Federal Register Vol. 83, No.120,

On May 30, 2018, the Secretary of Commerce (“Secretary”) issued a request for public comment on an investigation under section 232 of the Trade Expansion Act of 1962, as amended (19 U.S.C. 1862), to determine the effects on the national security of imports of automobiles, including cars, SUVs, vans and light trucks, and automotive parts (83 FR 24735). The Department of Commerce is extending the comment period on the notice published from June 22, 2018 to June 29, 2018. In addition, the Department of Commerce is extending the due date for rebuttal comments submitted in response to any comments filed on or before June 29, 2018 to July 13, 2018. The dates and location for the public hearings as well as other instructions to commenters remain unchanged. The Department believes that a 7-day extension for comments allows adequate additional time for interested persons to submit comments while still allowing this national security investigation to proceed expeditiously.

You may find background information about the stock assessment and WPSAR process, and details of the meeting agenda and special accommodations in the June 5, 2018, Federal Register notice: https://www.federalregister.gov/documents/2018/06/05/2018-11977/pacific-island-fisheries-western-pacific-stock-assessment-review-public-meeting.

In the Federal Register of June 5, 2018, (83 FR 26010) in FR Doc. 2018-11977, on page 26011, in the first column, the dates under the heading “Meeting Agenda for WPSAR Review” are corrected to read as follows:

The meeting times and agenda items are not changed.

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, or 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).

On January 3, 2018, NMFS received a request from DWW for an IHA to take marine mammals incidental to marine site characterization surveys off the coast of Massachusetts and Rhode Island in the area of the Commercial Lease of Submerged Lands for Renewable Energy Development on the Outer Continental Shelf (OCS-A 0486) and along potential submarine cable routes to a landfall location in either Rhode Island, Massachusetts or New York. A revised application was received on April 18, 2018. NMFS deemed that request to be adequate and complete. DWW's request is for take of 14 marine mammal species by Level B harassment. Neither DWW nor NMFS expects serious injury or mortality to result from this activity and the activity is expected to last no more than one year, therefore, an IHA is appropriate.

DWW proposes to conduct marine site characterization surveys, including high-resolution geophysical (HRG) and geotechnical surveys, in the area of the Commercial Lease of Submerged Lands for Renewable Energy Development on the Outer Continental Shelf #OCS-A 0486 (Lease Area) and along potential submarine cable routes to landfall locations in either Rhode Island, Massachusetts or Long Island, New York. The purpose of the marine site characterization surveys are to obtain a baseline assessment of seabed/sub-surface soil conditions in the Lease Area and cable route corridors to support the siting of potential future offshore wind projects. Underwater sound resulting from DWW's proposed site characterization surveys has the potential to result in incidental take of marine mammals in the form of behavioral harassment.

DWW's survey activities would occur in the Northwest Atlantic Ocean within Federal waters. Surveys would occur within the Bureau of Ocean Energy Management (BOEM) Rhode Island-Massachusetts Wind Energy Area (RI-MA WEA) which is located east of Long Island, New York and south of Rhode Island and Massachusetts (see Figure 1 in the IHA application). Water depths in the Lease Area range from 26 to 48 meters (m) (85 to 157 feet (ft)). For the purpose of this IHA the Lease Area and submarine cable corridor are collectively termed the Project Area. Surveys would occur from approximately June 15, 2018 through December 31, 2018. The estimated duration of the geophysical survey is expected to be up to 200 days and the estimated duration of the geotechnical survey is expected to be up to 100 days.

Geotechnical surveys would entail the use of core penetration testing, deep boring cores and vibracores. Geotechnical surveys are not expected to result in the take of marine mammals, as described in the Federal Register notice of the proposed IHA (83 FR 19711; May 4, 2018) and are not analyzed further in this document. Geophysical surveys would entail the use of a multibeam depth sounder, shallow penetration sub-bottom profiler (chirp), medium penetration sub-bottom profiler (boomer and sparker or bubble gun), sidescan sonar and marine magnetometer. The deployment of geophysical survey equipment, including the equipment planned for use during DWW's planned activity, produces sound in the marine environment that has the potential to result in harassment of marine mammals.

A detailed description of the planned survey activities, including types of survey equipment planned for use, is provided in the Federal Register notice of the proposed IHA (83 FR 19711; May 4, 2018). Since that time, no changes have been made to the planned activities. Therefore, a detailed description is not repeated here. We note, however, that one type of survey equipment was described incorrectly in the proposed IHA: The frequencies listed for the Edgetech 4125 sidescan sonar were incorrectly listed as 105 and 410 kilohertz (kHz); correct frequencies for the Edgetech 4125 are 400/900 kHz or 600/1600 kHz. Please refer to the Federal Register notice of the proposed IHA (83 FR 19711; May 4, 2018) for a detailed description of the specific activity.

NMFS published a notice of proposed IHA in the Federal Register on May 4, 2018 (83 FR 19711). During the 30-day public comment period, NMFS received comment letters from the Marine Mammal Commission (Commission) and from a group of non-governmental organizations (NGOs) including Natural Resources Defense Council, the National Wildlife Federation, the Conservation Law Foundation, Defenders of Wildlife, Southern Environmental Law Center, Surfrider Foundation, Sierra Club, and the International Fund for Animal Welfare. NMFS has posted the comments online at: www.fisheries.noaa.gov/national/marine-mammal-protection/incidental-take-authorizations-other-energy-activities-renewable. The following is a summary of the public comments received and NMFS' responses.

Comment 1: The Commission expressed concern that the method used to estimate the numbers of takes, which summed fractions of takes for each species across project days, does not account for and negates the intent of NMFS' 24 hour reset policy and recommended that NMFS share the rounding criteria with the Commission in a timely manner.

NMFS Response: NMFS appreciates the Commission's ongoing concern in this matter. Calculating predicted takes is not an exact science, and there are arguments for taking different mathematical approaches in different situations and for making qualitative adjustments in other situations. We believe, however, that the methodology used for take calculation in this IHA remains appropriate and is not at odds with the 24 hour reset policy the Commission references. We look forward to continued discussion with the Commission on this matter and will share draft guidance on this issue as soon as possible with the Commission.

Comment 2: The Commission recommended that, until behavioral thresholds are updated, NMFS require applicants to use the 120-decibel (dB) re 1 micropascal (μPa), rather than 160-dB re 1μPa, threshold for acoustic, non-impulsive sources (e.g., sub-bottom profilers/chirps, echosounders, and other sonars including side-scan and fish-finding).

NMFS Response: Certain sub-bottom profiling systems are appropriately considered to be impulsive sources (e.g., boomers, sparkers); therefore, the threshold of 160-dB re 1μPa will continue to be used for those sources. Other source types referenced by the Commission (e.g., chirp sub-bottom profilers, echosounders, and other sonars including side-scan and fish-finding) produce signals that are not necessarily strictly impulsive; however, NMFS finds that the 160-dB root mean square (rms) threshold is most appropriate for use in evaluating potential behavioral impacts to marine mammals because the temporal characteristics (i.e., intermittency) of these sources are better captured by this threshold. The 120-dB threshold is associated with continuous sources and was derived based on studies examining behavioral responses to drilling and dredging. Continuous sounds are those whose sound pressure level remains above that of the ambient sound, with negligibly small fluctuations in level (NIOSH, 1998; ANSI, 2005). Examples of sounds that NMFS would categorize as continuous are those associated with drilling or vibratory pile driving activities. Intermittent sounds are defined as sounds with interrupted levels of low or no sound (NIOSH, 1998). Thus, signals produced by these source types are not continuous but rather intermittent sounds. With regard to behavioral thresholds, we consider the temporal and spectral characteristics of signals produced by these source types to more closely resemble those of an impulse sound rather than a continuous sound. The threshold of 160-dB re 1μPa is typically associated with impulsive sources, which are inherently intermittent. Therefore, the 160-dB threshold (typically associated with impulsive sources) is more appropriate than the 120-dB threshold (typically associated with continuous sources) for estimating takes by behavioral harassment incidental to use of such sources.

Comment 3: The Commission requested clarification regarding certain issues associated with NMFS' notice that one-year renewals could be issued in certain limited circumstances and expressed concern that the process would bypass the public notice and comment requirements. The Commission also suggested that NMFS should discuss the possibility of renewals through a more general route, such as a rulemaking, instead of notice in a specific authorization. The Commission further recommended that if NMFS did not pursue a more general route, that the agency provide the Commission and the public with a legal analysis supporting our conclusion that this process is consistent with the requirements of section 101(a)(5)(D) of the MMPA.

NMFS Response: The process of issuing a renewal IHA does not bypass the public notice and comment requirements of the MMPA. The notice of the proposed IHA expressly notifies the public that under certain, limited conditions an applicant could seek a renewal IHA for an additional year. The notice describes the conditions under which such a renewal request could be considered and expressly seeks public comment in the event such a renewal is sought. Importantly, such renewals would be limited to circumstances where: The activities are identical or nearly identical to those analyzed in the proposed IHA; monitoring does not indicate impacts that were not previously analyzed and authorized; and, the mitigation and monitoring requirements remain the same, all of which allow the public to comment on the appropriateness and effects of a renewal at the same time the public provides comments on the initial IHA. NMFS has, however, modified the language for future proposed IHAs to clarify that all IHAs, including renewal IHAs, are valid for no more than one year and that the agency would consider only one renewal for a project at this time. In addition, notice of issuance or denial of a renewal IHA would be published in the Federal Register, as they are for all IHAs. The option for issuing renewal IHAs has been in NMFS's incidental take regulations since 1996. We will provide any additional information to the Commission and consider posting a description of the renewal process on our website before any renewal is issued utilizing this process.

Comment 4: The Commission recommended that NMFS increase the number of common dolphin takes and sperm whale takes, based on an assumption that the number proposed for authorization is insufficient for DWW's proposed survey, and that NMFS authorize at least 20 Level B harassment takes of Risso's dolphins, based on observations of Risso's dolphins during HRG surveys conducted by Deepwater Wind in the RI-MA WEA in 2017 (AIS Inc., 2017). The Commission further recommended that NMFS better evaluate the numbers of Level A and B harassment takes it plans to propose.

NMFS Response: NMFS considered the Commission's recommendations with regard to take numbers authorized for common dolphins, sperm whales and Risso's dolphins. The Commission noted that five sperm whales were observed during HRG surveys conducted by Deepwater Wind in the RI-MA WEA in 2017 and two were taken by Level B harassment, and expressed concern that the 2018 survey may be forced to shut down upon visual detection of sperm whales if the number of authorized takes of sperm whales is exceeded. However, results of the monitoring report from the 2017 IHA indicate that the majority of sperm whale detections during the 2017 survey were via passive acoustic monitoring (PAM), with only one confirmed visual detection which was outside the Level B zone at a distance of approximately 1,400 m from the vessel; both “takes” reported in the monitoring report were not based on visual detections but were instead based on acoustic detections that were localized within the Level B harassment zone (AIS Inc., 2017). However, for the IHA issued for 2017 surveys and for this IHA, NMFS does not consider animals detected acoustically but not confirmed visually by PSOs to have been taken by harassment. As the number of sperm whale takes in this IHA were based on the best available density data (e.g., Roberts et al. (2016)), and as shutdown of survey equipment based on PAM detection alone is not required for sperm whales in this IHA, we have concluded the number of sperm whale takes authorized is appropriate. The Commission noted that common dolphins were the most regularly observed marine mammal species during Deepwater Wind's 2017 HRG surveys in the RI-MA WEA, with 2,677 common dolphins observed (AIS Inc., 2017) and expressed concern that the 2018 survey may be forced to shut down upon visual detection of common dolphins if the number of authorized takes of common dolphins is exceeded. NMFS agrees that common dolphins are likely to be prevalent during DWW's survey activities; however, we note that while 2,677 common dolphins were observed during 2017 surveys, 346 common dolphins were taken by Level B harassment (AIS Inc., 2017). NMFS is authorizing nearly 3 times the number of takes of common dolphins in this IHA (910) compared to the number of takes of common dolphins that occurred during 2017 surveys (346). As the number of common dolphin takes in this IHA were based on the best available density data (e.g., Roberts et al. (2016)) and as this IHA authorizes nearly 3 times as many takes by Level B harassment of common dolphins compared to the number taken during Deepwater Wind's HRG surveys in 2017 (NMFS, 2017), we have concluded the number of common dolphin takes authorized is appropriate. The Commission noted that the monitoring report from the 2017 IHA issued to Deepwater Wind for HRG surveys in the RI-MA WEA indicated that eight Risso's dolphins were observed at 400 m from the source during Deepwater Wind's 2017 surveys and that the vessel had to avoid the Risso's dolphins to prevent unauthorized takes (AIS Inc., 2017). We agree with the Commission that, based on monitoring data from the 2017 IHA issued to Deepwater Wind for HRG surveys in the RI-MA WEA (AIS Inc., 2017), the planned survey may encounter Risso's dolphins, and, thus authorization for the take of Risso's dolphins is warranted in this IHA. We have therefore authorized takes of Risso's dolphins in this IHA (Table 6). NMFS carefully evaluates the number of Level A and Level B harassment takes it proposes to authorize, as illustrated by the Level of analysis incorporated in our notices of proposed IHAs, and we will continue to do so.

Comment 5: The NGOs expressed concern regarding the marine mammal density estimates used to calculate take. Specifically, the commenters stated the estimates derived from models presented in Roberts et al. (2016) may underrepresent density and seasonal presence of large whales in the survey area, and recommended that NMFS consider additional data sources in density modeling in future analyses of estimated take, including initial data from state monitoring efforts, existing passive acoustic monitoring data, opportunistic marine mammal sightings data, and other data sources.

NMFS Response: NMFS has determined that the data provided by Roberts et al. (2016) represents the best available information concerning marine mammal density in the survey area and has used it accordingly. NMFS has considered other available information, including that cited by the commenters, and determined that it does not contradict the information provided by Roberts et al. (2016). The information discussed by the commenters does not provide data in a format that is directly usable in an acoustic exposure analysis, and the commenters make no useful recommendation regarding how to do so. We will review the data sources recommended by the commenters and will consider their suitability for inclusion in future analyses, as requested by the commenters.

Comment 6: Regarding mitigation measures, the NGOs recommended NMFS impose a restriction on site assessment and characterization activities that have the potential to harass the North Atlantic right whale from November 1st to May 14th.

NMFS Response: In evaluating how mitigation may or may not be appropriate to ensure the least practicable adverse impact on species or stocks and their habitat, 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; and (2) the practicability of the measures for applicant implementation, which may consider such things as relative cost and impact on operations.

DWW determined the planned duration of the survey based on their data acquisition needs, which are largely driven by the Bureau of Ocean Energy Management's (BOEM) data acquisition requirements prior to required submission of a construction and operations plan (COP). Any effort on the part of NMFS to restrict the months during which the survey could operate would likely have the effect of forcing the applicant to conduct additional months of surveys the following year, resulting in increased costs incurred by the applicant and additional time on the water with associated additional production of underwater noise which could have further potential impacts to marine mammals. Thus the time and area restrictions recommended by the commenters would not be practicable for the applicant to implement and would to some degree offset the benefit of the recommended measure. In addition, our analysis of the potential impacts of the survey on right whales does not indicate that such closures are warranted, as potential impacts to right whales from the survey activities would be limited to short-term behavioral responses; no marine mammal injury is expected as a result of the survey, nor is injury authorized in the IHA. We also note that the majority of the survey is already scheduled to occur outside the time frame recommended for closure by the commenters; the survey is planned to occur from June 15 through December 31, while the commenters recommend a seasonal closure from November 1 through May 14. Thus, in consideration of the limited potential benefits of time and area restrictions, in concert with the impracticability and increased cost on the part of the applicant that would result from such restrictions, NMFS has determined that time and area restrictions are not warranted in this case. Existing mitigation measures, including exclusion zones, ramp-up of survey equipment, and vessel strike avoidance measures, are sufficiently protective to ensure the least practicable adverse impact on species or stocks and their habitat.

Comment 7: Regarding mitigation measures, the NGOs recommended that NMFS require that geophysical surveys commence, with ramp-up, during daylight hours only to maximize the probability that North Atlantic right whales are detected and confirmed clear of the exclusion zone, and that, if a right whale were detected in the exclusion zone during nighttime hours and the survey is shut down, developers should be required to wait until daylight hours for ramp-up to commence.

NMFS Response: We acknowledge the limitations inherent in detection of marine mammals at night. However, similar to the discussion above regarding time and area closures, restricting the ability of the applicant to ramp-up surveys only during daylight hours would have the potential to result in lengthy shutdowns of the survey equipment, which could result in the applicant failing to collect the data they have determined is necessary, which could result in the need to conduct additional surveys the following year. This would result in significantly increased costs incurred by the applicant. Thus the restriction suggested by the commenters would not be practicable for the applicant to implement. In addition, as described above, potential impacts to marine mammals from the survey activities would be limited to short-term behavioral responses. Restricting surveys in the manner suggested by the commenters may reduce marine mammal exposures by some degree in the short term, but would not result in any significant reduction in either intensity or duration of noise exposure. No injury is expected to result even in the absence of mitigation, given the very small estimated Level A harassment zones. In the event that NMFS imposed the restriction suggested by the commenters, potentially resulting in a second season of surveys required for the applicant, vessels would be on the water introducing noise into the marine environment for an extended period of time. Therefore, in addition to practicability concerns for the applicant, the restrictions recommended by the commenters could result in the surveys spending increased time on the water, which may result in greater overall exposure to sound for marine mammals; thus the commenters have failed to demonstrate that such a requirement would result in a net benefit for affected marine mammals. Therefore, in consideration of potential effectiveness of the recommended measure and its practicability for the applicant, NMFS has determined that restricting survey start-ups to daylight hours is not warranted in this case.

However, in recognition of the concerns raised by the commenters, we have added a mitigation requirement to the IHA that shutdown of geophysical survey equipment is required upon confirmed PAM detection of a North Atlantic right whale at night, even in the absence of visual confirmation, except in cases where the acoustic detection can be localized and the right whale can be confirmed as being beyond the 500 m exclusion zone (EZ); equipment may be re-started no sooner than 30 minutes after the last confirmed acoustic detection.

Comment 8: The NGOs recommended that NMFS require a 500 m EZ for marine mammals (with the exception of dolphins that voluntarily approach the vessel). Additionally, the NGOs recommended that protected species observers (PSOs) monitor to an extended 1,000 m EZ for North Atlantic right whales.

NMFS Response: Regarding the recommendation for a 1,000 m EZ specifically for North Atlantic right whales, we have determined that the 500 m EZ, as required in the IHA, is sufficiently protective. We note that the 500 m EZ exceeds the modeled distance to the Level B harassment isopleth (447 m), thus for North Atlantic right whales detected by PSOs this EZ would be expected to effectively minimize potential instances of injury and harassment.

Regarding the commenters' recommendation to require a 500 m EZ for all marine mammals (except dolphins that approach the vessel) we have determined the EZs as currently required in the IHA (described in Mitigation Measures, below) are sufficient to ensure the least practicable adverse impact on species or stocks and their habitat. The EZs would prevent all potential instances of marine mammal injury (though in this instance, injury would not be an expected outcome even in the absence of mitigation due to very small predicted isopleths corresponding to the Level A harassment threshold (Table 5) and would further prevent some instances of behavioral harassment, as well as limiting the intensity and/or duration of behavioral harassment that does occur. As NMFS has determined the EZs currently required in the IHA to be sufficiently protective, we do not think expanded EZs, beyond what is required in the IHA, are warranted.

Comment 9: The NGOs recommended that a combination of visual monitoring by PSOs and PAM should be required 24 hours per day.

NMFS Response: The PAM requirement has been included in the IHA because PAM was proposed by the applicant, and PAM is required in BOEM lease stipulations. We do not think the use of PAM is necessarily warranted for surveys using the sound sources proposed for use by DWW, due to relatively small areas that are expected to be ensonified to the Level A harassment threshold (Table 5). As we are not convinced that PAM is necessarily warranted for this type of survey, we do not think a requirement to expand the use of PAM to 24 hours a day during the survey is warranted. Expanding the PAM requirement to 24 hours a day may also result in increased costs on the part of the applicant. When the potential benefits of a 24 hour PAM requirement are considered in concert with the potential increased costs on the part of the applicant that would result from such a requirement, we determined a requirement for 24 hour PAM operation is not warranted in this case. Given the effects to marine mammals from the types of surveys authorized in this IHA are expected to be limited to behavioral harassment even in the absence of mitigation, we have determined the current requirements for visual and acoustic monitoring are sufficient to ensure the EZs and Watch Zone are adequately monitored for this particular activity.

Comment 10: The NGOs recommended that NMFS require a 10 knot speed restriction on all project-related vessels transiting to/from the survey area from November 1 through April 30 in New York state waters and the adjacent Block Island Seasonal Management Area (SMA) for North Atlantic right whales, and from February 1 to May 14 in Rhode Island and Massachusetts state waters outside of the Block Island SMA, and that all project vessels operating within the survey area should be required to maintain a speed of 10 knots or less during the entire survey period.

NMFS Response: NMFS has analyzed the potential for ship strike resulting from DWW's activity and has determined that the mitigation measures specific to ship strike avoidance are sufficient to avoid the potential for ship strike. These include: A requirement that all vessel operators comply with 10 knot (18.5 kilometer (km)/hour) or less speed restrictions in any SMA or Dynamic Management Area (DMA); a requirement that all vessel operators reduce vessel speed to 10 knots (18.5 km/hour) or less when any large whale, any mother/calf pairs, pods, or large assemblages of non-delphinoid cetaceans are observed within 100 m of an underway vessel; a requirement that all survey vessels maintain a separation distance of 500 m or greater from any sighted North Atlantic right whale; a requirement that, if underway, vessels must steer a course away from any sighted North Atlantic right whale at 10 knots or less until the 500 m minimum separation distance has been established; and a requirement that, if a North Atlantic right whale is sighted in a vessel's path, or within 500 m of an underway vessel, the underway vessel must reduce speed and shift the engine to neutral. Additional measures to prevent the potential for ship strike are discussed in more detail below (see the Mitigation section). We have determined that the ship strike avoidance measures are sufficient to ensure the least practicable adverse impact on species or stocks and their habitat. We also note that vessel strike during surveys is extremely unlikely based on the low vessel speed; the survey vessel would maintain a speed of approximately 4 knots (7.4 km/hour) while transiting survey lines.

Comment 11: The NGOs recommended that NMFS account for the potential for indirect ship strike risk resulting from habitat displacement in our analyses.

NMFS Response: NMFS determined that habitat displacement was not an expected outcome of the specified activity, therefore an analysis of potential impacts to marine mammals from habitat displacement is not warranted in this case.

Comment 12: The NGOs recommended that NMFS consider any existing siting and acoustic data and any new information that improves our understanding of marine mammal distribution and habitat use in the region in order to inform seasonal restrictions and mitigation measures in time for the November 2018 North Atlantic right whale migration period.

NMFS Response: We base our analyses on the best available information to inform mitigation measures in incidental take authorizations, and will continue to do so. Beyond a broad recommendation, the commenters have not provided us with any specific recommendations regarding data sources to consider, but we welcome future input, outside the comment period for this particular IHA, from interested parties on data sources that may be of use in analyzing the potential presence and movement patterns of North Atlantic right whales.

Comment 13: The NGOs recommended that NMFS encourage offshore wind developers to partner with scientists to collect data that would increase the understanding of the effectiveness of night vision and infra-red technologies off Rhode Island, Massachusetts, and the broader region, with a view towards greater reliance on these technologies to commence surveys during nighttime hours in the future.

NMFS Response: NMFS agrees with the NGOs that improved data on relative effectiveness of night vision and infra-red technologies would be beneficial and could help to inform future efforts at detection of marine mammals during nighttime activities. The commenters have not provided us with any specific recommendations to evaluate beyond a broad recommendation. However, we will encourage coordination and communication between offshore wind developers and researchers on effectiveness of night vision and infra-red technologies, to the extent possible. In recognition of the commenters' concerns, we have also added a requirement that the final report submitted to NMFS must include an assessment of the effectiveness of night vision equipment used during nighttime surveys, including comparisons of relative effectiveness among the different types of night vision equipment used.

Sections 3 and 4 of DWW's IHA 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' Stock Assessment Reports (SAR; www.fisheries.noaa.gov/national/marine-mammal-protection/marine-mammal-stock-assessment-reports-region) and more general information about these species (e.g., physical and behavioral descriptions) may be found on NMFS' website (www.fisheries.noaa.gov/species-directory). All species that could potentially occur in the proposed survey area are included in Table 5 of the IHA application. However, the temporal and/or spatial occurrence of several species listed in Table 5 of the IHA application is such that take of these species is not expected to occur, and they are not discussed further beyond the explanation provided here. Take of these species is not anticipated either because they have very low densities in the project area, are known to occur further offshore than the project area, or are considered very unlikely to occur in the project area during the proposed survey due to the species' seasonal occurrence in the area.

Table 2 lists all species with expected potential for occurrence in the survey area and with the potential to be taken as a result of the proposed survey and summarizes information related to the population or stock, including regulatory status under the MMPA and ESA and potential biological removal (PBR), where known. For taxonomy, we follow Committee on Taxonomy (2017). 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' SARs). While no mortality is anticipated or authorized here, PBR is included here as a gross indicator 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' 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' U.S. Atlantic SARs (e.g., Hayes et al., 2018). All values presented in Table 2 are the most recent available at the time of publication and are available in the 2017 draft Atlantic SARs (Hayes et al., 2018).

Four marine mammal species that are listed under the Endangered Species Act (ESA) may be present in the survey area and are included in the take request: The North Atlantic right whale, fin whale, sei whale, and sperm whale.

Though marine mammal species other than those listed in Table 1 are known to occur in the Northwest Atlantic Ocean, the temporal and/or spatial occurrence of several of these species is such that take of these species is not expected to occur, and they are therefore not discussed further beyond the explanation provided here. Take of these species is not anticipated either because they have very low densities in the project area (e.g., blue whale, Clymene dolphin, pantropical spotted dolphin, striped dolphin, spinner dolphin, killer whale, false killer whale, pygmy killer whale,), or, they are known to occur further offshore than the project area (e.g., beaked whales, short-finned pilot whale, rough toothed dolphin, Kogia spp.).

For the majority of species potentially present in the specific geographic region, NMFS has designated only a single generic stock (e.g., “western North Atlantic”) for management purposes. This includes the “Canadian east coast” stock of minke whales, which includes all minke whales found in U.S. waters. For humpback and sei whales, NMFS defines stocks on the basis of feeding locations, i.e., Gulf of Maine and Nova Scotia, respectively. However, our reference to humpback whales and sei whales in this document refers to any individuals of the species that are found in the specific geographic region.

A detailed description of the species and stocks likely to be affected by DWW's survey, including brief introductions to the species and relevant stocks as well as available information regarding population trends and threats, and information regarding local occurrence, were provided in the Federal Register notice of the proposed IHA (83 FR 19711; May 4, 2018); since that time, we are not aware of any changes in the status of these species and stocks; therefore, detailed descriptions are not repeated here. Please refer to that Federal Register notice for these descriptions. Please also refer to NMFS' website (www.fisheries.noaa.gov/species-directory) for generalized species accounts.

Information concerning marine mammal hearing, including marine mammal functional hearing groups, was provided in the Federal Register notice of the proposed IHA (83 FR 19711; May 4, 2018), therefore that information is not repeated here. Please refer to that Federal Register notice for this information. For further information about marine mammal functional hearing groups and associated frequency ranges, please see NMFS (2016) for a review of available information. Fifteen marine mammal species (thirteen cetacean and two pinniped (both phocid) species) have the reasonable potential to co-occur with the survey activities. Please refer to Table 1. Of the cetacean species that may be present, five are classified as low-frequency cetaceans (i.e., all mysticete species), seven are classified as mid-frequency cetaceans (i.e., all delphinid species and the sperm whale), and one is classified as a high-frequency cetacean (i.e., harbor porpoise).

The effects of underwater noise from DWW's geophysical survey activities have the potential to result in behavioral harassment of marine mammals in the vicinity of the survey area. The Federal Register notice of the proposed IHA (83 FR 19711; May 4, 2018) included a discussion of the effects of anthropogenic noise on marine mammals and their habitat, therefore that information is not repeated here; please refer to that Federal Register notice for that information. No instances of hearing threshold shifts, injury, serious injury, or mortality are expected as a result of the planned activities.

This section provides an estimate of the number of incidental takes authorized through the IHA, which will inform both NMFS' consideration of “small numbers” 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, 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 are by Level B harassment, as use of the HRG equipment has the potential to result in disruption of behavioral patterns for individual marine mammals. NMFS has determined take by Level A harassment is not an expected outcome of the proposed activity and thus we do not authorize the take of any marine mammals by Level A harassment. This is discussed in greater detail below. As described previously, no mortality or serious injury is anticipated or authorized for this activity. Below we describe how the take is estimated for this project.

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 take estimate.

NMFS uses 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 permanent threshold shift (PTS) of some degree (equated to Level A harassment).

Level B Harassment—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 sound source (e.g., frequency, predictability, duty cycle); the environment (e.g., bathymetry); and the receiving animals (hearing, motivation, experience, demography, behavioral context); therefore can be difficult to predict (Southall et al., 2007, Ellison et al. 2012). NMFS uses a generalized acoustic threshold based on received level to estimate the onset of Level B (behavioral) harassment. NMFS predicts that marine mammals may be behaviorally harassed when exposed to underwater anthropogenic noise above received levels 160 dB re 1 μPa (rms) for non-explosive impulsive (e.g., seismic HRG equipment) or intermittent (e.g., scientific sonar) sources. DWW's activity includes the use of impulsive sources. Therefore, the 160 dB re 1 μPa (rms) criteria is applicable for analysis of Level B harassment.

Level A Harassment—NMFS' Technical Guidance for Assessing the Effects of Anthropogenic Sound on Marine Mammal Hearing (NMFS 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 Technical Guidance identifies the received levels, or thresholds, above which individual marine mammals are predicted to experience changes in their hearing sensitivity for all underwater anthropogenic sound sources, reflects the best available science, and better predicts the potential for auditory injury than does NMFS' historical criteria.

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 Table 2 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: www.nmfs.noaa.gov/pr/acoustics/guidelines.htm. As described above, DWW's activity includes the use of intermittent and impulsive sources.

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

The survey would entail the use of HRG survey equipment. The distance to the isopleth corresponding to the threshold for Level B harassment was calculated for all HRG survey equipment with the potential to result in harassment of marine mammals using the spherical transmission loss (TL) equation: TL = 20log10. Results of modeling indicated that, of the HRG survey equipment planned for use that has the potential to result in harassment of marine mammals, the AA Dura-Spark would be expected to produce sound that would propagate the furthest in the water (Table 3); therefore, for the purposes of the take calculation, it was assumed the AA Dura-Spark would be active during the entirety of the survey. Thus the distance to the isopleth corresponding to the threshold for Level B harassment for the AA Dura-Spark (estimated at 447 m; Table 3) was used as the basis of the Level B take calculation for all marine mammals.

Predicted distances to Level A harassment isopleths, which vary based on marine mammal functional hearing groups (Table 4), were also calculated. The updated acoustic thresholds for impulsive sounds (such as HRG survey equipment) contained in the Technical Guidance (NMFS, 2016) were presented as dual metric acoustic thresholds using both cumulative sound exposure level (SELcum) and peak sound pressure level metrics. As dual metrics, NMFS considers onset of PTS (Level A harassment) to have occurred when either one of the two metrics is exceeded (i.e., metric resulting in the largest isopleth).

The SELcum metric considers both level and duration of exposure, as well as auditory weighting functions by marine mammal hearing group. In recognition of the fact that calculating Level A harassment ensonified areas could be more technically challenging to predict due to the duration component and the use of weighting functions in the new SELcum thresholds, NMFS developed an optional User Spreadsheet that includes tools to help predict a simple isopleth that can be used in conjunction with marine mammal density or occurrence to facilitate the estimation of take numbers. DWW used the NMFS optional User Spreadsheet to calculate distances to Level A harassment isopleths based on SELcum. To calculate distances to the Level A harassment isopleths based on peak pressure, the spherical spreading loss model was used (similar to the method used to calculate Level B isopleths as described above).

Modeling of distances to isopleths corresponding to Level A harassment was performed for all types of HRG equipment planned for use with the potential to result in harassment of marine mammals. Of the HRG equipment types modeled, the AA Dura Spark resulted in the largest distances to isopleths corresponding to Level A harassment for all marine mammal functional hearing groups; therefore, to be conservative, the isopleths modeled for the AA Dura Spark were used to estimate potential Level A take. Based on a conservative assumption that the AA Dura Spark would be operated at 1,000 joules during the survey, a peak source level of 223 dB re 1μPa was used for modeling Level A harassment isopleths based on peak pressure (Crocker & Fratantonio, 2016). Inputs to the NMFS optional User Spreadsheet for the AA Dura Spark are shown in Table 4. Modeled distances to isopleths corresponding to Level A harassment thresholds for the AA Dura Spark are shown in Table 5 (modeled distances to Level A harassment isopleths for all other types of HRG equipment planned for use are shown in Table 6 of the IHA application). As described above, NMFS considers onset of PTS (Level A harassment) to have occurred when either one of the two metrics is exceeded (i.e., metric resulting in the largest isopleth). In this case, modeled distances to isopleths corresponding to the Level A harassment threshold are greater based on the peak SPL metric than the SELcum metric for all marine mammal functional hearing groups (Table 5).

Due to the small estimated distances to Level A harassment thresholds for all marine mammal functional hearing groups, based on both SELcum and peak SPL (Table 5), and in consideration of the mitigation measures (see the Mitigation section for more detail), NMFS has determined that the likelihood of Level A take of marine mammals occurring as a result of the planned survey is so low as to be discountable.

We note that because of some of the assumptions included in the methods used, isopleths produced may be overestimates to some degree. Most of the acoustic sources planned for use in DWW's survey (including the AA Dura Spark) do not radiate sound equally in all directions but were designed instead to focus acoustic energy directly toward the sea floor. Therefore, the acoustic energy produced by these sources is not received equally in all directions around the source but is instead concentrated along some narrower plane depending on the beamwidth of the source. However, the calculated distances to isopleths do not account for this directionality of the sound source and are therefore conservative. Two types of geophysical survey equipment planned for use in the planned survey are omni-directional, however the modeled distances to isopleths corresponding to the Level B harassment threshold for these sources are smaller than that for the Dura Spark, and the Dura Spark was used to conservatively estimate take for the duration of the survey. For mobile sources, such as the planned survey, the User Spreadsheet predicts the closest distance at which a stationary animal would not incur PTS if the sound source traveled by the animal in a straight line at a constant speed.

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

The best available scientific information was considered in calculating marine mammal exposure estimates (the basis for estimating take). For cetacean species, densities calculated by Roberts et al. (2016) were used. The density data presented by Roberts et al. (2016) incorporates aerial and shipboard line-transect survey data from NMFS and from other organizations collected over the period 1992-2014. Roberts et al. (2016) modeled density from 8 physiographic and 16 dynamic oceanographic and biological covariates, and controlled for the influence of sea state, group size, availability bias, and perception bias on the probability of making a sighting. NMFS considers the models produced by Roberts et al. (2016) to be the best available source of data regarding cetacean densities for this project. More information, including the model results and supplementary information for each model, is available online at: seamap.env.duke.edu/models/Duke-EC-GOM-2015/.

For the purposes of the take calculations, density data from Roberts et al. (2016) were mapped using a geographic information system (GIS), using density data for the months June through December. Mean density per month for each species within the survey area was calculated by selecting 13 random raster cells selected from 100 square kilometers (km2) raster cells that were inside, or adjacent to, the RI-MA WEA (see Figure 1 in the IHA application). Estimates provided by the models are based on a grid cell size of 100 km2; therefore, model grid cell values were then divided by 100 to determine animals per km2.

Systematic, offshore, at-sea survey data for pinnipeds are more limited than those for cetaceans. The best available information concerning pinniped densities in the planned survey area is the U.S. Navy's Operating Area (OPAREA) Density Estimates (NODEs) (DoN, 2007). These density models utilized vessel-based and aerial survey data collected by NMFS from 1998-2005 during broad-scale abundance studies. Modeling methodology is detailed in DoN (2007). For the purposes of the take calculations, NODEs Density Estimates (DoN, 2007) as reported for the summer and fall seasons were used to estimate harbor seal and gray seal densities.

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

In order to estimate the number of marine mammals predicted to be exposed to sound levels that would result in harassment, radial distances to predicted isopleths corresponding to harassment thresholds are calculated, as described above. Those distances are then used to calculate the area(s) around the HRG survey equipment predicted to be ensonified to sound levels that exceed harassment thresholds. The area estimated to be ensonified to relevant thresholds in a single day of the survey is then calculated, based on areas predicted to be ensonified around the HRG survey equipment and the estimated trackline distance traveled per day by the survey vessel. DWW estimates a maximum daily track line distance of 110 km per day during HRG surveys. Based on the maximum estimated distance to the Level B harassment threshold of 447 m (Table 3) and the maximum estimated daily track line distance of 110 km, an area of 98.9 km2 would be ensonified to the Level B harassment threshold per day during HRG surveys.

The number of marine mammals expected to be incidentally taken per day is then calculated by estimating the number of each species predicted to occur within the daily ensonified area, using estimated marine mammal densities as described above. Estimated numbers of each species taken per day are then multiplied by the number of survey days (i.e., 200), and the product is then rounded, to generate an estimate of the total number of each species expected to be taken over the duration of the survey (Table 6).

The applicant estimated a total of 11 takes by Level A harassment of harbor porpoises, 5 takes by Level A harassment of harbor seals, and 7 takes by Level A harassment of gray seals would occur, in the absence of mitigation. However, as described above, due to the very small estimated distances to Level A harassment thresholds (Table 5), and in consideration of the mitigation measures, the likelihood of the planned survey resulting in take in the form of Level A harassment is considered so low as to be discountable; therefore, we do not authorize take of any marine mammals by Level A harassment. Although there are no exclusion zones (EZs) required for pinnipeds, the estimated distance to the isopleth corresponding to the Level A harassment threshold for pinnipeds is less than 2 m (Table 6); therefore, we determined the likelihood of an animal being taken within this proximity of the survey equipment to be so low as to be discountable. Authorized take numbers are shown in Table 6.

Species with Take Estimates Less than Mean Group Size: Using the approach described above to estimate take, the take estimates for the sei whale, long-finned pilot whale, Risso's dolphin and Atlantic spotted dolphin were less than the average group sizes estimated for these species (Table 6). However, information on the social structures and life histories of these species indicates these species are often encountered in groups. The results of take calculations support the likelihood that the survey is expected to encounter and to incidentally take these species, and we believe it is likely that these species may be encountered in groups. Therefore it is reasonable to conservatively assume that one group of each of these species will be taken during the planned survey. We authorize the take of the average group size for these species and stocks to account for the possibility that the planned survey encounters a group of any of these species or stocks (Table 6). Note that the take estimate for the sperm whale was not increased to average group size because, based on water depths in the survey area (26 to 48 m (52 to 92 ft)), it is very unlikely that groups of sperm whales, which tend to occur at greater depths, would be encountered by the survey.

We note that the IHA authorizes take of Risso's dolphins, though authorization for the take of Risso's dolphins was not proposed in the Federal Register notice of the proposed IHA (83 FR 19711; May 4, 2018). Though density estimates for Risso's dolphins in the survey area indicate they would not be expected in the survey area, based on public comments and a review of monitoring data from a previous IHA issued for a similar activity in 2017 (NMFS, 2017) we have determined that take authorization for Risso's dolphins is warranted. The monitoring report from the IHA issued to Deepwater Wind in 2017 for HRG surveys in the RI-MA WEA indicates that a single group of Risso's dolphins was observed by PSOs (though not taken by Level A or Level B harassment) during that survey (AIS Inc., 2017). As the activities authorized through this IHA are similar to those conducted by DWW in 2017 (i.e., HRG surveys conducted within the RI-MA WEA) NMFS has determined the planned survey may encounter Risso's dolphins and thus it is appropriate to authorize the take of Risso's dolphins. As take modeling based on density estimates (e.g., Roberts et. al (2016)) indicated no Risso's dolphins would be taken by the survey, but we have determined take authorization for Risso's dolphins is warranted and Risso's dolphins may be encountered in groups, we have authorized the take of a group of Risso's dolphins, based on mean group size for the species (Table 6). We also note that the take estimate for gray seals has been revised from the number proposed for authorization. In the Federal Register notice of the proposed IHA (83 FR 19711; May 4, 2018), the take number proposed for gray seals was based on an incorrect density estimate. The average density of gray seals in the survey area was reported as 0.0941067 per km2; however the correct density is 0.14116 per km2. The correct density has been used to re-calculate the authorized number of gray seal takes (Table 6).

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 relative cost and impact on operations.

Based on the applicant's request, which includes requirements relating to the BOEM lease stipulations associated with ESA-listed marine mammals, and specific information regarding the zones ensonified above NMFS thresholds, NMFS is requiring the following mitigation measures during the marine site characterization surveys.

Marine mammal exclusion zones (EZ) will be established around the HRG survey equipment and monitored by protected species observers (PSO) during HRG surveys as follows:

• 500 m EZ for North Atlantic right whales;

• 200 m EZ for all other ESA-listed cetaceans (including fin whale, sei whale and sperm whale); and

• 25 m EZ for harbor porpoises.

The applicant proposed a 500 m EZ for North Atlantic right whales and 200 m EZ for all other marine mammals; however, for non-ESA-listed marine mammals, based on estimated distances to isopleths corresponding with Level A harassment thresholds (Table 5), we determined EZs for species other than those described above were not warranted. If HRG survey equipment is shut down (as described below) due to a marine mammal being observed within or approaching the relevant EZs, ramp up of survey equipment may not commence until the animal(s) has been observed exiting the relevant EZ, or until an additional time period has elapsed with no further sighting of the animal (e.g., 15 minutes for harbor porpoises and 30 minutes for all large whale species). In addition to the EZs described above, PSOs will visually monitor and record the presence of all marine mammals within a 500 m Watch Zone. Marine mammals observed by PSOs within 447 m of geophysical survey equipment will be documented as taken by Level B harassment.

As per the BOEM lease, visual and acoustic monitoring of the established exclusion and monitoring zones will be performed by qualified and NMFS-approved PSOs. It will be the responsibility of the Lead PSO on duty to communicate the presence of marine mammals as well as to communicate the action(s) that are necessary to ensure mitigation and monitoring requirements are implemented as appropriate. PSOs will be equipped with binoculars and would estimate distances to marine mammals located in proximity to the vessel and/or exclusion zone using range finders. Reticulated binoculars will also be available to PSOs for use as appropriate based on conditions and visibility to support the siting and monitoring of marine species. Position data will be recorded using hand-held or vessel GPS units for each sighting. Observations will take place from the highest available vantage point on the survey vessel. During surveys conducted at night, night-vision equipment with infrared light-emitting diodes spotlights and/or infrared video monitoring will be available for PSO use, and passive acoustic monitoring (described below) will be used.

Prior to initiating HRG survey activities, DWW will implement a 30-minute pre-clearance period. During this period, the PSOs will ensure that no North Atlantic right whales are observed within 500 m of geophysical survey equipment, and that no other marine mammal species are observed within 200 m of geophysical survey equipment. Surveys may not begin until these zones have been clear of the relevant marine mammal species for 30 minutes. This pre-clearance requirement would include small delphinoids that approach the vessel (e.g., bow ride). PSOs would also continue to monitor the zone for 30 minutes after survey equipment is shut down or survey activity has concluded.

As proposed by the applicant and required by BOEM lease stipulations, PAM will be used to support monitoring during night time operations to provide for optimal acquisition of species detections at night. The PAM system will consist of an array of hydrophones with both broadband (sampling mid-range frequencies of 2 kHz to 200 kHz) and at least one low-frequency hydrophone (sampling range frequencies of 75 hertz (Hz) to 30 kHz). The PAM operator(s) will monitor acoustic signals in real time both aurally (using headphones) and visually (via sound analysis software). PAM operators will communicate nighttime detections to the lead PSO on duty who will ensure the implementation of the appropriate mitigation measure.

Shutdown of geophysical survey equipment is required upon confirmed PAM detection of a North Atlantic right whale at night, even in the absence of visual confirmation, except in cases where the acoustic detection can be localized and the right whale can be confirmed as being beyond the 500 m EZ; equipment may be re-started no sooner than 30 minutes after the last confirmed acoustic detection. However, aside from the required shutdown for right whales as described above, PAM detection alone would not trigger a requirement for any mitigation action to be taken upon acoustic detection of marine mammals, per BOEM requirements.

As proposed by the applicant, where technically feasible, a ramp-up procedure will be used for geophysical survey equipment capable of adjusting energy levels at the start or re-start of survey activities. The ramp-up procedure will be used at the beginning of HRG survey activities in order to provide additional protection to marine mammals near the survey area by allowing them to detect the presence of the survey and vacate the area prior to the commencement of survey equipment use at full energy. Ramp-up of the survey equipment will not begin until the relevant EZs have been cleared by the PSOs, as described above. Systems will be initiated at their lowest power output and will be incrementally increased to full power. If any marine mammals are detected within the EZ prior to or during the ramp-up, HRG equipment will be shut down (as described below).

If a marine mammal is observed within or approaching the relevant EZ (as described above) an immediate shutdown of the survey equipment is required. Subsequent restart of the survey equipment may only occur after the animal(s) has either been observed exiting the relevant EZ or until an additional time period has elapsed with no further sighting of the animal (e.g., 15 minutes for harbor porpoises and 30 minutes for North Atlantic right, fin, sei and sperm whales).

In addition, shutdown of geophysical survey equipment is required upon confirmed PAM detection of a North Atlantic right whale at night, even in the absence of visual confirmation, except in cases where the acoustic detection can be localized and the right whale can be confirmed as being beyond the 500 m EZ; equipment may be re-started no sooner than 30 minutes after the last confirmed acoustic detection.

As required in the BOEM lease, if the HRG equipment shuts down for reasons other than mitigation (i.e., mechanical or electronic failure) resulting in the cessation of the survey equipment for a period greater than 20 minutes, a 30 minute pre-clearance period (as described above) will precede the restart of the HRG survey equipment. If the pause is less than 20 minutes, the equipment may be restarted as soon as practicable at its full operational level only if visual surveys were continued diligently throughout the silent period and the EZs remained clear of marine mammals during that entire period. If visual surveys were not continued diligently during the pause of 20 minutes or less, a 30-minute pre-clearance period (as described above) will precede the re-start of the HRG survey equipment. Following a shutdown, HRG survey equipment may be restarted following pre-clearance of the zones as described above.

If a species for which authorization has not been granted, or, a species for which authorization has been granted but the authorized number of takes have been met, approaches or is observed within an EZ or within the area encompassing the Level B harassment isopleth (450 m), shutdown will occur.

Vessel strike avoidance measures will include, but are not limited to, the following, as required in the BOEM lease, except under circumstances when complying with these requirements would put the safety of the vessel or crew at risk:

• All vessel operators and crew will maintain vigilant watch for cetaceans and pinnipeds, and slow down or stop their vessel to avoid striking these protected species;

• All survey vessels greater than or equal to 65 ft (19.8 m) in overall length will comply with 10 knot (18.5 km/hr) or less speed restriction in any SMA per the NOAA ship strike reduction rule (73 FR 60173; October 10, 2008);

• All vessel operators will reduce vessel speed to 10 knots (18.5 km/hr) or less when any large whale, any mother/calf pairs, or large assemblages of non-delphinoid cetaceans are observed near (within 100 m (330 ft)) an underway vessel;

• All survey vessels will maintain a separation distance of 500 m (1640 ft) or greater from any sighted North Atlantic right whale;

• If underway, vessels must steer a course away from any sighted North Atlantic right whale at 10 knots (18.5 km/hr) or less until the 500 m (1640 ft) minimum separation distance has been established. If a North Atlantic right whale is sighted in a vessel's path, or within 500 m (330 ft) to an underway vessel, the underway vessel must reduce speed and shift the engine to neutral. Engines will not be engaged until the North Atlantic right whale has moved outside of the vessel's path and beyond 500 m. If stationary, the vessel must not engage engines until the North Atlantic right whale has moved beyond 500 m;

• All vessels will maintain a separation distance of 100 m (330 ft) or greater from any sighted non-delphinoid cetacean. If sighted, the vessel underway must reduce speed and shift the engine to neutral, and must not engage the engines until the non-delphinoid cetacean has moved outside of the vessel's path and beyond 100 m. If a survey vessel is stationary, the vessel will not engage engines until the non-delphinoid cetacean has moved out of the vessel's path and beyond 100 m;

• All vessels will maintain a separation distance of 50 m (164 ft) or greater from any sighted delphinoid cetacean. Any vessel underway remain parallel to a sighted delphinoid cetacean's course whenever possible, and avoid excessive speed or abrupt changes in direction. Any vessel underway reduces vessel speed to 10 knots (18.5 km/hr) or less when pods (including mother/calf pairs) or large assemblages of delphinoid cetaceans are observed. Vessels may not adjust course and speed until the delphinoid cetaceans have moved beyond 50 m and/or the abeam of the underway vessel;

• All vessels will maintain a separation distance of 50 m (164 ft) or greater from any sighted pinniped; and

• All vessels underway will not divert or alter course in order to approach any whale, delphinoid cetacean, or pinniped. Any vessel underway will avoid excessive speed or abrupt changes in direction to avoid injury to the sighted cetacean or pinniped.

DWW will ensure that vessel operators and crew maintain a vigilant watch for cetaceans and pinnipeds by slowing down or stopping the vessel to avoid striking marine mammals. Project-specific training will be conducted for all vessel crew prior to the start of the site characterization survey activities. Confirmation of the training and understanding of the requirements will be documented on a training course log sheet. Signing the log sheet will certify that the crew members understand and will comply with the necessary requirements throughout the survey activities.

The northern section of the survey area partially overlaps with a portion of a North Atlantic right whale SMA which occurs east of Long Island, New York, and south of Massachusetts and Rhode Island. This SMA is active from November 1 through April 30 of each year. Survey vessels that are >65 ft in length would be required to adhere to the mandatory vessel speed restrictions (<10 kn) when operating within the SMA during times when the SMA is active. In addition, between watch shifts, members of the monitoring team would consult NMFS' North Atlantic right whale reporting systems for the presence of North Atlantic right whales throughout survey operations. Members of the monitoring team would monitor the NMFS North Atlantic right whale reporting systems for the establishment of a Dynamic Management Area (DMA). If NMFS should establish a DMA in the survey area, within 24 hours of the establishment of the DMA DWW would coordinate with NMFS to shut down and/or alter the survey activities as needed to avoid right whales to the extent possible.

The mitigation measures are designed to avoid the already low potential for injury in addition to some Level B harassment, and to minimize the potential for vessel strikes. There are no known marine mammal rookeries or mating grounds in the survey area that would otherwise potentially warrant increased mitigation measures for marine mammals or their habitat (or both). The planned survey would occur in an area that has been identified as a biologically important area for migration for North Atlantic right whales. However, given the small spatial extent of the survey area relative to the substantially larger spatial extent of the right whale migratory area, the survey is not expected to appreciably reduce migratory habitat nor to negatively impact the migration of North Atlantic right whales, thus mitigation to address the survey's occurrence in North Atlantic right whale migratory habitat is not warranted. The survey area would partially overlap spatially with a biologically important feeding area for fin whales. However, the fin whale feeding area is sufficiently large (2,933 km2), and the acoustic footprint of the planned survey is sufficiently small (<100 km2 estimated to be ensonified to the Level B harassment threshold per day), that the survey is not expected to appreciably reduce fin whale feeding habitat nor to negatively impact the feeding of fin whales, thus mitigation to address the survey's occurrence in fin whale feeding habitat is not warranted. Further, we believe the mitigation measures are practicable for the applicant to implement.

Based on our evaluation of the applicant's proposed measures, NMFS has determined that the mitigation measures provide the means of effecting the least practicable impact on the affected species or stocks and their habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance.

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 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 survey 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 cumulative impacts from multiple stressors;

• How anticipated responses to stressors impact either: (1) Long-term fitness and survival of individual marine mammals; or (2) populations, species, or stocks;

• Effects on marine mammal habitat (e.g., marine mammal prey species, acoustic habitat, or other important physical components of marine mammal habitat); and

• Mitigation and monitoring effectiveness.

As described above, visual monitoring of the EZs and monitoring zone will be performed by qualified and NMFS-approved PSOs. PSO Qualifications will include completion of a PSO training course and documented field experience conducting similar surveys. As proposed by the applicant and required by BOEM, an observer team comprising a minimum of four NMFS-approved PSOs and a minimum of two certified PAM operator(s), operating in shifts, will be employed by DWW during the planned surveys. PSOs and PAM operators will work in shifts such that no one monitor will work more than 4 consecutive hours without a 2 hour break or longer than 12 hours during any 24 hour period. During daylight hours the PSOs will rotate in shifts of one on and three off, while during nighttime operations PSOs will work in pairs. The PAM operators will also be on call as necessary during daytime operations should visual observations become impaired. Each PSO will monitor 360 degrees of the field of vision.

Also as described above, PSOs will be equipped with binoculars and have the ability to estimate distances to marine mammals located in proximity to the vessel and/or exclusion zone using range finders. Reticulated binoculars will also be available to PSOs for use as appropriate based on conditions and visibility to support the sighting and monitoring of marine species. During night operations, PAM and night-vision equipment with infrared light-emitting diode spotlights and/or infrared video monitoring will be used to increase the ability to detect marine mammals. Position data will be recorded using hand-held or vessel global positioning system (GPS) units for each sighting. Observations will take place from the highest available vantage point on the survey vessel. General 360-degree scanning will occur during the monitoring periods, and target scanning by the PSO will occur when alerted of a marine mammal presence.

Data on all PAM/PSO observations will be recorded, including dates, times, and locations of survey operations; time of observation, location and weather; details of marine mammal sightings (e.g., species, numbers, behavior); and details of any observed taking (e.g., behavioral disturbances or injury/mortality).

Within 90 days after completion of survey activities, a final technical report will be provided to NMFS that fully documents the methods and monitoring protocols, summarizes the data recorded during monitoring, summarizes the number of marine mammals estimated to have been taken during survey activities (by species, when known), summarizes the mitigation actions taken during surveys (including what type of mitigation and the species and number of animals that prompted the mitigation action, when known), and provides an interpretation of the results and effectiveness of all mitigation and monitoring. Any recommendations made by NMFS must be addressed in the final report prior to acceptance by NMFS.

In addition to the final technical report, DWW will provide the reports described below as necessary during survey activities. In the unanticipated event that DWW's survey activities lead to an injury (Level A harassment) or mortality (e.g., ship-strike, gear interaction, and/or entanglement) of a marine mammal, DWW would immediately cease the specified activities and report the incident to the Chief of the Permits and Conservation Division, Office of Protected Resources and the NMFS Greater Atlantic Stranding Coordinator. The report would include the following information:

• Time, date, and location (latitude/longitude) of the incident;

• Name and type of vessel involved;

• Vessel's speed during and leading up to the incident;

• Description of the incident;

• Status of all sound source use in the 24 hours preceding the incident;

• Water depth;

• Environmental conditions (e.g., wind speed and direction, Beaufort sea state, cloud cover, and visibility);

• Description of all marine mammal observations in the 24 hours preceding the incident;

• Species identification or description of the animal(s) involved;

• Fate of the animal(s); and

• Photographs or video footage of the animal(s) (if equipment is available).

Activities would not resume until NMFS is able to review the circumstances of the event. NMFS would work with DWW to minimize reoccurrence of such an event in the future. DWW would not resume activities until notified by NMFS.

In the event that DWW discovers an injured or dead marine mammal and determines that the cause of the injury or death is unknown and the death is relatively recent (i.e., in less than a moderate state of decomposition), DWW would immediately report the incident to the Chief of the Permits and Conservation Division, Office of Protected Resources and the NMFS Greater Atlantic Stranding Coordinator. The report would include the same information identified in the paragraph above. Activities would be able to continue while NMFS reviews the circumstances of the incident. NMFS would work with DWW to determine if modifications in the activities are appropriate.

In the event that DWW discovers an injured or dead marine mammal and 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, or scavenger damage), DWW would report the incident to the Chief of the Permits and Conservation Division, Office of Protected Resources, and the NMFS Greater Atlantic Regional Stranding Coordinator, within 24 hours of the discovery. DWW would provide photographs or video footage (if available) or other documentation of the stranded animal sighting to NMFS. DWW may continue its operations under such a case.

NMFS has defined negligible impact 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).

To avoid repetition, our analysis applies to all the species listed in Table 6, given that NMFS expects the anticipated effects of the planned survey to be similar in nature.

NMFS does not anticipate that injury or mortality would occur as a result of DWW's planned survey, even in the absence of mitigation. Thus the IHA does not authorize any injury or mortality. As discussed in the Potential Effects section, non-auditory physical effects and vessel strike are not expected to occur.

We expect that all potential takes would be in the form of short-term Level B behavioral harassment in the form of temporary avoidance of the area or decreased foraging (if such activity were occurring), reactions that are considered to be of low severity and with no lasting biological consequences (e.g., Southall et al., 2007). Potential impacts to marine mammal habitat were discussed in the Federal Register notice of the proposed IHA (83 FR 19711; May 4, 2018) (see Potential Effects of the Specified Activity on Marine Mammals and their Habitat). Marine mammal habitat may be impacted by elevated sound levels, but these impacts would be temporary. In addition to being temporary and short in overall duration, the acoustic footprint of the planned survey is small relative to the overall distribution of the animals in the area and their use of the area. Feeding behavior is not likely to be significantly impacted. Prey species are mobile and are broadly distributed throughout the project area; therefore, marine mammals that may be temporarily displaced during survey activities are expected to be able to resume foraging once they have moved away from areas with disturbing levels of underwater noise. Because of the temporary nature of the disturbance and the availability of similar habitat and resources in the surrounding area, the impacts to marine mammals and the food sources that they utilize are not expected to cause significant or long-term consequences for individual marine mammals or their populations.

There are no rookeries or mating grounds known to be biologically important to marine mammals within the planned survey area. As described above, the survey area would overlap spatially and temporally with a biologically important feeding area for fin whales. The important fin whale feeding area occurs from March through October and stretches from an area south of Montauk Point to south of Martha's Vineyard. However, the fin whale feeding area is sufficiently large (2,933 km2), and the acoustic footprint of the planned survey is sufficiently small (<100 km2 estimated to be ensonified to the Level B harassment threshold per day), that fin whale feeding habitat would not be reduced appreciably. Any fin whales temporarily displaced from the survey area would be expected to have sufficient remaining feeding habitat available to them, and would not be prevented from feeding in other areas within the biologically important feeding habitat. In addition, any displacement of fin whales from the survey area would be expected to be temporary in nature. Therefore, we do not expect fin whale feeding to be negatively impacted by the planned survey. There are no feeding areas known to be biologically important to marine mammals within the project area with the exception of the aforementioned feeding area for fin whales. There is no designated critical habitat for any ESA-listed marine mammals in the survey area.

The survey area is within a biologically important migratory area for North Atlantic right whales (effective March-April and November-December) that extends from Massachusetts to Florida (LaBrecque, et al., 2015). Off the south coast of Massachusetts and Rhode Island, this biologically important migratory area extends from the coast to beyond the shelf break. Due to the fact that that the survey is temporary and short in overall duration, and the fact that the spatial acoustic footprint of the planned survey is very small relative to the spatial extent of the available migratory habitat in the area, right whale migration is not expected to be impacted by the planned survey.

The mitigation measures are expected to reduce the number and/or severity of takes by (1) giving animals the opportunity to move away from the sound source before HRG survey equipment reaches full energy; (2) preventing animals from being exposed to sound levels that may otherwise result in injury. Additional vessel strike avoidance requirements will further mitigate potential impacts to marine mammals during vessel transit to and within the survey area.

NMFS concludes that exposures to marine mammal species and stocks due to DWW's survey would result in only short-term (temporary and short in duration) effects to individuals exposed. Marine mammals may temporarily avoid the immediate area, but are not expected to permanently abandon the area. Major shifts in habitat use, distribution, or foraging success are not expected. NMFS does not anticipate the authorized take estimates to impact annual rates of recruitment or survival.

In summary and as described above, the following factors primarily support our 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, serious injury, or Level A harassment is anticipated or authorized;

• The anticipated impacts of the activity on marine mammals would be temporary behavioral changes due to avoidance of the area around the survey vessel;

• The availability of alternate areas of similar habitat value for marine mammals to temporarily vacate the survey area during the planned survey to avoid exposure to sounds from the activity;

• The project area does not contain areas of significance for mating or calving;

• Effects on species that serve as prey species for marine mammals from the survey would be temporary and would not be expected to reduce the availability of prey or to affect marine mammal feeding;

• The mitigation measures, including visual and acoustic monitoring, exclusion zones, and shutdown measures, are expected to minimize potential impacts to marine mammals.

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 monitoring and mitigation measures, NMFS finds that the total marine mammal take from the specified activity will have a negligible impact on all affected marine mammal species or stocks.

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 numbers of marine mammals that we authorize to be taken, for all species and stocks, would be considered small relative to the relevant stocks or populations (less than 11 percent of each species and stock). See Table 6. Based on the analysis contained herein of the proposed activity (including the mitigation and monitoring measures) and the anticipated take of marine mammals, NMFS finds that small numbers of marine mammals will be taken relative to the population size of the affected species or stocks.

There are no relevant subsistence uses of the affected marine mammal stocks or species implicated by this action. Therefore, NMFS has 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.

Section 7(a)(2) of the Endangered Species Act of 1973 (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 NMFS Greater Atlantic Regional Fisheries Office (GARFO), whenever we propose to authorize take for endangered or threatened species.

The NMFS Office of Protected Resources is authorizing the incidental take of four species of marine mammals which are listed under the ESA: The North Atlantic right, fin, sei, and sperm whale. BOEM consulted with NMFS GARFO under section 7 of the ESA on commercial wind lease issuance and site assessment activities on the Atlantic Outer Continental Shelf in Massachusetts, Rhode Island, New York and New Jersey Wind Energy Areas. The NMFS GARFO issued a Biological Opinion concluding that these activities may adversely affect but are not likely to jeopardize the continued existence of the North Atlantic right, fin, and sperm whale. The Biological Opinion can be found online at: www.fisheries.noaa.gov/national/marine-mammal-protection/incidental-take-authorizations-other-energy-activities-renewable. Upon request from the NMFS Office of Protected Resources, the NMFS GARFO will issue an amended incidental take statement associated with this Biological Opinion to include the takes of the ESA-listed marine mammal species authorized through this IHA.

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. Accordingly, NMFS prepared an Environmental Assessment (EA) and analyzed the potential impacts to marine mammals that would result from the project, as well as from a similar project proposed by Garden State Offshore Energy (a subsidiary of Deepwater Wind) off the coast of Delaware. A Finding of No Significant Impact (FONSI) was signed on June 13, 2018. A copy of the EA and FONSI is available online at: www.fisheries.noaa.gov/national/marine-mammal-protection/incidental-take-authorizations-other-energy-activities-renewable.

NMFS has issued an IHA to Deepwater Wind New England, LLC for conducting marine site characterization surveys offshore of Rhode Island and Massachusetts and along potential submarine cable routes, for a period of one year, provided the previously mentioned mitigation, monitoring, and reporting requirements are incorporated.

Presidential Executive Order (E.O.) 13795, Implementing an America-First Offshore Energy Strategy (82 FR 20815; April 28, 2017), states in section 2 that “It shall be the policy of the United States to encourage energy exploration and production, including on the Outer Continental Shelf, in order to maintain the Nation's position as a global energy leader and foster energy security and resilience for the benefit of the American people, while ensuring that any such activity is safe and environmentally responsible.”

Among the requirements of E.O. 13795 is section 10, which called for a review of NMFS' Technical Guidance as follows: “The Secretary of Commerce shall review [NMFS' Technical Guidance] for consistency with the policy set forth in Section 2 of this order and, after consultation with the appropriate Federal agencies, take all steps permitted by law to rescind or revise that guidance, if appropriate.”

The 2016 Technical Guidance referred to in E.O. 13795 is a technical document that compiles, interprets, and synthesizes scientific literature to produce updated received levels, or acoustic thresholds, above which individual marine mammals under NMFS' jurisdiction are predicted to experience changes in their hearing sensitivity (either temporary or permanent) for all underwater human-made sound sources. It is intended for use by NMFS analysts and managers and other relevant user groups and stakeholders, including other Federal agencies, when seeking to determine whether and how their activities are expected to result in hearing impacts to marine mammals via acoustic exposure. The Technical Guidance helps evaluate a proposed activity within a comprehensive effects analysis. It can inform decisions related to mitigation and monitoring requirements, but it does not mandate any specific mitigation. The Technical Guidance does not address or change NMFS' application of standards in the regulatory context, under applicable statutes, and does not create or confer any rights for or on any person, or operate to bind the public (i.e., the use of the Technical Guidance is not mandatory).

The Office of Management and Budget previously classified the Technical Guidance as a Highly Influential Scientific Assessment (HISA). As such, the document underwent three independent peer reviews, at three different stages its development, including a follow-up to one of the peer reviews, prior to its dissemination by NMFS in 2016. Details of each peer review are included within the Technical Guidance (Appendix C), and specific peer reviewer comments and NMFS' responses are at https://www.fisheries.noaa.gov/national/marine-mammal-protection/marine-mammal-acoustic-technical-guidance. In addition to three independent peer reviews, there were three public comment periods. The Federal Register Notice of Availability for the 2016 Guidance (81 FR 51694; August 4, 2016) summarizes substantive public comments and NMFS' responses.

To assist the Secretary of Commerce in the review of the Technical Guidance for consistency with the policy in section 2 of E.O. 13795, NMFS solicited public comment via a 45-day public comment period (82 FR 24950; May 31, 2017). Additionally, on September 25, 2017, NMFS hosted an Interagency Consultation meeting with representatives from the Bureau of Ocean Energy Management (BOEM), Department of State, Federal Highway Administration, Marine Mammal Commission, National Park Service, National Science Foundation, U.S. Air Force, U.S. Army Corps of Engineers, U.S. Geological Survey, and U.S. Navy.

During the public comment period, NMFS received 62 comments from Federal agencies (Bureau of Ocean Energy Management, U.S. Navy, and Marine Mammal Commission), oil and gas industry representatives, Members of Congress, subject matter experts, non-governmental organizations, and members of the public. Most of the comments (85%) recommended no changes to the Technical Guidance. No public commenter suggested rescinding the Technical Guidance. The U.S. Navy, Marine Mammal Commission, Members of Congress, and subject matter experts expressed support for the Technical Guidance's auditory injury thresholds as reflecting the best available science. The remaining comments (15%) focused on additional scientific publications for consideration or recommended revisions to improve implementation of the Technical Guidance.

At the Federal Interagency Consultation meeting, none of the Federal agencies recommended rescinding the Technical Guidance. They expressed support for the Technical Guidance's auditory injury thresholds and the science behind their derivation. Comments received at the meeting focused on improvements to implementation of the Technical Guidance.

During both the public comment period and the Interagency meeting, three key topic areas were raised: (1) The limited scientific data on the impacts of sound on baleen whale hearing; (2) the need to determine accurate sound exposure durations for all species of marine mammals; and (3) the need to improve the Technical Guidance's optional User Spreadsheet tool. Commenters also encouraged the agency to establish working groups to address these data gaps and future needs.

In response to the feedback received during the public comment period and the Interagency meeting, NMFS has improved the Technical Guidance and updated User Spreadsheet tool in several ways. Since none of the public commenters or Federal agencies offered additional scientific data to modify the auditory injury thresholds, including those for baleen whales, no changes are warranted on that topic at this time. Nevertheless, NMFS plans to convene a working group later in 2018 to continue to examine and refine the auditory injury thresholds for baleen whales as more scientific data become available. Also, since none of the public commenters or Federal agencies offered additional scientific data to modify the sound exposure durations for all species of marine mammals, no specific changes are warranted on that topic at this time either. Nevertheless, NMFS plans to convene a working group later in 2018 to evaluate sound exposure durations to determine whether revisions are appropriate for future updates of the Technical Guidance based on any new information.

To help applicants implement the Technical Guidance and optional User Spreadsheet tool, NMFS has: (a) Drafted a new User Manual for the optional User Spreadsheet that provides more detailed instructions and examples on how to use it and plans to submit this User Manual for public comment later in 2018 to gain input from stakeholders and inform future versions of this manual; (b) modified the optional User Spreadsheet to provide additional capabilities to assess auditory injury thresholds; (c) modified the current optional User Spreadsheet tool to facilitate assessing auditory injury thresholds for commonly used sound source; (d) modified the Technical Guidance to be more reflective of an updated international standard specifically developed for underwater acoustics that became available after the documents finalization in 2016; (e) included a summary and preliminary analysis of relevant scientific literature published since the 2016 Technical Guidance's finalization; and (f) updated the Technical Guidance to include the Navy's finalized version of their 2016 Technical Report that was used to derive the Technical Guidance's auditory injury thresholds.

The 2018 Revision to the Technical Guidance (NOAA Technical Memorandum NMFS-OPR-59) with the updated User Spreadsheet tool and the new companion User Manual is available in electronic form via the internet at https://www.fisheries.noaa.gov/national/marine-mammal-protection/marine-mammal-acoustic-technical-guidance.

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 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).

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 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 Categorical Exclusion B4 (incidental harassment authorizations with no anticipated serious injury or mortality) 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 determined that the issuance of the IHA qualifies to be categorically excluded from further NEPA review.

On January 22, 2018, NMFS received a request from WETA for an IHA to take marine mammals incidental to expansion and improvements at the downtown San Francisco ferry terminal. The application was determined to be adequate and complete on April 10, 2018. WETA's request was for take of seven species of marine mammals by Level A and Level B harassment. This authorization is valid from June 1, 2018 to May 31, 2019. Neither WETA nor NMFS expect serious injury or mortality to result from this activity and, therefore, an IHA is appropriate.

NMFS previously issued an IHA to WETA for similar work (82 FR 29521; June 29, 2017). WETA complied with all the requirements (e.g., mitigation, monitoring, and reporting) of the previous IHA and information regarding their monitoring results may be found in the “Estimated Take” section.

WETA is planning to expand berthing capacity at the Downtown San Francisco Ferry Terminal, located at the San Francisco Ferry Building, to support existing and future planned water transit services operated on San Francisco Bay by WETA and WETA's emergency operations. The Downtown San Francisco Ferry Terminal Expansion Project includes the construction of three new water transit gates and overwater berthing facilities, in addition to supportive landside improvements, such as additional passenger waiting and queueing areas, circulation improvements, and other water transit-related amenities. The new gates and other improvements would be designed to accommodate future planned water transit services between Downtown San Francisco and Antioch, Berkeley, Martinez, Hercules, Redwood City, Richmond, and Treasure Island, as well as emergency operation needs. The new gates will be constructed using 81 steel piles, ranging in diameter from 24 to 36 inches (in). All piles will be driven during the authorized in-water work window of June 1 to November 30, 2018.

A detailed description of the planned terminal expansion project is provided in the Federal Register notice for the proposed IHA (83 FR 18507; April 27, 2018). Since that time, no changes have been made to the planned construction activities. Therefore, a detailed description is not provided here. Please refer to that Federal Register notice for the description of the specific activity.

A notice of NMFS's proposal to issue an IHA to WETA was published in the Federal Register on April 27, 2018 (83 FR 18507). That notice described, in detail, WETA's activity, the marine mammal species that may be affected by the activity, and the anticipated effects on marine mammals. During the 30-day public comment period, NMFS received comments from the Marine Mammal Commission (Commission).

Comment 1: The Commission noted minor errors and missing information in the text of the notice and the proposed authorization. The Commission recommends that NMFS review its notices more thoroughly before submitting for publication.

Response 1: NMFS thanks the Commission for pointing out the errors in the Federal Register notice for the proposed authorization. NMFS has addressed those errors in the notice of issuance of the authorization. NMFS makes every effort to read notices thoroughly prior to publication and will continue this effort to publish the best possible product for public comment.

Comment 2: The Commission stated its concerns over the appropriateness of the manner in which Level A harassment zones are estimated. The Commission pointed out that for impact driving of 36-inch piles, the Level A harassment zone for high-frequency cetaceans was estimated to be 602 meters, which is greater than the 341 meter Level B harassment zone. The Commission recommended that NMFS consult with both internal and external scientists and acousticians to determine the relevant accumulation time that could result in Level A harassment based on associated permanent threshold shift from cumulative sound exposure levels.

Response 2: NMFS understands the Commission's concerns and continues to work to improve Level A harassment zone estimation based on realistic noise propagation models and energy accumulation scheme. Currently, Level A harassment zones are based on exposure of cumulative sound exposure levels over a period of one working day's pile driving duration or instantaneous peak sound pressure level, while Level B harassment zones are based on instantaneous root-mean-squared sound pressure level that contains 90 percent of acoustic energy. The difference in the metrics between sound exposure levels and sound pressure level in assessing Level A and Level B harassments reflects the fact that prolonged exposure of intense noise could lead to permanent threshold shift if the animal chooses to stay within the injury zone. Occasionally, the conservative assumptions built into the User Spreadsheet result in Level A zones that are larger than Level B zones. The process of impact assessments will continue to evolve as more scientific data become available.

Comment 3: The Commission recommended that NMFS refrain from using a source level reduction factor for sound attenuation device implementation during impact pile driving for all relevant incidental take authorizations due to the different noise level reduction at different received ranges.

Response 3:While it is true that noise level reduction measured at different received ranges does vary, given that both Level A and Level B estimation using geometric modeling is based on noise levels measured at near-source distances (~ 10m), NMFS believes it reasonable to use a source level reduction factor for sound attenuation device implementation during impact pile driving. In the case of the SF-OBB impact driving isopleth estimates using an air bubble curtain for source level reduction, NMFS reviewed Caltrans' bubble curtain “on and off” studies conducted in San Francisco Bay in 2003 and 2004. The equipment used for bubble curtains has likely improved since 2004 but due to concerns for fish species, Caltrans has not able to conduct “on and off” tests recently. Based on 74 measurements (37 with the bubble curtain on and 37 with the bubble curtain off) at both near (<100 m) and far (>100 m) distances, the linear averaged received level reduction is 6 dB. If limiting the data points (a total of 28 measurements, with 14 during bubble curtain on and 14 during bubble curtain off) to only near distance measurements, the linear averaged noise level reduction is 7 dB. Since impact zone analysis using geometric spreading model is typically based on measurements at near-source distance, we consider it appropriate to use a reduction of 7 dB as a noise level reduction factor for impact pile driving using an air bubble curtain system.

NMFS will evaluate the appropriateness of using a certain source level reduction factor for sound attenuation device implementation during impact pile driving for all relevant incidental take authorizations when more data become available.

Comment 4: The Commission recommended that NMFS promptly revise its draft rounding criteria and share it with the Commission.

Response 4: NMFS appreciates the Commission's ongoing concern in this matter. Calculating predicted take is not an exact science and there are arguments for taking different mathematical approaches in different situations, and for making qualitative adjustments in other situations. We believe, however, that the methodology used for take calculation in this IHA remains appropriate and is not at odds with the 24-hour reset policy the Commission references. We look forward to continued discussion with the Commission on this matter and will share the rounding guidance as soon as it is completed.

Comment 5: The Commission expressed concern about the lack of adequate time to provide public comments as well as the abbreviated timeframes during which NMFS is able to address public comments. The Commission recommended that NMFS ensure that it publishes and finalizes proposed IHAs sufficiently before the planned start date of the proposed activities to ensure full consideration is given to all comments received.

Response 5: NMFS will work to provide adequate time for public comment and response. NMFS also seeks to process IHA applications in a more expeditious manner.

Comment 6: The Commission requested clarification regarding certain issues associated with NMFS's notice that one-year renewals could be issued in certain limited circumstances and expressed concern that the process would bypass the public notice and comment requirements. The Commission also suggested that NMFS should discuss the possibility of renewals through a more general route, such as a rulemaking, instead of notice in a specific authorization. The Commission further recommended that if NMFS did not pursue a more general route, that the agency provide the Commission and the public with a legal analysis supporting our conclusion that this process is consistent with the requirements of section 101(a)(5)(D) of the MMPA.

Response 6: The process of issuing a renewal IHA does not bypass the public notice and comment requirements of the MMPA. The notice of the proposed IHA expressly notifies the public that under certain, limited conditions an applicant could seek a renewal IHA for an additional year. The notice describes the conditions under which such a renewal request could be considered and expressly seeks public comment in the event such a renewal is sought. Importantly, such renewals would be limited to circumstances where: The activities are identical or nearly identical to those analyzed in the proposed IHA; monitoring does not indicate impacts that were not previously analyzed and authorized; and, the mitigation and monitoring requirements remain the same, all of which allow the public to comment on the appropriateness and effects of a renewal at the same time the public provides comments on the initial IHA. NMFS has, however, modified the language for future proposed IHAs to clarify that all IHAs, including renewal IHAs, are valid for no more than one year and that the agency would consider only one renewal for a project at this time. In addition, notice of issuance or denial of a renewal IHA would be published in the Federal Register, as they are for all IHAs. Last, NMFS will publish on our website a description of the renewal process before any renewal is issued utilizing the new process.

A detailed description of the species likely to be affected by WETA's actions, including brief introductions to the species and relevant stocks as well as available information regarding population trends and threats, and information regarding local occurrence, are provided in WETA's application and the Federal Register notice for the proposed IHA (83 FR 18507; April 27, 2018). We are not aware of any changes in the status of these species and stocks; therefore, detailed descriptions are not provided here. Please refer to that Federal Register notice for these descriptions. Please refer to additional species information available in the NMFS stock assessment reports for the Pacific at https://www.fisheries.noaa.gov/resource/document/us-pacific-marine-mammal-stock-assessments-2016.

Table 1 lists all species with expected potential for occurrence near downtown San Francisco and summarizes information related to the population or stock, including regulatory status under the MMPA and ESA and potential biological removal (PBR), where known. 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 Stock Assessment Reports (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 SARs (Caretta et al., 2017). All values presented in Table 1 are the most recent available at the time of publication and are available in the 2016 SARs (Caretta et al., 2017).

All species that could potentially occur in the project area are included in Table 1. However, the temporal and/or spatial occurrence of humpback whales and Guadalupe fur seals is such that take is not expected to occur, and they are not discussed further beyond the explanation provided here. Humpback whales are rare visitors to the interior of San Francisco Bay. A recent, seasonal influx of humpback whales inside San Francisco Bay near the Golden Gate was recorded from April to November in 2016 and 2017 (Keener 2017). The Golden Gate is outside of this project's action area and humpback whales are not expected to be present during the project. Guadalupe fur seals occasionally range into the waters of Northern California and the Pacific Northwest. The Farallon Islands (off central California) and Channel Islands (off southern California) are used as haulouts during these movements (Simon 2016). Juvenile Guadalupe fur seals occasionally strand in the vicinity of San Francisco, especially during El Niño events. Most strandings along the California coast are animals younger than two years old, with evidence of malnutrition (NMFS 2017c). In the rare event that a Guadalupe fur seal or humpback whale is detected within the Level A or Level B harassment zones, work will cease until the animal has left the area (see “Mitigation”).

Information concerning marine mammal hearing, including marine mammal functional hearing groups, was provided in the Federal Register notice for the proposed IHA (83 FR 18507; April 27, 2018), therefore that information is not repeated here; please refer to that Federal Register notice for this information. For further information about marine mammal functional hearing groups and associated frequency ranges, please see NMFS (2016) for a review of available information. Seven marine mammal species (three cetacean and four pinniped (two phocid and two otariid) species) have the reasonable potential to co-occur with the construction activities. Of the cetacean species that may be present, one is classified as a low-frequency cetacean (i.e., gray whale), one is classified as a mid-frequency cetacean (i.e., bottlenose dolphin), and one is classified as a high-frequency cetacean (i.e., harbor porpoise).

The effects of underwater noise from pile driving activities for the Ferry Terminal Expansion Project have the potential to result in behavioral harassment of marine mammals in the vicinity of the action area. The Federal Register notice for the proposed IHA (83 FR 18507; April 27, 2018) included a discussion of the effects of anthropogenic noise on marine mammals, therefore that information is not repeated here; please refer to the Federal Register notice for that information. No instances of hearing threshold shifts, injury, serious injury, or mortality are expected as a result of the planned activities.

The main impact to habitat associated with the Ferry Terminal Expansion Project would be temporarily increased sound levels and the associated direct effects on marine mammals. The project would not result in permanent impacts to habitats used by marine mammals, such as haulout sits, but may have potential short-term impacts to food sources such as fish and minor impacts to the immediate substrate during installation of piles. These potential effects are discussed in detail in the Federal Register notice for the proposed IHA (83 FR 18507; April 27, 2018), therefore that information is not repeated here; please refer to that Federal Register notice for that information.

This section provides an estimate of the number of incidental takes authorized through this IHA, which will inform both NMFS' consideration of “small numbers” 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 primarily be by Level B harassment as exposure to acoustic sources (i.e., impact and vibratory pile driving) has the potential to result in disruption of behavioral patterns for individual marine mammals. There is also some potential for auditory injury (Level A harassment) to result, primarily for harbor seals and California sea lions due to larger predicted auditory injury zones. Auditory injury is unlikely to occur for cetaceans. The mitigation and monitoring measures are expected to minimize the severity of such taking to the extent practicable.

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 take estimate.

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 permanent threshold shift (PTS) of some degree (equated to Level A harassment).

Level B Harassment—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, Ellison et al., 2011). 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 decibels (dB) re 1 microPascal (μPa) (root mean square (rms)) for continuous (e.g., vibratory pile-driving, drilling) and above 160 dB re 1 μPa (rms) for non-explosive impulsive (e.g., seismic airguns and impact pile driving) or intermittent (e.g., scientific sonar) sources.

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

Level A harassment - NMFS' Technical Guidance for Assessing the Effects of Anthropogenic Sound on Marine Mammal Hearing (Technical Guidance, 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). WETA's activity includes the use of impulsive (impact pile driving) and non-impulsive (vibratory pile driving) sources.

These thresholds 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.

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

In-Water Disturbance during Vibratory Pile Driving—Level B behavioral disturbance may occur incidental to the use of a vibratory or impact hammer due to propagation of underwater noise during installation of new steel piles. A total of 81 steel piles will be installed at the Ferry Terminal. During the 2017 construction season, all piles were installed using a vibratory hammer. The hydroacoustic monitoring conducted for vibratory driving during the 2017 season has been used to establish the expected source values of piles driven during the 2018 construction season. The SLs were measured at 10 m for the 30- and 36-in piles and between 9 and 15 m for the 24-in piles. The SLs for 24-in piles were calculated using the measured values from 9 to 15 m normalized to 10 m. The median RMS values were used as the SLs to estimate take from vibratory driving. These values are provided in Table 3.

Additionally, monitoring conducted during 2017 construction established that for vibratory pile driving in the project area, the transmission loss is greater than the standard value of 15 used in typical take calculations. For estimating take from vibratory pile driving, Level B harassment zones were calculated using the average transmission loss measured during pile driving from June through August of 2017 minus one standard deviation of those measurements (22.26 − 3.51 = 18.75). Additional pile driving in September and November of 2017 yielded a mean transmission loss of 19.0. The F value originally calculated (18.75) is comparable to the final reported average and is slightly more conservative, and was therefore used to calculate the harassment zones from vibratory pile driving. Using the calculated transmission loss model (18.75logR), the in-water Level B harassment zones were determined for each pile size (Table 4). For 24-in steel piles driven with a vibratory hammer, the Level B harassment zone is expected to be 651 m (2,136 ft). For 30-in piles, the Level B harassment zone is expected to be 450 m (1,476 ft). For 36-in piles, the Level B harassment zone is expected to be 940 m (3,084 ft).

In-Water Disturbance During Impact Pile Driving—As stated previously, all piles installed in the 2017 construction season were installed solely using a vibratory hammer. However, the use of an impact hammer to install piles may be required; therefore, the effects of impact pile driving is discussed here. Level B behavioral disturbance may occur incidental to the use of an impact hammer due to the propagation of underwater noise during the installation of steel piles. Piles will be driven to approximately 120 to 140 ft below Mean Lower Low Water (MLLW). Installation of these pipe piles may require up to 1,800 strikes per piles from an impact hammer using a DelMag D46-32, or similar diesel hammer, producing approximately 122,000 foot-pounds maximum energy per blow, and 1.5 seconds per blow average.

Other projects constructed under similar circumstances were reviewed to estimate the approximate noise produced by the 24-, 30, and 36-in steel piles. These projects include the driving of similarly sized piles at the Alameda Bay Ship and Yacht project, the Rodeo Dock Repair project, and the Amorco Wharf Repair Project (Caltrans 2012). Bubble curtains will be used during the installation of these piles, which, based on guidance provided by Caltrans for a mid-sized steel piles (with a diameter greater than 24 but less than 48 in), is expected to reduce noise levels by 7 dB rms (Caltrans 2015a).

Because no impact pile driving was used in the 2017 construction season, no site-specific transmission loss measurements exist for this project. The Practical Spreading Loss Model (15logR) is used to determine the Level B harassment zones for each pile size (Table 4). Both 24- and 30-in steel piles have a SL of 183 dB rms re 1 µPa and therefore have the same Level B harassment zone of 341 m (1,120 ft). For 36-in piles, the Level B harassment zone is expected to be 541 m (1,775 ft).

Background

On June 6, 2018, NMFS published a notice of intent (NOI) and scoping announcement (83 FR 26267) to provide background information and to request public comment on potential adjustments to the Bluefish Fishery Management Plan (FMP) through an allocation amendment. The NOI provides the public with a formal opportunity to comment on the specific ideas mentioned in the scoping document, as well as any additional ideas and solutions that could improve Bluefish FMP.

In the original notice, the established comment period ended on July 6, 2018, before the last four scoping hearings were scheduled to take place, and without adequate time to receive public comment following the hearings. This correction extends the comment period to July 30, 2018, to appropriately encompass all of the scoping hearings, and to provide the Commission more time to accept final comments. In addition to the extension of the comment period, the location of the scoping hearing in Dover, Delaware, needed to be changed due to building availability. The date and time of this meeting (Thursday, June 21, 2018, at 6:00 p.m.) will remain the same.

In FR Doc. 2018-12105, in the Federal Register of Wednesday, June 6, 2018, on page 26268, in the second column of the table, in the fifth line, the address for the Delaware scoping hearing is corrected to read as follows:

Title; Associated Form; and OMB Number: TRICARE Select Enrollment, Disenrollment, and Change Form; DD Form 3043; OMB Control Number 0720-0061.

Type of Request: Extension.

Number of Respondents: 99,300.

Responses per Respondent: 1.

Annual Responses: 99,300.

Average Burden per Response: 15 minutes.

Annual Burden Hours: 24,825.

Needs and Uses: The information collection requirement is necessary to obtain each non-active duty TRICARE beneficiary's personal information needed to: (1) Complete his/her enrollment into the TRICARE Select health plan option, (2) dis-enroll a beneficiary, or (3) change a beneficiary's enrollment information (e.g., address, add a dependent, report other health insurance). This information is required to ensure the beneficiary's TRICARE benefits and claims are administered based on their TRICARE plan of choice. Without this new enrollment form, each non-active duty TRICARE beneficiary is automatically defaulted into direct care, limiting their health care options to military hospitals and clinics. These beneficiaries would have no TRICARE coverage when using the TRICARE network of providers for services not available at their local military hospital or clinic.

Affected Public: Individuals or Households.

Frequency: On occasion.

Respondent's Obligation: Voluntary.

OMB Desk Officer: Ms. Cortney Higgins.

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.

Requests for copies of the information collection proposal should be sent to Mr. Licari at [email protected].

The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that is described below. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.

Title of Collection: National Assessment of Educational Progress (NAEP) 2019 and 2020.

OMB Control Number: 1850-0928.

Type of Review: A revision of an existing information collection.

Respondents/Affected Public: Individuals or Households.

Total Estimated Number of Annual Responses: 712,888.

Total Estimated Number of Annual Burden Hours: 379,934.

Abstract: The National Assessment of Educational Progress (NAEP), conducted by the National Center for Education Statistics (NCES), is a federally authorized survey of student achievement at grades 4, 8, and 12 in various subject areas, such as mathematics, reading, writing, science, U.S. history, civics, geography, economics, technology and engineering literacy (TEL), and the arts. The National Assessment of Educational Progress Authorization Act (Pub. L. 107-279 Title III, section 303) requires the assessment to collect data on specified student groups and characteristics, including information organized by race/ethnicity, gender, socio-economic status, disability, and limited English proficiency. It requires fair and accurate presentation of achievement data and permits the collection of background, noncognitive, or descriptive information that is related to academic achievement and aids in fair reporting of results. The intent of the law is to provide representative sample data on student achievement for the nation, the states, and subpopulations of students and to monitor progress over time. The nature of NAEP is that burden alternates from a relatively low burden in national-level administration years to a substantial burden increase in state-level administration years when the sample has to allow for estimates for individual states and some of the large urban districts. The request to conduct NAEP 2017-2019 was approved in August 2016, with the latest change requests approved in March 2018 (OMB# 1850-0928 v.1-9). This request updates the scope, sampling, procedures, and materials to be used in NAEP in 2019 and 2020, including operational assessments, pilot tests, and special studies. The NAEP results will be reported to the public through the Nation's Report Card as well as other online NAEP tools.

The Department of Energy (DOE), Office of Fossil Energy (FE), is responsible for authorizing exports of domestically produced natural gas, including liquefied natural gas (LNG), to foreign nations pursuant to section 3 of the Natural Gas Act (NGA).1 Under section 3(a) of the NGA, DOE/FE reviews applications to export natural gas to countries with which the United States has not entered into a free trade agreement (FTA) requiring national treatment for trade in natural gas and with which trade is not prohibited by U.S. law or policy (non-FTA countries).2 NGA section 3(a) states that DOE “shall issue such order upon application, unless, after opportunity for hearing, it finds that the proposed exportation or importation will not be consistent with the public interest.” 3 DOE has consistently interpreted this provision as creating a rebuttable presumption that a proposed export of natural gas is in the public interest.4 Accordingly, DOE will conduct an informal adjudication and grant an application to export LNG to non-FTA countries under NGA section 3(a) unless DOE finds that the proposed exportation will not be consistent with the public interest.5 Additionally, under section 16 of the NGA, DOE is authorized to “prescribe, issue, make, amend, and rescind such [export] orders . . . as it may find necessary or appropriate . . .” to satisfy its statutory responsibilities.6

To date, DOE/FE has issued 29 final long-term authorizations to export LNG and compressed natural gas to non-FTA countries in a cumulative volume totaling 21.35 billion cubic feet per day of natural gas (approximately 7.79 trillion cubic feet per year).7 Each of these authorizations has a term of 20 years, with additional time provided for LNG export operations to commence. In each authorization, DOE/FE has included a statement acknowledging its authority under NGA section 16 to “make, amend, and rescind such [export] orders . . . as it may find necessary or appropriate . . . .” to satisfy its statutory responsibilities.8

In these authorizations, DOE has stated that “[s]ome commenters [have] asked DOE to clarify the circumstances under which the agency would exercise its authority to revoke (in whole or in part) previously issued LNG export authorizations.” 9 In response, DOE has stated that it “cannot precisely identify all the circumstances under which such action would be taken.” 10 DOE has maintained, however, that “ `[i]n the event of any unforeseen developments of such significant consequence as to put the public interest at risk, DOE/FE is fully authorized to take action as necessary to protect the public interest.' ” 11

DOE/FE has never rescinded a long-term non-FTA export authorization for any reason. Further, DOE has no record of ever having vacated or rescinded an authorization to import or export natural gas over the objections of the authorization holder.12

DOE has rescinded (or “vacated”) one long-term LNG export authorization to FTA countries (see supra note 2)—DOE/FE Order No. 3482, issued to Louisiana LNG Energy LLC (LLNG) on August 28, 2014.13 DOE/FE vacated this order in 2017 on the basis of LLNG's own prolonged inaction, after LLNG effectively self-terminated its proposed LNG export project.14 Specifically, LLNG: (i) Failed to participate in its on-going FERC process, such that FERC terminated LLNG's pre-filing review process; 15 and (ii) failed to comply with its DOE/FE reporting obligations under the terms of its FTA order, for a period of more than 18 months.16 Throughout this 18-month time period, DOE/FE made repeated efforts to contact LLNG, with no success.17 Even after DOE/FE issued an Order to Show Cause—inviting LLNG to respond and explain the circumstances—LLNG took no action.18 The evidence clearly showed that LLNG neither wished to move forward with its proposed LNG export facility nor to maintain its FTA authorization.19 DOE/FE therefore vacated LLNG's FTA authorization under NGA section 16, but it did so without objection by LLNG and without prejudice to LLNG, should LLNG wish to seek an export LNG authorization in the future.20

The LLNG proceeding was a highly unusual scenario where all evidence indicated that the company was no longer pursuing its proposed LNG export project and had, in fact, ceased to exist as a commercial operation. In vacating LLNG's FTA order without prejudice, DOE responded appropriately in both implementing its statutory authority under NGA section 16 and in upholding the integrity of its natural gas regulatory program under 10 CFR part 590.

Potential importers of U.S. LNG and financiers of LNG export projects (collectively, interested stakeholders) have expressed concern about DOE/FE rescinding one or more non-FTA export authorizations in the future. In raising this concern, they point to the language in the existing non-FTA authorizations (quoted above) in which DOE/FE has observed its authority under NGA section 16 to “make, amend, and rescind such [export] orders . . . as it may find necessary or appropriate . . . .” Citing DOE/FE's language, they have asked what potential “developments” in the U.S. LNG market could rise to the level of “such significant consequence as to put the public interest at risk”—such that DOE would unilaterally rescind one or more non-FTA export authorizations or take other action to protect the public interest under NGA section 3(a).

As a preliminary matter, DOE/FE wishes to allay concerns about the security of existing (or future) non-FTA export authorizations. In this policy statement, DOE/FE affirms its commitment to all export authorizations issued under the NGA, including long-term authorizations approving the export of LNG to non-FTA countries. As indicated above, DOE/FE currently has issued 29 final non-FTA export authorizations, based on a thorough consideration of the public interest under section 3(a) of the NGA. In each of these proceedings, DOE/FE reviewed a substantial administrative record addressing factors including economic impacts, international impacts, security of natural gas supply, and environmental impacts, among others. In granting each application, DOE/FE concluded that exports of U.S. LNG will generate net economic benefits to the broader U.S. economy and will provide energy security and environmental benefits to the global community (including emerging economies presently reliant upon more carbon intensive fuels).21

DOE/FE stands firmly behind these factual findings and legal conclusions—many of which have been challenged and upheld in federal court.22 Authorization holders, as well as any interested stakeholders, thus should have the utmost confidence in the validity of DOE/FE's LNG export authorizations for the full term of each non-FTA order. Indeed, as noted above, DOE has never rescinded a non-FTA export authorization for any reason. DOE has vacated one FTA order under NGA section 16, but the circumstances of that proceeding were based solely on the inaction of the authorization holder.23

As a matter of law, DOE preserves its authority to take action as necessary or appropriate to carry out its duties under the NGA.24 However, DOE does not foresee a scenario where it would rescind one or more non-FTA authorizations. The United States government takes very seriously the investment-backed expectations of private parties subject to its regulatory jurisdiction. In particular, DOE understands the far-ranging economic investments and natural gas supply commitments associated with these authorizations over their full term—affecting both U.S. and global interests. DOE emphasizes that it remains committed to the durability and stability of the export authorizations it has granted under the NGA, as well as to supporting the approved export of U.S. natural gas around the world.

The EPA is reviewing the primary NAAQS for sulfur oxides as required under section 109 (42 U.S.C. 7409) of the Clean Air Act (CAA). The EPA's proposed decision to retain the current primary NAAQS for sulfur oxides without revision was published in the Federal Register on June 8, 2018 (83 FR 26752). The Federal Register notice of the proposed decision specified a 45-day public comment period and indicated that a public hearing would be held during the public comment period if one was requested by June 15, 2018. On June 8, we received a request for a public hearing. In keeping with the schedule of this NAAQS review, which is governed by a consent decree, the date for the public hearing will be July 10, 2018. Further, consistent with CAA section 307(d)(5) (42 U.S.C. 7607(d)(5)), this notice additionally extends the public comment period by 17 days, until August 9, 2018.

The public hearing will provide interested parties the opportunity to present data, views, or arguments concerning the EPA's proposed decision in the current review of the primary NAAQS for sulfur oxides. The EPA may ask clarifying questions during the oral presentations, but will not respond to the presentations at that time. If you would like to present oral testimony at the hearing, please register using the online registration form available at: https://www.epa.gov/so2-pollution/primary-national-ambient-air-quality-standard-naaqs-sulfur-dioxide or notify Ms. Regina Chappell, U.S. Environmental Protection Agency, OAQPS (Mail Code C304-03), Research Triangle Park, NC 27711, telephone number: (919) 541-3650; fax number (919) 541-0942; email: [email protected], no later than 4:00 p.m. ET on July 6, 2018. Ms. Chappell will arrange a general time slot for you to speak. The EPA will make every effort to follow the schedule as closely as possible on the day of the hearing. Oral testimony will be limited to 5 minutes for each commenter. The EPA encourages commenters to provide the EPA with a copy of their oral testimony electronically (via email) or in hard copy form. Commenters should notify Ms. Chappell if they need specific translation services for non-English speaking commenters.

The public hearing will convene at 9:00 a.m. and end at 6:00 p.m. ET or 2 hours after the last registered speaker has spoken, whichever is earlier. The EPA will make every effort to accommodate all individuals interested in providing oral testimony. A lunch break is scheduled from 12:00 p.m. until 1:00 p.m. The hearing schedule, including the list of speakers, will be posted on the EPA's website at https://www.epa.gov/so2-pollution/primary-national-ambient-air-quality-standard-naaqs-sulfur-dioxide prior to the hearing. Verbatim transcripts of the hearing and written statements will be included in the docket for the action.

This hearing will be held at a U.S. government facility. Individuals planning to attend the hearing should be prepared to show valid picture identification, such as a driver's license, to the security staff in order to gain access to the meeting room. However, driver's licenses from states and territories that do not comply with the REAL ID Act will not be accepted as identification. The REAL ID Act, passed by Congress in 2005, established new requirements for entering federal facilities. These requirements took effect on July 21, 2014. If your driver's license is issued by American Samoa, you must present an alternative form of identification to enter the federal building where the public hearing will be held. Acceptable alternative forms of identification include: Federal employee badges, passports, enhanced driver's licenses and military identification cards. For additional information for the status of your state regarding the REAL ID Act, go to https://www.dhs.gov/real-id-enforcement-brief. For additional information on building access and alternative forms of identification, go to https://www.epa.gov/aboutepa/visiting-epa-headquarters.

The EPA has established a docket for this action under Docket ID No. EPA-HQ-OAR-2013-0566 (available at https://www.regulations.gov). The EPA has also made available information related to the proposed action on the following website: https://www.epa.gov/so2-pollution/primary-national-ambient-air-quality-standard-naaqs-sulfur-dioxide.

Titles and Form Number: EIB 18-02 Itemized Statement of Payments—US Costs for EXIM Credit Guarantee Facility.

OMB Number: XXXX-XXXX.

Type of Review: NEW.

Need and Use: The information collected will assist in determining compliance of disbursement requests for U.S. goods and services submitted to EXIM lenders under CGF transactions.

Affected Public: This form affects EXIM borrowers involved in financing U.S. goods and services under CGF transactions.

Annual Number of Respondents: 12.

Estimated Time per Respondent: 150 minutes.

Annual Burden Hours: 30 hours.

Frequency of Reporting or Use: As needed.

Government Expenses: None.

This form is submitted by the borrower to the CGF lender for review. The lender reports information regarding the disbursement electronically to EXIM using OMB Number 3048-0046 CGF (EIB 12-02) Disbursement Approval Request Report.

Titles and Form Number: EIB 18-05 Itemized Statement of Payments Long-term Guarantee and Direct Loan—Local Costs.

OMB Number: XXXX-XXXX.

Type of Review: NEW.

Need and Use: The information collected will assist in determining compliance of disbursement requests for local cost goods and services submitted to EXIM through an electronic disbursement portal under certain long-term guarantee and direct loan transactions.

Affected Public: This form affects EXIM borrowers involved in financing local cost goods and services under certain long-term guarantee and direct loan transactions.

Annual Number of Respondents: 25.

Estimated Time per Respondent: 30 minutes.

Annual Burden Hours: 12.5 hours.

Frequency of Reporting or Use: As needed.

Government Expenses:

Reviewing Time per Year: 12.5 hours.

Average Wages per Hour: $42.50.

Average Cost per Year: $531.25 (time * wages).

Benefits and Overhead: 20%.

Total Government Cost: $637.50.

Titles and Form Number: EIB 18-04 Itemized Statement of Payments—Long-term Guarantees and Direct Loans—U.S. Costs.

OMB Number: XXXX-XXXX.

Type of Review: NEW.

Need and Use: The information collected will assist in determining compliance of disbursement requests for U.S. goods and services submitted to EXIM through an electronic disbursement portal under certain long-term guarantee and direct loan transactions.

Affected Public: This form affects EXIM borrowers involved in financing U.S. goods and services under certain long-term guarantee and direct loan transactions.

Annual Number of Respondents: 75.

Estimated Time per Respondent: 150 minutes.

Annual Burden Hours: 187.5 hours.

Frequency of Reporting or Use: As needed.

Government Expenses:

Reviewing Time per Year: 187.5 hours.

Average Wages per Hour: $42.50.

Average Cost per Year: $7,968.75 (time * wages).

Benefits and Overhead: 20%.

Total Government Cost: $9,562.50.

Titles and Form Number: EIB 18-03 Itemized Statement of Payments—Local Costs for EXIM Credit Guarantee Facility.

OMB Number: XXXX-XXXX.

Type of Review: NEW.

Need and Use: The information collected will assist in determining compliance of disbursement requests for local cost goods and services submitted to EXIM lenders under CGF transactions.

Affected Public: This form affects EXIM borrowers involved in financing local cost goods and services under CGF transactions.

Annual Number of Respondents: 6.

Estimated Time per Respondent: 75 minutes.

Annual Burden Hours: 7.5 hours.

Frequency of Reporting or Use: As needed.

Government Expenses: None.

This form is submitted by the borrower to the CGF lender for review. The lender reports information regarding the disbursement electronically to EXIM using OMB Number 3048-0046 CGF (EIB 12-02) Disbursement Approval Request Report.

On June 15, 1984, the Office of Management and Budget (OMB) delegated to the Board authority under the Paperwork Reduction Act (PRA) to approve of and assign OMB control numbers to collection of information requests and requirements conducted or sponsored by the Board. Board-approved collections of information are incorporated into the official OMB inventory of currently approved collections of information. Copies of the Paperwork Reduction Act Submission, supporting statements and approved collection of information instrument(s) are placed into OMB's public docket files. The Board may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.

Report title: Federal Reserve Clearance for Board Public website Usability Surveys.

Agency form number: FR 3076.

OMB control number: 7100-0366.

Frequency: As needed.

Respondents: Individuals.

Estimated number of respondents: Surveys: 100, Focus Groups: 20.

Estimated average hours per response: Surveys: 0.25, Focus Groups: 1.5.

Estimated annual burden hours: 420.

General description of report: The FR 3076 is used to gather qualitative and quantitative information directly from users or potential users of the Board's website such as Congress, other government agencies, the public, economic educators, economists, financial institutions, financial literacy groups, and community development groups and more. Participation is voluntary.

The FR 3076 may seek information from users or potential users of various Board web pages, including press releases, data releases and downloads, reports, supervision manuals, brochures, new web pages, audio, video, and use of social media. Information gathered may also include general input on users' interests and needs, feedback on website navigation and layout, distribution channels, or other factors which may affect the ability of users to locate and access content online.

Qualitative surveys conducted using the FR 3076 would include data gathering methods such as focus groups and individual interviews. Quantitative surveys conducted using the FR 3076 would include surveys conducted online or via mobile device, by phone or by mail, emails, or a combination of these methods. The Board may contract with an outside vendor to conduct focus groups, interviews, or surveys, or the Board may collect the data directly.

As the Board's public website continues to evolve, the Board may seek input from users or potential users of Board's public website on questions such as the following:

• Did you find the content and layout relevant and of value?

• How did you find the content you were looking for?

• Was the navigation useful?

• How did you learn about the content?

• How did you access the content? (e.g.: Paper copy distributed at an event, online, or mobile device). If online or through a mobile device, was the document printed, viewed on a tablet, or on a computer screen?

• What suggestions do you have for improving the format and appearance of online presentation? (e.g.: Readability—font size, charts, and graphs; organization of information; and navigating—indexing, search tools, and links)

What other information would be of value to enhance the online tool or information?

Legal authorization and confidentiality: The Board uses its website and social media to communicate important information to the public about a variety of different issues. The Board is required to provide certain information on its website. For example, under section 2B of the Federal Reserve Act the Board is required to provide certain reports, audits, and other information that “the Board reasonably believes is necessary or helpful to the public in understanding the accounting, financial reporting, and internal controls of the Board and the Federal reserve banks.” (12 U.S.C. 225b(c)). In addition, the Board uses its website to provide the public with information about a variety of other matters, including information about the Board, its actions, and the economy. The responses to the FR 3076 help the Board determine how to most effectively communicate this information to the public in order to fulfill its statutory responsibilities. The FR 3076 is voluntary. The information collected by the FR 3076 is not considered to be confidential.

Current actions: On April 5, 2018 the Board published a notice in the Federal Register (83 FR 14640) requesting public comment for 60 days on the extension, without revision, of the Federal Reserve Clearance for Board Public website Usability Surveys. The comment period for this notice expired on June 4, 2017. The Board did not receive any comments.

(1) Oral Argument In the Matter of 1-800 Contacts, Inc., Docket No. 9372.

(2) Executive Session to follow Oral Argument In the Matter of 1-800 Contacts, Inc., Docket No. 9372.

On June 15, 2018, the five Commissioners were recorded as voting in the affirmative to conduct Matter Number One in open session, and to close Matter Number Two, and to withhold from this meeting notice such information as is exempt from disclosure under 5 U.S.C. 552b(c).

The Commission has determined that Matter Number Two may be closed under 5 U.S.C. 552b(c)(10), and that the public interest does not require the matter to be open.

The General Counsel has certified that Matter Number Two may properly be closed, citing the following relevant exemptive provision: 5 U.S.C. 552b(c)(10).

Expected to attend the closed meeting are the Commissioners themselves, an advisor to one of the Commissioners, and such other Commission staff as may be appropriate.

The Superfund Amendments and Reauthorization Act of 1986 (SARA) [42 U.S.C. 9601 et seq.] amended the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA or Superfund) [42 U.S.C. 9601 et seq.] by establishing certain requirements for ATSDR and the U.S. Environmental Protection Agency (EPA) regarding hazardous substances that are most commonly found at facilities on the CERCLA National Priorities List (NPL). Among these statutory requirements is a mandate for the Administrator of ATSDR to prepare toxicological profiles for each substance included on the priority list of hazardous substances [also called the Substance Priority List (SPL)]. This list identifies 275 hazardous substances that ATSDR and EPA have determined pose the most significant potential threat to human health. The SPL is available online at www.atsdr.cdc.gov/spl.

In addition, CERCLA provides ATSDR with the authority to prepare toxicological profiles for substances not found on the SPL. CERCLA authorizes ATSDR to establish and maintain inventory of literature, research, and studies on the health effects of toxic substances (CERCLA section 104(i)(1)(B)); to respond to requests for health consultations (CERCLA section 104(i)(4)); and to support the site-specific response actions conducted by the agency.

There have been two previous Public Comment periods for the Perfluoroalkyls toxicological profile, one in 2009 (74 FR 36492) and 2015 (80 FR 53157). Due to the public comments received to both notices, as well as new literature, we have revised the previous draft profile (including a revised Minimal Risk Level); therefore, ATSDR is releasing a revised draft profile for public comment.

The Draft Toxicological Profiles are available online at http://www.atsdr.cdc.gov/ToxProfiles and at www.regulations.gov, Docket No. ATSDR-2015-0004.

The National Occupational Research Agenda (NORA) is a partnership program created to stimulate innovative research and improved workplace practices. The national agenda is developed and implemented through the NORA sector and cross-sector councils. Each council develops and maintains an agenda for its sector or cross-sector.

Background: The National Occupational Research Agenda for Healthcare and Social Assistance (HCSA) is intended to identify the research, information, and actions most urgently needed to prevent occupational injuries. The National Occupational Research Agenda for HCSA provides a vehicle for stakeholders to describe the most relevant issues, gaps, and safety and health needs for the sector. Each NORA research agenda is meant to guide or promote high priority research efforts on a national level, conducted by various entities, including: government, higher education, and the private sector.

The first National Occupational Research Agenda for HCSA was published in 2009 for the second decade of NORA (2006-2016). The revised agenda was developed considering new information about injuries and illnesses, the state of the science, and the probability that new information and approaches will make a difference. As the steward of the NORA process, NIOSH invites comments on the draft National Occupational Research Agenda for HCSA. Comments expressing support or with specific recommendations to improve the Agenda are requested. A copy of the draft Agenda is available at https://www.regulations.gov (see Docket Number CDC-2018-0050).

Agenda: The committee will discuss new drug applications 209816, for omadacycline tablets, and 209817, for omadacycline injection, sponsored by Paratek Pharmaceuticals, Inc., for the proposed indications for the treatment of community acquired bacterial pneumonia and acute bacterial skin and skin structure infections.

FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's website after the meeting. Background material is available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting link.

Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. All electronic and written submissions submitted to the Docket (see ADDRESSES) on or before July 24, 2018, will be provided to the committee. Oral presentations from the public will be scheduled between approximately 11 a.m. and 12 noon. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before July 16, 2018. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by July 17, 2018.

Persons attending FDA's advisory committee meetings are advised that FDA is not responsible for providing access to electrical outlets.

For press inquiries, please contact the Office of Media Affairs at [email protected] or 301-796-4540.

FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Lauren Tesh (see FOR FURTHER INFORMATION CONTACT) at least 7 days in advance of the meeting.

FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our website at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures on public conduct during advisory committee meetings.

Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).

I. Background

FDA is announcing the availability of a draft guidance for industry entitled “Major Depressive Disorder: Developing Drugs for Treatment.” The purpose of this draft guidance is to assist sponsors in the clinical development of drugs for the monotherapeutic, combination, and adjunctive treatment of MDD. Specifically, this draft guidance addresses FDA's current thinking regarding the overall development program and clinical trial designs for antidepressant drug products. This draft guidance is intended to serve as a focus for continued discussions among FDA, pharmaceutical sponsors, the academic community, and the public.

This draft guidance revises the guidance for industry entitled “Guidelines for the Clinical Evaluation of Antidepressant Drugs” issued in September 1977. Major revisions were made to the 1977 guidance to align it with the FDA's current thinking on this topic.

This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on developing drugs for the treatment of MDD. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866.

This draft guidance refers to previously approved collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR parts 312 and 314 have been approved under OMB control numbers 0910-0014 and 0910-0001, respectively.

Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.

I. Background

FDA is announcing the availability of a draft guidance for industry entitled “Prescription Drug User Fee Waivers, Reductions, and Refunds for Drug and Biological Products.” This draft guidance provides recommendations to applicants regarding requests for waivers, reductions, or refunds of user fees assessed under sections 735 and 736 (21 U.S.C. 379g and 379h) of the Federal Food, Drug, and Cosmetic (FD&C) Act. This revised draft guidance describes the types of waivers, reductions, and refunds permitted under the user fee provisions of the FD&C Act and the procedures for submitting requests for waivers, reductions, refunds, and requests for reconsiderations or appeals. The revised draft guidance also provides additional clarification on certain issues such as user fee exemptions for orphan drugs and FDA's current thinking on considerations relevant to eligibility for user fee waivers, reductions, and refunds under the applicable statutory provisions.

This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on “Prescription Drug User Fee Waivers, Reductions, and Refunds for Drug and Biological Products.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This draft guidance is not subject to Executive Order 12866.

Under the Paperwork Reduction Act (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. “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.

The information collection of this draft guidance has been submitted for OMB renewal of approval under OMB control number 0910-0693. In addition, the collection of information associated with Form FDA 3397 has been previously approved under OMB control number 0910-0297. Collection of information associated with new drug application or biologics license applications have been previously approved under OMB control numbers 0910-0001 and 0910-0338, respectively. See section X of the draft guidance document.

Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.

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. “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 (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, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (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 through the use of automated collection techniques, when appropriate, and other forms of information technology.

This information collection supports Agency implementation of the Drug Quality and Security Act (DQSA) (Pub. L. 113-54), which amended the FD&C Act by adding new section 503B (21 U.S.C. 353b).

This notice solicits comments on adverse event reporting for outsourcing facilities under section 503B of the FD&C Act.

Under section 503B(b), a compounder can register as an outsourcing facility with FDA. If the conditions outlined in section 503B(a) of the FD&C Act are satisfied, a drug compounded by or under the direct supervision of a licensed pharmacist in an outsourcing facility is exempt from certain sections of the FD&C Act, including section 502(f)(1) (21 U.S.C. 352(f)(1)) (concerning the labeling of drugs with adequate directions for use) and section 505 (21 U.S.C. 355) (concerning the approval of human drug products under new drug applications (NDAs) or abbreviated new drug applications (ANDAs)). Drugs compounded in outsourcing facilities are not exempt from the requirements of section 501(a)(2)(B) of the FD&C Act (21 U.S.C. 351(a)(2)(B)) (concerning current good manufacturing practice for drugs).

Under section 503B(b)(5), an outsourcing facility must submit adverse event reports to FDA in accordance with the content and format requirements established through guidance or regulation under 21 CFR 310.305 (or any successor regulations). Accordingly, we developed the document, “Guidance for Industry: Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act”.1 The guidance explains electronic reporting of adverse events in accordance with § 310.305 with respect to outsourcing facilities.

Under § 310.305(c)(1), manufacturers, packers, and distributors of marketed prescription drug products that are not the subject of an approved NDA or ANDA, including, as set forth in the guidance, outsourcing facilities must submit to FDA adverse event reports within 15 calendar days of receiving the information and must submit follow-up reports within 15 calendar days of receipt of new information about the adverse event, or as requested by FDA. Outsourcing facilities must submit the adverse event report in an electronic format that FDA can process, review, and archive (collection of information is approved by OMB control number 0910-0291). A copy of the current labeling of the compounded drug product must be provided.

Under § 310.305(g), entities subject to the regulation must maintain for 10 years the records of all adverse events required to be reported under § 310.305. The outsourcing facility should also maintain records of its efforts to obtain the data elements described in the draft guidance for each adverse event report.

We estimate the burden of the information collection as follows:

This is the first extension of the information collection and we have retained the currently approved burden estimate. Based on our review of Agency data, we estimate that annually 55 outsourcing facilities (“Number of Respondents” and “Total Annual Responses” in table 1) will submit adverse event reports to FDA as specified in the guidance and that preparing and submitting this information will take approximately 1.1 hours per registrant (“Average Burden per Response” in table 1). Likewise, we estimate that annually 55 outsourcing facilities (“Number of Recordkeepers” in table 2) will maintain records of adverse events as specified in the guidance and that preparing and maintaining the records will take approximately 16 hours per registrant (“Average Burden per Recordkeeping” in table 2).

The holders of the applications listed in the table have informed FDA that these drug products are no longer marketed and have requested that FDA withdraw approval of the applications under the process in § 314.150(c) (21 CFR 314.150(c)). The applicants have also, by their requests, waived their opportunity for a hearing. Withdrawal of approval of an application or abbreviated application under § 314.150(c) is without prejudice to refiling.

This proposed information collection previously published in the Federal Register on February 22, 2018 at 83 FR 7752 with a 60 day public comment period. FEMA received two anonymous public comments that were not relevant to the information collection. The purpose of this notice is to notify the public that FEMA will submit the information collection abstracted below to the Office of Management and Budget for review and clearance.

Title: Transcript Request Form.

Type of Information Collection: New information collection.

OMB Number: 1660—NEW.

Form Titles and Numbers: FEMA Form 064-0-0-12, Transcript Request Form.

Abstract: FEMA provides training to advance the professional development of personnel engaged in fire prevention and control and emergency management activities through its Center for Domestic Preparedness (CDP), Emergency Management Institute (EMI), National Fire Academy (NFA), National Training and Education Division, National Domestic Preparedness Consortium, and Rural Domestic Preparedness Consortium. FEMA collects information from students who have completed courses at the National Fire Academy (NFA) and the Emergency Management Institute (EMI) for the purpose of fulfilling the student's request to provide a copy of their transcript for their personal records and/or for transmittal to an institution of higher education that delivers training and education also in support of the FEMA mission.

Affected Public: Individuals or households; Business or other for-profit; Not-for-profit institutions; State, Local or Tribal Government.

Estimated Number of Respondents: 4,500.

Estimated Number of Responses: 4,500.

Estimated Total Annual Burden Hours: 225 hours.

Estimated Total Annual Respondent Cost: $7,978.50.

Estimated Respondents' Operation and Maintenance Costs: $0.

Estimated Respondents' Capital and Start-Up Costs: $0.

Estimated Total Annual Cost to the Federal Government: $28,899.24.

Comments may be submitted as indicated in the ADDRESSES caption above. Comments are solicited to (a) evaluate whether the proposed data collection is necessary for the proper performance of the agency, including whether the information shall have practical utility; (b) 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; (c) enhance the quality, utility, and clarity of the information to be collected; and (d) 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.

Public Law 114-143, The IPAWS Modernization Act of 2015, and Presidential Executive Order 13407 establishes the policy for an effective, reliable, integrated, flexible, and comprehensive system to alert and warn the American people in situations of war, terrorist attack, natural disaster, or other hazards to public safety and wellbeing. The Integrated Public Alert and Warning System (IPAWS) is the Department of Homeland Security's (DHS) response to the Executive Order. The Stafford Act (U.S.C. Title 42, Chapter 68, Subchapter II) requires that FEMA make IPAWS available to Federal, State, and local agencies for the purpose of providing warning to governmental authorities and the civilian population in areas endangered by disasters. The information collected is used by FEMA to create a Memorandum of Agreement (MOA) that regulates the management, operations, and security of the information technology system connection between a Federal, State, territorial, tribal or local alerting authority and IPAWS-OPEN (Open Platform for Emergency Notifications).

Title: Integrated Public Alert and Warning Systems (IPAWS) Memorandum of Agreement Applications.

Type of Information Collection: Extension, without change, of a currently approved information collection.

OMB Number: 1660-0140.

FEMA Forms: FEMA Form 007-0-25, IPAWS Memorandum of Agreement (MOA) Application; FEMA Form 007-0-26, Memorandum of Agreement Application for Tribal Governments.

Abstract: A Federal, State, territorial, tribal, or local alerting authority that applies for authorization to use IPAWS is designated as a Collaborative Operating Group or “COG” by the IPAWS Program Management Office (PMO). Access to IPAWS is free; however, to send a message using IPAWS, an organization must procure its own IPAWS compatible software. To become a COG, a Memorandum of Agreement (MOA) governing system security must be executed between the sponsoring organization and FEMA.

Affected Public: State, Local or Tribal Government.

Estimated Number of Respondents: 160.

Estimated Number of Responses: 160.

Estimated Total Annual Burden Hours: 160 hours.

Estimated Total Annual Respondent Cost: $8,150.4.

Estimated Respondents' Operation and Maintenance Costs: $0.

Estimated Respondents' Capital and Start-Up Costs: $0.

Estimated Total Annual Cost to the Federal Government: $115,890.42.

Comments may be submitted as indicated in the ADDRESSES caption above. Comments are solicited to (a) evaluate whether the proposed data collection is necessary for the proper performance of the agency, including whether the information shall have practical utility; (b) 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; (c) enhance the quality, utility, and clarity of the information to be collected; and (d) 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.

The U.S. Fish and Wildlife Service (Service) uses a collision risk model (CRM) to predict the number of golden and bald eagles that may be killed at new wind facilities (USFWS 2013; New et al. 2015). The CRM incorporates existing knowledge of eagle use around a proposed wind facility (exposure) and the probability of an eagle colliding with an operating turbine (collision probability). Essentially, the CRM uses three estimates to generate an annual eagle fatality estimate in the form of a probability distribution. These estimates are: (1) A project-specific estimate of eagle exposure; (2) a project-specific estimate of the amount of hazardous area and time that will be created by the project; and (3) an estimate of the probability that an exposed eagle that enters the hazardous area will be struck and injured or killed by a turbine blade. The median (50th quantile) fatality rate of the CRM-generated probability distribution is the point on the distribution at which there is an equal risk of under- and overestimating eagle fatalities. The Service uses the 80th quantile of the CRM fatality probability distribution to determine the take limit for incidental take permits, which lowers the risk of underestimating eagle take to a 20% chance.

In our 2016 revision to the eagle take regulations (81 FR 91494, Dec. 16, 2016), the Service reaffirmed both our intent to use the CRM to obtain initial estimates of eagle fatalities at new wind facilities, and that we would undertake a review of the background data used in the model to generate the estimates. The model is constructed using a Bayesian framework, and as such incorporates existing information on eagle exposure and collision probability in the form of prior distributions (priors). The priors are formally combined with site-specific data on exposure and the amount of hazardous area and operational time for a site to estimate the expected number of annual eagle collision fatalities.

The current priors for the CRM use data for golden eagles from nine sites with complete survey effort information for exposure, and four sites for collision probability (New et al. 2015). There were no data available to estimate parameters specific to bald eagles when we initially developed the model, so the golden eagle priors were used as surrogates for bald eagles. Public comments on the 2016 eagle rule revision were critical of the Service's CRM because the priors for golden eagles had not been updated to include new information, and because priors have not been developed for bald eagles even though data on exposure and collision probability are now available for this species. In response to these comments, the Service committed to updating the golden eagle priors, and to explore whether sufficient data exist to develop separate bald eagle exposure and collision priors.

The Service has undertaken that analysis using all available data that meet specific criteria for both species of eagle. This notice announces the availability of a summary report of that analysis, which includes new exposure and collision priors for both species of eagle. The report may be downloaded from the Federal e-Rulemaking Portal: http://www.regulations.gov. Search for FWS-HQ-MB-2017-0092. You can also find the report on the Service's website at: https://www.fws.gov/birds/management/managed-species/eagle-management.php. The Service intends to incorporate these updated priors into our CRM after considering comments received in response to this notice; that update will be in the form of a revised version of Appendix D of the Eagle Conservation Plan Guidance (USFWS 2013).

For this update, the Service reviewed data sets for 419 wind energy facilities, but many did not meet our criteria for incorporation into the priors (see the summary report for criteria used to filter projects). Data from 71 new and the nine original wind projects were used for the updated exposure priors. Of these 80 sites, 61 provided data for golden eagles and 59 for bald eagles. For the collision priors, 18 new sites in addition to the original four sites were identified as having data sufficient to include in the updated collision priors. We used data from 21 sites for golden eagles and 14 for bald eagles in the collision-prior update. The updated exposure prior is lower for both species than the prior currently in use. The updated collision prior is slightly lower than the current prior for golden eagles and higher for bald eagles.

Many of the commenters on the 2016 eagle rule revision encouraged the Service to develop a specific bald eagle prior because they believe collision risk for bald eagles is lower than for golden eagles. The data available to the Service suggest that there is more variation in both exposure and collision risk for bald eagles, and that uncertainty results in a higher expected collision probability for this species. The Service does not regard this outcome as counter-intuitive, because the range in abundance of bald eagles across the landscape is far greater than for golden eagles, and where bald eagles are abundant, they engage in social behaviors and intra-specific interactions that may make them more vulnerable than golden eagles to collisions (81 FR 91552). Thus, the implication that bald eagles are at high risk at a few wind facilities, while their risk is much lower at many others, is tenable. The Service acknowledges, however, that the bald eagle collision prior is based on data from relatively few sites that do not span the range of bald eagle density conditions that exist across the country, and therefore may not be representative of all locations. Given this, the Service is considering three alternatives for how to incorporate species-specific priors for bald eagles into the CRM and fatality modeling process:

(1) Use the updated species-specific priors, and use the 80th quantile of the CRM fatality estimates as the initial permitted take number for permits, as is the current practice.

(2) Use the updated species-specific priors, but because the status of bald eagles is secure, adopt a risk-tolerant policy for bald eagles and select a more liberal quantile on the CRM fatality distribution as the initial permitted take number for this species.

(3) Given the limitations in data available to inform the bald eagle priors, initiate an expert elicitation process to further refine the bald eagle priors.

Under any of these scenarios, the Service would use data submitted under permits to make updates to the priors in the future.

Alternative 1 would mean that for a similar level of eagle use observed at a project site, the Service would use higher fatality estimates for bald eagles than for golden eagles. Alternative 2 would be a decision by the Service to be more `risk-tolerant' for bald eagles. This would mean that initial fatality predictions would be lower, however it would also likely mean that more permits would have to be amended to increase the permitted take over time (i.e., the Service would be underestimating take more often). Alternative 3 would be a decision by the Service that more information is needed to understand the potential variability of exposure and collision probability for bald eagles. Such a process could result in either higher or lower (or more variable) priors. With this notice, we are soliciting input from the public on these three alternatives, and we will take those comments into consideration in making a final decision.

Many commenters on the draft 2016 rule urged the Service to adopt changes to the golden eagle CRM priors based on a recent peer-reviewed scientific article by Bay et al. (2016). Service staff coordinated with authors of the Bay et al. paper in development of this update, and all data used in the Bay et al. paper that were available to us and that met our criteria were incorporated. The Service decided not to incorporate the results of the Bay et al. paper directly, however, for two main reasons. First, the Service could access and utilize more data than were used in the Bay et al. paper, and so our updated priors incorporate more recent information from a wider range of projects and sites than were used by Bay et al. Second, the Bay et al. analysis used a fatality estimator that did not account for the possibility of undetected eagle deaths during mortality monitoring when no dead eagles were found. The Service uses models in our update that account for imperfect detection when dead eagles are not encountered during monitoring, because there is ample evidence that finding no dead eagles does not mean there were no eagle fatalities. Thus, although the Service's updated collision probability for golden eagles is higher than that reported by Bay et al., our approach is more accurate and consistent with our risk-averse policy with respect to estimating and managing eagle take.

Written comments we receive become part of the public record associated with this action. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that the entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so. All submissions from organizations or businesses, and from individuals identifying themselves as representatives or officials of organizations or businesses, will be made available for public disclosure in their entirety.

We, the U.S. Geological Survey, in accordance with the Paperwork Reduction Act of 1995, provide the general public and other Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps us assess the impact of our information collection requirements and minimize the public's reporting burden. It also helps the public understand our information collection requirements and provide the requested data in the desired format.

We are soliciting comments on the proposed ICR that is described below. We are especially interested in public comment addressing the following issues: (1) Is the collection necessary to the proper functions of the USGS; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the USGS enhance the quality, utility, and clarity of the information to be collected; and (5) how might the USGS minimize the burden of this collection on the respondents, including through the use of information technology.

Comments that you submit in response to this notice are a matter of public record. We will include or summarize each comment in our request to OMB to approve this ICR. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you may ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.

Abstract: Respondents supply the U.S. Geological Survey with avian population data for more than 600 North American bird species. The survey data, resulting population trend estimates, and relative abundance estimates will be made available via the internet and through special publications, for use by Government agencies, industry, education programs, and the general public. We will protect information from respondents considered proprietary under the Freedom of Information Act (5 U.S.C. 552) and its' implementing regulations (43 CFR part 2), and under regulations at 30 CFR 250.197, “Data and information to be made available to the public or for limited inspection.” Responses are voluntary. No questions of a “sensitive” nature are asked.

Title of Collection: North American Breeding Bird Survey.

OMB Control Number: 1028-0079.

Form Number: None.

Type of Review: Extension of a currently approved collection.

Respondents/Affected Public: Individuals.

Total Estimated Number of Annual Respondents: 1,600.

Total Estimated Number of Annual Responses: 2,600.

Estimated Completion Time per Response: 11 minutes.

Total Estimated Number of Annual Burden Hours: 28,600.

Respondent's Obligation: Voluntary.

Frequency of Collection: Annually.

Total Estimated Annual Non-hour Burden Cost: $141,700. Mileage costs are on average $54.50 per response, based on approximate 100-mile round trip for data collection per response and 2018 federal mileage rate of $0.545 per mile.

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 authorities for this action are the Paperwork Reduction Act of 1995 (44 U.S.C. 3501, et seq.).

General Overview. The North Unit Irrigation District (NUID) operates and maintains the NUMC on the Deschutes Project located in the Deschutes River Basin, which supplies irrigation water to nearly 59,000 acres of farmland in Jefferson County, Oregon. Reclamation is considering allowing hydroelectric power development on the NUMC under a Lease of Power Privilege (LOPP).

A LOPP is a congressionally authorized alternative to Federal hydroelectric power development. It is a contractual right given to a non-federal entity to use a Reclamation asset for electric power generation consistent with Reclamation project purposes. Terms of a LOPP shall not exceed 40 years. General authority under Reclamation law for a LOPP includes, among others, the Town Sites and Power Development Act of 1906 (43 U.S.C. 522), the Reclamation Project Act of 1939 (43 U.S.C. 485h(c)) (1939 Act), and the Bureau of Reclamation Small Conduit Hydropower Development and Rural Jobs Act of 2013 (Act of August 9, 2013, 127 Stat. 498).

Reclamation will be responsible for compliance with the National Environmental Policy Act (NEPA) related to any project selected for consideration pursuant to this Notice of Intent. Reclamation will also lead necessary consultation with American Indian Tribal Governments and compliance with the National Historic Preservation Act, Endangered Species Act, and other related environmental regulations for all elements of the proposed project. A LOPP may be issued only after Reclamation has determined that NEPA and any other regulatory compliance requirements are completed.

On August 7, 2017, Reclamation received a formal proposal for non-federal hydroelectric power development from Kinet Inc. at 12 sites on the NUMC. Kinet Inc. proposes to develop these sites utilizing a new technology called linear Pelton turbines. This solicitation is exclusive to the following 12 NUMC sites:

Site Name—Mile 2 South.

Latitude Longitude—44.082201-121.286401.

Canal Mile Maker—1.78

Head (m)—6.1.

Flow (cms)—20.

Site Name—Mile 2 North.

Latitude Longitude—44.086971-121.274233.

Canal Mile Marker—2.11.

Head (m)—6.1.

Flow (cms)—20.

Site Name—Mile 3.

Latitude Longitude—44.092839-121.256296.

Canal Mile Marker—3.52.

Head (m)—6.1.

Flow (cms)—20.

Site Name—Mile 18.

Latitude Longitude—44.251184-121.128517.

Canal Mile Marker—18.34.

Head (m)—6.71.

Flow (cms)—21.

Site Name—Mile 19.

Latitude Longitude—44.2666-121.12075.

Canal Mile Marker—19.

Head (m)—4.4.

Flow (cms)—16.

Site Name Mile—20.

Latitude Longitude—44.2838-121.11471.

Canal Mile Marker—20.

Head (m)—5.36.

Flow (cms)—21.

Site Name Mile—43.

Latitude Longitude—44.500374-121.154865.

Canal Mile Marker—45.

Head (m)—18.2.

Flow (cms)—7.1.

Site Name—Mile 48.

Latitude Longitude—44.5368587-121.153547.

Canal Mile Marker—47.98.

Head (m)—3.66.

Flow (cms)—7.2.

Site Name—Mile 50 East.

Latitude Longitude—44.571091-121.158783.

Canal Mile Marker—19.

Head (m)—51.

Flow (cms)—2.98.

Site Name—Mile 50 West.

Latitude Longitude—44.572148-121.160127.

Canal Mile Marker—19.

Head (m)—3.05.

Flow (cms)—7.0.

Site Name—Mile 52 South.

Latitude Longitude—44.601337-121.162522.

Canal Mile Marker—53.69.

Head (m)—3.05.

Flow (cms)—7.0.

Site Name—Mile 52 North.

Latitude Longitude—44.603526-121.161854.

Canal Mile Marker—19.

Head (m)—3.05.

Flow (cms)—7.0.

Reclamation notified NUID of the Kinet Inc. proposal and solicited NUID's interest in submitting a proposal as a preferred entity. In a subsequent letter dated September 21, 2017, NUID declined interest in hydroelectric power development at the proposed sites. As a result, Reclamation is soliciting proposals for consideration to allow hydroelectric power development under a LOPP on the NUMC system.

1. Under this solicitation, Reclamation may only issue a LOPP for hydroelectric power development at the 12 identified NUMC sites described herein.

2. Any LOPP terms for hydroelectric power development on the NUMC must not interfere with existing contractual commitments related to operations and maintenance of the canal system. The lessee (i.e., successful proposing entity) will be required to enter into a contract with Reclamation. This contract will, (1) address requirements related to coordination of operations and maintenance with Deschutes Project stakeholders (including the NUID); and (2) stipulate that the lessee will be responsible for any increase in operations or maintenance costs that are attributable to the hydroelectric power development.

3. The lessee would be responsible for securing transfer and marketing of the power generated by the proposed project.

4. All costs incurred by the United States related to a proposed LOPP project will be at the expense of the lessee. Such costs include management and coordination of necessary Reclamation activities, provision of information, conduct of or assistance with regulatory compliance (including NEPA), consultation during design development and related to operations and maintenance under a LOPP, development of the LOPP, necessary contracts with outside consultants, or any other cost for which the government would be reimbursed by an applicant or the general public. In addition, the lessee will be required to make annual payments to the United States for the use of a government facility in the amount of at least 2-3 mills per kilowatt-hour of gross energy produced by the facility, measured at the generator(s).

5. The LOPP will include provisions for the mill rate to increase each year commensurate with inflation based on the previous 5-year average of the Gross Domestic Product (GDP) Price Deflator; however, the rate of increase will be capped at 5 percent. If the 5-year GDP Price Deflator average shows no change or deflation, the mill rate will remain the same as the previous year's rate. Annual payments to the United States will be deposited as a credit to the Reclamation fund and project to be applied against the total outstanding reimbursable repayment obligation for reimbursable project construction costs of the Deschutes Project pursuant to the existing construction cost allocation (not applied only against power construction costs). If the outstanding reimbursable repayment obligation for project construction costs is satisfied, then the payments will be held as a statutory credit for the project or program until an eligible reimbursable project expense is incurred against which the credit can be applied.

Interested parties should submit proposals specifically addressing the following qualifications, capabilities, and approach factors. Proposals submitted will be evaluated and ranked directly based on these factors. Additional information may be provided at the discretion of those submitting proposals.

(a) Qualifications of Proposing Entity: Provide relevant information describing/documenting the qualifications of the proposing entity to plan, design, and implement such a project, including, but not limited to:

• Type of organization.

• Business history, including length of time in business, experience in funding, and design and construction of similar projects.

• Industry rating(s) that indicate financial soundness and/or technical and managerial capability.

• Experience of key management personnel.

• History of any reorganizations or mergers with other companies (if applicable).

• Preference status (as applied to a LOPP, the term “preference entity” means an entity qualifying for preference under Section 9(c) of the 1939 Act as a municipality, public corporation or agency, or cooperative or other nonprofit organization financed in whole or in part by loans made pursuant to the Rural Electrification Act of 1936, as amended).

• Any other information not already requested above or in the following evaluation categories that demonstrates the interested entity's organizational, technical, and financial ability to perform all aspects of the work.

(b) Proposed Development Plan: Describe and provide mapping and drawings of proposed facilities and equipment comprising the LOPP project. Include descriptions and locations of structures, turbines, penstocks, transmission lines, access roads, and other appurtenant facilities.

Describe proposed capacities and general operation of the hydroelectric projects to include generation capacity, power source and power consumption, configuration, turbine generating capacity, distribution transmission line size and route, and other relevant aspects of the project.

Describe the ability of generation to provide ancillary services, such as regulation, spinning reserves, and volt-ampere reactive support, and information on the reliability of the generation, potential maintenance outage schedule, and duration.

(c) Proposed Approach to Acquisition of Necessary Property Rights: Specify plans for acquiring title to or the right to occupy and use all lands necessary for the proposed development, including such additional lands as may be required during construction. Address lands necessary for electrical distribution lines, access roads, and all aspects of project development and operation and maintenance.

(d) Long-Term Operation and Maintenance: Provide a description (with relevant references) of the project proponent's experience in operation and maintenance of hydroelectric or similar facilities once they are operational and over the long-term (i.e., the 40-year lease contemplated for the proposed development). Identify the organizational structure and plan for the long-term operation and maintenance of the proposed development. Define how the proposed development would operate in harmony with the NUMC system.

(e) Contractual Arrangements: Describe any anticipated contractual arrangements with project stakeholders of the Deschutes Project, including contractual arrangements to utilize water rights held by NUID. Define how the proposed development would operate in harmony with the NUMC system.

(f) Management Plan: Provide a management plan to accomplish such activities as planning, NEPA compliance, LOPP development, design, construction, facility testing, start-up of hydropower production, and preparation of an Emergency Action Plan. Prepare schedules of these activities as applicable. Describe what studies are necessary to accomplish the hydroelectric power development and how the studies would be implemented.

(g) Environmental Impact: Discuss potential significant adverse impacts from the proposed development on biophysical or sociocultural resource parameters. Of particular concern are potential impacts on any protected aquatic or terrestrial wildlife species or associated protected habitat. Other concerns may include, but are not limited to, the impact on land use adjacent to the proposed development, recreation at the surrounding areas, cultural resources, and Indian Trust assets. Provide information on the types and severity of expected impacts and proposed methods of resolving or mitigating these impacts.

Describe potential beneficial impacts that may be expected from the development to include such perspectives as energy conservation or using available water resources in the public interest.

Describe proposed studies to adequately define the extent of the adverse and beneficial impacts, potential severity, and potential alternatives to mitigate impacts.

(h) Other Study and/or Permit Requirements: Describe planned response to other applicable regulatory requirements, including the National Historic Preservation Act, Clean Water Act, Endangered Species Act, and state and local laws and licensing requirements. Also describe any known potential for impact on lands or resources of American Indian tribes, including trust resources.

(i) Project Development Costs and Economic Analysis: Estimate the costs of development, including the cost of studies to determine feasibility, environmental compliance, project design, construction, financing, and the amortized annual cost of the investment. Estimate annual operation and maintenance, replacement expenses, annual payments to the United States, and those potentially associated with the Deschutes Project. Estimate costs associated with any anticipated additional transmission or wheeling services. Identify proposed methods of financing the project. The anticipated return on investment should be estimated and an economic analysis should be presented that compares the present worth of all benefits and the costs of the project.

(j) Performance Guarantee and Assumption of Liability: Describe plans for (1) providing the government with performance bonds or irrevocable letter of credit covering completion of the proposed project, (2) assuming liability for damage to the operational and structural integrity of the NUMC or other aspects of the Deschutes Project caused by construction, operations and/or maintenance of the hydropower development, and (3) obtaining general liability insurance.

(k) Other Information: This final paragraph is provided for the applicant to include additional information considered relevant to Reclamation's selection process in this matter.

Reclamation will evaluate proposals received in response to this published notice. Proposals will be ranked according to response to the factors described in Fundamental Considerations and Requirements and Proposal Content Guidelines sections of this notice. In general, Reclamation will give more favorable consideration to proposals that (1) are well adapted to developing, conserving, and utilizing the water resource and protecting natural resources; (2) clearly demonstrate that the offeror is qualified to develop the hydropower facility and provide for long-term operation and maintenance; and (3) best share the economic benefits of the hydropower development among parties to the LOPP. A proposal will be deemed unacceptable if it is inconsistent with Deschutes Project purposes, as determined by Reclamation.

Reclamation will give preference to those entities that qualify as preference entities (as defined under Proposal Content Guidelines, item (a), of this notice) provided that the preference entity is well qualified and their proposal is at least as well adapted to developing, conserving, and utilizing the water and natural resources as other submitted proposals. Preference entities will be allowed 30 days to improve their proposals, if necessary, to be made at least equal to a proposal(s) that may have been submitted by a non-preference entity.

Reclamation will notify, in writing, all entities submitting proposals of Reclamation's decision regarding selection of the potential lessee. The selected potential lessee will have 15 months from the date of selection of the lessee to sign the preliminary lease, complete the requirements set forth in the preliminary lease, and to sign the LOPP. The lessee will then have up to 3 years from the date of the preliminary lease agreement to the beginning of construction. Maximum timeframes for construction will be determined by the Regional Director. Such timeframes may be adjusted for just cause resulting from actions and/or circumstances that are beyond the control of the lessee.

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 Walbro, LLC on June 14, 2018. 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 carburetors and products containing such carburetors. The complaint names as respondents: Ruixing Carburetor Manufacturing Co., Limited Zhejiang of China; Huayi Carburetor Factory of China; Tillotson of Ireland; Fujian Hualong Carburetor Co., Ltd. of China; Fuding Guangda General Machinery Co., Ltd. of China; Wuyi Henghai Tools Co., Ltd. of China; Fuding Youyi Trade Co., Ltd. of China; Amazon.com, Inc. of Seattle, WA; Amerisun Inc. of Itasca, IL; Ardisam, Inc. of Cumberland, WI; Buffalo Corporation of O'Fallon, MO; Cabela's Incorporated of Sidney, NE; Champion Power Equipment, Inc. of Santa Fe, CA; Feldmann Eng. & Mfg. Co., Inc. of Sheboygan Falls, WI; FNA Group, Inc. of Pleasant Prairie, WI; Frictionless World, LLC of Denver, CO; Generac Power Systems, Inc. of Waukesha, WI; Husqvarna Professional Products, Inc. of Charlotte, NC; Imperial Industrial Supply Co. d/b/a Duromax Power Equipment of Ontario, CA; Kmart Corporation of Hoffman Estates, IL; Lowe's Companies, Inc. of Mooresville, NC; Mat Industries, LLC of Lake Zurich, IL; Menards, Inc. of Eau Claire, WI; MTD Products Inc. of Valley City, OH; North American Tool Industries of Huntington, IN; Northern Tool & Equipment Co., Inc. of Burnsville, MN; QV Tools LLC of Las Vegas, NV; Sears, Roebuck and Co. of Hoffman Estates, IL; Target Corporation of Minneapolis, MN; Techtronics Industries Co. Ltd of d/b/a Techtronic Industries Power Equipment of Hong Kong; The Home Depot, Inc. of Atlanta, GA; Thunderbay Products of Clayton, WI; Tool Tuff Direct LLC of Golden, CO; Tractor Supply Company of Brentwood, TN; and Walmart Inc. of Bentonville, AR. The complainant requests that the Commission issue a general exclusion order, and in the alternative, issue a limited exclusion order, cease and desist orders, 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. 3323”) in a prominent place on the cover page and/or the first page. (See Handbook for Electonic Filing Procedures, Electronic Filing Procedures).1 Persons with questions regarding filing should contact the Secretary (202-205-2000).

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

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)).

Authority: The authority for institution of this investigation is contained in section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337 and in section 210.10 of the Commission's Rules of Practice and Procedure, 19 CFR 210.10 (2018).

Scope of Investigation: Having considered the complaint, the U.S. International Trade Commission, on June 14, 2018, ordered that—

(1) Pursuant to subsection (b) of section 337 of the Tariff Act of 1930, as amended, an investigation be instituted to determine whether there is a violation of subsection (a)(1)(B) of section 337 in the importation into the United States, the sale for importation, or the sale within the United States after importation of products identified in paragraph (2) by reason of infringement of one or more of claims 1-40 of the '230 patent; and claims 1-28 of the '018 patent; and whether an industry in the United States exists as required by subsection (a)(2) of section 337;

(2) Pursuant to section 210.10(b)(1) of the Commission's Rules of Practice and Procedure, 19 CFR 210.10(b)(1), the plain language description of the accused products or category of accused products, which defines the scope of the investigation, is “2′-fucosyllactose oligosaccharides”;

(3) Pursuant to Commission Rule 210.50(b)(1), 19 CFR 210.50(b)(1), the presiding administrative law judge shall take evidence or other information and hear arguments from the parties and other interested persons with respect to the public interest in this investigation, as appropriate, and provide the Commission with findings of fact and a recommended determination on this issue, which shall be limited to the statutory public interest factors set forth in 19 U.S.C. 1337(d)(1), (f)(1), (g)(1);

(4) For the purpose of the investigation so instituted, the following are hereby named as parties upon which this notice of investigation shall be served:

(a) The complainant is:Glycosyn LLC, 890 Winter Street, Suite 208, Waltham, MA 95131.

(b) The respondents are the following entities alleged to be in violation of section 337, and are the parties upon which the complaint is to be served: Jennewein Biotechnologie GmbH, Maarweg 32, D-53619 Rheinbreitbach, Germany.

(c) The Office of Unfair Import Investigations, U.S. International Trade Commission, 500 E Street SW, Suite 401, Washington, DC 20436; and

(5) For the investigation so instituted, the Chief Administrative Law Judge, U.S. International Trade Commission, shall designate the presiding Administrative Law Judge.

Responses to the complaint and the notice of investigation must be submitted by the named respondents in accordance with section 210.13 of the Commission's Rules of Practice and Procedure, 19 CFR 210.13. Pursuant to 19 CFR 201.16(e) and 210.13(a), such responses will be considered by the Commission if received not later than 20 days after the date of service by the Commission of the complaint and the notice of investigation. Extensions of time for submitting responses to the complaint and the notice of investigation will not be granted unless good cause therefor is shown.

Failure of a respondent to file a timely response to each allegation in the complaint and in this notice may be deemed to constitute a waiver of the right to appear and contest the allegations of the complaint and this notice, and to authorize the administrative law judge and the Commission, without further notice to the respondent, to find the facts to be as alleged in the complaint and this notice and to enter an initial determination and a final determination containing such findings, and may result in the issuance of an exclusion order or a cease and desist order or both directed against the respondent.

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 collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility;

—Evaluate the accuracy of the agency's estimate of the burden of the 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).

1. Type of information collection: Extension of Currently Approved Collection.

2. The Title of the Form/Collection: Title II of the Americans with Disabilities Act/Section 504 of the Rehabilitation Act of 1973 Discrimination Complaint Form.

3. The agency form number and applicable component of the Department sponsoring the collection: The document has no agency form number. The applicable component within the Department of Justice is the Disability Rights Section, Civil Rights Division.

4. Affected public who will be asked to respond, as well as a brief abstract:

Primary: Individuals alleging discrimination by public entities based on disability. Under title II of the Americans with Disabilities Act, an individual who believes that he or she has been subjected to discrimination on the basis of disability by a public entity may, by himself or herself or by an authorized representative, file a complaint. The Department of Justice must address the complaint or refer the complaint to the appropriate Federal agency. Any Federal agency that receives a complaint of discrimination on the basis of disability by a public entity must review the complaint to determine whether it has jurisdiction under Section 504. If the agency does not have jurisdiction under Section 504, it must determine whether it is the designated agency responsible for complaints filed against that public entity under title II of the ADA. If the agency does not have jurisdiction under section 504 and is not the designated agency under title II of the ADA, it must refer the complaint to the Department of Justice.

5. An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: 11,192 respondents per year at 0.75 hours per complaint 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 8,394 hours, which is equal to 11,192 respondents * .75 hours.

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.

Under the foreign labor certification programs administered by ETA, SWAs are funded through annually reimbursable grants. These grants fund certain activities that support the processing of applications for temporary labor certification filed by U.S. employers in order to hire foreign workers in the H-2B or H-2A visa categories to perform nonagricultural or agricultural services or labor. Under the grant agreements, SWAs must review and transmit, through the intrastate and interstate systems, job orders submitted by employers in order to recruit U.S. workers prior to filling the job openings with foreign workers.

In order to effectively monitor the administration of foreign labor certification activities by the SWAs, the Department requires the SWAs to report their workloads related to these activities on a quarterly basis. This collection of information is conducted through Form ETA-9127, Foreign Labor Certification Quarterly Activity Report. This report is critical for ensuring accountability and for future program management, including budget and workload management. ETA intends to revise the information collection by clarifying the Form ETA-9127 instructions and making minor changes to the PRA disclosure on the form.

The Department has proposed changes to the collection. Specifically, the Form ETA-9127 has been changed to capture information currently needed to make decisions on grant fund distribution.

Two questions were removed from Form ETA-9127. The first question removed referenced union contacts made by the SWA. This question was removed because this data is not currently reviewed by the grants management unit of ETA's OFLC. Union contacts are made by SWAs when the Chicago National Processing Center Certifying Officers have determined that the occupation or industry is traditionally or customarily unionized. In such circumstances, the Certifying Officer collects this information when confirming referrals with the SWAs during the certification process. Therefore, this information is available to the Department without engaging in this data collection. Continuing to collect such information would result in unwarranted data collection creating an undue burden on those filing the Form ETA-9127.

The second question removed is located in both the H-2A and H-2B sections, and prompts the SWA to list the most common deficiencies on the job order. The collection of this data is no longer needed because the Chicago NPC, which receives the job orders from the SWA, has addressed previously common deficiencies found on job orders in published Frequently Asked Questions and outreach to SWAs and employers. Again, continuing to collect such information would result in unwarranted data collection creating an undue burden on those filing the Form ETA-9127.

The Form ETA-9127 instructions have been modified in order to promote clarity because of some confusion expressed by the SWAs. Two terms, interstate and intrastate, have been segmented and defined in plain language to reduce this confusion and minimize the burden to the SWAs.

DOL 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 submissions of responses.

Type of Review: Revision.

Title of Collection: Form ETA-9127, Foreign Labor Certification Quarterly Activity Report.

OMB Control Number: 1205-0457.

Affected Public: State, local or tribal governments.

Form(s): ETA-9127.

Total Estimated Annual Respondents: 54.

Annual Frequency: Quarterly.

Total Estimated Annual Responses: 216.

Average Time per Response: 1 hour and 45 minutes.

Total Estimated Annual Burden Hours: 378.

Total Estimated Annual Other Costs Burden: $0.

Comments submitted in response to this comment request will be summarized and/or included in the request for OMB approval of the ICR; they will also become a matter of public record. Commenters are encouraged not to submit sensitive information (e.g., confidential business information or personally identifiable information such as a Social Security number).