The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to Sikorsky Model S-70, S-70A, S-70C, S-70C(M), and S-70C(M1) helicopters with T/R blade part number 70101-31000 (all dash numbers) and with a serial number up to and including A009-08915. The NPRM published in the Federal Register on September 6, 2019 (84 FR 46903). The NPRM was prompted by four incidents of disbonding between the T/R blade pitch horn and the torque tube on military-operated Model UH-60L and SH-60F helicopters. The disbonding produced minor to severe vibrations due to the mass imbalance. This condition may also occur on Sikorsky Model S-70, S-70A, S-70C, S-70C(M), and S-70C(M1) helicopters due to design similarity.

Disbonding between the T/R blade pitch horn and the torque tube, if not addressed, could result in the T/R blade pitch horn rocking in the torque tube, leading to increased T/R vibrations. These vibrations could lead to crushing of the torque tube and subsequent loss of control of the helicopter. While Sikorsky continues to test T/R blades returned from the field, investigation has revealed blades produced prior to manufacturing improvements implemented between 2006 and 2007 are prone to this disbonding. To address this condition, Sikorsky is assessing design change options to retrofit the affected T/R blades.

The NPRM proposed to require, before the first flight of each day, visually inspecting each T/R blade for any crack, leading edge erosion, and trailing edge skin disbonding and separation, paying particular attention to the area from the midspan to the pitch control horn; and tap inspecting for disbonding in the pitch horn to torque tube bond area. Depending on the outcome of these inspections, the NPRM proposed to require replacing the T/R blade. The FAA is issuing this AD to address the unsafe condition on these products.

The FAA gave the public the opportunity to participate in developing this AD. The FAA received no comments on the NPRM or on the determination of the cost to the public.

The FAA reviewed the relevant data and determined that air safety and the public interest require adopting this AD as proposed.

The FAA reviewed Sikorsky Aircraft Model S-70 Blackhawk Derivatives Maintenance Manual Temporary Revision No. 72, dated October 12, 2017. This service information specifies replacing a 10-hour/14-day T/R inspection with a before first flight of the day T/R inspection.

The FAA also reviewed section 5-3-13.2 Coin-Tapping Inspection Method of Sikorsky Technical Manual TM 1-70-23-3, Change 12, dated July 1, 2018. This service information specifies procedures for coin-tap inspecting T/R blades. This service information also specifies general repair limits and includes figures illustrating the different types of materials of the T/R blade skin and core regions.

The FAA considers this AD an interim action. The design approval holder is currently developing a modification that will address the unsafe condition identified in this AD. Once this modification is developed, approved, and available, we might consider additional rulemaking.

The FAA estimates that this AD affects 13 helicopters of U.S. registry. The FAA estimates that operators may incur the following costs in order to comply with this AD. Labor costs are estimated at $85 per work-hour.

Inspecting the T/R blades takes about 1 work-hour for an estimated cost of $85 per helicopter and $1,105 for the U.S. fleet, per inspection cycle.

Replacing a set of two T/R blades takes about 6 work-hours and parts cost about $192,304 for an estimated replacement cost of $192,814 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.

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

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

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

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

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

The FAA prepared an economic evaluation of the estimated costs to comply with this AD and placed it in the AD docket.

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

Authority for This Rulemaking

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it amends the Class E airspace extending upward from 700 feet above the surface at Neillsville Municipal Airport, Neillsville, WI, to support instrument flight rule operations at this airport.

The FAA published a notice of proposed rulemaking in the Federal Register (84 FR 54528; October 10, 2019) for Docket No. FAA-2019-0767 to amend the Class E airspace extending upward from 700 feet above the surface at Neillsville Municipal Airport, Neillsville, WI. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

Class E airspace designations are published in paragraph 6005 of FAA Order 7400.11D, dated August 8, 2019, and effective September 15, 2019, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.

This document amends FAA Order 7400.11D, Airspace Designations and Reporting Points, dated August 8, 2019, and effective September 15, 2019. FAA Order 7400.11D is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.11D lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

This amendment to Title 14 Code of Federal Regulations (14 CFR) part 71 amends the Class E airspace extending upward from 700 feet above the surface within a 6.3-mile radius of the Neillsville Municipal Airport, Neillsville, WI; and removes the NDB and the associated extension. This action is necessary due to the decommissioning and removal of the Neillsville NDB, and for the safety and management of instrument flight rules, at this airport.

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

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

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

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

This rule amends Title 14, Code of Federal Regulations, Part 97 (14 CFR part 97) by amending the referenced SIAPs. The complete regulatory description of each SIAP is listed on the appropriate FAA Form 8260, as modified by the National Flight Data Center (NFDC)/Permanent Notice to Airmen (P-NOTAM), and is incorporated by reference under 5 U.S.C. 552(a), 1 CFR part 51, and 14 CFR 97.20. The large number of SIAPs, their complex nature, and the need for a special format make their verbatim publication in the Federal Register expensive and impractical. Further, airmen do not use the regulatory text of the SIAPs, but refer to their graphic depiction on charts printed by publishers of aeronautical materials. Thus, the advantages of incorporation by reference are realized and publication of the complete description of each SIAP contained on FAA form documents is unnecessary.

This amendment provides the affected CFR sections, and specifies the SIAPs and Takeoff Minimums and ODPs with their applicable effective dates. This amendment also identifies the airport and its location, the procedure and the amendment number.

The material incorporated by reference is publicly available as listed in the ADDRESSES section.

The material incorporated by reference describes SIAPs, Takeoff Minimums and ODPs as identified in the amendatory language for part 97 of this final rule.

This amendment to 14 CFR part 97 is effective upon publication of each separate SIAP and Takeoff Minimums and ODP as amended in the transmittal. For safety and timeliness of change considerations, this amendment incorporates only specific changes contained for each SIAP and Takeoff Minimums and ODP as modified by FDC permanent NOTAMs.

The SIAPs and Takeoff Minimums and ODPs, as modified by FDC permanent NOTAM, and contained in this amendment are based on the criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these changes to SIAPs and Takeoff Minimums and ODPs, the TERPS criteria were applied only to specific conditions existing at the affected airports. All SIAP amendments in this rule have been previously issued by the FAA in a FDC NOTAM as an emergency action of immediate flight safety relating directly to published aeronautical charts.

The circumstances that created the need for these SIAP and Takeoff Minimums and ODP amendments require making them effective in less than 30 days.

Because of the close and immediate relationship between these SIAPs, Takeoff Minimums and ODPs, and safety in air commerce, I find that notice and public procedure under 5 U.S.C. 553(b) are impracticable and contrary to the public interest and, where applicable, under 5 U.S.C. 553(d), good cause exists for making these SIAPs effective in less than 30 days.

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

Accordingly, pursuant to the authority delegated to me, Title 14, Code of Federal regulations, Part 97, (14 CFR part 97), is amended by amending Standard Instrument Approach Procedures and Takeoff Minimums and ODPs, effective at 0901 UTC on the dates specified, as follows:

1. Pursuant to section 215(d)(2) of the Federal Power Act (FPA), 1 the Commission approves Reliability Standard CIP-012-1 (Cyber Security—Communications between Control Centers). The North American Electric Reliability Corporation (NERC), the Commission-certified Electric Reliability Organization (ERO), submitted Reliability Standard CIP-012-1 for Commission approval in response to a Commission directive in Order No. 822. 2 In Order No. 822, the Commission directed NERC, pursuant to section 215(d)(5) of the FPA, to develop modifications to the Reliability Standards to require responsible entities to implement controls to protect, at a minimum, communications links and sensitive bulk electric system data communicated between bulk electric system Control Centers “in a manner that is appropriately tailored to address the risks posed to the bulk electric system by the assets being protected ( i.e., high, medium, or low impact).”  3

2. Consistent with the directive in Order No. 822, Reliability Standard CIP-012-1 improves upon the currently-effective Critical Infrastructure Protection (CIP) Reliability Standards to mitigate cyber security risks associated with communications between bulk electric system Control Centers. Specifically, Reliability Standard CIP-012-1 supports situational awareness and reliable bulk electric system operations by requiring responsible entities to protect the confidentiality and integrity of Real-time Assessment  4 and Real-time monitoring data transmitted between bulk electric system Control Centers. Accordingly, the Commission approves Reliability Standard CIP-012-1 because it is largely responsive to the Commission's directive in Order No. 822 and improves the cyber security posture of responsible entities. We also approve the associated violation risk factors and violation severity levels, implementation plan, and effective date.

3. In addition, pursuant to section 215(d)(5) of the FPA, the Commission directs NERC to develop modifications to the CIP Reliability Standards to require protections regarding the availability of communication links and data communicated between bulk electric system Control Centers. As discussed in the notice of proposed rulemaking (NOPR), Reliability Standard CIP-012-1 does not require protections regarding the availability of communication links and data communicated between bulk electric system Control Centers, as directed in Order No. 822. 5 In the NOPR, the Commission indicated that it did not agree with NERC's assertion that currently-effective Reliability Standards address availability, and we are not persuaded by NOPR comments raising the same argument. Instead, pursuant to section 215(d)(5) of the FPA, we determine that the absence of a requirement that specifically pertains to the availability of communication links and data communicated between bulk electric system Control Centers represents a reliability gap in the CIP Reliability Standards that should be addressed by NERC.

4. The Commission, in the NOPR, also proposed to direct NERC to identify clearly the types of data that must be protected under Reliability Standard CIP-012-1. The NOPR expressed concern that Reliability Standard CIP-012-1 does not adequately identify the types of data covered by its requirements, due to, among other things, the fact that the term “Real-time monitoring” is not defined in the Reliability Standard or the NERC Glossary. After considering the NOPR comments, however, we determine not to direct the proposed modification based on the explanation of the types of data that must be protected set forth in the NOPR comments.

5. Section 215 of the FPA requires a Commission-certified ERO to develop mandatory and enforceable Reliability Standards, subject to Commission review and approval. Reliability Standards may be enforced by the ERO, subject to Commission oversight, or by the Commission independently. 6 Pursuant to section 215 of the FPA, the Commission established a process to select and certify an ERO, 7 and subsequently certified NERC. 8

6. In Order No. 822, the Commission approved seven modified CIP Reliability Standards and directed NERC to develop additional modifications to the CIP Reliability Standards. 9 Specifically, the Commission directed that NERC, among other things, develop modifications to the CIP Reliability Standards to require that responsible entities implement controls to protect, at a minimum, communications links and sensitive bulk electric system data communicated between bulk electric system Control Centers “in a manner that is appropriately tailored to address the risks posed to the bulk electric system by the assets being protected ( i.e., high, medium, or low impact).”  10 The Commission observed that NERC, as well as other commenters in that proceeding, “recognize that inter-Control Center communications play a critical role in maintaining bulk electric system reliability by . . . helping to maintain situational awareness and support reliable operations through timely and accurate communication between Control Centers.”  11

7. The Commission explained that Control Centers associated with responsible entities, including reliability coordinators, balancing authorities, and transmission operators, must be capable of receiving and storing a variety of bulk electric system data from their interconnected entities in order to adequately perform their reliability functions. The Commission, therefore, determined that “additional measures to protect both the integrity and availability of sensitive bulk electric system data are warranted.”  12

The Commission cautioned, however, that “not all communication network components and data pose the same risk to bulk electric system reliability and may not require the same level of protection.”  13 Therefore, the Commission determined that NERC should develop controls that reflect the risk being addressed in a reasonable manner.

8. On September 18, 2018, NERC submitted for Commission approval proposed Reliability Standard CIP-012-1 and the associated violation risk factors and violation severity levels, implementation plan, and effective date. 14 NERC states that the purpose of Reliability Standard CIP-012-1 is to help maintain situational awareness and reliable bulk electric system operations by protecting the confidentiality and integrity of Real-time Assessment and Real-time monitoring data transmitted between Control Centers.

9. NERC states that Reliability Standard CIP-012-1 “requires Responsible Entities to develop and implement a plan to address the risks posed by unauthorized disclosure (confidentiality) and unauthorized modification (integrity) of Real-time Assessment and Real-time monitoring data while being transmitted between applicable Control Centers.”  15 According to NERC, the required plan must include the following: (1) Identification of security protections; (2) identification of where the protections are applied; and (3) identification of the responsibilities of each entity in case a Control Center is owned or operated by different responsible entities. 16

10. As noted above, the types of data within the scope of Reliability Standard CIP-012-1 consist of Real-time Assessment and Real-time monitoring data exchanged between Control Centers. NERC states that it is critical that this information is accurate since responsible entities operate and monitor the bulk electric system based on this Real-time information. NERC explains that Reliability Standard CIP-012-1 “excludes other data typically transferred between Control Centers, such as Operational Planning Analysis data, that is not used by the Reliability Coordinator, Balancing Authority, and Transmission Operator in Real-time.”  17

11. NERC also indicates that data at rest and oral communications fall outside the scope of Reliability Standard CIP-012-1. Regarding data at rest, NERC states that the standard drafting team determined that since data at rest resides within BES Cyber Systems, 18 it is already protected by the controls mandated by Reliability Standards CIP-003-6 through CIP-011-2. According to NERC, oral communications are out of scope of Reliability Standard CIP-012-1 “because operators have the ability to terminate the call and initiate a new one via trusted means if they suspect a problem with, or compromise of, the communication channel.”  19 NERC notes that Reliability Standard COM-001-3 requires reliability coordinators, balancing authorities, and transmission operators to have alternative interpersonal communication capability, which could be used if there is a suspected compromise of oral communication on one channel.

12. On April 18, 2019, the Commission issued a NOPR proposing to approve Reliability Standard CIP-012-1 as just, reasonable, not unduly discriminatory or preferential, and in the public interest. 20 The NOPR stated that Reliability Standard CIP-012-1 is largely responsive to the Commission's directive in Order No. 822 and improves the cyber security posture of the bulk electric system by requiring responsible entities to protect the confidentiality and integrity of Real-time Assessment and Real-time monitoring data transmitted between bulk electric system Control Centers, which supports situational awareness and reliable bulk electric system operations.

13. While proposing to approve Reliability Standard CIP-012-1, the Commission also proposed to direct NERC to develop modifications to the CIP Reliability Standards to address potential reliability gaps. First, the NOPR stated that Reliability Standard CIP-012-1 does not require protections regarding the availability of communication links and data communicated between bulk electric system Control Centers as directed in Order No. 822. The NOPR explained that the Commission was not persuaded by NERC's explanation that certain currently-effective Reliability Standards address the issue of availability. Second, the NOPR raised a concern that Reliability Standard CIP-012-1 does not adequately identify the types of data covered by its requirements, due to, among other things, the fact that Real-time monitoring is not defined in the proposed Reliability Standard or the NERC Glossary. 21

14. In response to the NOPR, eight entities submitted comments. A list of commenters appears in Appendix A. The discussion below addresses the proposals in the NOPR as well as the NOPR comments.

15. Pursuant to section 215(d)(2) of the FPA, the Commission approves Reliability Standard CIP-012-1 as just, reasonable, not unduly discriminatory or preferential, and in the public interest. Reliability Standard CIP-012-1 largely addresses the Commission's directive in Order No. 822 because it will enhance existing protections for bulk electric system reliability by augmenting the currently-effective CIP Reliability Standards to mitigate cyber security risks associated with communications between bulk electric system Control Centers. Reliability Standard CIP-012-1 achieves this by requiring responsible entities to protect the confidentiality and integrity of Real-time Assessment and Real-time monitoring data transmitted between bulk electric system Control Centers, thereby supporting situational awareness and reliable bulk electric system operations.

16. While the Commission approves Reliability Standard CIP-012-1, we also determine that the reliability risks identified in Order No. 822 will not be fully addressed with the implementation of the Reliability Standard. As discussed below, a significant cyber security risk associated with the protection of communications links and sensitive bulk electric system data communicated between bulk electric system Control Centers remains because Reliability Standard CIP-012-1 does not address the availability of communication links and data communicated between bulk electric system Control Centers. To address this gap, the Commission directs NERC, pursuant to section 215(d)(5) of the FPA, to develop modifications to the CIP Reliability Standards to require protections regarding the availability of communication links and data communicated between bulk electric system Control Centers.

17. Below, we discuss the following issues: (A) Availability of bulk electric system communication links and data; and (B) scope of bulk electric system data that must be protected.

18. The NOPR stated that Reliability Standard CIP-012-1 does not address the availability component of the Commission's directive in Order No. 822. The NOPR identified this as a gap because ensuring timely and reliable access to and use of data is essential to the reliable operation of the bulk electric system. The NOPR indicated that the existing Reliability Standards cited in NERC's petition do not require responsible entities to protect the availability of sensitive bulk electric system data in a manner consistent with Order No. 822. 22 In particular, the NOPR stated that the cited Reliability Standards either do not apply to communications between individual Control Centers or, while their effect may be to support availability, the Reliability Standards do not create an obligation to protect availability. 23

19. NERC, Trade Associations, Tri-State and IRC do not support a directive that addresses the availability of communication links and data communicated between bulk electric system Control Centers. Reclamation, Appelbaum, and Liu express support for the directive, while Bonneville offers qualified support.

20. Comments opposing the proposed directive largely reiterate the petition's assertion that currently-effective Reliability Standards adequately protect the availability of communication links and data communicated between bulk electric system Control Centers. For example, NERC contends that “[w]hile IRO-002-5 and TOP-001-4 cover infrastructure within Control Centers, not between Control Centers, the requirements help protect the availability of data to be exchanged between Control Centers . . . [because] the data exchange infrastructure in scope of these requirements facilitates sending and receiving data between Control Centers.”  24 NERC explains that if “an applicable entity lost capability of some of this data exchange infrastructure, the applicable entity could continue to send and receive data between Control Centers because of the redundant data exchange infrastructure within its Control Center. 25 In addition, NERC states that Reliability Standards IRO-010-2 and TOP-003-3 require applicable entities to use a mutually agreeable security protocol between Control Centers. NERC explains that this supports availability by helping to ensure that conflicting protocols do not impede receipt of data between Control Centers.

21. NERC also contends that Reliability Standard EOP-008-2 helps support the availability of communication links between Control Centers by requiring reliability coordinators to have backup Control Center facilities, or backup Control Center functionality for balancing authorities and transmission operators, in addition to their primary Control Centers. NERC explains that “[t]hese backup facilities supply redundancy of some communication links and data exchange infrastructure and capabilities at the backup Control Center.”  26 NERC further explains that entities with geographically diverse primary and backup Control Centers may have communication links that are physically separate from one another. NERC concludes that although “geographic diversity alone will not always provide redundancy of communication links, having backup Control Centers with different paths to communicate with other Control Centers helps support availability of communication links.”  27

22. In addition, comments opposing the directive maintain that it is premature to require protections for the availability of the communication links and data at issue. NERC states that it recognizes that “there may be additional controls that could help address” risks to the availability of data and communication links and commits to “study the risks to availability of data and communication links between Control Centers and the current controls that support availability.”  28 Trade Associations, similarly, “encourage[s] the Commission to consider directing NERC to study the issue [of telecommunications security] to identify specific availability vulnerabilities and potential mitigation methods.”  29

23. IRC, while not supporting the proposed directive, “acknowledges that [the Commission] could require additional actions by responsible entities to promote the availability of [bulk electric system] communication links to the extent possible through contracts with telecommunications providers.”  30 IRC recommends a best efforts approach similar to how supply chain risks are addressed under Reliability Standard CIP-013-1. Specifically, IRC suggests that “NERC could adopt a standard that would require responsible entities, when negotiating these service contacts, to take reasonable steps or use best efforts to maximize the availability of communication links.”  31

24. Reclamation, in support of the Commission proposal, states that the availability of communication networks should encompass links between Control Centers owned by the same entity as well as Control Centers owned by different entities. Reclamation maintains that the requirements for electronic communications be parallel to the following requirements for oral communication contained in Reliability Standard COM-001-3: (1) Have electronic communication capability; (2) designate alternative electronic communication capability in the event of a failure of the primary communication capability; (3) test the alternate method of electronic communication; (4) notify the entity on the other end of the communication path if a failure is detected; and (5) establish mutually agreeable action to restore the electronic communication capability.

25. As an initial matter, Bonneville recommends delaying approval of Reliability Standard CIP-012-1 until NERC conducts a pilot project to study the most effective way to encrypt data while ensuring the data is available to responsible entities. However, if the Commission approves the Reliability Standard, Bonneville “agrees with the Commission's proposal to address the availability of communication links and data communicated between Control Centers.”  32 Bonneville explains that maintaining the availability of the communication links includes addressing both redundancy and recovery. Therefore, Bonneville recommends that, if Reliability Standard CIP-012-1 is approved, “the Commission order NERC to adopt modifications requiring Responsible Entities to have incident recovery plans/continuity of operation plans addressing planning for recovery time, capability, and capacity.”  33 Similarly, Appelbaum supports the proposed directive and contends that “a requirement for a continuing operations plan for loss of critical data resulting for the loss of Control Center functionality should be directed.”  34

26. We determine that modifications to the CIP Reliability Standards to address the availability of communication links and data communicated between bulk electric system control centers will enhance bulk electric system reliability. As the Commission stated in Order No. 822, bulk electric system Control Centers “must be capable of receiving and storing a variety of sensitive bulk electric system data from interconnected entities.”  35 We are not persuaded by the contention in the petition and comments that currently-effective Reliability Standards adequately address the directive in Order No. 822 regarding availability. Instead, we determine that the Reliability Standards cited by NERC either do not apply to communications between Control Centers or do not create an obligation to protect the availability of data between Control Centers. Accordingly, the directed modifications to the CIP Reliability Standards are not duplicative of existing Reliability Standards.

27. As the Commission explained in the NOPR, the existing Reliability Standards cited by NERC are not responsive to the availability directive in Order No. 822. 36 Reliability Standards IRO-002-5 and TOP-001-4 require responsible entities to have redundant and diversely routed data exchange infrastructure within the Control Center environment, but they do not address communications between individual Control Centers, which was the subject of the Commission's directive in Order No. 822. 37 While it is true that the infrastructure associated with communications within Control Centers may be useful to data exchange between Control Centers, nothing in the cited Reliability Standards creates an obligation to maintain data availability between Control Centers. Similarly, Reliability Standards IRO-010-2 and TOP-003-3 require responsible entities to have mutually agreeable security protocols for exchange of Real-time data, which may have the effect of contributing to greater availability; however, these requirements do not create an obligation, as directed in Order No. 822, to protect the availability of those communication capabilities and associated data by applying appropriate security controls.

28. As the NOPR explained, creating an obligation to protect availability, while affording flexibility in terms of what data is protected and how, is distinct from relying on currently-effective Reliability Standards whose effect may be to support availability. 38 The comments do not offer a new or persuasive reason to alter this view. For example, the Trade Associations repeat the line of reasoning in the NERC petition by “encourag[ing] the Commission to focus holistically on the broad requirements contained with [the] IRO and TOP standards, which focus on the performance requirements necessary to support Real-time monitoring and Real-time Assessments.”  39 In this circumstance, we disagree with that approach because, as the Commission observed in Order No. 822, “NERC and other commenters recognize that inter-Control Center communications play a critical role in maintaining bulk electric system reliability by, among other things, helping to maintain situational awareness and reliable bulk electric system operations through timely and accurate communication between Control Center.”  40 Thus, the holistic view urged by Trade Associations does not address the gap recognized by the Commission in Order No. 822.

29. The contention in NERC's comments that Reliability Standard EOP-008-2 could also help maintain the availability of communication links between bulk electric system Control Centers, rests on the same reasoning that the ancillary benefits of an existing Reliability Standard addresses the reliability gap identified by the Commission and concomitant availability directive in Order No. 822. While we agree that a requirement to maintain a backup Control Center arguably provides a level of redundancy for a responsible entity's overall operations, it does not require redundant and diversely routed communication paths between either the primary and backup Control Centers or third-party Control Centers.

30. In addition, we do not agree that it is premature to require protections for the availability of the communication links and data communicated between bulk electric system Control Centers. While NERC and Trade Associations advocate further study of the risks associated with availability, we conclude that the risks associated with losing the availability of either data or communication links between bulk electric system Control Centers is supported by the existing record and warrants a directive to modify the CIP Reliability Standards. 41

31. We address several related issues raised in the comments. Commenters raise a concern that directing NERC to address requirements for certain aspects of availability, in particular redundancy and diverse routing, could have significant impacts on responsible entities using third-party telecommunications providers. Specifically, Trade Associations notes that responsible entities “may not have sufficient control over the design of these networks to ensure that such requirements are met.”  42 Without control over these networks, commenters suggest that the only options for addressing availability would be to construct costly private networks or implement less secure internet-based connections. 43

32. We are not persuaded by these arguments. Rather, as IRC correctly notes in its discussion of the challenges raised in securing third-party telecommunications networks, while the Commission lacks jurisdiction over telecommunication service providers that may own and operate the communication links between bulk electric system Control Centers, the Commission has the authority to require responsible entities to take actions to promote the availability of communication links through service contracts with network providers. 44 For example, entities could enter into service contracts with telecommunication service providers that include an agreed-upon quality of service commitment to maintain the availability of the data exchange capability to minimize the availability risk. Such arrangements would mirror the approach in Reliability Standard CIP-013-1 (Cyber Security—Supply Chain Risk Management), which also involved non-jurisdictional entities. 45 NERC should likewise consider allowing responsible entities to contract with telecommunication service providers to minimize the risk of loss of availability of communication links and data communicated between bulk electric system Control Centers in cases where communications between Control Centers are managed by a third party.

33. We agree with Reclamation's comment that protections for the availability of communication links and data communicated between bulk electric system Control Centers should encompass both entity-owned and third-party owned Control Centers. The intent of the Commission's directive is for NERC to address the risks associated with the availability of communication links and data communicated between all bulk electric system Control Centers, which will require coordination between neighboring responsible entities.

34. We reject Bonneville's recommendation that the Commission delay approval of Reliability Standard CIP-012-1 to allow for a pilot project on encryption. The record in this proceeding does not support a delay, and Bonneville's request conflicts with the implementation plan proposed by NERC. 46 Moreover, the standard drafting team addressed the Commission's finding on this issue in Order No. 822. In Order No. 822, the Commission stated “that any lag in communication speed resulting from implementation of protections should only be measurable on the order of milliseconds and, therefore, will not adversely impact Control Center communications . . . [but that] technical issues should be considered by the standard drafting team . . . e.g., by making certain aspects of the revised CIP Standards eligible for Technical Feasibility Exceptions.”  47 In response, NERC stated that the standard drafting team “developed an objective-based rather than prescriptive requirement . . . [that] will allow Responsible Entities flexibility in mitigating the risks posed . . . in a manner suited to each of their respective operational environments.”  48 Accordingly, we determine not to delay approval of Reliability Standard CIP-012-1.

35. We agree with Bonneville and Appelbaum that maintaining the availability of communication networks and data should include provisions for incident recovery and continuity of operations in a responsible entity's compliance plan. We recognize that the redundancy of communication links cannot always be guaranteed; responsible entities should therefore plan for both recovery of compromised communication links and use of backup communication capability should it be needed for redundancy ( i.e., satellite or other alternate backup communications).

36. Accordingly, pursuant to section 215(d)(5) of the FPA, we direct that NERC develop modifications to the CIP Reliability Standards to require protections regarding the availability of communication links and data communicated between bulk electric system Control Centers, as discussed above.

37. The NOPR observed that Reliability Standard CIP-012-1 requires the protection of Real-time Assessment and Real-time monitoring data. The Commission explained that that while Real-time Assessment is defined in the NERC Glossary, Real-time monitoring data is not defined. Accordingly, the NOPR expressed concern that Reliability Standard CIP-012-1 does not clearly indicate the types of data to be protected. To address this, the Commission proposed to direct that NERC develop modifications to the CIP Reliability Standards to clearly identify the types of data that must be protected, including whether a NERC Glossary definition of Real-time monitoring would assist with implementation and compliance.

38. Appelbaum and Reclamation support the development of one or more definitions. Specifically, Reclamation recommends that the Commission direct NERC to develop definitions for the terms: (1) Real-time monitoring data; (2) Real-time data; (3) BES Data; (4) Operational Data; (5) System Planning Data; (6) availability and (7) Real-time monitoring. Appelbaum supports requiring a definition of Real-time monitoring given its importance to triggering alarms that system operators respond to and because it is an input to automatic dispatch.

39. NERC and other commenters maintain that a directive is unnecessary because the terms Real-time Assessment and Real-time monitoring are clear. NERC states that the “language used in proposed Reliability Standard CIP-012-1, `Real-time Assessment and Real-time monitoring data,' is sufficient to identify the data as described in TOP-003-3 and IRO-010-2.”  49 Specifically, NERC explains that since the IRO and TOP Reliability Standards are the only currently-effective Reliability Standards that use the phrase Real-time monitoring and the term Real-time Assessment, “[c]ompliance with these standards defines the data that is used in Real-time monitoring and Real-time Assessments.”  50 NERC concludes that by “using this language that is only referenced in the IRO and TOP Reliability Standards families, proposed CIP-012-1 brings the data identified pursuant to TOP-003-3 and IRO-010-2 into scope.”  51

40. Trade Associations and IRC concur with NERC that the scope of data subject to the requirements of proposed Reliability Standard CIP-012-1 is adequately clear. According to Trade Associations, responsible Entities and NERC understand that the types of data covered in CIP-012-1 is the data specified for Real-time Assessment and Real-time monitoring under TOP-003 and IRO-010. Similarly, IRC notes that “all responsible entities must already know the universe of data needed for Real-time Assessment and Real-time monitoring activities in order to comply with NERC Reliability Standards TOP-003-3 and IRO-010-2.”  52 Regarding the concern raised in the NOPR that the term Real-time monitoring is not defined, IRC states that it “sees no reason that the term should be presumed to mean something different from what it means in other places where it is used in the NERC Reliability Standards.”  53

41. While Bonneville does not take a position on the NOPR proposal, it notes a concern over “creating a compliance requirement to identify how different types of information are protected.”  54 Bonneville states that, generally, the use of the same data exchange infrastructure will result in all data using that infrastructure receiving the same protection regardless of data type. Therefore, Bonneville avers that, if the Commission directs NERC to define the scope of data to be protected, then “a Responsible Entity should have the option to show that all data types are protected at the highest level using the same security protocols, without having to identify and show how specific types of data are protected.”  55

42. In view of the comments, we determine not to adopt the NOPR proposal to direct modifications to define the scope of data covered by Reliability Standard CIP-012-1. NERC, Trade Associations and IRC agree that Reliability Standard CIP-012-1 requires the protection of Real-time Assessment and Real-time monitoring data identified under Reliability Standards TOP-003-3 and IRO-010-2. This point is also confirmed in the Technical Rationale document for Reliability Standard CIP-012-1. 56 We are persuaded that responsible entities must know the types of data needed for Real-time Assessment and Real-time monitoring activities in order to comply with Reliability Standards TOP-003-3 and IRO-010-2.

43. With this understanding, we are satisfied that the data protected under Reliability Standard CIP-012-1 is the same data identified under Reliability Standards TOP-003-3 and IRO-010-2. We determine that this clarification addresses the concern in the NOPR that not defining the types of data that must be protected under Reliability Standard CIP-012-1 could result in uneven compliance and enforcement. In addition, we agree with Bonneville that responsible entities may show that all data types are protected at the highest level using the same security protocols, without having to identify and show how specific types of data are protected, so long as the security protocols are reasonable.

44. The FERC-725B information collection requirements contained in this final action are subject to review by the Office of Management and Budget (OMB) under section 3507(d) of the Paperwork Reduction Act of 1995. 57 OMB's regulations require approval of certain information collection requirements imposed by agency rules. 58 Upon approval of a collection of information, OMB will assign an OMB control number and expiration date. Respondents subject to the filing requirements of this action will not be penalized for failing to respond to the collection of information unless the collection of information displays a valid OMB control number.

45. The Commission received no comments on the validity of the burden and cost estimates in the NOPR. The Commission is updating the burden estimates and labor costs contained in the NOPR. The Commission in this final action corrected an error from the NOPR in the row “Identification of Security Protection Application (if not owned by same Responsible Entity) (Requirement R1.3)” where the total number of hours was understated by 100,000, and all calculations based upon this error.

46. The Commission is submitting these reporting and recordkeeping requirements to OMB for its review and approval under section 3507(d) of the PRA. Comments are solicited on the Commission's need for this information, whether the information will have practical utility, the accuracy of the provided burden estimate, ways to enhance the quality, utility, and clarity of the information to be collected, and any suggested methods for minimizing the respondent's burden, including the use of automated information techniques.

47. The Commission bases its paperwork burden estimates on the changes in paperwork burden presented by Reliability Standard CIP-012-1.

48. The NERC Compliance Registry, as of December 2019, identifies approximately 1,482 unique U.S. entities that are subject to mandatory compliance with Reliability Standards. Of this total, we estimate that 719 entities will face an increased paperwork burden under proposed Reliability Standard CIP-012-1. Based on these assumptions, we estimate the following reporting burden:

49. The one-time burden (in Year 1) for the FERC-725B information collection will be averaged over three years:

50. The average annual number (for Years 1-3) of responses and burden for one-time and ongoing burden will total:

51. Title: Mandatory Reliability Standards for Critical Infrastructure Protection [CIP] Reliability Standards.

Action: Revisions to FERC-725B information collection.

OMB Control No.: 1902-0248.

Respondents: Businesses or other for-profit institutions; not-for-profit institutions.

Frequency of Responses: One-time and Ongoing.

Necessity of the Information: This final action approves the requested modifications to Reliability Standards pertaining to critical infrastructure protection. As discussed above, the Commission approves NERC's proposed Reliability Standard CIP-012-1 pursuant to section 215(d)(2) of the FPA because they improve upon the currently-effective suite of cyber security Reliability Standards.

Internal Review: The Commission has reviewed the proposed Reliability Standard and made a determination that its action is necessary to implement section 215 of the FPA.

52. Interested persons may obtain information on the reporting requirements by contacting the following: Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426 [Attention: Ellen Brown, Office of the Executive Director, email: DataClearance@ferc.gov, phone: (202) 502-8663, fax: (202) 273-0873].

53. Please send comments concerning the collection of information and the associated burden estimate to the Commission, and to the Office of Management and Budget, Office of Information and Regulatory Affairs, 725 17th Street NW, Washington, DC 20503, Washington, DC 20503 [Attention: Desk Officer for the Federal Energy Regulatory Commission]. For security reasons, comments to OMB should be submitted by email to: oira_submission@omb.eop.gov. Comments submitted to OMB should include FERC-725B (OMB Control No. 1902-0248).

54. The Commission is required to prepare an Environmental Assessment or an Environmental Impact Statement for any action that may have a significant adverse effect on the human environment. 62 The Commission has categorically excluded certain actions from this requirement as not having a significant effect on the human environment. Included in the exclusion are rules that are clarifying, corrective, or procedural or that do not substantially change the effect of the regulations being amended. 63 The actions herein fall within this categorical exclusion in the Commission's regulations.

55. The Regulatory Flexibility Act of 1980 (RFA) generally requires a description and analysis of proposed and final actions that will have significant economic impact on a substantial number of small entities. 64 The Small Business Administration's (SBA) Office of Size Standards develops the numerical definition of a small business. 65 The SBA revised its size standard for electric utilities (effective January 22, 2014) to a standard based on the number of employees, including affiliates (from the prior standard based on megawatt hour sales). 66

56. Reliability Standard CIP-012-1 is expected to impose an additional burden on 719 entities  67 (reliability coordinators [RC], generator operators [GOP], generator owners [GO], transmission operators [TOP], balancing authorities [BA], and transmission owners [TO]).

57. Of the 719 affected entities discussed above, we estimate that approximately 82% percent of the affected entities are small entities. We estimate that each of the 590 small entities to whom the modifications to Reliability Standard CIP-012-1 apply will incur one-time, non-paperwork cost in Year 1 of approximately $17,051, plus paperwork cost in Year 1 of $32,016, giving a total cost in Year 1 of $49,067. In Year 2 and Year 3, each entity will incur only the ongoing annual paperwork cost of $7,594. We do not consider the estimated costs for these 590 small entities to be a significant economic impact.

58. Accordingly, we certify that Reliability Standard CIP-012-1 will not have a significant economic impact on a substantial number of small entities.

59. This final action is effective April 7, 2020. The Commission has determined, with the concurrence of the Administrator of the Office of Information and Regulatory Affairs of OMB, that this action is not a “major rule” as defined in section 351 of the Small Business Regulatory Enforcement Fairness Act of 1996. This final action is being submitted to the Senate, House, and Government Accountability Office.

60. In addition to publishing the full text of this document in the Federal Register , the Commission provides all interested persons an opportunity to view and/or print the contents of this document via the internet through the Commission's Home Page ( http://www.ferc.gov ) and in the Commission's Public Reference Room during normal business hours (8:30 a.m. to 5:00 p.m. Eastern time) at 888 First Street NE, Room 2A, Washington, DC 20426.

61. From the Commission's Home Page on the internet, this information is available on eLibrary. The full text of this document is available on eLibrary in PDF and Microsoft Word format for viewing, printing, and/or downloading. To access this document in eLibrary, type the docket number of this document, excluding the last three digits, in the docket number field.

62. User assistance is available for eLibrary and the Commission's website during normal business hours from the Commission's Online Support at (202) 502-6652 (toll free at 1-866-208-3676) or email at ferconlinesupport@ferc.gov, or the Public Reference Room at (202) 502-8371, TTY (202) 502-8659. Email the Public Reference Room at public.referenceroom@ferc.gov.

Background

The Convention on Cultural Property Implementation Act, Public Law 97-446, 19 U.S.C. 2601 et seq. (“the Cultural Property Implementation Act”) 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))). Pursuant to the Cultural Property Implementation Act, the United States entered into a bilateral agreement with the Hashemite Kingdom of Jordan (Jordan) to impose import restrictions on certain Jordanian archaeological material. This rule announces that the United States is now imposing import restrictions on certain archaeological material from Jordan.

Under 19 U.S.C. 2602(a)(1), the United States must make certain determinations before entering into an agreement to impose import restrictions under 19 U.S.C. 2602(a)(2). On August 14, 2019, the Assistant Secretary for Educational and Cultural Affairs, United States Department of State, after consultation with and recommendation by the Cultural Property Advisory Committee, made the determinations required under the statute with respect to certain archaeological material originating in Jordan that is described in the Designated List set forth below in this document.

These determinations include the following: (1) That the cultural patrimony of Jordan is in jeopardy from the pillage of archaeological material representing Jordan's cultural heritage dating from approximately 1.5 million B.C. to A.D. 1750 (19 U.S.C. 2602(a)(1)(A)); (2) that the Jordanian government has taken measures consistent with the Convention to protect its cultural patrimony (19 U.S.C. 2602(a)(1)(B)); (3) that import restrictions imposed by the United States would be of substantial benefit in deterring a serious situation of pillage and remedies less drastic are not available (19 U.S.C. 2602(a)(1)(C)); and (4) that the application of import restrictions as set forth in this final rule is consistent with the general interests of the international community in the interchange of cultural property among nations for scientific, cultural, and educational purposes (19 U.S.C. 2602(a)(1)(D)). The Assistant Secretary also found that the material described in the determinations meets the statutory definition of “archaeological or ethnological material of the State Party” (19 U.S.C. 2601(2)).

On December 16, 2019, the United States and Jordan entered into a bilateral agreement, “Memorandum of Understanding between the Government of the United States of America and the Government of the Hashemite Kingdom of Jordan Concerning the Imposition of Import Restrictions on Categories of Archaeological Material of Jordan” (“the Agreement”), pursuant to the provisions of 19 U.S.C. 2602(a)(2). The Agreement enters into force on February 1, 2020, and enables the promulgation of import restrictions on categories of archaeological material representing Jordan's cultural heritage ranging in date from the Paleolithic period (approximately 1.5 million B.C.) to the middle of the Ottoman period in Jordan (A.D. 1750). A list of the categories of archaeological material subject to the import restrictions is set forth later in this document.

In accordance with the Agreement, importation of material designated below is subject to the restrictions of 19 U.S.C. 2606 and § 12.104g(a) of title 19 of the Code of Federal Regulations (19 CFR 12.104g(a)) and will be restricted from entry into the United States unless the conditions set forth in 19 U.S.C. 2606 and § 12.104c of the CBP regulations (19 CFR 12.104c) are met. CBP is amending § 12.104g(a) of the CBP regulations (19 CFR 12.104g(a)) to indicate that these import restrictions have been imposed.

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 Agreement still pertain and no cause for suspension of the Agreement exists. The import restrictions will expire on February 1, 2025, unless extended.

The Agreement between the United States and Jordan includes, but is not limited to, the categories of objects described in the Designated List set forth below. Importation of material on this list is restricted unless the material is accompanied by documentation certifying that the material left Jordan legally and not in violation of the export laws of Jordan.

The Designated List includes archaeological material in stone, metal, ceramic, and other categories ranging in date from the Paleolithic period (beginning around 1.5 million B.C.) to the middle of the Ottoman period in Jordan (A.D. 1750).

Approximate chronology of well-known archaeological periods and sites in Jordan:

1. Architectural Elements —This category includes doors, door frames, window fittings, columns, capitals, bases, lintels, jambs, archways, friezes, pilasters, engaged columns, altars, mihrabs (prayer niches), screens, fountains, inlays, and blocks from walls, floors, and ceilings of buildings. Architectural elements may be plain, molded, or carved and are often decorated with motifs and inscriptions. Marble, limestone, sandstone, and gypsum are most commonly used, in addition to porphyry and granite.

2. Mosaics —Floor mosaics are made from stone cut into small bits (tesserae) and laid into a plaster matrix. Wall and ceiling mosaics are made with a similar technique but may include tesserae of both stone and glass. Subjects can include landscapes, scenes of deities, humans, or animals, and activities such as hunting and fishing or religious imagery. There may also be vegetative, floral, or geometric motifs and imitations of stone.

3. Architectural and Non-Architectural Relief Sculptures —Types include carved slabs with figural, vegetative, floral, geometric, or other decorative motifs; carved relief vases; stelae; palettes and plaques. All types can sometimes be inscribed in various languages. Sculptures are used for architectural decoration, including in religious, funerary ( e.g., grave markers), votive, or commemorative monuments. Marble, limestone, and sandstone are most commonly used.

4. Monuments —Types include votive statues, funerary and votive stelae, and bases and base revetments in marble, limestone, and other kinds of stone. These may be painted, carved with relief sculpture, decorated with moldings, and/or carry dedicatory or funerary inscriptions in various languages.

5. Statuary —Statues are large-scale representations of deities, humans, animals, or hybrid figures in marble, limestone, or sandstone. Statuary figures may be painted.

6. Figurines —Figurines are small-scale representations of deities, humans, animals, or enigmatic forms such as the “violin-shaped” figures, in limestone, calcite, marble, greenstone, basalt, or sandstone.

7. Sepulchers —Types of burial containers include sarcophagi, caskets, reliquaries, and chest urns in marble, limestone, or other kinds of stone. Sepulchers may be plain or have figural, geometric, or floral motifs painted on them. They may be carved in relief and/or have decorative moldings.

8. Vessels and Containers —These include bowls, cups, jars, jugs, lamps, and flasks, and also smaller funerary urns and incense burners, in marble, basalt, limestone, calcite, alabaster, gypsum, or other stone. Sculpted vessels in the form of a human head or animal with a bowl on top (“pillar figures”) made of basalt are distinctive of the Chalcolithic period.

9. Furniture —Types include thrones, tables, and beds, from funerary or domestic contexts.

10. Tablets and Ostraca —Types include small-scale plaques and chips of stone used as surfaces for writing or drawing. These can be inscribed with pictographic, cuneiform, Aramaic, Greek, Punic, Latin, or Arabic scripts.

11. Tools and Weapons —Chipped stone types include blades (“Canaanean-type”), borers, scrapers, sickles, burins, notches, retouched flakes, cores, arrowheads, cleavers, knives, chisel, and microliths. Paleolithic period types are described as Acheulean, Mousterian, Ahmarian, Aurignacian, and Natufian complexes. Ground stone types include grinders ( e.g., mortars, pestles, millstones, whetstones, querns), choppers, spherical-shaped hand axes, hammers, mace heads, and weights. The most commonly used stones are flint, chert, limestone, granite, basalt, and obsidian; other examples are hematite and calcite.

12. Jewelry —Types include seals, beads, finger rings, masks, and other personal adornment in marble, limestone, or various semi-precious stones—including rock crystal, amethyst, jasper, agate, steatite, and carnelian.

13. Seals and Stamps —These are small devices with at least one side engraved with a design for stamping or sealing. They can be in the shapes of squares, disks, cones, cylinders, or animals.

1. Architectural Elements —These are baked clay (terracotta) elements used to decorate buildings. Examples include acroteria, antefixes, painted and relief plaques, revetments, carved and molded brick, knobs, roof tiles, and tile wall ornaments and panels.

2. Figurines —These include terracotta (clay) statues and statuettes in the shapes of deities, humans, and animals, ranging in height from approximately 5 cm to 20 cm (2 in to 8 in). Figurines may be undecorated or decorated with paint, appliques, or inscribed lines. Plaque types are made in a mold and have a flat back and image of a human form, often female, on the front.

3. Models —These are small-scale and in terracotta, including furniture such as chairs and beds, chariots, boats, and buildings.

4. Vessels —Types, forms, and decoration vary among archaeological styles and over time. Forms may be painted or unpainted, handmade or wheel-made and decorated with burnish, glazes, or carvings. Ceramic vessels can depict imagery of humans, deities, animals, floral decorations, or inscriptions. Some of the most well-known types are highlighted below:

a. Neolithic—This type is handmade and often decorated with a lustrous burnish and may also be decorated with appliqué and/or incision, sometimes with added paint. Yarmoukian style vessels feature banded herringbone impression. Jericho style vessels have slips and red pigment applied in geometric motifs.

b. Chalcolithic—This type is dominated by medium-sized holemouth or short-necked storage jars and holemouth cooking pots. Distinctive forms include cornet cups, fenestrated stands, necked churns, spoons, “torpedo” jars, and vessels in the shape of humans or animals. May be painted with geometric designs.

c. Bronze and Iron—Distinctive types include Grey Burnished Ware, Metallic Ware, Band Slip and Line Group painted decoration, Crackled Ware, Tall Yehudiyeh Ware, Khirbat Kerak Ware, Mycenaean types, Chocolate-on-White Ware, fenestrated stands, collared pithos jars, and holemouth jars with four pushed-up ledge handles on the shoulder.

d. Persian—This type includes locally produced wares, indistinguishable from other Iron period ceramics, as well as imported Greek wares from the fifth and fourth century B.C. Types include sausage jars, high-necked cooking pots, amphorae, narrow bottles, and bag-shaped perfume juglets.

e. Hellenistic—This type includes local and imported fine and coarse wares and amphorae. Examples include oil lamps, black-slipped pottery, rhodian amphorae, relief-bowls, plates, jugs and juglets, fishplates, and bowls with incurved and outcurved rims, mastoi, table amphorae, lagynoi, amphoriskoi and small vessels for unguents. Imports include black-slipped pottery from Greece, jugs and juglets, bowls, storage jars or cooking pots from Cyprus, and Rhodian wine amphoras.

f. Nabataean—This type is characterized by forms with thin walls and floral motifs, often red pottery with black designs. The designs on the wares are painted on or pressed into the surface with stamps and rouletting wheels. Vessels of this type come in a variety of shapes including plates, serving bowls, drinking bowls, flasks, jugs, amphoriskoi, and cooking pots.

g. Roman—This type includes fine and coarse wares, including terra sigillata and other red gloss wares, cooking wares and mortaria, and storage and shipping amphorae.

h. Byzantine—This type includes undecorated plain wares, utilitarian tableware, storage jars, serving vessels, cook pots, amphorae, and special shapes such as pilgrim flasks. The fineware “Jarash bowls,” which are often slipped and painted, are particularly distinctive. Other styles can be matte painted or glazed—including incised “sgraffitto”—and stamped with elaborate polychrome decorations using floral, geometric, human, and animal motifs.

i. Islamic and Ottoman—This type includes mostly unglazed earthen coarse wares as well as those painted with linear or vegetal designs. Examples include dark gray metallic wares with white paint; glazed fine cream wares; red-painted wares, including fine “palace wares;” and ceramic vessels imitating steatite vessels. The most common glazes are yellow, green, and blue. Vessels appear in a variety of shapes, including jars, jugs, bowls, basins, cups, zirs, and so-called “sugar cones” made of distinctly heavy ceramic.

5. Lamps —Lamps can be glazed or unglazed in “saucer,” “slipper” or other styles; they typically have rounded bodies with a hole on the top and in the nozzle, handles or lugs, and motifs such as beading, human faces, rosettes or other floral elements like bunched grapes or leaves. Inscriptions may also be found on the body. Later period examples may have straight or round, bulbous bodies with a flared top and several branches.

6. Seals and Sealings —These are small devices with at least one side engraved with a design for stamping or sealing. They can be in the shapes of squares, disks, cones, cylinders, or animals. Sealings are lumps of clay impressed with a seal used to secure doors or containers.

7. Tablets —Tablets are covered with wedge-shaped cuneiform characters or incised pictographs/hieroglyphics. Shapes range from very small rounded disk forms, to small square and rectangular pillow-shaped forms, to larger rectangular tablets. Tablets may be impressed with cylinder or stamp seals.

8. Ostraca —Ostraca are pottery sherds used as surfaces for writing or drawing.

9. Objects of Daily Use —These include game pieces, loom weights, toys, tobacco pipes, portable hearths, and andirons.

10. Sepulchers —Types of burial containers include reliquaries and ossuaries, the latter being rectangular in shape or in the shape of stylized animals with an opening in the short end of the container. Sepulchers may be decorated with paint or appliques, or incised.

1. Statuary —These are large- and small-scale, including deity, human, and animal figures in bronze, iron, silver, or gold. Common types are large-scale, free-standing statuary from approximately 1 m to 2.5 m (approximately 3 ft to 8 ft) in height and life-size busts ( i.e., head and shoulders of an individual).

2. Reliefs —These include plaques, appliques, stelae, and masks, often in bronze. Reliefs may include inscriptions in various languages.

3. Inscribed or Decorated Sheet —These are engraved inscriptions and thin metal sheets with engraved or impressed designs often used as attachments to furniture or figures. Primarily in bronze or lead, but also less frequently in gold and silver.

4. Vessels and Containers —Forms include bowls, cups, jars, jugs, strainers, cauldrons, and boxes, as well as vessels in the shape of an animal or part of an animal. This category also includes scroll and manuscript containers, reliquaries, and censers. In copper, bronze, silver, and/or gold. May portray deities, humans, or animals, as well as floral motifs in relief. They may include an inscription.

5. Jewelry —These include necklaces, chokers, pectorals, finger rings, beads, pendants, bells, belts, buckles, earrings, diadems, straight pins and fibulae, bracelets, anklets, girdles, wreaths and crowns, make-up accessories and tools, metal strigils (scrapers), crosses, and lamp-holders. In the Ottoman period, perforated coins were used as jewelry. In iron, bronze, silver, and gold. Metal can be inlaid with items such as colored stones and glass.

6. Seals —Seals are small devices with at least one side engraved with a design for stamping or sealing. Types include finger rings, amulets, and seals with a shank; in lead, tin, copper, bronze, silver, or gold.

7. Tools —Types include hooks, weights, axes, scrapers, hammerheads, trowels, locks, keys, nails, hinges, tweezers, mace heads, ingots, mirrors and fibulae (for pinning clothing), in copper, bronze, or iron.

8. Weapons and Armor —This includes body armor, such as helmets, cuirasses, bracers, and shin guards, shields, and horse armor; often decorated with elaborate designs that are engraved, embossed, or perforated. Both launching weapons ( e.g., spears, javelins, arrowheads) and hand-to-hand combat weapons ( e.g., swords, daggers, etc. ), in copper, bronze, and iron; and in silver and gold for ceremonial use.

9. Lamps —Lamps can be open saucer-type or closed, rounded bodies with a hole on the top and in the nozzle, handles or lugs. They can include decorative designs such as beading, human faces, animals or animal parts, rosettes or other floral elements. This category includes handheld lamps, candelabras, braziers, sconces, chandeliers, and lamp stands.

10. Coins —Some of the best-known types include:

a. Nabataean—Coins in silver, lead, copper or bronze and struck at Petra. They typically have cornucopiae or wreaths on the reverse and portrait of the ruler or rulers on the obverse.

b. Roman Provincial—Coins in silver and bronze were struck through the third century A.D. at Roman and Roman provincial mints of Abila (Abel), Adraa (Daraa), Charachmoba (Al-Karak), Dium, Esbous (Heshbon), Gadara (Umm Qais), Gerasa (Jerash), Medaba (Madaba), Pella, Petra, Philadelphia (Amman), Rabbathmoba (Aroer) Capitolias/Dion (Beit Ras), and Raphana. This type also includes the pseudo-autonomous coinage of the second and first centuries B.C.

c. Byzantine—Coins in bronze and struck at the Arab-Byzantine mint of Aylah/Elath (Aqaba).

d. Early Islamic—Coins in bronze or silver and struck at the Umayyad mints of Adraa (Daraa), Gerasa (Jerash), Philadelphia/Rabbath-Ammon (Amman) and under the Abbasids at Philadelphia/Rabbath-Ammon (Amman). These coins are epigraphic in design, featuring one or more lines of Arabic script. Some Abbasid bronze coins from Philadelphia/Rabbath-Ammon (Amman) feature a small flower-like design in the center of one side.

e. Crusader—These coins appear as thin, light-weight, low-quality-silver billon. Examples usually feature crosses and/or crude portraits or buildings as central images.

1. Small Statuary and Figurines —These include representations of deities, humans, or animals, in bone or ivory.

2. Reliefs, Plaques, Stelae, and Inlays —These are carved and sculpted and may have figurative, floral, and/or geometric motifs.

3. Jewelry —Types include amulets, pendants, combs, pins, spoons, bracelets, buckles, beads, and pectorals. Jewelry can be made of bone, ivory, amber, coral, mother-of-pearl, tortoise shell, and cowrie shell.

4. Seals and Stamps —These are small devices with at least one side engraved with a design for stamping or sealing. They can be in the shapes of squares, disks, cones, cylinders, or animals.

5. Vessels and Luxury Objects —Ivory, bone, and shell were used either alone or as inlays in luxury objects, including furniture, chests and boxes, writing and painting equipment, musical instruments, games, cosmetic containers, combs, jewelry, amulets, and seals.

6. Tools —Tools include bone points and awls, burnishers, needles, spatulae, and fish hooks.

7. Manuscripts —Archaeological manuscripts can be written or painted on specially prepared animal skins ( e.g., cattle, sheep, goat, camel skins) known as parchment or papyrus. They occur as single leaves, bound as a book or codex, or rolled into a scroll.

8. Human Remains —This includes skeletal remains from the human body, preserved in burials or other contexts. Particular to early periods are human skulls painted or covered with lime plaster and bitumen.

1. Architectural Elements —These include glass inlay and tesserae pieces from floor and wall mosaics, mirrors, and windowpanes.

2. Vessels and Containers —These can take various shapes, such as jars, bottles, bowls, beakers, goblets, candle holders, perfume jars ( unguentaria ), and flasks. Vessels and containers may have cut, incised, raised, enameled, molded, or painted decoration. Ancient examples may be engraved and/or light blue, blue-green, green, or colorless while those from later periods may include animal, floral, and/or geometric motifs.

3. Jewelry —Jewelry includes bracelets and rings (often twisted with colored glass), pendants, and beads in various shapes ( e.g., circular, globular), some with relief decoration including multi-colored “eye” beads.

4. Lamps —Lamps may have a straight or round bulbous body, some in the form of a goblet, with flared top, and engraved or moulding decorations and may have several branches.

1. Rock Art —Rock art can be painted and/or incised drawings on natural rock surfaces. Common motifs include humans, animals, geometric, and/or floral elements.

2. Wall Painting —With figurative (deities, humans, animals), floral, and/or geometric motifs, as well as funerary scenes. These are painted on stone, mud plaster, lime plaster (wet— buon fresco —and dry— secco fresco ), sometimes to imitate marble.

3. Stucco —This is a fine plaster used for coating wall surfaces or molding into architectural decorations such as reliefs, plaques, stelae, and inlays.

4. Jewelry —Jewelry includes plaster beads from the Neolithic period.

5. Figurines —Figurines can be human statuettes made of marl lime plaster. They can be full body or busts with one or two heads, and may have detailed facial and body features like arms, hands, and breasts.

1. Textiles —These include linen, hemp, and silk cloth used for burial wrapping, shrouds, garments, and sails. These also include linen and wool also used for garments and hangings.

2. Basketry —Plant fibers were used to make baskets and containers in a variety of shapes and sizes, as well as sandals and mats.

3. Rope —Rope and string were used for a great variety of purposes, including binding, lifting water for irrigation, fishing nets, measuring, lamp wicks, and stringing beads for jewelry and garments.

1. Jewelry and Personal Items —These include rings, bracelets, combs, and spindle whorls.

2. Containers —These include boxes, chests, and coffins.

Leather items include belts, sandals, necklaces, bracelets, and other items of personal adornment.

This amendment involves a foreign affairs function of the United States and is, therefore, being made without notice or public procedure (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 or Executive Order 13771 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 and section 4(a) of Executive Order 13771.

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.

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:

Background

The Convention on Cultural Property Implementation Act, Public Law 97-446, 19 U.S.C. 2601 et seq. (“the Cultural Property Implementation Act” or “Act”), 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 (823 U.N.T.S. 231 (1972)) (“the Convention”). Pursuant to the Cultural Property Implementation Act, the United States may enter into international agreements with another State Party to the Convention to impose import restrictions on eligible archaeological and ethnological material under procedures and requirements prescribed by the Act.

Under certain limited circumstances, the Cultural Property Implementation Act authorizes the imposition of import restrictions on an emergency basis (19 U.S.C. 2603). The emergency restrictions are effective for no more than five years from the date of the State Party's request and may be extended for three years where it is determined that the emergency condition continues to apply with respect to the covered material (19 U.S.C. 2603(c)(3)). These restrictions may also be continued pursuant to an agreement concluded within the meaning of the Act (19 U.S.C. 2603(c)(4)).

Pursuant to 19 U.S.C. 2602(a), the government of the Republic of Yemen (Yemen), a State Party to the Convention, requested on September 11, 2019, that import restrictions be imposed on certain archaeological and ethnological material, the pillage of which jeopardizes the cultural heritage of Yemen. The Cultural Property Implementation Act authorizes the President (or designee) to apply import restrictions on an emergency basis if the President determines that an emergency condition applies with respect to any archaeological or ethnological material of any requesting state (19 U.S.C. 2603).

On December 5, 2019, the Assistant Secretary for Educational and Cultural Affairs, United States Department of State, after consultation with and recommendation by the Cultural Property Advisory Committee, made the determinations necessary under the Act for the emergency imposition of import restrictions on certain archaeological material and ethnological material of the Islamic cultural heritage of Yemen. The Designated List below sets forth the categories of material to which the import restrictions apply. Thus, U.S. Customs and Border Protection (CBP) is amending § 12.104g(b) of title 19 of the Code of Federal Regulations (19 CFR 12.104g(b)) accordingly.

Importation of covered material from Yemen will be restricted for a five-year period from the date of request by Yemen, through September 11, 2024. Importation of such material from Yemen will continue to be restricted through that date unless the conditions set forth in 19 U.S.C. 2606 and 19 CFR 12.104c are met.

Archaeological material dates from approximately 200,000 B.C. to A.D. 1750 and represents the following periods, styles, and cultures: Paleolithic, Neolithic, South Arabian, Abyssinian, Sasanian, and Islamic (Umayyad, Abbasid, Ziyadid, Zaydi, Najahid, Sulaihid, Zurayid, Ayyubid, Rasulid, and Tahirid), among others. A chronological outline of pre-Islamic Yemen includes the Paleolithic Period (c. 200,000-8000 B.C.), Neolithic Period (8000-3000 B.C.), Post-Neolithic/Bronze Age (3500-1200 B.C.), South Arabian Period (Sabaean, Minean, Qataban, Hadhramaut, Himyarite) (1200 B.C.-A.D. 570), Abyssinian (c. 4th century A.D.-A.D. 578), and the Sasanian Period (A.D. 570-628). Subsequent archaeological material from the Islamic Period covers A.D. 628-1750. The Designated List set forth below is representative only. Any dates and dimensions are approximate.

1. Architectural Elements —Primarily in limestone, marble, and sandstone; including blocks from walls, floors, and ceilings; columns, capitals, bases, lintels, jambs, friezes, and pilasters; doors, door frames, and window fittings; engaged columns, altars, prayer niches, screens, fountains, mosaics, and inlays. May be plain, molded, carved, or inscribed in various languages and scripts. Common decorative motifs include ibex heads and full animals, oxen or bull heads, rosettes, and curvilinear vine and floral patterns, and may be incised or in high relief. Approximate date: 1200 B.C.-A.D. 1750.

2. Non-Architectural Relief Sculpture— In alabaster, limestone, marble, calcite, and other kinds of stone. Types include carved slabs and plaques, funerary and votive stelae, and bases and base revetments. These may be painted, incised, or carved with relief sculpture, decorated with moldings, and/or carry dedicatory or funerary inscriptions. South Arabian Period styles include face plaques and stelae: Funerary images of faces; may be combined with ceramic or plaster sculpture; may be inscribed or painted. Common decorative motifs either incised or in high relief include oxen or bull heads, other animals, mythological creatures, human figures, which are usually clothed, and vegetative and floral patterns; may be inscribed in South Arabian script. Approximate date: 1200 B.C.-A.D. 570.

3. Statuary— Primarily in alabaster, also in calcite, limestone, sandstone, softstone (chlorite), and marble. Large- and small-scale, including deities; human figures, which are usually clothed; animals such as bulls, ibex, and camels; and hybrid or mythological creatures. May be inscribed. Includes fragments of statues. Some pieces may also include different material types, including multiple types of stone, metal staffs, shell or bone eyes, and metal, glass, and semi-precious stone jewelry inlay. Approximate date: 1200 B.C.-A.D. 570.

4. Vessels and Containers— Primarily in alabaster, softstone (chlorite), and limestone; may also be marble, basalt, or other stone. Vessels may be conventional shapes such as bowls, cups, jars, jugs, platters, and flasks, and also include smaller funerary urns and incense burners. Common forms include, but are not limited to:

a. South Arabian Period containers for unguents, powders, and liquids in all shapes and sizes. They are flat-bottomed and often have lids. Some pieces have protruding pierced lug handles, which may or may not be in the shape of an animal, usually a bull or ibex. Vessels may be otherwise decorated or inscribed with South Arabian, or other script. Other forms include pedestal dishes, bowls, saucers, and three-legged cosmetic palettes, as well as small, rectangular, square-sided boxes, usually decorated with bull's heads, used as containers for smaller bottles. Incense burners from the South Arabian period are usually cuboid and decorated with astral symbols or South Arabian script. Approximate date: 1200 B.C.-A.D. 570.

b. Stone vessels continue in similar form through the Sasanian and Islamic Periods, particularly in softstone and alabaster. Includes all vessel types and lamps, usually with geometric incised decoration; may have Arabic script. Approximate date: A.D. 570-1750.

5. Furniture —In marble, alabaster, and other stone. May include thrones, tables, and other examples. Also includes pieces of furniture such as legs and feet that may have been attached to a wooden frame; may be funerary. Includes South Arabian Period libation and sacrificial altars, which are oblong or square slabs with raised rims; altars have a run-off channel for liquid, usually in the form of an animal including bull's head or ibex. Approximate date: 200,000-1200 B.C.

6. Tools and Weapons —In flint/chert, obsidian, limestone, tuff, basalt, and other stones. Prehistoric and protohistoric microliths (small stone tools). Chipped stone types include blades, borers, scrapers, sickles, cores, and arrowheads. Ground stone types include grinders ( e.g., mortars, pestles, millstones, whetstones), choppers, axes, hammers, and mace heads. Approximate date: 200,000-1200 B.C.

7. Jewelry, Seals, and Beads —In marble, limestone, and various semi-precious stones, including rock crystal, amethyst, garnet, jasper, agate, steatite, and carnelian. Seals may include animals, human figures, and/or inscriptions in various languages. Beads include cylindrical, spherical, conical, disc, and other types; may have cut, incised, or raised decoration.

1. Non-Architectural Relief Sculpture— Includes cast relief plaques or tablets, appliques, stelae, and masks; often in bronze or copper. Decoration includes human and animal figures, geometric, and floral motifs. May be inscribed/cast relief in South Arabian, Arabic, or other script. Approximate date: 1200 B.C.-A.D. 1750.

2. Statuary— Primarily in copper, bronze, silver, or gold; includes fragments of statues. Range from larger-than-life-size to small figurines; forms include human figures, which may be clothed or not; animals such as camels, ibex, oxen, bulls, and lions; or mythological creatures/figures; and trophies such as votive hands. May be painted or inscribed/cast relief in South Arabian, Arabic, or other script.

3. Vessels and Containers —Primarily in copper, bronze, or iron; Islamic Period includes more examples in silver and gold. May include forms such as bowls, cups, jars, jugs, strainers, buckets, cauldrons, boxes, oil lamps, incense burners, and scroll or manuscript containers; may occur in the shape of an animal or part of an animal. Decoration may include humans or animal figures, or geometric or floral motifs in relief. Incense burners from this period may be square or cylindrical; front decorated with astral symbols and/or animals. May be inscribed/cast relief in South Arabian, Arabic, or other script.

4. Furniture —Primarily in bronze and iron; may include thrones, tables, and other examples. Includes pieces of furniture and decorative fittings such as legs and feet that may have been attached to a wooden frame; or thin metal sheets with engraved or impressed designs.

5. Tools and Instruments —In copper, bronze, iron, silver, and gold. Types include hooks, weights, axes, scrapers, trowels, keys, ladles, tools of craftspersons such as carpenters, masons, and metal smiths. Approximate date: 1200 B.C.-A.D. 570.

6. Weapons and Armor —In copper, bronze, and iron. Body armor, such as helmets, cuirasses, shin guards, shields, and horse armor; often decorated with elaborate engraved, embossed, or perforated designs. Launching weapons (spears, javelins, socketed arrowheads); hand-to-hand combat weapons (swords, daggers, jambiyas); and sheaths. Approximate date: 1200 B.C.-A.D. 570.

7. Jewelry and Other Items for Personal Adornment —In iron, bronze, silver, and gold. Metal can be inlaid (with items such as colored stones, and glass). Types include necklaces, amulets and pendants, rings, bracelets, anklets, earrings, diadems, wreaths and crowns, beads, buttons, purses, belts, belt buckles, mirrors, and make-up accessories and tools.

8. Seals and Stamps —In lead, tin, copper, bronze, silver, and gold. Small devices with at least one side engraved with a design for stamping or sealing; includes rings, amulets, and seals with a shank; may include animals, human figures, and/or inscriptions in various languages.

9. Coins —A reference book for ancient, pre-Islamic material in Yemen is M. Huth, Coinage of the Caravan Kingdoms: Ancient Arabian Coins from the Collection of Martin Huth, New York, 2010, pp. 68-152. A reference book for Islamic coinage to A.D. 1750 is S. Album, Checklist of Islamic Coins, Santa Rosa, 2011, pp. 116-127. Some of the best-known types are described below:

a. Ancient—In gold, silver, and bronze/copper, with units ranging from tetradrachms down to various fractional levels.

i. Earliest coins from Yemen are imitations of silver tetradrachms from Athens; feature a bust of Athena on the obverse and an owl on the reverse. The style of these imitations is distinctive, and they are usually marked with Arabian monograms or graffiti. Approximate date: 500 B.C. and later.

ii. Minaeans produced schematic imitations of the Athenian coinage; these coins have angular shapes, often triangular. Style is distinctive with monograms with Arabian letters. Approximate date: 200 B.C.

iii. Sabaeans struck distinctive local imitations of Athenian tetradrachms, with or without monograms, often with the curved symbol of Almaqah to the right of the owl, and of smaller units than previously. In the 1st century A.D., the head of Athena is replaced with a male bust resembling Augustus; owl on the reverse continues, as do monograms and the curved symbol. In the 2nd and 3rd centuries A.D., a beardless male head appears on the coins with the curved symbol, and a facing bucranium (a bull's head) appears on the reverse with the curved symbol and monograms. Approximate date: 400 B.C.-A.D. 300.

iv. Himyarite coins feature beardless male heads on the obverse coupled with bearded male heads on the reverse. Various South Arabian monograms appear on the coins. Rulers include Yuhabirr, Karib'il Yehun`im Wattar, Amdan Yuhaqbid, Amdan Bayan, Tha'ran Ya`ub, Shamnar Yuhan`am, and unknown kings. Approximate date: 110 B.C.-A.D. 200.

v. Qatabians produced imitations of Athenian coins also in 2nd-4th century B.C., with or without monograms; distinctive style. From the 2nd century B.C. to the 2nd century A.D., head of Athena is replaced with male ruler portraits, including those of Yad'ab Dhubyan Yuhargib, Dhub, Hawfi`Amm Yuhan`am III, Shahr Yagul, Waraw'il Ghaylan, Shahr Hilal, Yad`ab Yanaf, and various unknown rulers. Reverses of early types have the owl, while later types have a second portrait on the reverse. Approximate date: 400 B.C.-A.D. 200.

vi. Bronze coins from Hadramawt have radiate male portraits in a circle on the obverse and a standing bull on the reverse; Arabian symbols appear. Approximate date: A.D. 200-400.

vii. Various South Arabian types imitate Athenian coins, Hellenistic Alexander tetradrachms with a head of Herakles on the obverse and Zeus seated on the reverse, and Ptolemaic coins with a cornucopia on the reverse. Style is distinctive; designs are accompanied by Arabian monograms.

b. Islamic Period—In gold, silver, and bronze, and including anonymous mints in Yemen, and coins of unknown rulers attributed to Yemen. Non-exclusive mints are the primary manufacturers of the listed coins, but there may be other production mints.

i. `Abbasid coins struck in gold, silver, and bronze, at non-exclusive mints San`a, Zabid, `Adan, Dhamar, `Aththar, and Baysh mints. Approximate date: A.D. 786-974.

ii. Coins of the Amirs of San`a, struck in gold, at the mint of San`a. Approximate date: A.D. 909-911.

iii. Rassid (1st period) coins struck in gold and silver at Sa`da, San`a, Tukhla', and `Aththar. Approximate date: A.D. 898-1014.

iv. Coins of the Amirs of Yemen, struck in silver, at an uncertain mint. Approximate date: A.D. 1000-1100.

v. Coins of the Amirs of `Aththar, struck in gold, at the mint of `Aththar. Approximate date: A.D. 957-988.

vi. Tarafid coins, struck in silver, at the mint of `Aththar. Approximate date: A.D. 991-1004.

vii. Ziyadid coins, struck in gold and silver, at non-exclusive mint Zabid. Approximate date: A.D. 955-1050s.

viii. Khawlanid coins, struck in silver, at the mint of San`a. Approximate date: A.D. 1046-1047.

ix. Najjahid coins, struck in gold, at the mints Zabid and Dathina. Approximate date: A.D. 1021-1158.

x. Sulayhid coins, struck in gold and debased silver, at non-exclusive mints Zabid, `Aththar, `Adan, Dhu Jibla. Approximate date: A.D. 1047-1137.

xi. Zuray'id coins, struck in gold, at the mints of `Adan and Dhu Jibla. Approximate date: A.D. 1111-1174.

xii. Coins of Mahdid of Zabid, struck in silver, at the mint of Zabid. Approximate date: A.D. 1159-1174.

xiii. Rassid (2nd period) coins, struck in gold and silver, at non-exclusive mints Zufar, San`a, Sa`da, Huth, Dhirwah, Kahlan, Muda', `Ayyan, Bukur, al-Jahili, and Dhamar. Approximate date: A.D. 1185-1390.

xiv. Ayyubid coins, struck in gold, silver, and bronze, at the mints of Zabid, `Adan, Ta`izz, San`a, al-Dumluwa, Bukur, and Mayban. Approximate date: A.D. 1174-1236.

xv. Rasulid coins, struck in gold, silver, and bronze, at non-exclusive mints `Adan, Zabid, al-Mahjam, Ta`izz, San`a, Tha'bat, and Hajja. Approximate date: A.D. 1229-1439.

xvi. Tahirid coins, struck in silver, at the mint of `Adan. Approximate date: A.D. 1517-1538.

xvii. Rassid (3rd period) coins, struck in silver and bronze, at the mints of San`a, Zafir, and Thula. Approximate date: A.D. 1506-1572.

xviii. Ottoman coins, struck in gold, silver and bronze, at the mints of Zabid, San`a, `Adan, Kawkaban, Ta`izz, Sa`da, al-Mukha, and Malhaz. Approximate date: A.D. 1520-1750.

1. Architectural Elements— Baked clay (terracotta) elements used to decorate buildings. Elements include acroteria, antefixes, painted and relief plaques, revetments, carved and molded brick, and wall ornaments and panels.

2. Non-Architectural Relief Sculpture— Types include carved slabs and plaques, funerary and votive stelae, and bases and base revetments. Common decorative motifs include ibex heads and full animals, oxen or bull heads, rosettes, and curvilinear vine and floral patterns, and may be incised or in high relief; inscribed with South Arabian, Arabic, or other script. Includes face plaques and stelae: Funerary images of faces; may be combined with ceramic or plaster sculpture; may be inscribed or painted. Approximate date: 1200 B.C.-A.D. 1750.

3. Statuary —Range from large to small figurines; forms include human figures, usually clothed; animals such as camels, ibex, oxen, bulls, and lions; or mythological creatures/figures; and trophies such as votive hands. May be glazed or painted; may include South Arabian script. Approximate date: 1200 B.C.-A.D. 570.

4. Vessels —Include utilitarian types and fine tableware, incense burners, and oil lamps.

a. Post-Neolithic/Bronze Age—Includes hand built grey-brown or reddish-brown coarseware with large black or white inclusions, occasionally burnished; and fineware, which can have slipwash or burnish with incised or punctate decoration. Some pieces may also have imprints of basketry. Common forms include but are not limited to platters and shallow bowls with flat bases, deep bowls and basins with rounded bases, rimmed hemispheric bowls with rounded bases, hole-mouthed jars, necked jars, and large storage jars. Approximate date: 3500-900 B.C.

b. South Arabian Period—Includes hand built reddish-brown, yellow, and gray fabrics, which may be unfinished, burnished, or slip-glazed; the most common is red-burnished slip with carinated vessel shapes. Common forms include but are not limited to small rimmed jugs with flat base; small beakers and goblets; rimmed bowls, jars, and vases with ring bases; cooking pots with flat bases and straight walls; hemispherical bowls with ledge handles, often with black burnished slip; plates/platters with flat bases; goblets; amphorae; and oil lamps. Decoration includes paint, punctuation, incised or pressed designs including South Arabian script, and raised dots. Imported Roman terra sigillata ware, Nabatean painted pottery, Iranian fine orange painted ware, and Indian red polished ware are also common. Incense burners from this period may be square or cylindrical; decorated with astral symbols or South Arabian script. Approximate date: 1200 B.C.-A.D. 570.

c. Sasanian-Islamic Period—Includes stoneware, pottery, and porcelain, which may be unglazed utilitarian wares or glazed types; local types include but are not limited to reddish, pink, and white fabrics with glaze styles including turquoise slip-painted, bright yellow glaze, green-painted glaze, salad ware (light green), pseudo-celadon glazed, brown-painted, and blue glazed on white slip; may include Arabic calligraphy. Imported types are also common and include Abbasid Period alkaline blue Sasanian-Islamic jars (A.D. 700-1100); Abbasid Period opaque white glazed bowls, either plain or decorated with cobalt (A.D. 800-900); and sgraffiatto types in various forms with red fabric and incised and painted designs on white slip including floral, geometric, human, and animal motifs (A.D. 1100-1400); other types from China, Arabo-Persian Gulf, Indian Ocean, and East Africa are also present. Oil lamps from this period typically have rounded bodies with a hole on the top and in the nozzle, and may have handles or lugs and figural motifs; include glazed ceramic lamps, which may have a straight or round bulbous body with flared top, and several branches. Approximate date: A.D. 570-1750.

1. Architectural Elements —Mosaics; designs include landscapes, scenes of deities, humans, or animals, and activities such as hunting and fishing. There may also be vegetative, floral, or geometric motifs; often with religious imagery. Approximate date: A.D. 500-1750.

2. Vessels —Forms include small jars, bowls, animal-shaped vessels, goblets, spherical forms, candle holders, perfume and unguent jars, and lamps; may have cut, incised, raised, enameled, molded, or painted decoration; various colors. South Arabian Period and early Islamic Period types may be engraved and/or colorless or blue, green, or orange; may include floral, and/or geometric motifs; may include Arabic calligraphy. Approximate date: 1200 B.C.-A.D. 1750.

3. Jewelry— Forms include beads that may be cylindrical, spherical, conical, disc, and others; may have cut, incised, or raised decoration; various colors; molded and carved glass gemstones; may include other types of glass inlay. Approximate date: 1200 B.C.-A.D. 1750.

1. Rock Art —Incised, pecked, or painted drawings on natural rock surfaces. Decoration includes crosses; humans; animals, particularly camels, ibex, and snakes; and geometric and/or floral designs; includes fragments. May include pre-Islamic graffiti, commonly in South Arabian script. Approximate date: 12,000 B.C.-A.D. 100.

2. Wall Painting— Decoration includes crosses; humans; animals, particularly camels, ibex, and snakes; and geometric and/or floral designs; includes fragments. Painted on wood, stone, and plaster. May be on domestic or public walls or tombs.

1. Stucco —Stucco reliefs, plaques, stelae, and inlays or other architectural decoration in stucco.

2. Face Plaques and Stelae —Funerary images of faces; may be combined with stone or ceramic sculpture; may be inscribed or painted.

—Linen cloth used for mummy wrapping. Approximate date: 500 B.C.-A.D. 500.

1. Books and Manuscripts —Either scrolls, sheets, or bound volumes; including both secular texts and Islamic religious texts such as Qurans. Text is often written on vellum or other parchment (cattle, sheep, goat, or camel) and then gathered in leather bindings. Paper may also be used. Types include books and manuscripts, often written in brown ink, and then further embellished with colorful floral or geometric motifs; covers may also be stamped, gilded, or inset with metal, glass, and semi-precious stones.

2. Items for Personal Adornment— Primarily in leather, including belts, sandals, shoes, armor, necklaces, bracelets, and other types of jewelry.

1. Architectural and Non-Architectural Relief Sculpture —Carved and inlaid wood panels, rooms, beams, balconies, stages, panels, ceilings, and doors, frequently decorated with religious, floral, or geometric motifs; may have script in Arabic. Bone, ivory, and shell reliefs, plaques, stelae, and inlays may be carved or sculpted; commonly include human or animal figures, floral, and/or geometric motifs.

2. Statuary and Figurines —Primarily small-size figurines; forms include human figures, which may be clothed or not; animals such as camels, ibex; oxen, bulls, and lions; or mythological creatures/figures. May be painted or inscribed/cast relief in South Arabian, Arabic, or other script.

3. Furniture —Primarily in wood; may include thrones, other chairs, tables, and other examples.

4. Personal Ornaments and Objects of Daily Use —Types include amulets, combs, pins, spoons, small containers, bracelets, buckles, and beads. Wood, bone, ivory, and shell were also used either alone or as inlays in luxury objects including furniture, chests and boxes, writing and painting equipment, musical instruments, games, cosmetic containers, combs, and jewelry.

5. Seals and Stamps— Small devices with at least one side engraved with a design for stamping or sealing; they can be discoid, cuboid, or conoid; may include animals, human figures, and/or inscriptions in various languages.

6. Human Remains —Bone and bone fragments.

Ethnological material of Islamic cultural heritage form part of the remains of the Islamic period culture and civilization ranging in date from A.D. 1517 to 1918. Some of these items may occur in archaeological contexts.

1. Architectural Elements —Primarily in limestone, marble, and sandstone; including blocks from walls, floors, and ceilings; columns, capitals, bases, lintels, jambs, friezes, and pilasters; doors, door frames, and window fittings; altars, prayer niches, screens, fountains, mosaics, and inlays. May be plain, molded, carved, or inscribed in Arabic. Common decorative motifs include geometric, floral, and religious motifs, and may be incised or in high relief.

2. Non-Architectural Relief Sculpture —In alabaster, limestone, marble, and other types of stone. Types include carved slabs with religious, floral, or geometric motifs. Includes inscribed plaques, stelae, memorial stones, and tombstones; primarily in marble; may be engraved with Arabic script.

3. Statuary —Primarily in marble, but also in limestone and sandstone. Large- and small-scale, such as human and animal figures. May be inscribed. Includes fragments of statues. Some pieces may also include different material types, including multiple types of stone, metal staffs, shell or bone eyes, and metal and semi-precious stone jewelry inlay.

4. Vessels and Containers —Primarily in alabaster, softstone (chlorite), and limestone; may also be marble, basalt, or other stone. Vessels may be conventional shapes such as bowls, cups, jars, jugs, platters, and flasks, and include smaller funerary urns, incense burners, and lamps.

1. Architectural Elements —Primarily copper, brass, lead, and alloys, including doors, door fixtures, chandeliers, screens.

2. Vessels and Containers —In brass, copper, silver, or gold; plain, engraved, or hammered. May include forms such as bowls, cups, jars, jugs, strainers, buckets, pitchers, plates, tea pots, boxes, oil lamps, incense burners, lamps, and scroll or manuscript containers.

3. Tools and Instruments —In copper, bronze, iron, silver, and gold. Types include hooks, weights, axes, scrapers, trowels, keys, ladles, tools of craftspersons such as carpenters, masons, and metal smiths, and scientific instruments such as measuring containers, clocks, and astrolabes.

4. Weapons and Armor —In copper, bronze, and iron. Body armor, such as helmets, cuirasses, shin guards, shields, and horse armor; often decorated with elaborate engraved, embossed, or perforated designs. Launching weapons (spears, javelins, socketed arrowheads); hand-to-hand combat weapons (swords, daggers, jambiyas); and sheaths.

5. Jewelry and Other Items for Personal Adornment —In iron, bronze, silver, and gold. Metal can be inlaid (with items such as colored stones, and glass). Types include necklaces, amulets and pendants, rings, bracelets, anklets, earrings, diadems, wreaths and crowns, beads, buttons, purses, belts, belt buckles, mirrors, and make-up accessories and tools.

6. Ceremonial and Religious —Includes boxes (such as Quran boxes), plaques, amulets and pendants, stamps, and seal rings.

1. Architectural Elements —Baked clay (terracotta) elements used to decorate buildings. Elements include painted and relief plaques, revetments, carved and molded brick, wall ornaments and panels and/or painted tile wall ornaments and panels, sometimes with Arabic script.

2. Vessels and Containers —Include utilitarian types and fine tableware, incense burners, and oil lamps. Include glazed, molded, and painted ceramics, and molds. Types include boxes, plates, lamps, jars, and flasks. May be plain or decorated with floral or geometric patterns, or Arabic script, primarily using blue, green, brown, black, or yellow colors.

1. Beads— Forms include cylindrical, spherical, conical, disc, and others; may have cut, incised, or raised decoration; various colors.

May depict courtly themes ( e.g., rulers, musicians, riders on camels) and city and architectural views, among others; may also be represented in manuscripts.

1. Religious Textiles —In linen, silk, and wool. Islamic textiles and fragments. Includes garments, hangings, shrine covers, and fragments.

2. Clothing —Embroidered veils and head coverings, traditional Islamic wedding and ceremonial clothing, for both religious and secular purposes.

3. Rugs —Primarily in wool; sometimes with reeds or leather. Both for decorative purposes as well as prayer. Often woven with floral or geometric designs in bright colors.

4. Baskets and Woven Mats —Plant fibers used to make baskets and containers in a variety of shapes and sizes; sandals and mats.

5. Nets and Ropes —Rope and string used for a variety of purposes, including binding, lifting water for irrigation, fishing, measuring, and stringing beads for jewelry and garments.

1. Books and Manuscripts —Either as sheets or bound volumes; including both secular texts and Islamic religious texts such as Qurans. Text is often written on vellum or other parchment (cattle, sheep, goat, or camel) then gathered in leather bindings. Paper may also be used. Types include books, scrolls, and manuscripts. May be decorated with colorful religious, geometric, or floral motifs.

2. Saddles, Saddle Bags, and Saddle Covers —Made of leather; for riding horses or camels.

3. Bags —In addition to saddlebags, include leather Quran pouches, or water pouches.

4. Items for Personal Adornment— Primarily in leather, including belts, sandals, shoes, armor, necklaces, bracelets, and other types of jewelry.

1. Architectural Elements —Includes doors, door fixtures, panels, beams, balconies, altars, stages, screens, ceilings, and tent posts. Types include doors, door frames, windows, window frames, walls, panels, beams, ceilings, balconies, altars. May be decorated with religious, geometric, or floral motifs; may have Arabic script.

2. Architectural and Non-Architectural Relief Sculpture —Carved and inlaid wood panels, rooms, beams, balconies, stages, panels, ceilings, and doors, frequently decorated with religious, floral, or geometric motifs; may have script in Arabic.

3. Ceremonial and Religious —Includes pulpits (minbars) and prayer niches (mihrabs); book holders, lecterns, and cabinets; Quran boxes or other smaller objects such as chests and cases; Islamic study tables.

4. Vessels and Containers —Boxes, containers, chests, and other utilitarian objects. May be carved, painted, or inlaid. May be decorated with religious, geometric, or floral motifs; may have Arabic script.

5. Furniture —Includes thrones, chairs, tables, book holders, and cabinets.

1. Vessels and Containers —Forms include small jars, perfume and unguent jars, and ritual vessels; may have cut, incised, raised, or painted decoration. May be decorated with religious, geometric, or floral motifs; may have Arabic script.

2. Ceremonial and Religious —Types include boxes, reliquaries (and their contents), plaques, amulets and pendants, stamps, and seal rings.

3. Inlays —For decorative furniture and architectural elements above.

This amendment involves a foreign affairs function of the United States and is, therefore, being made without notice or public procedure (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 or Executive Order 13771 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 and section 4(a) of Executive Order 13771.

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.

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 Centers for Disease Control and Prevention (CDC) is closely monitoring an outbreak of respiratory illness caused by a novel (new) coronavirus first identified in Wuhan City, Hubei Province, China. Coronaviruses are a large family of viruses that are common in many different species of animals, including camels, cattle, cats, and bats. Rarely, animal coronaviruses can infect people and then spread between people such as with Middle East Respiratory Syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS).

The potential for widespread transmission of this virus by infected individuals seeking to enter the United States threatens the security of our transportation system and infrastructure, and the national security. In an abundance of caution and to assist in preventing the introduction and spread of this communicable disease in the United States, DHS, in coordination with the CDC and other Federal, state and local agencies charged with protecting the American public, is implementing enhanced arrival protocols to ensure that all travelers with recent travel from the People's Republic of China are provided public health services. Entry screening is part of a layered approach used with other public health measures already in place to detect arriving travelers who are exhibiting overt signs of illness, reporting of ill travelers by air carriers during travel, and referral of ill travelers arriving at a U.S. port of entry by U.S. Customs and Border Protection (CBP) to appropriate public health officials to slow and prevent the spread of communicable disease into the United States.

To ensure that travelers with recent travel from the People's Republic of China are screened, DHS directs that all flights to the United States carrying persons who have recently traveled from, or were otherwise present within, the People's Republic of China arrive at airports where enhanced public health services and protocols are being implemented. While DHS anticipates working with air carriers to identify potential persons from the affected area prior to boarding, air carriers shall comply with the requirements of this document.

On Friday, January 31, 2020, DHS posted a document on the Federal Register public inspection page, announcing the DHS Secretary's decision that arrival restrictions would go into effect at 5 p.m. EST on Sunday, February 2, 2020 at seven airports. This document adds four additional airports to the list of airports where flights can land and describes when the arrival restrictions will include those airports.

DHS notes that implementation of the arrival restrictions in this document and in the January 31, 2020 document may entail technical and logistical difficulties for airlines. We are confident that all airlines will make every effort to comply. DHS is appreciative of good faith attempts at compliance by airlines.

Pursuant to 19 U.S.C. 1433(c), 19 CFR 122.32, 49 U.S.C. 114, and 49 CFR 1544.305 and 1546.105, DHS has the authority to limit the location where all flights entering the U.S. from abroad may land. Under this authority and effective for flights departing after 5 p.m. EST on Sunday, February 2, 2020, I hereby direct all operators of aircraft to ensure that all flights carrying persons who have recently traveled from, or were otherwise present within, the People's Republic of China only land at one of the following airports:

• John F. Kennedy International Airport (JFK), New York;

• Chicago O'Hare International Airport (ORD), Illinois;

• San Francisco International Airport (SFO), California;

• Seattle-Tacoma International Airport (SEA), Washington;

• Daniel K. Inouye International Airport (HNL), Hawaii;

• Los Angeles International Airport, (LAX), California;

• Hartsfield-Jackson Atlanta International Airport (ATL), Georgia;

• Washington-Dulles International Airport (IAD), Virginia;

Effective at 6:30 a.m. EST on Monday February 3, this list of airports is expanded to include:

• Newark Liberty International Airport (EWR), New Jersey.

Effective at 7:30 a.m. EST on Monday February 3, this list of airports is expanded to include:

• Dallas/Fort Worth International Airport (DFW), Texas; and

• Detroit Metropolitan Airport (DTW), Michigan.

This direction considers a person to have recently traveled from the People's Republic of China if that person departed from, or was otherwise present within, the People's Republic of China (excluding the special autonomous regions of Hong Kong and Macau) within 14 days of the date of the person's entry or attempted entry into the United States. Also, for purposes of this document, crew, and flights carrying only cargo ( i.e., no passengers or non-crew), are excluded from the measures herein. This direction is subject to any changes to the airport landing destination that may be required for aircraft and/or airspace safety as directed by the Federal Aviation Administration.

This list of affected airports may be modified by the Secretary of Homeland Security in consultation with the Secretary of Health and Human Services and the Secretary of Transportation. This list of affected airports may be modified by an updated publication in the Federal Register or by posting an advisory to follow at www.cbp.gov. The restrictions will remain in effect until superseded, modified, or revoked by publication in the Federal Register .

For purposes of this Federal Register document, “United States” means the States of the United States, the District of Columbia, and territories and possessions of the United States (including Puerto Rico, the Virgin Islands, American Samoa, the Northern Mariana Islands, the Trust Territory of the Pacific Islands, and Guam).

I. Background

Upon request, FDA has classified the HIV drug resistance genotyping assay using NGS technology as class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness. In addition, we believe this action will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens by placing the device into a lower device class than the automatic class III assignment.

The automatic assignment of class III occurs by operation of law and without any action by FDA, regardless of the level of risk posed by the new device. Any device that was not in commercial distribution before May 28, 1976, is automatically classified as, and remains within, class III and requires premarket approval unless and until FDA takes an action to classify or reclassify the device (see 21 U.S.C. 360c(f)(1)). We refer to these devices as “postamendments devices” because they were not in commercial distribution prior to the date of enactment of the Medical Device Amendments of 1976 (Pub. L. 94-295), which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act).

FDA may take a variety of actions in appropriate circumstances to classify or reclassify a device into class I or II. We may issue an order  1 finding a new device to be substantially equivalent under section 513(i) of the FD&C Act to a predicate device that does not require premarket approval (see 21 U.S.C. 360c(i)). We determine whether a new device is substantially equivalent to a predicate by means of the procedures for premarket notification under section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).

FDA may also classify a device through “De Novo” classification, a common name for the process authorized under section 513(f)(2) of the FD&C Act. Section 207 of the Food and Drug Administration Modernization Act of 1997 established the first procedure for De Novo classification (Pub. L. 105-115). Section 607 of the Food and Drug Administration Safety and Innovation Act modified the De Novo application process by adding a second procedure (Pub. L. 112-144). A device sponsor may utilize either procedure for De Novo classification.

Under the first procedure, the person submits a 510(k) for a device that has not previously been classified. After receiving an order from FDA classifying the device into class III under section 513(f)(1) of the FD&C Act, the person then requests a classification under section 513(f)(2).

Under the second procedure, rather than first submitting a 510(k) and then a request for classification, if the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence, that person requests a classification under section 513(f)(2) of the FD&C Act.

Under either procedure for De Novo classification, FDA is required to classify the device by written order within 120 days. The classification will be according to the criteria under section 513(a)(1) of the FD&C Act. Although the device was automatically within class III, the De Novo classification is considered to be the initial classification of the device.

We believe this De Novo classification will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens. When FDA classifies a device into class I or II via the De Novo process, the device can serve as a predicate for future devices of that type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a result, other device sponsors do not have to submit a De Novo request or premarket approval in order to market a substantially equivalent device (see 21 U.S.C. 360c(i), defining “substantial equivalence”). Instead, sponsors can use the 510(k) process, when necessary, to market their device.

On March 19, 2019, Vela Diagnostics USA Inc. submitted a request for De Novo classification of the SENTOSA SQ HIV Genotyping Assay. FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act.

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

Therefore, on November 5, 2019, FDA issued an order to the requester classifying the device into class II. FDA is codifying the classification of the device by adding 21 CFR 866.3955. We have named the generic type of device “Human immunodeficiency virus drug resistance genotyping assay using next generation sequencing technology,” and it is identified as a prescription in vitro diagnostic device intended for use in detecting HIV genomic mutations that confer resistance to specific antiretroviral drugs. The device is intended to be used as an aid in monitoring and treating HIV infection.

FDA has identified the following risks to health associated specifically with this type of device and the measures required to mitigate these risks in table 1.

FDA has determined that special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness. For a device to fall within this classification, and thus avoid automatic classification in class III, it would have to comply with the special controls named in this final order. The necessary special controls appear in the regulation codified by this order. This device is subject to premarket notification requirements under section 510(k) of the FD&C Act.

At the time of classification, HIV drug resistance genotyping assays using NGS technology are for prescription use only. Prescription devices are exempt from the requirement for adequate directions for use for the layperson under section 502(f)(1) of the FD&C Act and 21 CFR 801.5, as long as the conditions of 21 CFR 801.109 are met (referring to 21 U.S.C. 352(f)(1)).

Section 510(m)(2) of the FD&C Act provides that FDA may exempt a class II device from the premarket notification requirements under section 510(k) if, after notice of our intent to exempt and consideration of comments, we determine by order that premarket notification is not necessary to provide reasonable assurance of safety and effectiveness of the device. We are not announcing intent to exempt at this time.

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 of information. 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 the guidance document “De Novo Classification Process (Evaluation of Automatic Class III Designation)” have been approved under OMB control number 0910-0844; the collections of information in 21 CFR part 820, regarding quality system regulation, have been approved under OMB control number 0910-0073; the collections of information in part 807, subpart E, regarding premarket notification submissions, have been approved under OMB control number 0910-0120, and the collections of information in 21 CFR part 801, regarding labeling, have been approved under OMB control number 0910-0485.

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

I. Legal Authority II. Background III. Calculation of 2020 Adjustments IV. Procedural Requirements A. Statutes 1. National Environmental Policy Act 2. Regulatory Flexibility Act 3. Paperwork Reduction Act 4. Unfunded Mandates Reform Act 5. Small Business Regulatory Enforcement Fairness Act 6. Congressional Review Act B. Executive Orders (E.O.) 1. Governmental Actions and Interference With Constitutionally Protected Property Rights (E.O. 12630) 2. Regulatory Planning and Review (E.O. 12866); Improving Regulation and Regulatory Review (E.O. 13563); and Reducing Regulation and Controlling Regulatory Costs (E.O. 13771) 3. Civil Justice Reform (E.O. 12988) 4. Federalism (E.O. 13132) 5. Consultation and Coordination With Indian Tribal Governments (E.O. 13175) 6. Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (E.O. 13211) I. Legal Authority

OCSLA authorizes the Secretary of the Interior to impose a daily civil monetary penalty for a violation of OCSLA or its regulations, leases, permits, or orders and directs the Secretary to adjust the maximum penalty at least every three years to reflect any inflation increase in the Consumer Price Index. 43 U.S.C. 1350(b)(1). Similarly, OPA authorizes civil monetary penalties for failure to comply with OPA's financial responsibility provisions or its implementing regulations. 33 U.S.C. 2716a(a). OPA does not include a maximum daily civil penalty inflation adjustment provision. Id.

The FCPIA Improvements Act  1 requires that Federal agencies publish inflation adjustments to their civil monetary penalties in the Federal Register not later than January 15 annually. 2 Public Law 114-74, sec. 701(b)(1). The purposes behind these inflation adjustments are to maintain the deterrent effect of civil penalties and to further the policy goals of the underlying statutes. Federal Civil Penalties Inflation Adjustment Act of 1990, Public Law 101-410, sec. 2 (codified at 28 U.S.C. 2461 note).

BOEM implemented the 2019 inflation adjustment for its civil monetary penalties through a final rule published in the Federal Register on March 26, 2019, which accounted for inflation through October 2018. Oil and Gas and Sulfur Operations in the Outer Continental Shelf-Civil Penalties Inflation Adjustments, 84 FR 11,222 (Mar. 26, 2019). 3

For 2020, OMB issued guidance that explains agency statutory responsibilities for identifying applicable civil monetary penalties and performing the annual adjustment; publishing revisions to regulations to implement the adjustment in the Federal Register ; applying adjusted penalty levels; and performing agency oversight of inflation adjustments. Implementation of Penalty Inflation Adjustments for 2020, Pursuant to the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015, OMB Memorandum M-20-05, December 16, 2019 (OMB M-20-05), available at https://www.whitehouse.gov/wp-content/uploads/2019/12/M-20-05.pdf .

BOEM is implementing the 2020 inflation adjustments to the OCSLA and OPA maximum daily civil monetary penalties through this final rule pursuant to the FCPIA Improvements Act and OMB M-20-05. A proposed rule is unnecessary. The FCPIA Improvements Act expressly exempts annual civil penalty inflation adjustments from the Administrative Procedure Act's (APA) notice of proposed rulemaking, public comment, and standard effective date provisions. FCPIA Improvements Act, Public Law 114-74, sec. 701(b)(1)(D); APA, 5 U.S.C. 553. 4

OMB issued guidance to Federal agencies on implementing the 2020 annual civil monetary penalties inflation adjustments, including the adjustment multiplier: 1.01764. OMB M-20-05; FCPIA Improvements Act, sec. 701(b)(4). 5 In accordance with the FCPIA Improvements Act and OMB M-20-05, BOEM determined that the OCSLA and OPA maximum daily civil monetary penalties require annual inflation adjustments and is issuing this final rule adjusting those penalty amounts for inflation through October 2019.

For 2020, BOEM multiplied the current OCSLA maximum daily civil penalty of $44,675 by the multiplier 1.01764 to equal $45,463.07 rounded to nearest cent ($44,675 × 1.01764 = $45,463.07). The FCPIA Improvements Act requires the resulting amount be rounded to the nearest dollar. Accordingly, the 2020 adjusted OCSLA maximum daily civil penalty is $45,463.

For 2020, BOEM multiplied the current OPA maximum daily civil penalty amount of $47,357 by the multiplier 1.01764 to equal $48,192.38 rounded to nearest cent ($47,357 × 1.01764 = $48,192.38). The FCPIA Improvements Act requires that the resulting amount be rounded to the nearest dollar. Accordingly, the 2020 adjusted OPA maximum daily civil penalty is $48,192.

The adjusted penalty amounts take effect immediately upon publication of this rule. Under the FCPIA Improvements Act, the adjusted amounts apply to civil penalties assessed after the date the increase takes effect, even if the associated violation predates the increase.

This table summarizes BOEM's 2020 maximum daily civil monetary penalties for each OCSLA and OPA violation:

This rule does not constitute a major Federal action significantly affecting the quality of the human environment. A detailed statement under the National Environmental Policy Act (NEPA, 42 U.S.C. 4321 et seq. ) is not required because, as a regulation of an administrative nature, this rule is covered by a categorical exclusion. See 43 CFR 46.210(i). BOEM also has determined that the rule does not implicate any of the extraordinary circumstances listed in 43 CFR 46.215 that would require further analysis under NEPA. Therefore, a detailed statement under NEPA is not required.

The Regulatory Flexibility Act (RFA, 5 U.S.C. 601 et seq. ) requires an agency to prepare a regulatory flexibility analysis for all rules unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. The RFA applies only to rules for which an agency is required to first publish a proposed rule. See 5 U.S.C. 603(a) and 604(a). The FCPIA Improvements Act expressly exempts these annual inflation adjustments from the requirement to publish a proposed rule for notice and comment. FCPIA Improvements Act, Public Law 114-74, sec. 701(b)(1)(D); OMB M-20-05 at 4. Thus, the RFA does not apply to this rulemaking.

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

This rule does not impose an unfunded mandate on state, local, or tribal governments, or the private sector, of more than $164 million per year. The rule does not have a significant or unique effect on state, local, or tribal governments or the private sector. Therefore, a statement containing the information required by the Unfunded Mandates Reform Act (2 U.S.C. 1531 et seq. ) is not required.

This rule is not a major rule under 5 U.S.C. 804(2). This rule:

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

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

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

Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq. ) and OMB guidance, 6 the Office of Information and Regulatory Affairs (OIRA) designated this rule as not a major rule as defined by that act. 7 Office of Info. & Regulatory Affairs, Office of Mgmt. & Budget, Fall 2019 Unified Agenda of Regulatory and Deregulatory Actions , Dep't of the Interior, RIN 1010-AE03 (note the RIN for this rule is listed in error, the correct RIN is 1010-AE05), available at https://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201910&RIN=1010-AE03.

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

E.O. 12866 provides that OIRA will review all significant rules. OIRA has determined that this rule is not significant. See OMB M-20-05 at 3.

E.O. 13563 reaffirms the principles of E.O. 12866 while calling for improvements in the nation's regulatory system to reduce uncertainty and to promote predictability and the use of the best, most innovative, and least burdensome tools for achieving regulatory ends. E.O. 13563 directs agencies to consider regulatory approaches that reduce burdens and maintain flexibility and freedom of choice for the public where these approaches are relevant, feasible, and consistent with regulatory objectives. E.O. 13563 further emphasizes that regulations must be based on the best available science and that the rulemaking process must allow for public participation and an open exchange of ideas. However, there is no science being used in this rulemaking, as Congress directed agencies to adjust the maximum daily civil penalty amounts using a particular equation and BOEM does not have discretion to use any other factor in the adjustment. BOEM has developed this rule in a manner consistent with these requirements, to the extent relevant and feasible given the limited discretion provided agencies under the FCPIA Improvements Act.

E.O. 13771 directs Federal agencies to reduce the regulatory burden on regulated entities and control regulatory costs. E.O. 13771, however, applies only to significant regulatory actions, as defined in section 3(f) of E.O. 12866. OIRA has determined this rule is not significant. This final rule exclusively implements the annual inflation adjustments consistent with OMB's guidance and its determination that this rule is not a significant regulatory action. OMB M-20-05 at 3. Thus, this rule is not considered an E.O. 13771 regulatory action. Id.

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

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

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

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

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

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

For the reasons stated in the preamble, BOEM amends title 30, chapter V, subchapter B, parts 550 and 553 of the Code of Federal Regulations as follows:

I. Background II. Inflation-Adjusted Maximum Rates III. Procedural Requirements A. Regulatory Planning and Review (E.O. 12866) B. Regulatory Flexibility Act C. Small Business Regulatory Enforcement Fairness Act D. Unfunded Mandates Reform Act E. Takings (E.O. 12630) F. Federalism (E.O. 13132) G. Civil Justice Reform (E.O. 12988) H. Consultation With Indian Tribes (E.O. 13175) I. Paperwork Reduction Act J. National Environmental Policy Act K. Effects on the Energy Supply (E.O. 13211) L. Clarity of This Regulation M. Administrative Procedure Act I. Background

The Federal Civil Penalties Inflation Adjustment Act of 1990, as amended by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (collectively, “the Act”), codified at 28 U.S.C. 2461 (specifically, see the notes for more information), requires Federal agencies to adjust their civil monetary penalty (CMP) rates for inflation every year.

In accordance with sections 4 and 5 of the Act, the annual CMP inflation adjustment for 2020 is based on the percent change in the Consumer Price Index for all Urban Consumers (CPI-U) between October 2018 and October 2019. The CPI-U for October 2018 was 252.885, and for October 2019 was 257.346, for an increase of 1.764%. In accordance with section 5(a) of the Act, the new maximum CMP rates must be rounded to the nearest whole dollar. In accordance with section 6 of the Act, the new maximum penalty rates will apply only to CMPs, including those which are associated with violations predating the increase, that are assessed after the date the increase takes effect.

ONRR assesses CMPs under the Federal Oil and Gas Royalty Management Act, 30 U.S.C. 1719, and our regulations at 30 CFR part 1241. We calculate and assess CMPs per violation, at the applicable rate, for each day such violation continues.

This final rule increases the maximum CMP rates for each of the four categories of violations identified in 30 U.S.C. 1719(a)-(d) and 30 CFR part 1241. The following list identifies the existing ONRR regulations containing CMP rates and shows those rates before and after this increase.

Executive Order (E.O.) 12866 provides that the Office of Information and Regulatory Affairs (OIRA) in OMB will review all significant rules. OIRA has determined that this rule is not significant.

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

This rule will not have a significant economic effect on a substantial number of small entities under the Regulatory Flexibility Act (RFA), 5 U.S.C. 601, et seq., because the rule only makes adjustments for inflation. The Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 requires agencies to adjust civil penalties with an annual inflation adjustment. Therefore, the RFA does not apply to this rulemaking.

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

a. Does not have an annual effect on the economy of $100 million or more.

b. Will not cause a major increase in costs or prices for consumers; individual industries; Federal, State, local government agencies; or geographic regions.

c. Does not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of United States-based enterprises to compete with foreign-based enterprises.

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

This rule does not result in a taking of private property or otherwise have takings implications under E.O. 12630. Therefore, this rule does not require a takings implication assessment.

Under the criteria in section 1 of E.O. 13132, this rule does not have sufficient federalism implications to warrant the preparation of a federalism summary impact statement.

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

a. Meets the criteria of section 3(a), which requires that we review all regulations to eliminate errors and ambiguity and to write them to minimize litigation.

b. Meets the criteria of section 3(b)(2), which requires that we write all regulations in clear language, using clear legal standards.

The Department strives to strengthen its government-to-government relationship with Indian Tribes through a commitment to consultation with Indian Tribes and recognition of their right to self-governance and Tribal sovereignty. Under the Department's consultation policy and the criteria in E.O. 13175, we evaluated this rule and determined that it will have no substantial, direct effects on federally-recognized Indian Tribes and does not require consultation.

This rule:

(a) Does not contain any new information collection requirements.

(b) Does not require a submission to OMB under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501, et seq. ). See 5 CFR 1320.4(a)(2).

This rule does not constitute a major Federal action significantly affecting the quality of the human environment. We are not required to provide a detailed statement under NEPA because this rule qualifies for categorical exclusion under 43 CFR 46.210(i) in that this rule is “. . . of an administrative, financial, legal, technical, or procedural nature. . . .” We also have determined that this rule is not involved in any of the extraordinary circumstances listed in 43 CFR 46.215 that would require further analysis under NEPA.

This rule is not a significant energy action under the definition in E.O. 13211 and, therefore, does not require a Statement of Energy Effects.

We are required by E.O. 12866 (section 1(b)(12)), E.O. 12988 (section 3(b)(1)(B)), and E.O. 13563 (section 1(a)), and by the Presidential Memorandum of June 1, 1998, to write all rules in plain language. This means that each rule we publish must:

(a) Be logically organized.

(b) Use the active voice to address readers directly.

(c) Use common, everyday words and clear language rather than jargon.

(d) Be divided into short sections and sentences.

(e) Use lists and tables wherever possible.

If you feel that we have not met these requirements, send your comments to Luis.Aguilar@onrr.gov. Your comments should be as specific as possible. For example, you should tell us the number of the sections or paragraphs that you find unclear, which sections or sentences are too long, the sections where you feel lists or tables would be useful, etc.

The Act requires agencies to publish annual inflation adjustments by no later than January 15 of each year, notwithstanding section 553 of the Administrative Procedure Act (APA) (5 U.S.C. 553). OMB has interpreted this direction to mean that the usual APA public procedure for rulemaking—which includes public notice of a proposed rule, an opportunity for public comment, and a delay in the effective date of a final rule—is not required when agencies issue regulations to implement the annual adjustments to civil penalties that the Act requires. Accordingly, we are issuing the 2020 annual adjustments as a final rule without prior notice or an opportunity for comment and with an effective date immediately upon publication in the Federal Register .

Section 553(b) of the Administrative Procedure Act (APA) provides that, when an agency for good cause finds that “notice and public procedure . . . are impracticable, unnecessary, or contrary to the public interest,” the agency may issue a rule without providing notice and an opportunity for prior public comment. Under section 553(b), ONRR finds that there is good cause to promulgate this rule without first providing for public comment. ONRR is promulgating this final rule to implement the statutory directive in the Act, which requires agencies to publish a final rule and to update the civil penalty amounts by applying a specified formula. We have no discretion to vary the amount of the adjustment to reflect any views or suggestions provided by commenters. Accordingly, it would serve no purpose to provide an opportunity for public comment on this rule prior to promulgation. Thus, providing for notice and public comment is unnecessary.

Furthermore, ONRR finds under section 553(d)(3) of the APA that good cause exists to make this direct final rule effective immediately upon publication in the Federal Register . In the Act, Congress expressly required Federal agencies to publish annual inflation adjustments to civil penalties in the Federal Register no later than January 15 of every year, notwithstanding section 553 of the APA. Under the statutory framework and OMB guidance, the new penalty levels are to take effect immediately upon publication. Moreover, an effective date after January 15 would delay application of the new penalty levels, contrary to Congress's intent.

For the reasons discussed in the preamble, ONRR amends 30 CFR part 1241 as set forth below:

Electronic Availability

This document and additional information concerning OFAC are available on OFAC's website ( www.treasury.gov/ofac ).

On July 26, 2019, the President, invoking the authority of, inter alia, the International Emergency Economic Powers Act (50 U.S.C. 1701-1706) (IEEPA) and the United Nations Participation Act (22 U.S.C. 287c) (UNPA), issued Executive Order 13882 (84 FR 37055, July 30, 2019) (E.O. 13882).

In E.O. 13882, the President determined that the situation in Mali, including repeated violations of ceasefire arrangements made pursuant to the 2015 Agreement on Peace and Reconciliation in Mali; the expansion of terrorist activities into southern and central Mali; the intensification of drug trafficking and trafficking in persons, human rights abuses, and hostage-taking; and the intensification of attacks against civilians, the Malian defense and security forces, the United Nations Multidimensional Integrated Stabilizations Mission in Mali (MINUSMA), and international security presences, constitutes an unusual and extraordinary threat to the national security and foreign policy of the United States, and declared a national emergency to deal with that threat.

OFAC is issuing the Mali Sanctions Regulations, 31 CFR part 555 (the “Regulations”), to implement E.O. 13882, pursuant to authorities delegated to the Secretary of the Treasury in E.O. 13882. A copy of E.O. 13882 appears in appendix A to this part.

The Regulations are being published in abbreviated form at this time for the purpose of providing immediate guidance to the public. OFAC intends to supplement this part 555 with a more comprehensive set of regulations, which may include additional interpretive and definitional guidance, general licenses, and statements of licensing policy. The appendix to the Regulations will be removed when OFAC supplements this part with a more comprehensive set of regulations.

Because the Regulations involve a foreign affairs function, the provisions of Executive Order 12866 and the Administrative Procedure Act (5 U.S.C. 553) requiring notice of proposed rulemaking, opportunity for public participation, and delay in effective date, as well as the provisions of Executive Order 13771, are inapplicable. Because no notice of proposed rulemaking is required for this rule, the Regulatory Flexibility Act (5 U.S.C. 601-612) does not apply.

The collections of information related to the Regulations are contained in 31 CFR part 501 (the “Reporting, Procedures and Penalties Regulations”). Pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3507), those collections of information have been approved by the Office of Management and Budget under control number 1505-0164. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid control number.

On November 2, 2015, the President signed into law the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (2015 Act) (Pub. L. 114-74, sec. 701, 129 Stat. 599), which amended the Federal Civil Penalties Inflation Adjustment Act of 1990 (Pub. L. 101-410, 104 Stat. 890), to improve the effectiveness of civil monetary penalties and to maintain their deterrent effect. The 2015 Act was codified in a note following 28 U.S.C. 2461. The 2015 Act requires agencies to publish annual adjustments for inflation, based on the percent change between the Consumer Price Index (defined in the Act as the Consumer Price Index for all-urban consumers (CPI-U) published by the Department of Labor) for the month of October preceding the date of the adjustment and the prior year's October CPI-U. 28 U.S.C. 2461 note, secs. 4(a) and (b) and 5(b)(1). This rule implements the 2020 calendar year inflation adjustment amounts.

Under 38 U.S.C. 3710(g)(4)(B), VA is authorized to levy civil monetary penalties against private lenders that originate VA-guaranteed loans if a lender falsely certifies that they have complied with certain credit information and loan processing standards, as set forth by chapter 37, title 38 U.S.C. and part 36, title 38 CFR. Under section 3710(g)(4)(B), any lender who knowingly and willfully makes such a false certification shall be liable to the United States Government for a civil penalty equal to two times the amount of the Secretary's loss on the loan involved or to another appropriate amount, not to exceed $10,000, whichever is greater. VA implemented the penalty amount in 38 CFR 36.4340(k)(1)(i) and (k)(3). On December 16, 2019, OMB issued Circular M-20-05. This circular reflects that the October 2018 CPI-U was 252.855 and the October 2019 CPI-U was 257.346, resulting in an inflation adjustment multiplier of 1.01764. Accordingly, the calendar year 2020 inflation revision imposes an adjustment from $22,927 to $23,331.

Under 31 U.S.C. 3802, VA can impose monetary penalties against any person who makes, presents, or submits a claim or written statement to VA that the person knows or has reason to know is false, fictitious, or fraudulent, or who engages in other covered conduct. The statute permits, in addition to any other remedy that may be prescribed by law, a civil penalty of not more than $5,000 for each claim. 31 U.S.C. 3802(a)(1) and (2). VA implemented the penalty amount in 38 CFR 42.3(a)(1) and (b)(1). As previously noted, Circular M-20-05 reflects an inflation adjustment multiplier of 1.01764. Therefore, the calendar year 2020 inflation revision imposes an adjustment from $11,463 to $11,665.

Accordingly, VA is revising 38 CFR 36.4340(k)(1)(i) and (3) and 38 CFR 42.3(a)(1) and (b)(1) to reflect the 2020 inflationary adjustments for civil monetary penalties assessed or enforced by VA.

The Secretary of Veterans Affairs finds that there is good cause under 5 U.S.C. 553(b)(B) and (d)(3) to dispense with the opportunity for prior notice and public comment and to publish this rule with an immediate effective date. The 2015 Act requires agencies to make annual adjustments for inflation to the allowed amounts of civil monetary penalties “notwithstanding section 553 of title 5, United States Code.” 28 U.S.C. 2461 note, sec. 4(a) and (b). The penalty adjustments, and the methodology used to determine the adjustments, are set by the terms of the 2015 Act. VA has no discretion to make changes in those areas. Therefore, an opportunity for prior notice and public comment and a delayed effective date is unnecessary.

Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, and other advantages; distributive impacts; and equity). Executive Order 13563 (Improving Regulation and Regulatory Review) emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. The Office of Information and Regulatory Affairs has determined that this rule is not a significant regulatory action under Executive Order 12866. VA's impact analysis can be found as a supporting document at http://www.regulations.gov, usually within 48 hours after the rulemaking document is published. Additionally, a copy of the rulemaking and its impact analysis are available on VA's website at http://www.va.gov/orpm/, by following the link for “VA Regulations Published From FY 2004 Through Fiscal Year to Date.” This rule is not an Executive Order 13771 regulatory action because this rule is not significant under Executive Order 12866.

The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 1532, that agencies prepare an assessment of anticipated costs and benefits before issuing any rule that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any one year. This final rule will have no such effect on State, local, and tribal governments, or on the private sector.

This final rule contains no provisions constituting a collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521).

The Regulatory Flexibility Act, 5 U.S.C. 601 et seq. (RFA), imposes certain requirements on Federal agency rules that are subject to the notice and comment requirements of the Administrative Procedure Act (APA), 5 U.S.C. 553(b). This final rule is exempt from the notice and comment requirements of the APA because the 2015 Act directed the Department to issue the annual adjustments without regard to section 553 of the APA. Therefore, the requirements of the RFA applicable to notice and comment rulemaking do not apply to this rule. Accordingly, the Department is not required either to certify that the final rule would not have a significant economic impact on a substantial number of small entities or to conduct a regulatory flexibility analysis.

The Catalog of Federal Domestic Assistance number and title for the program affected by this document is 64.114, Veterans Housing Guaranteed and Insured Loans.

Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq. ), the Office of Information and Regulatory Affairs designated this rule as not a major rule, as defined by 5 U.S.C. 804(2).

The Secretary of Veterans Affairs approved this document and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs. Pamela Powers, Chief of Staff, Department of Veterans Affairs, approved this document on January 14, 2020, for publication.

For the reasons stated in the preamble, the Department of Veterans Affairs amends 38 CFR parts 36 and 42 as set forth below:

Throughout this document “we,” “us,” and “our” means the EPA.

For the purpose of this document, the following definitions apply:

In this document, Region 6 is making a finding that the affirmative defense provisions in Texas's SIP applicable to excess emissions that occur during upsets (30 TAC 101.222(b)), unplanned events (30 TAC 101.222(c)), upsets with respect to opacity limits (30 TAC 101.222(d)), and unplanned events with respect to opacity limits (30 TAC 101.222(e)) do not make Texas's SIP substantially inadequate to meet the requirements of the Act. Accordingly, Region 6 is withdrawing the SIP call issued to Texas that was published on June 12, 2015 (80 FR 33968-9).

The background for this action is discussed in detail in our April 29, 2019 (84 FR 17986) proposed action. In that document, Region 6 invited comment on its belief that the best policy may be to permit certain affirmative defense provisions in SIPs, consistent with the court's decision in Luminant Generation v. EPA, 714 F.3d 841 (5th Cir. 2013), cert. denied, 134 S. Ct. 387 (2013). See 84 FR 17990. Region 6 recognized that such a policy, if adopted, would depart from the policy set forth in the EPA's 2015 Startup, Shutdown and Malfunction (SSM) SIP Action. 1 EPA Region 6 also proposed to make a finding that the affirmative defense provisions in the Texas SIP applicable to excess emissions that occur during certain upset events  2 and unplanned maintenance, startup, or shutdown activities  3 would be consistent with CAA requirements if the alternative interpretation were adopted. Accordingly, Region 6 proposed to withdraw the SIP call  4 issued to Texas that was published on June 12, 2015.

The 60-day public comment period closed on June 28, 2019, and Region 6 received numerous comments on the proposed action. The public comments are included in the publicly posted docket associated with this action at www.regulations.gov. Region 6 reviewed all public comments received on the proposed action and considered them before finalizing this action. In this preamble, Region 6 provides a summary of certain significant comments received on the 2019 Proposal and the Region's response to those comments. The Response To Comment (RTC) document for this action summarizes and responds to all other relevant comments received. The RTC document may be found in the docket for this action.

The CAA creates a framework for cooperative state and Federal programs to prevent and control air pollution providing states with the “primary responsibility” for prevention and control of air pollution and flexibility for specific state needs and priorities. 5 The Act requires the EPA to identify pollutants that could endanger the public health and welfare and to establish national ambient air quality standards (NAAQS), which the EPA has done for six criteria pollutants. Each state prepares a State Implementation Plan (SIP) that identifies the controls and programs the state will use to attain and maintain the NAAQS. 6 In Texas, the Texas Commission on Environmental Quality (TCEQ) is the State agency responsible for implementing the requirements of the CAA related to SIPs. Since the EPA's approval of the initial Texas SIP in 1972, there has been a separate regulatory control strategy for unauthorized emissions  7 due to malfunction events based on the acknowledgement that imposition of civil penalties may not be appropriate every time unauthorized emissions result from such events. The regulatory regime has evolved since 1972, with each iteration tightening requirements. In 2005, TCEQ adopted the affirmative defenses found at 30 TAC 101.222(b)-(e). 8 The EPA approved these affirmative defense provisions related to upsets and unplanned maintenance, startup, or shutdown (MSS) activities as a revision to the Texas SIP in November 2010. 9 The EPA subsequently issued a SIP call for these provisions as part of its 2015 SSM SIP Action based on the position that the affirmative defense provisions made the SIP substantially inadequate to meet the requirements of the Act. The 2015 SSM SIP Action included SIP calls for 45 jurisdictions in 36 states. For more information concerning the SIP call issued to Texas, see section II.(C) of the proposed action (84 FR at 17988). On March 15, 2017, TCEQ petitioned the EPA to reconsider the SIP call issued to Texas in the 2015 SSM SIP Action.

As stated above, the EPA approved the affirmative defense provisions found at 30 TAC 101.222(b)-(e) as a revision to the Texas SIP in November 2010. 10 These provisions provide a narrowly tailored affirmative defense for emissions that exceed applicable emissions limitations that occur during upsets and unplanned MSS activities and are considered functionally equivalent to malfunctions. That is, the affirmative defense provisions in the EPA-approved Texas SIP apply to unplanned and unavoidable upset events and unplanned MSS activities that are not part of normal or routine operations and arise from sudden and unforeseeable events beyond the control of the operator. In addition, the affirmative defense provisions are inapplicable to emission events determined to be excessive  11 based on a number of criteria including frequency, duration, and impact on human health, and are unavailable in criminal actions or civil enforcement actions seeking administrative technical orders and actions for injunctive relief. In the context of an enforcement proceeding, 12 an affirmative defense is a response or defense put forward by a defendant, who bears the burden of proof, and the merits of which are independently and objectively evaluated in a judicial or administrative proceeding. See section IV.A of the proposed action for more information (84 FR 17991-92). The EPA's 2010 approval of the Texas SIP revision adding these affirmative defense provisions was subsequently challenged in court and upheld as reasonable under the Act by the U.S. Court of Appeals for the Fifth Circuit in Luminant. 714 F.3d 841.

The DGN fishery for swordfish and thresher shark (14 inch (36 cm) minimum mesh size) is federally managed under the Federal Fishery Management Plan for U.S. West Coast Fisheries for Highly Migratory Species (HMS FMP) and via regulations of the states of California and Oregon to conserve target and non-target stocks, including protected species that are incidentally captured. The HMS FMP was prepared by the Council and is implemented under the authority of the MSA by regulations at 50 CFR part 660.

The DGN fishery has been subject to a number of seasonal closures. Since 1982, it has been closed inside the entire U.S. West Coast exclusive economic zone (EEZ) from February 1 to April 30. In 1986, a closure was established within 75 miles (121 km) of the California mainland from June 1 through Aug 14 to conserve common thresher sharks; this closure was extended to include May in 1990 and later years. In 2001, NMFS implemented two Pacific sea turtle conservation areas on the U.S. West Coast with seasonal DGN restrictions to protect endangered leatherback and loggerhead sea turtles. The larger of the two closures spans the EEZ north of Point Conception, CA (34°27′ N latitude) to mid-Oregon (45° N latitude) and west to 129° W longitude. DGN fishing is prohibited annually within this conservation area from August 15 to November 15 to protect leatherback sea turtles. A smaller closure was implemented to protect Pacific loggerhead turtles from DGN gear from June 1—August 31 during a forecasted or occurring El Niño event, and is located south of Point Conception, CA, and east of 120° W longitude (72 FR 31756, June 8, 2007). The number of active vessels in the DGN fishery has remained under 50 vessels since 2003, with an average of 20 active vessels per year from 2010 through 2018.

NMFS' fleet-wide observer coverage target has been between 20 and 30 percent since 2013. Since some DGN vessels are unobservable due to safety or accommodations requirements, the observable vessels are observed at a rate higher than 30 percent to attain the fleet-wide 30 percent coverage. Four to six DGN vessels have been unobservable during each fishing season from 2011 to present.

In March 2012, the Council tasked NMFS with determining the steps needed to implement protected species hard caps in the DGN fishery. Originally concerned with sea turtle interactions, the Council expanded its scope to include marine mammals at its June 2014 meeting. At that meeting, the Council directed its Highly Migratory Species Management Team (HMSMT) to begin developing a range of alternatives to establish hard caps on high-priority protected species ( i.e., sea turtles and marine mammals) incidentally caught in the DGN fishery. In September 2014, the Council selected a Range of Alternatives and Preliminary Preferred Alternative (PPA); however, the HMSMT identified implementation issues with the Council's PPA, and an additional PPA, identified as the California Department of Fish and Wildlife (CDFW) PPA, was selected in March 2015. In June, the Council added a 2-year hard cap sub-option to the Council hard cap PPA and the CDFW hard cap PPA. An additional alternative that modified the CDFW PPA was added in September 2015. This alternative contained 2-year rolling hard caps based on observed mortality/injury; the Council selected this alternative as its Final Preferred Alternative (FPA).

The proposed rule to implement this FPA was published in the Federal Register on October 13, 2016, following NMFS' determination that it was consistent with the fishery management plan, plan amendment, the MSA, and other applicable law. Following public comment on the proposed rule, NMFS conducted further analysis of the economic effects of the action. This new analysis identified significant adverse short-term economic effects that were not identified at the proposed rule stage. Citing inconsistency with the purpose and need for the action and MSA National Standard 7 ( i.e., conservation and management measures shall, where practicable, minimize costs and avoid unnecessary duplication), NMFS withdrew the proposed rule on June 12, 2017. On July 12, 2017, an advocacy organization sued to compel publication of the proposed regulations, citing the theory that NMFS' initial determination under MSA § 304(b)(1)(A) could not be reversed by a subsequent negative determination, namely that the proposed regulations did not comport with applicable law. On October 24, 2018, the United States District Court for the Central District of California found that since NMFS had not published the proposed regulations as-is nor consulted with the Council on revisions after making an initial determination under MSA § 304(b)(1)(A) that they were consistent with applicable law, NMFS had exceeded its authority under the MSA and the Administrative Procedure Act, and remanded to NMFS for further action.

On January 8, 2020, the Court ordered NMFS to publish a final rule for hard caps by February 7, 2020. The order also states that NMFS shall consult with the Pacific Fishery Management Council (Council) before making any revisions to the proposed regulations. Because the Council's next meeting is not until March 2020, NMFS does not have an opportunity to consult with the Council on revisions to the regulations before the Court's deadline. Therefore, NMFS is publishing the hard caps regulations as they were originally proposed, without changes to the regulatory text, in accord with the order. After publishing the rule, NMFS intends to review all options for addressing the economic impacts to DGN fishery participants through a separate rulemaking, beginning with engagement of the Council to propose revisions through the Council's normal process. NMFS is soliciting public comment on this final rule to gather information that can be used to develop such a separate rulemaking.

The implementation of hard caps is intended to manage the fishery under the MSA to protect certain non-target species. Its purpose is not to manage marine mammal or endangered species populations, but rather to enhance the provisions of the Endangered Species Act (ESA) and the Marine Mammal Protection Act (MMPA) under MSA Section 303(b)(12) and National Standard 9. This final rule implements the Council's FPA, which establishes 2-year rolling hard caps on observed mortality and injury to fin, humpback, and sperm whales, leatherback, loggerhead, olive ridley, and green sea turtles, short-fin pilot whales, and bottlenose dolphins in the DGN fishery. The definition of injury is taken from the NMFS West Coast Region Observer Program field manual. Observers record protected species released as Alive, Injured, or Dead. Observer program staff review observer data forms and notes to make a final determination of the condition of entangled protected species. To determine whether a hard cap has been reached, NMFS will count observed mortalities and injuries to these species during the current DGN fishing season (May 1 through January 31) and the previous fishing season. If a cap is reached, the DGN fishery will close until the 2-year ( i.e., two fishing seasons) mortality and injury for all species falls below their hard cap value. The DGN fishery will then re-open on May 1 of the subsequent fishing season. The Council recommended hard cap values while DGN observer coverage is less than 75 percent; the Council will revisit hard cap values when observer coverage becomes greater than 75 percent.

NMFS will report observed protected species mortalities and injuries to help participants in the DGN fishery plan for the possibility of a hard cap being reached. If, as determined by NMFS, the DGN fleet meets or exceeds a hard cap, the fishery will be closed. Hard caps will be assessed over a rolling two-year period, by comparing the total number of mortalities and injuries during the current and previous fishing seasons to the hard caps. If a hard cap is reached or exceeded, the fishery will be closed until the two-year total of mortalities and injuries falls below the hard cap values for all species. Once the two-year total falls below the hard cap value for all species, the fishery will reopen on May 1 of the following fishing season. NMFS will publish a document in the Federal Register announcing the specified beginning and end dates of the closure. Upon the effective date identified in the Federal Register document, a DGN vessel may not be used to target, retain on board, transship, or land any additional fish using DGN gear in the U.S. West Coast EEZ during the period specified in the announcement. Any fish already on board a DGN fishing vessel on the effective date may be retained on board, transshipped, and/or landed, to the extent authorized by applicable laws and regulations, if they are landed within 4 days of the effective date. NMFS will notify vessel owners/operators of the closure by Vessel Monitoring System communication to the fleet stating when large-mesh drift gillnet fishing is closed. Notification will also be made by mail and a posting on the NMFS regional website.

NMFS received 20 comments, some of which included attachments and lists of signatories, during the comment period on the proposed rule. Of these, five comments supported the proposed rule as-is, nine supported the proposed rule and recommended additional or more stringent measures, five opposed the proposed rule entirely, and one opposed the proposed rule but recommended alternative approaches to regulating takes of non-target species by the DGN fishery. Major themes of the summarized comments and NMFS' responses are below.

All six of the comments in opposition to the proposed rule, and one comment in support of the proposed rule, stated concerns that fishery closures resulting from hard caps on protected species takes would cause significant economic harm to DGN fishery participants, many of whom are dependent on the fishery for a significant portion of their annual income. Commenters expressed a desire for more detailed economic analysis of the potential effects of fishery closures under the proposed rule. One comment stated that closures resulting from the proposed rule would force seafood processors to increase their imports of foreign-caught swordfish, due to reductions in domestic supply. One comment which generally supported the proposed rule recommended NMFS establish a compensation program to remunerate fishers for lost income during a potential closure.

Response: Following public comment on the proposed rule and associated analyses, NMFS conducted further economic analysis that found significant short-term economic effects not identified at the proposed rule stage. While the DGN fishery is not expected to close often under the regulations, the adverse economic effects to DGN participants in the event of a closure would be significant. The final EA, FRFA, and RIR demonstrate that DGN participants are highly dependent on the fishery for their annual landings and revenue, and they have little opportunity to offset economic losses by participating in other existing fisheries during a DGN closure.

Seven comments in support of the proposed rule expressed a desire for lower caps and/or a shorter management time horizon than the 2-year rolling hard caps outlined in the proposed rule. Of these comments, five recommended NMFS adopt Alternative 5 from the EA, which would establish one-year hard caps based on entanglements, rather than 2-year rolling hard caps based on mortality and serious injury (M&SI).

Response: The Council considered several other alternatives for this action. Descriptions of each of the alternatives are included in the EA and RIR. A rationale for why the other action alternatives were rejected is provided below.

Alternatives 1 through 4 presented significant challenges to implementation compared to the preferred alternative because they would use estimated M&SI based on observer coverage levels to evaluate the fishery against hard caps. The preferred alternative uses observed mortality and injury without the need to determine serious injury or to extrapolate data based on observer coverage in-season The current NMFS process under the MMPA for making M&SI determinations is an extensive and multi-step process that takes months to complete and occurs at the end of each calendar year. It was deemed that this process, therefore, would not be responsive enough to inseason interactions with protected species. NMFS would have to create an expedited M&SI assessment process to make a more timely determination, which would further delay this action. Additionally, observer coverage rates for the DGN fishery vary between and within fishing seasons. This makes it difficult to determine the coverage rate at the time an interaction occurs, thus influencing the hard cap limits. Similarly, using a generalized observer coverage rate is problematic because DGN vessels often participate in multiple fisheries based on environmental factors and the presence of different species. This adds to the variance in observer coverage levels over the course of a fishing season.

In response to the identified implementation issues, Council members developed Alternative 5 with two sub-Alternatives. Under Alternative 5 sub-option 1, the DGN fishery would be expected to meet or exceed a hard cap 7out of 13 fishing seasons, using historical observations (there is, however, less fishing effort in recent years, so the fishery is expected to close fewer than 7 times under this Alternative). Under Alternative 5 sub-option 2, the fishery would be expected to close in 14.6 percent of simulated seasons, with the possibility of closing for more than one full fishing season. The economic analysis showed that Alternative 5 would not be conducive to supporting an economically viable swordfish fishery.

Due to implementation issues identified with Alternatives 1 through 4, and the large decreases in effort, landings, revenue, and profits associated with Alternatives 5a and 5b, Alternative 6 was chosen as the preferred alternative. Alternative 6 was considered the least cost action alternative of those that did not present significant implementation issues.

Eight comments in support of the proposed rule expressed a desire to increase observer coverage in the DGN fishery, ideally to 100 percent. Commenters voiced concern that a hard caps regime with incomplete observer coverage may not adequately prevent takes of protected species. One comment in opposition to the proposed rule shared a similar concern, and recommended NMFS avoid the use of ratio estimates in determining total takes for the fishery under incomplete observer coverage.

Response: The Council developed the hard cap values based on less than 100 percent coverage, and indicated that they would revisit the values when observer coverage reaches 75 percent or greater in the DGN fishery. In 2015, the Council recommended increasing DGN monitoring to 100 percent using on-board observers or electronic monitoring. That action would be undertaken separately, and increased observer coverage was not a part of the proposed rule.

Five comments opposed the proposed rule on the grounds that it is not consistent with the legal requirements outlined in the MSA National Standards. MSA National Standard 8 states that conservation and management measures shall “provide for the sustained participation of [fishing] communities,” and “minimize adverse economic impacts on such communities.” Commenters expressed concern that fishery closures under the proposed rule would cause economic harm to fishery participants to a degree which could compromise the economic viability of the DGN fishery and preclude continued participation. Two commenters expressed additional concerns that the hard caps in the proposed rule are arbitrary, poorly defined, and not based on the best available science, therefore making them inconsistent with MSA National Standard 2.

Response: NMFS initially found the proposed rule consistent with MSA, its National Standards, and other applicable laws. Following public comment on the proposed rule, NMFS conducted additional economic analysis and found the regulations to be inconsistent with MSA National Standard 7 ( i.e., conservation and management measures shall, where practicable, minimize costs and avoid unnecessary duplication). NMFS intends to review all options for addressing the economic impacts to DGN fishery participants through a separate rulemaking, beginning with engagement of the Council to propose revisions through the Council's normal process. Such a rulemaking would need to be consistent with the other MSA National Standards, including 2 and 8.

Two commenters opposed the proposed rule on the grounds that the recent levels of bycatch impacts by the DGN fishery do not warrant additional regulation under MSA. One commenter questioned why additional regulation under MSA is needed, given that management schemes for endangered species and marine mammals already exist under ESA and MMPA. This commenter expressed concern that the proposed rule would diminish the effectiveness of the existing take reduction team (TRT) process under MMPA, and recommended that NMFS instead consult with the Pacific Ocean Cetacean TRT on processes to improve performance of the DGN fishery.

Response: Take of ESA-listed species in the DGN fishery is currently within the values authorized by an Incidental Take Statement issued as part of a 2013 ESA Biological Opinion on DGN fishing activities. Take of all marine mammals in the DGN fishery is currently below their Potential Biological Removal levels under the MMPA. The Council recommended protected species hard caps for the DGN fishery to address MSA National Standard 9 and Section 303 of the MSA ( i.e., to minimize bycatch and bycatch mortality and conserve non-target species to the extent practicable).

Two comments in opposition to the proposed rule expressed a concern that closing the DGN fishery due to hard caps violations would result in increased effort by foreign fisheries with different management regimes and potentially greater bycatch impacts, a theory known as the “transfer effect.” One commenter in support of the proposed rule acknowledged and challenged this notion, claiming there is no evidence to suggest such a response by foreign fisheries to the level of effort by U.S. domestic fisheries.

Response: There may be a market substitute if fewer swordfish are caught by DGN gear. For example, the Hawaii longline fishery lands swordfish on the U.S. West Coast and the U.S. imports swordfish from foreign fisheries. If swordfish buyers on the U.S. West Coast increase their purchases of swordfish from sources with less bycatch, then there could be a minor beneficial impact to the environment. If buyers increase purchases of swordfish from sources with higher bycatch, increased negative effects to the environment would be expected. However, NMFS' analysis did not predict which source or sources would fill the market demand in order to attempt to quantify these effects.

NMFS' initial determination of consistency with National Standard 7 of the Magnuson-Stevens Fishery Conservation and Management Act, and related concerns arising after the publication of the proposed rule, are discussed above. The Administrator, West Coast Region, NMFS, determined that the rule is consistent with all other applicable laws.

There are no new collection-of-information requirements associated with this action that are subject to the Paperwork Reduction Act (PRA), and existing collection-of-information requirements still apply under the following Control Number: 0648-0593. Notwithstanding any other provision of the law, no person is required to respond to, and no person shall be subject to penalty for failure to comply with, a collection-of-information subject to the requirements of the PRA, unless that collection-of-information displays a currently valid Office of Management and Budget control number.

NMFS prepared a final EA for this rule and concluded that there will be no significant impact on biological resources as a result of this action, based on the analysis contained in the EA. The action may result in significant adverse socioeconomic impacts in the event of a fishery closure. The action will have minor beneficial environmental impacts on target, not-target, and protected species and negative economic impacts to the DGN fleet. All of the proposed alternatives would result in a negative economic impact; however, the Council's final preferred alternative would result in a limited economic impact when compared to the other action alternatives (a more detailed explanation can be found in the FRFA). A copy of the final EA is available from NMFS (see ADDRESSES ).

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

This final rule is not an Executive Order 13771 regulatory action because this action is not significant under Executive Order 12866.

On December 29, 2015, the National Marine Fisheries Service (NMFS) issued a final rule establishing a small business size standard of $11 million in annual gross receipts for all businesses primarily engaged in the commercial fishing industry (NAICS 11411) for Regulatory Flexibility Act (RFA) compliance purposes only (80 FR 81194, December 29, 2015). The $11 million standard became effective on July 1, 2016, and is to be used in place of the U.S. Small Business Administration's (SBA) current standards of $20.5 million, $5.5 million, and $7.5 million for the finfish (NAICS 114111), shellfish (NAICS 114112), and other marine fishing (NAICS 114119) sectors of the U.S. commercial fishing industry in all NMFS rules subject to the RFA after July 1, 2016.

An initial regulatory flexibility analysis (IRFA) was prepared at the proposed rule stage, as required by section 603 of the RFA. This IRFA was finalized as an FRFA, recognizing significant adverse short-term economic effects that were not identified in the IRFA, on January 24, 2020. The FRFA describes the economic impact this final rule is expected to have on small entities. A description of the action, why it is being considered, and the legal basis for this action are contained at the beginning of this section in the preamble and in the SUMMARY section of the preamble. A summary of the analysis follows. A copy of this analysis is available from NMFS (see ).

There are currently 60 individual permit holders with valid Federal limited entry drift gillnet permits; however, many permits remain inactive. On average, 20 vessels participated in the fishery each year from 2010 through 2018. In 2018, 21 vessels participated in the fishery with total landings equaling 201 metric tons (mt) (round weight), about 10.1 mt on average per vessel. Total landings included 26 mt of common thresher shark, 11 mt of shortfin mako shark, 145 mt of swordfish, and 19 mt of tunas. All participants in the fishery are considered small businesses since average annual per vessel revenues persist well below the $11 million threshold.

The Council considered six alternatives for protected species hard caps for the DGN fishery before selecting Alternative 6 as their final preferred alternative. Compared to the baseline, the regulatory action ( i.e., based on Alternative 6) is expected to result in an ongoing $4,596 annual loss per vessel, based on a DGN fleet size of 20 vessels. These potential long-term adverse economic effects of the regulations appear to be limited. While the DGN fishery would not be expected to close often under the regulations, the short-term adverse economic effects to DGN participants in the event of any closure would be significant. The final EA, FRFA, and RIR demonstrate that DGN participants are highly dependent on the fishery for their annual landings and revenue and they have little opportunity to offset economic losses by participating in other fisheries during a DGN closure. If vessel operators are successful in reducing the frequency of hard cap species catch in the future, the DGN fishery would close less often. However, given the many existing regulatory measures to reduce protected species interactions in the DGN fishery to minimal levels, the degree to which further take reductions can be realized through fishermen's deliberate effort to avoid reaching caps cannot be determined. Alternative 6 is the least costly alternative that did not present significant implementation issues.

Action Alternatives 1 through 4 were estimated to produce fewer costs to the fleet than the FPA; however, these alternatives presented significant implementation challenges. The evaluation of the fishery against hard caps in each of these Alternatives was based on an estimated M&SI calculation derived from observer coverage levels. The current NMFS process under the MMPA for making M&SI determinations is an extensive and multi-step process that takes months to complete and occurs at the end of each calendar year. It was deemed that this process, therefore, would not be responsive enough to inseason interactions with protected species. NMFS would have to create an expedited M&SI assessment process to make a more timely determination, which would have further delayed this action. Additionally, observer coverage rates for the DGN fishery vary between and within fishing seasons. This makes it difficult to determine the coverage rate at the time an interaction occurs and then extrapolate observed M&SI for comparison to the hard caps. Similarly, using a generalized observer coverage rate is problematic because DGN vessels often participate in multiple fisheries based on environmental factors and the presence of different species. This adds to the variation in observer coverage levels over the course of a fishing season. Lastly, because fishing effort has been low compared to historical levels, a small change in observed fishing effort can have a significant effect on the observer coverage rate if unobserved effort does not change commensurately.

In response to the identified implementation issues with Alternatives 1 through 4, the CDFW proposed Alternative 5 with two sub-Alternatives. Based on Alternative 5 sub-option 1, the DGN fishery would be expected to meet or exceed a hard cap 7 out of 13 fishing seasons, using historical observations (there is, however, less fishing effort in recent years, so the fishery would be expected to close fewer than 7 times under this Alternative). Using Alternative 5 sub-option 2, the fishery would be expected to close in 14.6 percent of simulated seasons, with the possibility of closing for more than one full fishing season. The results of the economic analysis indicate that Alternative 5 would have greater economic impacts and not be conducive to supporting an economically viable swordfish fishery.

NMFS considers all entities subject to this action to be small entities as defined NMFS' size standards. The small entities that would be affected by the action are all U.S. commercial DGN vessels that may be used in the California/Oregon large-mesh DGN fishery. Because each affected vessel is a small business, the rule has an equal effect on all of these small entities. Therefore, the action will impact all these small entities in the same manner. This rule is anticipated to have a significant economic impact on a substantial number of small entities, or place small entities at a disadvantage to large entities.

For the reasons set out in the preamble, 50 CFR part 660 is amended as follows: