Federal Register Vol. 80, No.96,

Title: Importation of Christmas Cactus and Easter Cactus in Growing Media From the Netherlands and Denmark.

OMB Control Number: 0579-0266.

Type of Request: Extension of approval of an information collection.

Abstract: Under the Plant Protection Act (7 U.S.C. 7701 et seq.), the Secretary of Agriculture is authorized to restrict the importation, entry, or interstate movement of plants, plant products, and other articles to prevent the introduction of plant pests into the United States or their dissemination within the United States. The Secretary has delegated this authority to the Animal and Plant Health Inspection Service (APHIS).

The regulations contained in “Subpart—Plants for Planting” (7 CFR 319.37 through 319.37-14) prohibit or restrict, among other things, the importation of living plants, plant parts, and seeds for propagation. These regulations are intended to ensure that imported plants for planting do not serve as a host for plant pests, such as insects or pathogens, that can cause damage to U.S. agricultural and environmental resources.

Under these regulations, Christmas cactus and Easter cactus in approved growing media may be imported into the United States from the Netherlands and Denmark under certain conditions, which require the use of a phytosanitary certificate and declaration stating the plants were grown in accordance with specific conditions, an agreement between APHIS and the plant protection service of the country where the plants are grown, and an agreement between the foreign plant protection service and the grower.

We are asking the Office of Management and Budget (OMB) to approve our use of these information collection activities for an additional 3 years.

The purpose of this notice is to solicit comments from the public (as well as affected agencies) concerning our information collection. These comments will help us:

(1) Evaluate whether the collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility;

(2) Evaluate the accuracy of our estimate of the burden of the collection of information, including the validity of the methodology and assumptions used;

(3) Enhance the quality, utility, and clarity of the information to be collected; and

(4) Minimize the burden of the collection of information on those who are to respond, through use, as appropriate, of automated, electronic, mechanical, and other collection technologies; e.g., permitting electronic submission of responses.

Estimate of burden: The public reporting burden for this collection of information is estimated to average 0.57 hours per response.

Respondents: Foreign plant protection service officials and growers in the Netherlands and Denmark.

Estimated annual number of respondents: 20.

Estimated annual number of responses per respondent: 10.5.

Estimated annual number of responses: 210.

Estimated total annual burden on respondents: 120 hours. (Due to averaging, the total annual burden hours may not equal the product of the annual number of responses multiplied by the reporting burden per response.)

All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record.

This meeting is available to the public through the following toll-free call-in number: 888-437-9455 conference ID: 6159656. Any interested member of the public may call this number and listen to the meeting. An open comment period will be provided to allow members of the public to make a statement as time allows. The conference call operator will ask callers to identify themselves, the organization they are affiliated with (if any), and an email address prior to placing callers into the conference room. Callers can expect to incur charges for calls they initiate over wireless lines, and the Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Persons with hearing impairments may also follow the proceedings by first calling the Federal Relay Service at 1-800-977-8339 and providing the Service with the conference call number and conference ID number.

Members of the public are also entitled to submit written comments. The comments must be received in the Western Regional Office of the Commission by July 6, 2015. The address is Western Regional Office, U.S. Commission on Civil Rights, 300 N. Los Angeles Street, Suite 2010, Los Angeles, CA 90012. Persons wishing to email their comments may do so by sending them to Angelica Trevino, Civil Rights Analyst, Western Regional Office, at [email protected]. Persons who desire additional information should contact the Western Regional Office, at (213) 894-3437, (or for hearing impaired TDD 913-551-1414), or by email to [email protected]. Hearing-impaired persons who will attend the meeting and require the services of a sign language interpreter should contact the Regional Office at least ten (10) working days before the scheduled date of the meeting.

Records and documents discussed during the meeting will be available for public viewing prior to and after the meeting at http://facadatabase.gov/committee/meetings.aspx?cid=245 and clicking on the “Meeting Details” and “Documents” links. Records generated from this meeting may also be inspected and reproduced at the Western Regional Office, as they become available, both before and after the meeting. Persons interested in the work of this Committee are directed to the Commission's Web site, http://www.usccr.gov, or may contact the Western Regional Office at the above email or street address.

Agenda:

Public Call Information:

Background

In the Final Results, the Department valued certain wood inputs used by the respondent, Huafeng, with surrogate values and used Insular Rattan and Native Products Corporation's (“Insular Rattan”) 2009 financial statements, among others, to calculate surrogate financial ratios.4 The CIT twice remanded issues involving the Final Results to the Department, and, in its second redetermination, the Department valued certain wood inputs used by Huafeng with market economy purchase prices and revised the calculation of the surrogate financial ratios by excluding Insular Rattan's financial statements from the calculation.5 On November 14, 2013, the CIT sustained the final results of the Department's second redetermination and, in accordance with Timken, the Department published a notice of Amended Final Results. 6 The American Furniture Manufacturers Committee for Legal Trade and Vaughan-Bassett Furniture Company, Inc. appealed the valuation of wood inputs, but not the issue of excluding Insular Rattan's financial statements, to the CAFC. On December 1, 2014, the CAFC reversed the CIT's decision and vacated the Department's redetermination results in which it used market economy purchase prices, rather than surrogate values, to value certain of Huafeng's wood inputs. The CAFC directed the CIT to reinstate the Department's wood valuation in the first redetermination (using surrogate values for Huafeng's wood inputs). On January 28, 2015, the CIT ordered the Department to file a redetermination with the Court in which it continued to exclude Insular Rattan's financial statements from its calculations and reinstated the wood valuation from the first redetermination. Pursuant to the CIT's order, the Department filed the final results of its third redetermination with the CIT on March 27, 2015 in which it valued Huafeng's wood inputs using surrogate values and continued to exclude Insular Rattan's financial statements from its calculations.7 On April 21, 2015, the CIT sustained the Department's Remand Redetermination III. 8

In its decision in Timken, 893 F.2d at 341, as clarified by Diamond Sawblades, the CAFC held that, pursuant to section 516A(e) of the Tariff Act of 1930, as amended (“the Act”), the Department must publish a notice of a court decision that is not “in harmony” with a Department determination and must suspend liquidation of entries pending a “conclusive” court decision. The CIT's April 21, 2015, judgment sustaining the Department's Remand Redetermination III in which it valued certain wood inputs using surrogate values, rather than market economy purchase prices, constitutes a final decision of that court that is not in harmony with the Department's Amended Final Results. This notice is published in fulfillment of the publication requirements of Timken. Accordingly, the Department will continue the suspension of liquidation of the subject merchandise pending the expiration of the period of appeal, or if appealed, pending a final and conclusive court decision.

Because there is now a final court decision with respect to this case, the Department is amending its Amended Final Results with respect to Huafeng's weighted-average dumping margin for the period January 1, 2009 through December 31, 2009. In addition, the Department has amended the Amended Final Results for Nanhai and Dongguan, the separate rate respondents included in this final court decision. The remaining weighted-average dumping margins from the Final Results, as subsequently amended,9 remain unchanged.

In the event the CIT's ruling is not appealed or, if appealed, upheld by the CAFC, the Department will instruct CBP to liquidate entries of subject merchandise based on the revised assessment rates calculated by the Department.

This notice is issued and published in accordance with sections 516A(e)(1), 751(a)(1), and 777(i)(1) of the Act.

Background

Sections 101(a)(5)(A) and (D) of the MMPA (16 U.S.C. 1361 et seq.) direct the Secretary of Commerce 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.”

Section 101(a)(5)(D) of the MMPA established an expedited process by which citizens of the U.S. can apply for a one-year authorization to incidentally take small numbers of marine mammals by harassment, provided that there is no potential for serious injury or mortality to result from the activity. Section 101(a)(5)(D) establishes a 45-day time limit for NMFS review of an application followed by a 30-day public notice and comment period on any proposed authorizations for the incidental harassment of marine mammals. Within 45 days of the close of the comment period, NMFS must either issue or deny the authorization.

On April 1, 2014, WSDOT submitted a request to NOAA requesting an IHA for the possible harassment of small numbers of 11 marine mammal species incidental to construction associated with the Anacortes Tie-up Slips Dolphin and Wingwall Replacement in the city of Anacortes, on Fidalgo Island, adjacent to Guemes Channel, Skagit County, Washington, between September 1, 2015, and February 15, 2016. NMFS determined that the IHA application was complete on July 1, 2014.

A detailed description of the WSDOT's Anacortes tie-up slips dolphin and wingwall project is provided in the Federal Register notice for the proposed IHA (80 FR 11648; March 4, 2015). Since that time, no changes have been made to the proposed 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' proposal to issue an IHA to WSDOT was published in the Federal Register on March 4, 2015. That notice described, in detail, WSDOT'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). Specific comments and responses are provided below.

Comment 1: The Commission notes that the construction would be conducted in December and January, however, WSDOT's ambient noise measurements were conducted in March and showed that median ambient noise level at the proposed construction area is 123 dB re 1 µPa. The Commission states that the ambient noise levels would be lower in winter (December and January) than those were collected in March when vessel traffic is greater. Therefore, the Commission recommends that NMFS either (1) require WSDOT to measure ambient sound levels during winter and adjust the Level B harassment zones accordingly or (2) base the Level B harassment zones on the 120-dB re 1 µPa threshold and adjust the zones to ensure adequate protection for southern resident killer whales.

Response: NMFS worked with WSDOT and its acoustic consultant regarding the ambient noise levels in the vicinity of the construction area. In general, doubling the number of boats would only increase the background sound levels by about 3 decibels so adding or subtracting one boat will not have a substantial effect on the overall background sound levels. The ferry vessels dominate the sound levels in the areas around the terminals where WSDOT's measurement was collected. It is only expected a slight increase in sound levels in the summer months due to more recreational boats in the area. Both NMFS and WSDOT's acoustic consultant considers that sound levels between about September to May should be consistent from month to month and representative of the work period.

Nevertheless, WSDOT agreed that modeled 120 dB isopleths to be used as the threshold for Level B takes for vibratory pile driving and pile removal activities and submitted a updated monitoring plan to encompass this larger zone of influence (ZOI). The updated monitoring measures are discussed in details below in the “Mitigation Measure” and “Monitoring and Reporting” sections.

In addition, WSDOT is considering getting new winter background data prior to the start of the project. If the measurement shows smaller ZOI, WSDOT will inform NMFS with another revised monitoring plan that reflects the updated ZOI based on onsite measurements.

The revised ZOI does not change the number of marine mammals takes, because all animals within the general vicinity of the project are being considered for potential takes.

The marine mammal species under NMFS jurisdiction most likely to occur in the proposed construction area include Pacific harbor seal (Phoca vitulina richardsi), northern elephant seal (Mirounga angustirostris), California sea lion (Zalophus californianus), Steller sea lion (Eumetopias jubatus), killer whale (Orcinus orca) (transient and Southern Resident stocks), gray whale (Eschrichtius robustus), humpback whale (Megaptera novaeangliae), minke whale (Balaenoptera acutorostrata), harbor porpoise (Phocoena phocoena), Dall's porpoise (P. dali), and Pacific white-sided dolphin (Lagenorhynchus obliquidens). A list of the species and their status are provided in Table 1.

General information on the marine mammal species found in Washington coastal waters can be found in Caretta et al. (2014), which is available at the following URL: http://www.nmfs.noaa.gov/pr/sars/pdf/po2013.pdf. Refer to that document for information on these species. A list of marine mammals in the vicinity of the action and their status are provided in Table 3. Specific information concerning these species in the vicinity of the proposed action area is provided in detail in the WSDOT's IHA application.

The effects of underwater noise from in-water pile removal and pile driving associated with the construction activities for a tie-up slips dolphin and wingwall replacement project in Anacortes has the potential to result in behavioral harassment of marine mammal species and stocks in the vicinity of the action area. The Notice of Proposed IHA included a discussion of the effects of anthropogenic noise on marine mammals, which is not repeated here. No instances of hearing threshold shifts, injury, serious injury, or mortality are expected as a result of WSDOT's activities given the strong likelihood that marine mammals would avoid the immediate vicinity of the pile driving area.

The primary potential impacts to marine mammals and other marine species are associated with elevated sound levels, but the project may also result in additional effects to marine mammal prey species and short-term local water turbidity caused by in-water construction due to pile removal and pile driving. These potential effects are discussed in detail in the Federal Register notice for the proposed IHA and are not repeated here.

In order to issue an incidental take authorization 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 adverse 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.

For WSDOT's proposed Anacortes tie-up slips dolphin and wingwall replacement project, NMFS is requiring WSDOT to implement the following mitigation measures to minimize the potential impacts to marine mammals in the project vicinity as a result of the in-water construction activities.

To avoid potential injury to marine mammals, only vibratory pile hammer will be used for pile removal and pile driving.

Work would occur only during daylight hours, when visual monitoring of marine mammals can be conducted. In addition, all in-water construction will be limited to the period between September 1, 2015, and February 15, 2016.

Because WSDOT will not use impact pile driving for the proposed construction work, no Level A exclusion zone exists for marine mammals. NMFS currently uses received level of 120 dB as the onset of Level B harassment from non-impulse sources such as vibratory pile driving and pile removal. Although ambient measurement during March at the vicinity of Anacortes Ferry Terminal showed that the median ambient noise level is at 123 dB re 1 µPa, WSDOT will use 120 dB re 1 µPa as the isopleths for modeling its Level B harassment zone. WSDOT is considering collecting ambient noise data before in-water construction and adjust the Level B behavioral harassment zone based on measurements.

The 120-dB Level B harassment ZOIs from in-water vibratory pile removal and pile driving are modeled based on in-water measurements at the WSDOT Port Townsend Ferry Terminal (Laughlin 2011) and Friday Harbor Ferry Terminal (Laughlin 2010) constructions. These modeled results are presented in Table 2 below.

WSDOT will implement “soft start” (or ramp up) to reduce potential startling behavioral responses from marine mammals. Soft start requires contractors to initiate noise from the vibratory hammer for 15 seconds at reduced energy followed by a 1-minute waiting period. The procedure will be repeated two additional times. Each day, WSDOT will use the soft-start technique at the beginning of pile driving, or if pile driving has ceased for more than one hour.

WSDOT shall implement shutdown measures if southern resident killer whales are sighted within the vicinity of the project area and are approaching the Level B harassment zone (zone of influence, or ZOI) during in-water construction activities.

If a killer whale approaches the ZOI during pile driving or removal, and it is unknown whether it is a Southern Resident killer whale or a transient killer whale, it shall be assumed to be a Southern Resident killer whale and WSDOT shall implement the shutdown measure.

If a Southern Resident killer whale or an unidentified killer whale enters the ZOI undetected, in-water pile driving or pile removal shall be suspended until the whale exits the ZOI to avoid further level B harassment.

Further, WSDOT shall implement shutdown measures if the number of any allotted marine mammal takes reaches the limit under the IHA (if issued), if such marine mammals are sighted within the vicinity of the project area and are approaching the Level B harassment zone during in-water construction activities.

Prior to the start of pile driving, the Orca Network and/or Center for Whale Research will be contacted to find out the location of the nearest marine mammal sightings. The Orca Sightings Network consists of a list of over 600 (and growing) residents, scientists, and government agency personnel in the U.S. and Canada. Sightings are called or emailed into the Orca Network and immediately distributed to other sighting networks including: the Northwest Fisheries Science Center of NOAA Fisheries, the Center for Whale Research, Cascadia Research, the Whale Museum Hotline and the British Columbia Sightings Network.

`Sightings' information collected by the Orca Network includes detection by hydrophone. The SeaSound Remote Sensing Network is a system of interconnected hydrophones installed in the marine environment of Haro Strait (west side of San Juan Island) to study orca communication, in-water noise, bottom fish ecology and local climatic conditions. A hydrophone at the Port Townsend Marine Science Center measures average in-water sound levels and automatically detects unusual sounds. These passive acoustic devices allow researchers to hear when different marine mammals come into the region. This acoustic network, combined with the volunteer (incidental) visual sighting network allows researchers to document presence and location of various marine mammal species.

With this level of coordination in the region of activity, WSDOT will be able to get real-time information on the presence or absence of whales before starting any pile driving.

NMFS has carefully evaluated the mitigation measures and considered a range of other measures in the context of ensuring that NMFS prescribes the means of effecting the least practicable impact on the affected marine mammal species and stocks and their habitat. Our evaluation of potential measures included consideration of the following factors in relation to one another:

• The manner in which, and the degree to which, the successful implementation of the measure is expected to minimize adverse impacts to marine mammals

• The proven or likely efficacy of the specific measure to minimize adverse impacts as planned

• The practicability of the measure for applicant implementation.

Any mitigation measure(s) prescribed by NMFS should be able to accomplish, have a reasonable likelihood of accomplishing (based on current science), or contribute to the accomplishment of one or more of the general goals listed below:

(1) Avoidance or minimization of injury or death of marine mammals wherever possible (goals 2, 3, and 4 may contribute to this goal).

(2) A reduction in the numbers of marine mammals (total number or number at biologically important time or location) exposed to received levels of pile driving and pile removal or other activities expected to result in the take of marine mammals (this goal may contribute to 1, above, or to reducing harassment takes only).

(3) A reduction in the number of times (total number or number at biologically important time or location) individuals would be exposed to received levels of pile driving and pile removal, or other activities expected to result in the take of marine mammals (this goal may contribute to 1, above, or to reducing harassment takes only).

(4) A reduction in the intensity of exposures (either total number or number at biologically important time or location) to received levels of pile driving, or other activities expected to result in the take of marine mammals (this goal may contribute to a, above, or to reducing the severity of harassment takes only).

(5) Avoidance or minimization of adverse effects to marine mammal habitat, paying special attention to the food base, activities that block or limit passage to or from biologically important areas, permanent destruction of habitat, or temporary destruction/disturbance of habitat during a biologically important time.

(6) For monitoring directly related to mitigation—an increase in the probability of detecting marine mammals, thus allowing for more effective implementation of the mitigation.

Based on our evaluation of the prescribed mitigation measures, NMFS has determined the measures provide the means of effecting the least practicable impact on marine mammal species or stocks and their habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance.

In order to issue an incidental take authorization (ITA) 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 ITAs must include the suggested means of accomplishing the necessary monitoring and reporting that will result in increased knowledge of the species and of the level of taking or impacts on populations of marine mammals that are expected to be present in the proposed action area. WSDOT submitted a marine mammal monitoring plan as part of the IHA application, and updated the plan based on comments received from the Commission. The updated monitoring plan can be found at http://www.nmfs.noaa.gov/pr/permits/incidental.htm. The plan may be modified or supplemented based on comments or new information received from the public during the public comment period.

Monitoring measures prescribed by NMFS should accomplish one or more of the following general goals:

(1) An increase in the probability of detecting marine mammals, both within the mitigation zone (thus allowing for more effective implementation of the mitigation) and in general to generate more data to contribute to the analyses mentioned below;

(2) An increase in our understanding of how many marine mammals are likely to be exposed to levels of pile driving that we associate with specific adverse effects, such as behavioral harassment, TTS, or PTS;

(3) An increase in our understanding of how marine mammals respond to stimuli expected to result in take and how anticipated adverse effects on individuals (in different ways and to varying degrees) may impact the population, species, or stock (specifically through effects on annual rates of recruitment or survival) through any of the following methods:

Behavioral observations in the presence of stimuli compared to observations in the absence of stimuli (need to be able to accurately predict received level, distance from source, and other pertinent information);

Physiological measurements in the presence of stimuli compared to observations in the absence of stimuli (need to be able to accurately predict received level, distance from source, and other pertinent information);

Distribution and/or abundance comparisons in times or areas with concentrated stimuli versus times or areas without stimuli;

(4) An increased knowledge of the affected species; and

(5) An increase in our understanding of the effectiveness of certain mitigation and monitoring measures.

WSDOT shall employ NMFS-approved protected species observers (PSOs) to conduct marine mammal monitoring for its Anacortes tie-up dolphins and wingwall replacement project. The PSOs will observe and collect data on marine mammals in and around the project area for 30 minutes before, during, and for 30 minutes after all pile removal and pile installation work. If a PSO observes a marine mammal within a ZOI that appears to be disturbed by the work activity, the PSO will notify the work crew to initiate shutdown measures.

Monitoring of marine mammals around the construction site shall be conducted using high-quality binoculars (e.g., Zeiss, 10 × 42 power). Due to the different sizes of ZOIs from different pile sizes, two different ZOIs and monitoring protocols corresponding to a specific pile size will be established. Specifically, during vibratory timber removal, and 24″ steel vibratory pile driving and removal, one land-based PSO will monitor the area from the terminal work site, and one boat with a driver and a PSO will travel through the monitoring area. During 30/36″ vibratory pile driving, one land-based PSO will monitor the area from the terminal work site, and two boats with two drivers and two PSOs will travel through the monitoring area (see Figures 2 and 3 in WSDOT's updated Marine Mammal Monitoring Plan).

Data collection during marine mammal monitoring will consist of a count of all marine mammals by species, a description of behavior (if possible), location, direction of movement, type of construction that is occurring, time that pile replacement work begins and ends, any acoustic or visual disturbance, and time of the observation. Environmental conditions such as weather, visibility, temperature, tide level, current, and sea state would also be recorded.

WSDOT is required to submit a final monitoring report within 90 days after completion of the construction work or the expiration of the IHA (if issued), whichever comes earlier. This report shall detail the monitoring protocol, summarize the data recorded during monitoring, and estimate the number of marine mammals that may have been harassed. NMFS shall have an opportunity to provide comments on the report, and if NMFS has comments, WSDOT shall address the comments and submit a final report to NMFS within 30 days.

In addition, NMFS requires WSDOT to notify NMFS' Office of Protected Resources and NMFS' Stranding Network within 48 hours of sighting an injured or dead marine mammal in the vicinity of the construction site. WSDOT shall provide NMFS with the species or description of the animal(s), the condition of the animal(s) (including carcass condition, if the animal is dead), location, time of first discovery, observed behaviors (if alive), and photo or video (if available).

In the event that WSDOT finds an injured or dead marine mammal that is not in the vicinity of the construction area, WSDOT would report the same information as listed above to NMFS as soon as operationally feasible.

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].

As discussed above, in-water pile removal and pile driving (vibratory and impact) generate loud noises that could potentially harass marine mammals in the vicinity of WSDOT's proposed Anacortes Ferry Terminal tie-up slip dolphin and wingwall replacement project.

As mentioned earlier in this document, currently NMFS uses 120 dB re 1 µPa and 160 dB re 1 µPa at the received levels for the onset of Level B harassment from non-impulse (vibratory pile driving and removal) and impulse sources (impact pile driving) underwater, respectively. Table 3 summarizes the current NMFS marine mammal take criteria.

As explained above, ZOIs will be established that encompass the areas where received underwater sound pressure levels (SPLs) exceed the applicable thresholds for Level B harassment. In the case of WSDOT's proposed Anacortes construction project, the Level B harassment ZOI for non-impulse noise sources will be at the received level at 120 dB. This level may be revised and the Level B ZOI reestablished if WSDOT conduct an ambient noise measurement during the time of construction. There will not be a zone for Level A harassment in this case, because source levels from vibratory hammer do not exceed the threshold for Level A harassment, and no impact hammer will be used in the proposed project.

As mentioned earlier, the revised 120-dB Level B harassment ZOIs are modeled based on in-water measurements at the WSDOT Port Townsend Ferry Terminal (Laughlin 2011) and Friday Harbor Ferry Terminal (Laughlin 2010) constructions (Table 2). Incidental take is calculated for each species by estimating the likelihood of a marine mammal being present within a ZOI during active pile removal/driving. Expected marine mammal presence is determined by past observations and general abundance near the Anacortes ferry terminal during the construction window. Ideally, potential take is estimated by multiplying the area of the ZOI by the local animal density. This provides an estimate of the number of animals that might occupy the ZOI at any given moment. However, there are no density estimates for any Puget Sound population of marine mammal.

As a result, the take requests were estimated using local marine mammal data sets, and information from state and federal agencies. All haulout and observation data available are summarized in Section 3 of WSDOT's IHA application. Project duration is presented in Section 2 of WSDOT's IHA application.

The calculation for marine mammal exposures is estimated by:

Exposure estimate = N (number of animals in the area) * Number of days of pile removal/driving activity.

Estimates include Level B acoustical harassment during vibratory pile removal and driving. All estimates are conservative, as pile removal/driving will not be continuous during the work day. Using this approach, a summary of estimated takes of marine mammals incidental to WSDOT's Anacortes Ferry Terminal tip-up dolphins and wingwall replacement work are provided in Table 4.

Negligible impact is “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” (50 CFR 216.103). 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 Level B harassment 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 behavioral harassment, NMFS must consider other factors, such as the likely nature of any responses (their intensity, duration, etc.), the context of any responses (critical reproductive time or location, migration, etc.), as well as the number and nature of estimated Level A harassment takes, the number of estimated mortalities, and effects on habitat.

WSDOT's Anacortes Ferry Terminal tie-up dolphins and wingwall replacement project would involve vibratory pile removal and pile driving activities. Elevated underwater noises are expected to be generated as a result of these activities; however, these noises are expected to result in no mortality or Level A harassment and limited Level B harassment of marine mammals. WSDOT will not use impact hammer for pile driving, thus eliminating the potential for injury (including PTS) and TTS from noise impact. For vibratory pile removal and pile driving, noise levels are not expected to reach the level that may cause TTS, injury (including PTS), or mortality to marine mammals. Therefore, NMFS does not expect that any animals would experience Level A harassment (including injury or PTS) or Level B harassment in the form of TTS from being exposed to in-water pile removal and pile driving associated with WSDOT's construction project.

Additionally, the sum of noise from WSDOT's proposed Anacortes Ferry Terminal tie-up dolphins and wingwall replacement construction activities is confined to a limited area by surrounding landmasses; therefore, the noise generated is not expected to contribute to increased ocean ambient noise. In addition, due to shallow water depths in the project area, underwater sound propagation of low-frequency sound (which is the major noise source from pile driving) is expected to be poor.

In addition, WSDOT's proposed activities are localized and of short duration. The entire project area is limited to WSDOT's Anacortes Ferry Terminal construction work. The entire project would involve the removal of 272 existing piles and installation of 81 piles. The duration for the construction would involve 68 hours in 9 days for pile removal and 27 hours in 27 days for pile installation. These low-intensity, localized, and short-term noise exposures may cause brief startle reactions or short-term behavioral modification by the animals. These reactions and behavioral changes are expected to subside quickly when the exposures cease. Moreover, the proposed mitigation and monitoring measures are expected to reduce potential exposures and behavioral modifications even further. Additionally, no important feeding and/or reproductive areas for marine mammals are known to be near the proposed action area. Therefore, the take resulting from the proposed Anacortes Ferry Terminal tie-up dolphins and wingwall replacement work is not reasonably expected to, and is not reasonably likely to, adversely affect the marine mammal species or stocks through effects on annual rates of recruitment or survival.

The project area is not a prime habitat for marine mammals, nor is it considered an area frequented by marine mammals. Therefore, behavioral disturbances that could result from anthropogenic noise associated with WSDOT's construction activities are expected to affect only a small number of marine mammals on an infrequent and limited basis.

The project also is not expected to have significant adverse effects on affected marine mammals' habitat, as analyzed in detail in the “Anticipated Effects on Marine Mammal Habitat” section. The project activities would not modify existing marine mammal habitat. The activities may cause some fish to leave the area of disturbance, thus temporarily impacting marine mammals' foraging opportunities in a limited portion of the foraging range; but, because of the short duration of the activities and the relatively small area of the habitat that may be affected, the impacts to marine mammal habitat are not expected to cause significant or long-term negative consequences.

Based on the analysis contained herein of the likely effects of the specified activity on marine mammals and their habitat, and taking into consideration the implementation of the proposed monitoring and mitigation measures, NMFS finds that the total marine mammal take from WSDOT's Anacortes Ferry Terminal tie-up dolphins and wingwall replacement project will have a negligible impact on the affected marine mammal species or stocks.

Based on analyses provided above, it is estimated that approximately 900 harbor seals, 180 California sea lions, 360 Steller sea lions, 72 northern elephant seals, 612 harbor porpoises, 108 Dall's porpoises, 70 transient killer whales, 4 Southern Resident killer whales, 360 Pacific white-sided dolphins, 36 gray whales, 30 humpback whales, and 10 minke whales could be exposed to received noise levels that could cause Level B behavioral harassment from the proposed construction work at the Anacortes Ferry Terminal in Washington State. These numbers represent approximately 0.06% to 20% of the populations of these species that could be affected by Level B behavioral harassment, respectively (see Table 5 above), which are small percentages relative to the total populations of the affected species or stocks.

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 mitigation and monitoring measures, which are expected to reduce the number of marine mammals potentially affected by the proposed action, NMFS finds that small numbers of marine mammals will be taken relative to the populations of the affected species or stocks.

There are no subsistence uses of marine mammals in the proposed project area; and, thus, no subsistence uses impacted 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.

The humpback whale and the Southern Resident stock of killer whale are the only marine mammal species currently listed under the ESA that could occur in the vicinity of WSDOT's proposed construction projects. Under section 7 of the ESA, the Federal Highway Administration (FHWA) and WSDOT have consulted with NMFS West Coast Regional Office (WCRO) on the proposed WSDOT Anacortes Ferry Terminal tie-up slip dolphins and wingwall replacement project. WCRO issued a Biological Opinion on July 15, 2014, which concludes that the proposed Anacortes Ferry Terminal tie-up slip dolphins and wingwall replacement project may affect, but is not likely to adversely affect the listed marine mammal species and stocks.

The issuance of an IHA to WSDOT constitutes an agency action that authorizes an activity that may affect ESA-listed species and, therefore, is subject to section 7 of the ESA. As the effects of the activities on listed marine mammals were analyzed during a formal consultation between the FHWA and NMFS, and as the underlying action has not changed from that considered in the consultation, the discussion of effects that are contained in the Biological Opinion and accompanying memo issued to the FHWA on July 15, 2014, pertains also to this action. Therefore, NMFS has determined that issuance of an IHA for this activity would not lead to any effects to listed marine mammal species apart from those that were considered in the consultation on FHWA's action.

NMFS prepared an Environmental Assessment (EA) and analyzed the potential impacts to marine mammals that would result from WSDOT's Anacortes Ferry Terminal tie-up slip dolphins and wingwall replacement project. A Finding of No Significant Impact (FONSI) was signed in May 2015. A copy of the EA and FONSI is available upon request (see ADDRESSES).

NMFS has issued an IHA to WSDOT for the potential harassment of small numbers of 11 marine mammal species incidental to the Anacortes Ferry Terminal tie-up slip dolphins and wingwall replacement construction in Washington State, provided the previously mentioned mitigation, monitoring, and reporting requirements are incorporated.

Background

Sections 101(a)(5)(A) and (D) of the MMPA (16 U.S.C. 1361 et seq.), directs the Secretary of Commerce (Secretary) to allow, upon request, the incidental, but not intentional, taking of small numbers of marine mammals, by United States 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.

Authorization for the 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.”

Section 101(a)(5)(D) of the MMPA established an expedited process by which citizens of the United States can apply for an authorization to incidentally take small numbers of marine mammals by harassment. Section 101(a)(5)(D) of the MMPA establishes a 45-day time limit for NMFS's review of an application followed by a 30-day public notice and comment period on any proposed authorizations for the incidental harassment of small numbers of marine mammals. Within 45 days of the close of the public comment period, NMFS must either issue or deny the authorization.

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 February 25, 2015, NMFS received an application from the City of San Diego, Engineering and Capital Projects Department, requesting an IHA for the taking of marine mammals incidental to construction activities. NMFS determined that the IHA application was adequate and complete on April 9, 2015.

The City of San Diego would undertake the proposed construction activities between June 2015 and June 2016 at the Children's Pool Lifeguard Station in La Jolla, California. In-air noise generated from equipment used during the construction activities is likely to result in the take of marine mammals. The requested IHA would authorize the take, by Level B (behavioral) harassment, of small numbers of Pacific harbor seals (Phoca vitulina richardii), California sea lions (Zalophus californianus), and northern elephant seals (Mirounga angustirostris) incidental to construction activities of the Children's Pool Lifeguard Station at La Jolla, CA. Because the proposed construction activities were subject to delays and cannot be completed by June 27, 2015, the City of San Diego has requested a renewal of the 2014 to 2015 IHA for an additional year. The construction activities are planned to take place during June 2015 to June 2016 in La Jolla, CA. Regarding the previous IHA, NMFS published a notice in the Federal Register (79 FR 8160) on February 11, 2014, making preliminary determinations and proposing to issue an IHA. The notice initiated a 30-day public comment period. On June 6, 2014, NMFS published a notice in the Federal Register (79 FR 32699) announcing the issuance of an IHA. Additional information on the construction activities at the Children's Pool Lifeguard Station is contained in the IHA application, which is available upon request (see ADDRESSES).

Also, NMFS issued the City of San Diego an IHA in 2013 (78 FR 40705, July 8, 2013) for demolition and construction activities at the Children's Pool Lifeguard Station that were scheduled to be completed in 2013. Because the construction activities were subject to delays (e.g., nesting migratory birds, unexpected drainage pipes, unexpected demolition and construction planning, etc.) and could not be completed by December 15, 2013, the City of San Diego requested a renewal of the 2013 IHA for an additional year. Additional information on the construction activities at the Children's Pool Lifeguard Station is contained in the IHA application, which is available upon request (see ADDRESSES).

The City of San Diego plans to conduct construction activities at the Children's Pool Lifeguard Station in La Jolla, CA in order to meet the needs of the lifeguards at Children's Pool and the demand for lifeguard services. The overall project includes the demolition of the existing lifeguard station and construction of a new, three-story, lifeguard station on the same site. Demolition of the existing lifeguard station was completed in 2013 to 2014 and construction of the new lifeguard station is expected to be completed in 2015 to 2016. Because the previously existing lifeguard station was demolished and closed to entry, a temporary lifeguard tower was moved onto the bluff near the previous lifeguard station.

The City of San Diego is planning to begin/resume the project at the Children's Pool in La Jolla, CA on June 1, 2015, (see page 30 to 31 of the Negative Declaration in the IHA application) with completion of the new lifeguard station to be completed by December 15, 2015. The City of San Diego and NMFS are requiring a moratorium on all construction activities during harbor seal pupping and weaning (i.e., December 15th to May 30th; see page 5 of the Mitigated Negative Declaration in the IHA application). Therefore, work on this project can only be performed between June 1st and December 14th of any year.

Proposed construction activities would generally occur Monday through Friday (no work will occur on holidays) during daylight hours only, as stipulated in the “Mitigated Negative Declaration” included in the IHA application and local ordinances. As a modification to the original IHA, the City of San Diego has requested that planned construction activities be allowed on weekends (i.e., Saturday and Sunday to ensure completion of the project during 2015. The exact dates of the proposed activities depend on logistics and scheduling. The IHA is valid through June 2016 to allow for construction delays.

The La Jolla Children's Pool Lifeguard Station is located at 827 1/2 Coast Boulevard, La Jolla, CA 92037 (32° 50′ 50.02″ North, 117° 16′ 42.8″ West). The locations and distances (in ft) from the construction site to the Children's Pool haul-out area, breakwater ledge/rocks haul-out area, reef haul-out area, and Casa Beach haul-out area can be found in the City of San Diego's IHA application.

The Children's Pool was created in 1931 by building a breakwater wall which created a protected pool for swimming. Although partially filled with sand, the Children's Pool still has open water for swimming and a beach for sunbathing and beachcombing. The Children's Pool and nearby shore areas (i.e., shoreline, beaches, and reefs of La Jolla) are used by swimmers, sunbathers, SCUBA divers and snorkelers, shore/surf fishermen, school classes, tide pool explorers, kayakers, surfers, boogie and skim boarders, seal, sea lion, bird and nature watchers, and for other activities by the general public. Over the last three years (2010 through 2012), an average of 1,556,184 people have visited the Children's Pool annually, and lifeguards have taken an average of 8,147 preventive actions and 86 water rescues annually (CASA, 2010; 2011; 2012).

The previous lifeguard facility at Children's Pool, built in 1967, was old, deteriorating from saltwater intrusion, and no longer served the needs of the lifeguard staff or the beach-going public. The structure was condemned on February 22, 2008 due to its deteriorated condition and lack of structural integrity. Because the existing building was no longer viable, a temporary lifeguard tower was moved in. However, a new lifeguard station is required to meet the needs of the lifeguards and the demand for lifeguard services.

The overall project includes the demolition of the existing lifeguard station and construction of a new, three-story, lifeguard station on the same site. Demolition and removal of the existing lifeguard station was completed in 2013 to 2014 and construction of the new lifeguard station is expected to be completed in 2015 to 2016. The building contractor utilized excavators, backhoes, concrete saws, and jackhammers for demolishing the previous structure and has hauled the waste materials to an offsite landfill where it was separated into recycled content and waste. During the second year of construction (2014 to 2015) and in the same footprint as the old lifeguard station, the new lifeguard station is being constructed within and adjacent to the previous facility. Rough plumbing and electrical have been laid; the foundation has been poured and some of the steel structure has been erected. The new lifeguard facility is in an optimal location to provide lifeguard service to the community. The new, three-story, building will contain a lower level with beach access level public restrooms and showers, lifeguard lockers, and sewage pump room; a second level with two work stations, ready/observation room, kitchenette, restroom, and first aid station; and a third “observation” level (with a 270° view of the beach and nearby reef areas) with a single occupancy observation space, radio storage closet, and exterior catwalk. Interior stairs will link the floors. The existing below grade retaining walls will remain in place and new retaining walls will be constructed for a ramp from street level to the lower level for emergency vehicle beach access and pedestrian access to the lower level restrooms and showers. A 5.6 m (18. 5 ft) wall will be located along the north end of the lower level. The walls will be designed for a minimum design life of 50 years and will not be undermined from ongoing coastal erosion. The walls will not be readily viewed from Coast Boulevard, the public sidewalks or the surrounding community. Enhanced paving, seating and viewing space, drinking fountains, adapted landscaping, and water efficient irrigation will also be included.

The City of San Diego has divided the demolition and construction activities are divided into phases:

(1.) Mobilization and temporary facilities;

(2.) Demolition and site clearing;

(3.) Site preparation and utilities;

(4.) Building foundation;

(5.) Building shell;

(6.) Building exterior;

(7.) Building interior;

(8.) Site improvements; and

(9.) Final inspection and demobilization.

Demolition and construction of the new lifeguard station was initially estimated to take approximately 7 months (148 actual demolition and construction days) and be completed by December 15, 2013; however, demolition and construction did not start until later than previously planned in June 2013 and June 2014 due to the presence of nesting migratory birds (i.e., Western seagulls [Larus occidentalis] and eggs/chicks). There were additional unexpected delays in the demolition due to unforeseen underground structures at the site making it impossible to finish the project by December 15, 2013 or 2014. The City of San Diego completed phases 1 to 4 during 2013 and 2014. During the 2013 to 2014 construction window, the temporary on-site tower was removed and two temporary towers were installed nearby (one about 500 m [1,640.4 ft] south of the construction site and another about 1,000 m [3,280.8 ft] east of the construction site to serve citizens utilizing the beaches and ocean waters nearby. Construction of phases 5 to 9 would commence in June 2015, thereby necessitating a renewal of the previous IHA.

The notice of the final IHA for the City of San Diego's demolition and construction activities that was published in the Federal Register on July 8, 2013 (78 FR 40705) provides a detailed summary on phases 1 to 4 (i.e., mobilization and temporary facilities, demolition and site clearing, site preparation and utilities, and building foundation). Phases 5 to 9 include (phases overlap in time):

(5.) Building shell:

Pre-cast concrete panel walls, panel walls, rough carpentry and roof framing, wall board, cable railing, metal flashing, and roofing.

Equipment—crane, truck, fork lift, and hand/power tools.

Timeframe—Approximately 35 days.

This phase will be completed in 2015 and has a maximum source level of 100 dB.

(6.) Building exterior:

Doors and windows, siding paint, light fixtures, and plumbing fixtures.

Equipment—truck, hand/power tools, and chop saw.

Timeframe—Approximately 4 weeks.

This phase will be completed in 2015 and has a maximum source level of 100 dB.

(7.) Building interiors:

Walls, sewage lift station, rough and finish mechanical electrical plumbing structural (MEPS), wall board, door frames, doors and paint.

Equipment—truck, hand/power tools, and chop saw.

Timeframe—Approximately 37 days.

This phase will be completed in 2015 and has a maximum source level of 100 dB.

(8.) Site improvements:

Modify storm drain, concrete seat walls, curbs, and planters, fine grade, irrigation, hardscape, landscape, hand rails, plaques, and benches.

Equipment—backhoe, truck, hand/power tools, concrete pump/truck, and fork lift.

Timeframe—Approximately 37 days.

This phase will be completed in 2015 and has a maximum source level of 110 dB.

(9.) Final inspection and demobilization:

System testing, remove construction equipment, inspection, and corrections.

Equipment—truck, and hand/power tools.

Timeframe—Approximately 41 days.

This phase will be completed in 2015 and has a maximum source level of 100 dB.

The exact dates of the planned activities depend on logistics and scheduling.

Sound levels during all phases of the project would not exceed 110 dB re 20 μPa at five feet from the sound sources. The 110 dB estimate is based on equipment manufacturers' estimates obtained by the construction contractor. The City of San Diego utilized published or manufacturers' measurement data based on the proposed equipment (i.e., a backhoe, dump truck, cement pump, air compressor, electric screw guns, jackhammers, concrete saw, chop saw, and hand tools) to be utilized on the project site. Operation of the equipment is the primary activity within the range of construction activities that is likely to affect marine mammals by potentially exposing them to in-air (i.e., airborne or sub-aerial) noise. During the working day, the City of San Diego estimates there would be sound source levels above 90 dB re 20 μPa, including 65 days of 100 to 110 dB re 20 μPa at the construction site.

On average, pinnipeds will be about 30.5 meters (m) (100 feet [ft]) or more from the construction site with a potential minimum of about 15.2 m (50 ft). During 2013 and 2014, measured sound levels from the demolition equipment reaching the pinnipeds did not exceed approximately 90 dB re 20 μPa at the haul-out area closest to the demolition and construction and a peak of about 83 dB re 20 μPa at the mean hauling-out distance (30.5 m). The City of San Diego used the formula and online calculator on the Web site: http://sengpielaudio.com/calculator-distance.htm and measured distances from the sound source to determine the area of potential impacts from in-air sound. Table 1 of the City of San Diego's monitoring report provides mean sound and mean distance from sound sources by the type of equipment and monitoring location. The City of San Diego intends to continue to measure in-air background noise levels in the days immediately prior to, during, and after the construction activities.

Additional details regarding the proposed construction activities of the Children's Pool Lifeguard Station can be found in the City of San Diego's IHA application. The IHA application can also be found online at: http://www.nmfs.noaa.gov/pr/permits/incidental/construction.htm.

Three species of pinnipeds are known to or could occur in the Children's Pool proposed action area and off the Pacific coastline (see Table 1 below). Pacific harbor seals, California sea lions, and northern elephant seals are the three species of marine mammals that occur and are likely to be found within the immediate vicinity of the activity area. Therefore, these three species are likely to be exposed to effects of the proposed specified activities. A variety of other marine mammals have on occasion been reported in the coastal waters off southern California. These include gray whales, killer whales, bottlenose dolphins, Steller sea lions, northern fur seals, and Guadalupe fur seals. However, none of these species have been reported to occur in the immediate proposed action area of the Children's Pool beach. Therefore, NMFS does not expect, and is not authorizing, incidental take of other marine mammal species from the proposed specified activities. Table 1 below identifies the cetacean and pinnipeds species, their habitat, and conservation status in the nearshore area of the general region of the proposed project area.

The rocks and beaches at or near the Children's Pool in La Jolla, CA, are almost exclusively Pacific harbor seal hauling-out sites. On infrequent occasions, one or two California sea lions or a single juvenile northern elephant seal have been observed on the sand or rocks at or near the Children's Pool (i.e., breakwater ledge/rocks haul-out area, reef haul-out area, and Casa Beach haul-out area). These sites are not usual haul-out locations for California sea lions and/or northern elephant seals. The City of San Diego commissioned two studies of harbor seal abundance trends at the Children's Pool. Both studies reported that appearances of California sea lions and northern elephant seals are infrequent, but not rare at Children's Pool (Yochem and Stewart, 1998; Hanan, 2004; Hanan & Associates, 2011). During 2013, the City of San Diego observed one juvenile and three adult California sea lions and two juvenile northern elephant seals at the Children's Pool. During 2014, the City of San Diego observed 22 California sea lions (during 19 days) and 30 juvenile elephant seals (during 29 days) at the Children's Pool. Adult sea lions were also observed hauling out on rocks and cliffs near the Children's Pool.

Harbor seals are widely distributed in the North Atlantic and North Pacific. Two subspecies exist in the Pacific Ocean: P. v. stejnegeri in the western North Pacific near Japan, and P. v. richardii in the eastern North Pacific. The subspecies in the eastern North Pacific Ocean inhabits near-shore coastal and estuarine areas from Baja California, Mexico, to the Pribilof Islands in Alaska. These seals do not make extensive pelagic migrations, but do travel 300 to 500 kilometers (km) (162 to 270 nautical miles [nmi]) on occasion to find food or suitable breeding areas (Herder, 1986; Harvey and Goley, 2011). Previous assessments of the status of harbor seals have recognized three stocks along the west coast of the continental U.S.: (1) California, (2) Oregon and Washington outer coast waters, and (3) inland waters of Washington. An unknown number of harbor seals also occur along the west coast of Baja California, at least as far south as Isla Asuncion, which is about 100 miles south of Punta Eugenia. Animals along Baja California are not considered to be a part of the California stock because it is not known if there is any demographically significant movement of harbor seals between California and Mexico and there is no international agreement for joint management of harbor seals. Harbor seal presence at haul-out sites is seasonal with peaks in abundance during their pupping and molting periods. Pupping and molting periods are first observed to the south and progress northward up the coast with time (e.g., January to May near San Diego, April to June in Oregon and Washington) (Jeffries, 1984; Jeffries, 1985; Huber et al., 2001; Hanan, 2004; Hanan & Associates, 2011).

In California, approximately 400 to 600 harbor seal haul-out sites are distributed along the mainland coast and on offshore islands, including intertidal sandbars and ledges, rocky shores and islets, and beaches (Harvey et al., 1995; Hanan, 1996; Lowry et al., 2008). Preferred haul-out sites are those that are protected from the wind and waves, and allow access to deep water for foraging (Perrin et al., 2008). Of the known haul-out sites, 14 locations are rookeries (2 locations have multiple sites, for a total of 17 sites) on or near the mainland of California. The population of harbor seals has grown off the U.S. west coast and has led to new haul-out sites being used in California (Hanan, 1996). Harbor seals are one of the most common and frequently observed marine mammals along the coastal environment.

Harbor seals have been observed hauling-out and documented giving birth at the Children's Pool since the 1990's (Yochem and Stewart, 1998; Hanan & Associates, 2004). Pacific harbor seals haul-out year-round on beaches and rocks (i.e., breakwater ledge/rocks haul-out area, reef haul-out area, and Casa Beach haul-out area) below the lifeguard tower at Children's Pool. According to Yochem (2005), the Children's Pool beach site is used by harbor seals at all hours of the day and at all tides with the exception of occasional high tide/high swell events in which the entire beach is awash. It is one of the three known haul-out sites for this species in San Diego County. These animals have been observed in this area moving to/from the Children's Pool, exchanging with the rocky reef directly west of and adjacent to the breakwater and with Seal Rock, which is about 150 m (492 ft) west of the Children's Pool. Harbor seals have also been reported on the sandy beach just southwest of the Children's Pool. At low tide, additional space for hauling-out is available on the rocky reef areas outside the retaining wall and on beaches immediately southward. Haul-out times vary by time of year, from less than an hour to many hours. There have been no foraging studies at this site, but harbor seals have been observed in nearshore waters and kelp beds nearby, including La Jolla Cove.

The Children's Pool area is the only rookery in San Diego County and the only mainland rookery on the U.S. west coast between the border of Mexico and Point Mugu in Ventura County, CA (321.9 km [200 miles]). The number of harbor seals in this area has increased since 1979, and seals are documented to give birth on these beaches during December through May (Hanan, 2004; Hanan & Associates, 2011). The official start to pupping season is December 15. Females in an advanced stage of pregnancy begin to show up on the Children's Pool beach by late October to early November. Several studies have identified harbor seal behavior and estimated harbor seal numbers including patterns of daily and seasonal area use (Yochem and Stewart, 1998; Hanan & Associates, 2011; Linder, 2011). Males, females, and pups (in season) of all ages and stages of development are observed at the Children's Pool and adjacent areas.

In southern California, a considerable amount of information is known about the movements and ecology of harbor seals, but population structure in the region is not as well known (Stewart and Yochem, 1994, 2000; Keper et al., 2005; Hanan & Associates, 2011). Linder (2011) suggests that this population moves along the California coast and the beach at Children's Pool is part of a “regional network of interconnected” haul-out and pupping sites. Harbor seals often haul-out in protected bays, inlets, and beaches (Reeves et al., 1992). At and near the Children's Pool, harbor seals haul-out on the sand, rocks, and breakwater base in numbers of 0 to 15 harbor seals to a maximum of about 150 to 250 harbor seals depending on the time of day, season, and weather conditions (Hanan, 2004, Hanan & Associates, 2011; Linder, 2011). Because space is limited behind the breakwater at the Children's Pool, Linder (2011) predicted that it is unlikely that numbers will exceed 250 harbor seals. Based on monitoring from a camera, Western Alliance for Nature (WAN) reported that during the month of May 2013 up to 302 harbor seals were documented resting on the Children's Pool beach at any given time, with additional harbor seals on the rocks and in the water (Wan, personal communication). Almost every day, except for weekends, over 250 individual harbor seals were present on the beach. During the months of September 2012 to January 2013, the average number of harbor seals on the beach varied from 83 to 120 animals before people entered the beach or when people were behind the rope. During this same period, when people were on the beach and/or across the rope, the average number of harbor seals varied from 7 to 27. The City of San Diego observed 12 counts totaling more than 200 and a maximum of 238 animals during the 2014 to 2015 construction window. The weather (i.e., wind and/or rain) and the proximity of humans to the beach likely affect the presence of harbor seals on the beach.

Radio-tagging and photographic studies have revealed that only a portion of seals utilizing a hauling-out site are present at any specific moment or day (Hanan, 1996, 2005; Gilbert et al., 2005; Harvey and Goley, 2011; and Linder, 2011). These radio-tagging studies indicate that harbor seals in Santa Barbara County haul-out about 70 to 90% of the days annually (Hanan, 1996). The City of San Diego expects harbor seals to behave similarly at the Children's Pool. Tagged and branded harbor seals from other haul-out sites have been observed by Dr. Hanan at the Children's Pool. For example, harbor seals with red-stained heads and coats, which are typical of some harbor seals in San Francisco Bay have been observed at Children's Pool, indicating that seals tagged at other locations and haul-out sites visit the site. A few seals have been tagged at the Children's Pool and there are no reports of these tagged animals at other sites (probably because of very low re-sighting efforts and a small sample size [10 individuals radio-tagged]), which may indicate a degree of site-fidelity (Yochem and Stewart, 1998). These studies further indicate that seals are constantly moving along the coast including to/from the offshore islands and that there may be as many as 600 individual harbor seals using Children's Pool during a year, but certainly not all at one time.

The City of San Diego has fitted a polynomial curve to the number of expected harbor seals hauling-out at the Children's Pool by month (see Figure 1 of the IHA application and Figure 2 below) based on counts at the Children's Pool by Hanan (2004), Hanan & Associates (2011), Yochem and Stewart (1998), and the Children's Pool docents (Hanan, 2004). A three percent annual growth rate of the population was applied to Yochem and Stewart (1998) counts to normalize them to Hanan & Associates and docent counts in 2003 to 2004. Based on monitoring during 2013 to 2014, Dr. Hanan estimates that similar numbers of harbor seals hauling-out at Children's Pool during 2011 and would expect similar numbers in 2015 to 2016.

A complete count of all harbor seals in California is impossible because some are always away from the haul-out sites. A complete pup count (as is done for other pinnipeds in California) is also not possible because harbor seals are precocial, with pups entering the water almost immediately after birth. Population size is estimated by counting the number of seals ashore during the peak haul-out period (May to July) and by multiplying this count by a correction factor equal to the inverse of the estimated fraction of seals on land. Based on the most recent harbor seal counts (2009) and including a revised correction factor, the estimated population of harbor seals in California is 30,196 individuals (NMFS, 2011), with an estimated minimum population of 26,667 for the California stock of harbor seals. Counts of harbor seals in California increased from 1981 to 2004. The harbor seal is not listed under the ESA and the California stock is not considered depleted or strategic under the MMPA (Carretta et al., 2010).

The California sea lion is a full species, separate from the Galapagos sea lion (Zalophus wollebaeki) and the extinct Japanese sea lion (Zalophus japonicus) (Brunner, 2003; Wolf et al., 2007; Schramm et al., 2009). This species of sea lion is found from southern Mexico to southwestern Canada. The breeding areas of the California sea lion are on islands located in southern California, western Baja California, and the Gulf of California. A genetic analysis of California sea lions identified five genetically distinct geographic populations: (1) Pacific Temperate, (2) Pacific Subtropical, (3) Southern Gulf of California, (4) Central Gulf of California, and (5) Northern Gulf of California (Schramm et al., 2009). In that study, the Pacific Temperate population included rookeries within U.S. waters and the Coronados Islands just south of U.S./Mexico border. Animals from the Pacific Temperate population range north into Canadian waters, and movement of animals between U.S. waters and Baja California waters has been documented, though the distance between the major U.S. and Baja California rookeries is at least 740.8 km (400 nmi). Males from western Baja California rookeries may spend most of the year in the United States.

The entire California sea lion population cannot be counted because all age and sex classes are never ashore at the same time. In lieu of counting all sea lions, pups are counted during the breeding season (because this is the only age class that is ashore in its entirety), and the numbers of births is estimated from the pup count. The size of the population is then estimated from the number of births and the proportion of pups in the population. Censuses are conducted in July after all pups have been born. There are no rookeries at or near the Children's Pool, although in the past two years births have been reported at La Jolla Cove (about 0.75 km [0.47 miles] east of Children's Pool). Population estimates for the U.S. stock of California sea lions range from a minimum of 153,337 to an average estimate of 296,750 animals. They are considered to be at carrying capacity of the environment. The California sea lion is not listed under the ESA and the U.S. stock is not considered depleted or strategic under the MMPA.

Northern elephant seals breed and give birth in California (U.S.) and Baja California (Mexico), primarily on offshore islands (Stewart et al., 1994) from December to March (Stewart and Huber, 1993). Spatial segregation in foraging areas between males and females is evident from satellite tag data (Le Beouf et al., 2000). Males migrate to the Gulf of Alaska and western Aleutian Islands along the continental shelf to feed on benthic prey, while females migrate to pelagic areas in the Gulf of Alaska and the central North Pacific to feed on pelagic prey (Le Beouf et al., 2000). Adults return to land between March and August to molt, with males returning later than females. Adults return to their feeding areas again between their spring/summer molting and their winter breeding seasons.

Populations of northern elephant seals in the U.S. and Mexico have recovered after being nearly hunted to extinction (Stewart et al., 1994). Northern elephant seals underwent a severe population bottleneck and loss of genetic diversity when the population was reduced to an estimated 10 to 30 individuals (Hoelzel et al., 2002). However, movement and genetic exchange continues between rookeries when they start breeding (Huber et al., 1991). The California breeding population is now demographically isolated from the Baja California population. The California breeding population is considered in NMFS's stock assessment report to be a separate stock.

A complete population count of elephant seals is not possible because all age classes are not ashore simultaneously. Elephant seal population size is typically estimated by counting the number of pups produced and multiplying by the inverse of the expected ratio of pups to total animals (McCann, 1985). Based on counts of elephant seals at U.S. rookeries in 2010, Lowry et al. (2014) reported that 40,684 pups were born. Lowry et al. (2014) applied a multiplier of 4.4 to extrapolate from total pup counts to a population estimate of approximately 179,000 elephant seals. This multiplier is derived from life tables based on published elephant seal fecundity and survival rates, and reflects a population with approximately 23% pups (Cooper and Stewart, 1983; Le Boeuf and Reiter, 1988; Hindell 1991; Huber et al., 1991; Reiter and Le Boeuf, 1991; Clinton and Le Boeuf, 1993; Le Boeuf et al., 1994; Pistorius and Bester, 2002; McMahon et al., 2003; Pistorius et al., 2004; Condit et al., 2014). The minimum population size for northern elephant seals in 2010 can be estimated very conservatively as 81,368, which is equal to twice the observed pup count (to account for the pups and their mothers). The population is reported to have grown at 3.8% annually since 1988 (Lowry et al., 2014). Northern elephant seals are not listed under the ESA and are not considered as depleted or a strategic stock under the MMPA.

Further information on the biology and local distribution of these marine mammal species and others in the region can be found in the City of San Diego's IHA application, which is available upon request (see ADDRESSES), and the NMFS Marine Mammal Stock Assessment Reports, which are available online at: http://www.nmfs.noaa.gov/pr/sars/.

This section includes a summary and discussion of the ways that the types of stressors associated with the proposed specified activity (e.g., construction equipment and activities) have been observed to impact marine mammals. This discussion may also include reactions that we consider to rise to the level of a take and those that we do not consider to rise to the level of take (for example, with acoustics), we may include a discussion of studies that showed animals not reacting at all to sound or exhibiting barely measureable avoidance). This section is intended as a background of potential effects and does not consider either the specific manner in which this activity will be carried out or the mitigation that will be implemented, or how either of those will shape the anticipated impacts from this specific activity. The “Estimated Take by Incidental Harassment” section later in this document will include a quantitative analysis of the number of individuals that are expected to be taken by this activity. The “Negligible Impact Analysis” section will include the analysis of how this specific activity will impact marine mammals and will consider the content of this section, the “Estimated Take by Incidental Harassment” section, the “Proposed Mitigation” section, and the “Anticipated Effects on Marine Mammal Habitat” section to draw conclusions regarding the likely impacts of this activity on the reproductive success or survivorship of individuals and from that on the affected marine mammal populations or stocks.

When considering the influence of various kinds of sound on the marine environment, it is necessary to understand that different kinds of marine life are sensitive to different frequencies of sound. Based on available behavioral data, audiograms have been derived using auditory evoked potentials, anatomical modeling, and other data, Southall et al. (2007) designate “functional hearing groups” for marine mammals and estimate the lower and upper frequencies of functional hearing of the groups. The functional groups and the associated frequencies are indicated below (though animals are less sensitive to sounds at the outer edge of their functional range and most sensitive to sounds of frequencies within a smaller range somewhere in the middle of their functional hearing range):

• Low-frequency cetaceans (13 species of mysticetes): functional hearing is estimated to occur between approximately 7 Hz and 30 kHz;

• Mid-frequency cetaceans (32 species of dolphins, six species of larger toothed whales, and 19 species of beaked and bottlenose whales): functional hearing is estimated to occur between approximately 150 Hz and 160 kHz;

• High-frequency cetaceans (eight species of true porpoises, six species of river dolphins, Kogia spp., the franciscana (Pontoporia blainvillei), and four species of cephalorhynchids): functional hearing is estimated to occur between approximately 200 Hz and 180 kHz; and

• Phocid pinnipeds in water: functional hearing is estimated to occur between approximately 75 Hz and 100 kHz;

• Otariid pinnipeds in water: functional hearing is estimated to occur between approximately 100 Hz and 40 kHz.

As mentioned previously in this document, 3 marine mammal species (0 cetacean and 3 pinniped species) are likely to occur in the proposed action area. Of the 3 pinniped species likely to occur in the City of San Diego's proposed action area, 2 are classified as phocid pinnipeds (i.e., Pacific harbor seal and northern elephant seal) and, 1 is classified as an otariid pinniped (i.e., California sea lion) (Southall et al., 2007). The City of San Diego requests authorization for Level B harassment of these 3 species of marine mammals (i.e., Pacific harbor seals, California sea lions, and northern elephant seals) incidental to the use of equipment and its propagation of in-air noise from various acoustic mechanisms associated with the construction activities of the Children's Pool Lifeguard Station at La Jolla, CA discussed above. NMFS considers a species' functional hearing group when we analyze the effects of exposure to sound on marine mammals.

The notice of the proposed IHA (79 FR 8160, February 11, 2014) included a discussion of the effects of in-air sounds from construction activities on pinnipeds, which included tolerance, behavioral disturbance, and hearing impairment. NMFS refers readers to the City of San Diego's IHA application and NMFS's EA for additional information on the behavioral reactions (or lack thereof) by all types of marine mammals to high levels of in-air sounds.

The potential effects to marine mammals described in this section of the document generally do not take into consideration the monitoring and mitigation measures described later in this document (see the “Proposed Mitigation” and “Proposed Monitoring and Reporting” sections), which are designed to effect the least practicable impact on affected marine mammal species or stocks.

The rocks and beaches at or near the Children's Pool in La Jolla, CA, are almost exclusively Pacific harbor seal hauling-out sites. Harbor seals have been observed hauling-out and documented giving birth at the Children's Pool since the 1990's (Yochem and Stewart, 1998; Hanan & Associates, 2004). It is one of the three known haul-out sites for this species in San Diego County and is the only rookery in San Diego County and the only mainland rookery on the U.S. west coast between the border of Mexico and Point Mugu in Ventura County, CA. More information on this population of Pacific harbor seals can be found in the “Description of Marine Mammals in the Specified Geographic Area of the Proposed Specified Activity.”

The primary anticipated adverse impacts upon habitat consist of temporary changes to the in-air acoustic environment, as detailed in the notice of the proposed IHA (79 FR 8160, February 11, 2014). These changes are minor, temporary, and limited in duration to the period of the construction activities. The temporary impacts on the acoustic environment are not expected to have any permanent effects on the species or stock populations of marine mammals occurring at the Children's Pool.

All proposed construction activities are beyond or outside the habitat areas where harbor seals and other pinnipeds are found. Visual barriers would be erected to shield construction activities from the visual perception and potentially dampen acoustic effects on pinnipeds. Because the public occasionally harasses the harbor seals with various activities, the NMFS-qualified PSO monitoring the site would make observations and attempt to distinguish and attribute any observed harassment to the public or to the proposed construction activities and give all details in the observation report. If any short-term, temporary impacts to habitat due to sounds or visual presence of equipment and workers did occur, the City of San Diego would expect pinniped behavior to return to pre-construction conditions soon after the activities are completed, which is anticipated to occur before the next pupping season (Hanan & Associates, 2011).

The area of habitat affected is small and the effects are localized and temporary; thus there is no reason to expect any significant reduction in habitat available for foraging and other habitat uses. No aspect of the project is anticipated to have any permanent effect on the location or use of pinniped haul-outs or related habitat features in the area (Hanan & Associates, 2011). Further, the site is already very disturbed by member of the public who come to the area during the day and night to view the pinnipeds. The City of San Diego and NMFS do not project any loss or modification of physical habitat for these species. Any potential temporary loss or modification of habitat due to in-air noise or visual presence of equipment and workers during the proposed construction activities is expected by the City of San Diego and NMFS to be quickly restored after construction activities end and all equipment and barriers are removed.

For these reasons, NMFS anticipates that the proposed action would result in no impacts to marine mammal habitat beyond rendering the areas immediately around the Children's Pool less desirable during construction activities.

In order to issue an Incidental Take Authorization (ITA) under section 101(a)(5)(D) of the MMPA, NMFS must prescribe, where applicable, 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 (where relevant).

The City of San Diego has established the Children's Pool as a shared beach for pinnipeds and people (except during pupping season when the beach has been closed to the public). In the past, during the pupping season, a rope was placed along the upper part of the beach with signage to inform and designate how close people can come to the haul-out area and the pinnipeds. The timeframe for the rope has been extended so that it is now present year-round. The construction activities are planned to occur outside the harbor seal pupping and weaning periods.

The City of San Diego would implement the following proposed mitigation measures to help ensure the least practicable impact on marine mammals:

(1) Prohibition of construction during pupping season;

(2) Daily construction timing;

(3) Construction of visual and acoustic barriers;

(4) Use of Protected Species Observers;

(5) Establishment of buffer zones; and

(6) Potential abandonment survey.

Visual and acoustic barriers were constructed in 2013 to mitigate the effects of the construction activities. The visual and acoustic barriers were constructed of plywood, 1.2 to 2.4 m (4 to 8 ft) tall stood on end and held up by wood posts. The sheets of plywood were stood upright and held up with two wooden two by fours hinged to the top of the frame, so they could be collapsed and moved depending on the location and need for access by demolition and construction equipment. The barriers were placed at the site with input from NMFS Southwest Regional Office (SWRO) personnel so that they will hide as advantageously as possible the construction activities that may be seen by pinnipeds. The barriers appear to dampen the acoustic sound sources, but do not prevent sound from permeating the environment. The barriers also appear to hide and reduce visual cues that may stimulate behavioral reactions from the pinnipeds on the beach below. As the site is a beach with construction along the cliff and on flat areas above the cliff, a complete barrier cannot be constructed to hide all construction activities for the project. Once the walls of the lifeguard station's building are in place, much of the construction activities will take place above the Children's Pool beach (i.e., out of sight) as well as inside the building (i.e., a visual and partial sound barrier). There would be no activities in the ocean or closer to the water's edge and since harbor seals mate underwater in the ocean, there will be no impacts on mating activities. California sea lions and northern elephant seals are such infrequent users of this area and their rookeries are so far away (at least 104.6 km [65 miles] at offshore islands) that there will be no adverse impact on these species.

As part of the public comment process for the issuance of the previous 2013 IHA, NMFS modified several of the monitoring and mitigation measures included in the proposed IHA (78 FR 25958, May 3, 2013) for practicability reasons, and also included several additional measures in the final IHA (78 FR 40705, July 8, 2013). These included changing the pupping season from December 15th to May 15th and prohibiting construction activities during this time; extending construction activities from 7:00 a.m. to 7:00 p.m. to help assure that more work would be completed during the 2013 construction window; continuing monitoring for 60 days following the end of construction activities; and triggering a shut-down of construction activities in the unexpected event of abandonment of the Children's Pool site. The mitigation measure on scheduling the heaviest construction activities (with the highest sound levels) during the annual period of lowest haul-out occurrence (October to November) was originally included in the City of San Diego's Mitigated Negative Declaration when it was anticipated that the City of San Diego would obtain an IHA in the summer of 2012 and begin demolition and construction activities in the fall of 2012. This requirement has been removed because it is no longer practicable due to logistics, scheduling and to allow the planned activities to be completed before the next pupping season.

The activities proposed by the applicant includes a variety of measures calculated to minimize potential impacts on marine mammals, including:

Construction shall be prohibited during the Pacific harbor seal pupping season (December 15th to May 15th) and for an additional two weeks thereafter to accommodate lactation and weaning of late season pups. Thus, construction shall be prohibited from December 15th to June 1st.

Construction activities shall be scheduled, to the maximum extent practicable, during the daily period of lowest haul-out occurrence, from approximately 8:30 a.m. to 3:30 p.m. However, construction activities may be extended from 7 a.m. to 7 p.m. to help assure that the project can be completed during the 2015 construction window. Harbor seals typically have the highest daily or hourly haul-out period during the afternoon from 3 p.m. to 6 p.m.

A visual and acoustic barrier would be erected and maintained for the duration of the project to shield construction activities from beach view. The temporary barrier shall consist of 1/2 to 3/4 inch (1.3 to 1.9 centimeters [cm]) plywood constructed 1.8 to 2.4 m (6 to 8 ft) high depending on the location. The City of San Diego does not believe that a complete barrier can be constructed to hide all of the proposed construction activities. Once the walls of the lifeguard station building are in place, much of the proposed construction activities would take place on the bluff above the beach (thus out of sight) and inside the building, which would provide a visual and partial sound barrier.

Trained PSOs would be used to detect, document, and minimize impacts (i.e., possible shut-down of noise-generating operations [turning off the equipment so that in-air sounds associated with construction no longer exceed levels that are potentially harmful to marine mammals]) to marine mammals. More information about this measure is contained in the “Proposed Monitoring” section (below).

The City of San Diego shall establish buffer zones (i.e., where sound pressure levels are at or above 90 dB re 20 μPa for harbor seals and/or at or above 100 dB re 20 μPa for all pinniped species except harbor seals [for in-air noise]) around the construction activities so that in-air sounds associated with the construction activities no longer exceed levels that are potentially harmful to marine mammals.

To minimize in-air noise impacts on marine mammals, construction activities shall be limited to the period when the species of concern would be least likely to be in the project area. The construction window for construction activities shall be from June 1 to December 15, 2015. The IHA may extend to June 1 through June 27, 2016 to finish the construction activities if needed. Avoiding periods when the highest number of marine mammal individuals are in the action area is another mitigation measure to protect marine mammals from the proposed construction activities.

After the first two months of monitoring during construction activities, the City of San Diego will take the mean number of observed harbor seals at the Children's Pool in a 24-hour period across that two months and compare it to the mean of the lower 95 percent confidence interval in Figure 1 (see below). If the observed mean is lower, the City of San Diego would shut-down construction activities and work with NMFS and other harbor seal experts (e.g., Mark Lowry, Dr. Sarah Allen, Dr. Pamela Yochem, and/or Dr. Brent Stewart) to develop and implement a revised mitigation plan to further reduce the number of takes and potential impacts. Once a week every week thereafter, the City of San Diego will take the same mean of observed harbor seals across the previous three tide cycles (a tide cycle is approximately 2 weeks) and compare it to the 95% lower confidence interval in Figure 1 for the same time period. If the observed mean is lower, the City of San Diego would shut-down and take the action described above. If abandonment of the site is likely, monitoring would be expanded away from the Children's Pool to determine if animals have been temporarily displaced to known haul-out sites in the southern California area (e.g., north end of Torrey Pines, cave on the exposed ocean side of Point Loma, etc.). For the purpose of this action, NMFS will consider the Children's Pool site to possibly be abandoned if zero harbor seals are present each day during the daytime and nighttime hours for at least three tide cycles (a tide cycle is approximately 2 weeks), but this cannot be confirmed until observations continue to be zero during a full pupping and molting season.

More information regarding the City of San Diego's monitoring and mitigation measures for the proposed construction activities at the Children's Pool Lifeguard Station can be found in the IHA application.

NMFS has carefully evaluated the applicant's mitigation measures and considered a range of other measures in the context of ensuring that NMFS prescribes the means of effecting the least practicable impact on the affected marine mammal species and stocks and their habitat. NMFS's evaluation of potential measures included consideration of the following factors in relation to one another:

• The manner in which, and the degree to which, the successful implementation of the measure is expected to minimize adverse impacts to marine mammals;

• The proven or likely efficacy of the specific measure to minimize adverse impacts as planned; and

• The practicability of the measure for applicant implementation, including consideration of personnel safety, practicality of implementation, and impact on the effectiveness of the activity.

Any mitigation measure(s) prescribed by NMFS should be able to accomplish, have a reasonable likelihood of accomplishing (based on current science), or contribute to the accomplishment of one or more of the general goals listed below:

(1) Avoidance or minimization of injury or death of marine mammals wherever possible (goals 2, 3, and 4 may contribute to this goal).

(2) A reduction in the numbers of marine mammals (total number or number at biologically important time or location) exposed to received levels from construction equipment, or other activities expected to result in the take of marine mammals (this goal may contribute to 1, above, or to reducing harassment takes only).

(3) A reduction in the number of times (total number or number at biologically important time or location) individuals would be exposed to received levels from construction equipment, or other activities expected to result in the take of marine mammals (this goal may contribute to 1, above, or to reducing harassment takes only).

(4) A reduction in the intensity of exposures (either total number or number at biologically important time or location) to received levels from construction equipment, or other activities expected to result in the take of marine mammals (this goal may contribute to a, above, or to reducing the severity of harassment takes only).

(5) Avoidance of minimization of adverse effects to marine mammal habitat, paying special attention to the food base, activities that block or limit passage to or from biologically important areas, permanent destruction of habitat, or temporary destruction/disturbance of habitat during a biologically important time.

(6) For monitoring directly related to mitigation—an increase in the probability of detecting marine mammals, thus allowing for more effective implementation of the mitigation.

Based on NMFS's evaluation of the applicant's proposed measures, as well as other measures considered by NMFS or recommended by the public, NMFS has determined that the mitigation measures provide the means of effecting the least practicable impact on marine mammal species or stocks and their habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance.

In order to issue an ITA for an activity, section 101(a)(5)(D) of the MMPA states that NMFS must, where applicable, set forth “requirements pertaining to the monitoring and reporting of such taking.” The MMPA implementing regulations at 50 CFR 216.104 (a)(13) require that requests for ITAs include the suggested means of accomplishing the necessary monitoring and reporting that will result in increased knowledge of the species and of the level of taking or impacts on populations of marine mammals that are expected to be present in the proposed action area.

Monitoring measures prescribed by NMFS should accomplish one or more of the following general goals:

(1) An increase in the probability of detecting marine mammals, both within the mitigation zone (thus allowing for more effective implementation of the mitigation) and in general to generate more data to contribute to the analyses mentioned below;

(2) An increase in our understanding of how many marine mammals are likely to be exposed to levels from construction equipment that we associate with specific adverse effects, such as behavioral harassment, TTS or PTS;

(3) An increase in our understanding of how marine mammals respond to stimuli expected to result in take and how anticipated adverse effects on individuals (in different ways and to varying degrees) may impact the population, species, or stock (specifically through effects on annual rates of recruitment or survival) through any of the following methods:

• Behavioral observations in the presence of stimuli compared to observations in the absence of stimuli (need to be able to accurately predict received level, distance from source, and other pertinent information);

• Physiological measurements in the presence of stimuli compared to observations in the absence of stimuli (need to be able to accurately predict receive level, distance from the source, and other pertinent information);

• Distribution and/or abundance comparisons in times or areas with concentrated stimuli versus times or areas without stimuli;

(4) An increased knowledge of the affected species; and

(5) An increase in our understanding of the effectiveness of certain mitigation and monitoring measures.

The City of San Diego has developed a monitoring plan (see Appendix I, Mitigated Negative Declaration in the IHA application) based on discussions between the project biologist, Dr. Doyle Hanan, and NMFS biologists. The plan has been vetted by City of San Diego planners and reviewers. The plan has been formally presented to the public for review and comment. The City of San Diego has responded in writing and in public testimony (see City of San Diego Council Hearing, December 14, 2011) to all public concerns.

The monitoring plan involves surveying prior to construction activities, monitoring during construction activities by NMFS-approved PSOs with high-resolution binoculars and handheld digital sound level meters (measuring devices in the 30 to 130 dB re 20 µPa range), and post-construction monitoring. The City of San Diego would include sound measurements at and near the construction site in their initial survey prior to the activities as a background and baseline for the project. While no specific acoustic study is planned, the City of San Diego's Mitigated Negative Declaration states that marine mammal monitoring shall be conducted for three to five days prior to construction and shall include hourly systematic counts of pinnipeds using the beach, Seal Rock, and associated reef areas. Monitoring three to five days prior to construction will provide baseline data regarding recent haul-out behavior and patterns as well as background noise levels near the time of the proposed construction activities.

During the proposed construction activities, monitoring shall assess behavior and potential behavioral responses to construction noise and activities. PSOs would observe the proposed construction activities from a station along the breakwater wall and from the base of the cliff below the construction area. PSOs would be on site approximately 30 minutes before the start of proposed construction activities and would remain on site until 30 minutes after activities have ceased. Visual digital recordings and photographs shall be used to document individuals and behavioral responses to construction. The City of San Diego (i.e., PSOs) plans to make hourly counts of the number of pinnipeds present and record sound or visual events that result in behavioral responses and changes, whether during construction or from public stimuli. During these events, pictures and video will also be taken when possible. The “Mitigated Negative Declaration” states “monitoring shall assess behavior and potential behavioral responses to construction noise and activities. Visual digital recordings and photographs shall be used to document individuals and behavioral responses to construction.”

Monitors would have authority to stop construction as necessary depending on sound levels, pinniped presence, and distance from sound sources. Daily monitoring reports would be maintained for periodic summary reports to the City of San Diego and to NMFS. Observations would be entered into and maintained on Hanan & Associates computers. The City of San Diego plans to follow the reporting requirements in the Mitigated Negative Declaration, which states that “the biologist shall document field activity via the Consultant Site Visit Record. The Consultant Site Visit Record shall be either emailed or faxed to the City of San Diego's Mitigation Monitoring Coordination process (MMC) on the 1st day of monitoring, the 1st week of each month, the last day of monitoring, and immediately in the case of any undocumented discovery. The project biologist shall submit a final construction monitoring report to MMC within 30 days of construction completion.” The MMC “coordinates the monitoring of development projects and requires that changes are approved and implemented to be in conformance with the permit requirements and to minimize any damage to the environment.” These documents will also be sent to NMFS. Finally, the City of San Diego has modified its monitoring program to include 60 days of monitoring post-construction activities. Following construction, the City of San Diego would have a program of onsite PSOs that would randomly select a day per week to monitor.

NMFS notes that the WAN's La Jolla Harbor Seal Webcam was attached to the old (now demolished) lifeguard station and is no longer available online (http://www.wanconservancy.org/la_jolla_harbor_seal_earthcam.htm). The City of San Diego has stated that there is no suitable place to mount the camera at the construction site. Therefore, the City of San Diego cannot do periodic checks using the webcam for monitoring purposes as required by the 2013 IHA. However, the camera was not expected to replace NMFS-qualified PSOs at the site making accurate counts, measuring sound levels and observing the public and the construction, as well as the harbor seals. In the old camera view, a person may have been able to see visual evidence of Level B harassment but probably would not have been able to distinguish between harassment from construction activities and harassment from the public since the camera had a limited scope and only showed the Children's Pool beach and pinnipeds (usually a specific portion of the beach, but not the reef nor nearby beaches).

Consistent with NMFS procedures, the following marine mammal monitoring and reporting shall be performed for the proposed action:

(1) The PSO shall be approved by NMFS prior to construction activities.

(2) The NMFS-approved PSO shall attend the project site prior to, during, and after construction activities cease each day throughout the construction window.

(3) The PSO shall search for marine mammals within the Children's Pool area.

(4) The PSO shall be present during construction activities to observe for the presence of marine mammals in the vicinity of the specified activity. All such activity would occur during daylight hours (i.e., 30 minutes after sunrise and 30 minutes before sunset). If inclement weather limits visibility within the area of effect, the PSO would perform visual scans to the extent conditions allow.

(5) If marine mammals are sighted by the PSO within the acoustic threshold areas, the PSO shall record the number of marine mammals within the area of effect and the duration of their presence while the noise-generating activity is occurring. The PSO would also note whether the marine mammals appeared to respond to the noise and, if so, the nature of that response. The PSO shall record the following information: Date and time of initial sighting, tidal stage, weather conditions, Beaufort sea state, species, behavior (activity, group cohesiveness, direction and speed of travel, etc.), number, group composition, distance to sound source, number of animals impacted, construction activities occurring at time of sighting, and monitoring and mitigation measures implemented (or not implemented). The observations would be reported to NMFS.

(6) A final report would be submitted summarizing all in-air acoustic effects from construction activities and marine mammal monitoring during the time of the authorization, and any long term impacts from the project.

A written log of dates and times of monitoring activity will be kept. The log shall report the following information:

• Time of observer arrival on site;

• Time of the commencement of in-air noise generating activities, and description of the activities;

• Distances to all marine mammals relative to the sound source;

• Distances from the sound meter to each sound-producing activity when conducting sound measurements;

• For harbor seal observations, notes on seal behavior during noise-generating activity, as described above, and on the number and distribution of seals observed in the project vicinity;

• For observations of all marine mammals other than harbor seals, the time and duration of each animal's presence in the project vicinity; the number of animals observed; the behavior of each animal, including any response to noise-generating activities;

• Time of the cessation of in-air noise generating activities; and

• Time of observer departure from site.

All monitoring data collected during construction would be included in the biological monitoring notes to be submitted. A final report summarizing the construction monitoring and any general trends observed would also be submitted to NMFS within 90 days after monitoring has ended during the period of the lifeguard station construction.

The City of San Diego would notify NMFS Headquarters and the NMFS Southwest Regional Office prior to initiation of the construction activities. A draft final report must be submitted to NMFS within 90 days after the conclusion of the construction activities of the Children's Pool Lifeguard Station. The report would include a summary of the information gathered pursuant to the monitoring requirements set forth in the IHA, including dates and times of operations and all marine mammal sightings (dates, times, locations, species, behavioral observations [activity, group cohesiveness, direction and speed of travel, etc.], tidal stage, weather conditions, Beaufort sea state and wind force, associated construction activities). A final report must be submitted to the Regional Administrator within 30 days after receiving comments from NMFS on the draft final report. If no comments are received from NMFS, the draft final report would be considered to be the final report.

While the IHA does not authorize injury (i.e., Level A harassment), serious injury, or mortality, should the applicant, contractor, monitor or any other individual associated with the construction project observe an injured or dead marine mammal, the incident (regardless of cause) will be reported to NMFS as soon as practicable. The report should include species or description of animal, condition of animal, location, time first found, observed behaviors (if alive) and photo or video, if available.

In the unanticipated event that the City of San Diego discovers a live stranded marine mammal (sick and/or injured) at Children's Pool, they shall immediately contact Sea World's stranded animal hotline at 1-800-541-7235. Sea World shall also be notified if a dead stranded pinniped is found so that a necropsy can be performed. In all cases, NMFS shall be notified as well, but for immediate response purposes, Sea World shall be contacted first.

Reporting Prohibited Take—In the unanticipated event that the specified activity clearly causes the take of a marine mammal in a manner prohibited by this IHA, such as an injury (Level A harassment), serious injury, or mortality, the City of San Diego shall immediately cease the specified activities and immediately report the incident to the Chief of the Permits and Conservation Division, Office of Protected Resources, NMFS, at 301-427-8401 and/or by email to [email protected], [email protected], and the West Coast Regional Stranding Coordinator (562-980-3230). The report must include the following information:

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

• The type of activity involved;

• Description of the circumstances during and leading up to 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 marine mammal observations in the 24 hours preceding the incident; species identification or description of the animal(s) involved;

• The fate of the animal(s); and photographs or video footage of the animal (if equipment is available).

Activities shall not resume until NMFS is able to review the circumstances of the prohibited take. NMFS shall work with the City of San Diego to determine the action necessary to minimize the likelihood of further prohibited take and ensure MMPA compliance. The City of San Diego may not resume its activities until notified by NMFS via letter, email, or telephone.

Reporting an Injured or Dead Marine Mammal with an Unknown Cause of Death—In the event that the City of San Diego discovers an injured or dead marine mammal, and the lead PSO 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 as described in the next paragraph), the City of San Diego would immediately report the incident to the Chief of the Permits and Conservation Division, Office of Protected Resources, NMFS, at 301-427-8401, and/or by email to [email protected], [email protected], and the NMFS West Coast Regional Office (1-866-767-6114), and/or to the West Coast Regional Stranding Coordinator (562-980-3230). The report must include the same information identified above. Activities may continue while NMFS reviews the circumstances of the incident. NMFS would work with the City of San Diego to determine whether modification of the activities is appropriate.

Reporting an Injured or Dead Marine Mammal Not Related to the Activities—In the event that the City of San Diego discovers an injured or dead marine mammal, and the lead PSO determines that the injury or death is not associated with or related to the activities authorized (e.g., previously wounded animal, carcass with moderate to advanced decomposition, or scavenger damage), the City of San Diego shall report the incident to the Chief of the Permits and Conservation Division, Office of Protected Resources, NMFS, at 301-427-8401, and/or by email to [email protected], [email protected], and the NMFS West Coast Regional Office (1-866-767-6114) and/or to the West Coast Regional Stranding Coordinator (562-980-3230) within 24 hours of the discovery. The City of San Diego shall provide photographs or video footage (if available) or other documentation of the stranded animal sighting to NMFS and the Marine Mammal Stranding Network. Activities may continue while NMFS reviews the circumstances of the incident.

Hanan & Associates, Inc., on behalf of the City of San Diego, conducted marine mammal and in-air sound monitoring at six locations during demolition and construction activities at the Children's Pool Lifeguard Station in La Jolla, California from June 3, 2013 to February 12, 2014. Demolition and construction activities began on July 10, 2013 and were halted for the Pacific harbor seal pupping season (December 15, 2013 to June 1, 2014). During 115 days of visual and acoustic observations, Hanan & Associates counted a total of 61,631 Pacific harbor seals and 26,037 people. During the 2013 demolition and construction activities, Hanan & Associates observed a total of 15,673 takes by Level B harassment (i.e., alerts, movements, and flushes) that could be attributed to demolition and construction activities (5,095 takes), the general public (8,639 takes), and other sources (1,939 takes). As of April 15, 2014, at least 60 harbor seal pups (including 2 still births) have been born at the Children's Pool and there has been no indication of abandonment. In addition to the Pacific harbor seal sightings, PSOs recorded 11 sightings of cetaceans (gray whales and bottlenose dolphins), 4 sightings of California sea lions (1 juvenile, 3 adult), and 2 northern elephant seals (both juveniles) at the Children's Pool.

Hanan & Associates recorded mean in-air sound levels of 69.2 dB re 20 μPa (range of 55.6 to 93.7 dB re 20 μPa) during non-demolition and construction activities and 70.3 dB re 20 μPa (range of 50.7 to 103.1 dB re 20 μPa) during demolition and construction activities. During 2013, measured sound levels from the demolition equipment reaching the pinnipeds did not exceed approximately 90 dB re 20 μPa at the haul-out area closest to the demolition and construction activities, nor did they exceed a peak of about 83 dB re 20 μPa at the mean hauling-out distance (30.5 m).

2014 to 2015

Hanan & Associates, Inc., on behalf of the City of San Diego, conducted marine mammal and in-air sound monitoring at seven locations during demolition and construction activities at the Children's Pool Lifeguard Station in La Jolla, California from August 6, 2014 to March 15, 2015. Construction activities began on August 6, 2014 and were halted for the Pacific harbor seal pupping season (December 15, 2014 to June 1, 2015). During 127 days of visual and acoustic observations, Hanan & Associates counted a total of 63,598 Pacific harbor seals and 27,844 people. During the 2014 demolition and construction activities, Hanan & Associates observed a total of 20,259 takes by Level B harassment (i.e., alerts, movements, and flushes) that could be attributed to demolition and construction activities (7,424 takes), the general public (10,000 takes), and other sources (2,835 takes). As of March 13, 2015, at least 60 harbor seal pups (including 6 still or premature births) have been born at the Children's Pool and there has been no indication of abandonment. In addition to the Pacific harbor seal sightings, PSOs recorded 24 sightings of cetaceans (gray whales, common and bottlenose dolphins), 366 sightings of California sea lions (at Seal Rock, Children's Pool beach, South Casa Beach, and on the reef), and 1 northern elephant seals (1 juvenile on Children's Pool beach) at the Children's Pool. One dead adult and one dead juvenile California sea lion were sighted on the Children's Pool beach after the start of the beach closure and after the construction activities stopped for the pupping season. These strandings were reported to NMFS.

Hanan & Associates recorded mean in-air sound levels of 68.9 dB re 20 μPa (range of 51.5 to 97.2 dB re 20 μPa) during non-construction activities and 71.3 dB re 20 μPa (range of 49.4 to 102.7 dB re 20 μPa) during construction activities. During 2014, measured sound levels from the construction equipment reaching the pinnipeds did not exceed approximately 90 dB re 20 μPa at the haul-out area closest to the construction activities.

More information on the monitoring results from the City of San Diego's previous demolition and construction activities at the La Jolla Children's Pool Lifeguard Station can be found in the final monitoring reports. The 2013 to 2014 and 2014 to 2015 monitoring reports can be found online at: http://www.nmfs.noaa.gov/pr/permits/incidental/construction.htm#childrenspool.

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].

The City of San Diego and NMFS anticipate takes of Pacific harbor seals, California sea lions, and northern elephant seals by Level B (behavioral) harassment only incidental to the construction project at the Children's Pool. No takes by injury (Level A harassment), serious injury, or mortality are expected. NMFS will consider pinnipeds behaviorally reacting to the construction activities by flushing into the water, moving more than 1 m (3.3 ft), but not into the water; becoming alert and moving, but not moving more than 1 m; and changing direction of current movements by individuals as behavioral criteria for take by Level B harassment.

With proposed construction activities scheduled to begin in June 2015, the City of San Diego expects a range of 0 to 190 harbor seals to be present daily during June and a seasonal decline through November to about 0 to 50 harbor seals present daily. If all of the estimated harbor seals present are taken by incidental harassment each day, there could be a maximum of 10,000 takes (i.e., approximately 2,947 adult males and 2,211 juvenile males, 2,842 adult females and 2,000 juvenile females based on age and sex ratios presented in Harkonen et al., 1999) over the entire duration of the activities. An unknown portion of the incidental takes will be from repeated exposures as harbor seals leave and return to the Children's Pool area. A polynomial curve fit to counts by month was used by the City of San Diego to estimate the number of harbor seals expected to be hauled-out by day (see below and Figure 2 of the IHA application).

Assuming the total seals predicted to haul-out daily at the Children's Pool are exposed to sound levels that are considered Level B harassment during days where sound is predicted to exceed 90 dB at the construction site (65 days), there could be a maximum of approximately 10,000 incidental takes (i.e., exposures) of approximately up to 600 individual Pacific harbor seals over the duration of the activities. The estimated 600 individual Pacific harbor seals would be taken by Level B harassment multiple times during the proposed construction activities.

Very few California sea lions and/or northern elephant seals are ever observed at the Children's Pool (i.e., one or two individuals). The City of San Diego requests the authority to incidentally take (i.e., exposures) 10,000 Pacific harbor seals, 100 California sea lions, and 25 northern elephant seals, which will equate to 600, 2, and 1 individuals, respectively, being exposed multiple times. More information on the number of takes authorized, and the approximate percentage of the stock for the three species in the proposed action area can be found in Table 3 (below).

I. Background

NMFS' authority to make the loan resides in sections 1111 and 1112 of the Merchant Marine Act, 1936 (46 App. U.S.C. 1279(f) and 1279(g)(MMA)(title XI)).

The Program was authorized in the Consolidated Appropriations Act of 2005 (Section 209 of Title II of Division B of Pub. L. 108-447) and waives all of the fishing capacity reduction program requirements of the Magnuson-Stevens Act (Sections 312(b)-(e)) codified at 16 U.S.C. 1801 et seq. except for Sections (b)(1)(C) and (d) which state: (1) It must be cost-effective; and (2) it is subject to a referendum approved by a majority of permit holders.

NMFS published proposed program regulations on May 23, 2011 (76 FR 29707), and final program regulations on October 6, 2011 (76 FR 61985), to implement the reduction program. Subsequently, the Southeast Revitalization Association submitted a capacity reduction plan to NMFS. NMFS approved the plan on February 24, 2012. NMFS published the list of eligible voters on March 1, 2012 (77 FR 12568) and the notice of referendum period on March 29, 2012 (77 FR 19004). Interested persons should review these for further program details.

NMFS conducted a referendum where the majority of permit holders voted to repay a fishing capacity reduction loan to purchase the permits identified in the reduction plan.

On May 7, 2012, NMFS published another Federal Register document (77 FR 26744) advising the public that NMFS would tender the program's reduction payments to the 64 selected bidders who would permanently stop fishing with the permits they had relinquished in return for reduction payments. Subsequently, NMFS disbursed $13,133,030 in reduction payments to the 64 selected bidders.

NMFS published a Federal Register notice on July 16, 2012 (77 FR 41754) informing the public that fee collection would begin on July 22, 2012. Since then all harvesters of Southeast Alaska purse seine salmon must pay the fee and all fish buyers of Southeast Alaska purse seine salmon must collect the fee in accordance with the applicable regulations.

NMFS published a notice in the Federal Register on June 5, 2013 (78 FR 33810) to decrease the fee rate from 3.0% of landed value and any subsequent bonus payments to 1.5%, effective June 1, 2013.

The purpose of this notice is to adjust the fee rate for the reduction fishery in accordance with the framework rule's § 600.1013(b). Section 600.1013(b) directs NMFS to recalculate the fee to a rate that will be reasonably necessary to ensure reduction loan repayment within the specified 40-year term.

The initial fee applicable to the Southeast Alaska purse seine salmon program's reduction fishery was 3.0% of landed value and any subsequent bonus payments, which was decreased in June 2013 to 1.5%. NMFS has determined this fee rate is more than is needed to service the loan. Therefore, NMFS is decreasing the fee rate to 1.0% of landed value and any subsequent bonus payments which NMFS has determined is sufficient to ensure timely loan repayment. Fish buyers may continue to use Pay.gov to disburse collected fee deposits at: http://www.pay.gov/paygov/. Please visit the NMFS Web site for additional information at: http://www.nmfs.noaa.gov/mb/financial_services/buyback.htm.

The new fee rate for the Southeast Alaska purse seine salmon fishery is effective June 1, 2015.

Fish sellers and fish buyers must pay and collect the fee in the manner set out in 50 CFR 600.1107 and the framework rule. Consequently, all harvesters and fish buyers should read subpart L to 50 CFR 600.1013 to understand how fish harvesters must pay and fish buyers must collect the fee.

Title, Associated Form and OMB Number: TRICARE Young Adult Application; DD Form 2947; OMB Control Number 0720-0049.

Type of Request: Reinstatement.

Number of Respondents: 16,000.

Responses per Respondent: 2.

Annual Responses: 32,000.

Average Burden per Response: 15 minutes.

Annual Burden Hours: 8,000.

Needs and Uses: The information collection requirement is necessary to evaluate eligibility and qualifications of former young adult dependents applying for extended dependent coverage under the TRICARE Young Adult program.

Affected Public: Individuals or households.

Frequency: On occasion.

Respondent's Obligation: Required to obtain or retain benefits.

OMB Desk Officer: Ms. Meredith DeDona.

Written comments and recommendations on the proposed information collection should be sent to Ms. Meredith DeDona at the Office of Management and Budget, Desk Officer for DoD, Room 10236, New Executive Office Building, Washington, DC 20503.

You may also submit comments, identified by docket 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 number and title for this Federal Register document. The general policy for comments and other submissions from members of the public is to make these submissions available for public viewing on the Internet at http://www.regulations.gov as they are received without change, including any personal identifiers or contact information.

DOD Clearance Officer: Mr. Frederick Licari.

Written requests for copies of the information collection proposal should be sent to Mr. Licari at WHS/ESD Directives Division, 4800 Mark Center Drive, East Tower, Suite 02G09, Alexandria, VA 22350-3100.

This meeting is being held under the provisions of the Federal Advisory Committee Act of 1972 (5 U.S.C. Appendix, as amended), the Government in the Sunshine Act of 1976 (5 U.S.C. 552b, as amended), and 41 CFR 102-3.150. This notice is published in accordance with Section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463).

Pursuant to 5 U.S.C. 552b and 41 CFR 102-3.140 through 102-3.165, and the availability of space, this meeting is open to the public. Seating is on a first-come basis.

The purpose of the June 16, 2015 meeting is to review research and development projects requesting Strategic Environmental Research and Development Program funds as required by the SERDP Statute, U.S. Code ‐ Title 10, Subtitle A, Part IV, Chapter 172, § 2904. The full agenda follows:

Pursuant to 41 CFR 102-3.140, and section 10(a)(3) of the Federal Advisory Committee Act of 1972, the public or interested organizations may submit written statements to the Strategic Environmental Research and Development Program, Scientific Advisory Board. Written statements may be submitted to the committee at any time or in response to an approved meeting agenda.

All written statements shall be submitted to the Designated Federal Officer (DFO) for the Strategic Environmental Research and Development Program, Scientific Advisory Board. The DFO will ensure that the written statements are provided to the membership for their consideration. Contact information for the DFO can be obtained from the GSA's FACA Database at http://www.facadatabase.gov/. Time is allotted at the close of the meeting day for the public to make comments. Oral comments are limited to 5 minutes per person.

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: 2015-16—National Postsecondary Student Aid Study (NPSAS:16) Full Scale Institution Contacting And Enrollment List Collection.

OMB Control Number: 1850-0666.

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

Respondents/Affected Public: Individuals or Households.

Total Estimated Number of Annual Responses: 4,478.

Total Estimated Number of Annual Burden Hours: 4,081.

Abstract: The National Postsecondary Student Aid Study (NPSAS), a nationally representative study of how students and their families finance postsecondary education, was first implemented by the National Center for Education Statistics (NCES) in 1987 and has been fielded every 3 to 4 years since. The next major data collection will occur in 2016 following a field test collection in 2015. This submission is for the ninth cycle in the series, NPSAS:16, which will also serve as the base year study for the 2016 Baccalaureate and Beyond Longitudinal Study (B&B) which provides data on the various paths of recent college graduates into employment and additional education. The NPSAS:16 sample will include about 2,000 institutions and about 128,000 students. Institution contacting will begin in October 2015 and student data collection will be conducted from January through September 2016. A separate package to request clearance for student data collection (interviews and institution record data) will be submitted in the fall 2015. This submission includes contacting materials and collection of enrollment lists from institutions selected to participate in the full-scale study.

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: Graduate Assistance in Areas of National Need (GAANN) Performance Report.

OMB Control Number: 1840-0748.

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

Respondents/Affected Public: Private Sector, State, Local and Tribal Governments.

Total Estimated Number of Annual Responses: 291.

Total Estimated Number of Annual Burden Hours: 3,273.

Abstract: Graduate Assistance in Areas of National Need (GAANN) grantees must submit a performance report annually. The reports are used to evaluate grantee performance. Further, the data from the reports will be aggregated to evaluate the accomplishments and impact of the GAANN Program as a whole. Results will be reported to the Secretary in order to respond to GPRA requirements.

Purpose of the Board: The purpose of the Board is to make recommendations to DOE-EM and site management in the areas of environmental restoration, waste management, and related activities.

Tentative Agenda:

Public Participation: The meeting is open to the public. The EM SSAB, Hanford, welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Kristen Skopeck at least seven days in advance of the meeting at the phone number listed above. Written statements may be filed with the Board either before or after the meeting. Individuals who wish to make oral statements pertaining to agenda items should contact Kristen Skopeck at the address or telephone number listed above. Requests must be received five days prior to the meeting and reasonable provision will be made to include the presentation in the agenda. The Deputy Designated Federal Officer is empowered to conduct the meeting in a fashion that will facilitate the orderly conduct of business. Individuals wishing to make public comments will be provided a maximum of five minutes to present their comments.

Minutes: Minutes will be available by writing or calling Kristen Skopeck's office at the address or phone number listed above. Minutes will also be available at the following Web site: http://www.hanford.gov/page.cfm/hab.

General Information How can I get copies of this docket and other related information?

1. The EPA has established a docket for this action under Docket ID No. EPA-HQ-OARM-2015-0283. Publicly available docket materials are available either electronically through www.regulations.gov or in hard copy at the FY 2014 Service Contract Inventory Docket in the EPA Docket Center, (EPA/DC) EPA West, Room 3334, 1301 Constitution Avenue NW., Washington, DC. The EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the FY 2014 Service Contract Inventory Docket is (202) 566-1752.

2. Electronic Access. You may access this Federal Register document electronically through the EPA Internet under the “Federal Register” listings at http://www.epa.gov/fedrgstr/.

Under the Paperwork Reduction Act of 1995 (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. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each new proposed collection, each proposed extension of existing collection of information, and each reinstatement of previously approved information collection before submitting the collection to OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below.

Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology; and (e) estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information; and to transmit or otherwise disclose the information.

CDC Burden of Canine Brucellosis Information Collection—New—National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention (CDC).

Canine brucellosis is a bacterial infection caused by the organism Brucella canis. Few seroprevalence studies have been done to estimate the prevalence of canine brucellosis, most of which were conducted over 25 years ago. Two recent reports from Oklahoma and Wisconsin describe increasing prevalence in dogs; however, the national burden is not known. B. canis is also pathogenic to humans, although human infections are thought to be rare in the United States.

Unlike Brucella abortus, B. melitensis, and B. suis, B. canis is not classified as a select agent. As a result, laboratory identification of the organism in humans does not require reporting to the Laboratory Response Network. Brucella species-specific data are not collected in the Nationally Notifiable Disease Surveillance System at CDC, and there are no validated Brucella canis serological tests to diagnose disease in humans. For these reasons, there are no national estimates of B. canis prevalence in humans or canines.

Additionally, canine infections with other Brucella species have been reported in the literature. Zoonotic transmission is a concern with all Brucella species pathogenic to humans, and at least one human infection with B. suis related to canine contact has been reported. Neither the prevalence of canine brucellosis nor the potential risk of zoonotic spread to humans is known.

There has been interest in human brucellosis caused by B. canis among the public health community. However, the degree of public health importance of human B. canis infections has not yet been ascertained. The Council of State and Territorial Epidemiologists approved a position statement in 2012 that recommends increased focus on B. canis, and urges CDC to support the development of a human diagnostic assay.

The purpose of this information collection request is to estimate the burden of canine brucellosis in the United States, which will aid in the determination of the level of public health importance of human B. canis infections, and the potential for transmission of brucellosis from dogs. An estimate of disease burden in dogs will provide an idea of potential transmission between dogs and humans, and determine the need for future human public health studies, which is critical during this time of scarce resources.

Veterinary diagnostic laboratories throughout the United States will be solicited to provide information on the quantity of test requests and positive results for Brucella spp. in canines, outsourcing of clinical testing, state-wide policies for reporting of positive results, and policies for human exposure to clinical specimens or isolates.

The laboratories were identified through multiple sources: A review of the Animal and Plant Health Inspection Service-approved Brucella diagnostic laboratories, the National Animal Health Laboratory Network laboratories, the American Association of Veterinary Laboratory Diagnosticians (AAVLD), and an Internet search.

The outcomes of this information collection are to assess the burden of disease in the animal host (dogs, in this case), as well as evaluate the knowledge and practices of occupational exposures to the organism. The information collected will be used to guide a longer term strategy for identification of human cases, understanding risk factors and activities associated with zoonotic transmission, and eventually validation of a human diagnostic assay. These strategies will be implemented using other mechanisms.

The total annual burden is 129 hours.

Under the Paperwork Reduction Act of 1995 (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. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each new proposed collection, each proposed extension of existing collection of information, and each reinstatement of previously approved information collection before submitting the collection to OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below.

Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology; and (e) estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information; and to transmit or otherwise disclose the information.

National Intimate Partner and Sexual Violence Survey (NISVS)—Revision—(OMB Control No. 0920-0822, Expiration—6/30/2016), National Center for Injury Prevention and Control (NCIPC), Centers for Disease Control and Prevention (CDC).

In 2010, the National Intimate Partner and Sexual Violence Surveillance System (NISVSS) reported that approximately 6.9 million women and 5.6 million men experienced rape, physical violence and/or stalking by an intimate partner within the last year. The health care costs of Intimate Partner Violence (IPV) exceed $5.8 billion each year, nearly $3.9 billion of which is for direct medical and mental health care services.

In order to address this important public health problem, CDC implemented, beginning in 2010, the National Intimate Partner and Sexual Violence Surveillance System that produces national and state level estimates of Intimate Partner Violence (IPV), Sexual Violence (SV) and stalking on an annual basis.

This revision request is multi-faceted. CDC is requesting a continuation of data collection among non-institutionalized adult men and women aged 18 years or older in the United States assessing lifetime experiences of IPV, SV and stalking with a new and improved data collection tool. The revisions to the survey are aimed at reducing the time and complexity of the instrument, thus reducing the burden on the respondent. The simplified structure of the instrument will also reduce the complexity of the data set, making it more assessable for public use. Additionally, in collaboration with the Department of Defense (DoD), NISVS will collect information regarding the experiences of IPV, SV and stalking among active duty women and men in the military and wives of active duty men. This data collection will take place during the first three months of data collection.

To comply with OMB requirements, CDC is in the process of developing an expert panel to address methodological issues with the NISVS survey. The panel will meet multiple times over the course of the next year. The members of this panel will provide guidance on how to improve both survey design (methods, sampling frame, recruitment, mode of administration) and content/question wording with the goals of increasing response rates, reducing non-response bias, and maximizing the opportunities across Federal surveys for covering populations of interest. This change request also encompasses the implementation of the panel's recommendations to improve the survey.

In the bi-annual data collection periods, total of 170,000 households will be screened. After determining eligibility and consent, 25,000 will complete the survey. The average burden per screened respondent remains at three minutes (total burden in hours equals 8,500) while the average burden per surveyed respondent is 25 minutes (total burden in hours equals 10,417). The survey will be conducted among English or Spanish speaking male and female adults (18 years and older) living in the United States.

There are no costs to respondents other than their time.

On January 08, 2015, the Agency submitted a proposed collection of information entitled, “Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring” to OMB for review and clearance under 44 U.S.C. 3507. 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. OMB has now approved the information collection and has assigned OMB control number 0910-0409. The approval expires on April 30, 2018. A copy of the supporting statement for this information collection is available on the Internet at http://www.reginfo.gov/public/do/PRAMain.

The number of prescriptions filled for opioid drugs has increased drastically in recent years. In 2009 nearly 257 million prescriptions were written for opioid drugs in the United States. This number rose to nearly 260 million in 2012. The increased availability of opioid drugs appears to be contributing significantly to abuse and overdose in the United States. In 2013 there were approximately 16,235 deaths from overdose involving opioid drugs. That same year, there were 8,257 deaths from overdose involving heroin.

Naloxone, a mu-opioid antagonist, is a medication that can rapidly reverse the overdose of both prescription opioid drugs (e.g., OxyContin) and illicit opioid drugs (e.g., heroin). It is currently the standard treatment for those experiencing overdose and is commonly used by trained medical personnel in emergency departments and on ambulances. Its use among nonmedical personnel has also increased in recent years. The purpose of the public meeting is to explore issues surrounding the uptake of naloxone to treat opioid drug overdose. The meeting agenda will include topics on the clinical, regulatory, and legal implications of making naloxone more widely available. FDA will post the agenda and additional public meeting material approximately 2 days before the workshop at: http://www.fda.gov/Drugs/NewsEvents/ucm442236.htm.

A transcript will be made available approximately 45 days after the public meeting. It will be accessible at http://www.regulations.gov and may be viewed at the Division of Dockets Management (see Comments). A transcript will also be available in either hardcopy or on CD-ROM, after submission of a Freedom of Information request. Written requests are to be sent to Division of Freedom of Information (ELEM-1029), Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857.

I. Background

Sections 503A (21 U.S.C. 353a) and 503B (21 U.S.C. 353b) of the FD&C Act do not apply to the compounding of animal drugs. The FD&C Act does not distinguish between compounding animal drugs from bulk drug substances 1 and any other manufacturing or processing of animal drugs. Except with respect to the limited exemption provided by the FD&C Act described in this document, statutory provisions applicable to manufactured animal drugs under the FD&C Act also apply to compounded animal drugs.

Section 512(a)(4) and (5) of the FD&C Act (21 U.S.C. 360b(a)(4) and (5)) provide a limited exemption from certain requirements for use for compounded animal drugs made from already approved animal or human drugs. Such use is considered an extra-label use and the FD&C Act provides that a compounded drug is exempt from the approval requirements and requirements of section 502(f)(1) (21 U.S.C. 352(f)(1)) of the FD&C Act, if it meets the conditions set out in the statute and the extra-label use regulations at 21 CFR part 530.

Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a draft guidance for industry #230 entitled “Compounding Animal Drugs from Bulk Drug Substances” (GFI #230).2 The draft guidance describes conditions under which FDA does not generally intend to initiate enforcement action against State-licensed pharmacies, licensed veterinarians, and facilities registered as outsourcing facilities under section 503B of the FD&C Act (outsourcing facilities) that compound animal drugs from bulk drug substances.

For pharmacies, these conditions include receipt of a valid prescription for a compounded drug from a licensed veterinarian for an individually identified animal patient before the facility compounds the drug (with some limited compounding of an animal drug product in advance of receipt of a prescription in quantities based on a history of receipt of patient-specific prescriptions for that drug product). FDA recognizes that there may be some limited circumstances in which a drug compounded from one or more bulk drug substances should be available to a veterinarian for office use and is developing a list of such animal drug products and the bulk drug substances needed to make them applicable to drugs compounded by facilities registered as outsourcing facilities under section 503B of the FD&C Act. The draft guidance proposes that outsourcing facilities compound animal drugs only from bulk drug substances that will be listed in Appendix A of the final guidance, either pursuant to a veterinarian's order or pursuant to a patient-specific prescription. When a facility registered as an outsourcing facility under section 503B of the FD&C Act uses the listed bulk drug substances to make the specified drug products pursuant to an order from a licensed veterinarian without a prescription for an individually identified animal, FDA does not intend to take action under sections 512(a), 501(a)(5) (21 U.S.C. 351(a)(5)), 502(f), and 501(a)(2)(B) as long as such compounding is done in accordance with any associated conditions described in GFI #230. Although an outsourcing facility may fill a veterinarian's order for compounded animal drugs using bulk drug substances listed on Appendix A without obtaining prescriptions for individually identified animal patients, drugs produced by outsourcing facilities remain subject to the requirements in section 503(f) of the FD&C Act. Therefore, an outsourcing facility cannot dispense a compounded drug to the owner or caretaker of an animal patient without a prescription for that individually identified animal patient.

This list only applies to outsourcing facilities. This list does not limit what bulk drug substances State-licensed pharmacies or licensed veterinarians can use in compounding drugs in accordance with the conditions set forth in the draft guidance, including the condition pertaining to obtaining a patient-specific prescription.

FDA intends to include a bulk drug substance on Appendix A only when all of the following criteria are met:

• There is no marketed approved, conditionally approved, or index-listed animal drug that can be used as labeled to treat the condition;

• there is no marketed approved animal or human drug that could be used under section 512(a)(4) or (a)(5) of the FD&C Act and part 530 (addressing extra-label use of approved animal and human drugs) to treat the condition;

• the drug cannot be compounded from an approved animal or human drug;

• immediate treatment with the compounded drug is necessary to avoid animal suffering or death; and

• FDA has not identified a significant safety concern specific to the use of the bulk drug substance to compound animal drugs (under the listed conditions and limitations).

Inactive ingredients need not appear on Appendix A to be used in compounding animal drug products.

You may nominate specific bulk drug substances for inclusion on the list in Appendix A. Nominations will only be evaluated if they are for specific ingredients that meet the definition of a bulk drug substance in § 207.3(a)(4) (21 CFR 207.3(a)(4)). Nominated substances that do not meet this definition will not be included on the list.

To determine if a bulk drug substance should be included in Appendix A, FDA needs the following information about the bulk drug substance being nominated and the animal drug product(s) that will be compounded using such substance:

A statement that the nominated substance is an active ingredient that meets the definition of “bulk drug substance” in § 207.3(a)(4), and an explanation of why the substance is considered an active ingredient when it is used in the identified compounded drug product(s), citing to specific sources that describe the active properties of the substance.

• Ingredient name;

• chemical name;

• common name(s); and

• identifying codes, as available, from FDA's Unique Ingredient Identifiers used in the FDA/U.S. Pharmacopeial Convention (USP) Substance Registration System, available at http://fdasis.nlm.nih.gov/srs/. Because substance names can vary, this code, where available, will be used by the Agency to confirm the exact substance nominated and to identify multiple nominations of the same substance so the information can be reviewed together.

• Chemical grade of the ingredient;

• description of the strength, quality, stability, and purity of the ingredient;

• information about how the ingredient is supplied (e.g., powder, liquid); and

• information about recognition of the substance in foreign pharmacopeias and the status of its registration(s) in other countries, including whether information has been submitted to USP for consideration of monograph development.

• Information about the dosage form(s) into which the bulk drug substance will be compounded;

• information about the strength(s) of the compounded product(s); and

• information about the anticipated route(s) of administration of the compounded product(s).

For FDA to be able to meaningfully evaluate a substance, the information provided must be specific to the particular substance nominated and animal drug product to be compounded. A “boilerplate” or general explanation of need for compounding with bulk drug substances will not enable FDA to conduct an adequate review. Unless adequate supporting data are submitted for a bulk drug substance, FDA will be unable to consider it for inclusion in Appendix A.

Prescribers of compounded animal drug products may be in the best position to explain why a particular bulk drug substance meets the criteria for including a bulk drug substance on Appendix A and are encouraged to provide data in support of a nomination. The following information about need is necessary to provide adequate support for nominations to the Appendix A list:

• A statement identifying the species and condition(s) that the drug product to be compounded with the nominated bulk drug substance is intended to treat;

• a bibliography of safety and efficacy data for the drug compounded using the nominated substance, if available,3 including any relevant peer-reviewed veterinary literature;

• a list of animal drug products, if any, that are approved, conditionally approved, or index listed for the condition(s) in the species that the drug compounded with the nominated substance is intended to address;

• if there are FDA-approved or index listed drug products that address the same conditions in the same species, an explanation, supported by relevant veterinary literature, of why a compounded drug product is necessary (i.e., why the approved drug product is not suitable for a particular patient population);

• a review of the veterinary literature to determine whether there are FDA-approved animal or human drugs that could be prescribed as an extra-label use under section 512(a)(4) and (a)(5) of the FD&C Act and part 530 to treat the condition(s) in the species that the drug compounded with the nominated substance is intended to address;

• if the bulk drug substance is an active ingredient in an approved animal or human drug, an explanation, supported by appropriate scientific data, of why the animal drug product cannot be compounded from the approved drug under 21 CFR 530.13(b);

• an explanation, supported by relevant veterinary literature, of why the animal drug product to be compounded with the nominated bulk drug substance must be available to the veterinarian for immediate treatment to avoid animal suffering or death. Nominations should include specific information documenting that animal suffering or death will result if treatment is delayed until a compounded animal drug can be obtained pursuant to a prescription for an individually identified animal; and

• a discussion of any safety concerns associated with use of the nominated bulk drug substance or finished compounded product for the condition(s) in the species that the compounded drug is intended to address. If there are any safety concerns, an explanation, supported by veterinary literature, of why the concerns should not preclude inclusion of that bulk drug substance on Appendix A.

For efficient consolidation and review of nominations, nominators are encouraged to submit their nominations in a format that explicitly addresses each item previously listed in the order that they appear. To consider a bulk drug substance for inclusion in Appendix A, FDA must receive adequate supporting data for the substance. FDA cannot guarantee that all drugs nominated during the nomination period will be considered for inclusion on Appendix A prior to its initial publication. Nominations that are not evaluated during this first phase will receive consideration for later addition to Appendix A.

Individuals and organization may petition FDA to make additional amendments to Appendix A after it is published, in accordance with § 10.30.

Interested persons may submit either electronic nominations to http://www.regulations.gov or written nominations to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of nominations. Identify nominations with the docket number found in the brackets in the heading of this document. Received nominations may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

I. Draft Guidance

FDA is announcing the availability of a draft GFI #230 entitled “Compounding Animal Drugs from Bulk Drug Substances.” The draft guidance provides information to compounders of animal drugs and other interested stakeholders on FDA's application of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) with respect to the compounding of animal drugs from bulk drug substances.1

The Advisory Group is a non-discretionary federal advisory committee that was initially established under Executive Order 13544, dated June 10, 2010, to comply with the statutes under Section 4001 of the Patient Protection and Affordable Care Act, Public Law 111-148. The Advisory Group was established to assist in carrying out the mission of the National Prevention, Health Promotion, and Public Health Council (the Council). The Advisory Group provides recommendations and advice to the Council.

The Advisory Group was terminated on September 30, 2012, by Executive Order 13591, dated November 23, 2011. Authority for the Advisory Group to be re-established was given under Executive Order 13631, dated December 7, 2012. Authority for the Advisory Group to continue to operate until September 30, 2015, was given under Executive Order 13652, dated September 30, 2013.

It is authorized for the Advisory Group to consist of no more than 25 non-federal members. The Advisory Group currently has 21 members who were appointed by the President. The membership includes a diverse group of licensed health professionals, including integrative health practitioners who have expertise in (1) worksite health promotion; (2) community services, including community health centers; (3) preventive medicine; (4) health coaching; (5) public health education; (6) geriatrics; and (7) rehabilitation medicine.

Meeting descriptions and relevant materials will be published closer to the meeting dates at: http://www.surgeongeneral.gov/initiatives/prevention/advisorygrp/index.html.

Members of the public have the opportunity to participate in each meeting and/or provide comments to the Advisory Group. Public comment will be limited to 3 minutes per speaker. Individuals who wish to participate in the meetings and/or provide comments must register by 12:00 p.m. EST on June 4, 2015, for the meeting on June 11, 2015, and by 12:00 p.m. EST on August 24, 2015, for the meeting on August 31-September 1, 2015. In order to register, individuals must send their full name and affiliation via email to [email protected]. Individuals who need special assistance and/or accommodations, i.e., sign language interpretation or other reasonable accommodations, should indicate so when they register. Members of the public who wish to have materials distributed to the Advisory Group members at these scheduled meetings should submit those materials by June 4, 2015, for the June meeting and by August 24, 2015, for the August/September meeting.

This technology is directed to gene biomarkers for the diagnosis and potential treatment of acute ischemic stroke. Stroke is the third leading cause of death in the United States, of which 87% are ischemic stroke and result in death within 30 days in 8-12% of the cases. Currently, recombinant tissue plasminogen activator (rtPA, trade name alteplase), is the only FDA approved ischemic stroke treatment, and it is only effective when administered to patients within three hours from the onset of symptoms. Unfortunately, the median time from stroke symptom onset to presentation to the emergency department is 3-6 hours. Although advances in neuroimaging and clinical management have helped with patient survival rates, these techniques are not infallible and at times result in misdiagnosis. The biomarkers identified in this technology may be used to develop a diagnostic testing device for determining stroke subtype in the field.

The prospective exclusive license will be royalty bearing and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR part 404. The prospective exclusive license may be granted unless, within thirty (30) days from the date of this published notice, NIH receives written evidence and argument that establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR part 404.

Properly filed competing applications for a license filed in response to this notice will be treated as objections to the contemplated license. Comments and objections submitted in response to this notice will not be made available for public inspection, and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552.

OMB Control Number: 1018-0127.

Title: Horseshoe Crab Tagging Program.

Service Form Number(s): 3-2310 and 3-2311.

Type of Request: Extension of currently approved collection.

Description of Respondents: Tagging agencies include Federal and State agencies, universities, and biomedical companies. Members of the general public provide recapture information.

Respondent's Obligation: Voluntary.

Frequency of Collection: On occasion when horseshoe crabs are tagged and when horseshoe crabs are found or captured.

Estimated Annual Nonhour Burden Cost: None.

Abstract: Horseshoe crabs play a vital role commercially, biomedically, and ecologically along the Atlantic coast. Horseshoe crabs are commercially harvested and used as bait in eel and conch fisheries. Biomedical companies along the coast also collect and bleed horseshoe crabs at their facilities. Limulus Amoebocyte Lysate is derived from crab blood, which has no synthetic substitute, and is used by pharmaceutical companies to test sterility of products. Finally, migratory shorebirds also depend on the eggs of horseshoe crabs to refuel on their migrations from South America to the Arctic. One bird in particular, the red knot, feeds primarily on horseshoe crab eggs during its stopover. Effective January 12, 2015, the red knot was listed as threatened under the Endangered Species Act.

In 1998, the Atlantic States Marine Fisheries Commission (ASMFC), a management organization with representatives from each State on the Atlantic Coast, developed a horseshoe crab management plan. The ASMFC plan and its subsequent addenda established mandatory State-by-State harvest quotas, and created the 1,500-square-mile Carl N. Shuster, Jr., Horseshoe Crab Sanctuary off the mouth of Delaware Bay.

Restrictive measures have been taken in recent years, but populations are increasing slowly. Because horseshoe crabs do not breed until they are 9 years or older, it may take some time before the population measurably increases. Federal and State agencies, universities, and biomedical companies participate in a Horseshoe Crab Cooperative Tagging Program. The Maryland Fishery Resources Office, U.S. Fish and Wildlife Service, maintains the information that we collect under this program and uses it to evaluate migratory patterns, survival, and abundance of horseshoe crabs.

Agencies that tag and release the crabs complete FWS Form 3-2311 (Horseshoe Crab Tagging) and provide the Service with:

• Organization name.

• Contact person name.

• Tag number.

• Sex of crab.

• Prosomal width.

• Capture site, latitude, longitude, waterbody, State, and date.

Members of the public who recover tagged crabs provide the following information using the online submission form (http://www.fws.gov/crabtag/) or via a toll-free telephone number:

• Tag number.

• Whether or not tag was removed.

• Condition of crab.

• Date captured/found.

• Crab fate.

• Finder type.

• Capture method.

• Capture location.

• Reporter information.

• Comments.

Comments: On February 10, 2015, we published in the Federal Register (80 FR 7490) a notice of our intent to request that OMB renew approval for this information collection. In that notice, we solicited comments for 60 days, ending on April 13, 2015. We did not receive any comments.

We again invite comments concerning this information collection on:

• Whether or not the collection of information is necessary, including whether or not the information will have practical utility;

• The accuracy of our estimate of the burden for this collection of information;

• Ways to enhance the quality, utility, and clarity of the information to be collected; and

• Ways to minimize the burden of the collection of information on respondents.

Comments that you submit in response to this notice are a matter of public record. 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 can ask OMB in your comment to withhold your personal identifying information from public review, we cannot guarantee that it will be done.

I. Abstract

Nature and the outdoors have always been an important part of the fabric of American life. But, there are major questions about the present and future role of nature and the outdoors in our increasingly diverse, technologically oriented, and rapidly changing society. For our programs to remain relevant to American life today and tomorrow, we must be aware of public sentiment toward the part nature plays in the quality of our lifestyles.

It is for these reasons that we plan to use a quantitative survey to collect: Information on the attitudes that the public maintains towards the natural environment; the effects of contact with nature on participants' health and quality of life; the extent of contact with nature and obstacles to greater contact with nature; general knowledge of nature and wildlife; concerns toward selected environmental issues; and socio-demographic variables. Results will help improve the design and delivery of new or existing programs aimed at engaging the public in nature-related activities (e.g., outreach and educational programming at national wildlife refuges and national fish hatcheries).

OMB Control Number: 1018-New.

Title: National Initiative to Understand and Connect Americans and Nature.

Service Form Number: None.

Type of Request: Request for a new OMB control number.

Description of Respondents: Individuals.

Respondent's Obligation: Voluntary.

Frequency of Collection: One time.

Estimated Number of Respondents: 8,950.

Estimated Number of Annual Responses: 8,950.

Completion Time per Response: 20 minutes.

Estimated Annual Burden Hours: 2,983.

Estimated Annual Nonhour Burden Cost: None.

We invite comments concerning this information collection on:

• Whether or not the collection of information is necessary, including whether or not the information will have practical utility;

• The accuracy of our estimate of the burden for this collection of information;

• Ways to enhance the quality, utility, and clarity of the information to be collected; and

• Ways to minimize the burden of the collection of information on respondents.

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 IC. 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 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.

In accordance with the requirements of the Federal Advisory Committee Act, 5 U.S.C. App., we announce that the Trinity River Adaptive Management Working Group will hold a meeting.

The TAMWG affords stakeholders the opportunity to give policy, management, and technical input concerning Trinity River (California) restoration efforts to the TMC. The TMC interprets and recommends policy, coordinates and reviews management actions, and provides organizational budget oversight.

• Designated Federal Officer (DFO) updates, election of officers, review of charter and bylaws, and administrative procedures,

• TMC Chair update,

• Executive Director's update,

• TRRP Workgroup/Science Coordinator update, and Decision Support System update,

• TRRP Implementation update, 2015 sites, 2016 sites, and status of permits,

• Flow management, Water Year 2015 Central Valley Project water management update, BOR long-term fall flow plan update, and fall flow plan for Water Year 2015,

• Solicitor's guidance on the TRRP watershed efforts,

• FY 2016 Budget/work planning,

• TMC current issues,

• TRRP background/refresher,

• Gravel augmentation short-term needs, and long-term gravel plan status,

• TRRP Communications plan, and status,

• Status of fish returns and goals of the TRRP,

• Joint meeting with TMC in August, and

• Public Comment.

The final agenda will be posted on the Internet at http://www.fws.gov/arcata.

Interested members of the public may submit relevant information or questions for the TAMWG to consider during the meeting. Written statements must be received by the date listed in “Public Input,” so that the information may be available to the TAMWG for their consideration prior to this meeting. Written statements must be supplied to Elizabeth Hadley in one of the following formats: One hard copy with original signature, one electronic copy with original signature, and one electronic copy via email (acceptable file formats are Adobe Acrobat PDF, MS Word, PowerPoint, or rich text file).

Registered speakers who wish to expand on their oral statements, or those who wished to speak but could not be accommodated on the agenda, may submit written statements to Elizabeth Hadley up to 7 days after the meeting.

Summary minutes of the meeting will be maintained by Elizabeth Hadley (see FOR FURTHER INFORMATION CONTACT). The minutes will be available for public inspection within 14 days after the meeting, and will be posted on the TAMWG Web site at http://www.fws.gov/arcata.