Federal Register Vol. 83, No.2,

Discussion

The European Aviation Safety Agency (EASA), which is the aviation authority for the Member States of the European Union, has issued EASA Airworthiness Directive 2014-0144R1, dated June 10 2014; corrected June 11, 2014 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain ATR—GIE Avions de Transport Régional Model ATR 42-500 airplanes and Model ATR 72-212A airplanes. The MCAI states:

ATR has issued the following service information.

• ATR Service Bulletin ATR42-26-0031, dated April 30, 2014. This service information describes procedures for inspecting for damage and incorrect installation of the left-hand and right-hand engine fire extinguishing pipes, and corrective actions.

• ATR Service Bulletin ATR72-26-1027, dated April 30, 2014. This service information describes procedures for inspecting for damage and incorrect installation of the left-hand and right-hand engine fire extinguishing pipes, and corrective actions.

These documents are distinct since they apply to different airplane models. 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 of this AD.

This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with the State of Design Authority, we have been notified of the unsafe condition described in the MCAI and service information referenced above. We are issuing this AD because we evaluated all pertinent information and determined the unsafe condition exists and is likely to exist or develop on other products of the same type design.

There are currently no domestic operators of this product. Therefore, we find good cause that notice and opportunity for prior public comment are unnecessary. In addition, for the reasons 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 we did not precede it by notice and opportunity for public comment. We invite you to send any written relevant data, views, or arguments about this AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2017-1178; Product Identifier 2014-NM-144-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this AD. We will consider all comments received by the closing date and may amend this AD based on 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 AD.

Currently, there are no affected U.S.-registered airplanes. If an affected airplane is imported and placed on the U.S. Register in the future, we provide the following cost estimates to comply with this AD:

We estimate that it will take about 2 work-hours per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour. Required parts will cost $0 per product. Based on these figures, we estimate the cost of this AD will be $170 per product.

We also estimate that any necessary follow-on actions will take about 16 work-hours and require parts costing $1,360, for a cost of $2,720 per product. We have no way of determining the number of aircraft that might need these actions.

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 transport category airplanes to the Director of the System Oversight Division.

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

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

1. Is not a “significant regulatory action” under Executive Order 12866;

2. Is not a “significant rule” under the 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:

Discussion

The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA Airworthiness Directive 2015-0146, dated July 22, 2015; corrected July 24, 2015, (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Airbus Model A300 B4-600, B4-600R, and F4-600R series airplanes, and Model A300 C4-605R Variant F airplanes (collectively called Model A300-600 series airplanes); and Airbus Model A310 series airplanes. The MCAI states:

You may examine the MCAI on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-1180.

This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with the State of Design Authority, we have been notified of the unsafe condition described in the MCAI. We are issuing this AD because we evaluated all pertinent information and determined the unsafe condition exists and is likely to exist or develop on other products of these same type designs.

Since there are currently no domestic operators of this product, we find good cause that notice and opportunity for prior public comment are unnecessary. In addition, for the reason(s) 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 we did not precede it by notice and opportunity for public comment. We invite you to send any written relevant data, views, or arguments about this AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2017-1180; Product Identifier 2012-NM-201-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this AD. We will consider all comments received by the closing date and may amend this AD based on 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 AD.

Currently, there are no affected U.S.-registered airplanes. This AD requires contacting the FAA to obtain instructions for addressing the unsafe condition, and doing the actions specified in those instructions. Based on the actions specified in the MCAI AD, we are providing the following cost estimates for an affected airplane that is placed on the U.S. Register in the future:

We have received no definitive data that would enable us to provide cost estimates for the repair or replacement specified in this AD. We estimate the following costs to do any necessary on-condition reporting that would be required based on the results of the required action:

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

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 transport category airplanes to the Director of the System Oversight Division.

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

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

1. Is not a “significant regulatory action” under Executive Order 12866;

2. Is not a “significant rule” under the 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:

Discussion

We issued AD 2011-04-05, Amendment 39-16605 (76 FR 8612, February 15, 2011) (“AD 2011-04-05”), which applied to all Airbus Model A340-200, -300, -500, and -600 series airplanes. AD 2011-04-05 was prompted by a determination that certain steel forgings used to manufacture certain landing gear components were below specification limits, and the introduction of new ALIs. AD 2011-04-05 required revising the maintenance or inspection program to incorporate new ALIs. We issued AD 2011-04-05 to prevent the failure of certain life-limited parts, which could result in reduced structural integrity of the airplane.

Since we issued AD 2011-04-05, we have determined that more restrictive instructions or airworthiness limitations are needed to address the unsafe condition.

The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2014-0009, dated January 8, 2014 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for all Airbus Model A340-200, -300, -500, and -600 series airplanes. The MCAI states:

You may examine the MCAI on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-1181.

This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with the State of Design Authority, we have been notified of the unsafe condition described in the MCAI. We are issuing this AD because we evaluated all pertinent information and determined the unsafe condition exists and is likely to exist or develop on other products of the same type design.

Since there are currently no domestic operators of this product, we find good cause that notice and opportunity for prior public comment are unnecessary. In addition, for the reason(s) 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 we did not precede it by notice and opportunity for public comment. We invite you to send any written relevant data, views, or arguments about this AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2017-1181; Product Identifier 2014-NM-037-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this AD. We will consider all comments received by the closing date and may amend this AD based on 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 AD.

Currently, there are no affected U.S.-registered airplanes. This AD requires contacting the FAA to obtain instructions for addressing the unsafe condition, and doing the actions specified in those instructions. Based on the actions specified in the MCAI AD, we are providing the following cost estimates for an affected airplane that is placed on the U.S. Register in the future:

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 transport category airplanes to the Director of the System Oversight Division.

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

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

1. Is not a “significant regulatory action” under Executive Order 12866;

2. Is not a “significant rule” under the 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:

Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain The Boeing Company Model MD-11 and MD-11F airplanes. The NPRM published in the Federal Register on May 30, 2017 (82 FR 24597). The NPRM was prompted by fuel system reviews conducted by the manufacturer. The NPRM proposed to require a one-time inspection of the wire assemblies of the tail fuel tank transfer pumps to determine if metallic transitions are installed at the wire harness breakouts, and corrective actions if necessary. We are issuing this AD to detect and correct potential ignition sources inside the tail fuel tank, which, in combination with flammable vapors, could result in a fuel tank fire or explosion, and consequent loss of the airplane.

We gave the public the opportunity to participate in developing this final rule. The following presents the comments received on the NPRM and the FAA's response to each comment.

The Air Line Pilots Association International stated that it agreed with the intent of the NPRM.

Boeing asked that we clarify the description of the unsafe condition identified in paragraph (e) of the proposed AD to add the potential of fuel starvation as the end-level effect. Boeing stated that referenced service information specifies that the unsafe condition could result in engine fuel starvation.

We agree that damaged wires could result in fuel starvation as a potential unsafe condition. However, we have no SFAR88 analysis or service difficulty reports associated with the loss of system functions or fuel starvation from the chafed or damaged wires identified in this AD. We do have previous Special Federal Aviation Regulation 88 (SFAR88) ADs for wire harnesses in the same area that were issued to prevent wire chafing and potential ignition sources inside the fuel tank. The actions required by this AD are intended primarily to reduce the risk of other incidents of wires chafing and subsequent fuel tank fire or explosion. Therefore, we have made no change to this AD in this regard.

FedEx asked that the work-hours under the On-Condition Costs for the replacement be increased from 16 to 100. FedEx stated that the replacement cost specifies 16 work-hours, but noted that replacement of only one affected part will actually take about 100 hours. FedEx added that 100 work-hours is only for one damaged wire assembly.

United Parcel Service (UPS) asked that the work-hours under the On-Condition Costs for the replacement be increased from 16 to 244. UPS stated that it has previously replaced this wire harness and it required 244 work hours to complete the replacement. UPS also asked that the cost for parts for the repair be added. UPS stated that it has sourced the materials and the cost is $1,680 per airplane (or $168 per transition location).

We agree to revise the estimated on-condition work-hours. When issuing a service bulletin, Boeing estimates work-hours under expected conditions for direct labor only. As operators implement the service bulletin, they may find the actual work-hours are higher or lower than estimated. We have updated the Costs of Compliance section of this AD to reflect between 100 and 244 work-hours. We have also included the parts cost estimate provided for repairs.

FedEx asked that Boeing Alert Service Bulletin MD11-28A150 IN 02, dated February 24, 2017, be added to the service information cited in paragraph (g) of the proposed AD. FedEx stated that the one-time inspection and corrective actions in paragraph (g) specify performing a detailed inspection in accordance with the Accomplishment Instructions of Boeing Alert Service Bulletin MD11-28A150, dated October 6, 2016. FedEx added that since the referenced service information was issued, Boeing released an information notice (IN 02) with part numbers for three new wire assembly kits.

We disagree with the commenter's request. Boeing Alert Service Bulletin MD11-28A150 IN 02, dated February 24, 2017, provides updated kit information for the operators. The individual wire assembly part numbers in the new kits are the same wire assembly part numbers needed for the replacement required by this AD as specified in the figures in Part 3 of the Accomplishment Instructions of Boeing Alert Service Bulletin MD11-28A150, dated October 6, 2016. Since this AD only requires the replacement of certain individual wire assembly part numbers and not the kit part numbers that consist of the individual wire assembly part numbers, we have made no change to this AD in this regard.

FedEx and UPS requested that we clarify the actions specified in paragraph (h) of the proposed AD. FedEx stated that paragraph (h) of the proposed AD provides information to perform different tests than those listed in steps 1.f, 1.g., and 1.h. of Part 4 of the Accomplishment Instructions of Boeing Alert Service Bulletin MD11-28A150, dated October 6, 2016. FedEx stated it is not clear if the required test after rework is in accordance with steps 1.a. through 1.j. of Part 4 of Boeing Alert Service Bulletin MD11-28A150, dated October 6, 2016, or per the actions specified in (h)(1), (h)(2), and (h)(3) of this AD only. FedEx and UPS also stated that the proposed AD should require test procedures only for the section that Boeing Alert Service Bulletin MD11-28A150, dated October 6, 2016, is addressing and not all the systems associated with wire assemblies AJS9013 and AJS9014. FedEx and UPS also noted that the airplane maintenance manual (AMM) references in paragraphs (h)(1) and (h)(2) of the proposed AD are incorrect (AMM 28-28-01 should be AMM 28-08-01; AMM 26-21-02 should be AMM 28-21-02).

We agree to clarify which actions are required by this AD. Steps 1.f, 1.g., and 1.h. of Part 4 of the Accomplishment Instructions of Boeing Alert Service Bulletin MD11-28A150, dated October 6, 2016, are required for compliance (RC) after any rework is done and only address the system affected by this AD. The other steps identified as “RC exempt” as specified in Part 4 of the Accomplishment Instructions of Boeing Alert Service Bulletin MD11-28A150, dated October 6, 2016, are not a part of the requirements of this AD.

The intent of paragraph (h) of the proposed AD was to specify the corrective action for RC tests. Steps 1.f, 1.g., and 1.h. of Part 4 of the Accomplishment Instructions of Boeing Alert Service Bulletin MD11-28A150, dated October 6, 2016, specify to accomplish tests but the steps do not specify corrective actions if the tests fail. To clarify that the tests themselves are not exceptions to Boeing Alert Service Bulletin MD11-28A150, dated October 6, 2016, we have removed paragraph (h) of the proposed AD and included the corrective action statement for the tests in paragraph (g) of this AD.

We acknowledge that the AMM references in paragraphs (h)(1) and (h)(2) of the proposed AD were incorrect and note that the AMM references for the tests are identified correctly in Boeing Alert Service Bulletin MD11-28A150, dated October 6, 2016.

We reviewed the relevant data, considered the comments received, and determined that air safety and the public interest require adopting this final rule with the changes described previously and minor editorial changes. We have determined that these minor changes:

• Are consistent with the intent that was proposed in the NPRM for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM.

We also determined that these changes will not increase the economic burden on any operator or increase the scope of this final rule.

We reviewed Boeing Alert Service Bulletin MD11-28A150, dated October 6, 2016. The service information describes procedures for a one-time detailed inspection of the wire assemblies of the tail fuel tank transfer pumps to determine if metallic transitions are installed at the wire harness breakouts, and corrective actions that include repair and replacement of the wire assembly. 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 estimate that this AD affects 110 airplanes of U.S. registry. We estimate the following costs to comply with this AD:

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

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 transport category airplanes to the Director of the System Oversight 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:

Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to supersede AD 2017-02-03, Amendment 39-18782 (82 FR 10541, February 14, 2017) (“AD 2017-02-03”). AD 2017-02-03 applied to certain The Boeing Company Model 767-200, -300, and -400ER series airplanes. The NPRM published in the Federal Register on July 20, 2017 (82 FR 33465). The NPRM was prompted by a report of a malfunction of the EICAS during flight. The NPRM proposed to add airplanes to the applicability and, for certain airplanes, requires hose assembly removal and installation. We are issuing this AD to prevent an uncontrolled water leak from a defective potable water system coupling, which could cause the main equipment center (MEC) line replaceable units (LRUs) to become wet, resulting in an electrical short and potential loss of several functions essential for safe flight.

We gave the public the opportunity to participate in developing this AD. The following presents the comments received on the NPRM and the FAA's response to each comment.

Aviation Partners Boeing stated that the installation of winglets per STC ST01920SE does not affect the accomplishment of the manufacturer's service instructions.

We agree with the commenter that STC ST01920SE does not affect the accomplishment of the manufacturer's service instructions. Therefore, the installation of STC ST01920SE does not affect the ability to accomplish the actions required by this AD. We have not changed this AD in this regard.

Boeing requested that we delay issuance of the final rule until the manufacturer can release Revision 4 of Boeing Alert Service Bulletin 767-38A0073 in November 2017. Boeing pointed out that Revision 4 will not add any airplanes to the effectivity or make any substantial changes that will change the scope of the NPRM. Boeing mentioned that Revision 4 will expand usage of an optional tape material to all affected groups of airplanes because the originally specified tape is no longer available, and include an optional set of clamping instructions that can be used if needed to prevent a riding condition. Boeing also mentioned that Revision 4 will clarify what actions are required for each group of airplanes based on which revision of the service information has previously been accomplished. Boeing pointed out that revising the NPRM to refer to Revision 4 of Boeing Alert Service Bulletin 767-38A0073 would reduce the need for alternative method of compliance (AMOC) requests.

We do not consider that delaying this action until release of the planned service bulletin is warranted. Revision 4 of Boeing Alert Service Bulletin 767-38A0073 is not yet approved, and we cannot specify future revisions of service information in this AD. Revision 3 of Boeing Alert Service Bulletin 767-38A0073 is the current revision available, and it provides adequate information to address the identified unsafe condition. We have reviewed the proposed Revision 4 and as it does provide more options and clarifications which may be helpful, but are not required to accomplish the requirements of this AD. Therefore, we do not plan to wait for the release of Revision 4 of Boeing Alert Service Bulletin 767-38A0073 before issuing this AD. However, we have revised this AD to allow the use of BMS 5-179 tape, wherever Permacell P-29 is instructed to be used in Revision 3. We will consider requests for approval of an AMOC to allow the use of Revision 4 of Boeing Alert Service Bulletin 767-38A0073 after it has been published, under the provisions of paragraph (k)(1) of this AD.

Boeing requested that we revise paragraph (j) of the proposed AD to specify that part numbers CA620 series and CA625 series may not be installed on the locations specific to Boeing Alert Service Bulletin 767-38A0073, Revision 3, dated September 8, 2016. Boeing pointed out that the current wording of paragraph (j) of the proposed AD is being misinterpreted to apply to all airplane locations. Boeing also mentioned that multiple operators have requested revision to the Illustrated Parts Catalog (IPC) to remove listed part numbers CA620 series and CA625 series in other locations that are not affected by Boeing Alert Service Bulletin 767-38A0073, Revision 3, dated September 8, 2016.

We agree with the commenter for the reasons provided. We have revised paragraph (j) of this AD to specify “. . . for the locations identified in Boeing Alert Service Bulletin 767-38A0073, Revision 3, dated September 8, 2016.”

ABX AIR requested that we include prior AMOC approvals that were granted for AD 2017-02-03. ABX AIR mentioned that it operates airplanes that have been converted from passenger configuration to cargo configuration. ABX AIR pointed out that the potable water system and components have been removed from the airplanes during conversion. ABX AIR also pointed out that it had already received AMOC approval for AD 2017-02-03 in regards to the conversion to cargo configuration.

We agree with the commenter for the reasons provided. We have added paragraph (k)(4) to this AD to include prior AMOC approvals for AD 2017-02-03.

We reviewed the relevant data, considered the comments received, and determined that air safety and the public interest require adopting this AD with the changes described previously, and minor editorial changes. We have determined that these minor changes:

• Are consistent with the intent that was proposed in the NPRM for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM.

We also determined that these changes will not increase the economic burden on any operator or increase the scope of this AD.

We reviewed Boeing Alert Service Bulletin 767-38A0073, Revision 3, dated September 8, 2016 (“Boeing Alert Service Bulletin 767-38A0073, R3”). This service information describes procedures for, among other actions, removing three hose assemblies and installing four new hose assemblies. 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 estimate that this AD affects 139 airplanes of U.S. registry. We estimate the following costs to comply with this AD:

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

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 available 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 transport category airplanes to the Director of the System Oversight Division.

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

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

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

(2) 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:

Discussion

The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2015-00237R1, dated December 16, 2015 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”) to correct an unsafe condition for certain ATR-GIE Avions de Transport Régional Model ATR42-500 and ATR72-212A airplanes. The MCAI states:

Required actions also include AP or YD operational restrictions applicable for dual engine operation. You may examine the MCAI on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-1177.

Avions de Transport Régional has issued ATR Service Bulletin ATR42-31-0091, Revision 1, dated May 05, 2015; and ATR Service Bulletin ATR72-31-1092, Revision 2, dated March 31, 2015. The service information describes procedures for, among other things, modifying the software for the integrated avionics display (IAD), the core processing module (CPM), the switch module (SWM), and the flight warning main configuration file (FWMCF). These documents are distinct since they apply to different airplane models.

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

This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with the State of Design Authority, we have been notified of the unsafe condition described in the MCAI and service information referenced above. We are issuing this AD because we evaluated all pertinent information and determined the unsafe condition exists and is likely to exist or develop on other products of these same type designs.

There are currently no domestic operators of this product. Therefore, we find good cause that notice and opportunity for prior public comment are unnecessary. In addition, for the reason(s) 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 we did not precede it by notice and opportunity for public comment. We invite you to send any written relevant data, views, or arguments about this AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2017-1177; Product Identifier 2015-NM-195-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this AD. We will consider all comments received by the closing date and may amend this AD based on 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 AD.

Currently, there are no affected U.S.-registered airplanes. If an affected airplane is imported and placed on the U.S. Register in the future, we provide the following cost estimates to comply with this AD:

We estimate that it will take about 1 work-hour per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour. Based on these figures, we estimate the cost of this AD will be $85 per product.

In addition, we estimate that the optional modification will take about 3 work-hours for a cost of $255 per product.

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 transport category airplanes to the Director of the System Oversight Division.

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

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

1. Is not a “significant regulatory action” under Executive Order 12866;

2. Is not a “significant rule” under the 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:

Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain The Boeing Company Model 757-200, -200CB, and -300 series airplanes. The NPRM published in the Federal Register on June 2, 2017 (82 FR 25550). The NPRM was prompted by a report of fatigue cracking found in the fuselage frame web at station (STA) 1681, below the floor line at stringer S-17L. The NPRM proposed to require inspection of the fuselage frame for existing repairs, repetitive inspections of the frame, and applicable repairs. We are issuing this AD to detect and correct cracking of the fuselage frame at STA 1681, which could result in reduced structural integrity of the airplane.

We gave the public the opportunity to participate in developing this final rule. The following presents the comments received on the NPRM and the FAA's response to each comment.

United Airlines agreed with the content of the NPRM, and has started the proposed inspections.

FedEx's fleet of Model 757-200 airplanes was converted by VT Mobile Aerospace Engineering, Inc. (VT MAE), supplemental type certificate (STC) ST03562AT to a configuration similar to that of Boeing Model 757-200SF airplanes, and is no longer configured as passenger airplanes. FedEx stated, however, that per the VT MAE comments to the NPRM, the AD would still be effective for the converted FedEx fleet. FedEx noted that VT MAE has recommended that the airplane configuration groups identified in Boeing Alert Service Bulletin 757-53A0100, dated November 14, 2016, apply to the FedEx fleet. FedEx stated that it agrees with the airplane configuration groups cited by VT MAE and will comply with the actions in the proposed AD accordingly.

Boeing asked that we add Boeing Alert Service Bulletin 757-53A0100, Revision 1, dated September 14, 2017, to paragraphs (c), (g), (h)(1), and (h)(2) of the proposed AD as an alternative to using Boeing Alert Service Bulletin 757-53A0100, dated November 14, 2016 (referenced in the NPRM as the appropriate source of service information for accomplishing the actions). Boeing stated that the revised service information provides alternative inspections that allow longer inspection intervals.

We agree that this final rule should refer to the latest service information. Since we issued the NPRM, Boeing has released Boeing Alert Service Bulletin 757-53A0100, Revision 1, dated September 14, 2017. No additional work is necessary on airplanes on which the actions were performed before the effective date of this AD using Boeing Alert Service Bulletin 757-53A0100, dated November 14, 2016. We have therefore revised paragraphs (c), (g), (h)(1), and (h)(2) of this AD to refer to Boeing Alert Service Bulletin 757-53A0100, Revision 1, dated September 14, 2017. We have also added paragraph (i) to this AD to provide credit for using Boeing Alert Service Bulletin 757-53A0100, dated November 14, 2016, to accomplish the required actions before the effective date of this AD, and redesignated subsequent paragraphs accordingly.

Aviation Partners Boeing stated that accomplishing the STC ST01518SE does not affect compliance with the actions specified in the NPRM.

We agree with the commenter. We have redesignated paragraph (c) of the proposed AD as paragraph (c)(1) and added paragraph (c)(2) to this AD to state that installation of STC ST01518SE does not affect the ability to accomplish the actions required by this AD. Therefore, for airplanes on which STC ST01518SE is installed, a “change in product” alternative method of compliance (AMOC) approval request is not necessary to comply with the requirements of 14 CFR 39.17.

Delta Air Lines (Delta) asked that we clarify the following compliance time exception specified by paragraph (h)(1) of the proposed AD: “Where Boeing Alert Service Bulletin 757-53A0100, dated November 14, 2016, uses the phrase `after the original issue of this service bulletin' for determining compliance, for purposes of this AD, compliance is based on the effective date of this AD.” Delta noted that the allowance for the phrase “after the effective date of this AD” could not strictly be applied without requesting further clarification in accordance with paragraph (i) of the proposed AD. Delta recommended that this phrase match the language specified in the referenced service bulletin.

We agree with the commenter's request. We have revised the language in paragraph (h)(1) of this AD to address the commenter's concern.

FedEx asked that we revise the NPRM to specify that after repairs are done due to a crack finding, repetitive inspections be required only as based on the original equipment manufacturer (OEM), STC holder, or FAA requirements of the repair. FedEx also asked that the repetitive inspections be terminated for the portion of the inspection area covered by the repair. FedEx stated that Boeing Alert Service Bulletin 757-53A0100, dated November 14, 2016, specifies repetitive high frequency eddy current inspections in accordance with the applicable figure in the referenced service information, regardless of whether a repair is installed due to a crack finding. FedEx added that if a repair is installed due to a crack finding, repetitive inspections of the repair are required in accordance with the OEM/STC holder and FAA requirements.

We agree to provide clarification describing why the commenter's request to revise the NPRM is not necessary. The service bulletin is written such that the affected area is first inspected to determine if any repairs have been installed prior to the service bulletin. If an existing repair is found, then instructions are provided to contact Boeing for evaluation of the repair, to receive inspection instructions, and to do the inspection instructions. Paragraph (h)(2) of this AD requires that instructions received from Boeing are approved in accordance with AMOC procedures per paragraph (j) of this AD. The service bulletin then proceeds to address affected areas where an existing repair (as described above) does not exist by providing instructions to perform certain inspections to determine if a crack exists. When a crack is found, the service bulletin specifies to contact Boeing for repair instructions, do the repair, and then perform a repetitive inspection after a certain number of flight cycles for any crack in areas with no existing frame repair. These instructions must also be approved, per paragraph (h)(2) of this AD, in accordance with AMOC procedures per paragraph (j) of this AD. If a repair has been performed as a result of the previous inspection, the repetitive inspection is to be performed around the repair, but not of the repair itself. There are no repetitive inspections of the repairs specifically called out in the service bulletin. Each repetitive inspection in Tables 1 through Table 5 typically states at the end of the action, “in areas with no existing frame repair.” As clarified above, this means to inspect the area around the existing frame repair. Therefore, there is no need to terminate the repetitive inspections within the service bulletin for the portion of the inspection area now covered by a repair. However, as previously stated, inspections of the repairs themselves will be addressed by AMOC. We have not changed this AD in this regard.

FedEx asked that Boeing Alert Service Bulletin Information Notice 757-53A0100 IN 01, dated December 15, 2016, be referenced in the proposed AD. FedEx stated that IN 01 contains corrections to Boeing Alert Service Bulletin 757-53A0100, dated November 14, 2016.

We do not agree with the commenter's request. Boeing Alert Service Bulletin Information Notice 757-53A0100 IN 01, dated December 15, 2016, contains corrections to errors in Boeing Alert Service Bulletin 757-53A0100, dated November 14, 2016, but contains no technical changes. Those corrections are included in Boeing Alert Service Bulletin 757-53A0100, Revision 1, dated September 14, 2017, which, as explained previously, is referenced in this AD; therefore, we have not changed this AD in this regard.

We reviewed the relevant data, considered the comments received, and determined that air safety and the public interest require adopting this final rule with the changes described previously and minor editorial changes. We have determined that these minor changes:

• Are consistent with the intent that was proposed in the NPRM for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM.

We also determined that these changes will not increase the economic burden on any operator or increase the scope of this final rule.

We reviewed Boeing Alert Service Bulletin 757-53A0100, Revision 1, dated September 14, 2017. The service information describes procedures for inspection of the fuselage frame for existing frame and floor beam repairs, repetitive high frequency eddy current inspections for cracking in any area with no existing frame repair, and repetitive high and low frequency eddy current inspections for cracking in any area with no existing frame or floor beam repair; and repair. 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 estimate that this AD affects 606 airplanes of U.S. registry. We estimate the following costs to comply with this AD:

We have received no definitive data that would enable us to provide cost estimates for the on-condition repair specified in this AD.

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

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 transport category airplanes to the Director of the System Oversight 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:

I. Background

Upon request, FDA has classified the cervical intraepithelial neoplasia (CIN) test system as class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness. In addition, we believe this action will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens by placing the device into a lower device class than the automatic class III assignment.

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

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

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

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

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

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

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

On May 23, 2016, Ventana Medical Systems, Inc., submitted a request for De Novo classification of the CINtec Histology. FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act. We classify devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls that, in combination with the general controls, provide reasonable assurance of the safety and effectiveness of the device for its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the information submitted in the request, we determined that the device can be classified into class II with the establishment of special controls. FDA has determined that these special controls, in addition to the general controls, will provide reasonable assurance of the safety and effectiveness of the device.

Therefore, on March 4, 2017, FDA issued an order to the requestor classifying the device into class II. FDA is codifying the classification of the device by adding 21 CFR 864.1865. We have named the generic type of device the cervical intraepithelial neoplasia (CIN) test system, and it is identified as a device used to detect a biomarker associated with CIN in human tissues. The device is indicated as an adjunct test and not to be used as a stand-alone device. The test results must be interpreted in the context of the patient's clinical history including, but not limited to, prior and current cervical biopsy results, Papanicolaou (Pap) test results, human papillomavirus (HPV) test results, and morphology on hematoxylin and eosin (H&E) stained sections. This device is not intended to detect the presence of HPV.

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

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

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

This final order establishes special controls that refer to previously approved collections of information found in other FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR parts 801 and 809, regarding labeling, have been approved under OMB control number 0910-0485; the collections of information in part 807, subpart E, regarding premarket notification submissions, have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 814, subparts A through E, regarding premarket approval, have been approved under OMB control number 0910-0231; and the collections of information in the guidance document “De Novo Classification Process (Evaluation of Automatic Class III Designation)” have been approved under OMB control number 0910-0844.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 864 is amended as follows:

The Federal Civil Penalties Inflation Adjustment Act of 1990, Public Law 101-410, as amended by the Debt Collection Improvement Act of 1996, Public Law 104-134, required the head of each agency to adjust its CMPs for inflation no later than October 23, 1996 and required agencies to make adjustments at least once every four years thereafter. The Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015, Section 701 of Public Law 114-74 (the 2015 Act) further amended the 1990 Act by requiring agencies to adjust CMPs, if necessary, pursuant to a “catch-up” adjustment methodology prescribed by the 2015 Act, which mandated that the catch-up adjustment take effect no later than August 1, 2016. Additionally, the 2015 Act required agencies to make annual adjustments to their respective CMPs in accordance with guidance issued by the Office of Management and Budget (OMB).

Based on these statutes, the Department of State (the Department) published a final rule on June 8, 2016, to implement the “catch-up” provisions. See 81 FR 36791. The Department published its first annual update to its CMPs in January 2017. See 82 FR 3168.

On December 15, 2017, OMB notified agencies that the annual cost-of-living adjustment multiplier for 2018, based on the Consumer Price Index, is 1.02041. Additional information may be found in OMB Memorandum M-18-03, at: https://www.whitehouse.gov/wp-content/uploads/2017/11/M-18-03.pdf. This final rule amends Department CMPs for fiscal year 2018.

Within the Department of State (Title 22, Code of Federal Regulations), this rule affects four areas:

(1) Part 35, which implements the Program Fraud Civil Remedies Act of 1986 (PFCRA), codified at 31 U.S.C. 3801-3812;

(2) Part 103, which implements the Chemical Weapons Convention Implementation Act of 1998 (CWC Act);

(3) Part 127, which implements the penalty provisions of sections 38(e), 39A(c), and 40(k) of the Arms Export Control Act (AECA) (22 U.S.C. 2778(e), 2779a(c), 2780(k)); and

(4) Part 138, which implements Section 319 of Public Law 101-121, codified at 31 U.S.C. 1352, and prohibits recipients of federal contracts, grants, and loans from using appropriated funds for lobbying the Executive or Legislative Branches of the federal government in connection with a specific contract.

The PFRCA, enacted in 1986, authorizes agencies, with approval from the Department of Justice, to pursue individuals or firms for false claims. Applying all previous adjustments in accordance with the 2015 Act, the maximum liabilities under the PFRCA were $10,957, up to a maximum of $328,734. Applying the 2018 multiplier (1.02041) provided by OMB, the new maximum liabilities are as follows: $11,181 up to a maximum of $335,443.

The CWC Act provided domestic implementation of the Convention on the Prohibition of the Development, Production, Stockpiling, and Use of Chemical Weapons and on Their Destruction. The penalty provisions of the CWC Act are codified at 22 U.S.C. 6761. Applying all previous adjustments in accordance with the 2015 Act, the maximum amounts were as follows: Prohibited acts related to inspections, $36,849; for Recordkeeping violations, $7,370.

Applying the 2018 multiplier (1.02041) provided by OMB, the new maximum amounts are as follows: Prohibited acts related to inspections, $37,601; for Recordkeeping violations, $7,520.

The Assistant Secretary of State for Political-Military Affairs is responsible for the imposition of CMPs under the International Traffic in Arms Regulations (ITAR), which is administered by the Directorate of Defense Trade Controls (DDTC).

(1) AECA section 38(e):

Applying all previous adjustments in accordance with the 2015 Act, the maximum penalty under 22 U.S.C. 2778(e), or Section 38(e) of the AECA, was $1,111,908. Applying the 2018 multiplier (1.02041) provided by OMB, the new maximum penalty under 22 U.S.C. 278(e) is $1,134,602.

(2) AECA section 39A(c):

Applying all previous adjustments in accordance with the 2015 Act, the maximum penalty for 22 U.S.C. 2779a(c), or Section 39A(c) of the AECA, was $808,458. Applying the 2018 multiplier (1.02041) provided by OMB, the new maximum penalty for 22 U.S.C. 2779a(c) is $824,959.

(3) AECA section 40(k):

Applying all previous adjustments in accordance with the 2015 Act, the maximum penalty for 22 U.S.C. 2780(k), or Section 40(k) of the AECA, was $962,295 per violation. Applying the 2018 multiplier (1.02041) provided by OMB, the new maximum penalty per violation is $981,935.

Section 319 of Public Law 101-121, codified at 31 U.S.C. 1352, provides penalties for recipients of federal contracts, grants, and loans who use appropriated funds to lobby the Executive or Legislative Branches of the federal government in connection with a specific contract, grant, or loan. Any person who violates that prohibition is subject to a civil penalty. The statute also requires each person who requests or receives a federal contract, grant, cooperative agreement, loan, or a federal commitment to insure or guarantee a loan, to disclose any lobbying; there is a penalty for failure to disclose.

Applying all previous adjustments in accordance with the 2015 Act, the maximum penalties for both improper expenditures and failure to disclose, was: For first offenders, a penalty of $18,936; for others, not less than $19,246, and not more than $192,459. Applying the 2018 multiplier (1.02041) provided by OMB, the new maximums are: For first offenders, $19,322; for others, not less than $19,639, and not more than $196,387.

The revised CMP amounts will go into effect on the date this rule is published. All violations for which CMPs are assessed on or after the effective date of this rule, regardless of whether the violation occurred before the effective date, will be assessed at the adjusted penalty level.

The 2015 Act directed agencies to undertake an annual review of CMPs using a formula prescribed by the statute. Annual adjustments to CMPs are made in accordance with the guidance issued by OMB. As in this rulemaking, the Department of State will publish notification of annual inflation adjustments to CMPs in the Federal Register no later than January 15 of each year, with the adjusted amount taking effect immediately upon publication.

The Department of State is publishing this rule using the “good cause” exception to the Administrative Procedure Act (5 U.S.C. 553(b)), as the Department has determined that public comment on this rulemaking would be impractical, unnecessary, or contrary to the public interest. This rulemaking is mandatory; it implements Public Law 114-74. In addition, the Department of State finds good cause for this rule to be effective upon publication, as Congress has mandated that the penalty adjustments be effective on or before January 15th. See 5 U.S.C. 553(d)(3).

Because this rulemaking is exempt from 5 U.S.C. 553, a Regulatory Flexibility Analysis is not required.

This rule does not involve a mandate that will result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more in any year and it will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995.

This rule is not a major rule within the meaning of the Small Business Regulatory Enforcement Fairness Act of 1996.

This amendment will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, in accordance with Executive Order 13132, it is determined that this amendment does not have sufficient federalism implications to require consultations or warrant the preparation of a federalism summary impact statement.

The Department believes that benefits of the rulemaking outweigh any costs, and there are no feasible alternatives to this rulemaking. It is the Department's position that this rulemaking is not an economically significant rule under the criteria of Executive Order 12866, and is consistent with the provisions of Executive Order 13563. This rule is not an E.O. 13771 regulatory action because this rule is not significant under E.O. 12866.

The Department of State has reviewed the proposed amendment in light of Executive Order 12988 to eliminate ambiguity, minimize litigation, establish clear legal standards, and reduce burden.

The Department of State has determined that this rulemaking will not have tribal implications, will not impose substantial direct compliance costs on Indian tribal governments, and will not preempt tribal law. Accordingly, Executive Order 13175 does not apply to this rulemaking.

This rulemaking does not impose or revise any information collections subject to 44 U.S.C. Chapter 35.

For the reasons set forth above, 22 CFR parts 35, 103, 127, and 138 are amended as follows:

Coast Guard District Commanders and Captains of the Port (COTP) must be immediately responsive to the safety and security needs within their jurisdiction; therefore, District Commanders and COTPs have been delegated the authority to issue certain local regulations. Safety zones may be established for safety or environmental purposes. A safety zone may be stationary and described by fixed limits or it may be described as a zone around a vessel in motion. Security zones limit access to prevent injury or damage to vessels, ports, or waterfront facilities. Special local regulations are issued to enhance the safety of participants and spectators at regattas and other marine events. Drawbridge operation regulations authorize changes to drawbridge schedules to accommodate bridge repairs, seasonal vessel traffic, and local public events. Regulated Navigation Areas are water areas within a defined boundary for which regulations for vessels navigating within the area have been established by the regional Coast Guard District Commander.

Timely publication of these rules in the Federal Register may be precluded when a rule responds to an emergency, or when an event occurs without sufficient advance notice. The affected public is, however, often informed of these rules through Local Notices to Mariners, press releases, and other means. Moreover, actual notification is provided by Coast Guard patrol vessels enforcing the restrictions imposed by the rule. Because Federal Register publication was not possible before the end of the effective period, mariners were personally notified of the contents of these safety zones, security zones, special local regulations, regulated navigation areas or drawbridge operation regulations by Coast Guard officials on-scene prior to any enforcement action. However, the Coast Guard, by law, must publish in the Federal Register notice of substantive rules adopted. To meet this obligation without imposing undue expense on the public, the Coast Guard periodically publishes a list of these temporary safety zones, security zones, special local regulations, regulated navigation areas and drawbridge operation regulations. Permanent rules are not included in this list because they are published in their entirety in the Federal Register. Temporary rules are also published in their entirety if sufficient time is available to do so before they are placed in effect or terminated.

The following unpublished rules were placed in effect temporarily during the period between June 2014-June 2016 unless otherwise indicated. To view copies of these rules, visit www.regulations.gov and search by the docket number indicated in the list below.

I. Background

On February 9, 2016, SAMHSA published a Notice of Proposed Rulemaking (NPRM) in the Federal Register (81 FR 6988), proposing updates to the Confidentiality of Alcohol and Drug Abuse Patient Records (42 CFR part 2) regulations. These regulations implement title 42, section 290dd-2 of the United States Code pertaining to the Confidentiality of Substance Use Disorder Patient Records held by certain substance use disorder treatment programs that receive federal financial assistance. As SAMHSA explained in that NPRM, it proposed to update these regulations, last substantively amended in 1987, to reflect development of integrated health care models and the use of electronic exchange of patient information. SAMHSA also wished to maintain confidentiality protections for patient identifying information, as persons with substance use disorders still may encounter significant discrimination if their information is improperly disclosed.

On January 18, 2017, SAMHSA published a final rule (82 FR 6052). In response to public comments, the final rule provided for greater flexibility in disclosing patient identifying information within the health care system while continuing to address the need to protect the confidentiality of substance use disorder patient records. SAMHSA concurrently issued a supplemental notice of proposed rulemaking (SNPRM) (82 FR 5485) to solicit public comment on additional proposals including: The payment and health care operations-related disclosures that can be made to contractors, subcontractors, and legal representatives by lawful holders under the part 2 rule consent provisions; and the provisions governing disclosures for purposes of carrying out a Medicaid, Medicare or Children's Health Insurance Program (CHIP) audit or evaluation. SAMHSA also solicited comments on whether an abbreviated notice of the prohibition on re-disclosure should be used and, if so, under what circumstances.

SAMHSA received 55 comments on the SNPRM, and after considering those comments, is finalizing the proposed revisions, with some changes made in response to the public comments that were received. Some comments were outside the scope of the specific provisions SAMHSA proposed in the SNPRM or were inconsistent with SAMHSA's legal authority regarding the confidentiality of substance use disorder patient records. This final rule does not address these comments.

SAMHSA received a number of comments regarding alignment of 42 CFR part 2 with the Health Insurance Portability and Accountability Act (HIPAA) or the Health Information Technology for Economic and Clinical Health (HITECH) Act. Reasons cited by these commenters in support of aligning the regulations with HIPAA or HIPAA/HITECH Act were to: (1) Promote information flow between providers, including a clinically complete patient record; (2) allow providers and administrators of services greater discretion; (3) facilitate interoperability; (4) improve compliance; (5) enhance privacy protections by making confidentiality restrictions more uniform across health care settings; (6) promote more innovative models of health care delivery, including integrated and coordinated care, and value-based and population-based models; (7) establish uniform, workable regulations with respect to treatment, payment and operations; and (8) improve patient care and reduce stigma and potential harm to patients.

SAMHSA has attempted to align this final rule with HIPAA, the HITECH Act, and their implementing regulations to the extent feasible, based on the proposed revisions in the SNPRM, the public comments received, and the limitations on SAMHSA's authority in the governing statute, 42 U.S.C. 290dd-2. At the same time, it is important to note that part 2 and its authorizing statute are separate and distinct from HIPAA, the HITECH Act, and their implementing regulations. Part 2 provides more stringent federal protections than other health privacy laws such as HIPAA and seeks to protect individuals with substance use disorders who could be subject to discrimination and legal consequences in the event that their information is improperly used or disclosed. To the extent feasible given these restrictions, SAMHSA continues to review these issues, plans to explore additional alignment with HIPAA, and may consider additional rulemaking for 42 CFR part 2.

In the SNPRM, SAMHSA sought comment on whether an abbreviated notice of the prohibition on re-disclosure should be included in § 2.32 and on the circumstances under which such abbreviated notice should be used. The SNPRM provided an example of an abbreviated notice: “Data is subject to 42 CFR part 2. Use/disclose in conformance with part 2.” SAMHSA has adopted an abbreviated notice that is 80 characters long to fit in standard free-text space within health care electronic systems. The abbreviated notice in this final rule reads “Federal law/42 CFR part 2 prohibits unauthorized disclosure of these records.”

Several commenters expressed support for the abbreviated notice of the prohibition on re-disclosure because it provides more flexibility and efficiency in meeting the notice requirement. Several supportive commenters suggested potential technical solutions for conveying the prohibition on re-disclosure, such as communicating part 2 restrictions through codes, flags, pop-ups, or other signifiers. However, some of these commenters and others also explained that most of the suggestions are not technically feasible at this time, due to the lack of standardized electronic formats and transmission standards. One supportive commenter suggested SAMHSA work with the Department of Health and Human Services (HHS) and its agencies, including the Centers for Medicare & Medicaid Services (CMS), and the Office of Civil Rights (OCR), to explore whether HIPAA electronic transactions and code sets can be leveraged or modified to “flag” part 2 information and, once the recommendation becomes actionable, involve standard-setting bodies and the public. Several supportive commenters provided circumstances they thought were appropriate for an abbreviated notice of the prohibition on re-disclosure, including: (1) All electronic disclosures (because there may not currently be a standard mechanism to “flag” electronic information disclosures that are covered by part 2); (2) only paper disclosures; (3) limiting the use of the abbreviated notice to the exchange of records between part 2 programs (that would have familiarity with the concept of prohibition on re-disclosure); (4) exchange of records among part 2 programs and other entities (including third-party payers, and other lawful holders); and (5) using a single abbreviated notice for all circumstances. A couple of commenters indicated that having the notice of prohibition on re-disclosure accompany disclosures, as required by § 2.32, is important for ensuring compliance with part 2.

Commenters who opposed the abbreviated notice of the prohibition on re-disclosure expressed concerns that a shortened notice: (1) May be confusing or unclear to patients and professionals; (2) would fail to safeguard against unauthorized disclosures; and (3) would be insufficient to solve logistical concerns because, regardless of the length of the notice, systems will need to be put in place to tag substance use disorder information and send the notice with the information being disclosed. In addition, some commenters found the current notice to be sufficient.

SAMHSA also received comments stating that the SNPRM provided insufficient information to either support or oppose the abbreviated notice of the prohibition on re-disclosure because: (1) The purpose of the abbreviated notice was not made clear; and (2) it was unclear whether SAMHSA considered the impact the proposed abbreviated notice would have on electronic health records formats, system design and software development for clinical medical records format, or the impact on required HIPAA Administrative transactions. One commenter stated that an abbreviated notice of the prohibition on re-disclosure must contain, at a minimum, a clear warning label to prevent misuse and should state that any misuse is illegal under 42 CFR part 2.

The 42 CFR part 2 regulations in effect since 1983 have required that a notice of the prohibition on re-disclosure accompany each disclosure made with the patient's written consent. In the SNPRM, SAMHSA proposed the option of an abbreviated notice to satisfy the requirements of § 2.32 due to concerns about character limits in free-text fields within electronic health record systems. Specifically, many of the health care electronic systems have a standard maximum character limit of 80 characters in the free text space that may be used to transmit this notice.

While SAMHSA recognizes there may be technical issues to be resolved, after considering the totality of the comments, SAMHSA believes including an abbreviated notice of the prohibition on re-disclosure as an option will be beneficial to stakeholders, particularly those who use electronic health record systems to exchange data. However, because even commenters supporting inclusion of an abbreviated notice had differing views about the circumstances under which an abbreviated notice should be used, SAMHSA decided, consistent with its proposal, to allow use of an abbreviated notice in any instance in which a notice is required under the regulations. Recognizing concerns expressed by commenters that an abbreviated notice could be insufficient to convey understanding of part 2 requirements, SAMHSA encourages part 2 programs and other lawful holders using the abbreviated notice to discuss the requirements with those to whom they disclose patient identifying information. In response to comments received that the abbreviated notice did not provide an adequate warning against potential misuse of patient identifying information, SAMHSA, in this final rule, has modified the language in the abbreviated notice to more explicitly notify recipients that improper use or disclosure is prohibited under 42 CFR part 2.

In the SNPRM, SAMHSA proposed to explicitly list under §  2.33(b), specific types of activities for which any lawful holder of patient identifying information would be allowed to further disclose the minimal information necessary for specific payment and health care operations activities. SAMHSA proposed new regulatory text under §  2.33(c) that would require lawful holders that engage contractors and subcontractors to carry out payment and health care operations activities that entail the use or disclosure of patient identifying information to include specific contract provisions addressing compliance with part 2. In this final rule, SAMHSA finalizes the scope and requirements for permitted disclosures to contractors, subcontractors, and legal representatives for the purpose of payment and health care operations. SAMHSA does not retain the proposed list of payment and health care operations in the regulatory text and instead, moves this list to the preamble section of the final rule to serve as illustrative examples of permissible payment and health care operations activities. In addition, consistent with SAMHSA's prior statement in the SNPRM preamble, SAMHSA adds language to the regulatory text in § 2.33(b) to clarify that disclosures to contractors, subcontractors, and legal representatives are not permitted for substance use disorder patient diagnosis, treatment, or referral for treatment. SAMHSA finalizes §  2.33(c) in relation to contract language referencing compliance with 42 CFR part 2 and the protections of part 2 patient identifying information, but does not retain the proposed reference to permitted uses of patient identifying information consistent with the written consent.

In response to SAMHSA's request for comments on proposed revisions to § 2.33, SAMHSA received a number of comments supporting its proposal in § 2.33 to clarify that lawful holders of patient identifying information may disclose the minimum amount of information necessary to contractors, subcontractors, and legal representatives for payment and health care operations purposes. Several commenters cited practical concerns with the policy as stated in the January 18, 2017, final rule, including: (1) It is unrealistic to assume that lawful holders of patient identifying information such as third-party payers have the expertise and resources to carry out certain payment and health care operations without the assistance of contractors; (2) it is often not feasible to specify each contractor on a part 2 consent form; and (3) specifying contractors on a part 2 consent form unreasonably restricts a lawful holder from changing contractors. One commenter observed that essential payment and operations activities directly or indirectly benefit patients (e.g., by ensuring access to and coverage of treatment). One commenter supported the proposal because it further aligns part 2 with HIPAA, while another commenter expressed support for this or any proposal that would reduce the time and expense incurred by part 2 programs when seeking and obtaining patient consent where not necessary.

In the SNPRM, SAMHSA proposed clarifications to the final regulations issued on January 18, 2017, where they appeared to be needed, based on public comment. SAMHSA appreciates the support it received for clarifying the part 2 regulations. SAMHSA is finalizing those clarifications as proposed in § 2.33(b) except for the list of 17 specific types of payment and health care operations activities for which any lawful holder of patient identifying information would be allowed to further disclose to contractors, subcontractors, and legal representatives. As discussed below, this list of activities is being included in the preamble, rather than in regulatory text, in order to make clear that it is an illustrative rather than exhaustive list of the types of payment and health care operations activities that would be acceptable to SAMHSA. By removing the list from the regulatory text, SAMHSA intends for other appropriate payment and health care operations activities to be permitted under § 2.33 as the health care system continues to evolve. In addition, consistent with SAMHSA's prior statement in the SNPRM preamble, SAMHSA has added language to the regulatory text in § 2.33(b) to clarify that disclosures to contractors, subcontractors, and legal representatives are not permitted for activities related to a patient's diagnosis, treatment, or referral for treatment.

SAMHSA also received numerous comments opposing its proposal in § 2.33. The majority of these commenters were opposed to the changes because SAMHSA had not specified additional safeguards that would apply in connection with the disclosures. Some commenters expressed concern that the changes were too broad or would undermine overall part 2 protections. One commenter expressed concern that the risk of breaches might increase by permitting additional disclosures to facilitate health care operations. Several commenters noted that the revisions in § 2.33(b) would permit lawful holders greater latitude in sharing information with entities than would be afforded to patients. These commenters found that the revisions would permit patients to consent to sharing patient identifying information with lawful holders, who then are permitted to re-disclose that information to contractors, subcontractors, or legal representatives without notifying the patient. Conversely, patients would be prohibited from consenting to disclose patient identifying information to entities with whom they do not have a treating provider relationship without further designating an individual participant in that entity. As a result, these commenters questioned SAMHSA's intent for this proposal.

One commenter thought the SNPRM did not provide sufficient information to respond to the proposed § 2.33 because of the similarity of contractors and subcontractors with qualified service organizations (QSOs) under §§ 2.11 and 2.12, and the similarity to Business Associates under HIPAA. The commenter requested clarification on whether it is SAMHSA's intent to directly apply part 2 to these contractors and subcontractors in a manner similar to what was accomplished under the HIPAA Privacy and Security Rules for Business Associates of covered entities.

SAMHSA is seeking a balance between protecting the confidentiality of substance use disorder patient records and ensuring that the regulations do not pose a barrier to patients with substance use disorders who wish to participate in, and could benefit from, emerging health care models that promote integrated care and patient safety. Unauthorized disclosure of substance use disorder patient records can lead to a host of negative consequences, including loss of employment, loss of housing, loss of child custody, discrimination by medical professionals and insurers, arrest, prosecution, and incarceration. The purpose of the part 2 regulations is to ensure that a patient is not made more vulnerable by reason of the availability of their patient record than an individual with a substance use disorder who does not seek treatment. SAMHSA recognizes the legitimate needs of lawful holders of patient identifying information to disclose that information to their contractors, subcontractors, and legal representatives for purposes of payment and health care operations as long as the core protections of 42 CFR part 2 are maintained. SAMHSA notes that the part 2 regulations already state at § 2.13(a): “. . . Any disclosure made under the regulations in this section must be limited to that information which is necessary to carry out the purpose of the disclosure.” This provision helps to ensure that information is not shared more broadly than the purpose(s) for which the patient consents. With respect to the comment that proposed revisions in § 2.33(b) would provide lawful holders greater latitude in sharing information with entities for payment and health care operations purposes than would be afforded to patients, SAMHSA acknowledges this concern and will be convening a stakeholder meeting relative to part 2 as required by the 21st Century Cures Act (Pub. L. No: 114-255).

Finally, it is not SAMHSA's intent to apply part 2 to contractors and subcontractors in a manner similar to what was accomplished under the HIPAA Privacy and Security Rules for Business Associates in accordance with, respectively, sections 13404(a) and 13401(a) of the HITECH Act, 42 U.S.C. 17934(a), 17931(a). SAMHSA has attempted to align part 2 with HIPAA in this final rule to the extent such changes are permissible under 42 U.S.C. 290dd-2. Moreover, as discussed previously, SAMHSA plans to explore additional alignment with HIPAA and is considering additional rulemaking for 42 CFR part 2.

At the same time, part 2 and its authorizing statute are separate and distinct from HIPAA, the HITECH Act, and their implementing regulations. Because of its targeted population, part 2 and its authorizing statute provides more stringent federal protections than other health privacy laws, including the HIPAA Rules, in order to encourage individuals with substance use disorders to seek treatment.

Several commenters proposed an alternative approach to the proposed changes in § 2.33, which would instead allow lawful holders to contract with QSOs, just as part 2 programs currently do. One such commenter proposed that, instead of an explicit list of activities, § 2.33(b) should include a general statement that an entity that lawfully receives patient identifying information under a valid part 2 consent may disclose the information to its contractor under a QSO agreement (QSOA) if such disclosure is reasonably consistent with the terms of the consent. This commenter also proposed to revise the QSO definition to align it more closely with the HIPAA “business associate” concept. Two commenters questioned the distinction between the needs of part 2 programs and other lawful holders to engage third parties for operational assistance and requested that the QSO definition simply include lawful holders in the list of entities for which a QSO may provide services. One of these commenters stated that this alternative approach would give patients a choice and align better with patients' expectations without adding another layer of complexity.

SAMHSA declines to implement the suggested alternative approaches. SAMHSA agrees there are similarities between contractors under § 2.33(b) and QSOs. However, SAMHSA did not propose in the SNPRM to revise the provision on QSOs.

In the SNPRM, SAMHSA sought public comment on whether the proposed listing of permitted activities is adequate and appropriate to ensure the health care industry's ability to conduct necessary payment and health care operations, while still maintaining adequate confidentiality of substance use disorder patient records. SAMHSA also sought comment on the specific types of activities for which a lawful holder of patient identifying information would be allowed to further disclose the minimal information necessary for specific payment and health care operations activities described in the SNPRM. Further, SAMHSA requested public comment on additional purposes for which lawful holders should be able to disclose patient identifying information. SAMHSA is finalizing the clarifications, as proposed in § 2.33, but now includes the list of 17 specific types of payment and health care operations as illustrative examples in the preamble rather than the regulatory text.

Many commenters responded to SAMHSA's requests for comments on whether the proposed list of explicitly permitted payment and health care operations activities is adequate and appropriate. Several commenters expressly supported the list of payment and operations activities included in the SNPRM. One commenter stated that the proposed 17 categories of payment and operations activities are essential to allowing third-party payers and other lawful holders to reasonably operate. Another commenter observed that the proposed payment and health care operations activities represent significant progress toward SAMHSA's stated goal of modernizing 42 CFR part 2 to increase opportunities for individuals with substance use disorders to participate in new and emerging health care models and health information technology.

Numerous commenters recommended that care coordination and case management be added to the list, noting the importance of these services in the operational and treatment responsibilities in serving patients, including those with a dual diagnosis of mental health and substance use disorder. Conversely, several commenters recommended that SAMHSA include a statement in the regulatory text explicitly excluding care coordination and case management from § 2.33(b). Another commenter also stated that disclosures to contractors, subcontractors, and legal representatives should not include information concerning diagnosis, treatment and/or referral to treatment without a patient's express consent.

Several commenters were confused by, or disagreed with, SAMHSA's omission of treatment-related activities such as care coordination and case management from the list of payment and health care operations activities for which additional disclosures were proposed in the SNPRM. One such commenter stated that it was unclear why a contractor performing a treatment-related activity should be subject to greater confidentiality safeguards (e.g., specific consent) than an entity performing a payment or business-related activity. Others thought the benefits of care coordination outweighed any risk of including it on the list of permitted activities because SAMHSA also included on the list patient safety activities, which are inextricably linked to care coordination and case management. Another commenter, stating that health information technology and health information exchange are essential building blocks of integrated care, argued that the exclusion of care coordination and case management from permitted health care operations would make it extremely difficult for state Medicaid agencies, managed care organizations (MCOs), and providers to use this technology to provide high quality, integrated care. One commenter pointed out that third-party payers, to which disclosure would be permitted under the SNPRM, may perform care coordination and case management activities as well as payment and health care operations activities.

SAMHSA also received comments requesting a variety of additions to the list of permitted activities. In addition, SAMHSA received comments requesting clarification of some of the activities included on the list. Finally, two commenters observed that the rapid changes occurring in the health care payment and delivery system may make any list of permitted activities included in the final rule outdated very quickly.

A few commenters disagreed with including in the regulatory text a list of permitted payment and health care operations activities. One commenter thought SAMHSA should be more protective of vulnerable patients because the list was seen as a loophole that would result in patient identifying information being spread beyond the immediate point of care and being used in unforeseen ways. For consistency, one commenter requested that SAMHSA replicate HIPAA's definition of payment at 45 CFR164.501 for the purpose of collection activities under proposed § 2.33(b)(1).

SAMHSA also received a number of comments requesting that certain activities on the list of payment and health care operations activities be restricted or narrowed. A number of commenters requested that SAMHSA remove or narrow proposed § 2.33(b)(15) & (16) to ensure patients' protected substance use disorder information will not be used to limit or deny insurance coverage or access to health care. Some commenters expressed concern that the proposed § 2.33(b)(2) could be interpreted as allowing protected information to be disclosed to employers. Many of these commenters stated they did not support the SNPRM's proposed changes in general, or SAMHSA's proposal to permit lawful holders to disclose patient identifying information obtained pursuant to patient consent to contractors, subcontractors, and legal representatives for payment and health care operations purposes, in particular, without further protections and safeguards. Two commenters disagreed with the inclusion of five of the proposed activities (§§ 2.33(b)(6), 2.33(b)(10), 2.33(b)(12), 2.33(b)(15), and 2.33(b)(16)) because they could adversely affect patient enrollment in health plans and determinations regarding insurability, treatment, and eligibility.

Several commenters also requested additional protections to ensure lawful holders and their contractors, subcontractors, and legal representatives only use information protected under part 2 for the purposes listed in the patient's written consent.

While SAMHSA is finalizing the clarifications as proposed in § 2.33, SAMHSA is not including the list of 17 specific types of payment and health care operations in the regulatory text that would be the basis for further disclosures by a lawful holder of patient identifying information. Based on the numerous comments received requesting additions or clarifications to the list, as well as concerns that the rapid changes occurring in the health care payment and delivery system could render any list of activities included in the regulatory text outdated, SAMHSA has decided to include the list in the preamble of this final rule to illustrate the types of permissible payment and health care operations activities.

Examples of permissible activities under § 2.33(b) that SAMHSA considers to be payment and health care operations activities include:

• Billing, claims management, collections activities, obtaining payment under a contract for reinsurance, claims filing and related health care data processing;

• Clinical professional support services (e.g., quality assessment and improvement initiatives; utilization review and management services);

• Patient safety activities;

• Activities pertaining to:

• The training of student trainees and health care professionals;

• The assessment of practitioner competencies;

• The assessment of provider and/or health plan performance; and

• Training of non-health care professionals;

• Accreditation, certification, licensing, or credentialing activities;

• Underwriting, enrollment, premium rating, and other activities related to the creation, renewal, or replacement of a contract of health insurance or health benefits, and ceding, securing, or placing a contract for reinsurance of risk relating to claims for health care;

• Third-party liability coverage;

• Activities related to addressing fraud, waste and abuse;

• Conducting or arranging for medical review, legal services, and auditing functions;

• Business planning and development, such as conducting cost-management and planning-related analyses related to managing and operating, including formulary development and administration, development or improvement of methods of payment or coverage policies;

• Business management and general administrative activities, including management activities relating to implementation of and compliance with the requirements of this or other statutes or regulations;

• Customer services, including the provision of data analyses for policy holders, plan sponsors, or other customers;

• Resolution of internal grievances;

• The sale, transfer, merger, consolidation, or dissolution of an organization;

• Determinations of eligibility or coverage (e.g. coordination of benefit services or the determination of cost sharing amounts), and adjudication or subrogation of health benefit claims;

• Risk adjusting amounts due based on enrollee health status and demographic characteristics;

• Review of health care services with respect to medical necessity, coverage under a health plan, appropriateness of care, or justification of charges.

This list of payment and health care operations is substantively unchanged from that which was proposed as regulatory text in the SNPRM published on January 18, 2017. In this final rule, SAMHSA maintains its position that the payment and health care operations activities referenced in § 2.33 and listed in the preamble are not intended to encompass substance use disorder patient diagnosis, treatment, or referral for treatment. SAMHSA believes it is important to maintain patient choice in disclosing information to health care providers with whom patients have direct contact. For this reason, the final provision in § 2.33(b) is not intended to cover care coordination or case management and disclosures to contractors, subcontractors, and legal representatives to carry out such purposes are not permitted under this section. In addition, SAMHSA added language to the regulatory text in § 2.33(b) to clarify that disclosures to contractors, subcontractors and legal representatives are not permitted for activities related to a patient's diagnosis, treatment, or referral for treatment. SAMHSA notes that the position articulated in this final rule differs from the HIPAA Privacy Rule, under which `health care operations' encompasses such activities as case management and care coordination. However, SAMHSA appreciates the concerns expressed by some commenters about such issues as the exclusion of care coordination and case management from § 2.33(b). SAMHSA also appreciates comments received concerning potential risks of including care coordination, case management and other activities in § 2.33(b). Consistent with the 21st Century Cures Act, prior to March 21, 2018, the Secretary of HHS will convene relevant stakeholders to determine the effects of 42 CFR part 2 on patient care, health outcomes, and patient privacy. This meeting will provide stakeholders with an additional opportunity to provide further input to SAMHSA regarding implementation of part 2, including changes adopted in this final rule.

SAMHSA proposed new regulatory text requiring that lawful holders that engage contractors and subcontractors to carry out payment and health care operations that require using or disclosing patient identifying information include specific contract provisions requiring contractors and subcontractors to comply with the provisions of part 2. SAMHSA is finalizing this proposal except that it is not requiring that the contract specify the permitted uses of patient identifying information by the contractor, subcontractor, or legal representative. An appropriate comparable legal instrument will suffice in cases where there is otherwise no contract between the lawful holder and a legal representative who is retained voluntarily; when a legal representative is required to represent the lawful holder by law, the requirement for a contract or comparable legal instrument in § 2.33(c) shall not apply.

SAMHSA received several comments expressing general support for the proposed provisions in § 2.33(c) relating to contracts or legal agreements between lawful holders and their contractors, subcontractors, and legal representatives. One of these commenters agreed that limits should be placed on disclosures to contractors, such as allowing disclosure of only the minimum patient identifying information necessary for specific payment or health care operations.

A number of commenters, however, opposed including specific contract requirements in § 2.33(c) between lawful holders and their contractors requiring compliance with part 2. Many of these commenters stated that this provision would impose significant contract amendment burdens industry-wide and would be disruptive to business relationships. Commenters noted that business associate agreements under HIPAA as well as many contracts already require compliance with all applicable federal and state laws, which would include part 2. Some commenters requested that contract provisions requiring compliance with applicable federal laws and regulations be deemed as satisfying the requirement of proposed § 2.33(c) even if part 2 is not specifically mentioned. One commenter stated that contracts typically specify the purposes for which the contractor may use any confidential information and so it is not necessary to require language on specific permitted uses and disclosure of patient identifying information.

Some commenters stated that § 2.33(c) should not be included in future rulemaking. One such commenter requested that SAMHSA provide evidence that current contract language is not adequately addressing part 2 uses and disclosures by those entities specified in § 2.33(c). Another commenter requested that SAMHSA explore leveraging information technology to identify more efficient ways for patients to consent to disclosure. This commenter also recommended that SAMHSA conduct an assessment or promulgate an Advanced Notice of Proposed Rulemaking to solicit information to determine the adequacy of existing contracts or business processes to address information disclosures with contracted entities. Several commenters stated that SAMHSA could address concerns with an extension, by regulation, of the part 2 protections to any entity handling the information disclosed via consent.

SAMHSA received comments that asked that that the language in proposed § 2.33(c) be modified to allow the patient identifying information safeguards to be spelled out in the contract and/or business associates agreement.

SAMHSA is finalizing § 2.33(c) as proposed, but has revised the regulatory text to remove the reference to patient consent as it relates to the requirement to specify permitted uses of patient identifying information by the contractor, subcontractor, or legal representative. However, SAMHSA notes that § 2.13 requires that any disclosure made under the regulations must be limited to that information which is necessary to carry out the purpose of the disclosure. Therefore, to comply with § 2.13, lawful holders should ensure that the purpose section of the consent form is consistent with the role of or services provided by the contractor or subcontractor (e.g., “payment and health care operations”).

SAMHSA understands the concerns expressed by commenters regarding bringing contracts into compliance with § 2.33(c). To address these concerns, the final rule allows lawful holders two years from the effective date of the final rule to bring their contracts and legal agreements with contractors, subcontractors, and voluntary legal representatives into compliance. If lawful holders choose not to re-disclose patient identifying information to contractors, subcontractors, or legal representatives as specified under § 2.33(b), they do not have to comply with § 2.33(c).

SAMHSA disagrees with comments that propose allowing existing contractual language regarding general compliance with applicable federal laws to satisfy requirements under § 2.33(c). SAMHSA believes that it is important for part 2 to be specifically mentioned in contracts and legal agreements when lawful holders are disclosing part 2 patient identifying information to contractors, subcontractors and voluntary legal representatives under § 2.33(b). A fundamental principle of 42 CFR part 2 is that patients should have as much control as possible over their patient identifying information. Referencing part 2 in contracts will help to underscore the importance of compliance with part 2 provisions.

However, SAMHSA also recognizes that entities may have different approaches to ensuring compliance with part 2 and other laws. While SAMHSA requires compliance with § 2.33(c) for lawful holders who wish to disclose patient identifying information pursuant to § 2.33(b), SAMHSA is not specifying the exact contract language to be used.

With respect to the comment regarding limiting disclosures to the minimum information necessary, § 2.13 requires that any disclosure made must be limited to that information which is necessary to carry out the purpose of the disclosure. Contractors, subcontractors, and legal representatives will be required to comply with this and all applicable provisions under part 2. (Section 2.33(c) states that contractors and any subcontractors or legal representatives are fully bound by the provisions of part 2 upon receipt of patient identifying information).

One commenter requested that SAMHSA remove the following sentence from § 2.33(c): “In making such disclosure, the lawful holder should specify permitted uses of patient identifying information consistent with the written consent, by the contractor and any subcontractors or legal representatives to carry out the payment and health care operations activities listed in the preceding subparagraph, require such recipients to implement appropriate safeguards to prevent unauthorized uses and disclosures and require such recipients to report any unauthorized uses, disclosures, or breaches of patient identifying information to the lawful holder.” Commenters stated that lawful holders will not possess the written consent because it is typically held by the part 2 program and it would be impractical, if not impossible, for the written consent form to be passed on to other entities. Another commenter stated that mechanisms for transmitting written consent forms had yet to evolve.

A commenter stated that a prohibition on re-disclosure notice under § 2.32 should not be required when a disclosure from a contractor that is a cloud services provider is back to the lawful holder or is disclosed under the direction or control of the lawful holder because the cloud service provider would not have control over the disclosure and therefore could not accompany the disclosure with a notice related to § 2.32 and suggested alternative language.

Other commenters supported the provisions in proposed § 2.33(c) but specified additional safeguards that should be added or referenced. Several commenters requested that SAMHSA include another requirement in proposed § 2.33(c) that contractors, subcontractors, and legal representatives be bound by all of the requirements that apply to QSOs, as QSOs and contractors serve similar functions. These commenters stated that written contracts under proposed § 2.33(c), therefore, would require contractors, subcontractors, and legal representatives to agree to resist in judicial proceedings any efforts to obtain access to patient records identifying information related to substance use disorder diagnosis, treatment, or referral for treatment except as permitted by part 2. These commenters also expressed opposition to the SNPRM's proposed changes in general or SAMHSA's proposal to permit lawful holders to disclose patient identifying information obtained pursuant to patient consent to contractors, subcontractors and legal representatives, including for payment and health care operations purposes, without these and other protections. One commenter stated that a List of Disclosures requirement for lawful holders who wish to re-disclose patient identifying information to contractors, subcontractors, and legal representatives should be included in contractual language.

One commenter requested that SAMHSA require in the contractual text that contractors, subcontractors, and legal representatives use protected substance use disorder information only for the purpose(s) listed in the patient's written consent and that re-disclosure by contractors, subcontractors, and legal representatives to third parties be allowed only as long as the third party discloses the patient identifying information back to the contractors or lawful holders from which the information originated.

SAMHSA declines to provide specific and detailed contract language because SAMHSA believes lawful holders need the flexibility to include language that fits within their contract structures. However, regardless of the specific contractual language used, all lawful holders, contractors, subcontractors, and legal representatives must comply with applicable requirements specified in § 2.33(c) as well as the other applicable provisions in part 2.

SAMHSA does not require that part 2 consent forms be passed along to the contractor or subcontractor. SAMHSA has revised the regulatory text in § 2.33(c) to remove the reference to patient consent as it relates to the requirement to specify permitted uses of patient identifying information by the contractor, subcontractor, or legal representative. However, § 2.13 requires that any disclosure made under the regulations must be limited to that information which is necessary to carry out the purpose of the disclosure. Therefore, to comply with § 2.13, part 2 programs and other lawful holders should ensure that the purpose section of the consent form is consistent with the role of or services provided by the contractor or subcontractor (e.g., “payment and health care operations”). Those utilizing contractors or subcontractors should then inform those parties in their contracts that information governed by part 2 requires the contractor or subcontractor to take reasonable steps to prevent unauthorized uses and disclosures and to inform the lawful holder of any breaches and/or unauthorized uses. If a contractor receives information for quality assurance purposes, for instance, they should not be sharing it for other purposes, much less for activities not related to payment and health care operations. Section § 2.33(c) specifies the requirements of a written contract; it is up to the lawful holder and contractor to determine how their contracts should address these requirements.

With regard to cloud service providers storing patient identifying information for a lawful holder, SAMHSA declines to make the suggested changes to the language in § 2.33(c). Under § 2.33, lawful holders, contractors and their subcontractors are responsible for providing a prohibition on re-disclosure notice (§ 2.32) if they re-disclose patient identifying information to their contractors in order to meet the requirements of § 2.33. If other entities access the information as permitted by the lawful holder (because the other entities that gain access to the information via the cloud are contractors with the lawful holder (§ 2.33) and not the cloud services provider, or to fulfill the requirements on the written consent (§ 2.31), then the lawful holder (not the cloud service provider) is responsible for ensuring that a notice of the prohibition on re-disclosure is conveyed to those entities, along with the information.

Regardless of the specific contractual language used, all lawful holders, contractors, subcontractors, and legal representatives must comply with requirements specified in § 2.33(c) as well as the other applicable provisions in part 2. Therefore, with respect to the comments on contractors, subcontractors, and legal representatives resisting disclosure of patient records in judicial proceedings, SAMSHA notes that § 2.13(a) already states: “The patient records subject to the regulations in this part may be disclosed or used only as permitted by the regulations in this part and may not otherwise be disclosed or used in any civil, criminal, administrative, or legislative proceedings conducted by a federal, state or local authority.” In addition, § 2.13(a) already requires that any disclosures must be limited to the information which is necessary to carry out the purpose of the consent. In response to the request that the contract require compliance with the security requirements, § 2.16, Security for Records, already applies to part 2 programs and other lawful holders of patient identifying information, and, therefore, would apply to contractors, subcontractors, and legal representatives.

SAMHSA received a number of comments relative to Medicaid agencies and MCOs with which they contract; the commenters stated that MCOs are considered to be an extension of the Medicaid agency. Several of these commenters requested clarification that, under § 2.33(b), MCOs (one commenter noted that such organizations are called coordinated care organizations in that state) may disclose patient identifying information for health care operations and payment purposes to the state agency with which the organization is under contract. One commenter requested clarification that under § 2.33(b) lawful holders may disclose patient identifying information to the state Medicaid agency with which they are contracted. Another commenter requested that that this provision explicitly permit disclosures between managed care organizations, their contractors and a Medicaid program. Similarly, a commenter also pointed out that proposed § 2.33(b) would only allow a lawful holder to disclose to its own contractors and subcontractors, which would not relieve the administrative obstacles part 2 providers experience when trying to obtain insurance coverage for their patients because the part 2 programs would have to deal directly with a peer reviewer or utilization review company that is a subcontractor to the insurance company named on the consent form.

With regard to the comments on Medicaid agencies and the managed care organizations with which they contract, as well as those addressing administrative obstacles contractors may face in obtaining patient identifying information, the information can be disclosed directly to the contractor or subcontractor and does not need to first be disclosed to the lawful holder (i.e., recipient named on the consent form) and then subsequently re-disclosed, as long as the information is being used for the purposes of payment and health care operations. This is because contractors, legal representatives, and subcontractors are acting on behalf of the lawful holders based on contracts, legal agreements or mandates in law.

Two commenters, pointing to the varying definitions for “contractors” and “subcontractors” under different laws and regulations, requested that SAMHSA consider defining these terms.

SAMHSA did not propose to define “contractors” and “subcontractors” in its proposed rule and declines to do so now in the final rule. As stated in § 2.33(c), lawful holders who wish to disclose patient identifying information pursuant to subsection (b) of this section must enter into a written contract with the contractor (or appropriate comparable legal instrument in the case of a legal representative retained voluntarily by the lawful holder). In the case where there is a legal representative who is required to represent the lawful holder by law, the requirement for a contract or comparable legal instrument in § 2.33(c) shall not apply. SAMHSA believes this general understanding of a contractor or subcontractor provides the necessary flexibility for these types of arrangements while still ensuring that all parties must adhere to requirements and protections specified in § 2.33(c).

One commenter requested that SAMHSA add a new § 2.33(d) to state that “if the contractor, subcontractor, or legal representative needs patient identifying information directly from the part 2 program, the contractor, subcontractor, or legal representative must produce a copy of the agreement mandated by § 2.33(c) prior to the part 2 program releasing any information.”

SAMHSA declines to require contractors, subcontractors, and legal representatives to produce a copy of the agreement mandated by § 2.33(c) prior to the part 2 program releasing any information because SAMHSA did not propose to do so in the SNPRM. The decision as to whether to share this information would be at the discretion of the contracting parties.

One commenter stated that proposed § 2.33(b) should apply to all lawful holders (and not just those who received patient identifying information pursuant to a written consent), which would enable QSOs to disclose without consent to contractors and subcontractors.

SAMHSA declines to eliminate the requirement that § 2.33(b) only applies to lawful holders that receive patient identifying information pursuant to a written consent. SAMHSA believes that the consent requirement for lawful holders that fall under § 2.33(b) must be maintained and that § 2.33(b) should not apply to QSOs. Further, SAMHSA guidance indicates that a QSOA does not permit a QSO to re-disclose information to a third party unless that third party is a contract agent of the QSO, helping them provide services described in the QSOA, and only as long as the agent only further discloses the information back to the QSO or to the part 2 program from which it came.

SAMHSA recognizes that federal, state, and local governments often need to access all of the records, including part 2 program records, held by entities they regulate in order to appropriately evaluate compliance with applicable laws, rules, and policies. As a result, in the SNPRM, SAMHSA proposed regulatory changes to clarify that audits and evaluations may be performed on behalf of federal, state, and local governments providing financial assistance to, or regulating the activities of, lawful holders as well as part 2 programs. SAMHSA recognizes that federal, state, and local governments often need to access all of the records, including part 2 program records, held by entities they regulate in order to appropriately evaluate compliance with applicable laws, rules, and policies. For example, an Accountable Care Organization (ACO) or similar CMS-regulated health care models may wish to evaluate the impact of integrated care on several participating behavioral health care programs' quality of care, or a state may wish to do an audit to see how many individuals who leave state-supported correctional facilities subsequently receive substance use disorder treatment. In addition, SAMHSA proposed regulatory revisions to: Specify that audits and evaluations may be performed by contractors, subcontractors, or legal representatives on behalf of a third-party payers or a quality improvement organizations; and state that if disclosures are made under this section for a Medicare, Medicaid, or CHIP audit or evaluation, including a civil investigation or administrative remedy, further disclosures may be made to contractors, subcontractors, or legal representatives to carry out the audit or evaluation. SAMHSA is now finalizing these requirements. It has also made certain technical amendments to correct inadvertent omissions in the rule's text to effectuate SAMHSA's intent to permit disclosure and use of patient identifying information held by other lawful holders for audit and evaluation purposes, as well as to clarify and operationalize the requirements of this section.

SAMHSA received a range of comments concerning the proposed amendments with regard to permitted disclosures of patient identifying information to contractors, subcontractors, and legal representatives for purposes of carrying out an audit or evaluation under part 2. SAMHSA received a number of comments supporting these revisions. Several of the commenters also expressed support specifically for the provision allowing patient identifying information to be disclosed for purposes of carrying out an audit or evaluation, with some citing proposed § 2.53(a)(1)(i) in particular. Some commenters stated this particular revision would allow lawful holders of patient identifying information to disclose that information to audit and oversight entities in order to respond to an audit or evaluation request, and that clear authority to disclose patient identifying information for audits (which may include quality improvement and program integrity) is critical to Medicaid program operations. Another commenter supported the proposed changes because they would appear to allow disclosure of patient identifying information to a government agency authorized to regulate the activities of any lawful holder, not just a part 2 program or private payer, and because this change would at least partially conform to HIPAA's permissible disclosures to health system oversight agencies. The commenter, however, expressed concern that the proposed language did not make clear whether the government agency must obtain access to the records directly from the part 2 program rather than from the other lawful holder that the agency regulates, as obtaining records from the part 2 program posed communications challenges.

SAMHSA appreciates the support for the further amendments as set out in the regulatory text of § 2.53. Inclusion of these additional provisions reflects that contractors, subcontractors and legal representatives are increasingly involved in audit and evaluation activities. SAMHSA recognizes that federal, state, and local governments often need to access all of the records, including part 2 program records, held by entities they regulate in order to appropriately evaluate compliance with applicable laws, rules, and policies. We believe including these changes will assist in compliance with part 2 and other federal, state, and local rules and regulations and improve part 2 program quality.

With respect to the commenter's concern, if a government agency is auditing or evaluating a lawful holder, which it regulates, the agency may receive the patient identifying information necessary for that audit or evaluation directly from the lawful holder.

SAMHSA also received a number of comments opposing the proposal to permit re-disclosure of patient identifying information without patient consent to contractors and subcontractors for audit and evaluation purposes unless SAMHSA provides additional safeguards. Several of these commenters noted that the proposed changes to § 2.53 have the potential to greatly expand the universe of individuals and entities who may receive protected substance use disorder information without patient consent for audit and evaluation purposes.

A couple of commenters expressed concern that detailed patient records would be used for purposes of risk adjustment and reporting of the patient's severity of illness to predict health care cost expenditures and adjust payer payments. One commenter stated that, if data are being used to impact a patient's score or health coverage, patient consent should be required.

SAMHSA appreciates the array of recommendations commenters provided for possible restrictions and safeguards. SAMHSA is contemplating future rulemaking for 42 CFR part 2, and will take these recommendations under advisement at that time.

With regard to the suggestion that SAMHSA require patient consent if data could be used to affect a patient's health coverage or health score, SAMHSA reiterates that under the terms of § 2.53, patient identifying information may only be used for audit and evaluation purposes.

Two commenters stated that changes made to the SNPRM were predicated on the concept that part 2 confidentiality restrictions extend beyond part 2 programs to third parties, including lawful holders, contractors, subcontractors and legal representatives. These commenters, noting that no definitions exist in the regulatory text for “lawful holders,” “contractors,” or “subcontractors,” or “legal representatives,” requested that SAMHSA address whether the part 2 statute permits the extension of these restrictions beyond part 2 programs.

The statute (42 U.S.C. 290dd-2) authorizes SAMHSA to promulgate regulations to effectuate the confidentiality provisions governing substance use disorder patient records. The part 2 rule's applicability to third parties is a reasonable exercise of SAMHSA's statutory authority to ensure protection of part 2 information in the possession of lawful holders other than part 2 programs.

SAMHSA received several comments requesting that greatest weight be given to comments from patients and consumers who will be directly affected by any changes to part 2; one of these commenters made this request because patients entering treatment will likely be unable to anticipate complex re-disclosure risks for activities proposed by the SNPRM. In addition, a commenter requested that special consideration be given to comments from substance use disorder treatment providers.

Every comment received on the SNPRM was given careful consideration, and SAMHSA has endeavored in this final rule to take into account the varying perspectives of public commenters. SAMHSA is seeking a balance between ensuring that patients with substance use disorders have the ability to participate in, and benefit from, new and emerging health care models that promote integrated care and patient safety and ensuring the confidentiality of substance use disorder patient records, given the potential for discrimination, harm to reputations and relationships, and serious civil and criminal consequences that could result from impermissible disclosures.

In the SNPRM, SAMHSA stated that, if adopted, the proposed revisions should not result in any additional costs to part 2 programs. However, SAMHSA specifically sought comment on the implications of the proposed changes on the regulatory and financial impact, if any, of these proposed rules.

SAMHSA did not receive any comments on costs related to specific proposals made in the SNPRM or the RIA.

In the January 18, 2017, SNPRM, SAMHSA made several requests for public comments based on its expectation that there may be future 42 CFR part 2-related rulemaking. Those comments are summarized below.

In the SNPRM, SAMHSA sought comment on the proper mechanisms to convey the scope of the consent to lawful holders, contractors, subcontractors, and legal representatives, including those who are downstream recipients of patient identifying information given current electronic data exchange technical designs.

Commenters suggested that SAMHSA provide more clarity on these mechanisms, particularly given the current electronic exchange environment and recommended more specific ways to ensure patients retain control over how their information is disclosed. Another commenter asserted proposed consent requirements could be burdensome, and a third-party payer may be unable to assess part 2 program compliance with consent requirements.

SAMHSA has modified language in § 2.33(c) so as not to imply that the consent form must be provided to the recipient of part 2 records. Sections 2.13, 2.31, and other sections of part 2 require recipients of patient identifying information to have knowledge of 42 CFR part 2 as it relates to the purpose for which information is being disclosed and can be re-disclosed lawfully. Individuals and entities that disclose or receive patient identifying information via patient consent must be able to comply with these requirements.

In the SNPRM, SAMHSA specifically sought comments regarding the establishment of appropriate restrictions and safeguards on lawful holders and their contractors, subcontractors, and legal representatives' use and disclosure of patient identifying information for the purposes discussed in the SNPRM.

SAMHSA received a number of responses to this request for comments regarding the establishment of appropriate restrictions and safeguards. These comments recommended a wide array of patient protections and safeguards. While some commenters noted there is a legitimate need for lawful holders to disclose protected information to their contractors, subcontractors, and legal representatives for payment and health care operations purposes, many commenters expressed concern that the breadth of the proposed changes may undermine core protections under part 2, which give substance use disorder patients control over how their information is disclosed so as not to make them more vulnerable to potential negative consequences of such disclosures. Loss of employment, loss of housing, loss of child custody, discrimination by medical professionals and insurers, and arrest, prosecution, and incarceration were cited as potential negative consequences. Most commenters stated concern over, or even their opposition to, SAMHSA finalizing proposed changes in the SNPRM without including certain additional protections.

SAMHSA appreciates the array of recommendations commenters provided for possible restrictions and safeguards. SAMHSA believes that the existing restrictions and safeguards—including provisions limiting use of patient identifying information in criminal and civil procedures and requiring that any disclosure made under these regulations must be limited to that information which is necessary to carry out the purpose of the disclosure—are adequate.

Many commenters recommended the addition of specific anti-discrimination protections that would apply to disclosures pursuant to the proposed §§ 2.33(b) and 2.53. Commenters expressed concern over the potential for misuse of information and a desire to balance the increased flexibility of proposed §§ 2.33 and 2.53 with increased protections.

Promulgating rules that address discriminatory action is outside the scope of SAMHSA's legal authority.

Several commenters expressed concern that the proposed changes to § 2.33 would greatly expand access to patient identifying information by individuals and entities to whom the patient did not specifically consent and for purposes not always evident to the patient. These commenters, and a number of others, requested that SAMHSA require, at a minimum, a notification to patients on the consent form that they are consenting to the disclosure of their patient identifying information to both the recipient and the recipient's contractors, subcontractors, and legal representatives to the extent those contractors, subcontractors, and legal representatives need the information to carry out payment or health care operations purposes.

SAMHSA is contemplating future rulemaking for 42 CFR part 2 and will take these recommendations under consideration at that time. In addition, consistent with the 21st Century Cures Act, prior to March 21, 2018, the Secretary of HHS will convene relevant stakeholders to determine the effects of 42 CFR part 2 on patient care, health outcomes, and patient privacy. The information obtained at the meeting will help to inform the course of any further part 2 rule-making. SAMHSA will consider these comments on privacy and confidentiality in conjunction with those made during the stakeholder meeting.

Several commenters recommended adding a requirement that lawful holders who wish to re-disclose patient identifying information to contractors, subcontractors, and legal representatives be subject to the same List of Disclosures requirements that apply to intermediaries who disclose patient identifying information pursuant to a general designation under the consent requirements at § 2.31. In addition, a couple of commenters requested that SAMHSA impose a List of Disclosures requirement on audit and evaluation agencies. One commenter requested that SAMHSA not finalize the proposed changes in the SNPRM without mechanisms in place to enable individuals who have been adversely impacted to identify the source of a disclosure and initiate sanctions.

SAMHSA appreciates the recommendations to add mechanisms to enable individuals who have been adversely impacted to identify the source of a disclosure, including adding a List of Disclosures requirement. SAMHSA is contemplating future rulemaking for 42 CFR part 2, and will take these recommendations under consideration.

SAMHSA also received comments recommending other types of protections and safeguards. One commenter recommended SAMHSA reinforce patients' rights to file grievances and complaints and suggested that SAMHSA explore the ability to impose a confidentiality certificate on information disclosed to third parties similar to 42 U.S.C. 241(d), which protects the privacy of research subjects. A couple of commenters suggested strengthening patient protections by adding re-disclosure prohibitions in the statute similar to the confidentiality protections extended to certain veterans' medical records, including substance use disorder patient records in Title 38.

Another commenter stated that given stigma and risk of adverse impact, it was critical to have additional protections in place such as substantial penalties for disclosure violations and failure to maintain tracking of disclosures and mechanisms for an individual to identify and correct errors in an electronic health record and for identifying the source of the disclosed errors. This commenter stated that, because there is no clear mechanism to correct errors in records, it is critical that initial sharing of information be restricted until such mechanisms are developed.

In addition, two commenters stated that the proposed audit and evaluation revisions could conflict with intended court order protections at §§ 2.64 through 2.67 and requested SAMHSA clarify the necessity to obtain court orders in such investigations and prosecutions as a result of a Medicare, Medicaid, or CHIP audit or evaluation.

SAMHSA appreciates the recommendations for identifying the source of a disclosure under § 2.33, and strengthening language regarding a patient's right to file a grievance. SAMHSA is contemplating future rulemaking for 42 CFR part 2, and will take these recommendations under advisement at that time.

In addition, SAMHSA does not have the authority to make statutory revisions, so SAMHSA cannot add re-disclosure prohibitions to the authorizing statute. With regard to the comment regarding the imposition of substantial penalties, the part 2 regulations already include provisions to implement the statutory criminal penalties for violations. Further, SAMHSA does not have the authority to require a mechanism for making corrections in an electronic health record.

SAMSHA believes that permitting contractors, subcontractors, and legal representatives to obtain information for audit and evaluation purposes does not contradict or undermine protections currently within §§ 2.64 through 2.67. For instance, § 2.53 provides that the audit and evaluation provisions “do not authorize the part 2 program, the federal, state, or local government agency, or any other individual or entity to disclose or use patient identifying information obtained during the audit or evaluation for any purposes other than those necessary to complete the audit or evaluation.” Similarly, § 2.53(d) explicitly states that, except as provided, “patient identifying information disclosed under this section may be disclosed only back to the part 2 program or other lawful holder from which it was obtained and may be used only to carry out an audit or evaluation purpose or to investigate or prosecute criminal or other activities, as authorized by a court order entered under §  2.66.”

SAMHSA specifically sought comment on the implications of the proposed revisions on the privacy and confidentiality of substance use disorder patient records and the overall goals of 42 CFR part 2.

SAMHSA received several comments that addressed this request, some of which were general in nature, while others were specific to proposed revisions in either § 2.32 or in § 2.33. All commenters expressed support for preserving patients' confidentiality. One commenter expressed general concerns about parties trying to alter federal confidentiality protections in a manner that will not benefit patients. These concerns included prospective patients avoiding seeking treatment over fears that the proposed broader dissemination of their treatment information may lead to that information becoming known by friends, family, employers, insurers, and other providers of medical services. Commenters expressed concern regarding the privacy and confidentiality impact of the SNPRM changes to §§ 2.32 and 2.33. These commenters asserted that: (1) The changes would, over time, result in gradual disclosure of part 2 data as a result of failing to communicate through the notice the importance of avoiding improper re-disclosures; (2) substance use disorder patients would not likely agree to the broad use of their personal information for activities that they do not understand or are perhaps incapable of refusing (e.g., incompetent); and (3) terms such as “health care operations” and “quality improvement” are too general, allowing activities that have few limits or boundaries. A couple of commenters stated that the proposed changes would result in patients attempting to exclude their records from research and quality improvement systems or avoiding lifesaving treatment services. In addition, one commenter expressed concern that SAMHSA may have unintentionally abrogated its responsibility to protect vulnerable patients.

As stated previously, this final rule builds on efforts in the January 18, 2017, 42 CFR part 2 final rule (82 FR 6052) to better reflect changes in the health care system, such as the increasing use of electronic health records, and drive toward greater integration of physical and behavioral health care. Despite efforts to enhance integration, SAMHSA remains committed to protecting the confidentiality of patient records. This rule updates 42 CFR part 2 to balance these important needs. However, as an added protection and consistent with the 21st Century Cures Act, prior to March 21, 2018, the Secretary of HHS will convene relevant stakeholders to determine the effects of 42 CFR part 2 on patient care, health outcomes, and patient privacy. The information obtained at the meeting will help to inform the course of any further part 2 rule-making, and SAMHSA will consider these comments on privacy and confidentiality in conjunction with those made during the stakeholder meeting.

In this final rule, SAMHSA finalizes certain revisions to 42 CFR part 2 as follows: Prohibition on re-disclosure (§ 2.32); the disclosures permitted with written consent (§  2.33), including the payment and health care operations activities for which lawful holders may disclose patient identifying information to their contractors, subcontractors, and legal representatives. In addition, SAMHSA clarifies that the audit and evaluation provision (§  2.53) permits certain disclosures to contractors, subcontractors, and legal representatives for purposes of carrying out an audit or evaluation, and that audits and evaluations may be performed on behalf of federal, state, and local governments providing financial assistance to or regulating the activities of lawful holders of patient identifying information as well as part 2 programs.

Notably, SAMHSA explicitly sought comment on costs and benefits of its proposed changes. Of the 55 public comments received on the proposed rule, none substantively focused on cost or burden issues. Public comments support SAMHSA's view in this final rule that these modifications will enhance information-sharing and efficiency of such payment and health care operations as claims processing, business management, training, and customer service and facilitate audit and evaluation activities. Further, SAMHSA believes that the re-disclosure provisions will make it easier for some part 2 programs and other lawful holders to use electronic health systems.

The January 18, 2017, final rule noted that in “the absence of data and studies specifically focused on compliance with 42 CFR part 2, SAMHSA has estimated these costs based on a range of published costs associated with HIPAA implementation and compliance.” SAMHSA notes that the HIPAA Omnibus Final Rule (78 FR 5566, Jan. 25, 2013) similarly provided a transition period for covered entities to incorporate new provisions into agreements between business associates and covered entities (up to 20 months after publication of the final rule for some agreements, provided certain conditions were met) and anticipated that there would be little added cost as these contracts would already be required. SAMHSA believes that the cost of updating agreements among part 2 programs and other lawful holders to reflect the provisions adopted in this final rule would be negligible. In order to provide entities with maximum flexibility reflecting their unique contractual arrangements, contracts may include statements about required compliance with 42 CFR part 2; however, no specific language beyond this concept is required by the rule. This rule provides up to two years from the effective date to comply with this section. Because part 2 programs and other lawful holders can modify their contracts during the normal renegotiation of contracts as existing contracts expire or, if such contracts are not regularly updated, can make such changes up to two years from this final rule's effective date, new regulatory language required by § 2.33(c), as revised, should impose a minimal burden.

SAMHSA similarly believes that the abbreviated notice of the prohibition on re-disclosure adopted in this final rule provides additional options to part 2 entities that will facilitate adoption of electronic health records and reduce regulatory burdens. Entities not wishing to use the abbreviated notice may use the standard prohibition on re-disclosure notice. As the revised notice has limited characters, SAMHSA believes that it can be more readily used with existing electronic health record systems.

Under the Paperwork Reduction Act of 1995 (PRA), agencies are required to provide a 60-day notice in the Federal Register and solicit public comment before a collection of information requirement is submitted to the Office of Management and Budget (OMB) for review and approval. PRA issues were discussed in the SNPRM. SAMHSA stated that it anticipated no substantive changes in PRA requirements should changes proposed in the SNPRM be adopted. SAMHSA received no public comment on our assumptions as they relate to the PRA requirements. SAMHSA continues to believe that the final rule imposes no new PRA burdens.

SAMHSA has examined the impact of this final rule under Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13771 on Reducing Regulation and Controlling Regulatory Costs (January 30, 2017), Executive Order 13563 on Improving Regulation and Regulatory Review (January 18, 2011), the Regulatory Flexibility Act of 1980 (Pub. L. 96-354, September 19, 1980), the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4, March 22, 1995), and Executive Order 13132 on Federalism (August 4, 1999).

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 13771 requires that the costs associated with significant new regulations “shall, to the extent permitted by law, be offset by the elimination of existing costs associated with at least two prior regulations.” The changes finalized in this rule will not have an annual effect on the economy of $100 million or more in at least one year. Therefore, this final rule is not an economically significant regulatory action as defined by Executive Order 12866, or a significant regulation under Executive Order 13771. The Regulatory Flexibility Act (RFA) requires agencies that issue a regulation to analyze options for regulatory relief of small businesses if a rule has a significant impact on a substantial number of small entities. The RFA generally defines a “small entity” as (1) a proprietary firm meeting the size standards of the Small Business Administration; (2) a nonprofit organization that is not dominant in its field; or (3) a small government jurisdiction with a population of less than 50,000. (States and individuals are not included in the definition of “small entity”). For similar rules, HHS considers a rule to have a significant economic impact on a substantial number of small entities if at least five percent of small entities experience an impact of more than three percent of revenue. This final rule will not have a significant economic impact on a substantial number of small entities.

Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may 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 annually for inflation) in any one year.” This final rule does not trigger the Unfunded Mandates Reform Act, because it will not result in expenditures of this magnitude by states or other government entities.

This section contains corrections to the final regulations published in the Federal Register on January 18, 2017 (82 FR 6988). The word “manage” was inadvertently omitted from the regulation text at § 2.15 concerning incompetent and deceased patients. It should read “to manage their own affairs” rather than “to their own affairs.” A typographical error and reference in the regulation to “paragraph (a)(8)” should have instead read “paragraph (a)(6)” in the text of the regulations at § 2.35 concerning disclosures to elements of the criminal justice system which have referred patients. As a result, we are making technical corrections in 42 CFR part 2 at §§ 2.15 and 2.35.

Section 553 of the Administrative Procedure Act, 5 U.S.C. 553(b)(3)(B), provides that, when an agency for good cause finds that notice and public procedure are impracticable, unnecessary, or contrary to the public interest, the agency may issue a rule without providing notice and an opportunity for public comment. We have determined that there is good cause for making these technical corrections final without prior notice and opportunity for comment because the changes address minor typographical errors, misprints, or omissions, which are noncontroversial and do not substantively change the requirements of the rule. Furthermore, the minor corrections do not impose any additional obligations on any party. Thus, notice and public comment is impracticable, unnecessary, or contrary to the public interest.

SAMHSA is finalizing changes to clarify the payment and health care operations activities for which lawful holders may disclose patient identifying information to their contractors, subcontractors, and legal representatives. In addition, SAMHSA clarifies that the audit and evaluation provision permits certain disclosures to contractors, subcontractors, and legal representatives for purposes of carrying out an audit or evaluation under §  2.53. SAMHSA is finalizing changes to clarify that audits and evaluations may be performed on behalf of federal, state and local governments providing financial assistance to, or regulating the activities of lawful holders, as well as part 2 programs. The final rule also includes an abbreviated notice of the prohibition on re-disclosure. Finally, SAMHSA is making minor technical corrections to select provisions of the 42 CFR part 2 final rule published in the Federal Register on January 18, 2017.

For the reasons stated in the preamble of this final rule, 42 CFR part 2 is amended as follows:

The NFIP enables property owners to purchase Federal flood insurance that is not otherwise generally available from private insurers. In return, communities agree to adopt and administer local floodplain management measures aimed at protecting lives and new construction from future flooding. Section 1315 of the National Flood Insurance Act of 1968, as amended, 42 U.S.C. 4022, prohibits the sale of NFIP flood insurance unless an appropriate public body adopts adequate floodplain management measures with effective enforcement measures. The communities listed in this document no longer meet that statutory requirement for compliance with program regulations, 44 CFR part 59. Accordingly, the communities will be suspended on the effective date in the third column. As of that date, flood insurance will no longer be available in the community. We recognize that some of these communities may adopt and submit the required documentation of legally enforceable floodplain management measures after this rule is published but prior to the actual suspension date. These communities will not be suspended and will continue to be eligible for the sale of NFIP flood insurance. A notice withdrawing the suspension of such communities will be published in the Federal Register.

In addition, FEMA publishes a Flood Insurance Rate Map (FIRM) that identifies the Special Flood Hazard Areas (SFHAs) in these communities. The date of the FIRM, if one has been published, is indicated in the fourth column of the table. No direct Federal financial assistance (except assistance pursuant to the Robert T. Stafford Disaster Relief and Emergency Assistance Act not in connection with a flood) may be provided for construction or acquisition of buildings in identified SFHAs for communities not participating in the NFIP and identified for more than a year on FEMA's initial FIRM for the community as having flood-prone areas (section 202(a) of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4106(a), as amended). This prohibition against certain types of Federal assistance becomes effective for the communities listed on the date shown in the last column. The Administrator finds that notice and public comment procedures under 5 U.S.C. 553(b), are impracticable and unnecessary because communities listed in this final rule have been adequately notified.

Each community receives 6-month, 90-day, and 30-day notification letters addressed to the Chief Executive Officer stating that the community will be suspended unless the required floodplain management measures are met prior to the effective suspension date. Since these notifications were made, this final rule may take effect within less than 30 days.

National Environmental Policy Act. FEMA has determined that the community suspension(s) included in this rule is a non-discretionary action and therefore the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq.) does not apply.

Regulatory Flexibility Act. The Administrator has determined that this rule is exempt from the requirements of the Regulatory Flexibility Act because the National Flood Insurance Act of 1968, as amended, Section 1315, 42 U.S.C. 4022, prohibits flood insurance coverage unless an appropriate public body adopts adequate floodplain management measures with effective enforcement measures. The communities listed no longer comply with the statutory requirements, and after the effective date, flood insurance will no longer be available in the communities unless remedial action takes place.

Regulatory Classification. This final rule is not a significant regulatory action under the criteria of section 3(f) of Executive Order 12866 of September 30, 1993, Regulatory Planning and Review, 58 FR 51735.

Executive Order 13132, Federalism. This rule involves no policies that have federalism implications under Executive Order 13132.

Executive Order 12988, Civil Justice Reform. This rule meets the applicable standards of Executive Order 12988.

Paperwork Reduction Act. This rule does not involve any collection of information for purposes of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq.

Accordingly, 44 CFR part 64 is amended as follows:

This is a summary of the Public Notice (MF-II Challenge Process Handset Public Notice), WC Docket No. 10-90, WT Docket No. 10-208, DA 17-1218, adopted on December 20, 2017, and released on December 20, 2017. The complete text of the MF-II Challenge Process Handset Public Notice is available for public inspection and copying from 8:00 a.m. to 4:30 p.m. Eastern Time (ET) Monday through Thursday or from 8:00 a.m. to 11:30 a.m. ET on Fridays in the FCC Reference Information Center, 445 12th Street SW, Room CY-A257, Washington, DC 20554. The complete text is also available on the Commission's website at https://ecfsapi.fcc.gov/file/122011224060/DA-17-1218A1.pdf. Alternative formats are available to persons with disabilities by sending an email to [email protected] or by calling the Consumer & Governmental Affairs Bureau at (202) 418-0530 (voice), (202) 418-0432 (TTY).

1. The Rural Broadband Auctions Task Force (Task Force), in conjunction with the Wireline Competition Bureau and the Wireless Telecommunications Bureau (Bureaus), provides further requirements for the handsets that mobile wireless providers in the Mobility Fund Phase II (MF-II) challenge process must designate for challengers to use when conducting speed tests in areas deemed presumptively ineligible for MF-II support. In addition, the Bureaus adopt procedures for challengers to request access to the Universal Service Administrative Company (USAC) challenge process portal.

2. Under the MF-II Challenge Process Order, 82 FR 42473, September 8, 2017, the MF-II challenge process will begin with a new, one-time collection of current, standardized coverage data on qualified 4G LTE service, which the Commission will use to establish the map of areas presumptively eligible for MF-II support.

3. As part of the new, one-time data collection, each mobile wireless provider with qualified 4G LTE coverage is required to identify at least three readily-available handset models appropriate for testing its coverage, at least one of which must be compatible with industry-standard drive test software. The Commission also directed the Bureaus to propose and adopt further guidance on the types of devices that may be used for speed tests.

4. After release of the MF-II Challenge Process Order, the Task Force, in conjunction with the Bureaus, released instructions for submitting the new 4G LTE coverage data, including the handset list, and announced a deadline of January 4, 2018, to submit the required coverage information. Pursuant to the Commission's direction, the Bureaus subsequently sought comment on proposed requirements to ensure that at least one designated handset is compatible with industry-standard drive test software.

5. After consideration of these comments, the Bureaus provide further requirements for the types of devices that may be used for speed tests. First, each provider must identify in its filing at least one device that is either: (a) Officially supported by the latest versions of industry-standard drive test software, such as JDSU, ZK-SAM, Rohde & Schwartz, or TEMS; or (b) engineering-capable and able to be unlocked and put into diagnostic mode to interface with drive test software. Second, at least one of the three specified devices must run the Android operating system. This device can be the same device as the one that meets the requirements adopted for compatibility with drive-test software, but it need not be. Because the coverage data submitted by affiliated entities will be consolidated when made available to challengers through the USAC portal, the Bureaus will consolidate the submitted provider handset data for such entities to the extent that the lists of handsets differ.

6. Parties may file the foregoing handset information with their January 4, 2018 filings, or they may elect to supplement those filings with that handset information no later than thirty days following the publication of the MF-II Challenge Process Handset Public Notice in the Federal Register.

7. Participants in the MF-II challenge process must use the USAC portal to file a challenge and/or respond to a challenge, as well as to access certain information that is pertinent to a challenge. The Commission directed the Bureaus to detail the process by which an interested party may request a USAC account to access the portal.

8. The process for interested parties and challenged providers to request access to the USAC portal is as follows. Any eligible service provider wishing to participate in the challenge process must provide to the Commission, via web-based form, the legal name of the entity, its FCC Registration Number (FRN), and the name(s) and email address(es) of the user(s) (up to a maximum of three users) that should be granted access to the portal. Any government entity (i.e., a local, state, or Tribal government entity) that wishes to participate in the challenge process also must provide the legal name of the entity, its legal jurisdiction, and the name(s) and email address(es) of the user(s) (up to a maximum of three users) that should be granted access to the portal. The web page address and date by which to submit this contact information will be announced at a later date.

9. The Bureaus encourage parties that may have an interest in participating in the challenge process to provide this contact information as soon as the form is available. Providing this contact information does not represent a commitment or obligation to participate in the challenge process.

10. For a party that files a waiver petition with the Commission seeking to participate in the MF-II challenge process as a challenger (because it is not a service provider or a government entity), the Bureaus require such a party to submit the first and last name of the user(s) that should have access to the portal on its behalf, and the email address(es) of the user(s), up to a maximum of three users, as part of its petition for waiver. Any waiver petition must be submitted to [email protected]. The Bureaus strongly encourage any interested party to file a waiver petition as soon as practicable.

11. The MF-II Challenge Process Handset Public Notice implements the information collection requirements adopted in the MF-II Challenge Process Order and does not contain any new or modified information collection requirements subject to the Paperwork Reduction Act of 1995 (PRA), Public Law 104-13, 44 U.S.C. 3501-3520. The Commission sought and received PRA approval from the Office of Management and Budget (OMB) under its emergency processing procedures for the information collection requirements associated with the qualified 4G LTE coverage data collection, as adopted in the MF-II Challenge Process Order and further explained in the MF-II Challenge Process Handset Public Notice. The OMB control number for this collection is OMB 3060 1242. The Commission is currently seeking PRA approval for the information collection requirements related to the challenge process itself, as adopted in the MF-II Challenge Process Order and further explained in the MF-II Challenge Process Handset Public Notice. The MF-II Challenge Process Handset Public Notice does not adopt any additional information collection requirements beyond those adopted in the MF-II Challenge Process Order.

12. As required by the Regulatory Flexibility Act of 1980, as amended (RFA), the Commission prepared Initial Regulatory Flexibility Analyses (IRFAs) in connection with the USF/ICC Transformation FNPRM, 76 FR 78383, December 16, 2011, the 2014 CAF FNPRM, 80 FR 4445, January 27, 2015, and the MF-II FNPRM, 82 FR 13413, March 13, 2017 (collectively, MF-II FNPRMs). A Supplemental Initial Regulatory Flexibility Analysis (SIRFA) was also filed in the MF-II Challenge Process Comment Public Notice, 82 FR 51180, November 3, 2017, in this proceeding. The Commission sought written public comment on the proposals in MF-II FNPRMs and in the MF-II Challenge Process Comment Public Notice, including comments on the IRFAs and SIRFA. The Commission received three comments in response to the MF-II FNPRM IRFA. No comments were filed addressing the USF/ICC Transformation FNPRM IRFA, the 2014 CAF FNPRM IRFA, or the MF-II Challenge Process Comment Public Notice SIRFA. The Commission included Final Regulatory Flexibility Analyses (FRFAs) in connection with the 2014 CAF Order, the MF-II Order, and the MF-II Challenge Process Order (collectively, the MF-II Orders). This Supplemental Final Regulatory Flexibility Analysis (SFRFA) supplements the FRFAs in the MF-II Orders to reflect the actions taken in the MF-II Challenge Process Handset Public Notice and conforms to the RFA.

13. The MF-II Challenge Process Handset Public Notice provides further requirements on the handsets that mobile wireless providers in the MF-II challenge process must designate for challengers to use when conducting speed tests in areas deemed presumptively ineligible for MF-II support. In addition, the MF-II Challenge Process Handset Public Notice adopts procedures for challengers to request access to the USAC challenge process portal.

14. Following the release of the MF-II Orders, the Commission released the MF-II Challenge Process Comment Public Notice. The MF-II Challenge Process Comment Public Notice proposed and sought comment on specific parameters and procedures to implement the MF-II challenge process, including requirements for the provider-approved handsets that prospective challengers will use to conduct speed tests, and the process by which challengers and respondents can request access to the USAC portal. The MF-II Challenge Process Comment Public Notice did not change matters adopted in the MF-II Orders and requested comment on how the proposals in the MF-II Challenge Process Comment Public Notice might affect the previous regulatory flexibility analyses in this proceeding.

15. The MF-II Challenge Process Handset Public Notice establishes procedures for providers to identify at least three readily available handset models appropriate for testing those providers' coverage, and establishes that the Bureaus will consolidate submitted provider handset data for affiliated entities to the extent that the lists of handsets differ. In addition, providers are required to specify at least one handset running on the Android operating system, and at least one handset that is either compatible with the latest versions of drive test software, or is capable of being unlocked and configured to run the latest versions of drive test software.

16. The procedures also require all eligible service providers wishing to participate in the challenge process to provide to the Commission the legal name of the entity, its FRN, and the name(s) and email address(es) of the user(s) (up to a maximum of three users) that should be granted access to the portal. Any government entity (i.e., a local, state, or Tribal government entity) that wishes to participate in the challenge process also must provide the legal name of the entity, its legal jurisdiction, and the name(s) and email address(es) of the user(s) (up to a maximum of three users) that should be granted access to the portal. A web-based form will be used to collect this information. A party that files a waiver petition with the Commission seeking to participate in the MF-II challenge process as a challenger (because it is not a service provider or a government entity), must submit the first and last name of the user(s) that should have access to the portal on its behalf, and the email address(es) of the user(s), up to a maximum of three users, as part of its petition for waiver.

17. Finally, the requirements established in the MF-II Challenge Process Handset Public Notice are designed to anticipate the challenges faced by small entities (e.g., governmental entities or small service providers) in complying with the Bureaus' implementation of the Commission's rules and our proposals. For example, the requirement that providers specify a minimum of three devices, at least one of which must be running on the Android operating system, is intended to provide small entities with sufficient flexibility to choose a device that fits their needs and budgets.

18. Accordingly, the handset requirements and portal access procedures established in the MF-II Challenge Process Handset Public Notice are consistent with the MF-II Orders and the prior regulatory flexibility analyses set forth in this proceeding, and no changes to the Bureaus' earlier analyses are required.

19. There were no comments filed that specifically addressed the proposed procedures presented in the SIRFA.

20. Pursuant to the Small Business Jobs Act of 2010, which amended the RFA, the Commission is required to respond to any comments filed by the Chief Counsel for Advocacy of the Small Business Administration (SBA), and to provide a detailed statement of any change made to the proposed rule(s) as a result of those comments.

21. The Chief Counsel did not file any comments in response to the proposed procedures in this proceeding.

22. The RFA directs agencies to provide a description of and, where feasible, an estimate of the number of small entities that may be affected by the proposed rules, if adopted herein. The RFA generally defines the term “small entity” as having the same meaning as the terms “small business,” “small organization,” and “small governmental jurisdiction.” In addition, the term “small business” has the same meaning as the term “small business concern” under the Small Business Act. A “small business concern” is one which: (1) Is independently owned and operated; (2) is not dominant in its field of operation; and (3) satisfies any additional criteria established by the SBA.

23. As noted above, FRFAs were incorporated into the MF-II Orders. In those analyses, the Bureaus described in detail the small entities that might be significantly affected. In the MF-II Challenge Process Handset Public Notice, the Bureaus incorporate by reference the descriptions and estimates of the number of small entities from the previous FRFAs in the MF-II Orders.

24. The data, information and document collection required by the MF-II Orders as described in the previous FRFAs and the SIRFA in the MF-II Challenge Process Comment Public Notice in this proceeding are hereby incorporated by reference.

25. The RFA requires an agency to describe any significant alternatives that it has considered in reaching its proposed approach, which may include the following four alternatives (among others): (1) The establishment of differing compliance or reporting requirements or timetables that take into account the resources available to small entities; (2) the clarification, consolidation, or simplification of compliance or reporting requirements under the rule for small entities; (3) the use of performance, rather than design, standards; and (4) and exemption from coverage of the rule, or any part thereof, for small entities.

26. The analysis of the Commission's efforts to minimize the possible significant economic impact on small entities as described in the previous MF-II Order FRFAs are hereby incorporated by reference. As discussed above, the requirements and procedures established in the MF-II Challenge Process Handset Public Notice are intended to provide small entities with sufficient flexibility to choose a device that fits their needs and budgets thereby minimizing significant economic impact on small entities.

27. The Commission will send a copy of the MF-II Challenge Process Handset Public Notice, including this SFRFA, in a report to Congress pursuant to the Congressional Review Act. In addition, the Commission will send a copy of the MF-II Challenge Process Handset Public Notice, including this SFRFA, to the Chief Counsel for Advocacy of the SBA. A copy of the MF-II Challenge Process Handset Public Notice, and SFRFA (or summaries thereof) will also be published in the Federal Register.

28. For information on the one-time 4G LTE coverage data collection, see 4G LTE Collection Instructions Public Notice, or consult the Commission's MF-II 4G LTE Data Collection web page at www.fcc.gov/MF2-LTE-Collection. Please note that responses to the MF-II 4G LTE data collection are due by January 4, 2018. Parties with questions about the collection should email [email protected] or contact Ken Lynch at (202) 418-7356 or Ben Freeman at (202) 418-0628.

29. For further information concerning the MF-II Challenge Process Comment Public Notice, contact Jonathan McCormack, Auctions and Spectrum Access Division, Wireless Telecommunications Bureau, at (202) 418-0660.

This document consists of: (1) A final rule to list the Black Warrior waterdog as endangered and (2) a final critical habitat designation for the Black Warrior waterdog.

Why we need to publish a rule. Under the Endangered Species Act, a species may warrant protection through listing if it is endangered or threatened throughout all or a significant portion of its range. Listing a species as an endangered or threatened species can only be completed by issuing a rule.

What this rule does. This rule will finalize the listing of the Black Warrior waterdog (Necturus alabamensis) as an endangered species and will finalize designation of critical habitat for the species under the Act. We are designating critical habitat for the species in four units, on public and private property totaling 673 kilometers (420 miles) of streams and rivers in Blount, Etowah, Jefferson, Lawrence, Marshall, Tuscaloosa, Walker, and Winston Counties, Alabama. This rule adds the Black Warrior waterdog to the List of Endangered and Threatened Wildlife in title 50 of the Code of Federal Regulations at 50 CFR 17.11(h) and adds critical habitat for this species to 50 CFR 17.95(d).

The basis for our action. Under the Act, we may determine that a species is endangered or threatened based on any of the following five factors: (A) The present or threatened destruction, modification, or curtailment of its habitat or range; (B) overutilization for commercial, recreational, scientific, or educational purposes; (C) disease or predation; (D) the inadequacy of existing regulatory mechanisms; or (E) other natural or manmade factors affecting its continued existence. We have determined that the Black Warrior waterdog is endangered by habitat loss and water quality degradation resulting from point source and non-point source pollution, urbanization, legacy effects of past forestry and other land use practices, surface coal mining, sedimentation, and impoundments.

Under the Act, if we determine that any species is a threatened or endangered species we must, to the maximum extent prudent and determinable, designate critical habitat. Section 4(b)(2) of the Act states that the Secretary shall designate and make revisions to critical habitat on the basis of the best available scientific data after taking into consideration the economic impact, national security impact, and any other relevant impact of specifying any particular area as critical habitat. The Secretary may exclude an area from critical habitat if he determines that the benefits of such exclusion outweigh the benefits of specifying such area as part of the critical habitat, unless he determines, based on the best scientific data available, that the failure to designate such area as critical habitat will result in the extinction of the species.

Economic analysis. We prepared an economic analysis of the impacts of designating critical habitat. We published an announcement and solicited public comments on the draft economic analysis (81 FR 69475, October 6, 2016). The analysis found no significant economic impact of the designation of critical habitat.

Peer review and public comment. We sought comments from independent specialists to ensure that our designation is based on scientifically sound data, assumptions, and analyses. We invited these peer reviewers to comment on our listing proposal. We also considered all comments and information received from the public during the comment period.

Please refer to the proposed listing rule (81 FR 69500) and the proposed designation of critical habitat (81 FR 69475) for the Black Warrior waterdog, both published October 6, 2016, for a detailed description of previous Federal actions concerning this species.

In the proposed listing and critical habitat rules published on October 6, 2016, we requested that all interested parties submit written comments on the proposals by December 5, 2016. We also contacted appropriate Federal and State agencies, scientific experts and organizations, and other interested parties and invited them to comment on the proposal. Newspaper notices inviting general public comment were published in the following: AL.com; The Blount Countian; The Cullman Times; Daily Mountain Eagle; Decatur Daily; Moulton Advertiser; Northwest Alabamian; and The Times Record. We did not receive any requests for a public hearing.

In accordance with our peer review policy published in the Federal Register on July 1, 1994 (59 FR 34270), and our August 22, 2016, memorandum updating and clarifying the role of peer review of listing actions under the Act, we solicited expert opinions from five knowledgeable individuals with scientific expertise that included familiarity with the species and the geographic region in which the species occurs, the species' habitat and biological needs, and conservation biology principles. We received responses from four of the peer reviewers.

We reviewed all comments received from the peer reviewers for substantive issues and new information regarding critical habitat for the Black Warrior waterdog. The peer reviewers generally concurred with our methods and conclusions and provided additional information, clarifications, and suggestions to improve the final listing and critical habitat rule. Peer reviewer comments are summarized below and incorporated into the final rule as appropriate.

(1) Comment: Two reviewers stated that one of the proposed units, Lye Branch (Tuscaloosa County), should be removed from the critical habitat designation since the specimens collected there were not Black Warrior waterdog (Necturus alabamensis) but another species of Necturus, the Gulf Coast waterdog (N. beyeri).

Our Response: Based on the information provided, we have removed the Lye Branch unit from the designation in our critical habitat final rule. See Summary of Changes from the Proposed Rule, below, for more information.

(2) Comment: Several peer reviewers recommended that additional units be included in the critical habitat designation. Three peer reviewers recommended adding Clear Creek (Winston County), and two of those peer reviewers also recommended the addition of Turkey Creek (Jefferson County) to the critical habitat designation. One peer reviewer recommended “other headwater streams, as not to overlook streams potentially important to the recovery.” All three peer reviewers noted that these other areas have suitable habitat and potentially support (or may in the future support) the species and would be crucial to the recovery of the Black Warrior waterdog.

Our Response: The streams mentioned by the commenters are encompassed within the species' historical range, the upper Black Warrior Basin. However, the Black Warrior waterdog has never been documented in these headwater streams this far up in the basin, although some lower segments of these streams may contain suitable habitat. Since they do not provide connectivity between occupied sites for genetic exchange, and therefore it is unknown if a population of the species could be successfully reestablished in an area that never had waterdogs, we determined that these sites were not essential to the conservation of the species (see response to comment 11 below).

(3) Comment: One Federal agency and some public commenters expressed concern about the use of eDNA. The concern relates to the potential for “false positives” and potential limitations of the use of eDNA as a surrogate for species occurrence, as well as whether the use of eDNA warrants consideration as the best science to support both listing and designating critical habitat.

Our Response: Positive eDNA detections indicate that the DNA of the target species was present in the water sample (at the collection location), but it does not definitively reveal whether the species is still present. Studies on decay rate of eDNA indicate that it remains detectable for 2-3 weeks following release (Dejan et al. 2011), and, in using this guideline, we assume that the organismal source (Black Warrior waterdog) was present in the stream within the prior 2-3-week time window. Information that eDNA cannot provide is abundance of target species, whether the eDNA was derived from a living or dead individual(s), or if the population is viable.

We recognize that detection of eDNA does not confirm species' current presence with absolute certainty, because the target species may have died or moved from the sampled area. Additionally, a false positive, assuming presence of the targeted live organism at a site when it is absent, can occur if the eDNA was transported to the site via a flood, or transferred between drainages by human collectors. However, because eDNA persists for only a few weeks, the frequency of such false positives is likely low. A false positive could also occur if the eDNA in a sample was from a closely related species and that eDNA was not distinguishable from Black Warrior waterdog eDNA. However, researchers have identified and applied eDNA markers unique to the Black Warrior waterdog that are distinct from markers in other Necturus species (e.g., de Souza et al. p. 5 and S2), thus avoiding species misidentification.

Since the Black Warrior waterdog is difficult to capture, sampling for eDNA in the historical range of the species is an appropriate tool, bolstering confidence in assessing whether occupancy is likely. We used eDNA to narrow our focus on sites where additional sampling was more likely to capture live waterdogs, but we are not designating any streams as critical habitat, nor are we determining listing status, solely based on eDNA. That said, based on the comment, we have added more discussion about eDNA to the final rule.

(4) Comment: A Federal agency was concerned that our economic analysis may have been an underestimation of the costs associated with consultations under the Act, as well as of the number of additional consultations as a result of the listing and critical habitat designation for the Black Warrior waterdog.

Our Response: The economic analysis estimates that the incremental costs of critical habitat for the Black Warrior waterdog will be limited to administrative costs of consultation. This is due to the fact that all projects with a Federal nexus would already be subject to section 7 requirements regardless of whether critical habitat is designated due to the presence of the waterdog or other listed species with similar conservation needs. In addition, possible project modifications stemming from section 7 consultation are unlikely to be affected by the critical habitat designation because (a) the species is so closely associated with its aquatic habitat that there is unlikely to be a difference between measures needed to avoid jeopardizing the species in areas of occupied habitat and (b) in unoccupied areas, other listed aquatic species are impacted by similar factors as the waterdog. Specifically, there are 26 listed species that occur within the Black Warrior River Basin, including 14 aquatic species and 2 plant species that may be found within the critical habitat for the Black Warrior waterdog. Eight of these listed species have critical habitat that overlaps portions of the Black Warrior waterdog's critical habitat, and the entire range of the threatened flattened musk turtle (Sternotherus depressus) overlaps with the range of the Black Warrior waterdog. Therefore, any activities with a Federal nexus will be subject to section 7 consultation requirements regardless of the Black Warrior waterdog critical habitat designation.

Based on the historical consultation rate for species that co-occur or share habitat with the waterdog, the economic analysis estimates that fewer than 2 formal consultations, 23 informal consultations, and 206 technical assistance efforts are likely to occur in a given year.

(5) Comment: A Federal agency noted that some of its operations likely co-occur with proposed occupied and unoccupied critical habitat for the Black Warrior waterdog, at stream crossings used to access existing transmission line rights-of-way (ROWs) for maintenance purposes and construction of new transmission line ROWs. The Federal agency recommended that the Service specify suitable best management practices (BMPs) at stream crossings to minimize or prevent impacts to Black Warrior waterdog, so that actions at stream crossings either will not affect or are not likely to adversely affect this species.

Our Response: For stream crossing access for ROW and new transmission line construction, the Service will provide BMPs during informal or formal consultation. The additional administrative costs of such ROW projects with a Federal nexus are described above.

In accordance with policy, as published in the Federal Register on July 1, 1994 (59 FR 34272), we added “transmission line ROW maintenance” to the actions unlikely to result in a violation of section 9 of the Act if carried out in accordance with existing regulations (see Available Conservation Measures). These actions are now stated in the rule as “Normal agricultural practices, silvicultural practices, and transmission line ROW maintenance, including herbicide and pesticide use, which are carried out in accordance with any existing regulations, permits, and label requirements, and best management practices.”

(6) Comment: A State agency and some private organizations provided information on forestry compliance rates for BMPs and stream management zones (SMZs) and the positive impact on water quality.

Our Response: We acknowledge the improvements and progress that many agencies and organizations have made over the years in relation to land use and certified BMPs, including a 98 percent compliance rate in Alabama. We made changes to the listing and critical habitat designation to reflect these recent improvements in certified BMPs and forest management. We note that a majority of the adverse effects of forestry on waterdog habitat (e.g., sedimentation, streambank and channel modification) appear to be the legacy of activities conducted prior to the existence of the Act and various other laws designed to protect water quality and aquatic habitats.

(7) Comment: A commenter suggested that there is not sufficient information on the Black Warrior waterdog's biology and ecological relationships upon which to make a listing determination.

Our Response: We are required to make our listing determination based on the best scientific and commercial data available at the time of our rulemaking. We found that the Black Warrior waterdog warrants listing as an endangered species under the Act, based on the severity and immediacy of threats currently impacting the species. The overall range has been significantly reduced, and the remaining habitat and populations face threats from a variety of factors such as water quality degradation and small populations that are isolated from each other by unsuitable habitat created mainly by impoundments and pollution (Factors A and E) acting in combination to reduce the overall viability of the species. The risk of extinction is high because the number of populations has decreased, and the remaining populations are small, isolated, and have limited potential for recolonization (Factor E).

(8) Comment: One commenter requested that the Black Warrior waterdog be listed as threatened instead of endangered, due to lack of information on the species' biology and needs.

Our Response: We considered the best scientific and commercial data available regarding the Black Warrior waterdog to evaluate its status under the Act and found that the species meets the definition of endangered due to the species' contracted range, loss of habitat due to water quality degradation (sedimentation, toxins, and nutrients), fragmentation of the populations caused by impoundments, rangewide (not localized) threats, and ongoing threats that are presently acting on the species. A threatened species status is not appropriate for this species due to a reduction of suitable habitat available for the species and the severity of the stressors that are imminent and occurring rangewide, and are expected to continue into the future, such that the species is in immediate danger of extinction. Additionally, only two of the waterdog locations support strong numbers of animals to the point they can be collected on a routine basis. At the remaining sites surveyed since 1990, only one or two waterdogs have been captured, which speaks to the current poor status of the species.

(9) Comment: One commenter suggested the relevance of the flattened musk turtle as a surrogate species was not adequately explained.

Our Response: We used the flattened musk turtle as a surrogate species because the Black Warrior waterdog and flattened musk turtle occupy the same range and habitat, and similar factors influence the habitat and conservation of each species. However, we did not rely solely on the flattened musk turtle to discern the habitat needs of the Black Warrior waterdog. We also relied on information about the Neuse River waterdog (Necturus lewisi), a closely related species in the same genus, because of its similar biology and life history, as well as recently published Black Warrior waterdog research.

(10) Comment: One commenter noted that the lower 22.5 miles of Locust Fork and 44.5 miles of Mulberry Fork, both of which were proposed for designation as critical habitat, are navigable and used for barge traffic. The commenter requested that we consider whether those lower reaches exhibit the features of critical habitat for the Black Warrior waterdog. The commenter also requested that we identify measures to allow navigation maintenance activities “without unreasonable burdens of cost or time” if Section 7 consultation or Section 10 permitting is required.

Our Response: The Locust Fork critical habitat unit (Unit 2) is occupied by the Black Warrior waterdog and contains the following physical or biological features: Abundant rock crevices and rock slabs, leaf litter, and instream flow with moderate velocity and continuous daily discharge that allows for a longitudinal connectivity regime consisting of both surface runoff and ground water sources, exclusive of flushing flows caused by stormwater runoff, that are essential to the conservation of the Black Warrior waterdog. We have removed the Mulberry Fork unit (Unit 6 in the proposed rule), including its lower 44.5 miles from the final critical habitat rule. The Black Warrior waterdog has been extirpated from Mulberry Fork, likely because Mulberry Fork has incurred more habitat degradation in comparison to Locust Fork, where the waterdog remains extant. In short, Locust Fork meets the definition of critical habitat under the Act for occupied habitat. Mulberry Fork, however, does not meet the definition under the Act for unoccupied habitat as it is not essential for conservation of the species and therefore, is not included as critical habitat in the final rule (see our response to comment 11 below).

We would not expect direct effects to the species from navigation maintenance activities because areas with suitable physical and biological features in lower Locust Fork are close to the stream margins, away from the navigation channel. Navigation maintenance activities are unlikely to be affected by the critical habitat designation any more than they would be by the listing of the species because (a) the species is so closely associated with its aquatic habitat there is unlikely to be a difference between measures needed to avoid jeopardizing the species in areas of occupied habitat and (b) in unoccupied areas, other listed aquatic species are impacted by similar factors as the waterdog. Therefore, any activities with a Federal nexus will be subject to section 7 consultation requirements and, if necessary, section 10 permitting requirements to inform the consultation, regardless of the Black Warrior waterdog critical habitat designation.

(11) Comment: Several private organizations commented that our proposal to designate unoccupied areas as critical habitat had not been properly supported or explained in the proposed rule.

Our Response: In order to designate unoccupied areas, we are required by section 3(5)(A) of the Act to determine that such areas are essential for the conservation of the species. We determine from the record whether any unoccupied areas are necessary to support the species' recovery. The proposed rule outlined criteria for designation of critical habitat, which included a consideration of unoccupied areas that relied on the following criteria: (1) The importance of the stream to the overall status of the species and the contribution to the future recovery of the Black Warrior waterdog; (2) whether the area could be restored to contain the necessary habitat to support the Black Warrior waterdog; (3) whether the site provides connectivity between occupied sites for genetic exchange; and (4) whether a population of the species could potentially be reestablished in the area.

We received public comments indicating the Service inappropriately evaluated these units for inclusion in critical habitat and did not explain why these units were essential for the conservation of the Black Warrior waterdog. In response to these comments, we reevaluated the Lake Tuscaloosa, Lost Creek, and Mulberry Fork units, considering the four criteria listed above and the conservation strategy for the Black Warrior waterdog, and determined that our conclusion in the proposed rule, that the three unoccupied units are essential for the conservation of the Black Warrior waterdog, was in error.

Within the Lake Tuscaloosa unit, even though both of these sections are considered to be in the historical range of the species, both are isolated from each other and other populations of Black Warrior waterdog by two large impoundments (Lake Tuscaloosa and Holt Lake), and we had failed to consider this in the proposed rule. Upon further review, based on these impoundments, we now conclude habitat connectivity, one of the four criteria we considered in determining whether unoccupied areas are essential for the conservation of the species, is not met for the Lake Tuscaloosa unit. This lack of habitat connectivity with occupied sites in turn affects the unit's satisfaction of another criterion, the importance of the stream to the overall status of the species and its contribution to future recovery. Although this unit still contains suitable habitat in the upper reaches and may play a role in the recovery of the species, we find that because it does not provide habitat connectivity between occupied sites to allow for genetic exchange it is not essential for the conservation of the species.

Regarding the Lost Creek unoccupied unit, in a site assessment completed in March 2000, habitat in Lost Creek was determined to be poor to unsuitable water quality for the Black Warrior waterdog (Bailey 2000, pp. 7-8). This reduces the likelihood that a population of waterdogs could be established in this unit. More importantly, like the Lake Tuscaloosa unit, upon reevaluation we have determined that this unit is isolated from other occupied areas by an impoundment (Lake Tuscaloosa) and therefore lacks the connectivity to occupied stream reaches, which in the proposed rule was one of the criteria for determining that the area was essential for the conservation of the species. Similarly, the importance of the stream to the overall status of the species and the contribution to the future recovery are also reduced due to this lack of habitat connectivity with occupied sites. While this unit still contains somewhat suitable habitat in the upper reaches and may play a role in the recovery of the species, we find that, because it does not provide habitat connectivity between occupied sites to allow for genetic exchange, it is not essential for the conservation of the species.

Regarding the Mulberry Fork unit, as with the other two units we have, upon reevaluation, determined that impounded areas at the confluence of occupied tributary streams prohibit natural recolonization of this unit. The lower reach of Mulberry Fork is impounded by Bankhead Lake as far upstream as the mouth of Blackwater Creek (Bailey 2000, p. 9). In a site assessment completed in March 2000, habitat was described as a sluggish, muddy, and impounded area at the confluence with Sipsey Fork (Bailey 2000, p. 10). While this unit does connect to the occupied Blackwater Creek unit, the large expanse of impounded water provides a barrier to the Black Warrior waterdogs expanding from the occupied unit into Mulberry Fork. Therefore, since the Mulberry Fork unit is isolated from other occupied areas by impounded areas of unsuitable habitat, it does not meet the connectivity criteria we considered in determining whether unoccupied areas are essential for the conservation of the species. The importance of the stream to the overall status of the species and the contribution to the future recovery are also reduced due to this lack of habitat connectivity with occupied sites. While this unit still contains somewhat suitable habitat in the upper reaches and may play a role in the recovery of the species, we find that it does not provide habitat connectivity between occupied sites to allow for genetic exchange and is not essential for the conservation of the species.

Although the proposed units Lake Tuscaloosa, Lost Creek, and Mulberry Fork may have some degree of suitable habitat in the upper reaches and may be able to support the reintroduction of Black Warrior waterdogs, in the proposed rule we incorrectly determined that these areas were essential for the conservation of the species, as noted in the public comments. However, we correctly identified these units as providing habitat for reintroduction and future recovery activities.

Therefore, we have determined that these four units are not essential for Black Warrior waterdog conservation and have not included these units in this final critical habitat designation. Although we no longer regard the unoccupied units (Lake Tuscaloosa, Lost Creek, or Mulberry Fork) as essential for the conservation of the species, we recognize that these areas may offer suitable habitat through restoration for the Black Warrior waterdog and may be useful for ex situ (offsite) conservation measures at a future time.

We made the following significant changes to the rule based on peer review and public comments: We have removed four units from the final critical habitat designation—the Lye Branch, Lake Tuscaloosa, Lost Creek, and Mulberry Fork units.

Based on further analysis after taking into consideration information provided during the comment period, it was determined that the Lye Branch stream segment (16 kilometers (10 miles)) (set forth in the proposed rule as Unit 1) was not historically occupied by the Black Warrior waterdog but by another species of waterdog. Based on this information, we determined that the unit is outside the known historical range of the Black Warrior waterdog.

As described in our response to Comment 11, we have also removed the Lake Tuscaloosa unit, approximately 108 rkm (67 rmi) of stream and river habitat (set forth in the proposed rule as Unit 2), the Lost Creek unit, approximately 93 rkm (58 rmi) of stream and river habitat (set forth in the proposed rule as Unit 4), and the Mulberry Fork unit, approximately 183 rkm (114 rmi) of stream habitat (set forth in the proposed rule as Unit 6) from the final critical habitat designation because after further analysis we determined that those unoccupied areas were not essential for the conservation of the species and therefore did not fall within the definition of “critical habitat.”

The Black Warrior waterdog is a large, aquatic, nocturnal salamander that permanently retains a larval form and external gills throughout its life (Conant and Collins 1998, pp. 419-420). Found only in streams within the Black Warrior River Basin (Basin) in Alabama, the waterdog inhabits streams above the Fall Line, which is the contact zone between the Coastal Plain and the adjacent Piedmont physiographic province. Due to their highly permeable skin (Duellman and Trueb 1986, p. 197) and external gills, Black Warrior waterdogs are very sensitive to declines in water quality.

Historically, the waterdog was known from 11 sites, 2 of which have been lost due to impoundments. Since 1990 (current), the waterdog has been reported from 13 sites. These sites are in Blount (Blackburn Fork of the Little Warrior River), Marshall (Slab Creek, tributary to Locust Fork), Tuscaloosa (Yellow Creek, North River, Carroll Creek, Mulberry Fork), Walker (Lost Creek, Little Blackwater Creek), and Winston (Sipsey Fork, Blackwater Creek, Browns Creek, Brushy Creek, Capsey Creek) Counties, Alabama. Each of the 13 sites verified as a Black Warrior waterdog locality represents an individual population.

Information concerning the current status of Black Warrior waterdog populations is limited. Only the Sipsey Fork and Brushy Creek populations, in Bankhead National Forest (BNF), appear to be maintaining numbers sufficient enough to be captured regularly. At other sites surveyed since 1990, only one or two waterdogs have been captured. In Sipsey Fork, 52 waterdogs were captured over a 3-year period, representing 173,160 trap hours, a rate of 1 waterdog per 3,330 trap hours (Durflinger-Moreno et al. 2006, pp. 70-71). A high proportion of sexually mature individuals were captured during this period, suggesting that recruitment and survival rates of the young age classes may be low in Sipsey Fork (Durflinger-Moreno et al. 2006, p. 79). More recently, in surveys from 2012 to 2016 (Godwin 2016, entire), seven waterdogs were captured in Sipsey Fork (408 trap-nights; catch per unit effort (CPUE) = 0.017 waterdogs per trap-night) and four were captured in Brushy Creek (140 trap-nights; CPUE = 0.029). The density of Black Warrior waterdogs in Sipsey Fork and Brushy Creek in BNF, relative to the lower densities detected at other sites in the species' range, indicates the importance of this federally owned land for the species' recovery and long-term survival.

Because Black Warrior waterdogs are extremely difficult to detect in surveys, little is known regarding the species' demography. However, we may infer some of the characteristics of a healthy population based on capture data from the most the robust extant population (Durflinger-Moreno 2006, entire) in the Sipsey Fork drainage. We would expect a healthy population at a minimum to have an adult sex ratio close to 1:1. Additionally, a stable population would be expected to have larval, juvenile, and adult age classes present annually, as a measure of stable recruitment and reproduction rates. Species' abundance data are lacking, but in 1938, during spring and fall, 135 specimens were collected at a single site in Mulberry Fork (Bart et al. 1997, p. 193). In comparison, 52 waterdogs were captured in Sipsey Fork over three years of sampling, in 1994, 1995 and 1997. Thus, based on these historic and current data, and given the Sipsey Fork population is likely depressed relative to historic populations, a recovered or conserved species could be estimated to have aggregations of at least 100 individuals per year, represented by all age classes, and at multiple sites within each currently occupied sub-basin in the Black Warrior river.

The captures of four waterdogs in Brushy Creek confirmed the accuracy of eDNA (environmental DNA, described below) previously detected in Brushy Creek water samples (de Souza et al. 2016, p. 8). In 2013 and 2014, eDNA samples indicated Black Warrior waterdogs may still present in Rush Creek (Brushy Creek tributary) and Locust Fork, and newly found in Gurley Creek (Locust Fork tributary) and Yellow Creek (Big Yellow Creek/Black Warrior River tributary), although no waterdogs were captured at the time (Godwin 2014, pers. comm.). Similarly, in 2016, a Black Warrior waterdog was captured in Yellow Creek, validating the results of the eDNA survey in that stream.

Detecting the presence of the Black Warrior waterdog is difficult, presumably because the species currently occurs only at low densities. The relationship between cumulative number of site visits and the cumulative number of sites containing waterdogs indicated that 200 additional surveys would be needed to discover a single new locality for the species (Guyer 1997, p. 4). This relationship is further supported by the findings of de Souza (2016, p. 10), which indicated that, at an occupied site, 10 and 32 eDNA replicate water samples in the cool season and warm season, respectively, would be necessary for 95 percent detection probability of the waterdog.

Only through the use of eDNA have we been able to determine that the waterdog is likely present at some historical locations. Researchers use eDNA as a surveillance tool to monitor for the genetic presence of an aquatic species. According to Strickler (2015, p. 1), “. . . when an aquatic animal can't be seen or heard, it leaves traces of itself in the water by shedding skin, excreting waste, releasing gametes and decomposing. Investigators collect a water sample to detect the target species' DNA and determine whether the species has recently been in the water body.” Positive eDNA detections indicate that the DNA of the targeted species was present in a water sample at the collection location but do not definitively tell us that the species is still present. Studies on decay rate of eDNA indicate it remains 2 to 3 weeks following release (Dejean et al. 2011), and, in using this guideline, we assume that the organismal source (Black Warrior waterdog) was present in the stream within the prior 2- to 3-week time window. Information that eDNA cannot provide is the abundance of the target species, whether the eDNA was derived from living or dead individuals, or if the population is viable.

To prevent incorrectly identifying presence of Black Warrior waterdog based on eDNA when a similar species was present, de Souza et al. (2016 p. 5 and S2) included DNA from similar Necturus species in analyses of the eDNA samples from the Black Warrior drainage. Part of the eDNA analyses included a primer search (primers are used to amplify DNA samples) that identified the primers that combined with Black Warrior waterdog DNA but not the DNA of non-target Necturus species (de Souza et al. 2016, S2). Non-target species (those to avoid misidentifying as Black Warrior waterdog) in the analyses were N. lodingi, an undescribed species in Gulf drainages from Mobile Bay eastward (Shelton-Nix, p. 200), mudpuppy, dwarf waterdog, and Gulf Coast waterdog. Among the non-target species only the Gulf Coast waterdog could potentially co-occur naturally at sites along the Fall Line, since its range extends from the Coastal Plain to the Fall Line, whereas the Black Warrior waterdog range extends from the Piedmont to the Fall Line. It is also possible that mudpuppies could co-occur as a result of introductions by human transport from the Tennessee River drainage, which lies just north of Black Warrior drainage divide. In summary, given the analytical design applied to the eDNA, it is unlikely any samples were from Necturus species other than Black Warrior waterdog.

Black Warrior waterdogs are associated with stream depths of 1 to 4 meters (m) (3.3 to 13.1 feet (ft)), reduced sedimentation, and large leaf packs (leaves that fall into streams accumulate in packs usually behind branches, rocks, and other obstructions) supporting mayfly (Ephemeroptera spp.) and caddisfly (Trichoptera spp.) larvae.

Except for habitat affinities, life-history data concerning the Black Warrior waterdog and other species of Necturus waterdogs are somewhat limited. As closely related species in the same genus, there are general characteristics that all Necturus species share, such as retention of the larval state (e.g., gills) as adults. As an example, although geographically separated (allopatric), the Black Warrior waterdog and the Neuse River waterdog both utilize high-gradient streams that are above the Fall Line and contain hard substrate, leafpacks, and macroinvertebrates. Because the two species likely evolved in similar habitats, an influential factor in determining life-history traits, we used the Neuse River waterdog as a surrogate to decipher some of the biological and ecological attributes that have not yet been determined for the Black Warrior waterdog. When such data were lacking for the Neuse River waterdog and Black Warrior waterdog, we relied on data from other Necturus species.

The Act directs us to determine whether any species is an endangered species or a threatened species because of any one of five factors affecting its continued existence. In this section, we summarize the factors affecting the Black Warrior waterdog to assess the species' viability. For additional detail, see the proposed listing rule (81 FR 69500, October 6, 2016).

Water quality degradation is considered the primary reason for the extirpation of the Black Warrior waterdog over much of its historical range (Bailey 2000, pp. 19-20). Together with large impoundments (discussed below), it is the predominant threat to the continued existence of the species. Changes in water chemistry and flow patterns, resulting in a decrease in water quality and quantity, have detrimental effects on salamander ecology because they can render aquatic habitat unsuitable. Substrate modification is also a major concern for aquatic salamander species (Geismar 2005, p. 2; O'Donnell et al. 2006, p. 34). When interstitial spaces between substrates become compacted or filled with fine sediment, the amount of available foraging habitat and protective cover for salamanders is reduced, resulting in population declines. Most streams surveyed for the Black Warrior waterdog showed evidence of water quality degradation and were correspondingly biologically depauperate, lacking the full complement of species that would be expected under natural, undisturbed habitat conditions (Bailey 1992, p. 2; Bailey 1995, p. 11; Durflinger-Moreno et al. 2006, p. 78).

Contributors to water quality degradation in the Black Warrior Basin include point source (end of pipe) discharges and runoff from urban, mining, agricultural and, historically, forestry land uses (Deutsch et al. 1990, pp. 1-62; Upper Black Warrior Technical Task Force 1991, p. 1; O'Neil and Sheppard 2001, p. 2). These sources contribute pollution to the Basin via sediments, fertilizers, herbicides, pesticides, animal wastes, septic tank and gray water leakage, and oils and greases. Pollution has a direct effect on the survival of Black Warrior waterdogs, which, due to their highly permeable skin (Duellman and Trueb 1986, p. 197) and external gills, are very sensitive to declines in water quality.

Urbanization is a significant source of water quality degradation that can reduce the survival of aquatic organisms, including the Black warrior waterdog (Bowles et al. 2006, p. 119; Chippindale and Price 2005, pp. 196-197). Urban development can stress aquatic systems in a variety of ways, including increasing the frequency and magnitude of high flows in streams, increasing sedimentation, increasing contamination and toxicity, and changing stream morphology and water chemistry (Coles et al. 2012, pp. 1-3, 24, 38, 50-51). Sources and risks of an acute or catastrophic contamination event, such as a leak from an underground storage tank or a hazardous materials spill on a highway, increase as urbanization increases.

Several researchers have examined the negative impact of urbanization on stream salamander habitat, finding connections between salamander abundances and levels of development within a watershed. A study on the dusky salamander (Desmognathus fuscus) in Georgia (Orser and Shure 1972, p. 1,150) found a decrease in stream salamander density with increasing urban development. A similar relationship between populations and urbanization was found for dusky salamander, two-lined salamander (Eurycea bislineata), southern two-lined salamander (E. cirrigera), and other species in North Carolina (Price et al. 2006, pp. 437-439; Price et al. 2012a, p. 198), Maryland, and Virginia (Grant et al. 2009, pp. 1,372-1,375). Abundance of dusky and two-lined salamanders was most closely related to the amount and type of habitat within the entire watershed, as opposed to areas immediately adjacent to the stream (Willson and Dorcas 2003, pp. 768-770).

Large population centers such as the cities of Birmingham, Tuscaloosa, and Jasper contribute substantial runoff to the Black Warrior Basin. The watershed occupied by these three cities contains more industrial and residential land area than other river basins in Alabama. Streams draining these areas have a history of serious water quality problems, as described above. Entire species of fish, mussels, and snails (Mettee et al. 1989, pp. 14-16; Hartfield 1990, pp. 1-8), and populations of the flattened musk turtle (Service 1990, p. 3), have been extirpated from large areas of the watershed primarily due to water quality degradation.

Associated with urbanization is the development of transportation systems, including roads, rails, airports, locks, and docks. Accidents, crashes, and derailments, resulting in spills, occur along these transportation corridors. Since 1990, more than 1,200 spills in the Basin have been reported to the U.S. Coast Guard National Response Center. One of several spills in the Basin took place in the Black Warrior River in 2013. Approximately 164 gallons of crude oil were accidently pumped into the river. Emergency response teams cleaned the river, but a sheen of crude oil remained visible (Taylor 2013, entire). The threat from spills remains unchanged.

Runoff from forestry operations and road construction has been a source of pollution in the Basin when certified BMPs were not followed to protect streamside management zones (Hartfield 1990, pp. 4-6; Service 2000, p. 13). Forestry activities that were poorly or inadequately managed in the past can have long-lasting effects in the high-gradient, highly erodible soils within the Basin, as seen by the legacy effects on Bankhead National Forest (Laschet 2014, pers. obs.). However, modern forestry operations in Alabama have a certified BMP compliance of 98 percent and, therefore, mostly are not currently significant contributors to nonpoint source pollution. According to Alabama's BMPs for forestry, SMZs should be a width of 35 ft (50 ft for sensitive areas) from the stream bank, providing a level of protection to instream habitat. Recently, the forest industry has begun to self-regulate SMZs through a third-party certification program in which mills will not accept timber from foresters who do not comply with SMZ requirements.

Surface coal mining represents another threat to the biological integrity of streams in the Basin and has undoubtedly affected the distribution of the Black Warrior waterdog (Bailey 1995, p. 10). Strip mining for coal results in hydrologic disturbance (i.e., erosion, sedimentation, decline in groundwater levels, and general degradation of water quality) that affects many aquatic organisms (Service 2000, p. 12). Runoff from coal surface mining can generate pollution through acidification, increased mineralization, and sediment loading. Impacts are more often associated with past activities and abandoned mines, since presently operating mines are required to employ environmental safeguards established by the Federal Surface Mining Control and Reclamation Act of 1977 (30 U.S.C. 1201 et seq.) and the Clean Water Act of 1972 (33 U.S.C. 1251 et seq.) (Service 2000, p. 12).

Coal mining in the Basin is currently a threat to the Black Warrior waterdog. Abandoned mines that have been inadequately reclaimed will continue to contribute pollutants to streams into the future. Recently, new coal mines, which have the potential to discharge additional pollutants into the waters in the range of the Black Warrior waterdog, have been proposed in Sipsey Fork and Mulberry Fork (Dillard 2011, pers. comm.; Alabama Surface Mining Commission 2012, pp. 1-4).

In addition to water quality degradation, creation of large impoundments has reduced suitable habitat within the Basin. Two historical populations of the Black Warrior waterdog, Black Warrior River near Tuscaloosa and Mulberry Fork at Cordova, have been lost due to impoundments. Impoundments behind Bankhead, Lewis, and Holt dams have flooded thousands of hectares (acres) of habitat previously considered suitable for the Black Warrior waterdog. The entire main channel of the Black Warrior River, over 272 kilometers (km) (170 miles (mi)), has been affected by impoundments (Hartfield 1990, p. 7), which do not have the shallow, flowing water associated with the waterdog. As a result, impoundments generally are unsuitable habitat for the species, although on one occasion two waterdogs were found in the upper end of Lewis Smith Reservoir (U.S. Forest Service record, in Godwin 2016, p. 5) where Sipsey Fork enters and stream habitat transitions to lake habitat. The abundance of large predatory fish in impoundments further renders them unsuitable for the Black Warrior waterdog.

Historically, Brushy Creek was a tributary of Sipsey Fork. Construction of Lewis Smith Reservoir separated the flowing connection between Brushy Creek and Sipsey Fork, essentially splitting the single BNF population in two isolated halves. Impoundments have been entrapments for waterdogs, isolating and inhibiting genetic exchange between populations in tributaries no longer connected by suitable flowing habitat.

The Black Warrior waterdog has experienced substantial destruction, modification, and curtailment of its habitat and range. Specific species stressors include degradation of water quality and habitat from point source discharges and runoff, urbanization, legacy effects of poor forest management, surface coal mining, agriculture, and the construction of dams and their impoundments, together affecting hundreds of stream miles in the species' range. The amount of habitat already lost amplifies the current and future threat from point and nonpoint source pollution, accidental spills, and violation of permitted discharges. Due to a reduction of suitable habitat available for the species and the severity and magnitude of this stressor, we consider the present or threatened destruction, modification, or curtailment of habitat and range a threat to the Black Warrior waterdog. While changes to land management and river operations have reduced impacts to the river system, ongoing activities continue to affect water quality.

Based on best available data, there is no evidence that overutilization for commercial, recreational, scientific, or educational purposes is a threat to the Black Warrior waterdog.

No diseases or incidences of predation have been reported for the Black Warrior waterdog. Also, there is no evidence of predation on Necturus species by fish in creeks and streams as reported by Bart and Holzenthal (1985, p. 406). Predation of adult mudpuppy (N. maculosus) by fish, crayfish, turtles and watersnakes has been observed rarely (Petranka 1998, p. 429), and is almost certainly an occurrence for Black Warrior waterdogs as well. A study of dwarf waterdog (N. punctatus) feeding behavior in the presence of predators indicated movement of the species to leaf pack habitat was driven by food availability rather than predator avoidance (Sollenberger 2013, entire). Given the very infrequent observations of predation on waterdogs and no reports of deleterious effects of predation on Necturus species, we do not consider predation to be an important factor influencing Black Warrior waterdog populations. Therefore, the best available data do not indicate that disease or predation is a threat to the Black Warrior waterdog in its preferred habitat outside of impounded areas, which harbor greater densities of larger fish predators and are more open than stream habitats, providing less cover for avoiding potential predators such as birds.

Under this factor, we examine whether existing regulatory mechanisms are inadequate to address the threats to the Black Warrior waterdog discussed under other factors. Section 4(b)(1)(A) of the Act requires the Service to take into account “those efforts, if any, being made by any State or foreign nation, or any political subdivision of a State or foreign nation, to protect such species.” In relation to Factor D under the Act, we interpret this language to require the Service to consider relevant Federal, State, and Tribal laws and regulations, and other such mechanisms that may minimize any of the threats we describe in threat analyses under the other four factors, or otherwise enhance conservation of the species. We give strongest weight to statutes and their implementing regulations and to management direction that stems from those laws and regulations. An example would be State governmental actions enforced under a State statute or constitution, or Federal action under statute.

The Federal Surface Mining Control and Reclamation Act of 1977 (SMCRA), as amended December 22, 1987, requires all permitted mining operations to minimize disturbances and adverse impacts to fish, wildlife, and related environmental values, as well as implement enhancement measures where practicable. It further recognizes the importance of land and water resources restoration as a high priority in reclamation planning. However, the continued decline of many species, including the flattened musk turtle, fishes, and a number of mussels in the Black Warrior Basin, is often attributed to mining activities (Dodd et al. 1988, pp. 55-61; Mettee et al. 1989, pp. 12-13; Hartfield 1990, pp. 1-8; Bailey and Guyer 1998, pp. 77-83; Service 2000, pp. 12-13), even though SMCRA is in effect.

The Alabama Department of Conservation and Natural Resources (ADCNR) recently added the Black Warrior waterdog to its list of non-game State-protected species (ADCNR 2012, pp. 1-4). Although this change will make it more difficult to obtain a collecting permit for the species, it does not offer any additional protection for habitat loss and degradation. The ADCNR also recognizes the Black Warrior waterdog as a Priority 2 species of high conservation concern in its State Wildlife Action Plan due to its rarity and restricted distribution (ADCNR 2005, p. 298). However, this designation also does not offer any regulatory protections.

Alabama Department of Environmental Management (ADEM) has established minimum water-quality standards for some occupied stream segments within the Black Warrior River drainage under the authority of the Clean Water Act of 1972. These standards are believed to be protective of aquatic species. In Locust Fork, Mulberry Fork, and other tributaries of the Black Warrior River occupied by the Black Warrior waterdog, a combined total of 275 km (171 mi) have been identified on the Alabama 303(d) List (a list of water bodies failing to meet their designated water-use classifications) as impaired by siltation and nutrients (ADEM 2010, pp. 1-3). The sources of these impairments have been identified as runoff from agricultural fields, abandoned surface mines, and industrial or municipal sites. Multiple stream reaches within the occupied habitat of the Black Warrior waterdog (Locust Fork, Mulberry Fork, Yellow Creek, and North River) fail to meet current regulatory standards. Even with current regulations, surviving waterdog populations are negatively affected by discharges, highway construction, mining (current and unreclaimed sites), and other activities with a Federal nexus (see discussion under Factor A, above).

The remaining Black Warrior waterdog populations are isolated from each other by unsuitable habitat created by impoundments, pollution, and other factors as described under the Factor A discussion, above. Waterdog population densities are low even in the relatively best localities, and factors related to low population compound these threats.

Species that are restricted in range and population size are more likely to suffer loss of genetic diversity due to genetic drift, potentially increasing their susceptibility to inbreeding depression, decreasing their ability to adapt to environmental changes, and reducing the fitness of individuals (Soule 1980, pp. 157-158; Hunter 2002, pp. 97-101; Allendorf and Luikart 2007, pp. 117-146). These low population densities combined with fragmentation of habitat renders populations extremely vulnerable to inbreeding depression (negative genetic effects of small populations, e.g., Wright et al. 2008, p. 833) and may reduce mating to a frequency insufficient to sustain populations with newly recruited cohorts. Additionally, low population densities reduce species' resiliency to catastrophic events such as floods, droughts, or chemical spills (Black Warrior River Watershed Management Plan n.d., p. 4.4), which may be compounded by the effects of climate change in the future (see discussion below). It is likely that some of the Black Warrior waterdog populations are below the effective population size required to maintain long-term genetic and population viability. The long-term viability of a species is based on the conservation of numerous populations throughout its geographic range (Harris 1984, pp. 93-104), which provides a level of redundancy that reduces the risk of environmental change to the species as a whole (Shaffer and Stein 2000, p. 310). The level of isolation and fragmentation of Black Warrior waterdog populations makes natural repopulation following localized extirpations virtually impossible without human intervention.

Climate change has the potential to increase vulnerability of the Black Warrior waterdog to random catastrophic events. Various emissions scenarios suggest that, by the end of the 21st century, average global temperatures are expected to increase 0.3 °C to 4.8 °C (0.5 °F to 8.6 °F), relative to the period 1986-2005 (IPCC 2013, p. 15). By the end of 2100, it is virtually certain that there will be more frequent hot and fewer cold temperature extremes over most land areas on daily and seasonal timescales, and it is very likely that heat waves and extreme precipitation events will occur with a higher frequency and intensity (IPCC 2013, pp. 15-16). In the southeastern United States the frequency, duration, and intensity of droughts are likely to increase (Thomas et al. 2009, p. 112). Droughts cause decreases in water flow and dissolved oxygen levels and increases in temperature in the river system. Studies of aquatic salamanders have reported decreased occupancy, loss of eggs, decreased egg-laying, and extirpation from sites during periods of drought (Camp et al. 2000, p. 166; Miller et al. 2007, pp. 82-83; Price et al. 2012b, pp. 317-319).

Section 4 of the Act (16 U.S.C. 1533), and its implementing regulations at 50 CFR part 424, set forth the procedures for determining whether a species is an endangered species or threatened species and should be included on the Federal Lists of Endangered and Threatened Wildlife and Plants (i.e., “listed”). Under section 4(a)(1) of the Act, we may list a species based on (A) The present or threatened destruction, modification, or curtailment of its habitat or range; (B) Overutilization for commercial, recreational, scientific, or educational purposes; (C) Disease or predation; (D) The inadequacy of existing regulatory mechanisms; or (E) Other natural or manmade factors affecting its continued existence. Listing actions may be warranted based on any of the above threat factors, singly or in combination.

We have carefully assessed the best scientific and commercial data available regarding the past, present, and future threats to the Black Warrior waterdog. Two populations have been extirpated due to construction of dams that eliminated habitat on the Black Warrior River (Factor A). Current threats to the species include habitat destruction and degradation from point source pollution, runoff, and contaminant spills from industry, urbanization, surface coal mining, agriculture, and legacy effects of past forestry practices (Factor A). The small size and level of fragmentation of remaining Black Warrior waterdog populations leaves the species vulnerable to inbreeding depression and reduced genetic fitness, natural stochastic events, including storms and droughts (Factor E). Existing regulatory mechanisms have not led to a reduction or removal of threats impacting the Black Warrior waterdog (Factor D). These ongoing threats to the species are rangewide and expected to continue in the future.

The Black Warrior waterdog is currently in danger of extinction throughout its entire range due to the immediacy and severity of threats currently impacting the species. The risk of extinction is high because there are few (13) extant populations and the majority of the populations are small and isolated. Several of these populations are likely below the effective size needed to remain viable without human intervention, owing to barriers to natural immigration. Therefore, on the basis of the best available scientific and commercial information, we list the Black Warrior waterdog as an endangered species. We find that a threatened species status is not appropriate for this species due to a reduction of suitable habitat available for the species and the severity of the stressors that are imminent and occurring rangewide, are ongoing, and are expected to continue into the future, such that the species is in immediate danger of extinction. Additionally, only two waterdog populations appear to be maintaining numbers sufficiently large to be captured regularly. At the remaining sites surveyed since 1990, only one or two waterdogs have been captured, which speaks to the current poor status of the species. Because of the contracted range and small population size of Black Warrior waterdog and because the threats are occurring rangewide, are ongoing, and are expected to continue into the future, we conclude that the species is in immediate danger of extinction.

The Act defines an endangered species as any species that is “in danger of extinction throughout all or a significant portion of its range” and a threatened species as any species “that is likely to become endangered within the foreseeable future throughout all or a significant portion of its range.” The phrase “significant portion of its range” is not defined by the Act, and a district court has held that aspects of the Service's Final Policy on Interpretation of the Phrase “Significant Portion of Its Range” in the Endangered Species Act's Definitions of “Endangered Species and “Threatened Species” (79 FR 37577 (July 1, 2014)) (SPR Policy) were not valid. Center for Biological Diversity v. Jewel, No. 14-cv-02506-RM (D. Ariz. Mar. 29, 2017) (Pygmy-Owl Decision).

Although the court's order in that case has not yet gone into effect, if the court denies the pending motion for reconsideration, the SPR Policy would become vacated. Therefore, we have examined the plain language of the Act and court decisions addressing the Service's application of the SPR phrase in various listing decisions, and for purposes of this rulemaking we are applying the interpretation set out below for the phrase “significant portion of its range” and its context in determining whether or not a species is an endangered species or a threatened species. Because the interpretation we are applying is consistent with the SPR Policy, we summarize herein the bases for our interpretation, and also refer the public to the SPR Policy itself for a more-detailed explanation of our reasons for interpreting the phrase in this way.

An important factor that influences the question of whether an SPR analysis is necessary here is what the consequence would be if the Service were to find that the Black Warrior waterdog is in danger of extinction or likely to become so throughout a significant portion of its range. Two district court decisions have evaluated whether the outcomes of the Service's SPR determinations were reasonable. As described in the SPR Policy, both courts found that, once the Service determines that a “species”—which can include a species, subspecies, or DPS under ESA Section 3(16)—meets the definition of “endangered species” or “threatened species,” the species must be listed in its entirety and the Act's protections applied consistently to all members of that species (subject to modification of protections through special rules under sections 4(d) and 10(j) of the Act). See Defenders of Wildlife v. Salazar, 729 F. Supp. 2d 1207, 1222 (D. Mont. 2010) (delisting of the Northern Rocky Mountains DPS of gray wolf; appeal dismissed as moot because of public law vacating the listing, 2012 U.S. App. LEXIS 26769 (9th Cir. Nov. 7, 2012)); WildEarth Guardians v. Salazar, No. 09-00574-PHX-FJM, 2010 U.S. Dist. LEXIS 105253, 15-16 (D. Ariz. Sept. 30, 2010) (Gunnison's prairie dog). The issue has not been addressed by a Federal Court of Appeals.

Consistent with the district court case law, we interpret that the consequence of finding that the Black Warrior waterdog is in danger of extinction or likely to become so throughout a significant portion of its range would be that the entire species would be listed as an endangered species or threatened species, respectively, and the Act's protections would be applied to all individuals of the species wherever found. Thus, the “throughout all” phrase and the SPR phrase provide two independent bases for listing. We note that in the Act Congress placed the “all” language before the SPR phrase in the definitions of “endangered species” and “threatened species.” This suggests that Congress intended that an analysis based on consideration of the entire range should receive primary focus. Thus, the first step we undertook, above, in our assessment of the status of the species was to determine its status throughout all of its range. Having determined that the species is in danger of extinction throughout all of its range, we now examine whether it is necessary to determine its status throughout a significant portion of its range.

We conclude that in this situation we do not need to conduct an SPR analysis. This conclusion is consistent with the Act because the species is currently in danger of extinction throughout all of its range due either to high-magnitude threats across its range, or to threats that are so high in particular areas that they severely affect the species across its range. Therefore, the species is in danger of extinction throughout every portion of its range, and an analysis of whether the species is in danger of extinction or likely to become so throughout any significant portion of its range would be redundant and unnecessary. In addition, because the phrase “significant portion of its range” (SPR) could provide a second and independent basis for listing the Black Warrior waterdog in its entirety, an SPR analysis could would be either unnecessary or confusing. An SPR analysis could lead to a conclusion that, in addition to being an “endangered species” because of its status throughout all of its range, the Black Warrior waterdog is also an “endangered species” or “threatened species” because of its status throughout a significant portion of its range. The former clearly would be an unnecessary finding, because we have already determined that the species is an “endangered species” because of its status throughout all of its range. The latter would create confusion because it could lead to a conclusion that the species warrants listing both as an endangered species (because of its status throughout all of its range) and as a threatened species (because of its status in the SPR). We accordingly conclude that we do not need to conduct further analysis of whether the Black Warrior waterdog is in danger of extinction or likely to become so in the foreseeable future throughout a significant portion of its range.

Conservation measures provided to species listed as endangered or threatened under the Act include recognition, recovery actions, requirements for Federal protection, and prohibitions against certain practices. Recognition through listing actions results in public awareness and conservation by Federal, State, Tribal, and local agencies; private organizations; and individuals. The Act encourages cooperation with the States and other countries and calls for recovery actions to be carried out for listed species. The protection required by Federal agencies and the prohibitions against certain activities are discussed, in part, below.

The primary purpose of the Act is the conservation of endangered and threatened species and the ecosystems upon which they depend. The ultimate goal of such conservation efforts is the recovery of these listed species, so that they no longer need the protective measures of the Act. Section 4(f) of the Act calls for the Service to develop and implement recovery plans for the conservation of endangered and threatened species. The recovery planning process involves the identification of actions that are necessary to halt or reverse the species' decline by addressing the threats to its survival and recovery. The goal of this process is to restore listed species to a point where they are secure, self-sustaining, and functioning components of their ecosystems.

Recovery planning includes the development of a recovery outline, shortly after a species is listed, and preparation of a draft and final recovery plan. The recovery outline guides the immediate implementation of urgent recovery actions and describes the process to be used to develop a recovery plan. Revisions of the plan may be done to address continuing or new threats to the species, as new substantive information becomes available. The recovery plan also identifies recovery criteria for review of when a species may be ready for downlisting or delisting, and methods for monitoring recovery progress. Recovery plans also establish a framework for agencies to coordinate their recovery efforts and provide estimates of the cost of implementing recovery tasks. Recovery teams (composed of species experts, Federal and State agencies, nongovernmental organizations, and stakeholders) are often established to develop recovery plans. When completed, the recovery outline, draft recovery plan, and the final recovery plan will be available on our website (http://www.fws.gov/endangered), or from our Alabama Ecological Services Field Office (see ADDRESSES).

Implementation of recovery actions generally requires the participation of a broad range of partners, including other Federal agencies, States, Tribes, nongovernmental organizations, businesses, and private landowners. Examples of recovery actions include habitat restoration (e.g., restoration of native vegetation), research, captive propagation and reintroduction, and outreach and education. The recovery of many listed species cannot be accomplished solely on Federal lands because their range may occur primarily or solely on non-Federal lands. To achieve recovery of these species requires cooperative conservation efforts on private, State, and Tribal lands.

Following publication of this listing rule, funding for recovery actions will be available from a variety of sources, including Federal budgets, State programs, and cost share grants for non-Federal landowners, the academic community, and nongovernmental organizations. In addition, pursuant to section 6 of the Act, the State of Alabama would be eligible for Federal funds to implement management actions that promote the protection or recovery of the Black Warrior waterdog. Information on our grant programs that are available to aid species recovery can be found at: http://www.fws.gov/grants.

Please let us know if you are interested in participating in recovery efforts for the Black Warrior waterdog. Additionally, we invite you to submit any new information on this species whenever it becomes available and any information you may have for recovery planning purposes (see FOR FURTHER INFORMATION CONTACT).

Section 7(a) of the Act requires Federal agencies to evaluate their actions with respect to any species that is proposed or listed as an endangered or threatened species and with respect to its critical habitat, if any is designated. Regulations implementing this interagency cooperation provision of the Act are codified at 50 CFR part 402. Section 7(a)(2) of the Act requires Federal agencies to ensure that activities they authorize, fund, or carry out are not likely to jeopardize the continued existence of any endangered or threatened species or destroy or adversely modify its critical habitat. If a Federal action may affect a listed species or its critical habitat, the responsible Federal agency must enter into consultation with the Service.

Federal agency actions within Black Warrior waterdog habitat that may require consultation as described in the preceding paragraph include management and any other landscape-altering activities on Federal lands administered by the Service, U.S. Forest Service, and Bureau of Land Management; issuance of section 404 Clean Water Act permits by the U.S. Army Corps of Engineers; construction and maintenance of gas pipeline and power line rights-of-way by the Federal Energy Regulatory Commission; construction and maintenance of roads or highways by the Federal Highway Administration; land management practices supported by programs administered by the U.S. Department of Agriculture; Environmental Protection Agency pesticide registration; and projects funded through Federal loan programs which include, but are not limited to, roads and bridges, utilities, recreation sites, and other forms of development.

The Act and its implementing regulations set forth a series of general prohibitions and exceptions that apply to endangered wildlife. The prohibitions of section 9(a)(1) of the Act, codified at 50 CFR 17.21, make it illegal for any person subject to the jurisdiction of the United States to take (which includes harass, harm, pursue, hunt, shoot, wound, kill, trap, capture, or collect; or to attempt any of these) endangered wildlife within the United States or on the high seas. In addition, it is unlawful to import; export; deliver, receive, carry, transport, or ship in interstate or foreign commerce in the course of commercial activity; or sell or offer for sale in interstate or foreign commerce any listed species. It is also illegal to possess, sell, deliver, carry, transport, or ship any such wildlife that has been taken illegally. Certain exceptions apply to employees of the Service, the National Marine Fisheries Service, other Federal land management agencies, and State conservation agencies.

We may issue permits to carry out otherwise prohibited activities involving endangered wildlife under certain circumstances. Regulations governing permits are codified at 50 CFR 17.32. With regard to endangered wildlife, a permit may be issued for scientific purposes, to enhance the propagation or survival of the species, and for incidental take in connection with otherwise lawful activities. There are also certain statutory exemptions from the prohibitions, which are found in sections 9 and 10 of the Act.

It is our policy, as published in the Federal Register on July 1, 1994 (59 FR 34272), to identify to the maximum extent practicable at the time a species is listed, those activities that would or would not constitute a violation of section 9 of the Act. The intent of this policy is to increase public awareness of the effect of a listing on proposed and ongoing activities within the range of species. Based on the best available information, the following actions are unlikely to result in a violation of section 9, if these activities are carried out in accordance with existing regulations and permit requirements; this list is not comprehensive:

(1) Normal agricultural practices, silvicultural practices, and transmission line ROW maintenance, including herbicide and pesticide use, which are carried out in accordance with any existing regulations, permit, and label requirements, and certified best management practices; and

(2) Normal residential development and landscape activities, which are carried out in accordance with any existing regulations, permit requirements, and best management practices.

Based on the best available information, the following activities may potentially result in a violation of section 9 the Act; this list is not comprehensive:

(1) Unauthorized introduction of nonnative species that compete with or prey upon the Black Warrior waterdog;

(2) Unauthorized collecting, handling, possessing, selling, delivering, carrying, or transporting of the species, including import or export across State lines and international boundaries, except for properly documented antique specimens of this taxa, as defined by section 10(h)(1) of the Act;

(3) Unauthorized destruction or alteration of Black Warrior waterdog habitat that results in destruction or loss of leaf packs and rocky substrate (rock crevices in the creek or stream);

(4) Unauthorized discharge of chemicals or fill material into any waters in which the Black Warrior waterdog is known to occur; and

(5) Actions, intentional or otherwise, that would result in the destruction of eggs or cause mortality or injury to hatchling, juvenile, or adult Black Warrior waterdogs.

Questions regarding whether specific activities would constitute a violation of section 9 of the Act should be directed to the Alabama Ecological Services Field Office (see FOR FURTHER INFORMATION CONTACT).

Critical habitat is defined in section 3 of the Act as:

(1) The specific areas within the geographical area occupied by the species, at the time it is listed in accordance with the Act, on which are found those physical or biological features

(a) Essential to the conservation of the species, and

(b) Which may require special management considerations or protection; and

(2) Specific areas outside the geographical area occupied by the species at the time it is listed, upon a determination that such areas are essential for the conservation of the species.

Our regulations at 50 CFR 424.02 define “geographical area occupied by the species” as an area that may generally be delineated around species' occurrences, as determined by the Secretary (i.e., range). Such areas may include those areas used throughout all or part of the species' life cycle, even if not used on a regular basis (e.g., migratory corridors, seasonal habitats, and habitats used periodically, but not solely by vagrant individuals).

Conservation, as defined under section 3 of the Act, means to use and the use of all methods and procedures that are necessary to bring an endangered or threatened species to the point at which the measures provided pursuant to the Act are no longer necessary. Such methods and procedures include, but are not limited to, all activities associated with scientific resources management such as research, census, law enforcement, habitat acquisition and maintenance, propagation, live trapping, and transplantation, and, in the extraordinary case where population pressures within a given ecosystem cannot be otherwise relieved, may include regulated taking.

Critical habitat receives protection under section 7 of the Act through the requirement that Federal agencies ensure, in consultation with the Service, that any action they authorize, fund, or carry out is not likely to result in the destruction or adverse modification of critical habitat. The designation of critical habitat does not affect land ownership or establish a refuge, wilderness, reserve, preserve, or other conservation area. Such designation does not allow the government or public to access private lands. Such designation does not require implementation of restoration, recovery, or enhancement measures by non-Federal landowners. Where a landowner requests Federal agency funding or authorization for an action that may affect a listed species or critical habitat, the consultation requirements of section 7(a)(2) of the Act would apply, but even in the event of a destruction or adverse modification finding, the obligation of the Federal action agency and the landowner is not to restore or recover the species, but to implement reasonable and prudent alternatives to avoid destruction or adverse modification of critical habitat.

Under the first prong of the Act's definition of critical habitat, areas within the geographical area occupied by the species at the time it was listed are included in a critical habitat designation if they contain physical or biological features (1) which are essential to the conservation of the species and (2) which may require special management considerations or protection. For these areas, critical habitat designations identify, to the extent known using the best scientific data available, those physical or biological features that are essential to the conservation of the species (such as space, food, cover, and protected habitat). In identifying those physical and biological features within an area, we focus on the specific features that support the life-history needs of the species, including, but not limited to, water characteristics, soil type, geological features, prey, vegetation, symbiotic species, or other features. A feature may be a single habitat characteristic, or a more complex combination of habitat characteristics. Features may include habitat characteristics that support ephemeral or dynamic habitat conditions. Features may also be expressed in terms relating to principles of conservation biology, such as patch size, distribution distances, and connectivity.

Under the second prong of the Act's definition of critical habitat, we may designate critical habitat in areas outside the geographical area occupied by the species at the time it is listed, upon a determination that such areas are essential for the conservation of the species. For example, an area currently occupied by the species but that was not occupied at the time of listing may be essential to the conservation of the species and may be included in the critical habitat designation

Section 4 of the Act requires that we designate critical habitat on the basis of the best scientific data available. Further, our Policy on Information Standards Under the Act (published in the Federal Register on July 1, 1994 (59 FR 34271)), the Information Quality Act (section 515 of the Treasury and General Government Appropriations Act for Fiscal Year 2001 (Pub. L. 106-554; H.R. 5658)), and our associated Information Quality Guidelines, provide criteria, establish procedures, and provide guidance to ensure that our decisions are based on the best scientific and commercial data available. They require our staff, to the extent consistent with the Act and with the use of the best scientific and commercial data available, to use primary and original sources of information as the basis for recommendations to designate critical habitat.

When we are determining which areas should be designated as critical habitat, our primary source of information is generally the information developed during the listing process for the species. However, additional information sources may include the recovery plan for the species, articles in peer-reviewed journals, conservation plans developed by States and counties, scientific status surveys and studies, biological assessments, other unpublished materials, or experts' opinions or personal knowledge.

Habitat is dynamic, and species may move from one area to another over time. We recognize that critical habitat designated at a particular point in time may not include all of the habitat areas that we may later determine are necessary for the recovery of the species. For these reasons, a critical habitat designation does not signal that habitat outside the designated area is unimportant or may not be needed for recovery of the species. Areas that are important to the conservation of the species, both inside and outside the critical habitat designation, will continue to be subject to: (1) Conservation actions implemented under section 7(a)(1) of the Act, (2) regulatory protections afforded by the requirement in section 7(a)(2) of the Act for Federal agencies to ensure their actions are not likely to jeopardize the continued existence of any endangered or threatened species, and (3) section 9 of the Act's prohibitions on taking any individual of the species, including taking caused by actions that affect habitat. Federally funded or permitted projects affecting listed species outside their designated critical habitat areas may still result in jeopardy findings in some cases. These protections and conservation tools will continue to contribute to recovery of this species. Similarly, critical habitat designations made on the basis of the best available information at the time of designation will not control the direction and substance of future recovery plans, habitat conservation plans (HCPs), or other species conservation planning efforts if new information available at the time of these planning efforts calls for a different outcome.

In accordance with section 3(5)(A)(i) of the Act and regulations at 50 CFR 424.12(b), in determining which areas within the geographical area occupied by the species at the time of listing to designate as critical habitat, we consider the physical or biological features that are essential to the conservation of the species and which may require special management considerations or protection. For example, physical features might include gravel of a particular size required for spawning, alkali soil for seed germination, protective cover for migration, or susceptibility to flooding or fire that maintains necessary early-successional habitat characteristics. Biological features might include prey species, forage grasses, specific kinds or ages of trees for roosting or nesting, symbiotic fungi, or a particular level of nonnative species consistent with conservation needs of the listed species. The features may also be combinations of habitat characteristics and may encompass the relationship between characteristics or the necessary amount of a characteristic needed to support the life history of the species. In considering whether features are essential to the conservation of the species, the Service may consider an appropriate quality, quantity, and spatial and temporal arrangement of habitat characteristics in the context of the life-history needs, condition, and status of the species. These characteristics include but are not limited to space for individual and population growth and for normal behavior; food, water, air, light, minerals, or other nutritional or physiological requirements; cover or shelter; sites for breeding, reproduction, or rearing (or development) of offspring; and habitats that are protected from disturbance.

We derive the specific physical or biological features essential for Black Warrior waterdog from studies of this species' habitat, ecology, and life history as described below. Additional information can be found in the proposed listing (81 FR 69500) and critical habitat rule (81 FR 69475), both published in the Federal Register on October 6, 2016. We have determined that the following physical or biological features are essential for Black Warrior waterdog.

The Black Warrior waterdog is found in the Black Warrior Basin above the Fall Line, characterized by rocky habitat with little sand. According to Mount (1981, p. 23), optimal habitat for the flattened musk turtle, a species listed as threatened under the Act (52 FR 22418; June 11, 1987) that has the same range as the waterdog, consists of a “segment of a free flowing large creek or small river having the following characteristics: (1) Drainage area between 50 and 500 square miles, (2) depth averaging two feet, with vegetated shallows alternating with pools at least three to four feet deep, (3) pools with detectable current, (4) abundance of submerged rocks with crevices, overlapping flat rocks, or accumulations of boulders, (5) abundant molluscan fauna, (6) low silt load and minimal silt deposits, (7) relatively low nutrient content and bacterial count, (8) moderate temperatures (maximum 85 °F), and (9) minimal pollution by synthetic chemicals and toxic inorganic materials.” Since the Black Warrior waterdog and the flattened musk turtle occupy the same range and similar habitats, this description of optimal habitat is applicable to both species with the difference that the Black Warrior waterdog finds refuge under boulders or rocks and in crevices, lays its eggs on the underside of boulders, and uses deposited leaf packs (Bailey and Guyer 2004, pp. 36-37; Durflinger-Moreno et al. 2006, pp. 69, 76, 78) on the streambed, likely for foraging on aquatic insect larvae and for sheltering.

Necturus species in general have similar feeding habits, reproductive strategies, and physical characteristics. For example, although geographically separated (allopatric), the Black Warrior waterdog and the Neuse River waterdog both utilize high-gradient streams that are above the Fall Line and contain hard substrate, leafpacks, and macroinvertebrates. Because the two species likely evolved in similar habitats, an influential factor in determining life-history traits, we used the Neuse River waterdog as a surrogate to determine some of the biological and ecological attributes that have not yet been determined for the Black Warrior waterdog. When such data were lacking for the Neuse River waterdog and Black Warrior waterdog, we relied on data from other Necturus species. Furthermore, as discussed above, because the flattened musk turtle has an identical range to the Black Warrior waterdog, we relied on the turtle's known habitat affinities to identify some of the habitat features important to the Black Warrior waterdog.

The tributaries of the Neuse River have gradients similar to the tributaries of the Black Warrior River Basin. According to Ashton (1985, pp. 103-104), adult and juvenile Neuse River waterdogs use habitats characterized by moderate stream flow and relatively high dissolved oxygen concentrations, which is consistent with other Necturus species found in southern States. Studies of the Neuse River waterdog indicate that adult waterdogs use areas with large bedrock outcrops, large boulders with sandy-gravel bottoms, and stream banks with rock outcroppings.

The Black Warrior waterdog needs geomorphically stable streams with substrate consisting of clay or bedrock with little sand, and containing abundant rock crevices, rock slabs, and leaf packs. The connectivity of these stream habitats is also essential in accommodating growth and other normal behaviors of the Black Warrior waterdog and in promoting gene flow within the species.

Food—Feeding habits of the Black Warrior waterdog are likely similar to the feeding habits of Neuse River waterdog, since both species are found in similar microhabitats. Both adult and juvenile Neuse River waterdogs appear to be opportunistic feeders. Braswell and Ashton (1985 pp. 22-27) found that larval waterdog diets consist primarily of a variety of aquatic arthropods (orders Ostracoda, Copepoda, Isopoda, and Amphipoda) with some insect larvae (orders Odonata, Ephemeroptera, Plecoptera, Trichoptera, Diptera, and Coleoptera). Black Warrior waterdogs have been found in close association with mayfly (Ephemeroptera) and caddisfly (Tricoptera) larvae (Durflinger-Moreno et al. 2006). Adult Neuse River waterdog diet was more expansive than the juvenile diet and included aquatic arthropods, other aquatic and terrestrial invertebrates (earthworms, centipedes, beetles, grubs), and aquatic and terrestrial vertebrates (fish and salamanders) (Braswell and Ashton 1985, pp. 13, 24-25).

Since aquatic invertebrates are an important component of the Black Warrior waterdog's diet, it is essential to also take into consideration specific habitat requirements of these prey. Merrit and Cummins (1996) described caddisfly and mayfly habitat as a wide variety of standing and flowing water habitats, with the greatest diversity being found in rocky-bottom streams with an abundance of oxygen. As a result, they further identify the food sources for these aquatic insects as a variety of detritus (leaf packs), algae, diatoms, and macrophytes.

Water—As little is known about the specific water quality needs of the Black Warrior waterdog, we evaluated and based the water quality parameters on various factors, specifically Mount's (1983) description of optimal habitat, Neuse River waterdog literature, prey species requirements (insect larvae), Alabama Department of Environmental Management (ADEM) water quality standards, and water quality requirements for currently listed aquatic species found in the Basin, as follows: rush darter (Etheostoma phytophilum), Alabama moccasinshell (Medionidus acutissimus), dark pigtoe (Pleurobema furvum), orangenacre mucket (Lampsilis perovalis), ovate clubshell (Pleurobema perovatum), triangular kidneyshell (Ptychobranchus greenii), upland combshell (Epioblasma metastriata), and southern acornshell (Epioblasma othcaloogensis).

Appropriate water quality parameters to support the Black Warrior waterdog's primary prey base and other listed species in the Basin include:

• Water that lacks harmful levels of pollutants, including inorganic contaminants such as copper, arsenic, mercury, and cadmium; organic contaminants such as human and animal waste products; endocrine-disrupting chemicals; pesticides; nitrogen, potassium, and phosphorus fertilizers; and petroleum distillates (ADEM 2014, pp. 12-15);

• Water temperature not exceeding 85 °F;

• Dissolved oxygen 5.5 milligrams per liter (mg/L) or greater;

• Turbidity of an average monthly reading of 15 nephelometric turbidity units (NTUs; units to measure sediment discharge) above background readings;

• 115 mg/L of total suspended solids (measured as mg/L of sediment in water) or less; and

• A specific conductance (ability of water to conduct an electrical current, based on dissolved solids in the water) of no greater than 225 microsiemens (μS) per centimeter at 80 °F (October 10, 2012; 77 FR 61664).

The Black Warrior waterdog has similar hydrologic requirements as those of the Neuse River waterdog, which are usually found in streams greater than 15 meters (m) (50 feet (ft)) wide and deeper than 100 centimeters (cm) (3 ft) and are not found in streams where water flow ceases under normal summer dry weather conditions (Braswell and Aston 1985, pp. 26-30). However, based on eDNA detections, the Black Warrior waterdog could be using streams as narrow as 4 m (13 ft) wide (Godwin 2014, pers. comm.). In regard to instream flow, the Black Warrior waterdog benefits from moderate stream velocity and continuous daily discharge that allows for longitudinal connectivity (the pathway along the entire length of a stream).

The quality of the chemical and physical environment of the streams in the upper Black Warrior River Basin is essential to the survival of the Black Warrior waterdog. Optimal water quality lacks harmful levels of pollutants, including inorganic contaminants such as copper, arsenic, mercury, and cadmium; organic contaminants such as human and animal waste products; endocrine-disrupting chemicals; pesticides; nitrogen, potassium, and phosphorus fertilizers; and petroleum distillates (ADEM 2014, pp. 13-15). A decrease in water quality and instream flow would cause a decline in the major food species for the Black Warrior waterdog.

Natural variations of instream flows maintain the stream bottom substrates, providing oxygen and other attributes to various invertebrate life stages. Sedimentation contributes to turbidity of the water and has been shown to reduce photosynthesis in aquatic plants, suffocate aquatic insects, smother aquatic eggs, clog gills, and fill in essential interstitial spaces used by aquatic organisms for spawning and foraging. Sedimentation has been shown to wear away and suffocate periphyton (organisms that live attached to objects underwater) and disrupt aquatic insect communities (Waters 1995, pp. 53-86; Knight and Welch 2004, pp. 132-135).

Suitable substrates for the Black Warrior waterdog are dominated by clay or bedrock with little sand, and also contain abundant rock crevices and rock slabs for retreats (shelter) and areas for egg laying. Based on capture data, the Black Warrior waterdog utilizes leaf pack for shelter from predators and as foraging areas for prey species.

Little is known about the specific requirements of Black Warrior waterdog's reproduction. Based on Neuse River waterdog research, breeding sites are large bedrock outcrops or large boulders with sand and gravel beneath them (Ashton 1985, p. 95). Data collected from the Cincinnati Zoo (unpublished) indicate that the Black Warrior waterdog has similar tendencies of depositing eggs under rock slabs or in rock crevices, and the female guarding the eggs. Juvenile Black Warrior waterdogs are often found in leaf packs in the stream.

Sedimentation can be destructive to Black Warrior waterdogs and their habitat when it contains toxicants and is excessive. Bailey (2000, p. 2) reported that Black Warrior waterdogs are virtually in constant contact with the substrate and; therefore, also with any toxic chemicals present. He also reported that juveniles and adults are impacted by the exposure. Further, excessive sedimentation of the crevices and leaf packs removes foraging, feeding, breeding, and retreat areas for the Black Warrior waterdog (Laschet 2014, pers. obs.).

Currently, there are no areas that are undisturbed or that are representative of the historical geographical and ecological distribution of the species that the Black Warrior waterdog typically inhabits. The Bankhead National Forest is an area that can reveal a glimpse of representative historical geographical and ecological features of the species' habitat and is currently considered the stronghold of the species. Streams in this area typically are geomorphically stable with substrate consisting of clay or bedrock with little sand, and containing abundant rock crevices and rock slabs. These streams also contain cool, clean, flowing water having a dissolved oxygen level of 5.5 mg/L or higher; moderate water velocity; aquatic macroinvertabrate prey items; leaf packs; and adequate water quality (ADEM 2010, pp. 1-3).

In summary, based on the information described above, we have determined that the following physical or biological features are essential to the conservation of the Black Warrior waterdog.

(1) Geomorphically stable, medium to large streams (typically 4 m (13 ft) wide or greater) with:

(a) Substrate consisting of clay or bedrock with little sand, and containing abundant rock crevices, rock slabs, and leaf packs;

(b) Moderate water velocity; and

(c) Prey base of aquatic macroinvertebrates.

(2) Water that lacks harmful levels of pollutants, including inorganic contaminants such as copper, arsenic, mercury, and cadmium; organic contaminants such as human and animal waste products; endocrine-disrupting chemicals; pesticides; nitrogen, potassium, and phosphorus fertilizers; and petroleum distillates.

(3) Appropriate water quality parameters to support Black Warrior waterdog and primary prey base, including:

(a) Water temperature not exceeding 85 °F;

(b) Dissolved oxygen 5.5 mg/L or greater;

(c) Turbidity of an average monthly reading of 15 NTUs above background readings;

(d) 115 mg/L of total suspended solids or less; and

(e) A specific conductance of no greater than 225 μS per centimeter at 80 °F.

When designating critical habitat, we assess whether the specific areas within the geographical area occupied by the species at the time of listing contain features that are essential to the conservation of the species and which may require special management considerations or protection.

The features essential to the conservation of the Black Warrior waterdog may require special management considerations or protections to reduce the following threats: (1) Urbanization activities and inadequate stormwater management (such as stream channel modification for flood control or gravel extraction) that could cause an increase in bank erosion; (2) significant changes in the existing flow regime within the streams due to water diversion or withdrawal; (3) significant alteration of water quality; (4) significant alteration in quantity of groundwater, prevention of water percolating into the aquifer recharge zone, and alteration of spring discharge sites; (5) significant changes in stream bed material composition and quality due to changes in stream flow characteristics, construction projects, and maintenance activities; (6) off-road vehicle use; (7) sewer, gas, and water easements; (8) bridge construction; (9) culvert and pipe installation; and (10) other watershed and floodplain disturbances that release sediments or nutrients into the water.

Management activities that could ameliorate these threats include, but are not limited to: Use of certified BMPs designed to reduce sedimentation, erosion, and bank side destruction; select harvest of trees along banks, and leaving 50 percent canopy cover (of deciduous trees) along banks; moderation of surface and ground water withdrawals to maintain natural flow regimes; increased use of stormwater management and reduction of stormwater flows into the systems; preservation of headwater springs and spring runs; regulation of off-road vehicle use; and reduction of other watershed and floodplain disturbances that release sediments, pollutants, or nutrients into the water.

These management activities could protect the physical or biological features essential for the conservation of the species by eliminating, or reducing to negligible levels, the threats affecting the physical and biological features of each unit. The major threats to the Black Warrior waterdog habitat are sedimentation, water quality degradation (increased nutrients, turbidity, and toxins), and fragmentation from impoundments.

As required by section 4(b)(2) of the Act, we use the best scientific data available to designate critical habitat. In accordance with the Act and our implementing regulations at 50 CFR 424.12(b) we review available information pertaining to the habitat requirements of the species and identify specific areas within the geographical area occupied by the species at the time of listing and any specific areas outside the geographical area occupied by the species to be considered for designation as critical habitat. We are designating critical habitat in areas within the geographical area occupied by the Black Warrior waterdog at the time of listing in 2017. We are not designating any areas outside the geographic area occupied by the species because we did not find any areas that were essential for the conservation of the species (see explanation under response to comment 11, above).

For the purpose of designating critical habitat for the Black Warrior waterdog, we defined the geographical area currently occupied by the species. We used information from surveys and reports prepared by the Alabama Department of Conservation and Natural Resources, Alabama Geological Survey, Alabama Natural Heritage Program, Auburn University, Alabama Power Company, U.S. Forest Service, Natural Resources Conservation Service, and Service to identify the specific locations occupied by the Black Warrior waterdog. Currently, occupied habitat for the species is isolated and limited to four units. Within these four units, the species is located within seven tributaries in the Black Warrior River Basin. Three of the tributaries are on Bankhead National Forest (Winston County) and include Sipsey Fork, Brushy Creek, and Rush Creek. The other four tributaries are Locust Fork; Gurley Creek, which feeds into Locust Fork (Blount and Jefferson Counties); Blackwater/Browns Creek in Winston County; and Yellow Creek in Tuscaloosa County (Godwin 2014, entire). We have determined that these four units (which include all seven tributaries)—Sipsey Fork, Locust Fork, Blackwater Creek, and Yellow Creek—meet the criteria for designation as critical habitat. As discussed below, some of these units contain all of the identified elements of physical or biological features and support multiple life-history processes. Some units contain only some elements of the physical or biological features necessary to support the Black Warrior waterdog's particular use of that habitat.

In identifying critical habitat units for the Black Warrior waterdog, we proceeded through a multi-step process. We obtained and reviewed historical records for the Black Warrior waterdog's distribution from Bankhead National Forest and Alabama Natural Heritage Program, as well as both published and unpublished documentation from our files. Once the historical range was determined, we looked at whether the physical and biological features were present at these historical sites. Then, we reviewed surveys conducted over the last 8 years, including surveys currently being undertaken. We conducted species present-or-absent surveys of known and historical sites and sampled and observed the habitat. Since the Black Warrior waterdog is difficult to detect and capture, we contracted with Alabama Natural Heritage Program and Auburn University to conduct sampling surveys including the use of eDNA. With the survey results, we confirmed the Black Warrior waterdog's distribution in the Black Warrior River Basin. We determined occupied areas with data collected from surveys conducted over the last 8 years to present. We considered areas that do not have recent capture or sighting data to be unoccupied by the species.

Our approach to delineating critical habitat units was applied in the following manner:

(1) We overlaid Black Warrior waterdog locations into a GIS database. This provided us with the ability to examine slope, elevation, geologic type, hydrologic factors, vegetation community, and topographic features. These data points verified the previously recorded elevation ranges for Black Warrior waterdog.

(2) In addition to the GIS layers listed above, we then excluded impoundments and dams as barriers for the species, as described in Physical or Biological Features, above.

(3) We then drew critical habitat boundaries that captured the locations as discussed above. The final critical habitat designation was then mapped using Projected Coordinate System, NAD 1983 UTM Zone 16N with a Projection of Transverse Mercator.

When determining critical habitat boundaries, we made every effort to avoid including developed areas such as lands covered by buildings, pavement, and other structures because such lands lack physical or biological features necessary for the Black Warrior waterdog. The scale of the maps we prepared under the parameters for publication within the Code of Federal Regulations may not reflect the exclusion of such developed lands. Any such lands inadvertently left inside critical habitat boundaries shown on the maps of this rule have been excluded by text in the rule and are not designated as critical habitat. Therefore, a Federal action involving these lands would not trigger section 7 consultation with respect to critical habitat and the requirement of no adverse modification unless the specific action would affect the physical or biological features in the adjacent critical habitat.

We are designating as critical habitat streams that we have determined are occupied at the time of listing and contain physical or biological features to support life-history processes essential to the conservation of the species.

Four units were designated based on one or more of the elements of physical or biological features being present to support the Black Warrior waterdog's life processes. Some units contained all of the identified elements of physical or biological features and supported multiple life processes. Some units contained only some elements of the physical or biological features necessary to support the Black Warrior waterdog's particular use of that habitat.

The critical habitat designation is defined by the maps, as modified by any accompanying regulatory text, presented at the end of this document in the rule portion. We include more detailed information on the boundaries of the critical habitat designation in the preamble of this document. We will make the coordinates or plot points or both on which each map is based available to the public on http://www.regulations.gov at Docket No. FWS-R4-ES-2016-0031, on the Service's website at http://www.fws.gov/daphne/, and at the field office responsible for the designation (see FOR FURTHER INFORMATION CONTACT, above).

We are designating approximately 673 river kilometers (420 river miles) in five units as critical habitat for the Black Warrior waterdog. The critical habitat areas we describe below constitute our current best assessment of areas that meet the definition of critical habitat for the Black Warrior waterdog.

All of the areas designated as critical habitat for the Black Warrior waterdog include stream and river channels within the normal high water line.

Table 1 shows the occupancy status of each unit and units that overlap with existing critical habitat units for other federally listed species.

We present brief descriptions of all the units, and reasons why they meet the definition of critical habitat for the Black Warrior waterdog, below. All units are within private ownership, except Unit 4, which also includes Federal ownership.

Unit 1 includes 30 rkm (19 rmi) of stream and river habitat. The unit consists of the headwaters of Yellow Creek to Holt Lake. This area is within the geographical area occupied at the time of listing (i.e., currently occupied). Godwin (2016, pers. comm.) reported a capture of a Black Warrior waterdog in this area. This area contains the following physical or biological features that are essential for the Black Warrior waterdog: Abundant rock crevices and rock slabs, leaf litter, and instream flow with moderate velocity and continuous daily discharge that allows for a longitudinal connectivity regime inclusive of both surface runoff and ground water sources and exclusive of flushing flows caused by stormwater runoff.

Threats to the physical and biological features in Unit 1 that may require special management considerations or protection include:

• Agriculture, silviculture, and urbanization activities that could result in increased bank erosion;

• Significant changes in the existing flow regime due to inadequate stormwater management, water diversion, or water withdrawal;

• Significant alteration of water quality; and

• Significant changes in stream bed material composition and quality as a result of construction projects and maintenance activities; off-road vehicle use; sewer, gas, and water easements; bridge and road construction and maintenance; culvert and pipe installation; and other watershed and floodplain disturbances that release sediments or nutrients into the water.

Unit 2 includes 391 rkm (243 rmi) of stream and river habitat. The unit consists of the headwaters of Locust Fork to Bankhead Lake, from the headwaters of Slab Creek to the confluence of Locust Fork, from the headwaters of Blackburn Fork to the confluence of Locust Fork, and from the headwaters of Gurley Creek to the confluence of Locust Fork. This area is within the geographical area occupied at the time of listing (i.e., currently occupied). Based on a literature review by Bailey (2000, p. 1), Black Warrior waterdog specimens have been collected from the Locust Fork area. Black Warrior waterdogs were also collected in the upper Locust Fork in 2012 along with positive eDNA samples in this area. This area contains the following physical or biological features: Abundant rock crevices and rock slabs, leaf litter, and instream flow with moderate velocity and continuous daily discharge that allows for a longitudinal connectivity regime consisting of both surface runoff and ground water sources, exclusive of flushing flows caused by stormwater runoff, that are essential for the Black Warrior waterdog.

Threats to the physical and biological features in Unit 2 that may require special management considerations or protection include:

• Agriculture, silviculture, and urbanization activities that could result in increased bank erosion;

• Significant changes in the existing flow regime due to inadequate stormwater management, water diversion, or water withdrawal;

• Significant alteration of water quality; and

• Significant changes in stream bed material composition and quality as a result of construction projects and maintenance activities; off-road vehicle use; sewer, gas, and water easements; bridge and road construction and maintenance; culvert and pipe installation; and other watershed and floodplain disturbances that release sediments or nutrients into the water.

Unit 3 includes 128 rkm (80 rmi) of stream and river habitat. The unit consists of the headwaters of Blackwater Creek to the confluence of Mulberry Fork, and from the headwaters of Brown Creek to the confluence of Blackwater Creek. This area is within the geographical area occupied at the time of listing based on a literature review by Bailey (2000, p. 1). Black Warrior waterdogs were collected in Brown Creek in 2006. Black Warrior waterdogs were likely still present based on eDNA results (Godwin 2014, pers. comm.). This area contains the following physical or biological features: Abundant rock crevices and rock slabs, leaf litter, and instream flow with moderate velocity and continuous daily discharge that allows for longitudinal connectivity regime consisting of both surface runoff and ground water sources, exclusive of flushing flows caused by stormwater runoff, that are essential for the Black Warrior waterdog.

Threats to the physical and biological features in Unit 3 that may require special management considerations or protection include:

• Agriculture, silviculture, and urbanization activities that could result in increased bank erosion;

• Significant changes in the existing flow regime due to inadequate stormwater management, water diversion, or water withdrawal;

• Significant alteration of water quality; and

• Significant changes in stream bed material composition and quality as a result of construction projects and maintenance activities; off-road vehicle use; sewer, gas, and water easements; bridge and road construction and maintenance; culvert and pipe installation; and other watershed and floodplain disturbances that release sediments or nutrients into the water.

Unit 4 includes 124 rkm (78 rmi) of stream and river habitat. The unit consists of the headwaters of Sipsey Fork to Lewis Smith Lake, from the headwaters of Brushy Creek to Lewis Smith Lake, from the headwaters of Rush Creek to the confluence of Brushy Creek, and from the headwaters of Capsey Creek to the confluence of Brushy Creek. This area falls within the boundary of Bankhead National Forest, although some areas are private inholdings.

This area is within the geographical area occupied at the time of listing, based on recent captures (Godwin 2016, entire). This area contains the following physical or biological features: abundant rock crevices and rock slabs, leaf litter, and instream flow with moderate velocity and continuous daily discharge that allows for longitudinal connectivity consisting of both surface runoff and ground water sources, exclusive of flushing flows caused by stormwater runoff, that are essential for the Black Warrior waterdog.

Threats to the physical and biological features in Unit 4 that may require special management considerations or protection include:

• Agriculture, silviculture, and urbanization activities that could result in increased bank erosion;

• Significant changes in the existing flow regime due to inadequate stormwater management, water diversion, or water withdrawal;

• Significant alteration of water quality; and

• Significant changes in stream bed material composition and quality as a result of construction projects and maintenance activities; off-road vehicle use; sewer, gas, and water easements; bridge and road construction and maintenance; culvert and pipe installation; and other watershed and floodplain disturbances that release sediments or nutrients into the water.

Section 7(a)(2) of the Act requires Federal agencies, including the Service, to ensure that any action they fund, authorize, or carry out is not likely to jeopardize the continued existence of any endangered species or threatened species or result in the destruction or adverse modification of designated critical habitat of such species. In addition, section 7(a)(4) of the Act requires Federal agencies to confer with the Service on any agency action that is likely to jeopardize the continued existence of any species proposed to be listed under the Act or result in the destruction or adverse modification of proposed critical habitat.

We published a final regulation with a new definition of destruction or adverse modification on February 11, 2016 (81 FR 7214). Destruction or adverse modification means a direct or indirect alteration that appreciably diminishes the value of critical habitat for the conservation of a listed species. Such alterations may include, but are not limited to, those that alter the physical or biological features essential to the conservation of a species or that preclude or significantly delay development of such features.

If a Federal action may affect a listed species or its critical habitat, the responsible Federal agency (action agency) must enter into consultation with us. Examples of actions that are subject to the section 7 consultation process are actions on State, tribal, local, or private lands that require a Federal permit (such as a permit from the U.S. Army Corps of Engineers under section 404 of the Clean Water Act (33 U.S.C. 1251 et seq.) or a permit from the Service under section 10 of the Act) or that involve some other Federal action (such as funding from the Federal Highway Administration, Federal Aviation Administration, or the Federal Emergency Management Agency). Federal actions not affecting listed species or critical habitat, and actions on State, tribal, local, or private lands that are not federally funded or authorized, do not require section 7 consultation.

As a result of section 7 consultation, we document compliance with the requirements of section 7(a)(2) through our issuance of:

(1) A concurrence letter for Federal actions that may affect, but are not likely to adversely affect, listed species or critical habitat; or

(2) A biological opinion for Federal actions that may affect, and are likely to adversely affect, listed species or critical habitat.

When we issue a biological opinion concluding that a project is likely to jeopardize the continued existence of a listed species and/or destroy or adversely modify critical habitat, we provide reasonable and prudent alternatives to the project, if any are identifiable, that would avoid the likelihood of jeopardy and/or destruction or adverse modification of critical habitat. We define “reasonable and prudent alternatives” (at 50 CFR 402.02) as alternative actions identified during consultation that:

(1) Can be implemented in a manner consistent with the intended purpose of the action,

(2) Can be implemented consistent with the scope of the Federal agency's legal authority and jurisdiction,

(3) Are economically and technologically feasible, and

(4) Would, in the Director's opinion, avoid the likelihood of jeopardizing the continued existence of the listed species and/or avoid the likelihood of destroying or adversely modifying critical habitat.

Reasonable and prudent alternatives can vary from slight project modifications to extensive redesign or relocation of the project. Costs associated with implementing a reasonable and prudent alternative are similarly variable.

Regulations at 50 CFR 402.16 require Federal agencies to reinitiate consultation on previously reviewed actions in instances where we have listed a new species or subsequently designated critical habitat that may be affected and the Federal agency has retained discretionary involvement or control over the action (or the agency's discretionary involvement or control is authorized by law). Consequently, Federal agencies sometimes may need to request reinitiation of consultation with us on actions for which formal consultation has been completed, if those actions with discretionary involvement or control may affect subsequently listed species or designated critical habitat.

The key factor related to the adverse modification determination is whether, with implementation of the proposed Federal action, the affected critical habitat would continue to serve its intended conservation role for the species. Activities that may destroy or adversely modify critical habitat are those that result in a direct or indirect alteration that appreciably diminishes the value of critical habitat for the conservation of the Black Warrior waterdog. Such alterations may include, but are not limited to, those that alter the physical or biological features essential to the conservation of these species or that preclude or significantly delay development of such features. As discussed above, the role of critical habitat is to support physical or biological features essential to the conservation of a listed species and provide for the conservation of the species.

Section 4(b)(8) of the Act requires us to briefly evaluate and describe, in any proposed or final regulation that designates critical habitat, activities involving a Federal action that may destroy or adversely modify such habitat, or that may be affected by such designation.

Activities that may affect critical habitat, when carried out, funded, or authorized by a Federal agency, should result in consultation for the Black Warrior waterdog. These activities include, but are not limited to:

(1) Actions that would significantly alter water chemistry or temperature. Such activities could include, but are not limited to, release of chemicals, biological pollutants, or heated effluents into the surface water or connected groundwater at a point source or by dispersed release (non-point source). These activities could alter water conditions to levels that are beyond the tolerances of the species' prey items and result in direct or cumulative adverse effects to the Black Warrior waterdog and its lifecycle.

(2) Actions that would significantly increase sediment deposition within the stream channel. Such activities could include, but are not limited to, excessive sedimentation from livestock grazing, road construction, channel alteration, timber harvest, off-road vehicle use, and other watershed and floodplain disturbances. These activities could eliminate or reduce the habitat necessary for the growth and reproduction of the Black Warrior waterdog by increasing the sediment deposition to levels that would adversely affect its ability to complete its lifecycle.

(3) Actions that would significantly alter channel morphology or geometry. Such activities could include, but are not limited to, channelization, impoundment, road and bridge construction, mining, dredging, and destruction of riparian vegetation. These activities may lead to changes in water flows and levels that would degrade or eliminate the Black Warrior waterdog and/or its habitat. These actions can also lead to increased sedimentation and degradation in water quality to levels that are beyond the tolerances of the Black Warrior waterdog or its prey items.

Section 4(a)(3)(B)(i) of the Act (16 U.S.C. 1533(a)(3)(B)(i)) provides that: “The Secretary shall not designate as critical habitat any lands or other geographical areas owned or controlled by the Department of Defense, or designated for its use, that are subject to an integrated natural resources management plan [INRMP] prepared under section 101 of the Sikes Act (16 U.S.C. 670a), if the Secretary determines in writing that such plan provides a benefit to the species for which critical habitat is proposed for designation.” There are no Department of Defense lands with a completed INRMP within the final critical habitat designation.

Section 4(b)(2) of the Act states that the Secretary shall designate critical habitat on the basis of the best available scientific data after taking into consideration the economic impact, national security impact, and any other relevant impact of specifying any particular area as critical habitat. The Secretary may exclude an area from critical habitat if she determines that the benefits of such exclusion outweigh the benefits of specifying such area as part of the critical habitat, unless she determines, based on the best scientific data available, that the failure to designate such area as critical habitat will result in the extinction of the species. In making that determination, the statute, as well as the legislative history, is clear that the Secretary has broad discretion regarding which factor(s) to use and how much weight to give to any factor. In this final rule, we have not considered any areas for exclusion from critical habitat.

Section 4(b)(2) of the Act and its implementing regulations require that we consider the economic impact that may result from a designation of critical habitat. In order to consider economic impacts, we prepared an incremental effects memorandum (IEM) and screening analysis which, together with our narrative and interpretation of effects, constitute our draft economic analysis of the proposed critical habitat designation and related factors (IEc 2015). The analysis, dated July 15, 2015, was made available for public review from October 6, 2016, through December 5, 2016. Following the close of the comment period, we reviewed and evaluated all information submitted during the comment period that may pertain to our consideration of the probable incremental economic impacts of this critical habitat designation. Additional information relevant to the probable incremental economic impacts of critical habitat designation for the Black Warrior waterdog is summarized below and available in the screening analysis for the Black Warrior waterdog (IEc 2015, entire), available at http://www.regulations.gov in Docket No. FWS-R4-ES-2016-0031.

The final critical habitat designation for the Black Warrior waterdog is likely to result, annually, in less than 2 formal consultations, 23 informal consultations, and 206 technical assistance efforts related to silviculture, mining, impoundments, commercial and residential development, pipelines, agriculture and other activities that impact water quality. According to the finding in the screening analysis, the administrative cost of addressing adverse modification in the consultations is estimated to be between about $410 to $9,000 per consultation. Accordingly, the incremental administrative cost is not likely to exceed $150,000 annually. This designation of critical habitat is not likely to cause more requirements under State or local regulations, nor is it expected to have perceptional effects on the markets.

As discussed above, the Service considered the economic impacts of the critical habitat designation and the Secretary is not exercising his discretion to exclude any areas from this designation of critical habitat for the Black Warrior waterdog based economic impacts.

A copy of the IEM and screening analysis with supporting documents may be obtained by contacting the Alabama Ecological Services Field Office (see ADDRESSES) or by downloading from the internet at http://www.regulations.gov.

Section 4(a)(3)(B)(i) of the Act may not cover all DoD lands or areas that pose potential national-security concerns (e.g., a DoD installation that is in the process of revising its INRMP for a newly listed species or a species previously not covered). If a particular area is not covered under section 4(a)(3)(B)(i), national-security or homeland-security concerns are not a factor in the process of determining what areas meet the definition of “critical habitat.” Nevertheless, when designating critical habitat under section 4(b)(2), the Service must consider impacts on national security, including homeland security, on lands or areas not covered by section 4(a)(3)(B)(i). Accordingly, we will always consider for exclusion from the designation areas for which DoD, Department of Homeland Security (DHS), or another Federal agency has requested exclusion based on an assertion of national-security or homeland-security concerns. No DoD lands occur within or are affected by the designation.

Under section 4(b)(2) of the Act, we consider any other relevant impacts, in addition to economic impacts and impacts on national security. We consider a number of factors including whether there are permitted conservation plans covering the species in the area such as HCPs, safe harbor agreements, or candidate conservation agreements with assurances, or whether there are non-permitted conservation agreements and partnerships that would be encouraged by designation of, or exclusion from, critical habitat. In addition, we look at the existence of tribal conservation plans and partnerships and consider the government-to-government relationship of the United States with tribal entities. We also consider any social impacts that might occur because of the designation.

In preparing this final rule, we have determined that there are currently no permitted conservation plans or other non-permitted conservation agreements or partnerships for the Black Warrior waterdog, and the final designation does not include any tribal lands or tribal trust resources. We anticipate no impact on tribal lands, partnerships, permitted or non-permitted plans or agreements from this critical habitat designation. Accordingly, the Secretary is not exercising his discretion to exclude any areas from this final designation based on other relevant impacts.

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.

Under the Regulatory Flexibility Act (RFA; 5 U.S.C. 601 et seq.), as amended by the Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA; 5 U.S.C. 801 et seq.), whenever an agency is required to publish a notice of rulemaking for any proposed or final rule, it must prepare and make available for public comment a regulatory flexibility analysis that describes the effects of the rule on small entities (i.e., small businesses, small organizations, and small government jurisdictions). However, no regulatory flexibility analysis is required if the head of the agency certifies the rule will not have a significant economic impact on a substantial number of small entities. The SBREFA amended the RFA to require Federal agencies to provide a certification statement of the factual basis for certifying that the rule will not have a significant economic impact on a substantial number of small entities.

According to the Small Business Administration, small entities include small organizations such as independent nonprofit organizations; small governmental jurisdictions, including school boards and city and town governments that serve fewer than 50,000 residents; and small businesses (13 CFR 121.201). Small businesses include manufacturing and mining concerns with fewer than 500 employees, wholesale trade entities with fewer than 100 employees, retail and service businesses with less than $5 million in annual sales, general and heavy construction businesses with less than $27.5 million in annual business, special trade contractors doing less than $11.5 million in annual business, and agricultural businesses with annual sales less than $750,000. To determine if potential economic impacts to these small entities are significant, we considered the types of activities that might trigger regulatory impacts under this designation as well as types of project modifications that may result. In general, the term “significant economic impact” is meant to apply to a typical small business firm's business operations.

The Service's current understanding of the requirements under the RFA, as amended, and following recent court decisions, is that Federal agencies are required to evaluate the potential incremental impacts of rulemaking only on those entities directly regulated by the rulemaking itself, and therefore, not required to evaluate the potential impacts to indirectly regulated entities. The regulatory mechanism through which critical habitat protections are realized is section 7 of the Act, which requires Federal agencies, in consultation with the Service, to ensure that any action authorized, funded, or carried out by the Agency is not likely to destroy or adversely modify critical habitat. Therefore, under section 7 only Federal action agencies are directly subject to the specific regulatory requirement (avoiding destruction and adverse modification) imposed by critical habitat designation. Consequently, it is our position that only Federal action agencies will be directly regulated by this designation. There is no requirement under the RFA to evaluate the potential impacts to entities not directly regulated. Moreover, Federal agencies are not small entities. Therefore, because no small entities are directly regulated by this rulemaking, the Service certifies that the final critical habitat designation will not have a significant economic impact on a substantial number of small entities.

During the development of this final rule we reviewed and evaluated all information submitted during the comment period that may pertain to our consideration of the probable incremental economic impacts of this critical habitat designation. Based on this information, we affirm our certification that this final critical habitat designation will not have a significant economic impact on a substantial number of small entities, and a regulatory flexibility analysis is not required.

Executive Order 13211 (Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use) requires agencies to prepare Statements of Energy Effects when undertaking certain actions. OMB has provided guidance for implementing this Executive Order that outlines nine outcomes that may constitute “a significant adverse effect” when compared to not taking the regulatory action under consideration. The economic analysis finds that none of these criteria are relevant to this analysis. Thus, based on information in the economic analysis, energy-related impacts associated with Black Warrior waterdog conservation activities within critical habitat are not expected. As such, the designation of critical habitat is not expected to significantly affect energy supplies, distribution, or use. Therefore, this action is not a significant energy action, and no Statement of Energy Effects is required.

In accordance with the Unfunded Mandates Reform Act (2 U.S.C. 1501 et seq.), we make the following findings:

(1) This rule will not produce a Federal mandate. In general, a Federal mandate is a provision in legislation, statute, or regulation that would impose an enforceable duty upon State, local, or tribal governments, or the private sector, and includes both “Federal intergovernmental mandates” and “Federal private sector mandates.” These terms are defined in 2 U.S.C. 658(5)-(7). “Federal intergovernmental mandate” includes a regulation that “would impose an enforceable duty upon State, local, or tribal governments” with two exceptions. It excludes “a condition of Federal assistance.” It also excludes “a duty arising from participation in a voluntary Federal program,” unless the regulation “relates to a then-existing Federal program under which $500,000,000 or more is provided annually to State, local, and tribal governments under entitlement authority,” if the provision would “increase the stringency of conditions of assistance” or “place caps upon, or otherwise decrease, the Federal Government's responsibility to provide funding,” and the State, local, or tribal governments “lack authority” to adjust accordingly. At the time of enactment, these entitlement programs were: Medicaid; Aid to Families with Dependent Children work programs; Child Nutrition; Food Stamps; Social Services Block Grants; Vocational Rehabilitation State Grants; Foster Care, Adoption Assistance, and Independent Living; Family Support Welfare Services; and Child Support Enforcement. “Federal private sector mandate” includes a regulation that “would impose an enforceable duty upon the private sector, except (i) a condition of Federal assistance or (ii) a duty arising from participation in a voluntary Federal program.”

The designation of critical habitat does not impose a legally binding duty on non-Federal Government entities or private parties. Under the Act, the only regulatory effect is that Federal agencies must ensure that their actions do not destroy or adversely modify critical habitat under section 7. While non-Federal entities that receive Federal funding, assistance, or permits, or that otherwise require approval or authorization from a Federal agency for an action, may be indirectly impacted by the designation of critical habitat, the legally binding duty to avoid destruction or adverse modification of critical habitat rests squarely on the Federal agency. Furthermore, to the extent that non-Federal entities are indirectly impacted because they receive Federal assistance or participate in a voluntary Federal aid program, the Unfunded Mandates Reform Act would not apply, nor would critical habitat shift the costs of the large entitlement programs listed above onto State governments.

(2) We do not believe that this rule will significantly or uniquely affect small governments because it will not produce a Federal mandate of $100 million or greater in any year; that is, it is not a “significant regulatory action” under the Unfunded Mandates Reform Act. The designation of critical habitat imposes no obligations on State or local governments and, as such, a Small Government Agency Plan is not required.

In accordance with E.O. 12630 (Government Actions and Interference with Constitutionally Protected Private Property Rights), we have analyzed the potential takings implications of designating critical habitat for the Black Warrior waterdog in a takings implications assessment. The Act does not authorize the Service to regulate private actions on private lands or confiscate private property as a result of critical habitat designation. Designation of critical habitat does not affect land ownership, or establish any closures, or restrictions on use of or access to the designated areas. Furthermore, the designation of critical habitat does not affect landowner actions that do not require Federal funding or permits, nor does it preclude development of habitat conservation programs or issuance of incidental take permits to permit actions that do require Federal funding or permits to go forward. However, Federal agencies are prohibited from carrying out, funding, or authorizing actions that would destroy or adversely modify critical habitat. A takings implications assessment has been completed and concludes that this designation of critical habitat for the Black Warrior waterdog does not pose significant takings implications for lands within or affected by the designation.

In accordance with E.O. 13132 (Federalism), this final rule does not have significant Federalism effects. A Federalism assessment is not required. In keeping with Department of the Interior and Department of Commerce policy, we requested information from, and coordinated development of this final critical habitat designation with, appropriate State resource agencies in Alabama. We received comments from Alabama and have addressed them in the Summary of Comments and Recommendations section of the rule. From a federalism perspective, the designation of critical habitat directly affects only the responsibilities of Federal agencies. The Act imposes no other duties with respect to critical habitat, either for States and local governments, or for anyone else. As a result, the rule does not have substantial direct effects either on the States, or on the relationship between the national government and the States, or on the distribution of powers and responsibilities among the various levels of government. The designation may have some benefit to these governments because the areas that contain the features essential to the conservation of the species are more clearly defined, and the physical and biological features of the habitat necessary to the conservation of the species are specifically identified. This information does not alter where and what federally sponsored activities may occur. However, it may assist these local governments in long-range planning (because these local governments no longer have to wait for case-by-case section 7 consultations to occur).

Where State and local governments require approval or authorization from a Federal agency for actions that may affect critical habitat, consultation under section 7(a)(2) would be required. While non-Federal entities that receive Federal funding, assistance, or permits, or that otherwise require approval or authorization from a Federal agency for an action, may be indirectly impacted by the designation of critical habitat, the legally binding duty to avoid destruction or adverse modification of critical habitat rests squarely on the Federal agency.

In accordance with Executive Order 12988 (Civil Justice Reform), the Office of the Solicitor has determined that the rule does not unduly burden the judicial system and that it meets the applicable standards set forth in sections 3(a) and 3(b)(2) of the Order. We are designating critical habitat in accordance with the provisions of the Act. To assist the public in understanding the habitat needs of the species, the rule identifies the elements of physical or biological features essential to the conservation of the Black Warrior waterdog. The designated areas of critical habitat are presented on maps, and the rule provides several options for the interested public to obtain more detailed location information, if desired.

This rule does not contain any new collections of information that require approval by OMB under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). This rule will not impose recordkeeping or reporting requirements on State or local governments, individuals, businesses, or organizations. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

It is our position that, outside the jurisdiction of the U.S. Court of Appeals for the Tenth Circuit, we do not need to prepare environmental analyses pursuant to the National Environmental Policy Act in connection with designating critical habitat under the Act. We published a notice outlining our reasons for this determination in the Federal Register on October 25, 1983 (48 FR 49244). This position was upheld by the U.S. Court of Appeals for the Ninth Circuit (Douglas County v. Babbitt, 48 F.3d 1495 (9th Cir. 1995), cert. denied 516 U.S. 1042 (1996)).

In accordance with the President's memorandum of April 29, 1994 (Government-to-Government Relations with Native American Tribal Governments; 59 FR 22951), Executive Order 13175 (Consultation and Coordination With Indian Tribal Governments), 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. We determined that there are no tribal lands affected by the designation.

A complete list of all references cited is available on the internet at http://www.regulations.gov and upon request from the Alabama Ecological Services Field Office (see FOR FURTHER INFORMATION CONTACT).

The primary authors of this rulemaking are the staff members of the Alabama Ecological Services Field Office.

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 groundfish fishery in the GOA exclusive economic zone according to the Fishery Management Plan for Groundfish of the Gulf of Alaska (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679. Regulations governing sideboard protections for GOA groundfish fisheries appear at subpart B of 50 CFR part 680.

The A season allowance of the 2018 Pacific cod total allowable catch (TAC) apportioned to vessels using jig gear in the Central Regulatory Area of the GOA is 37 metric tons (mt), as established by the final 2017 and 2018 harvest specifications for groundfish of the GOA (82 FR 12032, February 27, 2017) and inseason adjustment (82 FR 12032, February 27, 2017).

In accordance with § 679.20(d)(1)(i), the Administrator, Alaska Region, NMFS (Regional Administrator) has determined that the A season allowance of the 2018 Pacific cod TAC apportioned to vessels using jig gear in the Central Regulatory Area of the GOA is necessary to account for the incidental catch in other anticipated fisheries. Therefore, the Regional Administrator is establishing a directed fishing allowance of 0 mt and is setting aside the remaining 37 mt as bycatch to support other anticipated groundfish fisheries. In accordance with § 679.20(d)(1)(iii), the Regional Administrator finds that this directed fishing allowance has been reached. Consequently, NMFS is prohibiting directed fishing for Pacific cod by vessels using jig gear in the Central Regulatory Area of the GOA. After the effective date of this closure the maximum retainable amounts at § 679.20(e) and (f) apply at any time during a trip.

This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the directed fishing closure of Pacific cod by vessels using jig gear in the Central Regulatory Area of the GOA. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of December 27, 2017.

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

This action is required by § 679.20 and is exempt from review under Executive Order 12866.

NMFS manages the groundfish fishery in the GOA exclusive economic zone according to the Fishery Management Plan for Groundfish of the Gulf of Alaska (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679. Regulations governing sideboard protections for GOA groundfish fisheries appear at subpart B of 50 CFR part 680.

The A season allowance of the 2018 Pacific cod total allowable catch (TAC) apportioned to catcher vessels using hook-and-line gear in the Western Regulatory Area of the GOA is 39 metric tons (mt), as established by the final 2017 and 2018 harvest specifications for groundfish of the GOA (82 FR 12032, February 27, 2017) and inseason adjustment (82 FR 60327, December 20, 2017).

In accordance with § 679.20(d)(1)(i), the Administrator, Alaska Region, NMFS (Regional Administrator) has determined that the A season allowance of the 2018 Pacific cod TAC apportioned to catcher vessels using hook-and-line gear in the Western Regulatory Area of the GOA will soon be reached. Therefore, the Regional Administrator is establishing a directed fishing allowance of 0 mt and is setting aside the remaining 39 mt as bycatch to support other anticipated groundfish fisheries. In accordance with § 679.20(d)(1)(iii), the Regional Administrator finds that this directed fishing allowance has been reached. Consequently, NMFS is prohibiting directed fishing for Pacific cod by catcher vessels using hook-and-line gear in the Western Regulatory Area of the GOA. After the effective date of this closure the maximum retainable amounts at § 679.20(e) and (f) apply at any time during a trip.

This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the directed fishing closure of Pacific cod by catcher vessels using hook-and-line gear in the Western Regulatory Area of the GOA. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of December 27, 2017.

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

This action is required by § 679.20 and is exempt from review under Executive Order 12866.