Background

The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to supersede AD 2012-02-07, Amendment 39-16930 (77 FR 4650, January 31, 2012), (“AD 2012-02-07”). AD 2012-02-07 applied to certain GE CF6-45A, CF6-45A2, CF6-50A, CF6-50C, CF6-50CA, CF6-50C1, CF6-50C2, CF6-50C2B, CF6-50C2D, CF6-50E, CF6-50E1, CF6-50E2, and CF6-50E2B model turbofan engines, including engines marked on the engine data plate as CF6-50C2-F and CF6-50C2-R, with a specified LPT rotor stage 3 disk, identified by part number (P/N), installed. The NPRM published in the Federal Register on December 08, 2022 (87 FR 75181). The NPRM was prompted by the occurrence of four events of separation of the LPT rotor assembly, occurring after the effective date of AD 2012-02-07, which resulted in the LPT rotor assembly departing the rear of the engine. Following the most recent separation event, the FAA determined that due to the complexity of AD 2012-02-07, the limitations of certain operators to access required equipment and training needed to accomplish the inspections, and the manufacturer's redesign of the LPT rotor stage 3 disk, AD 2012-02-07 required supersedure. The redesigned LPT rotor stage 3 disk, P/N 2453M80P01, has a thicker forward spacer arm, which reduces stress on the forward arm area and increases its high cycle fatigue alternating stress capability. In the NPRM, the FAA proposed to continue to require inspections of HPT and LPT rotor stage 1 and stage 2 blades, vibration surveys, and use of a lower life limit for the affected LPT rotor stage 3 disks. As a terminating action to the inspections, engine checks, and vibration surveys, the FAA also proposed to require removal and replacement of the LPT rotor stage 3 disk with a redesigned LPT rotor stage 3 disk. In the NPRM, the FAA also proposed to require revision of the compliance time of the drawdown plan for the removal and replacement of the LPT rotor stage 3 disk, and to prohibit the installation or reinstallation of certain LPT rotor stage 3 disks.

The FAA received comments from two commenters. Commenters included Air Line Pilots Association, International and The Boeing Company. All commenters supported the NPRM without change.

The FAA reviewed the relevant data, considered the comments received, and determined that air safety requires adopting the AD as proposed. Accordingly, the FAA is issuing this AD to address the unsafe condition on these products. Except for minor editorial changes, this AD is adopted as proposed in the NPRM.

The FAA estimates that this AD affects 26 engines installed on airplanes of U.S. registry.

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

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, Section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority.

The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701, General requirements. Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

The FAA has determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify that this AD:

(1) Is not a “significant regulatory action” under Executive Order 12866,

(2) Will not affect intrastate aviation in Alaska, and

(3) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:

Background

The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to all MHI RJ Aviation ULC Model CL-600-2C10 (Regional Jet Series 700, 701 & 702) airplanes, Model CL-600-2C11 (Regional Jet Series 550) airplanes, Model CL-600-2D15 (Regional Jet Series 705) airplanes, Model CL-600-2D24 (Regional Jet Series 900) airplanes, and Model CL-600-2E25 (Regional Jet Series 1000) airplanes. The NPRM published in the Federal Register on June 16, 2022 (87 FR 36269). The NPRM was prompted by AD CF-2021-38, dated November 5, 2021 (TCCA AD CF-2021-38), issued by Transport Canada, which is the aviation authority for Canada. TCCA AD CF-2021-38 states that a report was received of the emergency ram air valve part number GG670-95019-1 stuck in closed or partially open positions. An investigation revealed that the emergency ram air valve is failing due to corrosion of multiple sub-components, which causes an increase in the breakaway torque that cannot be overcome by the valve actuator.

In the NPRM, the FAA proposed to require revising the existing maintenance or inspection program, as applicable, to incorporate new or more restrictive airworthiness limitations.

The FAA issued a supplemental notice of proposed rulemaking (SNPRM) to amend 14 CFR part 39 by adding an AD that would apply to all MHI RJ Aviation ULC Model CL-600-2C10 (Regional Jet Series 700, 701 & 702) airplanes, Model CL-600-2C11 (Regional Jet Series 550) airplanes, Model CL-600-2D15 (Regional Jet Series 705) airplanes, Model CL-600-2D24 (Regional Jet Series 900) airplanes, and Model CL-600-2E25 (Regional Jet Series 1000) airplanes. The SNPRM published in the Federal Register on January 13, 2023 (88 FR 2279). The SNPRM was prompted by a determination that the existing maintenance or inspection program, as applicable, must be revised to incorporate two AMM tasks. In addition, Transport Canada revised AD CF-2021-38, dated November 5, 2021, and issued Transport Canada AD CF-2021-38R1, dated May 25, 2022 (TCCA AD CF-2021-38R1). In the SNPRM, the FAA proposed to require revising the existing maintenance or inspection program, as applicable, to incorporate two AMM tasks. The FAA is issuing this AD to address in-service reports of emergency ram air valve part number (P/N) GG670-95019-1 stuck in closed or partially open positions, which, if not corrected could result in a complete loss of outside air supply, leading to an increase in flight deck and cabin temperatures and a possible increased level of contaminated air (carbon monoxide, carbon dioxide, or ozone).

You may examine TCCA AD CF-2021-38 and TCCA AD CF-2021-38R1 in the AD docket at regulations.gov under Docket No. FAA-2022-0679.

The FAA received no comments on the SNPRM or on the determination of the cost to the public.

This product has been approved by the aviation authority of another country and is approved for operation in the United States. Pursuant to the FAA's bilateral agreement with this State of Design Authority, it has notified the FAA of the unsafe condition described in the TCCA AD referenced above. The FAA reviewed the relevant data and determined that air safety requires adopting this AD as proposed. Accordingly, the FAA is issuing this AD to address the unsafe condition on this product. Except for minor editorial changes, this AD is adopted as proposed in the SNPRM. None of the changes will increase the economic burden on any operator.

The FAA estimates that this AD affects 1,158 airplanes of U.S. registry. The FAA estimates the following costs to comply with this AD:

The FAA has determined that revising the maintenance or inspection program takes an average of 90 work-hours per operator, although the agency recognizes that this number may vary from operator to operator. Since operators incorporate maintenance or inspection program changes for their affected fleet(s), the FAA has determined that a per-operator estimate is more accurate than a per-airplane estimate. Therefore, the agency estimates the average total cost per operator to be $7,650 (90 work-hours × $85 per work-hour).

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.

The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: General requirements. Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

This AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify that this AD:

(1) Is not a “significant regulatory action” under Executive Order 12866,

(2) Will not affect intrastate aviation in Alaska, and

(3) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:

Background

The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to Viking Air Limited (type certificate previously held by Bombardier Inc. and de Havilland Inc.) Model DHC-2 Mk. I airplanes with STC No. SA01324CH installed. The NPRM published in the Federal Register on July 8, 2022 (87 FR 40749). The NPRM was prompted by a report that during an annual inspection of a Viking Air Limited Model DHC-2 Mk. I airplane, a gap was noted between the doubler and wing near station 42.5, requiring partial removal of the doubler and removal of the sealant between the doubler and the wing skin. Further inspection of the internal wing structure of that area with a borescope found damage in the forward spar caused by a drill during initial installation of the doubler. The doubler was installed as part of Wipaire, Inc. (Wipaire), STC No. SA01324CH. Inspection of the rest of the operator's fleet of airplanes with STC No. SA01324CH installed found a total of 7 out of 28 wings with drill start damage in the same area. Later inspections on these same airplanes on the outboard end of the doubler installation revealed improperly installed fasteners. As only a small fraction of the affected fleet has been inspected, the possible extent of damage in the field is unknown. Accordingly, the FAA determined that in addition to inspecting for drill starts and improperly installed fasteners, inspecting for corrosion and cracks is necessary. Damage of the main structural members of the wing could adversely affect the structural integrity of the airplane and could result in loss of control of the airplane.

The FAA received comments from Wipaire. The following presents the comments received on the NPRM and the FAA's response to each comment.

Wipaire requested that the unsafe condition statement in the Background section and paragraph (e) of the proposed AD be changed from “Damage of the main structural members of the wing could adversely affect the structural integrity of the airplane and could result in loss of control of the airplane” and suggested the wording “This condition, if not addressed, could have a slight adverse effect on the structural integrity of the airplane.” Wipaire stated that although the unsafe condition statement in the NPRM is technically correct, it is misleading to operators affected by the proposed AD. Wipaire noted that a structural analysis performed and approved by an FAA Designated Engineering Representative (DER) showed that this type of damage at this location had no appreciable effect on the overall strength of the spar. Wipaire explained that the doubler is installed inboard of the wing strut on the upper section of the wing and in this configuration the spar is predominately loaded compression so crack growth would be slow and detectable.

The FAA disagrees with the commenter's request. As only a small fraction of the affected fleet has been inspected, the extent of damage in the field is unknown. Accordingly, it is not accurate to say that the damage of the main structural members of the wing will not adversely affect the structural integrity of the wing, resulting in both the loss of the wing and loss of control of the airplane. No change was made to this AD regarding this issue.

Wipaire requested the Background section of the NPRM be changed from “6 out of 14 wings with drill start damage,” which is based off of inspection results of a single operator to the broader inspection results of “7 out of 28 wings with drill start damage,” because these results are based on Wipaire's record of inspections performed by multiple operators. Wipaire stated that, while still a statistically small sample size, the rewording to specify 28 wings provides a more accurate representation of the potential for damage existing fleet wide. Wipaire also mentioned that it hoped the FAA did not issue the NPRM using calculations based on “6 out of 14 wings.”

The FAA agrees with the commenter's statement that, in total, 7 wings were found to be damaged based on inspection results provided by Wipaire on January 26, 2022. The FAA has revised the Background section of this final rule to read “Inspection of the rest of the operator's fleet of airplanes with STC No. SA01324CH installed found a total of 7 out of 28 wings with drill start damage in the same area.”

Regarding issuing the AD based on the data of “6 out of 14 wings,” the FAA clarifies that under 14 CFR 39.5, issuance of an AD is based on the finding that an unsafe condition exists in a product and that condition is likely to exist or develop in other products of the same type design. The FAA does not issue an AD based upon a sample size of airplanes. The unsafe condition addressed in this AD is based on a report of damage in the main wing spar. This condition, if not addressed, could adversely affect the structural integrity of the airplane and result in loss of control of the airplane. Inspections and repair are therefore necessary to detect and correct damage in the main wing spar before it leads to structural failure.

Wipaire requested that the work-hours for doing the inspection be increased from 6 work-hours for a single side of the wing (left or right) to 12 work-hours for both sides of the wing. Wipaire justified the request by stating that due to the inspection requirement including the complete area under the doubler, the estimate should be increased.

The FAA agrees with the commenter's request and has increased the estimated work-hours for the inspection from 6 to 12 in the Costs of Compliance section in this AD.

Wipaire requested that estimated costs for developing a repair scheme and obtaining repair scheme approval be included in the Costs of Compliance section. Wipaire stated that these are additional costs on operators that were not accounted for in the NPRM.

The FAA acknowledges the commenter's concerns. The FAA recognizes that in accomplishing the requirements of any AD, operators might incur “incidental” costs in addition to the “direct” costs that are reflected in the cost analysis presented in the AD. However, the cost analysis in ADs typically does not include incidental costs. No change was made to this AD regarding this issue.

Wipaire requested that the FAA understand the feasibility of inspecting every bay (both forward and aft the spar) across the entire area and adjust the inspection requirements accordingly. Wipaire stated that the requirement to visually inspect the aircraft structure underneath the entire doubler between wing stations 30.26 and 126.36 may not be able to be accomplished without removal of the wing skins and that there are bays, especially on the forward side of the spar, that have very limited access through a combination of existing access panels and lightening holes in structural members. Wipaire recommended focusing the inspection only on areas where data and prior inspections support that damage have been found (fastener locations near the spar) because a smaller area of focus will lead to more thorough inspections and easier compliance for operators in the field. Wipaire further stated that the Background section of the NPRM indicated damage was found on the inboard side of the doubler and improperly installed fasteners on the outboard side of the doubler and recommended focusing on those areas for inspection.

The FAA disagrees with the commenter's request because there is other airplane structure under the doublers that could be damaged by the installation of STC No. SA01324CH. No change was made to this AD regarding this issue.

Wipaire stated that a borescope is needed to comply with the visual inspection requirement specified in the proposed AD. Wipaire explained that a borescope would be needed in order to view the area of inspection because there are multiple 90-degree bends due to access bays and lightening holes. Wipaire further stated that based on its experience, operators in Alaska might not have borescope equipment and personnel able to use that equipment readily available, which could lead to the inability to comply with the proposed AD as written.

The FAA acknowledges the commenter's concern. While a borescope inspection is acceptable, paragraph (g) of this AD states that a borescope, flashlight and mirror, or equivalent, may be used to do the visual inspection. The FAA's intent is that any inspection method that allows for visual inspection of 100 percent of the airplane structure complies with the visual inspection requirement. This AD also provides time to transport the airplane to a location with the resources and personnel to appropriately inspect the airplane. No change was made to this AD regarding this issue.

Wipaire requested that the FAA reword the proposed inspection requirement to “. . . visually inspect for drill starts, improperly installed fasteners, and corrosion or cracks related to the damage caused by any drill starts or improperly installed fasteners” because the wording for the proposed requirement to inspect for corrosion and cracks could be interpreted broadly and could be extended beyond the scope of the proposed AD. Wipaire stated that the proposed requirement to inspect generally for corrosion and cracks may lead to operators being less likely to comply with the requirements specified in the proposed AD in a timely manner.

The FAA disagrees with the commenter's request. Any crack or corrosion that is found, regardless if it is related to damage caused by any drill start or improperly installed fastener, must be addressed to keep the airplane in an airworthy condition. No change was made to this AD regarding this issue.

Wipaire requested that, if no cracks are found during the visual inspection specified in paragraph (g) of the proposed AD, special flight permits be allowed so an airplane can fly to a maintenance facility for repair work. Wipaire stated that the language in paragraph (g) of the proposed AD and the special flight permit prohibition in paragraph (i) of the proposed AD are not supported by the data it gathered during its investigation into this issue.

The FAA disagrees with the commenter's request to allow a special flight permit to repair the aircraft as long as cracks are not found. Drill starts, corrosion, and improperly installed fasteners contribute to the unsafe condition as well as cracks, and if any of these are found during the inspection, then they must be corrected before further flight after the inspection. The compliance time of this AD is 12 months and was established to coincide with the next annual inspection. Therefore, at the time of the inspection, the airplane should already be at a facility where the repair could be done. Thus, a special flight permit is not justified. No change was made to this AD regarding this issue.

The FAA reviewed the relevant data, considered any comments received, and determined that air safety requires adopting this AD as proposed. Accordingly, the FAA is issuing this AD to address the unsafe condition on these products. Except for minor editorial changes, and any other changes described previously, this AD is adopted as proposed in the NPRM. None of the changes will increase the economic burden on any operator.

The FAA reviewed a Wipaire letter, dated September 7, 2021. This letter requests that operators inspect the front wing spar (strap) and front (forward) spar aft flange for drill holes due to the installation of the top wing strap installed using Wipaire Drawing 5D1-790, which is an attachment to the letter. This letter also requests reporting all findings of damage to Wipaire.

The Wipaire letter, dated September 7, 2021, specifies inspecting the front spar and front spar aft flange between wing stations 42.5 and 56. This AD requires inspecting all airplane structure under the installed doubler between wing stations 30.26 and 126.36.

Airplanes modified by Wipaire STC No. SA01324CH are often used to transport cargo and supplies to remote areas of Alaska. The FAA estimates that roughly half of the U.S.-registered airplanes modified by STC No. SA01324CH are operating in Alaska. Since damage to the main structural members of the wing could result in loss of the airplane wing and therefore, loss of control of the airplane, the FAA has determined that the need to correct the unsafe conditions outweighs any impact on aviation in Alaska.

The FAA estimates that this AD affects 96 airplanes of U.S. registry.

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

The FAA estimates the following costs to do any necessary repairs that would be required based on the results of the inspection. The agency has no way of determining the number of airplanes that might need these repairs.

A federal agency may not conduct or sponsor, and a person is not required to respond to, nor shall a person be subject to a penalty for failure to comply with a collection of information subject to the requirements of the Paperwork Reduction Act unless that collection of information displays a currently valid OMB Control Number. The OMB Control Number for this information collection is 2120-0056. Public reporting for this collection of information is estimated to take approximately 1 hour per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. All responses to this collection of information are mandatory. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to: Information Collection Clearance Officer, Federal Aviation Administration, 10101 Hillwood Parkway, Fort Worth, TX 76177-1524.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.

The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: General requirements. Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

This AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify that this AD:

(1) Is not a “significant regulatory action” under Executive Order 12866, and

(2) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:

Authority for This Rulemaking

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 establishes Class E airspace to support IFR operations at Escalante Municipal Airport, Escalante, UT.

The FAA published a notice of proposed rulemaking (NPRM) in the Federal Register for FAA-2022-1561 (87 FR 77540; December 19, 2022) to establish Class E airspace extending upward from 700 feet above the surface at Escalante Municipal Airport, UT, in support of the airport's transition from VFR to IFR. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

This document amends FAA Order JO 7400.11G, Airspace Designations and Reporting Points, dated August 19, 2022, and effective September 15, 2022. FAA Order JO 7400.11G is publicly available as listed in the ADDRESSES section of this document. FAA Order JO 7400.11G lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

The FAA is amending 14 CFR part 71 by establishing Class E airspace beginning at 700 feet above the surface at Escalante Municipal Airport, UT. This airspace area will contain departing aircraft until reaching 1,200 feet above the surface, arriving aircraft below 1,500 feet above the surface, and circling maneuvers southwest of the airport. The proposed airspace is described in relation to the airport reference point and is approximately 7.5 nautical miles by 13.5 nautical miles in size to fully contain IFR operations at the airport.

The Class E5 airspace designation is published in paragraph 6005 of FAA Order JO 7400.11G, dated August 19, 2022, and effective September 15, 2022, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document will be published subsequently in FAA Order JO 7400.11, which is published annually and becomes 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.

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

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

This amendment to part 95 of the Federal Aviation Regulations (14 CFR part 95) amends, suspends, or revokes IFR altitudes governing the operation of all aircraft in flight over a specified route or any portion of that route, as well as the changeover points (COPs) for Federal airways, jet routes, or direct routes as prescribed in part 95.

The specified IFR altitudes, when used in conjunction with the prescribed changeover points for those routes, ensure navigation aid coverage that is adequate for safe flight operations and free of frequency interference. The reasons and circumstances that create the need for this amendment involve matters of flight safety and operational efficiency in the National Airspace System, are related to published aeronautical charts that are essential to the user, and provide for the safe and efficient use of the navigable airspace. In addition, those various reasons or circumstances require making this amendment effective before the next scheduled charting and publication date of the flight information to assure its timely availability to the user. The effective date of this amendment reflects those considerations. In view of the close and immediate relationship between these regulatory changes and safety in air commerce, I find that notice and public procedure before adopting this amendment are impracticable and contrary to the public interest and that good cause exists for making the amendment effective in less than 30 days.

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

Accordingly, pursuant to the authority delegated to me by the Administrator, part 95 of the Federal Aviation Regulations (14 CFR part 95) is amended as follows effective at 0901 UTC, April 20, 2023.

Background

The Census Bureau typically releases annual population estimates, in accordance with Title 13 of the United States Code (U.S.C.). These estimates are typically based to some extent upon the most recent Decennial Census of Population and Housing and compiled from the most current administrative and survey data available for that purpose. Although not required by any statute, the Census Bureau also typically offers an opportunity for local units of general-purpose government (hereinafter collectively “governmental unit”) to challenge these official estimates through its Population Estimates Challenge Program. Under this program, a governmental unit may challenge its population estimate by submitting additional data to the Census Bureau for evaluation, or by identifying a technical error in processing input data or producing the estimates. If the additional data are accepted during the review period by the Census Bureau, resulting in an updated population estimate, the Census Bureau will provide a written notification to the governmental unit and publish the revised estimate at www.census.gov. If the additional data are not accepted for a revised estimate, the Census Bureau will notify the governmental unit. In the challenge process, the Census Bureau will only accept a challenge when the evidence provided indicates the use of incorrect data, processes, or calculations in the estimates.

In this final rule, the Census Bureau amends its regulations to: (1) update the regulation's references pertaining to the input data which are used to produce the official population estimates, and (2) revise the evidence required to support a challenge.

The Census Bureau also solicited comments from the public about ways in which the program might be improved. In particular, the Census Bureau welcomed comments about (1) the methodology used in preparing the annual Population Estimates, (2) the sources of data that the agency considers (or does not consider) in preparing the annual Population Estimates, and (3) what sorts of factual or methodological arguments the agency considers (or does not consider) in evaluating a potential challenge.

Based on the public comments received, the Census Bureau is amending its final rule to: (1) retain the flexibility to accept a physical copy of challenge materials rather than exclusively accepting digital challenge submissions; and (2) increase communication with localities by encouraging the appropriate Federal State Cooperative for Population Estimates (FSCPE) members to serve as conduits with local governments in the review of pre-release estimates, to the extent that this is possible given data confidentiality requirements for pre-release data. Furthermore, to the extent that research findings indicate that additional recommendations/changes support the development of accurate estimates and ensure equity for all general-purpose governmental units, the Census Bureau is open to expanding the scope of the Challenge Program. Nonetheless, this is contingent on the Population Estimates Program (PEP)'s programmatic capacity, future research priorities, and the outcome of such research. For the reasons explained below, at least at this time, the Census Bureau is not implementing the comments that advocated for an expansion of the Program ( e.g., the use of more flexible methodology, a wider range of data sources to support a challenge, and removal of the county control). The Census Bureau intends, however, to study more closely the issues raised in those comments, and commits to conducting future research that will allow for regular enhancement of the current methodologies, and which would improve both the accuracy of the population estimates and the Challenge Program.

Currently, the Census Bureau begins the process of preparing population estimates by updating population information from the most recent decennial census and other sources with information found in the annual administrative records of Federal and State agencies. The Federal agencies provide tax records, Medicare records, and some vital records and group quarters information. The FSCPE members, designated by their respective governors to work in cooperation with the Census Bureau's Population Estimates Program to produce population estimates, also supply vital statistics and information about group quarters like college dorms or prisons. 1 The Census Bureau combines census base data, administrative records, and selected survey data ( e.g., data from the American Community Survey, American Housing Survey, and the Building Permit Survey) to produce current population estimates that usually begin with the last decennial census. Additionally, the Census Bureau's general-purpose governmental units' population estimates are provided to the FSCPE agencies in preliminary form for review and comment to resolve data processing issues identified during that period. For the purposes of this program, the District of Columbia is treated as a statistical equivalent of a county and, therefore, is eligible to participate.

A major priority for the Census Bureau is balancing the need to use the 2020 Census counts at the lowest level of estimates geography as the starting point in estimates production with the statutory obligation to protect the respondents' confidentiality at every stage of the data lifecycle. Since the 1990 Census, the Bureau has added “noise”—or variations from the actual count—to the collected data to ensure privacy and confidentiality. For 2020 Census data, the Census Bureau applied noise using a newer disclosure avoidance technique based on “differential privacy.”  2 The Census Bureau uses a housing unit method to distribute a county population to places within its legal boundaries. The components in this method include housing units estimates, average household population per housing unit, and an estimate of the population in group quarters. The estimation formula was simplified to increase the accuracy of the estimates and minimize the impact of differential privacy on the population estimates by reducing the number of components requiring privacy protection used to generate population estimates. Consequently, the occupancy rate and Persons Per Household (PPH) previously used in this method were replaced with the average household population per housing unit. The household population and the group quarters population used in the calculation of the estimate are the only two components subject to differential privacy protection compared to the prior three components—occupancy rate, PPH, and group quarters population—that would have otherwise required privacy protection. Therefore, the PPH and occupancy rate components are no longer inputs used to produce those population estimates. The distributive housing unit equation used to calculate the population estimates for governmental units is simplified to accommodate the application of the disclosure avoidance technique prior to releasing the estimates. As a result, the Census Bureau amends 15 CFR part 90 to revise: (1) the regulation's references pertaining to the input data which are used to produce the official population estimates, (2) where to file a challenge, and (3) the evidence required to support a challenge. These changes are captured in the updates to §§ 90.2, 90.7, and 90.8.

Previously, the Census Bureau published a final rule on January 9, 2020, in the Federal Register (85 FR 1100) to announce that the Census Bureau would temporarily suspend the Population Estimates Challenge Program to accommodate the taking of the 2020 Census and subsequent review and evaluation activities. Efforts to resume the program were delayed in response to the changes to the operational schedule for the 2020 Census which occurred due to the impacts of the COVID-19 pandemic. The Census Bureau followed the suspension of the Population Estimates Challenge Program with two Federal Register documents published on November 22, 2022. A document was posted in the Federal Register (87 FR 71240), entitled “Resumption of the Population Estimates Challenge Program,” which resumed the suspended program to provide eligible entities the opportunity to file requests for the review of population estimates for 2021 and subsequent years beginning with the Vintage  3 2022 series that is scheduled to be published in 2023. That rule also made clear that challenges to previous estimates series (for which the 90-day limitations period set forth in 15 CFR 90.6 had long since elapsed) would not be accepted. The resumption document did not implement revisions to the program or its requirements. On November 22, 2022, the Census Bureau published another notice of proposed rulemaking in the Federal Register (87 FR 71269) for its program, entitled “Resumption of the Population Estimates Challenge Program and Proposed Changes to the Program.” In that announcement, the Census Bureau solicited comments from the public about ways in which the program might be improved.

Background Unverified List

The UVL, found in supplement no. 6 to part 744 of the EAR (15 CFR parts 730-774), contains the names and addresses of foreign persons who are or have been parties to a transaction, as described in § 748.5 of the EAR, involving the export, reexport, or transfer (in-country) of items subject to the EAR. These foreign persons are added to the UVL because BIS or federal officials acting on BIS's behalf were unable to verify their bona fides ( i.e., legitimacy and reliability relating to the end use and end user of items subject to the EAR) through the completion of an end-use check. Sometimes these checks, such as a pre-license check (PLC) or a post-shipment verification (PSV), cannot be completed satisfactorily for reasons outside the U.S. Government's control.

There are any number of reasons why these checks cannot be completed to the satisfaction of the U.S. Government. The reasons include, but are not limited to: (1) reasons unrelated to the cooperation of the foreign party subject to the end-use check (for example, BIS sometimes initiates end-use checks but is unable to complete them because the foreign party cannot be found at the address indicated on the associated export documents and BIS cannot contact the party by telephone or email); (2) reasons related to a lack of cooperation by a host government that fails to schedule and facilitate the completion of an end-use check; for example, a host government agencies' lack of responses to requests to conduct end-use checks, actions preventing the scheduling of such checks, or refusals to schedule checks in a timely manner; or (3) when, during the end-use check, a recipient of items subject to the EAR is unable to produce the items that are the subject of the end-use check for visual inspection or provide sufficient documentation or other evidence to confirm the disposition of the items.

BIS's inability to confirm the bona fides of foreign persons subject to end-use checks raises concerns about the suitability of such persons as participants in future exports, reexports, or transfers (in-country) of items subject to the EAR; this also indicates a risk that such items may be diverted to prohibited end uses and/or end users. Under such circumstances, there may not be sufficient information to add the foreign person at issue to the Entity List (supplement no. 4 to part 744 of the EAR) under § 744.11 of the EAR. Therefore, BIS may add the foreign person to the UVL.

As provided in § 740.2(a)(17) of the EAR, the use of license exceptions for exports, reexports, and transfers (in-country) involving a party or parties to the transaction who are listed on the UVL is suspended. Additionally, under § 744.15(b) of the EAR, there is a requirement for exporters, re-exporters, and transferors to obtain (and maintain a record of) a UVL statement from a party or parties to the transaction who are listed on the UVL before proceeding with exports, reexports, and transfers (in-country) to such persons, when the exports, reexports and transfers (in-country) are not subject to a license requirement. Finally, pursuant to § 758.1(b)(8), Electronic Export Information (EEI) must be filed in the Automated Export System (AES) for all exports of tangible items subject to the EAR where parties to the transaction, as described in § 748.5(d) through (f), are listed on the UVL.

Requests for the removal of a UVL entry must be made in accordance with § 744.15(d) of the EAR. Decisions regarding the removal or modification of UVL entry will be made by the Deputy Assistant Secretary for Export Enforcement, based on a demonstration by the listed person of their bona fides.

This rule adds 32 persons to the UVL by amending supplement no. 6 to part 744 of the EAR to include their names and addresses. BIS is adding these persons pursuant to § 744.15(c) of the EAR. This final rule implements the decision to add the following 32 persons located in the following destinations to the UVL: Under Bulgaria, Vera Yordanova. Under Canada, Skymount Drones. Under China, Airpart Consolidated Trading; ECOM International (HK) Co., Ltd.; Guangzhou Trusme Electronics Technology Co., Ltd.; HK P&W Industry Co. Ltd. (HKPW); Jet-Prop International Forwarding (HK) Ltd.; Kesina Services; Lightstar Technology Ltd.; Shandong Yuehaitongxin Keji Ltd.; Shengwei Technology Co., Ltd.; Small Leopard Electronics Co., Ltd.; Solar Way (Hong Kong) Ltd.; Sunway Technology Electronics Ltd.; USETA Tech (HK) Ltd.; and Winners Global Trading Co. Under Germany, In Time Forwarding & Courier e.K. and One Light GMBH. Under Indonesia, PT Smart Cakrawala Aviation. Under Israel, CNG Labs. Under Malaysia, Golden Gamp Sdn Bhd. Under Saudi Arabia, Al Gihaz Co., Ltd. for Contracting and Trading. Under Singapore, Smart Cakrawala Aviation. Under Turkey, BLC Havacilik Saglik Medikal Insaat Elektrik Ic ve Dis Ticaret; Odak Kimya; Piro Deniz Motorlari; and Üçüzler Lojistik Gida Tekstil. Under the UAE, Al Kabiru Trading LLC; BNS Hardware; Delma Industrial Supply & Marine Services; Diamond River General Trading; and Masoud Afghan General Trading.

As a reminder, particularly with respect to partner countries, the Unverified List is not intended for use as a sanction against any particular country or government.

On August 13, 2018, the President signed into law the John S. McCain National Defense Authorization Act for Fiscal Year 2019, which included the Export Control Reform Act of 2018 (ECRA), 50 U.S.C. 4801-4852. ECRA provides the legal basis for BIS's principal authorities and serves as the authority under which BIS issues this final rule.

Shipments (1) that are removed from license exception eligibility or that are now subject to requirements in § 744.15 of the EAR as a result of this regulatory action; (2) that were eligible for export, reexport, or transfer (in-country) without a license before this regulatory action; and (3) that were on dock for loading, on lighter, laden aboard an exporting carrier, or enroute aboard a carrier to a port of export, on March 24, 2023, pursuant to actual orders, may proceed to that UVL listed person under the previous license exception eligibility or without a license and pursuant to the export clearance requirements set forth in Part 758 of the EAR that applied prior to this person being listed on the UVL, so long as the items have been exported from the United States, reexported or transferred (in-country) before April 22, 2023. Any such items not actually exported, reexported or transferred (in-country) before midnight on April 22, 2023, are subject to the requirements in § 744.15 of the EAR in accordance with this rule.

Executive Orders 13563 and 12866 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distribute impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This final rule is not a “significant regulatory action” under Executive Order 12866.

This rule does not contain policies with Federalism implications as that term is defined under Executive Order 13132.

Notwithstanding any other provision of law, no person is required to respond to, nor is subject to a penalty for failure to comply with, a collection of information, subject to the requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ) (PRA), unless that collection of information displays a currently valid Office of Management and Budget (OMB) Control Number.

The UVL additions contain collections of information approved by OMB under the following control numbers:

BIS believes that the overall increases in burdens and costs will be minimal and will fall within the already approved amounts for these existing collections. Additional information regarding these collections of information—including all background materials—can be found at https://www.reginfo.gov/public/do/PRAMain by using the search function to enter either the title of the collection or the OMB Control Number.

Pursuant to Section 4821 of ECRA, this action is exempt from the Administrative Procedure Act (5 U.S.C. 553) requirements for notice of proposed rulemaking and opportunity for public participation.

Further, no other law requires notice of proposed rulemaking or opportunity for public comment for this final rule. Because a notice of proposed rulemaking and an opportunity for public comment are not required under the Administrative Procedure Act or by any other law, the analytical requirements of the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ) are not applicable.

Accordingly, part 744 of the Export Administration Regulations (15 CFR parts 730 through 774) is amended as follows:

I. Background A. Food Labeling (21 CFR Part 101)

In the Federal Register of May 27, 2016 (81 FR 33742), we published a final rule entitled “Food Labeling: Revision of the Nutrition and Supplement Facts Labels” (the Nutrition Facts Label Final Rule). The Nutrition Facts Label Final Rule amended our labeling regulations for conventional foods and dietary supplements to provide updated nutrition information on the label to assist consumers in maintaining healthy dietary practices.

In the Federal Register of December 21, 2018 (83 FR 65493), we issued a technical amendment pertaining to the Nutrition Facts label requirements. The technical amendments corrected errors that were made in sample labels, restored incorrect deletions, corrected the edition of a reference cited in the Nutrition Facts Label Final Rule, and corrected cross-references to other regulations. However, certain errors remained, and so this rulemaking will provide additional corrections to sample labels and updates to office names.

In the Federal Register of February 10, 2014 (79 FR 7934), FDA published an interim final rule entitled “Current Good Manufacturing Practices, Quality Control Procedures, Quality Factors, Notification Requirements, and Records and Reports, for Infant Formula” (2014 interim final rule). In the Federal Register of June 10, 2014 (79 FR 33057), FDA issued a final rule, adopting, with some modifications, the 2014 interim final rule where FDA established notification requirements for adulterated or misbranded infant formula. The 2014 interim final rule included an incorrect statutory citation in this provision, and so this rulemaking is intended to correct the citation.

Our regulations in parts 170, 172, 173, and 184 (21 CFR parts 170, 172, 173, and 184) discuss the general principles for evaluating food additive safety, the use of food additives, and substances affirmed as GRAS. Our regulations reference office names and addresses that are no longer correct, reference an organization's name that is no longer correct, and include a potentially confusing reference to the Federal Food, Drug, and Cosmetic Act (FD&C Act); consequently, this rulemaking will update names and addresses and clarify a reference to the FD&C Act.

In the Federal Register of September 23, 1997 (62 FR 49886), FDA published a final rule entitled “Premarket Notification for a New Dietary Ingredient.” The final rule specifies the information a manufacturer or distributor must include in its premarket NDI notification and establishes the administrative procedures for these notifications. The regulation refers to an FDA office name and address that is no longer correct, and so this rulemaking will update the office name and address.

We are making technical amendments to our regulations in parts 101, 106, and 190 (21 CFR parts 101, 106, and 190) and parts 170, 172, 173, and 184. In general, part 101 pertains to food labeling, including the nutrition labeling of food. Part 106 pertains to current good manufacturing practice, quality control procedures, quality factors, records and reports, and notifications regarding infant formula. Part 170 pertains to food additives while part 172 pertains to food additives permitted for direct addition to food for human consumption. Part 173 pertains to secondary food additives permitted in food for human consumption. Part 184 pertains to direct food substances affirmed as generally recognized as safe. Part 190 pertains to dietary supplements.

Since we published the technical amendments to the final rule in the Federal Register , we have become aware of additional changes or corrections that are needed to the Nutrition Facts label requirements. These changes or corrections are non-substantive; for example, § 101.9(d)(11) and (j)(5)(ii)(B) (21 CFR 101.9(d)(11) and (j)(5)(ii)(B)) show sample Nutrition Facts labels. In one case, the sample label included an extra word in the phrasing of a nutrient declaration. In the other case, the sample label included a number that did not comply with the rounding requirements for certain nutrients. The technical amendment revises the sample labels. We describe these and other changes to the Food Labeling regulations below.

Our regulations in 21 CFR 101.4 discuss the designation of food ingredients and state that certain references are available for examination at the “Food and Drug Administration's Main Library.” The technical amendment revises where the references are available for examination to be FDA's Dockets Management Staff.

The Nutrition Facts Label Final Rule revised the name of the program office that is responsible for developing regulations and answering questions related to nutrition labeling, as well as for maintaining some references discussed throughout § 101.9. The program office's former name was the Office of Nutritional Products, Labeling and Dietary Supplements, and the Nutrition Facts Label Final Rule changed the program office's name to the Office of Nutrition and Food Labeling. However, our regulations in § 101.9(b)(7)(vi) continued to use the program office's former name. Therefore, this technical amendment revises § 101.9(b)(7)(vi) by replacing “Office of Nutritional Products, Labeling and Dietary Supplements” with “Office of Nutrition and Food Labeling.”

Our regulations in § 101.9(c)(8)(iv) provide the Reference Daily Intakes (RDIs), nomenclature, and units of measure for various vitamins and minerals that are essential in human nutrition. The regulation lists the vitamins and minerals in a table, and footnotes to the table provide additional information. Footnote 3 discusses the units of measure that may be used for vitamin A. The footnote says, in part, that the abbreviation “RAE” stands for “Retinol activity equivalents” and that 1 microgram RAE equals 1 microgram retinol, “2 microgram supplemental β-carotene” or “dietary 24 micrograms dietary β-cryptoxanthin.” The technical amendment replaces “2 microgram” with “2 micrograms” and deletes the word “dietary” before “24 micrograms.”

Our regulations in § 101.9(d)(11)(iii) contain a sample Nutrition Facts label in a tabular format. However, the sample label contains the statement “Includes 1g of Added Sugars.” Under § 101.9(c)(6)(iii), however, the correct statement is “Includes `X' g Added Sugars.” Therefore, the technical amendment revises the sample label by removing the word “of” so that the statement reads “Includes 1g Added Sugars.”

Our regulations in § 101.9(j)(5)(ii)(B) contain a sample Nutrition Facts label for a food intended for infants through 12 months of age. The sample label declares the amount of sodium to be 74 mg. Under § 101.9(c)(4), however, the amount of sodium declared on a Nutrition Facts label must be expressed to the nearest 5-milligram increment when the serving contains 5 to 140 milligrams of sodium. Therefore, the technical amendment provides a revised sample label correcting the amount of sodium from “74mg” to “75mg.”

Our regulations in § 101.9(j)(13)(i)(B) discuss requirements for foods in small packages. The Nutrition Facts Label Final Rule revised § 101.9(j)(13)(i)(B) so that the Nutrition Facts label on small packages would not be required to bear a footnote explaining what the “% Daily Value” means and manufacturers could voluntarily include an abbreviated footnote of “% DV = % Daily Value” in a type size no smaller than 6 point. Additionally, these requirements include, among other things, the minimum type size for required information. The minimum type size is specified as “no smaller than 6 point or all upper-case type of 1-16 inches.”

The inclusion of the alternate footnote option was inadvertently omitted when changes to the same paragraph, as described in the Federal Register of December 1, 2014 (79 FR 71259), became effective on December 1, 2016. Consequently, we are restoring the alternate footnote option. The technical amendment also corrects the minimum type size, in inches, to “ 1/16 inches” rather than “1-16 inches.”

Our regulations in § 101.9(j)(13)(ii)(A)( 1 ) provide a sample label for the tabular display for small packages. The sample label included an asterisk (*) after the “% DV” heading but omitted any footnote or other explanation as to what the asterisk was referring. The sample label also included “servings per container” and “serving size” declarations that are not consistent with our rounding regulations in § 101.9(b)(5)(i), which state that “Cups shall be expressed in 1/4 - or 1/3 -cup increments.”

Manufacturers may voluntarily include an abbreviated footnote “% DV = % Daily Value” for products in small packages, but because the sample label did not include the abbreviated footnote, the technical amendment removes the asterisk after the “% DV” heading in the sample label. The technical amendment also revises the serving size from “ 1/6 cup” to “ 1/3 cup” and the servings per container from “5 servings per container” to “about 3 servings per container” in the sample label.

Our regulations in § 101.9(j)(13)(ii)(A)( 2 ) provide a sample label for the linear display for small packages. The sample label included a “% DV” declaration of “Potas. (5% DV).” Under § 101.9(c)(8)(iii), however, the “% DV” for vitamins and minerals must be expressed to the nearest 2-percent increment up to and including the 10-percent level. Therefore, the technical amendment changes “Potas. (5% DV)” to “Potas. (6% DV)” in the sample label.

Our regulations in § 101.9(j)(13)(ii)(B) allow for the use of “Vit.” and “Potas.” as abbreviations for “Vitamin” and “Potassium,” respectively, on the labels of small and intermediate-sized packages. While our regulations in § 101.9(d)(12) also show the use of these abbreviations on the standard vertical side-by-side label illustration, indicating that we intended to permit this use, we failed to state explicitly that these abbreviations are permitted on labels other than the labels of small and intermediate-sized packages. In addition, the regulations allow for the use of “Total carb.” as an abbreviation for “Total carbohydrate” on dual-column displays and refers to other requirements in § 101.9 by their paragraph designations.

The technical amendment revises § 101.9(j)(13)(ii)(B) to clearly state that the use of “Vit.” and “Potas.” as abbreviations for “Vitamin” and “Potassium,” respectively, on the standard vertical side-by-side label display as shown in § 101.9(d)(12), is permitted in addition to their use on the labels of small and intermediate-sized packages. The technical amendment also revises § 101.9(j)(13)(ii)(B) to include “of this section” at the end of the sentence pertaining to “Total carbohydrate” so that it refers to “paragraphs (e)(5), (e)(6)(i), and (e)(6)(ii) of this section.”

Our regulations in 21 CFR 101.45 discuss the guidelines for voluntary nutrition labeling of raw fruits, vegetables, and fish and encourages submission of nutrient databases to the “Office of Nutritional Products, Labeling and Dietary Supplements (HFS-800).” The regulations also state that guidance is available from the “FDA Office of Food Labeling.” The technical amendment revises the office name to be “Office of Nutrition and Food Labeling (HFS-800), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740.”

Our regulations in 21 CFR 101.80 discuss dietary noncariogenic carbohydrate sweeteners and dental caries health claims. The regulations state that a reference is available for examination at the “Food and Drug Administration's Main Library.” The technical amendment revises where the reference is available for examination to be FDA's Dockets Management Staff.

Our regulations in 21 CFR 101.81 discuss soluble fiber from certain foods and risk of coronary heart disease health claims. The regulations state that certain references are available for examination at the “Food and Drug Administration's Main Library.” The technical amendment revises where the references are available for examination to be FDA's Dockets Management Staff.

Our regulations in 21 CFR 101.83 discuss plant sterol/stanol esters and risk of coronary heart disease health claims. The regulations state that certain references are available for examination at the “Food and Drug Administration's Main Library.” The technical amendment revises where the references are available for examination to be FDA's Dockets Management Staff.

Our regulations in part 101, subpart F, discuss specific requirements for descriptive claims that are neither nutrient content claims nor health claims. In 21 CFR 101.93 the requirements for notifications for certain types of statements for dietary supplements are discussed and submissions are directed to the “Office of Nutritional Products, Labeling and Dietary Supplements (HFS-810), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740.” The technical amendment revises the office name to be “Office of Dietary Supplement Programs (HFS-810),” which reflects the office's current name.

Our regulations in 21 CFR 101.108 discuss temporary exemptions for purposes of conducting authorized food labeling experiments. The regulation states that written proposals should be sent to the “Division of Dockets Management (HFA-305).” The technical amendment revises the office name to be “Dockets Management Staff (HFA-305).”

Our regulations in § 106.150(a)(1) state that a manufacturer must promptly notify us when the manufacturer has knowledge that reasonably supports the conclusion that an infant formula processed by that manufacturer and that has left an establishment controlled by the manufacturer may not provide the nutrients required by section 412(i) of the FD&C Act. The regulation was intended to provide a corresponding U.S. Code cite for section 412(i) of the FD&C Act and identifies the U.S. Code cite as 21 U.S.C. 350d(i). The U.S. Code citation should have been 21 U.S.C. 350a(i). Therefore, the technical amendment replaces “21 U.S.C. 350d(i)” with “21 U.S.C. 350a(i).”

The regulations in §§ 170.35(b)(1) and (b)(2), 170.38(b)(1) and (b)(2), and 170.39(e) and (g) (21 CFR 170.35(b)(1) and (b)(2), 170.38(b)(1) and (b)(2), and 170.39(e) and (g)) state that data, information, comments, or other documents are on display or available at the “Division of Dockets Management.” The technical amendment revises these regulations to replace “Division of Dockets Management” with “Dockets Management Staff” to reflect the office's current name.

Similarly, our regulations in § 170.39(d), (e), and (h) refer to the “Office of Premarket Approval.” The technical amendment replaces “Office of Premarket Approval” with “Office of Food Additive Safety” to reflect the office's current name.

Our regulations in 21 CFR 172.105, 172.133, 172.250, 172.859, 172.878, and 172.882 discuss the use of anoxomer, dimethyl carbonate, petroleum naphtha, sucrose fatty acid esters, white mineral oil, and synthetic isoparaffinic petroleum hydrocarbons as food additives, respectively, and state that certain references are available from the “Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740.” The technical amendment replaces all instances of “Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740” with “Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1200.” We are making this change to include the name and contact information of the office where the references are available.

Our regulations in 21 CFR 172.155 discuss the use of natamycin (also known as pimaricin) as a food additive. Section 172.155(c) states that a reference is available from the “Division of Product Policy (HFS-206)” and provides the office's address. The regulation also states that this reference is available for examination at the “Food and Drug Administration's Main Library.” The technical amendment: (1) updates the associated address of where the reference is available to be “Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1200;” and (2) revises where the reference is available for examination to be FDA's Dockets Management Staff.

Our regulations in 21 CFR 172.167, 172.185, 172.320, 172.345, 172.379, 172.380, 172.665, 172.712, 172.780, 172.810, 172.812, 172.831, 172.841, 172.862, and 172.867 discuss the use of silver nitrate and hydrogen peroxide solution, TBHQ, amino acids, folic acid (folacin), vitamin D 2 , vitamin D 3 , gellan gum, 1,3-butylene glycol, acacia (gum arabic), dioctyl sodium sulfosuccinate, glycine, sucralose, polydextrose, oleic acid derived from tall oil fatty acids, and olestra as food additives, respectively. The regulations state that certain references are available for examination at the “Food and Drug Administration's Main Library.” The technical amendment revises where the references are available for examination to be FDA's Dockets Management Staff.

Our regulations in 21 CFR 172.723 discuss the use of epoxidized soybean oil as a food additive. The regulations state that certain references may be examined at either the “Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1200” or the “Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039.” The technical amendment revises where the references are available for examination to be FDA's Docket Management Staff.

Our regulations in 21 CFR 172.736, 172.803, and 172.869 discuss the use of glycerides and polyglycides of hydrogenated vegetable oils, advantame, and sucrose oligoesters as food additives, respectively. The regulations state that certain references are available from either the “Office of Food Additive Safety, 5001 Campus Dr., College Park, MD 20740,” the “Office of Food Additive Safety, Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740,” or the “Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, 5001 Campus Dr., College Park, MD 20740” and are available for examination at the “Food and Drug Administration's Main Library.” The technical amendment: (1) updates the associated address of where the references are available to be the “Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1200;” and (2) revises where the references are available for examination to be FDA's Dockets Management Staff.

Our regulations in 21 CFR 172.785, 172.809, 172.829, and 172.833 discuss the use of Listeria -specific bacteriophage preparation, curdlan, neotame, and sucrose acetate isobutyrate as food additives, respectively. The regulations state that specific references are available from either the “Office of Food Additive Safety (HFS-200), Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039,” the “Office of Food Additive Safety (HFS-200), Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993,” or the “Office of Food Additive Safety (HFS-200), Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, 240-402-1200” and are available for examination at the “Center for Food Safety and Applied Nutrition's Library” or the “Food and Drug Administration's Main Library.” The technical amendment: (1) updates the associated address of where the references are available to be “Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1200;” and (2) revises where the references are available for examination to be FDA's Dockets Management Staff.

Our regulations in 21 CFR 172.800 and 172.886 discuss the use of acesulfame potassium and petroleum wax as food additives, respectively. The regulations state that certain references are available from the “Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740” and are available for examination at the “Food and Drug Administration's Main Library.” The technical amendment: (1) updates the associated address of where the references are available to be “Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1200;” and (2) revises where the references are available for examination to be FDA's Dockets Management Staff.

Our regulations in 21 CFR 172.804 discuss the use of aspartame as a food additive. The regulations discuss standards of identity established under “section 401 of the act” and, at paragraph (c)(2), states that a specific analytical method is available from the “Office of Premarket Approval (HFS-200), Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993” and are available for inspection at either the “Center for Food Safety and Applied Nutrition's Library” or the “Food and Drug Administration's Main Library.” The technical amendment: (1) revises “section 401 of the act” to read as “section 401 of the Federal Food, Drug, and Cosmetic Act” to clarify which statute is being referenced; (2) replaces “Office of Premarket Approval” with “Office of Food Additive Safety” to reflect the office's current name; (3) updates the associated address for the Office of Food Additive Safety; and (4) revises where the reference is available for examination to be FDA's Dockets Management Staff.

Our regulations in 21 CFR 172.864 discuss the use of synthetic fatty alcohols as a food additive. The regulation states that various analytical methods are either available from the “Office of Food Additive Safety, 5001 Campus Dr., College Park, MD 20740” or the “Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740.” The regulation also states that these references are available for examination at the “Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039.”The technical amendment: (1) replaces “Office of Food Additive Safety, 5001 Campus Dr., College Park, MD 20740” with “Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1200;” (2) replaces “Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039” with “Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday;” and (3) replaces “Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740” with “Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1200.” We are making this change to update the office address and contact information of the office where the references are available.

Our regulations in 21 CFR 173.25, 173.45, 173.228, 173.280, 173.310, 173.325, 173.356, 173.368, and 173.375 discuss the use of ion-exchange resins, polymaleic acid and its sodium salt, ethyl acetate, solvent extraction process for citric acid, boiler water additives, acidified sodium chlorite solutions, hydrogen peroxide, ozone, and cetylpyridinium chloride as secondary direct food additives, respectively, and state that certain references are available for examination from the “Food and Drug Administration's Main Library.” The technical amendment revises where the references are available for examination to be FDA's Dockets Management Staff.

Our regulations in 21 CFR 173.60, 173.65, 173.73, and 173.400 discuss the use of dimethylamine-epichlorohydrin copolymer, divinylbenzene copolymer, sodium polyacrylate, and dimethyldialkylammonium chloride as secondary direct food additives, respectively, and state that certain references are available from either the “Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740” or the “Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740.” The technical amendment replaces all instances of “Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740” or “Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740” with “Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1200.” We are making this change to update the name and contact information of the office where the references are available.

Our regulations in 21 CFR 173.115 discuss the use of alpha-acetolactate decarboxylase (α-ALDC) enzyme preparation derived from a recombinant Bacillus subtilis as a secondary direct food additive. The regulations state that certain references may be examined at the “Center for Food Safety and Applied Nutrition, 5001 Campus Dr., College Park, MD 20740.” The technical amendment revises where the references are available for examination to be FDA's Docket Management Staff.

Our regulations in 21 CFR 173.160 and 173.165 discuss the use of Candida guilliermondii and Candida lipolytica as secondary direct food additives, respectively, and state that certain references are available from the “Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740” and are available for examination at the “Food and Drug Administration's Main Library.” The technical amendment: (1) updates the associated address of where the references are available to be “Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1200;” and (2) revises where the references are available for examination to be FDA's Dockets Management Staff.

Our regulations in 21 CFR 173.300, 173.340, and 173.357 discuss the use of chlorine dioxide, defoaming agents, and materials used as fixing agents in the immobilization of enzyme preparations as secondary direct food additives, respectively, and state that certain references are available from the “Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740.” The regulations also state that the references are available for examination at the “Food and Drug Administration's Main Library.” The technical amendment: (1) revises the office contact information to add the office's telephone number, “240-402-1200,” to the end; and (2) revises where the references are available for examination to be FDA's Dockets Management Staff.

Our regulations in 21 CFR 173,370 discuss the use of peroxyacids as secondary direct food additives. The regulation in § 173.370(c) states that specific analytical methods can be obtained from the “Division of Petition Review” or are available for examination at the “Food and Drug Administration's Main Library.” The technical amendment: (1) updates the associated address of where the analytical methods can be obtained to be the “Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1200;” and (2) revises where the analytical methods are available for examination to be FDA's Dockets Management Staff.

Our regulations in part 184 discuss direct food substances affirmed as generally recognized as safe. Throughout part 184, the regulations state that certain references are available for examination at the “Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039.” The technical amendment revises where the references are available for examination to be “Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday.”

Our regulations in § 184.1538 (21 CFR 184.1538) discuss nisin preparation as a specific substance affirmed as GRAS. The regulation in § 184.1538(b) and (d) states that copies of a specific reference are available from the “Division of Dockets Management.” The technical amendment replaces “Division of Dockets Management” with “Dockets Management Staff” to reflect the current name and contact information of the office from which the reference is available.

Our regulations in part 190, subpart B, discuss NDI notifications. The regulation in 21 CFR 190.6(a) discusses the requirement for premarket notification and directs submissions to the “Office of Nutritional Products, Labeling and Dietary Supplements (HFS-820), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740.” The technical amendment updates the address to “Office of Dietary Supplement Programs (HFS-810), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740.” This technical amendment reflects our current organizational structure with regard to dietary supplements.

Publication of this document constitutes final action of these changes under the Administrative Procedure Act (APA) (5 U.S.C. 553). Under 5 U.S.C. 553(b)(3)(B) of the APA, an Agency may, for good cause, find (and incorporate the finding and a brief statement of reasons in the rules issued) that notice and public comment procedure on a rule is impracticable, unnecessary, or contrary to the public interest. We have determined that notice and public comment are unnecessary because these amendments only make technical or non-substantive changes, such as correcting sample labels, updating office or organization names, and updating addresses. For these reasons, we have determined that publishing a notice of proposed rulemaking and providing opportunity for public comment is unnecessary.

In addition, FDA finds good cause for these amendments to become effective on the date of publication of this action. The APA allows an effective date less than 30 days after publication as provided by an Agency for good cause found and published with the rule (5 U.S.C. 553(d)(3)). A delayed effective date is unnecessary in this case because the amendments do not impose any new regulatory requirements on affected parties. As a result, affected parties do not need time to prepare before the rule takes effect. Therefore, we find good cause for this correction to become effective on the date of publication of this action.

This final rule contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.

We have determined under 21 CFR 25.30(h) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

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

We have analyzed this rule in accordance with the principles set forth in Executive Order 13175. We have determined that the rule does not contain policies that have substantial direct effects on one or more Indian Tribes, on the relationship between the Federal Government and Indian Tribes, or on the distribution of power and responsibilities between the Federal Government and Indian Tribes. Accordingly, we conclude that the rule does not contain policies that have tribal implications as defined in the Executive Order and, consequently, a tribal summary impact statement is not required.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 101, 106, 170, 172, 173, 184, and 190 are amended as follows:

I. Background and Legal Authority

The OCSLA, at 43 U.S.C. 1350(b)(1), directs the Secretary of the Interior (Secretary) to adjust the OCSLA maximum daily civil penalty amount at least once every three years to reflect any increase in the CPI-U to account for inflation. On November 2, 2015, the President signed into law the FCPIA of 2015 (Sec. 701 of Pub. L. No. 114-74), which required Federal agencies to adjust the level of civil monetary penalties found in their regulations with an initial “catch-up” adjustment through rulemaking, if warranted, and then to make subsequent annual adjustments for inflation. The purpose of these adjustments is to maintain the deterrent effect of civil penalties and to further the policy goals of the underlying statutes. Agencies were required to publish the first annual inflation adjustments in the Federal Register by no later than January 15, 2017, and must publish recurring annual inflation adjustments by no later than January 15 of each subsequent year.

BSEE last updated the maximum daily civil penalty amounts in BSEE's regulations for OCSLA violations by a final rule published and effective on February 24, 2022. ( See 87 FR 10306). Consistent with OMB guidance, BSEE's final rule implemented the inflation adjustments required by the FCPIA of 2015 through October 2021.

The OMB Memorandum M-23-05 ( Implementation of Penalty Inflation Adjustments for 2023, Pursuant to the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015; available at https://www.whitehouse.gov/wp-content/uploads/2022/12/M-23-05-CMP-CMP-Guidance.pdf ) explains agency responsibilities for: identifying applicable penalties and performing the annual adjustment; publishing revisions to regulations to implement the adjustment in the Federal Register ; applying adjusted penalty levels; and performing agency oversight of inflation adjustments.

BSEE is promulgating this 2023 inflation adjustment for the OCSLA maximum daily civil penalties as a final rule pursuant to the provisions of the FCPIA of 2015 and OMB's guidance. A proposed rule is not required because the FCPIA of 2015 expressly exempted the annual inflation adjustments implemented pursuant to the FCPIA of 2015 from the pre-promulgation notice and comment requirements of the Administrative Procedure Act, 5 U.S.C. 553 et seq. (the APA), allowing those adjustments to be published as final rules. Specifically, the FCPIA of 2015 states that agencies shall adjust civil monetary penalties “notwithstanding Section 553 of the Administrative Procedure Act.” (FCPIA of 2015 at § 4(b)(2)). This interpretation of the FCPIA of 2015 is confirmed by OMB Memorandum M-23-05 at 3-4 (“This means that the public procedure the APA generally requires—notice, an opportunity for comment, and a delay in effective date—is not required for agencies to issue regulations implementing the annual adjustment.”).

In accordance with the FCPIA of 2015 and the guidance provided in OMB Memorandum M-23-05, BSEE has calculated the necessary inflation adjustment for the maximum daily civil monetary penalty amount in 30 CFR 250.1403 for violations of OCSLA. The previous OCSLA civil penalty inflation adjustment accounted for inflation through October 2021. The required annual civil penalty inflation adjustment promulgated through this rule accounts for inflation through October 2022.

Annual inflation adjustments are based on the percent change between the CPI-U for the October preceding the date of the adjustment and the prior year's October CPI-U. Consistent with the guidance in OMB Memorandum M-23-05, BSEE divided the October 2022 CPI-U by the October 2021 CPI-U to calculate the multiplying factor. In this case, the October 2022 CPI-U (298.012) divided by the October 2021 CPI-U (276.589) is 1.07745. OMB Memorandum M-23-05 confirms that this is the proper multiplier. (OMB Memorandum M-23-05 at 1, n.4).

The FCPIA of 2015 requires that BSEE adjust the OCSLA maximum daily civil penalty amount for inflation using the applicable 2023 multiplier (1.07745). Accordingly, BSEE multiplied the existing OCSLA maximum daily civil penalty amount ($48,862) by 1.07745 to arrive at the new maximum daily civil penalty amount ($52,646.36). The FCPIA of 2015 requires that the resulting amount be rounded to the nearest $1.00 at the end of the calculation process. Accordingly, the adjusted OCSLA maximum daily civil penalty for 2023 is $52,646.

The adjusted penalty levels take effect immediately upon publication of this rule. Pursuant to the FCPIA of 2015, the increase in the OCSLA maximum daily civil penalty amount applies to civil penalties assessed after the date the increase takes effect, even when the associated violation(s) predates such increase. Consistent with the provisions of OCSLA and the FCPIA of 2015, this rule adjusts the following maximum civil monetary penalty per day per violation as follows:

This rulemaking does not address any updates to the civil penalties related to Federal Oil and Gas Royalty Management Act (FOGRMA) violations. Per 86 FR 34132, BSEE regulations at 30 CFR part 250 Subpart N addressing maximum FOGRMA civil penalties (30 CFR 250.1453) cross-reference regulations of the Office of Natural Resources Revenue (ONRR) at 30 CFR 1251.52 that set maximum daily civil penalty amounts for FOGRMA violations that are not timely corrected. Please refer to the cross-referenced ONRR regulations for the most up to date FOGRMA civil penalty amounts.

Executive Order (E.O.) 12866 provides that the OMB Office of Information and Regulatory Affairs (OIRA) will review all significant rules. OIRA has determined that this rule is not significant. ( See OMB Memorandum M-23-05 at 3).

E.O. 13563 reaffirms the principles of E.O. 12866 while calling for improvements in the Nation's regulatory system to promote predictability, to reduce uncertainty, and to use the best, most innovative, and least burdensome tools for achieving regulatory ends. E.O. 13563 directs agencies to consider regulatory approaches that reduce burdens and maintain flexibility and freedom of choice for the public where these approaches are relevant, feasible, and consistent with regulatory objectives. E.O. 13563 further emphasizes that regulations must be based on the best available science and that the rulemaking process must allow for public participation and an open exchange of ideas. We have developed this rule in a manner consistent with these requirements, to the extent permitted by statute.

The Regulatory Flexibility Act (RFA) requires an agency to prepare a regulatory flexibility analysis for rules unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. The RFA applies only to rules for which an agency is required to first publish a proposed rule. ( See 5 U.S.C. 603(a) and 604(a)). The FCPIA of 2015 expressly exempts these annual inflation adjustments from the requirement to publish a proposed rule for notice and comment. ( See FCPIA of 2015 at § 4(b)(2); OMB Memorandum M-23-05 at 3-4). Thus, the RFA does not apply to this rulemaking.

This rule is not a major rule under 5 U.S.C. 804(2), the Congressional Review Act/Small Business Regulatory Enforcement Fairness Act. This rule:

(1) Does not have an annual effect on the economy of $100 million or more;

(2) Will not cause a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions; and

(3) Does not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S.-based enterprises to compete with foreign-based enterprises.

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

This rule does not effect a taking of private property or otherwise have takings implications under E.O. 12630. Therefore, a takings implication assessment is not required.

Under the criteria in section 1 of E.O. 13132, this rule does not have sufficient federalism implications to warrant the preparation of a federalism summary impact statement. To the extent that State and local governments have a role in Outer Continental Shelf activities, this rule will not affect that role. Therefore, a federalism summary impact statement is not required.

This rule complies with the requirements of E.O. 12988. Specifically, this rule:

(1) Meets the criteria of section 3(a) requiring that all regulations be reviewed to eliminate errors and ambiguity and be written to minimize litigation; and

(2) Meets the criteria of section 3(b)(2) requiring that all regulations be written in clear language and contain clear legal standards.

The Department of the Interior strives to strengthen its government-to-government relationship with Indian tribes through a commitment to consultation with Indian Tribes and recognition of their right to self-governance and Tribal sovereignty. We have evaluated this rule under the Department of the Interior's consultation policy, under Departmental Manual Part 512 Chapters 4 and 5, and under the criteria in E.O. 13175. We have determined that it has no substantial direct effects on Federally-recognized Indian Tribes or Alaska Native Claims Settlement Act (ANCSA) Corporations, and that consultation under the Department of the Interior's Tribal and ANCSA consultation policies is not required.

This rule does not contain information collection requirements, and a submission to the OMB under the Paperwork Reduction Act (44 U.S.C. 3501 et seq. ) is not required.

This rule does not constitute a major Federal action under the National Environmental Policy Act of 1969 (NEPA) because of the non-discretionary nature of the civil penalty adjustment as required by law ( see 40 CFR 1508.1(q)(1)(ii)). The FCPIA of 2015 requires BSEE to annually adjust the amounts of its civil penalties to account for inflation as measured by the Department of Labor's Consumer Price Index. Accordingly, BSEE has no discretion in the execution of the civil penalty adjustments reflected in this final rule. Because this rule is not a major Federal action, it is not subject to the requirements of NEPA. Even if this were a discretionary action subject to NEPA, which it is not, a detailed statement under NEPA would nevertheless not be required because, as a regulation of an administrative nature, this rule would otherwise be covered by a categorical exclusion ( see 43 CFR 46.210(i)). BSEE has determined that the rule does not implicate any of the extraordinary circumstances listed in 43 CFR 46.215 that would prevent reliance on the categorical exclusion. Therefore, a detailed statement under NEPA is not required.

This rule is not a significant energy action under the definition in E.O. 13211. Therefore, a Statement of Energy Effects is not required.

For the reasons given in the preamble, the BSEE amends title 30, chapter II, subchapter B, part 250 of the Code of Federal Regulations as follows.

Electronic Availability

This document and additional information concerning OFAC are available on OFAC's website: www.treas.gov/ofac.

On February 9, 2023, OFAC issued GL 23 to authorize certain transactions otherwise prohibited by the Syrian Sanctions Regulations, 31 CFR part 542. The GL was made available on OFAC's website ( www.treas.gov/ofac ) when it was issued. The GL has an expiration date of August 8, 2023. The text of the GL is provided below.

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

The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because it is impracticable and contrary to the public interest. Local authorities asked the Coast Guard to establish the security zone within several days of the request, therefore the Coast Guard lacks sufficient time to provide for a comment period and then consider those comments before issuing the rule, since this rule is needed by March 25, 2023. This rule s needed to prevent vessels from approaching the VIP location in Miami Beach, FL. It would be contrary to public interest to postpone establishing the temporary security zone.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register . Delaying the effective date of this rule would be impracticable because immediate action is needed to prevent interference with the VIP visit to Miami Beach, FL.

The Coast Guard is issuing this rule under authority in 46 U.S.C. 70124. The Captain of the Port (COTP) Miami has determined the VIP visit on March 25, 2023 presents a potential target for terrorist acts, sabotage, or other subversive acts, accidents, or other causes of a similar nature. This moving security zone is necessary to protect the official party, public, and surrounding waterways surrounding the M/V BISCAYNE LADY in Miami Beach, Florida.

This rule establishes a moving security zone from 6 p.m. through 11 p.m. on March 25, 2023. The moving security zone will cover all navigable waters within 100 yards of the M/V BISCAYNE LADY. No vessel or person will be permitted to enter the safety zone without obtaining permission from the COTP Miami or a designated representative. If authorization to enter, transit through, anchor in, or remain within the security zone is granted by the COTP or a designated representative, all persons and vessels receiving such authorization must comply with the instructions of the COTP or a designated representative.

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

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

This regulatory action determination is based on the size and location of the security zone. The moving security zone is limited in size and location as it will encompass all navigable waters within 100 yards of the M/V BISCAYNE LADY, transiting through the ICW in the vicinity of Miami Beach, FL. Although persons and vessels will not be able to enter, transit through, anchor in, or remain within the security zone without authorization from the Captain of the Port Miami or a designated representative, they may operate in the surrounding area during the enforcement period. Furthermore, the rule will allow vessels to seek permission to enter the zone. Persons and vessels may only enter, transit through, anchor in, or remain within the security zone during the enforcement period if authorized by the Captain of the Port Miami or a designated representative.

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

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

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

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

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

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

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

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

We have analyzed this rule under Department of Homeland Security Directive 023-01, Rev. 1, associated implementing instructions, and Environmental Planning COMDTINST 5090.1 (series), which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a temporary moving security zone lasting approximately 5 hours that will prohibit entry of persons or vessels during the VIP visit in Miami Beach, Florida. It is categorically excluded from further review under paragraph L60(d) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1.

A Draft Record of Environmental Consideration supporting this determination is available in the docket. For instructions on locating the docket, see the ADDRESSES section of this preamble.

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

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

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

The Coast Guard will enforce the safety zone in 33 CFR 165.1198 for the Military Ocean Terminal Concord, CA (MOTCO) regulated area from 12:01 a.m. on March 23, 2023, until 11:59 p.m. on March 29, 2023, or as announced via marine local broadcasts. This safety zone is necessary to protect personnel, vessels, and the marine environment from potential explosion within the explosive arc. The regulation for this safety zone, § 165.1198, specifies the location of the safety zone which encompasses the navigable waters in the area between 500 yards of MOTCO Pier 2 in position 38°03′30″ N, 122°01′14″ W and 3,000 yards of the pier. During the enforcement periods, as reflected in § 165.1198(d), if you are the operator of a vessel in the regulated area you must comply with the instructions of the COTP or the designated on-scene patrol personnel. Vessel operators desiring to anchor or otherwise loiter within the safety zone must contact Sector San Francisco Vessel Traffic Service at 415-556-2760 or VHF Channel 14 to obtain permission.

In addition to this notification of enforcement in the Federal Register , the Coast Guard plans to provide notification of this enforcement period via marine information broadcasts.

Background

This final rule is promulgated under the University and Small Business Patent Procedures Act of 1980, Public Law 96-517 (as amended), codified at title 35 of the United States Code (U.S.C.) 200 et seq., and commonly known as the “Bayh-Dole Act” or “Bayh-Dole,” and its implementing regulations, found at title 37 Code of Federal Regulations (CFR) parts 401 and 404.

The rule shall apply to all new funding agreements as defined in 37 CFR 401.2(a) that are executed after the effective date of the rule. The rule shall not apply to a funding agreement in effect on or before the effective date of the rule, provided that if such existing funding agreement is thereafter amended, the funding agency may, in its discretion, make the amended funding agreement subject to the rule prospectively.

On January 4, 2021, NIST published a notice of proposed rulemaking (NPRM) in the Federal Register (86 FR 35) requesting public comments on proposed revisions to the regulations at 37 CFR parts 401 and 404, as well as general comments relating to federal technology transfer practices. The NPRM described the statutory framework for the proposed rule revisions under the Bayh-Dole Act and its implementing regulations. NIST received 81,253 submissions during the public comment period, which closed on April 5, 2021, including comments, questions, suggestions, and recommendations from, inter alia, individual members of the public, public and private universities, professional associations, research institutions, and non-profit foundations. Of the 81,253 submissions received during the public comment period, the largest percentage of the comments related to the proposed addition to 37 CFR 401.6(e) regarding exercising march-in rights on the sole basis of product pricing. A discussion of these comments and NIST's response is included in Comment 8 below. During the public comment period, on February 25, 2021, NIST also held a public webinar in which the proposed changes were reviewed, and public statements were accepted and made a part of the record. NIST appreciates and has considered the comments received, and this final rule reflects a number of changes to the regulations proposed in the NPRM based on this feedback.

Additionally, severability clauses have been added to both Parts 401 and 404 in this final rule. In the event that any part of the regulations is stayed or determined to be invalid, the remaining provisions should be severable and remain in effect.

All submissions were carefully reviewed, and NIST thanks the public for its engagement. NIST's responses to comments within the scope of this rulemaking have been correlated by topic and are summarized below.

1. Comment: NIST's legal authority to promulgate regulations implementing the Bayh-Dole Act was questioned by one commenter, who asserted that the regulations should instead emanate directly from the Department of Commerce.

Response: Authority to issue these regulations is granted to the Secretary of Commerce under 35 U.S.C. 206 and has been properly delegated to the Director of NIST under Department of Commerce Department Organization Order 30-2A.

2. Comment: The NPRM stated that the rulemaking was not an “economically significant” regulatory action under Executive Order 12866, “as it does not have an effect on the economy of $100 million or more in any one year . . . .” This determination was questioned by a commenter based on the regulations' application “to all Federal agencies,” and the large number of inventions and patents in which the Federal Government maintains an interest.

Response: NIST determined at the proposed rule stage that this rulemaking is not an economically significant regulatory action under section 3(f)(1) of Executive Order 12866. NIST conducted an analysis, by looking at all the proposed changes and the effect of those changes on the existing regulations, and concluded that the changes to the regulations are primarily clarifications and a reorganization of existing content. NIST has compared the text of the proposed rule to the text of this final rule and affirms its earlier determination that the regulatory changes are not economically significant.

3. Comment: Two commenters objected to the proposed removal of § 401.1(a), which describes the effect of third-party funding on the ownership of a “subject invention” and the treatment of any invention created under a project that is closely related to, but separate from, a project funded by the Federal Government. The objecting commenters requested that these clarifications be maintained, as they are of use in determining whether or not an invention is a “subject invention.”

Response: NIST has re-inserted the introductory language at § 401.1(a) to maintain this additional guidance and clarification.

4. Comment: Multiple commenters were supportive of, objected to, and/or requested additional clarification on the proposed revisions to the newly designated § 401.6(a)(1) (previously § 401.6(b)). Those who objected or requested additional information generally expressed concern that this process would be adversarial or asked that other title holders, including exclusive licensees, also be permitted to attend the consultation.

Response: Both the original and the revised versions of this section establish an informal process between a funding agency and a contractor prior to the agency's initiation of march-in procedures, though the original version limited this process to “informal written or oral comments from the contractor as well as information relevant to the matter.” The proposed language expands this process to a full informal consultation and was more explicit about the nature of the consultation, explaining that the additional factfinding would allow the agency to better “understand the nature of the issue and consider possible actions other than exercising march-in rights.” It was not the intent of this addition to create an adversarial process; the intent was to encourage informal consultation and to potentially avoid the need to proceed to formal march-in procedures. Regarding commenters' requests to include licensees in the consultation, given its informal nature, agencies have discretion to include additional parties, if necessary. Therefore, NIST determined that explicitly including or requiring additional parties was unnecessary. To address commenters' concerns regarding the nature of the informal consultation, NIST has replaced “actions” with “alternatives” in this final rule and added the words “may also” to the statement regarding the funding agency's consideration of march-in alternatives.

5. Comment: One commenter objected to the requirement under the newly designated § 401.6(a)(1) (previously § 401.6(b)) that the contractor respond to an agency request for informal consultation within 30 days, expressing the opinion that contractors should be allowed a longer amount of time in which to respond.

Response: This 30-day response period was present in the previous regulations but required the contractor to provide written comments to the agency within 30 days. The revision provides this same 30-day period, but only requires the contractor to provide notice to the agency that the contractor wishes to proceed with informal consultation. Given that this revision only requires the contractor to make a determination regarding whether to participate in an informal consultation and not the time required to collect and compose comments, 30 days is a sufficient amount of time for a contractor to provide such notice, and NIST declines to lengthen the response period in this final rule.

6. Comment: A proposed revision to the newly designated § 401.6(a)(1) (previously § 401.6(b)) increased the amount of time for an agency to issue a decision as to whether or not it will pursue march-in rights following an informal consultation with a contractor from 60 days to 120 days. A commenter questioned the necessity of this longer response period.

Response: The longer period is believed appropriate to facilitate and ensure thorough agency consideration of all issues and supplementary information submitted by the contractor following informal consultation; thus, NIST has maintained the NPRM's extension from 60 days to 120 days in this final rule.

7. Comment: Several comments were received relating to newly designated § 401.6(a)(4) (previously § 401.6(e)), which concerns the confidentiality of information obtained during march-in proceedings. Concern was expressed over the addition of language that allows an agency to disclose information obtained during a march-in proceeding to persons outside the Federal Government when “otherwise required by law.”

Response: The intent of this additional language is to put contractors on notice that other laws may require disclosure of the information, and compliance with such laws is mandatory, whether or not the phrase in question is added to the regulations. NIST has maintained the phrase in this final rule.

8. Comment: The large majority of comments received related to the new language proposed at § 401.6(e). (The NPRM redesignated the previous § 401.6(e), which relates to fact-finding during the march-in process, as the new § 401.6(a)(4)). The proposed new § 401.6(e) of the NPRM stated that “[m]arch-in rights shall not be exercised exclusively based on the business decisions of the contractor regarding the pricing of commercial goods and services arising from the practical application of the invention.” These comments ranged in content. Many commenters stated that the provision should be removed and that the Federal Government's right to march-in should be exercised solely on the basis of product pricing. Some expressed general support for the addition, and others requested additional changes to further clarify and ensure that the Federal Government would not march-in based on product pricing.

Response: The large number of comments received on this issue raise questions that warrant further consideration. Consistent with this, on July 9, 2021, the President issued Executive Order 14036 (“Promoting Competition in the American Economy”), which, inter alia, directed the Secretary of Commerce, acting through the Director of NIST and in light of the policies set forth in the Executive Order, to consider not finalizing “any provisions on march-in rights and product pricing” in the NPRM. Given the comments received, NIST's examination of them, and the Executive Order, NIST removed this provision from the final rule. The circumstances in which an agency might exercise its right to march-in are enumerated in the regulations at § 401.14(j) and include (a) a contractor's failure to take action to achieve practical application of a subjection invention, (b) a contractor's failure to meet health or safety needs, (c) a contractor's failure to meet public use requirements, and (d) a contractor's failure to comply with the preference for United States industry. NIST intends to engage with stakeholders and agencies with the goal of developing a comprehensive framework for agencies considering the use of march-in provisions. In this final rule, § 401.6(e) of the NPRM is removed, and § 401.6(f) of the NPRM is redesignated as § 401.6(e).

9. Comment: The NPRM reorganized § 401.13, relocating certain paragraphs ( e.g., § 401.13(a) became § 401.14(c)(6)), removing outdated portions, and retitling the section from “Administration of patent rights clauses” to “Confidentiality of contractor submissions.” Several commenters that were supportive of the revisions asked NIST to expand the confidentiality provisions to apply to all information related to “subject inventions.”

Response: This final rule maintains the revisions to § 401.13 that were proposed in the NPRM, which includes confidentiality protections for contractor submissions under many circumstances. While NIST appreciates the importance of maintaining the confidentiality of information related to inventions for which patent protection has not yet been sought as well as business information, NIST cannot expand confidentiality provisions beyond those provided in the Bayh-Dole statute and therefore has not expanded the confidentiality provisions in this final rule.

10. Comment: Several commenters objected to the proposed change in § 401.14(a)(2) amending the definition of “subject invention.” These changes included a rephrasing of the definition and the incorporation of a clarifying statement explaining that “[a]n invention that is conceived and reduced to practice without the use of any federal funds is not considered a subject invention.”

Response: NIST has removed this revision from the final rule, as the additional guidance regarding inventions conceived without the use of any federal funds was reinstated at § 401.1(a), as discussed in Comment 3 above.

11. Comment: The NPRM revised § 401.14(c)(3), creating (c)(3)(i)-(iv). Several commenters expressed concern with the proposed additional language in § 401.14(c)(3)(ii) requiring that each provisional application filed after a first provisional application “contain additional written description of the subject invention not previously disclosed in a patent application.” Commenters pointed to the increasingly common practice of re-filing provisional applications since the United States moved to a first-to-file patent system, and there was also confusion expressed as to whether prior agency approval would be needed before the filing of additional provisional patent applications.

Response: NIST appreciates the submitted comments and the need for contractor flexibility in developing patent filing strategy. Therefore, NIST has removed the requirement that additional written description of the subject invention be included in subsequent provisional patent filings. NIST has further revised this provision to clarify that additional provisional patent applications may be filed until the nonprovisional application is timely filed in accordance with § 401.14(c)(3)(i) and allowing for additional extensions, if needed, granted under § 401.14(c)(5). Nothing in these regulations supersedes any deadlines or requirements imposed by the United States Patent and Trademark Office.

12. Comment: Under § 401.14(c)(3)(iv) and if required by the funding agency, a contractor must provide information related to patent filings, including the filing date, application number, title, a copy of the patent application, patent number, and issue date. One commenter requested that this section be revised to remove the discretionary aspect, instead requiring each agency to ask for this information.

Response: NIST notes that many agencies already request this information as a matter of course. However, NIST leaves the collection of specific information to the discretion of funding agencies.

13. Comment: Several commenters supported the revision to § 401.14(d) allowing agencies to release the contractor from the requirement to convey title to a subject invention to the agency, although many commenters requested that there be a timeframe in which the agency must respond to a request for release under this provision.

Response: NIST will work with the interagency community to provide additional guidance on the waiver process, as needed. Because each agency concerned must adhere to different internal requirements and processes in furtherance of their unique missions, a specific time limit for agency response would not be advisable, and NIST declines to impose the same in this final rule.

14. Comment: At § 401.14(k), (k)(4) of the regulations was revised and divided into the newly designated sections (k)(4) and (k)(5). Both the previous regulations and the NPRM contained the requirement at § 401.14(k)(4) that the contractor make efforts that are reasonable under the circumstances to attract licensees of subject inventions that are small business firms and, when appropriate, give preference to a small business firm when licensing a subject invention. Part of the previous § 401.14(k)(4) and the NPRM's newly designated § 401.14(k)(5) require that the contractor “negotiate changes to its licensing policies, procedures, or practices” with the funding agency if the funding agency's review of the contractor's licensing programs and decisions discloses that the contractor could take reasonable steps to more effectively implement the small business consideration requirements. Several commenters requested an amendment to the language changing “negotiate” to “consider.”

Response: The language in question was not proposed for revision, as the requirement that small business firms be given a preference in the licensing of subject inventions is statutory, 35 U.S.C. 202. Requiring a contractor to only “consider” reasonable changes to implement this statutory requirement would be inadequate; thus, NIST has maintained the requirement that a contractor negotiate such reasonable changes with a funding agency in this final rule.

15. Comment: One commenter objected to the removal of § 401.15, stating that guidance on deferred determinations should be retained.

Response: The guidance on deferred determinations previously found at § 401.15 has been substantially retained in § 401.9 of both the proposed and final rule.

16. Comment: Previously entitled “Electronic filing,” § 401.16 was revamped in the NPRM and retitled “Federal agency reporting requirements.” Its requirements relate to information that must be reported by agencies internally, within the Federal Government. Several commenters requested the addition of language that would limit the information being reported to only that data that is already available within the iEdison system, as well as text that would require the agencies to pull the information from iEdison when fulfilling their reporting obligations so as to avoid creating an additional reporting burden for contractors.

Response: As noted by the commenters, many of the data points for which reporting is required under § 401.16 are currently available via iEdison, and NIST intends to incorporate the remainder in a forthcoming update to the iEdison system to minimize the burden on agencies in fulfilling this requirement. However, while NIST appreciates the commenters' concerns and strongly supports the use of iEdison by funding agencies, NIST cannot mandate or compel agency use of iEdison, nor can NIST dictate the manner in which the agencies collect data. Accordingly, NIST declines to make the suggested revision in this final rule.

17. Comment: At § 404.2, entitled “Policy and objective,” the NPRM amended and expanded the previous text. Comments were received objecting to the proposed revisions, observing the text's brevity as compared to the stated objectives in 35 U.S.C. 200 and questioning its consistency with the definition of “practical application.”

Response: The text of 35 U.S.C. 200 remains governing law. The revisions at § 404.2 do not alter the definition of “practical application” found at § 401.2. The amended text does not consider payments as achieving “practical application”; it encourages the Federal Government to consider how the utilization of payments under a license agreement may encourage licensees to develop an invention in order to advance practical application and to promote commercialization by the licensee. NIST has slightly reworded § 404.2, in order to clarify the intent in this final rule.

18. Comment: One commenter objected to the removal of § 404.4 and requested additional language specific to certain action items, diseases, and/or products. NIST also received a comment from a federal agency to re-insert § 404.4, because the requirement to notify the public of federally owned inventions available for license is not found elsewhere within the regulation.

Response: The regulations are meant to apply to an invention without regard to invention type or industry sector, and therefore, NIST declines to add references to specific sectors, diseases, or products. However, although much of this section is already substantively included elsewhere, NIST agrees that the requirement to publish federally owned inventions is not. NIST will re-insert § 404.4 in its entirety keeping the language unchanged from the previous regulations.

19. Comment: Many commenters objected to the NPRM's proposed amendment of § 404.7(a)(1). The proposed rule retained the requirement that, prior to granting an exclusive, co-exclusive, or partially exclusive license on a Government owned invention, the Government must first publish a notice identifying the invention on which the proposed license is to be granted. However, the proposed rule removed the requirement that the identity of the prospective licensee of a Government owned invention also be published.

Response: In order to keep the public apprised of prospective licensees of Government owned inventions, NIST has reincorporated the requirement that the identity of such a prospective licensee be published alongside the invention into this final rule.

20. Comment: One commenter objected to the NPRM's proposed rewording at § 404.7(a)(3) (previously § 404.7(a)(1)(iii)). Under the previous language, before granting an exclusive, co-exclusive, or partially exclusive license to a Government owned invention, it was required that “[t]he Federal agency ha[d] not determined that the grant of such a license [would] tend substantially to lessen competition or create or maintain a violation of the Federal antitrust laws.” In the NPRM, the requirement of non-determination was altered into a requirement of affirmative determination, such that the license could be granted after “[t]he Federal agency has determined that the grant of such a license will not tend to substantially lessen competition or create or maintain a violation of the Federal antitrust laws.”

Response: The proposed changes in the NPRM were meant to mirror the wording in the corresponding statute at 35 U.S.C. 209(a)(4). While appreciative of the alternative language recommended, NIST only made one revision to the language proposed in the NPRM in this final rule, which moved the word “to” before the word “lessen” in order to mirror the exact wording at 35 U.S.C. 209(a)(4).

21. Comment: Several commenters objected to the NPRM's proposed addition of language at § 404.11(a)(3); § 404.11(a) lists the parties who may appeal certain agency decisions or determinations relating to Government owned inventions.

Response: Under this section, certain parties may appeal an agency decision or determination concerning the grant, denial, modification, or termination of a license, which, under § 404.5, an agency may grant “only if the applicant has supplied the Federal agency with a satisfactory plan for development or marketing of the invention, or both, and with information about the applicant's capability to fulfill the plan.” The added language at § 404.11(a)(3) provides that a person who files a written objection to an agency's notice of proposed licensing also demonstrate that the proposed license would deny that person the opportunity to commercialize the invention. If a third party who is not denied the opportunity to commercialize the invention opposes a proposed license, they need only find another party willing to license the invention to appeal. Requiring less would result in an appeal with the potential to result in no license or commercialization. Therefore, this additional language is maintained in the final rule.

1. Re-insert the guidance and examples in § 401.1(a).

2. Remove § 401.2(m)(4) from the definition of “patent application” and redesignate the proposed § 401.2(m)(5) as § 401.2(m)(4).

3. Remove § 401.2(n)(3) from the definition of “initial patent application,” redesignate §§ 401.2(n)(4) and (5) as §§ 401.2(n)(3) and (4) and remove “which designates the United States” from the newly designed § 401.2(n)(3).

4. Revise the first sentence of § 401.6(a)(1) to add “may also” and replace “actions” with “alternatives”.

5. Remove the proposed addition at § 401.6(e) regarding the consideration of pricing of commercial goods and services and redesignate the proposed § 401.6(f) as § 401.6(e).

6. Remove the proposed revisions to the definition of “subject invention” at § 401.14(a)(2).

7. Revise § 401.14(c)(3) by moving the last sentence of § 401.14(c)(3)(i) to § 401.14(c)(3)(ii).

8. Revise § 401.14(c)(3)(ii) to remove the requirement that additional written description be included in each provisional application filed following the initial patent application and to clarify that additional provisional applications may be filed so long as a nonprovisional is filed within the regulatory time frame, including any approved extensions.

9. Remove the proposed revision to § 401.14(f)(3).

10. Revise § 401.16 to add “(h) Summary of utilization information provided by contractors,” in accordance with the directive in Executive Order 14036 that the Secretary of Commerce, acting through the Director of NIST, consider such an addition to the regulations.

11. Add § 401.18 to include a severability clause in this Part.

12. Revise § 404.2 to clarify intent by stating that payments received under a license agreement may be considered as “a means for encouraging the licensee to develop an invention in order to advance practical application and to promote commercialization by the licensee.

13. Revise § 404.1(b) to add “and used in accordance with 15 U.S.C. 3710c(a)(1)(B),” to reiterate that royalties collected must be used in accordance with this statute.

14. Re-insert § 404.4 in its entirety.

15. Revise § 404.7(a)(1) to re-insert the phrase “and the prospective licensee” to the information required in a Notice of a prospective license.

16. Revise § 404.7(a)(3) to move the word “to” before the word “lessen” to be consistent with 35 U.S.C. 209(a)(4).

17. Add § 404.15 to include a severability clause in this Part.

This rulemaking is a significant regulatory action under section 3(f)(4) of Executive Order 12866. This rulemaking, however, is not an economically significant regulatory action under section 3(f)(1) of the Executive Order, as it does not have an effect on the economy of $100 million or more in any one year, and it does not have a material adverse effect on the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities. This rule only makes administrative changes for ease, clarity, and transparency, and therefore does not have economically significant effects.

This rule does not contain policies with Federalism implications as defined in Executive Order 13132.

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

Notwithstanding any other provision of law, no person is required to respond to, nor is subject to a penalty for failure to comply with, a collection of information, subject to the requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ) (PRA), unless that collection of information displays a currently valid Office of Management and Budget (OMB) Control Number. This rule contains a collection of information approved by OMB under the following control number: 0693-0090—iEdison. NIST believes any overall increases/decreases in burdens and costs will be minimal and will fall within the already approved amounts for the existing collection. The public may access the current version of the collection, including all supporting materials, at www.reginfo.gov/public/do/PRAMain.

This rule will not significantly affect the quality of the human environment. Therefore, an environmental assessment or Environmental Impact Statement is not required to be prepared under the National Environmental Policy Act of 1969.

For the reasons stated in the preamble, the National Institute of Standards and Technology amends 37 CFR parts 401 and 404 as follows:

Revisions to § 17.643 of Title 38, Code of Federal Regulations (CFR)

In a final rule published in the Federal Register (FR) on March 2, 2023, at 88 FR 13033, VA added the OMB collection number to § 17.643 for the PREL, which is a program in which VA repays educational loans to individuals who pursued a program of study leading to a degree in psychiatric medicine and who are seeking employment in VA. The Paperwork Reduction Act of 1995 (44 U.S.C. 3507). requires that VA consider the impact of paperwork and other information collection burdens imposed on the public. Under 44 U.S.C. 3507(a), an agency may not collect or sponsor the collection of information, nor may it impose an information collection requirement unless it displays a currently valid Office of Management and Budget (OMB) control number. See also 5 CFR 1320.8(b)(3)(vi). We had indicated in the DATES section of the final rule that the effective date for the OMB collection number was for § 17.644. However, the correct section for the OMB collection is § 17.643, not § 17.644. This document corrects the DATES section of that rule to reference the correct document and reflect the full history of the regulation.

In the Federal Register of March 2, 2023 in FR Doc. 2023-04144, on page 13033 in the third column, correct the DATES caption to read:

On December 27, 2021, the Coast Guard published an interim rule titled “Fire Safety on Small Passenger Vessels” that added several requirements for certain covered small passenger vessels. The requirements in the interim rule are based on 46 U.S.C. 3306(n), which was codified by section 8441 of the Elijah E. Cummings Coast Guard Authorization Act of 2020 (Pub. L. 116-283, Jan. 1, 2021). The statute directs the Secretary of the Department of Homeland Security (DHS) to prescribe fire safety regulations for small passenger vessels with overnight accommodations for passengers or operating on Oceans or Coastwise routes, excluding fishing vessels and ferries.

The interim rule contained four provisions that were delayed indefinitely, pending information collection approval from OMB under the Paperwork Reduction Act of 1995, 44 U.S.C. 3501-3520. On February 24, 2023, OMB, Office of Information and Regulatory Affairs, approved the additional information collection requirements in 46 CFR 122.507(b), 122.515(b), 185.507(b), and 185.515(a) within the existing OMB Control Number 1625-0057. Accordingly, we announce that §§ 122.507(b), 122.515(b), 185.507(b), and 185.515(a) are effective April 24, 2023.

Sections 122.507(b) and 185.507(b) relate to logging the occurrence of the mandatory passenger egress drills. Under these paragraphs, passenger egress drills must be logged or otherwise documented, including the date and time of the drill and the number of drill participants. The log will be used by the Coast Guard to confirm that the vessel operators are conducting the passenger egress drills.

Sections 122.515(b) and 185.515(a) contain the requirements for the vessel operator or owner to post the passenger safety bill in each passenger cabin and stateroom, and in passenger accommodation spaces.

These requirements for recording passenger egress drills and posting a passenger safety bill are based on the authority in 46 U.S.C. 3306(n)(3)(A)(vii) and (viii).

As we stated in the interim rule, the passenger emergency egress drills log requirement and the posting of the passenger safety bill apply to vessels regulated under 46 CFR subchapter T and K that have overnight accommodations for passengers.

For the reasons discussed in the preamble, the Coast Guard amends 46 CFR parts 122 and 185 as follows:

The proposed rule was published at 88 FR 3680 on January 20, 2023. The Petitioner filed comments in support of the petition reaffirming its commitment to apply for channel *13. No other comments were filed.

The Bureau believes the public interest would be served by substituting channel *13 for channel *3 at Roanoke, Virginia. The proposed channel substitution will improve viewers' access to the Station's PBS and other public television programming by improving reception and resolving low-VHF reception issues. The Petitioner further states that the Commission has recognized that although VHF reception issues are not universal, “environmental noise blockages affecting [VHF] signal strength and reception exist” and “[vary] widely from service area to service area.” According to the Petitioner, the Station's move from channel *3 to channel *13 is predicted to create an area where 64,309 persons are predicted to lose service without considering the service from other PBS stations. When taking into account the service provided by noncommercial educational stations WUNC-TV and WUNL-TV to the WBRA-TV noise limited service contour area, only 94 persons are predicted to lose access to PBS network programming, which is de minimis.

This is a synopsis of the Commission's Report and Order, MB Docket No. 23-14; RM-11943; DA 23-221, adopted March 15, 2023, and released March 15, 2023. The full text of this document is available for download at https://www.fcc.gov/edocs. To request materials in accessible formats for people with disabilities (braille, large print, electronic files, audio format), send an email to fcc504@fcc.gov or call the Consumer & Governmental Affairs Bureau at 202-418-0530 (voice), 202-418-0432 (tty).

This document does not contain information collection requirements subject to the Paperwork Reduction Act of 1995, Public Law 104-13. In addition, therefore, it does not contain any proposed information collection burden “for small business concerns with fewer than 25 employees,” pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, see 44 U.S.C. 3506(c)(4). Provisions of the Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, do not apply to this proceeding.

The Commission will send a copy of this Report and Order in a report to be sent to Congress and the Government Accountability Office pursuant to the Congressional Review Act, see 5 U.S.C. 801(a)(1)(A).

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

The Atlantic shark fisheries are managed under the 2006 Consolidated Atlantic Highly Migratory Species (HMS) Fishery Management Plan (FMP), its amendments, and implementing regulations (50 CFR part 635) issued under authority of the Magnuson-Stevens Fishery Conservation and Management Act (16 U.S.C. 1801 et seq. ). Section 635.27(b) describes the baseline quotas for different shark management groups and regions, describes the process for annual adjustments to those baseline quotas, and includes the criteria to consider for inseason quota transfers between regions and sub-regions. Section 635.28(b) describes quotas that are linked for management purposes.

On November 14, 2022 (87 FR 68104), NMFS announced the 2023 commercial western Gulf of Mexico aggregated LCS (72.0 mt dw; 158,724 lb dw) and eastern Gulf of Mexico aggregated LCS (85.5 mt dw; 188,593 lb dw) sub-regional quotas. Based on dealer reports received as of March 16, 2023, NMFS estimates that in the western Gulf of Mexico sub-region, approximately 72.0 mt dw (approximately 158,700 lb dw) or approximately 100 percent of the aggregated LCS sub-regional quota has been landed. In the eastern Gulf of Mexico sub-region, there has been no reported landings of aggregated LCS.

Regulations provide that quotas for certain shark species and/or management groups are linked, including western Gulf of Mexico hammerhead sharks and western Gulf of Mexico aggregated LCS (see § 635.28(b)(4)). Regulations further provide that for each pair of linked species and/or management groups, if landings reach, or are projected to reach, a threshold of 80 percent of the available quota and are also projected to reach 100 percent of the available quota before the end of the 2023 fishing year, NMFS will close the relevant shark management groups (see § 635.28(b)(3)). At this time, without further action, NMFS projects that the western Gulf of Mexico aggregated LCS management group quota has already been exceeded. Without a quota transfer, NMFS would need to close the western Gulf of Mexico aggregated LCS group and the linked western Gulf of Mexico hammerhead group.

Under § 635.27(b)(2), NMFS may transfer quota inseason between regions or sub-regions. Such transfers may occur for species or management groups that are the same in both regions or sub-regions and the quota is split for management purposes and not as a result of a stock assessment. As described at § 635.27(b)(1)(ii), the sub-regional splits for the quotas in the Gulf of Mexico region were done for management purposes. Therefore, NMFS may transfer aggregated LCS quota between Gulf of Mexico sub-regions. Before making any such transfer, NMFS must consider the following determination criteria in § 635.27(b)(2)(iii), and other relevant factors: (1) The usefulness of information obtained from catches in the particular management group for biological sampling and monitoring of the status of the respective shark species and/or management group; (2) the catches of the particular species and/or management group quota to date and the likelihood of closure of that segment of the fishery if no adjustment is made; (3) the projected ability of the vessels fishing under the particular species and/or management group quota to harvest the additional amount of corresponding quota before the end of the fishing year; (4) effects of the adjustment on the status of all shark species; (5) effects of the adjustment on accomplishing the objectives of the fishery management plan; (6) variations in seasonal distribution, abundance, or migration patterns of the appropriate shark species and/or management group; (7) effects of catch rates in one area precluding vessels in another area from having a reasonable opportunity to harvest a portion of the quota; and/or (8) review of dealer reports, daily landing trends, and the availability of the respective shark species and/or management group on the fishing grounds.

NMFS has determined that, for the Gulf of Mexico aggregated LCS sub-regional landings, the eastern Gulf of Mexico aggregated LCS sub-regional landings are not projected to reach their quota by the end of the year and that the western Gulf of Mexico aggregated LCS sub-regional quota has exceeded 80 percent (approximately 100 percent) of their quota and may have already exceeded the quota. Therefore, NMFS has considered the inseason quota transfer criteria, documented in the Quota Transfer section below, and determined that a transfer from the sub-regional eastern Gulf of Mexico aggregated LCS quota to the western Gulf of Mexico aggregated LCS quota is warranted to avoid potential closure of the western Gulf of Mexico aggregated LCS quota and the western Gulf of Mexico hammerhead shark quota, which are linked under § 635.28(b)(4)(iii), while fishing opportunities still exist.

After fully considering all the criteria listed above, NMFS is taking action to transfer aggregated LCS quota from the eastern Gulf of Mexico sub-regional quota to the western Gulf of Mexico sub-regional quota. NMFS' consideration of the relevant criteria found at § 635.27(b)(2)(iii) includes, but is not limited to, the following:

Regarding the usefulness of information obtained from catches in the particular category for biological sampling and monitoring of the status of the stock (§ 635.27(b)(2)(iii)(A)), biological samples collected by NMFS scientific observers on commercial vessels targeting aggregated LCS and hammerhead sharks continue to provide NMFS with valuable data for ongoing scientific studies of shark age and growth, migration, and reproductive status. This is especially important for the upcoming bull, spinner, and tiger shark assessments that are expected to begin in 2024.

Regarding the catches of the quotas to date and the likelihood of a fishery closure if no adjustment is made, commercial shark dealer data show that landings of the western Gulf of Mexico aggregated LCS have exceeded 80 percent of the quota (approximately 100 percent). Once the landings exceed the threshold of 80 percent of the quotas and are also projected to reach 100 percent before the end of the 2023 fishing year, the western Gulf of Mexico aggregated LCS and hammerhead shark management groups would need to close absent a transfer of additional quota.

NMFS also analyzed landings data, catch trends, and potential migration of the species involved (§ 635.27(b)(2)(iii)(C)-(D) and (F)-(H)) and determined that under current fishing rates, 40 mt dw (88,184 lb dw) of eastern Gulf of Mexico sub-regional aggregated LCS is a reasonable amount of quota to transfer, allowing fishermen the opportunity to fully utilize the available shark quotas while avoiding negative economic impacts that would occur by closing the shark management groups. This action will not have impacts beyond those already analyzed in the 2006 Consolidated HMS FMP and its amendments and thus is not expected to negatively impact the stock.

Regarding the effects of the adjustment on accomplishing the objectives of the 2006 Consolidated HMS FMP (§ 635.27(b)(2)(iii)(E)), this action is consistent with the quotas previously implemented and analyzed in the 2023 shark quota final rule (87 FR 68104, November 14, 2022) and in Amendment 5a (78 FR 40317, July 3, 2013) and Amendment 6 to the 2006 Consolidated HMS FMP (80 FR 50073, August 18, 2015). Specifically, this action is consistent with the objective of providing opportunities to fully harvest shark quotas without exceeding them.

Based on the considerations above, NMFS is transferring 40 mt dw (88,184 lb dw) of eastern Gulf of Mexico aggregated LCS sub-regional quota to the western Gulf of Mexico aggregated LCS sub-regional quota as of March 21, 2023. This quota transfer results in adjusted quotas of 45.5 mt dw (100,409 lb dw) for aggregated LCS in the eastern Gulf of Mexico sub-region and 112 mt dw (246,908 lb dw) for aggregated LCS management group in the western Gulf of Mexico sub-region. If landings and fishing rates do not increase substantially, transferring Gulf of Mexico aggregated LCS sub-regional quotas could allow the fisheries in each sub-region and region to remain open through the end of the 2023 fishing year.

Therefore, NMFS adjusts the eastern and western Gulf of Mexico aggregated LCS management group sub-regional quotas for the remainder of the 2023 shark fishing year, unless NMFS announces another quota transfer in the Federal Register or closes the fishery. NMFS may also announce future retention limit adjustments as needed throughout the remainder of the 2023 shark fishing year.

The boundary between the Gulf of Mexico region and the Atlantic region is defined at § 635.27(b)(1) as a line beginning on the East Coast of Florida at the mainland at 25°20.4′ N lat., proceeding due east. Any water and land to the south and west of that boundary is considered, for the purposes of monitoring and setting quotas, to be within the Gulf of Mexico region. The boundary between the western and eastern Gulf of Mexico sub-regions is drawn along 88°00′ W long. (§ 635.27(b)(1)(ii)).

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

The Assistant Administrator for NMFS (AA) finds that pursuant to 5 U.S.C. 553(b)(B), it is impracticable and contrary to the public interest to provide prior notice of, and an opportunity for public comment on, this action for the following reasons. Specifically, the regulations implementing the 2006 Consolidated HMS FMP and amendments provide for inseason adjustments to respond to the unpredictable nature of shark species availability on the fishing grounds, the migratory nature of these species, and the regional variations in the shark fisheries. Providing prior notice and an opportunity for public comment on this quota transfer is impracticable. NMFS could not have proposed this action earlier, as it needed to consider and respond to updated landings data, including the recently available March 2023 data, in deciding whether to transfer a portion of the eastern Gulf of Mexico sub-regional aggregated LCS quota to the western Gulf of Mexico sub-regional aggregated LCS quota. Delaying this action is contrary to the public interest, not only because it would likely result in a western Gulf of Mexico sub-regional aggregated LCS closure and associates costs to the fishery, but also administrative costs due to further agency action needed to re-open the fishery after quota is transferred. The delay would preclude the fishery from harvesting LCS in the western Gulf of Mexico sub-region that are available on the fishing grounds that might otherwise become unavailable during a delay. This action does not raise conservation or management concerns. Transferring quota from the eastern Gulf of Mexico sub-region to the western Gulf of Mexico sub-region would have a minimal risk of exceeding the aggregated LCS quotas in the Gulf of Mexico region. NMFS notes that the public had an opportunity to comment on the underlying rulemakings that established the commercial shark quotas and the inseason adjustment criteria.

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

NMFS manages the groundfish fishery in the BSAI exclusive economic zone according to the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679.

The A season apportionment of the 2023 Pacific cod TAC allocated to catcher/processors using pot gear in the BSAI is 922 metric tons (mt) as established by the final 2023 and 2024 harvest specifications for groundfish in the BSAI (88 FR 14926, March 10, 2023).

In accordance with § 679.20(d)(1)(iii), the Administrator, Alaska Region, NMFS (Regional Administrator), has determined that the A season apportionment of the 2023 Pacific cod TAC allocated as a directed fishing allowance to catcher/processors using pot gear in the BSAI will soon be reached. Consequently, NMFS is prohibiting directed fishing for Pacific cod by pot catcher/processors in the BSAI.

While this closure is effective the maximum retainable amounts at § 679.20(e) and (f) apply at any time during a trip.

NMFS issues this action pursuant to section 305(d) of the Magnuson-Stevens Act. This action is required by 50 CFR part 679, which was issued pursuant to section 304(b), and is exempt from review under Executive Order 12866.

Pursuant to 5 U.S.C. 553(b)(B), there is good cause to waive prior notice and an opportunity for public comment on this action, as notice and comment would be impracticable and contrary to the public interest, as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the closure of Pacific cod by catcher/processors using pot gear in the BSAI. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of March 20, 2023.

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