Federal Register Vol. 82, No.149,

Federal Register Volume 82, Issue 149 (August 4, 2017)

Page Range36319-36685
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82_FR_149
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82 149 Friday, August 4, 2017 Contents Agriculture Agriculture Department See

Forest Service

Alcohol Tobacco Firearms Alcohol, Tobacco, Firearms, and Explosives Bureau NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Release and Receipt of Imported Firearms, Ammunition and Defense Articles, 36420-36421 2017-16431 Centers Medicare Centers for Medicare & Medicaid Services RULES Medicare Program: FY 2018 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Requirements, 36638-36685 2017-16294 Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities for FY 2018, SNF Value-Based Purchasing Program, SNF Quality Reporting Program, Survey Team Composition, etc., 36530-36636 2017-16256 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 36403-36404 2017-16483 Medicare and Medicaid Programs: Quarterly Listing of Program Issuances—April through June 2017, 36404-36416 2017-16252 Children Children and Families Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 36416 2017-16390 Coast Guard Coast Guard RULES Drawbridge Operations: Isthmus Slough at Coos Bay, OR, 36332 2017-16425 Willamette River, Portland, OR, 36332-36333 2017-16424 Safety Zones: Mississippi River; New Orleans, LA, 36333-36335 2017-16436 Commerce Commerce Department See

International Trade Administration

See

National Oceanic and Atmospheric Administration

Commodity Futures Commodity Futures Trading Commission NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Security Futures Products, 36384-36385 2017-16459 Defense Department Defense Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 36385 2017-16420 Meetings: Department of Defense Military Family Readiness Council, 36385-36386 2017-16418 Drug Drug Enforcement Administration NOTICES Decisions and Orders: John D. Bray-Morris, M.D., 36421-36423 2017-16446 Marcia L. Sills, M.D., 36423-36449 2017-16442 Proposed Adjustments to the Aggregate Production Quotas for Schedule I and II Controlled Substances and Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2017, 36449-36454 2017-16440 Energy Department Energy Department See

Energy Efficiency and Renewable Energy Office

See

Federal Energy Regulatory Commission

Energy Efficiency Energy Efficiency and Renewable Energy Office PROPOSED RULES Energy Conservation Program: Test Procedure for Room Air Conditioners, 36349-36355 2017-16441 NOTICES Petitions for Waivers: Extension of Waiver to Panasonic Appliances Refrigeration Systems Corporation of America, 36386-36387 2017-16447 Environmental Protection Environmental Protection Agency RULES Approval and Promulgation of State Plans for Designated Facilities and Pollutants: Colorado, Montana, North Dakota, South Dakota, Utah, and Wyoming; Negative Declarations, 36335 2017-16492 Pesticide Tolerances; Exemptions: Beta cyclodextrin, methyl ethers, 36335-36341 2017-16373 NOTICES Applicability Determination Index Data System Recent Posting: Agency Applicability Determinations, Alternative Monitoring Decisions, and Regulatory Interpretations Pertaining to Standards of Performance for New Stationary Sources, National Emission Standards for Hazardous Air Pollutants, and the Stratospheric Ozone Protection Program, 36394-36400 2017-16499 Environmental Impact Statements; Availability, etc.: Weekly Receipts, 36400-36401 2017-16479 Export Import Export-Import Bank NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Claim and Proof of Loss, Working Capital Guarantee, 36401 2017-16102 Generic Clearance for Collection of Qualitative Feedback on Agency Service Delivery, 36401 2017-16103 Federal Aviation Federal Aviation Administration RULES Special Conditions: Airbus Model A330-841 and A330-941 (A330 NEO) Airplanes; Interaction of Systems and Structures, 36322-36326 2017-16416 Bombardier Inc. Model BD-700-2A12 and BD-700-2A13 Airplanes; Fuselage Post-Crash Fire Survivability, 36319-36320 2017-16413 Embraer S.A. Model ERJ 190-300 Airplane; Flight Envelope Protection: Normal Load Factor (g) Limiting, 36320-36322 2017-16414 Embraer S.A. Model ERJ 190-300 Airplane; Interaction of Systems and Structures, 36328-36332 2017-16415 Embraer S.A., Model ERJ 190-300 Series Airplanes; Design Roll Maneuver for Electronic Flight Controls, 36326-36328 2017-16417 Federal Communications Federal Communications Commission NOTICES Meetings: Open Commission, 36401-36402 2017-16474 Federal Deposit Federal Deposit Insurance Corporation NOTICES Terminations of Receivership: Public Savings Bank Huntingdon Valley, PA, 36402-36403 2017-16481 Federal Energy Federal Energy Regulatory Commission NOTICES Applications: Gulf South Pipeline Company, LP, 36392-36393 2017-16476 Availability of the Final Guidelines for Reporting on Cultural Resources Investigations for Natural Gas Projects, 36393 2017-16475 Combined Filings, 36388-36392 2017-16457 2017-16458 2017-16460 2017-16461 Environmental Assessments; Availability, etc.: Brookfield White Pine Hydro LLC, 36391-36392 2017-16478 Initial Market-Based Rate Filings Including Requests for Blanket Section 204 Authorizations: Cottonwood Wind Project, LLC, 36393-36394 2017-16462 SunE Beacon Site 2 LLC, 36389-36390 2017-16463 SunE Beacon Site 5 LLC, 36390 2017-16464 Staff Attendances, 36387-36388 2017-16477 Federal Railroad Federal Railroad Administration NOTICES Requests for Positive Train Control Safety Plan Approvals and System Certifications: Kansas City Southern Railway Co., 36522-36523 2017-16412 Forest Forest Service NOTICES Meetings: Fresno and Madera Counties Resource Advisory Committee, 36356-36357 36356 2017-16427 2017-16428 General Services General Services Administration NOTICES Meetings: World War One Centennial Commission; Correction, 36403 2017-16466 Health and Human Health and Human Services Department See

Centers for Medicare & Medicaid Services

See

Children and Families Administration

NOTICES Meetings: Presidential Advisory Council on HIV/AIDS, 36416-36417 2017-16465
Homeland Homeland Security Department See

Coast Guard

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 36417-36418 2017-16388
Interior Interior Department See

Ocean Energy Management Bureau

International Trade Adm International Trade Administration NOTICES Requests for Applications: Corporation for Travel Promotion (dba Brand USA), 36358 2017-16486 Requests for Nominations: United States-Brazil CEO Forum, 36357-36358 2017-16455 International Trade Com International Trade Commission NOTICES Complaints: Certain Microfluidic Devices, 36419-36420 2017-16394 Justice Department Justice Department See

Alcohol, Tobacco, Firearms, and Explosives Bureau

See

Drug Enforcement Administration

Labor Department Labor Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Claim for Continuance of Compensation, 36454-36455 2017-16423 NASA National Aeronautics and Space Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 36455-36456 2017-16387 National Oceanic National Oceanic and Atmospheric Administration RULES Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic: Coastal Migratory Pelagic Resources in the Gulf of Mexico and Atlantic Region; Framework Amendment 4, 36344-36348 2017-16469 Fisheries of the Exclusive Economic Zone Off Alaska: Kamchatka Flounder in the Bering Sea and Aleutian Islands Management Area, 36348 2017-16449 International Fisheries: Western and Central Pacific Fisheries for Highly Migratory Species; Bigeye Tuna Catch Limits in Longline Fisheries for 2017, 36341-36344 2017-16456 NOTICES Meetings: Advisory Committee on Commercial Remote Sensing, 36358-36359 2017-16470 Takes of Marine Mammals Incidental to Specified Activities: Pier Replacement Project in San Diego, CA, 36360-36384 2017-16453 Taking and Importing Marine Mammals: Navy Marine Structure Maintenance and Pile Replacement in Washington, 36359-36360 2017-16454 National Science National Science Foundation NOTICES Environmental Impact Statements; Availability, etc.: Arecibo Observatory, Arecibo, PR, 36456-36457 2017-16435 Meetings: Proposal Review, 36456 2017-16426 Nuclear Regulatory Nuclear Regulatory Commission NOTICES Guidance: Evaluating Deviations and Reporting Defects and Noncompliance, 36457-36458 2017-16429 Meetings; Sunshine Act, 36458-36459 2017-16617 Ocean Energy Management Ocean Energy Management Bureau NOTICES Environmental Impact Statements; Availability, etc.: Cape Wind Energy Project, 36418-36419 2017-16422 Geological and Geophysical Activities on the Gulf of Mexico Outer Continental Shelf, 36418 2017-16421 Pipeline Pipeline and Hazardous Materials Safety Administration NOTICES Hazardous Materials: Applications for Special Permits, 36523-36525 2017-16443 2017-16444 2017-16445 Postal Regulatory Postal Regulatory Commission NOTICES New Postal Products, 36459 2017-16467 Postal Service Postal Service NOTICES Meetings; Sunshine Act, 36459-36460 2017-16622 Saint Lawrence Saint Lawrence Seaway Development Corporation NOTICES Meetings: Advisory Board: Conference Call, 36525-36526 2017-16471 Securities Securities and Exchange Commission NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 36460 2017-16391 Applications: Sharespost 100 Fund and SP Investments Management, LLC, 36492-36494 2017-16393 USQ Core Real Estate Fund and Union Square Capital Partners, LLC, 36494-36497 2017-16392 Self-Regulatory Organizations; Proposed Rule Changes: Chicago Board Options Exchange, Inc., 36468-36469 2017-16397 Municipal Securities Rulemaking Board, 36472-36476 2017-16399 Nasdaq ISE, LLC, 36497-36508 2017-16398 NASDAQ PHLX LLC, 36469-36471 2017-16405 NASDAQ Stock Market LLC, 36460-36467 2017-16400 National Securities Clearing Corp., 36476-36492 2017-16395 2017-16401 NYSE Arca, Inc., 36510-36519 2017-16402 2017-16403 NYSE National, Inc., 36508-36510 2017-16404 Small Business Small Business Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 36519 2017-16406 State Department State Department NOTICES Meetings: International Telecommunication Advisory Committee, 36519-36520 2017-16242 Surface Transportation Surface Transportation Board NOTICES Joint Relocation Project Exemptions: The Indiana Rail Road Co., CSX Transportation Inc.; Terre Haute, IN, 36520-36521 2017-16433 Trade Representative Trade Representative, Office of United States NOTICES Meetings: Trade Policy Staff Committee, 36521-36522 2017-16389 Transportation Department Transportation Department See

Federal Aviation Administration

See

Federal Railroad Administration

See

Pipeline and Hazardous Materials Safety Administration

See

Saint Lawrence Seaway Development Corporation

Veteran Affairs Veterans Affairs Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Veterans Mortgage Life Insurance Statement, 36526 2017-16408 Vocational Rehabilitation and Employment Longitudinal Study Survey, 36526-36527 2017-16407 Separate Parts In This Issue Part II Health and Human Services Department, Centers for Medicare & Medicaid Services, 36530-36636 2017-16256 Part III Health and Human Services Department, Centers for Medicare & Medicaid Services, 36638-36685 2017-16294 Reader Aids

Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, and notice of recently enacted public laws.

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82 149 Friday, August 4, 2017 Rules and Regulations DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 25 [Docket No. FAA-2015-2393; Special Conditions No. 25-695-SC] Special Conditions: Bombardier Inc. Model BD-700-2A12 and BD-700-2A13 Airplanes; Fuselage Post-Crash Fire Survivability AGENCY:

Federal Aviation Administration (FAA), DOT.

ACTION:

Final special conditions.

SUMMARY:

These special conditions are issued for the Bombardier Inc. (Bombardier) Model BD-700-2A12 and BD-700-2A13 airplanes. These airplanes will have a novel or unusual design feature when compared to the state of technology envisioned in the airworthiness standards for transport category airplanes. This feature is an aluminum-lithium fuselage construction that may provide different levels of protection from post-crash fire threats than would similar airplanes constructed from traditional aluminum structure. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.

DATES:

Effective September 5, 2017.

FOR FURTHER INFORMATION CONTACT:

Alan Sinclair, FAA, Airframe and Cabin Safety Branch, ANM-115, Transport Airplane Directorate, Aircraft Certification Service, 1601 Lind Avenue SW., Renton, Washington, 98057-3356; telephone 425-227-2195; facsimile 425-227-1232.

SUPPLEMENTARY INFORMATION:

Background

On May 30, 2012, Bombardier applied for an amendment to type certificate no. T00003NY to include the new Model BD-700-2A12 and BD-700-2A13 airplanes. These airplanes are derivatives of the Model BD-700 series of airplanes and are marketed as the Bombardier Global 7000 (Model BD-700-2A12) and Global 8000 (Model BD-700-2A13). These airplanes are twin-engine, transport-category, executive-interior business jets. The maximum passenger capacity is 19 and the maximum takeoff weights are 106,250 lbs. (Model BD-700-2A12) and 104,800 lbs. (Model BD-700-2A13).

Type Certification Basis

Under the provisions of Title 14, Code of Federal Regulations (14 CFR) 21.101, Bombardier must show that the Model BD-700-2A12 and BD-700-2A13 airplanes meet the applicable provisions of the regulations listed in Type Certificate No. T00003NY, or the applicable regulations in effect on the date of application for the change, except for earlier amendments as agreed upon by the FAA.

If the Administrator finds that the applicable airworthiness regulations (i.e., 14 CFR part 25) do not contain adequate or appropriate safety standards for the Model BD-700-2A12 and BD-700-2A13 airplanes because of a novel or unusual design feature, special conditions are prescribed under the provisions of § 21.16.

Special conditions are initially applicable to the model for which they are issued. Should the type certificate for that model be amended later to include any other model that incorporates the same novel or unusual design feature, or should any other model already included on the same type certificate be modified to incorporate the same novel or unusual design feature, these special conditions would also apply to the other model under § 21.101.

In addition to the applicable airworthiness regulations and special conditions, the Model BD-700-2A12 and BD-700-2A13 airplanes must comply with the fuel-vent and exhaust-emission requirements of 14 CFR part 34, and the noise-certification requirements of 14 CFR part 36.

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

Novel or Unusual Design Feature

Bombardier Inc. Model BD-700-2A12 and BD-700-2A13 airplanes will incorporate the following novel or unusual design feature: The fuselage will be fabricated using aluminum-lithium alloy materials instead of conventional aluminum.

Discussion

The certification basis for the Bombardier Model BD-700-2A12 and BD-700-2A11 airplanes does not include the burn through requirements defined in § 25.856(b) because both airplane models have a passenger capacity of fewer than 20. The Model BD-700-2A12 and BD-700-2A13 airplanes are introducing a new material other than what has traditionally been shown to be survivable from a “toxic” standpoint. The applicant must ensure that the material being installed on an airplane does not introduce a new hazard that would reduce the survivability of the passengers during a post-crash situation, or that would provide levels of toxic fumes that would be lethal or incapacitating, thus preventing evacuation of the airplane in a crash scenario.

In accordance with § 21.16, fuselage structure that includes aluminum-lithium construction is an unusual design feature for large, transport-category airplanes certificated under 14 CFR part 25.

Regulations applicable to burn requirements, including §§ 25.853 and 25.856(a), remain valid for these airplanes, but do not protect against the threat generated from potentially toxic levels of gases produced from aluminum-lithium alloy materials.

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

Discussion of Comments

Notice of Proposed Special Conditions No. 25-16-07-SC for the Bombardier Model BD-700-2A12 and BD-700-2A13 airplanes was published in the Federal Register on October 26, 2016 (81 FR 74347). One comment was received.

The commenter acknowledged that the use of the aluminum-lithium alloy would require full certification to the existing regulations. However, they contend that the material is not novel and unusual and does not require special conditions.

The FAA does not agree. While it is true that, with the level of lithium in the alloys presently tested, the proposed aluminum-lithium alloy does not appear to pose a significant risk, the existing regulations, as discussed above, do not adequately address the use of this specific alloy technology. Lithium metal is highly flammable and toxic; therefore, the FAA is concerned about the use of lithium in aircraft alloys. The FAA did not have data on the properties of aluminum-lithium when exposed to a post-crash fire threat prior to applying these special conditions.

Therefore, special conditions are required until the regulations are amended to provide sufficient requirements for the application of this new alloy technology.

Applicability

As discussed above, these special conditions are applicable to the Bombardier Model BD-700-2A12 and BD-700-2A13 airplanes. Should Bombardier apply at a later date for a change to the type certificate to include another model incorporating the same novel or unusual design feature, these special conditions would apply to the other model as well.

Conclusion

This action affects only one novel or unusual design feature on Bombardier Model BD-700-2A12 and BD-700-2A13 airplanes. It is not a rule of general applicabilit.

List of Subjects in 14 CFR Part 25

Aircraft, Aviation safety, Reporting and recordkeeping requirements.

The authority citation for these special conditions is as follows:

Authority:

49 U.S.C. 106(g), 40113, 44701, 44702, 44704.

The Special Conditions

Accordingly, pursuant to the authority delegated to me by the Administrator, the following special conditions are issued as part of the type certification basis for Bombardier Model BD-700-2A12 and BD-700-2A13 airplanes.

The Model BD-700-2A12 and BD-700-2A13 airplanes must show that toxic levels of gases produced from the aluminum-lithium material, when exposed to a post-crash fire threat, are in no way an additional threat to the passengers, including, but not limited to, their ability to evacuate, when compared to traditional aluminum airplane materials.

Issued in Renton, Washington.

Victor Wicklund, Manager, Transport Standards Branch, Aircraft Certification Service.
[FR Doc. 2017-16413 Filed 8-3-17; 8:45 am] BILLING CODE 4910-13-P
DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 25 [Docket No. FAA-2017-0317; Special Conditions No. 25-694-SC] Special Conditions: Embraer S.A. Model ERJ 190-300 Airplane; Flight Envelope Protection: Normal Load Factor (g) Limiting AGENCY:

Federal Aviation Administration (FAA), DOT.

ACTION:

Final special conditions; request for comments.

SUMMARY:

These special conditions are issued for the Embraer S.A. (Embraer) Model ERJ 190-300 airplane. This airplane will have a novel or unusual design feature when compared to the state of technology envisioned in the airworthiness standards for transport-category airplanes. This design feature involves flight-envelope protection functions that limit such flight parameters as, for example, angle of attack, normal load factor, attitude, bank angle, and speed during normal operation. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.

DATES:

This action is effective on Embraer S.A. on August 4, 2017. We must receive your comments by September 18, 2017.

ADDRESSES:

Send comments identified by docket number FAA-2017-0317 using any of the following methods:

Federal eRegulations Portal: Go to http://www.regulations.gov/ and follow the online instructions for sending your comments electronically.

Mail: Send comments to Docket Operations, M-30, U.S. Department of Transportation (DOT), 1200 New Jersey Avenue SE., Room W12-140, West Building Ground Floor, Washington, DC 20590-0001.

Hand Delivery or Courier: Take comments to Docket Operations in Room W12-140 of the West Building Ground Floor at 1200 New Jersey Avenue SE., Washington, DC, between9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

Fax: Fax comments to Docket Operations at 202-493-2251.

Privacy: The FAA will post all comments it receives, without change, to http://www.regulations.gov/, including any personal information the commenter provides. Using the search function of the docket Web site, anyone can find and read the electronic form of all comments received into any FAA docket, including the name of the individual sending the comment (or signing the comment for an association, business, labor union, etc.). DOT's complete Privacy Act Statement can be found in the Federal Register published on April 11, 2000 (65 FR 19477-19478).

Docket: Background documents or comments received may be read at http://www.regulations.gov/ at any time. Follow the online instructions for accessing the docket or go to Docket Operations in Room W12-140 of the West Building Ground Floor at 1200 New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT:

Joe Jacobsen, FAA, Airplane and Flight Crew Interface Branch, ANM-111, Transport Airplane Directorate, Aircraft Certification Service, 1601 Lind Avenue SW., Renton, Washington 98057-3356; telephone 425-227-2011; facsimile 425-227-1320.

SUPPLEMENTARY INFORMATION:

The substance of these special conditions has been subject to the notice and comment period in several prior instances and has been derived without substantive change from those previously issued. It is unlikely that prior public comment would result in a significant change from the substance contained herein. Therefore, because a delay would significantly affect the certification of the airplane, the FAA has determined that prior public notice and comment are unnecessary and impracticable.

In addition, since the substance of these special conditions has been subject to the public comment process in several prior instances with no substantive comments received, the FAA finds it unnecessary to delay the effective date and finds that good cause exists for adopting these special conditions upon publication in the Federal Register.

The FAA is requesting comments to allow interested persons to submit views that may not have been submitted in response to the prior opportunities for comment described above.

Comments Invited

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

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

Background

On September 13, 2013, Embraer applied for an amendment to Type Certificate No. A57NM to include the new Model ERJ 190-300 airplane. The Model ERJ 190-300 airplane, which is a derivative of the Embraer Model ERJ 190-100 STD airplane currently approved under Type Certificate No. A57NM, is a 97- to 114-passenger transport-category airplane. The maximum take-off weight is 124,340 lbs (56,400 kg).

Type Certification Basis

Under the provisions of Title 14, Code of Federal Regulations (14 CFR) 21.101, Embraer must show that the Model ERJ 190-300 airplane meets the applicable provisions of the regulations listed in Type Certificate No. A57NM, or the applicable regulations in effect on the date of application for the change, except for earlier amendments as agreed upon by the FAA.

If the Administrator finds that the applicable airworthiness regulations (i.e., 14 CFR part 25) do not contain adequate or appropriate safety standards for the Model ERJ 190-300 airplane because of a novel or unusual design feature, special conditions are prescribed under the provisions of § 21.16.

Special conditions are initially applicable to the model for which they are issued. Should the type certificate for that model be amended later to include any other model that incorporates the same novel or unusual design feature, or should any other model already included on the same type certificate be modified to incorporate the same novel or unusual design feature, these special conditions would also apply to the other model under § 21.101.

In addition to the applicable airworthiness regulations and special conditions, the Model ERJ 190-300 airplane must comply with the fuel-vent and exhaust-emission requirements of 14 CFR part 34 and the noise-certification requirements of 14 CFR part 36.

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

Novel or Unusual Design Features

The Embraer Model ERJ 190-300 airplane will incorporate the following novel or unusual design feature: Flight-envelope protection functions that limit such flight parameters as, for example, angle of attack, normal load factor, attitude, bank angle, and speed during normal operation.

The Model ERJ 190-300 airplane incorporates normal load-factor limiting on a full-time basis, which prevents the pilot from exceeding the positive or negative airplane limit load factor. The application of this load-factor limiting function affects airplane-handling characteristics and may compromise the airplane's maneuverability and controllability. The current regulations do not contain adequate safety standards for these novel protection features.

Discussion

The Embraer Model ERJ 190-300 design has a complex, fully digital flight-control system, referred to as fly-by-wire (FBW) architecture. This FBW architecture provides closed-loop flight-control laws and multiple protection functions.

Airplanes with conventional flight-control systems (mechanical linkages) are limited in the pitch axis only by the elevator surface area and deflection limit. The elevator-control power is normally derived for adequate controllability and maneuverability at the most critical longitudinal pitching moment. The result is that, for traditional airplanes, maneuverability in excess of limit structural design values, within a significant portion of the flight envelope, is possible.

Part 25 does not specify requirements or policy for demonstrating maneuver control that imposes any handling-qualities requirements beyond the design limit structural loads. Nevertheless, the availability of this excess maneuver capacity, in the event of extreme emergency such as upset recoveries or collision avoidance, is recognized.

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

Applicability

As discussed above, these special conditions are applicable to the Embraer Model ERJ 190-300 airplane. Should Embraer apply at a later date for a change to the type certificate to include another model incorporating the same novel or unusual design feature, these special conditions would apply to that model as well.

Conclusion

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

List of Subjects in 14 CFR Part 25

Aircraft, Aviation safety, Reporting and recordkeeping requirements.

The authority citation for these special conditions is as follows:

Authority:

49 U.S.C. 106(g), 40113, 44701, 44702, 44704.

The Special Conditions

Accordingly, pursuant to the authority delegated to me by the Administrator, the following special conditions are issued as part of the type certification basis for Embraer Model ERJ 190-300 airplanes.

1. Normal Load Factor (g) Limiting. To meet the intent of adequate maneuverability and controllability required by § 25.143(a); and in addition to the requirements of § 25.143(a), and in the absence of other limiting factors, the following special conditions apply, based on § 25.333(b):

a. The positive limiting load factor must not be less than:

i. 2.5 g for the normal state of the electronic flight-control system with the high-lift devices retracted up to VMO/MMO. The positive limiting load factor may gradually be reduced to 2.25 g above VMO/MMO.

ii. 2.0 g for the normal state of the electronic flight-control system with the high-lift devices extended.

b. The negative limiting load factor must be equal to or more negative than:

i. Minus 1.0 g for the normal state of the electronic flight-control system with the high-lift devices retracted.

ii. 0.0 g for the normal state of the electronic flight-control system with high-lift devices extended

c. Maximum reachable positive load factor, wings level, may be limited by the characteristics of the electronic flight-control system or flight-envelope protections (other than load-factor protection), provided that:

i. The required values are readily achievable in turns, and

ii. Wings-level pitch-up is satisfactory.

d. Maximum achievable negative load factor may be limited by the characteristics of the electronic flight-control system or flight-envelope protections (other than load-factor protection), provided that:

i. Pitch-down responsiveness is satisfactory, and

ii. From level flight, 0g is readily achievable, or alternatively, a satisfactory trajectory change is readily achievable at operational speeds. For the FAA to consider a trajectory change as satisfactory, the applicant should propose and justify a pitch rate that provides sufficient maneuvering capability in the most critical scenarios.

e. Compliance demonstration with the above requirements may be performed without ice accretion on the airframe.

f. These special conditions do not impose an upper bound for the normal load-factor limit, nor do they require that the limiter exist. If the limit is set at a value beyond the structural design limit maneuvering load factor n of §§ 25.333(b), 25.337(b), and 25.337(c), then there should be a very obvious positive tactile feel built into the controller so that it serves as a deterrent to inadvertently exceeding the structural limit.

Issued in Renton, Washington. Victor Wicklund, Manager, Transport Standards Branch, Aircraft Certification Service.
[FR Doc. 2017-16414 Filed 8-3-17; 8:45 am] BILLING CODE 4910-13-P
DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 25 [Docket No. FAA-2017-0356; Special Conditions No. 25-696-SC] Special Conditions: Airbus Model A330-841 and A330-941 (A330 NEO) Airplanes; Interaction of Systems and Structures AGENCY:

Federal Aviation Administration (FAA), DOT.

ACTION:

Final special conditions; request for comments.

SUMMARY:

These special conditions are issued for the Airbus Model A330 NEO airplanes. This airplane will have novel or unusual design features when compared to the state of technology envisioned in the airworthiness standards for transport-category airplanes. These design features include systems that, directly or as a result of failure or malfunction, affect airplane structural performance. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.

DATES:

This action is effective on Airbus on August 4, 2017. We must receive your comments by September 18, 2017.

ADDRESSES:

Send comments identified by docket number FAA-2017-0356 using any of the following methods:

Federal eRegulations Portal: Go to http://www.regulations.gov/ and follow the online instructions for sending your comments electronically.

Mail: Send comments to Docket Operations, M-30, U.S. Department of Transportation (DOT), 1200 New Jersey Avenue SE., Room W12-140, West Building Ground Floor, Washington, DC 20590-0001.

Hand Delivery or Courier: Take comments to Docket Operations in Room W12-140 of the West Building Ground Floor at 1200 New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

Fax: Fax comments to Docket Operations at 202-493-2251.

Privacy: The FAA will post all comments it receives, without change, to http://www.regulations.gov/, including any personal information the commenter provides. Using the search function of the docket Web site, anyone can find and read the electronic form of all comments received into any FAA docket, including the name of the individual sending the comment (or signing the comment for an association, business, labor union, etc.). DOT's complete Privacy Act Statement can be found in the Federal Register published on April 11, 2000 (65 FR 19477-19478).

Docket: Background documents or comments received may be read at http://www.regulations.gov/ at any time. Follow the online instructions for accessing the docket or go to Docket Operations in Room W12-140 of the West Building Ground Floor at 1200 New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT:

Todd Martin, FAA, Airframe and Cabin Safety, ANM-115, Transport Airplane Directorate, Aircraft Certification Service, 1601 Lind Avenue SW., Renton, Washington 98057-3356; telephone 425-227-1178; facsimile 425-227-1320.

SUPPLEMENTARY INFORMATION:

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

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

Comments Invited

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

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

Background

On January 20, 2015, Airbus applied for an amendment to Type Certificate no. A46NM to include the new Model A330-841 (A330-800NEO) and A330-941 (A330-900NEO) airplanes, collectively marketed as Model A330NEO airplanes. These airplanes, which are derivatives of the Model A330-200 and A330-300 airplanes currently approved under Type Certificate no. A46NM, are wide-body, jet-engine airplanes with a maximum takeoff weight of 533,519 pounds, and a passenger capacity of 257 (A330-841); or a maximum takeoff weight of 535,503 pounds, and a passenger capacity of 287 (A330-941).

Type Certification Basis

Under the provisions of Title 14, Code of Federal Regulations (14 CFR) 21.101, Airbus must show that the Model A330NEO airplanes meet the applicable provisions of the regulations listed in Type Certificate No. A46NM, or the applicable regulations in effect on the date of application for the change except for earlier amendments as agreed upon by the FAA.

If the Administrator finds that the applicable airworthiness regulations (i.e., 14 CFR part 25) do not contain adequate or appropriate safety standards for Model A330NEO airplanes because of a novel or unusual design feature, special conditions are prescribed under the provisions of § 21.16.

Special conditions are initially applicable to the model for which they are issued. Should the type certificate for that model be amended later to include any other model that incorporates the same novel or unusual design feature, or should any other model already included on the same type certificate be modified to incorporate the same novel or unusual design feature, these special conditions would also apply to the other model under § 21.101.

In addition to the applicable airworthiness regulations and special conditions, the Airbus Model A330NEO airplanes must comply with the fuel-vent and exhaust-emission requirements of 14 CFR part 34 and the noise-certification requirements of 14 CFR part 36.

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

Novel or Unusual Design Features

The Airbus Model A330NEO airplanes will incorporate the following novel or unusual design features:

Systems that, directly or as a result of failure or malfunction, affect airplane structural performance. That is, the airplane's systems affect how it responds in maneuver and gust conditions, and thereby affect its structural capability. These systems may also affect the aeroelastic stability of the airplane. Such systems include flight control systems, autopilots, stability augmentation systems, load alleviation systems, and fuel management systems. These systems represent novel and unusual features when compared to the technology envisioned in the current airworthiness standards.

Discussion

Special conditions have been applied on past airplane programs to require consideration of the effects of systems on structures. The regulatory authorities and industry developed standardized criteria in the Aviation Rulemaking Advisory Committee (ARAC) forum based on the criteria defined in Advisory Circular (AC) 25.672-1, dated November 15, 1983. The ARAC recommendations have been incorporated in European Aviation Safety Agency (EASA) Certification Specifications (CS) 25.302 and CS 25 Appendix K, which are applicable to Airbus. FAA rulemaking on this subject is not complete, thus the need for the special conditions.

The special conditions are similar to those previously applied to other airplane models and to the requirements of CS 25.302. The major differences between these special conditions and the current CS 25.302 are as follows:

(1) Both the special conditions and CS 25.302 (and by reference Appendix K) specify the design load conditions to be considered. Effects of Systems on Structure, special conditions 2.a. and 3.b.i., clarify that, in some cases, different load conditions are to be considered due to other special conditions or equivalent-level-of-safety findings.

(2) Both the special conditions (see special condition 5, below) and CS 25.302 allow consideration of the probability of being in a dispatched configuration when assessing subsequent failures and potential “continuation of flight” loads. The special conditions, however, also allow using probability when assessing failures that induce loads at the “time of occurrence,” whereas CS 25.302 does not.

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

Applicability

As discussed above, these special conditions are applicable to Airbus Model A330NEO airplanes. Should Airbus apply at a later date for a change to the type certificate to include another model incorporating the same novel or unusual design feature, these special conditions would apply to that model as well.

Conclusion

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

The substance of these special conditions has been subject to the notice and comment period in several prior instances and has been derived without substantive change from those previously issued. It is unlikely that prior public comment would result in a significant change from the substance contained herein. Therefore, because a delay would significantly affect the certification of the airplane, which is imminent, the FAA has determined that prior public notice and comment are unnecessary and impracticable, and good cause exists for adopting these special conditions upon publication in the Federal Register. The FAA is requesting comments to allow interested persons to submit views that may not have been submitted in response to the prior opportunities for comment described above.

List of Subjects in 14 CFR Part 25

Aircraft, Aviation safety, Reporting and recordkeeping requirements.

The authority citation for these special conditions is as follows:

Authority:

49 U.S.C. 106(g), 40113, 44701, 44702, 44704.

The Special Conditions

Accordingly, pursuant to the authority delegated to me by the Administrator, the following special conditions are issued as part of the type certification basis for Airbus Model A330-841 and A330-941 airplanes.

For airplanes equipped with systems that affect structural performance, either directly or as a result of a failure or malfunction, the influence of these systems and their failure conditions must be taken into account when showing compliance with the requirements of part 25, subparts C and D.

For airplanes equipped with flight-control systems, autopilots, stability-augmentation systems, load-alleviation systems, fuel-management systems, and other systems that either directly, or as a result of failure or malfunction, affect structural performance, the following criteria must be used for showing compliance. If these special conditions are used for other systems, it may be necessary to adapt the criteria to the specific system.

1. The criteria defined herein only address the direct structural consequences of the system responses and performance. They cannot be considered in isolation, but should be included in the overall safety evaluation of the airplane. These criteria may, in some instances, duplicate standards already established for this evaluation. These criteria are only applicable to structure the failure of which could prevent continued safe flight and landing. Specific criteria that define acceptable limits on handling characteristics or stability requirements, when operating in the system-degraded or inoperative mode, are not provided in these special conditions.

2. Depending upon the specific characteristics of the airplane, additional studies that go beyond the criteria provided in these special conditions may be required to demonstrate the airplane's capability to meet other realistic conditions, such as alternative gust or maneuver descriptions for an airplane equipped with a load-alleviation system.

3. The following definitions are applicable to these special conditions.

a. Structural performance: Capability of the airplane to meet the structural requirements of part 25.

b. Flight limitations: Limitations that can be applied to the airplane flight conditions following an in-flight occurrence, and that are included in the airplane flight manual (e.g., speed limitations, avoidance of severe weather conditions, etc.).

c. Operational limitations: Limitations, including flight limitations, that can be applied to the airplane operating conditions before dispatch (e.g., fuel, payload and Master Minimum Equipment List limitations).

d. Probabilistic terms: Terms such as probable, improbable, and extremely improbable, as used in these special conditions, are the same as those used in § 25.1309.

e. Failure condition: This term is the same as that used in § 25.1309. However, these special conditions apply only to system-failure conditions that affect the structural performance of the airplane (e.g., system-failure conditions that induce loads, change the response of the airplane to inputs such as gusts or pilot actions, or lower flutter margins).

Effects of Systems on Structures

1. General. The following criteria will be used in determining the influence of a system and its failure conditions on the airplane structure.

2. System fully operative. With the system fully operative, the following apply:

a. Limit loads must be derived in all normal operating configurations of the system from all the limit conditions specified in part 25, subpart C (or defined by special conditions or findings of equivalent level of safety in lieu of those specified in subpart C), taking into account any special behavior of such a system or associated functions, or any effect on the structural performance of the airplane that may occur up to the limit loads. In particular, any significant nonlinearity (rate of displacement of control surface, thresholds, or any other system nonlinearities) must be accounted for in a realistic or conservative way when deriving limit loads from limit conditions.

b. The airplane must meet the strength requirements of part 25 (static strength, residual strength), using the specified factors to derive ultimate loads from the limit loads defined above. The effect of nonlinearities must be investigated beyond limit conditions to ensure that the behavior of the system presents no anomaly compared to the behavior below limit conditions. However, conditions beyond limit conditions need not be considered when it can be shown that the airplane has design features that will not allow it to exceed those limit conditions.

c. The airplane must meet the aeroelastic stability requirements of § 25.629.

3. System in the failure condition. For any system-failure condition not shown to be extremely improbable, the following apply:

a. At the time of occurrence. Starting from 1g level flight conditions, a realistic scenario, including pilot corrective actions, must be established to determine the loads occurring at the time of failure and immediately after the failure.

i. For static-strength substantiation, these loads, multiplied by an appropriate factor of safety that is related to the probability of occurrence of the failure, are ultimate loads to be considered for design. The factor of safety is defined in Figure 1, below.

ER04AU17.015

ii. For residual-strength substantiation, the airplane must be able to withstand two thirds of the ultimate loads defined in special condition 3.a.i. For pressurized cabins, these loads must be combined with the normal operating differential pressure.

iii. Freedom from aeroelastic instability must be shown up to the speeds defined in § 25.629(b)(2). For failure conditions that result in speeds beyond VC/MC, freedom from aeroelastic instability must be shown to increased speeds, so that the margins intended by § 25.629(b)(2) are maintained.

iv. Failures of the system that result in forced structural vibrations (oscillatory failures) must not produce loads that could result in detrimental deformation of primary structure.

b. For the continuation of the flight. For the airplane in the system-failed state, and considering any appropriate reconfiguration and flight limitations, the following apply:

i. The loads derived from the following conditions (or defined by special conditions or findings of equivalent level of safety in lieu of the following conditions) at speeds up to VC/MC (or the speed limitation prescribed for the remainder of the flight) must be determined:

1. The limit symmetrical maneuvering conditions specified in §§ 25.331 and 25.345.

2. the limit gust and turbulence conditions specified in §§ 25.341 and 25.345.

3. the limit rolling conditions specified in § 25.349, and the limit unsymmetrical conditions specified in §§ 25.367, and 25.427(b) and (c).

4. the limit yaw-maneuvering conditions specified in § 25.351.

5. the limit ground-loading conditions specified in §§ 25.473, 25.491, 25.493(d), and 25.503.

ii. For static-strength substantiation, each part of the structure must be able to withstand the loads in special condition 3.b.i., multiplied by a factor of safety depending on the probability of being in this failure state. The factor of safety is defined in Figure 2, below.

ER04AU17.016 Qj = (Tj)(Pj) Where: Tj = Average time spent in failure mode j (in hours) Pj = Probability of occurrence of failure mode j (per hour) Note:

If Pj is greater than 10 3 per flight hour, then a 1.5 factor of safety must be applied to all limit load conditions specified in part 25, subpart C.

iii. For residual-strength substantiation, the airplane must be able to withstand two-thirds of the ultimate loads defined in paragraph 3.b.ii. of these special conditions. For pressurized cabins, these loads must be combined with the normal operating differential pressure.

iv. If the loads induced by the failure condition have a significant effect on fatigue or damage tolerance, then their effects must be taken into account.

v. Freedom from aeroelastic instability must be shown up to a speed determined from Figure 3, below. Flutter clearance speeds V′ and V″ may be based on the speed limitation specified for the remainder of the flight using the margins defined by § 25.629(b).

ER04AU17.017 V′ = Clearance speed as defined by § 25.629(b)(2). V″ = Clearance speed as defined by § 25.629(b)(1). Qj = (Tj)(Pj) Where: Tj = Average time spent in failure mode j (in hours) Pj = Probability of occurrence of failure mode j (per hour) Note:

If Pj is greater than 10 3 per flight hour, then the flutter clearance speed must not be less than V″.

vi. Freedom from aeroelastic instability must also be shown up to V′ in Figure 3, above, for any probable system-failure condition, combined with any damage required or selected for investigation by § 25.571(b).

c. Consideration of certain failure conditions may be required by other sections of part 25 regardless of calculated system reliability. Where analysis shows the probability of these failure conditions to be less than 10 9 per flight hour, criteria other than those specified in this paragraph may be used for structural substantiation to show continued safe flight and landing.

4. Failure indications. For system-failure detection and indication, the following apply:

a. The system must be checked for failure conditions, not extremely improbable, that degrade the structural capability below the level required by part 25, or that significantly reduce the reliability of the remaining system. As far as reasonably practicable, the flightcrew must be made aware of these failures before flight. Certain elements of the control system, such as mechanical and hydraulic components, may use special periodic inspections, and electronic components may use daily checks, in lieu of detection and indication systems, to achieve the objective of this requirement. These certification-maintenance requirements must be limited to components that are not readily detectable by normal detection-and-indication systems, and where service history shows that inspections will provide an adequate level of safety.

b. The existence of any failure condition, not extremely improbable, during flight, that could significantly affect the structural capability of the airplane, and for which the associated reduction in airworthiness can be minimized by suitable flight limitations, must be signaled to the flightcrew. For example, failure conditions that result in a factor of safety between the airplane strength and the loads of part 25, subpart C below 1.25, or flutter margins below V″, must be signaled to the crew during flight.

5. Dispatch with known failure conditions. If the airplane is to be dispatched in a known system-failure condition that affects structural performance, or that affects the reliability of the remaining system to maintain structural performance, then the provisions of these special conditions must be met, including the provisions of special condition 2 for the dispatched condition, and special condition 3 for subsequent failures. Expected operational limitations may be taken into account in establishing Pj as the probability of failure occurrence for determining the safety margin in Figure 1. Flight limitations and expected operational limitations may be taken into account in establishing Qj as the combined probability of being in the dispatched failure condition and the subsequent failure condition for the safety margins in Figures 2 and 3. These limitations must be such that the probability of being in this combined failure state, and then subsequently encountering limit load conditions, is extremely improbable. No reduction in these safety margins is allowed if the subsequent system-failure rate is greater than 10 3 per flight hour.

Issued in Renton, Washington. Victor Wicklund, Manager, Transport Standards Branch, Aircraft Certification Service.
[FR Doc. 2017-16416 Filed 8-3-17; 8:45 am] BILLING CODE 4910-13-P
DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 25 [Docket No. FAA-2017-0732; Special Conditions No. 25-697-SC] Special Conditions: Embraer S.A., Model ERJ 190-300 Series Airplanes; Design Roll Maneuver for Electronic Flight Controls AGENCY:

Federal Aviation Administration (FAA), DOT.

ACTION:

Final special conditions; request for comments.

SUMMARY:

These special conditions are issued for the Embraer S.A. (Embraer) Model ERJ 190-300 series airplanes. These airplanes will have a novel or unusual design feature when compared to the state of technology envisioned in the airworthiness standards for transport category airplanes. This design feature is an electronic flight control system (EFCS) that provides control of the airplane through pilot inputs to the flight computer. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.

DATES:

This action is effective on Embraer on August 4, 2017. We must receive your comments by September 18, 2017.

ADDRESSES:

Send comments identified by docket number FAA-2017-0732 using any of the following methods:

Federal eRegulations Portal: Go to http://www.regulations.gov/and follow the online instructions for sending your comments electronically.

Mail: Send comments to Docket Operations, M-30, U.S. Department of Transportation (DOT), 1200 New Jersey Avenue SE., Room W12-140, West Building Ground Floor, Washington, DC 20590-0001.

Hand Delivery or Courier: Take comments to Docket Operations in Room W12-140 of the West Building Ground Floor at 1200 New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

Fax: Fax comments to Docket Operations at 202-493-2251.

Privacy: The FAA will post all comments it receives, without change, to http://www.regulations.gov/, including any personal information the commenter provides. Using the search function of the docket Web site, anyone can find and read the electronic form of all comments received into any FAA docket, including the name of the individual sending the comment (or signing the comment for an association, business, labor union, etc.). DOT's complete Privacy Act Statement can be found in the Federal Register published on April 11, 2000 (65 FR 19477-19478).

Docket: Background documents or comments received may be read at http://www.regulations.gov/ at any time. Follow the online instructions for accessing the docket or go to Docket Operations in Room W12-140 of the West Building Ground Floor at 1200 New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT:

Greg Schneider, FAA, Airframe and Cabin Safety Branch, ANM-115, Transport Airplane Directorate, Aircraft Certification Service, 1601 Lind Avenue SW., Renton, Washington, 98057-3356; telephone 425-227-2116; facsimile 425-227-1320.

SUPPLEMENTARY INFORMATION:

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

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

Comments Invited

The FAA is requesting comments to allow interested persons to submit views that may not have been submitted in response to the prior opportunities for comment described above. We invite interested people to take part in this rulemaking by sending written comments, data, or views. The most helpful comments reference a specific portion of the special conditions, explain the reason for any recommended change, and include supporting data.

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

Background

On September 13, 2013, Embraer applied for an amendment to Type Certificate (TC) no. A57NM to include the new Model ERJ 190-300 airplanes. The Model ERJ 190-300 airplane, which is a derivative of the Model ERJ 190-100 STD airplane currently approved under TC no. A57NM, is a 97-114 passenger transport-category airplane with two Pratt & Whitney Model PW1900G engines, a new wing design with a high aspect ratio and raked wingtip, and a digital fly-by-wire electronic flight-control system.

The flight-control system for the Model ERJ 190-300 airplane does not have a direct mechanical link nor a linear gain between the airplane flight-control surface and the pilot's flight-deck control device, which is not accounted for in title 14, Code of Federal Regulations (14 CFR) 25.349(a). Instead, a flight-control computer commands the airplane flight-control surfaces, based on input received from the flight-deck control device. The flight-control computer modifies pilot input before the command is given to the flight-control surface.

Type Certification Basis

Under the provisions of 14 CFR 21.101, Embraer must show that the Model ERJ 190-300 airplane meets the applicable provisions of the regulations listed in Type Certificate No. A57NM or the applicable regulations in effect on the date of application for the change, except for earlier amendments as agreed upon by the FAA.

If the Administrator finds that the applicable airworthiness regulations (i.e., 14 CFR part 25) do not contain adequate or appropriate safety standards for the Model ERJ 190-300 airplane because of a novel or unusual design feature, special conditions are prescribed under the provisions of § 21.16.

Special conditions are initially applicable to the Model for which they are issued. Should the type certificate for that model be amended later to include any other model that incorporates the same novel or unusual design features, or should any other model already included on the same type certificate be modified to incorporate the same novel or unusual design feature, these special conditions would also apply to the other model under § 21.101.

In addition to the applicable airworthiness regulations and special conditions, the ERJ 190-300 must comply with the fuel vent and exhaust emission requirements of 14 CFR part 34 and the noise-certification requirements of 14 CFR part 36.

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

Novel or Unusual Design Features

The ERJ 190-300 will incorporate the following novel or unusual design features: An electronic flight control system that provides control of the airplane through pilot inputs to the flight computer. Current part 25 airworthiness regulations account for control laws where aileron deflection is proportional to control stick deflection. They do not address any nonlinearities, i.e., situations where output does not change in the same proportion as input, or other effects on aileron actuation that may be caused by electronic flight controls.

Discussion

These special conditions differ from current regulatory requirements in that they require that the roll maneuver result from defined movements of the cockpit roll control as opposed to defined aileron deflections. Also, these special conditions require an additional load condition at design maneuvering speed (VA), in which the cockpit roll control is returned to neutral following the initial roll input.

These special conditions differ from similar special conditions previously issued on this topic. These special conditions are limited to the roll axis only, whereas other special conditions also included pitch and yaw axes. Special conditions are no longer needed for the yaw axis because 14 CFR 25.351 was revised at Amendment 25-91 to take into account effects of an electronic flight control system. No special conditions are needed for the pitch axis because the method that Embraer proposed for the pitch maneuver takes into account effects of an electronic flight control system.

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

Applicability

As discussed above, these special conditions are applicable to the Model ERJ 190-300 airplanes. Should Embraer apply at a later date for a change to the type certificate to include another model incorporating the same novel or unusual design feature, these special conditions would apply to that model as well.

Conclusion

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

List of Subjects in 14 CFR Part 25

Aircraft, Aviation safety, Reporting and recordkeeping requirements.

The authority citation for these special conditions is as follows:

Authority:

49 U.S.C. 106(g), 40113, 44701, 44702, 44704.

The Special Conditions

Accordingly, pursuant to the authority delegated to me by the Administrator, the following special conditions are issued as part of the type certification basis for the Embraer Model ERJ 190-300 series airplanes.

In lieu of compliance to 14 CFR 25.349(a), the Embraer Model ERJ 190-300 airplane must comply with the following:

The following conditions, speeds, and cockpit roll control motions (except as the motions may be limited by pilot effort) must be considered in combination with an airplane load factor of zero and of two-thirds of the positive maneuvering factor used in design. In determining the resulting control surface deflections, the torsional flexibility of the wing must be considered in accordance with 14 CFR 25.301(b).

(a) Conditions corresponding to steady rolling velocities must be investigated. In addition, conditions corresponding to maximum angular acceleration must be investigated for airplanes with engines or other weight concentrations outboard of the fuselage. For the angular acceleration conditions, zero rolling velocity may be assumed in the absence of a rational time history investigation of the maneuver.

(b) At VA, sudden movement of the cockpit roll control up to the limit is assumed. The position of the cockpit roll control must be maintained until a steady roll rate is achieved and then must be returned suddenly to the neutral position.

(c) At VC, the cockpit roll control must be moved suddenly and maintained so as to achieve a roll rate not less than that obtained in paragraph (b).

(d) At VD, the cockpit roll control must be moved suddenly and maintained so as to achieve a roll rate not less than one third of that obtained in paragraph (b).

Issued in Renton, Washington.

Victor Wicklund, Manager, Transport Standards Branch, Aircraft Certification Service.
[FR Doc. 2017-16417 Filed 8-3-17; 8:45 am] BILLING CODE 4910-13-P
DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 25 [Docket No. FAA-2017-0318; Special Conditions No. 25-693-SC] Special Conditions: Embraer S.A. Model ERJ 190-300 Airplane; Interaction of Systems and Structures AGENCY:

Federal Aviation Administration (FAA), DOT.

ACTION:

Final special conditions; request for comments.

SUMMARY:

These special conditions are issued for the Embraer S.A. (Embraer) Model ERJ 190-300 airplane. This airplane will have novel or unusual design features when compared to the state of technology envisioned in the airworthiness standards for transport-category airplanes. These design features include systems that, directly or as a result of failure or malfunction, affect airplane structural performance. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.

DATES:

This action is effective on Embraer on August 4, 2017. Send your comments by September 18, 2017.

ADDRESSES:

Send comments identified by docket number FAA-2017-0318 using any of the following methods:

Federal eRegulations Portal: Go to http://www.regulations.gov/ and follow the online instructions for sending your comments electronically.

Mail: Send comments to Docket Operations, M-30, U.S. Department of Transportation (DOT), 1200 New Jersey Avenue SE., Room W12-140, West Building Ground Floor, Washington, DC 20590-0001.

Hand Delivery or Courier: Take comments to Docket Operations in Room W12-140 of the West Building Ground Floor at 1200 New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

Fax: Fax comments to Docket Operations at 202-493-2251.

Privacy: The FAA will post all comments it receives, without change, to http://www.regulations.gov/, including any personal information the commenter provides. Using the search function of the docket Web site, anyone can find and read the electronic form of all comments received into any FAA docket, including the name of the individual sending the comment (or signing the comment for an association, business, labor union, etc.). DOT's complete Privacy Act Statement can be found in the Federal Register published on April 11, 2000 (65 FR 19477-19478).

Docket: Background documents or comments received may be read at http://www.regulations.gov/ at any time. Follow the online instructions for accessing the docket or go to Docket Operations in Room W12-140 of the West Building Ground Floor at 1200 New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT:

Greg Schneider, FAA, Airframe and Cabin Safety Branch, ANM-115, Transport Airplane Directorate, Aircraft Certification Service, 1601 Lind Avenue SW., Renton, Washington 98057-3356; telephone 425-227-2116; facsimile 425-227-1320.

SUPPLEMENTARY INFORMATION:

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

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

Comments Invited

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

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

Background

On September 13, 2013, Embraer applied for an amendment to Type Certificate No. A57NM to include the new Model ERJ 190-300 airplane. The Model ERJ 190-300 airplane, which is a derivative of the Embraer Model ERJ 190-100 STD airplane currently approved under Type Certificate No. A57NM, is a 97- to 114-passenger transport-category airplane. The maximum take-off weight is 124,340 lbs (56,400 kg).

Type Certification Basis

Under the provisions of Title 14, Code of Federal Regulations (14 CFR) 21.101, Embraer must show that the Model ERJ 190-300 airplane meets the applicable provisions of the regulations listed in Type Certificate No. A57NM, or the applicable regulations in effect on the date of application for the change, except for earlier amendments as agreed upon by the FAA.

If the Administrator finds that the applicable airworthiness regulations (i.e., 14 CFR part 25) do not contain adequate or appropriate safety standards for the Model ERJ 190-300 airplane because of a novel or unusual design feature, special conditions are prescribed under the provisions of § 21.16.

Special conditions are initially applicable to the model for which they are issued. Should the type certificate for that model be amended later to include any other model that incorporates the same novel or unusual design feature, or should any other model already included on the same type certificate be modified to incorporate the same novel or unusual design feature, these special conditions would also apply to the other model under § 21.101.

In addition to the applicable airworthiness regulations and special conditions, the Model ERJ 190-300 airplane must comply with the fuel-vent and exhaust-emission requirements of 14 CFR part 34 and the noise-certification requirements of 14 CFR part 36.

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

Novel or Unusual Design Features

The Embraer Model ERJ 190-300 airplane will incorporate the following novel or unusual design feature:

Systems that, directly or as a result of failure or malfunction, affect airplane structural performance. That is, the airplane's systems affect how it responds in maneuver and gust conditions, and thereby affect its structural capability. These systems may also affect the aeroelastic stability of the airplane. Such systems include flight control systems, autopilots, stability augmentation systems, load alleviation systems, and fuel management systems. These systems represent novel and unusual features when compared to the technology envisioned in the current airworthiness standards.

Discussion

Special conditions have been applied on past airplane programs to require consideration of the effects of systems on structures. The regulatory authorities and industry developed standardized criteria in the Aviation Rulemaking Advisory Committee (ARAC) forum based on the criteria defined in Advisory Circular (AC) 25.672-1, dated November 15, 1983. The ARAC recommendations have been incorporated in European Aviation Safety Agency (EASA) Certification Specifications (CS) 25.302 and CS 25 Appendix K, which are applicable to Embraer. FAA rulemaking on this subject is not complete, thus the need for the special conditions.

The special conditions are similar to those previously applied to other airplane models and to the requirements of CS 25.302. The major differences between these special conditions and the current CS 25.302 are as follows:

(1) Both the special conditions and CS 25.302 (and by reference Appendix K) specify the design load conditions to be considered. Effects of Systems on Structures, special conditions 2.a. and 3.b.i. clarify that, in some cases, different load conditions are to be considered due to other special conditions or equivalent-level-of-safety findings.

(2) Both the special conditions (see special condition 5, below) and CS 25.302 allow consideration of the probability of being in a dispatched configuration when assessing subsequent failures and potential “continuation of flight” loads. The special conditions, however, also allow using probability when assessing failures that induce loads at the “time of occurrence,” whereas CS 25.302 does not.

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

Applicability

As discussed above, these special conditions are applicable to the Embraer Model ERJ 190-300 airplane. Should Embraer apply at a later date for a change to the type certificate to include another model incorporating the same novel or unusual design feature, these special conditions would apply to that model as well.

Conclusion

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

The substance of these special conditions has been published in the Federal Register for public comment in several prior instances and has been derived without substantive change from those previously issued. It is unlikely that prior public comment would result in a significant change from the substance contained herein. Therefore, the FAA has determined that prior public notice and comment are unnecessary and impracticable, and good cause exists for adopting these special conditions upon publication in the Federal Register. The FAA is requesting comments to allow interested persons to submit views that may not have been submitted in response to the prior opportunities for comment described above.

List of Subjects in 14 CFR Part 25

Aircraft, Aviation safety, Reporting and recordkeeping requirements.

The authority citation for these special conditions is as follows:

Authority:

49 U.S.C. 106(g), 40113, 44701, 44702, 44704.

The Special Conditions

Accordingly, pursuant to the authority delegated to me by the Administrator, the following special conditions are issued as part of the type certification basis for Embraer Model ERJ 190-300 airplanes.

For airplanes equipped with systems that affect structural performance, either directly or as a result of a failure or malfunction, the influence of these systems and their failure conditions must be taken into account when showing compliance with the requirements of part 25, subparts C and D.

For airplanes equipped with flight-control systems, autopilots, stability-augmentation systems, load-alleviation systems, fuel-management systems, and other systems that either directly, or as a result of failure or malfunction, affect structural performance, the following criteria must be used for showing compliance. If these special conditions are used for other systems, it may be necessary to adapt the criteria to the specific system.

1. The criteria defined herein only address the direct structural consequences of the system responses and performance. They cannot be considered in isolation, but should be included in the overall safety evaluation of the airplane. These criteria may, in some instances, duplicate standards already established for this evaluation. These criteria are only applicable to structure the failure of which could prevent continued safe flight and landing. Specific criteria that define acceptable limits on handling characteristics or stability requirements, when operating in the system-degraded or inoperative mode, are not provided in these special conditions.

2. Depending upon the specific characteristics of the airplane, additional studies that go beyond the criteria provided in these special conditions may be required to demonstrate the airplane's capability to meet other realistic conditions, such as alternative gust or maneuver descriptions for an airplane equipped with a load-alleviation system.

3. The following definitions are applicable to these special conditions.

a. Structural performance: Capability of the airplane to meet the structural requirements of part 25.

b. Flight limitations: Limitations that can be applied to the airplane flight conditions following an in-flight occurrence, and that are included in the airplane flight manual (e.g., speed limitations, avoidance of severe weather conditions, etc.).

c. Operational limitations: Limitations, including flight limitations, that can be applied to the airplane operating conditions before dispatch (e.g., fuel, payload and master minimum-equipment list limitations).

d. Probabilistic terms: Terms such as probable, improbable, and extremely improbable, as used in these special conditions, are the same as those used in § 25.1309.

e. Failure condition: This term is the same as that used in § 25.1309. However, these special conditions apply only to system-failure conditions that affect the structural performance of the airplane (e.g., system-failure conditions that induce loads, change the response of the airplane to inputs such as gusts or pilot actions, or lower flutter margins).

Effects of Systems on Structures

1. General. The following criteria will be used in determining the influence of a system and its failure conditions on the airplane structure.

2. System fully operative. With the system fully operative, the following apply:

a. Limit loads must be derived in all normal operating configurations of the system from all the limit conditions specified in part 25, subpart C (or defined by special conditions or findings of equivalent level of safety in lieu of those specified in subpart C), taking into account any special behavior of such a system or associated functions, or any effect on the structural performance of the airplane that may occur up to the limit loads. In particular, any significant nonlinearity (rate of displacement of control surface, thresholds, or any other system nonlinearities) must be accounted for in a realistic or conservative way when deriving limit loads from limit conditions.

b. The airplane must meet the strength requirements of part 25 (static strength, residual strength), using the specified factors to derive ultimate loads from the limit loads defined above. The effect of nonlinearities must be investigated beyond limit conditions to ensure that the behavior of the system presents no anomaly compared to the behavior below limit conditions. However, conditions beyond limit conditions need not be considered when it can be shown that the airplane has design features that will not allow it to exceed those limit conditions.

c. The airplane must meet the aeroelastic stability requirements of § 25.629.

3. System in the failure condition. For any system-failure condition not shown to be extremely improbable, the following apply:

a. At the time of occurrence. Starting from 1g level flight conditions, a realistic scenario, including pilot corrective actions, must be established to determine the loads occurring at the time of failure and immediately after the failure.

i. For static-strength substantiation, these loads, multiplied by an appropriate factor of safety that is related to the probability of occurrence of the failure, are ultimate loads to be considered for design. The factor of safety is defined in Figure 1, below.

ER04AU17.012

ii. For residual-strength substantiation, the airplane must be able to withstand two thirds of the ultimate loads defined in special condition 3.a.i. For pressurized cabins, these loads must be combined with the normal operating differential pressure.

iii. Freedom from aeroelastic instability must be shown up to the speeds defined in § 25.629(b)(2). For failure conditions that result in speeds beyond VC/MC, freedom from aeroelastic instability must be shown to increased speeds, so that the margins intended by § 25.629(b)(2) are maintained.

iv. Failures of the system that result in forced structural vibrations (oscillatory failures) must not produce loads that could result in detrimental deformation of primary structure.

b. For the continuation of the flight. For the airplane in the system-failed state, and considering any appropriate reconfiguration and flight limitations, the following apply:

i. The loads derived from the following conditions (or defined by special conditions or findings of equivalent level of safety in lieu of the following conditions) at speeds up to VC/MC (or the speed limitation prescribed for the remainder of the flight) must be determined:

1. The limit symmetrical maneuvering conditions specified in §§ 25.331 and 25.345.

2. the limit gust and turbulence conditions specified in §§ 25.341 and 25.345.

3. the limit rolling conditions specified in § 25.349, and the limit unsymmetrical conditions specified in §§ 25.367, and 25.427(b) and (c).

4. the limit yaw-maneuvering conditions specified in § 25.351.

5. the limit ground-loading conditions specified in §§ 25.473, 25.491, 25.493(d), and 25.503.

ii. For static-strength substantiation, each part of the structure must be able to withstand the loads in special condition 3.b.i., multiplied by a factor of safety depending on the probability of being in this failure state. The factor of safety is defined in Figure 2, below.

ER04AU17.013 Qj = (Tj)(Pj) Where: Tj = Average time spent in failure mode j (in hours) Pj = Probability of occurrence of failure mode j (per hour) Note:

If Pj is greater than 10−3 per flight hour, then a 1.5 factor of safety must be applied to all limit load conditions specified in part 25, subpart C.

iii. For residual-strength substantiation, the airplane must be able to withstand two-thirds of the ultimate loads defined in paragraph 3.b.ii. of these special conditions. For pressurized cabins, these loads must be combined with the normal operating differential pressure.

iv. If the loads induced by the failure condition have a significant effect on fatigue or damage tolerance, then their effects must be taken into account.

v. Freedom from aeroelastic instability must be shown up to a speed determined from Figure 3, below. Flutter clearance speeds V′ and V″ may be based on the speed limitation specified for the remainder of the flight using the margins defined by § 25.629(b).

ER04AU17.014 V′ = Clearance speed as defined by § 25.629(b)(2) V″ = Clearance speed as defined by § 25.629(b)(1) Qj = (Tj)(Pj) Where: Tj = Average time spent in failure mode j (in hours) Pj = Probability of occurrence of failure mode j (per hour) Note:

If Pj is greater than 10−3 per flight hour, then the flutter clearance speed must not be less than V″.

vi. Freedom from aeroelastic instability must also be shown up to V′ in Figure 3, above, for any probable system-failure condition, combined with any damage required or selected for investigation by § 25.571(b).

c. Consideration of certain failure conditions may be required by other sections of part 25 regardless of calculated system reliability. Where analysis shows the probability of these failure conditions to be less than 10−9 per flight hour, criteria other than those specified in this paragraph may be used for structural substantiation to show continued safe flight and landing.

4. Failure indications. For system-failure detection and indication, the following apply:

a. The system must be checked for failure conditions, not extremely improbable, that degrade the structural capability below the level required by part 25, or that significantly reduce the reliability of the remaining system. As far as reasonably practicable, the flightcrew must be made aware of these failures before flight. Certain elements of the control system, such as mechanical and hydraulic components, may use special periodic inspections, and electronic components may use daily checks, in lieu of detection and indication systems, to achieve the objective of this requirement. These certification-maintenance requirements must be limited to components that are not readily detectable by normal detection-and-indication systems, and where service history shows that inspections will provide an adequate level of safety.

b. The existence of any failure condition, not extremely improbable, during flight, that could significantly affect the structural capability of the airplane, and for which the associated reduction in airworthiness can be minimized by suitable flight limitations, must be signaled to the flightcrew. For example, failure conditions that result in a factor of safety between the airplane strength and the loads of part 25, subpart C below 1.25, or flutter margins below V″, must be signaled to the crew during flight.

5. Dispatch with known failure conditions. If the airplane is to be dispatched in a known system-failure condition that affects structural performance, or that affects the reliability of the remaining system to maintain structural performance, then the provisions of these special conditions must be met, including the provisions of special condition 2 for the dispatched condition, and special condition 3 for subsequent failures. Expected operational limitations may be taken into account in establishing Pj as the probability of failure occurrence for determining the safety margin in Figure 1. Flight limitations and expected operational limitations may be taken into account in establishing Qj as the combined probability of being in the dispatched failure condition and the subsequent failure condition for the safety margins in Figures 2 and 3. These limitations must be such that the probability of being in this combined failure state, and then subsequently encountering limit load conditions, is extremely improbable. No reduction in these safety margins is allowed if the subsequent system-failure rate is greater than 10−3 per flight hour.

Issued in Renton, Washington. Victor Wicklund, Manager, Transport Standards Branch, Aircraft Certification Service.
[FR Doc. 2017-16415 Filed 8-3-17; 8:45 am] BILLING CODE 4910-13-P
DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 117 [Docket No. USCG-2017-0715] Drawbridge Operation Regulation; Isthmus Slough at Coos Bay, OR AGENCY:

Coast Guard, DHS.

ACTION:

Notice of deviation from drawbridge regulation.

SUMMARY:

The Coast Guard has issued a temporary deviation from the operating schedule that governs Oregon Department of Transportation's (ODOT) Isthmus Slough Bridge, mile 1.0 across Isthmus Slough at Coos Bay, OR. This deviation is necessary to accommodate painting and preservation and upgrading electrical systems. The deviation allows the bridge to operate in single leaf mode or one half of the bascule span, and reduce the vertical clearance of the non-functional leaf.

DATES:

This deviation is effective from 6 a.m. on September 1, 2017 to 6 a.m. on February 26, 2018.

ADDRESSES:

The docket for this deviation, USCG-2017-0715 is available at http://www.regulations.gov. Type the docket number in the “SEARCH” box and click “SEARCH.” Click on Open Docket Folder on the line associated with this deviation.

FOR FURTHER INFORMATION CONTACT:

If you have questions on this temporary deviation, call or email Mr. Danny McReynolds, Bridge Management Specialist, Thirteenth Coast Guard District; telephone 206-220-7234, email [email protected]

SUPPLEMENTARY INFORMATION:

ODOT, bridge owner, has requested a temporary deviation from the operating schedule for the Isthmus Slough Bridge, mile 1.0 across Isthmus Slough at Coos Bay, OR. The requested deviation is to accommodate painting and preservation and upgrading electrical systems. To facilitate this event, the double bascule bridge will operate in single leaf mode (half of the span), and reduce the vertical clearance of the non-functioning leaf. Isthmus Slough Bridge provides a vertical clearance of 28 feet in the closed-to-navigation position referenced to the vertical clearance above mean high water tide level. Ten feet of containment will be installed under the closed-to-navigation leaf only, and will reduce the vertical clearance to 18 feet. Vessels that do not require an opening may transit under the bridge at any time.

The normal operating schedule for the subject bridge is 33 CFR 117.879. This deviation allows the Isthmus Bridge to operate in single leaf, half opening, and reduce the vertical clearance of the non-functioning leaf by 10 feet to 18 feet; and need not open for maritime traffic from 6 a.m. on September 1, 2017 to 6 a.m. on February 26, 2018. The functional bascule leaf shall open on signal if at least 24 hours notice is given. Waterway usage on Isthmus Slough includes vessels ranging from small commercial tugs, commercial fishing vessels, police search and rescue to small pleasure craft.

Vessels able to pass through the bridge in the closed-to-navigation position may do so at any time. The bridge will be able open half of the double bascule in single leaf mode for emergencies as soon as possible, and there is no immediate alternate route for vessels to pass. The Coast Guard will inform the users of the waterway, through our Local and Broadcast Notices to Mariners, of the change in operating schedule for the bridges so that vessels can arrange their transits to minimize any impact caused by the temporary deviation.

In accordance with 33 CFR 117.35(e), the drawbridge must return to their regular operating schedule immediately at the end of the effective period of this temporary deviation. This deviation from the operating regulations is authorized under 33 CFR 117.35.

Dated: July 25, 2017. Steven Michael Fischer, Bridge Administrator, Thirteenth Coast Guard District.
[FR Doc. 2017-16425 Filed 8-3-17; 8:45 am] BILLING CODE 9110-04-P
DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 117 [Docket No. USCG-2017-0164] Drawbridge Operation Regulation; Willamette River, Portland, OR AGENCY:

Coast Guard, DHS.

ACTION:

Notice of deviation from drawbridge regulation; modification.

SUMMARY:

The Coast Guard has modified a temporary deviation from the operating schedule that governs the Broadway Bridge across the Willamette River, mile 11.7, at Portland, OR. The modified deviation changes the period the bridge may operate the double bascule span one side at a time, single leaf, and reduce the vertical clearance to install and test new equipment.

DATES:

This modified deviation is effective from 6 a.m. on August 16, 2017 to 6 p.m. on November 13, 2017.

ADDRESSES:

The docket for this deviation, USCG-2017-0164, is available at http://www.regulations.gov. Type the docket number in the “SEARCH” box and click “SEARCH.” Click on Open Docket Folder on the line associated with this deviation.

FOR FURTHER INFORMATION CONTACT:

If you have questions on this temporary deviation, call or email Mr. Danny McReynolds, Bridge Management Specialist, Thirteenth Coast Guard District; telephone 206-220-7234, email [email protected]

SUPPLEMENTARY INFORMATION:

On March 15, 2017, the Coast Guard published a temporary deviation entitled “Drawbridge Operation Regulation; Willamette River, Portland, OR.” in the Federal Register (82 FR 13757). That temporary deviation, from 7 p.m. on May 26, 2017 to 6 a.m. on September 20, 2017, allows the bridge to operate the double bascule span one side at a time, single leaf, to install and test new equipment. The bridge owner, Multnomah County, has requested a modification of the currently published deviation to cancel the dates before August 15, 2017, and extend the dates from 6 a.m. on August 16, 2017 to 6 p.m. on September 20, 2017; and from 6 a.m. on October 9, 2017, to 6 p.m. on November 13, 2017, in order to complete installation and test new equipment after delays with work contracts to the bridge deck.

The Broadway Bridge crosses the Willamette River at mile 11.7, and provides 90 feet of vertical clearance above Columbia River Datum 0.0 while in the closed-to-navigation position, and provides 125 feet of horizontal clearance with half the span open. The subject bridge operates in accordance with 33 CFR 117.897. This modified deviation allows the double bascule span of the Broadway Bridge to operate in single leaf mode for marine traffic. The deviation period allows the drawspan to operate single leaf and reduce the vertical clearance of the non-functional span from 90 feet to 80 feet during these dates: from 6 a.m. on August 16, 2017 to 6 p.m. on September 20, 2017; and from 6 a.m. on October 9, 2017, to 6 p.m. on November 13, 2017. The bridge shall operate in accordance to 33 CFR 117.897 at all other times. Waterway usage on this part of the Willamette River includes vessels ranging from commercial tug and barge to small pleasure craft. We have coordinated with the majority of known waterway users and there were no objections to this schedule.

Vessels able to pass through the bridge in the closed positions may do so at any time. The bridge will be able to open in single leaf for emergencies, and there is no immediate alternate route for vessels to pass. The Coast Guard will also inform the users of the waterways through our Local and Broadcast Notices to Mariners of the change in operating schedule for the bridge so that vessels can arrange their transits to minimize any impact caused by the modified deviation.

In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of the effective period of this temporary deviation. This deviation from the operating regulations is authorized under 33 CFR 117.35.

Dated: July 31, 2017. Steven Michael Fischer, Bridge Administrator, Thirteenth Coast Guard District.
[FR Doc. 2017-16424 Filed 8-3-17; 8:45 am] BILLING CODE 9110-04-P
DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket Number USCG-2017-0677] RIN 1625-AA00 Safety Zone; Mississippi River; New Orleans, LA AGENCY:

Coast Guard, DHS.

ACTION:

Temporary final rule.

SUMMARY:

The Coast Guard is establishing a temporary safety zone for navigable waters on the Mississippi River from mile marker (MM) 96 to MM 96.5 Above Head of Passes. The safety zone is needed to protect personnel, vessels, and the marine environment from potential hazards created by a fireworks display. Entry of vessels or persons into this zone is prohibited unless specifically authorized by the Captain of the Port, New Orleans (COTP).

DATES:

This rule is effective from 7:30 p.m. through 8:30 p.m. on August 21, 2017.

ADDRESSES:

To view documents mentioned in this preamble as being available in the docket, go to http://www.regulations.gov, type USCG-2017-0677 in the “SEARCH” box and click “SEARCH.” Click on Open Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT:

If you have questions on this rule, call or email Lieutenant Commander (LCDR) Howard Vacco, Sector New Orleans, at (504) 365-2281 or [email protected]

SUPPLEMENTARY INFORMATION: I. Table of Abbreviations CFR Code of Federal Regulations COTP Captain of the Port New Orleans DHS Department of Homeland Security FR Federal Register NPRM Notice of proposed rulemaking §  Section U.S.C. United States Code II. Background Information and Regulatory History

The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because it is impracticable. We must establish this safety zone by August 21, 2017 and we lack sufficient time to provide a reasonable comment period and then consider those comments before issuing the rule. It is also contrary to the public interest as it would delay the safety measures necessary to protect life and property from the possible hazards associated with the fireworks display launched from the waterway. The impacts on navigation are expected to be minimal as the safety zone will only be in effect for a short duration of one hour. The Coast Guard will notify the public and maritime community that the safety zone will be in effect and of its enforcement periods via Broadcast Notice to Mariners (BNM) and Marine Safety Information Bulletin (MSIB).

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register. Delaying the effective date of this rule is contrary to public interest because it would delay the safety measures necessary to respond to potential safety hazards associated with the fireworks display.

III. Legal Authority and Need for Rule

The Coast Guard is issuing this rule under authority in 33 U.S.C. 1231. The Captain of the Port New Orleans (COTP) has determined that potential hazards associated with a fireworks display on August 21, 2017 will be a safety concern for anyone on the navigable waterways within a one-half mile range of the fireworks. This rule is needed to protect personnel, vessels, and the marine environment in the navigable waters within the safety zone while the fireworks are being launched.

IV. Discussion of the Rule

This rule establishes a safety zone from 7:30 p.m. through 8:30 p.m. on August 21, 2017. The safety zone will cover all navigable waters from mile marker 96 to 96.5 Above Head of Passes on the Mississippi River. The duration of the zone is intended to protect personnel, vessels, and the marine environment in these navigable waters from the hazards of the fireworks. No vessel or person will be permitted to enter the safety zone without obtaining permission from the COTP or a designated representative.

V. Regulatory Analyses

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

A. Regulatory Planning and Review

Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13771 directs agencies to control regulatory costs through a budgeting process. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, this rule has not been reviewed by the Office of Management and Budget (OMB), and pursuant to OMB guidance it is exempt from the requirements of Executive Order 13771.

This regulatory action determination is based on the size, location, duration, and time-of-year of the safety zone. This safety zone will impact a small designated area of the Mississippi River for 1 hour. Moreover, the Coast Guard will issue BNMs via VHF-FM Channel 16 about the zone and the rule allows vessels to seek permission to enter the zone.

B. Impact on Small Entities

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

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

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

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

C. Collection of Information

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

D. Federalism and Indian Tribal Governments

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

Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this rule has implications for federalism or Indian tribes, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section above.

E. Unfunded Mandates Reform Act

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

F. Environment

We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969(42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves creating a safety zone lasting one hour that will prohibit entry and navigating between mile marker 96 to 96.5, Above Head of Passes on the Mississippi River. It is categorically excluded from further review under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. A Record of Environmental Consideration supporting this determination is available in the docket where indicated under ADDRESSES.

G. Protest Activities

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

List of Subjects in 33 CFR Part 165

Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.

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

PART 165—REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS 1. The authority citation for part 165 continues to read as follows: Authority:

33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security Delegation No. 0170.1.

2. Add § 165.T08-0677 to read as follows:
§ 165.T08-0677 Safety Zone; Mississippi River, New Orleans, LA.

(a) Location. The following area is a safety zone: All navigable waters of the Mississippi River between mile marker 96 and 96.5 Above Head of Passes.

(b) Effective period. This rule is effective from 7:30 p.m. through 8:30 p.m. on August 21, 2017.

(c) Regulations. (1) In accordance with the general regulations in § 165.23 of this part, entry into this zone is prohibited unless specifically authorized by the Captain of the Port New Orleans (COTP) or designated representative. A designated representative is a commissioned, warrant, or petty officer of the U.S. Coast Guard assigned to units under the operational control of USCG Sector New Orleans.

(2) Vessels requiring entry into this safety zone must request permission from the COTP or a designated representative. They may be contacted on VHF-FM Channel 16 or 67.

(3) Persons and vessels permitted to enter this safety zone must transit at their slowest safe speed and comply with all lawful directions issued by the COTP or the designated representative.

(d) Information broadcasts. The COTP or a designated representative will inform the public through Broadcast Notices to Mariners of any changes in the planned schedule.

Dated: July 31, 2017. Wayne R. Arguin, Captain, U.S. Coast Guard, Captain of the Port New Orleans.
[FR Doc. 2017-16436 Filed 8-3-17; 8:45 am] BILLING CODE 9110-04-P
ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 62 [EPA-R08-OAR-2017-0171; FRL-9965-78-Region 8] Approval and Promulgation of State Plans for Designated Facilities and Pollutants: Colorado, Montana, North Dakota, South Dakota, Utah, and Wyoming; Negative Declarations AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Withdrawal of direct final rule.

SUMMARY:

The Environmental Protection Agency (EPA) is withdrawing a direct final rule published on June 5, 2017, because one adverse comment was received during the public comment period. The withdrawn rule pertained to the EPA's receipt and approval of 20 negative declaration letters from EPA Region 8 states. These letters of negative declaration are statements by the state certifying the absence of designated facilities of a certain solid waste incinerator category or class within its jurisdiction, which obviates the statutory requirement for the state to develop a Clean Air Act (CAA) section 111(d)/129 State plan for the regulation of designated facilities of that particular category or class.

DATES:

Effective August 3, 2017, the direct final rule published at 82 FR 25734, June 5, 2017 is withdrawn.

FOR FURTHER INFORMATION CONTACT:

Gregory Lohrke, (303) 312-6396, [email protected]

SUPPLEMENTARY INFORMATION:

On June 5, 2017, the EPA published a direct final rule (82 FR 25734) approving several negative declarations submitted by Region 8 states, certifying the absence of designated facilities regulated under various Emissions Guidelines found in 40 CFR part 60. The promulgation of each negative declaration was to serve in lieu of a CAA section 111(d)/129 State plan, given the declared absence of facilities that would require such a State plan. The direct final rule was published without prior proposal because the EPA anticipated no adverse comments on a noncontroversial action. The direct final rule stated that if the action received adverse comment on or before July 5, 2017, the EPA would publish a timely withdrawal in the Federal Register. The EPA received one adverse comment and is accordingly withdrawing the direct final rule. In a separate, subsequent final rulemaking action, the EPA will address the comment received.

List of Subjects in 40 CFR Part 62

Environmental protection, Administrative practice and procedure, Air pollution control, Commercial industrial solid waste incineration, Intergovernmental relations, Municipal solid waste combustion, Other solid waste incineration, Reporting and recordkeeping requirements.

Dated: July 28, 2017. Debra H. Thomas, Acting Regional Administrator, Region 8. Accordingly, the amendments to 40 CFR part 62, subpart G, subpart BB, subpart JJ, subpart QQ, subpart TT, and subpart ZZ, published in the Federal Register on June 5, 2017 (82 FR 25734), are withdrawn as of August 3, 2017.
[FR Doc. 2017-16492 Filed 8-3-17; 8:45 am] BILLING CODE 6560-50-P
ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2016-0507; FRL-9963-58] Beta Cyclodextrin, Methyl Ethers; Exemption From the Requirement of a Tolerance AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Final rule.

SUMMARY:

This regulation establishes an exemption from the requirement of a tolerance for residues of beta cyclodextrin, methyl ethers (CAS Reg. No. 128446-36-6) when used as an inert ingredient (stabilizer and solvent) in pesticide formulations applied to growing crops pre-harvest limited to a maximum concentration of 40% by weight in the pesticide formulation. Lewis and Harrison, LLC, on behalf of Wacker Chemie AG submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting establishment of an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of beta cyclodextrin, methyl ethers that result from applications of pesticides consistent with the conditions in EPA regulations.

DATES:

This regulation is effective August 4, 2017. Objections and requests for hearings must be received on or before October 3, 2017, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES:

The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2016-0507, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPP Docket is (703) 305-5805. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT:

Michael Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone number: (703) 305-7090; email address: [email protected]

SUPPLEMENTARY INFORMATION:

I. General Information A. Does this action apply to me?

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

You may access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2016-0507 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before October 3, 2017. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2016-0507, by one of the following methods:

Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute.

Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.

Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html.

Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Petition for Exemption

In the Federal Register of February 7, 2017 (82 FR 9555) (FRL-9956-86), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the filing of a pesticide petition (IN-10964) by Lewis and Harrison, LLC (122 C St. NW., Suite 505, Washington, DC 20001), on behalf of Wacker Chemie AG (Hanns-Seidel-Platz 4, D-81737 Munich, Germany). The petition requested that 40 CFR 180.920 be amended by establishing an exemption from the requirement of a tolerance for residues of beta cyclodextrin, methyl ethers (CAS Reg. No. 128446-36-6) when used as an inert ingredient (stabilizer/solvent) in pesticide formulations applied to growing crops pre-harvest, limited to 40% by weight in the pesticide formulation. That document referenced a summary of the petition prepared by Lewis and Harrison, LLC, on behalf of Wacker Chemie AG, the petitioner, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.

The Agency is establishing an exemption from the requirement of a tolerance as requested, but is using the chemical abstract index name “beta-cyclodextrin, methyl ethers”, the assigned formal name rather than “methyl-beta-cyclodextrin”, the common name.

III. Inert Ingredient Definition

Inert ingredients are all ingredients that are not active ingredients as defined in 40 CFR 153.125 and include, but are not limited to, the following types of ingredients (except when they have a pesticidal efficacy of their own): Solvents such as alcohols and hydrocarbons; surfactants such as polyoxyethylene polymers and fatty acids; carriers such as clay and diatomaceous earth; thickeners such as carrageenan and modified cellulose; wetting, spreading, and dispersing agents; propellants in aerosol dispensers; microencapsulating agents; and emulsifiers. The term “inert” is not intended to imply nontoxicity; the ingredient may or may not be chemically active. Generally, EPA has exempted inert ingredients from the requirement of a tolerance based on the low toxicity of the individual inert ingredients.

IV. Aggregate Risk Assessment and Determination of Safety

Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue . . . .”

EPA establishes exemptions from the requirement of a tolerance only in those cases where it can be clearly demonstrated that the risks from aggregate exposure to pesticide chemical residues under reasonably foreseeable circumstances will pose no appreciable risks to human health. In order to determine the risks from aggregate exposure to pesticide inert ingredients, the Agency considers the toxicity of the inert in conjunction with possible exposure to residues of the inert ingredient through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. If EPA is able to determine that a finite tolerance is not necessary to ensure that there is a reasonable certainty that no harm will result from aggregate exposure to the inert ingredient, an exemption from the requirement of a tolerance may be established.

Consistent with FFDCA section 408(c)(2)(A), and the factors specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for beta cyclodextrin, methyl ethers including exposure resulting from the exemption established by this action. EPA's assessment of exposures and risks associated with beta cyclodextrin, methyl ethers follows.

A. Toxicological Profile

EPA has evaluated the available toxicity data and considered their validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Specific information on the studies received and the nature of the adverse effects caused by beta cyclodextrin, methyl ethers as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies are discussed in this unit.

All studies are conducted with beta cyclodextrin, methyl ethers except the developmental/reproduction toxicity studies which are conducted with beta-cyclodextrin (β-CD) and 2-hydroxypropyl-beta-cyclodextrin (HP-β-CD). These chemicals are structurally similar to beta cyclodextrin, methyl ethers and are considered suitable surrogates. A quantitative structural-activity relationship (QSAR) analysis demonstrates that results are nearly identical for these chemicals; therefore, data from the developmental/reproduction toxicity studies conducted with β-CD and HP-β-CD are used to assess potential developmental/reproduction toxicity from beta cyclodextrin, methyl ethers exposure.

The acute oral toxicity is low in rats and mice for beta cyclodextrin, methyl ethers. The lethal dose (LD50) is >8,000 milligrams/kilogram (mg/kg) in acute oral toxicity studies in the rat and mouse. Beta cyclodextrin, methyl ethers is not irritating to the skin in the rabbit. It is moderately irritating to the eyes in rabbits. Acute inhalation toxicity is low; the lethal concentration (LC50) is >2.95 milligram/liter (mg/L) (equivalent to 398 mg/kg). Beta cyclodextrin, methyl ethers is not a dermal sensitizer in the guinea pig maximization test.

Beta cyclodextrin, methyl ethers administered via the diet for 28 days causes tubular degeneration of the renal cortex at 1,000 milligrams/kilogram/day (mg/kg/day). The no-observed-adverse-effect level (NOAEL) is 300 mg/kg/day.

No fetal susceptibility was observed in any of the developmental and reproduction toxicity studies. Following oral administration of beta-cyclodextrin in rats and rabbits, no developmental toxicity was observed at doses as high as 5,000 mg/kg/day and 600 mg/kg/day, respectively. No maternal toxicity was observed at doses as high as 2,500 mg/kg/day and 600 mg/kg/day in rats and rabbits, respectively. Similarly, no developmental or maternal toxicity was observed in rats following oral exposure to doses of 2-hydroxypropyl-beta-cyclodextrin as high as 5,000 mg/kg/day and in rabbits following oral exposure to doses as high as 500 mg/kg/day. Following intravenous administration of 2-hydroxypropyl-beta-cyclodextrin to rats, slight maternal toxicity was observed at 400 mg/kg/day (with a NOAEL at 100 mg/kg/day), but no developmental toxicity was observed. No maternal or developmental toxicity was observed in rabbits exposed to doses of 2-hydroxypropyl-beta-cyclodextrin at 400 mg/kg/day, the highest dose tested. In the three-generation reproduction toxicity study in rats, no effects were observed in parental or offspring animals at doses up to 1,099 mg/kg/day beta-cyclodextrin. No reproduction effects were observed up to 2,277 mg/kg/day.

Beta cyclodextrin, methyl ethers administered for 26 weeks via gavage causes tubular vacuolation in the kidney at 500 mg/kg/day. The NOAEL is 100 mg/kg/day. The chronic reference dose (cRfD) is based on this study.

Carcinogenicity studies with beta cyclodextrin, methyl ethers are not available; however, a Deductive Estimation of Risk from Existing Knowledge (Derek) Nexus structural alert analysis was conducted with beta cyclodextrin, methyl ethers and indicated no structural alerts for carcinogenicity or mutagenicity. Therefore, beta cyclodextrin, methyl ethers is not expected to be carcinogenic.

All available mutagenicity studies (Ames tests, gene mutation, chromosomal aberrations, unscheduled DNA synthesis and micronucleus tests) were negative; therefore, beta cyclodextrin, methyl ethers is not mutagenic.

Although neurotoxicity and immunotoxicity studies are not available for review, evidence of neurotoxicity and immunotoxicity is not observed in the submitted studies.

Beta cyclodextrin, methyl ethers is not metabolized and very little is absorbed. Following oral exposure, it is mostly excreted in the feces and 0.92% is excreted in the urine. 0.97-0.92% of an orally administered dose is absorbed. A distribution study shows that beta cyclodextrin, methyl ethers is found along the gastrointestinal tract, in the kidney and bladder. Dermal absorption is estimated to be 0.4% in 126 hours in rats.

B. Toxicological Points of Departure/Levels of Concern

Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.

A summary of the toxicological endpoints for beta cyclodextrin, methyl ethers used for human risk assessment is shown in Table 1 of this unit.

Table 1—Summary of Toxicological Doses and Endpoints for Beta Cyclodextrin, Methyl Ethers for Use in Human Risk Assessment Exposure/scenario Point of departure and uncertainty/
  • safety factors
  • RfD, PAD, LOC for
  • risk assessment
  • Study and toxicological effects
    Acute dietary (General population including infants and children) An acute effect was not found in the database therefore an acute dietary assessment is not necessary. Chronic dietary (All populations) NOAEL = 100 mg/kg/day
  • UFA = 10x
  • UFH = 10x
  • FQPA SF = 1x
  • Chronic RfD = 1.00 mg/kg/day
  • cPAD = 1.00 mg/kg/day
  • 26-week Oral Toxicity Study-Rat
  • LOAEL = 500 mg/kg/day based on tubular degeneration in the kidneys.
  • Incidental oral short-term (1 to 30 days) NOAEL= 300 mg/kg/day
  • UFA = 10x
  • UFH = 10x
  • FQPA SF = 1x
  • LOC for MOE = 100 28-Day Oral Toxicity Study-Rat
  • LOAEL = 1,000 mg/kg/day based on tubular vacuolation in the kidneys.
  • Incidental oral intermediate-term (1 to 6 months) NOAEL = 100 mg/kg/day
  • UFA = 10x
  • UFH = 10x
  • FQPA SF = 1x
  • LOC for MOE = 100 26-week Oral Toxicity Study-Rat
  • LOAEL = 500 mg/kg/day based on tubular degeneration in the kidneys.
  • Dermal short-term (1 to 30 days) NOAEL = 300 mg/kg/day (dermal absorption rate = 0.4%)
  • UFA = 10x
  • UFH = 10x
  • FQPA SF = 1x
  • LOC for MOE = 100 28-Day Oral Toxicity Study-Rat
  • LOAEL = 1,000 mg/kg/day based on tubular vacuolation in the kidneys.
  • Dermal intermediate-term (1 to 6 months) NOAEL= 100 mg/kg/day (dermal absorption rate = 0.4%)
  • UFA = 10x
  • UFH = 10x
  • FQPA SF = 1x
  • LOC for MOE = 100 26-week Oral Toxicity Study-Rat
  • LOAEL = 500 mg/kg/day based on tubular degeneration in the kidneys.
  • Inhalation short-term (1 to 30 days) NOAEL= 300 mg/kg/day (inhalation absorption rate = 100%)
  • UFA = 10x
  • UFH = 10x
  • FQPA SF = 1x
  • LOC for MOE = 100 28-Day Oral Toxicity Study-Rat
  • LOAEL = 1,000 mg/kg/day based on tubular vacuolation in the kidneys.
  • Inhalation intermediate-term (1 to 6 months) NOAEL = 100 mg/kg/day (inhalation absorption rate = 100%)
  • UFA = 10x
  • UFH = 10x
  • FQPA SF = 1x
  • LOC for MOE = 100 26-week Oral Toxicity Study-Rat
  • LOAEL = 500 mg/kg/day based on tubular degeneration in the kidneys.
  • Cancer (Oral, dermal, inhalation) Based on a Derek structural alert analysis and the lack of mutagenicity, beta cyclodextrin, methyl ethers is considered not likely to be carcinogenic. FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFDB = to account for the absence of data or other data deficiency. UFH = potential variation in sensitivity among members of the human population (intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. UFS = use of a short-term study for long-term risk assessment.
    C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary exposure to beta cyclodextrin, methyl ethers, EPA considered exposure under the requested exemption from the requirement of a tolerance. EPA assessed dietary exposures from beta cyclodextrin, methyl ethers in food as follows:

    i. Dietary exposure (food and drinking water) to beta cyclodextrin, methyl ethers can occur following ingestion of foods with residues from treated crops. Because no adverse effects attributable to a single exposure of beta cyclodextrin, methyl ethers are seen in the toxicity databases, an acute dietary risk assessment is not necessary. For the chronic dietary risk assessment, EPA used the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCIDTM, Version 3.16, and food consumption information from the U.S. Department of Agriculture's (USDA's) 2003-2008 National Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). As to residue levels in food, no residue data were submitted for beta cyclodextrin, methyl ethers. In the absence of specific residue data, EPA has developed an approach which uses surrogate information to derive upper bound exposure estimates for the subject inert ingredient. Upper bound exposure estimates are based on the highest tolerance for a given commodity from a list of high use insecticides, herbicides, and fungicides. One hundred percent crop treated was assumed, default processing factors, and tolerance-level residues for all foods and use limitations of not more than 40% by weight in pesticide formulations. A complete description of the general approach taken to assess inert ingredient risks in the absence of residue data is contained in the memorandum entitled “Alkyl Amines Polyalkoxylates (Cluster 4): Acute and Chronic Aggregate (Food and Drinking Water) Dietary Exposure and Risk Assessments for the Inerts,” (D361707, S. Piper, 2/25/09) and can be found at http://www.regulations.gov in docket ID number EPA-HQ-OPP-2008-0738.

    2. Dietary exposure from drinking water. For the purpose of the screening level dietary risk assessment to support this request for an exemption from the requirement of a tolerance for beta cyclodextrin, methyl ethers, a conservative drinking water concentration value of 100 parts per billion (ppb) based on screening level modeling was used to assess the contribution to drinking water for the chronic dietary risk assessments for parent compound. These values were directly entered into the dietary exposure model.

    3. From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., textiles (clothing and diapers), carpets, swimming pools, and hard surface disinfection on walls, floors, tables).

    Beta cyclodextrin, methyl ethers may be used in inert ingredients in products that are registered for specific uses that may result in residential exposure, such as pesticides used in and around the home. The Agency conducted an assessment to represent conservative residential exposure by assessing beta cyclodextrin, methyl ethers in pesticide formulations (outdoor scenarios) and in disinfectant-type uses (indoor scenarios). The Agency's assessment of adult residential exposure combines high end dermal and inhalation handler exposure from liquids/backpack sprayer/home garden with a high end post application dermal exposure from contact with treated lawns. The Agency's assessment of children's residential exposure includes total post-application exposures associated with contact with treated surfaces (dermal and hand-to-mouth exposures).

    4. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.”

    EPA has not found beta cyclodextrin, methyl ethers to share a common mechanism of toxicity with any other substances, and beta cyclodextrin, methyl ethers does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that beta cyclodextrin, methyl ethers does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

    D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the Food Quality Protection Act (FQPA) Safety Factor (SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor.

    2. Prenatal and postnatal sensitivity. The toxicity database for beta cyclodextrin, methyl ethers contains developmental and 3-generation reproduction toxicity studies conducted with surrogate chemicals. Increased fetal susceptibility is not observed in any of the studies: The only fetal effects observed (slight embryotoxicity following oral exposure in developmental toxicity study in rabbits to 2-hydroxypropyl-beta-cyclodextrin at doses of 1,000 mg/kg/day) occurred in the presence of slight maternal toxicity (NOAEL of 500 mg/kg/day). In other studies involving oral exposure to beta-cyclodextrin and to 2-hydroxypropyl-beta-cyclodextrin in rats and rabbits, no adverse effects of statistical significance were observed in fetuses. In the three-generation reproduction toxicity study in rats, no effects were observed in parental or offspring animals at doses up to 1,099 mg/kg/day beta-cyclodextrin. No reproduction effects were observed up to 2,277 mg/kg/day.

    3. Conclusion. The toxicity database for beta cyclodextrin, methyl ethers contains subchronic, developmental, 3-generation reproduction toxicity and mutagenicity studies. Although there are no neurotoxicity or immunotoxicity studies, there is no need to retain the FQPA 10X safety factor because there is no indication of potential neurotoxicity or immunotoxicity in the available studies. Also, there is no need to retain the FQPA 10X safety factor for lack of an inhalation study because baseline inhalation margin of exposure (MOE) ranges from 86000-1400000 and more than adequately surpass the Agency's level of concern of MOEs<100 or MOEs<1,000 if an additional 10X were applied. In addition, the Agency used conservative exposure estimates, with 100 percent crop treated, tolerance-level residues, conservative drinking water modeling numbers, and a conservative assessment of potential residential exposure for infants and children. Based on the adequacy of the toxicity database and the conservative nature of the exposure assessment and the lack of concern for prenatal and postnatal sensitivity, the Agency has concluded that there is reliable data to determine that infants and children will be safe if the FQPA SF of 10x is reduced to 1x.

    E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists.

    1. Acute risk. An acute aggregate risk assessment takes into account acute exposure estimates from dietary consumption of food and drinking water. No adverse effect resulting from a single oral exposure was identified and no acute dietary endpoint was selected. Therefore, beta cyclodextrin, methyl ethers is not expected to pose an acute risk.

    2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to beta cyclodextrin, methyl ethers from food and water will utilize 56.6% of the cPAD for children 1-2 years old, the population group receiving the greatest exposure.

    3. Short-term risk. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level).

    Beta cyclodextrin, methyl ethers may be used as an inert ingredient in pesticide products that are registered for uses that could result in short-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures to beta cyclodextrin, methyl ethers.

    Using the exposure assumptions described above for short-term exposures, EPA has concluded the combined short-term food, water, and residential exposures result in aggregate MOEs of 1910 for both adult males and females respectively. EPA has concluded the combined short-term aggregated food, water, and residential pesticide exposures result in an aggregate MOE of 500 for children. Because EPA's level of concern for beta cyclodextrin, methyl ethers is a MOE of 100 or below, these MOEs are not of concern.

    4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level).

    Beta cyclodextrin, methyl ethers may be used as an inert ingredient in pesticide products that are registered for uses that could result in intermediate-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with intermediate-term residential exposures to beta cyclodextrin, methyl ethers.

    Using the exposure assumptions described above for intermediate-term exposures, EPA has concluded that the combined intermediate-term food, water, and residential exposures result in aggregate MOEs of 650 for adult males and females. EPA has concluded the combined intermediate-term aggregated food, water, and residential exposures result in an aggregate MOE of 170 for children. Because EPA's level of concern for beta cyclodextrin, methyl ethers is a MOE of 100 or below, these MOEs are not of concern.

    5. Aggregate cancer risk for U.S. population. Based on the lack of structural alerts in a DEREK structural alert analysis and the lack of mutagenicity, beta cyclodextrin, methyl ethers is not expected to pose a cancer risk to humans.

    6. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to beta cyclodextrin, methyl ethers residues.

    V. Other Considerations A. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since the Agency is not establishing a numerical tolerance for residues of beta cyclodextrin, methyl ethers in or on any food commodities. EPA is establishing limitations on the amount of beta cyclodextrin, methyl ethers that may be used in pesticide formulations applied to growing crops. These limitations will be enforced through the pesticide registration process under the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”), 7 U.S.C. 136 et seq. EPA will not register any pesticide formulation for use on growing crops pre-harvest for sale or distribution that exceeds 40% by weight of beta cyclodextrin, methyl ethers unless additional data are submitted.

    VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is established under 40 CFR 180.920 for beta cyclodextrin, methyl ethers (CAS Reg. No. 128446-36-6) when used as an inert ingredient (stabilizer and solvent) in pesticides applied to growing crops pre-harvest limited to a maximum concentration of 40% by weight in the pesticide formulation.

    VII. Statutory and Executive Order Reviews

    This action establishes an exemption from the requirement of a tolerance under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any special considerations under Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).

    Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the exemption in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), do not apply.

    This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq.).

    This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).

    VIII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

    List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.

    Dated: June 22, 2017. Michael L. Goodis, Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

    PART 180—[AMENDED] 1. The authority citation for part 180 continues to read as follows: Authority:

    21 U.S.C. 321(q), 346a and 371.

    2. In § 180.920, add alphabetically the entry “Beta Cyclodextrin, Methyl Ethers” to the table to read as follows:
    § 180.920 Inert ingredients used pre-harvest; exemptions from the requirement of a tolerance. Inert ingredients Limits Uses *         *         *         *         *         *         * Beta Cyclodextrin, Methyl Ethers (CAS Reg. No. 128446-36-6) 40% by weight Stabilizer and solvent. *         *         *         *         *         *         *
    [FR Doc. 2017-16373 Filed 8-3-17; 8:45 am] BILLING CODE 6560-50-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 300 [Docket No. 170329334-7665-01] RIN 0648-BG78 International Fisheries; Western and Central Pacific Fisheries for Highly Migratory Species; Bigeye Tuna Catch Limits in Longline Fisheries for 2017 AGENCY:

    National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.

    ACTION:

    Interim rule; request for comments.

    SUMMARY:

    NMFS issues regulations under authority of the Western and Central Pacific Fisheries Convention Implementation Act (WCPFC Implementation Act) to modify a limit on the amount of bigeye tuna (Thunnus obesus) that may be captured by U.S. longline vessels in the western and central Pacific Ocean (WCPO), to 3,138 metric tons (mt) for calendar year 2017. The limit does not apply to vessels in the longline fisheries of American Samoa, Guam, or the Commonwealth of the Northern Mariana Islands (CNMI). Once the limit of 3,138 mt is reached in 2017, retaining, transshipping, or landing bigeye tuna caught in the area of application of the Convention on the Conservation and Management of Highly Migratory Fish Stocks in the Western and Central Pacific Ocean (Convention), which comprises the majority of the WCPO, will be prohibited for the remainder of the calendar year, with certain exceptions. This action is necessary for the United States to satisfy its obligations under the Convention, to which it is a Contracting Party.

    DATES:

    Effective on August 4, 2017. Comments must be submitted in writing by September 5, 2017.

    ADDRESSES:

    You may submit comments on this document, identified by NOAA-NMFS-2017-0085, and the regulatory impact review (RIR) prepared for the interim rule, by either of the following methods:

    Electronic submission: Submit all electronic public comments via the Federal e-Rulemaking Portal.

    1. Go to www.regulations.gov/#!docketDetail;D=NOAA-NMFS-2017-0085,

    2. Click the “Comment Now!” icon, complete the required fields, and

    3. Enter or attach your comments.

    - OR -

    Mail: Submit written comments to Michael D. Tosatto, Regional Administrator, NMFS, Pacific Islands Regional Office (PIRO), 1845 Wasp Blvd., Building 176, Honolulu, HI 96818.

    Instructions: Comments sent by any other method, to any other address or individual, or received after the end of the comment period, might not be considered by NMFS. All comments received are a part of the public record and will generally be posted for public viewing on www.regulations.gov without change. All personal identifying information (e.g., name and address), confidential business information, or otherwise sensitive information submitted voluntarily by the sender will be publicly accessible. NMFS will accept anonymous comments (enter“N/A” in the required fields if you wish to remain anonymous).

    Copies of the RIR, and the programmatic environmental assessment and supplemental information report prepared for National Environmental Policy Act purposes are available at www.regulations.gov or may be obtained from Michael D. Tosatto, Regional Administrator, NMFS PIRO (see address above)

    FOR FURTHER INFORMATION CONTACT:

    Rini Ghosh, NMFS PIRO, 808-725-5033.

    SUPPLEMENTARY INFORMATION:

    Background on the Convention

    A map showing the boundaries of the area of application of the Convention (Convention Area), which comprises the majority of the WCPO, can be found on the WCPFC Web site at: www.wcpfc.int/doc/convention-area-map. The Convention focuses on the conservation and management of highly migratory species (HMS) and the management of fisheries for HMS. The objective of the Convention is to ensure, through effective management, the long-term conservation and sustainable use of HMS in the WCPO. To accomplish this objective, the Convention established the Commission on the Conservation and Management of Highly Migratory Fish Stocks in the Western and Central Pacific Ocean (Commission or WCPFC). The Commission includes Members, Cooperating Non-members, and Participating Territories (hereafter, collectively “Members”). The United States is a Member. American Samoa, Guam, and the CNMI are Participating Territories.

    As a Contracting Party to the Convention and a Member of the Commission, the United States is obligated to implement the decisions of the Commission. The WCPFC Implementation Act (16 U.S.C. 6901 et seq.) authorizes the Secretary of Commerce, in consultation with the Secretary of State and the Secretary of the Department in which the United States Coast Guard is operating (currently the Department of Homeland Security), to promulgate such regulations as may be necessary to carry out the obligations of the United States under the Convention, including implementation of the decisions of the Commission. The WCPFC Implementation Act further provides that the Secretary of Commerce shall ensure consistency, to the extent practicable, of fishery management programs administered under the WCPFC Implementation Act and the Magnuson-Stevens Fishery Conservation and Management Act (MSA; 16 U.S.C. 1801 et seq.), as well as other specific laws (see 16 U.S.C. 6905(b)). The Secretary of Commerce has delegated the authority to promulgate regulations under the WCPFC Implementation Act to NMFS.

    WCPFC Decision on Tropical Tunas

    At its Thirteenth Regular Session, in December 2016, the WCPFC adopted Conservation and Management Measure (CMM) 2016-01, “Conservation and Management Measure for Bigeye, Yellowfin and Skipjack Tuna in the Western and Central Pacific Ocean.” CMM 2016-01 is the most recent in a series of CMMs for the management of tropical tuna stocks under the purview of the Commission. CMM 2016-01 maintains the provisions of its predecessor, CMM 2015-01. These and other CMMs are available at: www.wcpfc.int/conservation-and-management-measures.

    The stated general objective of CMM 2016-01 and several of its predecessor CMMs is to ensure that the stocks of bigeye tuna (Thunnus obesus), yellowfin tuna (Thunnus albacares), and skipjack tuna (Katsuwonus pelamis) in the WCPO are, at a minimum, maintained at levels capable of producing their maximum sustainable yield as qualified by relevant environmental and economic factors. The CMM includes specific objectives for each of the three stocks: For each, the fishing mortality rate is to be reduced to or maintained at levels no greater than the fishing mortality rate associated with maximum sustainable yield.

    CMM 2016-01 went into effect February 2017, and is generally applicable for 2017. The CMM includes provisions for purse seine vessels, longline vessels, and other types of vessels that fish for HMS. The CMM's provisions for longline vessels include catch limits for bigeye tuna and a general provision not to increase catches of yellowfin tuna.

    The Action

    In 2016, NMFS established catch limits for bigeye tuna that may be captured in the Convention Area by longline gear and retained on board by fishing vessels of the United States for calendar years 2016 and 2017, putting into place provisions of CMM 2015-01, the predecessor to CMM 2016-01 (81 FR 41239). The limit for 2016 was set at 3,554 mt and the limit for 2017 was set at 3,345 mt. (Id.). As in CMM 2015-01, under paragraphs 40-42 of CMM 2016-01, Commission members are to limit catches by their longline vessels of bigeye tuna in the Convention Area to specified levels in 2017. Under CMM 2016-01, the applicable limit for the United States in 2017 continues to be 3,345 mt. In addition, paragraph 40 of CMM 2016-01 reiterates the provision of CMM 2015-01 that states that any catch overage in a given year shall be deducted from the catch limit for the following year. The Commission has not adopted limits for the longline fisheries of any of the U.S. Participating Territories, American Samoa, Guam, and the CNMI.

    This interim rule is limited to implementing the 2017 calendar year longline bigeye tuna catch limit for U.S. fisheries in the Convention Area, as mandated under CMM 2016-01 which continues the relevant provisions adopted by CMM 2015-01. As stated above, the Commission-adopted limit for 2017 continues to be 3,345 mt less any overage of the limit applicable in 2016. The limit for 2016 was 3,554 mt (see 81 FR 41239). There was an overage of 207 mt in 2016, so the limit for 2017 is 3,138 mt. This interim rule adjusts the 2017 limit from the established 3,345 mt to 3,138 mt.

    The 2017 longline bigeye tuna catch limit will apply only to U.S.-flagged longline vessels operating as part of the U.S. longline fisheries. The limit will not apply to U.S. longline vessels operating as part of the longline fisheries of American Samoa, the CNMI, or Guam. Existing regulations at 50 CFR 300.224(b), (c), and (d) detail the manner in which longline-caught bigeye tuna is attributed among the fisheries of the United States and the U.S. Participating Territories.

    Consistent with the basis for the limits prescribed in CMM 2016-01 and with regulations issued by NMFS to implement bigeye tuna catch limits in U.S. longline fisheries as described below, the catch limit is measured in terms of retained catches—that is, bigeye tuna that are caught by longline gear and retained on board the vessel.

    Announcement of the Limit Being Reached

    As set forth under the existing regulations at 50 CFR 300.224(e), if NMFS determines that the limit is expected to be reached in 2017, NMFS will publish a notice in the Federal Register to announce specific fishing restrictions that will be effective from the date the limit is expected to be reached until the end of the 2017 calendar year. NMFS will publish the notice of the restrictions at least 7 calendar days before the effective date to provide vessel owners and operators with advance notice. Periodic forecasts of the date the limit is expected to be reached will be made available to the public, such as by posting on a Web site, to help vessel owners and operators plan for the possibility of the limit being reached.

    Restrictions After the Limit is Reached

    As set forth under the existing regulations at 50 CFR 300.224(f), if the limit is reached, the restrictions that will be in effect will include the following:

    1. Retain on board, transship, or land bigeye tuna: Starting on the effective date of the restrictions and extending through December 31 of 2017, it will be prohibited to use a U.S. fishing vessel to retain on board, transship, or land bigeye tuna captured in the Convention Area by longline gear, except as follows:

    First, any bigeye tuna already on board a fishing vessel upon the effective date of the restrictions can be retained on board, transshipped, and/or landed, provided that they are landed within 14 days after the restrictions become effective. A vessel that had declared to NMFS pursuant to 50 CFR 665.803(a) that the current trip type is shallow-setting is not subject to this 14-day landing restriction, so these vessels will be able to land bigeye tuna more than 14 days after the restrictions become effective.

    Second, bigeye tuna captured by longline gear can be retained on board, transshipped, and/or landed if they are caught by a fishing vessel registered for use under a valid American Samoa Longline Limited Access Permit, or if they are landed in American Samoa, Guam, or the CNMI. However, the bigeye tuna must not be caught in the portion of the U.S. EEZ surrounding the Hawaiian Archipelago, and must be landed by a U.S. fishing vessel operated in compliance with a valid permit issued under 50 CFR 660.707 or 665.801.

    Third, bigeye tuna captured by longline gear can be retained on board, transshipped, and/or landed if they are caught by a vessel that is included in a specified fishing agreement under 50 CFR 665.819(d), in accordance with 50 CFR 300.224(f)(iv).

    2. Transshipment of bigeye tuna to certain vessels: Starting on the effective date of the restrictions and extending through December 31 of 2017, it will be prohibited to transship bigeye tuna caught in the Convention Area by longline gear to any vessel other than a U.S. fishing vessel operated in compliance with a valid permit issued under 50 CFR 660.707 or 665.801.

    3. Fishing inside and outside the Convention Area: To help ensure compliance with the restrictions related to bigeye tuna caught by longline gear in the Convention Area, the interim rule establishes two additional, related prohibitions that are in effect starting on the effective date of the restrictions and extending through December 31 of 2017. First, vessels are prohibited from fishing with longline gear both inside and outside the Convention Area during the same fishing trip, with the exception of a fishing trip that is in progress at the time the announced restrictions go into effect. In that exceptional case, the vessel still must land any bigeye tuna taken in the Convention Area within 14 days of the effective date of the restrictions, as described above. Second, if a vessel is used to fish using longline gear outside the Convention Area and enters the Convention Area at any time during the same fishing trip, the longline gear on the fishing vessel must be stowed in a manner so as not to be readily available for fishing while the vessel is in the Convention Area. These two prohibitions do not apply to the following vessels: (1) Vessels on declared shallow-setting trips pursuant to 50 CFR 665.803(a); and (2) vessels operating for the purposes of this rule as part of the longline fisheries of American Samoa, Guam, or the CNMI. This second group includes vessels registered for use under valid American Samoa Longline Limited Access Permits and vessels landing their bigeye tuna catch in one of the three U.S. Participating Territories, so long as these vessels conduct fishing activities in accordance with the conditions described above, and vessels included in a specified fishing agreement under 50 CFR 665.819(d), in accordance with 50 CFR 300.224(f)(iv).

    Classification

    The Administrator, Pacific Islands Region, NMFS, has determined that this interim rule is consistent with the WCPFC Implementation Act and other applicable laws.

    Administrative Procedure Act

    There is good cause under 5 U.S.C. 553(b)(B) to waive prior notice and the opportunity for public comment on this action, because prior notice and the opportunity for public comment would be contrary to the public interest. This rule adjusts a bigeye tuna catch limit for U.S. longline fisheries in the Convention Area for 2017. Data on the amount of the 2016 overage only recently became available, and NMFS must publish the revised limit for 2017 as soon as possible to ensure it is not exceeded and the United States complies with its international legal obligations with respect to CMM 2016-01. Based on preliminary data available to date, NMFS expects that the applicable limit of 3,138 mt is likely to be reached in late summer of 2017. Delaying this rule to allow for advance notice and public comment increases the risk that more than 3,138 mt of bigeye tuna would be caught by U.S. longline fisheries operating in the WCPO, potentially constituting non-compliance by the United States with respect to the longline bigeye tuna catch limit provisions of CMM 2016-01 for calendar year 2017. Because a delay in implementing this limit for 2017 could result in the United States violating its international legal obligations to conserve tropical tuna stocks in the WCPO, allowing advance notice and the opportunity for public comment would be contrary to the public interest.

    Additionally, prior notice and opportunity for public comment is unnecessary because this rule only adjusts a previously established limit for 2017 (see 81 FR 24772 and 81 FR 41239). In the preambles to the proposed rule and the final rule that established the 2017 limit, NMFS provided notice that if there was an overage of the limit for 2016, NMFS would adjust the 2017 limit in accordance with the provisions of CMM 2015-01 and any other pertinent Commission decisions in force at that time. (Id.) Moreover, affected entities have been subject to longline bigeye tuna limits in the Convention Area since 2009, and the adjusted limit is similar to the limits implemented from 2009-2016. The regulated entities have received information regarding NMFS' estimates of the 2017 longline bigeye tuna catch in the Convention Area and the approximate date the catch limit may be reached via NMFS' Web site and other means.

    NMFS will, however, take and consider public comments received on this interim final and, if appropriate, NMFS will issue a revised final rule in response to public comment.

    For the reasons articulated above, there is also good cause under 5 U.S.C. 553(d)(3) to waive the 30-day delay in effective date for this rule. As described above, NMFS must implement the longline bigeye tuna catch limit provisions of CMM 2016-01 for 2017 as soon as possible, in order to ensure that the catch limit is not exceeded. The catch limit is intended to reduce or otherwise control fishing pressure on bigeye tuna in the WCPO in order to restore this stock to levels capable of producing maximum sustainable yield on a continuing basis. According to the NMFS stock status determination criteria, bigeye tuna in the Pacific Ocean is currently experiencing overfishing. Failure to immediately implement the 2017 catch limit would result in additional fishing pressure on this stock, in violation of international and domestic legal obligations.

    Executive Order 12866

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

    Regulatory Flexibility Act

    Because prior notice and opportunity for public comment are not required for this rule by 5 U.S.C. 553, or any other law, the analytical requirements of the Regulatory Flexibility Act, 5 U.S.C. 601 et seq., are inapplicable. Therefore, no regulatory flexibility analysis was required and none has been prepared.

    List of Subjects in 50 CFR Part 300

    Administrative practice and procedure, Fish, Fisheries, Fishing, Marine resources, Reporting and recordkeeping requirements, Treaties.

    Dated: August 1, 2017. Samuel D. Rauch III, Deputy Assistant Administrator for Regulatory Programs, National Marine Fisheries Service.

    For the reasons set out in the preamble, 50 CFR part 300 is amended as follows:

    PART 300—INTERNATIONAL FISHERIES REGULATIONS Subpart O—Western and Central Pacific Fisheries for Highly Migratory Species 1. The authority citation for 50 CFR part 300, subpart O, continues to read as follows: Authority:

    16 U.S.C. 6901 et seq.

    2. In § 300.224, paragraph (a)(2) is revised to read as follows:
    § 300.224 Longline fishing restrictions.

    (a) * * *

    (2) During calendar year 2017 there is a limit of 3,138 metric tons of bigeye tuna that may be captured in the Convention Area by longline gear and retained on board by fishing vessels of the United States.

    [FR Doc. 2017-16456 Filed 8-3-17; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 622 [Docket No. 161103999-7615-02] RIN 0648-BG43 Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic; Coastal Migratory Pelagic Resources in the Gulf of Mexico and Atlantic Region; Framework Amendment 4 AGENCY:

    National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.

    ACTION:

    Final rule.

    SUMMARY:

    NMFS issues regulations to implement management measures described in Framework Amendment 4 to the Fishery Management Plan for the Coastal Migratory Pelagics Fishery of the Gulf of Mexico and Atlantic Region (FMP) as prepared and submitted by the South Atlantic Fishery Management Council (Council). For the recreational sector, this final rule establishes bag and vessel limits, and revises the minimum size limit and accountability measures (AMs) for Atlantic migratory group cobia (Atlantic cobia). This final rule also establishes a commercial trip limit for Atlantic cobia. Framework Amendment 4 and this final rule apply to the commercial and recreational harvest of Atlantic cobia in the exclusive economic zone (EEZ) from Georgia through New York. The purpose of Framework Amendment 4 and this final rule is to slow the rate of harvest of Atlantic cobia and reduce the likelihood that landings will exceed the commercial and recreational annual catch limits (ACL), thereby triggering the AMs and reducing harvest opportunities.

    DATES:

    This final rule is effective September 5, 2017.

    ADDRESSES:

    Electronic copies of Framework Amendment 4 may be obtained from the Southeast Regional Office Web site at http://sero.nmfs.noaa.gov/sustainable_fisheries/gulf_sa/cmp/2016/framework_am4/index.html. Framework Amendment 4 includes an environmental assessment, a Regulatory Flexibility Act (RFA) analysis, and a regulatory impact review.

    FOR FURTHER INFORMATION CONTACT:

    Karla Gore, Southeast Regional Office, NMFS, telephone: 727-551-5753, or email: [email protected]

    SUPPLEMENTARY INFORMATION:

    The coastal migratory pelagic fishery of the Gulf and Atlantic Regions is managed under the FMP and includes the management of the Gulf and Atlantic migratory groups of king mackerel, Spanish mackerel, and cobia. The FMP was prepared by the Council and is implemented through regulations at 50 CFR part 622 under authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act).

    On February 21, 2017, NMFS published a proposed rule to implement Framework Amendment 4 and requested public comment (82 FR 11166).

    The AM for the recreational sector requires that if the recreational annual catch limit (ACL) is exceeded, and the stock ACL (recreational ACL plus commercial ACL) is exceeded, the recreational AM is triggered. To determine whether an ACL was exceeded, the FMP requires that a 3-year average of landings be compared to the ACL unless an ACL changed, in which case the sequence of future ACLs begins again starting with a single year of landings compared to the ACL for that year, followed by 2-year average landings compared to the ACL in the next year, followed by a 3-year average of landings ACL for the third year and thereafter. Because Amendment 20B to the FMP changed the Atlantic cobia ACLs beginning in 2015 (80 FR 4216, January 27, 2015), NMFS could only use the 2015 landings to determine whether the recreational and stock ACLs were exceeded such that the AM was triggered for the 2016 fishing year. In 2015, recreational landings for Atlantic cobia exceeded the 2015 recreational ACL and the stock ACL, and the recreational AM required that the 2016 recreational season for Atlantic cobia in Federal waters close on June 20, 2016 (81 FR 12601, March 10, 2016).

    For the 2017 fishing year, the FMP required recreational landings to be averaged for the 2015 and 2016 fishing years, and the average of those landings exceeded the 2016 recreational ACL and the 2016 stock ACL. Therefore, the recreational AM was triggered, requiring that the 2017 recreational season for Atlantic cobia in Federal waters again close early in the fishing year on January 24, 2017 (82 FR 8363, January 25, 2017).

    These recreational closures likely had negative social and economic impacts on the recreational sector, including recreational anglers, charter vessels and headboat (for-hire) businesses.

    The following actions in Framework Amendment 4 and this final rule are intended to slow the rate of harvest of Atlantic cobia and reduce the likelihood that sector landings will exceed the sector and stock ACLs, thereby triggering the AMs and reducing harvest opportunities. The goal is to also provide equitable access for all participants in the Atlantic cobia component of the coastal migratory pelagics fishery.

    Management Measures Contained in This Final Rule

    For the recreational sector, this final rule establishes bag and vessel limits, and revises the minimum size limit and AMs for Atlantic cobia. This final rule also establishes a commercial trip limit for Atlantic cobia. As a result of the recreational bag and possession limits and the commercial trip limit, Atlantic migratory cobia will no longer be subject to the two fish per person per day possession limit for limited harvest species.

    Recreational Minimum Size Limit

    The current minimum size limit for the recreational harvest of Atlantic cobia in the EEZ is 33 inches (83.8 cm), fork length. This final rule increases the recreational minimum size limit for the Atlantic cobia recreational sector to 36 inches (91.4 cm), fork length. This modification will result in a recreational harvest reduction in the Atlantic, that in combination with the recreational bag and vessel limits, is expected to slow the rate of recreational harvest and thereby reduce the likelihood of exceeding the recreational and stock ACLs and thereby triggering the AM.

    Recreational Bag and Vessel Limits

    Atlantic cobia is currently a limited harvest species with a possession limit of two cobia per person per day for both the commercial and recreational sectors. This final rule would remove Atlantic cobia from the limited harvest species possession limit and would establish a recreational bag limit of one fish per person per day or six fish per vessel, whichever is more restrictive.

    Recreational AMs

    This final rule would enhance the recreational AMs for Atlantic cobia. Currently, if recreational landings of Atlantic cobia exceed the recreational ACL and the sum of the commercial and recreational landings of cobia exceed the stock ACL, then during the following fishing year, the length of the recreational fishing season will be reduced to ensure that the harvest achieves the recreational ACT, but does not exceed the recreational ACL. The current recreational AM uses a moving average of the most recent 3 years of landings to compare to the recreational ACL. Finally, if Atlantic cobia are overfished, and the stock ACL is exceeded, then during the following fishing year the recreational ACL and ACT would be reduced by the amount of any recreational ACL overage.

    The recreational AM in this final rule requires that if the recreational ACL and the stock ACL are exceeded, then during the following fishing year recreational landings will be monitored for a persistence in increased landings. Further, if necessary to prevent landings from exceeding the recreational ACL during the next fishing year, and based on the best scientific information available, the Assistant Administrator for Fisheries, NOAA (AA), will file a notification with the Office of the Federal Register to reduce the recreational vessel limit, to no less than two fish per vessel. NMFS notes that the recreational bag limit implemented through this final rule of one cobia per person would still apply during any reduction of the recreational vessel limit. Any reduction to the recreational vessel limit would only apply for the fishing year in which it is implemented. In addition, the AM requires that if the reduction to the vessel limit is insufficient to ensure that recreational landings will not exceed the recreational ACL, then the length of the recreational fishing season would be reduced to ensure that recreational landings do not exceed the recreational ACL in that fishing year. This AM is intended to help prevent recreational landings from exceeding the recreational ACL in that fishing year.

    The recreational vessel limit and the length of the recreational fishing season would not be reduced if NMFS determines, based on the best scientific information available, that a recreational vessel limit and fishing season reduction are unnecessary to prevent landings from exceeding the recreational ACL. The Council determined that first reducing the vessel limit to no less than two fish per vessel, prior to any reduction in or closure of the recreational sector, was a preferable first step in the AM rather than first reducing the length of the recreational season, because they determined that greater negative socio-economic impacts result from a reduced season.

    Also, this final rule will change the AM to compare the recreational ACL with the most recent single year of landings instead of a moving average of the most recent 3 years that was established in Amendment 18 to the FMP (76 FR 82058, December 29, 2011). The Council selected a comparison of 3-year average of landings to the recreational ACL as their preferred alternative in Amendment 18 because they decided that it would ensure that the amount of the previous year's total ACL overage would be accounted for in the subsequent year's AM protection with a reduced season, and thus would be biologically beneficial. However, the Council has reevaluated the use of a 3-year average in Framework Amendment 4, as well as in recent amendments to the FMP for the Snapper-Grouper Fishery of the South Atlantic Region (Snapper-Grouper FMP). The Council has determined that when using the methodology established through Amendment 18, an exceptionally high and unusual spike in landings incorporated into a 3-year running average could penalize anglers for the next several years whenever there is an evaluation of an ACL overage. Conversely, incorporating a year of abnormally low recreational landings into the 3-year average could result in an AM not being triggered when high landings are encountered in subsequent years, which could have negative biological effects on the stock. The revised AMs implemented here will reduce the likelihood of those longer term adverse effects.

    Furthermore, the Council is taking action through Framework Amendment 4 to enhance the recreational AM by considering both a reduction in the vessel limit and the recreational season length, if needed, to prevent recreational landings from exceeding the recreational ACL in that fishing year, instead of only reducing the length of the fishing season. Thus, the revised recreational AM provides additional measures to reduce the risk of exceeding the recreational ACL while providing opportunities to extend the recreational fishing season. Using the most recent year of landings for the cobia AM is expected to result in a more timely and accurate representation of recreational landings and therefore, respond to the best scientific information available.

    Commercial Trip Limit

    Currently, no specific commercial trip limit applies to Atlantic cobia. However, Atlantic cobia is currently a limited harvest species subject to a possession limit of two cobia per person per day for both the commercial and recreational sectors. This final rule will remove Atlantic cobia from the limited harvest species possession limit and establish a commercial trip limit for Atlantic cobia of two fish per person per day or six fish per vessel per day, whichever is more restrictive.

    Establishing a commercial trip limit with a maximum vessel limit will reduce the rate of harvest of cobia and increase the likelihood that the commercial and stock ACLs are not exceeded and the AMs are not triggered, resulting in a reduced season length or reduced vessel limit for the recreational sector and a commercial closure as a result of exceeding the commercial quota.

    Comments and Responses

    NMFS received a total of 133 comments on the proposed rule to implement Framework Amendment 4. The commenters included commercial, private recreational, and charter vessel fishing entities, representatives of fishing associations, and individuals from the general public. Several comments were in support of the measures in Framework Amendment 4 but some comments opposed at least one of the management measures. Most comments received were outside the scope of this amendment, including requests to modify the management boundary for Atlantic cobia, to transfer management of cobia to the states, and to reopen the Atlantic cobia recreational sector in Federal waters during 2017. Because those comments are outside of the scope of the actions considered in Framework Amendment 4 and the proposed rule, NMFS is not providing responses to those comments in this final rule. Many commenters raised the same issues, and NMFS responds to those collectively below, having identified seven distinct issues raised in the comments specific to Framework Amendment 4 and its proposed rule. These seven specific comments and NMFS' respective responses are summarized below.

    Comment 1: Several commenters recommended combinations of recreational minimum size limits and harvest limits that were different than the Council's preferred alternatives. The recommendations included retaining the recreational minimum size limit at 33 inches (83.8 cm), fork length, but decreasing the recreational bag limit to no more than one fish per person or four per vessel; increasing the minimum size limit to 36 inches (91.4 cm), total length, to reduce stress on the fish when trying to determine the fork length; increasing the minimum size limit to 40 inches (101.6 cm) but reducing recreational vessel limit to four fish per vessel; increasing the minimum size limit to 55 inches (139.7 cm) to protect spawning cobia; and creating upper and lower size limits (slot limit) to protect spawning females.

    Response: The Council evaluated alternatives for recreational minimum size limits and bag and vessel limits and considered public comments before choosing their preferred alternatives. The Council selected a minimum size limit of 36 inches (91.4 cm), fork length, because it closely aligned with the minimum size limits in effect in the state waters off North Carolina and Virginia, the states that account for the majority of Atlantic cobia landings and provides increased consistency in the regulations to aid law enforcement and avoid confusion among the public. Also, a size limit greater than 36 inches (91.4 cm) would remove only larger fish, which are most likely female, and that could have an impact on cobia spawning. The Council acknowledged that the recreational sector, particularly charter vessels and headboats, would be negatively affected by vessel limits which could preclude multiple paying passengers on board unable to keep a desired fish. The Council's selection of a recreational vessel limit of six cobia per vessel per day or a reduced bag limit of one cobia per person per day, whichever is more restrictive, balances the benefits to the cobia stock with the adverse impacts to the recreational sector. Ultimately, the Council determined that a vessel limit and a minimum size limit of 36 inches (91.4 cm), fork length, best meet the objectives of the amendment and the FMP by balancing both short and long-term social and economic impacts, and are the most appropriate measures to effectively slow the rate of harvest to avoid exceeding an ACL and triggering an AM that would restrict or prohibit access.

    Comment 2: The management measures proposed in Framework Amendment 4 should be re-examined after 1 year to determine if they were effective. If so, the measures should be relaxed after that time to allow an increased cobia recreational bag limit.

    Response: The Council's intent and the purpose of CMP Amendment 4 is to slow the rate of harvest and extend the cobia fishing seasons. NMFS and the Council will monitor the effectiveness of the cobia regulations in achieving those goals. The Council and NMFS may change management measures in the future, as appropriate.

    Comment 3: The recreational AM should apply in both Federal and state waters.

    Response: The Council does not have jurisdiction in state waters and cannot require states to issue compatible regulations for cobia. The states may or may not issue regulations compatible with the Federal regulations to make fisheries management in state and Federal waters consistent, but the states are not required to do so. The Atlantic States Marine Fisheries Commission (ASMFC) is developing a fishery management plan for cobia in state waters which would complement the Council's plan for management of cobia in Federal waters, but has also recently requested that the Council consider transferring management authority of Atlantic cobia to the ASMFC. Therefore, NMFS recognizes that regulations in state and Federal waters could change as a result of future management decisions.

    Comment 4: Commercial cobia fishermen should be subject to the same regulations as the recreational cobia fishermen, specifically for vessel limits, minimum size limits, and AMs.

    Response: This final rule implements similar regulations for the commercial and recreational sectors, including a commercial limit of two cobia per person or six per vessel, whichever is more restrictive, and a recreational limit of one cobia per person or six per vessel, whichever is more restrictive. This rule increases the recreational minimum size limit for the Atlantic cobia recreational sector from 33 to 36 inches (91.4 cm), fork length, while the commercial minimum size limit remains at 33 inches, fork length.

    In Framework Amendment 4, the Council and NMFS determined that more conservative regulations are appropriate for the recreational sector because recreational landings greatly exceeded their ACL and were 248 and 217 percent of the recreational ACL in 2015 and 2016, respectively. In comparison, commercial landings were 120 and 97 percent of the commercial ACL in 2015 and 2016, respectively, and the current sector allocations for Atlantic cobia are 8 percent of the stock ACL to the commercial sector and 92 percent to the recreational sector. There is greater uncertainty associated with catch estimates as a result of less timely catch reporting for the recreational sector compared to the commercial sector, because recreational landings are reported in 2-month intervals with a greater than 4-month time lag in the availability of information, while commercial landings are reported weekly with the information available within a week.

    Therefore, the Council determined, and NMFS agrees, that different management measures between sectors for Atlantic cobia is an appropriate approach to increase the likelihood that landings do not exceed the respective sector harvest limits.

    Comment 5: Recreational harvest of cobia should be allowed during the 2017 fishing season.

    Response: NMFS disagrees. NMFS was required to close the 2017 recreational season as a result of the recreational AM being triggered by an ACL overage. Total landings exceeded the recreational ACL and the total ACL in 2016, which required NMFS to reduce the length of the recreational fishing season in the following fishing year (2017) based on projections of when landings will reach the ACT. NMFS reviewed the best scientific information available and determined that the entire recreational ACL for Atlantic cobia will be caught in state waters during 2017, and the stock ACL will likely be exceeded, and therefore, NMFS closed the recreational harvest of cobia on January 24 (82 FR 8363, January 25, 2017).

    Comment 6: Changing the AM to use 1 year of data rather than the 3-year running average of data is flawed given the low number of cobia data intercepts. A 3-year running average of landings would more fairly represent the fishery because the data are flawed.

    Response: NMFS disagrees that the data are flawed, and expects that using the most recent year of landings for the AM should result in a more timely and accurate representation of recreational landings, and better responds to the best scientific information available. The Council previously selected a 3-year running average of landings for the recreational ACL as their preferred alternative in Amendment 18 because they decided that it would be biologically beneficial for the stock by accounting for an overage in the previous year. However, the Council has reevaluated the use of a 3-year average in Framework Amendment 4, as well as in recent amendments to the Snapper-Grouper FMP. The Council has determined that with the methodology established through Amendment 18, an exceptionally high and unusual spike in landings incorporated into a 3-year running average could penalize anglers for the next several years by unnecessarily triggering AMs. Conversely, incorporating a year of abnormally low recreational landings into the 3-year average could result in negative biological effects on the stock by not triggering an AM when it might be needed. The revised AMs implemented here will reduce the likelihood of those longer term adverse effects.

    The Council is taking action in Framework Amendment 4 to enhance the recreational AM by considering both a reduction in the vessel limit and the recreational season length, if needed, to prevent recreational landings from exceeding the recreational ACL in that fishing year.

    Comment 7: In violation of the Administrative Procedure Act (APA), the proposed revision to the recreational AM in Framework Amendment 4 was not subject to public comment and did not receive public support. Additionally, the public did not support the provision that allows for a shortened fishing year in the fishing year following an ACL overage.

    Response: NMFS disagrees that the revisions to the recreational AM are in violation of the APA. In fact, the public had multiple opportunities to comment at various stages of the rule's development. Framework Amendment 4 was subject to and available for public comment during public hearings conducted by the Council in August 2016 and the public Council meetings during September 2016. Framework Amendment 4 was available on the Council's Web site during the amendment's development and the public was able to submit comments to the Council directly about the amendment. Additionally, the proposed rule to implement Framework Amendment 4 was subject to a 30 day public comment period, as published in the Federal Register (82 FR 11166, February 21, 2017).

    Classification

    The Regional Administrator, Southeast Region, NMFS, has determined that this final rule is consistent with Framework Amendment 4, the Magnuson-Stevens Act, and other applicable law.

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

    The Magnuson-Stevens Act provides the statutory basis for this rule. No duplicative, overlapping, or conflicting Federal rules have been identified. In addition, no new reporting, recordkeeping, or other compliance requirements are introduced by this rule.

    The Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration (SBA) during the proposed rule stage that this rule, if adopted, would not have significant economic impacts on a substantial number of small entities. The factual basis for this determination was published in the proposed rule and is not repeated here. NMFS did not receive any comments from SBA's Office of Advocacy or the public on the certification in the proposed rule. As a result, a final regulatory flexibility analysis is not required and none was prepared.

    List of Subjects in 50 CFR Part 622

    Annual catch limits, Cobia, Fisheries, Fishing, Gulf of Mexico, South Atlantic.

    Dated: August 1, 2017. Samuel D. Rauch, III, Deputy Assistant Administrator for Regulatory Programs, National Marine Fisheries Service.

    For the reasons set out in the preamble, 50 CFR part 622 is amended as follows:

    PART 622—FISHERIES OF THE CARIBBEAN, GULF OF MEXICO, AND SOUTH ATLANTIC 1. The authority citation for part 622 continues to read as follows: Authority:

    16 U.S.C. 1801 et seq.

    2. In § 622.380, revise paragraph (a) to read as follows:
    § 622.380 Size limits.

    (a) Cobia. (1) In the Gulf—33 inches (83.8), fork length.

    (2) In the Mid-Atlantic or South Atlantic. (i) 33 inches (83.8), fork length, for cobia that are sold (commercial sector).

    (ii) 36 inches (91.4 cm), fork length, for cobia that are not sold (recreational sector).

    3. In § 622.382, revise paragraph (a) introductory text and add paragraph (a)(1)(vi) to read as follows:
    § 622.382 Bag and possession limits.

    (a) King mackerel, Spanish mackerel, and Atlantic migratory group cobia

    (1) * * *

    (vi) Atlantic migratory group cobia that are not sold (recreational sector)—1, not to exceed 6 fish per vessel per day.

    4. In § 622.383, revise paragraph (b) to read as follows:
    § 622.383 Limited harvest species.

    (b) Gulf migratory group cobia. No person may possess more than two Gulf migratory group cobia per day in or from the EEZ, regardless of the number of trips or duration of a trip.

    5. In § 622.385, add paragraph (c) to read as follows:
    § 622.385 Commercial trip limits.

    (c) Cobia. (1) Atlantic migratory group. Until the commercial ACL specified in § 622.384(d)(2) is reached, 2 fish per person, not to exceed 6 fish per vessel.

    (2) [Reserved]

    6. In § 622.388, revise paragraph (f) to read as follows:
    § 622.388 Annual catch limits (ACLs), annual catch targets (ACTs), and accountability measures (AMs).

    (f) Atlantic migratory group cobia. (1) The following ACLs and AMs apply to cobia that are sold (commercial sector):

    (i) If the sum of the cobia landings that are sold, as estimated by the SRD, reach or are projected to reach the quota specified in § 622.384(d)(2) (ACL), the AA will file a notification with the Office of the Federal Register to prohibit the sale and purchase of cobia for the remainder of the fishing year.

    (ii) In addition to the measures specified in paragraph (f)(1)(i) of this section, if the sum of the cobia landings that are sold and not sold in or from the Atlantic migratory group, as estimated by the SRD, exceeds the stock ACL, as specified in paragraph (f)(3) of this section, and Atlantic migratory group cobia are overfished, based on the most recent status of U.S. Fisheries Report to Congress, the AA will file a notification with the Office of the Federal Register, at or near the beginning of the following fishing year to reduce the applicable quota (ACL), as specified in paragraph (f)(1)(i) of this section, for that following year by the amount of any applicable sector-specific ACL overage in the prior fishing year.

    (2) The following ACLs and AMs apply to cobia that are not sold (recreational sector). If recreational landings for cobia, as estimated by the SRD, exceed both the recreational ACL of 620,000 lb (281,227 kg), and the stock ACL, as specified paragraph (f)(3) of this section, then during the following fishing year, recreational landings will be monitored for a persistence in increased landings, and, if necessary, the AA will file a notification with the Office of the Federal Register to reduce the recreational vessel limit, specified in § 622.382(a)(1)(vi), to no less than 2 fish per vessel to ensure recreational landings achieve the recreational ACT, but do not exceed the recreational ACL in that fishing year. Any recreational vessel limit reduction that is implemented as described in this paragraph is only applicable for the fishing year in which it is implemented. Additionally, if the reduction in the recreational vessel limit is determined by the AA to be insufficient to ensure that recreational landings will not exceed the recreational ACL, the AA will also reduce the length of the recreational fishing season by the amount necessary to ensure recreational landings do not exceed the recreational ACL in that fishing year. The recreational vessel limit and the length of the recreational fishing season will not be reduced if NMFS determines, based on the best scientific information available, that a recreational vessel limit and fishing season reduction are unnecessary. The recreational ACT is 500,000 lb (226,796 kg).

    (3) The stock ACL for Atlantic migratory group cobia is 670,000 lb (303,907 kg).

    [FR Doc. 2017-16469 Filed 8-3-17; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 679 [Docket No. 161020985-7181-02] RIN 0648-XF594 Fisheries of the Exclusive Economic Zone Off Alaska; Kamchatka Flounder in the Bering Sea and Aleutian Islands Management Area AGENCY:

    National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.

    ACTION:

    Temporary rule; closure.

    SUMMARY:

    NMFS is prohibiting directed fishing for Kamchatka flounder in the Bering Sea and Aleutian Islands management area (BSAI). This action is necessary to prevent exceeding the 2017 Kamchatka flounder initial total allowable catch (ITAC) in the BSAI.

    DATES:

    Effective 1200 hours, Alaska local time (A.l.t.), August 1, 2017, through 2400 hours, A.l.t., December 31, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Steve Whitney, 907-586-7228.

    SUPPLEMENTARY INFORMATION:

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

    The 2017 Kamchatka flounder ITAC in the BSAI is 4,250 metric tons (mt) as established by the final 2017 and 2018 harvest specifications for groundfish in the BSAI (82 FR 11826, February 27, 2017). In accordance with § 679.20(d)(1)(i), the Administrator, Alaska Region, NMFS (Regional Administrator), has determined that the 2017 Kamchatka flounder ITAC in the BSAI will soon be reached. Therefore, the Regional Administrator is establishing a directed fishing allowance of 2,000 mt, and is setting aside the remaining 2,250 mt as incidental catch. 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 Kamchatka flounder in the BSAI.

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

    Classification

    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 closure of Kamchatka flounder to directed fishing in the BSAI. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of July 31, 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.

    Authority:

    16 U.S.C. 1801 et seq.

    Dated: August 1, 2017. Emily H. Menashes, Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2017-16449 Filed 8-1-17; 4:15 pm] BILLING CODE 3510-22-P
    82 149 Friday, August 4, 2017 Proposed Rules DEPARTMENT OF ENERGY Office of Energy Efficiency and Renewable Energy 10 CFR Part 430 [EERE-2017-BT-TP-0012] Energy Conservation Program: Test Procedure for Room Air Conditioners AGENCY:

    Office of Energy Efficiency and Renewable Energy, Department of Energy.

    ACTION:

    Request for information (RFI).

    SUMMARY:

    The U.S. Department of Energy (“DOE”) is initiating a data collection process through this request for information to consider whether to amend DOE's test procedure for room air conditioners (“room ACs”). To inform interested parties and to facilitate this process, DOE has gathered data, identifying several issues associated with the currently applicable test procedure on which DOE is interested in receiving comment. The issues outlined in this document mainly concern issues initially identified in an RFI issued in 2015 considering amendments to the current energy conservation standards and test procedure for room ACs; harmonization with the recently established portable air conditioner (“portable AC”) test procedure; clarification of the test setup and testing conditions; updated industry test procedures for room ACs; and any additional topics that may inform DOE's decisions in a future test procedure rulemaking, including methods to reduce regulatory burden while ensuring the procedure's accuracy. DOE welcomes written comments from the public on any subject within the scope of this document (including topics not raised in this RFI).

    DATES:

    Written comments and information are requested on or before September 5, 2017.

    ADDRESSES:

    Interested persons are encouraged to submit comments using the Federal eRulemaking Portal at http://www.regulations.gov. Follow the instructions for submitting comments. Alternatively, interested persons may submit comments, identified by docket number EERE-2017-BT-TP-0012, by any of the following methods:

    Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments.

    Email: [email protected] Include the docket number EERE-2017-BT-TP-0012 in the subject line of the message.

    Postal Mail: Appliance and Equipment Standards Program, U.S. Department of Energy, Building Technologies Office, Mailstop EE-5B, 1000 Independence Avenue SW., Washington, DC 20585-0121. If possible, please submit all items on a compact disc (“CD”), in which case it is not necessary to include printed copies.

    Hand Delivery/Courier: Appliance and Equipment Standards Program, U.S. Department of Energy, Building Technologies Office, 950 L'Enfant Plaza SW., Suite 600, Washington, DC 20024. Telephone: (202) 586-6636. If possible, please submit all items on a CD, in which case it is not necessary to include printed copies.

    No telefacsimilies (faxes) will be accepted. For detailed instructions on submitting comments and additional information on this process, see section III of this document.

    Docket: The docket for this activity, which includes Federal Register notices, comments, and other supporting documents/materials, is available for review at http://www.regulations.gov. All documents in the docket are listed in the http://www.regulations.gov index. However, some documents listed in the index, such as those containing information that is exempt from public disclosure, may not be publicly available.

    The docket Web page can be found at https://www.regulations.gov/docket?D=EERE-2017-BT-TP-0012. The docket Web page will contain simple instructions on how to access all documents, including public comments, in the docket. See section III for information on how to submit comments through http://www.regulations.gov.

    FOR FURTHER INFORMATION CONTACT:

    Mr. Bryan Berringer, U.S. Department of Energy, Office of Energy Efficiency and Renewable Energy, Building Technologies Office, EE-5B, 1000 Independence Avenue SW., Washington, DC 20585-0121. Telephone: (202) 586-0371. Email: [email protected]

    Ms. Sarah Butler, U.S. Department of Energy, Office of the General Counsel, GC-33, 1000 Independence Avenue SW., Washington, DC 20585-0121. Telephone: (202) 586-1777. Email: [email protected]

    For further information on how to submit a comment or review other public comments and the docket, contact the Appliance and Equipment Standards Program staff at (202) 586-6636 or by email: [email protected]

    SUPPLEMENTARY INFORMATION:

    Table of Contents I. Introduction A. Authority and Background B. Rulemaking History 1. The January 2011 Final Rule 2. The June 2015 Request for Information II. Request for Information and Comments A. Harmonization with the Portable Air Conditioners Test Procedure 1. Test Conditions 2. Installation Heat Transfer and Leakage 3. Off-Cycle Mode B. Test Setup and Air Sampling C. Room Air Conditioner Referenced Test Procedures 1. American National Standards Institute/Association of Home Appliance Manufacturers RAC-1 2. American National Standards Institute/American Society of Heating, Refrigerating, and Air-Conditioning Engineers Standard 16 D. Other Test Procedure Topics III. Submission of Comments I. Introduction

    Room ACs are included in the list of “covered products” for which DOE is authorized to establish and amend energy conservation standards and test procedures. (42 U.S.C. 6292(a)(2)) DOE's test procedure for room ACs appears at title 10 of the Code of Federal Regulations (“CFR”) part 430, subpart B, appendix F (“appendix F”). The following sections discuss DOE's authority to establish and amend the test procedure for room ACs, as well as relevant background information regarding DOE's consideration of test procedures for this product.

    A. Authority and Background

    The Energy Policy and Conservation Act of 1975 (“EPCA” or “the Act”),1 Public Law 94-163 (42 U.S.C. 6291-6317, as codified), among other things, authorizes DOE to regulate the energy efficiency of a number of consumer products and industrial equipment. Title III, Part B 2 of EPCA established the Energy Conservation Program for Consumer Products Other Than Automobiles, which sets forth a variety of provisions designed to improve energy efficiency. These products include room ACs, the subject of this RFI. (42 U.S.C. 6292(a)(2))

    1 All references to EPCA in this document refer to the statute as amended through the Energy Efficiency Improvement Act of 2015 (EEIA 2015), Public Law 114-11 (April 30, 2015).

    2 For editorial reasons, upon codification in the U.S. Code, Part B was redesignated Part A.

    Under EPCA, DOE's energy conservation program consists essentially of four parts: (1) Testing, (2) labeling, (3) Federal energy conservation standards, and (4) certification and enforcement procedures. Relevant provisions of the Act specifically include definitions (42 U.S.C. 6291), energy conservation standards (42 U.S.C. 6295), test procedures (42 U.S.C. 6293), labeling provisions (42 U.S.C. 6294), and the authority to require information and reports from manufacturers (42 U.S.C. 6296).

    Federal energy efficiency requirements for covered products established under EPCA generally supersede State laws and regulations concerning energy conservation testing, labeling, and standards. (See 42 U.S.C. 6297) DOE may, however, grant waivers of Federal preemption for particular State laws or regulations, in accordance with the procedures and other provisions of EPCA. (42 U.S.C. 6297(d))

    The Federal testing requirements consist of test procedures that manufacturers of covered products must use as the basis for: (1) Certifying to DOE that their products comply with the applicable energy conservation standards adopted pursuant to EPCA (42 U.S.C. 6295(s)), and (2) making representations about the efficiency of those consumer products (42 U.S.C. 6293(c)). Similarly, DOE must use these test procedures to determine whether the products comply with relevant standards promulgated under EPCA. (42 U.S.C. 6295(s))

    Under 42 U.S.C. 6293, EPCA sets forth the criteria and procedures DOE must follow when prescribing or amending test procedures for covered products. EPCA requires that any test procedures prescribed or amended under this section shall be reasonably designed to produce test results which measure energy efficiency, energy use or estimated annual operating cost of a covered product during a representative average use cycle or period of use and shall not be unduly burdensome to conduct. (42 U.S.C. 6293(b)(3))

    In addition, if DOE determines that a test procedure amendment is warranted, it must publish a proposed test procedure and offer the public an opportunity to present oral and written comments on them. (42 U.S.C. 6293(b)(2))

    EPCA also requires that, at least once every 7 years, DOE evaluate test procedures for each type of covered equipment, including room ACs, to determine whether amended test procedures would more accurately or fully comply with the requirements for the test procedures to not be unduly burdensome to conduct and be reasonably designed to produce test results that reflect energy efficiency, energy use, and estimated operating costs during a representative average use cycle. (42 U.S.C. 6293(b)(1)(A)) If amended test procedures are appropriate, DOE must publish a final rule to incorporate the amendments. If DOE determines that test procedure revisions are not appropriate, DOE must publish its determination not to amend the test procedures. DOE is publishing this RFI to collect data and information to inform a potential test procedure rulemaking to satisfy the 7-year review requirement specified in EPCA, which requires that DOE publish, by January 6, 2018, either a final rule amending the test procedures or a determination that amended test procedures are not required. (42 U.S.C. 6293(b)(1)(A))

    B. Rulemaking History

    DOE's current test procedures for room ACs are codified at appendix F and the room AC performance metric calculations are codified at 10 CFR 430.23(f). Test procedures for room ACs were established on June 1, 1977, and were subsequently redesignated and editorially amended on June 29, 1979. 42 FR 27898 (June 1, 1977); 44 FR 37938 (June 29, 1979).

    1. The January 2011 Final Rule

    The Energy Independence and Security Act of 2007 (“EISA 2007”) amended EPCA, directing DOE to amend its energy efficiency test procedures for all covered products to include measures of standby mode and off mode energy consumption. (42 U.S.C. 6295(gg)(2)(A)) In compliance with the EISA 2007 requirements, on January 6, 2011, DOE published a final rule amending the room AC test procedure to include measurements of standby mode and off mode energy consumption and to introduce a new combined efficiency metric, Combined Energy Efficiency Ratio (“CEER”), that accounts for energy consumption in active mode, standby mode, and off mode. 76 FR 972. DOE also incorporated a new standard, International Electrotechnical Commission (“IEC”) Standard 62301, to measure the standby and off mode energy consumption. Id. In addition to IEC Standard 62301, the final rule updated the references to standards developed by the American National Standards Institute (“ANSI”), the Association of Home Appliance Manufacturers (“AHAM”), and the American Society of Heating, Refrigerating, and Air-Conditioning Engineers (“ASHRAE”). Id. In sum, the current room AC test procedure incorporates by reference three industry test standards: (1) ANSI/AHAM RAC-1-2008, “Room Air Conditioners” (“ANSI/AHAM RAC-1”); 3 (2) ANSI/ASHRAE Standard 16-1983 (RA 2009), “Method of Testing for Rating Room Air Conditioners and Packaged Terminal Air Conditioners” (“ANSI/ASHRAE 16”); 4 and (3) IEC Standard 62301, “Household electrical appliances—Measurement of standby power (first edition June 2005)”.5

    3 Copies can be purchased from http://webstore.ansi.org.

    4 Copies can be purchased from http://www.techstreet.com.

    5 Copies can be purchased from http://webstore.iec.ch.

    2. The June 2015 Request for Information

    DOE published an RFI (hereinafter the “June 2015 RFI”) regarding the energy conservation standards and the test procedures for room ACs. 80 FR 34843 (June 18, 2015). In addition to soliciting information regarding the energy conservations standards, the June 2015 RFI discussed and sought comment on the following test procedure related items: (1) Potential updates to the energy efficiency metric that would address performance in additional operating modes; (2) alternate methods for measuring cooling mode performance; (3) addressing heating mode performance and any relevant test methods, existing industry standards, operating conditions, and associated test burden; (4) methods for measuring part-load performance and the prevalence of units on the market with components optimized for efficient part-load operation; (5) testing and certification of units that can operate on multiple voltages; and (6) the energy usage associated with connected functionality. 80 FR 34843, 34846 34848. DOE received comments from interested parties pertaining to the test procedure in response to the June 2015 RFI.6

    6 All public comments are located in the energy conservation standards docket: http://www.regulations.gov/#!docketDetail;D=EERE-2014-BT-STD-0059.

    II. Request for Information and Comments

    In the following sections, DOE has identified a variety of issues on which it seeks input to aid in the development of the technical and economic analyses regarding whether amended test procedures for room ACs may be warranted. Specifically, DOE is requesting comment on any opportunities to streamline and simplify testing requirements for room ACs.

    Additionally, DOE welcomes comments on other issues relevant to the conduct of this process that may not specifically be identified in this document. In particular, DOE notes that under Executive Order 13771, “Reducing Regulation and Controlling Regulatory Costs,” Executive Branch agencies such as DOE are directed to manage the costs associated with the imposition of expenditures required to comply with Federal regulations. See 82 FR 9339 (Feb. 3, 2017). Pursuant to that Executive Order, DOE encourages the public to provide input on measures DOE could take to lower the cost of its regulations applicable to room ACs consistent with the requirements of EPCA. DOE also requests comment on the benefits and burdens of adopting any industry/voluntary consensus-based or other appropriate test procedure, without modification.

    A. Harmonization With the Portable Air Conditioners Test Procedure

    As discussed in the June 2015 RFI, DOE believes that consumers regard portable ACs and room ACs as similar products with similar function and consumer utility, because both are self-encased products powered by single-phase electric current that utilize refrigerant to provide cooling to defined spaces, and their product usage is broadly similar. See 80 FR 34843, 34845. Consequently, DOE believes that consumers are inclined to compare the two products based on their rated capacity and efficiency. Thus, harmonizing the test conditions for room ACs and portable ACs may allow consumers to make a more accurate comparison of the energy use or efficiency of the two products.

    DOE published a test procedure final rule for portable ACs on June 1, 2016 (hereinafter the “June 2016 Portable AC Final Rule”), in which DOE established test procedures for portable ACs in 10 CFR part 430, subpart B, appendix CC (“appendix CC”). 81 FR 35242. DOE assessed both the new portable AC test procedure and the room AC test procedure to determine whether any significant differences would impede an accurate consumer comparison of measured performance of the two covered products. DOE notes that the portable AC test procedure differentiates between single-duct and dual-duct portable ACs, which require different test conditions. For the purposes of the comparison with room ACs, DOE specifically considered the dual-duct testing provisions in the portable AC test procedure, because dual-duct portable ACs are most similar to room ACs in that the condenser inlet air is drawn from the unconditioned space, unlike single-duct portable ACs that draw condenser inlet air from the conditioned space. DOE identified several key differences between the test procedures in appendix F and appendix CC that lead to incomparable results. Specifically, the portable AC test procedure includes (1) two sets of test conditions for dual-duct portable ACs, one at 95 degrees Fahrenheit (“°F”) dry-bulb and 75 °F wet-bulb outdoor temperature (identical to the room AC test procedure) and the other at 83 °F dry-bulb and 67.5 °F wet-bulb outdoor temperature; 7 (2) a requirement that the test unit be set up and tested with all manufacturer-provided materials and the associated heat losses be accounted for in the energy efficiency metric; and (3) the consideration of energy consumption in off-cycle mode (as defined in appendix CC). In light of these differences, DOE is requesting feedback in this RFI on whether amendments to the room AC test procedure are warranted to harmonize the two test procedures in order to enable a more accurate comparison of portable AC and room AC performance. In the following subsections, DOE describes the differences between the two test procedures in greater detail and requests information on key topics related to their harmonization.

    7 For single-duct portable ACs, testing is only required at the 95 °F dry-bulb and 75 °F wet-bulb outdoor test condition. Single-duct portable ACs do not intake air from the unconditioned space and therefore performance of the unit while testing would be unchanged by the adjustment in outdoor test conditions. Thus, DOE requires numerical adjustments for the 83 °F dry-bulb and 67.5 °F wet-bulb outdoor condition when determining the seasonally adjusted cooling capacity and CEER for single-duct portable ACs. This approach minimizes test burden yet ensures that the performance of a single-duct and dual-duct portable AC can be compared.

    1. Test Conditions

    In a portable AC test procedure supplemental notice of proposed rulemaking (“SNOPR”), published on November 27, 2015 (hereinafter the “November 2015 Portable AC SNOPR”), DOE developed a climate analysis to determine the ideal cooling mode test conditions for portable ACs. 80 FR 74020, 74026. DOE considered 2012 climate data from the National Centers for Environmental Information (“NCEI”) 8 of the National Oceanic and Atmospheric Administration (“NOAA”) to determine the average dry-bulb temperature and relative humidity associated with the hottest 750 hours of the year in each state for which data were available.9 DOE then reviewed room AC ownership data from the 2009 Residential Energy Consumption Survey (“RECS”) 10 to identify room AC ownership by geographic region, as a proxy for portable AC ownership.11 Based on these data, DOE used a weighted-average approach to combine the average temperature and humidity for each state to determine a national average test condition representative of the hottest 750 hours of the year. DOE found that the national average dry-bulb temperature and relative humidity associated with the hottest 750 hours are 83 °F and 45 percent, respectively. DOE then proposed two cooling mode test conditions for dual-duct portable ACs in the November 2015 Portable AC SNOPR: (1) A higher outdoor temperature condition based on AHAM PAC-1-2015, “Portable Air Conditioners” (95 °F dry-bulb and 75 °F wet-bulb temperature), representing high-temperature conditions when cooling is most needed; and (2) the lower outdoor temperature condition based on the weighted-average temperature and humidity observed during the hottest 750 hours (83 °F dry-bulb and 67.5 °F wet-bulb temperature). Id. In the June 2016 Portable AC Final Rule, DOE adopted in appendix CC the cooling mode test conditions proposed in the November 2015 Portable AC SNOPR. 81 FR 35242, 35249-35251.

    8 The NCEI was formerly known as the National Climate Data Center.

    9 NCEI climate data are available online at: https://www.ncdc.noaa.gov/crn/qcdatasets.html.

    10 RECS data are available online at: http://www.eia.gov/consumption/residential/data/2009/.

    11 DOE utilized RECS data for room ACs because such data were not available for portable ACs.

    In the June 2016 Portable AC Final Rule, DOE also established an energy efficiency metric, CEER, which provides a representative measure of overall portable AC performance that accounts for the variability in performance during the cooling season. CEER for dual-duct portable ACs is calculated as follows:

    EP04AU17.018 Where: ACC95 = adjusted cooling capacity measured at an outdoor temperature of 95 °F in British thermal units per hour (Btu/h); ACC83 = adjusted cooling capacity measured at an outdoor temperature of 83 °F in Btu/h; AEC95 = total annual energy consumption in cooling mode at an outdoor temperature of 95 °F in kilowatt-hours per hear (kWh/year); AEC83 = total annual energy consumption in cooling mode at an outdoor temperature of 83 °F in kWh/year; k = 0.001 kWh/Wh conversion factor for watt-hours to kilowatt-hours; t = number of hours per year, 8,760. 81 FR 35242, 35268.

    Room ACs are currently tested with a single outdoor test condition, 95 °F dry-bulb and 75 °F wet-bulb temperature, which aligns with only one of the two cooling mode test conditions for dual-duct portable ACs. Considering the similarities between the two products (i.e., consumer utility, internal components, etc.) and the potential for consumers to compare the energy use or efficiency of both products, DOE seeks comment on whether it would be appropriate to harmonize the two test procedures by including an additional test condition for room AC cooling mode testing (83 °F dry-bulb and 67.5 °F wet-bulb temperature). Should this harmonization of test conditions occur, DOE would also investigate the applicability of the portable AC energy metric and determine if any modifications would be necessary for its application to room ACs.

    As noted in the June 2015 RFI, the current room AC test procedure measures only the full-load performance at outdoor ambient conditions of 95 °F dry-bulb and 75 °F wet-bulb temperature. 80 FR 34843, 34848. Therefore, available technologies that improve part-load performance, such as variable-speed compressors and variable-opening expansion devices, are not considered in the determination of the rated performance of a room AC under the current test procedure. Id. DOE expects that harmonizing the room AC test procedure with the portable AC test procedure by including an additional cooling mode test condition potentially would ensure the room AC efficiency metric is more representative of actual use, and it will capture benefits associated with variable-speed compressors and other components that improve part-load performance.

    Issue A.1.1 DOE seeks feedback on the harmonization of the room AC test procedure with the DOE test procedure for dual-duct portable ACs, specifically related to the inclusion of an additional cooling mode test condition.

    Issue A.1.2 DOE seeks information on the test burden and other potential impacts associated with the inclusion of an additional cooling mode test condition in the room AC test procedure.

    Issue A.1.3 DOE seeks information on the merits and limitations of utilizing the CEER efficiency metric adopted for dual-duct portable ACs for the purposes of rating room ACs.

    Issue A.1.4 DOE seeks information on the implementation and operation of variable-speed compressors and other components that will improve part-load performance for room ACs, and whether the dual rating conditions specified for testing of dual-duct portable ACs would capture benefits of these technologies for room ACs and be included in the revised test procedure.

    2. Installation Heat Transfer and Leakage

    The portable AC test procedure in appendix CC requires that the test unit be set up and tested with all manufacturer-provided materials (including the ducts, connectors for attaching the duct(s) to the test unit, sealing, insulation, and window mounting fixtures) to ensure that the performance measured during the test is reflective of actual installation and operation. The portable AC test procedure also accounts for the impacts of infiltration air, which is caused by negative pressure in the conditioned space created by the unit's operation, thereby driving unconditioned air into the space and impacting the overall cooling provided by the unit to the conditioned space.

    Room ACs are typically installed with side curtains or other window or wall mounting installation materials that, during typical operation, may allow air to leak through or around the materials and would impact the cooling provided to the conditioned space. However, DOE notes that when conducting the calorimeter test prescribed in ANSI/ASHRAE Standard 16 (as referenced by the current DOE room AC test procedure), the test unit is set up so all air leakage around the unit that would normally be present in a typical installation is precluded by means of sealing.

    Considering the requirements of EPCA for DOE to adopt test procedures that are representative of an average use cycle, which would encompass typical installation and operation, DOE requests comment on testing in accordance with the manufacturer-provided installation materials.

    Issue A.2.1 DOE seeks feedback on the harmonization of the room AC test set up requirements with those in the portable AC test procedure, specifically related to installation with all manufacturer-provided installation materials.

    Issue A.2.2 DOE requests information and data related to air and heat leakage through and around room AC installation materials, specifically side curtains and wall sleeves, which the current room AC test procedure does not capture. DOE request comment on whether these losses should be considered given the requirements of EPCA.

    3. Off-Cycle Mode

    In the June 2016 Portable AC Final Rule, DOE adopted a definition for “off-cycle mode” as a mode in which the portable air conditioner: (1) Has cycled off its main cooling or heating function by thermostat or temperature sensor signal; (2) may or may not operate its fan or blower; and (3) will reactivate the main function according to the thermostat or temperature sensor signal. 81 FR 35242, 35265. DOE notes that this off-cycle mode definition for portable ACs is different from an off-cycle mode definition that DOE proposed on December 9, 2008, in a NOPR for the previous room AC test procedure rulemaking, which explicitly excluded fan operation from the off-cycle mode.12 73 FR 74639, 74645 (Dec. 9, 2008) (hereinafter the “December 2008 NOPR”). By excluding the periods of fan operation from off-cycle mode that would be expected for a typical installation and usage, the definition proposed in the December 2008 NOPR excluded potentially significant energy consumption when compared to the definition adopted for portable ACs.

    12 DOE notes that the definition for off-cycle mode proposed in the December 2008 NOPR was not adopted in the June 2011 Final Rule.

    DOE also established provisions for determining the average off-cycle mode power in the June 2016 Portable AC Final Rule. 81 FR 35242, 35267. The portable AC off-cycle mode test is conducted following the cooling mode test under the same ambient conditions, and includes a 5-minute delay prior to measuring power consumption to allow for a brief period of fan operation while the evaporator returns to its non-cooling state. Because the evaporator is still cool at the end of compressor operation following cooling mode, additional room cooling is possible through continued fan operation at relatively low energy consumption. Therefore, DOE included the 5-minute delay before the start of off-cycle mode testing to prevent penalizing manufacturers for utilizing the cooling potential of the evaporator following the compressor cycle.

    In the June 2015 RFI, DOE requested comment on the merits and/or limitations of accounting for energy modes not currently included in the room AC test procedure, including off-cycle mode, referencing the definition proposed in the December 2008 NOPR. 80 FR 34843, 34846. In response to the June 2015 RFI, DOE received a comment opposed to the inclusion of off-cycle mode in the DOE test procedure for room ACs. However, due to the significant difference between that definition and the definition of off-cycle mode established in the portable AC test procedure, DOE is requesting feedback on including provisions for measuring average off-cycle mode power in the room AC test procedure, consistent with the portable AC test procedure.

    Issue A.3.1 DOE seeks feedback on the harmonization of the room AC test procedure with the portable AC test procedure, specifically related to the inclusion of off-cycle mode in the room AC test procedure.

    Issue A.3.2 DOE seeks feedback on the applicability of the portable AC off-cycle mode definition, provisions to measure average off-cycle mode power, and the inclusion of off-cycle mode in the efficiency metric for room ACs.

    Issue A.3.3 DOE requests information and data related to off-cycle mode, including input power levels, fan operation, time spent in that mode, etc.

    B. Test Setup and Air Sampling

    The current DOE room AC test procedure references certain sections of ANSI/AHAM RAC-1 and ANSI/ASHRAE 16 for the room AC cooling mode test conditions and test methods. Section 4.2.7 of ANSI/ASHRAE 16 requires the calorimeter chamber conditions to be verified by air sampled from a location that is representative of the temperatures surrounding the unit and that simulate the conditions in which the unit operates in the field. DOE notes that there is no procedure to verify if the measured chamber temperature reading is representative of conditions at the test unit condenser and evaporator inlet, which may be affected by recirculation from the condenser and evaporator exhaust, respectively, thereby potentially reducing test repeatability and reproducibility. As a result, DOE is seeking comment on this issue and any potential modifications to the test procedure that should be considered as part of this investigative effort.

    Issue B.1 DOE welcomes information on more specific requirements for air sampling device positioning within the calorimeter chamber to improve test repeatability.

    C. Room Air Conditioner Referenced Test Procedures 1. American National Standards Institute/Association of Home Appliance Manufacturers RAC-1

    The cooling mode test in appendix F is conducted in accordance with the testing conditions, methods, and calculations in sections 4, 5, 6.1, and 6.5 of the 2008 version of ANSI/AHAM RAC-1. Since DOE last revised its room AC test procedure in 2011, ANSI/AHAM RAC-1 has been updated and the current standard was released in 2015 (ANSI/AHAM RAC-1-2015, “Room Air Conditioners”). Based on review of the 2015 standard, DOE believes that the updates to ANSI/AHAM RAC-1 provide added specificity, but do not substantively impact the results of DOE's cooling mode test. Accordingly, DOE does not expect that updating the references to ANSI/AHAM RAC-1 in the room AC test procedure at appendix F would substantively affect testing results. DOE further notes that the 2015 update to ANSI/AHAM RAC-1 included adjustments to section organization, and DOE would consider updating section references as necessary if the 2015 version of ANSI/AHAM RAC-1 is incorporated by reference in the room AC test procedure at appendix F.

    Issue C.1.1 DOE seeks feedback on whether the references to ANSI/AHAM RAC-1-2008 in its test procedure at appendix F should be updated to certain sections of the most current version of ANSI/AHAM RAC-1, ANSI/AHAM RAC-1-2015.

    2. American National Standards Institute/American Society of Heating, Refrigerating, and Air-Conditioning Engineers Standard 16

    Appendix F currently references in its provisions for cooling mode test conditions, methods, and calculations the 1983 version of ANSI/ASHRAE 16, which was reaffirmed in 2009. ANSI/AHAM RAC-1-2015 also references the 1983 version of ANSI/ASHRAE 16 reaffirmed in 2009. A new version of ANSI/ASHRAE 16 was published in 2016, which includes many significant updates to the standard, including heating mode testing and an air enthalpy test approach as an alternative to the calorimeter approach, while the general cooling mode methodology remains unchanged.

    Issue C.2.1 DOE seeks feedback on the applicability of the recent updates to ANSI/ASHRAE 16 to the room AC test procedure in appendix F.

    Issue C.2.2 DOE welcomes feedback on whether the test procedure in appendix F should continue to reference the version of ANSI/ASHRAE 16 that was reaffirmed in 2009, consistent with the referenced version in both ANSI/AHAM RAC-1-2008 and ANSI/AHAM RAC-1-2015, or if appendix F should reference the 2016 version of ANSI/ASHRAE 16. If appendix F were to reference the 2016 version of ANSI/ASHRAE 16, DOE seeks information on modified instructions that would be required in appendix F to continue to reference certain sections of ANSI/AHAM RAC-1.

    D. Other Test Procedure Topics

    In addition to the issues identified earlier in this document, DOE welcomes comment on any other aspect of the existing test procedure for room ACs not already addressed by the specific areas identified in this document. DOE particularly seeks information that would improve the repeatability, reproducibility, and consumer representativeness of the test procedure. DOE also requests information that would help DOE create a procedure that would limit manufacturer test burden through streamlining or simplifying testing requirements. Comments regarding the repeatability and reproducibility are also welcome.

    DOE also requests feedback on any potential amendments to the existing test procedure that could be considered to address impacts on manufacturers, including small businesses. Regarding the Federal test method, DOE seeks comment on the degree to which the DOE test procedure should consider and be harmonized with the most recent relevant industry standards for room ACs and whether there are any changes to the Federal test method that would provide additional benefits to the public.

    Additionally, DOE requests comment on whether the existing test procedure limits a manufacturer's ability to provide additional features to consumers on room ACs. DOE particularly seeks information on how the test procedure could be amended to reduce the cost of new or additional features and make it more likely that such features are included on room ACs.

    III. Submission of Comments

    DOE invites all interested parties to submit in writing by September 5, 2017, comments and information on matters addressed in this RFI and on other matters relevant to DOE's test procedure for room ACs. These comments and information will aid in the development of a test procedure NOPR for room ACs if DOE determines that amended test procedures may be appropriate for these products.

    Submitting comments via http://www.regulations.gov. The http://www.regulations.gov Web page will require you to provide your name and contact information. Your contact information will be viewable to DOE Building Technologies staff only. Your contact information will not be publicly viewable except for your first and last names, organization name (if any), and submitter representative name (if any). If your comment is not processed properly because of technical difficulties, DOE will use this information to contact you. If DOE cannot read your comment due to technical difficulties and cannot contact you for clarification, DOE may not be able to consider your comment.

    However, your contact information will be publicly viewable if you include it in the comment or in any documents attached to your comment. Any information that you do not want to be publicly viewable should not be included in your comment, nor in any document attached to your comment. Persons viewing comments will see only first and last names, organization names, correspondence containing comments, and any documents submitted with the comments.

    Do not submit to http://www.regulations.gov information for which disclosure is restricted by statute, such as trade secrets and commercial or financial information (hereinafter referred to as Confidential Business Information (“CBI”)). Comments submitted through http://www.regulations.gov cannot be claimed as CBI. Comments received through the Web site will waive any CBI claims for the information submitted. For information on submitting CBI, see the Confidential Business Information section.

    DOE processes submissions made through http://www.regulations.gov before posting. Normally, comments will be posted within a few days of being submitted. However, if large volumes of comments are being processed simultaneously, your comment may not be viewable for up to several weeks. Please keep the comment tracking number that http://www.regulations.gov provides after you have successfully uploaded your comment.

    Submitting comments via email, hand delivery, or mail. Comments and documents submitted via email, hand delivery, or mail also will be posted to http://www.regulations.gov. If you do not want your personal contact information to be publicly viewable, do not include it in your comment or any accompanying documents. Instead, provide your contact information on a cover letter. Include your first and last names, email address, telephone number, and optional mailing address. The cover letter will not be publicly viewable as long as it does not include any comments.

    Include contact information each time you submit comments, data, documents, and other information to DOE. If you submit via mail or hand delivery, please provide all items on a CD, if feasible. It is not necessary to submit printed copies. No facsimiles (faxes) will be accepted.

    Comments, data, and other information submitted to DOE electronically should be provided in PDF (preferred), Microsoft Word or Excel, WordPerfect, or text (ASCII) file format. Provide documents that are not secured, written in English and free of any defects or viruses. Documents should not contain special characters or any form of encryption and, if possible, they should carry the electronic signature of the author.

    Campaign form letters. Please submit campaign form letters by the originating organization in batches of between 50 to 500 form letters per PDF or as one form letter with a list of supporters' names compiled into one or more PDFs. This reduces comment processing and posting time.

    Confidential Business Information. According to 10 CFR 1004.11, any person submitting information that he or she believes to be confidential and exempt by law from public disclosure should submit via email, postal mail, or hand delivery two well-marked copies: one copy of the document marked confidential including all the information believed to be confidential, and one copy of the document marked “non-confidential” with the information believed to be confidential deleted. Submit these documents via email or on a CD, if feasible. DOE will make its own determination about the confidential status of the information and treat it according to its determination.

    Factors of interest to DOE when evaluating requests to treat submitted information as confidential include (1) a description of the items, (2) whether and why such items are customarily treated as confidential within the industry, (3) whether the information is generally known by or available from other sources, (4) whether the information has previously been made available to others without obligation concerning its confidentiality, (5) an explanation of the competitive injury to the submitting person which would result from public disclosure, (6) when such information might lose its confidential character due to the passage of time, and (7) why disclosure of the information would be contrary to the public interest.

    It is DOE's policy that all comments may be included in the public docket, without change and as received, including any personal information provided in the comments (except information deemed to be exempt from public disclosure).

    DOE considers public participation to be a very important part of the process for developing test procedures. DOE actively encourages the participation and interaction of the public during the comment period in each stage of the rulemaking process. Interactions with and between members of the public provide a balanced discussion of the issues and assist DOE in the rulemaking process. Anyone who wishes to be added to the DOE mailing list to receive future notices and information about this process or would like to request a public meeting should contact Appliance and Equipment Standards Program staff at (202) 586-6636 or via email at [email protected]

    Issued in Washington, DC, on July 27, 2017. Kathleen Hogan, Ph.D., Deputy Assistant Secretary for Energy Efficiency, Energy Efficiency and Renewable Energy.
    [FR Doc. 2017-16441 Filed 8-3-17; 8:45 am] BILLING CODE -P
    82 149 Friday, August 4, 2017 Notices DEPARTMENT OF AGRICULTURE Forest Service Fresno and Madera Counties Resource Advisory Committee AGENCY:

    Forest Service, USDA.

    ACTION:

    Notice of meeting.

    SUMMARY:

    The Fresno and Madera Counties Resource Advisory Committee (RAC) will meet in Clovis, California. The committee is authorized under the Secure Rural Schools and Community Self-Determination Act (the Act) and operates in compliance with the Federal Advisory Committee Act. The purpose of the committee is to improve collaborative relationships and to provide advice and recommendations to the Forest Service concerning projects and funding consistent with the Act.

    DATES:

    The meeting will be held on August 31, 2017, from 6:00 p.m. to 8:00 p.m.

    All RAC meetings are subject to cancellation. For status of meeting prior to attendance, please contact the person listed under For Further Information Contact.

    ADDRESSES:

    The meeting will be held at the Sierra National Forest (NF) Supervisor's Office, 1600 Tollhouse Road, Clovis, California.

    Written comments may be submitted as described under Supplementary Information. All comments, including names and addresses when provided, are placed in the record and are available for public inspection and copying. The public may inspect comments received at the Sierra NF Supervisor's Office. Please call ahead to facilitate entry into the building.

    FOR FURTHER INFORMATION CONTACT:

    Julie Roberts, RAC Coordinator, by phone at 559-297-0706 or via email at [email protected]

    Individuals who use telecommunication devices for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339 between 8:00 a.m. and 8:00 p.m., Eastern Standard Time, Monday through Friday.

    SUPPLEMENTARY INFORMATION:

    The purpose of the meeting is to:

    1. Discuss and agree on general operating procedures,

    2. Elect a chair,

    3. Review project proposals, and

    4. Possibly vote to recommend project proposals for Title II Funds.

    The meeting is open to the public. The agenda will include time for people to make oral statements of three minutes or less. Individuals wishing to make an oral statement should request in writing by August 18, 2017, to be scheduled on the agenda. Anyone who would like to bring related matters to the attention of the committee may file written statements with the committee staff before or after the meeting. Written comments and requests for time for oral comments must be sent to Julie Roberts, RAC Coordinator, Sierra NF Supervisor's Office, 1600 Tollhouse Road, Clovis, California 93611; by email to [email protected], or via facsimile to 559-294-4809.

    Meeting Accommodations: If you are a person requiring reasonable accommodation, please make requests in advance for sign language interpreting, assistive listening devices, or other reasonable accommodation. For access to the facility or proceedings, please contact the person listed in the section titled For Further Information Contact. All reasonable accommodation requests are managed on a case by case basis.

    Dated: July 10, 2017. Glenn Casamassa, Associate Deputy Chief, National Forest System.
    [FR Doc. 2017-16427 Filed 8-3-17; 8:45 am] BILLING CODE 3411-15-P
    DEPARTMENT OF AGRICULTURE Forest Service Fresno and Madera Counties Resource Advisory Committee AGENCY:

    Forest Service, USDA.

    ACTION:

    Notice of meeting.

    SUMMARY:

    The Fresno and Madera Counties Resource Advisory Committee (RAC) will meet in Clovis, California. The committee is authorized under the Secure Rural Schools and Community Self-Determination Act (the Act) and operates in compliance with the Federal Advisory Committee Act. The purpose of the committee is to improve collaborative relationships and to provide advice and recommendations to the Forest Service concerning projects and funding consistent with the Act.

    DATES:

    The meeting will be held on August 24, 2017, from 6:00 p.m. to 8:00 p.m.

    All RAC meetings are subject to cancellation. For status of meeting prior to attendance, please contact the person listed under FOR FURTHER INFORMATION CONTACT.

    ADDRESSES:

    The meeting will be held at the Sierra National Forest (NF) Supervisor's Office, 1600 Tollhouse Road, Clovis, California.

    Written comments may be submitted as described under SUPPLEMENTARY INFORMATION. All comments, including names and addresses when provided, are placed in the record and are available for public inspection and copying. The public may inspect comments received at the Sierra NF Supervisor's Office. Please call ahead to facilitate entry into the building.

    FOR FURTHER INFORMATION CONTACT:

    Julie Roberts, RAC Coordinator, by phone at 559-297-0706 or via email at [email protected]

    Individuals who use telecommunication devices for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339 between 8:00 a.m. and 8:00 p.m., Eastern Standard Time, Monday through Friday.

    SUPPLEMENTARY INFORMATION:

    The purpose of the meeting is to:

    1. Discuss and agree on general operating procedures,

    2. Elect a chair,

    3. Review project proposals, and

    4. Possibly vote to recommend project proposals for Title II Funds.

    The meeting is open to the public. The agenda will include time for people to make oral statements of three minutes or less. Individuals wishing to make an oral statement should request in writing by August 11, 2017, to be scheduled on the agenda. Anyone who would like to bring related matters to the attention of the committee may file written statements with the committee staff before or after the meeting. Written comments and requests for time for oral comments must be sent to Julie Roberts, RAC Coordinator, Sierra NF Supervisor's Office, 1600 Tollhouse Road, Clovis, California 93611; by email to [email protected], or via facsimile to 559-294-4809.

    Meeting Accommodations: If you are a person requiring reasonable accommodation, please make requests in advance for sign language interpreting, assistive listening devices, or other reasonable accommodation. For access to the facility or proceedings, please contact the person listed in the section titled For Further Information Contact. All reasonable accommodation requests are managed on a case by case basis.

    Dated: July 10, 2017. Glenn Casamassa, Associate Deputy Chief, National Forest System.
    [FR Doc. 2017-16428 Filed 8-3-17; 8:45 am] BILLING CODE 3411-15-P
    DEPARTMENT OF COMMERCE International Trade Administration Request for Applicants for Appointment to the United States-Brazil CEO Forum AGENCY:

    International Trade Administration, Department of Commerce.

    ACTION:

    Notice.

    SUMMARY:

    In March 2007, the Governments of the United States and Brazil established the U.S.-Brazil CEO Forum. This notice announces the opportunity for up to twelve individuals for appointment to the U.S. Section of the Forum. The three-year term of the incoming members of the U.S. Section starts on October 1, 2017, and will expire September 30, 2020. Nominations received in response to this notice will also be considered for on-going appointments to fill any future vacancies that may arise before September 30, 2020.

    DATES:

    Applications for immediate consideration should be received no later than close of business August 25, 2017. After that date, applications will continue to be accepted through September 30, 2020 to fill any new vacancies that may arise.

    ADDRESSES:

    Please send requests for consideration to Raquel Silva, Office of Latin America and the Caribbean, U.S. Department of Commerce, either by email at [email protected] or by mail to U.S. Department of Commerce, 1401 Constitution Avenue NW., Room 30014, Washington, DC 20230.

    FOR FURTHER INFORMATION CONTACT:

    Raquel Silva, Office of Latin America and the Caribbean, U.S. Department of Commerce, telephone: (202) 482-4157.

    SUPPLEMENTARY INFORMATION:

    The Secretary of Commerce and the Director of the National Economic Council, together with the Planalto Casa Civil Minister (Presidential Chief of Staff) and the Brazilian Minister of Industry, Foreign Trade & Services, co-chair the U.S.-Brazil CEO Forum (Forum), pursuant to the Terms of Reference signed in March 2007 by the U.S. and Brazilian governments, as amended, which set forth the objectives and structure of the Forum. The Terms of Reference may be viewed at: http://www.trade.gov/ceo-forum/. The Forum, consisting of both private and public sector members, brings together leaders of the respective business communities of the United States and Brazil to discuss issues of mutual interest, particularly ways to strengthen the economic and commercial ties between the two countries. The Forum consists of the U.S. and Brazilian Government co-chairs and a Committee comprised of private sector members. The Committee is composed of two Sections, each consisting of approximately ten to twelve members from the private sector, representing the views and interests of the private sector business community in the United States and Brazil. Each government appoints the members to its respective Section. The Committee provides joint recommendations to the two governments that reflect private sector views, needs and concerns regarding the creation of an economic environment in which their respective private sectors can partner, thrive and enhance bilateral commercial ties to expand trade between the United States and Brazil.

    This notice seeks candidates to fill up to twelve positions on the U.S. Section of the Forum as well as any future vacancies that may arise before September 30, 2020. Each candidate must be the Chief Executive Officer or President (or have a comparable level of responsibility) of a U.S.-owned or -controlled company that is incorporated in and has its main headquarters in the United States and that is currently doing business in both Brazil and the United States. Each candidate also must be a U.S. citizen or otherwise legally authorized to work in the United States and able to travel to Brazil and locations in the United States to attend official Forum meetings as well as independent U.S. Section and Committee meetings. In addition, the candidate may not be a registered foreign agent under the Foreign Agents Registration Act of 1938, as amended. Evaluation of applications for membership in the U.S. Section by eligible individuals will be based on the following criteria:

    —A demonstrated commitment by the individual's company to the Brazilian market either through exports or investment. —A demonstrated strong interest in Brazil and its economic development. —The ability to offer a broad perspective and business experience to the discussions. —The ability to address cross-cutting issues that affect the entire business community. —The ability to initiate and be responsible for activities in which the Forum will be active.

    Members will be selected on the basis of who will best carry out the objectives of the Forum as stated in the Terms of Reference establishing the U.S.-Brazil CEO Forum. The U.S. Section of the Forum should also include members that represent a diversity of business sectors and geographic locations. To the extent possible, U.S. Section members also should represent a cross-section of small, medium, and large firms.

    U.S. members will receive no compensation for their participation in Forum-related activities. Individual members will be responsible for all travel and related expenses associated with their participation in the Forum, including attendance at Committee and Section meetings. Only appointed members may participate in official Forum meetings; substitutes and alternates will not be designated. According to the current Terms of Reference, members are normally to serve three-year terms, but may be reappointed.

    To be considered for membership, please submit the following information as instructed in the ADDRESSES and DATES captions above: Name(s) and title(s) of the individual(s) requesting consideration; name and address of company's headquarters; location of incorporation; information that the company is U.S.-owned or U.S.-controlled; size of the company; size of company's export trade, investment, and nature of operations or interest in Brazil; an affirmative statement that the applicant meets all Forum eligibility criteria and is neither registered nor required to register as a foreign agent under the Foreign Agents Registration Act of 1938, as amended; and a brief statement of why the candidate should be considered, including information about the candidate's ability to initiate and be responsible for activities in which the Forum will be active. Applications will be considered as they are received. All candidates will be notified of whether they have been selected.

    Dated: July 31, 2017. Alexander Peacher, Acting Director for the Office of Latin America & the Caribbean.
    [FR Doc. 2017-16455 Filed 8-3-17; 8:45 am] BILLING CODE 3510-HE-P
    DEPARTMENT OF COMMERCE International Trade Administration Corporation for Travel Promotion (dba Brand USA) AGENCY:

    International Trade Administration, U.S. Department of Commerce.

    ACTION:

    Notice of an opportunity for travel and tourism industry leaders to apply for membership on the Board of Directors of the Corporation for Travel Promotion.

    SUMMARY:

    The Department of Commerce is currently seeking applications from travel and tourism leaders from specific industries for membership on the Board of Directors (Board) of the Corporation for Travel Promotion (dba Brand USA). The purpose of the Board is to guide the Corporation for Travel Promotion on matters relating to the promotion of the United States as a travel destination and communication of travel facilitation issues, among other tasks.

    DATES:

    All applications must be received by the National Travel and Tourism Office by close of business on September 29, 2017.

    ADDRESSES:

    Electronic applications may be sent to: [email protected] Written applications can be submitted to Isabel Hill, Director, National Travel and Tourism Office, U.S. Department of Commerce, Mail Stop 10007, 1401 Constitution Avenue NW., Washington, DC 20230. Telephone: 202.482.0140. Email: [email protected]

    FOR FURTHER INFORMATION CONTACT:

    Julie Heizer, Deputy Director, National Travel and Tourism Office, Mail Stop 10003, 1401 Constitution Avenue NW., Washington, DC, 20230. Telephone: 202.482.4904. Email: [email protected]

    SUPPLEMENTARY INFORMATION:

    Background: The Travel Promotion Act of 2009 (TPA) was signed into law on March 4, 2010, and was amended in July 2010 and December 2014. The TPA established the Corporation for Travel Promotion (the Corporation), as a non-profit corporation charged with the development and execution of a plan to (A) provide useful information to those interested in traveling to the United States; (B) identify and address perceptions regarding U.S. entry policies; (C) maximize economic and diplomatic benefits of travel to the United States through the use of various promotional tools; (D) ensure that international travel benefits all States and the District of Columbia, and (E) identify opportunities to promote tourism to rural and urban areas equally, including areas not traditionally visited by international travelers.

    The Corporation (doing business as Brand USA) is governed by a Board of Directors, consisting of 11 members with knowledge of international travel promotion or marketing, broadly representing various regions of the United States. The TPA directs the Secretary of Commerce (after consultation with the Secretary of Homeland Security and the Secretary of State) to appoint the Board of Directors for the Corporation.

    At this time, the Department will be selecting three individuals with the appropriate expertise and experience from specific sectors of the travel and tourism industry to serve on the Board as follows:

    (A) 1 shall have appropriate expertise and experience in small business/retail;

    (B) 1 shall have appropriate expertise and experience in state tourism office; and

    (C) 1 shall have appropriate expertise and experience in travel distribution services.

    To be eligible for Board membership, individuals must have international travel and tourism marketing experience, be a current or former chief executive officer, chief financial officer, or chief marketing officer or have held an equivalent management position. Additional consideration will be given to individuals who have experience working in U.S. multinational entities with marketing budgets, and/or who are audit committee financial experts as defined by the Securities and Exchange Commission (in accordance with section 407 of Pub. L. 107-204 [15 U.S.C. 7265]). Individuals must be U.S. citizens, and in addition, cannot be federally registered lobbyists or registered as a foreign agent under the Foreign Agents Registration Act of 1938, as amended.

    Those selected for the Board must be able to meet the time and effort commitments of the Board.

    Board members serve at the discretion of the Secretary of Commerce (who may remove any member of the Board for good cause). The terms of office of each member of the Board appointed by the Secretary shall be three (3) years. Board members can serve a maximum of two consecutive full three-year terms. Board members are not considered Federal government employees by virtue of their service as a member of the Board and will receive no compensation from the Federal government for their participation in Board activities. Members participating in Board meetings and events may be paid actual travel expenses and per diem when away from their usual places of residence by the Corporation.

    Individuals who want to be considered for appointment to the Board should submit:

    1. Name, title, and personal resume of the individual requesting consideration, including address, email address and phone number; and

    2. A brief statement of why the person should be considered for appointment to the Board. This statement should also address the individual's relevant international travel and tourism marketing experience and indicate clearly the sector or sectors enumerated above in which the individual has the requisite expertise and experience. Individuals who have the requisite expertise and experience in more than one sector can be appointed for only one of those sectors. Appointments of members to the Board will be made by the Secretary of Commerce.

    3. An affirmative statement that the applicant is a U.S. citizen and further, is not required to register as a foreign agent under the Foreign Agents Registration Act of 1938, as amended, is also required.

    Dated: August 1, 2017. Julie P. Heizer, Deputy Director, National Travel and Tourism Office.
    [FR Doc. 2017-16486 Filed 8-3-17; 8:45 am] BILLING CODE 3510-DR-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration Meeting of the Advisory Committee on Commercial Remote Sensing ACTION:

    Notice of meeting.

    SUMMARY:

    The Advisory Committee on Commercial Remote Sensing (“ACCRES” or “the Committee”) will meet August 24, 2017.

    DATES:

    The meeting is scheduled as follows: August 24, 2017, 9:00 a.m.-4:30 p.m. There will be a one hour lunch break from 11:45 a.m.-12:45 p.m.

    ADDRESSES:

    The meeting will be held at the George Washington University, The Elliot School of International Affairs—Lindner Commons, 1957 E Street NW., Washington, DC 20052.

    FOR FURTHER INFORMATION CONTACT:

    Samira Patel, NOAA/NESDIS/CRSRA, 1335 East West Highway, Room 8247, Silver Spring, Maryland 20910; (301) 713-7077 or [email protected]

    SUPPLEMENTARY INFORMATION:

    As required by Section 10(a)(2) of the Federal Advisory Committee Act, 5 U.S.C. App. 2 (FACA) and its implementing regulations, see 41 CFR 102-3.150, notice is hereby given of the meeting of ACCRES. ACCRES was established by the Secretary of Commerce (Secretary) on May 21, 2002, to advise the Secretary of Commerce through the Under Secretary of Commerce for Oceans and Atmosphere on matters relating to the U.S. commercial remote sensing space industry and on the National Oceanic and Atmospheric Administration's activities to carry out the responsibilities of the Department of Commerce set forth in the National and Commercial Space Programs Act of 2010 (51 U.S.C. 60101 et seq.).

    Purpose of the Meeting and Matters To Be Considered

    The meeting will be open to the public pursuant to Section 10(a)(1) of the FACA. During the meeting, the Committee will receive updates on NOAA's Commercial Remote Sensing Regulatory Affairs activities, discuss updates to the new licensing conditions, and report out on committee task groups. The Committee will also discuss the new draft legislation related to commercial remote sensing activities recently introduced in the U.S. House of Representatives. The Committee will be available to receive public comments on its activities.

    Special Accommodations

    The meeting is physically accessible to people with disabilities. Requests for special accommodations may be directed to Samira Patel, NOAA/NESDIS/CRSRA, 1335 East West Highway, Room 8247, Silver Spring, Maryland 20910; (301) 713-7077 or [email protected]

    Additional Information and Public Comments

    Any member of the public who plans to attend the open meeting should RSVP to Samira Patel at (301) 713-7077, or [email protected] by August 18, 2017. Any member of the public wishing further information concerning the meeting or who wishes to submit oral or written comments should contact Tahara Dawkins, Designated Federal Officer for ACCRES, NOAA/NESDIS/CRSRA, 1335 East West Highway, Room 8260, Silver Spring, Maryland 20910; (301) 713-3385 or [email protected] Copies of the draft meeting agenda can be obtained from Samira Patel at (301) 713-7077, or [email protected]

    ACCRES expects that public statements presented at its meetings will not be repetitive of previously-submitted oral or written statements. In general, each individual or group making an oral presentation may be limited to a total time of five minutes. Written comments sent to NOAA/NESDIS/CRSRA on or before August 18, 2017 will be provided to Committee members in advance of the meeting. Comments received too close to the meeting date will normally be provided to Committee members at the meeting.

    Stephen M. Volz, Assistant Administrator for Satellite and Information Services.
    [FR Doc. 2017-16470 Filed 8-3-17; 8:45 am] BILLING CODE 3510-HR-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XF590 Taking and Importing Marine Mammals; Taking Marine Mammals Incidental to U.S. Navy Marine Structure Maintenance and Pile Replacement in Washington AGENCY:

    National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.

    ACTION:

    Notice; receipt of application for Letters of Authorization; request for comments and information.

    SUMMARY:

    NMFS has received a request from the U.S. Navy (Navy) for authorization to take small numbers of marine mammals incidental to conducting construction activities related to marine structure maintenance and pile replacement at facilities in Washington, over the course of five years from the date of issuance. Pursuant to regulations implementing the Marine Mammal Protection Act (MMPA), NMFS is announcing receipt of the Navy's request for the development and implementation of regulations governing the incidental taking of marine mammals. NMFS invites the public to provide information, suggestions, and comments on the Navy's application and request.

    DATES:

    Comments and information must be received no later than September 5, 2017.

    ADDRESSES:

    Comments on the applications should be addressed to Jolie Harrison, Chief, Permits and Conservation Division, Office of Protected Resources, National Marine Fisheries Service. Physical comments should be sent to 1315 East-West Highway, Silver Spring, MD 20910 and electronic comments should be sent to [email protected]

    Instructions: NMFS is not responsible for comments sent by any other method, to any other address or individual, or received after the end of the comment period. Comments received electronically, including all attachments, must not exceed a 25-megabyte file size. Attachments to electronic comments will be accepted in Microsoft Word or Excel or Adobe PDF file formats only. All comments received are a part of the public record and will generally be posted to the Internet at www.nmfs.noaa.gov/pr/permits/incidental/research.htm without change. All personal identifying information (e.g., name, address) voluntarily submitted by the commenter may be publicly accessible. Do not submit confidential business information or otherwise sensitive or protected information.

    FOR FURTHER INFORMATION CONTACT:

    Ben Laws, Office of Protected Resources, NMFS, (301) 427-8401. An electronic copy of the Navy's application may be obtained online at: www.nmfs.noaa.gov/pr/permits/incidental/construction.htm. In case of problems accessing these documents, please call the contact listed above.

    SUPPLEMENTARY INFORMATION: Background

    Sections 101(a)(5)(A) and (D) of the MMPA (16 U.S.C. 1361 et seq.) direct the Secretary of Commerce (as delegated to NMFS) to allow, upon request, the incidental, but not intentional, taking of small numbers of marine mammals by U.S. citizens who engage in a specified activity (other than commercial fishing) within a specified geographical region if certain findings are made and either regulations are issued or, if the taking is limited to harassment, a notice of a proposed authorization is provided to the public for review.

    An authorization for incidental takings shall be granted if NMFS finds that the taking will have a negligible impact on the species or stock(s), will not have an unmitigable adverse impact on the availability of the species or stock(s) for subsistence uses (where relevant), and if the permissible methods of taking and requirements pertaining to the mitigation, monitoring and reporting of such takings are set forth.

    NMFS has defined “negligible impact” in 50 CFR 216.103 as an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival.

    The MMPA states that the term “take” means to harass, hunt, capture, kill or attempt to harass, hunt, capture, or kill any marine mammal.

    Except with respect to certain activities not pertinent here, the MMPA defines “harassment” as: Any act of pursuit, torment, or annoyance which (i) has the potential to injure a marine mammal or marine mammal stock in the wild (Level A harassment); or (ii) has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering (Level B harassment).

    Summary of Request

    On July 24, 2017, NMFS received an adequate and complete application from the Navy requesting authorization for take of marine mammals incidental to construction activities related to marine structure maintenance and pile replacement at five Naval installations in Washington inland waters. The requested regulations would be valid for five years, from 2018 through 2023. The Navy plans to conduct necessary work, including impact and vibratory pile driving, to repair and maintain existing marine structures at six installations. The proposed action may incidentally expose marine mammals occurring in the vicinity to elevated levels of underwater sound, thereby resulting in incidental take, primarily by Level B harassment but also including some expected potential for Level A harassment. Therefore, the Navy requests authorization to incidentally take marine mammals.

    Specified Activities

    Washington Naval installations covered by this request include Naval Base Kitsap Bangor, Naval Base Kitsap Bremerton, Naval Base Kitsap Keyport, Naval Base Kitsap Manchester, Zelatched Point, and Naval Station Everett. To ensure continuance of necessary missions at these installations, the Navy must conduct annual maintenance and repair activities at existing marine waterfront structures, including removal and replacement of piles of various types and sizes. Exact timing and amount of necessary in-water work is unknown, but the Navy estimates replacing up to 822 structurally unsound piles over the 5-year period, including individual actions currently planned and estimates for future marine structure repairs. Construction will include use of impact and vibratory pile driving, including removal and installation of steel, concrete, plastic, and timber piles.

    Information Solicited

    Interested persons may submit information, suggestions, and comments concerning the Navy's request (see ADDRESSES). NMFS will consider all information, suggestions, and comments related to the request during the development of proposed regulations governing the incidental taking of marine mammals by the Navy, if appropriate.

    Dated: August 1, 2017. Catherine Marzin, Acting Deputy Director, Office of Protected Resources, National Marine Fisheries Service.
    [FR Doc. 2017-16454 Filed 8-3-17; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XF541 Takes of Marine Mammals Incidental to Specified Activities; Taking Marine Mammals Incidental to a Pier Replacement Project in San Diego, CA AGENCY:

    National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.

    ACTION:

    Notice; proposed incidental harassment authorization; request for comments.

    SUMMARY:

    NMFS has received a request from the U.S. Navy (Navy) for authorization to take marine mammals incidental to construction and demolition activities as part of a pier replacement project. Pursuant to the Marine Mammal Protection Act (MMPA), NMFS is requesting comments on its proposal to issue an incidental harassment authorization (IHA) to the Navy to incidentally take marine mammals, by Level B Harassment only, during the specified activity. NMFS will consider public comments prior to making any final decision on the issuance of the requested MMPA authorizations and agency responses will be summarized in the final notice of our decision.

    DATES:

    Comments and information must be received no later than September 5, 2017.

    ADDRESSES:

    Comments on the application should be addressed to Jolie Harrison, Chief, Permits and Conservation Division, Office of Protected Resources, National Marine Fisheries Service. Physical comments should be sent to 1315 East-West Highway, Silver Spring, MD 20910 and electronic comments should be sent to [email protected]

    Instructions: NMFS is not responsible for comments sent by any other method, to any other address or individual, or received after the end of the comment period. Comments received electronically, including all attachments, must not exceed a 25-megabyte file size. Attachments to electronic comments will be accepted in Microsoft Word or Excel or Adobe PDF file formats only. All comments received are a part of the public record and will generally be posted to the Internet at www.nmfs.noaa.gov/pr/permits/incidental/construction.htm without change. All personal identifying information (e.g., name, address) voluntarily submitted by the commenter may be publicly accessible. Do not submit confidential business information or otherwise sensitive or protected information.

    FOR FURTHER INFORMATION CONTACT:

    Laura McCue, Office of Protected Resources, NMFS, (301) 427-8401. Electronic copies of the application and supporting documents, as well as a list of the references cited in this document, may be obtained online at: www.nmfs.noaa.gov/pr/permits/incidental/construction.htm. In case of problems accessing these documents, please call the contact listed above.

    SUPPLEMENTARY INFORMATION: Background

    Sections 101(a)(5)(A) and (D) of the MMPA (16 U.S.C. 1361 et seq.) direct the Secretary of Commerce (as delegated to NMFS) to allow, upon request, the incidental, but not intentional, taking of small numbers of marine mammals by U.S. citizens who engage in a specified activity (other than commercial fishing) within a specified geographical region if certain findings are made and either regulations are issued or, if the taking is limited to harassment, a notice of a proposed authorization is provided to the public for review.

    An authorization for incidental takings shall be granted if NMFS finds that the taking will have a negligible impact on the species or stock(s), will not have an unmitigable adverse impact on the availability of the species or stock(s) for subsistence uses (where relevant), and if the permissible methods of taking and requirements pertaining to the mitigation, monitoring and reporting of such takings are set forth.

    NMFS has defined “negligible impact” in 50 CFR 216.103 as an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival.

    The MMPA states that the term “take” means to harass, hunt, capture, kill or attempt to harass, hunt, capture, or kill any marine mammal.

    Except with respect to certain activities not pertinent here, the MMPA defines “harassment” as: Any act of pursuit, torment, or annoyance which (i) has the potential to injure a marine mammal or marine mammal stock in the wild (Level A harassment); or (ii) has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering (Level B harassment).

    National Environmental Policy Act (NEPA)

    To comply with the National Environmental Policy Act of 1969 (NEPA; 42 U.S.C. 4321 et seq.) and NOAA Administrative Order (NAO) 216-6A, NMFS must review our proposed action (i.e., the issuance of an incidental harassment authorization) with respect to potential impacts on the human environment.

    This action is consistent with categories of activities identified in CE B4 of the Companion Manual for NOAA Administrative Order 216-6A, which do not individually or cumulatively have the potential for significant impacts on the quality of the human environment and for which we have not identified any extraordinary circumstances that would preclude this categorical exclusion. Accordingly, NMFS has preliminarily determined that the issuance of the proposed IHA qualifies to be categorically excluded from further NEPA review.

    We will review all comments submitted in response to this notice prior to concluding our NEPA process or making a final decision on the IHA request.

    Summary of Request

    On June 19, 2017, we received a request from the Navy for an IHA to take marine mammals incidental to pile installation and demolition associated with a pier replacement project in San Diego Bay at Naval Base Point Loma in San Diego, CA (NBPL), including a separate monitoring plan. The Navy also submitted a draft monitoring report on June 13, 2017, pursuant to requirements of the previous IHA. These final application and monitoring plan were deemed adequate and complete on July 20, 2017. The pier replacement project is planned to occur over multiple years; this proposed IHA would cover only the fifth year of work and would be valid for a period of one year from the date of issuance. Hereafter, use of the generic term “pile driving” may refer to both pile installation and removal unless otherwise noted. The Navy's request is for take of nine species of marine mammals by Level B harassment. Neither the Navy nor NMFS expect mortality to result from this activity and, therefore, an IHA is appropriate.

    Monitoring reports are available online at www.nmfs.noaa.gov/pr/permits/incidental/construction.htm and provide environmental information related to proposed issuance of this IHA for public review and comment.

    This proposed IHA would cover one year of a larger project for which the Navy obtained prior IHAs and this request for take authorization is for the fifth year of the project, following the IHAs issued effective from October 8, 2016, through October 7, 2017 (81 FR 66628), September 1, 2013, through August 31, 2014 (78 FR 44539), from October 8, 2014, through October 7, 2015 (79 FR 65378), and from October 8, 2015, through October 7, 2016 (80 FR 62032). The Navy complied with all the requirements (e.g., mitigation, monitoring, and reporting) of the previous IHA. Monitoring reports are available online at www.nmfs.noaa.gov/pr/permits/incidental/construction.htm and provide environmental information related to proposed issuance of this IHA for public review and comment.

    Description of the Specified Activity Overview

    NBPL provides berthing and support services for Navy submarines and other fleet assets. The existing fuel pier serves as a fuel depot for loading and unloading tankers and Navy underway replenishment vessels that refuel ships at sea (“oilers”), as well as transferring fuel to local replenishment vessels and other small craft operating in San Diego Bay, and is the only active Navy fueling facility in southern California. Portions of the pier are over one hundred years old, while the newer segment was constructed in 1942. The pier as a whole is significantly past its design service life and does not meet current construction standards.

    The Navy plans to demolish and remove the existing pier and associated pipelines and appurtenances while simultaneously replacing it with a generally similar structure that meets relevant standards for seismic strength and is designed to better accommodate modern Navy ships. Demolition and construction are planned to occur in two phases to maintain the fueling capabilities of the existing pier while the new pier is being constructed. During the fifth year of construction (the specified activity considered under this proposed IHA), the Navy anticipates construction at two locations: The fuel pier area and at the Naval Mine and Anti-Submarine Warfare Command (NMAWC), where the Navy's Marine Mammal Program (MMP) was temporarily moved during fuel pier construction (see Figure 1-1 in the Navy's application). At the fuel pier, the Navy anticipates finishing all the demolition, including removal of 180 square precast (PC) concrete and poly-concrete piles of varying sizes up to 24-in using a hydraulic pile cutter; cutting 30 66-in and 5 84-in concrete-filled steel caissons with a diamond wire saw; and removing 12 30-in steel piles by cutting with a plasma torch. Only the hydraulic pile cutting and diamond saw cutting of caissons reach Level B acoustic thresholds.

    At the NMAWC, twenty-three 16-in diameter PC concrete guide piles would be driven (by vibratory and/or impact hammer) to restore gangway access to the recreational marina. Sixty-four 16-in diameter round PC concrete guide piles will be removed at NMAWC by jetting followed by dry-pulling; dry pulling does not reach the Level B acoustic thresholds. Table 1 summarizes the construction activities during the fifth year of the Navy's project.

    Table 1—Construction Proposed To Be Complete During Fifth Year of NBPL Project Location and pile type or structure Number Removal/Demolition Pier 180 (Fuel Pier): Poly-concrete and PC concrete piles up to 24-in square 180 66″ concrete filled steel caissons 30 84″ concrete filled steel caissons 5 30″ steel at temporary south dolphin 12 Total—Pier 180 (Fuel Pier) 227 NMAWC: Extract 16″ PC round concrete 64 Total—NMAWC 64 Total Piles Removed 291 Installation NMAWC: 16″ PC concrete guide piles 23 Total Piles Removed 23 Notes: PC = precast.

    The proposed actions with the potential to incidentally harass marine mammals within the waters adjacent to NBPL are vibratory and impact pile installation and certain demolition (i.e., pile removal) techniques. Concurrent use of multiple pile driving rigs is not planned.

    Dates and Duration

    The proposed activities that would be authorized by this IHA, during the fifth year of work associated with the fuel pier project, would occur for one year from the date of issuance of this proposed IHA. Under the terms of a memorandum of understanding (MOU) between the Navy and the U.S. Fish and Wildlife Service (FWS), all noise- and turbidity-producing in-water activities in designated least tern foraging habitat are to be avoided during the period when least terns are present and engaged in nesting and foraging (a window from approximately May 1 through September 15). However, it is possible that in-water work not expected to result in production of significant noise or turbidity (e.g., demolition activities) could occur at any time during the period of validity of this proposed IHA. The conduct of any such work would be subject to approval from FWS under the terms of the MOU. We expect that in-water construction work would primarily occur from October through April. Pile driving would occur during normal working hours (approximately 7 a.m. to 6 p.m.), and would not occur earlier than 45 minutes after sunrise or later than 45 minutes before sunset.

    Specific Geographic Region

    NBPL is located on the peninsula of Point Loma near the mouth and along the northern edge of San Diego Bay (see Figures 1-1 and 1-2 in the Navy's application). San Diego Bay is a narrow, crescent-shaped natural embayment oriented northwest-southeast with an approximate length of 24 kilometers (km) and a total area of roughly 4,500 hectares (ha). The width of the bay ranges from 0.3 to 5.8 km, and depths range from 23 meters (m) mean lower low water (MLLW) near the tip of Ballast Point to less than 2 m at the southern end (see Figure 2-1 of the Navy's application). San Diego Bay is a heavily urbanized area with a mix of industrial, military, and recreational uses. The northern and central portions of the bay have been shaped by historic dredging to support large ship navigation. Dredging occurs as necessary to maintain constant depth within the navigation channel. Outside the navigation channel, the bay floor consists of platforms at depths that vary slightly. Sediments in northern San Diego Bay are relatively sandy as tidal currents tend to keep the finer silt and clay fractions in suspension, except in harbors and elsewhere in the lee of structures where water movement is diminished. Much of the shoreline consists of riprap and manmade structures. San Diego Bay is heavily used by commercial, recreational, and military vessels, with an average of over 80,000 vessel movements (in or out of the bay) per year (not including recreational boating within the Bay) (see Table 2-2 of the Navy's application). For more information about the specific geographic region, please see section 2.3 of the Navy's application.

    Detailed Description of Activities

    In order to provide context, we described the entire project in our Federal Register notice of proposed authorization associated with the first-year IHA (78 FR 30873; May 23, 2013). Please see that document for an overview of the entire fuel pier replacement project, or see the Navy's Environmental Assessment (2013) for more detail. Here, we provide an overview of relevant construction methods before describing only the specific project portions scheduled for completion during the fifth work window. Please see Section 1 of the Navy's application for full detail of construction scheduling for this period. For the fifth year of work, approximately 23 concrete piles would be installed at NMAWC. The Navy does not anticipate needing future IHAs related to completion of construction at NBPL, but would apply for a sixth IHA if construction is not completed under this IHA.

    Methods, Pile Installation—Vibratory hammers, which can be used to either install or extract a pile, contain a system of counter-rotating eccentric weights powered by hydraulic motors and are designed in such a way that horizontal vibrations cancel out, while vertical vibrations are transmitted into the pile. The pile driving machine is lifted and positioned over the pile by means of an excavator or crane, and is fastened to the pile by a clamp and/or bolts. The vibrations produced cause liquefaction of the substrate surrounding the pile, enabling the pile to be extracted or driven into the ground using the weight of the pile plus the hammer. Impact hammers use a rising and falling piston to repeatedly strike a pile and drive it into the ground.

    Non-steel piles are typically impact-driven for their entire embedment depth, in part because non-steel piles are often displacement piles (as opposed to pipe piles) and require some impact to allow substrate penetration. However, jetting may be used to advance displacement piles to a certain embedment depth. Pile jetting utilizes a directed flow of pressurized water to assist in pile placement. The jetting technique liquefies the soils at the pile tip during pile placement, reducing the friction between adjacent sub-grade soil particles around the water jet. This greatly decreases the bearing capacity of the soils below the pile tip, causing the pile to descend toward its final tip elevation with much less soil resistance, largely under its own weight.

    Methods, Pile Removal—There are multiple methods for pile removal. During previous demolition, piles were generally removed by cutting at the mudline, which can be accomplished in various ways. Piles are expected to be removed during this fifth-year IHA primarily using a pile cutter, which is a bladed hydraulic device that shears the pile off. The preferred method of removing the caisson elements is to cut them at the mudline and then into two sections using a diamond wire cutting saw. Existing caisson elements would be removed with a clamshell, which is a dredging bucket consisting of two similar halves that open/close at the bottom and are hinged at the top. The clamshell would be used to grasp and lift large components.

    Piles may also be removed by simply dry pulling, or pulling after the pile has been loosened using a vibratory hammer or a pneumatic chipper. Jetting may be another option to loosen piles that could not be removed through the previous procedures. Pile removal is not generally expected to require the use of vibratory extraction or pneumatic chipping, and these methods are considered as contingency in the event other methods of extraction are not successful.

    Construction—Construction work during the proposed fifth year of activity would include driving of concrete piles to restore dock access at NMAWC following Navy Marine Mammal Program (MMP) removal from NMAWC. This work is expected to require a total of 25 days.

    Demolition—Demolition of the old pier will be completed now that the new pier is operational. Much of the demolition work will be above-water, involving removal of the pier, pilings, plastic camels and fenders, but in-water structure removal will also occur, as described above under Methods, Pile Removal. The in-water portion of demolition work planned during the period of this proposed IHA is expected to require 156 days in total.

    NMAWC—As described above, the Navy also plans to return the MMP to its permanent location near the fuel pier, requiring extraction and installation of concrete piles to return the NMAWC site to its original condition. This work is expected to require 15 days.

    Description of Work Accomplished

    During the first in-water work season (2013-14), two primary activities were conducted: Relocation of the MMP and the Indicator Pile Program (IPP). During the second in-water work season (2014-15), the IPP was concluded and simultaneous construction of the new pier and demolition of the old pier begun. Production pile driving continued during the third in-water work season (2015-16). During the fourth in-water work season (2016-17) pile driving of fender piles and structural piles for the mooring dolphins for the new fuel pier was conducted, including two IPP piles, demolition of the old fuel pier, and pile driving and extraction at NMAWC.

    The Navy MMP, administered by Space and Naval Warfare Systems (SPAWAR) Command Systems Center (SSC), was moved approximately three kilometers to the NMAWC (see Figures 1-1 and 1-2 of the Navy's Year 1 monitoring report). Although not subject to the MMPA, SSC's working animals were temporarily relocated so that they will not be affected by the project. Over the course of 25 in-water construction days from January 28 to March 13, 2014, the Navy removed thirty and installed 81 concrete piles (12- and 16-in). See Table 3-2 of the Navy's Year 1 monitoring report for details. Installation was accomplished via a D19-42 American Pile Driving Equipment, Inc. (APE) diesel hammer with energy capacity of 23,566-42,800 ft-lbs and fitted with a hydraulic tripping cylinder with four adjustable power settings that could be reset while driving. Pile removal was accomplished by jetting and dead pull.

    The IPP was designed to validate the length of pile required and the method of installation (vibratory and impact) as well as to validate acoustic sound pressure levels of the various sizes and locations (i.e., shallow versus deeper water) of installed piles. Nine steel pipe test piles were vibratory- and impact-driven over ten work days from April 28 to May 15, 2014, including two 30-in and seven 36-in piles. All piles were initially installed using an APE Variable Moment 250 VM Vibratory Hammer Extractor powered by a model 765 hydraulic power source creating a maximum driving force of 2,389 kilonewtons (269 tons). Impact pile driving equipment consisted of a single acting diesel impact hammer model D62-22 DELMAG with energy capacity of 76,899-153,799 ft-lbs and fitted with a hydraulic tripping cylinder with four adjustable power settings that could be reset while driving. One additional 36-in pile was installed in Spring 2015, under the Year 2 IHA, to conclude the IPP.

    Production pile driving associated with construction of the new pier was begun in Fall 2014 and continued into Spring 2015. Both vibratory and impact driving was used, as described above, to install 238 steel pipe piles (four 18-in, 31 30-in, and 203 36-in diameter). Hammers used were the same as those described above. Demolition activity began in Spring 2015, and included the removal of four caissons, eighteen concrete fender piles, and a portion of concrete decking from the existing fuel pier. In total, this work consisted of 100 days of activity from October 16, 2014, through April 29, 2015. Of these 100 days of in-water work, 18 days involved only impact driving, 15 days included only vibratory driving, and 65 days where both types of driving occurred. The remaining two days involved only demolition activities. Please see the Year 2 monitoring report for more information.

    Production pile driving continued in early 2016 during three distinct construction periods from January 11 through April 30, 2016, with 161 piles installed over the course of 50 days. Because most structural steel pipe piles were installed under the Year 2 IHA, this work primarily involved placement of non-structural concrete fender piles. Both vibratory and impact driving was used, as described above, to install 132 16-in polycarbonate coated concrete fender piles and 23 24 x 30-in concrete fender piles. In addition, six 30-in steel pipe piles were installed as structural elements to support a mooring dolphin. Hammers used for the steel piles were the same as those described above. The 16-in concrete piles were driven using an APE single action diesel impact hammer model D25-32, with energy capacity of 29,484-58,245 ft-lbs and fitted with a manual power level modulator and shut off trip. The 24 x 30-in concrete piles were driven using an APE single action diesel impact hammer model D80-42, with energy capacity of 127,008-198,450 ft-lbs and fitted with a manual power level modulator and shut off trip. No demolition occurred during this period. Of the 50 days of in-water work, 45 days involved only impact driving, two days included only vibratory driving, and three days where both types of driving occurred. Please see the Year 3 monitoring report for more information.

    Production pile driving during Year 4 construction, from October 8, 2016 to April 30, 2017, included 68 piles of three types of piles driven with two different methods over 34 days: 30-in steel piles were driven with both vibratory and impact hammers, and the 24 x 30-in concrete and 16-in poly-concrete piles were installed with impact hammers. High pressure water jetting were used to “pre-drill” holes for the 24 x 30 in piles. In addition, Structural piles were installed for two dolphins to the south of the new fuel pier, fender piles were installed on the east and west sides of the new fuel pier as well as on one of the dolphins, and a single 16-inch poly-concrete pile (concrete pile lined with a polycarbonate outer sheath) was driven on the west side of the pier.

    Demolition during Year 4 included removal of the caissons from the north side of the old fuel pier, as well as removal of structural and fender piles sizes under, and adjacent to, the south and north sections of the old pier. Eighteen 84-in caissons were cut using a wire saw. A total of 278 piles were clipped, including 14-in, 18-in, and 24-in fender piles and 13-in polycarbonate and poly-concrete piles. Of the 69 days of in-water work, 42 days involved pile clipping and 27 days involved pile cutting. Please see the Year 4 monitoring report for more information.

    Additional work may be conducted under the existing IHA between September 15 and October 7, 2017, in which case the submitted monitoring report would be amended as necessary.

    Proposed mitigation, monitoring, and reporting measures are described in detail later in this document (please see Proposed Mitigation and Proposed Monitoring and Reporting).

    Description of Marine Mammals in the Area of the Specified Activity

    Species with the expected potential to be present during all or a portion of the in-water work window include the California sea lion (Zalophus californianus), harbor seal (Phoca vitulina richardii), northern elephant seal (Mirounga angustirostris), gray whale (Eschrichtius robustus), bottlenose dolphin (Tursiops truncatus truncatus), Pacific white-sided dolphin (Lagenorhynchus obliquidens), Risso's dolphin (Grampus griseus), and either short-beaked or long-beaked common dolphins (Delphinus spp.). California sea lions are present year-round and are very common in the project area, while bottlenose dolphins and harbor seals are common and likely to be present year-round but with more variable occurrence in San Diego Bay. Gray whales may be observed in San Diego Bay sporadically during migration periods. The remaining species are known to occur in nearshore waters outside San Diego Bay, but are generally only rarely observed near or in the bay. However, recent observations indicate that these species may occur in the project area and therefore could potentially be subject to incidental harassment from the aforementioned activities.

    There are four marine mammal species which are either resident or have known seasonal occurrence in the vicinity of San Diego Bay, including the California sea lion, harbor seal, bottlenose dolphin, and gray whale (see Figures 3-1 through 3-4 and 4-1 in the Navy's application). In addition, common dolphins (see Figure 3-4 in the Navy's application), the Pacific white-sided dolphin, Risso's dolphin, and northern elephant seals are known to occur in deeper waters in the vicinity of San Diego Bay and/or have been observed within the bay during the course of this project's monitoring. Although the latter three species of cetacean would not generally be expected to occur within the project area, the potential for changes in occurrence patterns in conjunction with recent observations leads us to believe that authorization of incidental take is warranted. Common dolphins have been documented regularly at the Navy's nearby Silver Strand Training Complex, and were observed in the project area during previous years of project activity. The Pacific white-sided dolphin has been sighted along a previously used transect on the opposite side of the Point Loma peninsula (Merkel and Associates, 2008) and there were several observations of Pacific white-sided dolphins during Year 2 monitoring. Risso's dolphin is fairly common in southern California coastal waters (e.g., Campbell et al., 2010), and could occur in the bay. Northern elephant seals are included based on their continuing increase in numbers along the Pacific coast (Carretta et al., 2016) and the likelihood that animals that reproduce on the islands offshore of Baja California and mainland Mexico—where the population is also increasing—could move through the project area during migration, as well as the observation of a juvenile seal near the fuel pier in April 2015.

    Note that common dolphins could be either short-beaked (Delphinus delphis delphis) or long-beaked (D. delphis bairdii) subspecies. While it is likely that common dolphins observed in the project area would be long-beaked, as it is the most frequently stranded species in the area from San Diego Bay to the U.S.-Mexico border (Danil and St. Leger 2011), the species distributions overlap and it is unlikely that observers would be able to differentiate them in the field. Therefore, we consider that any common dolphins observed—and any incidental take of common dolphins—could be either long- or short-beaked common dolphins.

    In addition, other species that occur in the Southern California Bight may have the potential for isolated occurrence within San Diego Bay or just offshore. In particular, a short-finned pilot whale (Globicephala macrorhynchus) was observed off Ballast Point, and a Steller sea lion (Eumetopias jubatus monteriensis) was seen in the project area during Year 2. These species are not typically observed near the project area and, unlike the previously mentioned species, we do not believe it likely that they will occur in the future. Given the unlikelihood of their exposure to sound generated from the project, these species are not considered further.

    Sections 3 and 4 of the application summarize available information regarding status and trends, distribution and habitat preferences, and behavior and life history, of the potentially affected species. Additional information regarding population trends and threats may be found in NMFS's Stock Assessment Reports (SAR; www.nmfs.noaa.gov/pr/sars/) and more general information about these species (e.g., physical and behavioral descriptions) may be found on NMFS's Web site (www.nmfs.noaa.gov/pr/species/mammals/).

    Table 2 lists all marine mammal species with expected potential for occurrence in the vicinity of NBPL during the project timeframe and summarizes key information, including regulatory status under the MMPA and ESA and potential biological removal (PBR), where known. See also Figures 3-1 through 3-5 of the Navy's application for observed occurrence of marine mammals in the project area. For taxonomy, we follow Committee on Taxonomy (2016). PBR is defined by the MMPA as the maximum number of animals, not including natural mortalities, that may be removed from a marine mammal stock while allowing that stock to reach or maintain its optimum sustainable population (as described in NMFS's SARs). While no mortality is anticipated or authorized here, PBR and annual serious injury and mortality from anthropogenic sources are included here as gross indicators of the status of the species and other threats.

    Marine mammal abundance estimates presented in this document represent the total number of individuals that make up a given stock or the total number estimated within a particular study or survey area. NMFS's stock abundance estimates for most species represent the total estimate of individuals within the geographic area, if known, that comprises that stock. For some species, this geographic area may extend beyond U.S. waters. All managed stocks in this region are assessed in NMFS's U.S. 2016 stock assessment report (SARs) (e.g., NMFS 2016). All values presented in Table 2 are the most recent available at the time of publication and are available in the 2016 SAR (available online at www.nmfs.noaa.gov/pr/sars).

    Table 2—Marine Mammals Potentially Present in the Vicinity of NBPL Species Stock ESA/MMPA status;
  • strategic
  • (Y/N) 1
  • Stock abundance
  • (CV, Nmin, most
  • recent abundance
  • survey) 2
  • PBR 3 Annual M/SI 4 Relative occurrence in San Diego Bay; season of occurrence
    Order Cetartiodactyla—Cetacea—Superfamily Mysticeti (baleen whales) Family Eschrichtiidae Gray whale Eastern North Pacific -; N 20,990 (0.05; 20,125; 2011) 624 132 Occasional migratory visitor; winter. Superfamily Odontoceti (toothed whales, dolphins, and porpoises) Family Delphinidae Bottlenose dolphin California coastal -; N 453 (0.06; 346; 2011) 2.7 ≥2.0 Common; year-round. Short-beaked common dolphin California/Oregon/Washington -; N 969,861 (0.17; 839,325; 2014) 8,393 ≥40 Occasional; year-round (but more common in warm season). Long-beaked common dolphin California -; N 101,305 (0.49; 68,432; 2014) 657 ≥35.4 Occasional; year-round (but more common in warm season). Pacific white-sided dolphin California/Oregon/Washington -; N 26,814 (0.28; 21,195; 2014) 191 7.5 Uncommon; year-round. Risso's dolphin California/Oregon/Washington -; N 6,336 (0.32; 4,817; 2014) 46 ≥3.7 Rare; year-round (but more common in cool season). Order Carnivora—Superfamily Pinnipedia Family Otariidae (eared seals and sea lions) California sea lion U.S. -; N 296,750 (n/a; 153,337; 2011) 9,200 389 Abundant; year-round. Family Phocidae (earless seals) Harbor seal California -; N 30,968 (n/a; 27,348; 2012) 1,641 43 Common; year-round. Northern elephant seal California breeding -; N 179,000 (n/a; 81,368; 2010) 4,882 8.8 Rare; year-round. 1 Endangered Species Act (ESA) status: Endangered (E), Threatened (T)/MMPA status: Depleted (D). A dash (-) indicates that the species is not listed under the ESA or designated as depleted under the MMPA. Under the MMPA, a strategic stock is one for which the level of direct human-caused mortality exceeds PBR (see footnote 3) or which is determined to be declining and likely to be listed under the ESA within the foreseeable future. Any species or stock listed under the ESA is automatically designated under the MMPA as depleted and as a strategic stock. 2 CV is coefficient of variation; Nmin is the minimum estimate of stock abundance. In some cases, CV is not applicable. For certain stocks of pinnipeds, abundance estimates are based upon observations of animals (often pups) ashore multiplied by some correction factor derived from knowledge of the species (or similar species) life history to arrive at a best abundance estimate; therefore, there is no associated CV. In these cases, the minimum abundance may represent actual counts of all animals ashore. 3 Potential biological removal, defined by the MMPA as the maximum number of animals, not including natural mortalities, that may be removed from a marine mammal stock while allowing that stock to reach or maintain its optimum sustainable population size (OSP). 4 These values, found in NMFS' SARs, represent annual levels of human-caused mortality plus serious injury from all sources combined (e.g., commercial fisheries, subsistence hunting, ship strike). Annual M/SI often cannot be determined precisely and is in some cases presented as a minimum value.

    All species that could potentially occur in the proposed survey areas are included in Table 2. As described below, all eight species (with nine managed stocks) temporally and spatially co-occur with the activity to the degree that take is reasonably likely to occur, and we have proposed authorizing it.

    Gray Whale

    Two populations of gray whales are recognized, Eastern and Western North Pacific (ENP and WNP). The two populations have historically been considered geographically isolated from each other; however, recent data from satellite-tracked whales indicates that there is some overlap between the stocks. Two WNP whales were tracked from Russian foraging areas along the Pacific rim to Baja California (Mate et al., 2011), and, in one case where the satellite tag remained attached to the whale for a longer period, a WNP whale was tracked from Russia to Mexico and back again (IWC, 2012). Between 22-24 WNP whales are known to have occurred in the eastern Pacific through comparisons of ENP and WNP photo-identification catalogs (IWC 2012; Weller et al., 2011; Burdin et al., 2011), and WNP animals comprised 8.1 percent of gray whales identified during a recent field season off of Vancouver Island (Weller et al., 2012). In addition, two genetic matches of WNP whales have been recorded off of Santa Barbara, CA (Lang et al., 2011). More recently, Urban et al. (2013) compared catalogs of photo-identified individuals from Mexico with photographs of whales off Russia and reported a total of 21 matches. Therefore, a portion of the WNP population is assumed to migrate, at least in some years, to the eastern Pacific during the winter breeding season.

    However, only ENP whales are expected to occur in the project area. The likelihood of any gray whale being exposed to project sound to the degree considered in this document is already low, as it would require a migrating whale to linger for an extended period of time, or for multiple migrating whales to linger for shorter periods of time. While such an occurrence is not unknown, it is uncommon. Further, of the approximately 20,000 gray whales migrating through the Southern California Bight, it is extremely unlikely that one found in San Diego Bay would be one of the approximately twenty WNP whales that have been documented in the eastern Pacific (less than one percent probability). The likelihood that a WNP whale would be exposed to elevated levels of sound from the specified activities is insignificant and discountable and WNP whales are not considered further in this document.

    Gray whale transitory occurrence inside San Diego Bay is sporadic and unpredictable. A mean group size of 2.9 gray whales was reported for both coastal (16 groups) and non-coastal (15 groups) areas around Southern California Bight. The largest group reported was nine animals. The largest group reported by U.S. Navy (in 1998) was 27 animals (Carretta et al., 2000). Gray whales are not expected in the project area except during the northward migration, when they are closest to the coast (Rice et al., 1981).

    Bottlenose Dolphin

    The California coastal stock of bottlenose dolphin is distinct from the offshore population and is resident in the immediate (within 1 km of shore) coastal waters, occurring primarily between Point Conception, California, and San Quintin, Mexico. Occasionally, during warm-water incursions such as during the 1982-1983 El Niño events, their range extends as far north as San Francisco Bay (Carretta et al., 2017). They are commonly found in groups of 2 to 15 individuals and in larger groups offshore.

    Coastal bottlenose dolphins have occurred sporadically and in highly variable numbers and locations in San Diego Bay. Navy surveys showed that bottlenose dolphins were most commonly sighted in April, and there were more dolphins observed during El Niño years.

    Pacific White-Sided Dolphin

    Pacific white-sided dolphins are endemic to temperate waters of the North Pacific Ocean, and are common both on the high seas and along the continental margins (Carretta et al., 2014). Off the U.S. west coast, Pacific white-sided dolphins occur primarily in shelf and slope waters. Sighting patterns from aerial and shipboard surveys conducted in California, Oregon and Washington suggest seasonal north-south movements, with animals found primarily off California during the colder water months and shifting northward into Oregon and Washington as water temperatures increase in late spring and summer (Carretta et al., 2014).

    Pacific white-sided dolphins are uncommon in San Diego Bay, but observations of this species increased during El Niño years. Monitoring during the Year 2 IHA documented 7 sightings of Pacific white-sided dolphins, comprising 27 individuals, with a mean group size of 3.85 individuals per sighting and an average of 0.28 individuals sighted per day of monitoring.

    Common Dolphin

    Short-beaked common dolphins are the most abundant cetacean off California and are widely distributed between the coast and at least 300 nmi offshore. In contrast, long-beaked common dolphins generally occur within 50 nmi of shore. Both species of common dolphin appear to shift their distributions seasonally and annually in response to oceanographic conditions and prey availability (Carretta et al., 2016). The long-beaked species apparently prefers shallower, warmer water than the short-beaked common dolphin (Perrin 2009). Both tend to be more abundant in coastal waters during warm-water months (Bearzi 2005).

    The occurrence of common dolphins inside San Diego Bay is uncommon (NAVFAC SW and POSD 2013). Small groups were observed briefly on several occasions in the northern part of the bay by Navy monitors during the IPP (May 2014). The animals were moving swiftly and could not be distinguished as to species, but the weight of evidence based on distributions of the two species and previous sightings of the long-beaked species near San Diego is that they were probably long-beaked common dolphins.

    California Sea Lion

    The entire population of California sea lions cannot be counted because all age and sex classes are never ashore at the same time. In lieu of counting all sea lions, pups are counted when all are ashore, in July during the breeding season, and the number of births is estimated from pup counts (Carretta et al., 2016). The size of the population is then estimated from the number of births and the proportion of pups in the population. Based on these censuses, the U.S. stock has generally increased from the early 1900s, to a current estimate of 296,750 (Carretta et al., 2016). There are indications that the California sea lion may have reached or is approaching carrying capacity, although more data are needed to confirm that leveling in growth persists (Carretta et al., 2016).

    The California sea lion is by far the most commonly-sighted pinniped species at sea or on land in the vicinity of NBPL and northern San Diego Bay. The Navy has conducted numerous marine mammal surveys overlapping the north San Diego Bay project area and the potential ZOI for impact and vibratory pile driving operations. California sea lions regularly occur on rocks, buoys and other structures, and especially on bait barges, although numbers vary greatly.

    Harbor Seal

    Harbor seals are considered abundant throughout most of their range from Baja California to the eastern Aleutian Islands. Peak numbers of harbor seals haul-out on land during late May to early June, which coincides with the peak of their molt. Harbor seals do not make extensive pelagic migrations, but do travel hundreds of km on occasion to find food or suitable breeding areas (Carretta et al., 2016). Based on likely foraging strategies, Grigg et al. (2009) reported seasonal shifts in harbor seal movements based on prey availability. In relationship to the entire California stock, harbor seals do not have a significant mainland California distribution south of Point Mugu.

    Harbor seals are relatively uncommon within San Diego Bay. Sightings in the Navy transect surveys of northern San Diego Bay through March 2012, and were limited to individuals outside of the ZOI, on the south side of Ballast Point (TDI 2012b; Jenkins 2012). However, Navy marine mammal monitoring for another project conducted intermittently at Pier 122 from 2010-2014 documented from zero to 4 harbor seals near Pier 122 (within the ZOI) at various times, with the greatest number of sightings during April and May (Jenkins 2012; Bowman 2014). An individual harbor seal was also frequently sighted near NMAWC during 2014 (McConchie 2014).

    Northern Elephant Seal

    A complete population count of elephant seals is not possible because all age classes are not ashore simultaneously. The population is estimated to have grown at 3.8% annually since 1988 (Lowry et al., 2014). Northern elephant seals breed and give birth in California (U.S.) and Baja California (Mexico), primarily on offshore islands. Populations of northern elephant seals in the U.S. and Mexico have recovered after being reduced to near extinction by hunting, undergoing a severe population bottleneck and loss of genetic diversity with the population reduced to only an estimated 10-30 individuals.

    Northern elephant seals occur in the southern California bight, and have the potential to occur in San Diego Bay (NAVFAC SW and POSD 2013), but the only recent documentation of occurrence was of a single distressed juvenile observed on the beach south and inshore of the Fuel Pier during the second year IHA. Given the continuing, long-term increase in the population of northern elephant seals (Lowry et al., 2014), there is an increasing possibility of occurrence in the project area.

    Marine Mammal Hearing

    Hearing is the most important sensory modality for marine mammals underwater, and exposure to anthropogenic sound can have deleterious effects. To appropriately assess the potential effects of exposure to sound, it is necessary to understand the frequency ranges marine mammals are able to hear. Current data indicate that not all marine mammal species have equal hearing capabilities (e.g., Richardson et al., 1995; Wartzok and Ketten 1999; Au and Hastings 2008). To reflect this, Southall et al. (2007) recommended that marine mammals be divided into functional hearing groups based on directly measured or estimated hearing ranges on the basis of available behavioral response data, audiograms derived using auditory evoked potential techniques, anatomical modeling, and other data. Note that no direct measurements of hearing ability have been successfully completed for mysticetes (i.e., low-frequency cetaceans). Subsequently, NMFS (2016) described generalized hearing ranges for these marine mammal hearing groups. Generalized hearing ranges were chosen based on the approximately 65 decibel (dB) threshold from the normalized composite audiograms, with the exception for lower limits for low-frequency cetaceans where the lower bound was deemed to be biologically implausible and the lower bound from Southall et al. (2007) retained. The functional groups and the associated frequencies are indicated below (note that these frequency ranges correspond to the range for the composite group, with the entire range not necessarily reflecting the capabilities of every species within that group):

    Low-frequency cetaceans (mysticetes): Generalized hearing is estimated to occur between approximately 7 Hz and 35 kHz, with best hearing estimated to be from 100 Hz to 8 kHz;

    Mid-frequency cetaceans (larger toothed whales, beaked whales, and most delphinids): Generalized hearing is estimated to occur between approximately 150 Hz and 160 kHz, with best hearing from 10 to less than 100 kHz;

    High-frequency cetaceans (porpoises, river dolphins, and members of the genera Kogia and Cephalorhynchus; including two members of the genus Lagenorhynchus, on the basis of recent echolocation data and genetic data): Generalized hearing is estimated to occur between approximately 275 Hz and 160 kHz.

    Pinnipeds in water; Phocidae (true seals): Generalized hearing is estimated to occur between approximately 50 hertz (Hz) to 86 kilohertz (kHz), with best hearing between 1-50 kHz;

    Pinnipeds in water; Otariidae (eared seals): Generalized hearing is estimated to occur between 60 Hz and 39 kHz, with best hearing between 2-48 kHz.

    The pinniped functional hearing group was modified from Southall et al. (2007) on the basis of data indicating that phocid species have consistently demonstrated an extended frequency range of hearing compared to otariids, especially in the higher frequency range (Hemilä et al., 2006; Kastelein et al., 2009; Reichmuth and Holt 2013).

    For more detail concerning these groups and associated frequency ranges, please see NMFS (2016) for a review of available information. Nine marine mammal species (six cetacean and three pinniped (1 otariid and 2 phocid species)) have the reasonable potential to co-occur with the proposed survey activities. Please refer to Table 2. Of the cetacean species that may be present, one is classified as low-frequency cetaceans (i.e., all mysticete species), and five are classified as mid-frequency cetaceans (i.e., all delphinid and ziphiid species and the sperm whale).

    Potential Effects of the Specified Activity on Marine Mammals and Their Habitat

    This section includes a summary and discussion of the ways that components of the specified activity may impact marine mammals and their habitat. The Estimated Take by Incidental Harassment section later in this document includes a quantitative analysis of the number of individuals that are expected to be taken by this activity. The Negligible Impact Analysis and Determination section considers the content of this section, the Estimated Take by Incidental Harassment section, and the Proposed Mitigation section, to draw conclusions regarding the likely impacts of these activities on the reproductive success or survivorship of individuals and how those impacts on individuals are likely to impact marine mammal species or stocks.

    We provided discussion of the potential effects of the specified activity on marine mammals and their habitat in our Federal Register notices of proposed authorization associated with the first- and second-year IHAs (78 FR 30873; May 23, 2013 and 79 FR 53026; September 5, 2014). The specified activity associated with this proposed IHA is substantially similar to those considered for the first- and second-year IHAs and the potential effects of the specified activity are the same as those identified in those documents. Therefore, we do not reprint the information here but refer the reader to those documents.

    In the aforementioned Federal Register notices, we also provided general background information on sound and marine mammal hearing and a description of sound sources and ambient sound and refer the reader to those documents. However, because certain terms are used frequently in this document, we provide brief definitions of relevant acoustic terminology below:

    Sound pressure level (SPL): Sound pressure is the force per unit area, usually expressed in microPascals (μPa), where one Pascal equals one Newton exerted over an area of one square meter. The SPL is expressed in dB as twenty times the logarithm to the base ten of the ratio between the pressure exerted by the sound to a referenced sound pressure. SPL is the quantity that is directly measured by a sound level meter. For underwater sound, SPL in dB is referenced to one microPascal (re 1 μPa), unless otherwise stated. For airborne sound, SPL in dB is referenced to 20 microPascals (re 20 μPa), unless otherwise stated.

    Frequency: Frequency is expressed in terms of oscillations, or cycles, per second. Cycles per second are commonly referred to as Hz. Typical human hearing ranges from 20 Hz to 20 kHz.

    Peak sound pressure: The instantaneous maximum of the absolute positive or negative pressure over the frequency range from 20 Hz to 20 kHz and presented in dB.

    Root mean square (rms) SPL: For impact pile driving, overall dB rms levels are characterized by integrating sound for each waveform across ninety percent of the acoustic energy in each wave and averaging all waves in the pile driving event. This value is referred to as the rms 90 percent. With this method, the time averaging per pulse varies.

    Sound Exposure Level (SEL): A measure of energy, specifically the dB level of the time integral of the squared-instantaneous sound pressure, normalized to a one second period. It is a useful metric for assessing cumulative exposure because it enables sounds of differing duration, to be compared in terms of total energy. The accumulated SEL (SELcum) is used to describe the SEL from multiple events (e.g., many pile strikes). This can be calculated directly as a logarithmic sum of the individual single-strike SELs for the pile strikes that were used to install the pile.

    Level Z weighted (unweighted), equivalent (LZ eq ): LZeq is a value recorded by the SLM that represents SEL SPL over a specified time period or interval. The LZeq is most typically referred to in one-second intervals or over an entire event.

    Level Z weighted (unweighted), fast (LZF max ): LZFmax is a value recorded by the SLM that represents the maximum rms value recorded for any 125 millisecond time frame during each individual recording.

    Estimated Take

    This section provides an estimate of the number of incidental takes proposed for authorization through this IHA, which will inform both NMFS' consideration of whether the number of takes is “small” and the negligible impact determination. Harassment is the only type of take expected to result from these activities. Except with respect to certain activities not pertinent here, section 3(18) of the MMPA defines “harassment” as: Any act of pursuit, torment, or annoyance which (i) has the potential to injure a marine mammal or marine mammal stock in the wild (Level A harassment); or (ii) has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering (Level B harassment).

    Authorized takes would be by Level B harassment only, in the form of disruption of behavioral patterns for individual marine mammals resulting from exposure to acoustic sources. Based on the nature of the activity and the anticipated effectiveness of the mitigation measures (i.e., shutdown, soft start, etc.—discussed in detail below in Proposed Mitigation section), Level A harassment is neither anticipated nor proposed to be authorized.

    As described previously, no mortality is anticipated or proposed to be authorized for this activity. Below we describe how the take is estimated.

    Described in the most basic way, we estimate take by considering: (1) Acoustic thresholds above which NMFS believes the best available science indicates marine mammals will be behaviorally harassed or incur some degree of permanent hearing impairment; (2) the area or volume of water that will be ensonified above these levels in a day; (3) the density or occurrence of marine mammals within these ensonified areas; and, (4) and the number of days of activities. Below, we describe these components in more detail and present the proposed take estimate.

    Acoustic Thresholds

    Using the best available science, NMFS has developed acoustic thresholds that identify the received level of underwater sound above which exposed marine mammals would be reasonably expected to be behaviorally harassed (equated to Level B harassment) or to incur PTS of some degree (equated to Level A harassment).

    Level B Harassment for non-explosive sources—Though significantly driven by received level, the onset of behavioral disturbance from anthropogenic noise exposure is also informed to varying degrees by other factors related to the source (e.g., frequency, predictability, duty cycle), the environment (e.g., bathymetry), and the receiving animals (hearing, motivation, experience, demography, behavioral context) and can be difficult to predict (Southall et al., 2007). Based on what the available science indicates and the practical need to use a threshold based on a factor that is both predictable and measurable for most activities, NMFS uses a generalized acoustic threshold based on received level to estimate the onset of behavioral harassment. NMFS predicts that marine mammals are likely to be behaviorally harassed in a manner we consider Level B harassment when exposed to underwater anthropogenic noise above received levels of 120 dB re 1 μPa (rms) for continuous (e.g. vibratory pile-driving, drilling) and above 160 dB re 1 μPa (rms) for non-explosive impulsive (e.g., impact pile driving) or intermittent (e.g., scientific sonar) sources.

    The Navy's proposed activity includes the use of continuous (vibratory pile driving, demolition) and impulsive (impact pile driving) sources, and therefore the 120 and 160 dB re 1 μPa (rms) are applicable.

    Level A harassment for non-explosive sources—NMFS's Technical Guidance for Assessing the Effects of Anthropogenic Sound on Marine Mammal Hearing (NOAA 2016) identifies dual criteria to assess auditory injury (Level A harassment) to five different marine mammal groups (based on hearing sensitivity) as a result of exposure to noise from two different types of sources (impulsive or non-impulsive). The Navy's construction project includes the use of impulsive (impact pile driving) and non-impulsive (vibratory pile driving) sources.

    These thresholds were developed by compiling and synthesizing the best available science and soliciting input multiple times from both the public and peer reviewers to inform the final product, and are provided in the table below. The references, analysis, and methodology used in the development of the thresholds are described in NMFS 2016 Technical Guidance, which may be accessed at: http://www.nmfs.noaa.gov/pr/acoustics/guidelines.htm.

    Table 3—Thresholds Identifying the Onset of Permanent Threshold Shift Hearing Group PTS onset acoustic thresholds *
  • (received level)
  • Impulsive Non-impulsive
    Low-frequency cetaceans Cell 1: Lpk,flat: 219 dB; LE,LF,24h: 183 dB Cell 2: LE,LF,24h: 199 dB. Mid-frequency cetaceans Cell 3: Lpk,flat: 230 dB; LE,MF,24h: 185 dB Cell 4: LE,MF,24h: 198 dB. High-frequency cetaceans Cell 5: Lpk,flat: 202 dB; LE,HF,24h: 155 dB Cell 6: LE,HF,24h: 173 dB. Phocid Pinnipeds (underwaters) Cell 7: Lpk,flat: 218 dB; LE,PW,24h: 185 dB Cell 8: LE,PW,24h: 201 dB. Otariid Pinnipeds (underwater) Cell 9: Lpk,flat: 232 dB; LE,OW,24h: 203 dB Cell 10: LE,OW,24h: 219 dB. NMFS 2016.
    Ensonified Area

    Here, we describe operational and environmental parameters of the activity that will feed into identifying the area ensonified above the acoustic thresholds.

    The intensity of pile driving or sounds is greatly influenced by factors such as the type of piles, hammers, and the physical environment in which the activity takes place. For the installation of 30-in steel piles and pile cutting activities, acoustic monitoring during the first and second IHA periods (NAVFAC 2015) resulted in empirical data that are directly applicable to the fifth IHA period in terms of the activities and the location, depth, sizes and types of piles.

    Table 4 identifies the sound source levels that are used in evaluating impact and vibratory pile driving and extraction in the current IHA application. Sound levels for the hydraulic pile cutter, diamond saw caisson cutting, and pile jetting were measured during the fourth IHA period (NAVFAC SW 2017). No acoustic data are available from the vibratory driving of 16-in concrete piles, so the data for vibratory installation of 30-in steel piles from the second IHA period are used as a conservative proxy (NAVFAC SW 2015). Finally, SPLs were measured for the impact driving of 16-in poly-concrete piles during the third IHA monitoring period (NAVFAC SW 2016a), and are used in this application for the same activities.

    Table 4—Underwater Sound Pressure Levels From Similar In Situ Monitored Construction Activities From Previous Years Project and location Pile size and type Method Water depth Measured sound pressure levels (rms) at 10 m
  • (dB re 1 μPa)
  • Mean 1 Max 2
    NBPL Fuel Pier, San Diego, CA 13 to 24-in concrete Hydraulic pile cutting 9 m (30 ft) 145 165.3 NBPL Fuel Pier, San Diego, CA 66- and 84-in steel caisson Diamond saw cutting 9 m (30 ft) 149 155.6 NBPL Fuel Pier, San Diego, CA 24-in concrete Jetting 9 m (30 ft) 155 159.9 NBPL Fuel Pier, San Diego, CA 30-in Steel Pipe Vibratory 9 m (30 ft) 162.5 3 162.5 NBPL Fuel Pier, San Diego, CA 16-in Poly-Concrete Impact 9 m (30 ft) 188.9 4 195 1 Mean source levels used from data from previous monitoring reports (NAVFAC SW 2015, 2016a, 2017). Mean source levels were used to calculate Level B ZOIs. 2 Maximum source levels used from data from previous monitoring reports (NAVFAC SW 2015, 2016a, 2017). Max source levels were used to calculate Level A ZOIs. Maximum source levels used were proposed by the Navy. 3 Mean source levels for 30-in steel pipe piles were used as a proxy to calculate ZOIs for vibratory driving of 16-in concrete guide piles (NAVFAC SW 2015). 4 The maximum source level is included for reference only. The distance to the Level B ZOI is based on in situ data collected for 16-in poly-concrete piles and was documented in NAVFAC SW (2016a).

    Scarce data exists on airborne and underwater noise levels associated with vibratory hammer extraction. However, it can reasonably be assumed that vibratory extraction emits SPLs that are no higher than SPLs caused by vibratory hammering of the same materials, and results in lower SPLs than caused by impact hammering comparable piles. For this application, the same value (162.5 dB re 1μPa) that was obtained for vibratory hammering of the 30-in steel piles at the Fuel Pier (NAVFAC SW 2015) is used for the vibratory hammering of 16-in round concrete piles at NMAWC. None of the peak SPLs for the various sound sources reach the injury thresholds identified in the new NMFS (2016) Technical Guidance; therefore, injury from peak sound levels is not considered further.

    Table 6 provides the calculated areas of Level A and Level B ZOIs associated with the impulsive and continuous sounds that are anticipated during the fifth-year IHA period. Table 5 provides the data that were used to calculate the distances to the Level A and B ZOIs presented in Table 6. It should be noted that the ZOI for Level A harassment would be closely monitored and subject to shutdowns if a marine mammal enters the area. The ZOI areas and maximum distances for the activities at the fuel pier and NMAWC are shown in Figures 6-1 and 6-2, respectively of the Navy's application. The figures reflect the conventional assumption that the natural or manmade shoreline acts as a barrier to underwater sound. It is generally accepted practice to model underwater sound propagation from pile driving as continuing in a straight line past a shoreline projection such as Ballast Point (Dahl 2012). Similarly, it is reasonable to assume that project sound would not propagate east of Zuniga Jetty (Dahl 2012).

    All of the ZOIs for potential Level A acoustic harassment (Table 6) would be buffered and encompassed by a larger shutdown zone. For example, the ZOIs for potential Level A acoustic harassment to pinnipeds from impact pile driving (Table 6) would be contained within a 60 m (196 ft) shutdown zone. For impact pile driving at NMAWC, two methods identified in NMFS (2016) were evaluated to determine the most conservative distances to the Level A ZOIs using: (1) rms SPL source levels; and (2) single strike equivalent SEL. The calculations showed that the first method was the most conservative and this method was subsequently used to determine the distances to the Level A ZOIs (Table 5). In all Level A ZOI calculations, the default values for the weighting factor adjustment and practical spreading for propagation loss were used (see Appendix A of the Navy's application).

    Table 5—Data Used To Calculate Distances to Level B ZOIs Activity Impact pile driving Vibratory pile driving Pile jetting Caisson cutting Pile clipping References for Source Level and Duration Year 3 report #1 (NAVFAC SW 2016a) Year 2 report (NAVFAC SW 2015) Year 4 report (NAVFAC SW 2017) Year 3 report #1 (NAVFAC SW 2016a) Year 4 report (NAVFAC SW 2017). Size & Type of Piles used for Source Data 16-in poly-concrete piles 30-in steel piles 24x30-in concrete piles 84-in caissons 24-in concrete piles. Source Level (rms SPL) 188.9 162.5 159.9 155.6 165.3. Distance to Level B ZOI (m) 270 1,848 1,165 631 2,511.

    The Level B ZOIs and distances are based on the validated SPLs directly measured during the IHA monitoring (NAVFAC SW 2014-2017), as available. For example, the distance to the Level B ZOI for impact driving of 16-in poly-concrete piles was 270 m (886 ft) during Year 3 monitoring (NAVFAC SW 2016a). In cases where monitoring data are not available to empirically measure the extent of the Level B ZOI (activities at NMAWC), “practical spreading loss” from the source at 10 m has been assumed (15 log[distance/10]) and used to calculate the maximum extent of the ZOI based on the applicable threshold. Computed distances to the threshold for acoustic disturbance from non-impulsive sources are based on the distances at which the project sound source declines to ambient. Because the mean ambient sound levels in San Diego Bay range from approximately 128 to 130 dB rms (NAVFAC SW 2015), the 120 dB acoustic threshold for the Level B ZOIs are based on an approximate value between 128 and 129 dB. The distances for all activities producing sound at NMAWC will be verified via hydrophone during project activities.

    Table 6—Calculated Maximum Areas of ZOIs and Distances to Relevant Thresholds Activity Measured/calculated distances to thresholds (m) and areas of ZOIs
  • (m2 or km2)
  • Underwater Level A 123 LF MF PW OW Level B 4 160 dB 120 dB 5 Airborne Level B 100 dB 6 90 dB 6
    Old Fuel Pier and Temporary Mooring Dolphin Demolition 66-inch and 84-inch caissons (Diamond saw cutting) 3.6 m
  • 41 m2
  • 0.3 m
  • <1 m2
  • 2.2 m
  • 15 m2
  • 0.2m
  • <1 m2
  • N/A 631 m
  • 0.7157 km2
  • N/A
    Concrete piles (Pile clipping) 1.2 m
  • 4 m2
  • 0.1 m
  • <1 m2
  • 0.7 m
  • < 1 m2
  • 0.0 m
  • 0 m2
  • N/A 2,511 m
  • 4.4512 km2
  • NMAWC Construction and Demolition 16-inch concrete piles (Vibratory extraction/driving) 8 8.3 m
  • 216 m2
  • 0.7 m
  • <1 m2
  • 5.1 m
  • 82 m2
  • 0.4 m
  • <1 m2
  • N/A 1,848 m
  • 2.4473 km2
  • 42 m
  • 5,503 m2
  • 149 m
  • 69,646 m2
  • 16-inch concrete piles (Impact driving) 9 63.4 m
  • 0.0126 km2
  • 2.3 m
  • 17 m2
  • 33.9 m
  • 3,610 m2
  • 2.5 m
  • 20 m2
  • 270 m
  • 0.1408 km2
  • N/A
    16-inch concrete piles (Jetting pile extraction) 3.9 m
  • 47.8 m2
  • 0.3 m
  • <1 m2
  • 2.4 m
  • 18 m2
  • 0.2 m
  • <1 m2
  • N/A 1,165m
  • 1.4268 km2
  • N/A
    1 If measured value thresholds are less than 10 m (33 ft), a minimum monitoring distance of 10 m (33 ft) would be implemented. 2 Based on measured mean source levels. The relevant data have been included in Appendix A of the Navy's application, which provides information from previous years' data collected as part of the Fuel Pier Project (NAVFAC SW 2015, 2016a, 2017). 3 LF = Low-frequency cetaceans; MF = Mid-frequency cetaceans; PW = Phocid pinnipeds; OW = Otariid pinnipeds. The high-frequency cetacean hearing group (HF) is omitted, because no species in the hearing group occur in, or around, the Project area. 4 Based on measured maximum source levels, unless otherwise stated. The relevant data have been included in Appendix A, which provides information from previous years' data collected as part of the Fuel Pier Project (NAVFAC SW 2015, 2016a, 2017). 5 Average ambient sound levels in San Diego Bay are approximately 128 to 130 dB rms (NAVFAC SW 2015), and all 120 dB Level B ZOIs are based on an approximate value between 128 and 129, which represents ambient levels in the Bay. 6 Airborne ZOIs based on conservative representative data (collected during 30-inch vibratory pile driving from IHA #4). Airborne noise levels did not exceed thresholds during IHA #4 monitoring of demolition activities. 7 Plasma torch noise levels are not expected to exceed underwater or airborne regulatory thresholds. 8 Based on conservative representative source levels of 162.5 dB rms (30-inch steel vibratory pile driving, NAVFAC SW 2015).
    Airborne Sound

    Although sea lions are known to haul-out regularly on man-made objects in the vicinity of the project site (see Figure 4-1 of the Navy's application), and harbor seals are occasionally observed hauled out on rocks along the shoreline in the vicinity of the project site, none of these are within the ZOIs for airborne sound, and we believe that incidents of take resulting solely from airborne sound are unlikely. The zones for sea lions are within the minimum shutdown zone defined for underwater sound and, although the zones for harbor seals are larger, they have not been observed to haul out as readily on man-made structure in the immediate vicinity of the project site. There is a possibility that an animal could surface in-water, but with head out, within one of the defined zones and thereby be exposed to levels of airborne sound that we associate with harassment, but any such occurrence would likely be accounted for in our estimation of incidental take from underwater sound.

    We generally recognize that pinnipeds occurring within an estimated airborne harassment zone, whether in the water or hauled out, could be exposed to airborne sound that may result in behavioral harassment. However, any animal exposed to airborne sound above the behavioral harassment threshold is likely to also be exposed to underwater sound above relevant thresholds (which are typically in all cases larger zones than those associated with airborne sound). Thus, the behavioral harassment of these animals is already accounted for in these estimates of potential take. Multiple incidents of exposure to sound above NMFS' thresholds for behavioral harassment are not believed to result in increased behavioral disturbance, in either nature or intensity of disturbance reaction. Therefore, we do not believe that authorization of incidental take resulting from airborne sound for pinnipeds is warranted, and airborne sound is not discussed further here. Distances associated with airborne sound and shown in Table 5 are for reference only.

    When NMFS Technical Guidance (2016) was published, in recognition of the fact that ensonified area/volume could be more technically challenging to predict because of the duration component in the new thresholds, we developed a User Spreadsheet that includes tools to help predict a simple isopleth that can be used in conjunction with marine mammal density or occurrence to help predict takes. We note that because of some of the assumptions included in the methods used for these tools, we anticipate that isopleths produced are typically going to be overestimates of some degree, which will result in some degree of overestimate of Level A take. However, these tools offer the best way to predict appropriate isopleths when more sophisticated 3D modeling methods are not available, and NMFS continues to develop ways to quantitatively refine these tools, and will qualitatively address the output where appropriate. For stationary sources such as vibratory pile driving, NMFS User Spreadsheet predicts the closest distance at which, if a marine mammal remained at that distance the whole duration of the activity, it would not incur PTS. Inputs used in the User Spreadsheet, and the resulting isopleths are reported below.

    Table 7—Level A User Spreadsheet Input Impact pile driving Vibratory pile driving Caisson cutting Pile clipping Pile jetting References for Source Level and Duration Year 3 report #1 (NAVFAC SW 2016a) Year 2 report (NAVFAC SW 2015) Year 3 report #1 (NAVFAC SW 2016a) Year 4 report (NAVFAC SW 2017) Year 4 report (NAVFAC SW 2017). Spreadsheet Tab Used (E.1) Impact pile driving (A.) Non-Impulse Stat-Cont (A.) Non-Impulse Stat-Cont (A.) Non-Impulse Stat-Cont (A.) Non-Impulse Stat-Cont. Source Level (Single Strike/shot SEL) 188.9 162.5 149 145 155. Weighting Factor Adjustment (kHz) 2 2.5 2.5 2.5 2.5. (a) Activity Duration (h) within 24-h period 0.71 0.95 6 2.82 1.74. Propagation (xLogR) 15 15 15 15 15. Distance of source level measurement (m) 10 10 10 10 10. Pulse duration (sec) 1 0.03 n/a n/a n/a n/a. Number of strikes in 1 h 193 n/a n/a n/a n/a. 1 Pulse duration was measured in previous construction years and the average pulse duration was 0.03 at 10 m (NAVFAC SW 2016a). Marine Mammal Occurrence

    In this section we provide the information about the presence, density, or group dynamics of marine mammals that will inform the take calculations.

    For all species, the best scientific information available was considered for use in the marine mammal take assessment calculations. Although various regional offshore surveys for marine mammals have been conducted, it is unlikely that these data would be representative of the species or numbers that may be encountered in San Diego Bay. However, the Navy has conducted a large number of ongoing site-specific marine mammal surveys during appropriate seasons (e.g., Merkel and Associates 2008; Johnson 2010, 2011; Lerma 2012, 2014). Whereas analyses for the first-year IHA relied on surveys conducted from 2007-12, continuing surveys by the Navy have generally indicated increasing abundance of all species and the second-year IHA relied on 2012-14 survey data. In addition, the Navy has developed estimates of marine mammal densities in waters associated with training and testing areas (including Hawaii-Southern California) for the Navy Marine Species Density Database (NMSDD). A technical report (Hanser et al., 2015) describes methodologies and available information used to derive these densities, which are based upon the best available information, except where specific local abundance information is available and applicable to a specific action area. The document is publicly available online at: nwtteis.com/DocumentsandReferences/NWTTDocuments/SupportingTechnicalDocuments.aspx (accessed July 13, 2017).

    Year 2 project monitoring showed even greater abundance of certain species, and we consider all of these data in order to provide the most up-to-date estimates for marine mammal abundances during the period of this proposed IHA. Although Years 3 and 4 project monitoring showed declines in marine mammal abundance in the vicinity of the project, we retain prior density estimates as a conservative measure for estimating exposure. Density information is shown in Table 9. These data are from dedicated line-transect surveys, required project marine mammal monitoring, opportunistic observations for more rarely observed species (see Figures 3-1 through 3-5 of the Navy's application), or the NMSDD.

    Take Calculation and Estimation

    Here we describe how the information provided above is brought together to produce a quantitative take estimate.

    The following assumptions are made when estimating potential incidences of take:

    • All marine mammal individuals potentially available are assumed to be present within the relevant area, and thus incidentally taken;

    • An individual can only be taken once during a 24-h period;

    • The assumed ZOIs and days of activity are as shown in Table 5; and,

    • Exposures to sound levels at or above the relevant thresholds equate to take, as defined by the MMPA.

    In this case, the estimation of marine mammal takes uses the following calculation:

    Exposure estimate = n * ZOI * days of total activity Where: n = density estimate used for each species/season. ZOI = sound threshold ZOI area; the area encompassed by all locations where the SPLs equal or exceed the threshold being evaluated.

    The ZOI impact area is estimated using the relevant distances in Table 5, assuming that sound radiates from a central point in the water column slightly offshore of the existing pier and taking into consideration the possible affected area due to topographical constraints of the action area (i.e., radial distances to thresholds are not always reached).

    Table 8—Areas of Acoustic Influence and Days of Activity Activity Number of days ZOI
  • (km2)
  • 66-inch and 84-inch caissons (Diamond saw cutting) 50 0.7157 Concrete piles (Pile clipping) 100 4.4512 16-inch concrete piles (Vibratory extraction/driving) 1 25 2.4473 16-inch concrete piles (Jetting pile extraction) 15 1.4268 1 We assume that impact driving of 16-in concrete piles would always occur on the same day as vibratory driving of the same piles. Therefore, the impact driving ZOI (0.1408 km2) would always be subsumed by the vibratory driving ZOI.

    There are a number of reasons why estimates of potential incidents of take may be conservative, assuming that available density and estimated ZOI areas are accurate. We assume, in the absence of information supporting a more refined conclusion, that the output of the calculation represents the number of individuals that may be taken by the specified activity. In fact, in the context of stationary activities such as pile driving and in areas where resident animals may be present, this number more realistically represents the number of incidents of take that may accrue to a smaller number of individuals. While pile driving can occur any day throughout the period of validity, and the analysis is conducted on a per day basis, only a fraction of that time (typically a matter of hours on any given day) is actually spent pile driving. The potential effectiveness of mitigation measures in reducing the number of takes is typically not quantified in the take estimation process. For these reasons, these take estimates may be conservative. See Table 9 for total estimated incidents of take.

    California Sea Lion

    During the second IHA period, an average of 90.35 California sea lions were seen per day within the maximum ZOI for pile driving, an area of 5.6752 km2 extending 3,000 m from the Fuel Pier. This equates to a density of 15.9201/km2. This density is used to estimate numbers of takes within the different ZOIs. NMFS estimates 8,971 Level B takes for this species. The maximum extents of the potential acoustic Level A ZOIs for cumulative exposure from all of the activities are much less than 10 m from the source, and therefore the 60-m shutdown zone will reduce the chance for Level A take. As a result, no Level A take of California sea lions is anticipated nor proposed to be authorized.

    Harbor Seal

    Sightings of harbor seals averaged 2.83 individuals per day during the period of the second IHA (NAVFAC SW 2015), a density of 0.4987/km2 within the maximum ZOI for pile driving. This density is used to estimate numbers of takes within the different ZOIs. NMFS estimates 281 Level B takes for this species. The maximum extent of the potential acoustic Level A ZOI for cumulative exposure from impact pile driving extends 34 m from the source; for all other activities, the Level A ZOIs are much less than 10 m from the source, therefore a 60-m shutdown zone will be in place to avoid Level A takes to harbor seals. Level A takes are not anticipated nor proposed for authorization.

    Northern Elephant Seal

    Only a single individual elephant seal was sighted during the second IHA period (NAVFAC SW 2015), but with increasing numbers (Carretta et al., 2016), they are considered a reasonable possibility to occur more frequently during the fifth IHA period. The regional density estimate of 0.0760/km2 (Navy 2017) is assumed for the project area. This density is used to estimate numbers of takes within the different ZOIs. NMFS estimates 43 Level B takes for this species. Potential takes would likely involve single individuals that are on the shoreline or structures at the identified location, or swimming in the vicinity, most likely near the mouth of the bay. The maximum extent of the potential acoustic Level A ZOI for cumulative exposure from impact pile driving extends 34 m from the source; for all other activities, the Level A ZOIs are much less than 10 m from the source, therefore a shutdown will be in place to avoid Level A takes to harbor seals. Level A takes are not anticipated nor proposed for authorization.

    Bottlenose Dolphin

    Coastal bottlenose dolphins can occur at any time of year in northern San Diego Bay. Numbers sighted have been highly variable but have increased in recent years (NAVFAC SW 2014, 2015). During the second IHA period, an average of 7.09 individuals was seen per day, a density of 1.2493/km2. This density is used to estimate numbers of takes within the different ZOIs. NMFS estimates 704 Level B takes for this species. The maximum extents of the potential acoustic Level A ZOIs for cumulative exposure from all of the activities are much less than 10 m from the source, and therefore the minimum 10 m shutdown will reduce the chance for Level A take. As a result, no Level A take of bottlenose dolphins is anticipated nor proposed to be authorized.

    Common Dolphin

    An average of 8.67 common dolphins was seen per day, a density of 1.5277/km2 within the maximum ZOI, during the second IHA period (NAVFAC SW 2015). This density is considerably higher than the regional density estimate for long-beaked common dolphins—the species most likely to occur (Navy 2017), but is reasonable for the project area given the group sizes observed for these species. Barlow (2010) reported average group sizes in southern California of 122 for short-beaked common dolphins and 195 for long-beaked common dolphins, and during the second IHA period, groups of approximately 170 and 300 individuals entered the project area on different occasions (NAVFAC SW 2015). Considering the possibility for one or more large groups of common dolphins to enter San Diego Bay during in-water activities and the fact that the Level B ZOIs will extend completely across the bay during pile driving, the density estimate is considered appropriate. A density of 1.5277/km2 is used to estimate numbers of takes within the different ZOIs. NMFS estimates 861 Level B takes for this species. The maximum extents of the potential acoustic Level A ZOIs for cumulative exposure from all of the activities are much less than 10 m from the source, and therefore the shutdown will reduce the chance for Level A take. As a result, no Level A take of bottlenose dolphins is anticipated nor proposed to be authorized.

    Pacific White-Sided Dolphin

    Pacific white-sided dolphins are more commonly seen offshore, but were documented in the project area on several occasions during the second IHA period. An average of 0.28 individuals per day was seen during the second IHA period (NAVFAC SW 2015), a density of 0.0493/km2 within the maximum ZOI. This density is used to estimate numbers of takes within the different ZOIs. NMFS estimates 28 Level B takes for this species. The maximum extents of the potential acoustic Level A ZOIs for cumulative exposure from all of the activities are much less than 10 m from the source, and therefore the shutdown will reduce the chance for Level A take. As a result, no Level A take of bottlenose dolphins is anticipated nor proposed to be authorized.

    Risso's Dolphin

    While there have been no sightings of Risso's dolphin within the project area, the species is considered a reasonable possibility for the fifth IHA period given recent El Niño conditions (Shane 1995) and its abundance in Southern California coastal waters (Jefferson et al. 2014). The upper limit of the regional density estimate, 0.2029/km2 (Navy 2017), is used to estimate numbers of takes within the different ZOIs. NMFS estimates 114 Level B takes for this species. The maximum extents of the potential acoustic Level A ZOIs for cumulative exposure from all of the activities are much less than 10 m from the source, and therefore the shutdown will reduce the chance for Level A take. As a result, no Level A take of bottlenose dolphins is anticipated nor proposed to be authorized.

    Gray Whale

    Gray whale occurrence within northern San Diego Bay is sporadic and would likely consist of one-few individuals that venture close to, or enter the bay for a brief period, and then continue on their migration. A density estimate based on the rare sightings of gray whales near the mouth of the bay during the second IHA period (NAVFAC SW 2015), would be less than 0.01/km2, which is slightly less than the regional density estimate of 0.0179/km2 in southern California waters during winter-spring (Navy 2017). The regional density estimate is applied here as a reasonable estimate given the possibility of animals moving closer to shore and entering the mouth of the bay during the fifth IHA period. This density is used to estimate numbers of takes within the different ZOIs. NMFS estimates 10 Level B takes for this species. The maximum extent of the potential acoustic Level A ZOI for cumulative exposure from impact pile driving extends 63 m from the source; for all other activities, the Level A ZOIs are much less than 10 m from the source. Gray whales are not expected to occur that close to the source; however, the Navy has proposed a minimum of 10 m (100 m for impact driving) shutdown will be in place to avoid Level A takes to gray whales. Level A takes are not anticipated nor proposed for authorization.

    Table 9—Calculations for Incidental Take Estimation Species Density Diamond saw cutting of 66-inch and 84-inch caissons Pile clipping concrete piles Vibratory
  • extraction/
  • driving of 16-inch concrete piles
  • Jetting pile extraction of 16 in concrete piles Total Level B takes * Total proposed authorized takes
  • (% of total stock)
  • California sea lion 15.9201 570 7086 974 341 8,971 3.023 Harbor seal 0.4987 18 222 31 11 281 0.907 Northern elephant seal 0.076 3 34 5 2 43 0.024 Bottlenose dolphin 1.2493 45 556 76 27 704 2 155 Common dolphin 1.5277 55 680 93 33 861 3 0.088; 4 0.85 Pacific white-sided dolphin 0.0493 2 22 3 1 28 0.104 Risso's dolphin 0.2027 7 90 12 4 114 1.799 Gray whale 0.0179 1 8 1 0 10 0.048 * Due to rounding of takes to the nearest whole number of animals, (which occurs at the very end, not per activity), totals may not always equal the sum of the takes from individual activities. 1 We assume that impact driving of steel piles would occur on the same day as vibratory driving of the same piles and that the zone for vibratory driving would always subsume the zone for impact driving. Therefore, separate estimates are not provided for impact driving of steel piles. 2 The proposed numbers of authorized take for bottlenose dolphins are higher relative to the total stock abundance estimate and would not represent small numbers if a significant portion of the take was for a new individual. However, these numbers represent the estimated incidents of take, not the number of individuals taken. That is, it is likely that a relatively small subset of California coastal bottlenose dolphins would be incidentally harassed by project activities. 3 SB = short-beaked common dolphin. 4 LB = long-beaked common dolphin.
    Proposed Mitigation

    In order to issue an IHA under section 101(a)(5)(D) of the MMPA, NMFS must set forth the permissible methods of taking pursuant to such activity, and other means of effecting the least practicable impact on such species or stock and its habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance, and on the availability of such species or stock for taking for certain subsistence uses (latter not applicable for this action). NMFS regulations require applicants for incidental take authorizations to include information about the availability and feasibility (economic and technological) of equipment, methods, and manner of conducting such activity or other means of effecting the least practicable adverse impact upon the affected species or stocks and their habitat (50 CFR 216.104(a)(11)).

    In evaluating how mitigation may or may not be appropriate to ensure the least practicable adverse impact on species or stocks and their habitat, as well as subsistence uses where applicable, we carefully consider two primary factors:

    (1) The manner in which, and the degree to which, the successful implementation of the measure(s) is expected to reduce impacts to marine mammals, marine mammal species or stocks, and their habitat. This considers the nature of the potential adverse impact being mitigated (likelihood, scope, range). It further considers the likelihood that the measure will be effective if implemented (probability of accomplishing the mitigating result if implemented as planned) the likelihood of effective implementation (probability implemented as planned). And;

    (2) The practicability of the measures for applicant implementation, which may consider such things as cost, impact on operations, and, in the case of a military readiness activity, personnel safety, practicality of implementation, and impact on the effectiveness of the military readiness activity.

    The mitigation strategies described below largely follow those required and successfully implemented under the first four IHAs associated with this project. For this proposed IHA, data from acoustic monitoring conducted during the first four years of work was used to estimate zones of influence (ZOIs; see Estimated Take by Incidental Harassment); these values were used to develop mitigation measures for pile driving activities at NBPL. The ZOIs effectively represent the mitigation zone that would be established around each pile to minimize Level A harassment to marine mammals, while providing estimates of the areas within which Level B harassment might occur. In addition, the Navy has defined buffers to the estimated Level A harassment zones to further reduce the potential for Level A harassment. In addition to the measures described later in this section, the Navy would conduct briefings between construction supervisors and crews, marine mammal monitoring team, acoustic monitoring team, and Navy staff prior to the start of all pile driving activity, and when new personnel join the work, in order to explain responsibilities, communication procedures, marine mammal monitoring protocol, and operational procedures.

    Monitoring and Shutdown for Pile Driving

    The following measures would apply to the Navy's mitigation through shutdown and disturbance zones:

    Shutdown Zone—For all pile driving and removal activities, the Navy will establish a shutdown zone intended to contain the area in which SPLs equal or exceed the calculated Level A zones (refer to table). The purpose of a shutdown zone is to define an area within which shutdown of activity would occur upon sighting of a marine mammal (or in anticipation of an animal entering the defined area), thus preventing injury of marine mammals (serious injury or death are unlikely outcomes even in the absence of mitigation measures). Estimated radial distances to the relevant thresholds are shown in Table 5. For certain activities, the shutdown zone would not exist because source levels indicate that the radial distance to the threshold would be less than 10 m. However, a minimum shutdown zone of 10 m will be established during all pile driving and removal activities, regardless of the estimated zone. In addition the Navy proposes to effect a buffered shutdown zone that is intended to significantly reduce the potential for Level A harassment given that, in particular, California sea lions are quite abundant in the project area and bottlenose dolphins may surface unpredictably and move erratically in an area with a large amount of construction equipment. These buffers are approximately double the distance to the Level A ZOI. These zones are also shown in Table 10. These precautionary measures are intended to prevent the already unlikely possibility of physical interaction with construction equipment and to establish a precautionary minimum zone with regard to acoustic effects.

    Table 10—Shutdown Zones for Level A ZOIs and Monitoring Zones for Level B Zones Activity Monitored distances to thresholds (meters [feet]) Underwater Level A (shutdown) LF 1 MF 1 PW 1 OW 1 Level B 160 dB 120 dB 2 Old Fuel Pier and Temporary Mooring Dolphin Demolition 66-inch and 84-inch caissons (Diamond saw cutting) 10 N/A 631 Concrete piles (Pile clipping) 10 N/A 2,511 NMAWC Construction and Demolition 16-inch concrete piles (Vibratory extraction/driving) 20 4 10 N/A 1,848 16-inch concrete piles (Impact driving) 100 5 60 6 857.7 N/A 16-inch concrete piles (Jetting pile extraction) 10 N/A 1,165 16-inch concrete piles (Pile dead-pull) 10 N/A 1 LF = Low-frequency cetaceans; MF = Mid-frequency cetaceans; PW = Phocid pinnipeds; OW = Otariid pinnipeds. The high-frequency cetacean hearing group (HF) is omitted, because no species in the hearing group occur in, or around, Project area. 2 Mean ambient sound levels in San Diego Bay are approximately 128 dB rms (NAVFAC SW 2015), and all 120 dB Level B ZOIs are based on the ambient value. The distances for all activities producing sound at NMAWC will be verified via hydrophone during project activities. 3 Airborne noise levels did not exceed regulatory thresholds during previous IHAs. No airborne monitoring will take place for diamond saw cutting of caissons, plasma torch cutting of temporary mooring dolphin 30-inch steel piles, jetting or dead-pull extraction of concrete piles. 4 Includes buffer of calculated Level A threshold out to 20 m (65.6 ft). 5 Includes buffer of calculated Level A threshold out to 100 m (328 ft). 6 Includes buffer of calculated Level A threshold out to 60 m (328 ft).

    Disturbance Zone—Disturbance zones are the areas in which SPLs equal or exceed 160 and 120 dB rms (for impulse and continuous sound, respectively). Disturbance zones provide utility for monitoring conducted for mitigation purposes (i.e., shutdown zone monitoring) by establishing monitoring protocols for areas adjacent to the shutdown zones. Monitoring of disturbance zones enables observers to be aware of and communicate the presence of marine mammals in the project area but outside the shutdown zone and thus prepare for potential shutdowns of activity. However, the primary purpose of disturbance zone monitoring is for documenting incidents of Level B harassment; disturbance zone monitoring is discussed in greater detail later (see Proposed Monitoring and Reporting). Nominal radial distances for disturbance zones are shown in Table 10.

    In order to document observed incidents of harassment, monitors record all marine mammal observations, regardless of location. The observer's location, as well as the location of the pile being driven, is known from a GPS. The location of the animal is estimated as a distance from the observer, which is then compared to the location from the pile. If acoustic monitoring is being conducted for that pile, a received SPL may be estimated, or the received level may be estimated on the basis of past or subsequent acoustic monitoring. It may then be determined whether the animal was exposed to sound levels constituting incidental harassment in post-processing of observational and acoustic data, and a precise accounting of observed incidences of harassment created. Therefore, although the predicted distances to behavioral harassment thresholds are useful for estimating incidental harassment for purposes of authorizing levels of incidental take, actual take may be determined in part through the use of empirical data.

    Acoustic measurements will continue during the fifth year of project activity and zones would be adjusted as indicated by empirical data. Please see the Navy's Acoustic and Marine Species Monitoring Plan (Monitoring Plan; available at www.nmfs.noaa.gov/pr/permits/incidental/construction.htm) for full details.

    Monitoring Protocols—Monitoring would be conducted before, during, and after pile driving activities. In addition, observers shall record all incidents of marine mammal occurrence, regardless of distance from activity, and shall document any behavioral reactions in concert with distance from piles being driven. Observations made outside the shutdown zone will not result in shutdown; that pile segment would be completed without cessation, unless the animal approaches or enters the shutdown zone, at which point all pile driving activities would be halted. Monitoring will take place from fifteen minutes prior to initiation through thirty minutes post-completion of pile driving activities. Pile driving activities include the time to remove a single pile or series of piles, as long as the time elapsed between uses of the pile driving equipment is no more than thirty minutes. Please see the Monitoring Plan for full details of the monitoring protocols.

    The following additional measures apply to visual monitoring:

    (1) Monitoring will be conducted by qualified observers, who will be placed at the best vantage point(s) practicable (as defined in the Monitoring Plan) to monitor for marine mammals and implement shutdown/delay procedures when applicable by calling for the shutdown to the hammer operator. Qualified observers are trained biologists, with the following minimum qualifications:

    (a) Visual acuity in both eyes (correction is permissible) sufficient for discernment of moving targets at the water's surface with ability to estimate target size and distance; use of binoculars may be necessary to correctly identify the target;

    (b) Ability to conduct field observations and collect data according to assigned protocols;

    (c) Experience or training in the field identification of marine mammals, including the identification of behaviors;

    (d) Sufficient training, orientation, or experience with the construction operation to provide for personal safety during observations;

    (e) Writing skills sufficient to prepare a report of observations including but not limited to the number and species of marine mammals observed; dates and times when in-water construction activities were conducted; dates and times when in-water construction activities were suspended to avoid potential incidental injury from construction sound of marine mammals observed within a defined shutdown zone; and marine mammal behavior; and

    (f) Ability to communicate orally, by radio or in person, with project personnel to provide real-time information on marine mammals observed in the area as necessary.

    (2) Prior to the start of pile driving activity, the shutdown zone will be monitored for fifteen minutes to ensure that it is clear of marine mammals. Pile driving will only commence once observers have declared the shutdown zone clear of marine mammals; animals will be allowed to remain in the shutdown zone (i.e., must leave of their own volition) and their behavior will be monitored and documented. The shutdown zone may only be declared clear, and pile driving started, when the entire shutdown zone is visible (i.e., when not obscured by dark, rain, fog, etc.). In addition, if such conditions should arise during impact pile driving that is already underway, the activity would be halted.

    (3) If a marine mammal approaches or enters the shutdown zone during the course of pile driving operations, activity will be halted and delayed until either the animal has voluntarily left and been visually confirmed beyond the shutdown zone or fifteen minutes have passed without re-detection of small cetaceans or pinnipeds and 30 minutes for gray whales. Monitoring will be conducted throughout the time required to drive a pile and for thirty minutes following the conclusion of pile driving.

    Sound Attenuation Devices

    The use of bubble curtains to reduce underwater sound from impact pile driving was considered prior to the start of the project but was determined to not be practicable. Use of a bubble curtain in a channel with substantial current may not be effective, as unconfined bubbles are likely to be swept away and confined curtain systems may be difficult to deploy effectively in high currents. Data gathered during monitoring of construction on the San Francisco-Oakland Bay Bridge indicated that no reduction in the overall linear sound level resulted from use of a bubble curtain in deep water with relatively strong current (Illingworth & Rodkin 2001). During project monitoring for pile driving associated with the Richmond-San Rafael Bridge, also in San Francisco Bay, it was observed that performance in moderate current was significantly reduced (Oestman et al., 2009). Lucke et al. (2011) also note that the effectiveness of most currently used curtain designs may be compromised in stronger currents and greater water depths. We believe that conditions (relatively deep water and strong tidal currents of up to 3 knots (kn)) at the project site would disperse the bubbles and compromise the effectiveness of sound attenuation.

    Timing Restrictions

    In-order to avoid impacts to least tern populations when they are most likely to be foraging and nesting, in-water work will be concentrated from October 1-April 1 or, depending on circumstances, to April 30. However, this limitation is in accordance with agreements between the Navy and FWS, and is not a requirement of this proposed IHA. All in-water construction activities would occur only from 45 minutes after sunrise to 45 minutes before sunset.

    Soft Start

    The use of a soft start procedure is believed to provide additional protection to marine mammals by warning or providing a chance to leave the area prior to the hammer operating at full capacity, and typically involves a requirement to initiate sound from the hammer at reduced energy followed by a waiting period. This procedure is repeated two additional times. It is difficult to specify the reduction in energy for any given hammer because of variation across drivers and, for impact hammers, the actual number of strikes at reduced energy will vary because operating the hammer at less than full power results in “bouncing” of the hammer as it strikes the pile, resulting in multiple “strikes.” The project will utilize soft start techniques for impact pile driving. We require an initial set of three strikes from the impact hammer at reduced energy, followed by a thirty-second waiting period, then two subsequent three strike sets. Soft start will be required at the beginning of each day's impact pile driving work and at any time following a cessation of impact pile driving of thirty minutes or longer; the requirement to implement soft start for impact driving is independent of whether vibratory driving has occurred within the prior thirty minutes.

    Based on our evaluation of the Navy's proposed measures, as well as any other potential measures that may be relevant to the specified activity, we have preliminarily determined that the proposed mitigation measures provide the means of effecting the least practicable impact on marine mammal species or stocks and their habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance.

    Proposed Monitoring and Reporting

    In order to issue an IHA for an activity, section 101(a)(5)(D) of the MMPA states that NMFS must set forth “requirements pertaining to the monitoring and reporting of such taking.” The MMPA implementing regulations at 50 CFR 216.104(a)(13) indicate that requests for incidental take authorizations must include the suggested means of accomplishing the necessary monitoring and reporting that will result in increased knowledge of the species and of the level of taking or impacts on populations of marine mammals that are expected to be present in the proposed action area. Effective reporting is critical both to compliance as well as ensuring that the most value is obtained from the required monitoring.

    Monitoring and reporting requirements prescribed by NMFS should contribute to improved understanding of one or more of the following:

    • Occurrence of marine mammal species or stocks in the area in which take is anticipated (e.g., presence, abundance, distribution, density).

    • Nature, scope, or context of likely marine mammal exposure to potential stressors/impacts (individual or cumulative, acute or chronic), through better understanding of: (1) Action or environment (e.g., source characterization, propagation, ambient noise); (2) Affected species (e.g., life history, dive patterns); (3) Co-occurrence of marine mammal species with the action; or (4) Biological or behavioral context of exposure (e.g., age, calving or feeding areas).

    • Individual marine mammal responses (behavioral or physiological) to acoustic stressors (acute, chronic, or cumulative), other stressors, or impacts from multiple stressors.

    • How anticipated responses to stressors impact either: (1) Long-term fitness and survival of an individual; or (2) Population, species, or stock.

    • Effects on marine mammal habitat (e.g. marine mammal prey species, acoustic habitat, or other important physical components of marine mammal habitat).

    • Mitigation and monitoring effectiveness.

    Please see the Monitoring Plan (available at www.nmfs.noaa.gov/pr/permits/incidental/construction.htm) for full details of the requirements for monitoring and reporting. Notional monitoring locations (for biological and acoustic monitoring) are shown in Figures 3-1 and 3-2 of the Plan. The purpose of this Plan is to provide protocols for acoustic and marine mammal monitoring implemented during pile driving and removal activities. We have preliminarily determined this monitoring plan, which is summarized here and which largely follows the monitoring strategies required and successfully implemented under the previous IHAs, to be sufficient to meet the MMPA's monitoring and reporting requirements. The previous monitoring plan was modified to integrate adaptive changes to the monitoring methodologies as well as updates to the scheduled construction activities. Monitoring objectives are as follows:

    • Monitor in-water construction activities, including the implementation of in-situ acoustic monitoring efforts to continue to measure SPLs from in-water construction and demolition activities not previously monitored or validated during the previous IHAs. This would include collection of acoustic data for activities and pile types for which sufficient data has not previously been collected, including for diamond saw cutting of caissons and pile clipping of the concrete piles during fuel pier demolition. The Navy also plans to collect acoustic data for vibratory extraction and/or driving, impact driving, jetting pile extraction and pile dead-pull of the concrete piles at NMAWC.

    • Monitor marine mammal occurrence and behavior during in-water construction activities to minimize marine mammal impacts and effectively document marine mammals occurring within ZOI boundaries.

    Collection of ambient underwater sound measurements in the absence of project activities has been concluded, as a rigorous baseline dataset for the project area has been developed.

    Acoustic Measurements

    The primary purpose of acoustic monitoring is to empirically verify modeled injury and behavioral disturbance zones (defined at radial distances to NMFS-specified thresholds; see Estimated Take by Incidental Harassment). For non-pulsed sound, distances will continue to be evaluated for attenuation to the point at which sound becomes indistinguishable from background levels. Empirical acoustic monitoring data will be used to document transmission loss values determined from past measurements and to examine site-specific differences in SPL and affected ZOIs on an as needed basis.

    Should monitoring results indicate it is appropriate to do so, marine mammal mitigation zones may be revised as necessary to encompass actual ZOIs. Acoustic monitoring will be conducted as specified in the approved Monitoring Plan. Please see Table 2-2 of the Plan for a list of equipment to be used during acoustic monitoring. Monitoring locations will be determined based on results of previous acoustic monitoring effort and the best professional judgment of acoustic technicians.

    For activities such as demolition of the old fuel pier and temporary mooring dolphin, the Navy will continue to collect in situ acoustic data to validate source levels and ZOIs. Environmental data would be collected including but not limited to: Wind speed and direction, air temperature, humidity, surface water temperature, water depth, wave height, weather conditions and other factors that could contribute to influencing the airborne and underwater sound levels (e.g., aircraft, boats). Full details of acoustic monitoring requirements may be found in section 4.2 of the Navy's Monitoring Plan.

    Visual Marine Mammal Observations

    The Navy will collect sighting data and behavioral responses to construction for marine mammal species observed in the region of activity during the period of activity. All observers will be trained in marine mammal identification and behaviors and are required to have no other construction-related tasks while conducting monitoring. The Navy will monitor the shutdown zone and disturbance zone before, during, and after pile driving as described under Proposed Mitigation and in the Monitoring Plan, with observers located at the best practicable vantage points. Notional monitoring locations are shown in Figures 3-3 and 3-4 of the Navy's Plan. Please see that plan, available at www.nmfs.noaa.gov/pr/permits/incidental/construction.htm, for full details of the required marine mammal monitoring. Section 3.2 of the Plan and Section 13 of the Navy's application offer more detail regarding monitoring protocols. Based on our requirements, the Navy would implement the following procedures for pile driving:

    • MMOs would be located at the best vantage point(s) in order to properly see the entire shutdown zone and as much of the disturbance zone as possible.

    • During all observation periods, observers will use binoculars and the naked eye to search continuously for marine mammals.

    • If the shutdown zones are obscured by fog or poor lighting conditions, pile driving at that location will not be initiated until that zone is visible. Should such conditions arise while impact driving is underway, the activity would be halted.

    • The shutdown and disturbance zones around the pile will be monitored for the presence of marine mammals before, during, and after any pile driving or removal activity.

    One MMO will be placed in the most effective position near the active construction/demolition platform in order to observe the respective shutdown zones for vibratory and impact pile driving or for applicable demolition activities. Monitoring would be primarily dedicated to observing the shutdown zone; however, MMOs would record all marine mammal sightings beyond these distances provided it did not interfere with their effectiveness at carrying out the shutdown procedures. Additional land, pier, or vessel-based MMOs will be positioned to monitor the shutdown zones and the buffer zones, as notionally indicated in Figures 3-3 and 3-4 of the Navy's application.

    For all pile driving and applicable demolition activities, a minimum of one observer shall monitor the shutdown zones. However, any action requiring the impact or vibratory hammer will necessitate two MMOs. For impact and vibratory pile driving of 16-in concrete piles, two observers shall be positioned for optimal monitoring of the surrounding waters.

    The MMOs will record all visible marine mammal sightings. Confirmed takes will be registered once the sightings data has been overlaid with the isopleths identified in Table 5 and visualized in Figures 6-2, 6-3, and 6-4 of the Navy's application, or based on refined acoustic data, if amendments to the ZOIs are needed. Acousticians on duty may be noting SPLs in real-time, but, to avoid biasing the observations, will not communicate that information directly to the MMOs. These platforms may move closer to, or farther from, the source depending on whether received SPLs are less than or greater than the regulatory threshold values. All MMOs will be in radio communication with each other so that the MMOs will know when to anticipate incoming marine mammal species and when they are tracking the same animals observed elsewhere.

    If any species for which take is not authorized is observed by a MMO during applicable construction or demolition activities, all construction will be stopped immediately. Pile driving will commence if the animal has not been seen inside the Level B ZOI for at least one hour of observation. If the animal is resighted again, pile driving will be stopped and a boat-based MMO (if available) will follow the animal until it has left the Level B ZOI. If the animal is resighted again, pile driving will be stopped and a boat-based MMO (if available) will follow the animal until it has left the Level B ZOI.

    Individuals implementing the monitoring protocol will assess its effectiveness using an adaptive approach. Monitoring biologists will use their best professional judgment throughout implementation and seek improvements to these methods when deemed appropriate. Any modifications to protocol will be coordinated between NMFS and the Navy.

    Data Collection

    We require that observers use approved data forms. Among other pieces of information, the Navy will record detailed information about any implementation of shutdowns, including the distance of animals to the pile and description of specific actions that ensued and resulting behavior of the animal, if any. In addition, the Navy will attempt to distinguish between the number of individual animals taken and the number of incidents of take. We require that, at a minimum, the following information be collected on the sighting forms:

    • Date and time that monitored activity begins or ends;

    • Construction activities occurring during each observation period;

    • Weather parameters (e.g., percent cover, visibility);

    • Water conditions (e.g., sea state, tide state);

    • Species, numbers, and, if possible, sex and age class of marine mammals;

    • Description of any observable marine mammal behavior patterns, including bearing and direction of travel and distance from pile driving activity, and if possible, the correlation to measured SPLs;

    • Distance from pile driving activities to marine mammals and distance from the marine mammals to the observation point;

    • Description of implementation of mitigation measures (e.g., shutdown or delay);

    • Locations of all marine mammal observations; and

    • Other human activity in the area.

    In addition, photographs would be taken of any gray whales observed. These photographs would be submitted to NMFS' West Coast Regional Office for comparison with photo-identification catalogs to determine whether the whale is a member of the WNP population.

    Reporting

    A draft report would be submitted to NMFS within 45 calendar days of the completion of marine mammal monitoring, or 60 days prior to the issuance of any subsequent IHA for this project, whichever comes first. The report will include marine mammal observations pre-activity, during-activity, and post-activity during pile driving days, and will also provide descriptions of any behavioral responses to construction activities by marine mammals and a complete description of all mitigation shutdowns and the results of those actions. A final report would be prepared and submitted within thirty days following resolution of comments on the draft report. Required contents of the monitoring reports are described in more detail in the Navy's Acoustic and Marine Species Monitoring Plan.

    Monitoring Results From Previously Authorized Activities

    The Navy complied with the mitigation and monitoring required under the previous authorizations for this project. Acoustic and marine mammal monitoring was implemented as required, with marine mammal monitoring occurring before, during, and after each pile driving event. During the course of Year 4 activities, the Navy did not exceed the take levels authorized under the IHA (please see the Navy's monitoring report for more details and below for further discussion).

    The general objectives of the monitoring plan were similar to those described above for the Year 5 monitoring plan. For acoustic monitoring, the primary goal was to continue to collect in situ data towards validation of the acoustic ZOIs defined based on previous data collection efforts and using the transmission loss modeling effort conducted prior to the start of the project, and to continue collection of data on background noise conditions in San Diego Bay.

    Acoustic Monitoring Results—For a full description of acoustic monitoring methodology, please see section 2.3 of the Navy's monitoring report, including Figure 2-3 for representative monitoring locations. Results from Years 1-4 are displayed in Table 11. Please see our notices of proposed IHAs for the Years 2, 3, and 4 IHAs (79 FR 53026, September 5, 2014; 80 FR 53115, September 2, 2015; and 81 FR 66628, September 28, 2016) or the Navy's Year 1 and 2 monitoring reports for more detailed description of monitoring accomplished during the first two years of the project.

    For acoustic monitoring associated with impact pile driving, continuous hydroacoustic monitoring systems were positioned at source (10 m from the pile) and opportunistically at predicted 160-dB Level B ZOIs. The far-field data collections were conducted at multiple locations during impact driving of 16-in concrete-filled poly piles and 24 x 30-in concrete fender piles, i.e., approximately 20 to 550 m from source. Hydrophones were deployed from the dock, barge, or moored vessel at half the water depth. The SPLs for driving of 30-in steel pipe piles were measured intermittently and archived (but not reported) because associated SPLs for the size, type, and location of the piles were previously validated. Source SPLs were recorded and analyzed for a minimum of five piles for each of the concrete pile types. Additional measurements were archived.

    SPLs of pile driving and demolition activities conducted during Year 2 fell within expected levels but varied spatially relative to the existing fuel pier structure and maximum source levels for individual piles (Table 11). For both vibratory and impact pile driving methods, results from the IPP (Year 1) and 2014/2015 production pile driving (Year 2) showed that transmission loss for piles driven in shallow water inside of the existing fuel pier was greater than piles driven in deep water outside of the existing pier. Differences in depth, sediment type, and existing in-water pier/wharf structures likely accounted for variations in transmission loss and measured differences in SPLs recorded at the shutdown and far-field locations for shallow versus deep piles of the same type and size. SPLs documented during vibratory and impact pile driving of shallow and deep steel pipe piles of the same size displayed notable differences in SPLs at shutdown range and to a lesser extent at source.

    Measurements of impact driving of concrete piles conducted during Year 3 produced greater than expected SPLs at source. Differences in the subsurface conditions may account for the discrepancy, as a hardened layer is found at approximately 20-40 m below the mudline. SPLs documented during driving of 16-in piles generally displayed relatively low sound source levels during initial driving then appreciable increases observed once the piles interacted with this layer. Measurements from driving of the square concrete piles showed greatest sound source levels during initial impact pile driving, which then decreased once the piles transitioned through the hardened layer. While source SPLs were observed to be greater than expected for both pile types, attenuation was also greater. Despite greater than expected source levels, the measured isopleth distances were similar to modeled predictions. Far-field impact pile driving results varied substantially between piles and locations for the various pile sizes, types, and locations. Both pile types were driven adjacent to the new fuel pier and source SPLs were subject to a wide variety of boundary conditions from recently driven piles and associated pier infrastructure. Further detail and discussion is provided in the Navy's report.

    During Year 4, measurements were conducted for pile clipping, caisson cutting, pile jetting, and airborne vibratory and impact driving. The average SPLs for pile clipping at source ranged from 138.0 to 144.6 dB rms, with maximum SPLs at source ranging from 156.1 to 165.3 dB rms (see Table 6-3 of the Navy's monitoring report). Measurements were conducted on eight piles and took one to three minutes to cut.

    Caisson demolition was conducted on 18 84-in concrete-filled caissons, with an average duration of approximately 6 hours per caisson. Underwater acoustic data was collected for seven caissons using the vibratory setting. For some of the recordings, there were two caissons being cut simultaneously and the acousticians captured the SPLs for comparison between a single cutter versus two cutters. If two cutters were running, the distance measured was from the closest caisson to the location. Average SPLs at source for a single cutter were 136.1 and 141.4 dB rms. Maximum SPLs at source for a single cutter were 140.9 and 146.5 dB rms. Average SPLs at source for two cutters running simultaneously were 146.5 and 149.0 dB rms. Maximum SPLs at source for two cutters running simultaneously were 149.0 and 155.6 dB rms. On average, there was a 10 dB difference between a single cutter and two at source. Far-field recordings for a single cutter were collected at far-field locations ranging from 20 to 430 m (66 to 1,411 ft), with documented maximum SPL values from 136.6 to 145.5 dB rms. Far-field recordings for two cutters were also collected at far-field locations ranging from 85 to 810 m (279 to 2,657 ft), with documented maximum SPL values from 133.2 to 146.8 dB rms.

    SPLs of pile installation activities for the 24 x 30 concrete piles had not been previously documented. The only jetting data collected during the Project was at NMAWC during the removal of 12-inch and 16-inch concrete piles. A total of sixteen 24 x 30 concrete non-structural fender piles were driven using two techniques: (1) Method 1 (M1) utilized a custom-made spud jet with four nozzles welded to the tip that used a high-pressure water system (900 gallons per minute with a maximum pounds per square inch [psi] of 300), to make the initial break through the bay point formation sediment layer; and (2) Method 2 (M2) used the 24 x 30 pile, outfitted with two pipes inside the full length of the pile, which then used a high-pressure water system (maximum psi of 300) to remove sediment and place the pile. Pile jetting averaged 24.5 minutes per pile and acoustic recordings were collected for the entire duration. Collection of underwater acoustic data were completed on six piles using the vibratory setting. For M1, the average sound pressure levels (SPL) at source ranged from 152.6 dB rms to 155.1 dB rms, and maximum SPLs at source ranged from 156.5 dB rms to 159.9 dB rms. For M2, the average SPL at source ranged from 133.0 dB to 149.8 dB and maximum SPLs at source ranged from 137.1 dB to 153.2 dB rms. A vessel based drift method was used to obtain far-field recordings during M1 and M2 jetting techniques; the vessel was initially positioned at the closest feasible distance to source, and then the allowed to drift on the natural tidal current until near ambient sound pressure levels were obtained. The SPLs at far-field for the first drift during jetting M1 reached near ambient at 165 m (541 ft) from pile with an SPL of 128.0 dB. The SPLs at far-field for the first drift during pile jetting M2 reached near ambient at 80 m (262 ft) from pile with an SPL of 127.6 dB. Recordings during the vessel drifts showed that jetting reached near ambient levels for both methods between 80 m (262 ft) and 165 m (541 ft; M1 and M2, respectively).

    Airborne sound levels were recorded during vibratory pile driving on fourteen 30-inch steel piles. The maximum recorded airborne dB rms values at source was 106.3 dB re 20 μPa, and average values ranged from 96.0 to 102.7 dB re 20 μPa. Airborne sound levels were recorded during impact pile driving on sixteen 30-inch steel piles. The maximum recorded airborne dB values at source was 118.5 dB re 20 μPa, and average values ranged from 105.8 to 112.5 dB re 20 μPa. Further detail and discussion is provided in the Navy's report.

    Table 11—Acoustic Monitoring Results for Year 4 Location Activity Pile type Number
  • of piles
  • measured
  • Average
  • underwater
  • SPL at 10 m
  • (dB rms)
  • Average
  • airborne SPL
  • (LZFmax) 1
  • Fuel Pier (Year 4) Pile Clipping 24-in square concrete pile 4 141 Caisson Demolition (1 cutter) 84-in caisson 10 136 Caisson Demolition (2 cutters) 84-in caisson 8 138 Vibratory 30-in steel (at source) 7 100 Vibratory 30-in steel (far field) 7 86 Impact 30-in steel (at source) 9 110 Impact 30-in steel (far field) 7 88 NMAWC (Year 4) Pile Jetting 24x30 10 147 1 Measured from Source (15.2 m) and Far-field Distances for 30-inch Steel Piles.

    Marine Mammal Monitoring Results—Marine mammal monitoring was conducted as required under the IHA and as described in the Year 4 monitoring plan and in our Federal Register notice of proposed authorization associated with the Year 4 IHA. For a full description of monitoring methodology, please see section 2 of the Navy's monitoring report, including Figure 2-1, 2-2, and 2-7 for representative monitoring locations and Figures 2-2 through 2-5 for monitoring zones. Monitoring protocols were managed adaptively during the course of the fourth-year IHA. Multiple shutdowns were implemented due to marine mammals being observed within buffered shutdown zones, but no animals were observed within actual predicted Level A harassment zones while pile driving was occurring (one harbor seal was seen within the Level A ZOI after a shutdown of construction had been implemented).

    Monitoring results are presented in Table 12. The Navy recorded all observations of marine mammals, including pre- and post-construction monitoring efforts. Animals observed during these periods or that were determined to be outside relevant ZOIs were not considered to represent incidents of take. Please see Figures 3-11, 3-12, 3-22, 3-23, 3-30, and 3-31 of the Navy's Monitoring Report for locations of observations and incidents of take relative to the project sites. Take authorization for the second-year authorization was informed by an assumption that 115 days of in-water construction would occur, whereas only fifty total days actually occurred. However, the actual observed rates per day were in all cases lower than what was assumed. Therefore, we expect that the Navy would not have exceeded the take allowances even if the full 115 days had been reached.

    There were considerably fewer individuals and sightings during the Year 3 IHA when compared to the same months during the Year 2 IHA, and only three species were observed. This may be due to environmental fluctuations as part of the on-going El Niño event. Water temperatures during Year 3 were warmer than during the same months during Year 2. Although the temperatures were still higher than the average water temperatures for the region prior to the current El Niño event, it shows that the event may have been dissipating. In addition, California sea lion strandings decreased. No evidently significant behavioral changes were reported.

    Similar to Year 3, there were considerably fewer individuals and sightings during the Year 4 IHA when compared to the same months during the Year 2 IHA, and only four species were observed. This may be due to environmental fluctuations as part of the on-going El Niño event. Water temperatures during Year 4 were slightly warmer than during the same months during Year 2. Although the temperatures were still higher than the average water temperatures for the region prior to the current El Niño event, it shows that the event may have been dissipating. In addition, California sea lion strandings decreased, but may be returning to numbers more commonly observed. No evidently significant behavioral changes were reported.

    Table 12—Marine Mammal Monitoring Results for Year 4 Species Total
  • sightings
  • Total
  • individuals
  • Observed
  • incidents
  • of Level B take
  • Extrapolated incidents of Level B
  • take 1
  • Total
  • estimated Level B take
  • California sea lion 717 2,037 156 1,835 1,991 Harbor seal 87 102 21 57 78 Bottlenose dolphin 18 45 4 144 148 Gray whale 1 1 0 13 13 1 Assumed density and unmonitored area of assumed Level B ZOI used with actual pile driving time to generate assumed take for unmonitored areas.
    Negligible Impact Analysis and Determination

    NMFS has defined negligible impact in 50 CFR 216.103 as an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival. A negligible impact finding is based on the lack of likely adverse effects on annual rates of recruitment or survival (i.e., population-level effects). An estimate of the number of takes alone is not enough information on which to base an impact determination. In addition to considering estimates of the number of marine mammals that might be “taken” through harassment, NMFS considers other factors, such as the likely nature of any responses (e.g., intensity, duration), the context of any responses (e.g., critical reproductive time or location, migration), as well as effects on habitat, and the likely effectiveness of the mitigation. We also assess the number, intensity, and context of estimated takes by evaluating this information relative to population status. Consistent with the 1989 preamble for NMFS's implementing regulations (54 FR 40338; September 29, 1989), the impacts from other past and ongoing anthropogenic activities are incorporated into this analysis via their impacts on the environmental baseline (e.g., as reflected in the regulatory status of the species, population size and growth rate where known, ongoing sources of human-caused mortality, or ambient noise levels).

    Construction and demolition activities associated with the pier replacement project, as outlined previously, have the potential to disturb or displace marine mammals. Specifically, the specified activities may result in take, in the form of Level B harassment (behavioral disturbance) only, from underwater sounds generated from pile driving. Potential takes could occur if individuals of these species are present in the ensonified zone when pile driving or removal is happening.

    No injury, serious injury, or mortality is anticipated given the nature of the activity and measures designed to minimize the possibility of injury to marine mammals. The potential for these outcomes is minimized through the construction method and the implementation of the planned mitigation measures. Impact pile driving produces short, sharp pulses with higher peak levels and much sharper rise time to reach those peaks. When impact driving is necessary, required measures (implementation of buffered shutdown zones) significantly reduce any possibility of injury. Given sufficient “notice” through use of soft start (for impact driving), marine mammals are expected to move away from a sound source that is annoying prior to its becoming potentially injurious. The likelihood that marine mammal detection ability by trained observers is high under the environmental conditions described for San Diego Bay (approaching 100 percent detection rate, as described by trained biologists conducting site-specific surveys) further enables the implementation of shutdowns to avoid injury, serious injury, or mortality.

    Effects on individuals that are taken by Level B harassment, on the basis of reports in the literature as well as monitoring from past years of this project and other similar activities, will likely be limited to reactions such as increased swimming speeds, increased surfacing time, or decreased foraging (if such activity were occurring) (e.g., Thorson and Reyff, 2006; HDR, 2012; Lerma, 2014). Most likely, individuals will simply move away from the sound source and be temporarily displaced from the areas of pile driving, although even this reaction has been observed primarily only in association with impact pile driving. In response to vibratory driving, pinnipeds (which may become somewhat habituated to human activity in industrial or urban waterways) have been observed to orient towards and sometimes move towards the sound. The pile driving activities analyzed here are similar to, or less impactful than, numerous other construction activities conducted in San Francisco Bay and in the Puget Sound region, which have taken place with no reported injuries or mortality to marine mammals, and no known long-term adverse consequences from behavioral harassment. Repeated exposures of individuals to levels of sound that may cause Level B harassment are unlikely to result in hearing impairment or to significantly disrupt foraging behavior. Thus, even repeated Level B harassment of some small subset of the overall stock is unlikely to result in any significant realized decrease in fitness for the affected individuals, and thus would not result in any adverse impact to the stock as a whole. Level B harassment will be reduced to the level of least practicable impact through use of mitigation measures described herein and, if sound produced by project activities is sufficiently disturbing, animals are likely to simply avoid the project area while the activity is occurring.

    In summary and as described above, the following factors primarily support our preliminary determination that the impacts resulting from this activity are not expected to adversely affect the species or stock through effects on annual rates of recruitment or survival:

    • No mortality is anticipated or authorized;

    • The anticipated incidents of Level B harassment consist of, at worst, temporary modifications in behavior;

    • The absence of any significant habitat within the project area, including rookeries, significant haul-outs, or known areas or features of special significance for foraging or reproduction; and

    • The presumed efficacy of the proposed mitigation measures in reducing the effects of the specified activity to the level of least practicable impact.

    Based on the analysis contained herein of the likely effects of the specified activity on marine mammals and their habitat, and taking into consideration the implementation of the proposed monitoring and mitigation measures, NMFS preliminarily finds that the total marine mammal take from the proposed activity will have a negligible impact on all affected marine mammal species or stocks.

    Small Numbers

    As noted above, only small numbers of incidental take may be authorized under Section 101(a)(5)(D) of the MMPA for specified activities other than military readiness activities. The MMPA does not define small numbers and so, in practice, where estimated numbers are available, NMFS compares the number of individuals taken to the most appropriate estimation of abundance of the relevant species or stock in our determination of whether an authorization is limited to small numbers of marine mammals. Additionally, other qualitative factors may be considered in the analysis, such as the temporal or spatial scale of the activities.

    The number of incidents of take proposed for authorization for these stocks, with the exception of the coastal bottlenose dolphin (see below), would be considered small relative to the relevant stocks or populations (see Table 9) even if each estimated taking occurred to a new individual. This is an extremely unlikely scenario as, for pinnipeds occurring at the NBPL waterfront, there will almost certainly be some overlap in individuals present day-to-day and in general, there is likely to be some overlap in individuals present day-to-day for animals in estuarine/inland waters.

    The proposed numbers of authorized take for bottlenose dolphins are higher relative to the total stock abundance estimate and would not represent small numbers if a significant portion of the take was for a new individual. However, these numbers represent the estimated incidents of take, not the number of individuals taken. That is, it is likely that a relatively small subset of California coastal bottlenose dolphins would be incidentally harassed by project activities. California coastal bottlenose dolphins range from San Francisco Bay to San Diego (and south into Mexico) and the specified activity would be stationary within an enclosed water body that is not recognized as an area of any special significance for coastal bottlenose dolphins (and is therefore not an area of dolphin aggregation, as evident in Navy observational records). We therefore believe that the estimated numbers of takes, were they to occur, likely represent repeated exposures of a much smaller number of bottlenose dolphins and that, based on the limited region of exposure in comparison with the known distribution of the coastal bottlenose dolphin, these estimated incidents of take represent small numbers of bottlenose dolphins.

    Based on the analysis contained herein of the proposed activity (including the proposed mitigation and monitoring measures) and the anticipated take of marine mammals, NMFS preliminarily finds that small numbers of marine mammals will be taken relative to the population size of the affected species or stocks.

    Impact on Availability of Affected Species for Taking for Subsistence Uses

    There are no relevant subsistence uses of the affected marine mammal stocks or species implicated by this action. Therefore, NMFS has preliminarily determined that the total taking of affected species or stocks would not have an unmitigable adverse impact on the availability of such species or stocks for taking for subsistence purposes.

    Endangered Species Act (ESA)

    Section 7(a)(2) of the Endangered Species Act of 1973 (ESA: 16 U.S.C. 1531 et seq.) requires that each Federal agency insure that any action it authorizes, funds, or carries out is not likely to jeopardize the continued existence of any endangered or threatened species or result in the destruction or adverse modification of designated critical habitat. To ensure ESA compliance for the issuance of IHAs, NMFS consults internally, in this case with the ESA Interagency Cooperation Division, whenever we propose to authorize take for endangered or threatened species.

    The Navy initiated informal consultation under section 7 of the ESA with NMFS Southwest Regional Office (now West Coast Regional Office) on March 5, 2013. NMFS concluded on May 16, 2013, that the proposed action may affect, but is not likely to adversely affect, WNP gray whales. The Navy has not requested authorization of the incidental take of WNP gray whales and no such authorization is proposed, and there are no other ESA-listed marine mammals found in the action area. Therefore, no consultation under the ESA is required.

    Proposed Authorization

    As a result of these preliminary determinations, NMFS proposes to issue an IHA to the Navy for conducting the described pier replacement activities in San Diego Bay, for a period of one year from the date of issuance, provided the previously mentioned mitigation, monitoring, and reporting requirements are incorporated. This section contains a draft of the IHA itself. The wording contained in this section is proposed for inclusion in the IHA (if issued).

    1. This Incidental Harassment Authorization (IHA) is valid from October 8, 2017, through October 7, 2018.

    2. This IHA is valid only for pile driving and removal activities associated with the Fuel Pier Replacement Project at the Naval Station Point Loma in San Diego Bay, California.

    3. General Conditions

    (a) A copy of this IHA must be in the possession of the Navy, its designees, and work crew personnel operating under the authority of this IHA.

    (b) The species authorized for taking are the harbor seal (Phoca vitulina richardii), California sea lion (Zalophus californianus), bottlenose dolphin (Tursiops truncatus truncatus), common dolphin (Delphinus delphis), northern elephant seal (Mirounga angustirostris), Pacific white-sided dolphin (Lagenorhynchus obliquidens), Risso's dolphin (Grampus griseus), and gray whale (Eschrichtius robustus).

    (c) The taking, by Level B harassment only, is limited to the species listed in condition 3(b). See Table 1 for numbers of take authorized.

    Table 1—Authorized Take Numbers, by Species Species Authorized
  • take
  • California sea lion 8,971 Harbor seal 281 Northern elephant seal 43 California coastal bottlenose dolphin 704 Common dolphin 861 Pacific white-sided dolphin 28 Risso's dolphin 114 Gray whale 10

    (d) The taking by injury (Level A harassment), serious injury, or death of any of the species listed in condition 3(b) of the Authorization or any taking of any other species of marine mammal is prohibited and may result in the modification, suspension, or revocation of this IHA.

    (e) The Navy shall conduct briefings between construction supervisors and crews, marine mammal monitoring team, acoustic monitoring team, and Navy staff prior to the start of all pile driving activity, and when new personnel join the work, in order to explain responsibilities, communication procedures, marine mammal monitoring protocol, and operational procedures.

    4. Mitigation Measures

    The holder of this Authorization is required to implement the following mitigation measures:

    (a) For all pile driving, the Navy shall implement a minimum shutdown zone of 10 m radius around the pile. If a marine mammal comes within or approaches the shutdown zone, such operations shall cease. See Table 2 for minimum radial distances required for shutdown zones.

    Table 2—Radial Distance to Shutdown and Disturbance Zones Associated With Relevant Thresholds, Including Buffers Activity Monitored distances to thresholds
  • (meters)
  • Underwater Level A LF 1 MF 1 PW 1 OW 1 Level B 160 dB 120 dB 2 Airborne Level B 100 dB 90 dB
    Old Fuel Pier and Temporary Mooring Dolphin Demolition 66-inch and 84-inch caissons (Diamond saw cutting) 10 N/A 631 N/A 3 Concrete piles (Pile clipping) 10 N/A 2,511 30-inch steel piles (Plasma torch cutting) 10 N/A NMAWC Construction and Demolition 16-inch concrete piles (Vibratory extraction/driving) 20 4 10 N/A 1,848 42 149 16-inch concrete piles (Impact driving) 100 5 60 6 270 N/A 16-inch concrete piles (Jetting pile extraction) 10 N/A 1,165 N/A 3 16-inch concrete piles (Pile dead-pull) 10 N/A 1 LF = Low-frequency cetaceans; MF = Mid-frequency cetaceans; PW = Phocid pinnipeds; OW = Otariid pinnipeds. The high-frequency cetacean hearing group (HF) is omitted, because no species in the hearing group occur in, or around, Project area. 2 Mean ambient sound levels in San Diego Bay are approximately 128 dB rms (NAVFAC SW 2015), and all 120 dB Level B ZOIs are based on the ambient value. 3 Airborne noise levels did not exceed regulatory thresholds during previous IHAs. No airborne monitoring will take place for diamond saw cutting of caissons, plasma torch cutting of temporary mooring dolphin 30-inch steel piles, jetting or dead-pull extraction of concrete piles. 4 Includes buffer of calculated Level A threshold out to 20 m (65.6 ft). 5 Includes buffer of calculated Level A threshold out to 100 m (328 ft). 6 Includes buffer of calculated Level A threshold out to 60 m (197 ft).

    (b) The Navy shall shutdown activity as appropriate upon observation of any species for which take is not authorized. Activity shall not be resumed until those species have been observed to leave the relevant zone or until one hour has elapsed.

    (c) The Navy shall deploy marine mammal observers as described below and as indicated in the Acoustic and Marine Species Monitoring Plan (Monitoring Plan; attached).

    i. For all pile driving and applicable demolition activities, a minimum of one observer shall monitor the shutdown zones. However, any action requiring the impact or vibratory hammer will necessitate two MMOs.

    ii. For impact and vibratory pile driving of 16-in concrete piles, two observers shall be positioned for optimal monitoring of the surrounding waters.

    iii. These observers shall record all observations of marine mammals, regardless of distance from the pile being driven, as well as behavior and potential behavioral reactions of the animals.

    iv. All observers shall be equipped for communication of marine mammal observations amongst themselves and to other relevant personnel (e.g., those necessary to effect activity delay or shutdown).

    (d) Monitoring shall take place from fifteen minutes prior to initiation of pile driving activity through thirty minutes post-completion of pile driving activity. Pre-activity monitoring shall be conducted for fifteen minutes to ensure that the shutdown zone is clear of marine mammals, and pile driving may commence when observers have declared the shutdown zone clear of marine mammals. In the event of a delay or shutdown of activity resulting from marine mammals in the shutdown zone, animals shall be allowed to remain in the shutdown zone (i.e., must leave of their own volition) and their behavior shall be monitored and documented. Monitoring shall occur throughout the time required to drive a pile. The shutdown zone must be determined to be clear during periods of good visibility (i.e., the entire shutdown zone and surrounding waters must be visible to the naked eye).

    (e) If a marine mammal approaches or enters the shutdown zone, all pile driving activities at that location shall be halted. If pile driving is halted or delayed due to the presence of a marine mammal, the activity may not commence or resume until either the animal has voluntarily left and been visually confirmed beyond the shutdown zone or 30 minutes have passed without re-detection of gray whales or 15 minutes for all other animals.

    (f) Monitoring shall be conducted by qualified observers, as described in the Monitoring Plan. Trained observers shall be placed from the best vantage point(s) practicable to monitor for marine mammals and implement shutdown or delay procedures when applicable through communication with the equipment operator.

    (g) The Navy shall use soft start techniques recommended by NMFS for impact pile driving. Soft start for impact drivers requires contractors to provide an initial set of strikes at reduced energy, followed by a thirty-second waiting period, then two subsequent reduced energy strike sets. Soft start shall be implemented at the start of each day's impact pile driving and at any time following cessation of impact pile driving for a period of 30 minutes or longer.

    (h) Pile driving shall only be conducted during daylight hours.

    5. Monitoring

    The holder of this Authorization is required to conduct marine mammal monitoring during pile driving activity. Marine mammal monitoring and reporting shall be conducted in accordance with the Monitoring Plan.

    (a) The Navy shall collect sighting data and behavioral responses to pile driving for marine mammal species observed in the region of activity during the period of activity. All observers shall be trained in marine mammal identification and behaviors, and shall have no other construction-related tasks while conducting monitoring.

    (b) For all marine mammal monitoring, the information shall be recorded as described in the Monitoring Plan.

    (c) The Navy shall conduct acoustic monitoring for representative scenarios of pile driving activity, as described in the Monitoring Plan.

    6. Reporting

    The holder of this Authorization is required to:

    (a) Submit a draft report on all monitoring conducted under the IHA within 45 calendar days of the completion of marine mammal and acoustic monitoring, or 60 days prior to the issuance of any subsequent IHA for this project, whichever comes first. A final report shall be prepared and submitted within thirty days following resolution of comments on the draft report from NMFS. This report must contain the informational elements described in the Monitoring Plan, at minimum (see attached), and shall also include:

    i. Detailed information about any implementation of shutdowns, including the distance of animals to the pile and description of specific actions that ensued and resulting behavior of the animal, if any.

    ii. Description of attempts to distinguish between the number of individual animals taken and the number of incidences of take, such as ability to track groups or individuals.

    iii. Results of acoustic monitoring, including the information described in in the Monitoring Plan.

    (b) Reporting injured or dead marine mammals:

    i. In the unanticipated event that the specified activity clearly causes the take of a marine mammal in a manner prohibited by this IHA, such as an injury (Level A harassment), serious injury, or mortality, Navy shall immediately cease the specified activities and report the incident to the Office of Protected Resources, NMFS, and the West Coast Regional Stranding Coordinator, NMFS. The report must include the following information:

    A. Time and date of the incident;

    B. Description of the incident;

    C. Environmental conditions (e.g., wind speed and direction, Beaufort sea state, cloud cover, and visibility);

    D. Description of all marine mammal observations in the 24 hours preceding the incident;

    E. Species identification or description of the animal(s) involved;

    F. Fate of the animal(s); and

    G. Photographs or video footage of the animal(s).

    Activities shall not resume until NMFS is able to review the circumstances of the prohibited take. NMFS will work with Navy to determine what measures are necessary to minimize the likelihood of further prohibited take and ensure MMPA compliance. Navy may not resume their activities until notified by NMFS.

    i. In the event that Navy discovers an injured or dead marine mammal, and the lead observer determines that the cause of the injury or death is unknown and the death is relatively recent (e.g., in less than a moderate state of decomposition), Navy shall immediately report the incident to the Office of Protected Resources, NMFS, and the West Coast Regional Stranding Coordinator, NMFS.

    The report must include the same information identified in 6(b)(i) of this IHA. Activities may continue while NMFS reviews the circumstances of the incident. NMFS will work with Navy to determine whether additional mitigation measures or modifications to the activities are appropriate.

    ii. In the event that Navy discovers an injured or dead marine mammal, and the lead observer determines that the injury or death is not associated with or related to the activities authorized in the IHA (e.g., previously wounded animal, carcass with moderate to advanced decomposition, scavenger damage), Navy shall report the incident to the Office of Protected Resources, NMFS, and the West Coast Regional Stranding Coordinator, NMFS, within 24 hours of the discovery. Navy shall provide photographs or video footage or other documentation of the stranded animal sighting to NMFS.

    7. This Authorization may be modified, suspended or withdrawn if the holder fails to abide by the conditions prescribed herein, or if the authorized taking is having more than a negligible impact on the species or stock of affected marine mammals.

    Request for Public Comments

    We request comment on our analysis, the draft authorization, and any other aspect of this Notice of Proposed IHA for Navy's pier replacement activities. Please include with your comments any supporting data or literature citations to help inform our final decision on Navy's request for an MMPA authorization.

    Dated: August 1, 2017. Catherine Marzin, Acting Deputy Director, Office of Protected Resources, National Marine Fisheries Service.
    [FR Doc. 2017-16453 Filed 8-3-17; 8:45 am] BILLING CODE 3510-22-P
    COMMODITY FUTURES TRADING COMMISSION Agency Information Collection Activities Relating to Security Futures Products AGENCY:

    Commodity Futures Trading Commission.

    ACTION:

    Notice.

    SUMMARY:

    The Commodity Futures Trading Commission (“Commission” or “CFTC”) is announcing an opportunity for public comment on the extension of a proposed collection of certain information by the agency. In compliance with the Paperwork Reduction Act of 1995, Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments, as described below, on the proposed Information Collection Request (“ICR”) relating to security futures products.

    DATES:

    Comments must be submitted on or before October 3, 2017.

    ADDRESSES:

    You may submit comments, identified by OMB Control No. 3038-0059 by any of the following methods:

    • The Agency's Web site, at http://comments.cftc.gov/. Follow the instructions for submitting comments through the Web site.

    Mail: Christopher Kirkpatrick, Secretary of the Commission, Commodity Futures Trading Commission, 1155 21st Street NW., Washington, DC 20581.

    Hand delivery/Courier: Same as Mail above.

    Federal eRulemaking Portal: http://www.regulations.gov/. Follow the instructions for submitting comments through the Portal.

    Please submit your comments using only one method.

    All comments must be submitted in English, or if not, accompanied by an English translation. Comments will be posted as received to http://www.cftc.gov. You should submit only information that you wish to make available publicly. If you wish the Commission to consider information that you believe is exempt from disclosure under the Freedom of Information Act, a petition for confidential treatment of the exempt information may be submitted according to the procedures established in § 145.9 of the Commission's regulations.1 The Commission reserves the right, but shall have no obligation, to review, pre-screen, filter, redact, refuse, or remove any or all of your submission from http://www.cftc.gov that it may deem to be inappropriate for publication, such as obscene language. All submissions that have been redacted or removed that contain comments on the merits of the ICR will be retained in the public comment file and will be considered as required under the Administrative Procedure Act and other applicable laws, and may be accessible under the Freedom of Information Act.

    1 17 CFR 145.9.

    FOR FURTHER INFORMATION CONTACT:

    David Steinberg, Associate Director, Division of Market Oversight, Commodity Futures Trading Commission, (202) 418-5102; email: [email protected], and refer to OMB Control No. 3038-0059.

    SUPPLEMENTARY INFORMATION:

    Under the PRA, Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of Information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3 and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA, 44 U.S.C. 3506(c)(2)(A), requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information before submitting the collection to OMB for approval. To comply with this requirement, the CFTC is publishing notice of the proposed collection of information listed below.

    Title: Part 41, Relating to Security Futures Products (OMB Control No. 3038-0059). This is a request for extension of a currently approved information collection.

    Affected Entities: Entities potentially affected by this action are businesses and other for-profit institutions.

    Abstract: Section 4d(c) of the Commodity Exchange Act (“CEA”), 7 U.S.C. 6d(c), requires the CFTC to consult with the Securities and Exchange Commission (“SEC”) and issue such rules, regulations, or orders as are necessary to avoid duplicative or conflicting regulations applicable to firms that are fully registered with the SEC as brokers or dealers and the CFTC as futures commission merchants involving provisions of the CEA that pertain to the treatment of customer funds. The CFTC, jointly with the SEC, issued regulations requiring such dually-registered firms to make choices as to how its customers' transactions in security futures products will be treated, either as securities transactions held in a securities account or as futures transactions held in a futures account. How an account is treated is important in the unlikely event of the insolvency of the firm. Securities accounts receive insurance protection under provisions of the Securities Investor Protection Act. By contrast, futures accounts are subject to the protections provided by the segregation requirements of the CEA.

    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. The OMB control numbers for the CFTC's regulations were published on December 30, 1981. See 46 FR 63035 (Dec. 30, 1981).

    The Commission would like to solicit comments to:

    • Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information will have a practical use;

    • Evaluate the accuracy of the Commission's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

    • Enhance the quality, usefulness, and clarity of the information to be collected; and

    • Minimize the burden of collection of information on those who are to respond, including through the use of appropriate automated electronic, mechanical, or other technological collection techniques or other forms of information technology; e.g., permitting electronic submission of responses.

    Burden Statement: The respondent burden for this collection is estimated to average 1.57 hours per response. This estimate includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; and transmit or otherwise disclose the information.

    Respondents/Affected Entities: 44.

    Estimated Number of Responses: 943.

    Estimated Total Annual Burden on Respondents: 1,482 hours.

    Frequency of Collection: On occasion.

    The regulations require no new start-up or operations and maintenance costs.

    Dated: August 1, 2017. Robert N. Sidman, Deputy Secretary of the Commission.
    [FR Doc. 2017-16459 Filed 8-3-17; 8:45 am] BILLING CODE 6351-01-P
    DEPARTMENT OF DEFENSE Office of the Secretary [Docket ID: DOD-2017-OS-0011] Submission for OMB Review; Comment Request ACTION:

    30-Day information collection notice.

    SUMMARY:

    The Department of Defense has submitted to OMB for clearance, the following proposal for collection of information under the provisions of the Paperwork Reduction Act.

    DATES:

    Consideration will be given to all comments received by September 5, 2017.

    ADDRESSES:

    Comments and recommendations on the proposed information collection should be emailed to Ms. Jasmeet Seehra, DoD Desk Officer, at [email protected] Please identify the proposed information collection by DoD Desk Officer and the Docket ID number and title of the information collection.

    FOR FURTHER INFORMATION CONTACT:

    Fred Licari, 571-372-0493, or [email protected]

    SUPPLEMENTARY INFORMATION:

    Title, Associated Form and OMB Number: Federal Write-In Absentee Ballot (FWAB); Standard Form 186; OMB Control Number 0704-0502.

    Type of Request: Reinstatement.

    Number of Respondents: 1,200,000.

    Responses per Respondent: 1.

    Annual Responses: 1,200,000.

    Average Burden per Response: 15 minutes.

    Annual Burden Hours: 300,000.

    Needs and Uses: The information collection requirement is necessary to fulfil the obligations of the Uniformed and Overseas Citizens Absentee Voting Act (UOCAVA), 52 U.S.C. 203, which requires the Secretary of Defense to prescribe official forms containing an absentee voter registration application, an absentee ballot request application, and a backup ballot. The forms are for use by the States to permit absent uniformed services voters and overseas voters to participate in general, special, primary and runoff elections for Federal office. The collected information will be retained by election officials to provide election materials, including absentee ballots, to the uniformed services, their eligible family members and overseas voters during the form's eligibility period provided by State law. No information from the Federal Write-In Absentee Ballot (FWAB) is collected or retained by the Federal government. The applicant is required to update and resubmit the information annually, whenever they change their mailing address or as otherwise required by State law. If the information is not submitted annually or whenever they change their mailing address, the applicant may not receive ballots for elections for Federal office in that calendar year.

    Affected Public: Individuals or households.

    Frequency: On occasion.

    Respondent's Obligation: Voluntary.

    OMB Desk Officer: Ms. Jasmeet Seehra.

    You may also submit comments and recommendations, identified by Docket ID number and title, by the following method:

    Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments.

    Instructions: All submissions received must include the agency name, Docket ID number and title for this Federal Register document. The general policy for comments and other submissions from members of the public is to make these submissions available for public viewing on the Internet at http://www.regulations.gov as they are received without change, including any personal identifiers or contact information.

    DOD Clearance Officer: Mr. Frederick Licari.

    Written requests for copies of the information collection proposal should be sent to Mr. Licari at WHS/ESD Directives Division, 4800 Mark Center Drive, East Tower, Suite 03F09, Alexandria, VA 22350-3100.

    Dated: July 31, 2017. Aaron Siegel, Alternate OSD Federal Register Liaison Officer, Department of Defense.
    [FR Doc. 2017-16420 Filed 8-3-17; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF DEFENSE Office of the Secretary Department of Defense Military Family Readiness Council; Notice of Federal Advisory Committee Meeting AGENCY:

    Under Secretary of Defense for Personnel and Readiness, DoD.

    ACTION:

    Notice of Federal Advisory Committee meeting.

    SUMMARY:

    The Department of Defense (DoD) is publishing this notice to announce that the following Federal Advisory Committee meeting of the Department of Defense Military Family Readiness Council will take place.

    DATES:

    This meeting is open to the public and will be held on Tuesday, August 29, 2017 from 1:00 p.m. to 3:00 p.m.

    ADDRESSES:

    1155 Defense Pentagon PLC2 Pentagon Library and Conference Center, Room B6, Washington, DC 20301.

    FOR FURTHER INFORMATION CONTACT:

    Ms. Melody McDonald or Dr. Randy Eltringham, (571) 372-0880 (Voice); (571) 372-5315 (Voice); (571) 372-0884 (Facsimile); OSD Pentagon OUSD P-R Mailbox Family Readiness Council, [email protected] (Email). Mailing address is Office of the Deputy Assistant Secretary of Defense (Military Community & Family Policy), Office of Family Readiness Policy, 4800 Mark Center Drive, Alexandria, VA 22350-2300, Room 3G15. The Official DoD MFRC Web site can be found at http://www.militaryonesource.mil/service-providers/mfrc.

    SUPPLEMENTARY INFORMATION:

    This meeting is being held under the provisions of the Federal Advisory Committee Act (FACA) of 1972 (5 U.S.C., Appendix, as amended), the Government in the Sunshine Act of 1976 (5 U.S.C. 552b, as amended), and 41 CFR 102-3.140 and 102-3.150.

    Purpose of the Meeting: This is the third and final meeting of the Council for FY2017. During this meeting, Council members will: (1) Review written public submissions and DoD and Military Services military family readiness related policy issuances that were published between August 1, 2016 and July 31, 2017; (2) Discuss and vote on recommendations to be forwarded to the Secretary of Defense. [Note: Draft recommendations will focus on topics reviewed by the Council during FY2017. Topics include services provided to Special Needs Families (medical, family and state-liaison support) and Community Collaboratives and Partnerships as a strategy for meeting Service and family member information, referral and service delivery needs.]; and (3) Make recommendations for areas on which the Council should focus during FY2018.

    Agenda

    Welcome & Administrative Remarks.

    Review of Written Public Submissions.

    Review of Military Family Readiness Related Policy Issuances.

    Presentation and Voting on MFRC Recommendations for the Secretary of Defense.

    Closing Remarks: Looking Ahead to FY2018.

    Note: Exact order may vary.

    Meeting Accessibility: Pursuant to 5 U.S.C. 552b and 41 CFR 102-3.140 through 102-3.165, this meeting is open to the public, subject to the availability of space, on an RSVP list basis. Members of the public who are entering the Pentagon should arrive at the Pentagon Visitors Center waiting area (Pentagon Metro Entrance) at 12:00 p.m. on the day of the meeting to allow time to pass through security check points and to be escorted to the meeting location. Members of the public need to email their RSVP to the Council at [email protected] no later than 5:00 p.m. on Tuesday, August 22, 2017 to confirm seating availability and to request an escort or a handicapped accessible transportation cart if needed.

    Written Statements: Interested persons may submit a written statement for review and consideration by the Council Chair and members. Written statements must not be longer than two type-written pages and should address the following details: The issue, discussion, and a recommended course of action. Additionally, those who make submissions are requested to avoid including personal identifiable information (PII) such as names of adults and children, phone numbers, addresses, social security numbers, etc.). Supporting documentation may also be included, as needed, to establish the appropriate historical context and to provide any necessary background information. Written submissions should be sent to the Council mailbox at [email protected] at least five (5) business days prior to the date of this meeting. If the written statement is not received at least five (5) business days prior to the meeting, the Designated Federal Officer (DFO) for the Council may choose to postpone consideration of the statement until the next open meeting of the Council. The DFO will review all timely submissions with the Council Chairman and ensure submitted written statements are provided to all members of the Council prior to the meeting that is subject to this notice.

    Dated: July 31, 2017. Aaron Siegel, Alternate OSD Federal Register Liaison Officer, Department of Defense.
    [FR Doc. 2017-16418 Filed 8-3-17; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF ENERGY Office of Energy Efficiency and Renewable Energy [Case No. RF-047] Extension of Waiver to Panasonic Appliances Refrigeration Systems Corporation of America (PAPRSA) From the Department of Energy Consumer Refrigerator and Refrigerator-Freezer Test Procedures AGENCY:

    Office of Energy Efficiency and Renewable Energy, Department of Energy.

    ACTION:

    Extension of waiver.

    SUMMARY:

    The U.S. Department of Energy (“DOE”) is granting a waiver extension (Case No. RF-047) to Panasonic Appliances Refrigeration Systems Corporation of America (“PAPRSA”) to waive the requirements of the DOE refrigerator and refrigerator-freezer test procedures for determining the energy consumption of a specific combination cooler-refrigerator basic model, PR5181WBC. Under this extension, PAPRSA is required to test and rate this basic model in accordance with the applicable DOE test procedure, with the exception that it must calculate energy consumption using a correction factor (“K-factor”) of 0.85.

    DATES:

    This extension of waiver applies starting on August 4, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Mr. Bryan Berringer, U.S. Department of Energy, Building Technologies Program, Mailstop EE-2J, 1000 Independence Avenue SW., Washington, DC 20585-0121. Telephone: (202) 586-0371, Email: [email protected]

    Mr. Michael Kido, U.S. Department of Energy, Office of the General Counsel, Mail Stop GC-33, Forrestal Building, 1000 Independence Avenue SW., Washington, DC 20585-0103. Telephone: (202) 586-8145. Email: [email protected]

    SUPPLEMENTARY INFORMATION:

    In accordance with 10 CFR 430.27(g), DOE gives notice of the issuance of its extension of waiver as set forth below. The extension of waiver grants PAPRSA a waiver from the applicable consumer refrigerator and refrigerator-freezer test procedures found in 10 CFR part 430, subpart B, appendix A for combination cooler-refrigerator basic model, PR5181WBC, provided that PAPRSA tests and rates the basic model using the alternate test procedure described in this notice. This extension prohibits PAPRSA from making representations concerning the energy efficiency of these products unless the product has been tested in a manner consistent with the provisions and restrictions in the alternate test procedure set forth in the extension below, and the representations fairly disclose those test results. Distributors, retailers, and private labelers are held to the same standard when making representations regarding the energy efficiency of these products. 42 U.S.C. 6293(c).

    I. Background and Authority

    Title III, Part B of the Energy Policy and Conservation Act of 1975, as amended (“EPCA”) (42 U.S.C. 6291-6309) established the Energy Conservation Program for Consumer Products Other Than Automobiles, a program that includes consumer refrigerators and refrigerator-freezers.1 Part B includes definitions, test procedures, labeling provisions, energy conservation standards, and the authority to require information and reports from manufacturers. Further, Part B authorizes the Secretary of Energy to prescribe test procedures that are reasonably designed to produce results that measure energy efficiency, energy use, or estimated operating costs, and that are not unduly burdensome to conduct. (42 U.S.C. 6293(b)(3)) The test procedure for refrigerators and refrigerator-freezers is set forth in 10 CFR part 430, subpart B, appendix A.

    1 For editorial reasons, upon codification in the U.S. Code, Part B was re-designated Part A.

    The regulations set forth in 10 CFR 430.27 contain provisions that allow a person to seek a waiver from the test procedure requirements for a particular basic model of a type of covered product when the petitioner's basic model for which the petition for waiver was submitted contains one or more design characteristics that: (1) Prevent testing according to the prescribed test procedure, or (2) cause the prescribed test procedures to evaluate the basic model in a manner so unrepresentative of its true energy consumption characteristics as to provide materially inaccurate comparative data. 10 CFR 430.27(a)(1). DOE may grant the waiver subject to conditions, including adherence to alternate test procedures. 10 CFR 430.27(f)(2). DOE recently published standards for miscellaneous refrigeration products (“MREFs”). See 81 FR 75194 (Oct. 28, 2016). Testing to demonstrate compliance with those standards will require manufacturers to use the MREF test procedure established in a final rule published in July 2016. See 81 FR 46768 (July 18, 2016) (MREF coverage determination and test procedure final rule) and 81 FR 49868 (July 29, 2016) (MREF test procedure final rule correction notice). Under these rules, DOE has determined that products such as those that are at issue here fall into the MREF category. Accordingly, consistent with these MREF-specific provisions, these products will be evaluated under prescribed procedures and against specified standards that are tailored to account for their particular characteristics.

    A petitioner may request that DOE extend the scope of a waiver or an interim waiver to include additional basic models employing the same technology as the basic model(s) set forth in the original petition. DOE will publish any such extension in the Federal Register. 10 CFR 430.27(g).

    II. PAPRSA's Extension of Waiver: Assertions and Determinations

    DOE issued a Decision and Order, in Case No. RF-022, granting PAPRSA 2 a waiver to test hybrid wine chiller/beverage center basic models (77 FR 49443 (August 16, 2012)). That waiver was extended to include additional basic models in Case Nos. RF-031 (78 FR 57139 (September 17, 2013)) and RF-041 (79 FR 55769 (September 17, 2014)). In Case No. RF-043, DOE issued an Order rescinding the Orders in Case Nos. RF-022, RF-031, and RF-041 due to erroneous formulae and reference to an obsolete DOE test procedure. That Order granted an interim waiver that covered all the basic models that were subject to the previous Orders, and one additional basic model for which PAPRSA had requested a waiver extension (81 FR 4270 (January 26, 2016)). Most recently, DOE issued a Decision and Order granting a waiver to all the basic models that had been subject to the interim waiver (82 FR 21209 (May 5, 2017)). The waiver required PAPRSA to test and rate the specified basic models in accordance with the applicable DOE test procedure, with the exception that it must calculate energy consumption using a correction factor (“K-factor”) of 0.85.

    2 The waiver was originally issued to Sanyo E&E Corporation, which has since changed its corporate name to PAPRSA.

    On May 3, 2017, PAPRSA requested an extension of that waiver, under 10 CFR 430.27(g), to a new basic model, PR5181WBC, that employs the same technology as the basic models set forth in the original petition for waiver. Specifically, PAPRSA states that basic model PR5181WBC employs the same wine compartment—beverage compartment technology and design characteristics as the basic models for which the original waiver was granted. That basic model achieves a wine-chiller compartment average temperature of 50 °F using a heater that prevents the wine-chiller compartment temperature from sinking below 42 °F. DOE is publishing at the end of this notice PAPRSA's request for extension of waiver in its entirety.

    III. Order

    After careful consideration of all the material submitted by PAPRSA, it is ordered that:

    (1) The request for extension of waiver submitted by the Panasonic Appliances Refrigeration Systems Corporation of America (Case No. RF-047) is hereby granted as set forth in the paragraphs below.

    (2) PAPRSA must test and rate the PAPRSA basic models specified in paragraph (3) using the current test procedure contained in 10 CFR part 430, subpart B, appendix A, with the exception that it must calculate energy consumption using a correction factor (“K-factor”) of 0.85.

    Therefore, the energy consumption is defined by:

    If compartment temperatures are below their respective standardized temperatures for both test settings (according to 10 CFR part 430, subpart B, appendix A, sec. 6.2.4.1):

    E = (ET1 × 0.85) + IET.

    If compartment temperatures are not below their respective standardized temperatures for both test settings, the higher of the two values calculated by the following two formulas (according to 10 CFR part 430, subpart B, appendix A, sec. 6.2.4.2):

    Energy consumption of the “cooler compartment”:

    ECooler Compartment = (ET1 + [(ET2 − ET1) × (55 °F−TW1)/(TW2−TW1)]) × 0.85 + IET

    Energy consumption of the “fresh food compartment”:

    EFreshFood Compartment = (ET1 + [(ET2-ET1) × (39 °F-TBC1)/(TBC2-TBC1)]) × 0.85 + IET.

    (3) This Order only applies to basic model PR5181WBC.

    (4) Representations. PAPRSA may make representations about the energy use of its combination cooler-refrigerator product for compliance, marketing, or other purposes only to the extent that such products have been tested in accordance with the provisions above and such representations fairly disclose the results of such testing.

    (5) This Order will terminate on October 28, 2019, in conjunction with the compliance date that applies to the recently published standards for miscellaneous refrigeration products (“MREFs”). See 81 FR 75194 (Oct. 28, 2016). Testing to demonstrate compliance with those standards must be performed in accordance with the MREF test procedure final rule. See 81 FR 46768 (July 18, 2016) (MREF test procedure final rule) and 81 FR 49868 (July 29, 2016) (MREF test procedure final rule correction notice).

    (6) This waiver is issued on the condition that the statements, representations, and documentary materials provided by the petitioner are valid. DOE may revoke or modify this waiver at any time if it determines the factual basis underlying the petition for waiver is incorrect, or the results from the alternate test procedure are unrepresentative of the basic models' true energy consumption characteristics.

    (7) Granting of this extension does not release a petitioner from the certification requirements set forth at 10 CFR part 429.

    Issued in Washington, DC, on July 28, 2017. Kathleen B. Hogan, Deputy Assistant Secretary for Energy Efficiency, Energy Efficiency and Renewable Energy.
    [FR Doc. 2017-16447 Filed 8-3-17; 8:45 am] BILLING CODE 6450-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Notice of Commissioner and Staff Attendance at North American Electric Reliability Corporation Meetings

    The Federal Energy Regulatory Commission (Commission) hereby gives notice that members of the Commission and/or Commission staff may attend the following meetings:

    North American Electric Reliability Corporation, Member Representatives Committee and Board of Trustees Meetings, Board of Trustees Corporate Governance and Human Resources Committee, Finance and Audit Committee, Compliance Committee, and Standards Oversight and Technology Committee Meetings.

    The Westin Ottawa, 11 Colonel By Drive, Ottawa, ON K1N 9H4 Canada.

    August 9 (8:00 a.m.-5:00 p.m. eastern time) and August 10 (8:30 a.m.-12:00 p.m. eastern time), 2017.

    Further information regarding these meetings may be found at: http://www.nerc.com/Pages/Calendar.aspx.

    The discussions at the meetings, which are open to the public, may address matters at issue in the following Commission proceedings:

    Docket No. RR15-2, North American Electric Reliability Corporation Docket No. RR17-6, North American Electric Reliability Corporation

    For further information, please contact Jonathan First, 202-502-8529, or [email protected]

    Dated: July 31, 2017. Kimberly D. Bose, Secretary.
    [FR Doc. 2017-16477 Filed 8-3-17; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Combined Notice of Filings #1

    Take notice that the Commission received the following electric rate filings:

    Docket Numbers: ER10-3246-012; ER10-2475-018; ER10-2474-018; ER13-1266-014; ER11-2044-022.

    Applicants: PacifiCorp, Nevada Power Company, Sierra Pacific Power Company, CalEnergy, LLC, MidAmerican Energy Company.

    Description: Notice of Non-Material Change in Status of the BHE MBR Sellers.

    Filed Date: 7/28/17.

    Accession Number: 20170728-5155.

    Comments Due: 5 p.m. ET 8/18/17.

    Docket Numbers: ER16-1456-008.

    Applicants: Talen Energy Marketing, LLC.

    Description: Compliance filing: Compliance Filing Cancelling Reactive Tariff to be effective 12/1/2016.

    Filed Date: 7/28/17.

    Accession Number: 20170728-5073.

    Comments Due: 5 p.m. ET 8/18/17.

    Docket Numbers: ER17-215-000.

    Applicants: Midcontinent Independent System Operator, Inc., Great River Energy, South Mississippi Electric Power Association.

    Description: Report Filing: 2017-07-28_Submittal of ROE refund report in Docket No. EL14-12 to be effective N/A.

    Filed Date: 7/28/17.

    Accession Number: 20170728-5154.

    Comments Due: 5 p.m. ET 8/18/17.

    Docket Numbers: ER17-1712-001.

    Applicants: Midcontinent Independent System Operator, Inc.

    Description: Tariff Amendment: 2017-07-28_Amendment to Compensation for Manual Redispatch Filing to be effective 12/31/9998.

    Filed Date: 7/28/17.

    Accession Number: 20170728-5065.

    Comments Due: 5 p.m. ET 8/18/17.

    Docket Numbers: ER17-2038-002.

    Applicants: Southwest Power Pool, Inc.

    Description: Tariff Amendment: 2198R23 Kansas Power Pool NITSA NOA to be effective 9/1/2017.

    Filed Date: 7/27/17.

    Accession Number: 20170727-5179.

    Comments Due: 5 p.m. ET 8/17/17.

    Docket Numbers: ER17-2170-000.

    Applicants: San Diego Gas & Electric Company.

    Description: Baseline eTariff Filing: Palo Verde North Gila Line ANPP High Voltage Switchyard Interconnection Agreement to be effective 7/28/2017.

    Filed Date: 7/27/17.

    Accession Number: 20170727-5152.

    Comments Due: 5 p.m. ET 8/17/17.

    Docket Numbers: ER17-2171-000.

    Applicants: Southern California Edison Company.

    Description: § 205(d) Rate Filing: Amended LGIA Willow Springs Solar, LLC to be effective 7/28/2017.

    Filed Date: 7/27/17.

    Accession Number: 20170727-5153.

    Comments Due: 5 p.m. ET 8/17/17.

    Docket Numbers: ER17-2172-000.

    Applicants: Southern California Edison Company.

    Description: § 205(d) Rate Filing: Amended LGIA North Rosamond Solar, LLC to be effective 7/28/2017.

    Filed Date: 7/27/17.

    Accession Number: 20170727-5156.

    Comments Due: 5 p.m. ET 8/17/17.

    Docket Numbers: ER17-2173-000.

    Applicants: Cedar Creek II, LLC.

    Description: § 205(d) Rate Filing: Revised Market-Based Rate Tariff to be effective 9/27/2017.

    Filed Date: 7/28/17.

    Accession Number: 20170728-5059.

    Comments Due: 5 p.m. ET 8/18/17.

    Docket Numbers: ER17-2174-000.

    Applicants: Southwest Power Pool, Inc.

    Description: § 205(d) Rate Filing: 1139R5 Southwestern Public Service Company NITSA NOA to be effective 7/1/2017.

    Filed Date: 7/28/17.

    Accession Number: 20170728-5072.

    Comments Due: 5 p.m. ET 8/18/17.

    Docket Numbers: ER17-2175-000.

    Applicants: Susquehanna Nuclear, LLC.

    Description: Compliance filing: Baseline Reactive Tariff for Susquehanna Nuclear, LLC (ER16-1456) to be effective 12/1/2016.

    Filed Date: 7/28/17.

    Accession Number: 20170728-5167.

    Comments Due: 5 p.m. ET 8/18/17.

    Docket Numbers: ER17-2176-000.

    Applicants: Brunner Island, LLC.

    Description: Compliance filing: Baseline Reactive Tariff for Brunner Island, LLC (ER16-1456) to be effective 12/1/2016.

    Filed Date: 7/28/17.

    Accession Number: 20170728-5172.

    Comments Due: 5 p.m. ET 8/18/17.

    Docket Numbers: ER17-2177-000.

    Applicants: Martins Creek, LLC.

    Description: Compliance filing: Baseline Reactive Tariff for Martins Creek, LLC (ER16-1456) to be effective 12/1/2016.

    Filed Date: 7/28/17.

    Accession Number: 20170728-5181.

    Comments Due: 5 p.m. ET 8/18/17.

    Docket Numbers: ER17-2178-000.

    Applicants: Montour, LLC.

    Description: Compliance filing: Baseline Reactive Tariff for Montour, LLC (ER16-1456) to be effective 12/1/2016.

    Filed Date: 7/28/17.

    Accession Number: 20170728-5195.

    Comments Due: 5 p.m. ET 8/18/17.

    The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.

    Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.

    eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Dated: July 28, 2017. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2017-16460 Filed 8-3-17; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Combined Notice of Filings #1

    Take notice that the Commission received the following electric corporate filings:

    Docket Numbers: EC17-142-000.

    Applicants: Exelon Generation Company, LLC, Exelon FitzPatrick, LLC.

    Description: Joint Application for Authorization Under Section 203 of the FPA of Exelon Generation Company, LLC, et. al.

    Filed Date: 7/28/17.

    Accession Number: 20170728-5234.

    Comments Due: 5 p.m. ET 8/18/17.

    Take notice that the Commission received the following exempt wholesale generator filings:

    Docket Numbers: EG17-131-000.

    Applicants: Cap Ridge Wind I, LLC.

    Description: Notice of Self-Certification of Exempt Wholesale Generator Status of Cap Ridge Wind I, LLC.

    Filed Date: 7/28/17.

    Accession Number: 20170728-5243.

    Comments Due: 5 p.m. ET 8/18/17.

    Docket Numbers: EG17-132-000.

    Applicants: Cap Ridge Wind II, LLC.

    Description: Notice of Self-Certification of Exempt Wholesale Generator Status of Cap Ridge Wind II, LLC.

    Filed Date: 7/28/17.

    Accession Number: 20170728-5245.

    Comments Due: 5 p.m. ET 8/18/17.

    Docket Numbers: EG17-133-000.

    Applicants: Cap Ridge Wind III, LLC.

    Description: Notice of Self-Certification of Exempt Wholesale Generator Status of Cap Ridge Wind III, LLC.

    Filed Date: 7/28/17.

    Accession Number: 20170728-5246.

    Comments Due: 5 p.m. ET 8/18/17.

    Docket Numbers: EG17-134-000.

    Applicants: Cap Ridge Wind IV, LLC.

    Description: Notice of Self-Certification of Exempt Wholesale Generator Status of Cap Ridge Wind IV, LLC.

    Filed Date: 7/28/17.

    Accession Number: 20170728-5248.

    Comments Due: 5 p.m. ET 8/18/17.

    Docket Numbers: EG17-135-000.

    Applicants: Cap Ridge Interconnection, LLC.

    Description: Notice of Self-Certification of Exempt Wholesale Generator Status of Cap Ridge Interconnection, LLC.

    Filed Date: 7/28/17.

    Accession Number: 20170728-5249.

    Comments Due: 5 p.m. ET 8/18/17.

    Take notice that the Commission received the following electric rate filings:

    Docket Numbers: ER10-2794-023; ER14-2672-008; ER12-1825-021.

    Applicants: EDF Trading North America, LLC, EDF Energy Services, LLC, EDF Industrial Power Services (CA), LLC.

    Description: Notice of Non-Material Change in Status of EDF Trading North America, LLC, et al.

    Filed Date: 7/28/17.

    Accession Number: 20170728-5233.

    Comments Due: 5 p.m. ET 8/18/17.

    Docket Numbers: ER17-2179-000.

    Applicants: California Independent System Operator Corporation.

    Description: § 205(d) Rate Filing: 2017-07-28 Remove Conceptual Statewide Plan Amendment to be effective 9/27/2017.

    Filed Date: 7/28/17.

    Accession Number: 20170728-5211.

    Comments Due: 5 p.m. ET 8/18/17.

    Docket Numbers: ER17-2180-000.

    Applicants: Southwest Power Pool, Inc.

    Description: § 205(d) Rate Filing: Attachment AE Revisions Regarding Staggered Start Resources to be effective 10/1/2017.

    Filed Date: 7/28/17.

    Accession Number: 20170728-5222.

    Comments Due: 5 p.m. ET 8/18/17.

    Docket Numbers: ER17-2181-000.

    Applicants: Pacific Gas and Electric Company.

    Description: § 205(d) Rate Filing: Q2 2017 Quarterly Filing of City and County of San Francisco's WDT SA (SA 275) to be effective 6/30/2017.

    Filed Date: 7/31/17.

    Accession Number: 20170731-5000.

    Comments Due: 5 p.m. ET 8/21/17.

    Docket Numbers: ER17-2182-000.

    Applicants: Coyote Canyon Energy LLC.

    Description: Tariff Cancellation: Coyote Canyon Energy MBR Tariff Cancellation to be effective 9/30/2017.

    Filed Date: 7/31/17.

    Accession Number: 20170731-5020.

    Comments Due: 5 p.m. ET 8/21/17.

    Docket Numbers: ER17-2183-000.

    Applicants: Duke Energy Progress, LLC

    Description: Tariff Cancellation: Cancellation of CCCP IA (OATT SA 206) to be effective 8/1/2017.

    Filed Date: 7/31/17.

    Accession Number: 20170731-5035.

    Comments Due: 5 p.m. ET 8/21/17.

    The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.

    Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.

    eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Dated: July 31, 2017. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2017-16457 Filed 8-3-17; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. ER17-2162-000] SunE Beacon Site 2 LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization

    This is a supplemental notice in the above-referenced proceeding SunE Beacon Site 2 LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.

    Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.

    Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is August 17, 2017.

    The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet access who will eFile a document and/or be listed as a contact for an intervenor must create and validate an eRegistration account using the eRegistration link. Select the eFiling link to log on and submit the intervention or protests.

    Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.

    The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the Web site that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email [email protected] or call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2017-16463 Filed 8-3-17; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. ER17-2163-000] SunE Beacon Site 5, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization

    This is a supplemental notice in the above-referenced proceeding SunE Beacon Site 5 LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.

    Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.

    Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is August 17, 2017.

    The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet access who will eFile a document and/or be listed as a contact for an intervenor must create and validate an eRegistration account using the eRegistration link. Select the eFiling link to log on and submit the intervention or protests.

    Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.

    The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the Web site that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email [email protected] or call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Dated: July 28, 2017. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2017-16464 Filed 8-3-17; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Combined Notice of Filings #2

    Take notice that the Commission received the following electric rate filings:

    Docket Numbers: ER16-372-005.

    Applicants: PJM Interconnection, L.L.C.

    Description: Compliance filing: Amendment to Compliance Filing in Docket No. ER16-372-003 to be effective 5/15/2017.

    Filed Date: 7/31/17.

    Accession Number: 20170731-5118.

    Comments Due: 5 p.m. ET 8/21/17.

    Docket Numbers: ER17-1649-001.

    Applicants: Florida Power & Light Company.

    Description: Tariff Amendment: Errata to the Original Point to Point Transmission Service Agreement No. 274 to be effective 10/1/2017.

    Filed Date: 7/31/17.

    Accession Number: 20170731-5222.

    Comments Due: 5 p.m. ET 8/21/17.

    Docket Numbers: ER17-2184-000.

    Applicants: New England Power Pool Participants Committee.

    Description: § 205(d) Rate Filing: Aug 2017 Membership Filing to be effective 8/1/2017.

    Filed Date: 7/31/17.

    Accession Number: 20170731-5131.

    Comments Due: 5 p.m. ET 8/21/17.

    Docket Numbers: ER17-2185-000.

    Applicants: Great Valley Solar 1, LLC.

    Description: Initial rate filing: Great Valley Solar 1, LLC Shared Facilities Agreement to be effective 10/1/2017.

    Filed Date: 7/31/17.

    Accession Number: 20170731-5135

    Comments Due: 5 p.m. ET 8/21/17.

    Docket Numbers: ER17-2186-000.

    Applicants: Madison Paper Industries.

    Description: Tariff Cancellation: cancellation filing to be effective 8/1/2017.

    Filed Date: 7/31/17.

    Accession Number: 20170731-5136.

    Comments Due: 5 p.m. ET 8/21/17.

    Docket Numbers: ER17-2187-000.

    Applicants: Southern California Edison Company.

    Description: Tariff Cancellation: Notice of Cancellation of ETCs for Azusa, Banning & Colton to be effective 9/30/2017.

    Filed Date: 7/31/17.

    Accession Number: 20170731-5137.

    Comments Due: 5 p.m. ET 8/21/17.

    Docket Numbers: ER17-2188-000.

    Applicants: Playa Solar 1, LLC.

    Description: Baseline eTariff Filing: Playa Solar 1 Notice of Change in Status and Request for Notice Waiver to be effective 8/1/2017.

    Filed Date: 7/31/17.

    Accession Number: 20170731-5147.

    Comments Due: 5 p.m. ET 8/21/17.

    Docket Numbers: ER17-2189-000.

    Applicants: Playa Solar 2, LLC.

    Description: Baseline eTariff Filing: Playa Solar 2 Notice of Change in Status and Request for Notice Waiver to be effective 8/1/2017.

    Filed Date: 7/31/17.

    Accession Number: 20170731-5152.

    Comments Due: 5 p.m. ET 8/21/17.

    Docket Numbers: ER17-2190-000.

    Applicants: Playa Solar 1, LLC.

    Description: § 205(d) Rate Filing: Playa 1 Refiling of SFA Under New Tariff Identifier—Notice Waiver Requested to be effective 8/1/2017.

    Filed Date: 7/31/17.

    Accession Number: 20170731-5161.

    Comments Due: 5 p.m. ET 8/21/17.

    Docket Numbers: ER17-2191-000.

    Applicants: PJM Interconnection, L.L.C.

    Description: § 205(d) Rate Filing: 2nd Quarter 2017 Updates to OA-RAA Member Lists to be effective 6/30/2017.

    Filed Date: 7/31/17.

    Accession Number: 20170731-5166.

    Comments Due: 5 p.m. ET 8/21/17.

    Docket Numbers: ER17-2192-000.

    Applicants: Playa Solar 1, LLC.

    Description: Tariff Cancellation: Complete Cancellation of Playa Solar 1 MBR Program Tariff Identifier to be effective 8/1/2017.

    Filed Date: 7/31/17.

    Accession Number: 20170731-5169.

    Comments Due: 5 p.m. ET 8/21/17.

    Docket Numbers: ER17-2193-000.

    Applicants: Great Valley Solar 1, LLC.

    Description: Initial rate filing: Great Valley Solar 1, LLC LGIA Co-Tenancy Agreement to be effective 10/1/2017.

    Filed Date: 7/31/17.

    Accession Number: 20170731-5170.

    Comments Due: 5 p.m. ET 8/21/17.

    Docket Numbers: ER17-2194-000.

    Applicants: Playa Solar 2, LLC.

    Description: § 205(d) Rate Filing: Playa 2 Refiling of SFA Under New Tariff Identifier—Notice Waiver Request to be effective 8/1/2017.

    Filed Date: 7/31/17.

    Accession Number: 20170731-5171.

    Comments Due: 5 p.m. ET 8/21/17.

    Docket Numbers: ER17-2195-000.

    Applicants: PJM Interconnection, L.L.C.

    Description: § 205(d) Rate Filing: Service Agreement Nos. 4518 and 4756, Queue No. W4-005 Phase I and II to be effective 6/30/2017.

    Filed Date: 7/31/17.

    Accession Number: 20170731-5172.

    Comments Due: 5 p.m. ET 8/21/17.

    Docket Numbers: ER17-2196-000.

    Applicants: Playa Solar 2, LLC.

    Description: Tariff Cancellation: Complete Cancellation of Playa Solar 2 MBR Program Tariff Identifier to be effective 8/1/2017.

    Filed Date: 7/31/17.

    Accession Number: 20170731-5174.

    Comments Due: 5 p.m. ET 8/21/17.

    Docket Numbers: ER17-2197-000.

    Applicants: Nevada Power Company.

    Description: § 205(d) Rate Filing: Rate Schedule No. 155 NPC/CRC Agreement to be effective 10/1/2017.

    Filed Date: 7/31/17.

    Accession Number: 20170731-5176.

    Comments Due: 5 p.m. ET 8/21/17.

    Docket Numbers: ER17-2198-000.

    Applicants: Central Maine Power Company.

    Description: § 205(d) Rate Filing: First Amendment to Bucksport Generation LLC Interconnection Agreement to be effective 8/1/2017.

    Filed Date: 7/31/17.

    Accession Number: 20170731-5194.

    Comments Due: 5 p.m. ET 8/21/17.

    Docket Numbers: ER17-2199-000.

    Applicants: Southwest Power Pool, Inc.

    Description: § 205(d) Rate Filing: 3215R3 People's Electric Cooperative NITSA NOA to be effective 7/1/2017.

    Filed Date: 7/31/17.

    Accession Number: 20170731-5223.

    Comments Due: 5 p.m. ET 8/21/17.

    Docket Numbers: ER17-2200-000.

    Applicants: PJM Interconnection, L.L.C.

    Description: § 205(d) Rate Filing: Revisions to OATT Attachments O and P re: Solar Generation Meteorological Data to be effective 9/29/2017.

    Filed Date: 7/31/17.

    Accession Number: 20170731-5240.

    Comments Due: 5 p.m. ET 8/21/17.

    The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.

    Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.

    eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Dated: July 31, 2017. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2017-16458 Filed 8-3-17; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Project No. 2531-075-ME] Brookfield White Pine Hydro LLC; Notice of Availability of Environmental Assessment

    In accordance with the National Environmental Policy Act of 1969 and the Federal Energy Regulatory Commission's (Commission) regulations, 18 CFR part 380 (Order No. 486, 52 FR 47897), the Office of Energy Projects has reviewed the application for a new license for the West Buxton Hydroelectric Project, located on the Saco River in York and Cumberland Counties, Maine, and has prepared an Environmental Assessment (EA). The project does not occupy federal land.

    The EA contains Commission staff's analysis of the potential effects of the project, and concludes that licensing the project, with appropriate environmental protective measures, would not constitute a major federal action that would significantly affect the quality of the human environment.

    A copy of the EA is available for review at the Commission in the Public Reference Room, or may be viewed on the Commission's Web site at http://www.ferc.gov using the eLibrary link. Enter the docket number, excluding the last three digits in the docket number field, to access the document. For assistance, contact FERC Online Support at [email protected], or at (866) 208-3676 (toll free) or (202) 502-8659 (TTY).

    You may also register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and issuances related to this project or other pending projects. For assistance, contact FERC Online Support.

    Any comments should be filed within 30 days from the date of this notice. The Commission strongly encourages electronic filing. Please file comments using the Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit brief comments up to 6,000 characters, without prior registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information at the end of your comments. For assistance, please contact FERC Online Support. In lieu of electronic filing, please send a paper copy to: Secretary, Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426. The first page of any filing should include docket number P-2531-075.

    For further information, contact Allan Creamer at (202) 502-8365, or via email at [email protected]

    Dated: July 31, 2017. Kimberly D. Bose, Secretary.
    [FR Doc. 2017-16478 Filed 8-3-17; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Combined Notice of Filings

    Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:

    Filings Instituting Proceedings

    Docket Numbers: RP17-912-000.

    Applicants: Algonquin Gas Transmission, LLC.

    Description: Algonquin Gas Transmission, LLC submits tariff filing per 154.204: Negotiated Rates—Bay State to BBPC 794308 & 794309 to be effective 8/1/2017.

    Filed Date: 07/24/2017.

    Accession Number: 20170724-5047.

    Comment Date: 5:00 p.m. Eastern Time on Monday, August 07, 2017.

    Docket Numbers: RP17-914-000.

    Applicants: Bluewater Gas Storage, LLC.

    Description: Bluewater Gas Storage, LLC submits tariff filing per 154.204: Bluewater Ownership Update Filing July 2017 to be effective 6/30/2017.

    Filed Date: 07/25/2017.

    Accession Number: 20170725-5038.

    Comment Date: 5:00 p.m. Eastern Time on Monday, August 07, 2017.

    The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.

    Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.

    eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Dated July 27, 2017. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2017-16461 Filed 8-3-17; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. CP17-476-000] Gulf South Pipeline Company, LP; Notice of Application

    Take notice that on July 20, 2017, Gulf South Pipeline Company, LP (Gulf South), 9 Greenway Plaza, Suite 2800, Houston, Texas 77046, filed an application pursuant to section 7(c) of the Natural Gas Act (NGA) and the Federal Energy Regulatory Commission's (Commission) regulations seeking authorization to construct, operate, and maintain: (1) A new 10,000 horsepower compressor station to be named the Westlake Compressor Station; (2) approximately 0.3 miles of 16-inch diameter natural gas pipeline; (3) a new delivery meter station; and (4) a new receipt meter station on an existing Gulf South facility site. These facilities are located in Calcasieu Parish, Louisiana, as more fully described in the application which is on file with the Commission and open to public inspection. The filing may also be viewed on the Web at http://www.ferc.gov using the “eLibrary” link. Enter the docket number excluding the last three digits in the docket number field to access the document. For assistance, contact FERC at [email protected] or call toll-free, (866) 208-3676 or TTY, (202) 502-8659.

    Any questions regarding this application should be directed to Kathy D. Fort, Manager Certificates & Tariffs, Gulf South Pipeline Company, LP, 610 West Second Street, Owensboro, Kentucky, 42301, or call (270) 688-6825, or by email: [email protected]

    Gulf South states the proposed Westlake Expansion Project will allow it to provide up to 200,000 dekatherms per day (Dth/d) of firm transportation service to Entergy Louisiana, LLC's proposed 980 megawatt natural gas-fired combined cycle electric generating unit to be located near Westlake, Louisiana.

    Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9, within 90 days of this Notice the Commission staff will either: Complete its environmental assessment (EA) and place it into the Commission's public record (eLibrary) for this proceeding; or issue a Notice of Schedule for Environmental Review. If a Notice of Schedule for Environmental Review is issued, it will indicate, among other milestones, the anticipated date for the Commission staff's issuance of the final environmental impact statement (FEIS) or EA for this proposal. The filing of the EA in the Commission's public record for this proceeding or the issuance of a Notice of Schedule for Environmental Review will serve to notify federal and state agencies of the timing for the completion of all necessary reviews, and the subsequent need to complete all federal authorizations within 90 days of the date of issuance of the Commission staff's FEIS or EA.

    There are two ways to become involved in the Commission's review of this project. First, any person wishing to obtain legal status by becoming a party to the proceedings for this project should, on or before the comment date stated below file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, a motion to intervene in accordance with the requirements of the Commission's Rules of Practice and Procedure (18 CFR 385.214 or 385.211) and the Regulations under the NGA (18 CFR 157.10). A person obtaining party status will be placed on the service list maintained by the Secretary of the Commission and will receive copies of all documents filed by the applicant and by all other parties. A party must submit 7 copies of filings made in the proceeding with the Commission and must mail a copy to the applicant and to every other party. Only parties to the proceeding can ask for court review of Commission orders in the proceeding.

    However, a person does not have to intervene in order to have comments considered. The second way to participate is by filing with the Secretary of the Commission, as soon as possible, an original and two copies of comments in support of or in opposition to this project. The Commission will consider these comments in determining the appropriate action to be taken, but the filing of a comment alone will not serve to make the filer a party to the proceeding. The Commission's rules require that persons filing comments in opposition to the project provide copies of their protests only to the party or parties directly involved in the protest.

    Persons who wish to comment only on the environmental review of this project should submit an original and two copies of their comments to the Secretary of the Commission. Environmental commentors will be placed on the Commission's environmental mailing list, will receive copies of the environmental documents, and will be notified of meetings associated with the Commission's environmental review process. Environmental commentors will not be required to serve copies of filed documents on all other parties. However, the non-party commentors will not receive copies of all documents filed by other parties or issued by the Commission (except for the mailing of environmental documents issued by the Commission) and will not have the right to seek court review of the Commission's final order.

    The Commission strongly encourages electronic filings of comments, protests and interventions in lieu of paper using the eFiling link at http://www.ferc.gov. Persons unable to file electronically should submit an original and 5 copies of the protest or intervention to the Federal Energy regulatory Commission, 888 First Street NE., Washington, DC 20426.

    Comment Date: 5:00 p.m. Eastern Time on August 21, 2017.

    Dated: July 31, 2017. Kimberly D. Bose, Secretary.
    [FR Doc. 2017-16476 Filed 8-3-17; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. AD15-10-000] Notice of Availability of the Final Guidelines for Reporting on Cultural Resources Investigations for Natural Gas Projects

    The staff of the Federal Energy Regulatory Commission's (FERC or Commission) Office of Energy Projects has finalized its revised Guidelines for Reporting on Cultural Resources Investigations for Natural Gas Projects (Guidelines), which was issued in draft form on January 25, 2017, for comment. The Guidelines have been revised to provide updated guidance on communicating with federally recognized tribes; clarifications regarding off-the-record communications; documentation for Blanket Certificate Programs; and to address substantive comments received on the draft Guidelines.

    The Guidelines can be found in Docket Number AD15-10-000. The full text of the Guidelines can be viewed on the Commission's Web site at http://www.ferc.gov/industries/gas/enviro/guidelines.asp.

    The Guidelines are intended to provide guidance to the industry. This manual does not substitute for, amend, or supersede the Commission's regulations under the Natural Gas Act of 1938 or the Commission's and Council on Environmental Quality's regulations under the National Environmental Policy Act. It imposes no new legal obligations and grants no additional rights.

    In response to the draft Guidelines, Commission staff received comments from federally recognized Indian tribes, industry representatives, federal and state agencies, and non-governmental organizations. Staff reviewed and considered each comment and modified several portions of the document in response. Staff declined to modify the document where comments either were too project- or location-specific to be included in general guidance, were already adequately/accurately addressed as written, or regarded topics that were not relevant to the Guidelines.

    All of the information related to the proposed updates to the Guidelines and submitted comments can be found on the FERC Web site (www.ferc.gov) using the eLibrary link. Click on the eLibrary link, click on Docket Search and in the Docket Number field enter the docket number AD15-10, excluding the last three digits. For assistance, please contact FERC Online Support at [email protected] or toll free at (866) 208-3676, or for TTY, contact (202) 502-8659. The eLibrary link also provides access to formal documents issued by the Commission, such as orders, notices, and rulemakings.

    Dated: July 31, 2017. Kimberly D. Bose, Secretary.
    [FR Doc. 2017-16475 Filed 8-3-17; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. ER17-2152-000] Cottonwood Wind Project, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization

    This is a supplemental notice in the above-referenced proceeding Cottonwood Wind Project, LLC 's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.

    Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.

    Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is August 17, 2017.

    The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet access who will eFile a document and/or be listed as a contact for an intervenor must create and validate an eRegistration account using the eRegistration link. Select the eFiling link to log on and submit the intervention or protests.

    Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.

    The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the Web site that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email [email protected] or call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Dated: July 28, 2017. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2017-16462 Filed 8-3-17; 8:45 am] BILLING CODE 6717-01-P
    ENVIRONMENTAL PROTECTION AGENCY [FRL-9965-55-OECA] Applicability Determination Index (ADI) Data System Recent Posting: Agency Applicability Determinations, Alternative Monitoring Decisions, and Regulatory Interpretations Pertaining to Standards of Performance for New Stationary Sources, National Emission Standards for Hazardous Air Pollutants, and the Stratospheric Ozone Protection Program AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice of availability.

    SUMMARY:

    This action announces applicability determinations, alternative monitoring decisions, and regulatory interpretations that EPA has made under the New Source Performance Standards (NSPS); the National Emission Standards for Hazardous Air Pollutants (NESHAP); and/or the Stratospheric Ozone Protection Program.

    FOR FURTHER INFORMATION CONTACT:

    An electronic copy of each complete document posted on the Applicability Determination Index (ADI) data system is available on the Internet through the Resources and Guidance Documents for Compliance Assistance page of the Clean Air Act Compliance Monitoring Web site under “Air” at: https://www2.epa.gov/compliance/resources-and-guidance-documents-compliance-assistance. The letters and memoranda on the ADI may be located by date, office of issuance, subpart, citation, control number, or by string word searches. For questions about the ADI or this notice, contact Maria Malave at EPA by phone at: (202) 564-7027, or by email at: [email protected] For technical questions about individual applicability determinations or monitoring decisions, refer to the contact person identified in the individual documents, or in the absence of a contact person, refer to the author of the document.

    SUPPLEMENTARY INFORMATION:

    Background

    The General Provisions of the NSPS in 40 Code of Federal Regulations (CFR) part 60 and the General Provisions of the NESHAP in 40 CFR part 61 provide that a source owner or operator may request a determination of whether certain intended actions constitute the commencement of construction, reconstruction, or modification. The EPA's written responses to these inquiries are commonly referred to as applicability determinations. See 40 CFR 60.5 and 61.06. Although the NESHAP part 63 regulations [which include Maximum Achievable Control Technology (MACT) standards and/or Generally Available Control Technology (GACT) standards] and Section 111(d) of the Clean Air Act (CAA) contain no specific regulatory provision providing that sources may request applicability determinations, the EPA also responds to written inquiries regarding applicability for the part 63 and Section 111(d) programs. The NSPS and NESHAP also allow sources to seek permission to use monitoring or recordkeeping that is different from the promulgated requirements. See 40 CFR 60.13(i), 61.14(g), 63.8(b)(1), 63.8(f), and 63.10(f).

    The EPA's written responses to these inquiries are commonly referred to as alternative monitoring decisions. Furthermore, the EPA responds to written inquiries about the broad range of NSPS and NESHAP regulatory requirements as they pertain to a whole source category.

    These inquiries may pertain, for example, to the type of sources to which the regulation applies, or to the testing, monitoring, recordkeeping, or reporting requirements contained in the regulation. The EPA's written responses to these inquiries are commonly referred to as regulatory interpretations.

    The EPA currently compiles EPA-issued NSPS and NESHAP applicability determinations, alternative monitoring decisions, and regulatory interpretations, and posts them to the ADI on a regular basis. In addition, the ADI contains EPA-issued responses to requests pursuant to the stratospheric ozone regulations, contained in 40 CFR part 82. The ADI is a data system on the Internet with over three thousand EPA letters and memoranda pertaining to the applicability, monitoring, recordkeeping, and reporting requirements of the NSPS, NESHAP, and stratospheric ozone regulations. Users can search for letters and memoranda by date, office of issuance, subpart, citation, control number, or by string word searches.

    Today's action comprises a summary of 31 such documents added to the ADI on July 21, 2017. This action lists the subject and header of each letter and memorandum, as well as a brief abstract of the letter or memorandum. Complete copies of these documents may be obtained from the ADI on the Internet through the through the Resources and Guidance Documents for Compliance Assistance page of the Clean Air Act Compliance Monitoring Web site under “Air” at: https://www2.epa.gov/compliance/resources-and-guidance-documents-compliance-assistance.

    Summary of Headers and Abstracts

    The following table identifies the database control number for each document posted on the ADI data system on July 21, 2017; the applicable category; the section(s) and/or subpart(s) of 40 CFR part 60, 61, or 63 (as applicable) addressed in the document; and the title of the document, which provides a brief description of the subject matter.

    We have also included an abstract of each document identified with its control number after the table. These abstracts are provided solely to alert the public to possible items of interest and are not intended as substitutes for the full text of the documents. This action does not change the status of any document with respect to whether it is “of nationwide scope or effect” for purposes of CAA section 307(b)(1). For example, this document does not convert an applicability determination for a particular source into a nationwide rule. Neither does it purport to make a previously non-binding document binding.

    ADI Determinations Uploaded on July 21, 2017 Control No. Categories Subparts Title 1600009 NSPS Ja Regulatory Interpretation on an Alternative Calibration Procedure for Hydrogen Sulfide Monitor at a Refinery. 1600010 NSPS Ec Alternate Monitoring Operating Parameter Limits for Two Waste Incinerators. 1600011 NSPS EEEE Alternative Operating Parameter Limits for Commercial Incinerator. 1600012 NSPS J, Ja Alternative Monitoring Plan for Hydrogen Sulfide in Portable Temporary Thermal Oxidizer Units at Refineries. 1600013 NSPS J, Ja Alternative Monitoring Plan for Hydrogen Sulfide in Portable Temporary Thermal Oxidizer Units at Refineries. 1600018 NSPS NNN, RRR Regulatory Interpretation for a Biodiesel Manufacturing Facility. 1600027 NSPS A, Ja Alternative Monitoring Plan for Span Gas Concentration and High Range Validation Standards for H2S CEMS at a Refinery. 1600028 NSPS J Alternative Monitoring Plan for Revised Process Parameter Limits at a Refinery. 1600029 NSPS A, Ec Alternative Monitoring Operating Parameter Limits for Air Pollution Control System at a Medical Waste Incinerator. 1600030 NSPS J Withdrawal of Alternative Monitoring Plan for Sulfur Loading Vent Stream at a Refinery. 1600031 NSPS J Alternative Monitoring Plan Revision for Re-Routed Vent Gas Stream at a Refinery. 1600032 NSPS Ja Alternative Monitoring Plan for Flares at a Refinery. 1600033 NSPS Ja Alternative Monitoring Plan for a Flare at a Refinery. 1600034 NSPS GG Alternative Monitoring Plan for NOX Emissions during Startup from Stationary Gas Turbines. 1600035 NSPS JJJJ Performance Test Waiver for Stationary Spark Ignition Internal Combustion Engines. 1600036 NSPS UUU Alternative Monitoring Plan for Bag Leak Detection System In Lieu of COMS at a Sand Reclamation Unit. 1600037 NSPS UUU Applicability Determination for Industrial Sand Dryer. 1600038 NSPS Ja Alternative Calibration Methods for Total Reduced Sulfur Analyzers at a Refinery. 1600039 NSPS UUU Alternative Monitoring Plan In Lieu of COMS at a Sand Reclamation Unit. 1600040 NSPS UUU Request for Exemption to Opacity Monitoring Requirements for Thermal Sand Reclamation Units. 1600041 NSPS JJJJ Alternative Test Method for Spark Ignition Engines. A160001 Asbestos, NESHAP M Waiver Request from Asbestos Testing for Bare Concrete Deck Bridges. A160002 Asbestos, NESHAP M Applicability Determination for Airport Taxiways. M160005 MACT XXXXXX Applicability Determination for a Steel Foundry. M160007 MACT, NESHAP JJJJ, SSSSS Applicability Determination for Mica Sheets Manufacturing. M160009 MACT, NESHAP VVVVVV Applicability Determination for Pharmaceutical Manufacturing Facility. M160017 MACT JJJJ Applicability Determination for Web Coating Manufacturing Facility. M160019 MACT, NSPS J, UUU Alternative Monitoring Plan for Wet Gas Scrubber at a Refinery. M160020 MACT, GACT, NESHAP, NSPS AAa, YYYYY, ZZZZZ Applicability Determination for a Steelmaking Facility. M160021 MACT JJJ Alternative Monitoring Method In Lieu of Continuous Flow Monitor for a Thermal Oxidizer. Z160005 MACT, NESHAP PPPPP, ZZZZ Applicability Determination for Engine Testing and Emissions Laboratory. Abstracts Abstract for [1600009]

    Q: Does the EPA approve the use of the same calibration gas to perform quality assurance checks on both the low and the high ranges for a dual range hydrogen sulfide (H2S) continuous emission monitoring system subject to 40 CFR part 60 subpart Ja at the Ergon Refinery in Vicksburg, Mississippi (Ergon)?

    A: Yes. Based on the information provided by the Mississippi Department of Environmental Quality (MDEQ), the EPA believes that the Ergon's proposed monitoring alternative is acceptable to satisfy the QA checks on the high concentration range for the Sola II analyzer. EPA's guidance to MDEQ is based upon the expectation that the monitor's higher range will rarely be used to demonstrate compliance because the H2S concentration at the inlet of the Refinery Flare will need to be below the monitor span value to meet the NSPS Ja limits, the highly linear response of the monitor should yield accurate results for the whole range of operation, and the safety hazards to plant employees associated with keeping high concentration H2S calibration gas cylinders onsite being valid concerns due to H2S high toxicity.

    Abstract for [1600010]

    Q: Does the EPA approve site-specific alternative monitoring operating parameter limits (OPLs) under NSPS subpart Ec for the operation of two hospital/medical/infectious waste incinerators (HMIWI) at the Stericycle Springhill facility located in Sarepta, Louisiana (Stericycle)?

    A: Yes. The EPA conditionally approves Stericycle's alternative OPLs, which are consistent with the permit conditions, the equipment configuration of the incinerators, and the operation of the associated air pollution control devices. EPA approval is contingent on Stericycle's successful completion of performance testing on both HWIMI to demonstrate compliance with NSPS subpart Ec emission limits. Stericycle shall conduct a performance test on each HMIWI in accordance with 40 CFR 60.8 and consistent with the proposed performance test plan included in the EPA response letter. If performance testing shows that the facility is not in compliance with NSPS Ee emission limits, retesting will be required, and the OPLs established for this petition approval may require modification, and in the event that new or modified OPLs must be established, a revised OPL petition must be submitted prior to retesting, along with a revised test plan for review and approval.

    Abstract for [1600011]

    Q: Does EPA approve the revision of alternative Operating Parameter Limits (OPLs) for additional control equipment used in lieu of a wet scrubber at a contraband incinerator operated by SW Border Incineration LLC, in McAllen, Texas, which meets the criteria of an Other Solid Waste Incinerator (OSWI) unit under NSPS subpart EEEE?

    A: Yes. The EPA approves the revision of alternative OPLs contingent on the successful completion of performance testing to demonstrate compliance with NSPS subpart EEEE emission limits. The previously approved and additional OPLs are consistent with the special conditions of Texas Air Permit, which the Texas Commission on Environmental Quality approved the test plan, along with the RATA protocols. If performance testing shows that the facility is not in compliance with NSPS EEEE emission limits, retesting will be required, and the OPLs established for this petition approval may require modification. If additional new or modified OPLs must be established to achieve and maintain compliance with NSPS EEEE, a revised OPL petition must be submitted prior to retesting, along with a revised test plan for review and approval.

    Abstract for [1600012]

    Q: Does the EPA approve an Alternative Monitoring Plan (AMP) in lieu of using a continuous emission monitoring system (CMS) for Event Corporation to monitor Hydrogen Sulfide (H2S) during tank degassing and similar operations controlled by a portable temporary thermal oxidizer subject to NSPS subpart J and NSPS subpart Ja at refineries located in the EPA Region 3?

    A: Yes. The EPA conditionally approves the AMP since installing and operating an H2S CMS would be technically impractical due to the short term nature of tank degassing and similar operations performed by Event at refineries located in EPA Region 3. EPA included the detailed AMP sampling steps and compliance demonstration procedures and conditions in the EPA final determination letter.

    Abstract for [1600013]

    Q: Does the EPA approve an Alternative Monitoring Plan (AMP) in lieu of using continuous emission monitoring system (CMS) for TriStar Global Energy Solution (Tristar) to monitor hydrogen sulfide (H2S) during tank degassing and similar operations controlled by portable temporary thermal oxidizer units subject to NSPS subpart J and NSPS subpart Ja, at refineries located in EPA Region 3?

    A: Yes. The EPA conditionally approves the AMP since installing and operating an H2S continuous emission monitoring system would be technically impractical due to the short term nature of tank degassing and similar operations performed by Tristar at refineries in EPA Region 3. The EPA included the AMP detailed sampling steps, the compliance demonstration procedures and conditions in the final determination letter.

    Abstract for [1600018]

    Q: Does the EPA determine that the proposed addition of a biodiesel manufacturing facility at a plant owned by Patriot Renewable Fuels (Patriot) and located in Annawan, Illinois is subject to 40 CFR part 60 subpart RRR (VOC Emissions from Synthetic Organic Chemical Manufacturing Industry (SOCMI) Reactor Processes)?

    A: Yes. Based on the information provided by the Illinois Environmental Protection Agency (Illinois EPA), the EPA believes that the proposed addition to the biodiesel plant would meet the applicability criteria of subpart RRR. Glycerol, is a chemical listed in 40 CFR 60.707. The EPA considers either of the following downstream uses as indicative of the production of a listed chemical as a “product”: (1) Production for sale of a listed chemical; or (2) use in another process where that listed chemical is needed. Glycerol is produced from com oil via a hydrolysis reaction during the manufacture of biodiesel. When sent to the fermenters, glycerol is used to increase the ethanol yield (i.e., it is needed in the process) and is, therefore, an intermediate (i.e., a compound that is produced for the use in the production of other compounds or chemicals) under 40 CFR 60.700. Because the glycerol sent to the fermenters is an intermediate, the glycerol is a product. Therefore, our guidance to Illinois EPA is that the Patriot facility would be considered an affected facility subject to Subpart RRR after the addition of the proposed biodiesel plant.

    Abstract for [1600027]

    Q: Does the EPA approve an alternative monitoring plan (AMP) to use alternative concentrations of span gases used to check daily calibration drift, and as high range validation standards used during cylinder gas audits (CGAs) and relative accuracy test audits (RATAs), under NSPS subpart A for the No. 2 flare Continuous Emission Monitoring System (CEMS) at the Delek Refining (Delek) facility located in Tyler, Texas and covered under NSPS subpart Ja?

    A: Yes. Based on the process data and detector information submitted, the EPA conditionally approves Delek's AMP to reduce the concentrations of the calibration gas and validation standards to certain specified range values on the No. 2 Flare CEMS. Delek must conduct linearity analysis on the pulsed ultraviolet fluorescence (PUVF) detector once every three years to determine the detector's linearity across the entire range of expected concentrations of gas vent streams. The analysis must demonstrate that linearity is maintained for the specified vent gas stream hydrogen sulfide (H2S) concentration range. A report of each completed linearity analysis must be submitted to the EPA Region 6 and to the State, and records must be maintained on-site.

    Abstract for [1600028]

    Q: Does the EPA approve revised process parameter limits for a previously approved Alternative Monitoring Plan (AMP) for the Valero Refining-Texas, LP facility (Valero) located in Corpus Christi, Texas and subject to NSPS subpart J?

    A: Yes. The EPA conditionally approves revised process parameter limits that should not exceed the new upper value for total sulfur and the higher proposed temperature. Valero must continue to follow the steps outlined in the previously approved AMP for monitoring the vent stream. If refinery operations change such that the sulfur content of the vent stream changes from representations made for the AMP, then Valero must document the changes and follow the appropriate steps outlined in 40 CFR 60.105(b)(3)(i)-(iii).

    Abstract for [1600029]

    Q: Does the EPA conditionally approve revised alternative monitoring Operating Parameter Limits (OPLs) for a pollution control system on a new medical waste incinerator subject to NSPS subpart Ec, which consists of a wet gas scrubber (WGS) followed by a carbon adsorber and cartridge filter, located at the University of Texas Medical Branch (UTMBG) in Galveston, Texas?

    A: Yes. Based on process-specific information and data provided by UTMBG, the EPA conditionally approves the revised operating parameters for the WGS, carbon adsorber and cartridge filter. UTMBG must conduct a second representative performance test in order to establish revised numerical limits for the operating parameters conditionally approved. The follow up performance testing must be conducted in accordance with 40 CFR 60.8 and State requirements, with no deviations from the EPA-approved test methods or quality assurance protocols. Other OPLs specified by Table 3 of NSPS subpart Ec and the facility's minor source air permit also must be included in the performance test if the changes affect those pollutants or operating limits. If performance testing shows that the facility is not in compliance with NSPS Ec emission limits, retesting will be required, and the OPLs established for this petition approval may require modification. If additional new or modified OPLs must be established to achieve and maintain compliance with NSPS Ee, a revised OPL petition must be submitted prior to retesting, along with a revised test plan for review and approval.

    Abstract for [1600030]

    Q: Does the EPA approve the withdrawal of a previously approved Alternative Monitoring Plan (AMP) for a sulfur loading vent stream at the Valero Mckee Refinery located in Sunray, Texas and covered under NSPS subpart J?

    A: Yes. The EPA approves the AMP withdrawal of a previously approved AMP because emissions from the tail gas incinerators are monitored for compliance with the sulfur dioxide (SO2) limit of 40 CFR 60. 104(a)(2)(i) via a continuous emissions monitoring system (CEMS), in accordance with 60.105(a)(3) of NSPS J, as modified on June, 24, 2008, and is consistent with the requirements of Paragraph 226 of the consent decree.

    Abstract for [1600031]

    Q: Does the EPA approve revisions to an Alternative Monitoring Plan (AMP) that was previously conditionally approved for re-routing a refinery fuel gas vent stream to an alternate combustion device at the Valero Refining-Meraux LLC (Valero Meraux) facility located in Meraux, Louisiana subject to NSPS subpart J?

    A: Yes. The EPA approves the revisions to a previously conditionally approved AMP. Valero Meraux proposed re-routing the affected refinery fuel gas vent gas stream to a reformer recharge heater instead of combusting the stream at a stripper reboiler heater. Valero Meraux is required to continue monitoring and controlling the relevant process parameters as summarized in the EPA's previous conditional AMP approval. If refinery operations change such that the sulfur content of the vent stream changes from representations made for the AMP, then Valero must document the changes and follow the appropriate steps outlined in 40 CFR 60. 105(b)(3)(i)-(iii).

    Abstract for [1600032]

    Q: Does the EPA approve the Alternative Monitoring Plan (AMP) to use the data obtained from the total sulfur (TS) continuous emissions monitoring system (CEMS) for one flare at plant 1 and one flare at plant 2 at the Suncor Energy (USA) Inc. (Suncor) Commerce City Refinery in Commerce City, Colorado subject to NSPS subpart Ja?

    A: Yes. The EPA approves Suncor's AMP for flares at plants 1 and 2, pursuant to 40 CFR 60.13(i), to use the data obtained from the TS CEMS low range two-point daily calibration drift and two-point quarterly audits, as well as a one-point challenge in the high range. Because Suncor is requesting this AMP based on a significant safety hazard to refinery personnel and because this monitoring is being performed to detect the threshold for a root cause analysis, not to monitor for compliance with an emission limit, the EPA will allow for minimal use of high concentration calibration gases. This approach avoids routine use of higher level calibration gases in the field; higher level gases are only used for quarterly audits and annual testing and could be brought on-site by a testing contractor and then removed after the test/audit.

    Abstract for [1600033]

    Q: Does the EPA approve the Alternative Monitoring Plan (AMP) to use the data obtained from the total sulfur (TS) continuous emissions monitoring system (CEMS) for a flare at plant 3 of the Suncor Energy (USA) Inc. (Suncor) Commerce City Refinery in Commerce City, Colorado subject to NSPS subpart Ja?

    A: Yes. The EPA approves Suncor's AMP for a flare at plant 3, pursuant to 40 CFR. 40 CFR 60.13(i), to use the data obtained from the TS CEMS low range two-point daily calibration drift and two-point quarterly audits, as well as a one-point challenge in the high range. Because Suncor is requesting this AMP based on a significant safety hazard to refinery personnel and because this monitoring is being performed to detect the threshold for a root cause analysis, not to monitor for compliance with an emission limit, the EPA will allow for minimal use of high concentration calibration gases. This approach avoids routine use of higher level calibration gases in the field; higher level gases are only used for quarterly audits and annual testing and could be brought on-site by a testing contractor and then removed after the test/audit.

    Abstract for [1600034]

    Q: Does the EPA approve an Alternative Monitoring Plan (AMP) under 40 CFR 60.13(i) for the monitoring of emissions using an emission factor to determine NOx emissions from two stationary gas combustion turbines located at the Power House (Plant) operated by the University of Colorado Boulder (UCB) in Boulder, Colorado, in lieu of determining emissions through Continuous Emissions Monitoring System (CEMS) installed on the bypass stack, to demonstrate compliance with the emission limit under NSPS subpart GG?

    A: Yes. Based on the most recent stack testing for NOx emissions during startup of turbine 1 and turbine 2, the EPA will allow UCB use of the 0.32 lb/MMBtu emission factor rather than determining emissions through CEMS installed on the bypass stack. The use of this emission factor provides a conservative emissions estimate and is consistent with UCB permit issued by the Colorado Department of Health and Environment (CDPHE) Air Pollution Control Division (APCD). The EPA or CDPHE APCD may require UCB to conduct additional testing of emissions at the bypass stack to verify the NOx concentrations during turbine startup.

    Abstract for [1600035]

    Q: Does the EPA approve waiver of a performance testing requirement for six identical stationary engines subject to 40 CFR part 60 subpart JJJJ at the Bio Town Ag facility in Reynolds, Indiana (Bio Town)?

    A: Yes. Based on the information Bio Town provided, the EPA approves the performance test waiver request for six identical stationary engines operated in the same manner, pursuant to 40 CFR 60.8(b)(4). Specifically, EPA approves conducting a performance test every 8,760 hours or 3 years, whichever comes first, for the three engines that were constructed in 2011, and a performance test for the three engines that were constructed in 2014, in a staggered schedule as provided in the determination letter. Bio Town must meet Section VII. 2 of the April 27, 2009, Clean Air Act National Stack Testing Guidance, which lists the conditions that must be met for approval of a performance test waiver for identical emissions units.

    Abstract for [1600036]

    Q: Does the EPA approve the use of a bag leak detection system (BLDS) as an alternative monitoring method in lieu of a continuous opacity monitoring system (COMS) for purposes of meeting the monitoring requirements under 40 CFR part 60 subpart UUU, Standards of Performance for Calciners and Dryers in Mineral Industries, at the Waupaca Foundry, Inc. plant (Waupaca) located in Tell City, Indiana?

    A: Yes. The EPA conditionally approves the Waupaca alternative monitoring method to use BLDS in lieu of a COMS or conducting daily Method 9 readings for the mechanical and thermal sand reclamation unit (P27) being installed at Waupaca's Plant 5. Waupaca will need to develop and prepare a site-specific monitoring plan for the BLDS installed under this alternative monitoring method and meet the conditions specified in the EPA response letter. In addition, Waupaca will need to revise its current major source construction permit for the sand reclamation project, as well as its Title V permit, to incorporate this alternative monitoring method. The approval of the proposed alternative monitoring method does not alter Waupaca's legal obligation to comply with all other applicable requirements associated with Subparts A and UUU, including meeting the opacity limit.

    Abstract for [1600037]

    Q1: Does the EPA determine the start-up date of Northern Industrial Sand's (NIS) sand dryer located in Auburn, Wisconsin and subject to 40 CFR part 60 subpart UUU is the date the construction permit was issued (June 18, 2015), or the date the sand dryer first processed sand (July 17, 2015)?

    A1: The EPA determines that the initial start-up of NIS's sand dryer in question is July 17, 2015. “Start-up” is defined at 40 CFR 60. 2 as the setting in operation of an “affected facility” for any purpose. Based on the information provided in your letter, the sand dryer at NIS first processed sand on July 17, 2015.

    Q2: For purposes of initial performance testing, does the EPA determine that the “180 days after start-up” requirement is based on consecutive days (including non-operational days) or operating days?

    A2: The EPA determines that the 180 days after start-up requirement is based on calendar days, not operating days. The General Provisions, at 40 CFR 60. 19(a), state “For the purposes of this part, time periods specified in days shall be measured in calendar days, even if the word `calendar' is absent, unless otherwise specified in an applicable requirement.” Neither the General Provisions, at 40 CFR60. 8, nor the requirements of performance testing under subpart UUU, at 40 CFR 60.732 and 60.736, define the time periods for performance testing as anything other than “days”.

    Q3: Does the EPA recommend any other options for NIS to consider for initial performance testing under subpart UUU before the 180-day deadline expires?

    A3: Yes. The EPA suggests two testing options. Option 1: NIS may conduct initial performance testing of the sand dryer at its desired maximum throughput and store the processed sand until needed. Based on the information provided, NIS has more than adequate storage capacity for the processed sand to test under this option. Option 2: NIS may conduct performance testing of the sand dryer at less than its desired maximum throughput. However, if this option is selected, NIS will need to take operational restrictions to the reduced throughput at which it tested to show compliance with subpart UUU. The operational restrictions will need to be incorporated into a federally enforceable document (typically a federally enforceable construction or operating permit). If, at a later date, NIS is able to operate at an increased throughput and desires to operate at that increased throughput, it will need to revise its underlying federally enforceable document to accommodate the increased throughput. NIS will also be required to conduct another performance test at that increased rate and demonstrate compliance with applicable limits.

    Q4: What does the EPA determine are the monitoring requirements following initial performance testing for the sand dryer?

    A4: Based on the information NIS provided, the EPA determines that the sand dryer is an industrial sand fluid bed dryer. The monitoring requirements are therefore either: (a) Installation and operation of a continuous opacity monitoring system (COMS), or (b) daily visible emission readings using U. S. EPA Reference Method 9 (for no less than 18 minutes each day). The monitoring requirements of subpart UUU are found at 40 CFR 60.734(a-d).

    Abstract for [1600038]

    Q1: Does EPA approve three alternative calibration methods for the total reduced sulfur (TRS) analyzers associated with three flares that are affected facilities under 40 CFR part 60 subpart Ja at the Lima Refining Company (Lima Refining) refinery in Lima, Ohio?

    A1: Based on the information provided by Lima Refining, EPA approves two of the three alternative calibration methods requested for the TRS monitors to address safety concerns involving storage, handling, and life expectancy (short expiration dates) of high hydrogen sulfide (H2S) concentration gas cylinders on site. The two conditional approved calibration methods are: (1) The use of low H2S concentration cylinders to calibrate TRS monitors provided that laboratory analyses demonstrate the linearity of the instruments for the target compound used across the entire sulfur concentration range expected; and (2) the use of a sample dilution system in conjunction with the TRS monitoring systems being installed provided that the dilution system can be challenged at the ratio Lima Refining intends to use, and the capability of the analyzer to detect the lowest expected concentrations of the target compound(s) under typical operating conditions when the gas is diluted at the dilution ratio selected. EPA is disapproving the use of a surrogate gas to calibrate the TRS monitoring systems. This disapproval is based on the fact that the monitoring requirements of subpart Ja are TRS specific. Approvable calibration methodologies should be based on pollutant specific monitoring, when such options are available, rather than a surrogate gas. Since there are feasible pollutant specific options, EPA disapproves the use of a surrogate gas to calibrate the TRS monitors.

    Q2: Does EPA approve single point calibrations for each of the TRS analyzers associated with three flares that are affected facilities under subpart Ja?

    A2: Yes. EPA approves Lima Refining's request to use single point calibrations for the daily calibration requirements (zero and one other target compound(s) concentration). However, Lima Refining must conduct multi-point calibrations on at least a quarterly basis. Other conditions and requirements of this approval are included in the EPA response letter.

    Q3: Does EPA approve a reduced span to that required by subpart Ja for the TRS analyzer associated with the aromatics flare that is an affected facility under subpart Ja?

    A3: Yes. EPA conditionally approves Lima Refining's request to reduce the instrument span from 5,000 ppm to 1,000 ppm for the aromatics flare (LIU flare) TRS monitoring system. This approval is based on the low expected TRS concentration from the aromatics flare. However, if readings associated with the aromatics flare exceed 1,000 ppm, then Lima Refining will need to re-span the TRS monitor to a higher value which includes the higher concentration measured.

    Abstract for [1600039]

    Q: Does EPA approve the use of daily visible emission observations and baghouse pressure drop readings associated with the thermal sand reclamation unit in lieu of a continuous opacity monitoring system (COMS) to meet the monitoring requirements of 40 CFR subpart UUU (Standards of Performance for Calciners and Dryers in Mineral Industries) at the Urschel Laboratories, Inc. (Urschel) in Valparaiso, IN?

    A: Yes. EPA conditionally approves the alternative monitoring method to meet the monitoring requirements of subpart UUU at 40 CFR 60.734. Urschel will need to evaluate and establish an appropriate range for the pressure drop across the baghouse based on a performance test at the thermal sand reclamation unit to ensure compliance with subpart UUU. The alternative monitoring program and associated recordkeeping and reporting approved through this letter must be incorporated into its federal enforceable state operating permit. Additional conditions and requirements of this approval are included in the EPA response letter.

    Abstract for [1600040]

    Q: Does EPA determine that the Urschel Laboratories, Inc. (Urschel) thermal sand reclamation unit located in Valparaiso, Indiana is exempt from the opacity monitoring requirements of 40 CFR part 60 subpart UUU (Standards of Performance for Calciners and Dryers in Mineral Industries) since its particulate emissions are well below 11 tons per year?

    A: No. EPA determines that Urschel's thermal sand reclamation unit is an affected facility subject to subpart UUU and is therefore subject to the monitoring requirements at 40 CFR 60.734. Since the thermal sand reclamation unit is not one of the listed facilities under 40 CFR 60.734(b) or (c) and does not use a wet control device (40 CFR 60.734(d)), Urschel must install and operate a continuous opacity monitoring system (COMS). However, the General Provisions at 40 CFR 60.13(i) provides an owner or operator of an affected facility the ability to request, among other things, alternative monitoring to that required by an applicable subpart.

    Abstract for [1600041]

    Q: Does the EPA approve using an alternative test method ASTM D-6348-12 in lieu of ASTM D-6348-03 for measuring pollutants in the engine exhaust per NSPS subpart JJJJ at Samson Resources Company's facilities on the Southern Ute Indian Reservation in La Plata County, Colorado?

    A: Yes. The EPA approves the use of the updated ASTM method, D-6348-12 in lieu of D-6348-03 as prescribed in Table 2 to NSPS JJJJ for performance testing of engines at the requested facilities, pursuant to 40 CFR 60.8(b)(2).

    Abstract for [A160001]

    Q1: Does the EPA approve a waiver from asbestos testing requirements for bare concrete deck bridges under 40 CFR part 61, subpart M (Asbestos NESHAP), for the Kansas Department of Transportation?

    A1: No. Under the Asbestos NESHAP, there is no regulatory provision that allows the EPA to issue a waiver.

    Q2: Does the EPA determine that bare concrete deck bridges are subject to the Asbestos NESHAP regulation?

    A2: Yes. The EPA determines that concrete is considered a building material and needs to be evaluated for asbestos-content. At a minimum, it must be thoroughly inspected.

    Abstract for [A160002]

    Q1: Does the EPA determine that airport taxiways are subject to 40 CFR part 61, subpart M (Asbestos NESHAP)?

    A1: Yes. The EPA indicated to the Missouri Department of Natural Resources (MO DNR) that airport taxiways are a “facility component” as defined in 40 CFR 61.141 and therefore subject to the regulation. At a minimum, the taxiway is subject to the thorough inspection requirement of the regulation. Further, MO DNR asks that EPA reconsider a previous applicability determination which stated airport runways were not subject to the Asbestos NESHAP. This applicability determination supersedes the June 20, 1997 applicability determination with ADI Control No. A970006.

    Q2: Does the EPA determine that repair operations on a taxiway are considered a renovation or demolition operation under the Asbestos NESHAP regulation?

    A2: Yes. The EPA determines if work is to be done on an airport taxiway, it is considered a renovation operation as there is no load-supporting structural member being wrecked or taken out as defined under the demolition definition.

    Abstract for [M160005]

    Q: Does EPA determine that McConway and Torley's Lawrenceville Foundry in Pittsburgh, Pennsylvania is subject to 40 CFR part 63 subpart XXXXXX (subpart 6X), NESHAP for Nine Metal Fabrication and Finishing Source Categories?

    A: No. EPA has determined that subpart 6X does not apply to the Lawrenceville Foundry based on not meeting rule applicability requirements due to current operations, an evaluation of the SIC/NAICS codes associated with the facility, and the corresponding activities in which the facility is primarily engaged in that involves manufacturing of railroad car couplings.

    Abstract for [M160007]

    Q1: Does EPA determine that the raw material used by Mica Company of Canada Incorporated (Mica Co.) at their Newport News, Virginia facility meets the definition of a “web” and that both manufacturing lines are subject to 40 CFR part 63 subpart JJJJ?

    A1: Based on the description provided by Mica Co., EPA determines that the raw material used by Mica Co. processing line 2 meets the definition of a “web” at 40 CFR 63.3300 since the mica paper is fed from a roll to the web coating line. Therefore, this processing line is subject to MACT subpart JJJJ. Processing line 1 does not meet the definition of web and is therefore not subject to MACT subpart JJJJ.

    Q2: Does EPA determine that the end products manufactured by Mica Co. meet the definition of a “refractory product” and that both processing lines are therefore subject to 40 CFR part 63 subpart SSSSS?

    A2: No. Based on the description provided by Mica Co., EPA determines that the mica sheet insulating products manufactured by Mica Co. do not meet the definition of a “refractory product” at 40 CFR 63.9824; therefore, the manufacturing lines are not subject to MACT subpart SSSSS.

    Abstract for [M160009]

    Q: Does EPA determine that the Teva Pharmaceuticals USA, Inc. Women's Health pharmaceutical manufacturing facility in Cincinnati, Ohio (Teva) is subject to the NESHAP subpart VVVVVV Title V Permit requirement if the facility took operational limits on organic compounds to become an area source before the effective date of the rule and now operate control devices, but would still be an area source without the controls?

    A: No. EPA determines that the Teva pharmaceutical manufacturing operations at the Cincinnati facility are not currently subject to the Title V requirement in NESHAP subpart VVVVVV. Since the facility took operational limits to obtain area source status prior to the effective date of the rule, the Title V NESHAP subpart VVVVVV requirement does not apply, even if it now operates controls. The facility does not rely on a control device to maintain HAP emissions below major source thresholds as was demonstrated with the potential to emit analysis.

    Abstract for [M160017]

    Q: Does EPA determine that the Owens Corning Insulating Systems, LLC (OC) a wool fiberglass products manufacturing plant located in Delmar, NY (Delmar), is subject to 40 CFR part 63 subpart JJJJ, NESHAP for Paper and Other Web Coating Manufacturing?

    A: Yes. Based on the information provided by OC, EPA determines that the Delmar plant still operates web coating lines after switching from a phenol-formaldehyde binder to a starch binder and thus remains subject to 40 CFR part 63 subpart JJJJ, and that the subsequent non applicability determination for 40 CFR part 63 subpart NNN, the NESHAP for Wool Fiberglass Manufacturing due to the binder switch is irrelevant to the applicability status of 40 CFR part 63 subpart JJJJ. This determination is consistent with the “Once-In-Always-In” policy. The Delmar plant has been required to comply with subpart JJJJ provisions (including emissions standards) since December 5, 2005, the first substantive compliance date of rule, based on 40 CFR 63.320(a) of the rule. The fact that OC chooses to comply with the subpart JJJJ emission standards at the Delmar plant using a method it was already using (i.e., the “[u]se of `as-purchased' compliant coating materials”) prior to the first substantive compliance date is irrelevant to the applicability analysis.

    Abstract for [M160019]

    Q: Does EPA approve an Alternative Monitoring Plan (AMP) for a Wet Gas Scrubber (WGS) on a Fluidized Catalytic Cracking Unit (FCCU) subject to NSPS part 60 subpart J, and also NESHAP subpart UUU, for parametric monitoring of opacity at the WGS in lieu of a Continuous Opacity Monitoring System, due to moisture interference on opacity readings in the stack at the Valero Refining Company (Valero) facility in Ardmore, Oklahoma (Valero)?

    A: Yes. Based upon the design of the WGS unit and the process specific information and performance test results provided by Valero, EPA approves the AMP request and its operating parameter limits (OPLs) for demonstrating compliance under NESHAP subpart UUU, which included minimum Liquid-to-Gas Ratio, minimum water pressure to the quench/spray tower nozzles, and minimum pressure drop across the Agglo-filtering module. Valero shall incorporate the terms of this AMP approval into the facility's New Source Review (NSR) and Title V permits for federal enforceability. If refinery operations change, Valero shall conduct another performance test to establish new limits for the OPLs listed in the EPA response letter.

    Abstract for [M160020]

    Q: Does EPA determine that the Ervin Amasteel facility in Adrian, Michigan should be classified as a steel foundry subject to requirements of the NESHAP for Iron and Steel Foundries Area Source, at 40 CFR part 63 subpart ZZZZZ, and not the requirements under the NESHAP for Area Sources for Electric Arc Furnace Steelmaking Facilities, at 40 CFR part 63 subpart YYYYY, and the Standards of Performance for Steel Plants: Electric Arc Furnaces and Argon-Oxygen Decarburization Vessels Constructed After August 17, 1983, at 40 CFR part 60 Subpart AAa (NSPS AAa)?

    A: No. EPA determines that the Ervin Amasteel facility is not subject to the requirements of NESHAP subpart ZZZZZ because the facility is not an iron and steel foundry as defined in 40 CFR 63.10906 of the rule. Therefore, the Ervin Amasteel facility remains subject to the applicable provisions of NESHAP subpart YYYYY and NSPS subpart AAa.

    Abstract for [M160021]

    Q: Does EPA approve an alternative monitoring method for the bypass valve line associated with the thermal oxidizer in lieu of a continuous flow monitor or securing the bypass valve with a car seal or lock-and-key type system to meet the monitoring requirements of 40 CFR part 63 subpart JJJ at the INEOS Barex USA LLC (INEOS) plant in Lima, Ohio?

    A: Yes. Based on the information provided by INEOS, including concerns about installation of a flow monitor on this particular bypass stream due to location and corrosion possibilities, EPA conditionally approves the alternative monitoring method that requires continuous monitoring of the bypass valve position associated with the thermal oxidizer in accordance with 40 CFR 63.8(f)(2) and (4). The recordkeeping and reporting conditions for approval are specified in the EPA response letter.

    Abstract for [Z160005]

    Q1: Does EPA determine that stationary engines being tested in a test cell at Maine Maritime Academy (MMA) in Castine, Maine would be subject to the NESHAP for Reciprocating Internal Combustion Engines (RICE), 40 CFR part 63 subpart ZZZZ?

    A1: No. EPA determines that because the engines in question will be tested at a stationary RICE test cell as defined in Subpart PPPPP, they are not subject to subpart ZZZZ consistent with 40 CFR 63.6675 of subpart ZZZZ.

    Q2: Does EPA determine that the proposed engine test cell at MMA, which is an area source of hazardous air pollutants, would be subject to the NESHAP for Engine Test Cell/Stands, 40 CFR part 63 subpart PPPPP?

    A2: No. EPA determines that as long as MMA remains an area source of hazardous air pollutants (HAPs), it is not subject to subpart PPPPP, which applies to owners or operators of engine test cells/stands at a major source of HAPs.

    Dated: July 20, 2017. David A. Hindin, Director, Office of Compliance, Office of Enforcement and Compliance Assurance.
    [FR Doc. 2017-16499 Filed 8-3-17; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY [ER-FRL-9034-5] Environmental Impact Statements; Notice of Availability

    Responsible Agency: Office of Federal Activities, General Information (202) 564-7146 or http://www.epa.gov/nepa.

    Weekly receipt of Environmental Impact Statements (EISs) Filed 07/24/2017 Through 07/28/2017 Pursuant to 40 CFR 1506.9. Notice

    Section 309(a) of the Clean Air Act requires that EPA make public its comments on EISs issued by other Federal agencies. EPA's comment letters on EISs are available at: http://www.epa.gov/compliance/nepa/eisdata.html.

    EIS No. 20170143, Final, FHWA, UT, I-80 and State Street Interchange, Contact: Brandon Weston, 801-965-4603.

    Under MAP-21 Section 1319, FHWA has issued a single FEIS and ROD. Therefore, the 30-day wait/review period under NEPA does not apply to this action.

    EIS No. 20170144, Final Supplement, BOEM, MA, Cape Wind Energy Project, Review Period Ends: 09/05/2017, Contact: Michelle Morin 703-787-1722. EIS No. 20170145, Final, NSF, PR, Arecibo Observatory, Review Period Ends: 09/05/2017, Contact: Elizabeth Pentecost 703-292-4907. EIS No. 20170146, Draft, USAF, AK, Air Force Proposal to Improve F-22 Operational Efficiency at Joint Base Elmendorf-Richardson (JBER), Alaska, Comment Period Ends: 09/18/2017, Contact: JBER Public Affairs 907-552-8151. EIS No. 20170147, Final, USFS, CA, Trestle Forest Health Project, Review Period Ends: 09/05/2017, Contact: Jennifer Marsolais 530-642-5187. EIS No. 20170148, Final, FERC, WV, Mountaineer Xpress and Gulf XPress Projects, Review Period Ends: 09/05/2017, Contact: Julia Yuan 202-502-8130. EIS No. 20170149, Final, BOEM, LA, Geological and Geophysical Activities on the Gulf of Mexico Outer Continental Shelf, Review Period Ends: 09/05/2017, Contact: Terri Thomas 504-736-2963. Dated: August 1, 2017. Dawn Roberts, Management Analyst, NEPA Compliance Division, Office of Federal Activities.
    [FR Doc. 2017-16479 Filed 8-3-17; 8:45 am] BILLING CODE 6560-50-P
    EXPORT-IMPORT BANK [Public Notice: 2017-6004] Agency Information Collection Activities: Comment Request for Form EIB 11-01, Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery AGENCY:

    Export-Import Bank of the United States.

    ACTION:

    Submission for OMB review and comments request.

    SUMMARY:

    The proposed clearance is designed to allow Ex-Im Bank to survey for the purpose of gaining insights into customers' experiences with the agency and to evaluate product and performance effectiveness. Customers' responses will help to identify potential areas of service improvement and rate overall program experiences.

    DATES:

    Comments must be received on or before September 5, 2017 to be assured of consideration.

    ADDRESSES:

    Comments may be submitted electronically on www.regulations.gov or by mail to Mardel West, Export-Import Bank of the United States, 811 Vermont Ave. NW., Washington, DC 20571.

    SUPPLEMENTARY INFORMATION:

    Affected Public: Individuals representing companies engaged in business with the Export-Import Bank of the U.S.

    Burden Hours

    Annual Number of Respondents: 3200.

    Estimated Time per Respondent: 45 minutes.

    Annual Public Burden Hours: 2400 hours.

    Frequency of Reporting of Use: On occasion.

    Government Expense

    Reviewing Time per year: 1,600 Hours.

    Average Wages per Hour: $42.50.

    Average Cost per Year: $68,000.

    Benefits and Overhead: 20%.

    Total government Cost: $81,600.

    Bassam Doughman, Project Manager, Export-Import Bank of the United States.
    [FR Doc. 2017-16103 Filed 8-3-17; 8:45 am] BILLING CODE 6690-01-P
    EXPORT-IMPORT BANK [Public Notice: 2017-6005] Agency Information Collection Activities: Comment Request on Form EIB 10-04 Notice of Claim and Proof of Loss, Working Capital Guarantee AGENCY:

    Export-Import Bank of the United States.

    ACTION:

    Submission for OMB review and comments request.

    SUMMARY:

    The Export-Import Bank of the United States (Ex-Im Bank), as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal Agencies to comment on the proposed information collection, as required by the Paperwork Reduction Act of 1995.

    DATES:

    Comments must be received on or before September 5, 2017 to be assured of consideration.

    ADDRESSES:

    Comments may be submitted electronically on www.regulations.gov or by mail to Mardel West, Export-Import Bank of the United States, 811 Vermont Ave. NW., Washington, DC 20571.

    SUPPLEMENTARY INFORMATION:

    By neutralizing the effect of export credit support offered by foreign governments and by absorbing credit risks that the private sector will not accept, Ex-Im Bank enables U.S. exporters to compete fairly in foreign markets on the basis of price and product. Under the Working Capital Guarantee Program, Ex-Im Bank provides repayment guarantees to lenders on secured, short-term working capital loans made to qualified exporters. The guarantee may be approved for a single loan or a revolving line of credit. In the event that a borrower defaults on a transaction guaranteed by Ex-Im Bank the guaranteed lender may seek payment by the submission of a claim.

    This collection of information is necessary, pursuant to 12 U.S.C. 635(a)(1), to determine if such claim complies with the terms and conditions of the relevant working capital guarantee. The Notice of Claim and Proof of Loss, Working Capital Guarantee is used to determine compliance with the terms of the guarantee and the appropriateness of paying a claim. Export-Import Bank customers are able to submit this form on paper or electronically.

    The information collection tool can be reviewed at: http://www.exim.gov/pub/pending/eib10-04.pdf.

    Title and Form Number: EIB 10-04 Notice of Claim and Proof of Loss, Working Capital Guarantee.

    OMB Number: 3048-0035.

    Type of Review: Regular.

    Need and Use: This collection of information is necessary, pursuant to 12 U.S.C. 635(a)(1), to determine if such claim complies with the terms and conditions of the relevant guarantee.

    Affected Public: This form affects entities involved in the export of U.S. goods and services.

    Annual Number of Respondents: 17.

    Estimated Time per Respondent: 1 hour.

    Annual Burden Hours: 17 hours.

    Frequency of Reporting of Use: As needed to request a claim payment.

    Government Expenses:

    Reviewing time per year: 17 hours.

    Average Wages per Hour: $42.50.

    Average Cost per Year: $722.50 (time*wages).

    Benefits and Overhead: 20%.

    Total Government Cost: $867.

    Bassam Doughman, Project Manager, Export-Import Bank of the United States.
    [FR Doc. 2017-16102 Filed 8-3-17; 8:45 am] BILLING CODE 6690-01-P
    FEDERAL COMMUNICATIONS COMMISSION Open Commission Meeting, Thursday, August 3, 2017 July 27, 2017.

    The Federal Communications Commission will hold an Open Meeting on the subjects listed below on Thursday, August 3, 2017 which is scheduled to commence at 10:30 a.m. in Room TW-C305, at 445 12th Street SW., Washington, DC.

    Item No. Bureau Subject 1 Wireline Competition Title: Connect America Fund Phase II Auction (Auction 903), (AU Docket No. 17-182). Summary: The Commission will consider a Public Notice to initiate the pre-auction process for the Connect America Fund Phase II auction which will award up to $1.98 billion over 10 years to service providers that commit to offer voice and broadband services to fixed locations in unserved high-cost areas. 2 Wireless Telecommunications Title: Connect America Fund (WC Docket No. 10-90); Universal Service Reform—Mobility Fund (WT Docket No. 10-208). Summary: The Commission will consider an Order on Reconsideration and Second Report and Order that lays out a robust challenge process that will enable the Commission to direct Mobility Fund Phase II support to primarily rural areas that lack unsubsidized 4G Long Term Evolution (LTE) service. 3 Wireline Competition Title: Modernizing the FCC Form 477 Data Program (WC Docket No. 11-10). Summary: The Commission will consider a Further Notice of Proposed Rulemaking that takes a focused look at the Commission's Form 477 to improve the value of the data we continue to collect. 4 Wireless Telecommunications Title: Expanding Flexible Use in Mid-Band Spectrum Between 3.7 and 24 GHz (GN Docket No. 17-183). Summary: The Commission will consider a Notice of Inquiry that explores opportunities for next generation services—particularly for wireless broadband—in the 3.7 GHz to 24 GHz spectrum range and asks about how we can increase efficient and effective use of this spectrum for the benefit of all services and users. 5 Wireless Telecommunications Title: Video Description: Implementation of the Twenty-First Century Communications and Video Accessibility Act of 2010 (MB Docket No. 11-43). Summary: The Commission will consider a Report and Order which increases the required hours of video described programming that covered broadcast stations and MVPDs must provide to consumers. 6 International Title: Implementation of Section 25.281(b) Transmitter Identification Requirements for Video Uplink Transmissions (IB Docket No. 12-267). Summary: The Commission will consider a Memorandum Opinion and Order that waives the requirement that satellite news trucks, and other temporary-fixed satellite earth stations transmitting digital video, comply with the Digital Video Broadcasting-Carrier Identification (DVB-CID) standard if the earth station uses a modulator that cannot meet the DVB-CID standard through a software upgrade. 7 Media Title: Hearing Designation Order. Summary: The Commission will consider a Hearing Designation Order. 8 Enforcement Title: Enforcement Bureau Action. Summary: The Commission will consider an enforcement action. *         *         *         *         *         *         * Consent Agenda The Commission will consider the following subject listed below as a consent agenda and this item will not be presented individually: 1 Enforcement Title: Enforcement Bureau Action. Summary: The Commission will consider an enforcement action.

    The meeting site is fully accessible to people using wheelchairs or other mobility aids. Sign language interpreters, open captioning, and assistive listening devices will be provided on site. Other reasonable accommodations for people with disabilities are available upon request. In your request, include a description of the accommodation you will need and a way we can contact you if we need more information. Last minute requests will be accepted, but may be impossible to fill. Send an email to: [email protected] or call the Consumer & Governmental Affairs Bureau at 202-418-0530 (voice), 202-418-0432 (TTY).

    Additional information concerning this meeting may be obtained from the Office of Media Relations, (202) 418-0500; TTY 1-888-835-5322. Audio/Video coverage of the meeting will be broadcast live with open captioning over the Internet from the FCC Live web page at www.fcc.gov/live.

    For a fee this meeting can be viewed live over George Mason University's Capitol Connection. The Capitol Connection also will carry the meeting live via the Internet. To purchase these services, call (703) 993-3100 or go to www.capitolconnection.gmu.edu.

    Federal Communications Commission. Katura Jackson, Federal Register Liaison Officer, Office of the Secretary.
    [FR Doc. 2017-16474 Filed 8-3-17; 8:45 am] BILLING CODE 6712-01-P
    FEDERAL DEPOSIT INSURANCE CORPORATION Notice to All Interested Parties of the Termination of the Receivership of 10389—Public Savings Bank, Huntingdon Valley, Pennsylvania

    Notice is hereby given that the Federal Deposit Insurance Corporation (“FDIC”) as Receiver for Public Savings Bank, Huntingdon Valley, Pennsylvania (“the Receiver”) intends to terminate its receivership for said institution. The FDIC was appointed receiver of Public Savings Bank on August 18, 2011. The liquidation of the receivership assets has been completed. To the extent permitted by available funds and in accordance with law, the Receiver will be making a final dividend payment to proven creditors.

    Based upon the foregoing, the Receiver has determined that the continued existence of the receivership will serve no useful purpose. Consequently, notice is given that the receivership shall be terminated, to be effective no sooner than thirty days after the date of this Notice. If any person wishes to comment concerning the termination of the receivership, such comment must be made in writing and sent within thirty days of the date of this Notice to: Federal Deposit Insurance Corporation, Division of Resolutions and Receiverships, Attention: Receivership Oversight Department 34.6, 1601 Bryan Street, Dallas, TX 75201.

    No comments concerning the termination of this receivership will be considered which are not sent within this time frame.

    Dated: August 1, 2017. Federal Deposit Insurance Corporation. Robert E. Feldman, Executive Secretary.
    [FR Doc. 2017-16481 Filed 8-3-17; 8:45 am] BILLING CODE 6714-01-P
    GENERAL SERVICES ADMINISTRATION [Notice-WWICC-2017-02; Docket No. 2017-0003; Sequence 2] World War One Centennial Commission; Notification of Change to Upcoming Public Advisory Meeting AGENCY:

    World War One Centennial Commission.

    ACTION:

    Meeting notice.

    SUMMARY:

    Notice of this meeting is being provided according to the requirements of the Federal Advisory Committee Act. This notice provides the schedule and agenda for the September 13, 2017 meeting of the World War One Centennial Commission (the Commission). The meeting is open to the public.

    DATES:

    Applicable: September 13, 2017.

    Meeting Date: The meeting will be held on Wednesday, September 13, 2017, starting at 10:00 a.m. Eastern Daylight Saving Time (EDT), and ending no later than 2:00 p.m., EDT. Written Comments may be submitted to the Commission and will be made part of the permanent record of the Commission. Comments must be received by 5:00 p.m., EDT, on September 8, 2017, and may be provided by email to [email protected].

    Contact Daniel S. Dayton at [email protected] to register to comment during the meeting's 30-minute public comment period. Registered speakers/organizations will be allowed 5 minutes and will need to provide written copies of their presentations. Requests to comment, together with presentations for the meeting must be received by 5:00 p.m. (EDT), on Friday, September 8, 2017. Please contact Mr. Dayton at the email address above to obtain meeting materials.

    FOR FURTHER INFORMATION CONTACT:

    Daniel S. Dayton, Designated Federal Officer, World War 1 Centennial Commission, 701 Pennsylvania Avenue NW., 123, Washington, DC 20004-2608 202-380-0725 (note: this is not a toll-free number).

    SUPPLEMENTARY INFORMATION: Background

    The World War One Centennial Commission was established by Public Law 112-272 (as amended), as a commission to ensure a suitable observance of the centennial of World War I, to provide for the designation of memorials to the service of members of the United States Armed Forces in World War I, and for other purposes. Under this authority, the Committee will plan, develop, and execute programs, projects, and activities to commemorate the centennial of World War I, encourage private organizations and State and local governments to organize and participate in activities commemorating the centennial of World War I, facilitate and coordinate activities throughout the United States relating to the centennial of World War I, serve as a clearinghouse for the collection and dissemination of information about events and plans for the centennial of World War I, and develop recommendations for Congress and the President for commemorating the centennial of World War I. The Commission does not have an appropriation and operates on donated funds.

    Agenda: Wednesday, September 13, 2017 Old Business • Acceptance of minutes of last meeting • Public Comment Period New Business • Executive Director's Report—Executive Director Dayton • Executive Committee Report—Commissioner Hamby • Financial Committee Report—Vice Chair Fountain • Memorial Report—Vice Chair Fountain • Fundraising Report—Commissioner Sedgwick • Education Report—Dr. O'Connell • Endorsements—(RFS)—Dr. Seefried • International Report—Dr. Seefried • Other Business • Chairman's Report • Set Next Meeting—December 13, 2017—PMML, Chicago, IL • Motion to Adjourn Dated: August 1, 2017. Daniel S. Dayton, Designated Federal Official, World War I Centennial Commission.
    [FR Doc. 2017-16466 Filed 8-3-17; 8:45 am] BILLING CODE 6820-95-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifiers: CMS-381] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY:

    Centers for Medicare & Medicaid Services.

    ACTION:

    Notice.

    SUMMARY:

    The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

    DATES:

    Comments must be received by October 3, 2017.

    ADDRESSES:

    When commenting, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be submitted in any one of the following ways:

    1. Electronically. You may send your comments electronically to http://www.regulations.gov. Follow the instructions for “Comment or Submission” or “More Search Options” to find the information collection document(s) that are accepting comments.

    2. By regular mail. You may mail written comments to the following address: CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development, Attention: Document Identifier/OMB Control Number ___, Room C4-26-05, 7500 Security Boulevard, Baltimore, Maryland 21244-1850.

    To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following:

    1. Access CMS' Web site address at http://www.cms.hhs.gov/PaperworkReductionActof1995.

    2. Email your request, including your address, phone number, OMB number, and CMS document identifier, to [email protected]

    3. Call the Reports Clearance Office at (410) 786-1326.

    FOR FURTHER INFORMATION CONTACT:

    William Parham at (410) 786-4669.

    SUPPLEMENTARY INFORMATION: Contents

    This notice sets out a summary of the use and burden associated with the following information collections. More detailed information can be found in each collection's supporting statement and associated materials (see ADDRESSES).

    CMS-381 Identification of Extension Units of Medicare Approved Outpatient Physical Therapy/Outpatient Speech Pathology (OPT/OSP) Providers and Supporting Regulations

    Under the PRA (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term “collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA requires federal agencies to publish a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice.

    Information Collection

    1. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Identification of Extension Units of Medicare Approved Outpatient Physical Therapy/Outpatient Speech Pathology (OPT/OSP) Providers and Supporting Regulations; Use: The provider uses the form to report to the state survey agency extension locations that it has added since the date of last report. The form is used by the state survey agencies and by our regional offices to identify and monitor extension locations to ensure their compliance with the federal requirements for the providers of outpatient physical therapy and speech-language pathology services. Form Number: CMS-381 (OMB control number: 0938-0273); Frequency: Annually; Affected Public: Private Sector; Business or other for-profit and not-for-profit institutions; Number of Respondents: 2,161; Total Annual Responses: 2,161; Total Annual Hours: 540. (For policy questions regarding this collection contact Sarah Fahrendorf at 410-786-3112.)

    Dated: August 1, 2017. William N. Parham, III, Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs.
    [FR Doc. 2017-16483 Filed 8-3-17; 8:45 am] BILLING CODE 4120-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS-9104-N] Medicare and Medicaid Programs; Quarterly Listing of Program Issuances—April through June 2017 AGENCY:

    Centers for Medicare & Medicaid Services (CMS), HHS.

    ACTION:

    Notice.

    SUMMARY:

    This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from April through June 2017, relating to the Medicare and Medicaid programs and other programs administered by CMS.

    FOR FURTHER INFORMATION CONTACT:

    It is possible that an interested party may need specific information and not be able to determine from the listed information whether the issuance or regulation would fulfill that need. Consequently, we are providing contact persons to answer general questions concerning each of the addenda published in this notice.

    Addenda Contact Phone number I CMS Manual Instructions Ismael Torres (410) 786-1864 II Regulation Documents Published in the Federal Register Terri Plumb (410) 786-4481 III CMS Rulings Tiffany Lafferty (410) 786-7548 IV Medicare National Coverage Determinations Wanda Belle, MPA (410) 786-7491 V FDA-Approved Category B IDEs John Manlove (410) 786-6877 VI Collections of Information William Parham (410) 786-4669 VII Medicare—Approved Carotid Stent Facilities Sarah Fulton, MHS (410) 786-2749 VIII American College of Cardiology-National Cardiovascular Data Registry Sites Sarah Fulton, MHS (410) 786-2749 IX Medicare's Active Coverage-Related Guidance Documents JoAnna Baldwin, MS (410) 786-7205 X One-time Notices Regarding National Coverage Provisions JoAnna Baldwin, MS (410) 786-7205 XI National Oncologic Positron Emission Tomography Registry Sites Stuart Caplan, RN, MAS (410) 786-8564 XII Medicare-Approved Ventricular Assist Device (Destination Therapy) Facilities Linda Gousis, JD (410) 786-8616 XIII Medicare-Approved Lung Volume Reduction Surgery Facilities Sarah Fulton, MHS (410) 786-2749 XIV Medicare-Approved Bariatric Surgery Facilities Sarah Fulton, MHS (410) 786-2749 XV Fluorodeoxyglucose Positron Emission Tomography for Dementia Trials Stuart Caplan, RN, MAS (410) 786-8564 All Other Information Annette Brewer (410) 786-6580
    SUPPLEMENTARY INFORMATION I. Background

    The Centers for Medicare & Medicaid Services (CMS) is responsible for administering the Medicare and Medicaid programs and coordination and oversight of private health insurance. Administration and oversight of these programs involves the following: (1) Furnishing information to Medicare and Medicaid beneficiaries, health care providers, and the public; and (2) maintaining effective communications with CMS regional offices, state governments, state Medicaid agencies, state survey agencies, various providers of health care, all Medicare contractors that process claims and pay bills, National Association of Insurance Commissioners (NAIC), health insurers, and other stakeholders. To implement the various statutes on which the programs are based, we issue regulations under the authority granted to the Secretary of the Department of Health and Human Services under sections 1102, 1871, 1902, and related provisions of the Social Security Act (the Act) and Public Health Service Act. We also issue various manuals, memoranda, and statements necessary to administer and oversee the programs efficiently.

    Section 1871(c) of the Act requires that we publish a list of all Medicare manual instructions, interpretive rules, statements of policy, and guidelines of general applicability not issued as regulations at least every 3 months in the Federal Register.

    II. Format for the Quarterly Issuance Notices

    This quarterly notice provides only the specific updates that have occurred in the 3-month period along with a hyperlink to the full listing that is available on the CMS Web site or the appropriate data registries that are used as our resources. This is the most current up-to-date information and will be available earlier than we publish our quarterly notice. We believe the Web site list provides more timely access for beneficiaries, providers, and suppliers. We also believe the Web site offers a more convenient tool for the public to find the full list of qualified providers for these specific services and offers more flexibility and “real time” accessibility. In addition, many of the Web sites have listservs; that is, the public can subscribe and receive immediate notification of any updates to the Web site. These listservs avoid the need to check the Web site, as notification of updates is automatic and sent to the subscriber as they occur. If assessing a Web site proves to be difficult, the contact person listed can provide information.

    III. How to Use the Notice

    This notice is organized into 15 addenda so that a reader may access the subjects published during the quarter covered by the notice to determine whether any are of particular interest. We expect this notice to be used in concert with previously published notices. Those unfamiliar with a description of our Medicare manuals should view the manuals at http://www.cms.gov/manuals.

    Dated: July 20, 2017. Kathleen Cantwell, Director, Office of Strategic Operations and Regulatory Affairs. BILLING CODE 4120-01-C EN04AU17.000 EN04AU17.001 EN04AU17.002 EN04AU17.003 EN04AU17.004 EN04AU17.005 EN04AU17.006 EN04AU17.007 EN04AU17.008 EN04AU17.009
    [FR Doc. 2017-16252 Filed 8-3-17; 8:45 am] BILLING CODE 4120-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Submission for OMB Review; Comment Request

    Title: Form OCSE-396, “Child Support Enforcement Program Quarterly Financial Report”, Form OCSE-34, “Child Support Enforcement Program Quarterly Collection Report”.

    OMB No.: 0970-0181.

    Description: Form OCSE-396 and Form OCSE-34 are financial reports submitted following the end of each fiscal quarter by grantees administering the Child Support Enforcement Program in accordance with plans approved under title IV-D of the Social Security Act. Submission of these forms enables grantees to meet their statutory and regulatory requirement to report program expenditures and child support collections, respectively, from the previous fiscal quarter.

    States use Form OCSE-396 to report quarterly expenditures made in the previous quarter and to estimate program expenditures to be made and the incentive payments to be earned in the upcoming quarter. The Administration for Children and Families provides Federal funding to States for the Child Support Enforcement Program at the rate of 66 percent for all allowable and legitimate administrative costs of this program.

    Tribes use OMB Form SF-425 to report quarterly expenditures made in the previous quarter. Form SF-425 is not included as part of this comment request.

    As part of this request, minor changes are being proposed only in response to amendments to Federal regulations:

    • 45 CFR 304.25(b) was amended to extend the quarterly reporting deadline for both reports from “30” to “45” days after the end of each fiscal quarter.

    • 45 CFR part 95 was amended to require that all expenditures for a Statewide Child Support Enforcement System will now require an approved Advanced Planning Document (APD). Therefore, Line 6 on Form OCSE-396, “ADP Costs Without APD Required” is being eliminated as no longer necessary.

    The necessary instructions are being amended in response to both changes.

    Respondents: 54 States (including Puerto Rico, Guam, the Virgin Islands and the District of Columbia) for Forms OCSE-396 and OCSE-34 plus approximately 60 Tribes for Form OCSE-34.

    Annual Burden Estimates Instrument Number of
  • respondents
  • Number of
  • responses per respondent
  • Average
  • burden hours
  • per response
  • Total burden hours
    Form OCSE-396 54 4 6 1,296 Form OCSE-34 114 4 14 6,384

    Estimated Total Annual Burden Hours: 7,680.

    Additional Information: Copies of the proposed collection may be obtained by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 330 C Street SW., Washington, DC 20201. Attention Reports Clearance Officer. All requests should be identified by the title of the information collection. Email address: [email protected]

    OMB Comment: OMB is required to make a decision concerning the collection of information between 30 and 60 days after publication of this document in the Federal Register. Therefore, a comment is best assured of having its full effect if OMB receives it within 30 days of publication. Written comments and recommendations for the proposed information collection should be sent directly to the following: Office of Management and Budget, Paperwork Reduction Project, Email: [email protected], Attn: Desk Officer for the Administration for Children and Families.

    Robert Sargis, Reports Clearance Officer.
    [FR Doc. 2017-16390 Filed 8-3-17; 8:45 am] BILLING CODE 4184-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Meeting of the Presidential Advisory Council on HIV/AIDS AGENCY:

    Office of the Assistant Secretary for Health, Office of the Secretary, Department of Health and Human Services.

    ACTION:

    Notice.

    SUMMARY:

    As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Service is hereby giving notice that the Presidential Advisory Council on HIV/AIDS (PACHA or the Council) will be holding a meeting and will discuss recommendations regarding programs, policies, and research to promote effective, prevention, treatment and cure of HIV disease and AIDS. The meeting will be open to the public.

    DATES:

    The Council meeting is scheduled to convene on Wednesday, August 30, 2017 from 9:00 a.m. to approximately 5:00 p.m. (ET). The meeting will be open to the public.

    ADDRESSES:

    200 Independence Avenue SW., Washington, DC 20201 in the Penthouse (eighth floor), Room 800.

    FOR FURTHER INFORMATION CONTACT:

    Ms. Caroline Talev, Public Health Analyst, Presidential Advisory Council on HIV/AIDS, 330 C Street SW., Room L106B, Washington, DC 20024; (202) 795-7622 or [email protected] More detailed information about PACHA can be obtained by accessing the Council's page on the AIDS.gov site at www.aids.gov/pacha.

    SUPPLEMENTARY INFORMATION:

    PACHA was established by Executive Order 12963, dated June 14, 1995, as amended by Executive Order 13009, dated June 14, 1996. In a memorandum, dated July 13, 2010, and under Executive Order 13703, dated July 30, 2015, the President gave certain authorities to the PACHA for implementation of the National HIV/AIDS Strategy for the United States (Strategy). PACHA is currently operating under the authority given in Executive Order 13708, dated September 30, 2015.

    PACHA provides advice, information, and recommendations to the Secretary regarding programs, policies, and research to promote effective treatment, prevention, and cure of HIV disease and AIDS, including considering common co-morbidities of those infected with HIV as needed, to promote effective HIV prevention and treatment and quality services to persons living with HIV disease and AIDS.

    Substantial progress has been made in addressing the domestic HIV epidemic since the Strategy was released in July 2010. Under Executive Order 13703, the National HIV/AIDS Strategy for the United States: Updated to 2020 (Updated Strategy) was released. PACHA shall contribute to the federal effort to improve HIV prevention and care.

    The functions of the Council are solely advisory in nature.

    The Council consists of not more than 25 members. Council members are selected from prominent community leaders with particular expertise in, or knowledge of, matters concerning HIV and AIDS, public health, global health, philanthropy, marketing or business, as well as other national leaders held in high esteem from other sectors of society. Council members are appointed by the Secretary or designee, in consultation with the White House. The agenda for the upcoming meeting will be posted on the HIV.gov Web site at https://www.hiv.gov/federal-response/pacha/about-pacha.

    Public attendance at the meeting is limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify Caroline Talev at [email protected] Due to space constraints, pre-registration for public attendance is advisable and can be accomplished by contacting Caroline Talev at [email protected] by close of business on Wednesday, August 23, 2017. Members of the public will have the opportunity to provide comments during the meeting. Comments will be limited to two minutes per speaker. Any individual who wishes to participate in the public comment session must register with Caroline Talev at [email protected] by close of business on Wednesday, August 23, 2017; registration for public comment will not be accepted by telephone. Individuals are encouraged to provide a written statement of any public comment(s) for accurate minute taking purposes. Any members of the public who wish to have printed material distributed to PACHA members at the meeting are asked to submit, at a minimum, 1 copy of the material(s) to Caroline Talev, no later than close of business on Wednesday, August 23, 2017.

    Dated: July 20, 2017. B. Kaye Hayes, Executive Director, Presidential Advisory Council on HIV/AIDS.
    [FR Doc. 2017-16465 Filed 8-3-17; 8:45 am] BILLING CODE 4150-43-P
    DEPARTMENT OF HOMELAND SECURITY Agency Information Collection Activities: Proposed Collection; Comment Request; The Department of Homeland Security, Office of Emergency Communications, SAFECOM Nationwide Survey (SNS) AGENCY:

    National Protection and Programs Directorate, DHS.

    ACTION:

    30-Day notice and request for comments; New Collection: 1670-NEW.

    SUMMARY:

    The Department of Homeland Security (DHS), National Protection and Programs Directorate (NPPD), Office of Cybersecurity and Communications (CS&C), Office of Emergency Communications, will submit the following Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995. DHS previously published this ICR in the Federal Register for 60 days. The notice published as 60-Day Request for Comment on Thursday, April 27, 2017. DHS received comments from two stakeholders indicating an appreciation for public outreach. As a next step in the administrative process, a second notice will be published in the Federal Register. Its purpose is to allow an additional 30 days for the public to provide comments about the notice.

    DATES:

    Comments are encouraged and will be accepted until September 5, 2017. DHS and OMB conducts this process in accordance with Controlling Paperwork Burdens on the Public rules and regulations. 5 CFR 1320.1 (1995).

    ADDRESSES:

    Interested persons are invited to submit written comments on the proposed ICR to the Office of Information and Regulatory Affairs, Office of Management and Budget (OMB). Comments should be addressed to OMB Desk Officer, Department of Homeland Security and sent via electronic mail to [email protected] or faxed to (202) 395-5806.

    SUPPLEMENTARY INFORMATION:

    Enactment of 6 U.S.C. 571 governs the Office of Emergency Communications (OEC) and establishes a Director with specific responsibilities. This includes assisting the DHS Secretary in developing and implementing a program to support and promote the ability of emergency response providers and relevant government officials to continue to communicate in the event of natural disasters, acts of terrorism, and other man-made disasters; and ensure, accelerate, and attain interoperable emergency communications nationwide. In addition, 6 U.S.C. 573 authorizes the DHS Secretary acting through the OEC Director to conduct a baseline assessment of communications capabilities among emergency response providers and relevant government officials at all levels of government no less than once every five years. OEC is tasked with conducting a periodic nationwide assessment of emergency communications.

    OEC's governing statute provides a framework for its periodic assessment. Accordingly, OEC, in coordination with its stakeholder partners, developed the SAFECOM Nationwide Survey (SNS). The survey's purpose is to gather information to assess capabilities currently available, and identify gaps based on the needs of emergency response providers. This information will allow OEC and its stakeholders to understand critical capabilities more clearly, and to target resources more efficiently for communications during response situations of all scales and scope, from day-to-day to out-of-the-ordinary situations.

    To gather baseline assessment information, OEC will deploy four versions of the SAFECOM Nationwide Survey (SNS) tailored to address emergency response entities at each level of government: Federal, State and territorial, tribal, and local. Each SNS version is built upon a foundation of core planning elements identified by OEC and its stakeholders as fundamental to achieve open and secure communications operability, interoperability, and continuity. These elements are interdependent critical success factors that must be addressed to plan for and implement public safety communications capabilities. These elements are recognized as Governance, Standard Operating Procedures, Training and Exercises, Technology, Usage, Security and Equipment.

    The SNS questions align with each of these elements. This design enables DHS to determine jurisdictional capability levels of operability, interoperability, and continuity as they collectively pertain to the use of emergency communications. For example, Governance questions will pertain to matters related to decision-making groups, agreements, funding, and strategic planning. Standard Operating Procedure questions will focus on procedures, guidelines, and content. Training and Exercise questions will focus on their nature, scope, and frequency. Technology questions will focus on infrastructure, solutions, and information-sharing. Usage questions will address frequency of use, proficiency, and resource capacity. Security will focus on cybersecurity in the context of emergency communications. Finally, Equipment questions focuses on the types of equipment or systems used. These SNS elements and sub-elements set forth the DHS OEC assessment framework. Collectively, will enable DHS OEC to fulfill its governing authority and identify a baseline of nationwide emergency communications capabilities.

    This is a new information collection. OMB is particularly interested in comments that:

    1. Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

    2. Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

    3. Enhance the quality, utility, and clarity of the information to be collected; and minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submissions of responses.

    Analysis

    Agency: Department of Homeland Security, National Protection and Programs Directorate, Office of Cybersecurity and Communications, Office of Emergency Communications.

    OMB Number: 1670-NEW.

    Frequency: Once every five years.

    Affected Public: Federal, State, local and private sector emergency response personnel.

    Number of Respondents: 3,002 annually.

    Estimated Time Per Respondent: 30 minutes.

    Total Burden Hours: 1,501 annual burden hours.

    Dated: July 28, 2017. David Epperson, Chief Information Officer.
    [FR Doc. 2017-16388 Filed 8-3-17; 8:45 am] BILLING CODE 9110-9P-P
    DEPARTMENT OF THE INTERIOR Bureau of Ocean Energy Management [Docket No. BOEM-2017-0034] Final Programmatic Environmental Impact Statement for Geological and Geophysical Activities on the Gulf of Mexico Outer Continental Shelf MMAA104000 AGENCY:

    Bureau of Ocean Energy Management, Interior.

    ACTION:

    Notice of availability of a Final Programmatic Environmental Impact Statement.

    SUMMARY:

    The Bureau of Ocean Energy Management (BOEM) is announcing the availability of a Final Programmatic Environmental Impact Statement (EIS) for evaluating potential environmental effects of geological and geophysical (G&G) activities in OCS waters of the GOM. The Final Programmatic EIS analyzes potential impacts of the proposed action, provides an analysis of reasonable alternatives to the proposed action, and identifies BOEM's preferred alternative. The Final Programmatic EIS considers G&G activities for BOEM's three programs, i.e., Oil and Gas, Renewable Energy, and Marine Minerals. These activities include, but are not limited to, seismic surveys (deep-penetration and high-resolution geophysical), sidescan-sonar surveys, electromagnetic surveys, and geological and geochemical sampling. The Final Programmatic EIS also evaluates mitigation measures to reduce potential impacts of G&G activities on marine resources, such as sound impacts to marine species and bottom-disturbance impacts on benthic communities and cultural resources.

    The Final Programmatic EIS is available on BOEM's Web sites at http://www.boem.gov/GOM-G-G-PEIS and http://www.boem.gov/nepaprocess/. BOEM will primarily distribute digital copies of the Final Programmatic EIS on compact discs. You may request a paper copy or the location of a library with a paper copy of the Final Programmatic EIS from Mr. Greg Kozlowski by telephone at (504) 736-2512 or by email at [email protected]

    FOR FURTHER INFORMATION CONTACT:

    Jill Lewandowski, Ph.D., Chief, Division of Environmental Assessment, Office of Environmental Programs, Bureau of Ocean Energy Management, 45600 Woodland Road, VAM-OEP, Sterling, VA 20166 or by email at [email protected]

    Authority: This Notice of Availability is published pursuant to the regulations (40 CFR part 1503 and 43 CFR part 46) implementing the provisions of the National Environmental Policy Act of 1969, as amended (42 U.S.C. 4321 et seq. (1988)).

    Dated: July 31, 2017. Walter D. Cruickshank, Acting Director, Bureau of Ocean Energy Management.
    [FR Doc. 2017-16421 Filed 8-3-17; 8:45 am] BILLING CODE 4310-MR-P
    DEPARTMENT OF THE INTERIOR Bureau of Ocean Energy Management [Docket No. BOEM-2017-0041] Final Supplemental Environmental Impact Statement for the Cape Wind Energy Project MMAA104000 AGENCY:

    Bureau of Ocean Energy Management, Interior.

    ACTION:

    Notice of availability of a final supplemental environmental impact statement.

    SUMMARY:

    The Bureau of Ocean Energy Management (BOEM) is announcing the availability of a Final Supplemental Environmental Impact Statement (Final SEIS) for the Cape Wind Energy Project. This supplement to the 2009 Final EIS has been prepared in response to a 2016 remand order of the U.S. Court of Appeals for the District of Columbia Circuit in Public Employees for Environmental Responsibility v. Hopper (see SUPPLEMENTARY INFORMATION for details).

    FOR FURTHER INFORMATION CONTACT:

    Michelle Morin, BOEM Office of Renewable Energy Programs, 45600 Woodland Road, Sterling, Virginia 20166, (703) 787-1722 or [email protected]

    SUPPLEMENTARY INFORMATION:

    On July 5, 2016, the U.S. Court of Appeals for the District of Columbia Circuit vacated the 2009 Cape Wind Energy Project Final EIS and ordered that BOEM: “supplement [the EIS] with adequate geological surveys before Cape Wind may begin construction.” Public Employees for Environmental Responsibility v. Hopper, 827 F.3d 1077, 1084 (D.C. Cir. 2016). The Court opined that: “[w]ithout adequate geological surveys, the [BOEM] cannot `ensure that the seafloor [will be] able to support' wind turbines.” Id. at 1083. While the Court found that: “[BOEM] therefore had violated NEPA (National Environmental Policy Act)” the Court noted that “. . . [it] does not necessarily mean that the project must be halted or that Cape Wind must redo the regulatory approval process.” Id. at 1083-4. The Court explicitly left undisturbed BOEM's 2010 decision to issue a lease to Cape Wind Associates (CWA) and BOEM's 2011 decision to approve CWA's Construction and Operations Plan (COP) for the Cape Wind Energy Project. Id. at 1084. In response to the Circuit Court's remand order, BOEM published the Draft SEIS for the Cape Wind Energy Project on March 31, 2017.

    The Draft SEIS considered the only two alternatives that remained relevant as a result of the Court's remand order and CWA's lease and the approved Cape Wind COP: The Proposed Action (affirming BOEM's issuance of the existing lease), and the No Action Alternative (requiring BOEM to rescind lease issuance). BOEM published a notice in the Federal Register on March 31, 2017, to announce the availability of the Draft SEIS and initiate a 45-day public comment period (82 FR 16060). All the comments received on the Draft SEIS are available for public viewing and can be found at: http://www.regulations.gov by searching for docket ID BOEM-2017-0008.

    In the Final SEIS for the Cape Wind Energy Project, BOEM examines the available geological survey data, including the geotechnical data and reports submitted to BOEM since the 2009 Final EIS, and any other relevant data that relate to the adequacy of the seafloor to support wind turbines in the lease area. The Final SEIS also includes a summary of all the comments received on the Draft SEIS and BOEM's responses to those comments. The Final SEIS can be found on BOEM's Web site at: https://www.boem.gov/Massachusetts-Cape-Wind/.

    Authority:

    This notice of availability to prepare a Final SEIS is in compliance with NEPA, as amended (42 U.S.C. 4231 et seq.), and is published pursuant to 40 CFR 1506.6.

    Dated: July 31, 2017. Walter D. Cruickshank, Acting Director, Bureau of Ocean Energy Management.
    [FR Doc. 2017-16422 Filed 8-3-17; 8:45 am] BILLING CODE 4310-MR-P
    INTERNATIONAL TRADE COMMISSION Notice of Receipt of Complaint; Solicitation of Comments Relating to the Public Interest AGENCY:

    U.S. International Trade Commission.

    ACTION:

    Notice.

    SUMMARY:

    Notice is hereby given that the U.S. International Trade Commission has received a complaint entitled Certain Microfluidic Devices DN 3239; the Commission is soliciting comments on any public interest issues raised by the complaint or complainant's filing pursuant to the Commission's Rules of Practice and Procedure.

    FOR FURTHER INFORMATION CONTACT:

    Lisa R. Barton, Secretary to the Commission, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone (202) 205-2000. The public version of the complaint can be accessed on the Commission's Electronic Document Information System (EDIS) at https://edis.usitc.gov, and will be available for inspection during official business hours (8:45 a.m. to 5:15 p.m.) in the Office of the Secretary, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone (202) 205-2000.

    General information concerning the Commission may also be obtained by accessing its Internet server at United States International Trade Commission (USITC) at https://www.usitc.gov. The public record for this investigation may be viewed on the Commission's Electronic Document Information System (EDIS) at https://edis.usitc.gov. Hearing-impaired persons are advised that information on this matter can be obtained by contacting the Commission's TDD terminal on (202) 205-1810.

    SUPPLEMENTARY INFORMATION:

    The Commission has received a complaint and a submission pursuant to § 210.8(b) of the Commission's Rules of Practice and Procedure filed on behalf of Bio-Rad Laboratories, Inc. and Lawrence Livermore National Security, LLC on July 31, 2017. The complaint alleges violations of section 337 of the Tariff Act of 1930 (19 U.S.C. 1337) in the importation into the United States, the sale for importation, and the sale within the United States after importation of certain microfluidic devices. The complaint names as a respondent 10X Genomics, Inc. of Pleasanton, CA. The complainant requests that the Commission issue a limited exclusion order, a cease and desist order, and impose a bond upon respondents' alleged infringing articles during the 60-day Presidential review period pursuant to 19 U.S.C. 1337(j).

    Proposed respondents, other interested parties, and members of the public are invited to file comments, not to exceed five (5) pages in length, inclusive of attachments, on any public interest issues raised by the complaint or § 210.8(b) filing. Comments should address whether issuance of the relief specifically requested by the complainant in this investigation would affect the public health and welfare in the United States, competitive conditions in the United States economy, the production of like or directly competitive articles in the United States, or United States consumers.

    In particular, the Commission is interested in comments that:

    (i) Explain how the articles potentially subject to the requested remedial orders are used in the United States;

    (ii) identify any public health, safety, or welfare concerns in the United States relating to the requested remedial orders;

    (iii) identify like or directly competitive articles that complainant, its licensees, or third parties make in the United States which could replace the subject articles if they were to be excluded;

    (iv) indicate whether complainant, complainant's licensees, and/or third party suppliers have the capacity to replace the volume of articles potentially subject to the requested exclusion order and/or a cease and desist order within a commercially reasonable time; and

    (v) explain how the requested remedial orders would impact United States consumers.

    Written submissions must be filed no later than by close of business, eight calendar days after the date of publication of this notice in the Federal Register. There will be further opportunities for comment on the public interest after the issuance of any final initial determination in this investigation.

    Persons filing written submissions must file the original document electronically on or before the deadlines stated above and submit 8 true paper copies to the Office of the Secretary by noon the next day pursuant to § 210.4(f) of the Commission's Rules of Practice and Procedure (19 CFR 210.4(f)). Submissions should refer to the docket number (“Docket No. 3239”) in a prominent place on the cover page and/or the first page. (See Handbook for Electronic Filing Procedures, Electronic Filing Procedures).1 Persons with questions regarding filing should contact the Secretary (202-205-2000).

    1 Handbook for Electronic Filing Procedures: https://www.usitc.gov/documents/handbook_on_filing_procedures.pdf.

    Any person desiring to submit a document to the Commission in confidence must request confidential treatment. All such requests should be directed to the Secretary to the Commission and must include a full statement of the reasons why the Commission should grant such treatment. See 19 CFR 201.6. Documents for which confidential treatment by the Commission is properly sought will be treated accordingly. All such requests should be directed to the Secretary to the Commission and must include a full statement of the reasons why the Commission should grant such treatment. See 19 CFR 201.6. Documents for which confidential treatment by the Commission is properly sought will be treated accordingly. All information, including confidential business information and documents for which confidential treatment is properly sought, submitted to the Commission for purposes of this Investigation may be disclosed to and used: (i) By the Commission, its employees and Offices, and contract personnel (a) for developing or maintaining the records of this or a related proceeding, or (b) in internal investigations, audits, reviews, and evaluations relating to the programs, personnel, and operations of the Commission including under 5 U.S.C. Appendix 3; or (ii) by U.S. government employees and contract personnel,2 solely for cybersecurity purposes. All nonconfidential written submissions will be available for public inspection at the Office of the Secretary and on EDIS.3

    2 All contract personnel will sign appropriate nondisclosure agreements.

    3 Electronic Document Information System (EDIS): https://edis.usitc.gov.

    This action is taken under the authority of section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and of §§ 201.10 and 210.8(c) of the Commission's Rules of Practice and Procedure (19 CFR 201.10, 210.8(c)).

    By order of the Commission.

    Issued: July 31, 2017. Lisa R. Barton, Secretary to the Commission.
    [FR Doc. 2017-16394 Filed 8-3-17; 8:45 am] BILLING CODE 7020-02-P
    DEPARTMENT OF JUSTICE Bureau of Alcohol, Tobacco, Firearms and Explosives [OMB Number 1140-0007] Agency Information Collection Activities; Proposed eCollection eComments Requested; Revision of a Currently Approved Collection; Release and Receipt of Imported Firearms, Ammunition and Defense Articles; ATF F 6A (5330.3C) AGENCY:

    Bureau of Alcohol, Tobacco, Firearms and Explosives, Department of Justice

    ACTION:

    60-Day notice.

    SUMMARY:

    The Department of Justice (DOJ), Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF), will submit the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The proposed collection 1140-0007 is being revised to change all references from “Implements of War” to “Defense Articles” including the title of the collection, which will be changed to Release and Receipt of Imported Firearms, Ammunition, and Defense Articles.

    DATES:

    Comments are encouraged and will be accepted for 60 days until October 3, 2017.

    FOR FURTHER INFORMATION CONTACT:

    If you have additional comments, particularly with respect to the estimated public burden or associated response time, have suggestions, need a copy of the proposed information collection instrument with instructions, or desire any additional information, please contact Desiree M. Dickinson, ATF Firearms and Explosives Imports Branch either by mail at 244 Needy Road, Martinsburg, WV 25405, or by email at [email protected]

    SUPPLEMENTARY INFORMATION:

    Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:

    —Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; —Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; —Evaluate whether and if so how the quality, utility, and clarity of the information to be collected can be enhanced; and —Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.

    Overview of this information collection:

    1. Type of Information Collection (check justification or form 83): Revision of a currently approved collection.

    2. The Title of the Form/Collection: Release and Receipt of Imported Firearms, Ammunition, and Defense Articles.

    3. The agency form number, if any, and the applicable component of the Department sponsoring the collection:

    Form number (if applicable): ATF F 6A (5330.3C).

    Component: Bureau of Alcohol, Tobacco, Firearms and Explosives, U.S. Department of Justice.

    4. Affected public who will be asked or required to respond, as well as a brief abstract:

    Primary: Individuals or households.

    Other (if applicable): Business or other for-profit, and not-for-profit institutions.

    Abstract: The data provided by this information collection request is used by ATF to determine if articles imported meet the statutory and regulatory criteria for importation and if the articles shown on the permit application have been actually imported.

    5. An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: An estimated 28,000 respondents will utilize the form, and it will take each respondent approximately 35 minutes to complete the form.

    6. An estimate of the total public burden (in hours) associated with the collection: The estimated annual public burden associated with this collection is 16,333 hours which is equal to 28,000 (# of respondents) * .58332 (35 minutes).

    7. An Explanation of the Change in Estimates: The adjustments associated with this collection are an increase in respondents by 8,000 and an increase in the total burden hours by 4,666.

    If additional information is required contact: Melody Braswell, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street NE., 3E.405A, Washington, DC 20530.

    Dated: August 1, 2017. Melody Braswell, Department Clearance Officer for PRA, U.S. Department of Justice.
    [FR Doc. 2017-16431 Filed 8-3-17; 8:45 am] BILLING CODE 4410-FY-P
    DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. 17-22] John D. Bray-Morris, M.D.; Decision and Order

    On February 15, 2017, the Assistant Administrator, Division of Diversion Control, Drug Enforcement Administration, issued an Order to Show Cause to John D. Bray-Morris, M.D. (hereinafter, Respondent), of Moriarty, New Mexico. The Show Cause Order proposed the revocation of Respondent's DEA Certificate of Registration No.FB5001538, on the ground that he does not hold authority to dispense controlled substances in New Mexico, the State in which he is registered with the Agency. Show Cause Order, at 1 (citing 21 U.S.C. 824(a)(3)).

    With respect to the Agency's jurisdiction, the Show Cause Order alleged that Respondent is registered as a practitioner authorized to dispense controlled substances in schedules II through V, at the registered address of 1108 Route 66, P.O. Box 1520, Moriarty, New Mexico. Id. The Show Cause Order alleged that this registration expires on July 31, 2017. Id.

    As for the substantive basis of the proposed action, the Show Cause Order alleged that on January 13, 2017, “the New Mexico [Medical] Board . . . entered an Order of Immediate Suspension and Notice of Contemplated Action . . . suspending [Respondent's] New Mexico Medical License No. 2003-0404 effective on that same date, which remains in effect until further Order of the Board, and that the Board contemplates additional action of restricting, suspending or revoking [his] license to practice as a physician.” Id. at 2. The Show Cause Order thus alleged that the Board's “Order prohibits [Respondent] from practicing medicine in the State of New Mexico.” Id.

    The Show Cause Order also alleged that the Board's Order of Immediate Suspension was based on Respondent's violation of an earlier Board order which suspended his medical license for violations of the State's Medical Practice Act. Id. The Show Cause Order alleged that these included “unprofessional or dishonorable conduct, including . . . injudicious prescribing . . . and violation of a drug law.” Id. The Show Cause Order alleged that the earlier Board order “commanded that [Respondent] abstain completely from the use of mind-altering substances and controlled substances . . . [and] that [he] enroll in and maintain compliance with, [the] New Mexico Monitored Treatment Program for habitual or excessive use of intoxicants or drugs.” Id. at 2.

    The Show Cause Order further alleged that the Board's 2017 Order of Immediate Suspension was based on numerous new allegations, including, inter alia, that Respondent “resumed the personal and unlawful use of opioid drugs” and that he “willfully thwarted the Board's drug screenings.” Id. The allegations also include that he “prescribed large and varied amounts of controlled substances to patients without adequate medical justification,” engaged in “injudicious and non-therapeutic prescribing of controlled substances,” “failed to screen patients for substance abuse disorders,” “diverted controlled substances that [he] prescribed . . . to patients from those patients for [his] personal use,” and “falsified” medical records “to justify the prescribing of controlled substances.” Id.

    The Show Cause Order thus alleged that pursuant to the Board's Order, Respondent is “not permitted to practice medicine in New Mexico” and therefore “lack[s] authority to handle controlled substances in” the State. Id. at 3. The Show Cause Order also asserted that Respondent's “lack of authority to handle controlled substances in New Mexico constitutes grounds to revoke [his] DEA [r]egistration.” Id. at 3 (citing 21 U.S.C. 802(21) and 824(a)(3)).

    The Show Cause Order notified Respondent of his right to request a hearing on the allegations or to submit a written statement while waiving his right to a hearing, and the procedure for electing either option. Show Cause Order, at 3-4 (citing 21 CFR 1301.43). Finally, the Order notified Respondent of his right to submit a corrective action plan. See 21 U.S.C. 824(c)(2)(C).

    On February 22, 2017, a DEA Diversion Investigator assigned to the Albuquerque District Office personally served the Show Cause Order on Respondent. Gov. Mot. for Summ. Disp., at GX D, at 1-2. Thereafter, on March 23, 2017, Respondent, through his counsel, requested a hearing on the allegations and a stay pending resolution of the New Mexico Medical Board matter, then scheduled for May 17-19, 2017. See Resp. Hrng. Req. The matter was placed on the docket of the Office of Administrative Law Judges, and assigned to Chief Administrative Law Judge John J. Mulrooney, II (hereinafter, CALJ).

    On March 23, 2017, the CALJ ordered the Government to “file proof of service” as well as evidence to support the lack of state authority allegation, as well as any motion for summary disposition, any motion challenging the timeliness of the hearing request, and any response to Respondent's stay request by March 31, 2017 at 2 p.m. See Order Directing the Filing of Government Evidence of Lack of State Authority Allegation and Briefing Schedule. The CALJ's order also directed that, in the event the Government filed a motion for summary disposition or a motion challenging the timeliness of his hearing request, Respondent was to file any response by April 10, 2017 at 2 p.m. Id.

    On March 31, 2017, the Government filed its Motion for Summary Disposition. See Gov. Mot. for Summ. Disp. As support for its Motion, the Government provided a copy of Respondent's Certificate of Registration showing that he is registered in New Mexico, a certified copy of the New Mexico Medical Board's Order of Immediate Suspension and Notice of Contemplated Action (Jan. 13, 2017), a printout of Respondent's licensing status as of March 25, 2017 from the Board's Web site, and a Declaration from a Diversion Investigator (DI). Id. at Exhibits A-D. Based on the suspension of his medical license by the New Mexico Medical Board, the Government moved for summary disposition and a recommendation by the ALJ that Respondent's DEA practitioner's registration be revoked and that any pending applications for a registration in New Mexico be denied. Mot. for Summ. Disp., at 8. The Government also requested that the CALJ deny Respondent's requests for a hearing and a stay of the proceeding. Id.

    On April 10, 2017, Respondent filed his reply, requesting that the ALJ deny the Government's motion and stay the matter until after the Board hearing. Respondent's Reply, at 1. While Respondent admitted that his license to practice medicine in New Mexico had been suspended, he stated that “he has not yet had an opportunity to challenge the allegations in the . . . Order” and that “a due process hearing [was] scheduled for May 17-18, 2017.” Id. Respondent stated that he “contests many of the allegations contained in the Summary Suspension Order and the Notice of Contemplated Action” and that “it will not be appropriate or proportional discipline for the Medical Board to uphold the suspension or to revoke his license.” Id. at 1-2.

    Respondent also argued that “[t]he plain language of Section 824(a)(3) provides that the loss of state authority constitutes a discretionary, not mandatory, basis for revocation.” Id. at 2. He further argued that “a stay . . . would afford [him] with his due process right to be heard in a meaningful manner in the State . . . proceeding.” Id. at 2 (citation omitted). He also argued that the Government would not suffer any prejudice should a stay be granted because “the Medical Board proceeding will be completed within the next few months.” Id. And finally, he contended that “[i]f . . . [he] prevailed in his administrative hearing in front of the Medical Board, it would be contrary to due process considerations and judicial economy to then force [him] to reapply for his” DEA registration. Id.

    On April 11, 2017, the CALJ granted the Government's motion and recommended that Respondent's registration be revoked. Order Denying The Respondent's Request For A Stay; Granting The Government's Motion For Summary Disposition; And Recommended Rulings, Findings Of Fact, Conclusions Of Law, And Decision of the Administrative Law Judge (hereinafter, R.D.), at 4-5.

    Denying Respondent's request for a stay, the CALJ noted that the Agency has repeatedly held that “revocation is warranted even where a practitioner's state authority has been summarily suspended and the State has yet to provide the practitioner with a hearing to challenge the State's action and at which he . . . may ultimately prevail.” Id. at 3 (quoting Kamal Tiwari, 76 FR 71604, 71606 (2011)). The CALJ also explained that “[e]ven when the Respondent is actively engaged in appealing a temporary decision, the Agency has noted that `[i]t is not DEA's policy to stay [administrative] proceedings . . . while registrants litigate in other forums,” id. (quoting Newcare Home Health Servs., 72 FR 42126, 42127 n.2), and that a stay “is `unlikely to ever be justified' due to ancillary proceedings.” Id. at 3-4 (citing Grider Drug #1 & Grider Drug #2, 77 FR 44070, 44104 n.97 (2012)).1

    1 The CALJ also cited Odette L. Campbell, 80 FR 41062, 41064 (2015), which he characterized as “holding revocation proceedings in abeyance at the post-hearing adjudication level for a lengthy period pending the resolution of both criminal fraud charges and concurrent state administrative proceedings against the respondent.” R.D. at 4. However, before the hearing was even held, Campbell allowed her registration to expire and she submitted an application only after she received a largely favorable decision from an ALJ. Thus, the matter did not involve a revocation, but rather, an application. Moreover, had Campbell been convicted of health care fraud, she would have been subject to mandatory exclusion from federal health care programs and her application would have been subject to denial on that basis.

    The CALJ also granted the Government's motion for summary disposition. Id. at 6. According to the CALJ, “[d]espite the discretionary language set forth in [section] 824(a)(3) and highlighted by the Respondent . . . DEA has long held that possession of authority under state law to dispense controlled substances is not only a prerequisite to obtaining a DEA registration but also an essential condition for maintaining it.” Id. at 4 (citing cases). The CALJ then explained that “[t]he basis for the Agency's position lies with two other statutes in the Controlled Substances Act (CSA) which requires that, in order to obtain or maintain a DEA registration, a practitioner must be authorized to handle controlled substances in the state in which he practices.” Id. (citing 21 U.S.C. 823(f) and 802(21)). The CALJ then explained that “[b]ecause, in the Agency's view, `possessing authority under state law to handle controlled substances is an essential condition for holding a DEA registration,' the Agency has consistently held that `the CSA requires the revocation of a registration issued to a practitioner who lacks [such] authority.' ” Id. at 5 (citations omitted). Because there is “no dispute . . . that . . . Respondent currently lacks state authority to handle controlled substances in New Mexico due to the Board['s Jan. 13, 2017] Order,” the CALJ held that “he is not entitled to maintain his . . . registration” and granted the Government's motion for summary disposition. Id. at 6.

    Neither party filed exceptions to the CALJ's Recommended Decision. Thereafter, the record was forwarded to my Office for Final Agency Action. Having considered the record and the Recommended Decision, I adopt the CALJ's recommendation that I revoke Respondent's registration.2 I make the following factual findings.

    2 I also adopt the ALJ's ruling denying Respondent's motion for a stay of the proceeding. As for Respondent's contention that a stay of this proceeding “would afford [him] with his due process right to be heard in a meaningful manner in the State . . . proceeding,” Resp.'s Reply, at 2, the New Mexico Board has an obligation to provide him with Due Process regardless of whether a stay is granted in this proceeding. See U.S. CONST., amend. XIV, § 1. As for his further contention that if he “prevailed . . . in front of the Medical Board, it would be contrary to due process considerations and judicial economy to . . . force [him] to reapply for his” DEA registration, all DEA registrants (including those who have never been subject to a DEA Show Cause proceeding) are required to periodically reapply for their registration; he also provides no authority for the notion that there is a property interest under the Due Process Clause in not having to periodically reapply for a registration. I thus reject his contention that he was entitled to a stay.

    Findings

    Respondent holds DEA Certificate of Registration No. FB5001538, pursuant to which he is authorized to dispense controlled substances in schedules II-V as a practitioner, at the registered address of 1108 Route 66, P.O. Box 1520, Moriarty, New Mexico. Mot. for Summ. Disp., at GX A. His registration does not expire until July 31, 2017. Id.

    On January 13, 2017, the New Mexico Medical Board issued an Order of Immediate Suspension and Notice of Contemplated Action to Respondent, suspending his license to practice medicine. Mot. for Summ. Disp., Exhibit B, at 1-8. According to Respondent, a Board hearing was scheduled for May 17-18, 2017. Resp. Reply, at 1. However, subsequent to the CALJ's issuance of his decision, Respondent has submitted no evidence showing that his license had been reinstated, and according to the Board's Web site of which I take official notice, Respondent's license to practice medicine in New Mexico remains suspended as of the date of this Order. See Respondent's Reply, at 1, see also Board Web site at http://cgi.docboard.org/cgi-shl/nhayer.exe. 3

    3 In accordance with the Administrative Procedure Act (APA), an agency “may take official notice of facts at any stage in a proceeding-even in the final decision.” U.S. Dept. of Justice, Attorney General's Manual on the Administrative Procedure Act 80 (1947) (Wm. W. Gaunt & Sons, Inc., Reprint 1979). In accordance with the APA and DEA's regulations, Respondent is “entitled on timely request to an opportunity to show to the contrary.” 5 U.S.C. 556(e); see also 21 CFR 1316.59(e). To allow Respondent the opportunity to refute the facts of which I take official notice, Respondent may file a motion for reconsideration within 15 calendar days of the date of service of this Order which shall commence on the date this Order is mailed.

    Discussion

    Pursuant to 21 U.S.C. 824(a)(3), the Attorney General is authorized to suspend or revoke a registration issued under section 823 of the Controlled Substances Act (CSA), “upon a finding that the registrant . . . has had his State license . . . suspended [or] revoked . . . by competent State authority and is no longer authorized by State law to engage in the . . . dispensing of controlled substances.” With respect to a practitioner, DEA has also long held that the possession of authority to dispense controlled substances under the laws of the State in which a practitioner engages in professional practice is a fundamental condition for obtaining and maintaining a practitioner's registration. See, e.g., James L. Hooper, 76 FR 71371 (2011), pet. for rev. denied, 481 Fed. Appx. 826 (4th Cir. 2012); Frederick Marsh Blanton, 43 FR 27616 (1978).

    This rule derives from the text of two provisions of the CSA. First, Congress defined “the term `practitioner' [to] mean[ ] a . . . physician . . . or other person licensed, registered or otherwise permitted, by . . . the jurisdiction in which he practices . . . to distribute, dispense, [or] administer . . . a controlled substance in the course of professional practice.” 21 U.S.C. 802(21). Second, in setting the requirements for obtaining a practitioner's registration, Congress directed that “[t]he Attorney General shall register practitioners . . . if the applicant is authorized to dispense . . . controlled substances under the laws of the State in which he practices.” 21 U.S.C. 823(f). Because Congress has clearly mandated that a practitioner possess state authority in order to be deemed a practitioner under the Act, DEA has held repeatedly that revocation of a practitioner's registration is the appropriate sanction whenever he is no longer authorized to dispense controlled substances under the laws of the State in which he practices medicine. See, e.g., Hooper, 76 FR at 71371-72; Sheran Arden Yeates, 71 FR 39130, 39131 (2006); Dominick A. Ricci, 58 FR 51104, 51105 (1993); Bobby Watts, 53 FR 11919, 11920 (1988); Blanton, 43 FR at 27616.

    Moreover, revocation is warranted even when a state board has resorted to summary process in suspending a practitioner's dispensing authority and the state has yet to provide the practitioner with a hearing to challenge the board's action. This is so “because `the controlling question' in a proceeding brought under 21 U.S.C. 824(a)(3) is whether the holder of a DEA registration “ `is currently authorized to handle controlled substances in the [S]tate.' ” Gentry Reeves Dunlop, 82 FR 8432, 8433 (2017) (quoting Hooper, 76 FR at 71371 (quoting Anne Lazar Thorn, 62 FR 12847, 12848 (1997))); see also Bourne Pharmacy, 72 FR 18273, 18274 (2007); Wingfield Drugs, 52 FR 27070, 27071 (1987). Thus, it is of no consequence that the New Mexico Board has employed summary process in suspending Registrant's state license. What is consequential is that Respondent is no longer currently authorized to dispense controlled substances in the State in which he is registered.

    In his reply to the Government's Motion for Summary Disposition, Respondent argued that the authority contained in 21 U.S.C. 824(a)(3) is a “discretionary, not mandatory basis for revocation.” Respondent's Reply, at 2. While Respondent cites James Alvin Chaney, 80 FR 57391 n.1 (2015), as support for his contention, footnote one of the Agency's Decision in Chaney addressed whether the respondent in that case had an active registration. Moreover, Respondent's contention that the Agency's sanction authority in cases involving a practitioner's loss of his state controlled substance dispensing authority remains discretionary, was squarely addressed and rejected in footnote 2 of the Chaney decision, as it has been in countless Agency decisions. See Chaney, 80 FR 57391 n.2; see also, e.g., Charles Szyman, 81 FR 64937, 64938 n.1 (2016); see also Rezik A. Saqer, 81 FR 22122, 22127 (2016); James L. Hooper, 76 FR 71371 (2011). And the Agency's rule has been upheld by two courts of appeals. See Hooper v. Holder, 481 Fed. Appx. 826, 828 (4th Cir. 2012) (“[b]ecause sections 823(f) and 802(21) make clear that a practitioner's registration is dependent upon the practitioner having state authority to dispense controlled substances, the [Administrator's] decision to construe section 824(a)(3) as mandating revocation upon suspension of a state license is not an unreasonable interpretation of the CSA”); Maynard v. DEA, 117 Fed. Appx. 941, 944-45 (5th Cir. 2004) (rejecting contention that DEA could not revoke practitioner's registration where state board's disciplinary panel “merely temporarily suspended” medical license “without notice”). I will therefore order that Respondent's registration be revoked and that any pending application be denied.

    Order

    Pursuant to the authority vested in me by 21 U.S.C. 824(a), as well as 28 CFR 0.100(b), I order that DEA Certificate of Registration No.FB5001538, issued to John D. Bray-Morris, M.D., be, and it hereby is, revoked. Pursuant to the authority vested in me by 21 U.S.C. 823(f), I further order that any pending application of John D. Bray-Morris, M.D., to renew or modify his registration, or for any other registration in the State of New Mexico, be, and it hereby is, denied. This Order is effective immediately.4

    4 For the same reasons that led the New Mexico Board to summarily suspend Respondent's medical license, I find that the public interest necessitates that this Order be effective immediately. 21 CFR 1316.67.

    Dated: July 27, 2017. Chuck Rosenberg, Acting Administrator.
    [FR Doc. 2017-16446 Filed 8-3-17; 8:45 am] BILLING CODE 4410-09-P
    DEPARTMENT OF JUSTICE Drug Enforcement Administration Marcia L. Sills, M.D.; Decision and Order

    On January 21, 2015, the Deputy Assistant Administrator, of the then Office of Diversion Control, Drug Enforcement Administration, issued an Order to Show Cause to Marcia L. Sills, M.D. (hereinafter, Respondent). The Show Cause Order proposed the revocation of Respondent's DEA Certificate of Registration AS1456361, pursuant to which she is authorized to dispense controlled substances in schedules II through V, at the registered location of 2741 NE 34 St., Fort Lauderdale, Florida. GE 1, at 6. As grounds for the proposed action, which also includes the denial of any pending application for renewal and any other applications for new DEA registrations, the Show Cause Order alleged that Respondent's “continued registration is inconsistent with the public interest.” Id. (citing 21 U.S.C. 824(a)(4) and 823(f)).

    With respect to the Agency's jurisdiction, the Show Cause Order alleged that while Respondent's registration was due to expire on February 28, 2014, she “submitted a timely renewal” application. Id. The Order thus asserted that her “registration continues in effect pursuant to 5 U.S.C. 558(c).” Id.

    As for the substantive grounds for the proceeding, the Show Cause Order set forth numerous allegations that between November 2011 and July 2012, Respondent violated Florida and Federal controlled substances laws in her prescribing of controlled substances to an undercover officer and seven other patients. Id. at 6-10. With respect to the undercover officer, the Order alleged that on both May 31, 2012 and July 16, 2012, Respondent issued prescriptions to him for both oxycodone 30 mg, a schedule II controlled substance, and clonazepam, a schedule IV controlled substance, which were not for a legitimate medical purpose in the usual course of professional practice under State and Federal law. Id. at 6-7. Specifically, the Order alleged, inter alia, that Respondent “failed to conduct a sufficient physical exam,” “failed to provide a legitimate diagnosis,” prescribed to the UC “despite evidence that he had illegally obtained controlled substances,” and had prescribed “large quantities” of oxycodone “absent any reliable evidence that [the UC] had any tolerance to opioid medication and increased the quantities absent a legitimate medical purpose.” Id. at 7. The Order also alleged that Respondent “assisted the UC in his attempts to obtain controlled substances from a pharmacy without arousing suspicions that the prescriptions were issued for other than a legitimate medical purpose.” Id. The Order thus alleged that Respondent violated both Federal and State law in issuing the oxycodone and clonazepam prescriptions. Id. (21 U.S.C. 829, 841(a); 21 CFR 1306.04(a) & 1301.71; Fla. Stat. Ann. §§ 455:44(3) & 456:072(1)(gg); Fla. Admin. Code r. 64B8-9.013).

    The Show Cause Order also alleged that a medical expert who reviewed at least eight medical files of patients (including the undercover officer) treated by Respondent “concluded that, in each case, [she] prescribed controlled substances to those patients without a legitimate medical purpose in the usual course of professional practice.” Id. The Order specifically alleged that the expert found that Respondent “distributed large amounts of controlled substances without conducting a sufficient medical history and/or physical examination and without determining the patients' tolerance to controlled substances,” and did so “even though the patients demonstrated evidence of drug abuse and/or diversion.” Id. at 7-8. The Order then set forth detailed allegations regarding her prescribing to seven patients (other than the undercover officer), who presented such evidence. Id. at 8-9.

    The Show Cause Order also notified Respondent of her right to request a hearing on the allegations, or to submit a written statement in lieu of a hearing, the procedure for electing either option, and the consequence for failing to elect either option. Id. at 10 (citing 21 CFR 1301.43). On February 2, 2015 the Government accomplished service by personally serving Respondent with the Show Cause Order. GE 26, at 4. (Declaration of Diversion Investigator (DI)).

    On February 6, 2015, Respondent filed a motion for extension of the time to respond to the Show Cause Order on the ground that she had been charged in a criminal case based on “essentially the same allegations and has maintained her [F]ifth [A]mendment right to remain silent pending trial” and that she “is not in a position to factually respond to this order until after her trial.” Motion for Extension of Time Pursuant to 21 CFR 1316.47(b). Respondent further requested that the proceeding be “abated . . . until the conclusion of the criminal matter.” Id. On February 9, 2015, the Chief Administrative Law Judge (CALJ) denied the motion. Order Denying Resp.'s Motion for an Enlargement of Time to Respond to Order to Show Cause.

    On February 19, 2015, Respondent filed a timely request for a hearing with the Office of Administrative Law Judges. In her request, Respondent “denie[d] all of the factual assertions” and legal conclusions of the Show Cause Order, and maintained that she “did not violate any of the provisions argued by the [G]overnment.” GE 20, at 1. However, on March 6, 2015, Respondent submitted a letter withdrawing her request for a hearing; the same day, the CALJ granted Respondent's request and terminated the proceeding. Id. at 3.

    On October 13, 2016, the Government submitted its Request for Final Agency Action and an evidentiary record. Based on Respondent's letter withdrawing her request for a hearing, I find that Respondent has waived her right to a hearing. 21 CFR 1301.43. I therefore issue this Decision and Order based on relevant evidence submitted by the Government. I make the following factual findings.

    Findings of Facts

    Respondent is a physician licensed by the State of Florida. Respondent is also the holder of DEA Certificate of Registration No. AS1456361, pursuant to which she is currently authorized to prescribe controlled substances in schedules II-V, at the registered address of 2741 NE 34 Street, Fort Lauderdale, Florida. GE 1, at 1. In addition, she is authorized to dispense Suboxone and Subutex, pursuant to the Drug Addiction Treatment Act of 2000 (DATA), for the purpose of treating up to 30 opiate-addicted patients. Id.; see 21 U.S.C. 823(g)(2).

    Respondent's registration was due to expire on February 28, 2014. While other agency records show that she submitted a renewal application on March 5, 2015, according to the Government, the “renewal was marked received by the DEA mail room on March 1, 2014,” and “was likely received several days prior to March 1, 2014” due to security screening measures. RFAA, at 1 n.1. Because Respondent's renewal was timely, I find her registration has remained in effect pending the resolution of this proceeding. See 5 U.S.C. 558(c). Government Request for Final Agency Action (RFAA), at 1.

    At all times relevant to this proceeding (November 2011 to July 2012), Respondent was employed at the Pompano Beach Medical Center (PBM), located at 553 E. Sample Road, Pompano Beach, Florida. PBM was the subject of a criminal investigation which included undercover operations conducted on May 31 and July 16, 2012 by a former DEA Task Force Officer and Broward County Sheriff's Office Detective (hereinafter “UC”) who posed as a patient at two medical appointments during which he was seen by Respondent, who prescribed various controlled substances to him.1 GE 26, at 2.

    1 On August 16, 2012, Respondent was arrested and charged with two counts of Illegal Prescribing of Controlled Substances, two counts of Delivery of a Controlled Substance, one count of Racketeering, and one count of Conspiracy to Commit Racketeering. Declaration of DI, at 2 (citing Florida Statutes §§ 893.13(8)(a)(1) and (2), 893.13(1)(a)(1), 895.03(1) and (4)).

    During both visits with Respondent, the UC used audio and visual recording devices. Id. at 2-3. As part of the record, the Government submitted DVDs of the recordings as well as transcriptions of the recordings.2 The Government also submitted copies of the prescriptions Respondent issued to the UC. GE 8, 10.

    2 The DI and the UC averred that true and accurate transcripts of the recordings were made and are provided in the evidence file, along with DVDs of the recordings. GE 25, at 5; GE 26, at 2-3. See also GE 3, 4, 5, 6, 7, 9.

    Following the UC's visits, the investigators obtained a state search warrant for PBM, and during the execution of the warrant, seized numerous patient files, including those of the UC and seven other patients. Id. at 4. The DI also obtained from various pharmacies copies of prescriptions which had been issued by Respondent to three of those patients. Id. Copies of the seven patient files and the prescriptions obtained by the DI are included in the evidence. See GE 12-18, 21, 23.

    The Government's Expert

    As part of its investigation, the Government retained Dr. Reuben M. Hoch, an Interventional Pain Medicine Specialist and Anesthesiologist, who reviewed the medical files, transcripts and recordings of the undercover officer's two visits with Respondent, as well as the patient files for seven other patients treated by Respondent. Dr. Hoch received his medical degree from the Sackler School of Medicine at Tel Aviv University in 1988. GE 2, at 1. He has done an internship in internal medicine and both a residency in anesthesiology and a fellowship in pain management at New York University. Id. at 2. He is Board Certified in Anesthesiology and Pain Medicine by the American Board of Anesthesiology. Id. at 3.

    Dr. Hoch, who is licensed in Florida and New York, currently practices pain medicine at Boca Raton Pain Medicine in Delray Beach, Florida, and previously served as the Chief of Multidisciplinary Pain Management Service in the Departments of Neurosurgery and Anesthesiology at The Brooklyn Hospital Center. Id. at 3-4. Dr. Hoch has served as an expert witness on approximately ten different occasions. Id. at 1. I find that Dr. Hoch is qualified to provide his expert opinion with regard to the prescribing practices of Respondent in her treatment of the UC and seven patients whose files he examined.

    The Undercover Visits

    On May 31, 2012, the UC presented at Pompano Beach Medical (PBM) and requested an appointment. GE 25, at 1 (Declaration of UC). The UC told the receptionist he had been working out of town for an extended period and had not been to PBM in the last five months.3 Id. After the receptionist retrieved his file, the UC encountered the clinic's owner and told him that he had been out of town working; the owner then directed the receptionist to `drug test' the UC. Id.

    3 The TFO, in his undercover capacity, had last visited PBM in January, 2012, and, prior to that from May-September 2011, when he was treated by different physicians.

    After the receptionist told the UC that the appointment would cost $230 plus $30 for the drug test, the UC made an appointment for later that day. Id. at 2. The UC returned later for his appointment and was drug tested. Id.

    He also filled out various forms, including one titled: “Patients [sic] Follow Up Sheet.” GE 11, at 36. On the form, the UC circled the neck portion of a body diagram to indicate where he felt pain; according to the UC, he did so “even though the MRI which [he] had previously provided to PBM was of [his] lower back.” GE 25, at 2; see also GE 11, at 36. He also answered “N” (for no) to two questions: (1) “Is the pain always there?” and (2) “Does the pain get worse when you move in certain ways?” GE 11, at 36. In response to “Has the pain affected any of the following: Social activities . . . Mobility . . . Work . . . Appetite . . . Exercise . . . Sleep?” the UC circled “Exercise.” Id. He also noted that he had not been in any accidents since he had last visited PBM. Id.

    On a numeric pain scale of 0-10, with 10 meaning “hurts worst,” [sic] the UC indicated the intensity of his pain as “0” “with medication” (“no pain”) and “2” “without medication” (“hurts little bit”). Id. Finally, he checked a printed statement stating “I am satisfied with my current medication. I would not like to change it,” and left unchecked the statement “I am not satisfied with my pain medication and would like to discuss changes.” Id. The UC then produced a urine specimen, had his weight and blood pressure recorded, and again spoke to the clinic owner, telling him that he had been in California where he had difficulty finding a pain clinic that would prescribe medications, and that it had been difficult to find pharmacies to fill prescriptions for oxycodone. GE 25, at 2 (UC's Declaration). According to the Drug Screen Results Form, which lists numerous controlled substances including “Opiates/Morphine,” “Benzodiazepine[s],” and “Oxycodone,” the UC tested negative for all drugs. GE 11, at 39.

    The UC then met with Respondent, telling her that he was a film stuntman who often travelled, that he had been away for work and just returned, and that he had “stiffness in [his] lower back and . . . neck.” GE 7, at 1-2 (Transcript of May 31, 2012 visit). Respondent asked the UC how long it had been going on, and UC told her he had seen “five . . . I think, six doctors” and “so I have a lot of times I have the stiffness . . . [u]mm aches.” Id. at 2. He then stated “two or three” years, and when Respondent asked: “It wasn't a car accident or anything?” UC replied: “No, no, no it's actually, no critical injury at all. It's you know muscle soreness from the work that I do.” Id. at 3; see generally GE 3, V-0002, at 14:10:54-14:13:30.4

    4 Due to the length of the citations to the videos, all such citations are provided at the end of each paragraph.

    Respondent, reading paperwork, then asked the UC a series of questions, including whether he had a lockbox or safe to keep medicine in (telling him he should get one when he responded “no”), whether he had little kids living with him, if he was on disability, and whether he had “any problems with sleeping or anxiety?” GE 7, at 3. The UC replied: “Once in a while. I used to take a little bit of Xanax to sleep, but I think I can probably work without it.” Id. Respondent stated: “Okay if you need anything to relax you for anxiety we use Klonopin instead of Xanax”; UC replied “Okay, I'll try it, sure.” Id. Respondent checked both “anxiety” and “insomnia” in the Pain History section of the visit note. Id.; see also GX 3, V-0002, at 14:13:30-14:14:00; GE 11, at 3.

    Respondent, who was still reading the form, then asked the UC if he had “seen another pain management doctor in 28 days?” UC responded “No.” GE 7, at 3. Id. Next, Respondent asked: “Your quality of life is better with than without the medicine I assume?” to which the UC replied “Yes.” Id. Respondent circled and/or checked the corresponding items on the form. GE 3, V-0002, at 14:14:00-14:14:08; GE 11, at 33.

    After asking about recent hospitalizations, chest pains, shortness of breath or cardiac problems, Respondent asked the UC if he “kn[ew] the risks of the medicine, addiction, overdose, death, damage to your liver or kidneys?” GE 7, at 3-4. Without waiting for a reply from the UC, Respondent added that “we have your blood work to check your liver and kidneys and I'll look at your MRI too.” Id. at 4; GE 3, V-0002, at 14:14:08-14:14:24.

    Respondent then asked UC to stand up “carefully . . . let me see how you can bend forward.” Id. UC responded: “I'm pretty . . . from what I do.” GE 7, at 4. The video recording shows that the UC stood up, turned to move his chair, and immediately bent down, touched his hands to the floor and straightened back up again. GE 3, V-0002, at 14:14:24-14:14:35. In his Declaration, the UC states he “quickly touched my hands to the floor without hesitation or pain.” GE 25, at 2.

    After asking the UC his age, Respondent asked: “[I]s your neck okay? . . . Good range of motion in your neck?” GE 7, at 4. UC, shook his head left to right, and replied: “Yeah I feel more stiffness when I do, you know, like I do heavy squats. Things like that. That's when I usually have those feelings.” Id. Respondent asked if UC had numbness or tingling in his legs, which he denied, asking “that would be bad, wouldn't it?” Id. Respondent explained “it means you might have a herniated disc that's you know pinching.” Id.; see also GE 3, V-0002, at 14:14:35-14:15:03.

    Respondent, while looking through paperwork, then stated: “so these labs are okay. And I want to look at your MRI.” GE 7, at 4. After briefly looking at the MRI, Respondent stated: “[n]othing too terrible . . . I don't see any herniated discs,” and while noting that he had a bulging disc, she added: “a bulge kind of doesn't mean anything. You've got spasms.” Id.; see also GE 3, V-0002, at 14:15:03-14:15:27.

    Continuing, Respondent stated: “we don't give narcotics for spasms . . . [a]nd we don't give [S]oma. I will give you another muscle relaxant.” GE 7, at 5. Respondent added: “[a]nd if you want something instead of Valium I'll give you something for that too.” Id. UC responded “Okay.” Id.; GE 3, V-0002, at 14:15:27-14:15:41.

    Respondent then told UC that Klonopin, “like Valium and Xanax, is for anxiety. And the reason why people take it at night is to reduce anxiety so they can sleep. It is not a sleeping pill.” GE 7, at 5. She added: “so Klonopin is long acting unlike Valium and Xanax which are short acting benzos [sic] every 3 to 4 hours, Klonopin is 12 to 24.” Id. When UC asked “When will I take it, at night before bed?” she responded: “It's up to you . . . [n]ight time before bed . . . [b]ut it's not going to zonk you out and it won't give you fogginess. It brings down anxiety a bit.” Id. The UC responded “Okay.” Id.; GE 3, V-0002, at 14:15:41-14:16:16. According to the UC, in all of his prior visits to PBM, he “never disclosed that [he] suffered from anxiety.” GE 25, at 3.

    Respondent, looking at the UC's file, then returned to discussing the UC's MRI, stating: “[o]kay so there's a bulge which by itself it wouldn't mean anything . . . [b]ut I'm gonna make a note here . . . the one up from your tailbone L4,5 . . . it has a small tear in the end which means that due to trauma, something was, the disc was trying to herniate and didn't quite make it . . . and also there is a little bit of pushing of the nerve . . . very little . . . but it is there.” GE 7, at 5-6. The UC interjected with “Okay” sporadically throughout Respondent's discussion. Id.; see also GE 3, V-0002, at 14:16:16-14:16:51.

    Respondent then asked the UC: “[h]ow much Roxicodone were you taking? We don't do 120. What were you taking four or five a day? Tell me.” GE 7, at 6. The UC responded “[y]es,” and Respondent asked: “About four a day? Okay we're good for that. And . . . the Klonopin, I'm going to give you a milligram. . . . I'm also gonna give you some ibuprofen. Because if your [sic] filling in Florida which I encourage you to so you're on the computer list. Then . . . for two reasons: number one, the pharmacists usually want a non-prescription drug, a non-controlled substance drug rather . . . and ibuprofen is also good for inflammation.” Id. UC responded with “Gotcha” and “Okay.” Id. Respondent continued: “If you need something to relax your muscles . . . Let me give you some Flexeril. It's cheap and it works.” Id.; GE 3, V-0002, at 14:17:10-14:18:15. Notably, Respondent had not even performed her physical exam prior to agreeing to prescribe the controlled substances to the UC.

    As the video shows, only after she discussed the dosing of Flexeril, did Respondent leave her desk chair and approach the UC, who stood up. According to the UC, Respondent “asked me to stand up again, placed a stethoscope on my chest for approximately two seconds, and asked me to sit.” GE 25, at 3 (UC Declaration). While the video feed was blocked during that action, the audio reveals that Respondent told UC a story about a former patient and that she did not stop talking during the time she placed the stethoscope on the UC's chest. She then had him sit, and, according to the UC, “squeezed my calves while asking if he had any tenderness here?” Id. UC replied “no.” GE 7, at 7. Again she asked: “[a]ny tenderness here?” Id. UC replied “No.” Id.; see also GE 25, at 6. According to the UC, Respondent “also struck my knees with a neurologic hammer to test my reflexes even though my feet still were planted on the floor.” GE 25, at 3; GE 3, V-0002, at 14:18:15-14:19:25. As the video shows, the tests Respondent performed totaled less than one minute. See generally GE 3, V-0002, at 14:14:24-14:14:35 and 14:18:34-14:19:18.

    After some unrelated discussion, Respondent asked the UC how often he came back, to which he replied “I'll come every 28 days.” GE 7, at 8. She then asked: “[d]o you try to spread your medicine out if you don't have it?”; the UC replied: “[y]eah well I do the best I can with what I have.” Id. Respondent told the UC: “[y]ou know the Roxicodones, this is the short acting. It's safe to break in half.” Id. UC then asked: “Gonna be thirties still?” Id. Respondent replied: “[t]hirties” and added “[w]e only give thirties.” Id. Respondent then advised the UC to use a pill cutter and told him that “the ones you can't break in half are the long acting. Because if you break them in half . . . the ones that they call (inaudible) you can overdose”; the UC said “Okay.” Id. Respondent added: “all the people that break them in half they're using them for the bad purposes and they don't overdose because their body is so addicted, so.” Id. After the UC stated “right,” Respondent added: “I'm not allowed to say that.” Id.; GE 3, V-0002, at 14:19:38-14:20:28.

    Respondent then asked the UC if he “had a pharmacy that would honor [his] prescriptions.” GX 25, at 3; GX 7, at 8. The UC told her that “last time I had a problem. And I actually . . . a friend . . . sent me to an online pharmacy . . . and I sent them and they sent them back I think it was in Georgia.” GX 7, at 9. Respondent told him “I would highly recommend not doing that anymore in Georgia because DEA is looking at things across the states. If you can find an online pharmacy . . . okay, a lot of them have been shut down since you've been here.” Id.; GE 3, V-0002, at 14:20:28-14:21:00.

    The UC then asked if there “are any pharmacies that are known to the facility here that are pretty . . .? ” and Respondent replied: “let's ask them in the front.” GX 7, at 9. Respondent stated that she “can't recommend one. They know who goes to where. If you have a relationship with one I then was gonna [sic] encourage you to go back . . . that's your best bet.” Id. The UC told Respondent that when he “tried to go there, they were out . . . and when I last went there, you know what they were telling me . . . a lot of people are moving to Dilaudid because the oxys are so short.” Id. Respondent replied: “[t]rue and the Dilaudid is getting short so then they moved to short acting morphine.” Id. Respondent then stated: “[s]o here's the deal, if you can't find this within a week, um anytime within a week . . . giving it a good college try, come back free and I'll swap it.” Id.; GE 3, V-0002, at 14:20:00-14:21:48.

    Respondent further told the UC what days of the week she was at the clinic, prompting him to ask: “[w]hat would you recommend? If it wasn't the oxycodone, morphine or Dilaudid?” GE 7, at 9. Respondent replied: “I would go with the Dilaudid myself.” Id. After summarizing her prescriptions to the UC, and a brief discussion of how and when to take the new prescriptions, she asked him if he had any allergies, to which he replied “no,” and the office visit ended. Id. at 9-10; GE 3, V-0002, at 14:21:48-14:22:52.

    Respondent wrote the UC prescriptions for 112 tablets Roxicodone (oxycodone) 30 mg “for pain,” 28 tablets Klonopin (clonazepam) 1 mg “for anxiety,” 56 tablets Ibuprofen 400 mg, and 28 tablets Flexeril 10 mg. GE 8 (copies of prescriptions); GE 11, at 32 (Encounter Summary). A report in the UC's file shows that he filled the Roxicodone prescription on June 5, 2012 at Coral Springs Specialty Pharmacy in Coral Springs, Florida. Id. at 22. An unsigned and undated handwritten note on the report page asks “Where is patient filling? Or did he have different address in past?” Id.

    The UC's file includes a three-page visit note signed by Respondent on May 31, 2012. GE 11, at 33-35. The first page lists the UC's name, date of the visit, and vital signs, below which is a section titled: “Pain History Follow Up”; this section includes various words to circle and fill-in-the-blank statements which correspond to the questions Respondent asked UC during the visit.5 Id. at 33.

    5 During the office visit, the video shows Respondent filling out the form, which lists various items which were either circled or had a place for providing a checkmark: Location of Pain: Neck, Back (upper mid lower) Radiation ____ Head Face Chest Abdomen, R/L: Shoulder F-arm Elbow Arm Wrist Hand Hip Thigh Leg Knee Ankle Foot, Duration of Pain ____ Severity of pain ____ mild ____ moderate ____ severe, Precipitating Event ____ MVA ____ Fall ____ Accident ____ Other ____ Unknown, Character of Pain __ throbbing __ sharp __ dull __ tingling Comorbidities __ anxiety __ insomnia __ other, Lock Box __ Y __ N Kids __ Y ___ Ages __ N Pysch Visits/SS Disability past 5 yr ___ Y___ N, Have you seen another Pain Management Doctor in the past 28 days? ___Y ___N, Pain Scale off meds (0-10) ____ Pain Scale on meds (0-10) ____, Quality of life OFF medications __ better __ worse / Quality of life ON medications __ better __ worse, New Events Since Last Visits ___________, GE 11, at 33.

    On the form, Respondent circled “back” and “lower” as the location of UC's pain, noted the “Duration of pain” as “3 yr[s],” and that the “Severity of Pain” was “severe” (as opposed to “mild” or “moderate”). Id. at 33. Under “precipitating event,” she wrote “unknown” with “work—stuntman” handwritten nearby. Id. Under “character of pain,” she checked “throbbing” and “sharp,” and listed “anxiety” and “insomnia” as “Co-morbidities.” Id.

    The form also contains blanks for noting the UC's “Pain Scale off meds (0-10)” and “on meds.” Id. In the blank for “off meds,” the form contains the scratched-out number “2,” followed by the number “5”; in the blank for “on meds,” the form states “0”. Id. As for the blanks regarding the UC's quality of life both off and on medications, Respondent checked “worse”' for “OFF medications” and “better” for “ON medications.” Id. After “New Events Since Last Visit” she wrote “stuntman for movies—was in Cal. Last here Jan 18, 2012.” Id.

    The form's first page also contains a checklist for ROS (Review of Systems), on which Respondent checked: “All negative unless checked.” Id. This page also includes a section captioned with “PE” (physical exam), which list various exams items. Id. In this section, Respondent drew check marks and diagonal lines through various findings to include: (1) “HEENT” (head, eyes, ears, nose and throat), with check mark through “inspection wnl,” (2) “Chest,” checkmark through “clear,” (3) “Cor,” diagonal line draw through “rrr,” (4) “Abd,” diagonal line drawn through “soft, non tender,” (5) “Skin,” diagonal line through “wnl, no rash,” (6) “Ext,” line drawn through “nontender, full ROM,” (7) Neuro/psych, with checkmark drawn through “Ox3,” and (8) “Gait,” with a check mark drawn through “normal.” Id.

    The form also includes four diagrams of the human body, including a posterior view; on this diagram, Respondent circled the neck and noted “ROM WN,” circled the lower back and noted “Flex 90 Ext 10,” and circled the back of the knees and noted “reflexes =.” Id. She also noted on this page that the UC's UDS (urine drug screen) was negative “today.” Id.

    The form's second page included entries for a Neurological exam. Id. at 34. Respondent checked “yes” for each item which included: “Cranial Nerves: II-XII intact,” “Sensory Exam: Gross wnl to light touch,” “Reflexes +2 bilateral and symmetric upper ext” and “+2 bilateral and symmetric lower ext,” “Muscle Strength: bilat upper and lower.” Id. Respondent also circled “−,” this noting that the UC had a negative straight leg raise with respect to both his right and left legs. Id.

    Under “Assessment,” Respondent made marks next to the following entries:

    Patient satisfied, doing well on current medication and treatment plan; pain condition stable.

    Patient taking meds as prescribed and no adverse side effects, no new problems and no changes;

    Denies any drug charges or arrests since last visit;

    Medication storage and safety issues addressed and patient uses lock box; Diagnosis and treatment plan are justified and based on diagnostic results, history and physical exam.6

    6 Respondent did not, however, make a mark next to the entry for “Activities of living, quality of life improved with medication.” GE 11, at 34.

    Id.

    Under “Diagnosis, Respondent checked “Anxiety,” “Disc Bulge,” “Muscle Spasms,” “CHRONIC NON-MALIG PAIN SYNDROME,” and “Other,” after which she made a handwritten note stating: “L45 Bulge tear annular Bilat neural foraminal encroachment.” Id.

    Under “Plan,” Respondent made lines through multiple entries. These included: (1) “wt loss, smoking cessation, reduce salt and caffeine, F/U with PCP”; (2)”, “refer to PT, neurologist, neurosurgeon, orthopedist, psychiatrist, addiction specialist as needed”; (3) “F/U in one month to follow the success of treatment and need for adjustments”; (4) “Patient understands importance of weaning meds to minimum effective dose”; (5) “Yoga, stretching exercises; Fish oil at 3-6 grams/day; glucosamine/Chondroitin Sulfate as suggested”; (6) “Discussed informed consent, risks/benefits of given medications, alternate therapies; pt understands”; and (7) “Continue meds,” followed by for a second time, “patient understands importance of weaning meds to minimum effective dose.” Id. Respondent did not, however, place a checkmark next to the entry for “urine tox screen twice a year or as needed to monitor addiction/diversion.” Id.

    The third page includes a pre-printed list of both controlled and non-controlled drugs. Of note, the only narcotic listed on the pre-printed form is Roxicodone in the 30 milligram dosage form, next to which the form contains the pre-printed notations of “#84 #112 #140 #168,” with “#112” circled on the UC's form. Id. at 35. Respondent also checked the box for Klonopin, circling the dosage of “1 mg” and the “#28,” as well as the boxes for the non-controlled drugs, Flexeril and Ibuprofen 400 mg #56. Id.

    On checking out, PBM's receptionist provided the UC with the four prescriptions. GE 25, at 3. She also provided him with an appointment card, which listed his next appointment as scheduled for June 28, 2012. Id.

    In his declaration, the UCs stated that at no time during his visit with Respondent did she inquire “about any past treatments for pain other than to note what other doctors at PBM had prescribed, that there was no inquiry into any underlying or coexisting diseases or conditions, the effect of pain on my physical and psychological function, or whether I had any history of substance abuse.” GE 25, at 5.

    On July 16, 2012, the UC returned to PBM. Id. at 3. See also generally; GE 5 V-0003 (video recording). On the “Follow-Up Sheet,” the UC again circled the neck region of a body diagram to show where he felt pain. GE 11, at 29. He also circled “N” for no in answer to the questions: “Is the pain always there?” and “Does the pain get worse when you move in certain ways?” Id.

    Another question on the form asked: “Has the pain affected any of the following: Social Activities, Work, Exercise, Mobility, Appetite, Sleep.” Id. The UC circled none of these. Id. The UC also indicated that intensity of his pain was “0” “With Medication” and “1-2” “Without Medication,” “1-2.” Id. However, the UC also checked the statement: “I am not satisfied with my medication and would like to discuss changes.” Id. 7

    7 Another document in the UC's medical file bears the caption “June ___ 2012 Audit Page Patient name” with his undercover name printed. GE 11, at 31. The sheet includes the note: “Intake 5/7/11—shoulder surgery 2002” and that an MRI was received on “5/12/11—Lumbar.” Id. It also lists UDSs as having been done on both “5/17/11” and “5/31/12” and that both were “negative,” as well as his “B/P” and Pulse at various visits. Id. While the sheet also includes the note “stuntman travels frequently for job in CA,” the sheet is blank in the spaces for “referral out,” “records ordered” and “records received.” Id. Indeed, the file contains no medical records from other physicians.

    After greeting the UC, Respondent asked him when he had last been to the clinic, to which the UC replied that he was two weeks late and offered the explanation that Respondent was gone the first week and then had a job out of town. GE 9, at 1-2. Respondent then spent several minutes preoccupied with a cellphone text message, after which she asked him a series of questions because the clinic had redone “all the forms” since his last visit. Id. at 2-4. While making notations on paperwork at her desk, Respondent asked: “[t]hrobbing, sharp, dull, what would you say?” Id. at 4. The UC replied “No, no just you know like I said that muscle soreness is the best way I can say it.” Id.; see also GE 5, V-0002, at 15:32:10-36:21, V-0003, at 15:36:30-15:36:41.

    Respondent then asked the UC “no disability, no rehab, no addiction?” to which the UC answered “no,” followed by whether he had ever “ha[d] surgery for [his] back?” and “physical therapy, injections?,” with the UC answering “no” and “nope.” GE 9, at 4; GE 5, V-0003, at 15:36:30-15:36:48.

    Respondent said, “Okay, just the meds. You haven't seen anyone else in the past 28 days?” GE 9, at 4. UC replied “No.” Id. GE 5, V-0003, at 15:36:48-53.

    Next, Respondent asked the UC for his pain level “[o]ff medicine . . . on a scale of ten to zero.” GE 9, at 4. After the UC replied: “[o]ff medicine, two,” Respondent looked up from her desk at him and demonstrated a line on the desk, explaining, “Okay, ten is the worst . . . zero is perfect. Without medicine it would be closer to ten.” Id. at 4-5. UC replied: “Okay, uh, what probably, I'm not sure, on the pain scale . . . four or five? Is that better?” Id.; see also GE 5, V-0003, at 15:36:53-15:37:17.

    Respondent then asked “Okay and then with medicine?” to which UC replied “Zero?” GE 9, at 5. Respondent stated that she was not “not trying to you know,” prompting the UC to state that he “totally underst[ood],” after which Respondent explained that “I have to go over this each time. . . . Pain worse lifting, bending, sitting, standing?” Id. UC replied: “Working out. You know just once in a while when I'm done working out.” Id.; GE 5, V-0003, at 15:37:17-15:37:33.

    Respondent asked: “What makes it better? Lying, resting, ice, heat, massage?”; the UC replied: “I don't really do any of those things, so it's you know, like I said, it's just” before Respondent interjected by stating “Meds” and asked “does the pain affect your work, sleep, mood, etc?.” GE 9, at 5. Id. UC answered “No,” prompting Respondent to ask: “[w]hat does the pain affect in your life?” to which Respondent replied: “my recovery time from working out for sure.” Id.; GE5, V-0003, at 15:37:33-15:37:52.

    Respondent replied “Okay. Uh, well we certainly wouldn't just give pain medicines and narcotics so your [sic] working out is better,” to which UC replied, “No, no, no I understand, I understand.” GE 9, at 5. The following exchange then ensued:

    Respondent: “So does the pain affect anything else in your life?”

    UC: “What are the options again?”

    Respondent: “Work” (stated slowly and emphatically).

    UC: “Let's say work.”

    Respondent: “Sleeping.”

    UC: “Work.”

    Respondent: “Relationships.”

    UC: “Work.”

    Id. at 5-6; GE 5, V-0003, at 15:37:52-15:38:14.

    Next, Respondent asked the UC if his “quality of life [is] better with medicine than without?”; UC answered “sure.” GE 9, at 6. Respondent then stated: “Otherwise you shouldn't be on the medicine,” to which the UC replied “right.” Id. Respondent also asked the UC, “no blood pressure, diabetes, nothing else?” and if he drank or smoked. Id. UC denied all but “drink[ing] socially but very rarely” and having “a cigar occasionally but that's about it ever.” Id.; GE 5, V-0003, at 15:38:14-15:38:37.

    After Respondent and the UC discussed at length whether he needed to obtain a lockbox or safe for his medicine to protect it from being stolen, Respondent looked at the UC's MRI and stated: “there was some muscle spasm there . . . bulges we don't treat. But your bulges have . . . what we call encroachment or it had narrowing of the disc in that area . . . which is kind of rare . . . I better put that down.” GE 9, at 8; GE 5, V-0003, at 15:38:37-15:42:13.

    Respondent then asked UC “so you satisfied with the medicine?” GE 9, at 9. UC told her that he thought she “took me down just a little bit less from the last doctor which is no big deal but the two weeks off . . . definitely, definitely ran out of medication so.” Id. After Respondent interjected “oh its gotta be,” the UC stated: “my friend had some. So I was able to just hold me over until now.” Id. Respondent nodded her head in agreement while the UC was talking and stated “which we try not to do.” Id. See generally GE 5, V-0003, at 15:42:13-15:42:53.

    UC then told Respondent that from the list of seven pharmacies he had obtained from PBM at his previous visit, the seventh pharmacy filled the prescriptions. GE 9, at 9. The UC further stated that: “[t]he first six said no or they didn't have it. The problem was that the last one is, the pharmacist said `I can fill the oxycodone, I can fill the ibuprofen, and I can fill the . . . other . . . I don't even remember what the other one was to t[ell] you the truth.” Id. Respondent looked at the chart and said, “Roxicodone, Klonopin,” and the UC told Respondent that the pharmacist told him “she wouldn't fill the clonazepam” and handed the prescription back to him, stating that she didn't “feel comfortable filling” it even though she had called and verified that the prescription was okay. Id.; GE 5, V-0003, at 15:42:53-15:43:29.

    Respondent noted that “Xanax is five times more dangerous than Klonopin,” and the video shows that Respondent threw her hands in the air and stated: “I don't understand this . . . this is a low dose. That is the first time I heard that.” GE 9, at 9. UC told her that the pharmacist told him to go fill it somewhere else, to which Respondent replied: “[t]hat's a cuckoo pharmacist.” Id. at 10. UC told Respondent he didn't fill it because he didn't want to get her or Steve (the clinic owner) in trouble, but “like I said my buddy just had a couple of Xanax and that was it.” Id.; GE 5, V-0003, at 15:43:29-15:44:05.

    Respondent the told the UC to “[g]o take it to another pharmacy. That's not doctor shopping.” GE 9, at 10. Continuing, Respondent stated: I want you to know doctor shopping is if you take more than one doctor . . . my prescription and another doctor to one or more pharmacies in 28 days. But if somebody refuses to fill a legitimate prescription you can go to another pharmacy. Try to go close to the same day so it all comes out the same.” Id.; GE 5, V-0003, at 15:44:05-15:44:27.

    Respondent then told UC she would “write that and I'll write another non-narcotic. She's gonna [sic] fill Roxicodone but she won't fill one milligram of Klonopin?” GE 9, at 10. The UC told Respondent that the pharmacist “said she wouldn't fill the oxycodone without the other ones either” and “I'm like okay. No. Fine. Fill them,” and Respondent told the UC to “[g]et another place.” Id.; GE 5, V-0003, at 15:44:27-15:44:40.

    UC stated that this was the reason he “was sending them out to Georgia and getting them sent back,” to which Respondent replied: “If you're gonna do that then I have to have proof that you're getting them filled. . . . The reason why we have the state law is so we can track the narcotics . . . the medicines and if they go to Georgia we can't track them in Florida.” GE 9, at 10-11. After the UC told Respondent he had “filled the last ones here,” Respondent told the UC that if he ever “filled out of state . . . get us a paper copy . . . the exact medicines, the dosage and the date.” Id. at 11; GE 5, V-0003, at 15:44:40-15:45:19.

    After re-iterating that it was not doctor shopping for the UC to take the Klonopin prescription to another pharmacy, Respondent asked him to “stand up . . . and let me see how you're bending.” GE 9, at 11.8 The UC stood up, bent his torso towards the floor and back up. Respondent listened to UC's back with a stethoscope and appeared to move his head, and asked “Any pain going back?” and “No pain here?” with the UC answering “no” to both questions. Id. at 12; see also GE 5, V-0003, at 15:45:19-15:46:22.

    8 Respondent asked the UC to stand up and bend at 15:45:36 of the video.

    Respondent then told the UC to sit down and face her, and after he sat down, Respondent appeared to lift one leg straight out and then the other, asking “Any pain in your back?” GE 9, at 12. The UC replied: “I'm just . . . my legs are just tight, tight, tight. I just did legs. My hamstrings feel like they're gonna light up.” Respondent replied “I'm talking about your back” and UC replied “No.” Id.; GE 5, V-0003, at 15:46:22-15:46:47.

    At this point, Respondent returned to her desk. As the video shows, the entire physical exam lasted just over one minute, during which the UC was never put in the supine position. GE 5, V-0003, at 15:45:36-15:46:47.

    The UC then told Respondent that “most problematic thing is when I do squats . . . . heavy squats” and this is “when I can feel the majority of any kind of stiffness in my back[,] but right now it feels good.” GE 9, at 12. The UC then asked Respondent if he should “have surgery for that tear,” with Respondent stating that she “wouldn't recommend it” and then asked if his pain “seem[ed] to be worse on one side versus the other.” Id. The UC said “no,” and asked “will it get worse gradually or no?” Id. Respondent replied that the UC did not have “a clear cut hernia,” but that the condition would not heal by itself and “might eventually develop into a hernia.” Id. However, after the UC mentioned that his father “had seven hernias,” and that “like three of them were repairs,” Respondent clarified that she was “talking about” the UC's “spinal column” and herniated discs. Id. at 12-13; GE 5, V-0003, at 15:46:48-15:47:59.

    After a short discussion of her having been “away for a couple of days,” Respondent, in an apparent reference to the quantity of the UC's next oxycodone prescription, stated: “Alright let's go to one forty,” prompting the UC to say “okay,” after which Respondent added: “I can't justify more than that.” GE 9, at 13; GE 5, V-0003, at 15:48:00-15:48:29.

    While writing the prescription Respondent again was distracted by a cell-phone text message, which she returned before repeating: “Okay so we're gonna [sic] go up to one forty . . . any side effects you let me know about. And I'm gonna write for Klonopin again.” GE 9, at 13-14. After another brief discussion of why the pharmacist had refused to fill the previous Klonopin prescription with Respondent stating that the Klonopin “is a very good match with oxycodone and doesn't potentiate the side effects of oxycodone,” Respondent told UC she was going to give him two non-narcotic prescriptions so he could “get them filled someplace else.” Id.; GE 5, V-0003, at 15:48:29-15:50:25.

    The UC and Respondent then discussed the street price of oxycodone, during which UC stated that “you can buy them on the street for [13] dollars,” prompting Respondent to state: “[n]o, [y]ou can't buy them on the street for [13] dollars” and that the price was “at least double” or “triple.” GE 9, at 14-15; GE 5, V-0003, at 15:50:25-15:50:53.

    The UC explained that he knew that oxycodone was “going for a lot of money up in Tennessee and places like that” and that “it's just crazy when you spend over a thousand dollars for a prescription”; Respondent stated: “but they'll fill the Roxicodone. I mean, I'm just flabbergasted.” GE 9, at 15. After the UC stated that he was also “taken back by that,” Respondent stated: “[t]his is gonna be [140] for the pain. . . . How can a pharmacist . . . they'll fill the oxycodone . . . but they, I promise you there was another reason why that wouldn't fill it. There had to be another reason.” Id. The UC told Respondent that “it was a name of a pharmacy they gave me here,” and after the UC reminded Respondent that the pharmacist had said that she did not “feel comfortable filling this drug,” Respondent stated that that was “a cover.” Id.; GE 5, V-0003, at 15:50:53-15:51:54.

    Respondent then told the UC that she was giving him “two small” “non-narcotic” prescriptions for “twenty-eight” ibuprofen “for each pharmacy that you might have to go to.” GE 9, at 15-16. She then told Respondent that “there's nothing to say if you went back to the same pharmacy . . . that another pharmacist wouldn't even bat an eyelash . . . because there's nothing to bat an eyelash over.” Id. at 16; GE 5, V-0003, at 15:51:54-15:52:50.

    Respondent then prepared on a computer prescriptions for 140 oxycodone 30 (“for pain”) and 28 Klonopin 1 mg (“for anxiety”), telling him to “hold onto the Klonopin. If they won't fill it just take it.” GE 9, at 16; see also GE 25, at 5. She also told the UC that “I want you to keep the extra ibuprofen so if they won't fill the Klonopin again . . . you have another non-narcotic to use,” and asked the UC: “[m]ake sense?” GE 9, at 17. The UC stated that “it does make sense,” and after an exchange of pleasantries, Respondent personally handed the UC one of the ibuprofen prescriptions and the visit with Respondent ended. Id.; GE 5, V-0003, at 15;52:50-15:53:45. Subsequently, a medical assistant handed the other prescriptions to the UC as well as an appointment card for his next visit. GX 25, at 5.

    In addition to the oxycodone and Klonopin prescriptions, Respondent provided the UC with a prescription for 28 Flexeril 10 mg “for muscle spasm,” and two prescriptions for 28 ibuprofen 400 mg. GE 10, at 1-5; see also GE 11; at 23 (July 16, 2012 Encounter Summary). Of note, the oxycodone prescription lists five different diagnoses: “Insomnia due to Medical Condition,” “Chronic Pain Syndrome,” “Lumbar Disc Displacement Without Myelopa,” “Lumbar or Lumbosacral Disc Degeneration,” and “Lumbago.” GE 10, at 1.

    In the UC's patient file for the July 16, 2012 visit, Respondent noted the lower back as the location of UC's pain, that the duration of his pain was three years, and checked the box indicating that his pain was “severe.”' GE 11, at 25. As for the precipitating event, Respondent checked the box for “unknown” and wrote “”work-stunt man.” Id. As to the character of his pain, she placed checkmarks next to “throbbing” and “sharp”; she also made markings indicating that “anxiety” and “insomnia” were comorbidities. Id.

    Respondent wrote the word “meds” to indicate his “previous pain management treatment.” Id.9 She also noted that “off meds” his pain was a “5” on a “0-10” scale, and “on meds,” his pain was “0.” Id. As to what made the UC's pain worse, Respondent checked “lifting,” “bending,” “sitting, standing in one position too long,” and “other,” after which she wrote “working out.” Id. She noted that only meds made his pain better. Id. She indicated that the pain affected the UC's sleep, mood, work (writing the word “most”), daily activities, energy, and relationships, and that his quality of life off medications was worse (as opposed to better) and that his quality of life was worse “off medications” and was better “on medications.” Id. She noted that the UC's past medical and surgery record had not been received, and under “social history,” she circled “none” for no history of “Etoh” (alcohol use), “smoke” and “drugs.” Id. She also drew a single dash in the space for urine drug screen results, and indicated his past imaging studies included an MRI. Id.

    9 Respondent drew relatively straight lines in the spaces next to the words “Surgery,” “PT,” and “Injections.” GE 11, at 25.

    On the second page, Respondent checked “All negative” for her review of the UC's systems. Id. at 26. As for the physical exam, Respondent either drew a circle or scribbled around various words to indicate that various portions of the purported exam were normal.10 Id. Respondent also documented that she had performed a neurological exam which included testing the UC's cranial nerves, a sensory exam, a deep tendon reflex test of both the upper and lower extremities, and a muscle strength test of both his “upper” and “lower,” each of which she found to be normal. Id. Respondent also made various entries indicating that she had performed various orthopedic tests, including a straight leg raise on his right leg which provided a positive result, a Kemps test of the UC's lumbar region which was also positive, as well as several other tests, none of which are corroborated by the video. Id.; see also GE 5, V-0002, at 15:32:50-15:36:21 and V-0003, at 15:36:30-15:54. This page also includes four diagrams of the human body including a posterior view, which appears to have the letter “T” for “Tenderness” drawn over the lower back and buttocks. GE 11, at 26.

    10 Specifically, for “Heent,” she circled “inspection”; for “Chest,” she drew scribble around “clear”; for “Cor,” she scribbled around “rrr”; for “Abd,” she scribbled over “soft”; for “ext,” she scribble over “nontender”; and for “Psych,” she circled “Ox3.”

    The form's third page includes Respondent's “Assessment.” Id. at 27. Therein, Respondent placed a check mark next on the line which states “Patient not satisfied, request change,” wherein she handwrote “still ↑ pain on 4 q day—stuntman.” Id. Respondent also placed a check mark on the line for “Patient will take meds as prescribed and reports no side effect” as well as the line for “Patient will take meds as prescribed and reports these side effects.” Id. Respondent also placed a checkmark next to the line for “Activities of living quality are improved with medication.” Id.

    In the Diagnosis section, Respondent checked “Anxiety,” “Disc Bulge,” “Muscle Spasms,” “Chronic Non-Malignant Pain Syndrome” and “Other,” after which she handwrote what appears as “post. Bulge c torn annulus + bilat foraminal encroachment.” Id. And in the section for her “Plan,” she made a checkmark next to “Referral: Ortho, Neuro, Psych, Sloan Center/Mr. Brown, CAP.” Id. She also indicated a negative “Tox screen” and negative “Chemistry screen”; however, neither test was done at this visit. Id. Finally, she placed check marks next to the entries for “Wt loss, smoking cessation, reduce salt and caffeine” and “Goal to relieve 80% of pain, accomplished.” Id.11 Id.

    11 The plan section also included entries for “[i]f any problems develop, go to ER for any emergency,” “[y]oga, stretching, swimming or other cardiovascular exercises suggested,” “[f]ish oil recommended at 3-6 grams per day/glucosamine and Chondroitin Sulfate recommended,” and “[d]iscussed informed consent, risks/benefits of given medications, alternative therapies; pt understands.” GE 11, at 27. Next to each of these Respondent made stray marks, the intent of which cannot be determined.

    As with the form used at the previous visit, page 3 lists both controlled and non-controlled medications with specific dosage quantities and quantities. As before, the only narcotic listed is Roxicodone 30 mg with four different quantities: 84, 112, 140 and 168. Consistent with the prescriptions she issued, Respondent checked “Roxicodone 30 mg and circled “#140,” as well as Klonopin and circled both “1 mg” and “#28.” Id. She also checked Flexeril and Ibuprofen 400mg. Id.

    The Expert's Review of Respondent's Prescribings to the UC

    Dr. Hoch, the Government's Expert, reviewed the medical files, transcripts and recordings of the UC's two visits with Respondent. Based on his review, the Expert found that Respondent “failed to establish a sufficient doctor/patient relationship with [UC] and that the prescribing of controlled substances was outside the usual course of professional practice and for other than a legitimate medical purpose.” GE 24, at 3. The Expert provided extensive reasons for his conclusion.

    First, the Expert explained that “[t]he documented record fails to show that [Respondent] conducted an adequate evaluation of the [UC]” in that “a complete medical history was not taken.” Id. According to the Expert, the records lack sufficient documentation “to show that [Respondent] made a serious inquiry into the cause of [UC's] pain.” Id. The Expert further explained that “[i]n a valid doctor/patient relationship, a physician must inquire into whether the pain is the result of an injury or another disease process. That was not sufficiently done. All [Respondent] did was determine that [UC] was a stunt performer and had not been in a car accident.” Id. at 3.

    The Expert also found that while the UC “stated that he had seen as many as six other doctors for his pain” and “signed a release authorizing [PB] to obtain and review his prior medical records,” there are no records from physicians who treated the UC prior to his going to PBM. Id. According to the Expert, “[i]n completing a sufficient medical history, it is important to review the records of other physicians who have treated the patient.” Id.

    The Expert further found that Respondent “failed to conduct an adequate physical examination of” the UC. Id. According to the Expert, during both physical exams, the UC “failed to demonstrate pain sufficient to justify the repeated prescribing of controlled substances, especially strong opioid medications such as thirty milligram tablets of oxycodone.” Id. The Expert specifically faulted Respondent for determining that the UC “suffered from muscle spasms without any evidence,” as well as for concluding that “he suffered from anxiety without any inquiry into his mental state or sleeping habits,” and when, “[i]n fact, [he] never disclosed that he suffered from anxiety.” Id. at 3-4. The Expert then observed that “Respondent noted `anxiety' in the medical record and issued prescriptions for clonazepam which specifically stated they were being issued to treat anxiety.” Id.

    The Expert also faulted Respondent for having increased the quantity of the UC's oxycodone prescription from 112 to 140 dosage units at the July 16, 2012 visit. Id. at 4. As the Expert found, Respondent “increased the amount of oxycodone she prescribed without any medical justification, falsely writing that [UC's] pain had increased, when, in fact, [UC] initially rated his untreated pain as a `2' and changed the rating only after being prompted.” Id.

    Next, the Expert faulted Respondent because she “also failed to determine and/or document the effect of pain on the [UC's] physical and psychological function.” Id. The Expert further noted that “[t]here is no documentation in the record to show that [Respondent] made any attempt to adequately address this important standard of pain management” and that she “appeared to coach [the UC] into stating that the pain affected his `work' after he repeatedly states he was seeking narcotics to recover from muscle soreness due to exercising.” Id.

    The Expert also found that Respondent “failed to create and/or document a sufficient treatment plan.” Id. The Expert explained that despite UC's history of treatment at PBM and receipt of “prescriptions for controlled substances on prior occasions, [Respondent] recommended no further diagnostic evaluations or other therapies.” Id. The Expert then observed that the UC's “MRI . . . failed to demonstrate serious enough pathology for him to receive the large amounts of controlled substances that were prescribed.” Id. The Expert further explained that “[b]ulging discs can usually be addressed by other means such as physical therapy, exercise, work strengthening programs, abdominal core training, anti-inflammatories, and at times, injections such as nerve blocks with corticosteroids,” but that “[n]one of these options was offered or discussed by” Respondent. Id. The Expert then opined that “[i]gnoring these options constitutes an inferior, if not non-existent, treatment plan.” Id.

    The Expert also concluded that his review of the transcripts and recordings of UC's visits with Respondent “indicates that [Respondent] herself doubted there was a legitimate medical need to prescribe the large amounts of opioid medications that were prescribed.” Id. The Expert specifically noted that “[i]nitially, on May 31, 2012, [Respondent] stated that [the UC's] MRI showed `nothing too terrible,'” adding that `a bulge kind of doesn't mean anything' and that she would not `give narcotics for spasms.' ” Id. (citing GE 7, at 4-5). The Expert also observed that “[o]n the second visit, [Respondent] said she `certainly wouldn't just give pain medicines and narcotics so [his] working out is better.' ” Id. (quoting GE 9, at 5).

    The Expert further noted that Respondent “never inquired as to the treatment UC may have received prior to coming to [PBM][,] [n]or did she discuss any non-narcotic treatment [he] may have received from any other doctor at PBM.” Id. Based on his “review of the medical records, transcripts and recordings” of UC's two visits with Respondent, the Expert opined that: “there was serious doubt as to whether treatment goals were being achieved. Yet there was no attempt by [Respondent] to evaluate the appropriateness of continued treatment except to increase the amount of narcotics and create a means by which [the UC] could fill his prescriptions without raising the legitimate concerns of pharmacists.” Id. In the Expert's opinion, “this shows there was an insufficient review of the course of treatment and the prescriptions provided by [Respondent] to [the UC were] inconsistent with [Respondent's] evaluation.” Id. at 4-5.

    Next, the Expert concluded that Respondent “failed to sufficiently monitor [the UC's] compliance in medication usage.” Id. at 5. The Expert noted that Respondent “was well aware that [the UC] had run out of medication, and had illegally obtained both oxycodone and alprazolam from one or more friends.” Id. The Expert noted that Respondent nonetheless “increased the amount of oxycodone from 112 tablets to 140 tablets solely because of concerns that [the UC] might not return within 28 days, not because of any increase in pain.” Id. (comparing GE 9, at 13 (discussing the two-week delay in appointment “you need it two weeks ahead of time . . . alright let's go to one forty”) with GE 11, at 27 (medical record showing UC's pain increased despite taking four tablets a day)).

    The Expert also found that Respondent “ignored the numerous inconsistencies in the records which constitute red flags for abuse and/or diversion.” Id. As support for this finding, the Expert noted that the medical record for July 16, 2012 indicates that the UC's pain affected his sleep, mood, work, daily activities, energy, and relationships, yet during the actual consultation, UC initially said the pain affected only his “recovery time from working out.” Id. However, when Respondent told the UC that this would not justify prescribing narcotics, the UC changed his answer to “work” and provided this answer in response to the questions of whether the pain affected his sleep and relationships. Id. (citing GE 11, at 5-6).

    The Expert also noted that at the July 16, 2012 visit, the UC initially stated that his pain “level was `two' without medication,” but when prompted by Respondent, he “changed it to `four or five.' ” Id. (citing GE 9, at 4-5). Moreover, the Expert noted that “the medical record for that date shows a pain level of 1-2 [on the patient follow-up sheet], and a pain level of 5” on the form signed by Respondent. Id. (citing GE 11, at 29 and 25). The Expert also noted that the form signed by Respondent documents that the UC's pain [was] made worse by “sitting, standing in one position too long,” but there is nothing on the record to indicate that he made such a claim. Id. (citing GE 11, at 29). The Expert thus opined that, at a minimum, Respondent “should have had a discussion with [the UC] about his need for more medication, and made specific inquiries to determine if and how [his] pain had increased,” given that the UC “demonstrated that he was at risk for misusing his medications.” Id.

    Next, the Government's Expert opined that “there was no legitimate medical justification for the amount of oxycodone prescribed to” the UC by Respondent. Id. As support for his opinion, the Expert noted that “prior to his first visit with [Respondent], [the UC] had not been seen by a [PBM] physician since January 18, 2012,” and therefore, “he was, in all likelihood, opiate naïve on May 31, 2012.” Id. The Expert then explained that “[p]rescribing 112 thirty milligram tablets of oxycodone in this situation was without medical justification and dangerous.” Id.

    The Expert also found that “there was no justification for increasing the amount [on] July 16, 2012.” Id. As Expert explained, although the UC “indicated he ran out of medication because he was two weeks late for his second appointment with [Respondent], there was no indication that he would be late again. Also, there was no notation in the file to prevent UC from returning in 28 days and receiving another prescription identical to the one received on July 16, 2012.” Id. The Expert thus found that Respondent “failed to inquire into, or otherwise determine, whether there was a legitimate medical need for the additional medication.” Id. She also “failed to adjust the quantity and frequency of the dose of oxycodone according to the intensity and duration of the pain and failed to justify the additional prescription on clear documentation of unrelieved pain.” Id.

    The Expert further opined that “there was no legitimate medical justification for prescribing clonazepam, a benzodiazepine utilized to treat anxiety and, in some cases, sleep disorders.” Id. The Expert specifically found that Respondent “made no attempt to a[ss]ess [the UC's] mental state or his sleeping habits.” Id. at 5-6. The Expert noted that during the UC's first visit with Respondent, he “provided no information about these conditions except to say he `used to take a little bit of Xanax to sleep, but [that he could] probably work without it.' ” Id. at 6. The Expert also observed that when the UC was asked during his second visit if “his pain affected his sleep, [he] said `work.' ” Id. (citing GE 9, at 5). The Expert thus found that “[t]he record is devoid of any medical evidence justifying the need for prescribing clonazepam.” Id. The Expert also noted that because Respondent “fail[ed] to retrieve or cancel” the clonazepam prescription that she had given the UC at the May 31, 2012 visit, she enabled the UC “to obtain twice the amount as directed . . . by providing a second prescription [to him] on July 16, 2012.” Id.

    The Expert's ultimate conclusion was that the controlled substance prescriptions Respondent provided to the UC “were not justified given [the UC's] complaints and medical findings, and certainly not in the dosages or frequencies prescribed.” Id. at 6. The Expert further opined that the controlled substance prescriptions Respondent issued to the UC “lacked a legitimate medical purpose and were issued outside the usual course of professional practice.” Id. at 15.

    The Expert's Review of Other Patient Charts D.G.

    On November 2, 2010, D.G., who was then 32 years old and listed his residence as being in Niceville, Florida, which is nearly 600 miles from Pompano Beach, first went to PBM and was seen by Dr. Gabriel Sanchez. GE 17, at 5, 22. According to the intake forms, D.G.'s chief complaint was “sharp, intermittent pain in neck & upper back” which started in 1999. Id. at 5. D.G. reported that on “a scale of 0-10,” with “0 being no pain and 10 being the worst possible pain,” his pain with medication was “4” and his pain without medication was “9,” and that the “inciting event[s] [were a] weightlifting accident, several car accidents.” Id. at 5. He further reported that he had chiropractic procedures, and that he tried anti-inflammatories and anti-depressants, as well as oxycodone, Xanax, Vicodin and Percocet. Id. D.G. also noted that he had seen other doctors for his pain and that he thought he may have “depression.” Id. On another form, he checked that his symptoms “in the past year” included migraine headaches, loss of sleep, and neck and shoulder pain. Id. at 6.

    D.G. also signed a Pain Management Agreement in which he agreed that the “controlled substance prescribed must be from the physician whose signature appears on this agreement or in his/her absence, by the covering physician, unless specific authorization is obtained for an exception.” Id. at 11. He also agreed that he would “not attempt to obtain controlled medications, including opiate pain medications, controlled stimulants, or anxiety medication from any other doctor.” Id. D.G. also signed two releases for the release of the information by which he authorized PBM to obtain a prescription profile from a pharmacy and diagnostic reports from a diagnostic center.12 Id. at 18, 20. However, while D.G. indicated on the intake forms that he had seen other doctors for his pain, as well as that he had previously used anti-depressants, his file does not contain a release for a physician's treatment records. See generally id. Moreover, while it appears that PBM obtained D.G.'s MRI report on the date of his first visit, it did not obtain his prescription profile until July 6, 2011. See id. at 120-22.

    12 D.G.'s patient file includes an MRI report dated April 10, 2010 which showed degenerative changes at C5-6 and C6-7, mild kyphosis at C5-6, a bulging disc at C4-5 with no spinal stenosis, narrowing of the disc at C5-6 and C6-7 with herniated disc protrusions and mild bone spurs. GE 17, at 132-133. D.G.'s file also includes a patient profile from Santa Rosa Pharmacy covering the period of January 1, 2011 through July 6, 2011. Id. at 120-22.

    D.G. was also subjected to a drug test at his first visit. Id. at 131. The test results were negative for all drugs. Id.

    At D.G.'s first visit, Dr. Gabriel Sanchez 13 documented his findings on a one-page form including a diagnosis of chronic discogenic neck pain and issued him prescriptions for 150 Oxycodone 30 mg, 60 Oxycodone 15 mg, 60 Xanax 2 mg, 30 Motrin 800, and 30 Nortriptyline 25 mg. Id. at 128-30. One month later on December 2, 2010, D.G. returned to PBM, where Dr. Sanchez reissued each of the prescriptions. Id. at 124-26.

    13 Dr. Sanchez's DEA registration was the subject of Show Cause proceedings and revoked effective October 25, 2013. See Gabriel Sanchez, 78 FR 59060 (2013).

    Thereafter, D.G. did not return to PBM until July 6, 2011. Id. at 117. While D.G. completed a Follow-Up Sheet on which he noted that his pain was “always there,” that it got “worse when [he] move[d] in certain ways,” that it affected multiple life activities and provided pain ratings both with and without medication, the two-page visit note is largely blank and contains no entries in the section of the form for documenting his prescriptions. Id. at 117-19. Nor does D.G.'s file contain copies of any prescriptions bearing the date of July 6, 2011. See generally id.

    D.G.'s record shows that his next visit occurred on September 7, 2011, on which date he again noted on the Follow-Up sheet that his pain was “always there,” that it got “worse when [he] moved in certain ways,” checked various activities his “pain affects,” and rated his pain “without medication” as an 8, and “with medication” as between 3 and 4. Id. at 113. At the visit, D.G. was required to complete a form titled as “MEDICAL DISCLOSURE (LAST 30 DAYS).” Id. at 115. On the form, D.G. wrote “N/A” in both the space where he was to list “Prescriptions [sic] meds from other physicians” and “Prescriptions [sic] medications from other source.” Id.

    Yet a Drug Screen Results Form indicates that D.G. tested positive for oxycodone at this visit. Id. at 116. Moreover, a form titled as “Patient Compliance Instructions,” which was signed by D.G. at this visit, states: “All Patients Must Pass Their Initial and Random Urine Drug Screening Test!” Id. at 114. However, notwithstanding the inconsistency between what D.G. reported on the Medical Disclosure Form and his positive oxycodone test, Dr. T.R. issued D.G. prescriptions for 140 Oxycodone 30, 25 Xanax 2 mg, 50 Mobic 7.5 mg, and 28 Nortriptyline 50 mg. Id. at 110-111.

    Thereafter, D.G. went to PBM monthly where he saw Dr. T.R., who increased his oxycodone 30 prescription from 140 to 168 du (during his November 2, 2011 visit “as per pt. request”) as well as 24 Xanax 2 mg, (along with Nortriptyline and Mobic), after which D.G. saw Dr. A.E., who also issued him prescriptions 168 du of oxycodone 30 and 24 Xanax 2 through March 22, 2012. Id. at 74-110.

    On April 19, 2012, D.G. was treated by Respondent. On his “Patients [sic] Follow-Up Sheet,” he again reported that his pain was always there, that it was worse when he moved in certain ways, and that it affected his social activities, work, exercise, mobility and sleep. Id. at 61. He rated his pain “with medication” as a 3 and “without medication” as an 8. Id. He also indicated that he was satisfied with his current medication and would not like to change it. Id.

    In the “Pain History Follow Up” section of the visit note, Respondent indicated that D.G. has severe neck pain which was throbbing, sharp, and tingling, that the pain's “duration” was 15 years, and wrote “football” as the precipitating event.14 Id. at 65. She checked “insomnia” under co-morbidities, and noted that his pain level was 8 when “off meds” and 3 when “on meds.” Id. Under “New Events Since Last Visit” she wrote “none—some ↑ pain at work.” Id.

    14 Respondent also drew a horizontal line (rather than a check mark) in the space for noting if the pain radiated. GE 17, at 65. It is unclear what this line was intended to document, if anything.

    Under Review of Systems, she indicated that all were negative. Id. Under PE [Physical Exam], she made checkmarks suggesting that she had examined D.G.'s HEENT, Chest, Cor, Abd, and made scribbles next to Skin, Ext, Neuro/psych and Gait. Id. She added handwritten notes regarding the extent to which he could rotate his neck as well his range of motion for the extension and flexion of his neck, a notation “Hand grip” followed by an illegible word, and noted “Lock Box discussed.” Id.

    On the second page of the note, Respondent placed check marks next to “yes” for various neurological exam items and made no notation that D.G. had any focal deficits. Id. at 64. In the orthopedic section, she indicated that she had done a straight leg raise test on both D.G.'s right and left legs with a negative result on each leg. Id.

    In the section for her “Assessment,” Respondent placed a checkmark next to “Patient satisfied, doing well on current medication and treatment plan; pain condition stable.” Id. She also placed a checkmark next to “Patient taking meds as prescribed and no adverse side effects, no new problems and no new changes.” And as for her “Diagnosis,” Respondent checked “Cervicalgia,” “Disc Herniation C56/67,” “Hypertension” and “Chronic Non-Malignant Pain Syndrome.” Id.

    Under Plan, Respondent marked a series of marks next to each item on the list, to include “wt. loss, smoking cessation, reduce salt and caffeine, F/U with PCP”; “Refer to PT, neurologist, neurosurgeon, orthopedist, psychiatrist, addiction specialist as needed”; “urine tox screen twice a year or as needed to monitor addiction/diversion”; “Yoga, stretching exercises, Fish oil at 3-6 grams/day; Glucosamine/Chondroitin Sulfate as suggested”; “Discussed informed consent, risks/benefits of given medications, alternate therapies; pt understands”; and “Continue meds, patient understands importance of weaning meds to minimum effective dose.” Id.

    As with the UC's visit notes, Page 3 contained a list of medications at varying strengths and dosages, but only listed a single narcotic, that being Roxicodone 30 mg, next to which Respondent wrote a checkmark and circled “#168” (the maximum number listed). Id. at 63. She also placed a checkmark next to Xanax, circling “2 mg” and handwrote “↓” and “#20” (fewer than the listed choices of #28 or #56). Id. In addition, she placed a checkmark next to Amitriptyline, after which she wrote “50” and circled “#28” and wrote in Lisinopril under “Other Meds.” Id. Under Radiology, she wrote “MRI Cervical,” and under Consults she wrote: “MS Contin 30 BID #56.” Id. On the form she also added: “Goal: Cont. working ↑ meds so He can cont his business.” Id. She also wrote “Labs next time” and signed and dated the form. Id.

    A computer-generated “Encounter Summary” lists diagnoses of “Cervical Spinal Stenosis,” “Cervicalgia,” and “Chronic Pain Syndrome.” Id. at 66. Under medications, it lists each of the drugs discussed above including 56 MS Contin 30 mg. Id. The Encounter Summary also lists a prescription for an “mri no contrast C Spine DX: herniated disc.” Id.

    On May 17, 2012, D.G. returned to PBM and again saw Respondent. D.G. filled out his “Patients [sic] Follow-Up Sheet” answering each question exactly as before, including indicating his pain was a “3” with medication and an “8” without medication. Id. at 58.

    Respondent filled out the Pain History Follow Up sheet, indicating that the neck was the location of D.G.'s pain, that it was severe, throbbing, and sharp, that it had been present for 15 years and precipitated by “football.” Id. at 55. She listed no new events since D.G.'s last visit. Also, she checked no co-morbidities and circled “N” for “Psych visits/SS Disability.” Id.

    Under ROS, she noted that all findings were negative, and in the PE section, she made a series of scribbles over the various descriptors for normal findings for each exam item. Id. On the body diagram's posterior view, she circled the neck portion and wrote “Rotation 80 R 90 L” as well as “Flex 45 Ext 10”; she also circled both elbows and noted “Reflex +2=”, and finally, she circled both hands and wrote “no hand numbness good grip.” Id.

    In the neurological exam section, she checked “Yes” next to each of the items listed, and in the orthopedic section, she again noted a negative for both a right and left leg raise test. Id. at 56. In the Assessment section, she placed a check mark next to “Patient satisfied, doing well on current medication and treatment plan; pain condition stable” and “Activities of living, quality of life improved with medication.” Id. 15

    15 Respondent made no mark next to “Patient taking meds as prescribed. . . .” GE 17, at 56.

    Under Diagnosis, she again checked Cervicalgia, Disc Herniation “C56/67,” Hypertension and Chronic Non-Malignant Pain Syndrome. Id. However, in contrast to D.G.'s previous visit, she also placed check marks next to “Anxiety” and Insomnia.” Id. Under Plan, she checked each item as at the previous visit, but circled “F/U with PCP” and noted “HTN.” Id. And below the Plan section, she handwrote “goal: cont to be sales rep.” Id.

    On the page containing the list of medications, strengths and dosages, Respondent again checked the boxes for Roxicodone 30 (circling “#168”), Xanax 2 mg (writing “↓” and “#15”), and Amitriptyline #28, writing “50” for the drug strength. Id. at 57. She noted “must get PCP to get BP evaluation [and] meds,” “MRI C-Cervical” and “MS Contin 30 BID #56,” and added notes about Lisinopril. Id. She also wrote “next mth. stop Xanax” and “Add Klonopin 1 mg BID #56” at the bottom of the page below her signature and the date. Id. The Encounter Summary printout reflects the prescriptions listed. Id. at 54.

    D.G.'s next appointment with Respondent was on June 14, 2012. Id. at 47. He reported no changes on the “Patients [sic] Follow-Up Sheet,” indicated that his pain level was 3 “with medication” and “8” “without medication,” and that he was satisfied with his current medication. Id. at 51.

    Respondent filled out the revised Pain History form, with few differences from the previous visit, notably that D.G.'s “Pain Scale off meds (0-10) [was] 10”; “Pain Scale on meds (0-10) [was] 3.” Id.at 47. She checked “insomnia” as a co-morbidity, and for the question “[w]hat makes your pain better,” she left blank “lying, resting, stretching, exercise, heat, ice massage” and checked “other” with “meds” handwritten next to it. Id. She also made a handwritten notation “Has Lock Box!” Id. On the line for what activities the pain affected, she place a checkmark next to sleep, a horizontal line next to mood, and short diagonal line next to work, energy, and relationships. Id. She also indicated that D.G.'s quality of life was worse “off medications” and better “on medications.” Id. Under “Past Imaging/Studies,” she circled “MRI” and noted “4-10 see DX section.” Id.

    As at the previous visit, she checked “all negative” in the review of system, scribbled over various normal findings in the physical exam section, circled “yes” for each item in the neurological section, and indicated that various “orthopedic” tests were negative. Id. at 48. She also noted that D.G.'s cervical range of motion was 45 degrees in flexion and 10 degrees in extension, and made findings as to D.G.'s ability to rotate his neck. Id.

    Under Assessment, Respondent checked the line for “Patient Satisfied, understands how to take current medication and treatment plan.” Id at 49. In the Diagnosis section, Respondent checked “Anxiety,” “Cervicalgia,” “Disc Herniation,” “Hypertension,” “Insomnia,” and “Chronic Non-Malig Pain Syndrome.” Id.

    As for her plan, Respondent checked the line for “PCP obtained/referred for following conditions” after which she added: “For HTN in Ft Walton Bch, Fl,” below which she wrote: “Pt will Bring copy of Doctors HTN Report Next Visit.” Id. She also noted: “Tox screen due 2 mths” and “Chemistry screen due now—pt will get,” as well as checked several other line items. Id.

    Respondent prescribed 168 Roxicodone 30 mg, 56 MS Contin 30 mg BID, discontinued the Xanax and added #56 Klonopin 1 mg.16 Id. at 49; see also id. at 45-46 (copies of Rxs and Encounter Summary). On a form with the caption: “Reason for Prescribing Over a 72 hour Quantity of Substance(s),” Respondent made additional notations, including: “CMP script—pt will do outside lab,” “UDS next 1-2 mth,” “C-Spine MRI with script given previously,” “Must see PCP for HTN Pt advised he must 1. Get labs 2. Bring copy of physician report on HTN or can not be seen next time.” Id. at 50.

    16 She also prescribed 28 Amitriptyline 50 mg.

    D.G.'s file contains a memo from the Clinic Director of the Hope Medical Clinic, a free clinic located in Destin, Florida, which was faxed to PBM on July 11, 2012, one day before D.G.'s next appointment. Id. at 42. The memo stated that D.G. “has an appointment with us on September 20th where we will be able to begin his long term primary care for chronic illness. Our program is full until this date as our services are at no cost to patients.” Id.

    On July 12, 2012, D.G. returned to PBM and again saw Respondent. On the “Patients [sic] Follow-Up Sheet,” he again indicated that the pain was “always there,” that it affected his social activities, work, exercise, mobility, and sleep, that the pain was 3 “with medication” and 8 “without medication,” and that he was satisfied with his current medication. Id. at 40.

    Respondent filled in the blanks in the Pain History section of the visit note, making the same notations as before, including that D.G.'s pain scale “off meds” was “10”, but “3” with medication. Id. at 35. She again noted that a cervical MRI from “4-10” was the only imaging report. Id. Her examination notations on the remaining forms were nearly identical to those made at the previous visit. See id. at 37-38. Moreover, she checked the same diagnosis findings and the same items under her plan. Id. Respondent again prescribed 168 Roxicodone 30 mg, 56 Klonopin 1 mg, 56 MS Contin 30 mg BID, and Amitriptyline. Id. at 38; see also id. at 33, 36 (copies of prescriptions and Encounter Summary).

    The Expert reviewed D.G.'s medical file, and concluded that the controlled substance prescriptions Respondent issued to D.G. between April 19, 2012 and July 12, 2012 were issued outside the usual course of professional practice. GE 24, at 13. The Expert set forth multiple reasons for his conclusion.17

    17 Earlier in his declaration, the Expert explained with respect to the individuals whose charts he reviewed, that Respondent “provided them with prescriptions for controlled substances in contravention of the standards of care and practice in the State of Florida and with indifference to various indicators or `red flags' that the patients were engaged in drug abuse and/or diversion.” GE 24, at 6.

    First, he found that “the medical history and physical examinations [were] inadequate and that it was not reasonable for Registrant to rely on the evaluations of other providers at” PBM. Id. He further found that Respondent “failed to conduct an adequate physical examination or take a satisfactory medical history of D.G.” in that “she relied on . . . superficial checklists which are insufficient for evaluating the types of complaints that D.G. communicated.” Id.

    The Expert also found that Respondent “prescribed additional narcotics without any medical justification.” Id. The Expert specifically noted that “on April 19, 2012, she added a prescription for morphine sulfate, stating that . . . D.G. needed more medication in order to continue his restaurant business and that his pain had increased at work.” Id. The Expert noted that that “[t]his contradicts statements D.G. made that same day, in which he declared he was satisfied with his current medication.” Id.

    The Expert further found that D.G.'s “records contain no evidence that [Respondent] addressed the effect of pain on D.G.'s physical and psychological function. The Expert further explained that “the checklist is devoid of any explanation for how D.G.'s pain affected his social activities, mobility, work, exercise or sleep.” Id. (citing GE 23, at 39-42, 49-52, 57-60, 62-63, 65-67).

    The Expert similarly opined that Respondent's “treatment plan was wholly inadequate and . . . consisted only of a checklist of recommendations.” Id. The Expert noted that there is no evidence that any of the recommendations were either discussed or followed. Id. He also noted that while Respondent placed a checkmark suggesting that referrals to physical therapy and other specialist physicians were part of her plan for D.G., there is no evidence “that any referrals were made.” Id. at 13-14.

    Finally, the Expert opined that Respondent “ignored numerous `red flags' for diversion.” Id. at 14. More specifically, the Expert noted that while D.G. had signed PBM's pain management agreement, in which he agreed that he would not obtain controlled substances from any other doctor, the Santa Rosa Pharmacy printout showed that he had obtained both oxycodone and alprazolam in June 2011. GE 24, at 14. Indeed, the printout showed that he had obtained controlled substances from another physician, who was located in Lake Clark Shores (which is in Palm Beach County), on multiple occasions between his visit in December 2010 and July 2011. GE 17, at 122.

    The Expert noted that on September 7, 2011, D.G. “tested positive for oxycodone despite no evidence he had received a prescription after June 2011.” GE 24, at 14. He also noted that “[o]n that date, [D.G.] denied having seen other `medicating prescribing pain doctors' and denied receiving any prescriptions from other physicians.” Id.

    Finally, the Expert noted that D.G. resided in Niceville, Florida, which is approximately 596 miles from PBM. Id. The Expert observed that “there was no information in the medical records to explain why D.G. would travel such an extraordinarily long distance” to receive medical care. Id. He then concluded that “[t]hese red flags indicate . . . that Respondent failed to monitor D.G.'s compliance in medication usage and failed to give special attention to D.G., who was clearly at risk for misusing his medications and posed a risk for medication misuse and/or diversion.” Id. The Expert thus concluded that the controlled substance prescriptions Respondent issued to D.G. “lacked a legitimate medical purpose and were issued outside of the usual course of professional practice.” Id. at 15.

    Patient J.A.

    On February 28, 2011, J.A., a resident of Plantation, Florida, was initially treated at PBM by Dr. Gabriel Sanchez. GE 18, at 132-33. At his first visit, his chief complaint was nerve damage to his back and neck which had started five years earlier. Id. at 4. J.A. wrote that the inciting event was “burn + hit with pot in back,” and that his pain was an 8 “with medication” and a 10 “without medication.” Id. He also reported he had had chiropractic procedures and trigger point injections, that he had tried anti-inflammatories and Gabapentin, as well as oxycodone, methadone, Xanax and Vicodin. Id. He also indicated that he had seen other doctors for his pain. Id.

    J.A. also signed two releases for medical records. Id. at 19-20. However, while an MRI was faxed to PBM, and that MRI report even lists the name of the referring physician, J.A.'s file contains no records from that physician or any other physician who treated him. Id. at 135; see generally GE 18.

    J.A. presented an MRI report for his lumbar spine (which was done two months earlier) which showed “[m]inimal central bulges L4-5 and L5-S1 without nerve root compressions” and “[m]inimal facet and ligamentum flavum hypertrophy at the same 2 levels.” Id. at 135. He was also subjected to a urine drug test. Id. at 134.

    According to the initial evaluation form, during the neurological exam, J.A. had a positive Spurlings test bilaterally and a positive straight leg raise test bilaterally. Id. at 133. Dr. Sanchez also documented range of motion findings for both J.A.'s cervical and lumbar spine, as well as that J.A. had chronic mid-back and neck pain for 8 years and that his MRI showed disc bulges at L4-S1. Id. The only other exam findings were that J.A.'s lungs were “clear” and his extremities were “N.” Id.

    Dr. Sanchez listed his diagnosis as “Chronic Discogenic Mid Back and Neck Pain.” Id. He prescribed to J.A.: 150 Oxycodone 30 mg, 60 Methadone 10 mg, 60 Xanax 2 mg, as well as 30 Ibuprofen 800 mg, and 30 Nortryptyline 25 mg. Id. at 131-33. Other notations on the evaluation note state: “Recommend Orthopedic evaluation,” “Needs blood work” and “Needs MRI Thoracic.” Id. at 133.

    J.A. was seen monthly at PBM by Dr. Sanchez and other physicians through July 2011, and again on October 24, 2011. Id. at 98-130. At his March 29, 2011 visit, J.A. reported that his pain relief was an “8-10/10” and Dr. Sanchez reissued the same set of prescriptions. Id. at 125-27. At his April 25, 2011 visit, J.A. reported that his pain with medication was a 4; Sanchez again issued the same set of prescriptions. Id. at 121-22.

    Yet at his May 26, 2011 visit, J.A. reported that his pain level was a 10 “with medication” and either 6 or 8 “without medication.” 18 A different doctor saw J.A., noting that he was at the clinic for a follow up of chronic “lower back” pain but also noting under his Physical Exam findings that J.A. was “in no acute distress.” Id. at 113. While this physician prescribed 150 oxycodone 30, he also reduced the quantity of J.A.'s methadone prescription to 28 dosage units and his Xanax prescription to 28 one (1) mg. dosage units. Id.

    18 As to the different ratings, on the numeric pain scale J.A. circled “8” and on the “Faces Pain Rating Scale” he circled “6.” GE 18, at 114.

    On June 23, 2011, J.A. was seen by still another doctor, who noted that he complained of “constant pain upper thoracic spine” and that his pain level was “9/10.” Id. at 109. The doctor noted that J.A. had said that he had gone for an MRI of the thoracic spine but that the MRI was not in the chart. Id. As for his PE findings, the doctor noted: “neck limited motion []flexion” and “[t]enderness over most of [t]horacic [s]pine.” Id. The doctor issued J.A. prescriptions for 140 oxycodone 30 mg and 28 Xanax 1 mg, while discontinuing the methadone. Id. at 107-09.

    J.A. returned to PBM on July 21, 2011, this time listing his pain as an 8 “with medication” and a “10” without medication. Id. at 103. The examining physician documented that J.A.'s pain radiated “down the back” and was “constant [and] aching.” He also drew diagonal lines next to “Physical Therapy” and “Chiro.” Id. at 103. As for his “Pertinent Physical Findings,” he listed “L/S F30 E10,” “Rotational ROM Fair,” “Head/Toe—wnl”; it also appears that he documented a positive finding on the “SLR,” although a portion of the entry is illegible. Id. at 104. The physician listed his diagnoses as “chronic Discogenic LBP” and “Lumber Facet Syndrome.” Id. The physician issued J.A. a prescription for 160 oxycodone 30. Id. He also resumed prescribing methadone 10 (28 dosage units) and doubled the strength of the Xanax prescription to 2 mg dosage units. Id.

    J.A. did not return to PBM until October 24, 2011, three months later, when he was seen by Dr. T.R. Id. at 95. On the “Patients [sic] Follow Up Sheet,” J.A. indicated that his pain was 6 “with medication” and 10 “without medication.” Id. at 100. However, he did not indicate that the pain affected any life activities. Id. He was also subjected to a drug test, which was positive for opiates/morphine, methadone and oxycodone, id. at 43, even though he had not been at the clinic in three months and denied seeing other pain physicians who prescribed medication. Id. at 98.

    Dr. T.R. noted his “pertinent physical exam” findings as “H/T N,” “SLR—thigh pain,” and the “L/S ROM” was “F 60” and “E 20.” Id. at 99. He listed his first diagnosis as “Chronic Multifactorial LBP” and listed the factors as “Discogenic” and “Lumber Facet Syndrome”; he listed his second diagnosis as Insomnia. Id. Dr. T.R. issued J.A. prescriptions for 154 du of oxycodone 30 and 24 du of Xanax 2 mg, as well as Gabapentin and Mobic (meloxicam). Id., see also id. at 95.

    On November 21, 2011, J.A. returned to PBM and saw Respondent for the first time. Id. at 93. A “Patients [sic] Follow-Up Sheet” in the record appears to have been completed by J.A. for that visit; it is, however, dated “5/17/63”, which, according to the copy of J.A.'s Florida Identification Card in his patient file, is his date of birth. Id. at 96, see also id. at 22, 23. J.A. circled the upper back/thoracic spine as the area where he felt pain, but did not answer the questions: “Is the pain always there?” and “Does the pain get worse when you move in certain ways?” Id. at 96. He further indicated that his pain level was a 7 “with medication” and 10 “without medication” but left unanswered the remaining question whether “the pain affected [sic] any of the following: Social Activities, Work, Exercise, Mobility, Appetite and Sleep.” Id. at 96. J.A. also signed a Patient Compliance Instruction form regarding drug testing, proper use of medication, prohibitions against self-medicating, and zero tolerance for doctor shopping, trafficking, selling and distributing medications. Id. at 97.

    Respondent completed a “Pain History Follow Up” where she indicated that the location of J.A.'s pain was his lower back. Id. at 93. She also circled the word “radiation” but then wrote “none”; she also placed checkmarks indicating that his pain was severe and throbbing, and sharp, and that he had experienced the pain since 2001 when he suffered an accident noted as “burn, chef-pot hit him.” Id. Under “Co-morbidities,” Respondent checked “anxiety” and “insomnia.” Id. She noted that J.A.'s “Pain Scale off meds (0-10)” was “9-10” and that his “Pain Scale on meds (0-10)” was “5-6.” Id.

    A handwritten note “10-24 UDS + opi + mtd + oxy” also appears on this form. Id. Under “ROS,” Respondent checked “all negative unless checked,” and for the various items listed under “PE,” she placed checkmarks or scribbled on the line next to normal findings. Id.

    On the view of body diagram, Respondent circled the back of the neck and noted “full ROM”; she also circled the entire back and wrote “no obvious scars or defects,” as well as the lower back, writing “ROM WNL.” Id. She also circled the back of the knees, but made no note, and off to the side of the diagram, she wrote: “Risks discussed Sills.” Id.

    In the Neurological section, she filled in the “Yes” line for all neurological exam items indicating that there were no focal deficits, and in the Orthopedic Section, she indicated that she did a straight leg raise test which was negative for both legs. Id. And at the bottom of the form, she wrote “old records show 10 yr ago 1° burn face & neck 2° back.” Id. J.A.'s patient file includes records from the Emergency Department of the SUNY Stony Brook University Hospital from May 2001 corroborating that he was treated for burns in the upper back and posterior neck region. Id. at 90-92. Those records show, however, that J.A. was treated and discharged within three hours. Id. at 88, 92.

    On the second page of the form for this visit, Respondent handwrote “no” next to the statement: “Patient satisfied, doing well on current medication and treatment plan; pain condition stable.” Id. at 94. She then put a checkmark next to each additional Assessment line entry, including “Patient taking meds as prescribed . . . no adverse side effects, no new problems and no changes,” “Activities of living, quality of life improved with medication,” as well as those regarding the denial of drug charges or arrests, medication storage and safety issues including lock box usage, and that the “diagnosis and treatment plan are justified and based on diagnostic results, history and physical exam.” Id.

    Under the Diagnosis section, Respondent checked “Disc Bulge” and handwrote “L45/L5S1,” as well as checked “Insomnia,” “Chronic Non-Malignant Pain Syndrome” and handwrote “Ligamentum flavum,” “Neuropathic pain?” and “Facet Hypertrophy.” Id. She checked off all “discussion points” under the Plan, and circled “neurologist” on the line stating: “refer to PT, neurologist, neurosurgeon, psychiatrist, addiction specialist as needed.” Id. She also handwrote “Labs next visit” and “work—[?] w/o pain.” Id.

    In the section for listing medications and other recommendations, she checked “Roxicodone 30 mg,” circled “#140” and handwrote “wean next visit”; she also checked “Xanax” and circled “1 mg” and “#28” and handwrote “wean ↓.” Id. She checked “Gabapentin,” circled “300 mg,” handwrote “BID” and circled “#168,” and under other meds, she added “Mobic 7.5 qd.” Id. Finally, under “Radiology,” she wrote “MRI c-spine” and under “Consults,” she wrote “neurology.” Id. The Encounter Summary for this visit reflects that Respondent wrote J.A. prescriptions for 140 Roxicodone 30 mg “for pain,” 28 Xanax 1 mg “for anxiety,” as well as for 168 Gabapentin 300 mg and 28 Mobic 7.5 mg. Id. at 89.

    Respondent next saw J.A. on December 19, 2011. Id. at 86. On the “Patients [sic] Follow-Up Sheet,” J.A. circled his upper back and thoracic spine, answered “yes” to the questions: “[i]s the pain always there?” and “[d]oes the pain get worse when you move in certain ways?” Id. J.A. did not, however, circle any life activities that his “pain affected.” Id. J.A. rated his pain as a 6 “with medication” and a 10 “without medication.” Id.

    Respondent filled out the Pain History Follow Up form indicating that J.A. complained of severe lower back pain with no radiation due to burns from the 2001 incident. Id. at 84. She also indicated that J.A.'s pain was “throbbing” and “sharp” and checked “insomnia” as a co-morbidity. Id. She indicated that J.A. had not seen another pain management doctor in the past 28 days, that his quality of life was worse “Off medications” and better “On medications,” and that he had been “working more hours” since his last visit. Id. at 84. Moreover, she noted that his pain scale “off meds” was “9-10” and “on meds” was 7-8. Id.

    In the ROS (Review of Systems) section, Respondent checked the line indicating “all negative,” and in the “PE” section, she checked the box for normal findings for every item except “Ext,” which she left blank. Id. On the posterior view of the body, Respondent circled the neck (next to which she wrote “Rom” followed by undecipherable scribble), the lower back (next to which she wrote “Ext 10 Flex 90”) and knees (next to which she wrote “Reflexes' followed by more scribble); off to the side of the diagram she wrote “Risks discussed.” Id. Finally, Respondent checked “yes” for each of the items listed under “Neurological,” thus indicating that there were no focal deficits, and indicated that she did a straight leg raise test which was negative on both legs. Id.

    On Respondent's Assessment checklist, she checked all options, including “Patient satisfied, doing well on current medication and treatment plan; pain condition stable” and “Activities of living, quality of life improved with medication.” Id. at 85. Under Diagnosis, Respondent checked “Cervicalgia,” “Disc Bulge” and wrote “L45/L51,” “Insomnia,” “Chronic Non-Malignant Pain Syndrome,” and under “Other, ” she added “Ligamentum Flavum,” “Needs neuro consult,” “Ligamentum [illegible] hypertrophy,” and “Facet Hypertrophy.” Id.

    Under Plan, she again checked “refer to PT, neurologist, neurosurgeon . . . as needed, circling “neurologist.” Id. She also placed checks marks next to multiple items, including “urine tox screen twice a year or as needed to monitor addiction/diversion.” Id. She also wrote “next time LABS,” “Plan on wean next visit,” “Couldn't get MRI—cspine → will get after holiday.” Id. On the line for consults, she wrote “neurology after 1-1-12” and “Pt. advised if no MRI + neuro consult by Feb—2011 cannot cont meds.” Id.

    As for the prescriptions, Respondent circled “Roxicodone 30 mg” and “#140,” “Xanax,” “1mg” and “#28, after which she wrote “wean more next visit.” Id. She also circled Gabapentin, and noted “Mobic 7.5 #35” under “Other Meds.” Id. The Encounter Summary for this visit reflects that she issued these four prescriptions to J.A. Id. at 82.

    On January 16, 2012, J.A. returned to PBM and again saw Respondent. Id. at 75. He again completed the “Patients [sic] Follow-Up Sheet” exactly as he did as at the previous visit, circling the upper back/thoracic spine on the body diagram, did not circle any life activities that were affected by his pain, and circled 6 for his pain “with medication” and 10 for “without medication.” Id. at 80.

    Respondent filled in the Pain History Section, on which she again indicated that J.A.'s pain was in his lower back, that it was severe, throbbing, and sharp, but did not radiate. Id. at 76. She checked insomnia as a co-morbidity. Id. And under “New Events since Last Visit,” she noted: “Lost Xanax & Gabapentin script.” Id.

    In the ROS section, she again noted that all systems were negative, and in the PE section, she drew either checkmarks or lines next to the normal findings for each of the various items. Id. And next to one of the body diagrams, she circled the neck (noting “rotation 45,” “Flex 45”and “Ext 5,”), the lower back (noting “Ext 10” and Flex 90”), and knees (noting “Reflexes +2”); she also noted “Risks discussed.” Id. In the Neurological section, she checked yes for each item indicating that they were normal, and in the Orthopedic section, she indicated that the straight leg raise test was negative for each leg. Id. at 77.

    In the Assessment section, she again made checkmarks next to each of the various items including that the patient was “doing well on current medication and treatment plan” and that the “Activities of living, quality of life improved with medication.” Id. Under Diagnosis, she checked “Cervicalgia,” “Disc Bulge” writing “L4/5L5S1,” “Insomnia,” “Chronic Non_malig Pain Syndrome,” and “Other,” after which she wrote “Ligamentum Flavum Hypertrophy,” “neuropath,” and “old burns on back.” Id.

    Under Plan, Respondent placed markings next to all but one of the line items and again circled “neurologist” in the line item regarding referrals.19 She also handwrote: “PLAN ↓ pain to cont work” at the bottom of the page. Id. at 77.

    19 Respondent did not, however, place any mark next to the line stating: “Continue meds, patient understands importance of weaning meds to minimum effective dose.”

    As for the prescriptions, Respondent checked: “Roxicodone” and circled “30 mg” and “#140.” Id. at 78. Next to the entry for Xanax, she wrote “last Xanax 2 days”; she also checked Xanax, next to which she wrote “.5,” circled “#28,” and wrote “weaning.” Id. Respondent noted that she was prescribing Gabapentin and Mobic 7.5 as before. Id. She further wrote: “needs neuro consult,” “getting MRI c-spine,” and “Pt advised again if no MRI by Feb no more meds!!” and circled “Pt. advised again.” Id. The Encounter Summary for the visit reflects the prescriptions for 140 Roxicodone 30 mg and 28 Xanax .5 mg, as well as the non-controlled medications. Id. at 75. The file also includes a Referral form signed by Respondent for an MRI on J.A.'s cervical spine. Id. at 83.

    J.A.'s file contains a report (dated February 8, 2012) for an MRI on his cervical spine. Id. at 117. The report lists the following findings: a midline bulge at the C3-C4 disc “without neuroforaminal narrowing,” a minimal disc bulge at the C4-C5, a disc bulge at C5-C6 “without neuroforaminal narrowing or central spinal canal stenosis,” an “irregularity of the endplates, anterior marginal osteophytes and a posterior bulge of the disc [at C6-C7] with extension into the left neural foramen with moderate to severe left neuroforaminal narrowing and moderate right stenosis,” and a bulging disc at C7-T1 “with right stenosis.” Id.

    On February 13, 2012, J.A. returned to PBM and again saw Respondent. Id. at 73. On the “Patients [sic] Follow Up Sheet,” J.A. circled his upper back/neck as the area of his pain, indicated that the pain affecting his “mobility,” but did not answer the question: “Does the pain get worse when you move in certain ways.” Id. As at the previous visits, J.A. indicated that his pain was a “6” “with medication” and a “10” and “without medication.” Id.

    In the Pain History Follow Up section, Respondent noted the location of J.A.'s pain as both his neck and lower back, that his pain was severe, throbbing and sharp, and that the precipitating event was a “fall” and not the previously reported incident when he was hit by a pot. Id. at 67. However, Respondent indicated there were no new events since last visit. Id.

    In the ROS section, she checked the line indicating that all were negative, and in the PE section, she placed checkmarks indicating that all exam items were normal. Id. On the body diagram, she circled the neck/cervical spine region and noted “Rotation 25 L R” and “Worse,” below which she wrote “Ext: 10” and “Flex 45” and “Better.” Id. She also circled the lower back and noted range of motion findings of “Ext 10” and “Flex 90,” as well as circled the knees and wrote “Reflex +2.” Id. She further noted that that J.A.'s recent MRI showed “mild bulges C3C6,” and “severe stenosis at “C6 7” and “C7 T1.” Id. Again she wrote: “Risks discussed.” Id.

    Under Neurological, she checked “Yes” for each exam item and wrote “+ bilat hand strength =,” and under Orthopedic, she indicated that the straight leg raise test was negative for both legs. Id. at 68. Under Assessment, she checked or drew a scribble next to each line. Under Diagnosis, she checked “Cervicalgia,” “Disc Bulge” writing “L45/L5S1,” “Disc Stenosis” writing “C-spine,” “Insomnia”, “Chronic Non-Malig Pain Syndrome,” and “Other,” under which she wrote “neuropathy” and “old burns on back.” Id.

    Under Plan, she checked or drew a scribble next to each item, and added “Pt. wants neuro sx [surgical] opinion.” Id. As for the prescriptions she checked “Roxicodone 30 mg,” circled “#168,” and added the notation: “increase due to need to have ↓ pain to work as server.” Id. at 69. She checked “Xanax,” wrote “.5,” and circled “#28.” Id. She also prescribed Gabapentin and Mobic. Id. The Encounter Summary for this visit lists prescriptions for 168 Roxicodone 30 mg and 28 Xanax .5 mg, as well as the other drugs. Id. at 66.

    On March 12, 2012, J.A. returned to PBM and again saw Respondent. Id. at 59. On the “Patients [sic] Follow-Up Sheet” which accompanies the visit note,20 J.A. circled “yes” in answering the questions: “Is the pain always there?” and “Does the pain get worse when you move in certain ways?” Id. He also circled his neck, mid-back and knee area on the body diagram to indicate his pain, and noted that his Pain Intensity ratings remained at 6 “with medication” and 10 “without medication.” Id. He also left blank the question regarding what life activities are affected by his pain. Id.

    20 J.A. dated this Patient Follow Up Sheet “2/12/12.” GE 18, at 64. However, this document was placed next to the visit notes for J.A.'s visit of March 12, 2012, and the evidence shows that J.A.'s February visit occurred on February 13, 2012.

    Respondent's notes in the Pain History Follow Up section, as well as her markings in the ROS and PE sections were exactly the same as those she made at J.A.'s previous visit. Id. at 60. As for her Range of Motion findings, with respect to J.A.'s neck, she noted: “rotation 45 LR Better.” Id. However, her other Range of Motion findings for J.A.'s neck and back, as well as her reflex test findings on his knees were exactly the same as before. Id. Respondent also noted “normal hand grip” and “risks discussed.” Id. Also, as at the previous visit, in the Neurological section, Respondent checked “yes” for each of the tests thus indicating that there were no focal deficits, and in the Orthopedic section, she indicated that both straight leg raise tests were negative. Id. at 61.

    Under Assessment, Respondent again placed a mark next to each line item. Id. She also circled each of the same diagnoses as at the previous visit, adding the note “c-spine” to the diagnosis of “Disc Bulge.” Id. Under Plan, Respondent placed a mark next to each item. Id. As for the prescriptions, she issued the same prescriptions of 168 Roxicodone 30 mg and 28 Xanax .5 mg (as well as Gabapentin and Mobic) as before. Id. at 62; see also id. at 59 (Encounter Summary listing prescriptions).

    Next to the medication list, Respondent also wrote: “Goal: cont to work as chef” and “needs meds to control pain so He can work + support Kids.” Id. Yet in the Pain History Follow Up, Respondent had circled “N” (rather than “Y”) in the space for noting whether the patient had “Kids”; she also left the blank the space for listing the “Ages” of any kids. Id. at 60.

    On April 9, 2012,21 J.A. returned to PBM and again saw Respondent. Respondent's notations were the same as to the location, character, levels and precipitating event of J.A.'s pain, and the co-morbidity of insomnia. Id. at 56. So too, Respondent circled “N,” indicating that J.A. did not have kids. Id. While Respondent wrote “none” as to whether there were new events since J.A.'s last visit, she added: “Patient Had long weekend—server for High Holy Days,” below which she wrote “Risk discussed.” Id.

    21 There is no Patient Follow Up Sheet in the file which is dated April 9, 2012. There are, however, two copies of the Follow Up Sheet dated 5/7/12. GE 18 at 53, 49.

    Under ROS, Respondent again indicated that all systems were negative, and under PE, she again placed marks indicating normal findings for her PE. Id. On the body diagram, she circled the neck (writing “Rotation 25 L R more”), the lower back (writing “Ext 10” and “Flex 45”), and the knees (writing “reflex +2”). Id. Under Neurological, she checked “Yes” for each item indicating that there were no focal deficits, and under Orthopedic, she indicated that she had done a negative straight leg raise test on both legs. Id. at 57.

    As before, in the Assessment section, Respondent made a mark next to each item. Id. She also listed the diagnoses of “Cervicalgia,” “Disc Bulge” after which she wrote “C spine” and “L45/L4S1,” “Disc Stenosis” after which she wrote “Cspine,” “Insomnia,” “Chronic Non-Malig Pain Syndrome,” and “Other” after which she wrote “neuropathy 2” and “Back Burns.” Id.

    Under Plan, Respondent placed a mark next to each of the line items. Id. Respondent also wrote: “goal cont to work as chef & support kids.” Id. at 58. Respondent reissued to J.A. prescriptions for 168 Roxicodone 30 mg, 28 Xanax .5 mg, as well as Gabapentin and Mobic. Id. at 58; see also id. at 55 (Encounter Summary).

    On May 7, 2012, J.A. returned to PBM and again saw Respondent. On the “Patients [sic] Follow-Up Sheet,” J.A. circled various areas of his body where he felt pain and against rated his pain as a 6 “with medication” and a 10 “without medication.” Id. at 49. However, J.A. did not answer any of the other questions on the form. Id.

    In the Pain History Follow Up section of the visit note, Respondent made the same notations as before, with the exception of noting under “New Events,” “heavy hours server.” Id. at 46. While the body diagram is not visible on this form, in the same place where the body diagram appears on the other forms, Respondent drew three circles with arrows and noted “Rotation L 25 R 45” near the top circle, “Reflex + 2,” “Ext 10” and “Flex 90” near the middle circle, and “Reflex +2” near the bottom circle; she also noted “Hand grip + 2.” Id.

    Respondent documented the exact same findings in the Neurological and Orthopedic sections of the visit note, and placed either a checkmark of vertical line through each item in the Assessment section. Id. at 47. Under Diagnosis, Respondent added “Anxiety” and “Muscle Spasm C spine” to her previous diagnoses of “Cervicalgia,” “Disc Bulge C-Spine L45/,” “Disc Stenosis C-spine,” “Insomnia,” “Chronic Non-Malig Pain Syndrome,” and Neuropathy 2” and “Back Burn.” Id.

    As for her Plan, Respondent placed a check mark next to the line stating: “wt lost, smoking cessation, reduce salt and caffeine, F/U with PCP,” circling the latter and writing “CXR.” Id. She also placed a checkmark next to the line for various types of referrals. Id. As for the other items, she either drew a diagonal or vertical line next to the item. Id. And on the last page, Respondent indicated that she was prescribing 168 Roxicodone 30 mg and 28 Xanax .5 mg, along with Flexeril (a non-controlled muscle relaxant) and Mobic. Id. at 48. See also id. at 45 (Encounter Summary listing prescriptions).

    On June 4, 2012, J.A. returned to PBM and saw Respondent for the final time.22 On the “Patients [sic] Follow-Up Sheet,” J.A. circled the neck, upper back and right knee on the body diagram to indicate where he felt pain. Id. at 40. He again indicated that his pain was a 6 “with medication” and a 10 “without medication.” Id. J.A. did not, however, answer any of the form's other questions nor indicate if he was “satisfied with [his] current medication.” Id.

    22 When J.A. returned to PBM on June 27, 2012, he saw a different doctor.

    In the Pain History Follow Up section, Respondent noted that J.A.'s pain was in his neck and lower back, that it was throbbing but not radiating, that it was precipitated by a “fall,” but did not check whether the “[s]everity of pain” was “mild,” “moderate,” or “severe.” Id. at 37. Respondent indicated that J.A.'s pain level was at the same numeric levels (6 with medication, 10 without) as he circled on the Follow-up Sheet. Id. She again indicated “N” for whether J.A. had kids, and in the line for listing “[n]ew events,” wrote: “still very heavy hours as server.” Id.

    In the ROS section, Respondent indicated that all were negative, and in the PE section, she indicted that each item was normal. Id. On the body diagram, Respondent circled the neck (writing “Rotation R 45 L 25” and “Flex 25 Ext 10”), the lower back (writing “Ext 10 Flex 45 worse”), the right elbow (writing “Reflexes + 2 bilat), and both knees (writing “Reflex +2”). Id. Respondent also wrote: “Hand grip +2.” Id. Under Neurological, Respondent circled “yes” for each exam item thus indicating that there were no focal deficits, and under Orthopedic, she indicated a negative finding for the straight leg raise test on both legs. Id. at 38.

    Under Assessment, Respondent circled the words “Patient satisfied” and “Patient taking meds as prescribed,” and she wrote “yes” next to the line stating “[a]ctivities of living, quality of life improved with medications.” Id. She also placed check marks next to the remaining three items. Id.

    As for her Diagnosis, Respondent checked (and notated) the exact same diagnoses as she did at J.A.'s previous visit. Id. In the Plan section, Respondent either placed check marks or circled portions of each item; as with the previous visit, she circled “F/U with PCP” and wrote “needs CXR-pt advised.” Id. And at the bottom of the page, she wrote: “goal Cont to work + support family.” Id. Respondent then documented the same medications as she prescribed at the previous visit: 168 Roxicodone 30 mg, 28 Xanax .5 mg, and the non-controlled drugs Flexeril and Mobic. Id. at 39; see also id. at 30 (copies of prescriptions). J.A. also signed a Patient Compliance Instruction sheet on that visit.23 Id. at 41.

    23 The file also contains a sheet titled “June 13 2012 audit page.” GE 18, at 44. This document lists handwritten notes pertaining to the dates that MRIs and labs were ordered and received, the dates of two UDSs and the results for one of the tests, blood pressure and pulse readings at J.A.'s visits, the date records were received (which lists only the May 2001 ER records), and “Referral[s] Out.” Id.

    Notably, the Referrals included the following notes: (1) “2/28/11—recommend ortho eval,” (2) “11/21/11—consult neurology,” (3) “5/7/12—F/U—PCP needs CXR,” with an arrow pointing to (4) “6/27/12—pt broke & can't have done.” Id. Respondent's initials appear at the bottom of the page. Id.

    The Government's Expert reviewed J.A.'s patient file and found that the medical history and physical examinations of J.A. were “inadequate and that it was not reasonable for Registrant to rely on the evaluations of other providers at” PBM. GE 24, at 14. The Expert also found that Respondent “failed to conduct an adequate physical examination or take a satisfactory medical history,” noting that “she relied on the superficial checklists which are insufficient for evaluating the types of complaints that J.A. communicated.” Id. The Expert further noted that on February 13, 2012, Respondent “prescribed additional narcotics without any medical justification” when she increased J.A.'s prescription for oxycodone from 140 tablets to 168 tablets “based solely on the bald statement that the patient needed `to have less pain to work.' ” Id.

    The Expert also found that J.A.'s patient file “contain[s] no evidence that [Respondent] addressed the effect of pain on J.A.'s physical and psychological function.” Id. at 15. The Expert further explained that “that the checklist is devoid of any explanation for how J.A.'s pain affected his social activities, mobility, work, exercise or sleep.” Id.

    Next, the Expert found that Respondent's “treatment plan was wholly inadequate,” because it “consisted of only a checklist of recommendations.” Id. He further observed that J.A.'s file “is devoid of any evidence that any of the recommendations were either discussed or followed.” Id. The Expert noted that Respondent “recommended Yoga and other exercise, fish oil and glucosamine/chondroitin sulfate,” and “also stated [that] she will “refer to PT, Neurologist, neurosurgeon, orthopedist, psychiatrist, addiction specialist as needed.” Id. The Expert then explained that “[t]here is no evidence that any of these alternative measures were attempted [or] that any referrals were made.” Id. at 15.

    Finally, the Expert also found that Respondent “ignored numerous red flags for diversion” with respect to J.A. Id. These included that “J.A. tested positive for methadone even though his last prescription for methadone had been issued five months earlier,” and “that he reported that he lost his Xanax, which was not discussed or resolved in the patient file.” Id. The Expert further noted that J.A. “presented a Florida Identification card instead of a valid driver's license” and that “[t]his raises questions as to whether . . . [J.A.] obtained the cars solely for the purpose of establishing temporary residence in Florida in order to obtain controlled substances” Id. The Expert thus concluded that J.A. “was clearly at risk for misusing his medications and posed a risk for medication misuse and/or diversion” and that Respondent “failed to monitor the patient's compliance in medication usage and failed to give special attention to J.A.” Id. The Expert further concluded that the controlled substance prescriptions Respondent issued to J.A. “lacked a legitimate medical purpose and were issued outside of the usual course of professional practice.” Id. at 15.

    Patient D.B.

    Patient D.B., a 66-year-old resident of Okeechobee, Florida, first presented at PMB on January 31, 2012 with a chief complaint of back pain which started “3 yrs ago.” GE 14, at 13. D.B. noted that there was no precipitating event, and that his pain level was a 2 “with medication” and a 7 “without medication.” Id. He further noted that he had undergone chiropractic procedures and that he had tried or been on anti-inflammatories, Dilaudid, Percocet, and Xanax. Id. He answered “yes” to the question: “Have you seen any other doctors for this pain?” Id. And on an exhaustive list of “symptoms you have or have had in the past year,” D.B. checked nervousness, back and hip, high blood pressure, appendicitis, arthritis, heart disease, hepatitis, high cholesterol and a pacemaker, among other things. Id. at 15. D.B. was also subjected to a drug screen which was negative for all items tested including “Opiates/Morphine” and “Oxycodone.” Id. at 10.

    On the visit note, another physician indicated that D.B. had a three-year history of middle and lower back pain as well as right and left hip pain, that the pain was moderate, severe, sharp and tingling; the physician also noted that D.B.'s pain “off meds” was an 8 and “on meds” a 3. Id. at 31. As to co-morbidities, the physician checked anxiety and insomnia. Id. As to previous pain management treatment, the physician circled only “medication” and next to the word “PM Center,” wrote “[n]one.” Id.

    As to what made D.B.'s pain worse, the physician placed checkmarks next to “lifting,” “bending” and “sitting”; she also circled “standing.” Id. As for what made D.B.'s pain better, the physician checked only resting. Id. The physician also placed checkmarks to indicate that the pain affected D.B.'s “sleep,” “mood,” “work,” “daily activities,” “energy,” and “relationships.” Id. After checking that D.B.'s was quality of life was “worse” off medications and “better” on them, the physician circled “none” for D.B.'s history of smoking and drug use, and circled “occ” for his alcohol use. Id.

    Under current meds, the physician listed several non-controlled drugs including aspirin, Plavix, Diovan, and Amlodipine, but no controlled substances. Id. Under past imaging, the physician checked “CT,” placed a checkmark in the space for inserting the date of a lumbar scan but no date and placed a check to indicate that a thoracic spine scan had been done but left blank the date.24 Id.

    24 The physician also noted the frequency of D.B.'s visits to his primary care physician and cardiologist, as well as listed various conditions he had such as “HTN,” “COPD,” “Hx of Syncope,” and that he had a pacemaker. GE 14, at 31.

    Under ROS, the physician indicated that all were negative, and under PE, the physician indicated normal findings with the exception of “mildly obese” on the line for Abd. Id. at 32. The physician documented four Range of Motion findings (“F 60, Ext 10, RL 65 and LL 65”), documented a positive straight leg raise test on each leg, and found no focal deficits with respect to any of the neurological exam items. Id. The physician further documented that D.B. “was treated for 72 HR w/Perocet by PMD and referred to Pain Clinic for further management of pain. Was offered surgery by his Orthopod but declined for now.” Id.

    Under Assessment, the physician placed a check mark next to each item. Id. Under Diagnosis, she checked “Hypertension,” “Lumbago,” “Sciatica,” “Chronic Non-Malig Pain Syndrome,” and “Other,” next to which she wrote “Schmorl's Nodes' and “multi level osteophytes.” 25 Id. at 33. Under Plan, placed a checkmark next to each item and wrote “No NSAIDS, PT is on Plavix and ASA [aspirin].” Id. The physician also noted that she was prescribing 112 Lortab 10/500 (hydrocodone/acetaminophen). Id.; see also id. at 30 (Encounter Summary).

    25 On the Encounter Summary, the physician noted an additional diagnosis of “Insomnia due to Medical Condition Classified Elsewhere.” GE 14, at 30.

    On February 28, 2012, D.B. returned to PBM and saw the same physician. Id. at 54. D.B. noted on the “Patients [sic] Follow-Up Sheet” that his pain was always there, that it affected his social activities and sleep, that his pain was a 3 “with medication” and a 7 “without medication.” Id.

    In the Pain History section of the visit note, the physician noted that D.B.'s pain was located in his lower back and radiated, as well as in his thigh, leg and knee, that the pain was severe, and its duration was “5 yrs.” Id. at 50. The physician also noted that D.B.'s pain was precipitated by a motor vehicle accident; she also checked insomnia as a co-morbidity. Id. She further noted the same pain ratings with and without medication as D.B. had listed on the “Patients [sic] Follow-Up Sheet.” Id. As for new activities since his last visit, Respondent noted that D.B.'s pacemaker had been checked one week ago and that D.B. “says activity level has increased, less anxiety.” Id. The physician also noted that DC complained of “inadequate pain control.” Id.

    Under ROS, the physician indicated that all were negative, and under PE, the physician circled normal findings for “Heent,” “Chest,” “Cor,” “Abd,” and “Neuro/psych” but made no markings as to “Skin,' “Ext,” and “Gait.” Id. As for the Neurological exam, the physician indicated that each exam item was normal with no focal deficits. Id. However, under Orthopedic, she made no findings as to either straight leg raise tests or range of motion. Id.

    In the Assessment section, the physician left unchecked each line item, and in the Diagnosis section, the physician checked “Insomnia,” “Lumbago,” “Sciatica,” “Chronic Non-Malig Pain Syndrome,” and “Other,” next to which she wrote “Osteophytosis,” “Schmorl's nodes,” and “OA.” The physician then placed a checkmark next to each item in the Plan section and noted that she was discontinuing the Lortab and changing the prescription to 112 dosage units of Roxicodone 30 mg (one pill four times a day) “for better pain control.” Id. at 51-52. The physician also issued a prescription for 15 dosage units of Xanax 1 mg for “insomnia/anxiety,” and a prescription for 28 dosage units of Colace, a non-controlled drug, for constipation. Id. at 52; see also id. at 56 (Encounter Summary).

    On March 5, 2012, D.B. returned to PBM and saw Respondent who noted that “Pt here 2-28-12” and that he had “brought back” both the oxycodone and Xanax prescriptions because he “couldn't get scripts filled st Lucie + Okeechobee three dif pharmacies where he lived.” Id. at 57. Respondent documented that she did a PE which was comprised of a straight leg raise test which was negative, that his range of motion of his lumbar spine was 45 degree in flexion and 10 degrees in extension, and that his patella reflexes were “+2.” Id. Respondent listed diagnoses of OA (osteoarthritis), HTN (hypertension), IDDM (insulin dependent diabetes mellitus), Osteopenia, Schmorl's nodes, and Kyphosis. Id. As for her “Plan,” Respondent listed “CT Lumbar,” and “Renew meds [discontinue] oxycodone.” Id. Respondent then listed prescriptions for 112 du of Dilaudid 8 mg, 15 Xanax 1 mg, and Colace. 26 Id.

    26 The Encounter Summary shows that Respondent also prescribed Ibuprofen. GE 14, at 59.

    D.B.'s file included a report of a CT scan on his lumbar spine which was done on March 15, 2012. Id. at 58. The report lists the radiologist's impression as: “[b]ulging annuli as discussed. Prominent bulging annulus and mild lumbar spinal stenosis at L4-5. Right paracentral calcified disc protrusion/spur at the L5-S1 level.” Id.

    On March 27, 2012, D.B. returned to PBM and again saw Respondent. Id. at 64. On the “Patients [sic] Follow-Up Sheet,” D.B circled his lower back as the location of his pain, reported that the pain was always there and got worse when he moved in certain ways, and that it affected his social activities, mobility and sleep. Id. He indicated that the intensity of his pain was 4 “with medication” and 8 “without medication.” Id.

    In the visit note's Pain History Follow Up section, Respondent noted that D.B.'s lower back pain was severe, throbbing, and sharp and had been precipitated by a motor vehicle accident in 2003. Id. at 60. She checked insomnia as a co-morbidity, noted that his pain scale off meds was “8” and on meds was “4,” that his quality of life “Off medications” was “worse” and his quality of life “ON medications” was “better.” Id. Also, following the words: “Psych visits/SS Disability past 5 yr,” she circled “Y.” Id.

    Under “ROS,” she indicated that all were negative. Id. Under “PE,” she placed a variety scribbles next to each item. Id. On the body diagram, she circled the thoracic spine (writing “Kyphosis”), the lumbar spine (noting Range of Motion findings of “Ext 10 Flex 90”), and the knees (noting “reflexes +2”); she also noted “−SLR” as well as “[r]isks discussed.” Id. Also, under “Neurological,” she checked each items as normal with no focal deficits. Id. at 63.

    In the Assessment section, Respondent indicated that D.B. was “satisfied, doing well on current medication and treatment plan,” that he was “taking meds as prescribed,” that he “denied any drug charges or arrests since [his] last visit,” and that the “diagnosis and treatment plan are justified and based on diagnostic results, history and physical exam.” Id. As for her Diagnosis, Respondent checked: “Disc Protrusion” and noted “L5S1,” “Disc Stenosis” and noted “L45,” “Hypertension,” “Chronic Non-Malignant Pain Syndrome,” and under “Other,” she wrote “pacer,” “OA,” “IDDM” (diabetes) and “osteophytes.” Id.

    Under Plan, she placed check marks next to each item and handwrote “Add glucosamine/chondroitin.” Id. On the medications page, Respondent noted that “April 2 is 28 days” and that she was prescribing 112 du of Dilaudid 8mg and 15 du of Xanax 1 mg, as well as Ibuprofen 400 mg and Colace 100 mg. Id. at 62. The Encounter Summary states, however, that both the Dilaudid and Xanax prescriptions were not to be “fill[ed] before [A]pril 2, 2012.” Id. at 61.

    On April 24, 2012, D.B. returned to PBM and again saw Respondent. Id. at 70. On the “Patients [sic] Follow-Up Sheet,” D.B. circled his lower back, again indicated that his pain was “always there” and got worse when he “move[d] in certain ways,” and that it affected his Social Activities and Mobility; he also indicated that his pain was a 4 “with medication” and an 8-9 “without medication.” Id. D.B. did not, however, indicate that the pain affected his “Sleep.” He also checked that he was “satisfied with [his] current medication” and “would not like to change it,” rather than the alternative choice of “not satisfied” and “would like to discuss changes.” Id.

    In the visit note's Pain History Follow Up section, Respondent filled in the form with few changes since the last visit, except to add “anxiety” to the list of co-morbidities and noted that D.B. was “Able to fill Dilaudid.” Id. at 66. Under ROS, Respondent again indicated that all were negative, and under PE, Respondent checked or circled normal findings for each exam item. Following the words: “Psych visits/SS Disability past 5 yr,” she circled “Y.” Id.

    On the body diagram, Respondent circled the thoracic spine (writing “Kyphosis”), the lumbar spine (noting Range of Motion findings of “Flex 90” and “Ext 10”), and the knees (noting “Reflex +2”). Id. She also placed checkmarks next to each of the Neurological exam items indicating that there were no focal deficits and noted that the straight leg raise test was negative for both legs. Id. at 68.

    As for her Assessment, Respondent either checked or placed a scribble for each item, and in the Diagnosis section, Respondent checked and added each of the same conditions as before with the exception of Hypertension which she did not check. Id. at 68. Under Plan, Respondent checked or drew a vertical line next to each item and again wrote an entry for glucosamine/chondroitin. Id. As for the medications, Respondent again prescribed 112 du of Dilaudid 8 mg, noted that she was discontinuing Xanax, and added 28 Klonopin 1 mg “[e]very [e]vening at [s]leep [t]ime.” 27 Id. at 67, 69.

    27 She also noted that she was prescribing Colace and Ibuprofen, although the latter drug is not listed in the Encounter Summary. Compare GE 14, at 69, with id. at 67.

    On May 31, 2012, D.B. returned to PBM and again saw Respondent. Id. at 72. On the “Patients [sic] Follow-Up Sheet,” he again reported that the pain was “always there,” got worse when he “moved in certain ways” and affected his “[s]ocial [a]ctivities” and “[m]obility.” Id. As to the intensity of his pain, D.B. reported that it was an “8” “with medication” and a “3” “without medication.” Id. D.B., however, indicated that he was satisfied with his current medication and would not like to change it. Id.

    In the Pain History Follow Up section of the visit note, Respondent again noted that D.B. suffered from lower back pain that was throbbing and sharp, and was precipitated by a 2003 motor vehicle accident. Id. at 76. Respondent checked “anxiety” and “insomnia” as co-morbidities,” and as to D.B.'s pain level, Respondent recorded that “off meds” it was 8, and “on meds” it was “4.” Id. Following the words: “Psych visits/SS Disability past 5 yr,” she circled “Y.” Id.

    Under ROS, Respondent checked the line to indicate that all were negative, and under PE, she again placed a checkmark or scribbled over the various normal findings for each exam item. Id. On the body diagram, she again circled the thoracic spine (writing Kyphosis), the lumbar spine (noting ROM findings of “Flex 90” and “Ext 10”), and the knees (noting “Reflex +2). Id. In the Neurological section, Respondent again indicated that each item was normal with no focal deficits, and in the Orthopedic section, she indicated that the straight leg raise test was negative on each leg. Id. at 74.

    Under Assessment, Respondent either placed a checkmark or vertical line through each item. Id. As for her diagnosis, Respondent added “Anxiety” and “Insomnia” to the previous diagnoses of “Disc Protrusion L5S1,” “Disc Stenosis L45,” “Chronic Non-Malig Pain Syndrome,” and “Other,” next to which she added the same diagnoses of “OA,” “Pacer,” “IDDM,” and Osteophytes.” Id.

    As for her Plan, Respondent either made a checkmark or drew a vertical line next to each item. Id. As for the medication, she noted that she was issuing prescriptions for 112 du of Dilaudid 8 mg, 56 Klonopin 1 mg “for anxiety,” 28 Ambien .5 mg (zolpidem, a schedule IV drug) “for insomnia,” as well as Colace and Ibuprofen. Id. at 75; see also id. at 77 (Encounter Summary). Of note, the Klonopin prescription was double the quantity of previous prescription and the Ambien was a new prescription.

    On June 28, 2012, D.B. returned to PBM and again saw Respondent. Id. at 78. He again reported that his pain was “always there,” that it “got worse when [he] move[d] in certain ways,” and affected his “Social Activities” and “Mobility.” Id. D.B. reported that his pain was a “4” with medication and a “9” without medication, and that he was “satisfied” with his “current medication” and “would not like to change it.” Id.

    In the Pain History section of the visit note, Respondent again documented that D.B.'s pain was in his lower back, that it was severe and throbbing, and that it was precipitated by a 2003 motor vehicle accident. Id. at 83. She again noted co-morbidities of anxiety and insomnia, as well as that he had “psych visits/ss disability” in the past five years, that his only previous pain management treatment were “meds,” and that “lifting” and “sitting/standing in one position too long” made his pain worse, and that the pain affected his “sleep,” “mood,”, “daily activities,” and “energy,” although “sleep” made his “pain better.” Id. Respondent also noted that his pain level was 8 “off meds” (D.B. had reported it as a “9”) and a 4 “on meds.” Id. She also indicated that his “quality of life OFF medications” was “worse” and his “quality of life ON medications” was “better.” Id. She also noted that a CT exam on “3-12 [had shown] stenosis.” Id.

    Under ROS, Respondent checked that all were negative, and under Physical Exam, she circled normal findings for each item. Id. at 80. However, she also noted “+ palmar erythema.” Id. Under Neurological, Respondent found each exam item to be normal with no focal deficits. Id. Under Orthopedic, Respondent circled “+” and “30-60” degrees for the straight leg raise test on each leg; noted that D.B.'s range of motion for his lumbar spine was “45” in flexion and “10” in extension; that Compression and Valsalva tests on his cervical spine were both negative; that a Kemps test on his lumbar spine was positive on the right side; and that his gait was normal. Id.

    In the Assessment section, Respondent placed checkmarks to indicate that D.B. was satisfied and understood how to take current medication, that he would take medication as prescribed and had no side effects, that his life activities and quality of life were improved with medications, that medication storage issues were addressed, and that he lived in a stable condition with no drug related activity or persons in his home. Id. at 81. As for her diagnoses, Respondent checked anxiety, back pain, disc bulge, disc protrusion, disc stenosis, hypertension, insomnia, chronic non-malig pain syndrome, and other, under which she “pacer” and “CAD [coronary artery disease] + stent.” Id.

    Under Plan, Respondent noted that “PCP obtained/referred for . . . HTN” and “chemistry screen due from PCP.” Id. As for the medications, Respondent checked Klonopin (circling “1mg” and “#56”) and Ambien (circling “5 mg” and “#28”), as well as Colace; she also wrote 112 Dilaudid 8 mg. Id.; see also id. at 82 (copies of prescriptions); id. at 93 (Encounter Summary).

    The file also contains a release for medical records (including progress notes, a prescription profile and diagnostic reports) from a particular doctor which D.B. executed on June 28, 2012. Id. at 91. However, the release was not faxed to the other doctor until July 24, 2012. Id. at 92.

    On July 23, 2012, D.B. saw Respondent a final time. Id. at 85. On the “Patients [sic] Follow-Up Sheet,” D.B. did not answer if the pain was “always there.” Id. at 86. However, he claimed that the pain affected his “Social Activities,” “Mobility,” and “Sleep,” as well as that it got “worse when [he] move[d] in certain ways?” Id. D.B. rated his pain as a “2” with medication and “8-9” without medication. Id. He also checked that he was “satisfied with [his] current medication” and “would not like to change it.” Id.

    In the Pain History section of the progress note, Respondent noted that the pain was in D.B.'s lower back, that it was severe, throbbing, and sharp, and that it was precipitated by a 2003 motor vehicle accident. Id. She again indicated that “lifting” and “sitting, standing in one position too long” made his pain worse and that sleep made his pain better. Id. As for what the pain affected, she place checkmarks next to “sleep” and “daily activities”; she also drew short diagonal lines next to “mood” and “energy.” Id. As for D.B.'s numeric pain rating, Respondent noted “8” for “off meds” and a “4” for “on meds,” which was different than the level (2) D.B. had circled. Id. at 85. Respondent also circled “Y” for “Pysch visits/SS Disability,” and noted that D.B.'s only previous pain management treatment was “meds.” Id.

    Respondent made no checkmarks next to any of the items under ROS, and under PE, she again circled normal findings for each of the exam areas. Id. at 88. Under Neurological, Respondent circle normal findings with no focal deficits for each exam item. Id. Under Orthopedic, Respondent circled “+” and “30-60” degrees for the straight leg raise test on each leg; noted that D.B.'s range of motion for his lumbar spine was “45” in flexion and “10” in extension; that Compression and Valsalva tests on his cervical spine were both negative; that a Kemps test on his lumbar spine was positive on the right side; and that his gait was normal. Id.

    In the Assessment section, Respondent placed checkmarks to indicate that D.B. was satisfied and understood how to take current medication, that he would take medication as prescribed and “reported no side effects,” that his life activities and quality of life were improved with medications, that medication storage issues were addressed, and he lived in a stable condition with no drug related activity or persons in his home. Id. at 89. As for her diagnoses, Respondent checked anxiety, back pain, disc bulge, disc protrusion, disc stenosis, hypertension, insomnia, chronic non-malig pain syndrome, and other, under which she wrote “pacer” and “CAD [coronary artery disease] + stent.” Id.

    Under Plan, she again noted “PCP obtained/referred for . . . HTN,” as well as “chemistry screen due next visit.” Id. She again prescribed 112 du of Dilaudid 8 mg, 56 du of Klonopin 1 mg for anxiety, 28 tablets of Ambien 5 mg for insomnia, and Colace. Id. at 84, 89.

    The Expert reviewed D.B.'s patient's file and found that “the medical history and physical examinations of D.B.” that were done by the other doctor at PBM were “inadequate and that it was not reasonable to rely on [those] evaluations.'” GE 24, at 9. The Expert also found that Respondent did not “conduct[] an adequate physical examination or t[ake] a satisfactory medical history,” and that she “relied on the superficial checklists which are insufficient for evaluating the types of complaints that D.B. communicated.” Id. He found that Respondent “prescribed both clonazepam for anxiety and zolpidem for insomnia, [but] fail[ed] to record any information whatsoever to justify these prescriptions other than baldly noting that D.B. had anxiety and insomnia.” Id. The Expert also noted that on May 31, 2102, Respondent increased D.B.'s clonazepam prescription “without any justification.” Id.

    Continuing, the Expert found that Respondent's “records contain no evidence that [she] addressed the effect of pain on D.B.'s physical and psychological function,” and that “[t]he checklist is devoid of any explanation for how D.B,'s pain affected his social activities, mobility, work, exercise or sleep.” Id. He also found that Respondent's “treatment plan was wholly inadequate and, again, consisted only of a checklist of recommendations” and that there was no “evidence that any of the recommendations were either discussed or followed.” Id. The Expert also noted that while Respondent “recommended `glucosamine/Chondroitin Sulfate,' and stated that she will `refer to PT, neurologist, neurosurgeon, orthopedist, psychiatrist, psychiatrist, addiction specialist as needed[,]' [t]here is no evidence that any of these alternative measures were attempted, [or] that any referrals were made.” Id.

    The Expert further found that Respondent “ignored numerous red flags for diversion” in her treatment of D.B., who lived “approximately 95 miles from” PBM in Okeechobee, Florida. Id. at 10. The Expert specifically noted that there was “nothing in the medical file to explain why D.B. would travel so far to obtain prescriptions.” Id. He also noted that “D.B. came to [PBM] as an opiate naïve patient, having tested negative for all controlled substances on January 31, 2012, and having no prescription history.” The Expert noted that D.B. “was given a large quantity of narcotic[s]” (112 du of hydrocodone) even though at the first visit he reported that his pain level “was `2' while medicated [and] he was currently on no medication.” Id. The Expert also noted that, notwithstanding that D.B. was prescribed hydrocodone, his pain level had increased to 3, and “despite an enormous increase in the amount of opioid medication that Respondent prescribed on March 5, 2012,” when she issued him a prescription for 112 du of Dilaudid 8 mg, his pain level with medication increased yet again to 4. Id.

    The Expert further noted that D.B.'s chart contain inconsistent statements as to the duration of his pain, with D.B. reporting at his first visit (Jan 31, 2012) that he had the pain for three years, which he then changed at his second visit (Feb. 28, 2012) to five years (having been precipitated by an auto accident), only to claim at his fourth visit (Mar. 27, 2012) that it was of nine years duration. Id. And the Expert noted that when D.B. told her that he was unable to fill the oxycodone and Xanax prescriptions at a pharmacy in his home town as well as in Port St. Lucie, Respondent “failed to investigate why [he] was allegedly refused service by three different pharmacies.” Id.

    The Expert thus concluded that “these red flags indicate to me that Registrant failed to monitor the patient's compliance in medication usage and failed to give special attention to [him], who was clearly at risk for misusing his medications and posed a risk for medication misuse and/or diversion.” Id. The Expert further concluded that the controlled substance prescriptions Respondent issued to D.B. “lacked a legitimate medical purpose and were issued outside of the usual course of professional practice.” Id. at 15.

    Other Patients

    In light of my findings with respect to the UC, D.G., J.A., and D.B., I deem it unnecessary to make detailed findings with respect to the remaining patients. I note, however, that the Expert concluded that Respondent ignored numerous red flags for diversion with each of these patients, including D.H. and J.B., who lived in Panama City, Florida, more than 500 miles from PBM, as well as W.B., who resided in Southport, Florida, which is approximately 547 miles from PBM. GE 24, at 7-8, 12-13. With respect to these patients, the Expert noted that there was “no information in the medical records to explain why [they] would travel such an extraordinarily long distance to receive what amounted to be superficial, substandard medical care.” Id. at 13-14.

    With respect to each of the seven chart review patients, the Expert opined that Respondent “repeatedly ignored readily identifiable red flags (aberrant behaviors) and continued to issue prescriptions for controlled substances despite unresolved red flags for abuse and/or diversion.” Id. at 15. The Expert also opined that Respondent “failed to prescribe in accordance with the level of care, skill and treatment recognized by a reasonably prudent physician under similar circumstances.” Id.

    Summing up, the Expert concluded that Respondent:

    failed to conduct a complete medical history and examination proportionate to the diagnosis that justified the treatment she provided. She failed to adequately document the (1) nature and intensity of the pain; (2) current and past treatments for pain; (3) underlying or coexisting disease and conditions; (4) the effect of pain on the patients' physical and psychological function. [She] failed to perform an adequate review of previous medical records, previous diagnostic studies, and each patient's history of alcohol and/or substance abuse. [She] failed to develop a written plan for assessing each patient's risk for aberrant drug-related behavior and monitor that risk. [She] failed to document an individualized treatment plan containing objectives to be used to determine treatment success . . . [and] failed to (1) adjust the drug therapy to the individual needs of the patient; (2) consider another's treatment modalities other than prescriptions for controlled substances; and (3) discuss the risk of abuse and addiction, as well as physical dependence and its consequences. Id. at 15-16. Discussion

    Section 304(a) of the Controlled Substances Act (CSA) provides that a registration to “dispense a controlled substance * * * may be suspended or revoked by the Attorney General upon a finding that the registrant * * * has committed such acts as would render his registration under section 823 of this title inconsistent with the public interest as determined under such section.” 21 U.S.C. 824(a)(4). With respect to a practitioner, the Act requires the consideration of the following factors in making the public interest determination:

    (1) The recommendation of the appropriate State licensing board or professional disciplinary authority.

    (2) The applicant's experience in dispensing * * * controlled substances.

    (3) The applicant's conviction record under Federal or State laws relating to the manufacture, distribution, or dispensing of controlled substances.

    (4) Compliance with applicable State, Federal, or local laws relating to controlled substances.

    (5) Such other conduct which may threaten the public health and safety. Id. § 823(f).

    “These factors are * * * considered in the disjunctive.” Robert A. Leslie, M.D., 68 FR 15227, 15230 (2003). I “may rely on any one or a combination of factors, and may give each factor the weight [I] deem[ ] appropriate in determining whether a registration should be revoked.” Id.; see also Volkman v. DEA, 567 F.3d 215, 222 (6th Cir. 2009). While I must consider each factor, I am “not required to make findings as to all of the factors.” Volkman, 567 F.3d at 222; see also Hoxie v. DEA, 419 F.3d 477, 482 (6th Cir. 2005); see also Morall v. DEA, 412 F.3d 165, 173-74 (D.C. Cir. 2005).

    “In short, this is not a contest in which score is kept; the Agency is not required to mechanically count up the factors and determine how many favor the Government and how many favor the registrant. Rather, it is an inquiry which focuses on protecting the public interest; what matters is the seriousness of the registrant's or applicant's misconduct.” Jayam Krishna-Iyer, 74 FR 459, 462 (2009). Accordingly, as the Tenth Circuit has recognized, findings under a single factor can support the revocation of a registration. MacKay v. DEA, 664 F.3d 808, 821 (10th Cir. 2011).

    The Government has the burden of proof. See 21 CFR 1301.44(e). Moreover, even where a Respondent waives her right to a hearing, the Government must provide substantial evidence to support the allegations and its proposed sanction. Gabriel Sanchez, 78 FR 59060, 59063 (2013).

    The Government contends that the evidence with respect to Factors Two, Four, and Five establishes that Respondent's registration is inconsistent with the public interest and should be revoked.28 Specifically, it argues that Respondent prescribed controlled substances to the UC and at least seven other patients without a legitimate medical purpose and/or outside the usual course of professional practice, and that she issued prescriptions without medical justification, without proper examinations, and in violation of both state and Federal law.

    28 As to Factor One, while Respondent is currently prohibited from practicing medicine, this is not the result of action taken by the Florida Board of Medicine but a condition of bail imposed by the Broward County Court. See Respondent's Motion for Extension of Time Pursuant to 21 CFR 1316.47(b). Moreover, there is no evidence that the Florida Department of Health has either made a recommendation to the Agency with respect to Respondent, or taken any disciplinary action against Respondent. See 21 U.S.C. 823(f)(1).

    However, even assuming that Respondent currently possesses authority to dispense controlled substances under Florida law and thus meets this requirement for maintaining her registration, see Frederic Marsh Blanton, 43 FR 27616 (1978), this finding is not dispositive of the public interest inquiry. Cf. Mortimer Levin, 57 FR 8680, 8681 (1992) (“[T]he Controlled Substances Act requires that the Administrator . . . make an independent determination [from that made by state officials] as to whether the granting of controlled substance privileges would be in the public interest.”). Accordingly, this factor is not dispositive either for, or against, the Government's proposed sanction of revocation. Paul Weir Battershell, 76 FR 44359, 44366 (2011) (citing Edmund Chein, 72 FR 6580, 6590 (2007), pet. for rev. denied, Chein v. DEA, 533 F.3d 828 (D.C. Cir. 2008)).

    As to Factor Three, there is no evidence that Respondent has been convicted of an offense under either federal or Florida law “relating to the manufacture, distribution or dispensing of controlled substances.” 21 U.S.C. 823(f)(3). However, there are a number of reasons why even a person who has engaged in criminal misconduct may never have been convicted of an offense under this factor, let alone prosecuted for one. Dewey C. MacKay, 75 FR 49956, 49973 (2010), pet. for rev. denied, MacKay v. DEA, 664 F.3d 808 (10th Cir. 2011). The Agency has therefore held that “the absence of such a conviction is of considerably less consequence in the public interest inquiry” and is therefore not dispositive. Id.

    Factors Two and Four—Respondent's Experience in Dispensing Controlled Substances and Record of Compliance With Applicable Controlled Substance Laws

    Under a longstanding DEA regulation, a prescription for a controlled substance is not “effective” unless it is “issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.” 21 CFR 1306.04(a). This regulation further provides that “an order purporting to be a prescription issued not in the usual course of professional treatment . . . is not a prescription within the meaning and intent of [21 U.S.C. 829] and . . . the person issuing it, shall be subject to the penalties provided for violations of the provisions of law related to controlled substances.” Id.; see also Fla. Stat. § 893.05(1) (“A practitioner, in good faith and in the course of his or her professional practice only, may prescribe . . . a controlled substance[.]”); id. § 893.13(1)(a) (rendering it “unlawful for any persons to sell, manufacture, or deliver . . . a controlled substance” except as authorized by the Florida Comprehensive Drug Abuse Prevention and Control Act, Fla. Stat. §§ 893.01 et seq.); id. § 458.331(q) (providing that prescribing “any controlled substance, other than in the course of the physician's professional practice,” is grounds for “disciplinary action”).29

    29 Florida law defines the term “prescription” to mean, in relevant part, “an order for drugs . . . written, signed, or transmitted by word of mouth, telephone, telegram, or other means of communication by a duly licensed practitioner licensed by the laws of the state to prescribe such drugs . . . issued in good faith and in the course of professional practice.” Fla. Stat. § 893.02(22).

    As the Supreme Court has explained, “the prescription requirement . . . ensures patients use controlled substances under the supervision of a doctor so as to prevent addiction and recreational abuse. As a corollary, [it] also bars doctors from peddling to patients who crave the drugs for those prohibited uses.” Gonzales v. Oregon, 546 U.S. 243, 274 (2006) (citing United States v. Moore, 423 U.S. 122, 135, 143 (1975)); United States v. Alerre, 430 F.3d 681, 691 (4th Cir. 2005), cert. denied, 574 U.S. 1113 (2006) (prescription requirement stands as a proscription against doctors acting not “as a healer[,] but as a seller of wares”).

    Under the CSA, it is fundamental that a practitioner must establish and maintain a legitimate doctor-patient relationship in order to act “in the usual course of . . . professional practice” and to issue a prescription for a “legitimate medical purpose.” Paul H. Volkman, 73 FR 30629, 30642 (2008), pet. for rev. denied, 567 F.3d 215, 223-24 (6th Cir. 2009); see also Moore, 423 U.S. at 142-43 (noting that evidence established that the physician exceeded the bounds of professional practice, when “he gave inadequate physical examinations or none at all,” “ignored the results of the tests he did make,” and “took no precautions against . . . misuse and diversion”). The CSA, however, generally looks to state law to determine whether a doctor and patient have established a legitimate doctor-patient relationship. Volkman, 73 FR 30642.

    By regulation, the Florida Board of Medicine has adopted “Standards for the Use of Controlled Substances for the Treatment of Pain.” Fla. Admin. Code r. 64B8-9.013. The Board has explained that these “standards are not intended to define complete or best practice, but rather to communicate what the Board considers to be within the boundaries of professional practice.” Id. r.64B8-9.013(1)(g) (2011-2012). At the time of the events at issue here, the Board's standards provided as follows:

    (a) Evaluation of the Patient. A complete medical history and physical examination must be conducted and documented in the medical record. The medical record shall document the nature and intensity of the pain, current and past treatments for pain, underlying or coexisting diseases or conditions, the effect of the pain on physical and psychological function, and history of substance abuse. The medical record also shall document the presence of one or more recognized medical indications for the use of a controlled substance.

    (b) Treatment Plan. The written treatment plan shall state objectives that will be used to determine treatment success, such as pain relief and improved physical and psychosocial function, and shall indicate if any further diagnostic evaluations or other treatments are planned. After treatment begins, the physician shall adjust drug therapy, if necessary, to the individual medical needs of each patient. Other treatment modalities or a rehabilitation program may be necessary depending on the etiology of the pain and the extent to which the pain is associated with physical and psychosocial impairment.

    (c) Informed Consent and Agreement for Treatment. The physician shall discuss the risks and benefits of the use of controlled substances with the patient, persons designated by the patient, or with the patient's surrogate or guardian if the patient is incompetent. The patient shall receive prescriptions from one physician and one pharmacy where possible. If the patient is determined to be at high risk for medication abuse or have a history of substance abuse, the physician shall employ the use of a written agreement between physician and patient outlining patient responsibilities, including, but not limited to:

    1. Urine/serum medication levels screening when requested;

    2. Number and frequency of all prescription refills; and

    3. Reasons for which drug therapy may be discontinued (i.e., violation of agreement).

    (d) Periodic Review. Based on the individual circumstances of the patient, the physician shall review the course of treatment and any new information about the etiology of the pain. Continuation or modification of therapy shall depend on the physician's evaluation of the patient's progress. If treatment goals are not being achieved, despite medication adjustments, the physician shall reevaluate the appropriateness of continued treatment. The physician shall monitor patient compliance in medication usage and related treatment plans.

    (e) Consultation. The physician shall be willing to refer the patient as necessary for additional evaluation and treatment in order to achieve treatment objectives. Special attention must be given to those pain patients who are at risk for misusing their medications and those whose living arrangements pose a risk for medication misuse or diversion. The management of pain in patients with a history of substance abuse or with a comorbid psychiatric disorder requires extra care, monitoring, and documentation, and may require consultation with or referral to an expert in the management of such patients.

    (f) Medical Records. The physician is required to keep accurate and complete records to include, but not be limited to:

    1. The complete medical history and a physical examination, including history of drug abuse or dependence, as appropriate;

    2. Diagnostic, therapeutic, and laboratory results;

    3. Evaluations and consultations;

    4. Treatment objectives;

    5. Discussion of risks and benefits;

    6. Treatments;

    7. Medications (including date, type, dosage, and quantity prescribed);

    8. Instructions and agreements;

    9. Drug testing results; and

    10. Periodic reviews. Records must remain current, maintained in an accessible manner, readily available for review, and must be in full compliance with [Fla. Admin. Code] rule 64B8-9.003 . . . and [Fla. Stat.] Section 458.331(1)(m). . . .

    Id. r.64B8-9.013(3)(a)-(f) (2011-2012).

    The Florida Board has further explained that it “will judge the validity of prescribing based on the physician's treatment of the patient and on available documentation, rather than on the quantity and chronicity of prescribing. The goal is to control the patient's pain for its duration while effectively addressing other aspects of the patient's functioning, including physical, psychological, social, and work-related factors.” Id. r. 64B8-9.01391)(g) (2011-2012).30

    30See also Fla. Admin. Code r. 64B8-9.003(2) (“A licensed physician shall maintain patient medical records in English, in a legible manner and with sufficient detail to clearly demonstrate why the course of treatment was undertaken.”); id. r. 64B8-9.003(3) (“The medical record shall contain sufficient information to identify the patient, support the diagnosis, justify the treatment and document the course and results of treatment accurately, by including, at a minimum, patient histories; examination results; test results; records of drugs prescribed . . . . ; reports of consultations and hospitalizations; and copies of records or reports or other documentation obtained from other health care practitioners at the request of the physician and relied upon by the physician in determining the appropriate treatment of the patient.”).

    Applying the Board's standards, the Government's Expert concluded that Respondent failed to establish a sufficient doctor/patient relationship with the UC. GE 24, at 3. He further opined that the controlled substance prescriptions issued by Respondent to the UC lacked a legitimate medical purpose and were issued outside of the usual course of professional practice. Id.; see 21 CFR 1306.04(a). Indeed, with respect to the UC, there is sufficient evidence even apart from the Expert's declaration to support the conclusion that Respondent violated 21 CFR 1306.04(a) when she prescribed controlled substances to the UC. See T.J. McNichol, 77 FR 57133, 57147 (2011) (discussing cases finding violations of 21 CFR 1306.04(a), 21 U.S.C. 841, and similar state laws without requiring expert testimony), pet. for rev. denied, 537 Fed. Appx. 905 (11th Cir. 2013).

    The Expert found that Respondent failed to make “a serious inquiry into the cause of the patient's pain” and failed to take a complete medical history of the UC's pain. Id. at 3. The Expert explained that “in a valid doctor/patient relationship, a physician must inquire into whether the pain is the result of an injury or another disease process” and that this “was not sufficiently done” as Respondent's questioning was limited to determining that the UC was a stunt man and had not been in a car accident and that there was “no critical injury at all.” Id., see also GE 7, at 3 (transcript of UC's visit with Respondent on May 31, 2012.) Indeed, the evidence shows that the UC simply complained of stiffness and muscle soreness from both his work and doing “heavy squats”; he also denied having numbness or tingling in his legs. GE 7, at 3-4.

    The Expert further noted that while the UC had stated that he had seen as many as six other doctors for his pain and provided signed releases for his medical records, those records were not obtained. GE 24, at 3. According to the Expert, as part of the history, “it is important to review the records of other physicians who have treated the patient.” Id. The Expert further noted that Respondent “never inquired as to the treatment UC may have received prior to coming to [PBM]” and did not “discuss any non-narcotic treatment [he] may have received from any other doctor at PBM.” Id. at 4. Also, in his declaration, the UC stated that Respondent never asked him if he had any history of substance abuse. GE 25, at 5.

    The Expert also found that Respondent failed to conduct an adequate physical examination of the UC, noting that he “failed to demonstrate pain sufficient to justify the repeated prescribing of controlled substances, especially strong opioid medications such as” oxycodone 30 mg. GE 24, at 3. Indeed, at his first visit, the UC reported that on a scale of 0 to 10, his pain level without medication was a 2. GE 11, at 36. Yet on the visit note, Respondent indicated that the UC's pain was severe and noted that his pain level “off meds” was a 5. Id. at 33. Respondent also indicated that the UC's pain was both “throbbing” and “sharp.” Id. Yet at no point during the UC's visit did he complain of having “throbbing” or “sharp” pain. Thus, the evidence supports the conclusion that Respondent falsified the UC's medical record by documenting symptoms which the UC never complained of and a higher pain level than what the UC complained of.

    Moreover, as the video shows, Respondent's physical exam was limited to having the UC bend over; sit down and turn his head from side to side; placing a stethoscope on his chest; having him sit down, extend his legs and squeeze his calves and ask if there was any tenderness; and striking his knees with a neurologic hammer while his feet were still placed on the floor. GE 3, V-0002, at 14:14:24-14:14:35 and 14:18:34-14:19:18; see also GE 25, at 2-3. Yet the visit note includes findings based on a variety of tests which were not done including testing his cranial nerves, doing a sensory exam, testing his reflexes for both the upper and lower extremities, testing his muscle strength both upper and lower, and doing a straight leg raise test on each leg. Compare GE 11, at 33-34 (visit note), with GE 3, at V-0002, at 14:14:24-14:14:35 and 14:18:34-14:19:18. Indeed, the video shows that the various tests Respondent performed as part of the physical exam lasted less than one minute.

    The Expert also found that Respondent diagnosed Respondent as having muscle spasms, without any evidence. Indeed, the UC never complained of spasms and the video shows that Respondent never palpated the UC's lower back. Moreover, Respondent diagnosed the UC has having anxiety and issued a clonazepam prescription to treat this condition, even though the UC told Respondent that “[o]nce in a while” he would “take a little bit of Xanax to sleep,” but he thought he could “probably work without it.” GE 11, at 4, see also id. at 27, 34. Also, in his declaration, the UC stated that during his visits to PBM, he “never disclosed that [he] suffered from anxiety.” GE 25, at 3.

    The Expert concluded that Registrant “failed to determine and/or document the effect of pain on UC's physical and psychological function, [because] there is no documentation in the record to show that she made any attempt to adequately address this important standard of pain management.” GE 24, at 4.

    The Expert also found that Respondent “failed to create and/or document a sufficient treatment plan.” Id. The Expert explained that despite UC's history of treatment at PBM and receipt of “prescriptions for controlled substances on prior occasions, [Respondent] recommended no further diagnostic evaluations or other therapies.” Id. The Expert then observed that the UC's “MRI . . . failed to demonstrate serious enough pathology for him to receive the large amounts of controlled substances that were prescribed.” Id. According to the Expert, “[b]ulging discs can usually be addressed by other means such as physical therapy, exercise, work strengthening programs, abdominal core training, anti-inflammatories, and at times, injections such as nerve blocks with corticosteroids,” but that “[n]one of these options was offered or discussed by” Respondent. Id. The Expert then opined that “[i]gnoring these options constitutes an inferior, if not non-existent, treatment plan.” Id.

    The Expert also found that the transcripts and recordings of UC's visits showed that Respondent “herself doubted there was a legitimate medical need to prescribe the large amounts of opioid medications that were prescribed.” Id. As the Expert noted, during the UC's May 31, 2012 visit, Respondent told the UC that his MRI showed “ `nothing too terrible,' ” that “ `a bulge kind of doesn't mean anything' ” and that she would not `give narcotics for spasms.' ” Id. (citing GE 7, at 4-5). The Expert also observed that “[o]n the second visit, [Respondent] said she `certainly wouldn't just give pain medicines and narcotics so [his] working out is better.' ” Id. (quoting GE 9, at 5).

    The Expert also concluded that there was no legitimate medical justification for the amount of oxycodone prescribed to the UC because, prior to the May 31, 2012 visit, the UC had not been seen by a pain clinic physician since January 18, 2012, and was, in all likelihood, opiate naïve at the May 31, 2012 visit. Id. at 5. As found above, at the May 31, 2012 visit, the UC was subjected to a drug test. GE 25, at 1. However, the UC tested negative for all controlled substances including opiates/morphine, oxycodone, and benzodiazepines. GE 11, at 39. According to the Expert, “[p]rescribing 112 thirty milligram tablets of oxycodone in this instance was without medical justification and dangerous.” Id.

    With respect to the July 16, 2012 visit, the Expert noted that Respondent increased the amount of the oxycodone prescription from 112 to 140 dosage units without any medical justification. As the evidence shows and the Expert found, while the UC reported that his pain without medication was a “2,” he changed it only after being prompted by Respondent. See GE 9, at 4-5; GE 24, at 5. Also, on the “Patients [sic] Follow-Up Sheet,” the UC did not indicate that the pain affected any of the five listed activities and when Respondent asked if the pain affected his “work, sleep, mood, etc,” the UC initially answered “no” before adding that it affected his “recovery time from working out.” Compare GE 11, at 29, with GE 9, at 5. This prompted Respondent to state that “we certainly wouldn't just give pain medicines and narcotics so your [sic] working out is better,” to which the UC replied that he understood. GE 9, at 5. Thereafter, Respondent coached the UC to state that the pain affected his work.31 Id.

    31 When asked at his second visit whether the pain affected his sleep, the UC replied “Work” and he had not circled “sleep” as being affected by his pain on the “Patients [sic] Follow-Up Sheet” he filled in at this visit. GE 11, at 29. As the Expert concluded, “the record is devoid of any medical evidence justifying the need for prescribing clonazepam.” GE 24, at 6. The Expert also found that by failing to retrieve or cancel the unfilled May 31, 2012 prescription at the July 16, 2012 visit, Respondent effectively enabled the UC to obtain twice the amount as directed by the physician when she gave him a second prescription. Id.

    Respondent also falsified the medical record at this visit by indicating that the UC's pain was made worse by “sitting, standing in one position too long,” as nothing in the record shows that the UC made such a claim. GE 11, at 25. And she again falsified the medical record by documenting findings for various neurological and orthopedic examination items (including a positive straight leg raise test on his left leg) when she never performed the tests. Compare GE 11, at 26 (visit note), with GE 5, V-0003, at 15:45:36-15:46:47.

    Moreover, while looking at the UC's MRI, Respondent again noted that “bulges we don't treat” but that there was “encroachment or . . . narrowing of the disc” and that “I better put that down.” GE 9, at 8 (emphasis added). As with Respondent's coaching the UC to change both his pain rating and the type of activities that his pain affected from his answer of “working out,” this supports the inference that Respondent was looking for any justification that she could place in the chart for issuing the oxycodone prescription. Still later during the physical exam, the UC did not complain of any pain in his back but only of having tight hamstrings; he also again told Respondent that when he had back stiffness, this was caused by doing “heavy squats.” GE 9, at 12. Moreover, the UC was two weeks late for the second visit with Respondent and told her that while he had run out of medication, he was able to get some from a friend.32 Id. at 10.

    32 The Expert also cited this as evidence of Respondent's failure to properly monitor the UC's compliance with his medication usage. GE 24, at 5. According to the Expert, “before prescribing so much additional oxycodone [as she did at the July 16, 2012 visit], Respondent should have had a discussion with [UC] about his need for more medication and made specific inquiries to determine if and how [his] pain had increased.” Id. The Expert thus concluded that Respondent failed to inquire or determine whether there was a legitimate medical need for the additional medication, and failed to adjust the quantity and frequency of the dose of oxycodone according to the intensity and duration of the pain and failed to justify the additional prescription on clear documentation of unrelieved pain. Id. And the Expert concluded that the UC demonstrated he was at risk for misusing his medications and that Registrant failed to give him the special attention required. Id. The Expert also concluded “that there was serious doubt as to whether treatment goals were being achieved. Yet, there was no attempt by [Respondent] to evaluate the appropriateness of continued treatment except to increase the amount of narcotics and create a means by which [the UC] could fill his prescriptions without raising the legitimate concerns of pharmacists.” Id. at 4. The Expert opined that “there was an insufficient review of the course of treatment and the prescriptions provided by [Respondent] to [the UC] [were] inconsistent with [her] evaluation.” Id. at 4-5.

    Based on the above, I conclude that Respondent knew that the UC was not a legitimate pain patient. I further conclude that Respondent acted outside of the usual course of professional practice and lacked a legitimate medical purpose in issuing each of the controlled substance prescriptions to the UC. 21 CFR 1306.04(a).

    As for D.G., I also conclude that Respondent acted outside of the usual course of professional practice and lacked a legitimate medical purpose when she prescribed controlled substances to him. 21 CFR 1306.04(a). As found above, D.G. resided in Niceville, Florida, which is located nearly 600 miles from Respondent's clinic. Yet there is no evidence in any of D.G.'s records that Respondent inquired as to why D.G. was travelling these distances to obtain controlled substances from PBM.

    Moreover, D.G.'s chart shows that while he obtained large prescriptions for multiple controlled substances at his first two visits at PBM, he then did not return to PBM until July 2011, seven months after his previous visit. To be sure, D.G.'s file contains a pharmacy printout showing that D.G. had obtained both oxycodone and alprazolam on multiple occasions (beginning on January 20, 2011 and ending on June 9, 2011) from a different physician who was located in Palm Beach County and yet filled each of the prescriptions in Santa Rosa Beach, Florida, which is in Walton County and near Niceville. Yet D.G.'s file contains no evidence that any inquiry was made as to why D.G. had returned to PBM. Nor is there any evidence that this other physician was contacted to determine whether D.G. was still seeing him.

    While there is no evidence that D.G. obtained prescriptions at PBM at his July 6, 2011 visit, on September 7, 2011 he returned to PBM and denied having received prescription medications from other physicians as well as other sources in the last 30 days. Yet D.G. tested positive for oxycodone. Again, nothing in the chart reflects that this inconsistency was resolved. While Respondent did not treat D.G. at this visit, this information was nonetheless in his chart.

    There are likely multiple legitimate pain management practices closer to Niceville, Florida than 600 miles (the distance to PBM) or 566 miles (the distance to Lake Clark Shores, where the other prescribing physician was located). Indeed, when D.G. finally presented evidence that he had made an appointment to treat his hypertension, he made the appointment with a free clinic in Destin, Florida, which is near Niceville. Yet the pharmacy profile showed that he paid cash for every prescription. GX 17, at 120-22. Likewise, given D.G.'s positive test for oxycodone while claiming that he had not obtained prescription medications from other sources clearly shows that he was non-compliant with the Pain Management Agreement he entered at his first visit.

    I hold that the evidence that D.G. was travelling nearly 600 miles (one way) to obtain prescriptions at PBM, his disappearance for months only to later return, and his aberrant drug test (all of which are apparent in the chart) supports the conclusion that Respondent subjectively believed that there was a high probability that D.G. was either abusing controlled substances and/or diverting them to others. See JM Pharmacy Group, Inc., 80 FR 28667, 28672 (2015) (citing Global-Tech Appliances, Inc., v. SEB S.A., 563 U.S. 754, 769-70 (2011)) . As D.G.'s chart contains no evidence showing that Respondent attempted to resolve any of these issues with him, I further hold that she “deliberately failed” to acquire actual knowledge that D.G.'s purpose in seeking the prescriptions was to either abuse them or divert them to others. I thus conclude Respondent acted outside of the usual course of professional practice and lacked a legitimate medical purpose when she prescribed controlled substances to D.G. 21 CFR 1306.04(a).

    The Expert's review of D.G.'s chart buttresses this conclusion. As he explained, it was not reasonable for Respondent to rely on the evaluations done by the other providers at PBM. Indeed, at his first visit, D.G. tested negative for all drugs. As the Expert opined with respect to the UC, D.G. was likely opiate naïve. Yet Dr. Sanchez proceeded to issue D.G. prescriptions for both 150 oxycodone 30 mg and 60 oxycodone 15 mg and 60 Xanax 2 mg. This is a quantity of oxycodone even greater than the quantity Respondent prescribed to the UC at the first visit (112 du of 30 mg), which the Expert explained was without medical justification and dangerous. GE 24, at 5; see also Roxicodone: Package Insert and Label Information, Dosage Information-Initial Dosage (“Initiate treatment with ROXICODONE in a dosing range of 5 to 15 mg every 4 to 6 hours for pain). Thus, this dosage was more than 2.5 times the maximum recommended starting dose.

    Moreover, as the Roxicodone Package Insert explains, “[c]oncomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.” Id. (Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants). Yet, Dr. Sanchez also prescribed Xanax in its strongest dosage form and neither of the visit notes contains a diagnosis of anxiety or findings that would support such a diagnosis. Indeed, at D.G.'s second visit, Sanchez drew a “0” next to sleep and wrote “Ok” next to “Overall Mood.” GE 17, at 126. The willingness of Dr. Sanchez to prescribe to these drugs to an opioid naive patient strongly suggests that PBM was not a legitimate medical practice but a pill mill.

    Nor do the visit notes prepared by the other PBM physicians who prescribed to D.G. suggest otherwise. Indeed, it is telling that the pre-printed medication lists on which the PBM doctors would note the prescriptions they issued, includes only a single narcotic—Roxicodone—and only a single dosage form—30 mg—which just happens to be the strongest dosage of immediate release oxycodone available.

    Moreover, the Expert found that Respondent “failed to conduct an adequate physical examination or take a satisfactory medical history of D.G.,” in that “she relied on . . . superficial checklists which are insufficient for evaluating the types of complaints [neck and back pain] that D.G. communicated.” Id. at 13. The Expert also found that D.G.'s “records contain no evidence that [Respondent] addressed the effect of pain on D.G.'s physical and psychological function,” even though the Florida Board's rule requires that a physician document “the effect of the pain on physical and psychological function.” Fla. Admin Code r. 64B8-9.013(1)(g). As the Expert observed, “the checklist is devoid of any explanation for how D.G.'s pain affected his social activities, mobility, work, exercise or sleep.” Id. (citing GE 23, at 39-42, 49-52, 57-60, 62-63, 65-67).

    The Expert similarly found that Respondent's “treatment plan was wholly inadequate and . . . consisted only of a checklist of recommendations.” Id. The Expert noted that there is no evidence that any of the recommendations were either discussed or followed. Id. He also noted that while Respondent placed a checkmark suggesting that referrals to physical therapy and other specialist physicians were part of her plan for D.G., there is no evidence “that any referrals were made.” Id. at 13-14.

    Finally, the Expert also found that Respondent “prescribed additional narcotics without any medical justification.” Id. at 13. The Expert specifically noted that “on April 19, 2012, she added a prescription for [56 du of morphine sulfate [30 mg], stating that . . . D.G. needed more medication in order to continue his restaurant business and that his pain had increased at work.” Id. The Expert noted that “[t]his contradicts statements D.G. made that same day, in which he declared he was satisfied with his current medication.” Id. Moreover, on the “Patients [sic] Follow-Up Sheet” he completed at his April 19, 2012 visit, D.G. reported the exact same pain level with medication—“3” on a scale of 0 to 10—as he did at his previous visit. Compare GE 17, at 61, 71. D.G.'s record contains no further explanation as to how his pain at work had increased and how it affected his ability to function. See generally GE 17.

    I therefore conclude that the record supports a finding that Respondent acted outside of the usual course of professional practice and lacked a legitimate medical purpose in issuing the controlled substance prescriptions to D.G. 21 CFR 1306.04(a).

    As for J.A., the evidence shows that he tested positive for opiates/morphine, methadone, and oxycodone at his October 24, 2011 visit to PBM, which immediately preceded his first visit with Respondent (Nov. 21, 2011). Notably, J.A.'s records showed that his previous visit to PBM was three months earlier on July 22, 2011, at which he received prescriptions for oxycodone and methadone for a 28-day supply. Moreover, at the October 24, 2011 visit, J.A. denied having seen any “other medication prescribing pain docs.” GE 18, at 98. While J.A.'s drug test was clearly aberrant, the October 24, 2011 visit note contains no documentation that J.A. was questioned as to why he was positive for these drugs when he had not been to the clinic in three months and denied seeing any “other medication prescribing pain doctor doctors.”

    More importantly, in the visit note Respondent prepared for J.A.'s November 21, 2011 visit, she noted that his October 24, 2011 drug screen was positive for opiates, methadone and oxycodone, and yet there is no evidence that Respondent questioned J.A. as to why he was positive for these drugs given his absence from the clinic and his having denied seeing other pain doctors. Here again, this evidence supports a finding that Respondent was willfully blind to J.A.'s likely purpose in seeking the prescriptions. She nonetheless issued him prescriptions for 140 Roxicodone 30 mg and 28 Xanax 1 mg, the latter being prescribed for anxiety.33

    33 Respondent noted under “new events since last visit” that J.A. reported that he lost his Xanax and gabapentin prescriptions on his January 16, 2012 visit with Respondent, and Respondent again noted that he “lost Xanax 2 days” on the medications sheet. GE 18, at 76, 78. While there is no other notation by Respondent that she discussed the lost medications with J.A., she wrote him a new prescription for 28 tablets of .5 mg Xanax along with prescriptions for the other medications.

    As to the latter prescription, while Respondent checked “insomnia” but not “anxiety” as one of her diagnoses, Respondent made no findings to support either diagnosis. Indeed, on the “Patients [sic] Follow-Up Sheet,” J.A. did not circle any of the six items (which included social activities and sleep) as being affected by his pain. Moreover, the Expert found that Respondent failed to conduct an adequate physical examination or take a satisfactory medical history to properly evaluate J.A.'s complaints. GE 24, at 14. The Expert also found that J.A.'s file “contains no evidence that [Respondent] addressed the effect of pain on J.A.'s physical and psychological function.” Id. at 15.

    The Expert further found that Respondent's treatment plan was wholly inadequate. Id. Indeed, while in the Plan section of the visit note, Respondent checked the line for referrals and circled the word “neurology” to suggest that she was making such a referral, there is no evidence that any such referral was ever made or that J.A. ever went to a neurologist.34 Id. Moreover, while in the December 19, 2011 visit note, Respondent wrote that if J.A. did not obtain a “neuro” consultation “by Feb 2011” [sic], he “cannot cont. meds,” GE 18, at 85, Respondent continued to prescribe both Roxicodone 30 mg and Xanax at each of J.A.'s monthly visits which occurred through June 4, 2012. While Respondent did eventually reduce J.A.'s Xanax prescription to the .5 milligram dosage form, at no point did she make findings to support her diagnosis of anxiety or insomnia.

    34 Even at J.A.'s February 2012 visit, which purportedly was the cut-off date for him to obtain a neurological consultation, Respondent noted: “Pt. wants neuro sx [surgical] opinion.” GE 18, at 68. There is, however, no notation as to why J.A. never got this opinion in the course of his seeing Respondent.

    J.A.'s chart also states that at his first visit, the attending physician recommended that he obtain an orthopedic evaluation. GE 18, at 133. Here too, there is no evidence that J.A. ever obtained an orthopedic evaluation.

    Moreover, notwithstanding J.A.'s failure to comply with her instruction that if he did not obtain a “neuro consult” by his February visit, she would not continue the prescriptions, at the February 2012 visit, Respondent increased his Roxicodone 30 prescription to 168 dosage units. Id. at 69. On the visit note, Respondent noted: “increase due to need to have ↓pain to work as server.” Id. The Expert explained that Respondent's decision to increase the prescription was “based solely on the bald statement that the patient needed `to have less pain to work.' ” GE 24, at 14. The Expert further explained that this statement did not provide a “medical justification” to support the increase in the prescription. Id.

    Of further note, while at J.A.'s first visit to PBM in February 2011, he reported that he had previously been treated by other physicians for his pain and provided signed release forms, GE 18, at 4, 19; the only such records obtained (other than an MRI report) was for his ER visit in May 2001, a decade earlier. As the Expert explained in discussing the UC's file, “[i]n completing a sufficient medical history, it is important to review the records of other physicians who have treated the patient.” GX 24, at 3. Of further note, Respondent saw J.A. eight times over the course of seven months and yet never obtained records from treating physicians other than those who attended J.A. during the May 2001 ER visit.

    Accordingly, I find that the record supports the conclusion that Respondent acted outside of the usual course of professional practice and lacked a legitimate medical purpose in prescribing controlled substances to J.A. 21 CFR 1306.04(a).

    Turning to Respondent's prescribing to D.B., as the Expert noted, the history of the origin of his pain changed multiple time during the course of his visits to PBM. Significantly, at his initial visit, D.B. noted that his pain had started had three years earlier and he answered “No” as to whether there was “an inciting event[] (Such as a car accident).” GE 14, at 13. One month later, his pain was of five years duration and had been precipitated by a car accident. Id. at 50. And one month later, when Respondent saw him for the second time,35 the duration of his pain had increased to nine years. Id. at 60. The Expert found D.B.'s changing story regarding the origin of his pain to be highly suspicious. GE 24, at 10. And the Expert also found it suspicious that D.B. resided in Okeechobee, Florida, approximately 95 miles from PBM, and yet was travelling to PBM to obtain prescriptions. Id. As the Expert noted, there is “nothing in the medical file to explain why D.B. would travel so far to obtain [the] prescriptions.” Id. Moreover, the Expert also noted that while D.B. told Respondent that the three pharmacies would not fill the oxycodone 30 and Xanax prescriptions he obtained from a different doctor one week earlier, Respondent “also failed to investigate why [he] was allegedly refused service by” the pharmacies. Id.

    35 Respondent had seen D.B. three weeks earlier when he reported that he could not fill the oxycodone 30 and Xanax prescriptions written by another PBM doctor.

    The Expert further noted that at D.B.'s initial visit, he reported that his pain level was a 2 with medication and his drug screen results showed that he was negative for all drugs including oxycodone and opiates/morphine. GE 24, at 10; see also GE 14, at 10, 13. According to the Expert, “having tested negative for all controlled substances and having no prescription history, D.B. was an opioid naïve patient.” GE 24, at 10. While a different doctor prescribed “a large quantity of narcotics” (112 du of hydrocodone 10 mg), when D.B. returned for his second visit, he then complained of that pain level on medication had increased to “3.” Id. Moreover, even after Respondent changed his prescription to 112 Dilaudid 8 mg, which the Expert characterized as “an enormous increase in the amount of opioid medication” over his prior hydrocodone prescription, at his next visit, D.B. reported that his pain had increased to “4” with medication. Id.

    Based on the “red flags” of the distance D.B. was travelling, the changes in his story of how and when his pain originated, his story of being unable to fill the prescriptions at three different pharmacies, and his report of increasing pain levels even after being prescribed large and increasing dosages of narcotics, the Expert concluded that D.B. “was clearly at risk for misusing his medications and posed a risk for medication misuse and/or diversion” and that Respondent “failed to monitor [D.B.'s] compliance in medication usage and failed to give special attention to” him. Id.; see also Fla. Admin. Code r.64B8-9.013(1)(e). Moreover, based on these circumstances, I find that Respondent subjectively believed that there was a high probability that D.B. was seeking the medications to either abuse them or divert them to others, and deliberately failed to acquire actual knowledge of his purpose in obtaining the prescriptions.

    The Expert also found that “the medical history and physical examinations of D.B.” that were done by the other doctor at PBM were “inadequate and that it was not reasonable [for Respondent] to rely on [those] evaluations.' ” GE 24, at 9. The Expert further found that Respondent did not “conduct[ ] an adequate physical examination or t[ake] a satisfactory medical history,” and she “relied on the superficial checklists which are insufficient for evaluating the types of complaints that D.B. communicated.” Id.

    Moreover, as the Expert explained in discussing the UC, in determining a patient's pain history, “it is important to review the records of other physicians who have treated the patient.” Id. at 3. While D.B. noted on the form he completed at his first visit to PBM that he had “seen . . . other doctors for this pain,” GE 14, at 13, his file contains no records from any physician who treated him for his back pain.36 See generally GE 14.

    36 Of further note, on several progress notes, Respondent circled “Y” next to the entry for “Psych visits/SS Disability past 5 yr[s].” See GE 14, at 60 (Mar. 27 visit), 66 (April 24 visit), 76 (May 31 visit), and 83 (June 28 visit). Yet no such records are in his file.

    The Expert also found that Respondent's “records contain no evidence that [she] addressed the effect of pain on D.B's physical and psychological function,” and that “[t]he checklist is devoid of any explanation for how D.B,'s pain affected his social activities, mobility, work, exercise or sleep.” GE 24, at 9. The Expert further found that Respondent “prescribed both clonazepam for anxiety and zolpidem for insomnia, [but] fail[ed] to record any information whatsoever to justify these prescriptions other than baldly noting that D.B. had anxiety and insomnia.” Id. The Expert also noted that on May 31, 2012, Respondent increased D.B.'s clonazepam prescription “without any justification.” Id.

    With respect to Respondent's treatment plan, the Expert found that it “was wholly inadequate and, again, consisted only of a checklist of recommendations,” and that there was no “evidence that any of the recommendations were either discussed or followed.” Id. The Expert also noted that while Respondent “recommended `glucosamine/Chondroitin Sulfate,' and stated that that she will `refer to PT, neurologist, neurosurgeon, orthopedist, psychiatrist, psychiatrist, addiction specialist as needed[,]' [t]here is no evidence that any of these alternative measures were attempted, [or] that any referrals were made.” Id.

    Based on the above, I conclude that Respondent acted outside of the usual course of professional practice and lacked a legitimate medical purpose when she prescribed controlled substances to D.B. Indeed, with respect to D.G., J.A., and D.B., the Expert concluded that Respondent “provided them with prescriptions for controlled substances in contravention of the standards of care and practice in the State of Florida and with indifference to various indicators or `red flags' that the patients were engaged in drug abuse and/or diversion.” Id. at 6.

    Factor Five—Such Other Conduct Which May Threaten Public Health and Safety

    The Government argues that Respondent's acts in providing the UC with two Ibuprofen prescriptions to help him fill his controlled substance prescriptions without suspicion constitute conduct to be considered under Factor Five (such other conduct which may threaten the public health and safety). RFAA, at 19. It contends there is “a substantial relationship between the conduct and the CSA's purpose of preventing drug abuse and diversion.” Id. (citing Zvi H. Perper, M.D., 77 FR 64131, 64141 (2012) (quoting Tony T. Bui, 75 FR 49979, 49988 (2010))).

    In Perper, the Agency adopted the ALJ's legal conclusion that the act of providing a prescription for a non-controlled drug such as Ibuprofen so as not to arouse a pharmacist's suspicion as to the legality of a controlled substance prescription and induce him to fill the prescription constitutes actionable misconduct under Factor Five. See 77 FR at 64141. Such conduct is, in essence, a form of subterfuge, and may threaten public health and safety by inducing a pharmacist into believing a controlled substance prescription is lawful rather than questioning its validity and refusing to fill it. Cf. 21 U.S.C. 843(a)(3) (“It shall be unlawful for any person knowingly or intentionally . . . to acquire or obtain possession of a controlled substance by misrepresentation, fraud, forgery, deception, or subterfuge.”).

    Here, the evidence shows that at the UC's first visit, Respondent told him that she “was gonna [sic] give you some ibuprofen. Because if you['re] filling in Florida which I encourage you to do so you're on the computer list. Then . . . for two reasons: Number one, the pharmacists usually want a non-prescription drug, a non-controlled substance drug rather . . . and ibuprofen is also good for inflammation.” GE 7, at 6.

    At his second visit, the UC told Respondent that a pharmacist refused to fill the Klonopin prescription she had issued previously. GE 9, at 9. Respondent advised the UC to take the prescription to another pharmacy and told him that it is not doctor-shopping if the pharmacist refused to fill the prescription; she also told the UC that she would “write that [Klonopin] and I'll write another non-narcotic.” Id. at 10. Respondent subsequently stated she would “give [the UC] two small prescriptions” for ibuprofen and “one narcotic for each pharmacy that [he] might have to go to.” Id. at 16. She added “I want you to keep the extra ibuprofen so if they won't fill the Klonopin again you have another non-narcotic to use.” Id. at 17.

    In advising the UC how to avoid encountering difficulties in filling his prescriptions for controlled substances and in issuing non-narcotic prescriptions to minimize any suspicions by pharmacists, Respondent engaged in “[s]uch other conduct which may threaten the public health and safety”). See Perper, 77 FR at 64141. Cf. Nelson A. Smith, 58 FR 65403, 65404 (1993) (holding that using strategies “to avoid detection . . . such as falsifying patients charts and suggesting that the recipients of . . . illegal prescriptions go to different pharmacies” is actionable misconduct under Factor Five).

    I therefore hold that the Government's evidence with respect to Factors Two, Four, and Five establishes that Registrant “has committed such acts as would render her registration . . . inconsistent with the public interest.” 21 U.S.C. 824(a)(4). Because Respondent waived her right to a hearing (or to submit a written statement in lieu of a hearing), there is no evidence in the record to refute the conclusion that her continued registration is “inconsistent with the public interest.” Id. Accordingly, I will order that Respondent's registration be revoked and that any pending applications be denied.

    Order

    Pursuant to the authority vested in me by 21 U.S.C. 823(f) and 824(a), as well as 28 CFR 0.100(b), I order that DEA Certificate of Registration No. AS1456361, issued to Marcia L. Sills, M.D., be, and it hereby is, revoked. I further order that any pending application of Marcia L. Sills to renew or modify the above registration, or any pending application of Marcia L. Sills for any other registration, be, and it hereby is, denied. This Order is effective September 5, 2017.

    Dated: July 27, 2017. Chuck Rosenberg, Acting Administrator.
    [FR Doc. 2017-16442 Filed 8-3-17; 8:45 am] BILLING CODE 4410-09-P
    DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. DEA-470P] Proposed Adjustments to the Aggregate Production Quotas for Schedule I and II Controlled Substances and Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2017 AGENCY:

    Drug Enforcement Administration, Department of Justice.

    ACTION:

    Notice with request for comments.

    SUMMARY:

    The Drug Enforcement Administration (DEA) proposes to adjust the 2017 aggregate production quotas for several controlled substances in schedules I and II of the Controlled Substances Act and assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine.

    DATES:

    Interested persons may file written comments on this notice in accordance with 21 CFR 1303.13(c) and 1315.13(d). Electronic comments must be submitted, and written comments must be postmarked, on or before September 5, 2017. Commenters should be aware that the electronic Federal Docket Management System will not accept comments after 11:59 p.m. Eastern Time on the last day of the comment period.

    Based on comments received in response to this notice, the Administrator may hold a public hearing on one or more issues raised. In the event the Administrator decides in his sole discretion to hold such a hearing, the Administrator will publish a notice of any such hearing in the Federal Register. After consideration of any comments or objections, or after a hearing, if one is held, the Administrator will publish in the Federal Register a final order establishing the 2017 adjusted aggregate production quotas for schedule I and II controlled substances, and an assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine.

    ADDRESSES:

    To ensure proper handling of comments, please reference “Docket No. DEA-470P” on all correspondence, including any attachments. The Drug Enforcement Administration encourages that all comments be submitted electronically through the Federal eRulemaking Portal which provides the ability to type short comments directly into the comment field on the Web page or attach a file for lengthier comments. Please go to http://www.regulations.gov and follow the online instructions at that site for submitting comments. Upon completion of your submission you will receive a Comment Tracking Number for your comment. Please be aware that submitted comments are not instantaneously available for public view on Regulations.gov. If you have received a Comment Tracking Number, your comment has been successfully submitted and there is no need to resubmit the same comment. Paper comments that duplicate electronic submissions are not necessary and are discouraged. Should you wish to mail a paper comment in lieu of an electronic comment, it should be sent via regular or express mail to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152.

    FOR FURTHER INFORMATION CONTACT:

    Michael J. Lewis, Diversion Control Division, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152, Telephone: (202) 598-6812.

    SUPPLEMENTARY INFORMATION:

    Posting of Public Comments

    Please note that all comments received in response to this docket are considered part of the public record. They will, unless reasonable cause is given, be made available by the Drug Enforcement Administration (DEA) for public inspection online at http://www.regulations.gov. Such information includes personal identifying information (such as your name, address, etc.) voluntarily submitted by the commenter.

    The Freedom of Information Act (FOIA) applies to all comments received. If you want to submit personal identifying information (such as your name, address, etc.) as part of your comment, but do not want it to be made publicly available, you must include the phrase “PERSONAL IDENTIFYING INFORMATION” in the first paragraph of your comment. You must also place all the personal identifying information you do not want made publicly available in the first paragraph of your comment and identify what information you want redacted.

    If you want to submit confidential business information as part of your comment, but do not want it to be made publicly available, you must include the phrase “CONFIDENTIAL BUSINESS INFORMATION” in the first paragraph of your comment. You must also prominently identify confidential business information to be redacted within the comment.

    Comments containing personal identifying information or confidential business information identified and located as directed above will generally be made available in redacted form. If a comment contains so much confidential business information or personal identifying information that it cannot be effectively redacted, all or part of that comment may not be made publicly available. Comments posted to http://www.regulations.gov may include any personal identifying information (such as name, address, and phone number) included in the text of your electronic submission that is not identified as directed above as confidential.

    An electronic copy of this document is available at http://www.regulations.gov for easy reference.

    Legal Authority and Background

    Section 306 of the Controlled Substances Act (CSA) (21 U.S.C. 826) requires the Attorney General to establish aggregate production quotas for each basic class of controlled substance listed in schedules I and II and for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine. The Attorney General has delegated this function to the Administrator of the DEA pursuant to 28 CFR 0.100.

    The DEA established the 2017 aggregate production quotas for substances in schedules I and II and the assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine on October 5, 2016 (81 FR 69079). That notice stipulated that, in accordance with 21 CFR 1303.13 and 1315.13, all aggregate production quotas and assessments of annual need are subject to adjustment.

    Analysis for Proposed Adjusted 2017 Aggregate Production Quotas and Assessment of Annual Needs

    The DEA proposes to adjust the established 2017 aggregate production quotas and assessment of annual needs for certain schedule I and II controlled substances, and the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine, to be manufactured in the United States in 2017 to provide for the estimated medical, scientific, research, and industrial needs of the United States, for lawful export requirements, and for the establishment and maintenance of reserve stocks. These quotas do not include imports of controlled substances for use in industrial processes.

    In determining the proposed adjustment, the Acting Administrator has taken into account the criteria in accordance with 21 CFR 1303.13 (adjustment of aggregate production quotas for controlled substances) and 21 CFR 1315.13 (adjustment of the assessment of annual needs for ephedrine, pseudoephedrine, and phenylpropanolamine). The DEA determined whether to propose an adjustment of the aggregate production quotas and assessment of annual needs for 2017 by considering: (1) Changes in the demand for that class or chemical, changes in the national rate of net disposal of the class or chemical, and changes in the rate of net disposal of the class or chemical by registrants holding individual manufacturing quotas for the class; (2) whether any increased demand for that class or chemical, the national and/or individual rates of net disposal of that class or chemical are temporary, short term, or long term; (3) whether any increased demand for that class or chemical can be met through existing inventories, increased individual manufacturing quotas, or increased importation, without increasing the aggregate production quota; (4) whether any decreased demand for that class or chemical will result in excessive inventory accumulation by all persons registered to handle that class or chemical; and (5) other factors affecting medical, scientific, research, and industrial needs in the United States and lawful export requirements, as the Acting Administrator finds relevant. These quotas do not include imports of controlled substances for use in industrial processes.

    The Acting Administrator also considered updated information obtained from 2016 year-end inventories, 2016 disposition data submitted by quota applicants, estimates of the medical needs of the United States, product development, and other information made available to the DEA after the initial aggregate production quotas and assessment of annual needs had been established. Other factors the Acting Administrator considered in calculating the aggregate production quotas, but not the assessment of annual needs, include product development requirements of both bulk and finished dosage form manufacturers, and other pertinent information. In determining the proposed adjusted 2017 assessment of annual needs, the DEA used the calculation methodology previously described in the 2010 and 2011 established assessment of annual needs (74 FR 60294, Nov. 20, 2009, and 75 FR 79407, Dec. 20, 2010, respectively).

    The Acting Administrator, therefore, proposes that the year 2017 aggregate production quotas for the nine temporarily scheduled substances be established, and to adjust the 2017 aggregate production quotas for certain schedule I and II controlled substances and assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine, expressed in grams of anhydrous acid or base, as follows:

    Basic class Established 2017 quotas
  • (g)
  • Proposed
  • Revised 2017
  • quotas
  • (g)
  • Temporarily Scheduled Substances 4-Fluoroisobutyryl fentanyl N/A 30. 5F-ADB; 5F-MDMB-PINACA (methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate) N/A 30. 5F-AMB (methyl 2-(1-(5-fluoropentyl)-1H-indazole-3-carboxamido)-3-methylbutanoate) N/A 30. 5F-APINACA; 5F-AKB48 (N-(adamantan-1-yl)-1-(5-fluoropentyl)-1H-indazole-3-carboxamide) N/A 30. ADB-FUBINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(4-fluorobenzyl)-1H-indazole-3-carboxamide) N/A 30. MDMB-CHMICA; MMB-CHMINACA (methyl 2-(1-(cyclohexylmethyl)-1H-indole-3-carboxamido)-3,3-dimethylbutanoate) N/A 30. MDMB-FUBINACA (methyl 2-(1-(4-fluorobenzyl)-1H-indazole-3-carboxamido)-3,3-dimethylbutanoate) N/A 30. Furanyl fentanyl N/A 30. U-47700 N/A 30. Schedule I 1-(1-Phenylcyclohexyl)pyrrolidine 10 no change. 1-(5-Fluoropentyl)-3-(1-naphthoyl)indole (AM2201) 30 no change. 1-(5-Fluoropentyl)-3-(2-iodobenzoyl)indole (AM694) 30 no change. 1-[1-(2-Thienyl)cyclohexyl]piperidine 15 no change. 1-Benzylpiperazine 25 no change. 1-Methyl-4-phenyl-4-propionoxypiperidine 2 no change. 2-(2,5-Dimethoxy-4-ethylphenyl)ethanamine (2C-E) 30 no change. 2-(2,5-Dimethoxy-4-methylphenyl)ethanamine (2C-D) 30 no change. 2-(2,5-Dimethoxy-4-nitro-phenyl)ethanamine (2C-N) 30 no change. 2-(2,5-Dimethoxy-4-n-propylphenyl)ethanamine (2C-P) 30 no change. 2-(2,5-Dimethoxyphenyl)ethanamine (2C-H) 30 no change. 2-(4-Bromo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25B-NBOMe; 2C-B-NBOMe; 25B; Cimbi-36) 25 no change. 2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine (2C-C) 30 no change. 2-(4-Chloro-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25C-NBOMe; 2C-C-NBOMe; 25C; Cimbi-82) 25 no change. 2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine (2C-I) 30 no change. 2-(4-Iodo-2,5-dimethoxyphenyl)-N-(2-methoxybenzyl)ethanamine (25I-NBOMe; 2C-I-NBOMe; 25I; Cimbi-5) 5 30. 2,5-Dimethoxy-4-ethylamphetamine (DOET) 25 no change. 2,5-Dimethoxy-4-n-propylthiophenethylamine 25 no change. 2,5-Dimethoxyamphetamine 25 no change. 2-[4-(Ethylthio)-2,5-dimethoxyphenyl]ethanamine (2C-T-2) 30 no change. 2-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine (2C-T-4) 30 no change. 3,4,5-Trimethoxyamphetamine 25 no change. 3,4-Methylenedioxyamphetamine (MDA) 55 no change. 3,4-Methylenedioxymethamphetamine (MDMA) 50 no change. 3,4-Methylenedioxy-N-ethylamphetamine (MDEA) 40 no change. 3,4-Methylenedioxy-N-methylcathinone (methylone) 40 no change. 3,4-Methylenedioxypyrovalerone (MDPV) 35 no change. 3-FMC; 3-Fluoro-N-methylcathinone 25 no change. 3-Methylfentanyl 2 30. 3-Methylthiofentanyl 2 30. 4-Bromo-2,5-dimethoxyamphetamine (DOB) 25 no change. 4-Bromo-2,5-dimethoxyphenethylamine (2-CB) 25 no change. 4-FMC; Flephedrone 25 no change. 4-MEC; 4-Methyl-N-ethylcathinone 25 no change. 4-Methoxyamphetamine 150 no change. 4-Methyl-2,5-dimethoxyamphetamine (DOM) 25 no change. 4-Methylaminorex 25 no change. 4-Methyl-N-methylcathinone (mephedrone) 45 no change. 4-Methyl-α-pyrrolidinopropiophenone (4-MePPP) 25 no change. 5-(1,1-Dimethylheptyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol 50 no change. 5-(1,1-Dimethyloctyl)-2-[(1R,3S)-3-hydroxycyclohexyl]-phenol (cannabicyclohexanol or CP-47,497 C8-homolog) 40 no change. 5-Fluoro-PB-22; 5F-PB-22 20 no change. 5-Fluoro-UR144, XLR11 ([1-(5-fluoro-pentyl)-1Hindol-3-yl](2,2,3,3-tetramethylcyclopropyl)methanone 25 no change. 5-Methoxy-3,4-methylenedioxyamphetamine 25 no change. 5-Methoxy-N,N-diisopropyltryptamine 25 no change. 5-Methoxy-N,N-dimethyltryptamine 25 no change. AB-CHMINACA 15 30. AB-FUBINACA 50 no change. AB-PINACA 15 30. Acetyl Fentanyl 100 no change. Acetyl-alpha-methylfentanyl 2 30. Acetyldihydrocodeine 2 30. Acetylmethadol 2 no change. ADB-PINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-pentyl-1H-indazole-3-carboxamide) 50 no change. AH-7921 30 no change. Allylprodine 2 no change. Alphacetylmethadol 2 no change. alpha-Ethyltryptamine 25 no change. Alphameprodine 2 no change. Alphamethadol 2 no change. alpha-Methylfentanyl 2 30. alpha-Methylthiofentanyl 2 30. alpha-Methyltryptamine (AMT) 25 no change. alpha-Pyrrolidinobutiophenone (α-PBP) 25 no change. alpha-Pyrrolidinopentiophenone (α-PVP) 25 no change. Aminorex 25 no change. APINCA, AKB48 (N-(1-adamantyl)-1-pentyl-1H-indazole-3-carboxamide) 25 no change. Benzylmorphine 2 30. Betacetylmethadol 2 no change. beta-Hydroxy-3-methylfentanyl 2 30. beta-Hydroxyfentanyl 2 30. beta-Hydroxythiofentanyl 30 no change. Betameprodine 2 no change. Betamethadol 4 no change. Betaprodine 2 no change. Bufotenine 3 no change. Butylone 25 no change. Butyryl fentanyl 30 no change. Cathinone 24 no change. Codeine methylbromide 5 30. Codeine-N-oxide 305 330 Desomorphine 25 no change. Diethyltryptamine 25 no change. Difenoxin 8,750 no change. Dihydromorphine 1,566,000 no change. Dimethyltryptamine 35 no change. Dipipanone 5 no change. Etorphine Zero 30. Fenethylline 5 30. gamma-Hydroxybutyric acid 56,200,000 no change. Heroin 25 45. Hydromorphinol 2 no change. Hydroxypethidine 2 no change. Ibogaine 5 30. JWH-018 and AM678 (1-Pentyl-3-(1-naphthoyl)indole) 35 no change. JWH-019 (1-Hexyl-3-(1-naphthoyl)indole) 45 no change. JWH-073 (1-Butyl-3-(1-naphthoyl)indole) 45 no change. JWH-081 (1-Pentyl-3-[1-(4-methoxynaphthoyl)]indole) 30 no change. JWH-122 (1-Pentyl-3-(4-methyl-1-naphthoyl)indole) 30 no change. JWH-200 (1-[2-(4-Morpholinyl)ethyl]-3-(1-naphthoyl)indole) 35 no change. JWH-203 (1-Pentyl-3-(2-chlorophenylacetyl)indole) 30 no change. JWH-250 (1-Pentyl-3-(2-methoxyphenylacetyl)indole) 30 no change. JWH-398 (1-Pentyl-3-(4-chloro-1-naphthoyl)indole) 30 no change. Lysergic acid diethylamide (LSD) 10 40. MAB-CHMINACA; ADB-CHMINACA (N-(1-amino-3,3-dimethyl-1-oxobutan-2-yl)-1-(cyclohexylmethyl)-1H-indazole-3-carboxamide) Zero 30. Marihuana 472,000 no change. Mecloqualone Zero 30. Mescaline 25 no change. Methaqualone 10 60. Methcathinone 25 no change. Methyldesorphine 5 no change. Methyldihydromorphine 2 no change. Morphine methylbromide 5 no change. Morphine methylsulfonate 5 no change. Morphine-N-oxide 350 no change. N,N-Dimethylamphetamine 25 no change. Naphyrone 25 no change. N-Ethyl-1-phenylcyclohexylamine 5 no change. N-Ethylamphetamine 24 no change. N-Hydroxy-3,4-methylenedioxyamphetamine 24 no change. Noracymethadol 2 no change. Norlevorphanol 52 55. Normethadone 2 no change. Normorphine 40 no change. Para-fluorofentanyl 5 25. Parahexyl 5 no change. PB-22; QUPIC 20 no change. Pentedrone 25 no change. Pentylone 25 no change. Phenomorphan 2 no change. Pholcodine 5 no change. Psilocybin 30 no change. Psilocyn 50 no change. SR-18 and RCS-8 (1-Cyclohexylethyl-3-(2-methoxyphenylacetyl)indole) 45 no change. SR-19 and RCS-4 (1-Pentyl-3-[(4-methoxy)-benzoyl]indole) 30 no change. Tetrahydrocannabinols 409,000 no change. Thiofentanyl 2 25. THJ-2201 ([1-(5-fluoropentyl)-1H-indazol-3-yl](naphthalen-1-yl)methanone) 15 30. Tilidine 25 no change. Trimeperidine 2 no change. UR-144 (1-pentyl-1H-indol-3-yl)(2,2,3,3-tetramethylcyclopropyl)methanone 25 no change. Schedule II 1-Phenylcyclohexylamine 4 no change. 1-Piperidinocyclohexanecarbonitrile 4 no change. 4-Anilino-N-phenethyl-4-piperidine (ANPP) 1,750,000 no change. Alfentanil 4,200 no change. Alphaprodine 2 no change. Amobarbital 20,100 no change. Amphetamine (for conversion) 12,000,000 no change. Amphetamine (for sale) 42,400,000 no change. Carfentanil 10 20. Cocaine 103,400 no change. Codeine (for conversion) 40,000,000 no change. Codeine (for sale) 45,000,000 no change. Dextropropoxyphene 15 35. Dihydrocodeine 281,100 422,000. Dihydroetorphine 2 no change. Diphenoxylate (for conversion) 15,000 no change. Diphenoxylate (for sale) 820,000 1,110,000. Ecgonine 99,000 no change. Ethylmorphine 2 30. Etorphine hydrochloride 32 no change. Fentanyl 1,750,000 no change. Glutethimide 2 no change. Hydrocodone (for conversion) 122,000 no change. Hydrocodone (for sale) 58,410,000 no change. Hydromorphone 5,140,800 no change. Isomethadone 4 30. Levo-alphacetylmethadol (LAAM) 3 5. Levomethorphan 10 30. Levorphanol 8,300 12,900. Lisdexamfetamine 19,000,000 no change. Meperidine 3,706,000 no change. Meperidine Intermediate-A 5 no change. Meperidine Intermediate-B 9 30. Meperidine Intermediate-C 5 no change. Metazocine 15 no change. Methadone (for sale) 23,700,000 no change. Methadone Intermediate 25,600,000 no change. Methamphetamine 1,539,100 no change. [900,000 grams of levo-desoxyephedrine for use in a non-controlled, non-prescription product; 600,000 grams for methamphetamine mostly for conversion to a schedule III product; and 39,100 grams for methamphetamine (for sale)]. Methylphenidate 73,000,000 no change. Morphine (for conversion) 27,300,000 no change. Morphine (for sale) 41,000,000 no change. Nabilone 19,000 no change. Noroxymorphone (for conversion) 17,700,000 no change. Noroxymorphone (for sale) 400,000 no change. Opium (powder) 90,000 no change. Opium (tincture) 907,200 600,000. Oripavine 22,000,000 22,700,000. Oxycodone (for conversion) 2,610,000 no change. Oxycodone (for sale) 108,510,000 no change. Oxymorphone (for conversion) 22,300,000 no change. Oxymorphone (for sale) 4,200,000 no change. Pentobarbital 27,500,000 no change. Phenazocine 5 no change. Phencyclidine 20 35. Phenmetrazine 2 25. Phenylacetone 20 40. Racemethorphan 2 5. Racemorphan 2 5. Remifentanil 3,000 no change. Secobarbital 172,002 no change. Sufentanil 4,000 no change. Tapentadol 21,000,000 no change. Thebaine 100,000,000 no change. List I Chemicals Ephedrine (for conversion) 50,000 no change. Ephedrine (for sale) 5,360,000 no change. Phenylpropanolamine (for conversion) 15,000,000 no change. Phenylpropanolamine (for sale) 8,500,000 no change. Pseudoephedrine (for conversion) 40 no change. Pseudoephedrine (for sale) 200,00,000 no change.

    The Acting Administrator further proposes that aggregate production quotas for all other schedule I and II controlled substances included in 21 CFR 1308.11 and 1308.12 remain at zero. In accordance with 21 CFR 1303.13 and 21 CFR 1315.13, upon consideration of the relevant factors, the Acting Administrator may adjust the 2017 aggregate production quotas and assessment of annual needs as needed.

    Conclusion

    After consideration of any comments or objections, or after a hearing, if one is held, the Acting Administrator will issue and publish in the Federal Register a final order establishing any adjustment of 2017 aggregate production quota for each basic class of controlled substances in schedules I and II and established assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine, 21 CFR 1303.13(c) and 1315.13(f).

    Dated: July 27, 2017. Chuck Rosenberg, Acting Administrator.
    [FR Doc. 2017-16440 Filed 8-3-17; 8:45 am] BILLING CODE 4410-09-P
    DEPARTMENT OF LABOR Office of the Secretary Agency Information Collection Activities; Submission for OMB Review; Comment Request; Claim for Continuance of Compensation ACTION:

    Notice of availability; request for comments.

    SUMMARY:

    The Department of Labor (DOL) is submitting the Office of Workers' Compensation Programs (OWCP) sponsored information collection request (ICR) revision titled, “Claim for Continuance of Compensation,” to the Office of Management and Budget (OMB) for review and approval for use in accordance with the Paperwork Reduction Act (PRA) of 1995. Public comments on the ICR are invited.

    DATES:

    The OMB will consider all written comments that agency receives on or before September 5, 2017.

    ADDRESSES:

    A copy of this ICR with applicable supporting documentation; including a description of the likely respondents, proposed frequency of response, and estimated total burden may be obtained free of charge from the RegInfo.gov Web site at http://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=201703-1240-005 (this link will only become active on the day following publication of this notice) or by contacting Michel Smyth by telephone at 202-693-4129, TTY 202-693-8064, (these are not toll-free numbers) or sending an email to [email protected]

    Submit comments about this request by mail or courier to the Office of Information and Regulatory Affairs, Attn: OMB Desk Officer for DOL-OWCP, Office of Management and Budget, Room 10235, 725 17th Street NW., Washington, DC 20503; by Fax: 202-395-5806 (this is not a toll-free number); or by email: [email protected] Commenters are encouraged, but not required, to send a courtesy copy of any comments by mail or courier to the U.S. Department of Labor-OASAM, Office of the Chief Information Officer, Attn: Departmental Information Compliance Management Program, Room N1301, 200 Constitution Avenue NW., Washington, DC 20210; or by email: [email protected]

    FOR FURTHER INFORMATION CONTACT:

    Michel Smyth by telephone at 202-693-4129, TTY 202-693-8064, (these are not toll-free numbers) or sending an email to [email protected]

    Authority:

    44 U.S.C. 3507(a)(1)(D).

    SUPPLEMENTARY INFORMATION:

    This ICR seeks approval under the PRA for revisions to the Claim for Continuance of Compensation (Form CA-12) information collection. The OWCP uses Form CA-12 to obtain information from eligible survivors receiving death benefits for an extended period of time. This information is necessary to ensure the OWCP pays accurate compensation. This information collection has been classified as a revision, because the Form CA-12 instructions and several questions have been revised and electronic submission into case records is now available.

    This information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless it is approved by the OMB under the PRA and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information that does not display a valid Control Number. See 5 CFR 1320.5(a) and 1320.6. The DOL obtains OMB approval for this information collection under Control Number 1240-0015. The DOL notes that existing information collection requirements submitted to the OMB receive a month-to-month extension while they undergo review. New requirements would only take effect upon OMB approval. For additional substantive information about this ICR, see the related notice published in the Federal Register on April 5, 2017 (82 FR 16633).

    Interested parties are encouraged to send comments to the OMB, Office of Information and Regulatory Affairs at the address shown in the ADDRESSES section within thirty (30) days of publication of this notice in the Federal Register. In order to help ensure appropriate consideration, comments should mention OMB Control Number 1240-0015. The OMB is particularly interested in comments that:

    • Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

    • Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

    • Enhance the quality, utility, and clarity of the information to be collected; and

    • Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.

    Agency: DOL-OWCP.

    Title of Collection: Claim for Continuance of Compensation.

    OMB Control Number: 1240-0015.

    Affected Public: Individuals or Households.

    Total Estimated Number of Respondents: 3,552.

    Total Estimated Number of Responses: 3,552.

    Total Estimated Annual Time Burden: 295 hours.

    Total Estimated Annual Other Costs Burden: $1,847.

    Dated: July 31, 2017. Michel Smyth, Departmental Clearance Officer.
    [FR Doc. 2017-16423 Filed 8-3-17; 8:45 am] BILLING CODE 4510-CH-P
    NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [Notice: (17-056)] Notice of Information Collection AGENCY:

    National Aeronautics and Space Administration (NASA).

    ACTION:

    Notice of information collection.

    SUMMARY:

    The National Aeronautics and Space Administration, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995.

    DATES:

    All comments should be submitted within 30 calendar days from August 4, 2017.

    ADDRESSES:

    Interested persons are invited to submit written comments regarding the proposed information collection to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 7th Street NW., Washington, DC 20543. Attention: Desk Officer for NASA.

    FOR FURTHER INFORMATION CONTACT:

    Requests for additional information or copies of the information collection instrument(s) and instructions should be directed to Frances Teel, NASA PRA Clearance Officer, NASA Headquarters, 300 E Street SW., Mail Code JF000, Washington, DC 20546, (202) 358-2225.

    SUPPLEMENTARY INFORMATION: I. Abstract

    The National Aeronautics and Space Administration (NASA) Office of Diversity and Equal Opportunity and the Office of Procurement, in accordance with Title VI of the Civil Rights Act of 1964, Title IX of the Education Amendments of 1972, Section 504 of the Rehabilitation Act of 1973, and the Age Discrimination Act of 1975, requires grant awardees to submit an assurance of non-discrimination (NASA Form 1206) as part of their initial grant application package. The requirement for assurance of nondiscrimination compliance associated with federally assisted programs is long standing, derives from civil rights implementing regulations, and extends to the grant recipient's sub-grantees, contractors, successors, transferees, and assignees. Grant selectees are required to submit compliance information triennially when their award period exceeds 36 consecutive months. This information collection will also be used to enable NASA to conduct post-award civil rights compliance reviews.

    II. Method of Collection

    Electronic.

    III. Data

    Title: NASA Assurance of Civil Rights Compliance.

    OMB Number: 2700-0148.

    Type of Review: Reinstatement without change of an existing information collection.

    Affected Public: Business, other for-profit, or not-for-profit.

    Estimated Number of Respondents: 800.

    Estimated Annual Responses: 250.

    Estimated Time per Response: 4 hours.

    Estimated Total Annual Burden Hours: 16.6.

    Estimated Total Annual Cost: $120.

    IV. Request for Comments

    Comments are invited on: (1) Whether the proposed collection of information is necessary for the proper performance of the functions of NASA, including whether the information collected has practical utility; (2) the accuracy of NASA's estimate of the burden (including hours and cost) of the proposed collection of information; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including automated collection techniques or the use of other forms of information technology.

    Comments submitted in response to this notice will be summarized and included in the request to OMB for approval of this information collection. They will also become a matter of public record.

    Frances Teel, NASA PRA Clearance Officer.
    [FR Doc. 2017-16387 Filed 8-3-17; 8:45 am] BILLING CODE 7510-13-P
    NATIONAL SCIENCE FOUNDATION Proposal Review; Notice of Meetings

    In accordance with the Federal Advisory Committee Act (Pub. L. 92-463, as amended), the National Science Foundation (NSF) announces its intent to hold proposal review meetings throughout the year. The purpose of these meetings is to provide advice and recommendations concerning proposals submitted to the NSF for financial support. The agenda for each of these meetings is to review and evaluate proposals as part of the selection process for awards. The review and evaluation may also include assessment of the progress of awarded proposals. These meetings will primarily take place at NSF's current headquarters, 4201 Wilson Blvd., Arlington, Virginia 22230 or NSF's new headquarters, 2415 Eisenhower Avenue, Alexandria, VA 22314.

    These meetings will be closed to the public. The proposals being reviewed include information of a proprietary or confidential nature, including technical information; financial data, such as salaries; and personal information concerning individuals associated with the proposals. These matters are exempt under 5 U.S.C. 552b(c), (4) and (6) of the Government in the Sunshine Act. NSF will continue to review the agenda and merits of each meeting for overall compliance of the Federal Advisory Committee Act.

    These closed proposal review meetings will not be announced on an individual basis in the Federal Register. NSF intends to publish a notice similar to this on a quarterly basis. For an advance listing of the closed proposal review meetings that include the names of the proposal review panel and the time, date, place, and any information on changes, corrections, or cancellations, please visit the NSF Web site: https://www.nsf.gov/events/advisory.jsp. This information may also be requested by telephoning, 703-292-8687.

    Dated: August 1, 2017. Crystal Robinson, Committee Management Officer.
    [FR Doc. 2017-16426 Filed 8-3-17; 8:45 am] BILLING CODE 7555-01-P
    NATIONAL SCIENCE FOUNDATION Final Environmental Impact Statement (FEIS) for the Arecibo Observatory, Arecibo, Puerto Rico AGENCY:

    National Science Foundation.

    ACTION:

    Notice of availability.

    SUMMARY:

    The National Science Foundation (NSF) announces the availability of the Final Environmental Impact Statement (FEIS) for Arecibo Observatory. This Final EIS identifies and analyzes the potential consequences of the following alternatives: Alternative 1, Collaboration with Interested Parties for Continued Science-focused Operations (Agency-preferred Alternative); Alternative 2, Collaboration with Interested Parties for Transition to Education-focused Operations; Alternative 3, Mothballing of Facilities; Alternative 4, Partial Demolition and Site Restoration; and Alternative 5, Complete Demolition and Site Restoration; and the No Action Alternative, Continued NSF Investment for Science‐focused Operations. It also proposes mitigation measures to minimize the adverse impacts from demolition or operation of the alternatives where such impacts may occur. Consultation under Section 106 of the National Historic Preservation Act (NHPA) is being conducted concurrent to the NEPA process.

    DATES:

    The National Science Foundation will execute a Record of Decision no sooner than 30 days after the date of publication of the Notice of Availability published in the Federal Register by the Environmental Protection Agency.

    ADDRESSES:

    The Final EIS is made available for public inspection on-line at www.nsf.gov/AST. A Spanish translation of the Executive Summary of the Final EIS is posted.

    A copy of the DEIS will be available for review at the following libraries in Puerto Rico:

    Biblioteca Electrónica Pública Municipal Nicolás Nadal Barreto, 210 Calle Santiago Iglesias, Arecibo, PR, Phone: (787) 878-1178 Archivo General y Biblioteca Nacional de PR, 500 Avenida Juan Ponce De León, San Juan, PR, Phone: (787) 725-1060 ext. 2001
    FOR FURTHER INFORMATION CONTACT:

    Ms. Elizabeth Pentecost, Re: Arecibo Observatory, 4201 Wilson Blvd., Room 1045, Arlington, VA 22230; [email protected]; 703-292-4907.

    SUPPLEMENTARY INFORMATION:

    The Arecibo Observatory is an NSF-owned scientific research and education facility located in Puerto Rico. In 2011, NSF awarded a Cooperative Agreement to SRI International (SRI), which together with Universities Space Research Association (USRA) and Universidad Metropolitana (UMET) formed the Arecibo Management Team to operate and maintain the Arecibo Observatory for the benefit of research communities. The initial 5-year period of performance of the Cooperative Agreement was extended 18 months, to 31 March 2018. Arecibo Observatory enables research in three scientific disciplines: space and atmospheric sciences, radio astronomy, and solar system radar studies; the last of these is largely funded through a research award to USRA from the National Aeronautics and Space Administration. An education and public outreach program complements the Arecibo Observatory scientific program. A key component of the Arecibo Observatory research facility is a 305-meter diameter, fixed, spherical reflector. Arecibo Observatory infrastructure includes instrumentation for radio and radar astronomy and ionospheric physics, office and laboratory buildings, a heavily utilized visitor and education facility, and lodging facilities for visiting scientists.

    Through a series of academic community-based and portfolio reviews, NSF identified the need to divest of several facilities from its portfolio in order to retain the balance of capabilities needed to deliver the best performance on the key science of the present decade and beyond. In 2016, NSF completed a feasibility study to inform and define options for the observatory's future disposition that would involve significantly decreasing or eliminating NSF funding of Arecibo. Concurrently, NSF sought viable concepts of operations from the scientific community via a Dear Colleague Letter NSF 16-005 (see www.nsf.gov/AST). NSF issued a Notice of Intent to prepare an EIS on May 23, 2016, held scoping meetings on June 7, 2016, and held a 30-day public comment period that closed on June 23, 2016. On September 30, 2016, NSF issued a Dear Colleague Letter NSF 16-144 (see www.nsf.gov/AST) to notify the Observatory stakeholder community that NSF intended to issue a follow-up solicitation, requesting the submission of formal proposals involving the continued operation of Arecibo Observatory to provide additional information for the decision process for the ultimate disposition of Arecibo Observatory. The solicitation (NSF 17-538) was released on January 25, 2017.

    The Draft EIS was made available for public review and comment from October 28, 2016, through December 12, 2016. The full Draft EIS was also posted on the NSF, Division of Astronomical Sciences Web site (www.nsf.gov/AST) and hard copies were delivered to local libraries. During the review period, the NSF received over 400 comments—the majority of comments were against closing the Arecibo Observatory and suggestions for what resources to include in the EIS. After considering all comments received, the NSF prepared the Final EIS. There are no substantive changes to the range of alternatives considered. Alternative 1 is identified as the “Agency-preferred Alternative.”

    Dated: August 1, 2017. Suzanne H. Plimpton, Reports Clearance Officer, National Science Foundation.
    [FR Doc. 2017-16435 Filed 8-3-17; 8:45 am] BILLING CODE 7555-01-P
    NUCLEAR REGULATORY COMMISSION [NRC-2017-0171] Evaluating Deviations and Reporting Defects and Noncompliance AGENCY:

    Nuclear Regulatory Commission.

    ACTION:

    Draft regulatory guide; request for comment.

    SUMMARY:

    The U.S. Nuclear Regulatory Commission (NRC) is issuing for public comment draft regulatory guide (DG), DG-1291, “Evaluating Deviations and Reporting Defects and Noncompliance Under 10 CFR part 21.” This DG describes methods that the NRC staff considers acceptable for complying with the provisions of the regulations.

    DATES:

    Submit comments by October 3, 2017. Comments received after this date will be considered if it is practical to do so, but the NRC is able to ensure consideration only for comments received on or before this date. Although a time limit is given, comments and suggestions in connection with items for inclusion in guides currently being developed or improvements in all published guides are encouraged at any time.

    ADDRESSES:

    You may submit comments by any of the following methods (unless this document describes a different method for submitting comments on a specified subject):

    Federal Rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2017-0171. Address questions about NRC dockets to Carol Gallagher; telephone: 301-415-3463; email: [email protected] For technical questions, contact the individuals listed in the FOR FURTHER INFORMATION CONTACT section of this document.

    Mail comments to: Cindy Bladey, Office of Administration, Mail Stop: TWFN-8-D36M, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001.

    For additional direction on accessing information and submitting comments, see “Obtaining Information and Submitting Comments” in the SUPPLEMENTARY INFORMATION section of this document.

    FOR FURTHER INFORMATION CONTACT:

    Paul Prescott, Office of New Reactors, telephone: 301-415-6263; email: [email protected], and Stephen Burton, Office of Nuclear Regulatory Research, telephone: 301-415-7000; email: [email protected] Both are staff of the U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001.

    SUPPLEMENTARY INFORMATION: I. Obtaining Information and Submitting Comments A. Obtaining Information

    Please refer to Docket ID NRC-2017-0171 when contacting the NRC about the availability of information regarding this action. You may obtain publicly-available information related to this action, by any of the following methods:

    Federal Rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2017-0171.

    NRC's Agencywide Documents Access and Management System (ADAMS): You may obtain publicly-available documents online in the ADAMS Public Documents collection at http://www.nrc.gov/reading-rm/adams.html. To begin the search, select “ADAMS Public Documents” and then select “Begin Web-based ADAMS Search.” For problems with ADAMS, please contact the NRC's Public Document Room (PDR) reference staff at 1-800-397-4209, 301-415-4737, or by email to [email protected] The DG is available in ADAMS under Accession No. ML16165A298.

    NRC's PDR: You may examine and purchase copies of public documents at the NRC's PDR, Room O1-F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852.

    B. Submitting Comments

    Please include Docket ID NRC-2017-0171 in your comment submission.

    The NRC cautions you not to include identifying or contact information that you do not want to be publicly disclosed in your comment submission. The NRC posts all comment submissions at http://www.regulations.gov as well as enters the comment submissions into ADAMS. The NRC does not routinely edit comment submissions to remove identifying or contact information.

    If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment submissions into ADAMS.

    II. Additional Information

    The NRC is issuing for public comment a draft regulatory guide in the NRC's “Regulatory Guide” series. This series was developed to describe and make available to the public information regarding methods that are acceptable to the NRC staff for implementing specific parts of the NRC's regulations, techniques that the staff uses in evaluating specific issues or postulated events, and data that the staff needs in its review of applications for permits and licenses.

    The draft regulatory guide, entitled, “Evaluating Deviations and Reporting Defects and Noncompliance Under 10 CFR part 21,” is a proposed new guide temporarily identified by its task number, DG-1291. The DG-1291 describes methods that the NRC staff considers acceptable for complying with the provisions of part 21 of title 10 of the Code of Federal Regulations (10 CFR), “Reporting of Defects and Noncompliance.”

    The DG-1291 provides licensees and applicants with formal guidance for an acceptable method of evaluating and reporting defects under 10 CFR part 21. This new guidance will aid in minimizing compliance challenges to licensees and vendors that have been identified through inspection activities. Specifically, this DG approves NRC licensees' use of a method of evaluating and reporting defects described in NEI 14-09, “Guidelines for Implementations of 10 CFR part 21 Reporting of Defects and Noncompliance,” Revision 1 (ADAMS Accession No. ML16054A825).

    III. Specific Request for Comments

    The NRC seeks comments on DG-1291, “Evaluating Deviations and Reporting Defects and Noncompliance Under 10 CFR part 21,” and requests feedback from commenters about potential regulatory positions that would: (1) Not approve alternative methods for addressing types and locations of postings required under § 21.6 of the regulations in this part, Section 206 of the Energy Reorganization Act of 1974, and the procedures adopted pursuant to the regulations in part 21; and (2) describe training that should be provided for the implementation of procedures adopted pursuant to the regulations.

    1. The Nuclear Energy Institute (NEI) developed guidance on implementing the regulatory requirements in 10 CFR part 21. The guidance is contained in NEI 14-09, “Guidelines for Implementation of 10 CFR part 21 Reporting of Defects and Noncompliance,” Revision 1 dated August 2014. The guidance in NEI 14-09 interprets NRC's regulations to allow postings to be hard copies, digital copies, or a combination of both. In addition, links to electronic postings may be identified on “sites” commonly frequented by workers during the performance of work subject to 10 CFR part 21.

    The staff position regarding electronic versions of the documents required by 10 CFR part 21 was provided in “NRC Responses to 10 CFR part 21 and Fuel Cycle Facility Questions Received during the Vendor Workshop on New Reactor Construction,” in December 2008 (ADAMS Accession No. ML092660129). Question 27 asked, “What are the posting requirements for work at home?” The NRC staff's response stated, “Section 21.6 requires that every premise in the U.S. where activities subject to part 21 are conducted, posts current copies of (1) the regulations in part 21; (2) Section 206 of the Energy Reorganization Act of 1974; and (3) company procedures adopted pursuant to the regulations in part 21 must be posted in a conspicuous location. If work subject to part 21 is being done at a residence, then that location constitutes a premise for which the relevant notifications must be posted under § 21.6. If posting of the regulations is not practicable at the residence, then the staff considers access to part 21, Section 206, and the company's applicable part 21 reporting procedure, via the internet by `work at home' personnel to be adequate.”

    The NRC is seeking input regarding the adequacy of alternative posting methods and what additional clarity could be provided in the regulatory guide for addressing alternative types and locations of postings required under § 21.6 for the regulations in this part, Section 206 of the Energy Reorganization Act of 1974, and the procedures adopted pursuant to the regulations in this part regardless of the work location.

    2. The guidance in NEI 14-09 states, “10 CFR part 21 does not establish requirements for training of personnel involved in 10 CFR part 21 activities. However, as a good practice, appropriate familiarization and training in the requirements of 10 CFR part 21 should be provided initially, and as appropriate on an ongoing basis, as necessary. As another good practice, an organization should designate individuals capable of assisting the staff in part 21 evaluation, reporting requirements and training requirements.”

    The staff position regarding training of personnel involved in 10 CFR part 21 activities was provided in NUREG-0302, “Remarks Presented (Questions/Answers Discussed) at Public Regional Meetings to Discuss Regulations (10 CFR part 21) for Reporting of Defects and Noncompliance,” Revision 1, dated July 1977 (ADAMS Accession No. ML062080399). Question 10 on page 21.61-4 asked, “Can an organization be cited under part 21 for not conducting training on procedures required by part 21?” The NRC staff's response stated, “part 21 does not include a requirement for training.” However, the NRC's current position is that training of personnel involved in 10 CFR part 21 activities would be covered under 10 CFR 50.120, “Training and qualification of nuclear power plant personnel.”

    The NRC is seeking input regarding the position proposed in DG-1291 which approves NEI 14-09 for use because 10 CFR part 21 has no specific requirements for training and the regulation does not provide guidance requiring training of personnel.

    3. Are there topics that are not addressed in the RG that should be addressed? Conversely, are there topics addressed in the RG that need not be addressed?

    IV. Backfitting and Issue Finality

    This DG approves a method for evaluating and reporting defects under 10 CFR part 21. Issuance of this DG, if finalized, would not constitute backfitting as defined in 10 CFR 50.109 (the Backfit Rule) and would not otherwise be inconsistent with the issue finality provisions in 10 CFR part 52. As discussed in the “Implementation” section of this DG, the NRC has no current intention to impose this guide, if finalized, on holders of current operating licenses or combined licenses.

    Dated at Rockville, Maryland, this 26th day of July, 2017.

    For the Nuclear Regulatory Commission.

    Thomas H. Boyce, Chief, Regulatory Guidance and Generic Issues Branch, Division of Engineering, Office of Nuclear Regulatory Research.
    [FR Doc. 2017-16429 Filed 8-3-17; 8:45 am] BILLING CODE 7590-01-P
    NUCLEAR REGULATORY COMMISSION [NRC-2017-0001] Sunshine Act Meeting Notice DATE:

    Weeks of August 7, 14, 21, 28, September 4, 11, 2017.

    PLACE:

    Commissioners' Conference Room, 11555 Rockville Pike, Rockville, Maryland.

    STATUS:

    Public and Closed.

    Week of August 7, 2017

    There are no meetings scheduled for the week of August 7, 2017.

    Week of August 14, 2017—Tentative

    There are no meetings scheduled for the week of August 14, 2017.

    Week of August 21, 2017—Tentative

    There are no meetings scheduled for the week of August 21, 2017.

    Week of August 28, 2017—Tentative

    There are no meetings scheduled for the week of August 28, 2017.

    Week of September 4, 2017—Tentative Wednesday, September 6, 2017 1:30 p.m. NRC All Employees Meeting (Public Meeting), Marriott Bethesda North Hotel, 5701 Marinelli Road, Rockville, MD 20852. Thursday, September 7, 2017 10:00 a.m. Briefing on NRC International Activities (Closed—Ex. 1 & 9). Week of September 11, 2017—Tentative

    There are no meetings scheduled for the week of September 11, 2017.

    The schedule for Commission meetings is subject to change on short notice. For more information or to verify the status of meetings, contact Denise McGovern at 301-415-0681 or via email at [email protected]

    The NRC Commission Meeting Schedule can be found on the Internet at: http://www.nrc.gov/public-involve/public-meetings/schedule.html.

    The NRC provides reasonable accommodation to individuals with disabilities where appropriate. If you need a reasonable accommodation to participate in these public meetings, or need this meeting notice or the transcript or other information from the public meetings in another format (e.g., braille, large print), please notify Kimberly Meyer, NRC Disability Program Manager, at 301-287-0739, by videophone at 240-428-3217, or by email at [email protected] Determinations on requests for reasonable accommodation will be made on a case-by-case basis.

    Members of the public may request to receive this information electronically. If you would like to be added to the distribution, please contact the Nuclear Regulatory Commission, Office of the Secretary, Washington, DC 20555 (301-415-1969), or email [email protected] or [email protected]

    Dated: August 2, 2017. Denise L. McGovern, Policy Coordinator, Office of the Secretary.
    [FR Doc. 2017-16617 Filed 8-2-17; 4:15 pm] BILLING CODE 7590-01-P
    POSTAL REGULATORY COMMISSION [Docket Nos. CP2017-231; CP2017-232; CP2017-233] New Postal Products AGENCY:

    Postal Regulatory Commission.

    ACTION:

    Notice.

    SUMMARY:

    The Commission is noticing a recent Postal Service filing for the Commission's consideration concerning negotiated service agreements. This notice informs the public of the filing, invites public comment, and takes other administrative steps.

    DATES:

    Comments are due: August 8, 2017.

    ADDRESSES:

    Submit comments electronically via the Commission's Filing Online system at http://www.prc.gov. Those who cannot submit comments electronically should contact the person identified in the FOR FURTHER INFORMATION CONTACT section by telephone for advice on filing alternatives.

    FOR FURTHER INFORMATION CONTACT:

    David A. Trissell, General Counsel, at 202-789-6820.

    SUPPLEMENTARY INFORMATION: Table of Contents I. Introduction II. Docketed Proceeding(s) I. Introduction

    The Commission gives notice that the Postal Service filed request(s) for the Commission to consider matters related to negotiated service agreement(s). The request(s) may propose the addition or removal of a negotiated service agreement from the market dominant or the competitive product list, or the modification of an existing product currently appearing on the market dominant or the competitive product list.

    Section II identifies the docket number(s) associated with each Postal Service request, the title of each Postal Service request, the request's acceptance date, and the authority cited by the Postal Service for each request. For each request, the Commission appoints an officer of the Commission to represent the interests of the general public in the proceeding, pursuant to 39 U.S.C. 505 (Public Representative). Section II also establishes comment deadline(s) pertaining to each request.

    The public portions of the Postal Service's request(s) can be accessed via the Commission's Web site (http://www.prc.gov). Non-public portions of the Postal Service's request(s), if any, can be accessed through compliance with the requirements of 39 CFR 3007.40.

    The Commission invites comments on whether the Postal Service's request(s) in the captioned docket(s) are consistent with the policies of title 39. For request(s) that the Postal Service states concern market dominant product(s), applicable statutory and regulatory requirements include 39 U.S.C. 3622, 39 U.S.C. 3642, 39 CFR part 3010, and 39 CFR part 3020, subpart B. For request(s) that the Postal Service states concern competitive product(s), applicable statutory and regulatory requirements include 39 U.S.C. 3632, 39 U.S.C. 3633, 39 U.S.C. 3642, 39 CFR part 3015, and 39 CFR part 3020, subpart B. Comment deadline(s) for each request appear in section II.

    II. Docketed Proceeding(s)

    1. Docket No(s).: CP2017-231; Filing Title: Notice of the United States Postal Service of Filing a Functionally Equivalent Global Plus 1D Negotiated Service Agreement and Application for Non-Public Treatment of Materials Filed Under Seal; Filing Acceptance Date: July 31, 2017; Filing Authority: 39 CFR 3015.5; Public Representative: Lyudmila Y. Bzhilyanskaya; Comments Due: August 8, 2017.

    2. Docket No(s).: CP2017-232; Filing Title: Notice of the United States Postal Service of Filing a Functionally Equivalent Global Plus 1D Negotiated Service Agreement and Application for Non-Public Treatment of Materials Filed Under Seal; Filing Acceptance Date: July 31, 2017; Filing Authority: 39 CFR 3015.5; Public Representative: Jennaca D. Upperman; Comments Due: August 8, 2017.

    3. Docket No(s).: CP2017-233; Filing Title: Notice of the United States Postal Service of Filing a Functionally Equivalent Global Plus 1D Negotiated Service Agreement and Application for Non-Public Treatment of Materials Filed Under Seal; Filing Acceptance Date: July 31, 2017; Filing Authority: 39 CFR 3015.5; Public Representative: Jennaca D. Upperman; Comments Due: August 8, 2017.

    This notice will be published in the Federal Register.

    Stacy L. Ruble, Secretary.
    [FR Doc. 2017-16467 Filed 8-3-17; 8:45 am] BILLING CODE 7710-FW-P
    POSTAL SERVICE Temporary Emergency Committee of the Board of Governors; Sunshine Act Meeting; Correction AGENCY:

    Postal Service.

    ACTION:

    Notice; correction.

    SUMMARY:

    The Postal Service published a document in the Federal Register of August 2, 2017, providing notice of a closed meeting of the Temporary Emergency Committee of the Board of Governors. The document specified an incorrect day of the week for the date of the meeting.

    FOR FURTHER INFORMATION CONTACT:

    Julie S. Moore, (202) 268-4800.

    Corrections

    In the Federal Register of August 2, 2017, in FR Doc. 2017-16301:

    1. On page 36007, in the third column, correct the Dates and Times caption to read:

    DATES AND TIMES:

    Monday, August 7, 2017, at 9:00 a.m.

    2. On page 36008, in the first column, correct the first line to read:

    Monday, August 7, 2017, at 9:00 a.m.

    Dated: August 2, 2017. Julie S. Moore, Secretary.
    [FR Doc. 2017-16622 Filed 8-2-17; 4:15 pm] BILLING CODE 7710-12-P
    SECURITIES AND EXCHANGE COMMISSION Proposed Collection; Comment Request Upon Written Request, Copies Available From: Securities and Exchange Commission, Office of FOIA Services, 100 F Street NE., Washington, DC 20549-2736. Extension: Rule 498, SEC File No. 270-574, OMB Control No. 3235-0648

    Notice is hereby given that, pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.) (“Paperwork Reduction Act”), the Securities and Exchange Commission (the “Commission”) is soliciting comments on the collection of information summarized below. The Commission plans to submit this existing collection of information to the Office of Management and Budget (“OMB”) for extension and approval.

    Rule 498 (17 CFR 230.498) under the Securities Act of 1933 (15 U.S.C. 77a et seq.) (“Securities Act”) permits open-end management investment companies (“funds”) to satisfy their prospectus delivery obligations under the Securities Act by sending or giving key information directly to investors in the form of a summary prospectus (“Summary Prospectus”) and providing the statutory prospectus on a Web site. Upon an investor's request, funds are also required to send the statutory prospectus to the investor. In addition, under rule 498, a fund that relies on the rule to meet its statutory prospectus delivery obligations must make available, free of charge, the fund's current Summary Prospectus, statutory prospectus, statement of additional information, and most recent annual and semi-annual reports to shareholders at the Web site address specified in the required Summary Prospectus legend.1 A Summary Prospectus that complies with rule 498 is deemed to be a prospectus that is authorized under Section 10(b) of the Securities Act and Section 24(g) of the Investment Company Act of 1940 (15 U.S.C. 80a-1 et seq.).

    1 17 CFR 270.498(e)(1).

    The purpose of rule 498 is to enable a fund to provide investors with a Summary Prospectus containing key information necessary to evaluate an investment in the fund. Unlike many other federal information collections, which are primarily for the use and benefit of the collecting agency, this information collection is primarily for the use and benefit of investors. The information filed with the Commission also permits the verification of compliance with securities law requirements and assures the public availability and dissemination of the information.

    Based on an analysis of fund filings, the Commission estimates that approximately 10,532 portfolios are using a Summary Prospectus. The Commission estimates that the annual hourly burden per portfolio associated with the compilation of the information required on the cover page or the beginning of the Summary Prospectus is 0.5 hours, and estimates that the annual hourly burden per portfolio to comply with the Web site posting requirement is approximately 1 hour, requiring a total of 1.5 hours per portfolio per year.2 Thus the total annual hour burden associated with these requirements of the rule is approximately 15,798.3 The Commission estimates that the annual cost burden is approximately $15,900 per portfolio, for a total annual cost burden of approximately $167,458,800.4

    2 0.5 hours per portfolio + 1 hour per portfolio = 1.5 hours per portfolio. The Commission believes that funds that have opted to use the Summary Prospectus have already incurred the estimated one-time hour burden to initially comply with rule 498, and therefore the estimated burden hours to initially comply with rule 498 and the associated costs are not included in these estimates.

    3 1.5 hours per portfolio × 10,532 portfolios = 15,798 hours.

    4 $15,900 per portfolio × 9,082 portfolios = $144,403,800.

    Estimates of average burden hours are made solely for the purposes of the Paperwork Reduction Act and are not derived from a comprehensive or even a representative survey or study of the costs of Commission rules and forms. Under rule 498, use of the Summary Prospectus is voluntary, but the rule's requirements regarding provision of the statutory prospectus upon investor request are mandatory for funds that elect to send or give a Summary Prospectus in reliance upon rule 498. The information provided under rule 498 will not be kept confidential. 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.

    Written comments are invited on: (a) Whether the collections of information are necessary for the proper performance of the functions of the Commission, including whether the information has practical utility; (b) the accuracy of the Commission's estimate of the burdens of the collections of information; (c) ways to enhance the quality, utility, and clarity of the information collected; and (d) ways to minimize the burdens of the collections of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted in writing within 60 days of this publication.

    Please direct your written comments to Pamela Dyson, Director/Chief Information Officer, Securities and Exchange Commission, C/O Remi Pavlik-Simon, 100 F Street NE., Washington, DC 20549; or send an email to: [email protected]

    Dated: July 31, 2017. Eduardo A. Aleman, Assistant Secretary.
    [FR Doc. 2017-16391 Filed 8-3-17; 8:45 am] BILLING CODE 8011-01-P
    SECURITIES AND EXCHANGE COMMISSION [Release No. 34-81265; File No. SR-NASDAQ-2017-038] Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing of Amendment No. 1, and Order Granting Accelerated Approval of a Proposed Rule Change, as Modified by Amendments No. 1 and 2, Relating to the First Trust Municipal High Income ETF July 31, 2017. I. Introduction

    On May 16, 2017, The NASDAQ Stock Market LLC (“Nasdaq” or “Exchange”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”) 1 and Rule 19b-4 thereunder,2 a proposed rule change relating to the First Trust Municipal High Income ETF (“Fund”) of First Trust Exchange-Traded Fund III (“Trust”), the shares of which have been approved by the Commission for listing and trading under Nasdaq Rule 5735 (“Managed Fund Shares”). The proposed rule change was published for comment in the Federal Register on June 2, 2017.3 On July 10, 2017, the Exchange filed Amendment No. 1 to the proposed rule change.4 On July 11, 2017, the Commission designated a longer period within which to approve the proposed rule change, disapprove the proposed rule change, or institute proceedings to determine whether to disapprove the proposed rule change.5 On July 13, 2017, the Exchange filed Amendment No. 2 to the proposed rule change.6 The Commission has received no comments on the proposal. The Commission is publishing this notice to solicit comments on Amendment No. 1 from interested persons, and is approving the proposed rule change, as modified by Amendments No. 1 and 2, on an accelerated basis.

    1 15 U.S.C. 78s(b)(1).

    2 17 CFR 240.19b-4.

    3See Securities Exchange Act Release No. 80802 (May 26, 2017), 82 FR 25648 (Jun. 2, 2017) (“Notice”).

    4 In Amendment No. 1, which amended and replaced the proposed rule change in its entirety, the Exchange: (a) modified the requirement that the Fund invest at least 65% of its net assets in Municipal Securities (as defined herein) that are rated below investment grade to at least 50% of its net assets; (b) modified the limitation that the Fund invest up to 35% of its net assets in investment grade Municipal Securities to up to 50% of its net assets; and (c) removed references to the Liquidity Rule. Amendment No. 1 to the proposed rule change is available on the Commission's Web site at: https://www.sec.gov/comments/sr-nasdaq-2017-038/nasdaq2017038-1841718-155073.pdf.

    5See Securities Exchange Act Release No. 81123 (Jul. 11, 2017), 82 FR 32737 (Jul. 17, 2017). The Commission designated August 31, 2017, as the date by which the Commission shall either approve or disapprove, or institute proceedings to determine whether to disapprove, the proposed rule change. See id.

    6 In Amendment No. 2, which partially amended the proposed rule change, as modified by Amendment No. 1, the Exchange provided the rationale with respect to the modifications to the percentages of investment grade and non-investment grade Municipal Securities in which the Fund may invest. Because Amendment No. 2 makes clarifying changes and does not present unique or novel regulatory issues, it is not subject to notice and comment. Amendment No. 2 is available on the Commission's Web site at: https://www.sec.gov/comments/sr-nasdaq-2017-038/nasdaq2017038-1851791-155341.pdf. See infra notes 30-32 (noting where the Exchange provided the rationale with respect to the modifications to the percentages of investment grade and non-investment grade Municipal Securities in Amendment No. 2).

    II. The Exchange's Description of the Proposed Rule Change, as Modified by Amendments No. 1 and 2

    In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.

    A. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change 1. Purpose

    The Commission has approved the listing and trading of Shares under Nasdaq Rule 5735, which governs the listing and trading of Managed Fund Shares on the Exchange.7 However, no Shares are currently listed and traded on the Exchange. The Exchange believes the proposed rule change reflects no significant issues not previously addressed in the Prior Release.

    7 The Commission approved Nasdaq Rule 5735 in Securities Exchange Act Release No. 57962 (June 13, 2008), 73 FR 35175 (June 20, 2008) (SR-NASDAQ-2008-039). The Commission previously approved the listing and trading of the Shares of the Fund. See Securities Exchange Act Release No. 78913 (September 23, 2016), 81 FR 69109 (October 5, 2016) (SR-NASDAQ-2016-002) (“Prior Release”).

    The Fund is an actively-managed exchange-traded fund (“ETF”). The Shares will be offered by the Trust, which was established as a Massachusetts business trust on January 9, 2008. The Trust, which is registered with the Commission as an investment company under the Investment Company Act of 1940 (the “1940 Act”), has filed a registration statement on Form N-1A (“Registration Statement”) relating to the Fund with the Commission. 8 The Fund is a series of the Trust.

    8See Post-Effective Amendment No. 27 to Registration Statement on Form N-1A for the Trust, dated August 31, 2015 (File Nos. 333-176976 and 811-22245). The descriptions of the Fund and the Shares contained herein are based, in part, on information in the Registration Statement. Before Shares are publicly offered, the Trust will file a post-effective amendment to its Registration Statement. The changes in this proposed rule change will not be implemented for the Fund until the post-effective amendment to the Registration Statement becomes effective. First Trust Advisors L.P. (the “Adviser”) represents that the Adviser will not implement the changes described herein until the instant proposed rule change is operative.

    The primary purpose of this proposed rule change is to modify certain representations set forth in the Prior Release. Since the Prior Release, in evaluating its ability to construct a portfolio that would both enable the Fund to pursue its investment objectives effectively and satisfy the representations set forth in the Prior Release, the Adviser determined that, based on certain factors, including regulatory and market developments with portfolio management implications, additional flexibility would be needed to launch and operate the Fund. Additionally, the Adviser took into account that recent increases in interest rates have been accompanied by substantial outflows from mutual funds and ETFs, and that future interest rate swings may spark increased market volatility and trigger potentially dramatic inflows and outflows. To enable the Fund to operate effectively (including, in addition to pursuing its investment objectives, responding to potential market volatility), the Adviser believes that additional portfolio management flexibility is needed and warranted. Additionally, for the reasons discussed in more detail below, the Exchange believes that the proposal is consistent with Section 6(b)(5) of the Act.

    As a related matter, the Exchange notes that although the Prior Release included certain representations that were based on the generic listing standards for index-based ETFs, the Exchange's “generic listing standards” for actively-managed ETFs (the “Active ETF Generic Listing Standards”) 9 were recently adopted and, with one exception, the Fund's proposed revised representations would meet or exceed similar requirements for portfolios of fixed income securities set forth in Nasdaq Rule 5735(b)(1)(B) under the Active ETF Generic Listing Standards (“Rule 5735(b)(1)(B)”). In addition, this proposed rule change would make certain changes to the description of the Fund's investments. Further, to provide the Adviser with greater flexibility in hedging interest rate risks associated with the Fund's portfolio investments, this proposed rule change would expand the Fund's ability to invest in derivatives by permitting it to invest in over-the-counter (“OTC”) forward contracts and OTC swaps, subject to a limitation that would be consistent with the limitation on investments in OTC derivatives set forth in Nasdaq Rule 5735(b)(1)(E) under the Active ETF Generic Listing Standards (“Rule 5735(b)(1)(E)”).

    9See Securities Exchange Act Release No. 78918 (September 23, 2016), 81 FR 67033 (September 29, 2016).

    Changes to Representations

    The Prior Release noted that the Fund would be actively managed and not tied to an index, but that under normal market conditions, on a continuous basis determined at the time of purchase, its portfolio of Municipal Securities (as defined in the Prior Release) would generally meet, as applicable, all except for two of the criteria for non-actively managed, index-based, fixed income ETFs contained in Nasdaq Rule 5705(b)(4)(A), as described therein. More specifically, the Prior Release stated that, under normal market conditions, the Fund's portfolio of Municipal Securities would meet the requirements of: (i) Nasdaq Rule 5705(b)(4)(A)(i) (requiring that the index or portfolio consist of “Fixed Income Securities”); (ii) Nasdaq Rule 5705(b)(4)(A)(iv) (requiring that no component fixed income security (excluding Treasury securities) represent more than 30% of the weight of the index or portfolio, and that the five highest weighted component fixed income securities do not, in the aggregate, account for more than 65% of the weight of the index or portfolio); and (iii) Nasdaq Rule 5705(b)(4)(A)(v) (requiring that an underlying index or portfolio (excluding one consisting entirely of exempted securities) include securities from a minimum of 13 non-affiliated issuers) (collectively, the “Rule 5705-Related Representations”).

    Additionally, the Prior Release noted that Nasdaq Rule 5705(b)(4)(A)(iii) (relating to convertible securities) was inapplicable to the Fund's portfolio of Municipal Securities. Further, the Prior Release provided that the Fund's portfolio of Municipal Securities may not satisfy 5705(b)(4)(A)(vi) (requiring that component securities that in the aggregate account for at least 90% of the weight of the index or portfolio be either exempted securities or from a specified type of issuer) and that it would not generally satisfy Rule 5705(b)(4)(A)(ii) (requiring that components that in the aggregate account for at least 75% of the weight of the index or portfolio have a minimum original principal amount outstanding of $100 million or more). However, the Prior Release stated that under normal market conditions, at least 40% (based on dollar amount invested) of the Municipal Securities in which the Fund invested would be issued by issuers with total outstanding debt issuances that, in the aggregate, have a minimum amount of municipal debt outstanding at the time of purchase of $75 million or more (the “40/75 Representation”).10

    10 As noted in the Prior Release, the Commission has previously issued orders approving proposed rule changes relating to the listing and trading under NYSE Arca Equities Rule 5.2(j)(3), Commentary .02 (which governs the listing and trading of fixed-income index ETFs on NYSE Arca, Inc.) to various ETFs that track indexes comprised of municipal securities (including high-yield municipal index ETFs) that did not meet the analogous requirement included in Commentary .02(a)(2) to NYSE Arca Equities Rule 5.2(j)(3), but demonstrated that the portfolio of municipal securities in which the ETFs would invest would be sufficiently liquid (including Securities Exchange Act Release Nos. 75376 (July 7, 2015), 80 FR 40113 (July 13, 2015) (SR-NYSEArca-2015-18) (order approving listing and trading of Vanguard Tax-Exempt Bond Index Fund); 71232 (January 3, 2014), 79 FR 1662 (January 9, 2014) (SR-NYSEArca-2013-118) (order approving listing and trading of Market Vectors Short High-Yield Municipal Index ETF); and 63881 (February 9, 2011), 76 FR 9065 (February 16, 2011) (SR-NYSEArca-2010-120) (order approving listing and trading of SPDR Nuveen S&P High Yield Municipal Bond ETF)). See also Securities Exchange Act Release Nos. 67985 (October 4, 2012), 77 FR 61804 (October 11, 2012) (SR-NYSEArca-2012-92) (order approving listing and trading of iShares 2018 S&P AMT-Free Municipal Series and iShares 2019 S&P AMT-Free Municipal Series); 72464 (June 25, 2014), 79 FR 37373 (July 1, 2014) (SR-NYSEArca-2014-45) (order approving continued listing and trading of PowerShares Insured California Municipal Bond Portfolio, PowerShares Insured National Municipal Bond Portfolio and PowerShares Insured New York Municipal Bond Portfolio); 72523 (July 2, 2014), 79 FR 39016 (July 9, 2014) (SR-NYSEArca-2014-37) (order approving listing and trading of iShares 2020 S&P AMT-Free Municipal Series); 75468 (July 16, 2015), 80 FR 43500 (July 22, 2015) (SR-NYSEArca-2015-25) (order approving listing and trading of iShares iBonds Dec 2021 AMT-Free Muni Bond ETF and iShares iBonds Dec 2022 AMT-Free Muni Bond ETF); 78329 (July 14, 2016), 81 FR 47217 (July 20, 2016) (SR-BatsBZX-2016-01) (order approving listing and trading of VanEck Vectors AMT-Free 6-8 Year Municipal Index ETF, VanEck Vectors AMT-Free 8-12 Year Municipal Index ETF, and VanEck Vectors AMT-Free 12-17 Year Municipal Index ETF); and 79885 (January 26, 2017), 82 FR 8963 (February 1, 2017) (SR-NYSEArca-2016-100) (order approving listing and trading of Direxion Daily Municipal Bond Taxable Bear 1X Fund).

    In addition to the Rule 5705-Related Representations and the 40/75 Representation, the Prior Release provided that under normal market conditions, except for the initial invest-up period and periods of high cash inflows or outflows,11 the Fund's investments in Municipal Securities would provide exposure (based on dollar amount invested) to (a) at least 10 different industries (with no more than 25% of the value of the Fund's net assets comprised of Municipal Securities that provide exposure to any single industry) and (b) at least 15 different states (with no more than 30% of the value of the Fund's net assets comprised of Municipal Securities that provide exposure to any single state) (collectively, the “Industry/State Representations”). Additionally, the Prior Release stated that under normal market conditions, except for the initial invest-up period and periods of high cash inflows or outflows, (a) with respect to 75% of the Fund's net assets, the Fund's exposure to any single borrower (based on dollar amount invested) would not exceed 3% of the value of the Fund's net assets and (b) with respect to 15% of the Fund's net assets, the Fund's exposure to any single borrower (based on dollar amount invested) would not exceed 5% of the value of the Fund's net assets (collectively, the “Borrower Exposure Representations”).

    11 As described in the Prior Release, the term “initial invest-up period” means the six-week period following the commencement of trading of