On October 23, 2020, the FDIC issued an IFR allowing insured depository institutions (IDIs) to determine the applicability of part 363 of the FDIC's regulations for fiscal years ending in 2021 based on the lesser of the IDI's (a) consolidated total assets as of December 31, 2019; or (b) consolidated total assets as of the beginning of their fiscal years ending in 2021.

Notwithstanding the temporary relief provided by the IFR, IDIs remain subject to any audit and reporting requirements applicable under other laws and regulations. Also, the FDIC reserves the authority to require an IDI to comply with one or more requirements under part 363 if the FDIC determines that asset growth was related to a merger or acquisition.

This correcting amendment makes no change to the relief provided by the IFR originally published, but clarifies the authority citation and revises 12 CFR 363.1 by removing the temporary relief regarding the applicability of annual independent audits and reporting requirements for fiscal years ending in 2021 from paragraph (a) and adding the temporary relief into paragraph (e).

For the reasons stated in the preamble, the FDIC makes the following correcting amendment to 12 CFR part 363:

The FAA invites you to send any written data, views, or arguments about this final rule. Send your comments to an address listed under ADDRESSES . Include “Docket No. FAA-2021-1008; Project Identifier MCAI-2021-01210-T” at the beginning of your comments. The most helpful comments reference a specific portion of the final rule, explain the reason for any recommended change, and include supporting data. The FAA will consider all comments received by the closing date and may amend this final rule because of those comments.

Except for Confidential Business Information (CBI) as described in the following paragraph, and other information as described in 14 CFR 11.35, the FAA will post all comments received, without change, to https://www.regulations.gov, including any personal information you provide. The agency will also post a report summarizing each substantive verbal contact received about this final rule.

CBI is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to this AD contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to this AD, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission containing CBI as “PROPIN.” The FAA will treat such marked submissions as confidential under the FOIA, and they will not be placed in the public docket of this AD. Submissions containing CBI should be sent to Shahram Daneshmandi, Aerospace Engineer, Large Aircraft Section, FAA, International Validation Branch, 2200 South 216th St., Des Moines, WA 98198; telephone and fax 206-231-3220; email Shahram.Daneshmandi@faa.gov. Any commentary that the FAA receives which is not specifically designated as CBI will be placed in the public docket for this rulemaking.

EASA, which is the Technical Agent for the Member States of the European Union, has issued EASA Emergency AD 2021-0237-E, dated November 4, 2021 (EASA AD 2021-0237-E) (also referred to as the MCAI), to correct an unsafe condition for certain ATR—GIE Avions de Transport Régional Model ATR42-200, -300, -320, -400, and -500 airplanes and Model ATR72-101, -102, -201, -202, -211, -212, and -212A airplanes. ATR—GIE Avions de Transport Régional Model ATR42-400 airplanes are not certificated by the FAA and are not included on the U.S. type certificate data sheet; this AD therefore does not include those airplanes in the applicability.

This AD was prompted by a report that the AMM maintenance procedure ATR-A-26-12-60-00ZZZ-281Z-A “Scheduled Inspection of the Engine Fire Detection Loops” incorrectly described a visual inspection of the fire handle. The maintenance procedure specified to verify that the snap wire material attaching the fire handle locking hold-plate was a stainless steel lockwire where it should have specified either an aluminum snap wire or a copper snap wire. If the engine fire handle fails, the flightcrew might not be able to extinguish an engine fire using the engine fire extinguisher system, which is the primary method for extinguishing engine fires. The FAA is issuing this AD to address this condition, which, if not detected and corrected, and combined with an engine fire, could lead to a failure of the engine fire handle to operate, possibly resulting in an uncontrolled engine fire and reduced control of the airplane. See the MCAI for additional background information.

EASA AD 2021-0237-E specifies procedures for a general visual inspection of both engine's fire handles for an incorrect snap wire, and applicable corrective actions. Corrective actions include removing the incorrect snap wire, installing the correct snap wire, and installing the safety seal. This material is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

These products have been approved by the aviation authority of another country and are 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 MCAI described above. The FAA is issuing this AD after determining that the unsafe condition described previously is likely to exist or develop on other products of these same type designs.

This AD requires accomplishing the actions specified in EASA AD 2021-0237-E described previously, except for any differences identified as exceptions in the regulatory text of this AD.

In the FAA's ongoing efforts to improve the efficiency of the AD process, the FAA developed a process to use some civil aviation authority (CAA) ADs as the primary source of information for compliance with requirements for corresponding FAA ADs. The FAA has been coordinating this process with manufacturers and CAAs. As a result, EASA AD 2021-0237-E is incorporated by reference in this AD. This AD requires compliance with EASA AD 2021-0237-E in its entirety through that incorporation, except for any differences identified as exceptions in the regulatory text of this AD. Using common terms that are the same as the heading of a particular section in EASA AD 2021-0237-E does not mean that operators need comply only with that section. For example, where the AD requirement refers to “all required actions and compliance times,” compliance with this AD requirement is not limited to the section titled “Required Action(s) and Compliance Time(s)” in EASA AD 2021-0237-E. Service information required by EASA AD 2021-0237-E for compliance will be available at https://www.regulations.gov by searching for and locating Docket No. FAA-2021-1008 after this AD is published.

Section 553(b)(3)(B) of the Administrative Procedure Act (APA) (5 U.S.C. 551 et seq. ) authorizes agencies to dispense with notice and comment procedures for rules when the agency, for “good cause,” finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under this section, an agency, upon finding good cause, may issue a final rule without providing notice and seeking comment prior to issuance. Further, section 553(d) of the APA authorizes agencies to make rules effective in less than thirty days, upon a finding of good cause.

An unsafe condition exists that requires the immediate adoption of this AD without providing an opportunity for public comments prior to adoption. The FAA has found that the risk to the flying public justifies foregoing notice and comment prior to adoption of this rule because if the installation of the incorrect snap wire material on the engine's fire handles is not detected and corrected, this condition, combined with an engine fire, could lead to a failure of the engine fire handle to operate, possibly resulting in an uncontrolled engine fire and reduced control of the airplane. In addition, the compliance time for the required action is shorter than the time necessary for the public to comment and for publication of the final rule. Accordingly, notice and opportunity for prior public comment are impracticable and contrary to the public interest pursuant to 5 U.S.C. 553(b)(3)(B).

In addition, the FAA finds that good cause exists pursuant to 5 U.S.C. 553(d) for making this amendment effective in less than 30 days, for the same reasons the FAA found good cause to forego notice and comment.

The requirements of the RFA do not apply when an agency finds good cause pursuant to 5 U.S.C. 553 to adopt a rule without prior notice and comment. Because the FAA has determined that it has good cause to adopt this rule without notice and comment, RFA analysis is not required.

The FAA estimates that this AD affects 71 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 on-condition action that would be required based on the results of any required actions. The FAA has no way of determining the number of aircraft that might need this on-condition action:

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 affect intrastate aviation in Alaska.

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

Transport Canada, which is the aviation authority for Canada, has issued Transport Canada AD CF-2021-26, dated July 26, 2021 (Transport Canada AD CF-2021-26), to correct an unsafe condition for Bell Textron Canada Limited Model 430 helicopters, serial numbers 49001 through 49129. Transport Canada advises of an in-flight failure of an M/R clevis which resulted in loss of control of the helicopter and fatal injuries to occupants. Transport Canada further advises that the M/R clevis part number (P/N) 430-010-432-101 fractured at the exposed thread area above the nut, which was consistent with fatigue damage. Transport Canada also advises an inspection of the failed part determined universal bearing P/N 212-010-412-001 of the M/R pitch link assembly had excessive wear and increased resistance to rotation. Transport Canada states a similar accident previously occurred on the same model helicopter in which the M/R clevis was found to have fractured at the neck area due to fatigue damage. Transport Canada states the restriction in freedom of movement of the universal bearing can cause increased loads on the M/R pitch link assembly and subsequent fatigue failure of the M/R clevis prior to its life limit. Finally, Transport Canada advises the accident investigation is still ongoing. This condition, if not addressed, could result in crack initiation at the M/R clevis neck or threaded area and failure of the M/R pitch link, resulting in loss of control of the helicopter.

Accordingly, Transport Canada AD CF-2021-26 requires visually inspecting the M/R clevis and rod end for wear and damage and performing corrective actions. Transport Canada AD CF-2021-26 also requires for certain part-numbered M/R rotor pitch link assemblies that have accumulated 5000 hours air time or less and have a universal bearing P/N 212-010-412-001 that is unserviceable, replacing the universal bearing. Transport Canada AD CF-2021-26 requires for certain part-numbered M/R pitch link assemblies that have accumulated more than 5,000 hours air time and have a universal bearing P/N 212-010-412-001 with signs of binding or stiffness, replacing both the universal bearing and the M/R clevis or if the universal bearing is unserviceable but there are no signs of binding or stiffness, replacing only the universal bearing.

Transport Canada AD CF-2021-26 requires performing a purge grease of each universal bearing and performing a magnetic particle inspection of the M/R clevis to detect cracks, replacing any M/R clevis with cracks, or if the M/R clevis does not have any cracks, replacing any missing cadmium plating.

Additionally, Transport Canada AD CF-2021-26 requires after the initial visual and magnetic particle inspections, performing recurring visual inspections of the M/R clevis for corrosion and mechanical damage and performing corrective actions as needed. Transport Canada AD CF-2021-26 also requires performing recurring visual inspections of the universal bearing for binding, stiffness, wear, damage looseness, excess axial and radial play, and performing corrective actions as needed. Transport Canada AD CF-2021-26 requires reporting any cracks or M/R clevises that are beyond published limits to Bell Product Support Engineering. Transport Canada considers its AD an interim action and states that further AD action may follow.

These helicopters have been approved by the aviation authority of Canada and are approved for operation in the United States. Pursuant to the FAA's bilateral agreement with Canada, Transport Canada, its technical representative, has notified the FAA of the unsafe condition described in its AD. The FAA is issuing this AD after evaluating all known relevant information and determining that the unsafe condition described previously is likely to exist or develop on other helicopters of these same type designs.

The FAA reviewed Bell Alert Service Bulletin 430-21-60, dated July 13, 2021. This service information specifies procedures to visually inspect the M/R clevis and rod ends for wear or damage, the M/R clevis for corrosion or mechanical damage and the universal bearings for binding, stiffness, wear, looseness, excess axial and radial play, and damage. This service information also specifies procedures to perform a magnetic particle inspection, and recurring inspections of each M/R clevis and each universal bearing.

This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

This AD requires within 25 hours time-in-service (TIS) or 30 days, whichever occurs first after the effective date of this AD, removing and dissembling a certain part-numbered M/R pitch link assembly and visually inspecting a certain part-numbered M/R clevis and rod end for wear, corrosion, and damage, which may be indicated by distortion, bending, a crack, or damaged M/R clevis threads, and removing any affected parts from service before further flight. This AD also requires visually inspecting a certain part-numbered universal bearing for binding, stiffness, wear, looseness, excess axial and radial play, and damage, which may be indicated by distortion, bending, or a crack. If certain discrepancies are found, and a certain part-numbered M/R pitch link assembly that has accumulated 5,000 or less total hours TIS is installed, this AD requires before further flight, removing a certain part-numbered universal bearing from service. If certain discrepancies are found, and a certain part-numbered M/R pitch link assembly that has accumulated more than 5,000 total hours TIS is installed, this AD requires before further flight and depending on the discrepancies, removing a certain part-numbered universal bearing and the M/R clevis from service or removing only the universal bearing from service.

This AD also requires performing a purge grease of each universal bearing and performing a magnetic particle inspection of each M/R clevis for a crack in accordance with the applicable service information. Following the magnetic particle inspection, if there is a crack, this AD requires before further flight, removing each affected M/R clevis from service. If there is no crack, this AD requires performing a selective brush cadmium plating and applying a chromate conversion coating.

This AD requires within 50 hours TIS after completion of the initial inspections required by this AD, and thereafter at intervals not to exceed 50 hours TIS, using a 10X magnifying glass, visually inspecting the neck and threaded area of each M/R clevis for wear, corrosion, and damage, which may be indicated by distortion, bending, a crack, or damaged M/R clevis threads, and depending on the inspection results before further flight, removing the affected part from service and replacing with an airworthy part, and repeating the magnetic particle inspection of each M/R clevis.

Finally, AD requires within 150 hours TIS after the completion of the initial inspections required by this AD, and thereafter at intervals not to exceed 150 hours TIS, repeating the visual inspection of each universal bearing for binding, stiffness, wear, looseness, excess axial and radial play, and damage, and performing a purge grease of each universal bearing.

Transport Canada AD CF-2021-26 specifies compliance times in terms of air time, whereas this AD requires using hours TIS. Where the service information required by Transport Canada AD CF-2021-26 specifies to report any signs of cracking to Bell Product Support Engineering, this AD does not require reporting any information. Transport Canada AD CF-2021-26 specifies replacing any affected part, whereas this AD requires removing the affected part from service and then replacing with an airworthy part.

The FAA considers this AD to be an interim action. Once final action has been identified, the FAA might consider further rulemaking.

Section 553(b)(3)(B) of the Administrative Procedure Act (APA) (5 U.S.C. 551 et seq. ) authorizes agencies to dispense with notice and comment procedures for rules when the agency, for “good cause,” finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under this section, an agency, upon finding good cause, may issue a final rule without providing notice and seeking comment prior to issuance. Further, section 553(d) of the APA authorizes agencies to make rules effective in less than thirty days, upon a finding of good cause.

An unsafe condition exists that requires the immediate adoption of this AD without providing an opportunity for public comments prior to adoption. The FAA has found that the risk to the flying public justifies foregoing notice and comment prior to adoption of this rule because if not corrected, the unsafe condition could lead to crack initiation at the M/R clevis neck or threaded area and consequent failure of the M/R pitch link, resulting in loss of control of the helicopter.

In addition, the compliance time for the required actions is within 25 hours TIS or 30 days, whichever occurs first after the effective date of this AD, a shorter time period than the time necessary for the public to comment and for publication of the final rule.

Therefore, notice and opportunity for prior public comment are impracticable and contrary to public interest pursuant to 5 U.S.C. 553(b)(3)(B). In addition, the FAA finds that good cause exists pursuant to 5 U.S.C. 553(d) for making this amendment effective in less than 30 days, for the same reasons the FAA found good cause to forgo notice and comment.

The FAA invites you to send any written data, views, or arguments about this final rule. Send your comments to an address listed under ADDRESSES . Include “Docket No. FAA-2021-1011; Project Identifier MCAI-2020-00867-R” at the beginning of your comments. The most helpful comments reference a specific portion of the final rule, explain the reason for any recommended change, and include supporting data. The FAA will consider all comments received by the closing date and may amend this final rule because of those comments.

Except for Confidential Business Information (CBI) as described in the following paragraph, and other information as described in 14 CFR 11.35, the FAA will post all comments received, without change, to https://www.regulations.gov, including any personal information you provide. The agency will also post a report summarizing each substantive verbal contact received about this final rule.

CBI is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to this AD contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to this AD, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission containing CBI as “PROPIN.” The FAA will treat such marked submissions as confidential under the FOIA, and they will not be placed in the public docket of this AD. Submissions containing CBI should be sent to Hal Jensen, Aerospace Engineer, Operational Safety Branch, Compliance & Airworthiness Division, FAA, 950 L'Enfant Plaza N SW, Washington, DC 20024; telephone (202) 267-9167; email hal.jensen@faa.gov. Any commentary that the FAA receives which is not specifically designated as CBI will be placed in the public docket for this rulemaking.

The requirements of the Regulatory Flexibility Act (RFA) do not apply when an agency finds good cause pursuant to 5 U.S.C. 553 to adopt a rule without prior notice and comment. Because the FAA has determined that it has good cause to adopt this rule without prior notice and comment, RFA analysis is not required.

The FAA estimates that this AD affects 29 helicopters of U.S. Registry. Labor rates are estimated at $85 per work-hour. Based on these numbers, the FAA estimates the following costs to comply with this AD.

Removing and disassembling each M/R pitch link assembly and inspecting each M/R clevis and rod end takes about 4 work-hours for an estimated cost of $340 per inspection and $9,860 for the U.S. fleet.

Inspecting each universal bearing takes about 4 work-hours for an estimated cost of $340 per inspection and $9,860 for the U.S. fleet.

If required, replacing each universal bearing takes about 4 work-hours for an estimated cost of $340 and parts cost about $1,000 for an estimated cost of $1,340 per replacement.

If required, replacing each universal bearing and each M/R clevis takes about 8 work-hours for an estimated cost of $680 and parts cost about $3,000 for an estimated cost of $3,680 per replacement of both parts.

Performing a purge grease on each universal bearing takes about 0.25 work-hours for an estimated cost of $22 per purge.

Performing a magnetic particle inspection of each M/R clevis takes about 2 work-hours for an estimated cost of $170 per inspection.

Performing a selective brush cadmium plating takes about 4 work-hours for an estimated cost of $340 per helicopter.

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, I certify that this AD:

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

(2) Will not affect intrastate aviation in Alaska.

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

On January 15, 2021, the FAA published a final rule titled “Remote Identification of Unmanned Aircraft” (Remote ID final rule) with an original effective date of March 16, 2021. 1   2 The Remote ID final rule requires the remote identification of unmanned aircraft in the airspace of the United States. Remote identification is the capability of an unmanned aircraft, in flight, to provide certain identification, location, and performance information that people on the ground and other airspace users can receive.

In addition to the operating requirements, the Remote ID final rule provides the design and production requirements for the production of remote identification unmanned aircraft or broadcast modules. These requirements describe the performance standards for remote identification without establishing a specific means or process for regulated entities to follow. 3 A person designing or producing a standard remote identification unmanned aircraft or remote identification broadcast module must show that the unmanned aircraft or broadcast module meets the performance requirements of the rule by following an FAA-accepted means of compliance. A means of compliance submitted to the FAA for acceptance must show that an unmanned aircraft or broadcast module produced using it would meet the performance requirements of title 14 of the Code of Federal Regulations part 89 (14 CFR part 89). This policy statement only addresses the performance requirements and compliance path for the standard remote identification unmanned aircraft.

Part 89 requires the following 8 message elements to be broadcast from a standard remote identification unmanned aircraft: (1) Unmanned aircraft unique identifier; (2) an indication of the control station's latitude and longitude; (3) an indication of the control station's altitude; (4) an indication of the unmanned aircraft's latitude and longitude; (5) an indication of the unmanned aircraft's altitude; (6) a time mark; (7) an indication of the emergency status of the unmanned aircraft system; and (8) velocity. Additionally, all standard remote identification unmanned aircraft must meet certain minimum requirements regarding the transmission of the message elements including the minimum performance requirements related to positional accuracy, geometric altitude accuracy, message latency, and message transmission rate. These minimum performance requirements for the message elements are design requirements; any specific test method for ensuring that the unmanned aircraft design meets this accuracy requirement will be reviewed and evaluated by the FAA as a part of the means of compliance acceptance process.

Part 89 establishes the accuracy requirement for the reported geometric altitude for the control station of a standard remote identification unmanned aircraft. Specifically, § 89.310(h)(2) requires that the reported geometric altitude of the control station must be accurate to within 15 feet of the true geometric altitude, with 95 percent probability. The Remote ID final rule did not specify how a means of compliance should address this requirement. In order to guide producers to develop standard remote identification unmanned aircraft that meet the FAA's standards, this policy statement informs developers of one potential means of compliance that would be acceptable to the FAA to demonstrate compliance with meeting the geometric altitude requirement. Persons developing a means of compliance for a standard remote identification unmanned aircraft in accordance with 14 CFR part 89, subpart E, may incorporate the method described in this policy statement as part of their means of compliance. The FAA emphasizes, however, that other ways of demonstrating compliance with § 89.310(h)(2) may be acceptable.

This statement of policy describes one acceptable way, but not the only way, that the accuracy requirements for the reported geometric altitude of the control station of a standard remote identification unmanned aircraft can meet the minimum performance requirement in § 89.310(h)(2). The FAA is not requiring developers of means of compliance to include the specific method provided in this statement of policy.

A means of compliance that requires the unmanned aircraft system (UAS) control station position source to be a global navigation satellite system (GNSS) receiver utilizing Global Positioning System (GPS) and Wide Area Augmentation System (WAAS) satellite signals to determine the geometric altitude of the control station would be an acceptable method for a means of compliance to demonstrate that the unmanned aircraft built according to its specifications would meet the accuracy requirement in § 89.310(h)(2). The WAAS Performance Analysis report from the second quarter of 2021 shows that GNSS receivers utilizing GPS with a satellite-based augmentation system indicates a worst-site 95% vertical accuracy of 5 feet for the continental United States. 4 This report demonstrates that GNSS receivers utilizing GPS/WAAS can achieve the necessary vertical position accuracy across the National Airspace System to meet the reported geometric altitude requirement of § 89.310(h)(2).

The FAA recognizes that UAS technology, which includes remote identification technology, is continually evolving and improving. Accordingly, the FAA expects that other methods may be available to meet this requirement other than the one mentioned in this policy statement, and nothing about this statement should preclude developers of means of compliance from including other technological methods of meeting the vertical accuracy requirements for the reported geometric altitude of the control station. This statement of policy solely addresses one method of demonstrating compliance with § 89.310(h)(2); note that any means of compliance submitted to the FAA must also adequately address the other requirements in part 89, subparts D and E, in order to be accepted by the FAA.

A copy of the Remote ID final rule as well as all background materials may be viewed online at https://www.regulations.gov using the docket number listed above. A copy of this statement of policy will also be placed in the docket for that rule. Electronic retrieval help and guidelines are available on the website. It is available 24 hours each day, 365 days each year. An electronic copy of this document may also be downloaded from the Office of the Federal Register's website at https://www.FederalRegister.gov and the Government Publishing Office's website at https://www.GovInfo.gov.

Copies may also be obtained by sending a request to the Federal Aviation Administration, Office of Rulemaking, ARM-1, 800 Independence Avenue SW, Washington, DC 20591, or by calling (202) 267-9677. Requestors must identify the docket or amendment number of this rulemaking.

As appropriate, the FAA will incorporate this policy into applicable FAA Orders and publications, such as Advisory Circulars, as they are updated. The agency will also continually review this policy in the interest of aviation safety. The FAA reserves the right to update this policy if the agency collects or receives additional information.

This policy does not have the force and effect of law and is not meant to bind the public in any way, it is intended only to provide clarity to the public regarding existing requirements under the law or agency policies.

Pursuant to the Convention on Cultural Property Implementation Act, Public Law 97-446, 19 U.S.C. 2601 et seq. (hereinafter, “the Cultural Property Implementation Act”), which implements the 1970 United Nations Educational, Scientific and Cultural Organization (UNESCO) Convention on the Means of Prohibiting and Preventing the Illicit Import, Export and Transfer of Ownership of Cultural Property (hereinafter, “the Convention” (823 U.N.T.S. 231 (1972)), the United States entered into a bilateral agreement with Greece on November 21, 2011. The Memorandum of Understanding (MOU) enabled the promulgation of import restrictions on archaeological material representing Greece's cultural heritage from the Upper Paleolithic (beginning approximately 20,000 B.C.) through the 15th century A.D., and ecclesiastical ethnological material representing Greece's Byzantine cultural heritage (approximately the 4th century through the 15th century A.D.).

On December 1, 2011, U.S. Customs and Border Protection (CBP) published CBP Dec. 11-25, in the Federal Register (76 FR 74691), which amended 19 CFR 12.104g(a) to indicate the imposition of these restrictions and included a list designating the types of archaeological and ecclesiastical ethnological material covered by the restrictions. The restrictions were subsequently extended in 2016. CBP published a final rule (CBP Dec. 16-21) in the Federal Register (81 FR 84458), following the exchange of diplomatic notes, extending the import restrictions for a period of five years until November 21, 2021.

Import restrictions listed at 19 CFR 12.104g(a) are effective for no more than five years beginning on the date on which the agreement enters into force with respect to the United States. This period may be extended for additional periods of not more than five years if it is determined that the factors which justified the initial agreement still pertain and no cause for suspension of the agreement exists. Since the initial notice was published on December 1, 2011, the import restrictions have been extended once. Following the exchange of diplomatic notes, CBP published a final rule (CBP Dec. 16-21) in the Federal Register (81 FR 84458), to extend the import restrictions for a period of five years to November 21, 2021.

On August 20, 2020, the United States Department of State proposed in the Federal Register (85 FR 51544), to extend the MOU between the United States and Greece concerning the import restrictions on certain categories of archeological and ecclesiastical ethnological material of Greece. On March 21, 2021, the Acting Assistant Secretary for Educational and Cultural Affairs, Department of State, after consultation with and recommendations by the Cultural Property Advisory Committee, determined that the cultural heritage of Greece continues to be in jeopardy from pillage of certain archaeological and ecclesiastical ethnological material, and that the import restrictions should be extended for an additional five years.

Subsequently, on September 22, 2021, the Governments of the United States and Greece entered into a new agreement, titled “Memorandum of Understanding between the Government of the United States of America and the Government of the Hellenic Republic Concerning the Imposition of Import Restrictions on Categories of Certain Archaeological and Ethnological Materials of the Hellenic Republic,” which is effective on November 21, 2021. The new MOU supersedes the existing MOU that first entered into force on November 21, 2011. Pursuant to the new MOU, the import restrictions will remain in effect for an additional five years.

Accordingly, CBP is amending 19 CFR 12.104g(a) to reflect the extension of the import restrictions. The restrictions are to continue in effect until November 21, 2026. Importation of such material of Greece, as described in the Designated List below, shall be restricted through that date unless the conditions set forth in 19 U.S.C. 2606 and 19 CFR 12.104c are met.

The Designated List and additional information may also be found at the following website address: https://eca.state.gov/cultural-heritage-center/cultural-property-advisory-committee/current-import-restrictions by selecting the material for “Greece.”

The Designated List contained in CBP Dec. 11-25, which describes the types of articles to which the import restrictions apply, is amended to reflect the addition of certain archaeological and ecclesiastical ethnological material to the Designated List. To fulfill the terms of the new MOU, the Designated List of cultural property is amended in this document to add certain coins from the Byzantine and Medieval periods, to clarify pottery styles, and to include post-Byzantine ethnological material dating up to A.D. 1830, as well as clarify certain provisions of the Designated List contained in CBP Dec. 11-25 by making minor revisions to the language, organization, and numbering of the Designated List. For the reader's convenience, CBP is reproducing the Designated List contained in CBP Dec. 11-25 in its entirety, with the changes, below.

The Designated List includes archaeological material from Greece ranging in date from approximately the 3rd millennium B.C. to 15th century A.D., and ecclesiastical ethnological material from Greece from the Early Christian, Byzantine, and post-Byzantine periods, including objects made from A.D. 324 through 1830.

The archaeological materials represent the following periods, styles, and cultures: Upper Paleolithic, Neolithic, Minoan, Cycladic, Helladic, Mycenaean, Submycenaean, Geometric, Orientalizing, Archaic, Classical, Hellenistic, Roman, Byzantine, and Medieval.

1. Sculpture

a. Architectural Elements—In marble, limestone, gypsum, and other kinds of stone. Types include acroteria, antefixes, architrave, base, basin, capital, caryatid, coffer, column, crowning, fountain, frieze, pediment, pilaster, mask, metope, mosaic and inlay, jamb, tile, triglyph, tympanum, wellhead, revetment, cut stone paving, tiles. Approximate date: 3rd millennium B.C. to 15th century A.D.

b. Monuments—In marble, limestone, and other kinds of stone. Types include menhir, “horns of consecration,” votive statues, funerary and votive stelae, and bases and base revetments, and columnar grave monuments. These may be painted, carved with relief sculpture, and/or carry dedicatory or funerary inscriptions. Approximate date: 3rd millennium B.C. to 15th century A.D.

c. Sarcophagi—In marble, limestone, and other kinds of stone. Some have figural scenes painted on them, others have figural scenes carved in relief, and some just have decorative moldings. Approximate date: 3rd millennium B.C. to 15th century A.D.

d. Large Statuary—Primarily in marble, also in limestone and sandstone, including fragments of statues. Subject matter includes human and animal figures and groups of figures in the round. Common types are largescale, free-standing statuary from approximately 1 m to 2.5 m in height and life-size busts (head and shoulders of an individual). The style may be naturalistic, as in the Classical Period, highly stylized, as in the Bronze Age culture of the Cyclades, or somewhere in between. Approximate date: 4th millennium B.C. to 15th century A.D.

e. Small Statuary and Figurines—In marble and other stone. Subject matter includes human and animal figures and groups of figures in the round. These range from approximately 10 cm to 1 m in height. The style may be naturalistic, as in the Classical Period, highly stylized, as in the Bronze Age culture of the Cyclades, or somewhere in between. Approximate date: 20,000 B.C. to 15th century A.D.

f. Reliefs—In marble and other stone. Types include carved slabs with figural, vegetative, floral, or decorative motifs, sometimes inscribed, and carved relief vases. Used for architectural decoration, funerary, votive, or commemorative monuments. Approximate date: 3rd millennium B.C. to 15th century A.D.

g. Furniture—In marble and other stone. Types include tables; thrones; beds; and altars, round or rectangular. Approximate date: 12th century B.C. to 15th century A.D.

2. Vessels—In marble, steatite, rock crystal, and other stone. These may belong to conventional shapes such as bowls, cups, jars, jugs, and lamps, or may occur in the shape of an animal or human, or part of an animal or human. Approximate date: 7th millennium B.C. to 15th century A.D.

3. Tools and Weapons—In flint/chert, obsidian, and other hard stones. Chipped stone types include blades, small blades, borers, scrapers, sickles, cores, arrow heads, and spindle whorls. Ground stone types include grinders ( e.g., mortars, pestles, millstones, whetstones), choppers, axes, hammers, and mace heads. Approximate date: 20,000 B.C. to 15th century A.D.

4. Seals and Beads—In marble, limestone, and various semiprecious stones including rock crystal, amethyst, jasper, agate, steatite, and carnelian. Approximate date: 6th millennium B.C. to 15th century A.D.

1. Sculpture

a. Large Statuary—Primarily in bronze, including fragments of statues. Subject matter includes human and animal figures and groups of figures in the round. Common types are large-scale, free-standing statuary from approximately 1 m to 2.5 m in height and life-size busts (head and shoulders of an individual). Approximate date: 2nd millennium B.C. to A.D. 324.

b. Small Statuary and Figurines—Subject matter includes human and animal figures, groups of figures in the round, masks, and plaques. These range from approximately 10 cm to 1 m in height. Approximate date: 3rd millennium B.C. to A.D. 324.

c. Inscribed or Decorated Sheet Metal—In bronze, lead, and gold. Engraved inscriptions, “curse tablets,” “Orphic/Dionysiac tablets,” and thin metal sheets with engraved or impressed designs often used as attachments to furniture and clothing. Approximate date: 4th millennium B.C. to 15th century A.D.

2. Vessels—In bronze, gold, and silver. These may belong to conventional shapes such as bowls, cups, jars, jugs, strainers, cauldrons, and lamps, or may occur in the shape of an animal or part of an animal. Approximate date: 5th millennium B.C. to 15th century A.D.

3. Personal Ornaments—In bronze, gold, and silver. Types include rings, beads, pendants, belts, belt buckles, earrings, diadems, spangles, straight and safety pins (fibulae), necklaces, mirrors, wreaths, cuffs, and funerary masks. Approximate date: 7th millennium B.C. to 15th century A.D.

4. Tools—In copper, bronze, iron, and lead. Types include hooks, weights, axes, scrapers, (strigils), trowels, keys; the tools of craftspersons such as carpenters, masons and metal smiths; and medical tools such as needles, spoons, lancets, and forceps. Approximate date: 4th millennium B.C. to 15th century A.D.

5. Weapons and Armor—In copper, bronze, iron and lead. Types include both launching weapons (spears and javelins) and weapons for hand-to-hand combat (swords, daggers, etc.). Armor includes body armor, such as helmets, cuirasses, shin guards, and shields, and horse armor often decorated with elaborate engraved, embossed, or perforated designs. Approximate date: 6th millennium B.C. to 30 B.C.

6. Seals and Tokens—In lead, tin, copper, bronze, silver, and gold. Types include rings, amulets, and seals with shank. Approximate date: 4th millennium B.C. to 15th century A.D.

7. Coins—Many of the mints of the listed coins can be found in B.V. Head, Historia Numorum: A Manual of Greek Numismatics (London, 1911) and C.M. Kraay, Archaic and Classical Greek Coins (London, 1976). Many of the Roman provincial mints in Greece are listed in A. Burnett et al., Roman Provincial Coinage I: From the Death of Caesar to the Death of Vitellius (44 BC-AD 69) (London, 1992) and id., Roman Provincial Coinage II: From Vespasian to Domitian (AD 69-96) (London, 1999).

a. Greek Bronze Coins—Struck by city-states, leagues, and kingdoms that operated in the territory of the modern Greek state (including the ancient territories of the Peloponnese, Central Greece, Thessaly, Epirus, Crete and those parts of the territories of ancient Macedonia, Thrace and the Aegean islands that lay within the boundaries of the modern Greek state). Approximate date: 5th century B.C. to late 1st century B.C.

b. Greek Silver Coins—This category includes the small denomination coins of the city-states of Aegina, Athens, and Corinth, and the Kingdom of Macedonia under Philip II and Alexander the Great. Such coins weigh less than approximately 10 grams and are known as obols, diobols, triobols, hemidrachms, and drachms. Also included are all denominations of coins struck by the other city-states, leagues, and kingdoms that operated in the territory of the modern Greek state (including the ancient territories of the Peloponnese, Central Greece, Thessaly, Epirus, Crete, and those parts of the territories of ancient Macedonia, Thrace and the Aegean islands that lie within the boundaries of the modern Greek state). Approximate date: 6th century B.C. to late 1st century B.C.

c. Roman Coins Struck in Greece —In silver and bronze, struck at Roman and Roman provincial mints that operated in the territory of the modern Greek state (including the ancient territories of the Peloponnese, Central Greece, Thessaly, Epirus, Crete, and those parts of the territories of ancient Macedonia, Thrace and the Aegean islands that lie within the boundaries of the modern Greek state). Approximate date: late 2nd century B.C. to 3rd century A.D.

d. Coins from the Byzantine and Medieval Periods —This category includes coin types such as those of the Byzantine and medieval Frankish and Venetian states that circulated primarily in Greece, ranging in date from approximately the 3rd century A.D. to the 15th century A.D.

1. Sculpture

a. Architectural Elements—Baked clay (terracotta) elements used to decorate buildings. Elements include acroteria, antefixes, painted and relief plaques, metopes, cornices, roof tiles, revetments, and brick. Approximate date: 3rd millennium B.C. to 30 B.C.

b. Large Statuary—Subject matter includes human and animal figures and groups of figures in the round. Common types are large-scale, free-standing statuary from approximately 1 m to 2.5 m in height and life-size busts (head and shoulders of an individual). Approximate date: 3rd millennium B.C. to 30 B.C.

c. Small Statuary—Subject matter is varied and includes human and animal figures, human body parts, groups of figures in the round, shrines, houses, and chariots. Includes Mycenaean and later Tanagra figurines. These range from approximately 10 cm to 1 m in height. Approximate date: 7th millennium B.C. to A.D. 324.

d. Sarcophagi —Block- or tub-shaped chests, often painted, known as larnax (plural, larnakes). Approximate date: 3rd millennium B.C. to 30 B.C.

2. Vessels

a. Neolithic Pottery—Handmade, often decorated with a lustrous burnish, decorated with appliqué and/or incision, sometimes with added paint. These come in a variety of shapes from simple bowls and vases with three or four legs to handled scoops and large storage jars. Approximate date: 7th millennium B.C. to 3rd millennium B.C.

b. Minoan, Cycladic, and Mycenaean Pottery—Handmade and wheelmade pottery in shapes for tableware, serving, storing, and processing, with lustrous burnished, matte, appliqué, incised, and painted decoration; includes local styles such as Kamares ware, Pictorial Style, and extraordinary shapes such as “frying pans” and “kernoi.” Approximate dates: 4th millennium B.C. to 12th century B.C.

c. “Submycenean” and Pottery of the Geometric Period (including “sub-Geometric”)— Handmade and wheelmade pottery that succeeds the styles of the Late Bronze Age and is produced in decorated and undecorated styles, often reflecting that of the Late Bronze Age but predominately using compasses for circles and linear “geometric” decoration, as well as schematic representations of humans, animals and birds. This category also includes Proto-Attic Black and White style pottery. Approximate dates: 12th century B.C. to 7th century B.C.

d. Attic Black Glaze, Black Figure, Red Figure and White Ground Pottery—These are made in a specific set of shapes ( e.g., amphorae, kraters, hydriae, oinochoi, kylikes) decorated with black painted figures on a clear clay ground (Black Figure), decorative elements in reserve with background fired black (Red Figure), and multi-colored figures painted on a white ground (White Ground). Approximate date: 6th century B.C. to 4th century B.C.

e. Corinthian Pottery—Painted pottery made in Corinth in a specific range of shapes for perfume and unguents and for drinking or pouring liquids. The very characteristic painted and incised designs depict human and animal figural scenes, rows of animals, and floral decoration. Approximate date: 8th century B.C. to 6th century B.C.

f. West Slope Ware—This ware is named after a type of pottery from the west slope of the Athenian Acropolis. It has a black-glaze with relief and polychrome decoration and was produced first in Athens in the fourth century B.C., but the style is also manufactured elsewhere, such as at Corinth, Macedonia and Crete down to the first century B.C. Approximate date: 4th century B.C. to 1st century B.C.

g. Moldmade Bowls—These bowls with relief decoration were developed in Athens in the late third century B.C. and soon manufactured elsewhere, such as in Corinth and Argos. Patterns include pine-cone scales, leaves, petals, or figural scenes. They have black glaze, often with a metallic sheen. Approximate date: 3rd century B.C. to 1st century B.C.

h. Utilitarian Ware—Includes undecorated plates, cooking pots, water jars (plain and incised), plain perfume jars (unguentaria), and transport amphorae (often with stamped handles). Approximate date: 6th century B.C. to A.D. 324.

i. Byzantine Pottery—Includes undecorated plain wares, utilitarian, tableware, serving and storage jars, special shapes such as pilgrim flasks, and can be matte painted or glazed, including incised “sgraffitto” and stamped with elaborate polychrome decorations using floral, geometric, human, and animal motifs; it is generally locally manufactured, though places like Corinth were major producers. Approximate date: 324 A.D. to 15th century A.D.

3. Inscriptions—These are typically unbaked and should be handled with extreme care, even when hard-fired through accidental burning. They typically take the form of tablets shaped like leaves of rectangular or square shape and they are often lined, with incised, and sometimes stamped, characters known as “Linear A” and “Linear B.” Approximate date: 2nd millennium B.C. to 12th century B.C.

4. Lamps—Can be handmade, wheelmade, or moldmade. Shapes include open with a pinched nozzle, partially enclosed with a rim, or covered with a decorated disc. Athens and Corinth were major producers. Approximate date: 7th century B.C. to A.D. 324.

5. Loom Weights—Shapes include conical, pyramidal, disc or rings. Can be stamped, incised, or glazed. Approximate date: 7th millennium B.C. to 15th century A.D.

1. Small Statuary and Figurines—Subject matter includes human and animal figures and groups of figures in the round. These range from approximately 10 cm to 1 m in height. Approximate date: 7th millennium B.C. to 15th century A.D.

2. Personal Ornaments—In bone, ivory, and spondylus shell. Types include amulets, combs, pins, spoons, small containers, bracelets, buckles, and beads. Approximate date: 7th millennium B.C. to 15th century A.D.

3. Seals and Stamps—Small devices with at least one side engraved with a design for stamping or sealing; they can be discoid, cuboid, conoid, or in the shape of animals or fantastic creatures ( e.g., a scarab). Approximate date: 7th millennium B.C. to 2nd millennium B.C.

4. Musical Instruments—In bone, ivory and tortoise shell. Types include pipe and flute. Approximate date: 3rd millennium B.C. to 15th century A.D.

5. Ostrich Egg Vessels—Often decorated with an incised scene ( e.g., geometric, animal, human, etc.). Approximate date: 3rd millennium B.C. to 2nd millennium B.C.

6. Furniture—Bone and ivory furniture inlays and veneers. Approximate date: 2nd millennium B.C. to 15th century A.D.

1. Vessels—Shapes include small jars, bowls, animal shaped, goblet, spherical, candle holders, perfume jars (unguentaria). Approximate date: 2nd millennium B.C. to 15th century A.D.

2. Beads—Globular and relief beads. Approximate date: beginning in 2nd millennium B.C.

3. Small Statuary—Includes human and animal figures in the round, scarabs, and other imitations of eastern themes. These range from approximately 3 to 20 cm in height. Approximate date: 2nd millennium to 7th century B.C.

Clothing or fragments of clothing or carpets or cloth for hanging. Approximate date: 1100 B.C. to 15th century A.D.

Documents made from papyrus and written upon in ink; these are often rolled, fragmentary, and should be handled with extreme care. Approximately 7th century B.C. to A.D. 324.

1. Domestic and Public Wall Painting—These are painted on mudplaster, lime plaster (wet—buon fresco—and dry—secco fresco); types include simple applied color, bands and borders, landscapes, scenes of people and/or animals in natural or built settings. Approximate date: 3rd millennium B.C. to A.D. 324.

2. Tomb Paintings—Paintings on plaster or stone, sometimes geometric or floral but usually depicting gods, goddesses, or funerary scenes. Approximate date: 2nd millennium B.C. to A.D. 500.

3. Panel Paintings on wood depicting gods, goddesses, or funerary scenes. Approximate date: 1st millennium B.C. to A.D. 324.

Floor mosaics including landscapes, scenes of humans or gods, and activities such as hunting and fishing. They are made from stone, tile, or glass cut into small bits (tesserae) and laid into a plaster matrix. There may also be vegetative, floral, or decorative motifs. Approximate date: 5th century B.C. to A.D. 500.

The ecclesiastical ethnological materials represent the Early Christian and Byzantine, and post-Byzantine periods and include objects made from A.D. 324 through 1830.

1. Architectural Elements—In marble and other stone, including upright “closure” slabs, circular marking slabs omphalion, which may be decorated with crosses, human, or animal figures.

2. Monuments—In marble and other stone; types such as funerary inscriptions.

3. Vessels—Containers for holy water.

4. Reliefs—In marble and other stone, used for architectural decoration. May be carved as icons in which religious figures predominate in the figural decoration.

5. Furniture—In marble and other stone. Types include thrones and altars.

1. Reliefs—Cast as icons in which religious figures predominate in the figural decoration.

2. Boxes—Containers of gold and silver, used as reliquaries for sacred human remains. Carved and engraved decoration includes religious figures, scenes from the Bible, floral and geometric designs.

3. Vessels—Containers of lead, which carried aromatic oils and are called “pilgrim flasks.”

4. Ceremonial paraphernalia—In bronze, silver, and gold including asterisks, censers (incense burners), communion chalices and disks, book covers, lances, liturgical items like ciborium ( artophorion ), book covers, benediction or processional crosses, bishop's crowns, buckles, and chests. These are often decorated with molded or incised geometric motifs or scenes from the Bible, inscriptions in Greek, and encrusted with semi-precious or precious stones. The gems themselves may be engraved with religious figures or inscriptions. Ecclesiastical treasure may include all of the above, as well as rings, earrings, and necklaces (some decorated with ecclesiastical themes) and other implements ( e.g., spoons).

Vessels which carried aromatic oils and are called “pilgrim flasks.”

Ceremonial paraphernalia including boxes, reliquaries (and their contents), plaques, pendants, candelabra, stamp rings, crosses. Carved and engraved decoration includes religious figures, scenes from the Bible, and floral and geometric designs.

Wooden objects include architectural elements such as painted wood screens (iconostasis) and lypira; carved doors, crosses, painted wooden beams from churches or monasteries, and monastery seals; furniture such as thrones, pulpit bases ( proskinitaria ), lecturns ( analogia ); chests, and other objects, including musical instruments. Religious figures predominate in the painted and carved figural decoration. Ecclesiastical furniture and architectural elements may also be decorated with geometric or floral designs and/or inlaid with glass or other material.

Vessels of glass include lamps, candle sticks, and other ritual vessels.

Ecclesiastical garments and other ritual textiles, including robes, vestments ( sakkos, phelonion, omophorion, epitrachelion, epigonation ), and altar clothes. They are often of a fine fabric and richly embroidered in silver and gold. Embroidered designs include religious motifs and figures, floral, and geometric designs.

Documents such as illuminated manuscripts occur in single leaves or bound as a book or “codex” and are written or painted on animal skins (cattle, sheep/goat, camel) known as parchment. Illuminated manuscripts, printed books used for religious/ritual purposes, and icons may also be printed on paper in the post-Byzantine period.

1. Wall paintings—On various kinds of plaster and which generally portray religious images and scenes of Biblical events. Surrounding paintings may contain animal, floral, or geometric designs, including borders and bands.

2. Panel Paintings (Icons)—Smaller versions of the scenes on wall paintings, and may be partially covered with gold or silver, sometimes encrusted with semi-precious or precious stones and are usually painted on a wooden panel, often for inclusion in a wooden screen (iconastasis).

Wall mosaics generally portray religious images and scenes of Biblical events. Surrounding panels may contain animal, floral, or geometric designs. They are made from stone and glass cut into small bits (tesserae) and laid into a plaster matrix.

This amendment involves a foreign affairs function of the United States and is, therefore, being made without notice or public procedure; see 5 U.S.C. 553(a)(1). For the same reason, a delayed effective date is not required under 5 U.S.C. 553(d)(3).

Because no notice of proposed rulemaking is required, the provisions of the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ) do not apply.

CBP has determined that this document is not a regulation or rule subject to the provisions of Executive Order 12866 because it pertains to a foreign affairs function of the United States, as described above, and therefore is specifically exempted by section 3(d)(2) of Executive Order 12866.

This regulation is being issued in accordance with 19 CFR 0.1(a)(1) pertaining to the Secretary of the Treasury's authority (or that of his/her delegate) to approve regulations related to customs revenue functions.

Troy A. Miller, Acting Commissioner, U.S. Customs and Border Protection, having reviewed and approved this document, is delegating the authority to electronically sign this document to Robert F. Altneu, who is the Director of the Regulations and Disclosure Law Division for CBP, for purposes of publication in the Federal Register .

For the reasons set forth above, part 12 of title 19 of the Code of Federal Regulations (19 CFR part 12) is amended as set forth below:

The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended, establishes a comprehensive system for the regulation of medical devices intended for human use. Section 513 of the FD&C Act (21 U.S.C. 360c) established three classes of devices, reflecting the regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three classes of devices are class I (general controls), class II (general and special controls), and class III (general controls and premarket approval).

Devices that were not in commercial distribution prior to May 28, 1976 (generally referred to as postamendments devices), are automatically classified by section 513(f)(1) of the FD&C Act into class III without any FDA rulemaking process. Those devices remain in class III and require premarket approval unless, and until: (1) FDA reclassifies the device into class I or II or (2) FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of the FD&C Act, to a predicate device that does not require premarket approval. FDA determines whether new devices are substantially equivalent to predicate devices by means of premarket notification procedures in section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807, subpart E (21 CFR part 807, subpart E).

A postamendments device that has been initially classified in class III under section 513(f)(1) of the FD&C Act may be reclassified into class I or II under section 513(f)(3) of the FD&C Act. Section 513(f)(3) of the FD&C Act provides that FDA, acting by administrative order, can reclassify the device into class I or II on its own initiative, or in response to a petition from the manufacturer or importer of the device. To change the classification of the device, the proposed new class must have sufficient regulatory controls to provide a reasonable assurance of the safety and effectiveness of the device for its intended use.

FDA relies upon “valid scientific evidence,” as defined in section 513(a)(3) of the FD&C Act and 21 CFR 860.7(c)(2), in the classification process to determine the level of regulation for devices. To be considered in the reclassification process, the “valid scientific evidence” upon which the Agency relies must be publicly available (see section 520(c) of the FD&C Act (21 U.S.C. 360j(c))). Publicly available information excludes trade secret and/or confidential commercial information, e.g., the contents of a pending premarket approval application (PMA) (see section 520(c) of the FD&C Act).

FDA published a proposed order in the Federal Register of April 2, 2020 (85 FR 18483), to reclassify nucleic acid-based HCV RNA devices intended for the qualitative or quantitative detection or genotyping of HCV RNA, postamendment class III devices, into class II (general controls and special controls), subject to premarket notification. FDA has considered the information available to the Agency, including the deliberations of the March 22, 2018, Microbiology Devices Panel (2018 Panel), and comments from the public docket and has determined that there is sufficient information to establish special controls to effectively mitigate the risks to health identified in section V of the proposed order, and that these special controls, together with general controls, provide a reasonable assurance of safety and effectiveness when applied to nucleic acid-based HCV RNA devices intended for the qualitative or quantitative detection or genotyping of HCV RNA.

Therefore, in accordance with section 513(f)(3) of the FD&C Act, FDA, on its own initiative, is issuing this final order to reclassify nucleic acid-based HCV RNA devices intended for the qualitative or quantitative detection or genotyping of HCV RNA from class III to class II (general and special controls). 1

On April 2, 2020, FDA published in the Federal Register a proposed order to reclassify nucleic acid-based HCV RNA devices intended for the qualitative or quantitative detection or genotyping of HCV RNA from class III to class II, subject to premarket notification. The comment period on the proposed order closed on June 1, 2020. In response to the proposed order, FDA received comments from industry, healthcare associations, public health departments, and individual consumers by the close of the comment period, some of which contained one or more comments on one or more issues. We describe and respond to the comments in this section of the document. Certain comments are grouped based on common themes; we grouped similar comments together under the same number and listed them numerically.

The order of response to the commenters is purely for organizational purposes and does not signify the comment's value or importance nor the order in which comments were received. Please note that in some cases we separated different issues discussed by the same commenter and designated them as distinct comments for purposes of our responses.

(Comment 1) FDA received numerous comments in favor of the proposed reclassification of nucleic acid-based HCV RNA devices intended for the qualitative or quantitative detection or genotyping of HCV RNA from class III to class II with special controls. Commenters stated they believed that special controls, along with general controls, could provide a reasonable assurance of the safety and effectiveness of these devices. In addition, they believed that the decreased regulatory burden resulting from the reclassification could encourage further development of, and provide patients more timely access to, these devices. Overall, there was a general consensus among the commenters that the proposed special controls are necessary and sufficient to mitigate the risks to health of patients presented by these devices and to provide reasonable assurance of the safety and effectiveness of these devices.

(Response 1) Based on the evidence considered, comments received in response to the proposed order, and deliberations of the 2018 Panel, FDA agrees with the commenters that reclassification of nucleic acid-based HCV RNA devices for the qualitative or quantitative detection or genotyping of HCV RNA from class III into class II and that special controls, in addition to general controls, can provide a reasonable assurance of the safety and effectiveness of these devices. In addition, FDA expects that the reclassification of these devices would enable more manufacturers to develop them such that patients would benefit from increased access to safe and effective tests.

(Comment 2) One comment objected to the proposed reclassification of these devices from class III into class II on the basis that the commenter was not provided adequate notification of the proposed reclassification.

(Response 2) FDA disagrees with this comment as FDA provided notice of our proposed reclassification of these devices with the publication of the proposed order in the Federal Register on April 2, 2020, in accordance with section 513(f)(3) of the FD&C Act and 21 CFR part 860. In addition, as discussed further in the proposed order, a public meeting of the 2018 Panel was held where FDA discussed the possible reclassification of nucleic acid-based HCV RNA tests and the Panel members agreed unanimously with the proposal.

(Comment 3) Several commenters had questions about the scope of the proposed reclassification order. Several commenters noted that the proposed reclassification order identified these devices as nucleic-acid based HCV RNA tests for prescription use and suggested that the reclassification order should also include tests intended for over-the-counter (OTC) use. In addition, one commenter suggested that FDA's reclassification order should also include HCV antigen tests, tests for hepatitis A and hepatitis B, and also that the reclassification should include other specimen types for nucleic acid-based HCV RNA tests beyond those identified in the proposed order ( e.g., urine or saliva).

(Response 3) These comments are beyond the scope of FDA's proposed reclassification order, which applies only to nucleic acid-based HCV RNA tests that have been previously approved by FDA. FDA has not approved any nucleic acid-based HCV RNA tests intended for OTC use, and FDA believes that a nucleic acid-based HCV RNA test intended for OTC use would be a new type of device not previously classified based on the criteria at section 513(a)(1) of the FD&C Act and, as a result, such postamendments device would be automatically classified into class III by operation of section 513(f)(1) of the FD&C Act.

Similarly, to date, FDA has only approved nucleic acid-based HCV RNA tests intended for use with human serum or plasma, and new specimen types are beyond the scope of FDA's proposed reclassification order.

(Comment 4) Several commenters expressed support of FDA's proposal to rename these devices from “nucleic acid-based hepatitis C virus (HCV) ribonucleic acid (RNA) assay devices” to “nucleic acid-based hepatitis C virus (HCV) ribonucleic acid (RNA) tests.” These commenters believed that the new name for these devices made clear that these are diagnostic tests and is consistent with the naming of similar diagnostic devices.

(Response 4) FDA believes that the new identification name of these devices—“nucleic acid-based hepatitis C virus (HCV) ribonucleic acid (RNA) tests”—is both understandable to consumers and industry and is consistent with the naming of similar diagnostic devices and agrees with these commenters. As discussed further below in section III, FDA on its own initiative has revised the device identification of nucleic-acid based HCV RNA to be codified in § 866.3170(a) (21 CFR 866.3170(a)).

(Comment 5) One commenter suggested that the proposed special control requiring cross-reactivity studies may not be necessary and suggested instead that interfering substance studies be conducted according to “CLSI-EP-7-A2: Interference Testing in Clinical Chemistry: Approved Guideline—Second Edition” (Ref. 1).

(Response 5) FDA disagrees with this comment and believes that the special control requiring cross-reactivity studies that include samples from HCV RNA negative subjects with other causes of liver disease, including autoimmune hepatitis, alcoholic liver disease, chronic hepatitis B virus, primary biliary cirrhosis, and nonalcoholic steatohepatitis, when applicable, is necessary to provide a reasonable assurance of the safety and effectiveness of these devices (see § 866.3170(b)(2)(iv)). FDA also believes that specifying a standard explicitly as part of the special controls that manufacturers must follow is not necessary and would prohibit the use of a new standard in the event that the version of the standard specified in the special controls is revised and/or updated.

(Comment 6) One commenter suggested that FDA provide additional details regarding the study design and analysis required for devices intended for the quantitative detection of HCV RNA by the special control in § 866.3170(b)(4)(C). In addition, the commenter requested clarification on the requirement for clinical studies for nucleic-acid based HCA RNA tests intended for Point of Care (PoC) use and inquired whether the sample size for such studies should be larger than for the other clinical studies required by the special controls.

(Response 6) FDA disagrees with this comment and does not believe that additional specificity is required to provide a reasonable assurance of the safety and effectiveness of these devices because the appropriate sample size for a required study may be influenced by the technology at issue and/or type of device under review.

FDA recommends that device manufacturers interested in obtaining FDA feedback on their study design submit a pre-submission (Ref. 2). In addition, FDA publishes our decision summaries for previously approved or cleared devices for in vitro diagnostic testing on our website and these summaries can be useful aids for manufacturers to obtain information on the study designs used to support the marketing authorizations of other nucleic-acid based HCV RNA tests (Refs. 3 and 4).

Based on the information discussed in the preamble to the proposed order (April 2, 2020), the comments received for the proposed order, the 2018 Panel delibrations (Ref. 5), and FDA's experiences over the years in reviewing these devices, FDA concludes that special controls, in conjunction with general controls, will provide a reasonable assurance of the safety and effectiveness of nucleic-acid based HCV RNA tests. FDA is adopting its findings under section 513(f)(3) of the FD&C Act, as published in the preamble to the proposed order. FDA is issuing this final order to reclassify nucleic acid-based HCV RNA devices intended for the qualitative or quantitative detection or genotyping of HCV RNA from class III to class II, and to establish special controls by revising 21 CFR part 866. In this final order, the Agency has identified the special controls under section 513(a)(1)(B) of the FD&C Act that, together with general controls, provide a reasonable assurance of the safety and effectiveness of these devices.

Section 510(m) of the FD&C Act provides that FDA may exempt a class II device from the premarket notification requirements under section 510(k) of the FD&C Act, if FDA determines that premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device. FDA has determined that premarket notification is necessary to provide a reasonable assurance of the safety and effectiveness of nucleic-acid based HCV RNA tests. Therefore, these devices are not exempt from premarket notification requirements. Persons who intend to market a new nucleic-acid based HCV RNA device intended for the qualitative or quantitative detection or genotyping of HCV RNA must submit to FDA a premarket notification, obtain clearance, and demonstrate compliance with the special controls included in this final order, prior to marketing the device.

These devices are assigned the generic name “nucleic-acid based hepatitis C virus ribonucleic acid tests” and are identified as in vitro diagnostic devices intended for prescription use as an aid in the diagnosis of HCV infection in specified populations, and/or as an aid in the management of HCV-infected patients including guiding the selection of genotype-specific treatment in individuals with chronic HCV infection. These tests are intended for use with human serum or plasma. These tests are not intended for use as a donor screening test for the presence of HCV antibodies in blood, blood products, or tissue donors.

Under this final order, nucleic acid-based HCV RNA tests are identified as prescription use only devices and as such, nucleic acid-based HCV RNA tests must satisfy prescription labeling requirements for in vitro diagnostic products (see 21 CFR 809.10(a)(4) and (b)(5)(ii)). Under 21 CFR 807.81, the device continues to be subject to 510(k) requirements.

As part of the process for issuance of this final order and on its own initiative, FDA has identified previously approved nucleic-acid based HCV RNA tests for use as an aid in diagnosis of HCV infection without prior evidence of HCV antibodies. In this final order, FDA has revised the device identification of nucleic-acid based HCV RNA tests to be codified in § 866.3170(a) to clarify that nucleic acid-based HCV RNA tests can include devices used as an aid for diagnosis of HCV infection in specified populations without prior evidence of HCV antibodies because FDA believes that it may be appropriate to use these devices as a one-step diagnostic assay and in the absence of evidence of HCV antibodies.

Prior to the amendments in the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144) (FDASIA), section 513(e) of the FD&C Act provided for FDA to issue regulations to reclassify devices. Although section 513(e), as amended by FDASIA, requires FDA to issue final orders rather than regulations, it also provides for FDA to revoke previously issued regulations by order. FDA will continue to codify classifications and reclassifications in the Code of Federal Regulations (CFR). Changes resulting from final orders will appear in the CFR as changes to codified classification determinations or as newly codified orders. Therefore, under section 513(e)(1)(A)(i), as amended by FDASIA, in this final order, we are proposing to codify the classification of nucleic-acid based hepatitis C virus ribonucleic acid tests in the new § 866.3170, under which nucleic-acid based HCV RNA tests would be reclassified into class II.

The Agency has determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

This final order establishes special controls that refer to previously approved FDA collections. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections of information in part 807, subpart E have been approved under OMB control number 0910-0120; the collections of information in 21 CFR parts 801and 809 have been approved under OMB control number 0910-0485; and the collections of information in 21 CFR part 820 have been approved under OMB control number 0910-0073.

The following references marked with an asterisk (*) are on display at the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they also are available electronically at https://www.regulations.gov. References without asterisks are not on public display at https://www.regulations.gov because they have copyright restrictions. Some may be available at the website address, if listed. References without asterisks are available for viewing only at the Dockets Management Staff. FDA has verified the website addresses, as of the date this document publishes in the Federal Register , but websites are subject to change over time.

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

The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended, establishes a comprehensive system for the regulation of medical devices intended for human use. Section 513 of the FD&C Act (21 U.S.C. 360c) established three classes of devices, reflecting the regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three classes of devices are class I (general controls), class II (general and special controls), and class III (general controls and premarket approval).

Devices that were not in commercial distribution prior to May 28, 1976 (generally referred to as postamendments devices), are automatically classified by section 513(f)(1) of the FD&C Act into class III without any FDA rulemaking process. 1 Those devices remain in class III and require premarket approval unless, and until, (1) FDA reclassifies the device into class I or II, or (2) FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of the FD&C Act, to a predicate device that does not require premarket approval. FDA determines whether new devices are substantially equivalent to predicate devices by means of premarket notification procedures in section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807), subpart E, of the regulations.

A postamendments device that has been initially classified in class III under section 513(f)(1) of the FD&C Act may be reclassified into class I or II under section 513(f)(3) of the FD&C Act. Section 513(f)(3) of the FD&C Act provides that FDA, acting by administrative order, can reclassify the device into class I or II on its own initiative, or in response to a petition from the manufacturer or importer of the device. To change the classification of the device, the proposed new class must have sufficient regulatory controls to provide a reasonable assurance of the safety and effectiveness of the device for its intended use.

FDA relies upon “valid scientific evidence,” as defined in section 513(a)(3) of the FD&C Act and § 860.7(c)(2) (21 CFR 860.7(c)(2)), in the classification process to determine the level of regulation for devices. To be considered in the reclassification process, the “valid scientific evidence” upon which the Agency relies must be publicly available (see section 520(c) of the FD&C Act (21 U.S.C. 360j(c))). Publicly available information excludes trade secret and/or confidential commercial information, e.g., the contents of a pending premarket approval application (PMA) (see section 520(c) of the FD&C Act).

FDA published a proposed order in the Federal Register of April 2, 2020 (85 FR 18490), to reclassify these device types from class III into class II (general controls and special controls), subject to premarket notification. FDA has considered the information available to the Agency, including the deliberations of the March 22, 2018, Microbiology Devices Panel (2018 Panel), and comments from the public docket to determine that there is sufficient information to establish special controls to effectively mitigate the risks to the health identified in section V of the proposed order, and that these special controls, together with general controls, provide a reasonable assurance of safety and effectiveness when applied to certain HCV antibody assay devices intended for the qualitative detection of HCV.

Therefore, in accordance with section 513(f)(3) of the FD&C Act, FDA, on its own initiative, is issuing this final order to reclassify certain HCV antibody assay devices intended for the qualitative detection of HCV from class III to class II (general and special controls). 2

On April 2, 2020, FDA published in the Federal Register a proposed order (85 FR 18490) to reclassify certain HCV antibody assay devices intended for the qualitative detection of HCV from class III to class II, subject to premarket notification. The comment period on the proposed order closed on June 1, 2020. In response to the proposed order, FDA received comments from industry, healthcare associations, public health departments, and individual consumers by the close of the comment period, some of which contained one or more comments on one or more issues. We describe and respond to the comments in this section of the document. Certain comments are grouped based on common themes; we grouped similar comments together under the same number and listed them numerically.

The order of response to the commenters is purely for organizational purposes and does not signify the comment's value or importance nor the order in which comments were received. Please note that in some cases we separated different issues discussed by the same commenter and designated them as distinct comments for purposes of our responses.

(Comment 1) FDA received numerous comments in favor of the proposed reclassification of certain HCV antibody assay devices intended for the qualitative detection of HCV from class III to class II with special controls. Commenters stated they believed that special controls, along with general controls, could provide a reasonable assurance of the safety and effectiveness of these devices. In addition, they believed that the decreased regulatory burden resulting from the reclassification could encourage further development of, and provide patients more timely access to, these devices. Overall, there was a general consensus among the commenters that the proposed special controls are necessary and sufficient to mitigate the risks to health of patients presented by these devices and to provide reasonable assurance of the safety and effectiveness of these devices.

(Response 1) Based on the evidence considered, comments received in response to the proposed order and deliberations of the 2018 Panel, FDA agrees with the commenters that reclassification of certain HCV antibody assay devices for the qualitative detection of HCV from class III into class II and that special controls, in addition to general controls, can provide a reasonable assurance of the safety and effectiveness of these devices. In addition, FDA expects that the reclassification of these devices would enable more manufacturers to develop them such that patients would benefit from increased access to safe and effective tests.

(Comment 2) One comment expressed concerns about the proposed reclassification of these devices from class III into class II. The commenter suggested that there was not enough justification to reclassify these devices at this time and asked for clarification on FDA's justification proposing this reclassification. The commenter also asked for clarification on whether a high demand of these devices was a consideration in FDA's proposed reclassification order.

(Response 2) Based on the evidence considered, comments received in response to the proposed order and deliberations of the 2018 Panel, FDA disagrees with this comment and continues to believe that reclassification of these devices is justified for the reasons identified in the proposed order (85 FR 18490). FDA's justification for reclassifying these devices is based on the unanimous recommendation of the 2018 Panel, FDA's accumulated experience with these devices from review submissions, and from published peer-reviewed literature. In addition, FDA believes that the special controls identified in this final order, in addition to the general controls, will provide a reasonable assurance of the safety and effectiveness of these devices.

FDA relies upon “valid scientific evidence” as defined in section 513(a)(3) of the FD&C Act and § 860.7(c)(2) in the classification process to determine the level of regulation for devices. FDA believes the standard in section 513(a)(1)(B) of the FD&C Act is met as there is sufficient information to establish special controls, which, in addition to general controls, will provide reasonable assurance of the safety and effectiveness of these devices. While FDA expects that the reclassification of these devices would enable more manufacturers to develop HCV antibody tests such that patients would benefit from increased access to safe and effective tests, this is not a consideration in the Agency's reclassification determination.

(Comment 3) Several commenters had questions about the scope of the proposed reclassification order. Several commenters noted that the proposed reclassification order identified these devices as HCV antibody tests for prescription use and suggested that the reclassification order should also include HCV antibody tests intended for over-the-counter (OTC) use. In addition, one commenter suggested that FDA's reclassification order should also include HCV antigen tests, tests for hepatitis A and hepatitis B, and also that the reclassification should include other specimen types for HCV antibody tests beyond those identified in the proposed order ( e.g., urine or saliva).

(Response 3) These comments are beyond the scope of FDA's proposed reclassification order which applies only to HCV antibody tests that have been previously approved by FDA. FDA has not approved any HCV antibody tests intended for OTC use and FDA believes that an HCV antibody tests intended for OTC use would be a new type of device not previously classified based on the criteria at section 513(a)(1) of the FD&C Act and, as a result, such postamendments devices would be automatically classified into class III by operation of section 513(f)(1) of the FD&C Act. FDA believes that an HCV antibody test intended for OTC use may be a good candidate for the De Novo classification process under section 513(f)(2) of the FD&C Act (Refs. 1 and 2). FDA recommends that device manufacturers interested in marketing an HCV antibody test for OTC use submit a Pre-Submission to request FDA feedback on the studies and data that may be necessary to support a De Novo request (Ref. 3).

Similarly, to date, FDA has only approved HCV antibody tests intended for use with human serum or plasma and new specimen types are beyond the scope of this reclassification order.

(Comment 4) Several commenters expressed support of FDA's proposal to rename these devices from “hepatitis C virus antibody assay devices” to “hepatitis C virus (HCV) antibody tests.” These commenters believed that the new name for these devices made clear that these are diagnostic tests and is consistent with the naming of similar diagnostic devices. Alternatively, several commenters provided suggestions on FDA's proposal to rename these devices to “hepatitis C virus (HCV) antibody tests.” One commenter suggested renaming these devices “HCV serological tests.” Another commenter suggested renaming these devices “hepatitis C virus (HCV) antibody test devices.”

(Response 4) FDA believes that the new identification of these devices as “hepatitis C virus (HCV) antibody tests” is both understandable to consumers and industry and is consistent with the naming of similar diagnostic devices.

FDA disagrees with those commenters that proposed renaming these devices “HCV serological tests” or “hepatitis C virus (HCV) antibody test devices” as FDA believes that the identification of these devices as “hepatitis C virus (HCV) antibody tests” adequately identifies the types of devices that would be affected by this reclassification action and is clear and consistent with the naming of similar diagnostic devices.

(Comment 5) One commenter suggested that HCV antibody tests could be classified in part 866 (21 CFR part 866) after “Hepatitis A virus (HAV) serological reagents” which are currently classified under 21 CFR 866.3310.

(Response 5) FDA disagrees with this comment because FDA believes that the classification of HCV antibody tests under § 866.3169 (21 CFR 866.3169) is appropriate. In addition, FDA has proposed to reclassify nucleic acid-based HCV ribonucleic acid (RNA) devices intended for the qualitative or quantitative detection or genotyping of HCV RNA under § 866.3170 (21 CFR 866.3170) (85 FR 18483). The classification of HCV antibody tests in § 866.3169 would allow for these devices to be located next to nucleic acid-based HCV RNA tests in the Code of Federal Regulations (CFR).

(Comment 6) One commenter requested that FDA state the time that it generally takes for FDA to review 510(k) submissions and PMA applications.

(Response 6) Review times for a particular device may vary but the FD&C Act requires manufacturers to submit a 510(k) to FDA at least 90 days before introducing, or before delivering for introduction, a device into interstate commerce (see section 510(k) of the FD&C Act). For comparison, FDA has 180 days to review a PMA starting on the date an application is accepted for filing (see section 515(d) of the FD&C Act (21 U.S.C. 360e(d)) and 21 CFR 814.40).

(Comment 7) One comment indicated a patient who was diagnosed with hepatitis was successfully treated. Another comment requested that FDA consider reducing the prices of HCV antibody tests as a result of their reclassification.

(Response 7) Each of these comments are outside the scope of this reclassification action.

(Comment 8) Several comments expressed general support of the special controls identified in the proposed order and believed they would provide a reasonable assurance of safety and effectiveness of these devices. In addition, several commenters suggested that FDA revise the special controls to include a requirement that the labeling identify where and when these devices may be used consistent with infection control standards and FDA guidance documents for infection control. Additionally, it was suggested that the labeling specify the special populations of patients for which test performance may be affected.

(Response 8) FDA continues to believe that the special controls identified in the proposed order and finalized in this final order are sufficient to provide a reasonable assurance of safety and effectiveness of HCV antibody tests.

FDA disagrees that a further level of specificity is necessary for inclusion within the special controls to provide a reasonable assurance of safety and effectiveness for these devices and wants to ensure that the special controls remain appropriate and applicable to provide a reasonable assurance of safety and effectiveness for these devices over time. Further, performance of these devices may evolve over time for special populations and any special populations for which performance of these devices may be affected are required to be included in the labeling for these devices by the special controls (see § 866.3169(b)(1)(ii)(A)).

Based on the information discussed in the preamble to the proposed order (85 FR 18490), the comments received for the proposed order, the 2018 Panel deliberations (Ref. 4), and FDA's experiences over the years in reviewing these device types, FDA concludes that special controls, in conjunction with general controls, will provide a reasonable assurance of the safety and effectiveness of HCV antibody tests. FDA is adopting its findings under section 513(f)(3) of the FD&C Act, as published in the preamble to the proposed order. FDA is issuing this final order to reclassify HCV antibody tests intended for the qualitative detection of HCV from class III to class II, and establishing special controls by revising part 866. In this final order, the Agency has identified the special controls under section 513(a)(1)(B) of the FD&C Act that, together with general controls, provide a reasonable assurance of the safety and effectiveness of these devices.

Section 510(m) of the FD&C Act provides that FDA may exempt a class II device from the premarket notification requirements under section 510(k) of the FD&C Act, if FDA determines that premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device. FDA has determined that premarket notification is necessary to provide a reasonable assurance of the safety and effectiveness of HCV antibody tests. Therefore, this device type is not exempt from premarket notification requirements. Persons who intend to market a new HCV antibody assay device must submit to FDA a premarket notification, obtain clearance, and demonstrate compliance with the special controls included in this final order, prior to marketing the device.

These devices are assigned the generic name “HCV antibody tests” and identified as in vitro diagnostic devices intended for use with human serum, plasma, or other matrices as a prescription device that aids in the diagnosis of HCV infection in persons with signs and symptoms of hepatitis and in persons at risk for hepatitis C infection. The test is not intended for screening blood, plasma, cell, or tissue donors.

Under this final order, HCV antibody tests are identified as prescription use only devices and as such, HCV antibody tests must satisfy prescription labeling requirements for in vitro diagnostic products (see 21 CFR 809.10(a)(4) and (b)(5)(ii)). Under 21 CFR 807.81, the device continues to be subject to 510(k) requirements.

Prior to the amendments in the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144) (FDASIA), section 513(e) of the FD&C Act provided for FDA to issue regulations to reclassify devices. Although section 513(e), as amended by FDASIA, requires FDA to issue final orders rather than regulations, it also provides for FDA to revoke previously issued regulations by order. FDA will continue to codify classifications and reclassifications in the CFR. Changes resulting from final orders will appear in the CFR as changes to codified classification determinations or as newly codified orders. Therefore, under section 513(e)(1)(A)(i), as amended by FDASIA, in this final order, we are proposing to codify the classification of hepatitis c virus antibody tests in the new § 866.3169, under which HCV antibody tests would be reclassified into class II.

The Agency has determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

This final order establishes special controls that refer to previously approved FDA collections. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections of information in part 807, subpart E have been approved under OMB control number 0910-0120; the collections of information in 21 CFR parts 801 and 809 have been approved under OMB control number 0910-0485; and the collections of information in 21 CFR part 820 have been approved under OMB control number 0910-0073.

The following references are on display at the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500 and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they also are available electronically at https://www.regulations.gov. FDA has verified the website addresses, as of the date this document publishes in the Federal Register , but websites are subject to change over time.

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

The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended, establishes a comprehensive system for the regulation of medical devices intended for human use. Section 513 of the FD&C Act (21 U.S.C. 360c) established three categories (classes) of devices, reflecting the regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three categories of devices are class I (general controls), class II (special controls), and class III (premarket approval).

Under section 513(d)(1) of the FD&C Act, devices that were in commercial distribution before the enactment of the Medical Device Amendments of 1976 (the 1976 amendments) (Pub. L. 94-295), May 28, 1976 (generally referred to as “preamendments devices”), are classified after FDA: (1) Receives a recommendation from a device classification panel (an FDA advisory committee); (2) publishes the panel's recommendation for comment, along with a proposed regulation classifying the device; and (3) publishes a final regulation classifying the device. FDA has classified most preamendments devices under these procedures.

A preamendments device that has been classified into class III and devices found substantially equivalent by means of premarket notification (510(k)) procedures to such a preamendments device or to a device within that type (both the preamendments and substantially equivalent devices are referred to as preamendments class III devices) may be marketed without submission of a PMA until FDA issues a final order under section 515(b) of the FD&C Act (21 U.S.C. 360e(b)) requiring premarket approval. Section 515(b)(1) of the FD&C Act directs FDA to issue an order requiring premarket approval for a preamendments class III device.

Section 515(f) of the FD&C Act provides an alternative pathway for meeting the premarket approval requirement. Under section 515(f), manufacturers may meet the premarket approval requirement if they file a notice of completion of a PDP approved under section 515(f)(4) of the FD&C Act and FDA declares the PDP completed under section 515(f)(6)(B) of the FD&C Act. Accordingly, the manufacturer of a preamendments class III device may comply with a call for PMAs by filing a PMA or a notice of completion of a PDP. In practice, however, the option of filing a notice of completion of a PDP has rarely been used. For simplicity, although the PDP option remains available to manufacturers in response to a final order under section 515(b) of the FD&C Act, this document will refer only to the requirement for the filing and obtaining approval of a PMA.

On July 9, 2012, Congress enacted the Food and Drug Administration Safety and Innovation Act (FDASIA) (Pub. L. 112-144). Section 608(b) of FDASIA amended section 515(b) of the FD&C Act, changing the process for requiring premarket approval for a preamendments class III device from rulemaking to an administrative order.

Section 515(b)(1) of the FD&C Act sets forth the process for issuing a final order. Specifically, prior to the issuance of a final order requiring premarket approval for a preamendments class III device, the following must occur: (1) Publication of a proposed order in the Federal Register ; (2) a meeting of a device classification panel described in section 513(b) of the FD&C Act; and (3) consideration of comments to a public docket.

In June 2013, FDA held a meeting of a device classification panel described in section 513(b) of the FD&C Act to discuss the classification of multiple use blood lancets for multiple patient use (Ref. 1). Although, to FDA's knowledge, no device is currently being marketed for this use, one device has been cleared for this use. This device classification panel meeting discussed whether multiple use blood lancets for multiple patient use should be reclassified into class III or remain in class I, and the discussion included whether PMAs should be required for these devices. The panel recommended that, because multiple use blood lancets for multiple patient use present a potential unreasonable risk of illness or injury and insufficient information exists to establish special controls for multiple use blood lancets for multiple patient use, the device should be reclassified into class III. FDA is not aware of new information that would provide a basis for a different recommendation or findings.

On March 3, 2016, FDA published a proposed order (81 FR 11140) to reclassify multiple use blood lancets for multiple patient use from class I (general controls), exempt from premarket notification, into class III (premarket approval). On March 3, 2016, FDA published a second proposed order (81 FR 11151) to require the filing of a PMA following the reclassification of multiple use blood lancets for multiple patient use from class I to class III.

Section 515(b)(3) of the FD&C Act provides that FDA shall, after the close of the comment period on the proposed order, consideration of any comments received, and a meeting of a device classification panel described in section 513(b) of the FD&C Act, issue a final order to require premarket approval or publish a document terminating the proceeding together with the reasons for such termination. If FDA terminates the proceeding, FDA is required to initiate reclassification of the device under section 513(e) of the FD&C Act, unless the reason for termination is that the device is a banned device under section 516 of the FD&C Act (21 U.S.C. 360f).

A preamendments class III device may be commercially distributed without a PMA until 90 days after FDA issues a final order requiring premarket approval for the device, or 30 months after final classification of the device under section 513 of the FD&C Act becomes effective, whichever is later (section 501(f)(2)(B) of the FD&C Act (21 U.S.C. 351(f)(2)(B)). Elsewhere in this issue of the Federal Register , FDA is issuing a final order to reclassify multiple use blood lancets for multiple patient use from class I to class III. Therefore, the date by which a PMA for multiple use blood lancets for multiple patient use must be filed is May 22, 2024. If a PMA is not filed for such device by May 22, 2024, as specified in section 501(f)(2)(B) of the FD&C Act, then the device would be deemed adulterated under section 501(f) of the FD&C Act unless the device is distributed for investigational use under an approved application for an investigational device exemption (IDE).

In response to the proposed order to require the filing of a PMA for multiple use blood lancets for multiple patient use, FDA received two comments. The comments and FDA responses to the comments are summarized in this section. The number assigned to each comment is purely for organizational purposes and does not signify the comment's value or importance or the order in which it was submitted.

(Comment 1) Comment supports regulation of blood lancets to lower the risk of injury associated with such devices during home use, including use by patients who may have shaking hands due to low blood sugar.

(Response 1) FDA agrees that blood lancets, including multiple use blood lancets for multiple patient use, should be regulated to provide a reasonable assurance of the safety and effectiveness for these devices.

(Comment 2) Comment recommends banning multiple use blood lancets for multiple patient use because the devices present a potential unreasonable risk of illness that cannot be adequately addressed through the PMA process and single patient lancets are available.

(Response 2) Section 516 of the FD&C Act gives FDA the authority to ban a device. Section 516 authorizes FDA to ban a device when, on the basis of all available data and information, FDA finds that the device presents substantial deception or an unreasonable and substantial risk of illness or injury and, where such deception or risk could be corrected or eliminated by labeling or change in labeling and with respect to which the Secretary of the Department of Health and Human Services (Secretary) provided written notice to the manufacturer specifying the deception or risk of illness or injury, the labeling or change in labeling to correct the deception or eliminate or reduce such risk, and the period within which such labeling or change in labeling was to be done, such labeling or change in labeling was not done within such period.

As stated earlier in this document, FDA issued a proposed order (81 FR 11151) under section 515(b) of the FD&C Act to require the filing of PMAs for multiple use blood lancets for multiple patient use following reclassification, which would require an individual demonstration of a reasonable assurance of safety and effectiveness for such a device before it may be marketed. In the proposed order, FDA recognized and agreed with the recommendations from the Panel  1 that based on the available scientific evidence, multiple use blood lancets for multiple patient use should be reclassified to class III because these devices present a potential unreasonable risk of illness or injury and insufficient information exists to establish special controls for these devices because there is no evidence that they can be adequately cleaned and disinfected and there is no proven method of doing so. To FDA's knowledge, although one device has been cleared for this use, no device is currently being marketed for this use. FDA believes that evidence may be provided through a PMA to demonstrate a reasonable assurance of safety and effectiveness of the device. Additionally, such evidence may provide additional information to allow FDA to impose controls to mitigate the risk and more clearly characterize the benefits of these devices. At this time and on the basis of all available data and information, FDA does not believe that this device presents substantial deception or an unreasonable and substantial risk of illness or injury to support a ban.

Under section 515(b)(3) of the FD&C Act, FDA is adopting its findings as published in the proposed order (81 FR 11151) and is issuing this final order to require the filing of a PMA for multiple use blood lancets for multiple patient use. This final order will revise 21 CFR part 878. Elsewhere in this issue of the Federal Register , FDA is reclassifying multiple use blood lancets for multiple patient use into class III under section 513(e) of the FD&C Act.

Under the final order, a PMA is required to be filed on or before May 22, 2024, for any of these preamendments class III devices that were in commercial distribution before May 28, 1976, or that have been found by FDA to be substantially equivalent to such a device on or before May 22, 2024. An applicant of a device subject to this order that was legally in commercial distribution before May 28, 1976, or that has been found to be substantially equivalent to a device that was legally in commercial distribution before May 28, 1976, may continue marketing such class III device during FDA's review of the PMA provided that the PMA is filed on or May 22, 2024. However, if FDA denies approval of the PMA, then the device will be deemed adulterated under section 501(f)(1)(A) of the FD&C Act, and commercial distribution of the device must cease immediately. Any other device subject to this order is required to have an approved PMA in effect before it may be marketed. FDA intends to review any PMA for the device within 180 days of the date of filing. FDA cautions that under section 515(d)(1)(B)(i) of the FD&C Act, the Agency may not enter into an agreement to extend the review period for a PMA beyond 180 days unless the Agency finds that “the continued availability of the device is necessary for the public health.”

If a PMA for any of the preamendments class III devices subject to this order is not filed on or before May 22, 2024, that device will be deemed adulterated under section 501(f)(1)(A) of the FD&C Act, and commercial distribution of the device must cease immediately. FDA requests that manufacturers take action to prevent the further use of multiple use blood lancets for multiple patient use for which no PMA has been filed.

The device may, however, be distributed for investigational use, if the applicable requirements of the IDE regulations (part 812 (21 CFR part 812)), including obtaining IDE approval, are met on or before May 22, 2024. There will be no extended period for filing an IDE or exemption from the IDE requirements (see § 812.2(d)), and clinical studies may not be initiated without appropriate IDE approvals, as required.

Until the date when a PMA must be filed, any multiple use blood lancet for multiple patient use not in commercial distribution as of the effective date of this order is subject to premarket notification under section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and 21 CFR part 807, subpart E, unless the device is exempt from 510(k) because the applicable requirements of part 812, including obtaining IDE approval, are met.

Prior to the amendments by FDASIA, section 515(b) of the FD&C Act provided for FDA to issue regulations to require approval of an application for premarket approval for preamendments devices or devices found substantially equivalent to preamendments devices. Section 515(b) of the FD&C Act, as amended by FDASIA, provides for FDA to require approval of an application for premarket approval for such devices by issuing a final order following the issuance of a proposed order in the Federal Register . FDA will continue to codify the requirement for an application for premarket approval in the Code of Federal Regulations (CFR). Therefore, under section 515(b)(1) of the FD&C Act, as amended by FDASIA, in this final order, FDA is requiring approval of an application for premarket approval for multiple use blood lancets for multiple patient use and the Agency is making the language in 21 CFR 878.4850 consistent with this final order.

We have determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

FDA concludes that this final order contains no new collection of information. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not required. This final order refers to previously approved FDA collections of information. These collections of information are subject to review by OMB under the PRA. The collections of information in 21 CFR part 814, subparts A through E, have been approved under OMB control number 0910-0231. The collections of information in part 807, subpart E, have been approved under OMB control number 0910-0120. The collections of information in 21 CFR part 801 have been approved under OMB control number 0910-0485. The collections of information in part 812 have been approved under OMB control number 0910-0078.

The following reference is on display at the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and is available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; it is also available electronically at https://www.regulations.gov. FDA has verified the website address, as of the date this document publishes in the Federal Register , but websites are subject to change over time.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 878, as amended elsewhere in this issue of the Federal Register , is further amended as follows:

In October 2020, the Fisher Island Ferry Communities Association relocated its ferry terminal to the Biscayne Bay Causeway Island Slip (Slip), west of the Coast Guard Base Miami Beach, Miami Beach, FL. The Slip is the primary terminal for the movement of residents, workers, and goods from Terminal Island to Fisher Island. Prior to October 2020, maritime traffic in the Biscayne Bay Causeway Island Basin (Basin) was limited in scope to occasional private yachts and Coast Guard assets. The addition of ferry traffic at the Slip has resulted in a substantial increase in maritime traffic in the Basin. The Basin has a length of approximately 380 yards and a width of approximately 97 yards. The increase in traffic, particularly of the Fisher Island Ferry, presents a hazard to Coast Guard assets operating in the Basin as the ferries occasionally pass within the Basin, dangerously close to Coast Guard assets. Additionally, and particularly when passing within the Basin, the ferries create a disrupting, and at times dangerous wake, adversely affecting Coast Guard routine operations and personnel. The passing maneuvers and resultant wake also create hazardous conditions during certain cutter operations, such as onloading and offloading of ammunition or refueling. The Coast Guard's Seventh District Commander has determined the increased ferry traffic, passing maneuvers, and resultant wake presents a safety and operational concern to Coast Guard personnel and assets moored in the Biscayne Bay Causeway Island Basin.

In response, on April 14, 2021, the Coast Guard published a notice of proposed rulemaking (NPRM) titled, “Regulated Navigation Area: Biscayne Bay Causeway Island Slip, Miami Beach, FL” (86 FR 19599). There we stated why we issued the NPRM, and invited comments on our proposed regulatory action related to this Regulated Navigation Area. During the comment period that ended May 14, 2021, we received 0 comments.

The Coast Guard is issuing this rule under authority in 46 U.S.C. 70034. The Coast Guard's Seventh District Commander has determined that potential hazards associated with the increased maritime traffic in the Biscayne Bay Causeway Island Basin (Basin), where ferries occasionally pass within the Basin dangerously close to Coast Guard assets, is a safety and operational concern. The purpose of this regulation is to ensure navigational safety, protection of Coast Guard assets and personnel, and to facilitate safe execution of Coast Guard statutory missions.

As noted above, we received no comments on the NPRM published April 14, 2021. We are making one change in the regulatory text. We discovered that the section number in the CFR, 33 CFR 165.789 is already in use. Section 165.789 contains a safety zone regulation. Therefore, we are revising the section number for this Regulated Navigation Area in the final rule regulatory text. We are deleting “165.789,” and replacing it with “165.790.”

This rule establishes a permanent Regulated Navigation Area that will require all persons and vessels to transit the regulated area at a speed that creates minimum wake, seven miles per hour or less, to safeguard damage to Coast Guard assets, disrupting operations, and/or injuring Coast Guard personnel. Additionally, this rule will prohibit vessels from passing other vessels making way within the regulated area. This Regulated Navigation Area covers all navigable waters within the Biscayne Bay Causeway Island Slip, immediately west of the Coast Guard Base Miami Beach, Miami Beach, FL.

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 Regulated Navigation area. The Regulated Navigation Area will only affect vessels entering, and passing within, the Biscayne Bay Causeway Island Slip in Miami Beach, Miami Beach, FL. Vessels will continue to operate within the Biscayne Bay Causeway Island Slip with the only restriction being the requirement to operate at speeds below seven miles per hour and avoid passing other vessels making way within the regulated area. Moreover, upon activating the Regulated Navigation Area, the Coast Guard will notify the local maritime community through various means including, Local Notice to Mariners and Broadcast Notice to Mariners issued on VHF-FM marine radio channel 16.

The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard received 0 comments from the Small Business Administration on this rulemaking. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.

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

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

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

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

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

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

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

We have analyzed this rule under Department of Homeland Security Directive 023-01, Rev. 1, associated implementing instructions, and Environmental Planning COMDTINST 5090.1 (series), which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a Regulated Navigation Area requiring all persons and vessels to transit the regulated area at a speed that creates minimum wake, seven miles or less, and to avoid passing other vessels making way within the regulated area. Normally such actions are categorically excluded from further review under paragraph L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1. A Record of Environmental Consideration supporting this determination is available in the docket. For instructions on locating the docket, see the ADDRESSES section of this preamble.

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

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

On August 3, 2020, the USPTO published a final rule in the Federal Register that included a new fee set forth in § 1.16(u) with an effective date of January 1, 2022. See Setting and Adjusting Patent Fees in Fiscal Year 2020, 85 FR 46932. As specified in § 1.16(u), the fee is due for any application filed on or after January 1, 2022, under 35 U.S.C. 111 for an original patent—except design, plant, or provisional applications—where the specification, claims, and/or abstract do not conform to the USPTO requirements for submission in DOCX format. Therefore, the fee is due for nonprovisional utility applications filed under 35 U.S.C. 111, including continuing applications, that are not filed in DOCX format.

The USPTO conducted two pilot programs for filing applications in DOCX format. The eMod Text Pilot Program was conducted between August 2016 and September 2017. The USPTO then expanded the ability to file patent applications in DOCX format in EFS-Web to all users in September 2017. In 2018, the USPTO launched Patent Center and conducted the Patent Center Text Pilot Program from June 2018 through April 2020. All applicants have been able to file applications in DOCX format in Patent Center since April 2020. Information about Patent Center is available at www.uspto.gov/patents/apply/patent-center. In addition, the USPTO has held many discussions with stakeholders to ensure a fair and reasonable transition to the DOCX format.

The USPTO is delaying the effective date of the fee set forth in § 1.16(u) until January 1, 2023. The delay will enable the USPTO to provide enhanced testing of its information technology systems as more users file in DOCX. The delay also will give applicants more time to adjust to filing patent applications in DOCX format.

Applicants are strongly encouraged to begin filing patent applications in DOCX format before the new effective date of the fee. Applicants are also reminded that they can file test submissions through Patent Center training mode to practice filing in DOCX. In addition, prior to the new effective date of the fee, the USPTO plans to provide an additional testing opportunity for applicants to file patent applications in DOCX format to encourage more applicants to acclimate to the process. Details of the opportunity will be announced in a forthcoming notice. Furthermore, applicants who have not yet taken advantage of the DOCX training sessions hosted by the USPTO are strongly encouraged to do so. Information on filing application documents in DOCX and a link to the DOCX training sessions are available at www.uspto.gov/patents/docx.

A. Administrative Procedure Act: This final rule revises the effective date of a final rule published on August 3, 2020, implementing a non-DOCX filing surcharge fee, and is a rule of agency practice and procedure pursuant to 5 U.S.C. 553(b)(A). See JEM Broad. Co. v. F.C.C., 22 F.3d 32 (D.C. Cir. 1994) (“[T]he `critical feature' of the procedural exception [in 5 U.S.C. 553(b)(A)] `is that it covers agency actions that do not themselves alter the rights or interests of parties, although [they] may alter the manner in which the parties present themselves or their viewpoints to the agency.' ” (quoting Batterton v. Marshall, 648 F.2d 694, 707 (D.C. Cir. 1980))); see also Bachow Commc'ns Inc. v. F.C.C., 237 F.3d 683, 690 (D.C. Cir. 2001) (rules governing an application process are procedural under the Administrative Procedure Act); Inova Alexandria Hosp. v. Shalala, 244 F.3d 342, 350 (4th Cir. 2001) (rules for handling appeals were procedural where they did not change the substantive standard for reviewing claims). Accordingly, prior notice and opportunity for public comment are not required pursuant to 5 U.S.C. 553(b) or (c) (or any other law). See Cooper Techs. Co. v. Dudas, 536 F.3d 1330, 1336-37 (Fed. Cir. 2008) (stating that 5 U.S.C. 553, and thus 35 U.S.C. 2(b)(2)(B), do not require notice and comment rulemaking for “interpretative rules, general statements of policy, or rules of agency organization, procedure, or practice” (quoting 5 U.S.C. 553(b)(A))).

Moreover, the Director of the USPTO, pursuant to authority at 5 U.S.C. 553(b)(B), finds good cause to adopt the change to the effective date of § 1.16(u) in this final rule without prior notice and an opportunity for public comment, as such procedures would be impracticable and contrary to the public interest. The change to the effective date will provide the public an opportunity to more fully comprehend the nature of, and prepare to comply with, the DOCX format before the new fee is effective. Delay of this provision to provide prior notice and comment procedures is also impracticable because it would allow § 1.16(u) to go into effect before the public is ready for the DOCX format. In addition, the Director finds good cause under 5 U.S.C. 553(d)(3) to waive the 30-day delay in effectiveness of this rule. Immediate implementation of the delay in effective date of the fee is in the public interest because it will provide the public an opportunity to more fully comprehend the nature of, and prepare to comply with, the DOCX format before the new fee in § 1.16(u) is effective.

B. Regulatory Flexibility Act: As prior notice and an opportunity for public comment are not required pursuant to 5 U.S.C. 553 or any other law, neither a regulatory flexibility analysis nor a certification under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ) is required. See 5 U.S.C. 603.

C. Executive Order 12866 (Regulatory Planning and Review): This rulemaking has been determined to be not significant for purposes of Executive Order 12866 (Sept. 30, 1993).

D. Paperwork Reduction Act: The Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)) requires that the USPTO consider the impact of paperwork and other information collection burdens imposed on the public. The USPTO has determined that there are no new requirements for information collection associated with this final rule.

For the reasons stated in the preamble, the Office amends 37 CFR part 1 as follows:

This is a synopsis of the Commission's Order, in Gen Docket No. 12-268; FCC 21-111, adopted on October 22, 2021 and released on October 25, 2021. The full text of this document is available for download at https://docs.fcc.gov/public/attachments/FCC-21-111A1.pdf. To request materials in accessible formats (braille, large print, computer diskettes, or audio recordings), please send an email to FCC504@fcc.gov or call the Consumer & Government Affairs Bureau at (202) 418-0530 (VOICE), (202) 418-0432 (TTY).

Channel allotments for full power television stations in the United States, its territories, and possessions are listed and codified in 47 CFR part 73 of the Commission's rules, and applicants for full power television stations may only apply to construct on the channels designated in the codified Table of Allotments and only in the communities listed therein. To accommodate the analog to digital television transition, in 1997 the Commission allotted a paired DTV channel to analog television licensees and permittees. All full power stations terminated analog operations on June 12, 2009 (with minor and temporary exceptions) and thereafter broadcast solely on its allotted digital channel. In 2012, Congress passed the Spectrum Act that required the Commission to reorganize the ultra-high frequency (UHF) band using a two-sided incentive auction that reallocated broadcast television spectrum for mobile broadband services, which included a repacking process that reorganized and assigned new channels to full power and Class A broadcast TV stations that would remain on the air after the auction. In implementing the Spectrum Act, the Commission decided, after seeking comment on the issue, that it would not use a codified Table or rulemaking procedures to implement channel changes resulting from the repacking process, instead determining that the Table would be amended to codify all new full power channel assignments after completion of the repacking and channel substitution process.

As a result of the incentive auction, 145 broadcast stations accepted incentive payments to relinquish their spectrum rights and either go off the air or, in some cases, continue broadcasting through a channel sharing arrangement. In addition, as a result of the repacking process, 987 full power and Class A stations were reassigned to new channels, and twenty-four winning channel sharing bidders filed applications to change their station's community of license. After the incentive auction, the Media Bureau opened two filing windows for stations that were repacked. These windows permitted certain reassigned stations or band changing stations to seek alternate channels. A total of 49 stations applied for an alternate channel during these two windows and received a construction permit for a new channel.

With the incentive auction and 39-month post-incentive auction transition period completed in July 2019, the Media Bureau lifted a number of filing freezes, effective November 2020, that pertained to the 2018 Table. Specifically, the Media Bureau lifted freezes on:

• Petitions for rulemaking to change channels in the Table of Allotments.

• Petitions for rulemaking for new allotments.

• Petitions for rulemaking to change communities of license.

The Bureau received almost 50 petitions, primarily to substitute a UHF channel for a VHF channel, to change a station's community of license, or to allot a new channel. The majority have been acted on and the changes effective, and the effective channel or community changes are reflected in the new Table. All the petitions were subject to a Notice of Proposed Rulemaking seeking comment on the proposed rule changes and all were adopted through a Report and Order, pursuant to the Administrative Procedure Act, and published in the Federal Register .

The Post-Transition Table of Allotments. The Order adopts a Table that reflects all previously approved changes since the last table of allotments update in 2018. Specifically, the new Table reflects the following actions by the Commission, described above: (1) The incentive auction and television repacking process authorized by the Spectrum Act; (2) channel changes requested by stations assigned to new channels as part of the incentive auction repacking process; and (3) changes adopted after lifting the freeze in November 2020 on the filing of rulemaking petitions to change the 2018 Table. In the Order, the Commission found good cause to make these revisions to the Table without notice and comment. See 5 U.S.C. 553(b)(3)(B) (providing that notice and comment are not required “when the agency for good cause finds . . . that notice and public procedure thereon are impracticable, unnecessary, or contrary to the public interest”). These revisions merely correct outdated information from the 2018 Table as a result of channel reassignments and/or community of license changes that have already been approved by the Commission.

Deletion of Obsolete Rules. The Order also adopts non-substantive, technical revisions to certain rules in 47 CFR parts 1, 73, and 74 that are now outdated given the reallocation of television channels 38 through 51 for wireless broadband uses, the previous reallocation of channels 52 through 69 for wireless use at the end of the DTV transition in June 2009, and the conversion from analog to digital television technology.

Rulemaking Proceedings. The Order amends 47 CFR 1.420(a), (g), (h), and (i), which specify the procedures for amending the TV Table of Allotments, by deleting cross-references to “§ 73.606(b)” and replacing them with “§ 73.622(j),” the updated Table of Allotments adopted in the Order.

Television Broadcast Stations. The Order amends 47 CFR 73.622 to delete the obsolete Tables in § 73.622(b) and (i), which are superseded by § 73.622(j), the updated Table of Allotments adopted in the Order. The Order also amends 47 CFR 73.606 by deleting the cross-reference to “§ 73.622(i)” and adding a cross-reference to “§ 73.622(j),” and designates 47 CFR 73.622(j) as the “successor regulation” to 47 CFR 73.606. The Order also amends certain part 73 rules to remove references to channels and frequency bands that are no longer in-core television spectrum given the reallocation of channels 38 through 51 through the incentive auction repack and the previous reallocation of channels 52 through 69 at the end of the DTV transition in June 2009, and/or refer to obsolete rule § 73.606(b), § 73.622(b), or § 73.622(i) or reference analog TV stations or operations, or otherwise irrelevant information. Specifically, the Order deletes references to the 2018 Table, the obsolete rules sections, and references to channel numbers that are now out-of-core for television stations in each of the following: §§ 73.603(a); 73.613(b); 73.614(b)(5), 73.616(a); 73.622(a)(1) and (2), (b), (e)(1) and (2), (f)(1), (g), (i); 73.623 (a), and (c), and (g); 73.681; 73.687(a)(1) and (4), (e)(3) and (4), (i); 73.699; 73.1690 (a)(8) and (c)(3) and (4); 73.3572 (a)(1) and (4)(ii); 73.6006; 73.6010(a) and (c); 73.7000. The Order also deletes irrelevant information from § 73.625(a). This rule sets forth the community coverage contour signal strength that stations must provide to the entire principal community to be served, and the deleted material sets forth the signal strength of a station's noise limited contour, and thus, has no applicability to § 73.625(a). Deleting it does not alter the rule and avoids confusion. Finally, the Order deletes § 73.3700(f), which sets forth the requirements for filing service rule waiver requests immediately following the close of the incentive auction in 2017. Such waiver requests were required to be submitted no later than May 15, 2017 and all such requests have been disposed of in decisions that are now final.

Low Power TV, TV Translator, and TV Booster Stations. The Order also amends a number of Part 74 rules that apply to low power and television translator stations to remove references to channels and frequency bands that are no longer in-core television spectrum and/or reference analog TV operations which are no longer permitted, specifically, 47 CFR 74.702(a)(2) and (3), (b); 74.703 (f) and (g); 74.707; 74.735(a), (b), and (c); 74.786 (c) and (d)-(g); 74.787(c); 74.792(a); and 74.795(c)(1).

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 has determined, and the Administrator of the Office of Information and Regulatory Affairs, Office of Management and Budget, concurs that this rule is “non-major” under the Congressional Review Act, 5 U.S.C. 804(2). The Commission will also send a copy of this Order to Congress and the Government Accountability office, pursuant to 5 U.S.C. 801(a)(1)(A).

For the reasons discussed in the preamble, the Federal Communications Commission amends 47 CFR parts 1, 73, and 74 as follows:

This document responds to a petition for reconsideration of a November 3, 2020 final rule that amended NHTSA's regulation on anthropomorphic test devices (ATD) (49 CFR part 572) to add design and performance specifications for a test dummy representing a 3-year-old child, called the “Q3s” test dummy. 1 The specifications and qualification tests for the Q3s are set forth in a new subpart W of part 572. The Q3s is an instrumented dummy that can assess the performance of child restraint systems in protecting small children in side impacts. The Q3s weighs 14.5 kilograms (kg) (32.0 pounds) and has a seated height of 556 millimeters (mm), and is representative of a 50th percentile 3-year-old child. The Q3s dummy's main parts (head, thorax, neck, shoulder, spine, abdomen, pelvis, and relevant instrumentation) and biofidelity are described in detail in the November 2020 final rule.

Humanetics Innovative Solutions Inc. (HIS), submitted a timely petition for reconsideration to NHTSA on December 18, 2020. The petition explained the need for corrections to several of the Q3s drawings. First, HIS explained that on drawing 020-6100, LUMBAR SPINE CABLE ASSEMBLY, the dimension across the cable swage corners is 7.10 millimeters (mm) maximum. HIS stated that it had made the determination in 2016 that this dimension would result in the cable interfering with the thru hole on parts 020-6002 and 020-6003, which have minimum thru hole dimensions of 6.97 mm. Although HIS corrected internal manufacturing drawings to reflect this change, these changes were “inadvertently missed in the updated Q3s drawings submitted to the NHTSA in the 2016 drawing package.” As a result, HIS's petition recommends the following:

In addition to the above, HIS states there is a typographical error in a tolerance value on drawing 020-6003. There is currently a specification of the outside diameter of a hole chamfer stated as 9.5 ± 0.02 mm. HIS states that the 0.02 mm tolerance is an error and the correct tolerance resides in the “tolerance box,” which would make the tolerance on this dimension 0.2 mm.

In response to the HIS petition, NHTSA investigated the dimensions in questions on the parts depicted in drawings 020-6002 and 020-6003. Upon initial analysis of the petition, it was apparent to the agency that HIS's recommended dimension and tolerance of 7.30 +0.1/−0.5 mm was meant to be 7.30 +0.1/−0.05 mm, i.e., the minus tolerance was supposed to be −0.05, not −0.5, as the suggestion by HIS would have increased the lower tolerance by nearly 17 times. The agency contacted HIS and the petitioner verified the “−0.5” was an error, and that it intended the value to be “−0.05” instead. 3 Thus, the remainder of our analysis is based on a recommended dimension and tolerance of 7.30 +0.1/−0.05 mm.

The agency measured the parts depicted on drawings 020-6002 and 020-6003 on 4 sets of parts and found that the holes' outer diameters matched the 7.30 +0.1/−0.05 mm dimensions. Thus, the HIS recommended dimension and tolerance is acceptable. The agency notes that the specified dimension must also be modified on drawings 020-6001-U and 020-6001-2.

With respect to drawing 020-6003, NHTSA agrees that the tolerance should be ±0.2 mm, as indicated in the tolerance block for the drawing. 4 Accordingly, the 9.5 mm dimension on the drawing is now to have a range from 9.3 to 9.7 mm, inclusive. 5

While examining the drawings associated with the parts in question, NHTSA found minor errors in drawing 020-6000-S and 020-6001-S that we are correcting in this document. First, on drawing 020-6000-S, ITEM 2 on the drawing (HEX JAM NUT, M6 X 1 ZINK, Part No. 5000144V) should be specified as a quantity of 2, rather than 1. Second, on drawing 020-6001-S, NOTES 2 and 3, need revision to indicate a jam nut is being used instead of a lock nut. These corrections are explained in more detail below.

Currently, the NOTES 2 and 3 are set forth as follows:

These notes reference outdated assembly procedures that were appropriate for a lock nut. Prior to finalizing the Q3s dummy, the lock nut assembly was replaced by a jam nut assembly. This necessitated a change to the NOTES, but that was inadvertently overlooked. The corrected notes are as follows:

Finally, NHTSA became award of an error in the “Procedures for Assembly, Disassembly, and Inspection” (PADI) related to the pubic load cell of the dummy. This error is unrelated to the changes to lumbar spine and the revisions to the engineering drawings.

The pubic load cell is contained within a subassembly that includes a rubber buffer block. It is a single-axis load cell which measures the lateral force (Fy) within the dummy's pelvis at its pubic symphysis. Depending on whether the dummy is used for a right side or a left side impact, the subassembly is flipped so that the buffer block is always placed between the load cell and the source of the impact force. Either way, the force registered by the load cell should always be negative when the pelvis is compressed. This convention is consistent with SAE J1733, Sign Convention for Vehicle Crash Testing, which is subtended by the regulatory text in § 572.219 Test Conditions and Instrumentation.

The PADI includes dummy manipulations to check all load cell polarities to assure that they wired correctly. The manipulations for the pubic load cell were mistakenly included in Table C-6, Polarity Check Data Sheet for Displacement Transducers. Also, the load cell was described as an “external” load cell, but it is actually an “internal” load cell in accordance with SAE J1733. The difference between an external vs. an internal load cell is explained in SAE J1733 and does affect the interpretation of a load.

Moreover, the PADI included separate manipulations for the right side installation and the left side installation. The right side check produced the correct polarity. However, the left side manipulation indicated a (+) polarity for pubic compression, which is incorrect according the SAE J1733.

In the revised PADI, the manipulations are moved to Table C-5, Polarity Check Data Sheet for Load Cells. The load cell is correctly categorized as an “internal” load cell, and a single manipulation covers the polarity check for either a right side or a left side installation. We note that a single manipulation is all that is needed to assure that the load cell registers a negative polarity when the pubic symphysis is compressed. SAE J1733 also describes a single manipulation to check the pubic load cell. The corrected manipulation is:

This final rule changes the regulatory text of part 572, subpart W to incorporate by reference a new drawing package, parts list, and PADI for the Q3s dummy, all dated January 2021. The new drawing package, parts list, and PADI will be placed in the same docket as the supporting material for the November 2020 file rule (Docket NHTSA-2020-0088). Although only a few drawings have been corrected in the previous drawing package, we are issuing a new drawing package because we believe it is easier for users of the Q3s to change out the whole drawing package for the ATD than having to search for and replace various individual drawings.

The following changes will be made to the drawings for the dummy:

In addition, the date on the coversheet of the Parts List will be changed to January 2021 and the revision levels of the affected parts will be updated.

The following changes will be made to the PADI for the dummy:

In addition, the date on the coversheet of the PADI will be changed to January 2021.

NHTSA has reviewed this final rule under the Department of Transportation's administrative rulemaking orders and procedures. This rulemaking is not significant under E.O. 12866 and was not reviewed by the Office of Management and Budget (OMB). The underlying final rule incorporating the Q3s test dummy into 49 CFR part 572 was not considered significant. Specifications in part 572 do not impose any requirements on anyone. Businesses are affected only if they choose to manufacture or test with an ATD in part 572. Further, this final rule simply corrects errors in the drawing package of the dummy to reflect how it has been manufactured for the past several years. As such, this final rule has minimal impact on costs or benefits. Accordingly, no further regulatory evaluation is necessary.

Pursuant to the Regulatory Flexibility Act (5 U.S.C. 601 et seq., as amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA) of 1996), whenever an agency is required to publish a proposed or final rule, it must prepare and make available for public comment a regulatory flexibility analysis that describes the effect of the rule on small entities ( i.e., small businesses, small organizations, and small governmental jurisdictions), unless the head of the agency certifies the rule will not have a significant economic impact on a substantial number of small entities. The Small Business Administration's regulations at 13 CFR part 121 define a small business, in part, as a business entity “which operates primarily within the United States.” (13 CFR 121.105(a)).

NHTSA has considered the effects of this rulemaking under the Regulatory Flexibility Act. I hereby certify that this rulemaking action will not have a significant economic impact on a substantial number of small entities. This action will not have a significant economic impact on a substantial number of small entities because this final rule simply corrects errors in the drawing package of the Q3s dummy to reflect how it has been manufactured for the past several years. Thus, this final rule has minimal impact on costs or benefits. In addition, specifications in part 572 do not impose any requirements on anyone. Businesses are affected only if they choose to manufacture or test with the dummy. NHTSA will use the ATD in agency testing but does not require anyone to manufacture the dummy or to test motor vehicles or motor vehicle equipment with it.

NHTSA has analyzed this final rule for the purposes of the National Environmental Policy Act and determined that it will not have any significant impact on the quality of the human environment.

Executive Order 13045 (62 FR 19885, April 23, 1997) applies to any rule that: (1) Is determined to be “economically significant” as defined under E.O. 12866, and (2) concerns an environmental, health, or safety risk that NHTSA has reason to believe may have a disproportionate effect on children. If the regulatory action meets both criteria, NHTSA must evaluate the environmental health or safety effects of the planned rule on children, and explain why the planned regulation is preferable to other potentially effective and reasonably feasible alternatives considered by the agency. This final rule is not subject to the Executive Order because it is not economically significant as defined in E.O. 12866.

NHTSA has examined today's final rule pursuant to Executive Order 13132 (64 FR 43255, August 10, 1999) and concluded that no additional consultation with States, local governments or their representatives is mandated beyond the rulemaking process. The agency has concluded that this final rule will not have federalism implications because the rule would not have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This final rule will not impose any requirements on anyone. Businesses will be affected only if they choose to manufacture or test with the dummy.

Further, no consultation is needed to discuss the preemptive effect of today's final rule. NHTSA's safety standards can have preemptive effect in two ways, but this rule amends 49 CFR part 572 and is not a safety standard. 6 This part 572 final rule will not impose any requirements on anyone.

With respect to the review of the promulgation of a new regulation, section 3(b) of Executive Order 12988, “Civil Justice Reform” (61 FR 4729, February 7, 1996) requires that Executive agencies make every reasonable effort to ensure that the regulation: (1) Clearly specifies the preemptive effect; (2) clearly specifies the effect on existing Federal law or regulation; (3) provides a clear legal standard for affected conduct, while promoting simplification and burden reduction; (4) clearly specifies the retroactive effect, if any; (5) adequately defines key terms; and (6) addresses other important issues affecting clarity and general draftsmanship under any guidelines issued by the Attorney General. This document is consistent with that requirement. Pursuant to this Order, NHTSA notes as follows.

The issue of preemption is discussed above in connection with E.O. 13132. NHTSA notes further that there is no requirement that individuals submit a petition for reconsideration or pursue other administrative proceeding before they may file suit in court.

Under the Paperwork Reduction Act of 1995, a person is not required to respond to a collection of information by a Federal agency unless the collection displays a valid control number from the Office of Management and Budget (OMB). This final rule will not have any requirements that are considered to be information collection requirements as defined by the OMB in 5 CFR part 1320.

Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272) directs NHTSA to use voluntary consensus standards in its regulatory activities unless doing so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards ( e.g., materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by voluntary consensus standards bodies. The NTTAA directs NHTSA to provide Congress, through OMB, explanations when the agency decides not to use available and applicable voluntary consensus standards. There are no voluntary consensus standards relevant to this final rule.

Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA), Public Law 104-4, requires Federal agencies to prepare a written assessment of the costs, benefits, and other effects of proposed or final rules that include a Federal mandate likely to result in the expenditure by State, local, or tribal governments, in the aggregate, or by the private sector, of more than $100 million annually (adjusted for inflation with base year of 1995). Before promulgating a NHTSA rule for which a written statement is needed, section 205 of the UMRA generally requires the agency to identify and consider a reasonable number of regulatory alternatives and adopt the least costly, most cost-effective, or least burdensome alternative that achieves the objectives of the rule. This final rule will not impose any unfunded mandates under the UMRA. This rule does not meet the definition of a Federal mandate because it does not impose requirements on anyone.

Under regulations issued by the Office of the Federal Register (1 CFR 51.5(a)), an agency, as part of a final rule that includes material incorporated by reference, must summarize in the preamble of the final rule the material it incorporates by reference and discuss the ways the material is reasonably available to interested parties or how the agency worked to make materials available to interested parties.

In this final rule, NHTSA incorporates by reference a new technical data package for the Q3s consisting of a set of engineering drawings for the test dummy, and a parts list. Q3s dummies manufactured to meet the qualification requirements and the technical data package will be uniform in their design, construction, and response to impact forces.

NHTSA has placed a copy of the updated technical data package in the docket listed at the beginning of this document. Interested persons can download a copy of the materials or view the materials online by accessing www.Regulations.gov. Telephone: 1-877-378-5457. The material is also available for inspection at the Department of Transportation, Docket Operations, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC. Telephone: 202-366-9826. The material is also available for inspection by contacting NHTSA's Chief Counsel's Office at the phone number and address set forth in the For Further Information section of this document. The material is available for review at NHTSA and is available for purchase from SAE International.

Executive Order 12866 requires each agency to write all rules in plain language. Application of the principles of plain language includes consideration of the following questions:

Has the agency organized the material to suit the public's needs?

Are the requirements in the rule clearly stated?

Does the rule contain technical language or jargon that is not clear?

Would a different format (grouping and order of sections, use of headings, paragraphing) make the rule easier to understand?

Would more (but shorter) sections be better?

Could the agency improve clarity by adding tables, lists, or diagrams?

What else could the agency do to make this rulemaking easier to understand?

If you have any responses to these questions, please send them to NHTSA.

The Department of Transportation assigns a regulation identifier number (RIN) to each regulatory action listed in the Unified Agenda of Federal Regulations. The Regulatory Information Service Center publishes the Unified Agenda in April and October of each year. You may use the RIN contained in the heading at the beginning of this document to find this action in the Unified Agenda.

In consideration of the foregoing, NHTSA amends 49 CFR part 572 as follows:

Pacific whiting ( Merluccius productus ) is a very productive species with highly variable recruitment (the biomass of fish that mature and enter the fishery each year) and a relatively short life span compared to other groundfish species. Pacific whiting has the largest annual allowable harvest levels (by volume) of the more than 90 groundfish species managed under the Pacific Coast Groundfish Fishery Management Plan (FMP), which governs the groundfish fishery off Washington, Oregon, and California. The coastwide Pacific whiting stock is managed jointly by the United States and Canada, and mature Pacific whiting are commonly available to vessels operating in U.S. waters from April through December. Background on the stock assessment, and the establishment of the 2021 Total Allowable Catch (TAC), for Pacific whiting was provided in the final rule for the 2021 Pacific whiting harvest specifications, published June 23, 2021 (86 FR 32804). Pacific whiting is allocated to the Pacific Coast treaty tribes (tribal fishery) and to three non-tribal commercial sectors: The catcher/processor cooperative (C/P Co-op), the mothership cooperative (MS Co-op), and the Shorebased Individual Fishery Quota (IFQ) Program.

This notice announces the reapportionment of 34,645 metric tons (mt) of Pacific whiting from the tribal allocation to the non-tribal commercial sectors. This reapportionment was effective on September 15, 2021. Regulations at 50 CFR 660.131(h) contain provisions that allow the Regional Administrator to reapportion Pacific whiting from the tribal allocation, specified at 50 CFR 660.50, that will not be harvested by the end of the fishing year to other sectors.

For 2021, the Pacific Coast treaty tribes were allocated 64,645 mt of Pacific whiting. The best available information on September 15, 2021, indicated that at least 34,645 mt of the tribal allocation would not be harvested by December 31, 2021. As required under the 2017 Endangered Species Act (ESA) Section 7(a)(2) biological opinion on the effects of the Pacific Coast Groundfish Fishery Management Plan on listed salmonids, NMFS considered the number and bycatch rate of Chinook salmon taken by the Pacific whiting fishery sectors prior to reapportionment. Based on the best available information in early September 2021, NMFS determined there was little risk that the reapportionment would cause the Pacific whiting sector fisheries to exceed the guideline limit of 11,000 Chinook salmon under current regulations and practices. In early September, incidental take of Chinook salmon by the non-tribal sector was 4 percent of the guideline limit. While the incidental take of Chinook salmon was higher compared to the same period in the previous year, the total take this year is still well below the guideline limit.

To allow for increased utilization of the resource, on September 15, 2021, NMFS reapportioned 34,645 mt from the Tribal sector to the Shorebased IFQ Program, C/P Co-op, and MS Co-op in proportion to each sector's original allocation. Reapportioning this amount is expected to allow for greater attainment of the TAC while not limiting tribal harvest opportunities for the remainder of the year. NMFS provided notice of the reapportionment on September 15, 2021, via emails sent directly to fishing businesses and individuals. Reapportionment was effective the same day as the notice.

The amounts of Pacific whiting available for 2021 before and after the reapportionment are described in Table 1 below.

NMFS issues this action pursuant to section 305(d) of the Magnuson-Stevens Act. This action is required by 50 CFR 660.55 (i), 660.60(d), and 660.131(h), and is exempt from review under Executive Order 12866.

NOAA's Assistant Administrator for Fisheries (AA) finds that good cause exists for this notification to be issued without affording prior notice and opportunity for public comment pursuant to 5 U.S.C. 553(b)(B), because such notification would be impracticable and contrary to the public interest. As previously noted, NMFS provided actual notice of the reapportionment to fishery participants at the time of the action. Prior notice and opportunity for public comment on this reapportionment was impracticable because NMFS had insufficient time to provide prior notice between the time the information about the progress of the fishery needed to make this determination became available and the time at which fishery modifications had to be implemented in order to allow fishery participants access to the available fish during the remainder of the fishing season. For the same reasons, the AA also finds good cause to waive the 30-day delay in effectiveness for these actions, required under 5 U.S.C. 553(d)(3).