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 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 would amend the Class D airspace at Fort Worth Spinks Airport, Fort Worth, TX, and the Class E airspace extending upward from 700 feet above the surface at Granbury Regional Airport, Granbury, TX, contained within the Dallas-Fort Worth, TX, airspace legal description, to support instrument flight rule operations at these airports.

Interested parties are invited to participate in this proposed rulemaking by submitting such written data, views, or arguments, as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. Communications should identify both docket numbers and be submitted in triplicate to the address listed above. Commenters wishing the FAA to acknowledge receipt of their comments on this notice must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2021-1047/Airspace Docket No. 21-ASW-23.” The postcard will be date/time stamped and returned to the commenter.

All communications received before the specified closing date for comments will be considered before taking action on the proposed rule. The proposal contained in this notice may be changed in light of the comments received. A report summarizing each substantive public contact with FAA personnel concerned with this rulemaking will be filed in the docket.

An electronic copy of this document may be downloaded through the internet at https://www.regulations.gov. Recently published rulemaking documents can also be accessed through the FAA's web page at https://www.faa.gov/air_traffic/publications/airspace_amendments/.

You may review the public docket containing the proposal, any comments received, and any final disposition in person in the Dockets Office (see the ADDRESSES section for the address and phone number) between 9:00 a.m. and 5:00 p.m., Monday through Friday, except federal holidays. An informal docket may also be examined during normal business hours at the Federal Aviation Administration, Air Traffic Organization, Central Service Center, Operations Support Group, 10101 Hillwood Parkway, Fort Worth, TX 76177.

This document proposes to amend FAA Order JO 7400.11F, Airspace Designations and Reporting Points, dated August 10, 2021, and effective September 15, 2021. FAA Order JO 7400.11F is publicly available as listed in the ADDRESSES section of this document. FAA Order JO 7400.11F lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

The FAA is proposing an amendment to 14 CFR part 71 by:

Amending the Class D airspace at Fort Worth Spinks Airport, Fort Worth, TX, by updating the geographic coordinates of the airport to coincide with the FAA's aeronautical database;

And amending the Class E airspace extending upward from 700 feet above the surface within an 8.8-mile (increased from a 6.3-mile) radius of Granbury Regional Airport, Granbury, TX, contained within the Dallas-Fort Worth, TX, airspace legal description; and updating the geographic coordinates of Fort Worth Spinks Airport, Fort Worth, TX, also contained within the Dallas-Fort Worth, TX airspace legal description, to coincide with the FAA's aeronautical database.

This action is necessary due to an airspace review due to the cancellation of the instrument procedures and implementation of new instrument procedures at Granbury Regional Airport.

Class D and E airspace designations are published in paragraphs 5000 and 6005, respectively, of FAA Order JO 7400.11F, dated August 10, 2021, and effective September 15, 2021, which is incorporated by reference in 14 CFR 71.1. The Class D and E airspace designations listed in this document will be published subsequently in FAA Order JO 7400.11.

FAA Order JO 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.

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, is non-controversial and unlikely to result in adverse or negative comments. 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 will only affect air traffic procedures and air navigation, it is certified that this rule, when promulgated, would not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

This proposal will be subject to an environmental analysis in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures” prior to any FAA final regulatory action.

Accordingly, pursuant to the authority delegated to me, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows:

In fiscal year 2017, the Alcohol and Tobacco Tax and Trade Bureau (TTB) began an evaluation of the information collected during the course of TTB's permit and registration applications. The purpose was to identify ways to streamline the application and registration process, reduce burden on the regulated industry, and ensure that the process collects, where possible, only information that is necessary to meet the agency's statutory obligations. TTB's general approach was to identify information being collected that could be eliminated without hindering TTB's ability to evaluate an applicant's qualifications and to more narrowly focus the application questions to capture only the information that is needed. In addition, TTB also considered whether there were any requests made in the application process that were so commonly approved that the regulations themselves could be amended to accommodate them without the need to submit the request.

Similarly, on June 14, 2017, the Treasury Department (Treasury) published in the Federal Register (82 FR 27217) a Request for Information inviting members of the public to submit views and recommendations for Treasury regulations that can be eliminated, modified, or streamlined in order to reduce burdens. TTB reviewed comments received in response to this request and identified proposals that related to the permit application process or, more generally, to beginning business in a TTB-regulated industry.

Through TTB's internal evaluation and consideration of the public input, TTB has identified deregulatory actions that TTB can take by amending regulations and also, where rulemaking is not required, by amending guidance and forms. While this document addresses distilled spirits plants, users and dealers of specially denatured alcohol and tax-free alcohol, and Federal Alcohol Administration Act basic permit holders, TTB intends to engage in further rulemaking to address other regulated industries within the context of their respective statutory eligibility requirements. Specifically, TTB will address in separate rulemakings the Internal Revenue Code (IRC) registration and notice requirements for wine and beer producers, respectively, as well as IRC requirements for TTB-regulated tobacco businesses.

With respect to distilled spirits plants (DSPs), this document proposes to amend the regulations to eliminate or narrow the range of information that must be submitted with applications for permits or registrations to more directly respond to TTB's statutory obligations and permit or registration eligibility criteria. Proposed amendments include:

• Eliminating various requirements to submit operational information. Specifically, TTB proposes eliminating eight (8) regulatory provisions requiring submission of information including, but not limited to, descriptions of production procedures and storage systems.

• Tailoring requirements to describe the DSP premises more narrowly to specifically correspond with statutory requirements, and consolidating requirements to provide descriptions of alternation operations with the general DSP premises description.

• Replacing requirements to submit narrative descriptions of DSP security with certifications that the applicant's security measures will comply with enumerated regulatory requirements.

• Eliminating requirements to provide serial numbers of DSP equipment in the application, thereby allowing equipment to be reported in the aggregate where applicable and allowing a DSP application to be submitted prior to physical receipt of the equipment.

TTB is also proposing to amend the regulations to increase industry flexibility without imposing regulatory burden. These amendments benefit DSPs, users and dealers of specially denatured alcohol and tax-free alcohol, and, where appropriate under statute, Federal Alcohol Administration Act basic permit holders. Proposed amendments include:

• Extending deadlines for reporting certain changes in the business from 30 days to 60 days.

• Allowing regulated businesses to add or remove trade names by submitting a notification to TTB rather than applying for TTB approval.

• Allowing regulated businesses to maintain required records at a location other than the permitted premises without first obtaining TTB approval.

Section II of this document includes more in-depth discussion of the proposed amendments.

As noted above, TTB's deregulatory strategy also includes streamlining longstanding policies and practices implementing existing regulations. TTB has already begun deploying such streamlining efforts in response to both TTB's internal evaluation of application processes and to comments received from the public.

For instance, TTB has implemented significant reductions in the information collected on form TTB F 5000.9, Personnel Questionnaire—Alcohol and Tobacco (the Personnel Questionnaire) and its electronic equivalent in response to comments submitted to Treasury through the Request for Information. TTB collects the Personnel Questionnaire as part of the application process for most types of permits or registrations. The Personnel Questionnaire collects information about individuals involved in an applicant's business (such as a business's officers, directors, or principal investors), including information about such individuals' identity, employment and residence history, investment in the business, prior involvement in TTB-regulated businesses, and criminal record, if any. The collection of this information has been approved by the Office of Management and Budget under Information Collection number 1513-0002.

TTB uses this information to determine whether the applicant, including the individuals involved in the applicant business, meet the statutory eligibility criteria for obtaining a permit or registration. These criteria are set forth in detail in section 1(B) of this document. Upon careful review, TTB recognized that it could reduce the information collected through the Personnel Questionnaire. TTB has revised form TTB F 5000.9 and its electronic equivalent in Permits Online to substantially reduce the number of required fields and to eliminate some of the most time-consuming fields (such as general employment history and residence history). TTB also has stopped collecting supporting documentation for certain types of investment in an applicant business ( e.g., bank statements, loan documentation, promissory notes, etc.).

The Federal Alcohol Administration Act (FAA Act, 27 U.S.C. 201, et seq. ) and chapter 51 of the IRC, 26 U.S.C. chapter 51, require persons intending to engage in certain distilled spirits-related businesses to obtain a permit, or approval of a registration, from the Secretary of the Treasury (Secretary) before beginning operations. Many distillers engage in operations that require both a permit under the FAA Act and a registration under the IRC. The amendments proposed in this document generally relate to the application requirements for such permits and registrations, including requirements to report certain changes in the regulated businesses. Additionally, amendments proposed in this document address application requirements for permits under the FAA Act for operations as importers or wholesalers of distilled spirits, wine, and/or malt beverages.

The FAA Act requires that persons seeking to engage in business as producers of distilled spirits, or as importers or wholesalers of distilled spirits, wine, and malt beverages, obtain a permit before beginning operations. See 27 U.S.C. 203. The term “distilled spirits,” when used in the context of the FAA Act, applies only to distilled spirits for nonindustrial use. The TTB regulations at 27 CFR 1.60 set out uses of spirits that are regarded as “industrial.” The FAA Act at 27 U.S.C. 204(c) provides that the Secretary will prescribe the manner and form of all applications for basic permits. Note that the FAA Act also requires permits for producing, rectifying, or blending wine and that these activities also require qualification under the IRC; TTB plans to modernize wine-specific permit requirements in a separate rulemaking document.

Chapter 51 of the IRC contains excise tax and related provisions concerning distilled spirits, wines, and beer. This includes requirements that persons intending to engage in certain activities related to producing, using, or dealing in distilled spirits obtain a registration and/or permit from the Secretary before beginning operations. As noted above, TTB will address in a separate rulemaking the application requirements under the IRC for bonded wine cellars, bonded wineries, taxpaid wine bottling houses, and brewer's notices.

The IRC requires each person seeking to establish a distilled spirits plant, before commencing operations, to apply for and receive notice of registration of the plant. See 26 U.S.C. 5171(c). Those persons whose distilled spirits plant operations are not required to obtain a basic permit under the FAA Act are required to obtain an IRC operating permit. See 26 U.S.C. 5171(d). The applications for registrations and permits are to be in such manner and form as the Secretary prescribes by regulation. See 26 U.S.C. 5172 (registrations); 5171(d)(1) and 5271(b)(1) (operating permits).

The IRC provides for the issuance of permits to establish plants for the purpose of producing, processing, storing, using, and/or distributing distilled spirits that are exclusively for fuel use (“alcohol fuel plants”). While alcohol fuel plants, as a type of distilled spirits plant, are generally subject to the registration and permitting requirements of sections 5171(c) and (d), and any associated qualification requirements, the IRC at 26 U.S.C. 5181 provides authority to prescribe by regulation a streamlined application process for such plants, see 26 U.S.C. 5181, which TTB has done.

The IRC also governs permits relating to the procurement and use of denatured distilled spirits, and the use of non-beverage spirits for certain tax-free purposes. See 26 U.S.C. 5271. Section 5271 provides that no person may procure or use distilled spirits free of tax under the provisions of 26 U.S.C. 5214(a)(2) or (3); or procure, deal in, or use specifically denatured distilled spirits; or recover specifically or completely denatured distilled spirits, until he or she has applied for and received a permit to do so from the Secretary. The application for such permit is to be as prescribed by regulation. See 26 U.S.C. 5271(b)(1).

The IRC requires persons seeking to engage in the business of manufacturing vinegar by the vaporizing process to first apply for and receive approval of a registration from the Secretary, the application for which is to be as prescribed by regulation. See 26 U.S.C. 5502.

Finally, the IRC requires all wholesale dealers and retail dealers of distilled spirits, wine, and beer to register with the Secretary. See 26 U.S.C. 5124.

The FAA Act and IRC set forth eligibility criteria (including criteria rendering an applicant ineligible) for many of the above permits and registrations. The FAA Act provides that an applicant is not entitled to a basic permit—including those applying as producers of distilled spirits and those applying as importers or wholesalers of distilled spirits, wine, and beer—if the applicant has been convicted of a felony within the previous 5 years or a misdemeanor under any Federal law relating to liquor within the previous 3 years. See 27 U.S.C. 204(a)(2). Under this statutory provision, the “applicant” includes, in the case of a corporation, any of its officers, directors, or principal stockholders. Section 204(a)(2) also provides that an applicant is not entitled to a basic permit if the applicant is, by reason of his or her business experience, financial standing, or trade connections, not likely to maintain operations in conformity with Federal law.

The IRC similarly provides that an application for a distilled spirits operating permit may be denied if—among other reasons—the applicant (including the principal stockholders of a corporation) is, by reason of his or her financial standing or trade connections, not likely to maintain operations in compliance with chapter 51 of the IRC. See 26 U.S.C. 5271(c), 5171(d). Specifically, these eligibility criteria apply to permits required for distilled spirits plants that are not otherwise required to obtain an FAA Act basic permit, such as distilled spirits plants that distill for industrial use. These eligibility criteria also apply to permits for alcohol fuel plants under 26 U.S.C. 5181. See 27 CFR 19.678. A permit to use tax-free alcohol, to use or deal in specially denatured distilled spirits, or to recover specially or completely denatured distilled spirits may also be denied for the same reasons. See 26 U.S.C. 5271(c).

TTB administers chapter 51 (distilled spirits, wine, and beer) of the IRC, as well as the FAA Act, pursuant to Treasury Order 120-01, dated December 10, 2013, through which the Secretary has delegated to TTB certain IRC and FAA Act administrative and enforcement authorities, including those related to the issuance of the permits and registrations covered under this rulemaking.

Section 2(d) of the FAA Act, Public Law 74-401 (1935) authorizes the Secretary “to prescribe such rules and regulations as may be necessary to carry out [its] powers and duties” under the FAA Act. Section 7805(a) of the IRC (26 U.S.C. 7805(a)) provides the general authority to the Secretary to issue regulations to carry out the provisions of the IRC.

Pursuant to its delegated authorities described above, TTB has promulgated regulations setting forth the application requirements for permits or registrations related to distilled spirits operations in title 27 of the Code of Federal Regulations (CFR), at the following parts:

• 27 CFR part 1, FAA Act basic permits ( i.e., distillers, rectifiers, and blenders of distilled spirits; distilled spirits warehousemen; and alcohol importers and wholesalers);

• 27 CFR part 19, IRC registrations and operating permits for distilled spirits plants, vinegar plant permits, and alcohol fuel plant permits (categorized as small, medium, and large alcohol fuel plants);

• 27 CFR part 20, IRC permits for denatured spirits dealers and users;

• 27 CFR part 22, IRC permits for tax-free alcohol users; and

• 27 CFR part 31, IRC registrations for alcohol beverage dealers.

The following TTB forms and their electronic equivalents collect much of the information required to be submitted when applying for the above permits and/or registrations:

• TTB F 5100.24, Application for Basic Permit Under the Federal Alcohol Administration Act, approved by the Office of Management and Budget (OMB) under Information Collection number 1513-0018;

• TTB F 5100.18, Application for Amended Basic Permit Under the Federal Alcohol Administration Act, approved by OMB under Information collection number 1513-0019;

• TTB F 5110.25, Application for Operating Permit Under 26 U.S.C. 5171(d), approved by OMB under Information Collection number 1513-0040;

• TTB F 5110.41, Registration of Distilled Spirits Plant, approved by OMB under Information Collection number 1513-0048;

• TTB F 5110.74, Application for an Alcohol Fuel Producer Under 26 U.S.C. 5181, approved by OMB under Information Collection number 1513-0051;

• TTB F 5150.22, Application for an Industrial Alcohol User Permit, approved by OMB under Information Collection number 1513-0028; and

• TTB F 5000.9, Personnel Questionnaire—Alcohol and Tobacco Products, approved by OMB under Information Collection number 1513-0002.

Pursuant to TTB's IRC and FAA Act authorities described above, TTB has also promulgated regulations imposing procedural and substantive requirements on these regulated businesses. These include requirements to report certain changes in the business affecting the permit or registration ( e.g., changes in address or location, changes in stockholders or officers, directors, managers, etc.). These also include recordkeeping requirements that are generally set forth pursuant to other authority in the IRC. See, e.g., 26 U.S.C. 5207 (records of distilled spirits plant proprietors), 26 U.S.C. 5275 (records of dealers and users of denatured spirits and/or industrial alcohol), and 26 U.S.C. 5121-5122 (records of wholesale and retail dealers of distilled spirits).

This notice of proposed rulemaking includes proposed amendments to these reporting and recordkeeping requirements. The regulations implementing such requirements are set forth in title 27 of the CFR, at the following parts:

• 27 CFR part 1, reporting of business changes for FAA Act basic permits;

• 27 CFR part 17, recordkeeping requirements for manufacturers of nonbeverage products claiming drawback on taxpaid distilled spirits used in the manufacturing process;

• 27 CFR part 19, recordkeeping and inventory requirements, and reporting of business changes, for distilled spirits plants, vinegar plants, and alcohol fuel plants;

• 27 CFR part 20, recordkeeping requirements, and reporting of business changes, for denatured spirits dealers and users;

• 27 CFR part 22, recordkeeping requirements, and reporting of business changes, for tax-free alcohol users;

• 27 CFR part 26, recordkeeping requirements concerning liquors and articles brought in from Puerto Rico and the Virgin Islands;

• 27 CFR part 27, recordkeeping requirements for importers of distilled spirits, wine, and beer;

• 27 CFR part 28, recordkeeping requirements concerning exportation of distilled spirits, wine, and beer; and

• 27 CFR part 31, recordkeeping requirements and reporting of business changes for alcohol beverage dealers (including wholesalers).

The electronic equivalent of each application form set forth above is available through the TTB Permits Online system. The Permits Online system eliminates redundancy by allowing the filer to input information only once, instead of repeating information on multiple paper application forms. Similarly, with respect to the reporting requirements described above, in instances where TTB's regulations refer to submitting a “letterhead notice” (as defined in 27 CFR 19.1), industry members may provide such notices electronically in Permits Online. Unlike applications, these types of notices do not require TTB approval.

TTB plans to publish notices of proposed rulemaking to propose generally similar amendments to regulations governing wine, beer, tobacco products, and processed tobacco-related applications and operations, set forth in 27 CFR parts 24, 25, 40, 41, and 44. Liberalizing amendments related to FAA Act basic permits as importers and wholesalers (including as importers or wholesalers of wine and/or malt beverages) and as wine producers are included in this document and will not be included in the notices of proposed rulemaking relating to wine or beer.

The amendments proposed in this document are intended to modernize and streamline the applications and application processes for distilled spirits-related permits and registrations under the IRC and FAA Act, and for FAA Act basic permits required for importers and wholesalers of alcohol beverages. As noted above, TTB's general approach was to identify information currently being collected that TTB no longer needs in order to evaluate an applicant's qualifications and to provide more clarity and specificity in the application questions and instructions. The proposed amendments also relax reporting requirements on certain changes to the business.

TTB is proposing to eliminate requirements to provide certain operational information when applying for a DSP registration. The TTB regulations at 27 CFR 19.73 prescribe, in general, information that must be included in an application for registration under the IRC as a DSP. Paragraphs (a)(13) through (15) of § 19.73 prescribe the operational information that must be submitted if the DSP applicant intends to operate as a distiller, warehouseman, or processor, respectively. (A “warehouseman” is a proprietor of a DSP who stores bulk distilled spirits.) TTB has determined that much of the information currently required by § 19.73(a)(13) through (15) is no longer needed for TTB to evaluate whether an applicant qualifies for a registration. As a result, TTB proposes to eliminate the following regulatory sections:

a. 27 CFR 19.73(a)(13)(ii), 19.77(a), and 19.121, requiring that an applicant intending to operate as a distiller submit a statement of production procedures, setting forth the contents of the statement, and requiring that a DSP proprietor report changes to its production procedures.

b. 27 CFR 19.73(a)(13)(iii) and 19.77(b), requiring that an applicant intending to operate as a distiller submit a statement as to whether spirits will be redistilled and referencing formula requirements associated with such redistillation. 1

c. 27 CFR 19.73(a)(14)(i), requiring that an applicant intending to operate as a warehouseman submit a narrative description of its storage system.

d. 27 CFR 19.73(a)(14)(ii), requiring that an applicant intending to operate as a warehouseman submit a statement of the total amount of bulk wine gallons that can be stored.

e. 27 CFR 19.73(a)(15)(ii), requiring that an applicant intending to operate as a processor submit a narrative description of the storage system for spirits bottled and cased or otherwise packaged and placed in approved containers for removal from the bonded premises.

TTB is also proposing to amend 27 CFR 19.75 to eliminate the requirement to provide in the application for registration the serial number of each tank, still, and condenser to be used by the DSP. While such equipment must continue to be physically marked with a serial number on the DSP premises pursuant to 27 CFR 19.189, removing the requirement to provide serial numbers in the application will provide applicants greater flexibility to report their equipment in the aggregate. For instance, ten (10) of the same type of tank will not need to be listed separately to account for the different serial numbers. Additionally, allowing equipment to be reported on the application without serial numbers allows applicants to submit an application before equipment that has been ordered is physically received. TTB proposes similar amendments at 27 CFR 20.42 and 22.42 to remove requirements to provide serial numbers of equipment to be used by applicants for permits as users of denatured alcohol and of tax-free alcohol.

TTB is proposing to relax or eliminate requirements to submit certain information describing the DSP premises and its security with an application for registration. As stated above, the TTB regulations at 27 CFR 19.73 prescribe, in general, information that must be included in an application for registration as a DSP. Among the information required to be submitted with such application are descriptions of the DSP premises and the security measures to be employed at the DSP. Much of this information is currently collected in an open-ended narrative format. TTB believes that, in general, more direct questions and certifications would enable applicants to better understand what information must be submitted, reduce the need for additional submissions and follow-up communication between TTB and applicants, and speed up the application review process. Further, TTB has determined that some of the information currently required in these areas is unnecessary or overly specific for the purpose of evaluating a registration application. As a result, TTB also proposes to relax or eliminate certain requirements to submit such information.

Therefore, TTB proposes to amend the following regulatory sections:

a. 27 CFR 19.74. Section 19.73(a)(8) requires that an application for registration as a DSP include a description of the plant in accordance with § 19.74. Section 19.74 sets forth the specific information to be included in the description, which includes: (1) A description of each tract of land covered by the plant; (2) identification of the bonded and any general premises; (3) descriptions of each building and outside tank that will be used for production, storage, and processing of spirits and for denaturing spirits, articles, or wines; and (4) identification of the room(s) or floor(s) of a building that will be used for plant operations, if the plant consists of less than the entire building in which it is situated. TTB proposes to amend § 19.74 to remove the requirement to provide a description of the tract of land and to further clarify the specific information to be submitted as follows: (1) Overall dimensions of the building(s) housing the DSP; (2) the dimensions of the bonded premises and any general premises; (3) any internal walls establishing the boundaries of the bonded premises and general premises; (4) the external doors of the DSP premises; (5) any portions of the plant premises that are outdoors, including the location of any outdoor tanks; and (6) any adjacent retail premises that are to be operated by the applicant. TTB believes that these descriptive elements are the minimum necessary to allow TTB to evaluate whether the premises is adequate to protect the revenue and otherwise complies with the statutory restrictions on DSP locations set forth at 26 U.S.C. 5178. The proposed amendments provide flexibility to submit this information in narrative form or diagram form, whichever is better suited to the applicant's circumstances. The proposed amendments also provide that photographs of any of the required elements must be submitted upon request of the appropriate TTB officer.

b. 27 CFR 19.119 and 19.122. Under current § 19.119, a DSP proprietor is required to amend his or her registration prior to extending or curtailing any part of the plant premises, except for certain operations described in §§ 19.142 (alternation for customs purposes) and 19.143 (alternation for other purposes). Section 19.122 currently requires that a DSP proprietor file a letterhead notice prior to making any material changes to the construction or use of the buildings or equipment at the DSP, other than changes covered by §§ 19.119, 19.142, and 19.143. TTB proposes to consolidate these requirements into a single § 19.119, and to further amend that section consistent with the proposed amendments to § 19.74. Specifically, in the revised § 19.119, the current text of § 19.119 regarding extension or curtailment of the premises would be maintained, but TTB proposes to incorporate as a new paragraph the provisions of the current § 19.122 relating to changes in construction or use of buildings. TTB further proposes to amend this new paragraph to no longer require the proprietor to describe in detail “any material change in the construction or use of buildings or equipment” but instead require the reporting of changes to the premises (other than those covered by current § 19.119, § 19.142, or § 19.143) that would render inaccurate the description submitted with the registration or submitted separately or previously by the proprietor with another amendment. TTB is also proposing to remove the requirement that the change described in the letterhead notice also be subsequently incorporated into the next submission of an application for amended registration on TTB F 5110.41 where such amendment would not otherwise require submission of a premises description. However, to the extent that subsequent applications for an amended registration make any further reportable changes to the premises, an up-to-date description must be submitted.

c. 27 CFR 19.673(b)(2), 19.675(b)(2), and 19.676(b)(2). TTB proposes amendments similar to those described above in point (a) to the requirements associated with applications for alcohol fuel plant permits, at §§ 19.673(b)(2), 19.675(b)(2), and 19.676(b)(2). Note that the illustration of adjacent retail premises is not applicable to alcohol fuel plants.

d. 27 CFR 19.643(b). TTB proposes amendments similar to those discussed in point (a) above to the requirement that applicants for a vinegar plant registration provide a “description of the plant premises,” at § 19.643(b). Note that the illustration of adjacent retail premises is not applicable to vinegar plants.

e. 27 CFR 19.141(a), 19.142(b), and 19.143(b). Sections 19.141 through 19.143 each provide procedures for alternation of the DSP premises. Specifically, § 19.141 prescribes procedures related to alternation of proprietors, § 19.142 prescribes procedures related to alternation for customs purposes, and § 19.143 prescribes procedures related to alternation for other purposes (such as use of the premises as a bonded wine cellar or brewery). One of the prescribed procedures to engage in each type of alternation is that the proprietor must submit with his or her application for registration as a DSP a diagram of the part of the plant that will be alternated, as well as a description of the areas, rooms or buildings, or combination of rooms or buildings that will be alternated. In the case of §§ 19.141(a) and 19.142(b), the applicant must also provide a description of the method that the applicant will use to separate the alternated premises from any premises not subject to alternation. TTB believes that the information collected under these sections can be consolidated into the premises description(s) required under § 19.73(a)(8). Accordingly, TTB proposes to amend these sections to require that such information be included in the description(s) submitted under § 19.73(a)(8). TTB also proposes conforming amendments to §§ 19.141(b) and 19.142(c).

f. 27 CFR 19.692(b)(2). TTB proposes amendments similar to those described in the previous paragraph to the qualification requirements for an alternating proprietorship as an alcohol fuel plant, at § 19.692(b)(2).

g. 27 CFR 19.73(a)(12), 19.76, and 19.192. Section 19.73(a)(12) requires that an application for registration as a DSP include a statement of plant security measures in accordance with § 19.76. Under § 19.76, the plant security statement must include a “general description of plant security,” a “statement regarding the use of guard personnel,” and other similar statements regarding the use of alarm systems and locks. Plant security as a continuing requirement for a permit is also addressed at § 19.192, which generally requires that a DSP proprietor provide adequate security to protect the revenue, and specifies requirements relating to building construction and the locking mechanisms to be used on storage tanks and points of entry to the DSP premises. Section 19.192(f) also sets forth specifications for locks to be used in DSPs. TTB believes that the narrative statements concerning plant security required under §§ 19.73(a)(12) and 19.76 are overly broad and should be more consistent with the ongoing requirements of the permit set forth in § 19.192. Accordingly, TTB proposes to eliminate § 19.76 and to amend § 19.73(a)(12) to instead require that an application for registration as a DSP include a certification that the plant's security will be compliant with the requirements of § 19.192. TTB also believes that the specifications for locks set forth in § 19.192(f) are unnecessarily specific, and proposes to replace those specifications with a requirement that the locks used to secure the plant be of a class and construction that is usual and customary in the industry to secure commercial property.

h. 27 CFR 19.673(b)(6), 19.675(b)(6), and 19.676(b)(6). TTB proposes to amend the application requirements for alcohol fuel plant permits consistent with those described in the previous paragraph. The proposed amendments require, instead of narrative descriptions of the plant's security measures, a certification that plant security will be in accordance with the requirements of 27 CFR 19.703 and 19.704.

TTB proposes amendments to standardize and clarify the scope of the collection of information related to persons holding certain levels of ownership interest in an applicant business. These “statements of interest” are collected in accordance with statutory provisions setting forth eligibility criteria for obtaining such permits and/or registrations. Information about persons with ownership interests in applicant businesses also assists TTB in the protection and collection of the revenue.

The FAA Act at 27 U.S.C. 204(a)(2) provides that an applicant will not be entitled to a basic permit if—among other reasons—the applicant (including the principal stockholders of a corporate applicant) is, by reason of his or her business experience, financial standing, or trade connections, not likely to maintain operations in conformance with Federal law. Currently, TTB practice has been to interpret a “principal stockholder” to be any person holding ten (10) percent or more of any class of stock in a corporation or of any class of ownership in any other limited liability entity. 2

The IRC at 26 U.S.C. 5271(c)(2) similarly provides that an application for a permit to use tax-free alcohol, or to use or deal in specially denatured distilled spirits, may be denied if—among other reasons—the applicant (including any “principal stockholders”) is, by reason of his or her business experience, financial standing, or trade connections, not likely to maintain operations in compliance with chapter 51 of the IRC. Pursuant to 26 U.S.C. 5171(d), the eligibility criteria of section 5271(c) also apply to operating permit applications for DSPs that are not required to obtain an FAA Act basic permit, such as DSPs that produce distilled spirits for industrial use and alcohol fuel plants.

Further, the IRC at 26 U.S.C. 5172 requires that an application for a DSP registration identify the applicant and persons interested in the business. This provision applies to DSPs whether or not they are required to obtain an FAA Act basic permit. Note that, while alcohol fuel plants have separate application processes pursuant to 26 U.S.C. 5181, those application processes fulfill the qualification requirements of 26 U.S.C. 5171. Accordingly, TTB has implemented through regulation the requirement that alcohol fuel plant applicants report the principal persons involved in the business and/or the persons having an ownership interest in the business at 27 CFR 19.675 (for medium plant permit applications) and at 19.676 and 19.677 (for large plant permit applications). 3

TTB has promulgated regulations under the above IRC authorities requiring statements of interest at: (1) 27 CFR 19.73, 19.92, and 19.93, for DSP registrations and operating permits; (2) 27 CFR 19.677, for large alcohol fuel plant permits; (3) 27 CFR 20.42 and 20.45, for specially denatured spirits dealer and user permits; and (4) 27 CFR 22.42 and 22.45, for tax-free alcohol user permits. Additionally, the application for an FAA Act basic permit requires a listing of the owners and principal stockholders of an applicant business, as well as details concerning their investment in the business. See 27 CFR 1.25, TTB F 5100.24 (approved by the Office of Management and Budget under Information Collection number 1513-0018).

TTB proposes amendments to §§ 19.93, 19.677, 20.45, and 22.45 to standardize the collection of the basic identifying information of persons with an interest in the applicant's business. The amendments provide that (1) the requirement to disclose basic identifying information ( i.e., names and addresses) of persons with an ownership interest applies to persons with an ownership interest of 10 percent or greater; and (2) where a “person” holding such an interest is a legal entity other than an individual, the applicant must provide the name, title, and place of residence (city and state) of a representative individual for that entity. The representative individual generally will be the individual designated by the entity to represent the entity's interest in the applicant business or, in the absence of a designated individual, an owner, chief officer or manager, or person with similar authority within the entity. TTB believes that this is the minimum amount of information required to allow TTB to identify the individuals with an interest in the applicant business and to evaluate the applicant as to its trade connections and financial standing, including in circumstances where business entities have substantial ownership interests in the applicant.

TTB proposes minor conforming amendments to 27 CFR 1.27, 1.42, 1.44, 19.114, 19.127, 19.130, 19.684, and 19.687 to incorporate the description of ownership interests set forth above into requirements for reporting changes in ownership interests. TTB also proposes conforming amendments to 27 CFR 1.24, 19.96, 19.678, and 31.114 to incorporate this description of ownership interests into regulations describing criteria for qualification or denial of permits.

TTB proposes to extend the deadline for reporting certain changes in a permitted business to 60 days. The TTB regulations generally require that when there is a change in the information filed with TTB as part of an application for a permit or registration under the FAA Act or IRC, the proprietor of the business must notify TTB of the change. The timing and form of this notification differs depending on the type of permit or registration, and the type of business change that has occurred or will occur.

Some business changes must be reported to TTB within a certain amount of time following the change, generally within 30 days. For example, the TTB regulations at 27 CFR 19.687 require that the proprietor of a medium or large alcohol fuel plant submit a letterhead notice to TTB within 30 days of any change to the list of officers, directors, members, managers, or other principal persons provided with the application for the permit.

In the case of a change in control of the business, a permit or registration may automatically terminate and/or become invalid following the change in control unless a new application is filed within 30 days of the change in control. The TTB regulations generally provide for the outstanding permit to remain in effect pending a final decision on the new application, as long as that application is timely filed.

Comments received in response to Treasury's request for information, described above in section I(A), suggest that 30 days is too short a time for regulated entities to assemble the information that is required to be filed in connection with various changes in the business. These comments suggested that such filing deadlines should be extended to 60 days.

TTB reviewed these proposals and concluded that extending existing deadlines for reporting certain changes in the business (including in some cases by applying for a new or amended permit or registration) from 30 to 60 days would not, in general, pose risk to the revenue or raise other concerns with regard to permits and/or registrations issued under the authority of the IRC. Accordingly, TTB proposes to extend such deadlines as described immediately below. Requirements and timeframes related to FAA Act permits are discussed separately at the end of this section. FAA Act permits have a different statutory basis, which sets forth certain reporting timeframes that TTB is unable to modify by regulation. In some circumstances, industry members holding both an FAA Act permit and an IRC registration (such as DSPs producing nonindustrial spirits) will be limited by the shorter statutory reporting period of the FAA Act.

In 27 CFR part 19, TTB proposes to amend the following sections to extend reporting deadlines for changes in the permitted business to 60 days: §§ 19.112, 19.114, and 19.123 relating to DSP registrations; §§ 19.126, 19.127, and 19.130 relating to DSP operating permits; § 19.644 relating to vinegar plants; and §§ 19.683, 19.684, 19.686, 19.687, and 19.691 relating to alcohol fuel plants.

Concerning DSP registrations, 27 CFR 19.112 provides the general rules for amending a registration, and requires that, “if there is a change in any of the information in the proprietor's current, approved notice of registration, the proprietor must amend the registration” within 30 days of the change unless another time period is specified by another, more specific regulation. Section 19.114 requires that a DSP proprietor “notify TTB of any changes in the list of stockholders or persons with interest that was filed with TTB” as part of the registration application and provides that, “if the change results in a change of control, the proprietor must file form TTB F 5110.41, Registration of Distilled Spirits Plant, within 30 days of the change.” TTB proposes to extend each of these deadlines from 30 days to 60 days. Section 19.123 requires that a DSP proprietor notify TTB if any change is made to the statement of plant security filed under 27 CFR 19.76. TTB proposes in this document (as discussed above) to remove § 19.76 entirely, and accordingly proposes to remove § 19.123.

TTB also proposes conforming amendments in 27 CFR 19.80 to clarify that, when an IRC operating permit or an FAA Act permit remains in effect pending final TTB action on a new application for such a permit necessitated by a business change, the approved notice of registration associated with that permit also remains valid during that time.

Concerning DSP operating permits, which apply to industrial alcohol operations, § 19.126 provides the general rules for amending a permit and requires that, “if there is a change in any of the information that the proprietor provided as part of the current approved application for an operating permit, the proprietor must amend the operating permit” within 30 days of the change unless another time period is specified by another, more specific regulation. Section 19.127 provides for the automatic termination of a DSP operating permit under certain circumstances. In the case of a corporation, § 19.127 provides that the operating permit will terminate 30 days following a change in actual or legal control of the corporation, but if an application for a new permit is submitted within that 30 days, the outstanding permit may remain in effect until TTB takes final action on the new application. Section 19.130 requires that the proprietor notify TTB of any changes in the list of stockholders or persons with interest that was filed in connection with the operating permit application. If such a change results in a change in actual or legal control of the business, the proprietor must file an application for a new permit within 30 days. TTB proposes to extend each of these deadlines from 30 to 60 days. With respect to the automatic termination provisions of § 19.127, the proposed amendments also necessarily extend the timeframe for termination to 60 days.

Concerning vinegar plants, § 19.644 provides that the proprietor of a vinegar plant must “immediately” notify TTB in writing of “any change in the information that was provided in an approved application.” TTB proposes to amend this section to require the notification be made within 60 days of the change.

Concerning alcohol fuel plants, § 19.683 provides the general rules for amending a permit and requires that, “if there is a change relating to any of the information contained in, or considered a part of, the application” for an alcohol fuel plant permit, “the proprietor must amend the information previously submitted within 30 days of the change” unless another time period is specified by another, more specific regulation. Section 19.684 provides for the automatic termination of an alcohol fuel plant permit under certain circumstances. In the case of a corporation, the permit will terminate 30 days following a change in actual or legal control of the corporation, but if an application for a new permit is submitted within those 30 days, the outstanding permit may remain in effect until TTB takes final action on the new application. Section 19.686 provides that, “When there is a change in the name of the individual, firm, corporation, or other entity holding the permit, the proprietor must file an application to amend the permit . . . within 30 days of the change.” Section 19.687 requires that the proprietor provide TTB with letterhead notice within 30 days of any change to the list of officers, directors, members, managers, or other principal persons provided with the application for a permit as a medium or large alcohol fuel plant. Section 19.691 states that, “if there is a change in the address of an alcohol fuel plant that does not involve a change in the location or area of the plant itself, the proprietor must submit a letterhead notice to the appropriate TTB officer within 30 days of the change.” TTB proposes to extend each of these deadlines from 30 to 60 days. With respect to the automatic termination provisions of § 19.684, the proposed amendments also necessarily extend the timeframe for termination to 60 days.

Concerning permits for dealers or users of denatured alcohol and rum, TTB proposes to amend provisions in 27 CFR part 20 to extend a similar 30-day requirement to 60 days, and to remove one notification requirement. Section 20.56 requires that a permittee submit a written notification to TTB within 30 days of certain changes “relating to any of the information contained in, or considered a part of[,] the application” for a permit. Section 20.57 requires that the permit holder provide written notice to TTB within 10 days of a change in proprietorship or a change in actual or legal control of the business. Section 20.57 further provides that the permit will terminate 30 days following a change in proprietorship or control, unless the permit holder submits an application for a new permit within 30 days of the change, in which case the outstanding permit may remain in effect until TTB takes final action on the new application. TTB proposes to extend the filing deadline of § 20.56 from 30 to 60 days, and to remove the 10-day notification requirement of § 20.57. With respect to the automatic termination provisions of § 20.57, the proposed amendments extend the timeframe for termination to 60 days.

Concerning permits for users of tax-free (industrial) alcohol, TTB proposes to amend §§ 22.57 and 22.58. Section 22.57 requires that such a permittee submit a written notification to TTB within 30 days of certain changes “relating to any of the information contained in, or considered a part of[,] the application” for a permit. Section 22.58 requires that the permit holder provide written notice to TTB within 10 days of a change in proprietorship or a change in actual or legal control of the business. Section 22.58 further provides that the permit will terminate 30 days following a change in proprietorship or control, unless the permit holder submits an application for a new permit within 30 days of the change, in which case the outstanding permit may remain in effect until TTB takes final action on the new application. TTB proposes to remove the 10-day notification requirement of § 22.58. TTB proposes to extend the filing deadline of § 22.57 from 30 to 60 days. With respect to the automatic termination provisions of § 22.58, the proposed amendments also extend the timeframe for termination to 60 days.

In 27 CFR part 31, concerning alcohol beverage dealers, TTB proposes to amend § 31.138 to provide 60 days for an alcohol beverage dealer to notify TTB of the discontinuance of their business, rather than the current 30 days.

As noted above, FAA Act basic permits are subject to certain reporting timeframes, similar to some of those IRC timeframes discussed above, that TTB is unable to extend by regulation because they are statutory. Specifically, the FAA Act at 27 U.S.C. 204(g) provides that FAA Act permits cannot be sold or transferred, and will automatically terminate 30 days after a transfer by operation of law or a change in actual or legal control of the permitted business. However, section 204(g)(2) also provides that if an application for a new permit is submitted within 30 days of such a change, the outstanding permit remains in effect until TTB takes final action on the new application. These provisions are implemented in TTB regulations at 27 CFR 1.44. TTB cannot extend the § 1.44 deadline for filing a new permit application from 30 to 60 days, because the 30-day provision is in the statute (cited above). However, TTB is proposing to amend 27 CFR 1.42 to clarify that any changes in the ownership, management, or control of the business, including changes that fall under § 1.44, must be reported to TTB within 30 days rather than “immediately,” as currently required. If the change requires the filing of a new application under § 1.44, a timely application will also satisfy the notification requirement of § 1.42.

Industry members who hold both a basic permit under the authority of the FAA Act and a registration under the authority of the IRC (such as DSPs producing nonindustrial spirits) should be aware that an extension of the timeframes applicable to the registration issued under the IRC does not apply in any way to the basic permit under the FAA Act. As a result, such DSPs must still report changes in the ownership or management of their business within 30 days (and submit any required applications within 30 days) to comply with the requirements of their FAA Act basic permit.

TTB proposes amendments to the regulations at 27 CFR 1.40, 19.129, 20.61, 22.62, and 31.132 to allow changes to, or additions of, trade names through a notification to TTB rather than through an amended permit or registration. These regulations apply to holders of FAA Act basic permits, DSP operating permits, specially denatured spirits user and dealer permits, tax-free alcohol user permits, and alcohol beverage dealer registrations, respectively. The regulations currently require that holders of such permits or registrations apply for and obtain an amended permit or submit an amended registration before engaging in operations under a new trade name (see, e.g., 27 CFR 19.129) or requesting FAA Act label approval reflecting a new trade name (see 27 CFR 5.36(f)). Currently, TTB automatically approves trade name amendments. Consistent with this policy, TTB is also proposing to amend 27 CFR 19.94 to remove the requirement that an applicant for an original DSP operating permit submit supporting documentation for the trade names identified in the application. TTB's proposed amendments generally would update regulations to reflect that industry members may begin operations under the new name immediately after notifying TTB.

TTB notes that, while this amendment would allow industry members to immediately begin operations under a new trade name upon notifying TTB, it remains the responsibility of the permit holder or registered alcohol dealer to ensure that any trade name is properly registered with the applicable state or local government. Industry members should further note that the FAA Act prohibits false or misleading statements on alcohol beverage labels, and TTB will not approve an application for label approval proposing to use a trade name on a label that gives a misleading impression as to the age, origin, or identity of the product. The FAA Act also prohibits the use of misleading trade names when advertising distilled spirits for beverage purposes.

As part of its evaluation of permit and registration applications, TTB sought to identify types of requests to vary from the regulations that were commonly submitted along with a permit or registration application. One common request relevant to distilled spirits is to retain required records at a location other than the premises covered under the permit or registration. TTB is proposing amendments to recordkeeping requirements in parts 17, 20, 22, 26, 27, 28, and 31 to allow records to be stored at a location other than the permitted premises, and allow applicants to notify TTB of their intention to store records at an off-premises location as part of the application process. The amendments provide that required records must still be made available at the permitted premises upon request, but that copies (including electronic copies) will generally satisfy this requirement.

The TTB regulations at 27 CFR 19.573 provide that a DSP's records may be maintained at the DSP or at a central recordkeeping location maintained by the DSP proprietor. In the latter case, the proprietor must submit a letterhead notice to TTB informing TTB of the location where the records are kept. Section 19.574, concerning availability of records, further provides that if records are kept at a location other than the DSP premises, they must nonetheless be made available at the DSP premises upon request, generally within two days of the request.

The current recordkeeping requirements applicable to TTB-regulated manufacturers of nonbeverage products, specially denatured spirits dealers and users, tax-free alcohol users, importers, wholesalers, and alcohol beverage dealers do not similarly allow records to be maintained at a location other than the premises covered by the permit or registration. As a result, such proprietors generally must submit a request for specific authorization to retain records at a central recordkeeping location rather than at the premises covered by the permit or registration. TTB proposes to amend the record retention requirements applicable to such entities ( i.e., record retention requirements in 27 CFR parts 17, 20, 22, 26, 27, 28, and 31) to reflect those set forth in §§ 19.573 and 19.574, described above. TTB also proposes amendments to § 19.574, as well as other record retention provisions in part 19, intended to clarify that an industry member generally may satisfy a request for documents by providing copies of such documents, including electronic copies.

TTB invites comments from interested members of the public on this proposed rulemaking. TTB also invites comments on any additional means to streamline application processes within the parameters of TTB's statutory obligations.

You may submit comments on this proposal as an individual or on behalf of a business or other organization via the Regulations.gov website or via postal mail, as described in the ADDRESSES section of this document. Your comment must reference Notice No. 207 and must be submitted or postmarked by the closing date shown in the DATES section of this document. You may upload or include attachments with your comment. You also may submit a comment requesting a public hearing on this proposal. The TTB Administrator reserves the right to determine whether to hold a public hearing. If TTB schedules a public hearing, it will publish notification of the date, time, and place for the hearing in the Federal Register .

All submitted comments and attachments are part of the rulemaking record and are subject to public disclosure. Do not enclose any material in your comments that you consider confidential or that is inappropriate for disclosure.

TTB will post, and you may view, copies of this document, its supporting materials, and any comments TTB receives about this proposal within the related Regulations.gov docket. In general, TTB will post comments as submitted, and it will not redact any identifying or contact information from the body of a comment or attachment.

Please contact TTB's Regulations and Rulings division by email using the web form available at https://www.ttb.gov/contact-rrd, or by telephone at 202-453-2265, if you have any questions regarding comments on this proposal or to request copies of this document, its supporting materials, or the comments received in response.

It has been determined that this proposed rule is not a significant regulatory action as defined by Executive Order 12866. Therefore, a regulatory impact assessment is not required.

In accordance with the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ), TTB has analyzed the potential economic effects of this action on small entities. In lieu of the initial regulatory flexibility analysis required to accompany proposed rules under 5 U.S.C. 603, section 605 allows the head of an agency to certify that a rule will not, if promulgated, have a significant economic impact on a substantial number of small entities. The following analysis provides the factual basis for TTB's certification under section 605.

While TTB believes the majority of businesses subject to this proposed rule are small businesses, the changes proposed in this document will not have a significant impact on those small entities. The proposed amendments are generally aimed at reducing burden on regulated entities of all sizes by: (1) Eliminating the collection of certain information from applications for permits or registrations; (2) replacing required narrative descriptions of an applicant's premises with more specific description requirements; (3) extending deadlines for reporting certain changes in a permitted or registered business; (4) relaxing the requirements associated with amending the trade names available for use by a permitted or registered business; (5) allowing the maintenance of required records at locations other than the permitted or registered premises; and (6) clarifying and limiting which individuals are required to submit certain background information in connection with an application for permit or registration. Many of the proposed changes are consistent with recommendations submitted by industry in response to Treasury's request for recommendations for Treasury regulations that can be eliminated, modified, or streamlined in order to reduce burdens.

Examples of eliminating the collection of information from applications for permits or registrations are the proposed amendments to §§ 19.73(a)(12), 19.76, and 19.123, which eliminate a requirement that an applicant for a DSP registration submit a statement of plant security measures and replace it with a requirement that the applicant certify its premises is in compliance with the security specifications already established at § 19.192. Additionally, proposed amendments to § 19.75 eliminate the requirement to provide in the application for registration the serial numbers of the tanks, stills, and condensers to be used on the DSP premises, allowing an application to be filed when equipment is on order but not yet received.

The proposed amendments to §§ 19.73, 19.74, 19.141, 19.142, 19.143, 19.643, 19.673, 19.675, 19.676, and 19.692 replace requirements for narrative descriptions of an applicant's DSP premises with requirements to submit more specific information regarding the premises. For example, in connection with an application for registration as a DSP, § 19.74 currently requires a detailed narrative description of the DSP premises, including each tract of land covered by the DSP, featuring “directions and distances in enough detail to enable the appropriate TTB officer to readily determine the boundaries of the plant.” The proposed amendments to § 19.74 remove the narrative description requirements and instead require the submission of more limited information illustrating certain specified attributes.

An example of extending deadlines for reporting changes in a permitted or registered business is the proposed amendment to § 19.112, which provides the general rules for notifying TTB of any changes in the information included in a DSP's notice of registration. Section 19.112 generally requires that when such changes occur, the proprietor must file specified documentation with TTB to amend the registration within 30 days. The proposed amendments to § 19.112 extend this deadline to 60 days. TTB proposes similar amendments at §§ 19.114, 19.126, 19.127, 19.130, 19.644, 19.683, 19.684, 19.686, 19.687, 19.691, 20.56, 20.57, 22.57, 22.58, and 31.138.

An example of relaxing the reporting requirements associated with changes in the trade names available for use by a permitted or registered business is the proposed amendment to § 19.129. Section 19.129 currently requires that a proprietor of a DSP apply for, and receive approval of, an amended operating permit prior to operating under a new trade name. The proposed amendment to § 19.129 allows the addition of a new trade name through a letterhead notice that does not require TTB approval. TTB proposes similar amendments at §§ 1.40, 20.61, 22.62, and 31.132.

Concerning records maintenance, current recordkeeping requirements applicable to manufacturers of nonbeverage products, specially denatured spirits dealers and users, tax-free alcohol users, importers, wholesalers, and alcohol beverage dealers do not allow records to be maintained at a location other than the premises covered by the permit or registration. The proposed amendments to §§ 17.161, 17.171, 20.267, 22.164, 26.174, 26.275, 26.310, 27.136, 28.45, 31.152, 31.172, and 31.181 generally allow for the maintenance of required records at locations other than the permitted or registered premises upon letterhead notice to TTB.

With respect to the collection of applicant background information, TTB proposes amendments to 27 CFR 19.93, 19.677, 20.45, and 22.45 to clarify the individuals who are required to submit statements of financial interest in a business applying for a distilled spirits-related permit or registration. The proposed amendments clarify that: (1) Such statements of interest are required only from persons with an ownership interest in the applicant of 10 percent or greater; and (2) where a “person” holding such an interest is a legal entity other than an individual, an applicant must submit basic identifying information about a representative individual for that entity.

In conclusion, while the entities affected by the proposed rule include a substantial number of small entities, the effects of the changes in this proposed rule are expected to be positive for the affected entities.

In accordance with the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ), TTB certifies that this proposed rule, if promulgated, will not have a significant economic impact on a substantial number of small entities. The proposed rule will not impose, or otherwise cause, a significant increase in reporting, recordkeeping, or other compliance burdens on a substantial number of small entities. The proposed rule is not expected to have significant secondary or incidental effects on a substantial number of small entities. Accordingly, a regulatory flexibility analysis is not required. Pursuant to 26 U.S.C. 7805(f), TTB will submit the proposed regulations to the Chief Counsel for Advocacy of the Small Business Administration for comment on the impact of the proposed regulations on small businesses.

Regulations addressed in this document contain current collections of information that have been previously reviewed and approved by the Office of Management and Budget (OMB) in accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3504(h)) and assigned control numbers 1513-0002, 1513-0018, 1513-0019, 1513-0028, 1513-0040, 1513-0041, 1513-0044, 1513-0048, 1513-0051, 1513-0052, 1513-0059, 1513-0060, 1513-0061, 1513-0062, 1513-0065, 1513-0066, 1513-0073, 1513-0075, 1513-0088, 1513-0089, and 1513-0112. The specific regulatory sections in this proposed rule that contain collections of information, either current or proposed, are §§ 1.27, 1.40, 1.42, 1.44, 17.161, 19.73, 19.74, 19.75, 19.93, 19.94, 19.112, 19.114, 19.119, 19.126, 19.127, 19.129, 19.130, 19.141, 19.142, 19.143, 19.192, 19.574, 19.643, 19.644, 19.673, 19.675, 19.676, 19.677, 19.683, 19.684, 19.686, 19.687, 19.691, 19.692, 20.42, 20.45, 20.56, 20.57, 20.61, 20.267, 22.42, 22.45, 22.57, 22.58, 22.62, 22.164, 26.174, 26.275, 26.310, 27.136, 28.45, 31.114, 31.132, 31.138, 31.152, 31.172, and 31.181. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid control number assigned by OMB.

The amendments that TTB proposes in this document, along with certain corresponding policy changes, are designed to reduce the overall burden associated with the information collections noted above. In general, the proposed amendments involve: (1) Eliminating the collection of certain information from applications for permits or registrations; (2) replacing required narrative descriptions of an applicant's premises with more specific information; (3) extending deadlines for reporting certain changes in a permitted or registered business; (4) relaxing the requirements associated with amending the trade names available for use by a permitted or registered business; (5) allowing the maintenance of required records at locations other than the permitted or registered premises; and (6 clarifying which individuals are required to submit certain background information in connection with an application for permit or registration.

To reduce the amount of information collected in applications for distilled spirits-related permits or registrations, TTB proposes to amend 27 CFR 19.73, 19.75, and 19.192, and to eliminate 27 CFR 19.76, 19.77, and 19.123. Proposed amendments to § 19.73(a)(13) and the elimination of § 19.77 eliminate requirements that an applicant for a DSP registration intending to operate as a distiller submit a statement of its production procedures and a statement as to whether spirits will be redistilled. Proposed amendments to current § 19.73(a)(14) eliminate requirements that an applicant for a DSP registration intending to operate as a warehouseman submit a narrative description of its storage system and a statement of the total amount of bulk wine gallons that can be stored. Additionally, proposed amendments to current § 19.73(a)(15) eliminate requirements that an applicant for a DSP registration intending to operate as a processor submit a narrative description of the storage system for spirits bottled and cased or otherwise packaged and placed in approved containers for removal from the bonded premises. Proposed amendments to §§ 19.73(a)(12) and 19.192, and the elimination of §§ 19.76 and 19.123, eliminate a requirement that an applicant for a DSP registration submit a statement of plant security measures and replace it with a requirement that the applicant certify its premises is in compliance with the security specifications already established at § 19.192. The amendments to § 19.192 also generalize the required specifications for locks to be used on the DSP premises. The proposed amendments to § 19.75 eliminate the requirement to provide in the application for registration the serial numbers of the tanks, stills, and condensers to be used on the DSP premises. Sections 19.73, 19.75, 19.76, 19.77, 19.123, and 19.192 are currently included in the collection of information assigned OMB control number 1513-0048. TTB has submitted to OMB a revision of that information collection to account for the reduced burden of the proposed amendments.

Similar to the amendments to § 19.75 described in the previous paragraph, TTB proposes amendments 27 CFR 20.42 and 22.42 to remove requirements to provide serial numbers of equipment to be used by applicants for permits as users of denatured alcohol and of tax-free alcohol. Sections 20.42 and 22.42 are currently included in the collection of information assigned OMB control number 1513-0028. TTB has submitted to OMB a revision of that information collection to account for the reduced burden of the proposed amendments.

To replace required narrative descriptions of applicant premises with more specific information and certifications, TTB proposes amendments to 27 CFR 19.73, 19.74, 19.141, 19.142, 19.143, 19.643, 19.673, 19.675, 19.676, and 19.692. The proposed amendments to § 19.74 eliminate requirements to submit detailed narrative descriptions of the plant and certain of its attributes, and replace these requirements with a more specific set of information and certifications. TTB proposes similar amendments with respect to applications for alcohol fuel plant permits at §§ 19.673, 19.675, and 19.676; and with respect to applications for vinegar plants at § 19.643. Sections 19.141, 19.142, and 19.143 each relate to qualifying to alternate the DSP premises. TTB proposes amendments to these sections to eliminate requirements to submit narrative statements describing the areas to be alternated and the means by which the alternated areas will be separated from other parts of the premises. TTB's proposed amendments require more specific information. TTB proposes similar amendments to with respect to alternation of an alcohol fuel plant at § 19.692.

Sections 19.74 and 19.143 are currently included in the collection of information assigned OMB control number 1513-0048; §§ 19.141 and 19.142 are being added to the collection of information assigned OMB control number 1513-0048 in revisions submitted to OMB (these sections were inadvertently not referenced in the supporting statement, but their burden has been accounted for); §§ 19.673, 19.675, and 19.676 are currently included in the collection of information assigned OMB control number 1513-0051; and the amended provisions of § 19.692 are currently included in the collection of information assigned OMB control number 1513-0051. TTB has submitted to OMB revisions of those information collections to account for the reduced burden of the proposed amendments. The information collected under § 19.643 is not subject to the Paperwork Reduction Act due to the limited number of respondents.

The TTB regulations generally require that, when there is a change in the information filed with TTB as part of an application for a permit or registration, the proprietor of the regulated business must notify TTB of the change. To extend deadlines for reporting certain changes in a permitted or registered business, TTB proposes amendments to 27 CFR 19.112, 19.114, 19.126, 19.127, 19.130, 19.644, 19.683, 19.684, 19.686, 19.687, 19.691, 20.56, 20.57, 22.57, 22.58, and 31.138. In each case, the deadline for reporting the specified change in the business is extended to 60 days, typically from 30 days (in some cases, current regulatory text required industry to inform TTB “immediately” of certain changes; see, e.g., § 19.644). Sections 19.112 and 19.114 are currently included in the collection of information assigned OMB control number 1513-0048; §§ 19.126 and 19.130 are currently included in the collection of information assigned OMB control number 1513-0040; §§ 19.683, 19.684, and 19.686 are currently included in the collection of information assigned OMB control number 1513-0051; §§ 19.683, 19.687, and 19.691 are currently included in the collection of information assigned OMB control number 1513-0052 (additionally, the letterhead application provisions of § 19.686 are being added to this collection of information in revisions submitted to OMB); §§ 20.56 and 20.57 are currently included in the collection of information assigned OMB control number 1513-0061; §§ 22.57 and 22.58 are currently included in the collection of information assigned OMB control number 1513-0060; and § 31.138 is currently included in the collection of information assigned OMB control number 1513-0112. TTB has submitted to OMB revisions of those information collections to account for the reduced burden of the proposed amendments. The revision to number 1513-0040 also adds a reference to § 19.127. The information collected under § 19.644 is not subject to the Paperwork Reduction Act due to the limited number of respondents.

The TTB regulations generally require that changes to, or additions of, the trade names under which a permitted or registered business may operate be made by filing for an amended permit or registration. Such applications would need to be approved prior to the applicant beginning operations under the new trade name. To relax the requirements associated with altering the trade names available for use by a permitted or registered business, TTB proposes amendments to 27 CFR 1.40, 19.129, 20.61, 22.62, and 31.132. The amendments would allow changes to, or additions of, trade names to be accomplished by a letterhead notice. TTB also proposes an amendment to 27 CFR 19.94 to remove the requirement that an applicant for an original DSP operating permit submit supporting documentation for the trade names identified in the application. Section 1.40 is currently included in the collection of information assigned OMB control number 1513-0019; §§ 19.94 and 19.129 are currently included in the collection of information assigned OMB control number 1513-0040; § 20.61 is currently included in the collection of information assigned OMB control number 1513-0061; § 22.62 is currently included in the collection of information assigned OMB control number 1513-0060; and § 31.132 currently included in the collection of information assigned OMB control number 1513-0112. TTB has submitted to OMB revisions of those information collections to account for the reduced burden of the proposed amendments.

The current recordkeeping requirements applicable to specially denatured spirits dealers and users, tax-free alcohol users, manufacturers of nonbeverage products, importers, wholesalers, and alcohol beverage dealers do not allow records to be maintained at a location other than the premises covered by the permit or registration. As a result, such proprietors generally must submit a request for specific authorization to retain records at a central recordkeeping location rather than the premises covered by the permit or registration. To allow the maintenance of required records at locations other than the permitted or registered premises, TTB proposes amendments to 27 CFR 17.161, 17.171, 20.267, 22.164, 26.174, 26.275, 26.310, 27.136, 28.45, 31.152, 31.172, and 31.181. These amendments, as well as amendments to 27 CFR 19.574, also clarify that an industry member generally may satisfy a request for documents by providing copies of such documents, including electronic copies. Sections 17.161 and 17.171 are currently included in the collection of information assigned OMB control number 1513-0073; § 19.574 is currently included in the collection of information assigned OMB control number 1513-0041; the general record retention provisions of § 22.164 are currently included in the collection of information assigned OMB control number 1513-0059, while the proposed notice associated with off-premises records retention has been added to the collection of information assigned OMB control number 1513-0060 in revisions submitted to OMB. In addition, § 20.267 is currently included in OMB control number 1513-0062; §§ 26.174 and 26.310 are currently included in the collection of information assigned OMB control number 1513-0089; § 28.45 is currently included in the collection of information assigned OMB control number 1513-0075; §§ 31.152 and 31.172 are currently included in the collection of information assigned OMB control number 1513-0065; § 31.181 is currently included in the collection of information assigned OMB control number 1513-0066; and §§ 19.574, 26.174, 26.310, and 27.136 are currently included in the collection of information assigned OMB control number 1513-0088. TTB has submitted to OMB revisions of those information collections as needed to account for the reduced burden of the proposed amendments. Additionally, the revision to OMB control number 1513-0088 adds references to §§ 26.275 and 28.45. TTB also submitted to OMB a revision of the information collection assigned OMB control number 1513-0061, to add a reference to § 20.267.

With respect to the collection of applicant background information, TTB proposes amendments to 27 CFR 19.93, 19.677, 20.45, 22.45, and 31.114 to clarify the individuals who are required to submit statements of financial interest in the applicant business. The above regulations generally require statements disclosing the identities of persons holding certain levels of ownership in a business applying for a distilled spirits-related registration or permit be submitted with such applications. The proposed amendments clarify that (1) Such statements of interest are required only from persons with an ownership interest in the applicant of 10 percent or greater; and (2) where a “person” holding such an interest is a legal entity other than an individual, an applicant must submit basic identifying information about a representative individual for that entity. Section 19.93 is currently included in the collection of information assigned OMB control number 1513-0040, and TTB has proposed revisions to also include it in the collection of information assigned OMB control number 1513-0048; § 19.677 is currently included in the collection of information assigned OMB control number 1513-0051; §§ 20.45 and 22.45 are currently included in the collection of information assigned OMB control number 1513-0028; and § 31.114 is currently included in the collection of information assigned OMB control number 1513-0112. TTB proposes conforming amendments to 27 CFR 1.27, 1.42, 1.44, 19.114, 19.127, 19.130, 19.684, and 19.687, each relating to reporting changes in the ownership of the applicant or permitted business, to update the description of ownership interests consistent with the amendments described above. Section 1.27 is currently included in the collection of information assigned OMB control number 1513-0018; § 1.42 is currently included in the collection of information assigned OMB control number 1513-0019; § 19.114 is currently included in the collection of information assigned OMB control number 1513-0048; § 19.130 is currently included in the collection of information assigned OMB control number 1513-0040; § 19.684 currently included in the collection of information assigned OMB control number 1513-0051; and § 19.687 is currently included in the collection of information assigned OMB control number 1513-0052. TTB has submitted to OMB revisions of the collections of information assigned OMB control numbers 1513-0019 and 1513-0040 to add references to §§ 1.44 and 19.127, respectively. The burden for these sections was already accounted for, but citations to these sections were left out in error.

As noted above, TTB has submitted the revised information collection requirements to OMB for review. Comments on these revised recordkeeping and reporting requirements should be sent to OMB at Office of Management and Budget, Attention: Desk Officer for the Department of the Treasury, Office of Information and Regulatory Affairs, Washington, DC 20503 or by email to OIRA_submissions@omb.eop.gov. A copy should also be sent to TTB by any of the methods previously described. Comments on the information collections should be submitted no later than February 1, 2022. Comments are specifically requested concerning:

• Whether the collections of information submitted to OMB are necessary for the proper performance of the functions of the Alcohol and Tobacco Tax and Trade Bureau, including whether the information will have practical utility;

• The accuracy of the estimated burdens associated with the collections of information submitted to OMB;

• How to enhance the quality, utility, and clarity of the information to be collected;

• How to minimize the burden of complying with the proposed revisions of the collections of information, including the application of automated collection techniques or other forms of information technology; and

• Estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information.

For the reasons discussed above in the preamble, TTB proposes to amend 27 CFR parts 1, 17, 19, 20, 22, 26, 27, 28, and 31 as follows:

On October 27, 2021, OSHA issued an ANPRM to initiate rulemaking to protect indoor and outdoor workers from hazardous heat and to obtain additional information about the extent and nature of hazardous heat in the workplace and the nature and effectiveness of interventions and controls used to prevent heat-related injury and illness.

The public comment period for the ANPRM was to close on December 27, 2021, 60 days after publication of the ANPRM. However, OSHA received requests from stakeholders to extend the comment period by an additional 30 days (Document ID 0145) or 60 days (Document ID 0101, 0133, 0141, 0143, 0144, 0148, 0152, 0159). These stakeholders explained that they need additional time to carefully review the questions in the ANPRM, obtain input from members, and provide comments (see, e.g., Document ID 0101).

OSHA agrees to an extension of the public comment period and believes a 30-day extension is sufficient and appropriate in order to balance the agency's need for timely input to inform how the agency will proceed with the rulemaking with these stakeholder requests. Therefore, OSHA is extending the public comment period until January 26, 2022.

Douglas L. Parker, Assistant Secretary of Labor for Occupational Safety and Health, U.S. Department of Labor, 200 Constitution Avenue NW, Washington, DC 20210, authorized the preparation of this document pursuant to the following authorities: Sections 4, 6, and 8 of the Occupational Safety and Health Act of 1970 (29 U.S.C. 653, 655, 657); Secretary of Labor's Order 8-2020 (85 FR 58393 (Sept. 18, 2020)); 29 CFR part 1911; and 5 U.S.C. 553.

Inspection of Public Comments: All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following website as soon as possible after they have been received: http://www.regulations.gov. Follow the search instructions on that website to view public comments. CMS will not post on Regulations.gov public comments that make threats to individuals or institutions or suggest that the individual will take actions to harm the individual. CMS continues to encourage individuals not to submit duplicative comments. We will post acceptable comments from multiple unique commenters even if the content is identical or nearly identical to other comments.

The organ donation and transplantation system (known and referred to herein as the transplant ecosystem) in the United States comprises a vast network of institutions dedicated to ensuring that patients are evaluated and, if appropriate, placed onto the organ transplant waitlist, and that those on the organ transplant waitlists receive lifesaving organ transplants. These entities include organ procurement organizations (OPOs), charged with identifying eligible donors and procuring organs from deceased donors; transplant programs, located within transplant hospitals, that perform transplantation procedures from living and deceased donors; and donor hospitals that notify OPOs of the imminent death of potential donors and assist the OPO in the management of the donor and the procurement of the donor's organs. OPOs, donor hospitals, and transplant programs rely on a close collaborative relationship to ensure that organs are successfully procured and appropriately placed with transplant programs. Further, OPOs rely on families or next-of-kin, or the deceased donor themselves (if they made the decision to donate prior to death), who voluntarily make the choice to save lives and become donors. OPOs also have the role of compassionately discussing donation issues with donor families and educating the public on organ donation. In calendar year 2020, there were a total of 39,034 transplants. 1 These transplants resulted from 12,587 deceased donors and 5,725 living donors. For deceased donors, this represents about a 6 percent increase over 2019. 2 However, there continues to be a chronic substantial unmet need for transplantable organs as the number of people who need an organ transplant increases in the United States. As of November 2, 2021, there are 106,712 patients waiting for organ transplants.

On the other side of the care spectrum and prior to transplantation, end-stage renal disease (ESRD) facilities, also known as dialysis facilities, are charged with delivering safe, adequate dialysis to patients with ESRD. ESRD facilities also educate patients on their treatment options, including kidney transplantation, and ultimately refer patients to transplant programs for evaluation and potential kidney transplantation. ESRD is complete kidney impairment that is irreversible, permanent and requires either a regular course of dialysis or kidney transplantation to maintain life. In the United States, approximately 37 million patients suffer from chronic kidney disease (CKD)  3 and more than 785,000 have ESRD. 4

We have made changes to the existing CMS regulations with the goal of making impactful changes to the transplantation ecosystem and improving patient health, safety, and outcomes in transplant programs, OPOs, and ESRD facilities. On September 30, 2019, we published the final rule, “Regulatory Provisions To Promote Program Efficiency, Transparency, and Burden Reduction; Fire Safety Requirements for Certain Dialysis Facilities; Hospital and Critical Access Hospital (CAH) Changes To Promote Innovation, Flexibility, and Improvement in Patient Care” (84 FR 51732) and finalized changes to the transplant program regulations by eliminating the data, clinical experience, and outcome requirements for re-approval of transplant programs. This action removed disincentives to transplantation by encouraging the use of organs that may be perceived as being less than ideal, but could still be used for transplantation with improved outcomes over traditional therapies such as dialysis. On December 2, 2020, in response to Executive Order 13879, which aimed to increase the utilization of available organs, we published a final rule entitled, “Organ Procurement Organizations Conditions for Coverage: Revisions to the Outcome Measure Requirements for Organ Procurement Organizations (85 FR 77898),” which revised the OPO conditions for coverage (CfCs) by replacing the previous outcome measures with new transparent, reliable, and objective outcome measures. While these regulatory changes recently went into effect with the goal of creating improvements in the performance of these entities and the delivery of care to patients additional system-wide improvements may be necessary to further improve patient health and safety and outcomes in transplant programs, OPOs, and ESRD facilities. In addition, CMS is actively working to identify and address disparities and inequities across these programs. We discuss the inequities that exist in organ donation, transplantation, and dialysis and ask questions regarding how the CoPs/CfCs can address and improve these issues later in this RFI. We are soliciting comments on ways to:

In addition, we are soliciting information related to opportunities, inefficiencies, and inequities in the transplant ecosystem and what can be done to ensure all segments of our healthcare systems are invested and accountable in ensuring improvements to organ donation and transplantation rates.

Transplant programs, located within a hospital that has a Medicare provider agreement, provide transplantation services for one or more specific organs. Transplant programs must comply with the Medicare transplant program conditions of participation (CoPs) regulations at 42 CFR 482.68 through 482.104, and with the hospital CoPs at §§ 482.1 through 482.58. There are several types of CMS-approved transplant programs including heart, lung, liver, kidney, intestine, pancreas, and multi-organ. The transplant program CoPs were finalized and effective in 2007 and updated again in 2019 (84 FR 51732).

While we have made refinements to the transplant program CoPs over the years, more work is still necessary to improve the transplantation ecosystem. As evidenced through several studies and Organ Procurement and Transplantation Network (OPTN) data, the number of organs discarded continues to be high and we believe that this number could be significantly reduced. For example, in 2018, there were 37,852 organs recovered from deceased donors. Of these, 5,085 organs were discarded, with 3,755 of those organs being kidneys, 278 being pancreata, 707 livers, 3 intestines, 23 hearts, and 319 lungs. 5 Transplant programs must play an important role in reducing the organ discard rate and can do so by accepting and utilizing more organs that are deemed “marginal”, thus ensuring that more patients on the waitlist receive lifesaving transplants. Research indicates that many of the organs deemed as “marginal” that are denied are later transplanted successfully into patients at other transplant centers or they are discarded despite having similar or better quality characteristics to organs that are successfully transplanted elsewhere (see discussion in section II.C.5). 6 7 We are requesting the public's input on issues pertaining to potential changes to the transplant program CoPs, transplant recipient patient's rights, and equity in organ transplantation, in order to achieve these goals.

We are seeking public comments on the following questions:

1. For patients and their families: Are transplant programs meeting your specific needs and are you satisfied with the care that you have received? Specifically, what type of information are you receiving from your transplant program or transplant surgeon?

2. Do transplant programs adequately protect the health and safety of living donors and transplant patients? Please provide data, research, studies, or firsthand accounts that would be illustrative of how transplant programs are performing with regards to adequately protecting patient health and safety.

3. How can the current transplant program CoPs be improved in order to incentivize and ensure performance quality in organ transplantation?

4. Do the initial approval requirements at § 482.80 create barriers to the establishment of new transplant programs? Do they require an excessive amount of hospital resources at program launch, resulting in hospitals retaining lower performing transplant programs? What alternatives for ensuring quality and oversight should be considered?

5. We are seeking ways to harmonize policies across the primary HHS agencies (CMS, the Health Resources and Services Administration (HRSA), and the Food and Drug Administration (FDA)) that are involved in regulating stakeholders in the transplant ecosystem so that our requirements are not duplicative, conflicting, or overly burdensome. Are there any current requirements for transplant programs, ESRD facilities, or OPOs that are unnecessarily duplicative of or in conflict with OPTN policies or policies that are covered by other government agencies?  8 What are the impacts of these duplicative requirements on organ utilization and transplant program/ESRD facility/OPO quality and efficiency?

6. Are there additional requirements that CMS could implement that would improve the manner, effectiveness and timeliness of communication between OPOs, donor hospitals, and transplant programs?

7. Are there additional data, studies, and detailed information on why the current number of organ discards remains high, despite CMS' decision to eliminate the requirements for data submission, clinical experience, and outcome requirements for re-approval?

8. The industry as a whole has acknowledged that changes cannot be made solely to one part of the transplantation system. Similar to the outcome requirements that OPOs must meet, should CMS again consider additional metrics of performance in relation to the organ transplantation rate, considering that the number of organs discarded remains high? What should these metrics be? Are there additional quality measures that CMS should consider to measure a transplant program's performance? For a meaningful evaluation of transplant program outcomes from the recipient point of view, please comment on meaningful outcome measures that should be included in the transplant outcomes evaluations.

9. In the context of organ shortage and expanded use of marginal, suboptimal quality organs, and transplantation into standard and high-risk recipients, we are seeking public comments from the recipient perspective and expectations on meaningful measures including but not limited to graft survival benefit, shorter waiting list time, frailty improvement and quality of life after transplant, and other transplant benefits.

10. How can CMS meaningfully measure transplant outcomes without dis-incentivizing transplantation of marginal organs or dis-incentivizing performing transplants on higher risk patients?

Section 482.102 “Patient and living donor rights” provides specific rights for the patients on the waiting lists and transplant recipients. However, these enumerated rights do not address transparency regarding organ offers made for the patient on a transplant program's waiting list. There is no requirement for the transplant center or surgeon to notify a patient on the waiting list that there has been an organ offered for them.

Research has shown that less than 16 percent of deceased donor kidneys are accepted without being declined at least once. 9 In addition, as discussed later in this RFI, there are concerns that kidneys may be declined for reasons other than organ quality. We believe that there should be some degree of transparency between the transplant program or surgeon and the patient on the waiting list. Although we believe there should be some degree of transparency and accountability, we want to avoid causing the patient undue anxiety. Therefore, we are seeking comments on the degree of transparency that we should require of programs to ensure that transplant patients on the wait list receive the information they need to make decisions about their care and ensure that transplant programs and surgeons are accountable and transparent in their decisions to decline organs.

Specifically, we are seeking public comments on the following question:

We are also requesting feedback from individuals who are on a waiting list or who have received a transplant, their families, advocates, and caregivers regarding patient education, support, and information on transplantation. We are interested in understanding how the CoPs/CfCs, in particular the patient and transplant recipient rights requirements, could be revised to ensure that transplant programs, ESRD facilities, and OPOs are providing appropriate education and information to patients and their families on organ transplantation. This would ensure that patients, particularly those in underserved communities, are aware of their ability to access a lifesaving organ transplant, which will lead to better long-term health outcomes. While we use the term “transplant program,” please include any communication or information that you have received from other health care providers such as physicians or hospitals in your responses.

Specifically, we are seeking public comments on the following questions:

On January 20 through January 21, 2021, President Biden issued three executive orders addressing issues of health equity:

• Executive Order On Advancing Racial Equity and Support for Underserved Communities Through the Federal Government (E.O. 13985, 86 FR 7009, January 20, 2021);

• Executive Order on Preventing and Combating Discrimination on the Basis of Gender Identity or Sexual Orientation (E.O. 13988, 86 FR 7023, January 25, 2021); and

• Executive Order or Ensuring an Equitable Pandemic Response and Recovery (E.O. 13995, 86 FR 7193, January 26, 2021).

We are committed to supporting the President's Executive Orders by “advancing equity for all, including people of color and others who have been historically underserved, marginalized, and adversely affected by persistent poverty and inequality”. 10 Such efforts extend to ensuring equity within the organ transplantation and donation system for all populations, including racial and ethnic minorities and people with disabilities. Organ transplantation and donation in the United States remains highly inequitable amongst racial and ethnic minorities as compared to White Americans. As one study notes regarding kidney transplants, “racial disparities were observed in access to referral, transplant evaluation, waitlisting and organ receipt” and “SES [socioeconomic status] explained almost one-third of the lower rate of transplant among black versus white patients, but even after adjustment for demographic, clinical and SES factors, blacks had a 59 percent lower rate of transplant than whites”. 11 In addition, Black/African Americans, Hispanics/Latinos, Asian Americans, and other minorities are at a higher risk of illnesses that may eventually lead to kidney failure, such as diabetes and high blood pressure. 12 “Black/African Americans are almost 4 times more likely and Hispanics or Latinos are 1.3 times more likely to have kidney failure as compared to White Americans.”  13 Yet those Black/African American and Hispanic/Latinos patients on dialysis are less likely to be placed on the transplant waitlist and also have a lower likelihood of transplantation. 14 In particular, Black/African Americans make up the largest group of minorities in need of an organ transplant and yet the number of organ transplants performed on Black/African Americans in 2020 was 28.5 percent of the number of Black/African Americans currently waiting for a transplant. The number of transplants performed on White Americans, however, was 40.4 percent of the number currently waiting. 15

There are many theories that have been posited as to why these racial and ethnic inequities in transplantation exist. A person's social determinants of health (those additional social and economic factors that are driven by systemic racism and social policies) affect a wide range of health and quality of life risks and outcomes. 16 These can therefore be contributing factors that lead to inequities in transplantation and impact a patient's access to dialysis and placement on the waitlist. In addition, low health literacy, lack of healthcare coverage, and lack of economic, environmental, and other social opportunities can contribute to poorer health outcomes in general. However, studies have also shown that medical practices can contribute to inequities in transplantation. Delays in referrals to kidney transplantation, in particular, may be due “. . . in part, to clinicians' implicit or explicit biases, including physician misperceptions about the benefits of transplants for Black individuals or discordant and inaccurate beliefs regarding causes or prevalence of these disparities”. 17 Another contributing factor to inequities in transplantation could also be due to the widespread use of the Chronic Kidney Disease Epidemiology (CKD-EPI) equation used by kidney transplant programs, which measures kidney function and includes an adjustment for race (Black/African American) that often under-identifies chronic kidney disease in Black/African Americans and denies them equitable appropriate intervention, which in turn could have an impact on the time a patient waits for a kidney transplant. The use of race in the calculation of the estimated glomerular filtration rate (eGFR) has been questioned recently and the OPTN has solicited public feedback on reassessing the inclusion of race in eGFR equations. 18

In addition, inequity exists for people with disabilities who similarly need access to organ transplantation. A 2019 National Council on Disability report found that people with disabilities are frequently denied equal access to receive organ transplants based solely on their disability status. 19 Providers and transplant centers also often assume that people with disabilities, especially those with intellectual disabilities, will have worse outcomes after transplantation. A survey conducted in 2008 of pediatric transplant centers determined that “43 percent always or usually consider intellectual disabilities an absolute or relative contraindication to transplant due to assumptions about quality of life, concerns regarding `compliance or long-term self-care' `financial concerns', and `the functional prognosis of the delay itself' ”. 20 However, individuals with disabilities can have equally positive outcomes, and the disability should have very limited impact on the individual's ability to adhere to post-transplant care, if they receive adequate support. 21 These individuals must be afforded equal access to transplantation services in accordance with federal civil rights laws, and the value of their lives are no less than those individuals who are without disabilities. This inequity exists despite numerous federal and state prohibitions on discrimination on the basis of race, color, national origin, and disability.

As the discussion on inequity for racial and ethnic minorities and people with disabilities demonstrates, there remain outstanding issues, including those that lead to inequities in transplantation. It is imperative that racial and ethnic minorities as well as those with disabilities are afforded the same opportunities to receive a life- saving organ transplant as their non-disabled, white counterparts. Further, addressing these issues in transplantation will have intersectional impacts for individuals that belong to more than one group.

We acknowledge that this and other critical improvements cannot, and will not, be achieved only through revisions to the transplant CoPs, OPO CfCs alone, or the ESRD facility CfCs. Thus, we are asking the public for specific ideas on advancing equity within the organ transplantation ecosystem, as they pertain to changes to the health and safety standards for transplant programs and OPOs. Specifically, we are seeking public comments on the following questions:

On September 29, 2020, we published a final rule entitled, “Medicare Program; Specialty Care Models To Improve Quality of Care and Reduce Expenditures” (85 FR 61114), hereinafter referred to as the Specialty Care Models final rule. Among other things, the Specialty Care Models final rule finalized the End-Stage Renal Disease (ESRD) Treatment Choices (ETC) Model, which is designed to encourage greater use of home dialysis and kidney transplants for Medicare beneficiaries with ESRD, while reducing Medicare expenditures and preserving or enhancing the quality of care furnished to beneficiaries with ESRD. As described in the Specialty Care Models final rule, both of these modalities have support among health care providers and patients as preferable alternatives to in-center hemodialysis, but utilization has been less than in other developed nations (85 FR 61263).

Interventions that can slow progression of CKD include early identification of the disease, controlling blood pressure, controlling blood glucose, reducing albuminuria, eating a healthy diet, and maintaining a healthy lifestyle. We would like to learn what patient, clinician and system factors would help patients maintain or improve their health. We are also interested in knowing various approaches to identifying those at risk of developing CKD and ways to improve CKD detection rates. Additionally, we are interested in actions that aim to close health equity gaps in CKD detection, education and care and would like to learn about these and other health equity concerns among this patient population. Feedback on ways to increase interventions and awareness of health inequities may further improve patient centered ESRD health and safety CfCs, or may impact future CfCs for health equity. To that end, we request the public's help in answering the following questions:

Transition to dialysis is too often a surprise, with as many as half of all new dialysis patients having never previously seen a nephrologist. We are interested in learning about how patients with CKD receive appropriate information on kidney health and modality options, including transplantation. Transitional care units are specialized programs offered by dialysis facilities that provide medical and psychosocial support during the peridialysis initiation period. The goal of these units is to improve awareness of all aspects of renal replacement therapy, including modalities, access, transplantation options, and nutritional and psychosocial aspects of the disease enabling patients to make informed decisions regarding their care. In addition, we would like more information on transitional units.

Under the current CfCs at 42 CFR 494.70(a)(7) the patient has the right to be informed about all treatment modalities and settings, including but not limited to, transplantation, home dialysis modalities (home hemodialysis, intermittent peritoneal dialysis, continuous ambulatory peritoneal dialysis, continuous cycling peritoneal dialysis), and in-facility hemodialysis. Once they are stable on a specific modality, patients are infrequently aware that they are able to change modalities. In 2018, 72 percent of Black or African-American patients with ERSD received in-center hemodialysis versus only 57 percent of White patients. This data point may indicate that more White ESRD patients receive home dialysis than Black or African-American patients. 25 We would like information on the following questions:

There are several means by which dialysis services are currently provided to nursing home residents, including transporting a resident to a local dialysis facility, dialysis facilities located on the campus of a nursing home, qualified dialysis facility staff that comes to the nursing home, or trained nursing home staff that provides dialysis services. The population of dialysis patients who receive home dialysis care in nursing homes is small, but it is an especially high-risk population. Our internal analysis shows that the percentage of dialysis patients in a nursing home was approximately 17 percent (89,568) in 2018. Most dialysis facilities (93 percent) had at least one patient in a nursing home. Only a small fraction of these dialysis patients (<1 percent) appear to receive dialysis treatment in a nursing home setting annually. There are no limitations to the number of agreements a dialysis facility may have with nursing homes to provide home dialysis services. We have received reports where some nursing homes are over 100 miles away or across the state from the dialysis facility where the agreement to provide care exists. We are concerned that this poses concerns for oversight of the dialysis care and services in providing timely support services and patient assessments as well as necessary equipment & supplies. We must ensure that these patients are receiving safe and appropriate dialysis care. We seek answers to the following questions:

We are also seeking information on the potential certification and safe use of alternate types of facilities that can provide dialysis treatments outside of an individual's home or resident care facility, such as mobile units. Mobile dialysis units are not currently defined or certified by CMS.

We have received significant public interest and questions related to staff-assisted home dialysis, which is not a separately paid service, but is covered as part of the ESRD Prospective Payment System (PPS) bundled payment. A dialysis facility may provide qualified staff members in the patient's home to assist them in performing their home dialysis treatments as long as the facility provides Home Training and Support services specified at (42 CFR 494.100(a)). The dialysis staff member functions in the role of the patient's caregiver and monitors the patient throughout the dialysis treatment. The dialysis facility maintains overall responsibility and oversight to ensure appropriate, qualified staff are assigned and trained and provides supervision of staff members as indicated. Employees performing staff assisted dialysis must meet the personnel qualification requirements at § 494.140. In addition, staff who provide staff-assisted home dialysis must meet any state scope of practice requirements and any other applicable state laws.

CMS recently revised the OPO performance metrics that will be implemented in the 2022 through 2026 recertification cycle (85 FR 77898). The changes were made to improve upon the current measures by using objective and reliable data that will incentivize OPOs to ensure all viable organs are transplanted, apply greater oversight to OPOs while driving higher performance, and as a result, save more lives. We implemented a tiered approach based on thresholds set prior to the performance period using a previous year's data, while also using a median rate for assessing OPOs. We will assign OPOs to tiers based on whether performance exceeded these thresholds. OPOs assigned to tier 1 are those OPOs with performance rates for both measures (donation rate and transplantation rate) that are not statistically below the lowest rates among the highest 25 percent of all OPOs. These OPOs are automatically recertified after successfully complying with the remaining Conditions for Coverage and can compete for other open areas (provided they meet all other requirements). OPOs assigned to tier 2 are those whose performance for both measures statistically meet or exceed the median rates for all OPOs but do not meet tier 1 requirements for both measures. The designated service areas (DSAs) for these OPOs will be opened for competition and these OPOs must compete to retain their DSA. Additionally, these OPOs can compete for other open areas (provided they meet all other requirements). OPOs assigned to tier 3 are OPOs whose performance rate for either measure is statistically below the respective median rate for all OPOs. These OPOs will be decertified and their areas opened for competition. If no OPO applies to compete for the area, CMS may select a single OPO to take over the entire open area or may adjust the service area boundaries of two or more contiguous OPOs to incorporate the open area.

Although we believe our new assessment approach will incentivize OPO performance, resulting in clustering of rates close to the highest performers, eventually the margin between the top 25 percent and the median will begin to narrow. Once OPO performance on the outcome measures reaches this level, CMS will need to consider other factors that differentiate highly functioning OPOs from those that are less highly functioning. We are interested in exploring what factors CMS may consider in this regard and ways to measure performance in these areas.

We are interested in ensuring our processes for the assessment of OPO performance are continually evolving and reflective of current industry standards and technological capabilities while providing the necessary incentives and rewards based on the dynamics within the OPO community and organ donation-transplantation ecosystem. We seek public comment to facilitate fair and equitable oversight of OPOs while ensuring we continually drive performance to ensure more lifesaving organs are available to individuals on transplant waitlists.

In addition, we are assessing ways that we can improve the current recertification and competition processes. We ask the public for specific information on how these CfCs can be modified to ensure that OPOs are recertified and competition occurs in such a manner that would allow for the seamless determination of recertification for an OPO at the end of the recertification cycle, or the assignment of a new OPO to an open DSA. Therefore, we are asking the following questions:

While many organs are transported to recipients with organ recovery teams, some organs need to be transported independently via common or commercial carrier in order to reach the intended recipient at a transplant hospital. A recent media report of organs being lost or delayed in transport, mainly through commercial airlines, have raised concern regarding the risks associated with unaccompanied organ transport. The tracking of these organs during transport is often subpar, using outdated methods. 26 Lost or delayed organs lead to the unnecessary discards and missed opportunities for those waiting for a lifesaving organ transplant. Ensuring that organs arrive at the transplant hospital in a timely manner is of the utmost importance.

Recovered organs that are ready for transplant must first be preserved, packed, stored, and transported to the transplant hospital. The OPTN has specific policies for the transport of organs including requirements for packaging, labeling, shipping and storage of organs and vessels. 27 Such processes are extremely important in reducing errors and help ensure that donated organs are matched correctly and efficiently with the identified recipient. However, there are currently no specific requirements, such as real-time tracking, for OPOs that utilize organ transport via common or commercial carriers. An OPO may choose a transport and tracking method that it believes is most appropriate based on the particular circumstances; however, these choices sometimes have resulted in lost opportunities for transplantation. Therefore, we are asking the public the following questions:

Under the OPO CfCs, OPOs are required to have agreements with 95 percent of the Medicare and Medicaid participating hospitals and critical access hospitals in its DSA that have both a ventilator and an operating room and have not been granted a waiver by CMS to work with another OPO. The agreement must describe the responsibilities of both the OPO and hospital or critical access hospital in regards to organ donation. Hence, the first step in the organ donation process is for the donor hospital to timely notify the appropriate OPO of all deaths and imminent deaths in the hospital (42 CFR 482.45(a)(1)).

The notification and timing of referrals to OPOs is critical to ensure the identification of potential donors and availability of organs for transplantation. The failure to make this referral is a significant reason a potential donor who is medically suitable for organ donation does not become a donor. 28 This should be done as soon as possible to give the OPO time to evaluate the person to determine if he or she is a potential donor and, if so, obtain consent and begin managing the potential donor's care to maximize the chances of organ recovery. CMS does not define “imminent death” or “timely referral” but requires that these terms be defined in the agreement between the OPO and the hospital (42 CFR 486.322(a)).

Some members of the OPO community have advocated for invasive mechanical ventilation to be a clinical trigger that would require a referral to the OPO. Most of the potential donors will be on invasive mechanical ventilation. A person being assessed for brain death criteria will be on invasive mechanical ventilation due to their inability to breathe. In addition, potential donation after cardiac death (DCD) donors will most likely be on invasive mechanical ventilation prior to any decision to discontinue life support due to devastating injuries. If the decision has been made to withdraw life support, it is critical that the OPO know of these individuals before invasive mechanical ventilation is withdrawn to give the OPO time to evaluate the potential donor and obtain consent for donation.

Since CMS does not specifically define “imminent death” or “timely referral,” it has been suggested that this may result in variable performance in this requirement due to lack of any national standards. Some have indicated that reporting timelines vary from hospital to hospital and the demands of patient care can cause unintended delays in this process. One recommendation to reduce the variation in timeliness of reporting is automating real time donor referral thereby removing the subjective element of identifying potential organ donors and reducing the variation in timeliness of reporting. 29

CMS is interested in learning more about the capabilities hospitals and OPOs may currently have for transmitting and receiving automated referrals. We are particularly interested in the experience of OPOs and donor hospitals that have successfully piloted or implemented the use of automated donor referral systems.

We welcome comments from staff in the electronic medical record (EMR) and EHR industries on ways to automate reporting requirements in a cost-effective manner, as well as how such an approach may be implemented on a national scale. We would like to better understand what technical requirements are necessary and how any changes can be duplicated across hospital EHR systems nationally with minimal burden to the industry.

Finally, we are also interested in challenges OPOs may have in gaining access to donor hospital EHRs for organ procurement activities once referrals are received. Since OPOs have agreements with a large number of hospitals within its DSA, and timely access to potential donor information facilitates donation, we are interested to learn of any potential barriers to accessing information via EMRs and how CMS may facilitate better access to information through its requirements.

Organs from deceased donors are nearly always recovered in donor hospitals. However, OPOs have pointed out that there can be numerous challenges in recovering organs in this setting, and the overall process of organ procurement is often time consuming and logistically challenging. Unless an organ(s) is going to be recovered and transplanted in the same hospital, transplant surgeons must often travel to the donor hospital to surgically recover the organ(s). This procedure is complex and time-sensitive, especially for extra-renal organs. Depending upon the organs intended to be procured from the donor, multiple teams of recovery surgeons may need to travel to the donor hospital. Due to competing priorities in a donor hospital, donors often receive lower priority for operating room time and may experience delays in special tests, such as echocardiograms, biopsies, or cardiac catheterizations. These delays may result in increased costs for procurement of the organ(s) or in not being able to procure organs from a donor due to medical complications during a protracted timeframe while on mechanical ventilation. Additionally, OPOs are responsible for all costs for donor evaluation and medical management once declaration of death and consent for donation occurs. These costs are reimbursed by transplant hospitals, other OPOs and Medicare for Medicare beneficiaries. Donor evaluation and management tasks can include a range of laboratory, imaging, and diagnostic procedures that OPOs report they may complete at a fraction of the cost they pay for these services at donor hospitals.

CMS is aware of at least 10 OPOs that have developed dedicated facilities to recover organs from donors. These facilities are independent of the donor hospital location from which the donor was referred. These facilities do not provide routine medical care but they may provide a range of services to facilitate donor evaluation and management and organ recovery. In addition, the only potential donors who would be transferred to these facilities would have been declared dead by brain death criteria and the OPO would have already received appropriate consent for organ donation.

There are few published studies evaluating the effectiveness of organ recovery facilities. 30 31 While these studies highlight the potential benefits, the practice has not been universally adopted by OPOs and growth of these facilities is relatively slow. Federal oversight of tissue collection is provided under the Public Health Service Act (PHS Act) and FDA regulations on human cells, tissue, and cellular and tissue-based products, or HCT/Ps (21 CFR part 1271). However, organ recovery facilities are not specifically addressed in the OPO CfCs and Medicare does not currently compensate OPOs for some activities associated with operation of these facilities, such as transportation of the donor to the OPO's facility.

CMS is interested in learning about the potential benefits and concerns for the use of organ recovery facilities in greater detail and determining whether it would be appropriate or beneficial to establish specific health and safety requirements that would apply to these facilities. Specifically, CMS would like to explore aspects related to the effectiveness, operations, donor families, and impacts to other stakeholders. Since this is an emerging model of practice, there is limited information currently available. We are requesting public comments that provide evidence-based conclusions, such as additional peer-reviewed literature, that we should consider to inform any future rulemaking. Additionally, we are requesting that commenters share any experiences in operating or interacting with staff from OPOs with organ recovery facilities. Finally, we are particularly interested in the experience of donor families and patient advocates and seek comments from these individuals and any organizations representing donor families. While much of the information reviewed by CMS highlights the benefits of organ recovery facilities, we are also interested in learning of specific risks or adverse outcomes associated with these facilities.

Effectiveness:

1. What benefits and risks may OPOs experience in regards to cost-effectiveness, organ yield, and organ quality from operating an organ recovery facility?

2. Are there particular benefits to securing organs from marginal or extended criteria donors while at an organ recovery facility?

3. Are OPOs able to achieve better placement of these organs relative to organs recovered at donor hospitals?

Operations:

1. What medical evaluation diagnostic procedures are commonly performed in these organ recovery facilities?

2. What special equipment needs, such as laboratory and imaging, are necessary?

3. What supplies, such as pharmaceuticals, should be considered?

4. Which professional staff are needed and what are their qualifications for operating an organ recovery facility?

5. What specific risks may be associated with operating a facility for the recovery of organs outside a donor hospital?

6. What state or local requirements apply to the currently existing facilities, including health and safety and fire?

Impacts on other stakeholders:

1. Are there any negative impacts or disincentives to donor hospitals or transplant centers?

2. How does having an organ recovery facility impact tissue recovery and the relationships with tissue banks in the DSA?  32

Impacts on Donor Families:

1. Were you satisfied with the request for donation discussion by the OPO representative and how did this affection your decision for donation?

2. How does organ donation at organ recovery facilities impact donor families?

3. Does the process for transfer to organ recovery facility make the process more difficult for the donor family if the facility is remote from the donor hospital? How are distance challenges addressed to ensure family involvement in the donation process?

4. What are the reasons why donor families reject transfer from the donor hospital to an organ recovery facility? If you have personal experience with this issue, what reasons led you and your family to the decision to reject transfer?

5. Have there been any studies specifically focused on evaluating donor family satisfaction when utilizing an OPO operated organ recovery facility versus traditional organ recovery in donor hospitals?

6. What aspects do donor families find particularly beneficial and which are challenging for them?

In response to our recent rulemaking (85 FR 77898), some commenters raised concerns about the new definition of “donor,” which excludes “zero organ donors.” While there is no commonly accepted definition of a “zero organ donor,” it is generally interpreted to mean a situation where the donation process was initiated but no organ was transplanted. Our internal analysis during this rulemaking indicated that in 2018, there were 1,255 organs procured from 593 “zero organ donors,” but never transplanted. Commenters claimed that excluding “zero organ donors” from the donation rate may discourage OPOs from pursuing extended criteria or marginal and complex donors, which is inconsistent with our goal of increasing organ donation.

More recent data indicates that the number of “zero organ donors” is increasing significantly. A recent internal analysis indicates that “zero organ donors” increased by 31 percent between 2019 and 2020 (746 to 977) and 76 percent from 2017 through 2020 (555 to 977). In 2017, these donors represented 5 percent (555) of all deceased donors and 25 percent (1,215) of all discarded organs. In 2020, “zero organ donors” increased to 8 percent (977) of all deceased donors and 31 percent (2,051) of all discarded organs. During the past decade, the rate of “zero organ donors” ranged from a low of 5.3 percent to a high of 8.5 percent in 2020 with an average annual rate of 6.0 percent.

In addition to “zero organ donors” where no organs from a donor are transplanted, there are many donors that have organs recovered and transplanted while other organs from the same donor are discarded. The number of all organ discards (including organs from zero organ donors) has increased steadily over the past 15 years. There were 3,553 discarded organs (including kidney, liver, heart, pancreas, lung, and intestine) in 2005, 3,878 discarded organs in 2010 (increase of 9.1 percent), 4,439 discarded organs in 2015 (increase of 14.5 percent), and 6,512 discarded organs in 2020 (increase of 31.8 percent). Overall, there were a total of 71,335 discarded organs in the 16-year period inclusive of the years 2005 to 2020. The rate of organ discards increased from 10.5 percent to 13.4 percent during this same period highlighting the increased frequency of discarding organs. Historically, kidney discards represent the largest number of discarded organs accounting for 77.6 percent (5,051) of all organ discards in 2020 despite over 91,000 candidates registered on the waitlist for a kidney transplant. 33 The Scientific Registry of Transplant Recipients (SRTR) data indicate that many organs that are not recovered or are discarded are a result of failure to locate a recipient for the organs. Additionally, many of these organs have a disposition reason code of “other” despite a range of options for categorizing the organs. 34 While there may be many medically appropriate reasons for organ discards or non-recovery, such as infection, organ trauma, poor organ function and anatomical abnormalities, we are concerned with the increasing number of organs that go unused and are subsequently discarded. We are interested in ways to better understand and identify these issues and incentivize a reduction in these numbers through policy options.

The elimination of outcome measures for recertification of transplant programs was intended to eliminate provider disincentives for performing transplantations, improve organ procurement for transplantation, and increase organ utilization through increased acceptance of organs that previously may have been declined. Since the change in the transplant program outcome measures was only implemented in 2019, we only have 1 year of data to assess at this time. However, data from 2020 demonstrates a continued increase in the number of “zero organ donors” and discarded organs suggesting the policy change may not be achieving the desired outcome indicating other factors may be impacting placement of organs. While we acknowledge the complexity that is involved in the placement of organs, we are seeking information on additional factors to consider and methods that may facilitate improvements in this area through OPO and transplant center collaboration.

Recent research indicates that factors beyond organ quality impact acceptance behavior by transplant centers. These factors may include donor characteristics, geographic area, characteristics of the organ donation-transplantation environment within a DSA, and timing such as interruptions caused by weekends and holidays. 35 This often results in missed opportunities for many patients on the waitlist and frequently leads to organ discards. Some of these organs are initially rejected only to later be accepted at other centers and successfully transplanted in patients lower on the waitlist. Recent studies have found that many kidneys that were discarded had similar or better quality characteristics to those that had been successfully transplanted. 36 37 Additionally, candidates for transplantation are frequently not aware of organs being declined on their behalf and may not be informed of the reason for the decline. Center-level organ acceptance practices eliminate a patient-centered approach to involvement in decision making on the advantages and disadvantages to organ acceptance versus continuation of existing care while remaining on a waitlist. 38 This may result in significant negative quality of life impacts for potential organ recipients, and even death, while waiting for a better organ after many potentially acceptable offers were declined on behalf of the patient. The net effect is the discard of lifesaving organs, frequently without potential recipient involvement in the decision-making process, while there is a shortage of organs for over 106,000 individuals. 39

Given the impact from reducing the number of organ discards, CMS is interested in exploring policy options that may assist in this effort. We are seeking information that we can act upon to strengthen requirements as well as information where additional burden reduction may facilitate improvement. We are seeking input on areas where our policies may create additional burdens or conflict with policies of the OPTN. We are particularly interested in ways to facilitate better communication and collaboration between OPOs and transplant centers and how this information can be incorporated into our requirements.

There are many quality improvement tools and initiatives available to OPOs and transplant centers through the OPTN, and potentially within the industry itself that may foster improvements in reducing the number of “zero organ donors” and organ discards. OPOs and transplant programs that do not take full advantage of the resources available to improve performance may continue to unnecessarily waste these lifesaving organs.

Patient rights and patient-centered care are a vitally important aspect of organ donation and transplantation. Ensuring individuals have the information needed to make informed decisions about their care is essential and transparency is an important component of this process. We believe that patients and their families should have increased awareness of practices at OPOs and transplant centers. OPOs that have a high discard rate and transplant centers that have a high rate of declining organs are a concern in that many potentially life-savings organs are wasted and patients are at greater risk for dying while waiting for a transplant.

In the May 31, 2006 final rule entitled, “Conditions for Coverage for Organ Procurement Organizations (OPOs)” (71 FR 30982), we noted that commenters expressed concern that we did not include specific requirements related to Donation after Cardiac Death (DCD) (71 FR 30985). In this rulemaking, our intention was not to avoid addressing the issue of DCD, nor did we specifically encourage OPOs to recover organs from cardiac death donors. Rather, we stated that we believed DCD donation was addressed in three separate sections of the CFCs, specifically 42 CFR 486.322, Relationships with hospitals, critical access hospitals, and tissue banks; § 486.324, Administration and governing body; and § 486.344, Evaluation and management of potential donors and organ replacement and recovery. Therefore, we finalized the requirements to facilitate our oversight of donation after cardiac death and not disadvantage OPOs that did not pursue these donors. We indicated that we understood donation after cardiac death was an evolving practice and was not yet accepted in every area of the country. Some donor hospitals were reluctant to permit donation after cardiac death in their facilities and some transplant surgeons were unwilling to transplant organs from such donors into their patients. Thus, some OPOs were hesitant to advocate donation after cardiac death in their service areas.

CMS is interested in better understanding both the successes and the challenges that OPOs face in implementing DCD organ donation. We are interested in learning whether and to what extent the clinical, scientific, and general environment for DCD donation has changed in recent years and if commenters have specific recommendations in regards to policy options related to DCD donation that may be beneficial.

CMS is interested in exploring the relationship between hospitals, OPOs, and tissue banks and how these relationships may have evolved over time, particularly since publication of the OPO final rule in 2006. Currently, hospitals are required to have an agreement with at least one tissue bank and at least one eye bank to cooperate in the retrieval, processing, preservation, storage and distribution of tissues and eyes, to assure that all usable tissues and eyes are obtained from potential donors provided these activities do not interfere with organ donation.

Additionally, regulations at § 486.322(c) require that OPOs have arrangements to cooperate with tissue banks that have agreements with hospitals and critical access hospitals with which the OPO has agreements. These regulations include cooperating on a range of potential activities to ensure that all usable tissues are obtained from potential donors. These activities may include screening and referrals; obtaining informed consent; managing tissue retrieval, processing, preservation, storage, and distribution; and providing designated requestor training. CMS does not regulate tissue banks, also known as tissue establishments. Instead, oversight over such establishments is primarily provided by FDA.

In drafting requirements for OPOs with respect to such agreements with tissue banks, in 2006, CMS considered three factors including (1) an OPO's role as the agency that receives most referrals of deaths and imminent deaths from the hospitals in its service area (unless referrals are screened by a third-party designated by the OPO); (2) the need to show sensitivity toward the circumstances of potential organ and tissue donor families (such as ensuring that potential donor families are not approached by more than one agency unnecessarily); and (3) the statutory requirement that an OPO have arrangements to cooperate with tissue banks to assure that all useable tissues are obtained. The CfCs were intended to ensure OPOs maintain a collaborative relationship with tissue banks in their area but OPOs are only required to have agreements with those tissue banks that have agreements with hospitals in their DSA.

We noted in our 2006 final rule “Medicare and Medicaid Programs; Conditions for Coverage for Organ Procurement Organizations (OPOs)” (71 FR 31007), that many OPOs were beginning to establish tissue banking services. We seek input on the changes that have occurred since then to better understand how this service has evolved and if changes to the existing requirements are necessary.

While the primary mission of an OPO is to maximize the number of viable organs it recovers for transplantation, OPOs also serve a role in providing organs to the research community. Currently, OPOs are assessed on both these aspects of organ donation as a requirement of the outcome measures at § 486.318. During recent rulemaking revising these measures (85 FR 77898), CMS eliminated the assessment of organs for research focusing the measures on the primary mission of OPOs in providing organs for transplantation. This change is scheduled to be implemented during the next OPO certification period beginning in 2022. The one exception to this change was the inclusion of pancreata procured for islet cell transplantation or research that was included in the outcome measures in order to comply with the Pancreatic Islet Cell Transplantation Act of 2004. While this recent rulemaking accomplished our goal of developing more transparent, reliable, and objective outcome measures that will drive higher performance, it also leaves some areas that CMS may consider in future rulemaking. Specifically, CMS is interested in exploring the need for continued support for obtaining organs for research as well as possible alternative approaches to address the requirements of the Pancreatic Islet Cell Transplantation Act. Additionally, we are seeking information on approaches that align with our efforts to have transparent, reliable, and easily verifiable information while minimizing burdens associated with any potential future changes.

Providing organs for research is an important aspect for assisting researchers in discovering new treatments for debilitating and fatal diseases. The Department of Health & Human Services defines research at 45 CFR 46.102(l). For our purpose of assessing OPO performance, we consider three categories of organs including: organs transplanted into patients with no research interventions (conventional transplants); organs that have had a research intervention that are transplanted into patients; and organs used exclusively for research purposes. In recent rulemaking (85 FR 77902), we indicated the transplant and research communities commonly described the transplantation of organs into humans using research protocols (for example, deceased donor intervention research) as both transplants and research. Generally, such research involves the transplantation of organs into transplant candidates that is generally considered clinical care while simultaneously qualifying as human subject research. Therefore, in establishing the new OPO performance measures, we consider organs used for research as applying to organs procured and used only for research purposes whereas organs transplanted into human subjects are counted as part of clinical care and included in the outcome measures. For example, in regards to assessing OPO performance in providing organs for research purposes as relating to organs that have been manipulated for research purposes but are not transplanted into a human recipient. This interpretation, used only for assessing OPOs on performance outcome measures, provides a level of demarcation for counting organs transplanted into human subjects (including those as part of a research protocol) versus those that are utilized strictly for research purposes, and aligns with our assessment of an OPO's primary mission with data that is independently verifiable. As previously noted, pancreata procured for research are also counted in the performance measures based on statutory requirement.

Given the importance of research to continued innovation in transplant medicine, CMS is interested in exploring the issue of incentivizing the placement of organs with researchers without detracting from the OPOs primary mission of providing organs for transplantation.

The use of vascular composite allografts (VCAs) is an evolving area of practice that involves the transplantation of multiple tissue types that may include skin, bone, muscles, blood vessels, nerves, and connective tissue. It includes body structures such as a face, limb (for example, arms, hands, fingers, legs, toes), bone, soft tissue (for example, larynges and abdominal wall), and/or reproductive organs. According to data from the OPTN, there have been approximately 110 VCA transplantations in the United States. While VCA transplantations are relatively infrequent and the goals of surgery are restorative and life-enhancing, versus lifesaving, they can provide profound quality of life benefits for the recipient. FDA regulates human cells, tissues, and cellular and tissue-based products (HCT/Ps) under 21 CFR part 1271. Prior to 2014, VCAs were not explicitly excluded from the definition of HCT/Ps under FDA's regulations and therefore were subject to FDA oversight, while HRSA regulated vascularized human organs through the OPTN, which sets policies related to the procurement, transplantation, and allocation of human organs, at regulations under 42 CFR part 121 (the “OPTN final rule”). In enacting the National Organ Transplant Act (NOTA) in 1984, the Congress gave the Secretary the authority to expand the definition of organ in regulation. Prior to 2013, VCAs were not included in the definition of organ and the classification of VCAs as HCT/Ps previously excluded them from regulation by HRSA. However, in 2013 the Secretary changed the definition of “organ” in the OPTN final rule to include VCAs shifting oversight responsibilities to HRSA (78 FR 40033, July 3, 2013). By including VCAs within the OPTN final rule's definition of “organs”, transplants involving VCA are subject to the requirements of the OPTN final rule and explicitly excluded from the definition of HCT/Ps under FDA regulations. This change became effective on July 3, 2014. The rule established specific criteria for body parts to qualify as VCAs.

In establishing the regulatory requirements for the oversight of VCAs through the OPTN, HRSA requires the body part to have specific characteristics to be considered a VCA. The characteristics include a body part that is: (1) Vascularized and requires blood flow by surgical connection of blood vessels to function after transplantation; (2) containing multiple tissue types; (3) recovered from a human donor as an anatomical/structural unit; (4) transplanted into a human recipient as an anatomical/structural unit; (5) minimally manipulated (that is, processing that does not alter the original relevant characteristics of the organ relating to the organ's utility for reconstruction, repair, or replacement; (6) for homologous use (the replacement or supplementation of a recipient's organ with an organ that performs the same basic function or functions in the recipient as in the donor; (7) not combined with another article such as a device; (8) susceptible to ischemia and, therefore, only stored temporarily and not cryopreserved; and (9) susceptible to allograft rejection, generally requiring immunosuppression that may increase infectious disease risk to the recipient.

Despite the change in the definition of organ by HRSA, CMS has not made changes to its definition of “organ” in oversight of solid organ transplantation through the CoPs at 42 CFR part 482 subpart E. However, we are seeking comment on whether or not we should revise its definition of organ to correspond to that of HRSA. We seek comment on ways to support this evolving area of practice while providing necessary health and safety oversight for transplant recipients.

The Medicare Payment Advisory Commission (MedPAC) has stated that many dialysis facilities are operated as a joint venture between a dialysis organization and physicians. Joint ventures allow participating partners to share in the management, profits, and losses of an entity. 40 MedPAC has noted concerns raised in the literature that joint ventures between dialysis organizations and physicians create financial incentives for participating physicians that could inappropriately influence decisions about patient. 41

The health care industry is increasingly interested in identifying Medicare-enrolled providers and suppliers and their associations with other health care groups/organizations. CMS has been working on improving provider and supplier enrollment transparency by making data available for use by the healthcare community for research and to increase awareness in the provider and supplier community about enrollment information on file with CMS. 42 43 Recently, CMS has received requests from the research community for data to study the business practices of dialysis facilities and the effect of joint ventures between nephrologists and dialysis facilities. These researchers have reported difficulty in performing the research due to the lack of information on these financial arrangements collected by CMS.

When a provider enrolls in Medicare, CMS collects information that is self-reported by the provider on individuals and organizations with 5 percent or greater direct or indirect ownership of, a partnership interest in, and/or managing control of the provider. 44 Institutional providers, such as dialysis facilities, may self-report whether their affiliation with a Chain Home Office is a joint-venture or partnership on their enrollment application.

In addition to efforts to increase transparency of Medicare enrollment information and in order to learn more about the impact of nephrology joint ventures for the purpose of these efforts, CMS is seeking information on the following questions:

This is a request for information (RFI) only. In accordance with the implementing regulations of the Paperwork Reduction Act of 1995 (PRA), specifically 5 CFR 1320.3(h)(4), this general solicitation is exempt from the PRA. Facts or opinions submitted in response to general solicitations of comments from the public, published in the Federal Register or other publications, regardless of the form or format thereof, provided that no person is required to supply specific information pertaining to the commenter, other than that necessary for self-identification, as a condition of the agency's full consideration, are not generally considered information collections and therefore not subject to the PRA.

This RFI is issued solely for information and planning purposes; it does not constitute a Request for Proposal (RFP), applications, proposal abstracts, or quotations. This RFI does not commit the United States Government to contract for any supplies or services or make a grant award. Further, we are not seeking proposals through this RFI and will not accept unsolicited proposals. Responders are advised that the United States Government will not pay for any information or administrative costs incurred in response to this RFI; all costs associated with responding to this RFI will be solely at the interested party's expense. We note that not responding to this RFI does not preclude participation in any future procurement, if conducted. It is the responsibility of the potential responders to monitor this RFI announcement for additional information pertaining to this request. In addition, we note that CMS will not respond to questions about the policy issues raised in this RFI.

We will consider all input as we develop future regulatory proposals or future subregulatory policy guidance. We may or may not choose to contact individual responders. Such communications would be for the sole purpose of clarifying statements in the responders' written responses. Contractor support personnel may be used to review responses to this RFI. Responses to this RFI are not offers and cannot be accepted by the Government to form a binding contract or issue a grant. Information obtained as a result of this RFI may be used by the Government for program planning on a non-attribution basis. Respondents should not include any information that might be considered proprietary or confidential. This RFI should not be construed as a commitment or authorization to incur costs for which reimbursement would be required or sought. All submissions become United States Government property and will not be returned. In addition, we may publicly post the public comments received, or a summary of those public comments.

I, Chiquita Brooks-LaSure, Administrator of the Centers for Medicare & Medicaid Services, approved this document on August 4, 2021.

Federal regulations at 50 CFR part 679 implement the FMP and govern the groundfish fisheries in the BSAI. The Council prepared the FMP, and NMFS approved it, under the Magnuson-Stevens Act. General regulations governing U.S. fisheries also appear at 50 CFR part 600.

The FMP and its implementing regulations require that NMFS, after consultation with the Council, specify annually the total allowable catch (TAC) for each target species category. The sum of TACs for all groundfish species in the BSAI must be within the optimum yield (OY) range of 1.4 million to 2.0 million metric tons (mt) (see § 679.20(a)(1)(i)(A)). Section 679.20(c)(1) further requires that NMFS publish proposed harvest specifications in the Federal Register and solicit public comments on proposed annual TACs and apportionments thereof; prohibited species catch (PSC) allowances; prohibited species quota (PSQ) reserves established by § 679.21; seasonal allowances of pollock, Pacific cod, and Atka mackerel TAC; American Fisheries Act allocations; Amendment 80 allocations; Community Development Quota (CDQ) reserve amounts established by § 679.20(b)(1)(ii); and acceptable biological catch (ABC) surpluses and reserves for CDQ groups and Amendment 80 cooperatives for flathead sole, rock sole, and yellowfin sole. The proposed harvest specifications set forth in Tables 1 through 15 of this action satisfy these requirements.

Under § 679.20(c)(3), NMFS will publish the final 2022 and 2023 harvest specifications after (1) considering comments received within the comment period (see DATES ), (2) consulting with the Council at its December 2021 meeting, (3) considering information presented in the 2022 SIR to the Final EIS that assesses the need to prepare a Supplemental EIS (see ADDRESSES ), and (4) considering information presented in the final 2021 SAFE report prepared for the 2022 and 2023 groundfish fisheries.

For 2022 and 2023, the Board of Fisheries (BOF) for the State of Alaska (State) established the guideline harvest level (GHL) for vessels using pot gear in State waters in the Bering Sea subarea (BS). The 2021 BS GHL was set at 10 percent of the 2021 BS ABC (86 FR 11449, February 25, 2021). The State's pot gear BS GHL will increase one percent annually up to 15 percent of the BS ABC, if at least 90 percent of the GHL is harvested by November 15 of the preceding year. In 2021, 90 percent of the GHL was harvested by November 15, 2021, which triggers a 1 percent increase in the GHL in 2022 and results in a 2022 GHL of 11 percent of the proposed Pacific cod BS ABC. If at least 90 percent of the 2022 BS GHL is not harvested by November 15, 2022, then the 2023 BS GHL will remain at the same percent (11 percent) as the 2022 BS GHL. If 90 percent of the 2022 BS GHL is harvested by November 15, 2022, then the 2023 BS GHL will increase by 1 percent and the 2023 BS TAC will be set to account for the increased BS GHL. Also, for 2022 and 2023, the BOF established an additional GHL for vessels using jig gear in State waters in the BS equal to 45 mt of Pacific cod. The Council and its BSAI Groundfish Plan Team (Plan Team), Scientific and Statistical Committee (SSC), and Advisory Panel (AP) recommended that the sum of all State and Federal water Pacific cod removals from the BS not exceed the proposed ABC recommendations for Pacific cod in the BS. Accordingly, the Council recommended, and NMFS proposes, that the 2022 and 2023 Pacific cod TACs in the BS account for the State's GHLs for Pacific cod caught in State waters.

For 2022 and 2023, the BOF for the State established the GHL in State waters in the Aleutian Islands subarea (AI). In 2021, 90 percent of the GHL has been harvested by November 15, 2021, and results in a 2022 GHL of 39 percent of the proposed Pacific cod AI ABC. The AI GHL may not exceed 39 percent of the AI ABC or 15 million pounds (6,804 mt). In 2022, 39 percent of the proposed 2022 and 2023 AI ABC is 8,034 mt, which exceeds the AI GHL limit of 6,804 mt. The Council and its Plan Team, SSC, and AP recommended that the sum of all State and Federal water Pacific cod removals from the AI not exceed the proposed ABC recommendations for Pacific cod in the AI. Accordingly, the Council recommended, and NMFS proposes, that the 2022 and 2023 Pacific cod TACs in the AI account for the State's GHL of 6,804 mt for Pacific cod caught in State waters.

In October 2021, the Council's SSC, its AP, and the Council reviewed the most recent biological and harvest information on the condition of the BSAI groundfish stocks. The Plan Team compiled and presented this information in the final 2020 SAFE report for the BSAI groundfish fisheries, dated November 2020 (see ADDRESSES ). The final 2021 SAFE report will be available from the same source.

The proposed 2022 and 2023 harvest specifications are based on the final 2022 harvest specifications published in February 2021 (86 FR 11449, February 25, 2021), which were set after consideration of the most recent 2020 SAFE report, and are based on the initial survey data that were presented at the September 2021 Plan Team meeting. The proposed 2022 and 2023 harvest specifications in this action are subject to change in the final harvest specifications to be published by NMFS following the Council's December 2021 meeting.

In November 2021, the Plan Team will update the 2020 SAFE report to include new information collected during 2021, such as NMFS stock surveys, revised stock assessments, and catch data. The Plan Team will compile this information and present the draft 2021 SAFE report at the December 2021 Council meeting. At that meeting, the SSC and the Council will review the 2021 SAFE report, and the Council will approve the 2021 SAFE report. The Council will consider information in the 2021 SAFE report, recommendations from the November 2021 Plan Team meeting and December 2021 SSC and AP meetings, public testimony, and relevant written comments in making its recommendations for the final 2022 and 2023 harvest specifications.

In previous years, the most significant changes (relative to the amount of assessed tonnage of fish) to the Overfishing Levels (OFLs) and ABCs from the proposed to the final harvest specifications have been based on the most recent NMFS stock surveys. These surveys provide updated estimates of stock biomass and spatial distribution, and inform changes to the models or the models' results used for producing stock assessments. Any changes to models used in stock assessments will be recommended by the Plan Team in November 2021, reviewed by the SSC in December 2021, and then included in the final 2021 SAFE report. Model changes can result in changes to final OFLs, ABCs, and TACs. The final 2021 SAFE report will include the most recent information, such as catch data.

The final harvest specification amounts for these stocks are not expected to vary greatly from these proposed harvest specification amounts. If the 2021 SAFE report indicates that the stock biomass trend is increasing for a species, then the final 2022 and 2023 harvest specifications may reflect an increase from the proposed harvest specifications. Conversely, if the 2021 SAFE report indicates that the stock biomass trend is decreasing for a species, then the final 2022 and 2023 harvest specifications may reflect a decrease from the proposed harvest specifications. In addition to changes driven by biomass trends, there may be changes in TACs due to the sum of ABCs exceeding 2 million mt. Since the regulations require TACs to be set to an OY between 1.4 and 2 million mt, the Council may be required to recommend TACs that are lower than the ABCs recommended by the Plan Team and the SSC, if setting all TACs equal to ABCs would cause the sum of TACs to exceed an OY of 2 million mt. Generally, total ABCs greatly exceed 2 million mt in years with a large pollock biomass. For both 2022 and 2023, NMFS anticipates that the sum of the final ABCs will exceed 2 million mt. NMFS expects that the final TACs for the BSAI for both 2022 and 2023 will equal 2 million mt each year.

The proposed 2022 and 2023 OFLs and ABCs are based on the best available biological and scientific information, including projected biomass trends, information on assumed distribution of stock biomass, and revised technical methods used to calculate stock biomass. The FMP specifies a series of six tiers to define OFLs and ABCs based on the level of reliable information available to fishery scientists. Tier 1 represents the highest level of information quality available, while Tier 6 represents the lowest. The proposed 2022 and 2023 TACs are based on the best available biological and socioeconomic information.

In October 2021, the SSC adopted the proposed 2022 and 2023 OFLs and ABCs recommended by the Plan Team for all groundfish. The Council adopted the SSC's OFL and ABC recommendations. The OFL and ABC amounts are unchanged from the final 2022 harvest specifications published in the Federal Register on February 25, 2021 (86 FR 11449). The sum of the proposed 2022 and 2023 ABCs for all assessed groundfish is 2,682,318 mt. The sum of the proposed TACs is 2,000,000 mt.

The Council recommended proposed 2022 and 2023 TACs that are equal to the proposed ABCs for 2022 and 2023 BS sablefish, Central AI Atka mackerel, BS and Eastern AI Atka mackerel, BS Pacific ocean perch, Central AI Pacific ocean perch, Eastern AI Pacific ocean perch, Central AI and Western AI blackspotted and rougheye rockfish, and AI “other rockfish.” The Council recommended proposed TACs less than the respective proposed ABCs for all other species. Section 679.20(a)(5)(iii)(B)( 1 ) requires the AI pollock TAC to be set at 19,000 mt when the AI pollock ABC equals or exceeds 19,000 mt. The Bogoslof pollock TAC is set to accommodate incidental catch amounts. TACs are set so that the sum of the overall TAC does not exceed the BSAI OY.

The proposed groundfish OFLs, ABCs, and TACs are subject to change pending the completion of the final 2021 SAFE report, public comment, and the Council's recommendations for the final 2022 and 2023 harvest specifications during its December 2021 meeting. These proposed amounts are consistent with the biological condition of groundfish stocks as described in the 2020 SAFE report. The proposed ABCs reflect harvest amounts that are less than the specified overfishing levels. The proposed TACs have been adjusted for other biological information and socioeconomic considerations, including maintaining the entire TAC within the required OY range. Pursuant to Section 3.2.3.4.1 of the FMP, the Council could recommend adjusting the final TACs “if warranted on the basis of bycatch considerations, management uncertainty, or socioeconomic considerations; or if required in order to cause the sum of the TACs to fall within the OY range.” Table 1 lists the proposed 2022 and 2023 OFL, ABC, TAC, initial TAC (ITAC), and CDQ amounts for groundfish for the BSAI. The proposed apportionment of TAC amounts among fisheries and seasons is discussed below.

Section 679.20(b)(1)(i) requires NMFS to reserve 15 percent of the TAC for each target species category (except for pollock, hook-and-line and pot gear allocation of sablefish, and Amendment 80 species) in a nonspecified reserve. Section 679.20(b)(1)(ii)(B) requires that NMFS allocate 20 percent of the hook-and-line or pot gear allocation of sablefish to the fixed gear sablefish CDQ reserve for each subarea. Section 679.20(b)(1)(ii)(D) requires that NMFS allocate 7.5 percent of the trawl gear allocation of sablefish and 10.7 percent of BS Greenland turbot and BSAI arrowtooth flounder TACs to the respective CDQ reserves. Section 679.20(b)(1)(ii)(C) requires that NMFS allocate 10.7 percent of the TACs for Atka mackerel, AI Pacific ocean perch, yellowfin sole, rock sole, flathead sole, and Pacific cod to the respective CDQ reserves. Sections 679.20(a)(5)(i)(A) and 679.31(a) require allocation of 10 percent of the BS pollock TAC to the pollock CDQ directed fishing allowance (DFA). Sections 679.20(a)(5)(iii)(B)( 2 )( i ) and 679.31(a) require 10 percent of the AI pollock TAC be allocated to the pollock CDQ DFA. The entire Bogoslof District pollock TAC is allocated as an ICA pursuant to § 679.20(a)(5)(ii) because the Bogoslof District is closed to directed fishing for pollock by regulation (§ 679.22(a)(7)(B)). With the exception of the hook-and-line or pot gear sablefish CDQ reserve, the regulations do not further apportion the CDQ reserves by gear.

Pursuant to § 679.20(a)(5)(i)(A)( 1 ), NMFS proposes a pollock ICA of 4 percent of the BS pollock TAC after subtracting the 10 percent CDQ DFA. This allowance is based on NMFS's examination of the pollock incidentally retained and discarded catch, including the incidental catch by CDQ vessels, in target fisheries other than pollock from 2000 through 2021. During this 22-year period, the pollock incidental catch ranged from a low of 2.2 percent in 2006 to a high of 4.6 percent in 2014, with a 22-year average of 3 percent. Pursuant to § 679.20(a)(5)(iii)(B)( 2 )( i ) and ( ii ), NMFS proposes a pollock ICA of 15 percent or 2,500 mt of the AI pollock TAC after subtracting the 10 percent CDQ DFA. This allowance is based on NMFS's examination of the pollock incidental catch, including the incidental catch by CDQ vessels, in target fisheries other than pollock from 2003 through 2021. During this 19-year period, the incidental catch of pollock ranged from a low of 5 percent in 2006 to a high of 17 percent in 2014, with a 19-year average of 9 percent.

Pursuant to § 679.20(a)(8) and (10), NMFS proposes ICAs of 3,000 mt of flathead sole, 6,000 mt of rock sole, 4,000 mt of yellowfin sole, 10 mt of Western Aleutian District Pacific ocean perch, 60 mt of Central Aleutian District Pacific ocean perch, 100 mt of Eastern Aleutian District Pacific ocean perch, 20 mt of Western Aleutian District Atka mackerel, 75 mt of Central Aleutian District Atka mackerel, and 800 mt of Eastern Aleutian District and BS Atka mackerel, after subtracting the 10.7 percent CDQ reserves. These ICAs are based on NMFS's examination of the incidental catch in other target fisheries from 2003 through 2021.

The regulations do not designate the remainder of the nonspecified reserve by species or species group. Any amount of the reserve may be apportioned to a target species that contributed to the nonspecified reserve during the year, provided that such apportionments are consistent with § 679.20(a)(3) and do not result in overfishing (see § 679.20(b)(1)(i)).

Section 679.20(a)(5)(i)(A) requires that BS pollock TAC be apportioned as a DFA, after subtracting 10 percent for the CDQ Program and 4 percent for the ICA, as follows: 50 percent to the inshore sector, 40 percent to the catcher/processor (CP) sector, and 10 percent to the mothership sector. In the BS, 45 percent of the DFA is allocated to the A season (January 20 to June 10), and 55 percent of the DFA is allocated to the B season (June 10 to November 1) (§§ 679.20(a)(5)(i)(B)( 1 ) and 679.23(e)(2)). The AI directed pollock fishery allocation to the Aleut Corporation is the amount of pollock TAC remaining in the AI after subtracting 1,900 mt for the CDQ DFA (10 percent), and 2,500 mt for the ICA (§ 679.20(a)(5)(iii)(B)( 2 )). In the AI, the total A season apportionment of the pollock TAC (including the AI directed fishery allocation, the CDQ DFA, and the ICA) may equal up to 40 percent of the ABC for AI pollock, and the remainder of the pollock TAC is allocated to the B season (§ 679.20(a)(5)(iii)(B)( 3 )). Table 2 lists these proposed 2022 and 2023 amounts.

Section 679.20(a)(5)(iii)(B)( 6 ) sets harvest limits for pollock in the A season (January 20 to June 10) in Areas 543, 542, and 541. In Area 543, the A season pollock harvest limit is no more than 5 percent of the AI pollock ABC. In Area 542, the A season pollock harvest limit is no more than 15 percent of the AI pollock ABC. In Area 541, the A season pollock harvest limit is no more than 30 percent of the AI pollock ABC.

Section 679.20(a)(5)(i)(A)( 4 ) includes several specific requirements regarding BS pollock allocations. First, it requires that 8.5 percent of the pollock allocated to the CP sector be available for harvest by AFA catcher vessels (CVs) with CP sector endorsements, unless the Regional Administrator receives a cooperative contract that allows the distribution of harvest among AFA CPs and AFA CVs in a manner agreed to by all members. Second, AFA CPs not listed in the AFA are limited to harvesting not more than 0.5 percent of the pollock allocated to the CP sector. Table 2 lists the proposed 2022 and 2023 allocations of pollock TAC. Tables 13, 14, and 15 list the AFA CP and CV harvesting sideboard limits. The BS inshore pollock cooperative and open access sector allocations are based on the submission of AFA inshore cooperative applications due to NMFS on December 1 of each calendar year. Because AFA inshore cooperative applications for 2022 have not been submitted to NMFS, and NMFS therefore cannot calculate 2022 allocations, NMFS has not included inshore cooperative tables in these proposed harvest specifications. NMFS will post the 2022 AFA inshore pollock cooperative and open access sector allocations on the Alaska Region website at https://www.fisheries.noaa.gov/alaska/sustainable-fisheries/alaska-fisheries-management-reports prior to the start of the fishing year on January 1, 2022, based on the harvest specifications effective on that date.

Table 2 also lists proposed seasonal apportionments of pollock and harvest limits within the Steller Sea Lion Conservation Area (SCA). The harvest of pollock within the SCA, as defined at § 679.22(a)(7)(vii), is limited to no more than 28 percent of the annual pollock DFA before 12:00 noon, April 1, as provided in § 679.20(a)(5)(i)(C). The A season pollock SCA harvest limit will be apportioned to each sector in proportion to each sector's allocated percentage of the DFA.

Section 679.20(a)(8) allocates the Atka mackerel TACs to the Amendment 80 and BSAI trawl limited access sectors, after subtracting the CDQ reserves, ICAs for the BSAI trawl limited access sector and non-trawl gear sectors, and the jig gear allocation (Table 3). The percentage of the ITAC for Atka mackerel allocated to the Amendment 80 and BSAI trawl limited access sectors is listed in Table 33 to 50 CFR part 679 and in § 679.91. Pursuant to § 679.20(a)(8)(i), up to 2 percent of the Eastern Aleutian District and Bering Sea subarea Atka mackerel TAC may be allocated to vessels using jig gear. The percent of this allocation is recommended annually by the Council based on several criteria, including the anticipated harvest capacity of the jig gear fleet. The Council recommended, and NMFS proposes, a 0.5 percent allocation of the Atka mackerel TAC in the Eastern Aleutian District and Bering Sea subarea to jig gear in 2022 and 2023.

Section 679.20(a)(8)(ii)(A) apportions the Atka mackerel TAC into two equal seasonal allowances. Section 679.23(e)(3) sets the first seasonal allowance for directed fishing with trawl gear from January 20 through June 10 (A season), and the second seasonal allowance from June 10 through December 31 (B season). Section 679.23(e)(4)(iii) applies Atka mackerel seasons to trawl CDQ Atka mackerel fishing. The ICA and jig gear allocations are not apportioned by season.

Sections 679.20(a)(8)(ii)(C)( 1 )( i ) and ( ii ) limit Atka mackerel catch within waters 0 nautical miles (nmi) to 20 nmi of Steller sea lion sites listed in Table 6 to 50 CFR part 679 and located west of 178° W longitude to no more than 60 percent of the annual TACs in Areas 542 and 543, and equally divides the annual TAC between the A and B seasons as defined at § 679.23(e)(3). Section 679.20(a)(8)(ii)(C)( 2 ) requires that the annual TAC in Area 543 will be no more than 65 percent of the ABC in Area 543. Section 679.20(a)(8)(ii)(D) requires that any unharvested Atka mackerel A season allowance that is added to the B season be prohibited from being harvested within waters 0 nm to 20 nmi of Steller sea lion sites listed in Table 6 to 50 CFR part 679 and located in Areas 541, 542, and 543.

Table 3 lists the proposed 2022 and 2023 Atka mackerel season allowances, area allowances, and the sector allocations. One Amendment 80 cooperative has formed for the 2022 fishing year. Because all Amendment 80 vessels are part of the cooperative, no allocation to the Amendment 80 limited access sector is required for 2022. The 2023 allocations for Atka mackerel between Amendment 80 cooperatives and the Amendment 80 limited access sector will not be known until eligible participants apply for participation in the program by November 1, 2022. NMFS will post the 2023 Amendment 80 cooperatives and Amendment 80 limited access sector allocations on the Alaska Region website at https://www.fisheries.noaa.gov/alaska/sustainable-fisheries/sustainable-fisheries-alaska prior to the start of the fishing year on January 1, 2023, based on the harvest specifications effective on that date.

The Council separated BS and AI subarea OFLs, ABCs, and TACs for Pacific cod in 2014 (79 FR 12108, March 4, 2014). Section 679.20(b)(1)(ii)(C) allocates 10.7 percent of the BS TAC and the AI TAC to the CDQ Program. After CDQ allocations have been deducted from the respective BS and AI Pacific cod TACs, the remaining BS and AI Pacific cod TACs are combined for calculating further BSAI Pacific cod sector allocations. If the non-CDQ Pacific cod TAC is or will be reached in either the BS or the AI subareas, NMFS will prohibit directed fishing for non-CDQ Pacific cod in that subarea, as provided in § 679.20(d)(1)(iii).

Section 679.20(a)(7)(i) and (ii) allocate to the non-CDQ sectors the combined BSAI Pacific cod TAC, after subtracting 10.7 percent for the CDQ Program, as follows: 1.4 percent to vessels using jig gear, 2.0 percent to hook-and-line or pot CVs less than 60 ft (18.3 m) length overall (LOA), 0.2 percent to hook-and-line CVs greater than or equal to 60 ft (18.3 m) LOA, 48.7 percent to hook-and-line CPs, 8.4 percent to pot CVs greater than or equal to 60 ft (18.3 m) LOA, 1.5 percent to pot CPs, 2.3 percent to AFA trawl CPs, 13.4 percent to the Amendment 80 sector, and 22.1 percent to trawl CVs. The BSAI ICA for the hook-and-line and pot sectors will be deducted from the aggregate portion of BSAI Pacific cod TAC allocated to the hook-and-line and pot sectors. For 2022 and 2023, the Regional Administrator proposes a BSAI ICA of 400 mt, based on anticipated incidental catch by these sectors in other fisheries.

The BSAI ITAC allocation of Pacific cod to the Amendment 80 sector is established in Table 33 to 50 CFR part 679 and § 679.91. One Amendment 80 cooperative has formed for the 2022 fishing year. Because all Amendment 80 vessels are part of the cooperative, no allocation to the Amendment 80 limited access sector is required for 2022. The 2023 allocations for Pacific cod between Amendment 80 cooperatives and the Amendment 80 limited access sector will not be known until eligible participants apply for participation in the program by November 1, 2022. NMFS will post the 2023 Amendment 80 cooperatives and Amendment 80 limited access allocations on the Alaska Region website at https://www.fisheries.noaa.gov/alaska/sustainable-fisheries/sustainable-fisheries-alaska prior to the start of the fishing year on January 1, 2023, based on the harvest specifications effective on that date.

The sector allocations of Pacific cod are apportioned into seasonal allowances to disperse the Pacific cod fisheries over the fishing year (see §§ 679.20(a)(7)(i)(B), 679.20 (a)(7)(iv)(A), and 679.23(e)(5)). In accordance with § 679.20(a)(7)(iv)(B) and (C), any unused portion of a Pacific cod seasonal allowance for any sector, except the jig sector, will become available at the beginning of that sector's next seasonal allowance.

Section 679.20(a)(7)(vii) requires that the Regional Administrator establish an Area 543 Pacific cod harvest limit based on Pacific cod abundance in Area 543 as determined by the annual stock assessment process. Based on the 2020 stock assessment, the Regional Administrator has preliminarily determined for 2022 and 2023 that the estimated amount of Pacific cod abundance in Area 543 is 15.7 percent of total AI abundance. NMFS will first subtract the State GHL Pacific cod amount from the AI Pacific cod ABC. Then NMFS will determine the harvest limit in Area 543 by multiplying the percentage of Pacific cod estimated in Area 543 (15.7 percent) by the remaining ABC for AI Pacific cod. Based on these calculations, which rely on the 2020 stock assessment, the proposed Area 543 harvest limit is 2,166 mt. However, the final Area 543 harvest limit could change if the Pacific cod abundance in Area 543 changes based on the stock assessment in the final 2021 SAFE report.

On March 21, 2019, the final rule adopting Amendment 113 to the FMP (81 FR 84434, November 23, 2016) was vacated by the U.S. District Court for the District of Columbia ( Groundfish Forum v. Ross, No. 16-2495 (D.D.C. March 21, 2019)), and the corresponding regulations implementing Amendment 113 are no longer in effect. Therefore, this proposed rule is not specifying amounts for the AI Pacific Cod Catcher Vessel Harvest Set-Aside Program (see §  679.20(a)(7)(viii)).

Table 4 lists the CDQ and non-CDQ seasonal allowances by gear based on the proposed 2022 and 2023 Pacific cod TACs; the sector allocations of Pacific cod; and the seasons set forth at § 679.23(e)(5).

Section 679.20(a)(4)(iii) and (iv) require allocation of sablefish TAC for the BS and AI between trawl gear and hook-and-line or pot gear. Gear allocations of the sablefish TAC for the BS are 50 percent for trawl gear and 50 percent for hook-and-line or pot gear. Gear allocations of the TAC for the AI are 25 percent for trawl gear and 75 percent for hook-and-line or pot gear. Section 679.20(b)(1)(ii)(B) requires that NMFS apportion 20 percent of the hook-and-line or pot gear allocation of sablefish TAC to the CDQ reserve for each subarea. Also, § 679.20(b)(1)(ii)(D)( 1 ) requires that 7.5 percent of the trawl gear allocation of sablefish TAC from the nonspecified reserve, established under § 679.20(b)(1)(i), be apportioned to the CDQ reserve. The Council recommended that only trawl sablefish TAC be established biennially. The harvest specifications for the hook-and-line or pot gear sablefish Individual Fishing Quota (IFQ) fisheries are limited to the 2022 fishing year to ensure those fisheries are conducted concurrently with the halibut IFQ fishery. Concurrent sablefish and halibut IFQ fisheries reduce the potential for discards of halibut and sablefish in those fisheries. The sablefish IFQ fisheries remain closed at the beginning of each fishing year until the final harvest specifications for the sablefish IFQ fisheries are in effect. Table 5 lists the proposed 2022 and 2023 gear allocations of the sablefish TAC and CDQ reserve amounts.

Section 679.20(a)(10)(i) and (ii) require that NMFS allocate AI Pacific ocean perch, and BSAI flathead sole, rock sole, and yellowfin sole TACs between the Amendment 80 sector and the BSAI trawl limited access sector, after subtracting 10.7 percent for the CDQ reserves and amounts for ICAs for the BSAI trawl limited access sector and vessels using non-trawl gear. The allocation of the ITAC for AI Pacific ocean perch, and BSAI flathead sole, rock sole, and yellowfin sole to the Amendment 80 sector is established in Tables 33 and 34 to 50 CFR part 679 and in § 679.91.

One Amendment 80 cooperative has formed for the 2022 fishing year. Because all Amendment 80 vessels are part of the cooperative, no allocation to the Amendment 80 limited access sector is required for 2022. The 2023 allocations for Amendment 80 species between Amendment 80 cooperatives and the Amendment 80 limited access sector will not be known until eligible participants apply for participation in the program by November 1, 2022. NMFS will post the 2023 Amendment 80 cooperatives and Amendment 80 limited access sector allocations on the Alaska Region website at https://www.fisheries.noaa.gov/alaska/sustainable-fisheries/sustainable-fisheries-alaska prior to the start of the fishing year on January 1, 2023, based on the harvest specifications effective on that date. Table 6 lists the proposed 2022 and 2023 allocations of the AI Pacific ocean perch, and BSAI flathead sole, rock sole, and yellowfin sole TACs.

Section 679.2 defines the ABC surplus for flathead sole, rock sole, and yellowfin sole as the difference between the annual ABC and TAC for each species. Section 679.20(b)(1)(iii) establishes ABC reserves for flathead sole, rock sole, and yellowfin sole. The ABC surpluses and the ABC reserves are necessary to mitigate the operational variability, environmental conditions, and economic factors that may constrain the CDQ groups and the Amendment 80 cooperatives from achieving, on a continuing basis, the optimum yield in the BSAI groundfish fisheries. NMFS, after consultation with the Council, may set the ABC reserve at or below the ABC surplus for each species, thus maintaining the TAC below ABC limits. An amount equal to 10.7 percent of the ABC reserves will be allocated as CDQ ABC reserves for flathead sole, rock sole, and yellowfin sole. Section 679.31(b)(4) establishes the annual allocations of CDQ ABC reserves among the CDQ groups. The Amendment 80 ABC reserves are the ABC reserves minus the CDQ ABC reserves and are allocated to each Amendment 80 cooperative pursuant to § 679.91(i)(2), which establishes each Amendment 80 cooperative ABC reserve to be the ratio of each cooperatives' quota share units and the total Amendment 80 quota share units, multiplied by the Amendment 80 ABC reserve for each respective species. Table 7 lists the proposed 2022 and 2023 ABC surplus and ABC reserves for BSAI flathead sole, rock sole, and yellowfin sole.

Section 679.21(b), (e), (f), and (g) set forth the BSAI PSC limits. Pursuant to § 679.21(b)(1), the annual BSAI halibut PSC limits total 3,515 mt. Section 679.21(b)(1) allocates 315 mt of the halibut PSC limit as the PSQ reserve for use by the groundfish CDQ Program, 1,745 mt of the halibut PSC limit for the Amendment 80 sector, 745 mt of the halibut PSC limit for the BSAI trawl limited access sector, and 710 mt of the halibut PSC limit for the BSAI non-trawl sector.

Section 679.21(b)(1)(iii)(A) and (B) authorize apportionment of the BSAI non-trawl halibut PSC limit into PSC allowances among six fishery categories, and § 679.21(b)(1)(ii)(A) and (B), (e)(3)(i)(B), and (e)(3)(iv) require apportionment of the BSAI trawl limited access sector's halibut and crab PSC limits into PSC allowances among seven fishery categories. Table 10 lists the proposed fishery PSC allowances for the BSAI trawl limited access sector fisheries, and Table 11 lists the proposed fishery PSC allowances for the non-trawl fisheries.

Pursuant to Section 3.6 of the FMP, the Council recommends, and NMFS proposes, that certain specified non-trawl fisheries be exempt from the halibut PSC limit. As in past years, after consultation with the Council, NMFS proposes to exempt the pot gear fishery, the jig gear fishery, and the sablefish IFQ hook-and-line gear fishery categories from halibut bycatch restrictions for the following reasons: (1) The pot gear fisheries have low halibut bycatch mortality; (2) NMFS estimates halibut mortality for the jig gear fleet to be negligible because of the small size of the fishery and the selectivity of the gear; and (3) the sablefish and halibut IFQ fisheries have low halibut bycatch mortality because the IFQ Program requires legal-size halibut to be retained by vessels using fixed gear if a halibut IFQ permit holder or a hired master is aboard and is holding unused halibut IFQ for that vessel category and the IFQ regulatory area in which the vessel is operating (§ 679.7(f)(11)).

As of October 18, 2021, total groundfish catch for the pot gear fishery in the BSAI was 32,658 mt, with an associated halibut bycatch mortality of 7 mt. The 2021 jig gear fishery harvested about 20 mt of groundfish. Most vessels in the jig gear fleet are exempt from observer coverage requirements. As a result, observer data are not available on halibut bycatch in the jig gear fishery. As mentioned above, NMFS estimates a negligible amount of halibut bycatch mortality because of the selective nature of jig gear and the low mortality rate of halibut caught with jig gear and released.

Under § 679.21(f)(2), NMFS annually allocates portions of either 33,318, 45,000, 47,591, or 60,000 Chinook salmon PSC limits among the AFA sectors, depending on past bycatch performance, on whether Chinook salmon bycatch incentive plan agreements (IPAs) are formed, and on whether NMFS determines it is a low Chinook salmon abundance year. NMFS will determine that it is a low Chinook salmon abundance year when abundance of Chinook salmon in western Alaska is less than or equal to 250,000 Chinook salmon. The State provides to NMFS an estimate of Chinook salmon abundance using the 3-System Index for western Alaska, based on the Kuskokwim, Unalakleet, and Upper Yukon aggregate stock grouping.

If an AFA sector participates in an approved IPA and has not exceeded its performance standard under § 679.21(f)(6), and if it is not a low Chinook salmon abundance year, then NMFS will allocate a portion of the 60,000 Chinook salmon PSC limit to that sector as specified in § 679.21(f)(3)(iii)(A). If no IPA is approved, or if the sector has exceeded its performance standard under § 679.21(f)(6), and if it is not a low abundance year, then NMFS will allocate a portion of the 47,591 Chinook salmon PSC limit to that sector as specified in § 679.21(f)(3)(iii)(C). If an AFA sector participates in an approved IPA and has not exceeded its performance standard under § 679.21(f)(6) in a low abundance year, then NMFS will allocate a portion of the 45,000 Chinook salmon PSC limit to that sector as specified in § 679.21(f)(3)(iii)(B). If no IPA is approved, or if the sector has exceeded its performance standard under § 679.21(f)(6), and if in a low abundance year, then NMFS will allocate a portion of the 33,318 Chinook salmon PSC limit to that sector as specified in § 679.21(f)(3)(iii)(D).

NMFS has determined that 2021 was a low Chinook salmon abundance year, based on the State's estimate that Chinook salmon abundance in western Alaska is less than 250,000 Chinook salmon. Therefore, in 2022, the Chinook salmon PSC limit is 45,000 Chinook salmon, allocated to each sector as specified in § 679.21(f)(3)(iii)(B). The AFA sector Chinook salmon allocations are also seasonally apportioned with 70 percent of the allocation for the A season pollock fishery, and 30 percent of the allocation for the B season pollock fishery (§§ 679.21(f)(3)(i) and 679.23(e)(2)). In 2022, the Chinook salmon bycatch performance standard under § 679.21(f)(6) is 33,318 Chinook salmon, allocated to each sector as specified in § 679.21(f)(3)(iii)(D). NMFS publishes the approved IPAs, allocations, and reports at https://www.fisheries.noaa.gov/alaska/sustainable-fisheries/sustainable-fisheries-alaska.

Section 679.21(g)(2)(i) specifies 700 fish as the 2022 and 2023 Chinook salmon PSC limit for the AI pollock fishery. Section 679.21(g)(2)(ii) allocates 7.5 percent, or 53 Chinook salmon, as the AI PSQ reserve for the CDQ Program, and allocates the remaining 647 Chinook salmon to the non-CDQ fisheries.

Section 679.21(f)(14)(i) specifies 42,000 fish as the 2022 and 2023 non-Chinook salmon PSC limit for vessels using trawl gear from August 15 through October 14 in the Catcher Vessel Operational Area (CVOA). Section 679.21(f)(14)(ii) allocates 10.7 percent, or 4,494 non-Chinook salmon, in the CVOA as the PSQ reserve for the CDQ Program, and allocates the remaining 37,506 non-Chinook salmon in the CVOA to the non-CDQ fisheries.

PSC limits for crab and herring are specified annually based on abundance and spawning biomass. Due to the lack of new information as of October 2021 regarding herring PSC limits and apportionments, the Council recommended, and NMFS proposes, basing the proposed herring 2022 and 2023 PSC limits and apportionments on the 2020 survey data. The Council will reconsider these amounts in December 2021. Section 679.21(e)(3)(i)(A)( 1 ) allocates 10.7 percent of each trawl gear PSC limit specified for crab as a PSQ reserve for use by the groundfish CDQ Program.

Based on the most recent (2021) survey data, the red king crab mature female abundance is estimated at 6.432 million red king crabs, and the effective spawning biomass is estimated at 20,862 million lbs (9,463 mt). Based on the criteria set out at § 679.21(e)(1)(i), the proposed 2022 and 2023 PSC limit of red king crab in Zone 1 for trawl gear is 32,000 animals. This limit derives from the mature female abundance estimate below 8.4 million red king crab.

Section 679.21(e)(3)(ii)(B)( 2 ) establishes criteria under which NMFS must specify an annual red king crab bycatch limit for the Red King Crab Savings Subarea (RKCSS) if the State has established a GHL fishery for red king crab in the Bristol Bay area in the previous year. The State's Department of Fish and Game (ADF&G) and NMFS have reviewed the final 2021 NMFS trawl survey data for the Bristol Bay red king crab stock. The stock is estimated to be below the regulatory threshold for opening a fishery. Therefore, the State did not establish a GHL for the Bristol Bay red king crab fishery, and the fishery will remain closed for the 2021/2022 crab season. Also, NMFS and the Council will not specify an amount of the red king crab bycatch limit, annually established under § 679.21(e)(1)(i), for the RKCSS. Therefore, NMFS will close directed fishing for vessels using non-pelagic trawl gear in the RKCSS for 2022. NMFS and the Council will assess the RKCSS closure for 2023 if the State's ADF&G establishes a GHL for the 2022/2023 red king crab fishery in the Bristol Bay area.

Based on the most recent (2021) survey data from the NMFS annual bottom trawl survey, Tanner crab ( Chionoecetes bairdi ) abundance is estimated at 385 million animals. Pursuant to criteria set out at § 679.21(e)(1)(ii), the calculated 2022 and 2023 C. bairdi crab PSC limit for trawl gear is 830,000 animals in Zone 1, and 2,520,000 animals in Zone 2. The limit in Zone 1 is based on the abundance of C. bairdi (estimated at 385 million animals), which is over 270 million to 400 million animals. The limit in Zone 2 is based on the abundance of C. bairdi (estimated at 385 million animals), which is over 290 million to 400 million animals.

Pursuant to § 679.21(e)(1)(iii), the PSC limit for trawl gear for snow crab ( C. opilio ) is based on total abundance as indicated by the NMFS annual bottom trawl survey. The C. opilio crab PSC limit in the C. opilio bycatch limitation zone (COBLZ) is set at 0.1133 percent of the Bering Sea abundance index minus 150,000 crabs, unless a minimum or maximum PSC limit applies. Based on the most recent (2021) survey estimate of 1.42 billion animals, the calculated C. opilio crab PSC limit is 1,608,860 animals. Because 0.1133 percent multiplied by the total abundance is less than 4.5 million, the minimum PSC limit applies and the PSC limit will be 4.350 million animals.

Pursuant to § 679.21(e)(1)(v), the PSC limit of Pacific herring caught while conducting any trawl operation for BSAI groundfish is 1 percent of the annual eastern Bering Sea herring biomass. The best estimate of 2022 and 2023 herring biomass is 272,281 mt. This amount was developed by the Alaska Department of Fish and Game based on biomass for spawning aggregations. Therefore, the herring PSC limit proposed for 2022 and 2023 is 2,723 mt for all trawl gear as listed in Tables 8 and 9.

Section 679.21(e)(3)(i)(A) requires that PSQ reserves be subtracted from the total trawl PSC limits. The 2022 crab and halibut PSC limits assigned to the Amendment 80 and BSAI trawl limited access sectors are listed in Table 35 to 50 CFR part 679. The resulting proposed allocations of crab and halibut PSC limits to CDQ PSQ, the Amendment 80 sector, and the BSAI trawl limited access sector are listed in Table 8. Pursuant to §§  679.21(b)(1)(i), 679.21(e)(3)(vi), and 679.91(d) through (f), crab and halibut trawl PSC limits assigned to the Amendment 80 sector are then further allocated to Amendment 80 cooperatives as cooperative quotas. Crab and halibut PSC cooperative quotas assigned to Amendment 80 cooperatives are not allocated to specific fishery categories.

One Amendment 80 cooperative has formed for the 2022 fishing year. Because all Amendment 80 vessels are part of the cooperative, no PSC limit allocation to the Amendment 80 limited access sector is required for 2022. The 2023 PSC limit allocations between Amendment 80 cooperatives and the Amendment 80 limited access sector will not be known until eligible participants apply for participation in the program by November 1, 2022. NMFS will post the 2023 Amendment 80 cooperatives and Amendment 80 limited access sector allocations on the Alaska Region website at https://www.fisheries.noaa.gov/alaska/sustainable-fisheries/sustainable-fisheries-alaska prior to the start of the fishing year on January 1, 2023, based on the harvest specifications effective on that date.

Section 679.21(b)(2) and (e)(5) authorize NMFS, after consulting with the Council, to establish seasonal apportionments of halibut and crab PSC amounts for the BSAI non-trawl, BSAI trawl limited access, and Amendment 80 limited access sectors to maximize the ability of the fleet to harvest the available groundfish TAC and to minimize bycatch. The factors considered are (1) seasonal distribution of prohibited species, (2) seasonal distribution of target groundfish species relative to prohibited species distribution, (3) prohibited species bycatch needs on a seasonal basis relevant to prohibited species biomass and expected catches of target groundfish species, (4) expected variations in bycatch rates throughout the year, (5) expected changes in directed groundfish fishing seasons, (6) expected start of fishing effort, and (7) economic effects of establishing seasonal prohibited species apportionments on segments of the target groundfish industry. Based on this criteria, the Council recommended, and NMFS proposes, the seasonal PSC apportionments in Tables 10 and 11 to maximize harvest among gear types, fisheries, and seasons, while minimizing bycatch of PSC.

To monitor halibut bycatch mortality allowances and apportionments, the Regional Administrator uses observed halibut incidental catch rates, halibut discard mortality rates (DMRs), and estimates of groundfish catch to project when a fishery's halibut bycatch mortality allowance or seasonal apportionment is reached. Halibut incidental catch rates are based on observers' estimates of halibut incidental catch in the groundfish fishery. DMRs are estimates of the proportion of incidentally caught halibut that do not survive after being returned to the sea. The cumulative halibut mortality that accrues to a particular halibut PSC limit is the product of a DMR multiplied by the estimated halibut PSC. DMRs are estimated using the best scientific information available in conjunction with the annual BSAI stock assessment process. The DMR methodology and findings are included as an appendix to the annual BSAI groundfish SAFE report.

In 2016, the DMR estimation methodology underwent revisions per the Council's directive. An interagency halibut working group (International Pacific Halibut Commission, Council, and NMFS staff) developed improved estimation methods that have undergone review by the Plan Team, SSC, and the Council. A summary of the revised methodology is included in the BSAI proposed 2017 and 2018 harvest specifications (81 FR 87863, December 6, 2016), and the comprehensive discussion of the working group's statistical methodology is available from the Council (see ADDRESSES ). The DMR working group's revised methodology is intended to improve estimation accuracy, transparency, and transferability used for calculating DMRs. The working group will continue to consider improvements to the methodology used to calculate halibut mortality, including potential changes to the reference period (the period of data used for calculating the DMRs). Future DMRs may change based on additional years of observer sampling, which could provide more recent and accurate data and which could improve the accuracy of estimation and progress on methodology. The methodology will continue to ensure that NMFS is using DMRs that more accurately reflect halibut mortality, which will inform the different sectors of their estimated halibut mortality and allow specific sectors to respond with methods that could reduce mortality and, eventually, the DMR for that sector.

In October 2021, the Council recommended halibut DMRs derived from the revised methodology for the proposed 2022 and 2023 DMRs. The proposed 2022 and 2023 DMRs use an updated 2-year reference period. Comparing the proposed 2022 and 2023 DMRs to the final DMRs from the 2021 and 2022 harvest specifications, the DMR for pelagic trawl gear remained at 100 percent, the DMR for motherships and CPs using non-pelagic trawl gear remained at 84 percent, the DMR for CVs using non-pelagic trawl gear increased to 62 percent from 59 percent, the DMR for CPs using hook-and-line gear increased to 10 percent from 9 percent, the DMR for CVs using hook-and-line gear increased to 10 percent from 9 percent, and the DMR for pot gear increased to 33 percent from 32 percent. Table 12 lists the proposed 2022 and 2023 DMRs.

Pursuant to § 679.64(a), the Regional Administrator is responsible for restricting the ability of listed AFA CPs to engage in directed fishing for groundfish species other than pollock to protect participants in other groundfish fisheries from adverse effects resulting from the AFA fishery and from fishery cooperatives in the directed pollock fishery. These restrictions are set out as sideboard limits on catch. On February 8, 2019, NMFS published a final rule (84 FR 2723) that implemented regulations to prohibit non-exempt AFA CPs from directed fishing for groundfish species or species groups subject to sideboard limits (see § 679.20(d)(1)(iv)(D) and Table 54 to 50 CFR part 679). NMFS proposes to exempt AFA CPs from a yellowfin sole sideboard limit pursuant to § 679.64(a)(1)(v) because the proposed 2022 and 2023 aggregate ITAC of yellowfin sole assigned to the Amendment 80 sector and BSAI trawl limited access sector is greater than 125,000 mt.

Section 679.64(a)(2) and Tables 40 and 41 to 50 CFR part 679 establish a formula for calculating PSC sideboard limits for halibut and crab caught by listed AFA CPs. The basis for these sideboard limits is described in detail in the final rules implementing the major provisions of the AFA (67 FR 79692, December 30, 2002) and Amendment 80 (72 FR 52668, September 14, 2007). PSC species listed in Table 13 that are caught by listed AFA CPs participating in any groundfish fishery other than pollock will accrue against the proposed 2022 and 2023 PSC sideboard limits for the listed AFA CPs. Section 679.21(b)(4)(iii), (e)(3)(v), and (e)(7) authorize NMFS to close directed fishing for groundfish other than pollock for listed AFA CPs once a proposed 2022 or 2023 PSC sideboard limit listed in Table 13 is reached. Pursuant to § 679.21(b)(1)(ii)(C) and (e)(3)(ii)(C), halibut or crab PSC by listed AFA CPs while fishing for pollock will accrue against the PSC allowances annually specified for the pollock/Atka mackerel/“other species” fishery categories, according to § 679.21(b)(1)(ii)(B) and (e)(3)(iv).

Pursuant to §  679.64(b), the Regional Administrator is responsible for restricting the ability of AFA CVs to engage in directed fishing for groundfish species other than pollock to protect participants in other groundfish fisheries from adverse effects resulting from the AFA and from fishery cooperatives in the pollock directed fishery. On February 8, 2019, NMFS published a final rule (84 FR 2723) that implemented regulations to prohibit non-exempt AFA CVs from directed fishing for a majority of the groundfish species or species groups subject to sideboard limits (see § 679.20(d)(1)(iv)(D) and Table 55 to 50 CFR part 679). The remainder of the sideboard limits for non-exempt AFA CVs are proposed in Table 14.

Section 679.64(b)(3) and (b)(4) establish formulas for setting AFA CV groundfish and halibut and crab PSC sideboard limits for the BSAI. The basis for these sideboard limits is described in detail in the final rules implementing the major provisions of the AFA (67 FR 79692, December 30, 2002) and Amendment 80 (72 FR 52668, September 14, 2007). NMFS proposes to exempt AFA CVs from a yellowfin sole sideboard limit pursuant to § 679.64(b)(6) because the proposed 2022 and 2023 aggregate ITAC of yellowfin sole assigned to the Amendment 80 sector and BSAI trawl limited access sector is greater than 125,000 mt. Table 14 lists the proposed 2022 and 2023 AFA CV sideboard limits.

Halibut and crab PSC limits listed in Table 15 that are caught by AFA CVs participating in any groundfish fishery other than pollock will accrue against the 2022 and 2023 PSC sideboard limits for the AFA CVs. Section 679.21(b)(4)(iii), (e)(3)(v), and (e)(7) authorize NMFS to close directed fishing for groundfish other than pollock for AFA CVs once a proposed 2022 and 2023 PSC sideboard limit listed in Table 15 is reached. Pursuant to § 679.21(b)(1)(ii)(C) and (e)(3)(ii)(C), halibut or crab PSC by AFA CVs while fishing for pollock will accrue against the PSC allowances annually specified for the pollock/Atka mackerel/“other species” fishery categories under § 679.21(b)(1)(ii)(B) and (e)(3)(iv).

NMFS has determined that the proposed harvest specifications are consistent with the FMP and preliminarily determined that the proposed harvest specifications are consistent with the Magnuson-Stevens Act and other applicable laws, subject to further review after public comment.

This action is authorized under 50 CFR 679.20 and is exempt from review under Executive Order 12866.

NMFS prepared an EIS for the Alaska groundfish harvest specifications and alternative harvest strategies (see ADDRESSES ) and made it available to the public on January 12, 2007 (72 FR 1512). On February 13, 2007, NMFS issued the ROD for the Final EIS. A SIR is being prepared for the final 2022 and 2023 harvest specifications to provide a subsequent assessment of the action and to address the need to prepare a Supplemental EIS (40 CFR 1501.11(b); § 1502.9(d)(1)). Copies of the Final EIS, ROD, and annual SIRs for this action are available from NMFS (see ADDRESSES ). The Final EIS analyzes the environmental, social, and economic consequences of the proposed groundfish harvest specifications and alternative harvest strategies on resources in the action area. Based on the analysis in the Final EIS, NMFS concluded that the preferred alternative (Alternative 2) provides the best balance among relevant environmental, social, and economic considerations and allows for continued management of the groundfish fisheries based on the most recent, best scientific information.

This Initial Regulatory Flexibility Analysis (IRFA) was prepared for this proposed rule, as required by Section 603 of the Regulatory Flexibility Act (RFA) (5 U.S.C. 603), to describe the economic impact this proposed rule, if adopted, would have on small entities. The IRFA describes the action; the reasons why this proposed rule is proposed; the objectives and legal basis for this proposed rule; the estimated number and description of directly regulated small entities to which this proposed rule would apply; the recordkeeping, reporting, and other compliance requirements of this proposed rule; and the relevant Federal rules that may duplicate, overlap, or conflict with this proposed rule. The IRFA also describes significant alternatives to this proposed rule that would accomplish the stated objectives of the Magnuson-Stevens Act, and any other applicable statutes, and that would minimize any significant economic impact of this proposed rule on small entities. The description of the proposed action, its purpose, and the legal basis are explained earlier in the preamble and are not repeated here.

For RFA purposes only, NMFS has established a small business size standard for businesses, including their affiliates, whose primary industry is commercial fishing (see 50 CFR 200.2). A business primarily engaged in commercial fishing (NAICS code 11411) is classified as a small business if it is independently owned and operated, is not dominant in its field of operation (including its affiliates), and has combined annual gross receipts not in excess of $11 million for all its affiliated operations worldwide. A shoreside processor primarily involved in seafood processing (NAICS code 311710) is classified as a small business if it is independently owned and operated, is not dominant in its field of operation (including its affiliates), and has combined annual employment, counting all individuals employed on a full-time, part-time, or other basis, not in excess of 750 employees for all its affiliated operations worldwide.

The entities directly regulated by the groundfish harvest specifications include: (a) Entities operating vessels with groundfish Federal fisheries permits (FFPs) catching FMP groundfish in Federal waters (including those receiving direction allocations of groundfish); (b) all entities operating vessels, regardless of whether they hold groundfish FFPs, catching FMP groundfish in the state-waters parallel fisheries; and (c) all entities operating vessels fishing for halibut inside three miles of the shore (whether or not they have FFPs). In 2020 (the most recent year of complete data), there were 288 individual CVs and CPs with gross revenues less than or equal to $11 million as well as six CDQ groups. This estimate does not account for corporate affiliations among vessels, and for cooperative affiliations among fishing entities, since some of the fishing vessels operating in the BSAI are members of AFA inshore pollock cooperatives, Gulf of Alaska Rockfish Program cooperatives, or BSAI Crab Rationalization Program cooperatives. Vessels that participate in these cooperatives are considered to be large entities within the meaning of the RFA because the aggregate gross receipts of all participating members exceed the $11 million threshold. After accounting for membership in these cooperatives, there are an estimated 155 small CV and 4 small CP entities remaining in the BSAI groundfish sector. However, the estimate of these 155 CVs may be an overstatement of the number of small entities. This latter group of vessels had average gross revenues that varied by gear type. Average gross revenues for hook-and-line CVs, pot gear CVs, trawl gear CVs, hook-and-line CPs, and pot gear CPs are estimated to be $530,000, $1.1 million, $2.8 million, $6.6 million, and $3.1 million, respectively.

The action under consideration is the proposed 2022 and 2023 harvest specifications, apportionments, and prohibited species catch limits for the groundfish fishery of the BSAI. This action is necessary to establish harvest limits for groundfish during the 2022 and 2023 fishing years and is taken in accordance with the FMP prepared by the Council pursuant to the Magnuson-Stevens Act. The establishment of the proposed harvest specifications is governed by the Council's harvest strategy to govern the catch of groundfish in the BSAI. This strategy was selected from among five alternatives, with the preferred alternative harvest strategy being one in which the TACs fall within the range of ABCs recommended by the SSC. Under the preferred harvest strategy, TACs are set to a level that falls within the range of ABCs recommended by the SSC; the sum of the TACs must achieve the OY specified in the FMP. While the specific numbers that the harvest strategy produces may vary from year to year, the methodology used for the preferred harvest strategy remains constant.

The TACs associated with preferred harvest strategy are those recommended by the Council in October 2021. OFLs and ABCs for the species were based on recommendations prepared by the Council's Plan Team in September 2021, and reviewed by the Council's SSC in October 2021. The Council based its TAC recommendations on those of its AP, which were consistent with the SSC's OFL and ABC recommendations. The sum of all TACs remains within the OY for the BSAI consistent with § 679.20(a)(1)(i)(A). Because setting all TACs equal to ABCs would cause the sum of TACs to exceed an OY of 2 million mt, TACs for some species or species groups are lower than the ABCs recommended by the Plan Team and the SSC.

The proposed 2022 and 2023 OFLs and ABCs are based on the best available biological information, including projected biomass trends, information on assumed distribution of stock biomass, and revised technical methods to calculate stock biomass. The proposed 2022 and 2023 TACs are based on the best available biological and socioeconomic information. The proposed 2022 and 2023 OFLs, ABCs, and TACs are consistent with the biological condition of groundfish stocks as described in the 2020 SAFE report, which is the most recent, completed SAFE report.

Under this action, the proposed ABCs reflect harvest amounts that are less than the specified overfishing levels. The proposed TACs are within the range of proposed ABCs recommended by the SSC and do not exceed the biological limits recommended by the SSC (the ABCs and overfishing levels). For some species and species groups in the BSAI, the Council recommended, and NMFS proposes, proposed TACs equal to proposed ABCs, which is intended to maximize harvest opportunities in the BSAI.

However, NMFS cannot set TACs for all species in the BSAI equal to their ABCs due to the constraining OY limit of two million mt. For this reason, some proposed TACs are less than the proposed ABCs. The specific reductions are reviewed and recommended by the Council's AP, and the Council in turn adopted the AP's TAC recommendations for the proposed 2022 and 2023 TACs.

Based upon the best available scientific data, and in consideration of the Council's objectives of this action, it appears that there are no significant alternatives to the proposed rule that have the potential to accomplish the stated objectives of the Magnuson-Stevens Act and any other applicable statutes and that have the potential to minimize any significant adverse economic impact of the proposed rule on small entities. This action is economically beneficial to entities operating in the BSAI, including small entities. The action proposes TACs for commercially-valuable species in the BSAI and allows for the continued prosecution of the fishery, thereby creating the opportunity for fishery revenue. After public process during which the Council solicited input from stakeholders, the Council concluded that the proposed harvest specifications would best accomplish the stated objectives articulated in the preamble for this proposed rule, and in applicable statutes, and would minimize to the extent practicable adverse economic impacts on the universe of directly regulated small entities.

This action does not modify recordkeeping or reporting requirements, or duplicate, overlap, or conflict with any Federal rules.

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

Adverse impacts on marine mammals or endangered or threatened species resulting from fishing activities conducted under these harvest specifications are discussed in the Final EIS and its accompanying annual SIRs (see ADDRESSES ).