or end of each trip, by accessing https://hmspermits.noaa.gov, using the HMS Catch Reporting app, or calling 888-872-8862 (Monday through Friday from 8 a.m. until 4:30 p.m.).

NMFS issues this action pursuant to section 305(d) of the Magnuson-Stevens Act (16 U.S.C. 1855(d)) and regulations at 50 CFR part 635, and this action is exempt from review under Executive Order 12866.

The Assistant Administrator for NMFS (AA) finds that pursuant to 5 U.S.C. 553(b)(B), it is impracticable and contrary to the public interest to provide prior notice of, and an opportunity for public comment on, this action for the following reasons. Specifically, the regulations implementing the 2006 Consolidated HMS FMP and its amendments provide for inseason adjustments and fishery closures to respond to the unpredictable nature of BFT availability on the fishing grounds, the migratory nature of this species, and the regional variations in the BFT fishery. Providing for prior notice and opportunity to comment is impracticable and contrary to the public interest as this fishery is currently underway and, based on landings information, the Angling category Gulf of Mexico area trophy fishery subquota has been reached and exceeded. Delaying this action could result in further excessive trophy BFT landings that may result in future potential quota reductions for the Angling category, depending on the magnitude of a potential Angling category overharvest. NMFS must close the Gulf of Mexico area trophy BFT fishery before additional landings of these sizes of BFT occur. Taking this action does not raise conservation and management concerns, and would support effective management of the BFT fishery. NMFS notes that the public had an opportunity to comment on the underlying rulemakings that established the U.S. BFT quota and the inseason adjustment criteria.

For all of the above reasons, the AA also finds that pursuant to 5 U.S.C. 553(d), there is good cause to waive the 30-day delay in effectiveness.

The DGN fishery is managed under the Fishery Management Plan for U.S. West Coast Fisheries for Highly Migratory Species (50 CFR part 660, subpart K) and occurs off the coast of California. NMFS regulations state that “No person may fish with, set, or haul back drift gillnet gear in U.S. waters of the Pacific Ocean east of the 120° W meridian from June 1 through August 31 during a forecasted, or occurring, El Niño event off the coast of southern California” (50 CFR 660.713(c)(2)). This area, which corresponds to the Southern California Bight (SCB), is referred to in the regulations as the “Pacific loggerhead conservation area.”

Under 50 CFR 660.713(c)(2)(ii), the AA is to rely on information developed by NOAA offices (the Climate Prediction Center (CPC) and the West Coast Office of the Coast Watch program) to make the determination that an El Niño event is forecasted or occurring off southern California. The AA is to use monthly sea surface temperature (SST) charts to determine whether there are warmer-than-normal SSTs off southern California “during the months prior to the closure months for years in which an El Niño event has been declared” by the CPC. Specifically, the AA is to use SST data from the second and third months prior to the month of closure. To make a determination for a closure to begin in June, the AA is using data from March and April.

NMFS published these regulations to protect loggerhead sea turtles, which are listed under the Endangered Species Act. The regulations addressed a reasonable and prudent alternative (RPA) included in NMFS' 2000 biological opinion for this fishery. The biological opinion concluded that bycatch in the DGN fishery was likely to jeopardize the continued existence of loggerhead sea turtles and, as an RPA, recommended the fishery be closed during summer months when El Niño conditions are present to avoid the likelihood of jeopardy. NMFS implemented the Pacific Loggerhead Conservation Area regulations in 2003 to address this RPA. The regulations were amended in 2007 (72 FR 31756, June 8, 2007).

On May 9, 2024, the CPC issued an El Niño Advisory. Under the CPC's El Nino/Southern Oscillation (ENSO) diagnostic system, an El Niño Advisory is issued when El Niño conditions are observed and expected to continue. In May 2024, NMFS staff reviewed the SST anomalies in the SCB during March and April of 2024, relying on SST maps available through NOAA's Coast Watch program (for details see https://coastwatch.pfeg.noaa.gov/erddap/index.html ). These maps indicated that SSTs were above normal in the SCB. NMFS concluded that a determination that El Niño conditions are occurring off southern California is warranted based on SSTs that were warmer than normal during March and April, 2024, consistent with regulations at 50 CFR 660.713(c)(2)(ii).

If SSTs return to normal or below normal during a closure period, regulations at 50 CFR 660.713(c)(2)(iii) state that the AA may re-open the fishery after publishing a Federal Register notice announcing that El Niño conditions are no longer present in the SCB. The CPC report on May 9, 2024, indicates a transition from El Niño to ENSO-neutral likely in the next month. The CPC also indicates a La Niña may develop in June-August (with a 49 percent chance) or July-September (with a 69 percent chance).

This action is required by regulations at 50 CFR 660.713 and is exempt from Office of Management and Budget review under Executive Order 12866.

NMFS finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) for the time-area closure of the DGN fishery. Notice and comment procedures for this action are impracticable and contrary to the public interest. The most recent El Niño determination occurred on May 9, 2024, and regulations require that the closure period begin on June 1; therefore, there is insufficient time for notice and comment procedures. For the same reasons, NMFS also finds good cause under 5 U.S.C. 553(d)(3) to waive the general requirement for a 30-day delay in effectiveness for this action. This measure is based upon the best available information and is necessary for the conservation of loggerhead sea turtles. The closure period anticipated by the regulation ends, at the latest, on August 31, 2024. A delay in effectiveness may allow the fishery to interact with and injure or kill loggerhead sea turtles that may occur within the SCB during the time period in which the regulation was intended to protect loggerheads.

NMFS manages the Cook Inlet EEZ Area according to the Fishery Management Plan for Salmon Fisheries in the EEZ off Alaska (Salmon FMP). The intended effect of this action is to conserve and manage the salmon resources in Cook Inlet EEZ Area in accordance with the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act). Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR parts 600 and 679.

In accordance with § 679.118(c)(1)(ii), the Regional Administrator has determined it is necessary to close Chinook salmon recreational fishing for conservation and management purposes and is prohibiting recreational fishing for Chinook salmon in the Cook Inlet EEZ Area. In making this determination, the Regional Administrator has considered the following factors: the low proposed Chinook salmon acceptable biological catch in the Cook Inlet EEZ Area (270), anticipated harvest rates, expected mortality, and the potential number of participants.

NMFS issues this action pursuant to section 305(d) of the Magnuson-Stevens Act. This action is authorized by 50 CFR 679.118(c)(1)(ii), which was issued pursuant to section 304(c), and is necessary to carry out the Salmon FMP. This action is exempt from review under Executive Order 12866.

Pursuant to 5 U.S.C. 553(b)(B), there is good cause to waive prior notice and an opportunity for public comment on this action. Notice and comment would be impracticable and contrary to the public interest, as it would prevent NMFS from responding to the most recent information regarding the status of Cook Inlet Chinook salmon stocks in a timely fashion. This action is being taken pursuant to regulations implementing amendment 16 to the Salmon FMP (April 30, 2024, 89 FR 34718). These Federal salmon management measures—which generally allow for recreational harvest of all salmon stocks in the Cook Inlet EEZ year-round—become effective May 30, 2024. Therefore, publishing a notification providing time for public comment would delay the closure of the Cook Inlet EEZ to recreational Chinook salmon fishing until after the regulations that otherwise authorize such fishing become effective. A delay of this closure would prevent the accomplishment of the conservation and management objectives for the Cook Inlet EEZ Area salmon fishery, resulting in recreational harvest of Chinook salmon that is not supported by current stock levels.

The Assistant Administrator for Fisheries, NOAA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.