Federal Register Vol. 83, No.15,

Authority for This Rulemaking

The Federal Employees Health Benefits (FEHB) Program is administered by the Office of Personnel Management (OPM) in accordance with Title 5, Chapter 89 of the United States Code and our implementing regulations at title 5, part 890 of the Code of Federal Regulations. The statute establishes the basic rules for benefits, enrollment, and participation. OPM contracts with health benefits plans to provide coverage under the statute. OPM is authorized to prescribe regulations to govern the time, manner and conditions under which an employee can enroll in a health benefits plan under the FEHB Program and the beginning and end dates of coverage for annuitants and family members.

The Federal Employees Health Benefits (FEHB) Program provides health insurance to about 8.2 million Federal employees, retirees, and their dependents each year. It is the largest employer-sponsored health insurance program in the country providing more than $53 billion in health care benefits annually. Coverage options available to eligible individuals include self only, self plus one or self and family coverage in an approved health benefits plan. Eligible family members include the spouse of an employee or annuitant and a child under 26 years of age, including adopted children, stepchildren or foster children or a child regardless of age who is incapable of self-support because of mental or physical disability which existed before age 26.

On December 1, 2016, OPM published a proposed rule (81 FR 86902) to 1) provide that proof of family member eligibility may be required for coverage under an FEHB Program self plus one or self and family enrollment and 2) to establish the circumstances under which individuals covered under an existing self plus one or self and family FEHB enrollment will be removed from such enrollment and the processes for removal, where the enrollee does not provide adequate documentation of eligibility. Previously, under 5 CFR 890.302, all eligible family members are covered under a self and family enrollment. The regulations did not address the removal of an erroneously-covered ineligible individual from an existing self plus one or self and family enrollment.

On the same date, the Office of Personnel Management (OPM) published a Notice of Proposed Rulemaking (NPRM) (81 FR 86898) allowing certain eligible family members to be removed from self plus one and self and family enrollments in limited circumstances. This would change the current provision at 5 CFR 890.302, which provides that all family members that are eligible according to the FEHB Act (5 U.S.C. 8901) are automatically covered under a self and family enrollment.

This regulation merges and finalizes these two proposed regulations. The proposed regulations were published separately, but have now been merged for regulatory efficiency as both proposed regulations address title 5, Code of Federal Regulations, §§ 890.302, Coverage of Family Members, and 890.308, Disenrollment.

Both proposed regulations had 60-day comment periods. The regulations concerning ineligible family members received four comments: One from an interested citizen, one from an agency HR employee and one from a trade group representing FEHB Program plans with one duplicate comment. Two of the comments were supportive of the proposed rule and none objected to the proposed regulation. The proposed rule concerning eligible family members received three comments: one from an interested citizen, one from an agency HR employee and one from a trade group representing FEHB Program plans. Two of the comments were supportive of the proposed rules and none objected to the change in policy.

One commenter requested that OPM specify whether a submission of a reconsideration request delays the effective date of the initial removal. The provisions added in § 890.308(e) and (f) mirror the processes outlined in § 890.308(a) for disenrollment of employees. That provision does not provide a delayed effective date for reconsideration and so we are not adding one to this section. If an enrollee or the removed individual seeks reconsideration and the agency or OPM finds the family member to be eligible, the family member will receive retroactive coverage.

One commenter asked whether OPM is now requesting that agencies to track family members. This regulation does not require agencies to track family members, but forthcoming sub-regulatory guidance may require agencies to collect proof of eligibility in certain circumstances. The regulations amend § 890.302 to provide that proof of family member eligibility must be provided upon request by a carrier, employing office, or OPM.

Two commenters asked how an FEHB Program carrier would be aware of an initial determination of ineligibility under proposed § 890.308(f)(1) and requested further guidance on all required methods of notification to FEHB Program carriers. Section 890.308(f)(1) states that the employing office or OPM, as applicable, will direct the carrier to remove the individual if proof of eligibility is not provided by the enrollee. OPM will publish a Benefits Administration Letter (available at https://www.opm.gov/healthcare-insurance/healthcare/reference-materials/#url=BALs) and a Carrier Letter (available at https://www.opm.gov/healthcare-insurance/healthcare/carriers/#url=Carrier-Letters) following the publication of this regulation to carriers and to agencies providing a specific process to notify carriers and/or employing offices of any coverage changes effectuated under this regulation. One commenter further added that the carrier should receive the reasoning behind the removal of the individual. Accordingly, the final rule provides that the employing office or OPM shall provide a copy of the letter sent to the enrollee concerning removal under § 890.308(f)(1) to the carrier.

One commenter suggested that OPM add an effective date for a removal under § 890.308(f)(3) and (e)(3) where fraud or intentional misrepresentation are found. OPM has updated the final regulation to specify that if fraud or intentional misrepresentation of material fact is found, the effective date of the removal is the date of loss of eligibility.

One commenter suggested that OPM add examples to § 890.308(g) to clarify how temporary continuation of coverage (TCC), conversion and extension of coverage rules will operate under the regulations. An example has been added to clarify that an individual will not be eligible to receive TCC, conversion or an extension of coverage unless the removal is effectuated within the time limit currently required under existing regulations.

One commenter asked who will be responsible for collecting documentation and determining proof of eligibility status and whether that information will need to be forwarded to FEHB Program carriers. The proposed rule provided and the final rule maintains that employing offices will be responsible for collecting documentation and determining proof of eligibility status and that the information will be sent to FEHB Program carriers. Two commenters asked that OPM specify how this information should be provided to carriers and how it should be maintained and tracked. OPM plans to publish a Benefits Administration Letter and a Carrier Letter to employing offices and FEHB Program carriers following the publication of this regulation including a process for agencies to inform carriers of changes in covered family members and documentation that needs to be collected to effectuate a change.

One commenter requested that OPM change the proposed effective date of removals. The proposed rule makes the removal effective on the first day of the pay period following a notarized request received from the family member at issue and on the first day of the second pay period following a request to remove a child received from the enrollee. The commenter requested that the effective date be the first day of the third pay period for enrollees who pay premiums bi-weekly and the second pay period for enrollees who pay premiums monthly as the effective date for either type of family member removal. OPM agrees that this avoids unnecessary benefit overpayments and ensures that a family member has sufficient time to obtain replacement health benefits coverage. The final rule makes this change.

We have also made minor, non-substantive editorial changes to the regulation for editorial consistency and to improve clarity. In addition, we have updated the regulation to clarify that either the enrollee or the removed individual can provide proof of eligibility or request reconsideration of the initial decision.

The FEHB Program currently has a total of 262 health plan options for employees to choose from for their health benefits coverage. Historically, about 18,000 of FEHB participants switch health care plans in any given year. There are approximately 4 million family members covered under FEHB Program. While this rule may lower costs to the FEHB Program by reducing the number of eligible and ineligible family members, OPM does not have data available to calculate specific rates. However, OPM has found anecdotal evidence which estimates between 1-3 percent of spouses and 4-12 percent of children in commercial health plans are ineligible for coverage. So, we anticipate this rule will not have widespread applicability across the Program.

Executive Orders 13563 and 12866 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has been designated a “significant regulatory action,” under Executive Order 12866.

This final rule is not subject to the requirements of E.O. 13771 (82 FR 9339, February 3, 2017) because it is related to agency organization, management, or personnel.

I certify that this regulation will not have a significant economic impact on a substantial number of small entities.

We have examined this rule in accordance with Executive Order 13132, Federalism, and have determined that this rule will not have any negative impact on the rights, roles, and responsibilities of State, local, or Tribal governments.

The Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35; see 5 CFR part 1320) requires that the U.S. Office of Management and Budget (OMB) approve all collections of information by a Federal agency from the public before they can be implemented. Respondents are not required to respond to any collection of information unless it displays a current valid OMB control number. OPM is not proposing any additional collections in this rule. This rule involves an OMB approved collection of information subject to the PRA—OMB No. 3206-0160, Health Benefits Election Form. The public reporting burden for this collection is estimated to average 30 minutes per response, including time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. The total burden hour estimate for this form is 9,000 hours. The systems of record notice for this collection is: OPM/Central 1 Civil Service Retirement and Insurance Records, available at https://www.opm.gov/information-management/privacy-policy/sorn/opm-sorn-central-1-civil-service-retirement-and-insurance-records.pdf.

For the reasons set forth in the preamble, OPM amends 5 CFR part 890 as follows:

The FAA has determined that notice of, and opportunity for prior public comment on, these special conditions is impracticable because these procedures would significantly delay issuance of the design approval and thus delivery of the affected airplanes.

In addition, the substance of these special conditions has been published in the Federal Register for public comment in several prior instances with no substantive comments received. The FAA, therefore, finds it unnecessary to delay the effective date, and finds good cause for making these special conditions effective upon publication in the Federal Register.

We invite interested people to take part in this rulemaking by sending written comments, data, or views. The most helpful comments reference a specific portion of the special conditions, explain the reason for any recommended change, and include supporting data.

We will consider all comments we receive by the closing date for comments. We may change these special conditions based on the comments we receive.

On February 1, 2017, Preferred Improvements, LLC, applied for a supplemental type certificate to install a Saab Grintek Impi II tracking system on Boeing Model DC3C airplanes. The tracking system sends altitude and speed information to a ground station via a modem, which contains a rechargeable lithium ion battery.

The Boeing Model DC3C airplane is a narrow-body transport category airplane powered by twin-turbine/piston wing-mounted engines. The airplane has a maximum takeoff weight of 26,900 pounds with seating for 2 crewmembers and 32 passengers.

Under the provisions of title 14, Code of Federal Regulations (14 CFR) 21.101, Preferred Improvements, LLC, must show that the Boeing Model DC3C airplanes, as changed, continue to meet the applicable provisions of the regulations listed in Type Certificate No. A669, or the applicable regulations in effect on the date of application for the change, except for earlier amendments as agreed upon by the FAA.

If the Administrator finds that the applicable airworthiness regulations (i.e., 14 CFR part 25) do not contain adequate or appropriate safety standards for these airplanes, as modified by Preferred Improvements, LLC, because of a novel or unusual design feature, special conditions are prescribed under the provisions of § 21.16.

Special conditions are initially applicable to the models for which they are issued. Should the applicant apply for a supplemental type certificate to modify any other models included on the same type certificates to incorporate the same novel or unusual design feature, these special conditions would also apply to the other models under § 21.101.

In addition to the applicable airworthiness regulations and special conditions, Boeing Model DC3C airplanes, as modified by Preferred Improvements, LLC, must comply with the fuel vent and exhaust emission requirements of 14 CFR part 34, and the noise certification requirements of 14 CFR part 36.

The FAA issues special conditions, as defined in 14 CFR 11.19, in accordance with § 11.38, and they become part of the type certification basis under § 21.101.

Boeing Model DC3C airplanes, as modified by Preferred Improvements, LLC, will incorporate the following novel or unusual design feature: airplane tracking system with a modem containing a rechargeable lithium ion battery.

The battery system consists of the battery, battery charger, and any protective, monitoring, and alerting circuitry or hardware inside or outside of the battery. It also includes vents (where necessary) and packaging. For the purpose of these special conditions, a battery and battery system are referred to as a battery.

Rechargeable lithium batteries are considered to be a novel or unusual design feature in transport category airplanes, with respect to the requirements in § 25.1353. This type of battery has certain failure, operational, and maintenance characteristics that differ significantly from those of the nickel-cadmium and lead-acid rechargeable batteries currently approved for installation on transport category airplanes. These batteries introduce higher energy levels into airplane systems through new chemical compositions in various battery-cell sizes and construction. Interconnection of these cells in battery packs introduces failure modes that require unique design considerations, such as provisions for thermal management.

Special Condition 1 requires that each individual cell within a rechargeable lithium battery be designed to maintain safe temperatures and pressures. Special Condition 2 addresses these same issues but for the entire battery. Special Condition 2 requires the battery be designed to prevent propagation of a thermal event, such as self-sustained, uncontrolled increases in temperature or pressure from one cell to adjacent cells.

Special Conditions 1 and 2 are intended to ensure that the cells and battery are designed to eliminate the potential for uncontrollable failures. However, a certain number of failures will occur due to various factors beyond the control of the designer. Therefore, other special conditions are intended to protect the airplane and its occupants if failure occurs.

Special Conditions 3, 7, and 8 are self-explanatory.

Special Condition 4 clarifies that the flammable fluid fire-protection requirements of § 25.863 apply to rechargeable lithium battery installations. Section 25.863 is applicable to areas of the airplane that could be exposed to flammable fluid leakage from airplane systems. Rechargeable lithium batteries contain electrolyte that is a flammable fluid.

Special Condition 5 requires each rechargeable lithium battery installation to not damage surrounding structure or adjacent systems, equipment, or electrical wiring from corrosive fluids or gases that may escape in such a way as to cause a major or more severe failure condition. Special Condition 6 requires each rechargeable lithium battery installation to have provisions to prevent any hazardous effect on airplane structure or systems caused by the maximum amount of heat it can generate due to any failure of it or its individual cells. The means of meeting special conditions 5 and 6 may be the same, but they are independent requirements addressing different hazards. Special Condition 5 addresses corrosive fluids and gases, whereas Special Condition 6 addresses heat.

Special Condition 9 requires rechargeable lithium batteries to have “automatic” means due to the fast acting nature of lithium battery chemical reactions. Manual intervention would not be timely or effective in mitigating the hazards associated with these batteries.

These conditions apply to all rechargeable lithium battery installations in lieu of § 25.1353(b)(1) through (4) at amendment 25-123, or § 25.1353(c)(1) through (4) at earlier amendments. These regulations will remain in effect for other battery installations on these airplanes.

These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.

As discussed above, these special conditions are applicable to Boeing Model DC3C airplanes as modified by Preferred Improvements, LLC. Should Preferred Improvements, LLC, apply at a later date for a supplemental type certificate to modify any other model included on Type Certificate No. A699 to incorporate the same novel or unusual design feature, these special conditions would apply to those models as well.

This action affects only a certain novel or unusual design feature on one model of airplane. It is not a rule of general applicability.

The authority citation for these special conditions is as follows:

Accordingly, pursuant to the authority delegated to me by the Administrator, the following special conditions are issued as part of the type certification basis for Boeing Model DC3C airplanes as modified by Preferred Improvements, LLC.

In lieu of § 25.1353(b)(1) through (4) at amendment 25-123, or § 25.1353(c)(1) through (4) at earlier amendments, each rechargeable lithium battery installation must:

1. Be designed to maintain safe cell temperatures and pressures under all foreseeable operating conditions to prevent fire and explosion.

2. Be designed to prevent the occurrence of self-sustaining, uncontrollable increases in temperature or pressure, and automatically control the charge rate of each cell to protect against adverse operating conditions, such as cell imbalance, back charging, overcharging and overheating.

3. Not emit explosive or toxic gases, either in normal operation or as a result of its failure that may accumulate in hazardous quantities within the airplane.

4. Meet the requirements of § 25.863.

5. Not damage surrounding structure or adjacent systems, equipment, or electrical wiring from corrosive fluids or gases that may escape in such a way as to cause a major or more-severe failure condition.

6. Have provisions to prevent any hazardous effect on airplane structure or systems caused by the maximum amount of heat it can generate due to any failure of it or its individual cells.

7. Have a failure sensing and warning system to alert the flight crew if its failure affects safe operation of the airplane.

8. If its function is required for safe operation of the airplane, have a monitoring and warning feature that alerts the flight crew when its charge state falls below acceptable levels.

9. Have a means to automatically disconnect from its charging source in the event of an over-temperature condition, cell failure or battery failure.

Discussion

We received a report from Piper Aircraft, Inc., that they had a quality control issue that resulted in the installation of fuel tank selector covers with the placement of the left and right fuel tank selector placards installed in reverse on certain Piper Aircraft, Inc. Models PA-28-140, PA-28-150, PA-28-151, PA-28-160, PA-28-161, PA-28-180, PA-28-181, PA-28-236, PA-28-201T, PA-28R-180, PA-28R-200, PA-28R-201, PA-28R-201T, PA-28RT-201, and PA-28RT-201T airplanes. This condition, if not addressed, could result in fuel management errors resulting in fuel starvation and loss of engine power in flight. We are issuing this AD to address the unsafe condition on these products.

We reviewed Piper Aircraft, Inc. Service Bulletin No. 1309, dated October 10, 2017. The service bulletin describes procedures for inspecting the fuel tank selector cover to verify the left and right fuel tank selector placards are located at the 12:00 and 3:00 clock positions, respectively, and replacing those that are improperly located with new placards. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

We are issuing this AD because we evaluated all the relevant information and determined the unsafe condition described previously is likely to exist or develop in other products of the same type design.

This AD requires accomplishing the actions specified in the service information described previously.

An unsafe condition exists that requires the immediate adoption of this AD without providing an opportunity for public comments prior to adoption. The FAA has found that the risk to the flying public justifies waiving notice and comment prior to adoption of this rule because improper fuel selection could result in fuel starvation and loss of engine power in flight. Therefore, we find good cause that notice and opportunity for prior public comment are impracticable. In addition, for the reason stated above, we find that good cause exists for making this amendment effective in less than 30 days.

This AD is a final rule that involves requirements affecting flight safety and was not preceded by notice and an opportunity for public comment. However, we invite you to send any written data, views, or arguments about this final rule. Send your comments to an address listed under the ADDRESSES section. Include the docket number FAA-2018-0015 and Product Identifier 2017-CE-045-AD at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this final rule. We will consider all comments received by the closing date and may amend this final rule because of those comments.

We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We will also post a report summarizing each substantive verbal contact we receive about this final rule.

We estimate that this AD affects 17,957 airplanes, of U.S. registry.

We estimate the following costs to comply with this AD:

We estimate the following costs to do any necessary replacements that would be required based on the results of the inspection. We have no way of determining the number of aircraft that might need this replacements:

According to the manufacturer, some of the costs of this AD may be covered under warranty, thereby reducing the cost impact on affected individuals. We do not control warranty coverage for affected individuals. As a result, we have included all costs in our cost estimate.

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.

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

This AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to small airplanes, gliders, and domestic business jet transport airplanes and associated appliances to the Director of the Policy and Innovation Division.

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) Is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),

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

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

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

Authority for This Rulemaking

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the U.S. Code. Subtitle 1, 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 makes a clerical correction to the geographic coordinates of Kane Community Hospital Heliport, Kane, PA.

The FAA Aeronautical Information Services branch found the Class E airspace extending upward from 700 feet above the surface at Kane Community Hospital Heliport, Kane, PA, along with the related point in space coordinates, were incorrect as published in FAA Order 7400.11B, Airspace Designations and Reporting Points. The latitude degree for the heliport and the longitude degree for the point in space coordinates were incorrect in the Order.

A clerical amendment in the legal description also is made to the airspace designation, removing the name of the town listed before the airport name description.

Class E airspace designations are published in paragraph 6005 of FAA Order 7400.11B dated August 3, 2017, and effective September 15, 2017, which is incorporated by reference in 14 CFR part 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.

This document amends FAA Order 7400.11B, Airspace Designations and Reporting Points, dated August 3, 2017, and effective September 15, 2017. FAA Order 7400.11B is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.11B lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

This action amends Title 14 Code of Federal Regulations (14 CFR) part 71 by correcting the geographic coordinates of the heliport reference point and point in space coordinates of Kane Community Hospital Heliport in Class E airspace extending upward from 700 feet above the surface to be in concert with the FAA's aeronautical database.

This is an administrative change and does not affect the boundaries, or operating requirements of the airspace, therefore, notice and public procedure under 5 U.S.C. 553(b) are unnecessary.

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. Therefore, this regulation: (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:

I. Background

The Textile Fiber Products Identification Act (“Textile Act”) 1 and implementing Textile Rules require marketers to, among other things, attach a label to each covered textile fiber product disclosing: (1) The generic names and percentages by weight of the constituent fibers in the product; (2) the name under which the manufacturer or other responsible company does business, i.e., the product's marketer's name,2 or other specified identifier in lieu of that name,3 and (3) the name of the country where the product was processed or manufactured.4 Section 303.19(a) allows the owners of registered word trademarks who use these trademarks as house marks to disclose such trademarks in lieu of their names. However, before doing so, the company must file a copy of their USPTO registration with the Commission. The Commission imposed this requirement in 1959, presumably to obviate the need for the Commission to obtain paper copies of registrations from the USPTO. However, registered house marks now can be found by searching online or at the USPTO's website (www.uspto.gov).

In a Notice of Proposed Rulemaking published on June 28, 2017,5 the Commission proposed amending Section 303.19 to: (1) Delete the requirement that an owner of a registered word trademark used as a house mark furnish the FTC with a copy of the mark's registration with the USPTO before using the mark on labels, and (2) no longer restrict the use of such trademarks to only those employed as house marks. The Commission received three comments in response.6

As discussed below, based on the record, the Commission has determined to amend the Textile Rules to delete the requirement trademark owners furnish the FTC with a copy of the mark's USPTO registration before using the mark on labels. Based on the comments received, however, the Commission declines to eliminate the provision allowing only trademarks used as house marks.

Comments: The AAFA and Appelbaum comments supported the Commission's proposal to eliminate the requirement that businesses provide the Commission with a copy of a word trademark's USPTO registration prior to using these marks. AAFA asserted that simplifying the Textile Rules would “eliminate confusion, both for the business community and for consumers.” 7 De La Cruz, however, opposed this proposed amendment, arguing that the current Section 303.19(a) “keeps trade in order” and “discourages trademark infringement,” 8 but did not offer support for these contentions.

Discussion: Based on the record, the Commission amends Section 303.19(a) of the Textile Rules to delete the requirement that an owner of a registered word trademark furnish the FTC with a copy of the mark's registration with the USPTO prior to using the mark in lieu of a marketer's name. Commenters and the Commission's experience indicate that eliminating the submission requirement will reduce compliance costs for marketers without reducing protections for consumers. Specifically, the Commission and consumers can readily identify a registrant by searching for a marketer's house mark on the USPTO's online database or other online resources.9 Moreover, Commission staff has not consulted the files of house marks submitted to the Commission for many years, if ever, nor has it received requests from the public to do so. The Commission therefore concludes that the current submission requirement is neither necessary nor useful to enable the Commission or consumers to identify marketers of textile fiber products.

Comments: Commenters Appelbaum and De La Cruz opposed the Commission's proposal to eliminate the provision allowing only trademarks used as house marks to be used in lieu of marketers' names. Appelbaum asserted that the proposed amendment was premised on an assumption a word trademark is “unique,” when, in fact, word trademarks may be “very similar,” preventing consumers from effectively searching online for business owners.10 Appelbaum further noted that, in contrast, house marks did not present this problem because “a house mark is more uniquely associated with a business and less likely to be imitated.” 11 De La Cruz stated without further analysis that the current Section 303.19(a) “keeps trade in order” and “discourages trademark infringement.” 12 The AAFA supported this proposed amendment without explanation.13

Discussion: The Commission declines to amend Section 303.19(a) of the Textile Rules to permit the use of word trademarks other than house marks in lieu of marketers' names. The comments and staff research indicate that such an amendment would impose new burdens and additional costs on consumers and others to identify marketers of textile fiber products.

In particular, the record indicates that it can be difficult to find the identity of a specific registrant using a word trademark, rather than a house mark. Word trademarks that are not house marks can be registered for specific goods or services, and identical word trademarks can be registered numerous times for different goods or services.14 Consequently, simple searches on the USPTO's online database can produce hundreds or thousands of responses.15 Although sophisticated searches produce far fewer responses, such searches may require more training and expertise than many consumers are likely to possess.16 In contrast, to register a house mark as a trademark, the USPTO requires that an applicant indicate that it will use that house mark “for a full line of products” so that consumers can identify a manufacturer or seller from that house mark.17 Therefore, it is significantly easier to identify a house mark owner from a USPTO search.18

Accordingly, the Commission will continue to allow only owners of registered word trademarks who use these trademarks as house marks to disclose such trademarks in lieu of their names.

The Textile Rules contain various “collection of information” (e.g., disclosure and recordkeeping) requirements for which the Commission has obtained clearance from the Office of Management and Budget (“OMB”) under the Paperwork Reduction Act (“PRA”).19 The amended Textile Rules do not impose any additional collection of information requirements.

The Regulatory Flexibility Act (RFA), 5 U.S.C. 601-612, requires that the Commission provide an Initial Regulatory Flexibility Analysis (IRFA) with a Proposed Rule, and a Final Regulatory Flexibility Analysis (FRFA) with the final Rule, unless the Commission certifies that the Rule will not have a significant economic impact on a substantial number of small entities.20

The Commission anticipates that the final amendment will not have a significant economic impact on a substantial number of small entities. In the Commission's view, the amendment should not increase the costs of small entities that manufacture or import textile fiber products, but may reduce costs associated with furnishing a copy of a registered word trademark used as a house mark to the FTC. Therefore, based on available information, the Commission certifies that amending the Textile Rules will not have a significant economic impact on a substantial number of small businesses. Although the Commission certifies under the RFA that the amendment will not have a significant impact on a substantial number of small entities, the Commission has determined, nonetheless, that it is appropriate to publish a Final Regulatory Flexibility Analysis to inquire into the impact of the proposed amendment on small entities. Therefore, the Commission has prepared the following analysis:

Although the Commission has certified under the RFA that the amendments would not have a significant impact on a substantial number of small entities, the Commission has determined, nonetheless, that it is appropriate to publish an FRFA in order to explain the impact of the amendments on small entities as follows:

The Commission is amending the Rules to provide greater flexibility in complying with the Rules' disclosure requirements by permitting textile fiber product marketers to use registered house marks to identify themselves without sending registration copies to the Commission.

The Commission did not receive any comments specifically related to the impact of the final amendment on small businesses. In addition, the Commission did not receive any comments filed by the Chief Counsel for Advocacy of the Small Business Administration.

Under the Small Business Size Standards issued by the Small Business Administration, textile apparel manufacturers qualify as small businesses if they have 500 or fewer employees. Clothing wholesalers qualify as small business if they have 100 or fewer employees. The Commission's staff has estimated that approximately 22,642 textile fiber product manufacturers and importers are covered by the Textile Rules' disclosure requirements.21 A substantial number of these entities likely qualify as small businesses. The Commission estimates that the amendment will not have a significant impact on small businesses because it does not impose any new obligations on them, but may reduce filing costs associated with the Textile Rules.

The amendment deletes a filing requirement, thus providing greater flexibility to companies covered by the Textile Rules. The amendment is not expected to increase any reporting, recordkeeping, or other requirements associated with the Textile Rules, and is expected to decrease reporting requirements.

The Commission did not propose any specific small entity exemption or other significant alternatives because the amendment is expected to decrease reporting requirements and will not impose any new requirements or compliance costs. No comments identified any new compliance costs, and several comments argued the amendment will reduce compliance costs.

For the reasons discussed in the preamble, the Commission amends part 303 of title 16, Code of Federal Regulations, as follows:

It has been determined this is a major rule within the meaning of the Congressional Review Act (CRA). 5 U.S.C. 804(2). Major rules generally cannot take effect until 60 days after the date on which the rule is published in the Federal Register. 5 U.S.C. 801(a)(3). However, the CRA provides that “any rule for which an agency for good cause finds (and incorporates the finding and a brief statement of reasons therefor in the rule issued) that notice and public procedure thereon are impracticable, unnecessary, or contrary to the public interest, shall take effect at such time as the Federal agency promulgating the rule determines.” 5 U.S.C. 808. As is discussed below, DEA finds there is good cause to issue these amendments as a final rule without notice and comment, because these amendments merely conform the implementing regulations with recent amendments to the CSA contained in CARA that have already taken effect. Accordingly, DEA has determined this rule will take effect January 22, 2018.

On July 22, 2016, the President signed the Comprehensive Addiction and Recovery Act (CARA) into law as Public Law 114-198. Section 303 of the CARA amended certain provisions of 21 U.S.C. 823(g)(2), which is the subsection of the Controlled Substance Act (CSA) that sets forth the conditions under which a practitioner may, without being separately registered under subsection 823(g)(1), dispense a narcotic drug in Schedule III, IV, or V for the purpose of maintenance treatment or detoxification treatment. Maintenance treatment is the dispensing of a narcotic drug, in excess of twenty-one days, for the treatment of dependence upon heroin or other morphine-like drugs (21 U.S.C. 802(29)). A detoxification treatment is the term given when a narcotic drug is dispensed in decreasing doses, not exceeding one hundred and eighty days, “to alleviate adverse physiological or psychological effects incident to withdrawal from the continuous or sustained use of a narcotic drug,” with the ultimate goal of bringing a patient to a narcotic drug-free state (21 U.S.C. 802(30)).

Specifically, section 303 of the CARA temporarily expands the types of practitioners who may dispense a narcotic drug in Schedule III, IV, or V for the purpose of maintenance treatment or detoxification treatment without being separately registered as a narcotic treatment program. Whereas prior to the CARA, only qualified physicians were permitted to dispense narcotic drugs in this manner, the CARA now temporarily permits certain nurse practitioners and physician assistants to qualify to do so. The CARA achieves this result by (1) inserting the term “qualifying practitioner” in place of “qualifying physician” in 21 U.S.C. 823(g)(2)(B)(i) and (2) defining “qualifying practitioner” to include not only a physician, but also (until October 1, 2021) a “qualifying other practitioner,” which includes a nurse practitioner or physician assistant who meets certain qualifications set forth in paragraph 823(g)(2)(G)(iv). More precisely, section 303 of the CARA defines “qualifying other practitioner” as a nurse practitioner or physician assistant who satisfies each of the following criteria:

(I) The nurse practitioner or physician assistant is licensed under State law to prescribe schedule III, IV, or V medications for the treatment of pain;

(II) The nurse practitioner or physician assistant must complete not fewer than 24 hours of initial training.

(III) The nurse practitioner or physician assistant is supervised by, or works in collaboration with, a qualifying physician, if the nurse practitioner or physician assistant is required by State law to prescribe medications for the treatment of opioid use disorder in collaboration with or under the supervision of a physician; and

The Secretary determines in collaboration with, a qualifying physician, if the nurse practitioner or physician assistant is supervised by, or works in collaboration with, a qualifying physician, if the nurse practitioner can treat and manage opiate-dependent patients. The Secretary may, by regulation, revise the requirements for being qualifying other practitioner.

This section of the CARA further provides that the Secretary of Health and Human Services (HHS) may, by regulation, revise the foregoing requirements for being a qualifying other practitioner.

The CARA also makes some technical revisions to 21 U.S.C. 823(g)(2) that do not materially alter the meaning of this subsection. Nonetheless, because the DEA regulations currently contain the older statutory language, DEA is hereby revising this part of the regulations to reflect the new statutory language.

Under the CSA, the Secretary of HHS may, by regulation, increase the maximum number of patients that a practitioner may treat pursuant to 21 U.S.C. 823(g)(2). 21 U.S.C. 823(g)(2)(B)(iii)(III). On July 8, 2016, the Secretary issued a final rule increasing this number to 275. 81 FR 44712. As stated therein, to be eligible for the patient limit of 275, the practitioner must possess a current waiver to treat up to 100 patients under 21 U.S.C. 823(g)(2) and meet additional criteria set forth in 42 CFR 8.610-8.625.1 DEA is hereby amending its regulations to reflect these new limits.

As indicated, this final rule amends the DEA regulations only to the extent necessary to be consistent with current federal law (as modified by the CARA) and current federal regulations issued by HHS. The qualifying practitioner amendments in the CARA alter the provisions of the CSA that DEA previously implemented in its regulations, and DEA is therefore obligated to update those regulations. With respect to the HHS regulations, the CSA gives sole authority to HHS to change the maximum number of patients per practitioner under 21 U.S.C. 823(g)(2), and where HHS does so, DEA is obligated to apply that number. As a result, DEA has no discretion not to amend its regulations as is being done in this final rule. Indeed, the new provisions issued under this final rule are already in effect by virtue of the CARA and the HHS final rule regarding patient limits. This final rule simply updates the DEA regulations to reflect these new provisions. Public comment on these amendments to the DEA regulations would therefore serve no purpose. Because notice and public comment are unnecessary, DEA finds there is good cause within the meaning of the Administrative Procedure Act (APA) to issue these amendments as a final rule without notice and comment, because these amendments merely conform the implementing regulations with recent amendments to the CSA contained in CARA that have already taken effect (see 5 U.S.C. 553(b)(B), relating to notice and comment procedures). “[W]hen regulations merely restate the statute they implement, notice-and-comment procedures are unnecessary”. Gray Panthers Advocacy Committee v. Sullivan, 936 F.2d 1284, 1291 (D.C. Cir. 1991); see also Komjathy v. Nat. Trans. Safety Bd., 832 F.2d 1294, 1296 (D.C. Cir. 1987) (when a rule “does no more than repeat, virtually verbatim, the statutory grant of authority” notice-and-comment procedures are not required). Therefore, we are issuing these amendments as a final rule, effective upon publication in the Federal Register. This rule constitutes final action on these changes under the APA (5 U.S.C. 553).

As explained above, DEA is obligated to issue this final rule to revise its regulations so that they are consistent with the provisions of the CSA that were amended by the CARA and the HHS final rule increasing the patient limit under 21 U.S.C. 823(g)(2). In issuing this final rule, DEA has not gone beyond the statutory text enacted by Congress or the final rule issued by HHS. Thus, DEA would have to issue this final rule regardless of the outcome of the agency's regulatory analysis. Nonetheless, DEA conducted this analysis as discussed below.

This final rule was developed in accordance with the principles of Executive Orders 12866 and 13563. Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health, and safety effects; distributive impacts; and equity). Executive Order 13563 is supplemental to and reaffirms the principles, structures, and definitions governing regulatory review as established in Executive Order 12866. Executive Order 12866 classifies a “significant regulatory action,” requiring review by the Office of Management and Budget (OMB), as any regulatory action that is likely to result in a rule that may: (1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities; (2) create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; (3) materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order.

1. The DEA expects that this final rule will have an annual effect on the economy of $100 million or more in at least one year and therefore is an economically significant regulatory action. The analysis of benefits and costs is below.

2. This regulatory action is not likely to result in a rule that may create a serious inconsistency or otherwise interfere with an action taken or planned by another agency. This final rule amends the DEA regulations only to the extent necessary to be consistent with current federal law (as modified by the CARA) and current federal regulations issued by HHS. The qualifying practitioner amendments in the CARA alter the provisions of the CSA that DEA previously implemented in its regulations, and DEA is therefore obligated to update those regulations. With respect to the HHS regulations, the CSA gives sole authority to HHS to change the maximum number of patients per practitioner under 21 U.S.C. 823(g)(2), and where HHS does so, DEA is obligated to apply that number.

3. This regulatory action is not likely to result in a rule that may materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof. The Diversion Control Fee Account, which the DEA administers and which involves registration fees, is not directly affected. This regulatory action temporarily expanding the types of practitioners and increasing the maximum number of patients that a practitioner may treat as described in detail above represents a minor modification to the registration procedures within the Diversion Control Program and does not necessitate a change in registration fees.

4. This regulatory action is not likely to result in a rule that may raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order. This final rule amends the DEA regulations only to the extent necessary to be consistent with current federal law (as modified by the CARA) and current federal regulations issued by HHS. The qualifying practitioner amendments in the CARA alter the provisions of the CSA that DEA previously implemented in its regulations, and DEA is therefore obligated to update those regulations. With respect to the HHS regulations, the CSA gives sole authority to HHS to change the maximum number of patients per practitioner under 21 U.S.C. 823(g)(2), and where HHS does so, DEA is obligated to apply that number. This regulatory action therefore does not raise novel legal or policy issues.

The economic, interagency, budgetary, legal, and policy implications of this final rule have been examined and it has been determined to be a significant regulatory action under Executive Order 12866, and therefore, has been submitted to the OMB for review.

On July 22, 2016, the Comprehensive Addiction and Recovery Act of 2016 (CARA) became law. One section of the CARA amended the Controlled Substances Act (CSA) to expand the categories of practitioners who may, under certain conditions on a temporary basis, dispense a narcotic drug in Schedule III, IV, or V for the purpose of maintenance treatment or detoxification treatment. Separately, the Department of Health and Human Services (HHS), by final rule effective August 8, 2016, increased to 275 the maximum number of patients that a practitioner may treat for opioid use disorder without being separately registered under the CSA for that purpose. The DEA is amending its regulations to incorporate these statutory and regulatory changes.

In addition to the legal requirement to implement the statute, this rule also implements one of the objectives of the statute; expand availability of medication-assisted treatment (MAT) for opioid addiction. As supported by research, there is a gap between those who need treatment for opioid addition and treatment providers (“treatment gap”). An increase in treatment availability is expected to result in more patients treated.

Substance Abuse and Mental Health Services Administration (SAMHSA) independently researched the issue of the treatment gap in its recent rule: Medication Assisted Treatment for Opioid Use Disorders, 81 FR 44712, 44729 (July 8, 2016). SAMHSA found that “. . . there is significant unmet need for MAT treatment among individuals with opioid use disorders . . . Evidence suggests that utilization of buprenorphine is limited directly by the existence of treatment limits.” A research article in American Journal of Public Health concluded that there are significant gaps between treatment need and capacity at the state and national levels, with 96% of states and District of Columbia having opioid abuse or dependence rates higher than their buprenorphine treatment capacity rates.2 According to research by The Pew Charitable Trust, “[i]n the U.S. only 49 percent of people with an opioid dependence can potentially receive treatment because too few doctors prescribe the medicine, and those that do can serve only a limited number of patients because of federal restrictions.” 3 Also, patients located in rural areas are negatively impacted by the limits because there are fewer doctors certified to prescribe buprenorphine.4 One research article examined the availability of MAT by U.S. counties and determined that more than 30 million persons live in counties without access to buprenorphine treatment.5

This final rule amends the DEA regulations only to the extent necessary to be consistent with current federal law (as modified by the CARA) and current federal regulations issued by HHS. The qualifying practitioner amendments in the CARA alter the provisions of the CSA that DEA previously implemented in its regulations, and DEA is therefore obligated to update those regulations. With respect to the HHS regulations, the CSA gives sole authority to HHS to change the maximum number of patients per practitioner under 21 U.S.C. 823(g)(2), and where HHS does so, DEA is obligated to apply that number. As a result, DEA has no discretion not to amend its regulations as is being done in this final rule. Indeed, the new provisions issued under this final rule are already in effect by virtue of the CARA and the HHS final rule regarding patient limits. This final rule simply updates the DEA regulations to reflect these new provisions; thus, no alternative approaches are possible.

This analysis is limited to the provisions associated with the section of the CARA that amended the CSA to expand the categories of practitioners who may, under certain conditions on a temporary basis, dispense a narcotic drug in schedule III, IV, or V for the purpose of maintenance treatment or detoxification treatment. The HHS rule that increased to 275 the maximum number of patients that a practitioner may treat for opioid use disorder without being separately registered under the CSA was promulgated under HHS' authority; therefore, that section of the CARA was excluded from this analysis. This is a summary; a detailed economic analysis of the proposed rule can be found in the rulemaking docket at http://www.regulations.gov.

Benefits, in the form of economic burden (health care costs, criminal justice costs, and lost productivity costs) reductions, are expected to be generated from the expansion of the categories of practitioners who may dispense a narcotic drug in schedule III, IV, or V for the purpose of maintenance treatment or detoxification treatment. The DEA anticipates the expansion of the categories of practitioners will lead to an increase in the number of treatment providers, which will lead to an increase in the number of patients (who did not have access to treatment prior to this rule) treated, resulting in the reduction in the economic burden due to opioid abuse.

Cost of the rule is associated with treatment cost and the cost to practitioners of obtaining authority to dispense a narcotic drug in schedule III, IV, or V for the purpose of maintenance treatment or detoxification treatment. While these costs are not directly attributable to this rule, obtaining dispensing authority and treating patients are required to generate the benefits of the rule, and thus, included in this analysis. Although the new treatment providers in the expanded category, qualifying other practitioners, will also need to comply with treatment-specific recordkeeping requirements, the cost of compliance is included in the estimated cost of treatment. Finally, there is potential for added risk of diversion from more practitioners having the authority to dispense narcotic drug in schedule III, IV, or V for the purpose of maintenance treatment or detoxification treatment.

The DEA estimates the total benefit (economic burden reduction) is $208 million, $374 million, $467 million, $560 million, and $654 million in years 1, 2, 3, 4, and 5, respectively; the total cost of treatment is $133 million, $238 million, $298 million, $358 million, and $417 million in years 1, 2, 3, 4, and 5, respectively; and the total cost of obtaining DATA-waived status is $7 million and $4 million in years 1 and 2, respectively; resulting in a net benefit of $68 million, $132 million, $169 million, $202 million, and $237 million in years 1, 2, 3, 4, and 5, respectively. The table below contains the summary of benefits and costs.

At 3% discount rate, the present value of benefits is $2,044 million, the present value of costs is $1,315 million and the net present value (NPV) is $729 million. At 7% discount rate, the present value of benefits is $1,796 million, the present value of costs is $1,156 million and the NPV is $640 million.6 The net benefits in years 1 to 5 equate to an annualized net benefit of $159 million at 3% and $156 million at 7% over five years. The table below summarizes the present value and annualized benefit calculations.

This final rule meets the applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform to eliminate ambiguity, minimize litigation, establish clear legal standards, and reduce burden.

This rulemaking does not have federalism implications warranting the application of Executive Order 13132. The final rule does not have substantial direct effects on the States, on the relationship between the national government and the States, or the distribution of power and responsibilities among the various levels of government.

This final rule does not have substantial direct effects on the States, on the relationship between the national government and the States, or the distribution of power and responsibilities between the Federal Government and Indian tribes.

This final rule is considered an E.O. 13771 deregulatory action. The rule is an enabling rule which expands the options for opioid treatment. Details on the expected economic effects of this rule can be found in the rule's economic impact analysis.

The Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612) applies to rules that are subject to notice and comment under section 553(b) of the APA. As explained above, the DEA determined that there was good cause to exempt this final rule from notice and comment. Consequently, the RFA does not apply to this final rule.

This final rule will not result in the expenditure by state, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted for inflation) in any one year, and will not significantly or uniquely affect small governments. Therefore, no actions were deemed under the provisions of the Unfunded Mandates Reform Act of 1995, 2 U.S.C. 1532.

This rule is a major rule as defined by the Congressional Review Act. 5 U.S.C. 804. This rule will result in an annual effect on the economy of $100 million or more as a result of economic burden reductions. However, it will not cause a major increase in costs or prices; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of the United States-based companies to compete with foreign based companies in domestic and export markets. The DEA has submitted a copy of this final rule to both Houses of Congress and to the Comptroller General.

This action does not impose a new collection of information requirement under the Paperwork Reduction Act of 1995. 44 U.S.C. 3501-3521

For the reasons set out above, the DEA amends 21 CFR part 1301 as follows:

ONRR's “official correspondence” includes significant documents we send to industry, such as invoices, notices of audit, orders, and notices of enforcement. Historically, Department of the Interior (Department) regulations authorized ONRR to serve official correspondence by conventional means—U.S. mail, personal delivery, or private mailing service, such as FedEx or U.P.S. On August 23, 2013, ONRR published in the Federal Register a direct final rule amending its regulations on service of official correspondence (78 FR 52431). The 2013 direct final rule augmented the authorized methods of service to include electronic service, as long as the electronic service was secure and provided for a receipt.

The 2013 direct final rule provided for a 30-day public comment period. In the 2013 direct final rule, we stated that if we received significant adverse comment during that period, we would withdraw the rule. During the public comment period, we received significant adverse comments. We attempted to withdraw the 2013 direct final rule before it went into effect on October 22, but had insufficient time to do so due to the October 2013 government shutdown. Because the rule should have been withdrawn, we consider the rule legally defective, and we have not enforced it. We would withdraw the 2013 direct final rule now, but the time limit for withdrawal has expired. Instead, we are publishing this rule to repeal the defective 2013 direct final rule and restore the former regulatory language governing service of official correspondence.

Because this rule makes no changes to the legal obligations or rights of non-governmental entities, the Department finds that good cause exists under 5 U.S.C. 553(d)(3) to make this rule effective immediately upon publication in the Federal Register rather than 30 days after publication.

This is a final rulemaking with no request for comments. Under section 553(b), ONRR generally publishes a rule in a proposed form and solicits public comment on it before issuing the final rule. However, section 553(b)(3)(B) provides an exception to the public comment requirement if the agency finds good cause to omit advance notice and public participation. Good cause is shown when public comment is “impracticable, unnecessary, or contrary to the public interest.” We find that in this case, because we are simply restoring the former noncontroversial regulatory language, public comment is unnecessary.

This rule repeals the direct final rule (78 FR 52431) and restores the former regulatory language governing service of official correspondence in sections 1218.540(a) and (d) of title 30 of the Code of Federal Regulations (CFR). This rule removes the language that currently appears in section 1218.540(a) allowing ONRR to serve official correspondence using any electronic method of delivery that provides for a receipt of delivery, or, if there is no receipt, the date of delivery otherwise documented. This rule also removes mention of electronic service from section 1218.540(d), which pertains to constructive service. This rule does not make any substantive changes to the regulations or requirements in section 1218.540(a) or (d). It simply restores the original procedures for ONRR's service of official correspondence—removing the amendments made in the previously published direct final rule.

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. Also, this rule is not an E.O. 13771 regulatory action because this rule is not significant under E.O. 12866.

Executive Order 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. Executive Order 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. Executive Order 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.

The Regulatory Flexibility Act (RFA) 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). This rule will impact large and small entities but will not have a significant economic effect on either because this is a technical rule restoring the original service of official correspondence regulation language. Thus, 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 is only a technical rule restoring the original service of official correspondence regulation language.

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 is a technical rule.

Under the criteria in section 2 of E.O. 12630, this rule does not have any significant takings implications. This rule will not impose conditions or limitations on the use of any private property. 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. Therefore, as a technical rule, it does not require 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 the Indian Tribes through a commitment to consultation with the 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 technical 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. The procedural changes resulting from these amendments have no consequences with respect to the physical environment. This rule will not alter in any material way natural resource exploration, production, or transportation.

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.

For the reasons discussed in the preamble, ONRR amends 30 CFR part 1218 as set forth below:

Background Information

The Federal Civil Penalties Inflation Adjustment Act of 1990, Public Law 101-410, 104 Stat. 890 (28 U.S.C. 2461, note), as amended by the Debt Collection Improvement Act of 1996, Public Law 104-134, April 26, 1996, and further amended by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (the 2015 Act), Public Law 114-74, November 2, 2015, required agencies to annually adjust the level of CMPs for inflation to improve their effectiveness and maintain their deterrent effect. The 2015 Act required that not later than July 1, 2016, and not later than January 15 of every year thereafter, the head of each agency must adjust each CMP within its jurisdiction by the inflation adjustment described in the 2015 Act. The inflation adjustment is determined by increasing the maximum CMP or the range of minimum and maximum CMPs, as applicable, for each CMP by the cost-of-living adjustment, rounded to the nearest multiple of $1. The cost-of-living adjustment is the percentage (if any) for each CMP by which the Consumer Price Index (CPI) for the month of October preceding the date of the adjustment (January 15), exceeds the CPI for the month of October in the previous calendar year.

The initial catch up adjustments for inflation to the Department of Defense's CMPs were published as an interim final rule in the Federal Register on May 26, 2016 (81 FR 33389-33391) and became effective on that date. The interim final rule was published as a final rule without change on September 12, 2016 (81 FR 62629-62631), effective that date. The revised methodology for agencies for 2018 and each year thereafter provides for the improvement of the effectiveness of CMPs and to maintain their deterrent effect. Effective 2018, agencies' annual adjustments for inflation to CMPs shall take effect not later than January 15. The Department of Defense is adjusting the level of all civil monetary penalties under its jurisdiction by the Office of Management and Budget (OMB) directed cost-of-living adjustment multiplier for 2018 of 1.02041 prescribed in OMB Memorandum M-18-03, “Implementation of Penalty Inflation Adjustments for 2018, pursuant to the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015,” dated December 15, 2017. The Department of Defense's 2018 adjustments for inflation to CMPs apply only to those CMPs, including those whose associated violation predated such adjustment, which are assessed by the Department of Defense after the effective date of the new CMP level.

Pursuant to 5 U.S.C. 553(b)B, there is good cause to issue this rule without prior public notice or opportunity for public comment because it would be impracticable and unnecessary. The Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (Section 701(b)) requires agencies, effective 2017, to make annual adjustments for inflation to CMPs notwithstanding section 553 of title 5, United States Code. Additionally, the methodology used, effective 2017, for adjusting CMPs for inflation is established in statute, with no discretion provided to agencies regarding the substance of the adjustments for inflation to CMPs. The Department of Defense is charged only with performing ministerial computations to determine the dollar amount of adjustments for inflation to CMPs.

Further, there are no significant costs associated with the regulatory revisions that would impose any mandates on the Department of Defense, Federal, State or local governments, or the private sector. Accordingly, prior public notice and an opportunity for public comment are not required for this rule. The benefit of this rule is the Department of Defense anticipates that civil monetary penalty collections may increase in the future due to new penalty authorities and other changes in this rule. However, it is difficult to accurately predict the extent of any increase, if any, due to a variety of factors, such as budget and staff resources, the number and quality of civil penalty referrals or leads, and the length of time needed to investigate and resolve a case.

Executive Orders 13563 and 12866 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distribute impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has not been designated a “significant regulatory action,” because it does not: (1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy; a section of the economy; productivity; competition; jobs; the environment; public health or safety; or State, local, or tribal governments or communities; (2) create a serious inconsistency or otherwise interfere with an action taken or planned by another Agency; (3) materially alter the budgetary impact of entitlements, grants, user fees, or loan programs, or the rights and obligations of recipients thereof; or (4) raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in these Executive Orders.

Executive Order 13771 requires that for every significant regulation promulgated, an agency must identify two for elimination and offset its costs. This rule is exempt from these requirements because it has been deemed not significant by the Office of Management and Budget.

Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) (2 U.S.C. 1532) requires agencies to assess anticipated costs and benefits before issuing any rule the mandates of which require spending in any year of $100 million in 1995 dollars, updated annually for inflation. In 2016, that threshold is approximately $146 million. This rule will not mandate any requirements for State, local, or tribal governments, nor will it affect private sector costs.

Because notice of proposed rulemaking and opportunity for comment are not required pursuant to 5 U.S.C. 553, or any other law, the analytical requirements of the Regulatory Flexibility Act (5 U.S.C. 601, et seq.) are inapplicable. Therefore, a regulatory flexibility analysis is not required and has not been prepared.

The Department of Defense determined that provisions of the Paperwork Reduction Act of 1995, Public Law 104-13, 44 U.S.C. Chapter 35, and its implementing regulations, 5 CFR part 1320, do not apply to this rule because there are no new or revised recordkeeping or reporting requirements.

Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a rule that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has Federalism implications. This final rule will not have a substantial effect on State and local governments.

Accordingly, 32 CFR part 269 is amended as follows.

Background

Under Title VIII of the Alaska National Interest Lands Conservation Act (ANILCA) (16 U.S.C. 3111-3126), the Secretary of the Interior and the Secretary of Agriculture (Secretaries) jointly implement the Federal Subsistence Management Program. This program provides a preference for take of fish and wildlife resources for subsistence uses on Federal public lands and waters in Alaska. The Secretaries published temporary regulations to carry out this program in the Federal Register on June 29, 1990 (55 FR 27114), and published final regulations in the Federal Register on May 29, 1992 (57 FR 22940). The Program managers have subsequently amended these regulations a number of times. Because this program is a joint effort between Interior and Agriculture, these regulations are located in two titles of the Code of Federal Regulations (CFR): Title 36, “Parks, Forests, and Public Property,” and Title 50, “Wildlife and Fisheries,” at 36 CFR 242.1-242.28 and 50 CFR 100.1-100.28, respectively. The regulations contain subparts as follows: Subpart A, General Provisions; Subpart B, Program Structure; Subpart C, Board Determinations; and Subpart D, Subsistence Taking of Fish and Wildlife.

Consistent with subpart B of these regulations, the Secretaries established a Federal Subsistence Board to administer the Federal Subsistence Management Program. The Board comprises:

• A Chair appointed by the Secretary of the Interior with concurrence of the Secretary of Agriculture;

• The Alaska Regional Director, U.S. Fish and Wildlife Service;

• The Alaska Regional Director, National Park Service;

• The Alaska State Director, Bureau of Land Management;

• The Alaska Regional Director, Bureau of Indian Affairs;

• The Alaska Regional Forester, USDA Forest Service; and

• Two public members appointed by the Secretary of the Interior with concurrence of the Secretary of Agriculture.

Through the Board, these agencies participate in the development of regulations for subparts C and D, which, among other things, set forth program eligibility and specific harvest seasons and limits.

In administering the program, the Secretaries divided Alaska into 10 subsistence resource regions, each of which is represented by a Federal Subsistence Regional Advisory Council (Council). The Councils provide a forum for rural residents with personal knowledge of local conditions and resource requirements to have a meaningful role in the subsistence management of fish and wildlife on Federal public lands in Alaska. The Council members represent varied geographical, cultural, and user interests within each region.

The Board addresses customary and traditional use determinations during the applicable biennial cycle. Section __.24 (customary and traditional use determinations) was originally published in the Federal Register on May 29, 1992 (57 FR 22940). The regulations at 36 CFR 242.4 and 50 CFR 100.4 define “customary and traditional use” as “a long-established, consistent pattern of use, incorporating beliefs and customs which have been transmitted from generation to generation. . . .” Since 1992, the Board has made a number of customary and traditional use determinations at the request of affected subsistence users. Those modifications, along with some administrative corrections, were published in the Federal Register as follows:

The Departments published a proposed rule on February 22, 2016 (81 FR 8675), to amend the fish section of subparts C and D of 36 CFR part 242 and 50 CFR part 100. The proposed rule opened a comment period, which closed on April 1, 2016. The Departments advertised the proposed rule by mail, email, web page, social media, radio, and newspaper, and comments were submitted via www.regulations.gov to Docket No. FWS-R7-SM-2015-0003. During that period, the Councils met and, in addition to other Council business, received suggestions for proposals from the public. The Board received a total of 15 proposals for changes to subparts C and D; this included 1 proposal that was deemed invalid because it was beyond the scope of the Board's authority. After the comment period closed, the Board prepared a booklet describing the proposals and distributed it to the public. The proposals were also available online. The public then had an additional 45 days in which to comment on the proposals for changes to the regulations.

The 10 Councils met again, received public comments, and formulated their recommendations to the Board on proposals for their respective regions. The Councils had a substantial role in reviewing the proposed rule and making recommendations for the final rule. Moreover, a Council Chair, or a designated representative, presented each Council's recommendations at the Board's public meeting of January 10-12, 2017. These final regulations reflect Board review and consideration of Council recommendations, Tribal and Alaska Native corporation consultations, and public comments. The public received extensive opportunity to review and comment on all changes.

Of the 14 valid proposals, 10 were on the Board's regular agenda and 4 were on the consensus agenda. The consensus agenda is made up of proposals for which there is agreement among the affected Councils, a majority of the Interagency Staff Committee members, and the Alaska Department of Fish and Game concerning a proposed regulatory action. Anyone may request that the Board remove a proposal from the consensus agenda and place it on the non-consensus (regular) agenda. The Board votes en masse on the consensus agenda after deliberation and action on all other proposals.

Of the proposals on the consensus agenda, the Board adopted one; adopted two with modification; and rejected one. Analysis and justification for the action taken on each proposal on the consensus agenda are available for review at the Office of Subsistence Management, 1011 East Tudor Road, Mail Stop 121, Anchorage, AK 99503, or on the Office of Subsistence Management website (https://www.doi.gov/subsistence). Of the proposals on the regular (non-consensus) agenda, the Board adopted one; adopted three with modification; rejected one; deferred one; withdrew three at the requests of the proponents; and took no action on one.

The Board rejected, deferred, or took no action on three non-consensus proposals. The rejected proposals were recommended for rejection by one or more of the Councils unless noted below.

The Board rejected a proposal to allow for the harvest of early-run Chinook Salmon in sub-district 5D of the Yukon River based on conservation concerns and treaty obligations. This action was supported by three Councils and contrary to the recommendation of one Council.

The Board deferred action on one proposal to restructure the management plans, fishing schedules, and methods and means and allow for independent action to be taken by the in-season manager on the Kuskokwim River. Action on this proposal was deferred until the next fish cycle, until the affected entities come to a conclusion, or a request to readdress this proposal is submitted.

The Board took no action on one proposal for the Kenai River. This decision was based on its earlier action on a similar proposal addressing a community gillnet.

The Board adopted or adopted with modification four non-consensus proposals. Modifications were suggested by the affected Council(s), developed during the analysis process, or developed during the Board's public deliberations. All of the adopted proposals were recommended for adoption by at least one of the Councils unless noted below.

The Board adopted a proposal to revise harvest limits to allow harvest once the mid-range of the interim management escapement goal and the total allowable catch goal are projected to be achieved on the Yukon River.

The Board adopted a proposal with modification to revise the methods and means for the use of gillnets in Racetrack Slough of the Koyukuk River and the sloughs of the Huslia River drainage.

The Board adopted a proposal with modification to revise the season dates for the experimental community gillnet fishery on the Kasilof River for the residents of Ninilchik.

The Board adopted a proposal to revise the season dates, reporting requirements, and household harvest limits, require the live release of Rainbow Trout and Dolly Varden, remove the requirement of an operational plan, and revise permit conditions for the community gillnet fishery on the Kenai River for the residents of Ninilchik.

These final regulations reflect Board review and consideration of Council recommendations, Tribal and Alaska Native corporation consultations, and public comments. Because this rule concerns public lands managed by an agency or agencies in both the Departments of Agriculture and the Interior, identical text will be incorporated into 36 CFR part 242 and 50 CFR part 100.

The Board has provided extensive opportunity for public input and involvement in compliance with Administrative Procedure Act requirements, including publishing a proposed rule in the Federal Register, participation in multiple Council meetings, additional public review and comment on all proposals for regulatory change, and opportunity for additional public comment during the Board meeting prior to deliberation. Additionally, an administrative mechanism exists (and has been used by the public) to request reconsideration of the Board's decision on any particular proposal for regulatory change (36 CFR 242.20 and 50 CFR 100.20). Therefore, the Board believes that sufficient public notice and opportunity for involvement have been given to affected persons regarding Board decisions.

In the more than 25 years that the Program has been operating, no benefit to the public has been demonstrated by delaying the effective date of the subsistence regulations. A lapse in regulatory control could affect the continued viability of fish or wildlife populations and future subsistence opportunities for rural Alaskans, and would generally fail to serve the overall public interest. Therefore, the Board finds good cause pursuant to 5 U.S.C. 553(d)(3) to make this rule effective upon the date set forth in DATES to ensure continued operation of the subsistence program.

A Draft Environmental Impact Statement that described four alternatives for developing a Federal Subsistence Management Program was distributed for public comment on October 7, 1991. The Final Environmental Impact Statement (FEIS) was published on February 28, 1992. The Record of Decision (ROD) on Subsistence Management for Federal Public Lands in Alaska was signed April 6, 1992. The selected alternative in the FEIS (Alternative IV) defined the administrative framework of an annual regulatory cycle for subsistence regulations.

The following Federal Register documents pertain to this rulemaking:

A 1997 environmental assessment dealt with the expansion of Federal jurisdiction over fisheries and is available at the office listed under FOR FURTHER INFORMATION CONTACT. The Secretary of the Interior, with concurrence of the Secretary of Agriculture, determined that expansion of Federal jurisdiction does not constitute a major Federal action significantly affecting the human environment and, therefore, signed a Finding of No Significant Impact.

An ANILCA section 810 analysis was completed as part of the FEIS process on the Federal Subsistence Management Program. The intent of all Federal subsistence regulations is to accord subsistence uses of fish and wildlife on public lands a priority over the taking of fish and wildlife on such lands for other purposes, unless restriction is necessary to conserve healthy fish and wildlife populations. The final section 810 analysis determination appeared in the April 6, 1992, ROD and concluded that the Program, under Alternative IV with an annual process for setting subsistence regulations, may have some local impacts on subsistence uses, but will not likely restrict subsistence uses significantly.

During the subsequent environmental assessment process for extending fisheries jurisdiction, an evaluation of the effects of this rule was conducted in accordance with section 810. That evaluation also supported the Secretaries' determination that the rule will not reach the “may significantly restrict” threshold that would require notice and hearings under ANILCA section 810(a).

An agency may not conduct or sponsor and you are not required to respond to a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number. This rule does not contain any new collections of information that require OMB approval. OMB has reviewed and approved the collections of information associated with the subsistence regulations at 36 CFR part 242 and 50 CFR part 100, and assigned OMB Control Number 1018-0075, which expires June 30, 2019.

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

Executive Order 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. The executive order 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 have developed this rule in a manner consistent with these requirements.

The Regulatory Flexibility Act of 1980 (5 U.S.C. 601 et seq.) requires preparation of flexibility analyses for rules that will have a significant effect on a substantial number of small entities, which include small businesses, organizations, or governmental jurisdictions. In general, the resources to be harvested under this rule are already being harvested and consumed by the local harvester and do not result in an additional dollar benefit to the economy. However, we estimate that two million pounds of meat are harvested by subsistence users annually and, if given an estimated dollar value of $3.00 per pound, this amount would equate to about $6 million in food value Statewide. Based upon the amounts and values cited above, the Departments certify that this rulemaking will not have a significant economic effect on a substantial number of small entities within the meaning of the Regulatory Flexibility Act.

Under the Small Business Regulatory Enforcement Fairness Act (5 U.S.C. 801 et seq.), this rule is not a major rule. It does not have an effect on the economy of $100 million or more, will not cause a major increase in costs or prices for consumers, and does not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S.-based enterprises to compete with foreign-based enterprises.

Title VIII of ANILCA requires the Secretaries to administer a subsistence priority on public lands. The scope of this Program is limited by definition to certain public lands. Likewise, these regulations have no potential takings of private property implications as defined by Executive Order 12630.

The Secretaries have determined and certify pursuant to the Unfunded Mandates Reform Act, 2 U.S.C. 1502 et seq., that this rulemaking will not impose a cost of $100 million or more in any given year on local or State governments or private entities. The implementation of this rule is by Federal agencies, and there is no cost imposed on any State or local entities or tribal governments.

The Secretaries have determined that these regulations meet the applicable standards provided in sections 3(a) and 3(b)(2) of Executive Order 12988, regarding civil justice reform.

In accordance with Executive Order 13132, the rule does not have sufficient Federalism implications to warrant the preparation of a Federalism summary impact statement. Title VIII of ANILCA precludes the State from exercising subsistence management authority over fish and wildlife resources on Federal lands unless it meets certain requirements.

The Alaska National Interest Lands Conservation Act, Title VIII, does not provide specific rights to tribes for the subsistence taking of wildlife, fish, and shellfish. However, the Board provided Federally recognized Tribes and Alaska Native corporations opportunities to consult on this rule. Consultation with Alaska Native corporations are based on Public Law 108-199, div. H, Sec. 161, Jan. 23, 2004, 118 Stat. 452, as amended by Public Law 108-447, div. H, title V, Sec. 518, Dec. 8, 2004, 118 Stat. 3267, which provides that: “The Director of the Office of Management and Budget and all Federal agencies shall hereafter consult with Alaska Native corporations on the same basis as Indian tribes under Executive Order No. 13175.”

The Secretaries, through the Board, provided a variety of opportunities for consultation: Commenting on proposed changes to the existing rule; engaging in dialogue at the Council meetings; engaging in dialogue at the Board's meetings; and providing input in person, by mail, email, or phone at any time during the rulemaking process.

On April 12, 2016, the Board provided Federally recognized Tribes and Alaska Native Corporations a specific opportunity to consult on this rule prior to the start of its public regulatory meeting. Federally recognized Tribes and Alaska Native Corporations were notified by mail and telephone and were given the opportunity to attend in person or via teleconference.

This Executive Order requires agencies to prepare Statements of Energy Effects when undertaking certain actions. However, this rule is not a significant regulatory action under E.O. 13211, affecting energy supply, distribution, or use, and no Statement of Energy Effects is required.

Theo Matuskowitz drafted these regulations under the guidance of Eugene R. Peltola, Jr. of the Office of Subsistence Management, Alaska Regional Office, U.S. Fish and Wildlife Service, Anchorage, Alaska. Additional assistance was provided by:

• Daniel Sharp, Alaska State Office, Bureau of Land Management;

• Mary McBurney, Alaska Regional Office, National Park Service;

• Dr. Glenn Chen, Alaska Regional Office, Bureau of Indian Affairs;

• Carol Damberg, Alaska Regional Office, U.S. Fish and Wildlife Service; and

• Thomas Whitford, Alaska Regional Office, USDA Forest Service.

For the reasons set out in the preamble, the Federal Subsistence Board amends title 36, part 242, and title 50, part 100, of the Code of Federal Regulations, as set forth below.

On October 11, 2017 (82 FR 47115), the Postal Service published its revised privacy regulations to implement numerous non-substantive editorial changes effective on the same date. These changes included renaming certain offices with privacy-related duties, modification of the roles of employees tasked with implementing aspects of the privacy regulations, and minor editorial changes to postal privacy policy to improve its consistency and clarity. The Postal Service is now adding clarifying language to ensure the purpose of a contract or interagency agreement complies with the Postal Reorganization Act and the Privacy Act of 1974.

For the reasons stated in the preamble, the Postal Service amends 39 CFR chapter I as follows:

Section 1007(a)(2) of the Legal Services Corporation Act (Act), 42 U.S.C. 2996f(a)(2), requires LSC to establish maximum income levels for individuals eligible for legal assistance. Section 1611.3(c) of LSC's regulations establishes a maximum income level equivalent to 125% of the Federal Poverty Guidelines (Guidelines), which HHS is responsible for updating and issuing. 45 CFR 1611.3(c).

Each year, LSC updates Appendix A to 45 CFR part 1611 to provide client income eligibility standards based on the most recent Guidelines. The figures for 2018, set out below, are equivalent to 125% of the Guidelines published by HHS on January 18, 2018, 83 FR 2642.

In addition, LSC is publishing a chart listing income levels that are 200% of the Guidelines. This chart is for reference purposes only as an aid to recipients in assessing the financial eligibility of an applicant whose income is greater than 125% of the applicable Guidelines amount, but less than 200% of the applicable Guidelines amount (and who may be found to be financially eligible under duly adopted exceptions to the annual income ceiling in accordance with 45 CFR 1611.3, 1611.4, and 1611.5).

Except where there are minor variances due to rounding, the amount by which the guideline increases for each additional member of the household is a consistent amount.

Executive Summary

Why we need to publish a rule—Under the Act, a species warrants protection through listing if it is endangered or threatened. Conversely, a species may be removed from the Federal List of Endangered and Threatened Wildlife (List) if the Act's protections are determined to be no longer required based on recovery, original data error, or extinction. Removing a species from the List can be completed only by issuing a rule. This rule finalizes the removal of the eastern puma (=cougar) (Puma (=Felis) concolor couguar) from the List due to extinction, as proposed on June 17, 2015 (80 FR 34595).

The basis for our action—Our decision to remove the eastern puma from the List due to extinction is based on information and analysis showing that the eastern puma likely has been extinct for many decades, long before its listing under the Act. Eastern puma sightings have not been confirmed since the 1930s, and genetic and forensic testing has confirmed that recent validated puma sightings in the East, outside Florida, were animals released or escaped from captivity, or wild pumas dispersing eastward from western North America.

Peer review and public comment—During two comment periods on the proposed rule (June 17 through August 17, 2015 [80 FR 34595, June 15, 2015]; and June 28 through July 28, 2016 [81 FR 41925, June 28, 2016]), we sought review from the public and from independent scientific experts to ensure that our final determination responds to public concerns and is based on scientifically sound data, assumptions, and analyses. We received comments from the public on several substantive issues, including the basis for delisting, the likelihood that any undetected population of eastern puma continues to exist, the potential for restoring pumas to Eastern North America, and protection of nonlisted pumas occurring within the eastern puma's historical range. We also received peer review comments from scientists with expertise in puma population ecology, management, demographics, conservation, and population genetics. Expert comments focused primarily on the likelihood of eastern puma extinction and on North American puma taxonomy. In preparing the final rule, we considered all comments and information received during both comment periods. The proposed rule and other materials relating to this final rule can be accessed at: http://www.regulations.gov under Docket No. FWS-R5-ES-2015-0001.

The eastern puma (=cougar) was originally listed as an endangered species on June 4, 1973 (38 FR 14678). On June 17, 2015, the Service published a proposed rule (80 FR 34595) to remove the eastern puma from the List, with a comment period extending through August 17, 2015. The comment period for the proposed rule was subsequently reopened on June 28, 2016 (81 FR 41925). For more information on previous Federal actions concerning the eastern puma, refer to the proposed rule available at: http://www.regulations.gov under Docket No. FWS-R5-ES-2015-0001.

Here we summarize the biological and legal basis for delisting the eastern puma. For more detailed information, refer to the proposed rule and supplemental documents available at: http://www.regulations.gov under Docket No. FWS-R5-ES-2015-0001.

The eastern puma (Puma (=Felis) concolor couguar) is federally listed as a subspecies of puma. The puma is the most widely distributed native wild land mammal in the New World. At the time of European contact, it occurred through most of North, Central, and South America. In North America, breeding populations still occupy approximately one-third of their historical range but are now absent from eastern regions outside of Florida. The puma was documented historically in a variety of eastern habitats from the Everglades in the Southeast to temperate forests in the Northeast. Aside from presence reports, few historical records exist regarding the natural history of the eastern puma subspecies.

The eastern puma has a long and varied taxonomic history, as described in the Service's 5-year status review of this subspecies (USFWS 2011, pp. 29-35). Until recently, standard practice was to refer to the puma species as Puma concolor (Linnaeus 1771) and the eastern puma subspecies as Puma concolor couguar. The taxonomic assignment of puma subspecies is now under question; at issue is whether North American pumas constitute a single subspecies or multiple subspecies. As discussed in detail in our response to comment 4 (see Summary of Comments and Responses, below), the Service acknowledges the broad acceptance within the scientific community of a single North American subspecies, identified as Puma concolor couguar (applying the scientific nomenclature that has been used to refer to the eastern puma subspecies to all North American pumas), based on genetic analysis. However, the Service has not yet conducted a comprehensive assessment of all available scientific information pertinent to North American puma taxonomy, including any potential subspecies. We will undertake a comprehensive assessment of North American puma taxonomy in our status assessment for the Florida panther, and will determine whether to accept a single North American subspecies taxonomy. Since determining whether an entity is listable is relevant only to extant species, such a comprehensive treatment is unnecessary for the eastern puma, but will be necessary for completing the status assessment for the Florida panther. In the absence of a comprehensive analysis concluding that the Young and Goldman (1946) taxonomy is no longer the best available information on taxonomy, we evaluate for purposes of this rule the status of the listed entity—the eastern puma subspecies—and whether or not it has become extinct.

There is little basis for believing that the ecology of eastern pumas was significantly different from puma ecology elsewhere on the continent. Therefore, in lieu of information specific to eastern pumas, our biological understanding of this subspecies relies on puma studies conducted in various regions of North America and, to the extent possible, from eastern puma historical records and museum specimens. This information is detailed in the 2011 status review for the eastern puma (USFWS 2011, pp. 6-8).

Details regarding historical eastern puma abundance and distribution are provided in USFWS 2011 (pp. 8-29, 36-56). Although records indicate that the eastern puma was formerly wide-ranging and apparently abundant at the time of European settlement, only 26 historical specimens from seven eastern States and one Canadian province reside in museums or other collections. Based on this evidence, Young and Goldman (1946) and the 1982 recovery plan for the eastern cougar (USFWS 1982, pp. 1-2) generally described the eastern puma's historical range as southeastern Ontario, southern Quebec, and New Brunswick in Canada, and a region bounded from Maine to Michigan, Illinois, Kentucky, and South Carolina in the Eastern United States. The most recently published assessment of the eastern puma in Canada, conducted by the Committee on the Status of Endangered Wildlife in Canada (COSEWIC), described the subspecies' range as Ontario, Quebec, and eastern Canada (Scott 1998, pp. v, 10, 29-30). Scott (1998, p. v, 29) indicated that “Manitoba is the easternmost part of Canada for which there is objective evidence of the virtually uninterrupted survival of a cougar population from European settlement to the present. Genetically, this population must have been closely related to, if not identical with, the original eastern cougars in western Ontario, and less closely related to the original cougars in Quebec and the Maritimes.” Note, however, our response to comment 11 (see Summary of Comments and Responses), which indicates that despite the persistent presence of pumas in Manitoba, we cannot infer from the available evidence that puma occurrence there represents an extant puma population.

The historical literature indicates that puma populations were considered largely extirpated in Eastern North America (except for Florida and perhaps the Smoky Mountains) by the 1870s and in the Midwest by 1900. Their disappearance was attributed primarily to persecution stemming from fear of large predators, competition with game species, and occasional depredation of livestock. Other causes of eastern puma losses during the late 1800s included declining habitat conditions and the near-extirpation of their primary prey base, white-tailed deer. By 1929, eastern pumas were believed to be “virtually extinct,” and Young and Goldman (1946) concurred that “they became extinct many years ago.”

Conversely, puma records from New Brunswick in 1932 and Maine in 1938 suggest that a population may have persisted in northernmost New England and eastern Canada. In the Service's 1976 status review (Nowak 1976), R.M. Nowak professed his belief that the large number of unverified sightings of pumas constituted evidence that some populations had either survived or become reestablished in the central and eastern parts of the continent and may have increased in number since the 1940s. Similarly, R.L. Downing, as stated in the Eastern Cougar Recovery Plan (USFWS 1982, pp. 4, 7), had thought it possible that a small population may have persisted in the southern Appalachians into the 1920s; however, his investigations during preparation of the recovery plan led him to conclude that “no breeding cougar populations have been substantiated within the former range of F.c. couguar since the 1920s” (USFWS 1982, p. 6). This analysis and conclusion were shared by F. Scott in his COSEWIC review (Scott 1998, entire).

Thus, the most recent confirmed eastern puma sightings date from the mid-1800s to around 1930. Confirmed reports of pumas in Eastern North America (outside Florida) since then have been shown to be either western puma dispersers, as in Missouri, or released or escaped animals, as in Newfoundland.

Although habitat conditions now appear to be suitable for puma presence in various portions of the historical range described for the eastern puma, the many decades of both habitat and prey losses belie the sustained survival and reproduction of this subspecies over that time. A more detailed discussion of the historical status, current confirmed and unconfirmed puma sightings, potential habitat, and legal protection of the eastern puma in the States and provinces is provided in the 5-year status review (USFWS 2011, pp. 8-26).

We have not made substantive changes from the proposed rule (80 FR 34595, June 17, 2015). In this final rule, we have added or corrected text to clarify information and respond to input received during the public and peer review comment periods regarding the proposal. These changes have been incorporated into this final rule as presented below.

In the proposed rule (80 FR 34595, June 15, 2015), we requested that all interested parties submit written comments on the proposal by August 17, 2015. We also solicited peer review of the scientific basis for the proposal by reopening the comment period on June 28, 2016 (81 FR 41925). As appropriate, Federal and State agencies, tribes, scientific organizations, and other interested parties were contacted directly and invited to comment on the proposal. Press releases inviting general public comment were widely distributed, and notices were placed on Service websites.

We did not receive any requests for a public hearing. During the two public comment periods, a total of 75 letters submitted from organizations or individuals addressed the proposed delisting of the eastern puma. Attached to one letter was an appeal containing 2,730 names and addresses of individuals opposed to removing the eastern puma from the List. Many letters contained applicable information, which has been incorporated into this final rule as appropriate. Substantive public comments and peer review comments, with our responses, are summarized below.

(1) Comment: The North Carolina Wildlife Resources Commission (NCWRC) concurred with our finding that pumas are extirpated from the State of North Carolina. Based on that finding and its consideration of the Service's 2011 status review, the NCWRC indicated there is sufficient evidence to remove the eastern puma from the List.

Our response: We agree with the NCWRC.

(2) Comment: The Commonwealth of Virginia Department of Game and Inland Fisheries (VDGIF) supports delisting of the eastern puma consistent with our 2011 finding (USFWS 2011) that all known populations have been extirpated from their former range. The VDGIF believes that any wild pumas which may appear in the future will prove to be dispersers from western populations.

Our response: We agree with the VDGIF.

(3) Comment: Several commenters expressed concern that delisting would prevent the Service from reestablishing or reintroducing pumas in Eastern North America where suitable habitat and prey populations now occur. As a top-level carnivore, pumas are needed to restore balance to ecosystems in Eastern North America, where this role in biotic communities has been missing for over a century. Some commenters cited Cardoza and Langlois (2002) and Maehr et al. (2003), who encouraged proactive leadership on the part of government agencies to assess the possibility of reintroducing pumas to Eastern North America.

In commenting on the ecological importance of pumas as apex predators, several reviewers noted that ungulate populations (like white-tailed deer) have overpopulated in their absence. Ungulate overpopulation may cause overbrowsing, “trophic cascades,” and reduced biodiversity (Goetch et al. 2011). It may also lead to declines in mast production (McShea et al. 2007), understory recruitment of certain tree species, and reduced ground-nesting bird habitat (Rawinsky 2008) across the eastern deciduous forest. In addition to maintaining biodiversity and ecosystem functioning (Ripple et al. 2014), restoring pumas would reduce risk to the public from vehicle collisions with deer and other large ungulates (Gilbert et al. 2016) and would reduce human health issues associated with deer ticks as a vector for Lyme disease (Kilpatrick et al. 2014). Some commenters noted that restoring pumas to unoccupied portions of their historical range would be similar to the Service's restoration of wolves to unoccupied portions of their historical range.

Finally, some commenters argued that the reestablishment or reintroduction of other puma subspecies into the historical range of the eastern puma should not be considered until the status of the eastern puma as extinct is officially recognized through removal of the subspecies from the List. They indicated that delisting the eastern puma could eliminate complications associated with Federal listing and open the door for State restoration projects.

Our response: The Service acknowledges the science concerning the important ecological role that pumas and other large carnivores serve as apex predators (e.g., Kunkel et al. 2013, Ripple et al. 2014, Wallach et al. 2015) as well as the ecological consequences of high populations of ungulates (e.g., Russell et al. 2001, Ripple and Beschta 2006, McShea et al. 2007, Rossell et al. 2007, Baiser et al. 2008, Rawinsky 2008, Beschta and Ripple 2009, Goetsch et al. 2011, Brousseau et al. 2013, Cardinal et al. 2012a, Cardinal et al. 2012b). We agree that ecological science supports the contention that healthy populations of large carnivores can maintain balance in ecosystems and ameliorate adverse effects such as damage to native vegetation from grazing ungulates (e.g., Ripple et al. 2010) and population increases of small carnivores (e.g., LaPoint et al. 2015). We also acknowledge the potential value of puma recolonization associated with reducing vehicle-deer collisions (Gilbert et al. 2016).

The Service recognizes that within the historical range of the eastern puma there are large, intact areas of habitat with suitable prey resources and little human disturbance that could support puma populations (USFWS 2011, pp. 8, 11-25). Scientific articles published before and after our 2011 review conclude that potential habitat for pumas occurs in the Southeast (Keddy 2009), Georgia (Anco 2011), the Midwest (Smith et al. 2015), the Adirondack region of New York (Laundre 2013), numerous locations in New England (Glick 2014), and the Great Lakes region (O'Neil et al. 2014). Some authors predict that pumas will continue to expand their range eastward and naturally recolonize some areas of Eastern North America (LaRue and Nielsen 2014).

Despite the apparent opportunities for puma recolonizations or reintroductions, the Service does not have the authority under the Act to pursue establishment of other puma subspecies within the historical range of the eastern puma. Furthermore, while the purpose of the Act is to provide a means whereby the ecosystems upon which endangered and threatened species depend may be conserved, the Act gives the Service the authority to pursue ecosystem conservation only to the extent necessary to recover listed species. Thus, the Service cannot maintain the extinct eastern puma subspecies on the List for the purpose of facilitating restoration of other, nonlisted puma subspecies, whether to address overpopulation of deer and other ungulates or to achieve any other objective.

Delisting the eastern puma subspecies, in and of itself, would not foreclose future opportunities to reestablish pumas in Eastern North America. Although extinction of the eastern puma obviously precludes reintroduction of this particular subspecies, we concur that officially recognizing the eastern puma as extinct by removing it from the List could eliminate any perceived complications associated with the establishment of other, nonlisted puma populations into the historical range of the eastern puma. We note that authority over the establishment of nonlisted puma populations resides with the States.

(4) Comment: Several commenters questioned the conclusions in the Service's 2011 status review (pp. 29-35) regarding the taxonomy of the eastern puma subspecies. One individual asked why the Service concluded that “Young and Goldman's (1946) taxonomy of cougars was inadequate, even by the standards of their time . . .” yet incorporated this flawed taxonomy into its delisting recommendation. Several reviewers indicated that the published range maps of the subspecies were vague and poorly defined, and that the locations of specimens used to determine these ranges were not depicted on the maps. In addition, several reviewers commented that the best available science includes the genetic data indicating that all North American pumas should be classified as a single subspecies (Culver et al. 2000). Some commenters suggested that recent evidence of pumas dispersing far from the Dakotas supports the hypothesis that the North American puma functions as one extensive population with no restrictions to mating.

A few commenters asserted that, based on the widespread acceptance of genetic information leading to the recommendation to revise the taxonomy to recognize all pumas in North America as a single subspecies, the Service should delist the eastern puma subspecies on the basis of original data error rather than extinction. They also stated that, were the Service to determine that delisting is called for due to data error, we must withdraw the proposed rule and publish a new proposal explaining our rationale.

Finally, some commenters suggested that, to resolve these taxonomic questions, the Service should conduct a complete taxonomic review and analysis of the subspecies status of North American pumas, including genetic, morphological, ecological, and behavioral considerations, prior to making a listing determination.

Our response: The 5-year review in 2011 recommended that the Service propose delisting the eastern puma, and that recommendation was based on extinction (p. 57) and not on taxonomy. We note that delisting the eastern puma based on either extinction or original data error would lead to the same outcome, that is, the eastern puma's removal from the Federal List of Endangered and Threatened Wildlife.

The 2011 status review recognized that more-recent genetic information introduced “significant ambiguities” in the species taxonomy that Young and Goldman had outlined in 1946. However, rather than recommending delisting as a result of those ambiguities, the status review recommended that a full taxonomic analysis be conducted to determine whether the taxonomy should be revised (p. 35). Since completion of our eastern puma status review in 2011, there appears to have been increasing acceptance of scientific nomenclature indicating a single subspecies, Puma concolor couguar (Kerr 1792), in North America. For example:

• The Smithsonian Institution's Museum of Natural History documents current taxonomy (http://vertebrates.si.edu/msw/mswcfapp/msw/taxon_browser) and recognizes a single North American subspecies of puma, P.c. couguar, citing W.C. Wozencraft (Wilson and Reeder 2005).

• The Federal government's Interagency Taxonomic Information System (ITIS, http://www.itis.gov/), with the Department of the Interior and the Service as partners, aims to set governmental taxonomic standards and “to incorporate classifications that have gained broad acceptance in the taxonomic literature and by professionals who work with the taxa concerned.” It is important to note, however, that the Service does not consider ITIS to be a legal authority for statutory or regulatory purposes. The ITIS acknowledges a single North American subspecies, P.c. couguar, and calls all separate North American subspecies (=synonyms) invalid taxa, based on expert input from A.L. Gardner (Curator of North American Mammals and Chief of Mammal Section, National Biological Services, Smithsonian Institution), W.C. Wozencraft (Wilson and Reeder 2005), and prior references (Hall 1981, Currier 1983, Wilson and Reeder 1993, and Wilson and Ruff 1999).

• In 2009, the Convention for the International Trade of Endangered Species of Wild Flora and Fauna (CITES) received a proposal from Canada to review the taxonomy and classification of the genus Puma (https://cites.org/sites/default/files/eng/com/ac/24/E24-18-02.pdf). CITES reviewed the standard nomenclatural procedures, and reviewers recommended accepting a single North American subspecies, P.c. couguar. The Convention referred this “technical issue” to the Animals Committee for review. As of February 5, 2015, the CITES Appendices (https://www.cites.org/eng/app/appendices.php) continued to list the subspecies P.c. couguar and P.c. coryi as separate subspecies. The Animals Committee next reviewed the status of North American pumas on September 3, 2015 (https://cites.org/sites/default/files/eng/com/ac/28/E-AC28-20-03-02.pdf), when Canada and the United States proposed that the eastern puma (P.c. couguar) and the Florida panther (P.c. coryi) subspecies be transferred to Appendix II, because “P.c. couguar is considered extinct . . .” and there is ample protection under the Act for the Florida panther. Concerning taxonomy, “There is uncertainty regarding the traditional subspecies classification of Puma concolor. Recent genetic work suggests that most traditionally described subspecies are poorly differentiated (Culver et al. 2000), and the new proposed taxonomy has been adopted by the most recent version of Wilson and Reeder (2005) and by the International Union for the Conservation of Nature (IUCN, 2008). CITES continues to acknowledge the subspecies coryi and couguar based on Wilson and Reeder (2nd Edition 1993).” On October 5, 2016, CITES considered a formal proposal to move all North American pumas to Appendix II (https://cites.org/sites/default/files/eng/cop/17/prop/CA_puma.pdf), which concluded that the eastern puma subspecies was extinct by 1900. The CITES Committee accepted the proposal by consensus and also agreed that the taxonomic reference for Puma concolor would henceforth be Wilson and Reader (2005), with all North American cougars belonging to a single subspecies, P.c. couguar (https://cites.org/sites/default/files/eng/cop/17/CITES_CoP17_DECISIONS.pdf, last accessed June 5, 2017).

• The IUCN now recognizes one subspecies of cougar (Puma concolor) in North America: P.c. couguar. Concerning its most recent taxonomic decisions, “A more recent study of mtDNA in pumas throughout their range, although with lower sample sizes, supports only two main geographical groupings of North America populations having colonized since circa. 8,000 years before present (Caragiulo et al. 2013) . . . On this basis, we tentatively recognize two subspecies within Puma concolor: Puma concolor concolor . . . [and] Puma concolor couguar (Kerr 1792)” (Kitchener et al. 2017, p. 33).

• The Global Biodiversity Information Facility (GBIF, http://www.gbif.org/) recognizes one subspecies of cougar in North America, P.c. couguar. All other subspecies are considered synonyms for P.c. couguar based on the conclusions of ITIS, January 3, 2011.

• NatureServe currently acknowledges several subspecies, including P.c. couguar and P.c. coryi, but notes, “. . . mtDNA analysis by Culver et al. (2000) indicated that Puma concolor was genetically homogeneous in overall variation across North America, relative to Central and South American populations” (http://explorer.natureserve.org/servlet/NatureServe?searchSpeciesUid=ELEMENT_GLOBAL.2.101183, last accessed June 5, 2017).

Although some authorities indicate acceptance of a taxonomy identifying a single North American puma subspecies (USFWS 2011, pp. 29-35), others continue to recognize the eastern puma as a separate subspecies. This has created an ambiguous situation that does not clearly replace Young and Goldman as the best scientific and commercial data available on puma taxonomy. We conclude that, despite its deficiencies, Young and Goldman (1946) remains the best available taxonomic information for the puma. We anticipate that in our status assessment for the Florida panther, now underway, we will complete a comprehensive taxonomic treatment that considers all other available scientific information—including morphological, ecological, and behavioral factors, in addition to genetics.

Notwithstanding the commenters' questions about the taxonomy of the species, we continue to base the delisting of the eastern puma on extinction for several reasons. First, although the Act and its implementing regulations at 50 CFR 424.11(d) allow for species to be delisted for reasons of recovery, extinction, or error in the original data for classification, neither the Act nor the implementing regulations compel the Service to choose one basis for delisting over another when more than one basis is available.

Second, the eastern puma's existence has been questioned for decades—long before its listing as an endangered species under the Act. We therefore place importance on officially acknowledging our finding, through this rulemaking, that the listed entity is extinct. Clear recognition of this finding should also forestall any speculation that we have discovered evidence of the existence of eastern pumas, a perception that could be triggered by changing the basis for delisting from extinction to original data error.

Third, because the eastern puma has likely been extinct since the early to mid-1900s, and because its existence had not been confirmed at the time of listing, delisting due to extinction in this case could be considered a delisting due to original data error that is more precisely described as “prior extinction.” And because the eastern puma's existence was questioned long before listing, while new information bringing its taxonomy into doubt did not appear until well after listing, original data error based on prior extinction reasonably has precedence over original data error based on a more-recent taxonomic understanding.

Fourth, although delisting the eastern puma due to taxonomic error would have no immediate effect on the listed status of the Florida panther, it could presuppose the taxonomic status of P.c. coryi and thus cause confusion regarding the current protections afforded the Florida panther under the Act.

Finally, accepting that all pumas in North America are a single subspecies would not fully address the question as to whether the eastern puma is a listable entity. When a vertebrate animal is found not to be a valid species or subspecies, a determination that it is not a listable entity requires that it further be found not to be a “distinct population segment” (DPS) of a vertebrate species as defined in the Act and in the 1996 Interagency Distinct Population Segment policy (61 FR 4722, February 7, 1996). The eastern puma does not qualify as a DPS because it is extinct (see also our response to comment 5). Extinction, therefore, is the most fundamental basis for delisting, because it is justified whether or not the eastern puma ever constituted a taxonomically listable entity.

In sum, while the best available scientific information provides some evidence that North American pumas constitute a single subspecies, taxonomic revision awaits full resolution and does not constitute the most fundamental basis for delisting the eastern puma. The best available information also indicates that the entity described as the eastern puma was extirpated throughout its historical range long before its listing, and that this is a primary and sufficiently proven basis for delisting.

We note that the consequences of delisting the eastern puma with regard to Federal protection of dispersing western pumas are the same whether delisting were to be based on extinction or taxonomic error (see our response to comment 3, above). Western pumas dispersing into the historical range of the eastern puma subspecies currently lack protection under the Act and would not receive protection under either delisting scenario. Dispersing western pumas receive, and will continue to receive, those protections afforded by individual States.

(5) Comment: We received comments that the eastern puma should be re-listed as a DPS so that dispersing pumas from western populations could be protected from take under the Act. One person commented that the eastern puma should be re-listed under the significant portion of the range (SPR) provision of the Act.

Our response: Our DPS policy (61 FR 4722, February 7, 1996) requires that, for a population to be determined to be a DPS, it must be discrete, significant, and endangered or threatened. Because we have determined that the eastern puma subspecies no longer exists, it cannot be considered to be currently discrete, significant, and endangered or threatened, and so cannot be a DPS.

The Service's 2014 SPR policy (79 FR 37577, July 1, 2014) states that listing considerations are based solely on the status of the species in its current range. Regardless of the status of our 2014 SPR policy, the Service maintains this position. Because we have determined that the eastern puma subspecies is extinct—that is, that it does not exist in any part of its range and, therefore, has no current range—it cannot be considered endangered or threatened throughout all of its range or in any portion of its range. Therefore, a continued listing of the eastern puma based on endangered or threatened status within a significant portion of its range is not possible.

(6) Comment: Several reviewers pointed to scientific evidence that populations of eastern pumas still exist, primarily in Canada. Some commented that pumas are nearly impossible to detect and can live in suboptimal habitats (citing Stoner et al. 2006, Stoner et al. 2013a, and Stoner et al. 2013b), and others noted the tens of thousands of eyewitness reports (Glick 2014). Some commented that it is impossible to prove extinction and provided examples of species that have gone undetected for many decades or were thought to be extinct before being rediscovered.

Our response: We addressed many of these points in our 2011 status review. The Service continues to conclude that the best available scientific information, including information published since 2011, supports our finding that breeding populations of pumas no longer exist in Eastern North America outside of Florida. Although there is evidence of individual pumas (not breeding populations), there is no proof whatsoever that any pumas discovered since the 1930s within the eastern puma's historical range are members of the listed eastern puma subspecies.

Commenters cited Cumberland and Demsey (1994), Cardoza and Langlois (2002), Maehr et al. (2003), Bertrand et al. (2006), Rosatte (2011), Mallory et al. (2012), Lang et al. (2013), and Glick (2014) as corroborating documentation for the occurrence of extant puma populations in eastern Canada. Our review of these sources found that Cumberland and Demsey (1994) documented a single puma (from tracks) in New Brunswick in 1992, concluding that “these data lend little support to the existence of a remnant Eastern Cougar population. It is possible that the animal responsible for the tracks could have been an escaped or released animal.” Bertrand et al. (2006) documented hair samples from two pumas in Fundy National Park in New Brunswick in 2003. One of these was from South America, indicative of an escaped or released pet, and there has been no further evidence confirming the existence of pumas in New Brunswick since 2003. Lang et al. (2013) collected 19 confirmed puma hair samples in eastern Canada from scratching post stations from 2001 to 2012. Several of these samples likely were from the same animal. Two samples were shown to be from the same pumas reported by Bertrand et al. (2006), while six were Central and South American haplotypes (assumed to be released pets), and 10 were of North American origin (whether captive or wild was undetermined). They also evaluated the origin of three known mortalities from 1992 to 2002. One was of South American origin, one was of North American origin (uncertain whether captive origin or wild), and one was of unknown origin. From these data, Lang et al. (2013) concluded that pumas have been present in eastern Canada but provide no confirmation of the existence of the eastern puma or evidence of any breeding population of pumas. Rosatte (2011) documented 21 puma occurrences with a high degree of certainty in Ontario from 1998 to 2010, including 15 confirmed tracks, 1 hair sample consistent with pumas, genetic confirmation of 2 scats, and 3 photographs “consistent with a cougar.” Mallory et al. (2012) collected eight “potential” puma hairs (Sudbury, Ontario) identified by hair scale pattern, and reanalyzed a scat collected in 2004 from Wainfleet, Ontario, and reported in Rosatte (2011). Mallory et al. (2012) reported that trapping records from 1919 to 1984 contained no information on puma pelts sold in Ontario or in eastern Canada except for eight animals sold in Quebec from 1919 to 1920; the origin of these animals (Quebec or western Canada) cannot be confirmed. Finally, Rosatte et al. (2015) documented six additional occurrences in Ontario from 2012 to 2014, including one scat sample (North or South America haplotype not reported), three photographs, one set of tracks, one pregnant female shot (captive origin), and one young male captured (believed to be of captive origin).

Most of these authors (e.g., Cumberland and Demsey 1994, Bertrand et al. 2006, Rosatte 2011, Lang et al. 2013) acknowledge that the pumas reported recently in eastern Canada were most likely escaped or released pets or dispersers from areas supporting extant populations, as we concluded in our 2011 status review. Bertrand et al. (2006) reported that the two pumas documented in New Brunswick could be members of a remnant population, although this conclusion is contradicted by the fact that they recognized one of the two as being of South American origin. Rosatte (2011) believed that pumas may not have been extirpated in Ontario: “In my opinion, the majority of Cougars currently in Ontario are most likely a genetic mixture of escaped/released captives (or their offspring), immigrants (or their offspring), and/or native animals . . . In view of this, at least some native Cougars in Ontario may have survived the decimation of eastern Cougar populations in the 1800s. This would be feasible, given the size of Ontario (area of more than 1 million km2) and the remoteness of the province, especially in the north. However, the presence of Cougars in Ontario between the 1930s and 1980s may also have been the result of immigration from the west or escaped/released captive animals (Bolgiano and Roberts 2005).” Mallory et al. (2012) indicated that the origin of the pumas in Ontario “remains unclear,” but added, “Nevertheless, sightings of Cougars with kittens and reports of young animals suggest that a breeding population exists in Ontario and adjacent provinces (Wright 1953, Nero and Wrigley 1977, Gerson 1988, Rosatte 2011).” We note that Bertrand et al. (2006), Rosatte (2011), and Mallory et al. (2012) provide no confirmed evidence of adult or lactating female pumas, kittens, or breeding, or of an abundance of confirmed occurrences typically associated with small puma populations such as those occurring in Nebraska, the Dakotas, and Florida. Neither do they document any evidence of a continuous presence of pumas in their study areas since the late 1800s.

Given the absence of trapping records and confirmed historical records in eastern Canada since the late 1800s, the best available information points to the extirpation of puma populations in this portion of the eastern puma's historical range. Areas of Canada most likely to have been historically occupied by eastern pumas (southern Ontario and Quebec, New Brunswick, and Nova Scotia) were extensively trapped and logged, and evidence of a small breeding population would, in all probability, have been noted. With no confirmation of breeding pumas in eastern Canada for many decades, the Service concludes that those puma populations were extirpated. Further, because there is no indication of breeding or the abundant evidence of presence typically associated with small, reproducing populations, the Service concludes that the individual pumas occasionally found in Eastern Canada and the Eastern United States (outside Florida) are escaped or released pets or animals that have dispersed from western populations (or, rarely, Florida); refer to Comment 16 below for more detail).

One commenter mistakenly indicated that, among other investigators, Cardoza and Langlois (2002) and Maehr et al. (2003) provide substantial scientific evidence that eastern pumas continue to exist. On the contrary, Cardoza and Langlois (2002) shared skepticism of the plethora of anecdotal reports and sightings, concluding that “the search for cougars in the East must be conducted as a scientific endeavor.” They encouraged the Service to delist the eastern puma if it is extinct or re-list it as a DPS if any populations exist. If the subspecies were to remain listed, they encouraged the Service to revise the recovery plan, because “agencies have failed to meet the objective of . . . having found or established . . .” at least three self-sustaining populations. Maehr et al. (2003) called for recovery of pumas in Eastern North America but provided no documentation of a persistent population outside of Florida.

(7) Comment: We received several comments stating that pumas are wary and cryptic and could possibly escape detection for many years (citing Stoner et al. 2006, 2013).

Our response: Using data on puma harvests in Utah, Stoner et al. (2013) predicted that remote habitats are more likely to harbor relict populations of pumas, regardless of habitat quality, when range contractions are caused by humans. That is, pumas faced with human-induced range contraction were more likely to recede along a gradient determined by human population density rather than habitat quality; thus, remote, low-quality habitats may have greater refugia value to pumas.

Puma refugia in western North America are often characterized by remote, steep, mountainous terrain with little infrastructure for human access and relatively low ungulate populations (Stoner et al. 2013). In contrast, potential refugia for pumas in Eastern North America (e.g., Laundre 2013, Glick 2014, O'Neil et al. 2014) are neither mountainous nor remote, are readily accessible and continue to be heavily used by humans, and exist in a landscape having much higher human density (Glick 2014). Observing that small puma populations in refugia in Florida, Nebraska, and the Dakotas leave ample evidence of their presence (USFWS 2011, pp. 42-43), we infer that any remnant population of pumas persisting in Eastern North America outside Florida would have left a more or less continuous record of credible evidence since the late 1800s (e.g., pumas trapped and shot, road mortalities, carcasses, tracks, and/or photographs). Although one person commented that species can go many decades without being sighted, or can be thought extinct before being rediscovered (so-called “Lazarus species”), we received no comments providing scientific data indicating that a small, breeding population of pumas exists, only conjecture that they may exist. We agree that the historical record and the best available scientific information presented in our 2011 status review, along with scientific articles published since then, provide evidence that individual pumas (of captive origin or dispersing animals) are encountered with increasing frequency in Eastern North America. Nonetheless, there is no available scientific information, nor has any evidence been provided in comments on the proposed rule, that a breeding population of pumas has persisted in Eastern North America anywhere other than Florida.

(8) Comment: Some commenters maintained that delisting a species based on extinction requires absolute certainty that it is gone, while one reviewer requested that the Service document extinction using valid statistical methods with appropriate statistical power. The same reviewer stated that we must clearly demonstrate that the eastern puma subspecies is extinct according to government regulations at 50 CFR 424.11(d)(3).

Our response: Proving whether a taxon is extant or extinct presents a dilemma for conservation biologists (Diamond 1987). With regard to delisting on the basis of extinction, the Act's implementing regulations at 50 CFR 424.11(d) describe the burden of proof: “Unless all individuals of the listed species had been previously identified and located, and were later found to be extirpated from their previous range, a sufficient period of time must be allowed before delisting to indicate clearly that the species is extinct.”

The IUCN Standards and Petitions Subcommittee (IUCN 2014) has established criteria to track the conservation status of species, and it is instructive to consider those criteria here. The “extinct” category is used by the IUCN when there is evidence beyond a reasonable doubt that the last individual of a taxon has died, recognizing that this is extremely difficult to detect. The IUCN designates a taxon as extinct only after adequate surveys have failed to record the species and local or unconfirmed reports have been investigated and discounted. Relevant types of evidence supporting an IUCN designation of extinct include the following (Butchart et al. 2006):

• For species with recent last records, the decline has been well documented;

• Severe threatening processes are known to have occurred (e.g., extensive habitat loss, the spread of alien invasive predators, intensive hunting); and

• The species possesses attributes known to predispose taxa to extinction (e.g., flightlessness for birds).

Such evidence should be balanced against the following opposing considerations (Butchart et al. 2006):

• Recent field work has been inadequate (surveys have been insufficiently intensive/extensive or inappropriately timed, or the species' range is inaccessible, remote, unsafe, or inadequately known);

• The species is difficult to detect (it is cryptic, inconspicuous, nocturnal, nomadic, or silent, or its vocalizations are unknown, identification is difficult, or the species occurs at low densities);

• There have been reasonably convincing recent local reports or unconfirmed sightings; and

• Suitable habitat (free of introduced predators and pathogens, if relevant) remains within the species' known range, and/or allospecies or congeners may survive despite similar threatening processes.

The IUCN has not issued a determination that the eastern puma subspecies, P.c. couguar, is extinct, because they have accepted that all pumas in North America constitute one subspecies that is extant in Florida and western North America. However, the IUCN standards for extinction have been met for the eastern puma.

Many decades have passed since documentation of the last credible eastern puma records, which are contained in the scientific literature and are documented for each State and province within the eastern puma's historical range in our 2011 status review. In addition, severe threats (indiscriminate shooting, trapping, poisoning, deforestation, and extirpation of ungulate prey in much of the range) were evident at the time eastern puma populations were extirpated. Further, pumas are prone to extirpation because of their relatively small population sizes and low population densities, large habitat area requirements, and relatively slow population growth traits (Purvis et al. 2000).

Service-sponsored surveys in the early 1980s in the southern (Downing 1994a, 1994b) and northern (Brocke and VanDyke 1985) parts of the eastern puma's historical range failed to detect any pumas, noting that while difficulty of detection may be expected in the South, it should not be particularly difficult to detect pumas in the North, where there is snow. Our 2011 review also describes numerous other wildlife surveys that did not detect a breeding population of pumas in Eastern North America outside of Florida, and negative survey data are available for many portions of the historical range that still have intact habitat. Despite suggestions that we conduct further surveys, we are not aware of areas within the historical range of the eastern puma with enough evidence of a breeding population to merit the additional effort.

In our 2011 status review, we acknowledged the thousands of reported puma sightings while noting that 90 to 95 percent of these sightings have been shown to be invalid (Brocke 1981, Downing 1984, Hamilton 2006); these invalid reports have generally involved instances of misidentification and, at times, deliberate hoaxes. With respect to increasing frequency of confirmed puma sightings in recent years, we recognize that suitable habitat is available within the historical range of the eastern puma (see our response to comment 3, above), that past threats have been largely eliminated (with some level of protection for dispersing pumas), and that, according to some biologists, western pumas will continue to expand their range eastward (e.g., LaRue and Nielsen 2015).

There is no regulatory requirement for the Service to conduct statistical analyses in order to draw conclusions about extinction. Both our 2011 status review and our review of scientific information that has become available since then point to overwhelming evidence that the eastern puma subspecies is extinct (see also our earlier responses to comments 2, 7, and 10). Given that the last eastern pumas that were assumed to have existed were killed in Maine (1938) and New Brunswick (1932), the preponderance of scientific evidence fully supports our conclusion that breeding populations of pumas in Eastern North America outside of Florida and, until recent decades, Manitoba have been absent for at least the past 80 years, and that pumas recently sighted within the historical range of the eastern puma are escaped or released pets and western (and, rarely, Florida) dispersers. This conclusion and our use of the best available scientific information were sustained by peer reviewers (see comment 20, below).

(9) Comment: One commenter stated that puma populations in South Dakota, North Dakota, and Nebraska may be at the western edge of the eastern puma's historical range and may still retain genetic structure similar to the eastern puma subspecies. Thus, eastern pumas exist and should remain listed.

Our response: Pumas were extirpated from most of the Dakotas and Nebraska by the early 1900s (Thompson 2009, Wilson et al. 2010). Since 1970, breeding populations of pumas farther west—within the mapped range of the subspecies P.c. hippolestes—have expanded their ranges into eastern Montana (Desimone et al. 2005), eastern Wyoming (Moody et al. 2005), eastern Colorado, eastern New Mexico, eastern Texas, western North and South Dakota, and Nebraska (Wilson et al. 2010, LaRue et al. 2012). Molecular genetic data show that pumas in the Black Hills of South Dakota are most closely related to pumas in Wyoming (Thomson 2009, Jaurez et al. 2015), and that pumas breeding in Nebraska are likely from Wyoming and South Dakota (Wilson et al. 2010). The Service has found no evidence that pumas in the Dakotas and Nebraska are descended from the eastern puma subspecies.

(10) Comment: We received one comment about high hunting mortality in the easternmost puma populations in the Dakotas and Nebraska, raising a concern about fewer eastward-dispersing pumas to potentially recolonize former habitat. This commenter questioned the accuracy of the Service's statements that “cougar populations are growing in the West” and “pumas may continue to disperse into midwestern states.”

Our response: This comment is outside the scope of this rule, which concerns only the delisting of the eastern cougar due to extinction.

(11) Comment: We received one comment that cited Morrison (2015) to dispute information in our 2011 status review indicating that the easternmost extant breeding population of pumas in Canada occurs in Manitoba.

Our response: Morrison (2015) stated that a newly colonized area in southwest Saskatchewan and southeast Alberta “now supports the easternmost confirmed breeding population of cougars in Canada.” However, the scientific information available at the time of our 2011 review, including the 1998 COSEWIC review of pumas in Canada (Scott 1998), indicated that the easternmost breeding population of pumas occurred in Manitoba (USFWS 2011, pp. 11-12; Hutlet 2005). In addition, Watkins (2006) documented multiple confirmed puma reports in Manitoba, including two pumas killed in 2004. Another puma, radio tagged in South Dakota, was killed in Manitoba in 2008. Most recently, individual pumas in Manitoba have been trapped in 2011 and killed in 2015 and 2016 (http://www.naturenorth.com/winter/Cougar/Cougar_1.html).

Manitoba biologists have documented 20 occurrences of pumas since 2002 (carcasses, tracks, photos), including 6 puma carcasses (3 male and 3 female) since 2004. However, there has been no conclusive evidence of kittens or lactating females, and thus breeding status is uncertain. Biologists are unsure whether an increased number of dispersing pumas in Manitoba is on the cusp of developing a breeding population or whether a small breeding population currently exists (W. Watkins, Manitoba Conservation and Water Stewardship, email dated February 1, 2016). In either event, there is no evidence showing that any of these pumas is the eastern puma subspecies.

(12) Comment: We received numerous comments from people who believed they had seen a puma or evidence of a puma (deer kills, vocalizations, missing pets, dead livestock, tracks, game camera photos, collections of alleged sightings on maps, YouTube videos). Some reviewers expressed concern that pumas are dangerous and bound to attack humans, and others asserted that the sheer number of sighting reports proves the existence of eastern pumas.

Our response: As discussed in our response to comment 8, above, we acknowledge the thousands of reports of pumas in Eastern North America, but most of these are unverified and, in the majority of cases, represent misidentifications (Downing 1984, Brocke and VanDyke 1985, Hamilton 2006, South Dakota Fish, Wildlife and Parks 2005). Still, confirmed occurrences of pumas within the historical range of the eastern puma are increasing, particularly in the Midwest (LaRue et al. 2012, LaRue and Nielsen 2015). The best available scientific information supports the conclusion that confirmed occurrences of pumas in Eastern North America are released or escaped pets or dispersers from western populations. In recent decades, pumas have incrementally expanded their breeding population eastward in both Canada and the United States, and LaRue and Nielsen (2014) provide a scientific rationale for why range expansion will likely continue.

(13) Comment: One commenter stated that Michigan has a resident population of pumas (citing a 1994 book by D. Evers, Endangered and Threatened Wildlife of Michigan, and Swanson and Rusz 2006), asserting that these are neither escaped or released pets nor transients moving east from South Dakota. The commenter contends that Michigan has a long, uninterrupted history (80 years) of puma presence, including puma reports from 1966 and 1984 (i.e., before the Black Hills population in South Dakota was large enough to have dispersing animals) and further notes that the Michigan Department of Natural Resources (MDNR) verified puma evidence in 2008 and 2009. The commenter suggested that the Service ought to collect puma samples, conduct a full genetic analysis of samples collected in each State/region, and review related information about pumas in eastern Canada.

Our response: We have reviewed all information provided by the public with respect to pumas in Michigan along with data obtained for the 2011 status review and information obtained since then. Regarding a resident Michigan puma population, the MDNR stated (in a letter dated March 30, 2007) that “all available information suggests the eastern puma subspecies was extirpated after the turn of the century [1900].” The MDNR also expressed concerns about the scientific validity of information presented in Swanson and Rusz (2006), except for one confirmed occurrence in Delta County (2004). Kurta and Schwartz (2007) further refuted Swanson and Rusz's (2006) conclusion that a population of eight pumas existed in Michigan.

Nonetheless, as in most eastern States and provinces, there continue to be numerous reports of pumas in Michigan, the most credible of which are investigated by the MDNR following its response protocol. At the time of the 2011 review, the MDNR had confirmed one puma report from Alcona County (1998) and one “likely” occurrence in Menominee County (2004). Since then, additional confirmed occurrences have been documented in the Upper Peninsula of Michigan in Ontonagon County (two in 2011), Houghton County (one in 2011), Keweenaw County (three in 2011), Baraga County (one in 2011, two in 2012), Marquette County (four in 2012, two in 2013), Delta County (one in 2015), Menominee County (one in 2010, two in 2012, one in 2015), Schoolcraft County (one carcass in 2015), Luce County (one in 2013, one in 2014), Mackinac County (two in 2014), and Chippewa County (one in 2014).

Noting that many of these records could represent multiple confirmations of the same animal, the number of confirmed puma occurrences in the Upper of Peninsula of Michigan has totaled 27 since 2010. This is in marked contrast to the number of confirmed puma records in Nebraska (255 since 2010), with its small breeding population of about 25 pumas.

The overall record of pumas dispersing eastward has grown substantially since the 2011 status review, with 271 confirmed puma occurrences east of documented breeding areas in the Dakotas, Nebraska, Colorado, and Texas (www.cougarnet.org/confirmations). The majority of these animals are dispersing juvenile males (although see our response to comment 11 concerning Manitoba). Many scientists, including MDNR biologists, think it possible that a breeding population of pumas could become reestablished in Michigan and other midwestern States and Canadian provinces; however, at this time, the MDNR has concluded that pumas in Michigan, documented exclusively in the Upper Peninsula, are all dispersing animals from western populations (R. Mason, MDNR Wildlife Division, emails dated 2 February 2016). All four puma carcasses examined by MDNR to date (mortalities from various causes), as well as trail camera photos where sex can be determined, have been males. The MDNR has no current evidence of any females and no evidence of puma reproduction in Michigan (R. Mason, MDNR Wildlife Division, emails dated 2 February 2016). Similarly, the Service has not found evidence that breeding occurs east of Saskatchewan, North Dakota, South Dakota, and Nebraska.

(14) Comment: One commenter contested the genetic basis for the South Dakota origin of the puma killed in Connecticut in 2014.

Our response: The Service recently reviewed Hawley et al. (2016) regarding the puma killed in Connecticut in 2014. DNA samples from this puma had mitochondrial DNA consistent with haplotype “M,” which is widespread in North American pumas (Culver et al. 2000, Culver and Schwartz 2011). Structure analysis indicated that, genetically, this animal was most closely related to the subpopulation of pumas found in the Black Hills of South Dakota. Assignment tests showed that this animal had a 99.9-percent chance of originating from the South Dakota puma population compared to other populations in the database (U.S. Forest Service Rocky Mountain Research Lab, Missoula, Montana).

(15) Comment: Several reviewers expressed concern that, after delisting of the eastern puma, pumas occurring or dispersing into the former range of the eastern puma would be left unprotected. Some commenters observed that State laws would not adequately protect pumas in the absence of its Federal listing, noting that only 7 of 19 States in the historical range protect the subspecies under a State endangered species law or its equivalent. Thus, the Act's protections against take are needed to promote natural recolonization of animals with genetics identical to pumas originally occurring in Eastern North America. Others commented that pumas need to be managed at a metapopulation level to ensure access to refugia and safe passage between populations.

Our response: Advances in molecular biology in the last 10 to 15 years have enabled scientists to document the origin of many of the pumas reported in Eastern North America. Further, within the last 5 years, advances in isotope analysis allow determinations of whether an animal has had a history of being in captivity. Analyses have revealed that some of the pumas found in Eastern North America are of South American origin or show evidence of having been in captivity. Outside Florida (with the exception of the panther killed in Georgia in 2008; see comment 16, below), pumas of North American origin have been found to be either wild western pumas or to have been captive animals.

The take protections of the Act do not extend to nonlisted pumas, irrespective of their origin or the fact that they have been found within the eastern puma's historical range. However, despite the Act's inapplicability to these pumas, some States have enforced their respective wildlife laws to protect all pumas within their jurisdictions. In addition to the take prohibitions associated with some State endangered species laws, many States within the historical range have closed seasons on pumas, affording some level of protection, and similar provincial protections are provided to pumas that may disperse into eastern Canada. Florida panthers, wherever they occur, continue to be protected from take under the Act, and all other pumas occurring in Florida continue to be protected under a similarity of appearance designation (32 FR 4001, March 11, 1967).

We emphasize that the authority and responsibility for protection and management of pumas not listed under the Act resides with the States, and balancing a public interest in natural recolonization with the concern for public, pet, and livestock safety will be a challenging endeavor. Recent studies of public attitudes toward pumas recolonizing or being reintroduced in Eastern North America provide a good foundation for management plans, policy decisions, and educational initiatives (Davenport et al. 2010, Thornton and Quinn 2010, Jacobsen et al. 2012, Bruskotter and Wilson 2014, McGovern and Kretser 2014, Smith et al. 2015, McGovern and Kretzer 2015). These human dimension studies also identify the many social and political challenges associated with such initiatives.

(16) Comment: Some commenters expressed a concern that if the eastern puma is delisted, there will be no protection under the Act for Florida panthers that disperse beyond Florida. Pumas can travel long distances (over 1,000 miles); thus, dispersing Florida panthers could potentially occur through much of the historical range of the eastern puma subspecies. Protection from take is important for the natural range expansion of the Florida panther. Some commenters suggested that the Florida panther be reclassified as a DPS to ensure continued Federal protection from take. Commenters also stated that Florida panthers are a source population that could, potentially, naturally recolonize other parts of Eastern North America.

Our response: As a listed subspecies, Florida panthers are protected under the Act from take wherever they occur—both in and outside of Florida. For instance, a dispersing Florida panther killed in Georgia in 2008 was protected under the Act and became a subject of Federal investigation. These protections against take of Florida panthers will continue in the event of delisting the eastern puma on the basis of extinction.

(17) Comment: Several commenters suggested that the Service update its analysis to consider new information regarding confirmed puma sightings in the historical range of the eastern puma. The Service should actively search for new reports of pumas within their Eastern North America historical range.

Our response: Since completing our 2011 status review, we have continued to monitor confirmed records of pumas in Eastern North America (e.g., through cougarnet.org; see earlier comments 2, 7, and 10). We also refer reports and sightings of pumas we receive to the respective State wildlife agencies. Although pumas continue to be confirmed in Eastern North America, the available scientific information fully supports our conclusion that these animals are released or escaped pets or dispersers from western populations or, rarely, Florida. To date, there remains a complete lack of evidence of breeding eastern pumas in locations not already documented in the 2011 review, and despite many additional puma reports in Eastern North America, the best available information indicates that the eastern puma subspecies is extinct. For these reasons, it is not necessary or advisable to conduct surveys or actively solicit additional reports of pumas in Eastern North America to determine eastern puma status.

(18) Comment: Several commenters stated that the current listing requires insignificant funding and staff resources, and that therefore it does no harm to keep eastern pumas on the List. The Service should thus heed the precautionary principle (Simson 2015) and give listed pumas the benefit of the doubt. Furthermore, the Service has already set a precedent for listing species in unoccupied portions of their historical range (e.g., wolves).

Our response: Section 4(b)(1)(A) of the Act requires that listing decisions under section 4(a)(1) be made solely on the basis of the best scientific and commercial data available. Therefore, in making the determination whether to delist the eastern puma, we did not consider the funding and staffing consequences of keeping it on the List or removing it from the List. Nonetheless, the Service disagrees that retaining the extinct eastern puma on the List has no repercussions. Keeping an extinct entity on the List can cause confusion—in this case, confusion over whether escaped or released captive pumas and dispersing animals from non ESA-listed western puma populations are protected when found in the historical range of the eastern puma. Confusion surrounding the Service's responsibilities relating to pumas also unnecessarily complicates the States' management of puma issues. Additionally, this final rule will not change the Act's protections for the Florida panther (P.c. coryi). Florida panthers, wherever they occur, continue to be protected from take under the Act, and all other pumas occurring in Florida continue to be protected under a similarity of appearance designation (32 FR 4001, March 11, 1967). Pumas occurring elsewhere in the U.S. do not receive the protections of the Act.

There also continue to be costs associated with retaining the eastern puma on the List. Maintaining the eastern puma on the List obligates the Service to continue to compile information relating to puma science and reported sightings and to respond to reported sightings. The Service therefore expends considerable staff time addressing puma reports and questions, diverting limited resources from conservation efforts for listed species that still exist.

While many listed species have areas of unoccupied range, there is no precedent for listing a species when its entire range is unoccupied because the entity is extinct. It is important to recognize that under the Act the Service cannot list a “vacant” range—we can list only species, subspecies, and DPSs. Thus, if a species as defined by the Act is determined to be extinct, we can neither list it nor keep it listed. We acknowledge that this commenter could be implying that the eastern puma should remain listed because its entire unoccupied historical range represents a portion of the historical range of a higher-level taxon to which it belongs (e.g., a North American subspecies). However, for any higher-level taxon of puma to be listed, the Service would need to determine that it meets the definition of an endangered species or a threatened species, and this determination must be based on its status where it currently occurs, not on its status as absent in a portion of its historical range.

Almost 80 years have passed (including more than 40 years while listed under the Act) with no confirmation of the existence of the eastern puma. In addition to the effort and resources put into evaluating all available scientific evidence, this amount of time is sufficient to determine the extinction of an animal that is not difficult to detect wherever it exists as a breeding population—this reasoning satisfies the precautionary principle. See also our response to comment 8.

(19) Comment: Some commenters suggested that the Service develop a recovery plan to address puma recolonization and habitat protection across the North American continent. One commenter was impressed by the California Department of Fish and Wildlife's draft wolf plan, (https://www.ca.gov/conservation.mammals/gray-wolf), developed before wolves began to breed in that State, and would like to see a study of the issues State wildlife agencies anticipate if pumas should naturally recolonize the East and Midwest.

Our response: Because the eastern puma listing imparts no protection either directly or indirectly to other pumas, there would be no benefit to retaining the listed status of the extinct subspecies for the purpose of allowing State wildlife agencies to prepare for recolonization of pumas from western populations to Eastern North America. For a species that has recovered, delisting may require States to demonstrate that the species will be managed to maintain its recovered status, and States often develop management plans to show that their oversight will be adequate to address any emerging or reemerging threats. Because we are delisting due to extinction rather than recovery, there is no need for States to foresee problems and demonstrate adequate management solutions for the eastern puma.

Section 4 of the Act authorizes the Service to develop recovery plans for species listed as endangered or threatened. With regard to listed pumas, recovery plans were developed for the eastern puma (http://ecos.fws.gov/docs/recovery_plan/820802.pdf) and Florida panther (http://ecos.fws.gov/docs/recovery_plan/081218.pdf). The eastern puma recovery plan called for the discovery or establishment of at least three self-sustaining populations. This goal has proven to be unachievable given the absence of any source individuals, making the plan moot. Finalization of this rule will not affect the Florida panther recovery plan, which will continue to be implemented.

In some instances, the Service has promoted the development of multi-State conservation plans for species that are petitioned or are candidates for Federal listing (e.g., sage grouse, New England cottontail); however, we do not have the authority to develop recovery plans for nonlisted species (i.e., for pumas dispersing from western populations). The Federal government does share authority for managing and conserving fish and wildlife with the States, but our limited fiscal resources are focused on Federal trust resources, including threatened and endangered species, migratory birds, and migratory fish. Thus, it would be inappropriate for the Service to oblige States to develop a plan for recolonizing or reintroducing nonlisted pumas, nor would we have any authority to require that Canadian provinces participate in such an effort.

In accordance with our 1994 peer review policy (59 FR 34270, July 1, 1994), we invited six independent scientists to comment on our proposed delisting proposal (81 FR 41925, June 28, 2016). These individuals are recognized for their expertise in large carnivore ecology and management, with particular knowledge in one or more of the following areas: puma population ecology, management, demographics, conservation, and population genetics. In response to our request, we received comments from five experts.

We reviewed all peer review comments for substantive issues and new information regarding the status of the eastern puma. With the exception of our position in the proposed rule on current North American puma taxonomy, the peer reviewers largely endorsed our methods and overall conclusions, and provided new information and suggestions to improve the final rule. Specific peer review comments are addressed below and incorporated as appropriate into this rule or into supplemental documents (such as references cited), available at: http://www.regulations.gov under Docket No. FWS-R5-ES-2015-0001.

(20) Peer review comment: With regard to the current status of the eastern puma, three reviewers concurred with the Service's conclusion that there are no breeding populations of pumas in the historical range of the eastern puma and that the eastern puma subspecies is extinct, and agreed that the Service adequately documented this conclusion with the best available scientific information. One reviewer cited unpublished genetic data showing that all puma samples from Eastern North America evaluated in her laboratory were of South American origin, consistent with animals originating from captive sources, while another reviewer concluded that pumas in Eastern North America are not extinct but live in a highly discrete, endangered population segment in southern Florida. Two reviewers concurred that the vast majority of recently documented sightings represent either misidentifications or misrepresentations, and that the rare confirmed reports are likely dispersers from western puma populations or pumas that have been released or escaped from captivity.

One reviewer provided extensive comments and data concerning confirmed puma reports in Eastern North America. Based on this information, the reviewer surmised that there is not a breeding population of pumas within the historical range of the eastern puma. This reviewer also discussed published studies that suggest evidence of resident puma populations in Eastern North America (e.g., Johnston 2002, Bertrand et al. 2006, Swanson and Rusz 2006, Rosatte 2011, Mallory 2012), concluding that most of these claims were based on unreliable eyewitness accounts and noting the lack of evidence of kittens. The reviewer disagreed with the reasoning presented in some of these papers that a breeding population of pumas could exist within the historical range of the eastern puma without being detected. This reviewer also reviewed genetic evidence from Bertrand et al. 2006, Swanson and Rusz 2006, Kurta et al. 2007, Mallory et al. 2012, Lang et al. 2013, and Rosatte 2013, and, based on these collective sources, concluded that recent confirmed reports do not constitute compelling evidence of a breeding population, and that the confirmed individuals within the historical range represent animals that have dispersed from western populations.

Our response: We concur with these comments, which validate or further corroborate the best available scientific information and conclusions in our 2011 status review (USFWS 2011).

(21) Peer review comment: Four of the five peer reviewers stated that the best available scientific information (Culver et al. 2000, Culver 2010) supports the conclusion that there is a single subspecies of puma, Puma concolor couguar, in North America. A fifth peer reviewer did not comment on this issue. Two peer reviewers noted that the revised taxonomy, P.c. couguar, is identical to the nomenclature used for the listed eastern puma subspecies, which could create confusion with a determination that the listed eastern puma subspecies, P.c. couguar, is extinct. These peer reviewers recommended that the Service accept the revised taxonomy and consider the single North American subspecies extant but extirpated within the historical range previously delineated for the eastern puma. Another peer reviewer further suggested that genetic evidence, documentation of long-distance dispersal of pumas, and lack of geographic barriers support a single North American subspecies. Two peer reviewers pointed out that species-wide morphological studies based on more than 1,000 puma skulls (Gay 1994, Gay and Best 1996, Wilkens et al. 1997) did not support separation of populations into the 32 previously described subspecies, with one reviewer discussing Wilkens et al.'s (1997) findings of the skull measurements, pelage color, mid-dorsal whorl, kinked tail, and deformed sperm thought to be unique to the Florida panther. Based on morphological and genetic studies, these two peer reviewers concluded there was no evidence that the eastern puma was ever a valid subspecies and suggested that the Service should delist based on taxonomic error. One reviewer suggested that the incorrect original classification of the eastern puma subspecies may warrant a reassessment of taxonomy. Another peer reviewer indicated that the original subspecies designation was arbitrary and the eastern puma still persists as the Florida panther.

Our response: These peer review comments reflect those expressed by many public reviewers, to which we provide a detailed response under comment 4, above. Although mounting evidence appears to support a single North American puma subspecies, resolution of any remaining uncertainty would constitute an additional, rather than a preemptive, line of reasoning for delisting the eastern puma. Because we have determined that drawing a conclusion regarding a revision of North American subspecies taxonomy is not necessary to delist the eastern puma based on extinction, we have no compelling basis for withdrawing our proposal to delist due to extinction in order to consider delisting due to original data error. Therefore, for the purposes of this regulatory action, we continue to treat the eastern puma as a subspecies as originally listed under the Act.

(22) Peer review comment: Two peer reviewers commented that the only remnant population of pumas in Eastern North America persists in Florida, and that it should be designated as a DPS. Going further, one of these reviewers suggested that an endangered DPS designation should encompass the entire historical range of the Florida panther and the eastern puma subspecies.

Our response: These peer review comments are similar to several comments from the public, and our response is discussed in detail under comments 4 and 5.

(23) Peer review comment: One reviewer suggested that a recovery plan should be developed for pumas in Eastern North America including, specifically, pumas from Florida. This recovery plan should also include translocating animals from western puma populations and protecting dispersing individuals from western populations.

Our response: We address this issue in our response to public comments concerning a recovery plan for pumas in Eastern North America (see our response to comment 19).

Section 4 of the Act and its implementing regulations (50 CFR part 424) set forth the procedures for listing species, reclassifying species, and removing species from listed status. “Species” is defined by the Act as including any species or subspecies of fish or wildlife or plants, and any distinct population segment of any species of vertebrate fish or wildlife which interbreeds when mature (16 U.S.C. 1532(16)). To determine whether a species should be listed as endangered or threatened, we assess the likelihood of its continued existence using the five factors described in section 4(a)(1) of the Act (see Consideration of Factors Affecting the Species, below). A species may be reclassified or removed from the List on the same basis. With regard to delisting a species due to extinction, “a sufficient period of time must be allowed before delisting to indicate clearly that the species is extinct” (50 CFR 424.11(d)(1)). According to these dual standards, we must determine whether the eastern puma subspecies is a valid listed entity that remains extant in order to determine its appropriate listing status.

With regard to the validity of the eastern puma as a subspecies and, therefore, as a listable entity, we recognize that support for a single North American subspecies has gained wide acceptance in the scientific community. However, the Service has not yet conducted a comprehensive assessment of all available scientific information pertinent to North American puma taxonomy and therefore has not yet drawn a conclusion whether to accept the single North American subspecies taxonomy. Furthermore, the Service has determined that, because drawing a conclusion on the single North American subspecies taxonomy is not needed to delist the eastern puma based on extinction, we have no essential basis for withdrawing our proposal to delist due to extinction in order to consider delisting due to original data error. Therefore, for the purposes of this regulatory action, we continue to treat the eastern puma as a subspecies as originally listed under the Act.

With regard to a determination that the eastern puma subspecies is extinct, it is important to note that the continuing presence of pumas in Eastern North America is not debated. However, physical and genetic evidence indicates that pumas recently observed in Eastern North America are released or escaped captive animals, with the exception of some wild pumas that have dispersed from western populations or, rarely, Florida.

Most significantly, no evidence whatsoever has been found to show that either individuals or relict populations of the eastern puma subspecies remain extant. The most recent confirmed records of pumas native to Eastern North America are from Tennessee (1930), New Brunswick (1932), and Maine (1938). These records coincide with the extirpation of white-tailed deer in most of the eastern puma's range in the 1800s, with the exception of a few remaining large forest tracts, and a shift of eastern pumas toward the northern periphery of their historical range during that time. In contrast, areas throughout North America that still support extant populations of native pumas have had a long and continuous record of confirmed occurrences.

Given the puma's life span, generally thought to be 10 to 11 years, it is implausible that nonbreeding eastern pumas could have persisted in the wild without being detected for more than seven decades and under conditions of habitat loss and lack of their primary prey base. By the same token, it is highly improbable that a breeding population of the subspecies could have gone undetected for that long. Together with the complete lack of either a recent report or a long-term record of eastern puma presence, these factors are indicative of the long-term absence of this subspecies.

In summary, we find that pumas (except for single transients) are reasonably detectable, that no contemporary puma sightings in Eastern North America have been verified as the eastern puma subspecies since 1938, and that it is extremely unlikely that undetected individuals or eastern puma populations could have survived the long period during which most of their habitat was lost and their primary prey was nearly extirpated. We therefore conclude that the eastern puma subspecies, Puma (=Felis) concolor couguar, is extinct.

As mentioned under Assessment of Species Status above, section 4 of the Act and its implementing regulations (50 CFR part 424) set forth the procedures for listing, reclassifying, or removing species from listed status. When we evaluate whether a species should be listed as an endangered species or threatened species, we must consider the five listing factors described in section 4(a)(1) of the Act: (A) The present or threatened destruction, modification, or curtailment of the species' habitat or range; (B) overutilization for commercial, recreational, scientific, or educational purposes; (C) disease or predation; (D) the inadequacy of existing regulatory mechanisms; and (E) other natural or manmade factors affecting the species' continued existence. We must consider these same factors in reclassifying a species or removing it from the List. Discussion of these factors and their application to the eastern puma follows. The principal factors leading to the listing of the eastern puma were widespread persecution (via poisoning, trapping, hunting, and bounties) (factors B and D), decline of forested habitat (factor A), and near-extirpation of white-tailed deer populations during the 1800s (factor A). Other natural or manmade factors affecting the species' continued existence (factor E) and disease or predation (factor C) were not identified as threats. These impacts led to the extirpation of most eastern puma populations by 1900. However, because we have determined that all populations of pumas described as the eastern puma have been extirpated and no longer exist, analysis of the five factors under section 4(a)(1) of the Act, which apply to threats facing extant populations, is immaterial.

As stated above, given the period of time that has passed without verification of even a single eastern puma, the Service concludes that the last remaining members of this subspecies perished decades ago. Therefore, the eastern puma is no longer extant and cannot be evaluated as an endangered species or threatened species.

After a thorough review of all available information, we have determined that the subspecies Puma (=Felis) concolor couguar is extinct. Based upon this determination and taking into consideration the definitions of “endangered species” and “threatened species” contained in the Act and the reasons for delisting as specified in 50 CFR 424.11(d), upon its effective date this rule removes the eastern puma from the List of Endangered and Threatened Wildlife at 50 CFR 17.11.

Conservation measures provided to species listed as endangered or as threatened under the Act include recognition, recovery actions, requirements for Federal protection, and prohibitions against certain practices. However, because the Service has determined the eastern puma to be extinct, this final rule removes any Federal conservation measures for any individual eastern pumas as originally listed on June 4, 1973 (38 FR 14678) (Puma (=Felis) concolor couguar). This final rule will not change the Act's protections for the Florida panther (P.c. coryi).

This final rule revises 50 CFR 17.11 by removing the eastern puma from the List of Endangered and Threatened Wildlife due to extinction. Upon the effective date of this rule, the prohibitions and conservation measures provided by the Act will no longer apply to this subspecies. There is no designated critical habitat for the eastern puma.

Section 4(g)(1) of the Act, added in the 1988 reauthorization, requires the Service to implement a program, in cooperation with the States, to monitor for not less than 5 years the status of all species that have recovered and been removed from the Lists of Endangered and Threatened Wildlife and Plants (50 CFR 17.11 and 17.12). Because we have determined that the eastern puma is extinct, post-delisting monitoring is not warranted.

We have determined that an environmental assessment or an environmental impact statement, as defined under the authority of the National Environmental Policy Act of 1969, need not be prepared in connection with regulations adopted pursuant to section 4(a) of the Act. We published a notice outlining our reasons for this determination in the Federal Register on October 25, 1983 (48 FR 49244).

In accordance with the President's memorandum of April 29, 1994, Government-to-Government Relations with Native American Tribal Governments (59 FR 22951), E.O. 13175, and the Department of the Interior's manual at 512 DM 2, we readily acknowledge our responsibility to communicate meaningfully with recognized Federal Tribes on a government-to-government basis. In accordance with Secretarial Order 3206 of June 5, 1997 (American Indian Tribal Rights, Federal-Tribal Trust Responsibilities, and the Endangered Species Act), we readily acknowledge our responsibilities to work directly with Tribes in developing programs for healthy ecosystems, to acknowledge that tribal lands are not subject to the same controls as Federal public lands, to remain sensitive to Indian culture, and to make information available to Tribes. Accordingly, the Service communicated with Tribes during the public comment period on the proposed rule and received no comments expressing concern about our conclusion that the eastern puma is extinct.

A complete list of references is available as a supplemental document at http://www.regulations.gov under Docket No. FWS-R5-ES-2015-0001. References are also posted on http://www.fws.gov/northeast/ecougar.

The primary authors of this rule are the staff members of the Service's Maine Fish and Wildlife Service Complex, Ecological Services Maine Field Office, and the Hadley, Massachusetts, Regional Office (see FOR FURTHER INFORMATION CONTACT).

Accordingly, we amend part 17, subchapter B of chapter I, title 50 of the Code of Federal Regulations, as set forth below:

NMFS manages the Northwestern Hawaiian Islands (NWHI) commercial lobster fishery under the Fishery Ecosystem Plan for the Hawaiian Archipelago. The regulations at 50 CFR 665.252(b) require NMFS to publish an annual harvest guideline for lobster Permit Area 1, comprised of Federal waters around the NWHI.

Regulations governing the Papahanaumokuakea Marine National Monument in the NWHI prohibit the unpermitted removal of monument resources (50 CFR 404.7), and establish a zero annual harvest guideline for lobsters (50 CFR 404.10(a)). Accordingly, NMFS establishes the harvest guideline for the NWHI commercial lobster fishery for calendar year 2018 at zero lobsters. Harvest of NWHI lobster resources is not allowed.