Federal Register Vol. 81, No.220,

Section 504(a) of the Trade Facilitation and Trade Enforcement Act of 2015 (“Act”), amended the Export Enhancement Act of 1988 to add a new section 2313A. Section 2313A notes that U.S. policy is to promote exports as an opportunity for small businesses, and in exercising their powers and functions to advance that policy, all Federal agencies shall work constructively with State and local agencies engaged in export promotion and export financing activities. Section 2313A directs the President to establish the State and Federal Export Promotion Coordination Working Group (“Working Group”) under the TPCC with the purposes to:

(1) Identify issues related to the coordination of Federal resources relating to export promotion and export financing with such resources provided by State and local governments;

(2) identify ways to improve coordination with respect to export promotion and export financing activities through the TPCC annual strategic plan;

(3) develop a strategy for improving coordination of Federal and State resources relating to export promotion and export financing, including methods to eliminate duplication of effort and overlapping functions; and

(4) develop a strategic plan for considering and implementing the suggestions of the Working Group as part of the TPCC annual strategic plan.

The President issued Executive Order No. 13733, Delegation of Certain Authorities and Assignment of Certain Functions under the Trade Facilitation and Trade Enforcement Act of 2015, on July 22, 2016, assigning to the Secretary of Commerce the function under Section 2313A(b) of establishing the Working Group. In the Executive Order, the President further directed that, in carrying out its functions, the State and Federal Export Promotion Coordination Working Group shall also coordinate with local and municipal governments representing regionally diverse areas.

The Secretary of Commerce shall select the members of the Working Group, who shall include representatives from State trade agencies and local and municipal governments representing regionally diverse areas and representatives of the federal departments and agencies that are represented on the TPCC. The Working Group will comprise up to sixteen members. Representatives from State trade agencies must be: (1) Elected officers of a State, or (2) State employees designated by an elected State officer to represent the State trade agency with authority to act on his or her behalf. Representatives from local and municipal governments must be: (1) Elected officers or (2) local or municipal employees designated by an elected officer to represent the local and municipal government with authority to act on his or her behalf.

Because the Working Group will be an intergovernmental committee composed wholly of full-time or part-time Federal Government officers or employees, State government elected officers or their designees, and local and municipal elected officials or their designees, all of whom will be acting in their official capacities solely to exchange views, information, or advice relating to the management and implementation of Federal programs established by statute that explicitly share intergovernmental responsibilities and administration, the Working Group is not covered by the Federal Advisory Committee Act, 5 U.S.C. App.

Members appointed as representatives from State trade agencies and local and municipal governments will not receive any Federal compensation for their services and will not be reimbursed for travel expenses. Meetings will be held in person and/or via teleconference. The TPCC will make every effort to use technology to allow for remote participation in meetings, but there will be times when in-person meetings will be necessary. The TPCC will strive to provide members of the Working Group notice of meetings at least 15 calendar days in advance.

The TPCC Secretariat seeks nominations for representatives from State trade agencies and local and municipal governments to the Working Group. For purposes of this notice, a “State trade agency” is the lead official governmental trade promotion agency for a State, and includes separately established trade agencies as well as trade offices within a State agency or department or the Office of the Governor. A “local or municipal government” includes, but is not limited to, town, city, and county governments. The TPCC seeks representation of regionally diverse areas. Qualified individuals may self-nominate or be nominated by a senior level State government or local or municipal government official. To be considered, nominators should submit the following information:

(1) Name, title, and relevant contact information (including phone and email address) for the nominee, the state trade agency that the nominee would represent or the local or municipal government the nominee would represent;

(2) A resume or short biography of the nominee, including professional and academic credentials.

(3) A statement of the nominee's role in state, local, or municipal export promotion activities. Should more information be needed, TPCC staff will contact the nominee. If nominees are not an elected official, a letter may be requested from an elected official that indicates the nominee has been designated to participate in the Working Group on his or her behalf.

Nominators should submit the above information via electronic transmission to [email protected]. The submission must be received on or before 5:00 p.m. (ET) on November 25, 2016. Nominations submitted in response to the prior notice, including those received after October 24, 2016, will be considered and do not need to be resubmitted.

The Mid-Atlantic Fishery Management Council's Atlantic Mackerel, Squid, and Butterfish (MSB) Committee will meet jointly with the MSB Advisory Panel to develop recommendations on alternatives to include in an Amendment that could affect the squid fisheries. The amendment could reduce the capacities of the longfin squid and Illex squid fleets. The Council is considering this action because of concern that activation of latent capacity in the squid fisheries could lead to excessive fishing effort and increased catch of non-target species. Several other issues are being considered as well: (1) New permits for Maine/northern states; (2) re-evaluation of longfin squid trimesters; (3) longfin squid buffer zones beyond state waters in the area south of Martha's Vineyard/Nantucket; and (4) revision of the goals and objectives of the MSB Fishery Management Plan. A detailed agenda and background documents will be made available on the Council's Web site, at www.mafmc.org, prior to the meeting. Additional information is also available at the Web page for this action: http://www.mafmc.org/actions/squid-capacity-amendment.

These meetings are physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aid should be directed to M. Jan Saunders, (302) 526-5251, at least 5 business days prior to the meeting date.

Sections 101(a)(5)(A) and (D) of the MMPA (16 U.S.C. 1361 et seq.) direct the Secretary of Commerce (Secretary) to allow, upon request, the incidental, but not intentional taking 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 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 June 9, 2015, NMFS received an application from Excelerate and Tetra Tech, on behalf of NEG and Algonquin, for an annual IHA and a subsequent five-year letter of authorization (LOA) pursuant to a rulemaking under section 101(a)(5)(A), to take 14 species of marine mammals by Level B harassment incidental to operations, maintenance, and repair of the NEG Port and the Pipeline Lateral facilities in Massachusetts Bay. They are: North Atlantic right whale, humpback whale, fin whale, sei whale, minke whale, long-finned pilot whale, Atlantic white-sided dolphin, bottlenose dolphin, short-beaked common dolphin, killer whale, Risso's dolphin, harbor porpoise, harbor seal, and gray seal. Since the NEG Port and Pipeline Lateral operation, maintenance, and repair activities have the potential to take marine mammals, a marine mammal take authorization under the MMPA is warranted. NMFS issued an IHA to NEG and Algonquin on December 22, 2015 (81 FR 744; January 7, 2016). The IHA is valid until December 22, 2016. In June 2016 NMFS learned that NEG and Algonquin are considering decommissioning the NEG Port in the foreseeable future. Upon discussion with Excelerate and Tetra Tech, it was agreed that instead of conducting a rulemaking for five years of incidental take authorization that may not be needed, NMFS will process another one-year IHA to NEG and Algonquin to cover marine mammal takes from its operations, maintenance, and repair work from December 23, 2016 through December 22, 2017.

NMFS first issued an IHA to NEG and Algonquin to allow for the incidental harassment of small numbers of marine mammals resulting from the construction and operation of the NEG Port and the Pipeline Lateral (72 FR 27077; May 14, 2007). Subsequently, NMFS issued five one-year IHAs for the take of marine mammals incidental to the operation of the NEG Port activity pursuant to section 101(a)(5)(D) of the MMPA (73 FR 29485; May 21, 2008, 74 FR 45613; September 3, 2009 75 FR 53672; September 1, 2010, and 76 FR 62778; October 11, 2011). After that, NMFS issued two one-year IHAs to NEG and Algonquin to take marine mammals incidental to the operations of the NEG Port as well as maintenance and repair (79 FR 78806; December 31, 2014, 81 FR 744; January 7, 2016).

The proposed NEG and Algonquin activities include the following:

NEG Port Operations: The NEG Port operations involve docking of NEG vessels and regasification of NEG for delivery to shore. Noises generated during these activities, especially from the NEG vessel's dynamic positioning (DP) thrusters during docking, could result in takes of marine mammals in the port vicinity by level B behavioral harassment.

NEG Port Maintenance and Repair: Regular maintenance and occasional repair of the NEG Port are expected to occur throughout the NEG Port operation period. Machinery used during these activities generate noises that could result in takes of marine mammals in the port vicinity by Level B behavioral harassment.

Algonquin Pipeline Lateral Routine Operations and Maintenance: The Algonquin Pipeline Lateral that is used for gas delivery would be inspected regularly to ensure proper operations. The work would be done using support vessels operating in dynamic positioning mode. Noises generated from these activities could result in takes of marine mammals in the vicinity of Pipeline Lateral by Level B behavioral harassment.

Unplanned Pipeline Repair Activities: Unplanned repair activities may be required from time to time at a location along the Pipeline Lateral in west Massachusetts Bay, as shown in Figure 2.1 of the application. The repair would involve the use of a dive vessel operating in dynamic positioning mode. Noise generated from this activity could result in takes of marine mammals in the vicinity of repair work by Level B behavioral harassment.

An IHA was previously issued to NEG and Algonquin for this activity on December 22, 2014 (79 FR 78806; December 31, 2014), based on activities described on Excelerate and Tetra Tech's IHA application submitted in June 2014 and on the Federal Register notice for the proposed IHA (78 FR 69049; November 18, 2013). The latest application submitted by Excelerate and Tetra Tech on June 9, 2015 contains the same information on project descriptions as described in the June 2014 IHA application. There is no change on the NEG and Algonquin's proposed NEG Port and Pipeline Lateral operations and maintenance and repair. Please refer to these documents for a detailed description of NEG and Algonquin's proposed NEG Port and Pipeline Lateral operations and maintenance and repair activities.

Marine mammal species that potentially occur in the vicinity of the Northeast Gateway facility include the North Atlantic right whale, humpback whale, fin whale, sei whale, minke whale, long-finned pilot whale, Atlantic white-sided dolphin, bottlenose dolphin, common dolphin, killer whale, Risso's dolphin, harbor porpoise, harbor seal, and gray seal. General information on the distribution of these marine mammal species can be found in NMFS Stock Assessment Reports (Waring et al., 2016). This latter document is available at: http://www.nmfs.noaa.gov/pr/sars/pdf/atlantic2015_final.pdf. Additional information regarding these species within the NEG's proposed action area is provided below, with a summary in Table 1.

The highest abundance for humpback whales is distributed primarily along a relatively narrow corridor following the 100-meter (m) (328-feet (ft)) isobath across the southern Gulf of Maine from the northwestern slope of Georges Bank, south to the Great South Channel, and northward alongside Cape Cod to Stellwagen Bank and Jeffreys Ledge. The relative abundance of whales increases in the spring with the highest occurrence along the slope waters (between the 40- and 140-m, or 131- and 459-ft, isobaths) off Cape Cod and Davis Bank, Stellwagen Basin and Tillies Basin and between the 50- and 200-m (164- and 656-t) isobaths along the inner slope of Georges Bank. High abundance is also estimated for the waters around Platts Bank. In the summer months, abundance increases markedly over the shallow waters (<50 m, or <164 ft) of Stellwagen Bank, the waters (100-200 m or 328-656 ft) between Platts Bank and Jeffreys Ledge, the steep slopes (between the 30- and 160-m isobaths) of Phelps and Davis Bank north of the Great South Channel towards Cape Cod, and between the 50- and 100-m (164- and 328-ft) isobath for almost the entire length of the steeply sloping northern edge of Georges Bank. This general distribution pattern persists in all seasons except winter, when humpbacks remain at high abundance in only a few locations including Porpoise and Neddick Basins adjacent to Jeffreys Ledge, northern Stellwagen Bank and Tillies Basin, and the Great South Channel. The best estimate of abundance for Gulf of Maine, formerly western North Atlantic, humpback whales is 823 animals (Waring et al., 2016).

Spatial patterns of habitat utilization by fin whales are very similar to those of humpback whales. Spring and summer high-use areas follow the 100-m (328 ft) isobath along the northern edge of Georges Bank (between the 50- and 200-m (164- and 656-ft) isobaths), and northward from the Great South Channel (between the 50-and 160-m, or 164- and 525-ft, isobaths). Waters around Cashes Ledge, Platts Bank, and Jeffreys Ledge are all high-use areas in the summer months. Stellwagen Bank is a high-use area for fin whales in all seasons, with highest abundance occurring over the southern Stellwagen Bank in the summer months. In fact, the southern portion of the Stellwagen Bank National Marine Sanctuary (SBNMS) is used more frequently than the northern portion in all months except winter, when high abundance is recorded over the northern tip of Stellwagen Bank. In addition to Stellwagen Bank, high abundance in winter is estimated for Jeffreys Ledge and the adjacent Porpoise Basin (100- to 160-m, 328- to 656-ft, isobaths), as well as Georges Basin and northern Georges Bank. The best estimate of abundance for the western North Atlantic stock of fin whales is 1,618 (Waring et al., 2016). Currently, there are insufficient data to determine population trends for this species.

Like other piscivorous baleen whales, highest abundance for minke whale is strongly associated with regions between the 50- and 100-m (164- and 328-ft) isobaths, but with a slightly stronger preference for the shallower waters along the slopes of Davis Bank, Phelps Bank, Great South Channel and Georges Shoals on Georges Bank. Minke whales are sighted in the SBNMS in all seasons, with highest abundance estimated for the shallow waters (approximately 40 m, or 131 ft) over southern Stellwagen Bank in the summer and fall months. Platts Bank, Cashes Ledge, Jeffreys Ledge, and the adjacent basins (Neddick, Porpoise and Scantium) also support high relative abundance. Very low densities of minke whales remain throughout most of the southern Gulf of Maine in winter. The best estimate of abundance for the Canadian East Coast stock, which occurs from the western half of the Davis Strait to the Gulf of Mexico, of minke whales is 20,741 animals (Waring et al., 2016). Currently, there are insufficient data to determine population trends for this species.

North Atlantic right whales are generally distributed widely across the southern Gulf of Maine in spring with highest abundance located over the deeper waters (100- to 160-m (328- to 525-ft) isobaths) on the northern edge of the Great South Channel and deep waters (100-300 m, 328-984 ft) parallel to the 100-m (328-ft) isobath of northern Georges Bank and Georges Basin. High abundance is also found in the shallowest waters (< 30 m, or <98 ft) of Cape Cod Bay, over Platts Bank and around Cashes Ledge. Lower relative abundance is estimated over deep-water basins including Wilkinson Basin, Rodgers Basin and Franklin Basin. In the summer months, right whales move almost entirely away from the coast to deep waters over basins in the central Gulf of Maine (Wilkinson Basin, Cashes Basin between the 160- and 200-m (525- and 656-ft) isobaths) and north of Georges Bank (Rogers, Crowell and Georges Basins). Highest abundance is found north of the 100-m (328-ft) isobath at the Great South Channel and over the deep slope waters and basins along the northern edge of Georges Bank. The waters between Fippennies Ledge and Cashes Ledge are also estimated as high-use areas. In the fall months, right whales are sighted infrequently in the Gulf of Maine, with highest densities over Jeffreys Ledge and over deeper waters near Cashes Ledge and Wilkinson Basin. In winter, Cape Cod Bay, Scantum Basin, Jeffreys Ledge, and Cashes Ledge were the main high-use areas. Although SBNMS does not appear to support the highest abundance of right whales, sightings within SBNMS are reported for all four seasons, albeit at low relative abundance. Highest sighting within SBNMS occurred along the southern edge of the Bank.

The western North Atlantic minimum stock size is based on a census of individual whales identified using photo-identification techniques. A review of the photo-ID recapture database as it existed on 20 October 2014 indicated that 476 individually recognized whales in the catalog were known to be alive during 2011. This number represents a minimum population size. This is a direct count and has no associated coefficient of variation (Waring et al., 2016). Examination of the minimum number alive population index calculated from the individual sightings database, as it existed on 20 October 2014, for the years 1990-2011 suggests a positive and slowly accelerating trend in population size. These data reveal a significant increase in the number of catalogued whales with a geometric mean growth rate for the period of 2.8 percent (Waring et al., 2016).

The long-finned pilot whale is more generally found along the edge of the continental shelf (a depth of 330 to 3,300 ft or 100 to 1,000 m), choosing areas of high relief or submerged banks in cold or temperate shoreline waters. This species is split between two subspecies: The Northern and Southern subspecies. The Southern subspecies is circumpolar with northern limits of Brazil and South Africa. The Northern subspecies, which could be encountered during operation of the NEG Port, ranges from North Carolina to Greenland (Reeves et al., 2002; Wilson and Ruff 1999). In the western North Atlantic, long-finned pilot whales are pelagic, occurring in especially high densities in winter and spring over the continental slope, then moving inshore and onto the shelf in summer and autumn following squid and mackerel populations (Reeves et al., 2002). They frequently travel into the central and northern Georges Bank, Great South Channel, and Gulf of Maine areas during the summer and early fall (May and October) (NOAA 1993). According to the species stock report, the population estimate for the Western North Atlantic long-finned pilot whale is 5,636 individuals (Waring et al., 2010). Currently, there are insufficient data to determine population trends for the long-finned pilot whale.

In spring, summer and fall, Atlantic white-sided dolphins are widespread throughout the southern Gulf of Maine, with the high-use areas widely located either side of the 100-m (328-ft) isobath along the northern edge of Georges Bank, and north from the Great South Channel to Stellwagen Bank, Jeffreys Ledge, Platts Bank and Cashes Ledge. In spring, high-use areas exist in the Great South Channel, northern Georges Bank, the steeply sloping edge of Davis Bank and Cape Cod, southern Stellwagen Bank and the waters between Jeffreys Ledge and Platts Bank. In summer, there is a shift and expansion of habitat toward the east and northeast. High-use areas are identified along most of the northern edge of Georges Bank between the 50- and 200-m (164- and 656-ft) isobaths and northward from the Great South Channel along the slopes of Davis Bank and Cape Cod. High numbers of sightings are also recorded over Truxton Swell, Wilkinson Basin, Cashes Ledge and the bathymetrically complex area northeast of Platts Bank. High numbers of sightings of white-sided dolphin are recorded within SBNMS in all seasons, with highest density in summer and most widespread distributions in spring located mainly over the southern end of Stellwagen Bank. In winter, high numbers of sightings are recorded at the northern tip of Stellwagen Bank and Tillies Basin.

A comparison of spatial distribution patterns for all baleen whales (Mysticeti) and all porpoises and dolphins combined show that both groups have very similar spatial patterns of high- and low-use areas. The baleen whales, whether piscivorous or planktivorous, are more concentrated than the dolphins and porpoises. They utilize a corridor that extended broadly along the most linear and steeply sloping edges in the southern Gulf of Maine indicated broadly by the 100-m (328-ft) isobath. Stellwagen Bank and Jeffreys Ledge support a high abundance of baleen whales throughout the year. Species richness maps indicate that high-use areas for individual whales and dolphin species co-occur, resulting in similar patterns of species richness primarily along the southern portion of the 100-m (328-ft) isobath extending northeast and northwest from the Great South Channel. The southern edge of Stellwagen Bank and the waters around the northern tip of Cape Cod are also highlighted as supporting high cetacean species richness. Intermediate to high numbers of species are also calculated for the waters surrounding Jeffreys Ledge, the entire Stellwagen Bank, Platts Bank, Fippennies Ledge and Cashes Ledge. The best estimate of abundance for the western North Atlantic stock of white-sided dolphins is 48,819 (Waring et al., 2016). A trend analysis has not been conducted for this species.

Although these five species are some of the most widely distributed small cetacean species in the world (Jefferson et al., 1993), they are not commonly seen in the vicinity of the proposed project area in Massachusetts Bay (Wiley et al., 1994; Northeast Gateway Marine Mammal Monitoring Weekly Reports 2007). The total number of killer whales off the eastern U.S. coast is unknown, and present data are insufficient to calculate a minimum population estimate or to determine the population trends for this stock (Blaylock et al., 1995). The best estimate of abundance for the western North Atlantic stock of common dolphins is 173,486 animals, and a trend analysis has not been conducted for this species (Waring et al., 2016). There are several stocks of bottlenose dolphins found along the eastern United States from Maine to Florida. The stock that may occur in the area of the Neptune Port is the western North Atlantic coastal northern migratory stock of bottlenose dolphins. The best estimate of abundance for this stock is 11,548 animals (Waring et al., 2016). There are insufficient data to determine the population trend for this stock. The best estimate of abundance for the western North Atlantic stock of Risso's dolphins is 18,250 animals (Waring et al., 2016). There are insufficient data to determine the population trend for this stock. The best estimate of abundance for the Gulf of Maine/Bay of Fundy stock of harbor porpoise is 79,833 animals (Waring et al., 2016). A trend analysis has not been conducted for this species.

In the U.S. waters of the western North Atlantic, both harbor and gray seals are usually found from the coast of Maine south to southern New England and New York (Waring et al., 2010).

Along the southern New England and New York coasts, harbor seals occur seasonally from September through late May (Schneider and Payne 1983). In recent years, their seasonal interval along the southern New England to New Jersey coasts has increased (deHart 2002). In U.S. waters, harbor seal breeding and pupping normally occur in waters north of the New Hampshire/Maine border, although breeding has occurred as far south as Cape Cod in the early part of the 20th century (Temte et al., 1991; Katona et al., 1993). The best estimate of abundance for the western North Atlantic stock of harbor seals is 75,834 animals (Waring et al., 2016). Although gray seals are often seen off the coast from New England to Labrador, within the U.S. waters, only small numbers of gray seals have been observed pupping on several isolated islands along the Maine coast and in Nantucket-Vineyard Sound, Massachusetts (Katona et al., 1993; Rough, 1995). In the late 1990s, a year-round breeding population of approximately 400 gray seals was documented on outer Cape Cod and Muskeget Island (Warring et al., 2007). Depending on the model used, the minimum estimate for the Canadian gray seal population was estimated to range between 125,541 and 169,064 animals (Trzcinski et al., 2005, cited in Waring et al., 2009); however, present data are insufficient to calculate the minimum population estimate for U.S. waters. Waring et al. (2016) note that gray seal abundance in the U.S. Atlantic is likely increasing, but the rate of increase is unknown.

This section includes a summary and discussion of the ways that the types of stressors associated with the specified activity (e.g., pile removal and pile driving) 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 a take (for example, with acoustics, we may include a discussion of studies that showed animals not reacting at all to sound or exhibiting barely measurable 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 and 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. NMFS (2016) designate “marine mammal hearing groups” for marine mammals and estimate the lower and upper frequencies of functional hearing of the groups. The marine mammal hearing groups and the associated frequencies are indicated below (though animals are less sensitive to sounds at the outer edge of their range and most sensitive to sounds of frequencies within a smaller range somewhere in the middle of their hearing range):

• Low frequency cetaceans (13 species of mysticetes): Functional hearing is estimated to occur between approximately 7 Hertz (Hz) and 35 kilo Hertz (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, the franciscana, and four species of cephalorhynchids): Functional hearing is estimated to occur between approximately 275 Hz and 160 kHz;

• Phocid pinnipeds (true seals): Functional hearing is estimated between 50 Hz to 86 kHz; and

• Otariid pinnipeds (sea lions and fur seals): Functional hearing is estimated between 60 Hz to 39 kHz.

Species found in the vicinity of the NEG Port and Pipeline Lateral operations and maintenance and repair area include five low-frequency cetacean species (North Atlantic right whale, humpback whale, fin whale, sei whale, and minke whale), six mid-frequency cetacean species (long-finned pilot whale, Atlantic white-sided dolphin, bottlenose dolphin, common dolphin, Risso's dolphin, and killer whale), one high-frequency cetacean species (harbor porpoise), and two pinniped species (harbor seal and gray seal) (Table 1).

The proposed NEG Port operations and maintenance and repair activities could adversely affect marine mammal species and stocks by exposing them to elevated noise levels in the vicinity of the activity area.

Marine mammals exposed to high intensity sound repeatedly or for prolonged periods can experience hearing threshold shift (TS), which is the loss of hearing sensitivity at certain frequency ranges (Kastak et al., 1999; Schlundt et al., 2000; Finneran et al., 2002; 2005). TS can be permanent (PTS), in which case the loss of hearing sensitivity is unrecoverable, or temporary (TTS), in which case the animal's hearing threshold will recover over time (Southall et al., 2007). Since marine mammals depend on acoustic cues for vital biological functions, such as orientation, communication, finding prey, and avoiding predators, marine mammals that suffer from PTS or TTS will have reduced fitness in survival and reproduction, either permanently or temporarily. Repeated noise exposure that leads to TTS could cause PTS.

In addition, chronic exposure to excessive, though not high-intensity, noise could cause masking at particular frequencies for marine mammals that utilize sound for vital biological functions (Clark et al., 2009). Acoustic masking can interfere with detection of acoustic signals such as communication calls, echolocation sounds, and environmental sounds important to marine mammals. Therefore, under certain circumstances, marine mammals whose acoustical sensors or environment are being severely masked could also be impaired from maximizing their performance fitness in survival and reproduction.

Masking occurs at the frequency band which the animals utilize. Therefore, since noise generated from in-water vibratory pile driving and removal is mostly concentrated at low frequency ranges, it may have less effect on high frequency echolocation sounds by odontocetes (toothed whales). However, lower frequency man-made noises are more likely to affect detection of communication calls and other potentially important natural sounds such as surf and prey noise. It may also affect communication signals when they occur near the noise band and thus reduce the communication space of animals (e.g., Clark et al., 2009) and cause increased stress levels (e.g., Foote et al., 2004; Holt et al., 2009).

Unlike TS, masking can potentially affect the species at population, community, or even ecosystem levels, as well as individual levels. Masking affects both senders and receivers of the signals and could have long-term chronic effects on marine mammal species and populations. Recent science suggests that low frequency ambient sound levels have increased by as much as 20 decibel (dB) (more than 3 times in terms of sound pressure level (SPL)) in the world's ocean from pre-industrial periods, and most of these increases are from distant shipping (Hildebrand 2009). All anthropogenic noise sources, such as those from vessel traffic, vessel docking, and stationing while operating DP thrusters, dredging and pipe laying associated with NEG Port and Pipeline Lateral maintenance and repair, and NEG regasification activities, contribute to the elevated ambient noise levels, thus increasing potential for or severity of masking.

Finally, exposure of marine mammals to certain sounds could lead to behavioral disturbance (Richardson et al., 1995), such as: changing durations of surfacing and dives, number of blows per surfacing, or moving direction and/or speed; reduced/increased vocal activities; changing/cessation of certain behavioral activities (such as socializing or feeding); visible startle response or aggressive behavior (such as tail/fluke slapping or jaw clapping); avoidance of areas where noise sources are located; and/or flight responses (e.g., pinnipeds flushing into water from haulouts or rookeries).

The biological significance of many of these behavioral disturbances is difficult to predict, especially if the detected disturbances appear minor. However, the consequences of behavioral modification are expected to be biologically significant if the change affects growth, survival, and/or reproduction.

The onset of behavioral disturbance from anthropogenic noise depends on both external factors (characteristics of noise sources and their paths) and the receiving animals (hearing, motivation, experience, demography) and is also difficult to predict (Southall et al., 2007). Currently NMFS uses 160 dB re 1 microPascal (root-mean-square) (μPa (rms)) at received level for impulse noises (such as impact pile driving) as the onset of marine mammal behavioral harassment, and 120 dB re 1 μPa (rms) for non-impulse noises (such as operating DP thrusters, dredging, pipe laying, and NEG regasification). No impulse noise is expected from the NEG and Algonquin's proposed NEG Port and Pipeline Lateral operation, maintenance, and repair activities. For the NEG Port and Pipeline Lateral operations and maintenance and repair activities, only the 120 dB re 1 μPa (rms) threshold is considered because only non-impulse noise sources would be generated.

The proposed action area is considered biologically important habitat for the North Atlantic right, fin, humpback, and minke whales during part of the seasons, and it is adjacent to the SBNMS. There is no critical habitat in the vicinity of the proposed action area.

Operation of the NEG Port will not result in short-term effects, however, long-term effects on the marine environment, including alteration of the seafloor conditions, continued disturbance of the seafloor, regular withdrawal of sea water, and regular generation of underwater noise, will result from NEG Port operations. Specifically, a small area (0.14 acre) along the Pipeline Lateral has been permanently altered (armored) at two cable crossings. In addition, the structures associated with the NEG Port (flowlines, mooring wire rope and chain, suction anchors, and pipeline end manifolds) occupy 4.8 acres of seafloor. An additional area of the seafloor of up to 43 acres (worst case scenario based on severe 100-year storm with Energy Bridge Regasification Vehicle (EBRV) occupying both submerged turret loading (STL) buoys will be subject to disturbance due to chain sweep while the buoys are occupied. Given the relatively small size of the NEG Port area that will be directly affected by Port operations, NMFS does not anticipate that habitat loss will be significant.

EBRVs are currently authorized to withdraw an average of 4.97 million gallons per day (mgd) and 2.6 billion gallons per year of sea water for general ship operations during cargo delivery activities at the NEG Port. However, as we explained in the Federal Register notice for the 2015 IHA (78 FR 69049; November 18, 2013), during the operations of the NEG Port facility, it was revealed that significantly more water usage is needed than what was originally evaluated in the final USCG Environmental Impact Statement/Environmental Impact Report (EIS/EIR). The updates for the needed water intake and discharge temperature are:

• 11 billion gallons of total annual water use at the Port;

• Maximum daily intake volume of up to 56 mgd at a rate of 0.45 ft per second when an EBRV is not able to achieve the heat recovery system (HRS) it is the capability of reducing water use during the regasification process) mode of operation; and,

• Maximum daily change in discharge temperature of 12ºC (53.6ºF) from ambient from the vessel's main condenser cooling system.

Under the requested water-use scenario, Tetra Tech (2011) conducted an environmental analysis on the potential impacts to marine mammals and their prey. To evaluate impacts to phytoplankton under the increased water usage, the biomass of phytoplankton lost from the Massachusetts Bay ecosystem was estimated based on the method presented in the final EIS/EIR. Phytoplankton densities of 65,000 to 390,000 cells/gallon were multiplied by the annual planned activities of withdrawal rate of 11 billion gallons to estimate a loss of 7.15 × 1014 to 4.29 × 1015 cells per year. Assuming a dry-weight biomass of 10−10 to 10−11 gramper cell (g/cell), an estimated 7.2 kilograms (kg) to 429 kg of biomass would be lost from Massachusetts Bay under the proposed activity, up to approximately 4.2 times that estimated in the final EIS/EIR for the permitted operational scenario. An order of magnitude estimate of the effect of this annual biomass loss on the regional food web can be calculated assuming a 10 percent transfer of biomass from one trophic level to the next (Sumich 1988) following the method used in the final EIS/EIR. This suggests that the loss of 7.2 kg to 429 kg of phytoplankton will result in the loss of about 0.7 kg to 42.9 kg of zooplankton, less than 0.1 kg to 4.3 kg of small planktivorous fish, and up to 0.4 kg of large piscivorous fish (approximately equivalent to a single 1=pound striped bass). Relative to the biomass of these trophic levels in the project area, this biomass loss is minor and consistent with the findings in the final EIS/EIR.

In addition, zooplankton losses will also increase proportionally to the increase in water withdrawn. The final EIS/EIR used densities of zooplankton determined by the sampling conducted by the Massachusetts Water Resource Authority (MWRA) to characterize the area around its offshore outfall and assumed a mean zooplankton density of 34.9 x 103 organisms per m3. Applying this density, the water withdrawal volume under the proposed activity would result in the entrainment of 2.2 x 1010 zooplankton individuals per trip or 1.5 x 1012 individuals per year. Assuming an average biomass of 0.63 x10-6 g per individual, this would result in the loss of 14.1 kg of zooplankton per shipment or 916.5 kg of zooplankton per year. As discussed for phytoplankton, biomass transfers from one trophic level to the next at a rate of about 10 percent. Therefore, this entrainment of zooplankton would result in loss of about 91.6 kg of planktivorous fish and 9.2 kg of large piscivorous fish (approximately equivalent to two 9-pound striped bass). These losses are minor relative to the total biomass of these trophic levels in Massachusetts Bay.

Finally, ichthyoplankton (fish eggs and larvae) losses and equivalent age one juvenile fish estimates under the proposed activity were made based on actual monthly ichthyoplankton data collected in the port area from October 2005 through December 2009 and the proposed activity withdrawal volume of 11 billion gallons per year evenly distributed among months (0.92 billion gallons per month) as a worst-case scenario, representing the maximum number of NEG Port deliveries during any given month. Similarly, the lower, upper, and mean annual entrainment estimates are based on the lower and upper 95 percent confidence limits, of the monthly mean ichthyoplankton densities, and the monthly mean estimates multiplied by the monthly withdrawal rate of 0.92 billion gallons per month. At this withdrawal rate approximately 106 million eggs and 67 million larvae are estimated to be lost (see Table 4.2-2 of the IHA application). The most abundant species and life stages estimated to be entrained under the proposed activity are cunner post yolk-sac larvae (33.3 million), yellowtail flounder/Labridae eggs (27.4 million) and hake species eggs (18.7 million). Together, these species and life stages accounted for approximately 46 percent of the total entrainment estimated. Entrainment was estimated to be highest in June through July when 97.4 million eggs and larvae (approximately 57 percent of the annual total) were estimated to be entrained. However, the demand for natural gas and corresponding NEG Port activities will likely be greatest during the winter heating season (November through March) when impacts from entrainment will likely be lower.

These estimated losses are not significant given the very high natural mortality of ichthyoplankton. This comparison was done in the final EIS/EIR where ichthyoplankton losses based on historic regional ichthyoplankton densities and a withdrawal rate of approximately 2.6 billion gallons per year were represented by the equivalent number of age-one fish. Under the final EIS/EIR withdrawal scenario, equivalent age-one losses due to entrainment ranged from 1 haddock to 43,431 sand lance (Tetra Tech 2010). Equivalent age-one losses under the conditions when no NEG Port operation occurrence were recalculated using Northeast Gateway monitoring data in order to facilitate comparisons between the permitted scenario and the updated scenario. Using Northeast Gateway monitoring data, withdrawal of 2.6 billion gallons per year would result in equivalent age-one losses ranging from less than 1 haddock to 5,602 American sand lance. By comparison, equivalent age one losses under the proposed activity withdrawal rate of 11 billion gallons per year ranged from less than 1 haddock to 23,701 sand lance and were generally similar to or less than those in the final EIS/EIR. Substantially more equivalent age-one Atlantic herring, pollock, and butterfish were estimated to be lost under the final EIS/EIR at a withdrawal rate of 2.6 billion gallons per year, while substantially more equivalent age-one Atlantic cod, silver hake and hake species, cunner, and Atlantic mackerel are estimated to be lost under the proposed activity.

Although no reliable annual food consumption rates of baleen whales are available for comparison, based on the calculated quantities of phytoplankton, zooplankton, and ichthyoplankton removal analyzed above, it is reasonable to conclude that baleen whale predation rates would dwarf any reasonable estimates of prey removals by NEG Port operations.

As stated earlier, NEG Port will require scheduled maintenance inspections using either divers or remote operated vehicles (ROVs). The duration of these inspections are not anticipated to be more than two 8-hour working days. An EBRV will not be required to support these annual inspections. Water usage during the NEG Port maintenance would be limited to the standard requirements of NEG's normal support vessel. As with all vessels operating in Massachusetts Bay, sea water uptake and discharge is required to support engine cooling, typically using a once-through system. The rate of seawater uptake varies with the ship's horsepower and activity and therefore will differ between vessels and activity type. For example, the Gateway Endeavor is a 90-foot vessel powered with a 1,200-horsepower diesel engine with a four-pump seawater cooling system. This system requires seawater intake of about 68 gallons per minute (gpm) while idling and up to about 150 gpm at full power. Use of full power is required generally for transit. A conservatively high estimate of vessel activity for the Gateway Endeavor would be operation at idle for 75 percent of the time and full power for 25 percent of the time. During the routine activities this would equate to approximately 42,480 gallons of seawater per 8-hour work day. When compared to the engine cooling requirements of an EBRV over an 8-hour period (approximately 18 million gallons), the Gateway Endeavour uses about 0.2 percent of the EBRV requirement. To put this water use into context, potential effects from the water-use scenario of 56 mgd have been concluded to be orders of magnitude less than the natural fluctuations of Massachusetts Bay and Cape Cod Bay and not detectable. Water use by support vessels during routine port activities would not materially add to the overall impacts.

Certain maintenance and repair activities may also require the presence of an EBRV at the NEG Port. Such instances may include maintenance and repair on the STL Buoy, vessel commissioning, and any onboard equipment malfunction or failure occurring while a vessel is present for cargo delivery. Because the requested water-use scenario allows for daily water use of up to 56 mgd to support standard EBRV requirements when not operating in the HRS mode, vessels would be able to remain at the NEG Port as necessary to support all such maintenance and repair scenarios. Therefore, NMFS considers that NEG Port maintenance and repair would have negligible impacts to marine mammal habitat in the proposed activity area.

As stated earlier, proper care and maintenance of the Pipeline Lateral should minimize the likelihood of an unanticipated maintenance and/or repair event. However, unanticipated activities may occur from time to time if facility components become damaged or malfunction. Unanticipated repairs may range from relatively minor activities requiring minimal equipment and one or two diver/ROV support vessels to major activities requiring larger construction-type vessels similar to those used to support the construction and installation of the facility.

Major repair activities, although unlikely, may include repairing or replacement of pipeline manifolds or sections of the Pipeline Lateral. This type of work would likely require the use of large specialty construction vessels such as those used during the construction and installation of the NEG Port and Pipeline Lateral. The duration of a major unplanned activity would depend upon the type of repair work involved and would require careful planning and coordination.

Turbidity would likely be a potential effect of Pipeline Lateral maintenance and repair activities on listed species. In addition, the possible removal of benthic or planktonic species, resulting from relatively minor construction vessel water use requirements, as measured in comparison to EBRV water use, is unlikely to affect in a measurable way the food sources available to marine mammals. Thus, any impacts to marine mammal habitat are not expected to cause significant or long-term consequences for individual marine mammals or their populations.

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. NMFS regulations require applicants for incidental take authorizations to include information about the availability and feasibility (economic and technological) of equipment, methods, and manner of conducting such activity or other means of effecting the least practicable adverse impact upon the affected species or stocks and their habitat.

For the proposed NEG's NEG Port operations and maintenance and repair activities, Excelerate and Tetra Tech worked with NMFS to develop mitigation measures to minimize the potential impacts to marine mammal populations in the project vicinity as a result of the NEG Port and Pipeline Lateral operations and maintenance and repair activities. The primary purpose of these proposed mitigation measures is to ensure that no marine mammal would be injured or killed by vessels transiting the NEG Port facility, and to minimize the intensity of noise exposure of marine mammals in the activity area. For the proposed NEG Port and Pipeline Lateral operations and maintenance and repair, the following mitigation measures are proposed.

All vessels shall utilize the International Maritime Organization (IMO)-approved Boston Traffic Separation Scheme (TSS) on their approach to and departure from the NEG Port and/or the repair/maintenance area at the earliest practicable point of transit in order to avoid the risk of whale strikes.

Upon entering the TSS and areas where North Atlantic right whales are known to occur, including the Great South Channel Seasonal Management Area (GSC-SMA) and the SBNMS, EBRVs shall go into “Heightened Awareness” as described below.

(1) Prior to entering and navigating the modified TSS, the Master of the vessel shall:

• Consult Navigational Telex (NAVTEX), NOAA Weather Radio, the NOAA Right Whale Sighting Advisory System (SAS) or other means to obtain current right whale sighting information as well as the most recent Cornell acoustic monitoring buoy data for the potential presence of marine mammals;

• Post a look-out to visually monitor for the presence of marine mammals;

• Provide the USCG required 96-hour notification of an arriving EBRV to allow the NEG Port manager to notify Cornell of vessel arrival.

(2) The look-out shall concentrate his/her observation efforts within the 2-mile radius ZOI from the maneuvering EBRV.

(3) If marine mammal detection was reported by NAVTEX, NOAA Weather Radio, SAS and/or an acoustic monitoring buoy, the look-out shall concentrate visual monitoring efforts towards the areas of the most recent detection.

(4) If the look-out (or any other member of the crew) visually detects a marine mammal within the 2-mile radius ZOI of a maneuvering EBRV, he/she will take the following actions:

• The Officer-of-the-Watch shall be notified immediately; who shall then relay the sighting information to the Master of the vessel to ensure action(s) can be taken to avoid physical contact with marine mammals; and

• The sighting shall be recorded in the sighting log by the designated look-out.

In accordance with 50 CFR 224.103(c), all vessels associated with NEG Port and Pipeline Lateral activities shall not approach closer than 500 yards (yd, 460 m) to a North Atlantic right whale and 100 yd (91 m) to other whales to the extent physically feasible given navigational constraints. In addition, when approaching and departing the project area, vessels shall be operated so as to remain at least 1 kilometer away from any visually-detected North Atlantic right whales.

In response to active right whale sightings and active acoustic detections, and taking into account exceptional circumstances, EBRVs as well as repair and maintenance vessels shall take appropriate actions to minimize the risk of striking whales. Specifically vessels shall:

(1) Respond to active right whale sightings and/or Dynamic Management Areas (DMAs) reported on the Mandatory Ship Reporting (MSR) or SAS by concentrating monitoring efforts towards the area of most recent detection and reducing speed to 10 knots or less if the vessel is within the boundaries of a DMA or within the circular area centered on an area 8 nautical miles (nmi) in radius from a sighting location;

(2) Respond to active acoustic detections by concentrating monitoring efforts towards the area of most recent detection and reducing speed to 10 knots or less within an area 5 nm in radius centered on the detecting auto-detection buoy (AB); and

(3) Respond to additional sightings made by the designated look-outs within a 2-mile radius of the vessel by slowing the vessel to 10 knots or less and concentrating monitoring efforts towards the area of most recent sighting.

All vessels operated under NEG and Algonquin must follow the established specific speed restrictions when calling at the NEG Port. The specific speed restrictions required for all vessels (i.e., EBRVs and vessels associated with maintenance and repair) consist of the following:

(1) Vessels shall reduce their maximum transit speed while in the TSS from 12 knots or less to 10 knots or less from March 1 to April 30 in all waters bounded by straight lines connecting the following points in the order stated below unless an emergency situation dictates for an alternate speed. This area shall hereafter be referred to as the Off Race Point Seasonal Management Area (ORP-SMA) and tracks NMFS regulations at 50 CFR 224.105:

(2) Vessels shall reduce their maximum transit speed while in the TSS to 10 knots or less unless an emergency situation dictates for an alternate speed from April 1 to July 31 in all waters bounded by straight lines connecting the following points in the order stated below. This area shall hereafter be referred to as the GSC-SMA and tracks NMFS regulations at 50 CFR 224.105:

(3) Vessels are not expected to transit the Cape Cod Bay or the Cape Cod Canal; however, in the event that transit through the Cape Cod Bay or the Cape Cod Canal is required, vessels shall reduce maximum transit speed to 10 knots or less from January 1 to May 15 in all waters in Cape Cod Bay, extending to all shorelines of Cape Cod Bay, with a northern boundary of 42°12′ N. latitude and the Cape Cod Canal. This area shall hereafter be referred to as the Cape Cod Bay Seasonal Management Area (CCB-SMA);

(4) All Vessels transiting to and from the project area shall report their activities to the mandatory reporting Section of the USCG to remain apprised of North Atlantic right whale movements within the area. All vessels entering and exiting the MSRA shall report their activities to WHALESNORTH. Vessel operators shall contact the USCG by standard procedures promulgated through the Notice to Mariner system;

(5) All Vessels greater than or equal to 300 gross tons (GT) shall maintain a speed of 10 knots or less, unless an emergency situation requires speeds greater than 10 knots; and

(6) All Vessels less than 300 GT traveling between the shore and the project area that are not generally restricted to 10 knots will contact the Mandatory Ship Reporting (MSR) system, the USCG, or the project site before leaving shore for reports of active DMAs and/or recent right whale sightings and, consistent with navigation safety, restrict speeds to 10 knots or less within 5 miles (mi) (8 km) of any sighting location, when traveling in any of the seasonal management areas (SMAs) or when traveling in any active DMA.

In addition to the general marine mammal avoidance requirements identified above, vessels calling on the NEG Port must comply with the following additional requirements:

(1) EBRVs shall travel at 10 knots maximum speed when transiting to/from the TSS or to/from the NEG Port/Pipeline Lateral area. For EBRVs, at 1.86 mi (3 km) from the NEG Port, speed will be reduced to 3 knots and to less than 1 knot at 1,640 ft (500 m) from the NEG buoys, unless an emergency situation dictates the need for an alternate speed;

(2) EBRVs that are approaching or departing from the NEG Port and are within the Area to be Avoided (ATBA) surrounding the NEG Port, shall remain at least 1 km away from any visually-detected North Atlantic right whale and at least 100 yd (91 m) away from all other visually-detected whales unless an emergency situation requires that the vessel stay its course. During EBRV maneuvering, the Vessel Master shall designate at least one look-out to be exclusively and continuously monitoring for the presence of marine mammals at all times while the EBRV is approaching or departing from the NEG Port;

(3) During NEG Port operations, in the event that a whale is visually observed within 1 km of the NEG Port or a confirmed acoustic detection is reported on either of the two ABs closest to the NEG Port (western-most in the TSS array), departing EBRVs shall delay their departure from the NEG Port, unless an emergency situation requires that departure is not delayed. This departure delay shall continue until either the observed whale has been visually (during daylight hours) confirmed as more than 1 km from the NEG Port or 30 minutes have passed without another confirmed detection either acoustically within the acoustic detection range of the two ABs closest to the NEG Port, or visually within 1 km from the NEG Port.

Vessel captains shall focus on reducing DP thruster power to the maximum extent practicable, taking into account vessel and Port safety, during the operation activities. Vessel captains will shut down thrusters whenever they are not needed.

(1) The Northeast Gateway shall conduct empirical source level measurements on all noise emitting from construction equipment and all vessels that are involved in maintenance/repair work.

(2) If DP systems are to be employed and/or activities will emit noise with a source level of 139 dB re 1 μPa at 1 m, activities shall be conducted in accordance with the requirements for DP systems listed above.

(3) Northeast Gateway shall provide the NMFS Headquarters Office of the Protected Resources, NMFS Northeast Region Ship Strike Coordinator, and SBNMS with a minimum of 30-days notice prior to any planned repair and/or maintenance activity. For any unplanned/emergency repair/maintenance activity, Northeast Gateway shall notify the agencies as soon as it determines that repair work must be conducted. Northeast Gateway shall continue to keep the agencies apprised of repair work plans as further details (e.g., the time, location, and nature of the repair) become available. A final notification shall be provided to agencies 72 hours prior to crews being deployed into the field.

(1) Pipeline maintenance/repair vessels less than 300 GT traveling between the shore and the maintenance/repair area that are not generally restricted to 10 knots shall contact the MSR system, the USCG, or the project site before leaving shore for reports of active DMAs and/or recent right whale sightings and, consistent with navigation safety, restrict speeds to 10 knots or less within 5 mi (8 km) of any sighting location, when travelling in any of the seasonal management areas (SMAs) as defined above.

(2) Maintenance/repair vessels greater than 300 GT shall not exceed 10 knots, unless an emergency situation that requires speeds greater than 10 knots.

(3) Planned maintenance and repair activities shall be restricted to the period between May 1 and November 30 when most of the majority of North Atlantic right whales are absent in the area.

(4) Unplanned/emergency maintenance and repair activities shall be conducted utilizing anchor-moored dive vessel whenever operationally possible.

(5) Algonquin shall also provide the NMFS Office of the Protected Resources, NMFS Northeast Region Ship Strike Coordinator, and SBNMS with a minimum of 30-day notice prior to any planned repair and/or maintenance activity. For any unplanned/emergency repair/maintenance activity, Northeast Gateway shall notify the agencies as soon as it determines that repair work must be conducted. Algonquin shall continue to keep the agencies apprised of repair work plans as further details (e.g., the time, location, and nature of the repair) become available. A final notification shall be provided to agencies 72 hours prior to crews being deployed into the field.

(6) If DP systems are to be employed and/or activities will emit noise with a source level of 139 dB re 1 μPa at 1 m, activities shall be conducted in accordance with the requirements for DP systems listed in (5)(b)(ii).

(7) In the event that a whale is visually observed within 0.5 mi (0.8 km) of a repair or maintenance vessel, the vessel superintendent or on-deck supervisor shall be notified immediately. The vessel's crew shall be put on a heightened state of alert and the marine mammal shall be monitored constantly to determine if it is moving toward the repair or maintenance area.

(8) Repair/maintenance vessel(s) must cease any movement and/or cease all activities that emit noises with source level of 139 dB re 1 μPa @1 m or higher when a right whale is sighted within or approaching at 500 yd (457 meters) from the vessel. The source level of 139 dB corresponds to 120 dB received level at 500 yd (457 meters). Repair and maintenance work may resume after the marine mammal is positively reconfirmed outside the established zones (500 yd (457 meters)) or 30 minutes have passed without a redetection. Any vessels transiting the maintenance area, such as barges or tugs, must also maintain these separation distances.

(9) Repair/maintenance vessel(s) must cease any movement and/or cease all activities that emit noises with source level of 139 dB re 1 μPa @1 m or higher when a marine mammal other than a right whale is sighted within or approaching at 100 yd (91 m) from the vessel. Repair and maintenance work may resume after the marine mammal is positively reconfirmed outside the established zones (100 yd (91 meters)) or 30 minutes have passed without a redetection. Any vessels transiting the maintenance area, such as barges or tugs, must also maintain these separation distances.

(10) Algonquin and associated contractors shall also comply with the following:

• Operations involving excessively noisy equipment (source level exceeding 139 dB re 1μPa @1 m) shall “ramp-up” sound sources, allowing whales a chance to leave the area before sounds reach maximum levels. In addition, Northeast Gateway, Algonquin, and other associated contractors shall maintain equipment to manufacturers' specifications, including any sound-muffling devices or engine covers in order to minimize noise effects. Noisy construction equipment shall only be used as needed and equipment shall be turned off when not in operation;

• Any material that has the potential to entangle marine mammals (e.g., anchor lines, cables, rope or other construction debris) shall only be deployed as needed and measures shall be taken to minimize the chance of entanglement;

• For any material that has the potential to entangle marine mammals, such material shall be removed from the water immediately unless such action jeopardizes the safety of the vessel and crew as determined by the Captain of the vessel; and

• In the event that a marine mammal becomes entangled, the marine mammal coordinator and/or protected species observer (PSO) will notify NMFS (if outside the SBNMS), and SBNMS staff (if inside the SBNMS) immediately so that a rescue effort may be initiated.

(11) All maintenance/repair activities shall be scheduled to occur between May 1 and November 30. However, in the event of unplanned/emergency repair work that cannot be scheduled during the preferred May through November work window, the following additional measures shall be followed for Pipeline Lateral maintenance and repair related activities between December and April:

• Between December 1 and April 30, if on-board PSOs do not have at least 0.5-mile visibility, they shall call for a shutdown. At the time of shutdown, the use of thrusters must be minimized. If there are potential safety problems due to the shutdown, the captain will decide what operations can safely be shut down;

• Prior to leaving the dock to begin transit, the barge shall contact one of the PSOs on watch to receive an update of sightings within the visual observation area. If the PSO has observed a North Atlantic right whale within 30 minutes of the transit start, the vessel shall hold for 30 minutes and again get a clearance to leave from the PSOs on board. PSOs shall assess whale activity and visual observation ability at the time of the transit request to clear the barge for release;

• Transit route, destination, sea conditions and any marine mammal sightings/mitigation actions during watch shall be recorded in the log book. Any whale sightings within 1,000 meters of the vessel shall result in a high alert and slow speed of 4 knots or less and a sighting within 750 m shall result in idle speed and/or ceasing all movement;

• The material barges and tugs used in repair and maintenance shall transit from the operations dock to the work sites during daylight hours when possible provided the safety of the vessels is not compromised. Should transit at night be required, the maximum speed of the tug shall be 5 knots; and

• All repair vessels must maintain a speed of 10 knots or less during daylight hours. All vessels shall operate at 5 knots or less at all times within 5 km of the repair area.

Vessels associated with maintaining the AB network operating as part of the mitigation/monitoring protocols shall adhere to the following speed restrictions and marine mammal monitoring requirements.

(1) In accordance with 50 CFR 224.103 (c), all vessels associated with NEG Port activities shall not approach closer than 500 yd (460 meters) to a North Atlantic right whale.

(2) All vessels shall obtain the latest DMA or right whale sighting information via the NAVTEX, MSR, SAS, NOAA Weather Radio, or other available means prior to operations.

NMFS has carefully evaluated the applicant's proposed mitigation 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; and

• 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 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);

(4) 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 and

(5) 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 applicant's proposed measures that include vessel speed reduction, noise level related shutdown measures, and ramping up procedures, NMFS has preliminarily determined that the proposed mitigation measures provide the means of effecting the least practicable impact on marine mammals species or stocks and their habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance.

In order to issue an IHA for an activity, section 101(a)(5)(D) of the MMPA states that NMFS must set forth, “requirements pertaining to the monitoring and reporting of such taking.” The MMPA implementing regulations at 50 CFR 216.104 (a)(13) indicate that requests for IHAs 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. Tetra Tech submitted a marine mammal monitoring plan as part of the IHA application. It 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); and

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.

Vessel-based monitoring for marine mammals shall be done by trained look-outs during NEG Port and Pipeline Lateral operations and maintenance and repair activities. The observers shall monitor the occurrence of marine mammals near the vessels during NEG Port and Pipeline Lateral related activities. Lookout duties include watching for and identifying marine mammals; recording their numbers, distances, and reactions to the activities; and documenting “take by harassment.” The vessel look-outs assigned to visually monitor for the presence of marine mammals shall be provided with the following:

(1) Recent NAVTEX, NOAA Weather Radio, SAS and/or acoustic monitoring buoy detection data;

(2) Binoculars to support observations;

(3) Marine mammal detection guide sheets; and

(4) Sighting log.

All individuals onboard the EBRVs responsible for the navigation duties and any other personnel that could be assigned to monitor for marine mammals shall receive training on marine mammal sighting/reporting and vessel strike avoidance measures.

While an EBRV is navigating within the designated TSS, there shall be three people with look-out duties on or near the bridge of the ship including the Master, the Officer-of-the-Watch and the Helmsman-on-watch. In addition to the standard watch procedures, while the EBRV is transiting within the designated TSS, maneuvering within the ATBA, and/or while actively engaging in the use of thrusters, an additional look-out shall be designated to exclusively and continuously monitor for marine mammals.

All sightings of marine mammals by the designated look-out, individuals posted to navigational look-out duties, and/or any other crew member while the EBRV is transiting within the TSS, maneuvering within the ATBA and/or when actively engaging in the use of thrusters, shall be immediately reported to the Officer-of-the-Watch who shall then alert the Master. The Master or Officer-of-the-Watch shall ensure the required reporting procedures are followed and the designated marine mammal look-out records all pertinent information relevant to the sighting.

Visual sightings made by look-outs from the EBRVs shall be recorded using a standard sighting log form. Estimated locations shall be reported for each individual and/or group of individuals categorized by species when known. This data shall be entered into a database and a summary of monthly sighting activity shall be provided to NMFS. Estimates of take and copies of these log sheets shall also be included in the reports to NMFS.

Two qualified and NMFS-approved PSOs shall be assigned to each vessel that will use DP systems during maintenance and repair related activities. PSOs shall operate individually in designated shifts to accommodate adequate rest schedules. Additional PSOs shall be assigned to additional vessels if AB data indicates that sound levels exceed 120 dB re 1 µPa, further then 100 m (328 ft) from these vessels.

All PSOs shall receive NMFS-approved marine mammal observer training and be approved in advance by NMFS after review of their resume. All PSOs shall have direct field experience on marine mammal vessels and/or aerial surveys in the Atlantic Ocean/Gulf of Mexico.

PSOs (one primary and one secondary) shall be responsible for visually locating marine mammals at the ocean's surface and, to the extent possible, identifying the species. The primary PSO shall act as the identification specialist and the secondary PSO will serve as data recorder and also assist with identification. Both PSOs shall have responsibility for monitoring for the presence of marine mammals and sea turtles. Specifically PSO's shall:

(1) Monitor at all hours of the day, scanning the ocean surface by eye for a minimum of 40 minutes every hour;

(2) Monitor the area where maintenance and repair work is conducted beginning at daybreak using 25x power binoculars and/or hand-held binoculars. Night vision devices must be provided as standard equipment for monitoring during low-light hours and at night;

(3) Conduct general 360° visual monitoring during any given watch period and target scanning by the observer shall occur when alerted of a whale presence;

(4) Alert the vessel superintendent or construction crew supervisor of visual detections within 2 mi (3.31 km) immediately;and

(5) Record all sightings on marine mammal field sighting logs. Specifically, all data shall be entered at the time of observation, notes of activities will be kept, and a daily report prepared and attached to the daily field sighting log form. The basic reporting requirements include the following:

• Beaufort sea state;

• Wind speed;

• Wind direction;

• Temperature;

• Precipitation;

• Glare;

• Percent cloud cover;

• Number of animals;

• Species;

• Position;

• Distance;

• Behavior;

• Direction of movement; and

• Apparent reaction to construction activity.

In the event that a whale is visually observed within the 2-mi (3.31-km) ZOI of a DP vessel or other construction vessel that has shown to emit noise with source level in excess of 139 dB re 1 μPa @1 m, the PSO will notify the repair/maintenance construction crew to minimize the use of thrusters until the animal has moved away, unless there are divers in the water or an ROV is deployed.

Northeast Gateway shall deploy 10 ABs within the Separation Zone of the TSS for the operational life of the Project. The ABs shall be used to detect a calling North Atlantic right whale an average of 5 nmi from each AB. The AB system shall be the primary detection mechanism that alerts the EBRV Master to the occurrence of right whales, heightens EBRV awareness, and triggers necessary mitigation actions as described above. Northeast Gateway shall conduct short-term passive acoustic monitoring to document sound levels during:

(1) The initial operational events in the 2015-2016 winter heating season;

(2) Regular deliveries outside the winter heating season should such deliveries occur; and

(3) Scheduled and unscheduled maintenance and repair activities.

Northeast Gateway shall conduct long-term monitoring of the noise environment in Massachusetts Bay in the vicinity of the NEG Port and Pipeline Lateral using marine autonomous recording units (MARUs) when there is anticipated to be more than 5 NEG shipments in a 30-day period or over 20 shipments in a 6-month period.

The acoustic data collected shall be analyzed to document the seasonal occurrences and overall distributions of whales (primarily fin, humpback and right whales) within approximately 10 nmi of the NEG Port and shall measure and document the noise “budget” of Massachusetts Bay so as to eventually assist in determining whether or not an overall increase in noise in the Bay associated with the Project might be having a potentially negative impact on marine mammals.

Northeast Gateway shall make all acoustic data, including data previously collected by the MARUs during prior construction, operations, and maintenance and repair activities, available to NOAA. Data storage will be the responsibility of NOAA.

(1) Ten ABs that have been deployed since 2007 shall be used to continuously screen the low-frequency acoustic environment (less than 1,000 Hertz) for right whale contact calls occurring within an approximately 5-nm radius from each buoy (the AB's detection range).

(2) Once a confirmed detection is made, the Master of any EBRVs operating in the area will be alerted immediately.

(1) If the repair/maintenance work is located outside of the detectible range of the 10 project area ABs, Northeast Gateway and Algonquin shall consult with NOAA (NMFS and SBNMS) to determine if the work to be conducted warrants the temporary installation of an additional AB(s) to help detect and provide early warnings for potential occurrence of right whales in the vicinity of the repair area.

(2) The number of ABs installed around the activity site shall be commensurate with the type and spatial extent of maintenance/repair work required, but must be sufficient to detect vocalizing right whales within the 120-dB impact zone.

(3) Should acoustic monitoring be deemed necessary during a planned or unplanned/emergency repair and/or maintenance event, active monitoring for right whale calls shall begin 24 hours prior to the start of activities.

(4) Source level data from the acoustic recording units deployed in the NEG Port and/or Pipeline Lateral maintenance and repair area shall be provided to NMFS.

(a) Throughout NEG Port and Pipeline Lateral operations, Northeast Gateway and Algonquin shall provide a monthly Monitoring Report. The Monitoring Report shall include:

• Both copies of the raw visual EBRV lookout sighting information of marine mammals that occurred within 2 miles of the EBRV while the vessel transits within the TSS, maneuvers within the ATBA, and/or when actively engaging in the use of thrusters, and a summary of the data collected by the look-outs over each reporting period;

• Copies of the raw PSO sightings information on marine mammals gathered during pipeline repair or maintenance activities. This visual sighting data shall then be correlated to periods of thruster activity to provide estimates of marine mammal takes (per species/species class) that took place during each reporting period; and

• Conclusion of any planned or unplanned/emergency repair and/or maintenance period, a report shall be submitted to NMFS summarizing the repair/maintenance activities, marine mammal sightings (both visual and acoustic), empirical source-level measurements taken during the repair work, and any mitigation measures taken.

(b) During the maintenance and repair of NEG Port and Pipeline Lateral components, weekly status reports shall be provided to NOAA (both NMFS and SBNMS) using standardized reporting forms. The weekly reports shall include data collected for each distinct marine mammal species observed in the repair/maintenance area during the period that maintenance and repair activities were taking place. The weekly reports shall include the following information:

• Location (in longitude and latitude coordinates), time, and the nature of the maintenance and repair activities;

• Indication of whether a DP system was operated, and if so, the number of thrusters being used and the time and duration of DP operation;

• Marine mammals observed in the area (number, species, age group, and initial behavior);

• The distance of observed marine mammals from the maintenance and repair activities;

• Changes, if any, in marine mammal behaviors during the observation;

• A description of any mitigation measures (power-down, shutdown, etc.) implemented;

• Weather condition (Beaufort sea state, wind speed, wind direction, ambient temperature, precipitation, and percent cloud cover etc.);

• Condition of the observation (visibility and glare); and

• Details of passive acoustic detections and any action taken in response to those detections.

In the unanticipated event that survey operations clearly cause the take of a marine mammal in a manner prohibited by the proposed IHA, such as an injury (Level A harassment), serious injury or mortality (e.g., ship-strike, gear interaction, and/or entanglement), NEG and/or Algonquin shall immediately cease activities and immediately report the incident to the Supervisor of the Incidental Take Program, Permits and Conservation Division, Office of Protected Resources, NMFS and the Northeast Regional Stranding Coordinators. The report must include the following information:

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

• The name and type of vessel involved;

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

• Description of the incident;

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

• Water depth;

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

• Description of 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 NEG and/or Algonquin to determine what is necessary to minimize the likelihood of further prohibited take and ensure Marine Mammal Protection Act (MMPA) compliance. NEG and/or Algonquin may not resume their activities until notified by NMFS via letter, email, or telephone.

In the event that NEG and/or Algonquin 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), NEG and/or Algonquin will immediately (i.e., within 24 hours of the discovery) report the incident to the Supervisor of the Incidental Take Program, Permits and Conservation Division, Office of Protected Resources, NMFS, and the NMFS Northeast Stranding Coordinators. The report must include the same information identified above. Activities may continue while NMFS reviews the circumstances of the incident. NMFS will work with NEG and/or Algonquin to determine whether modifications in the activities are appropriate.

In the event that NEG or Algonquin 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 (if the IHA is issued) (e.g., previously wounded animal, carcass with moderate to advanced decomposition, or scavenger damage), NEG and/or Algonquin shall report the incident to the Supervisor of the Incidental Take Program, Permits and Conservation Division, Office of Protected Resources, NMFS, and the NMFS Northeast Stranding Coordinators, within 24 hours of the discovery. NEG and/or Algonquin shall provide photographs or video footage (if available) or other documentation of the stranded animal sighting to NMFS and the Marine Mammal Stranding Network. NEG and/or Algonquin can continue its operations under such a case.

Prior marine mammal monitoring during NEG Port and Pipeline Lateral operation, maintenance and repair activities and monthly marine mammal observation memorandums (NEG 2010; 2015; 2016) indicate that only a small number of marine mammals were observed during these activities. Only one NEG Port operation occurred within the dates of the current IHA (starting December 23, 2015) and only one unidentified small whale was observed at a distance of 2 nmi from the NEG vessel on January 17, 2016. No other NEG Port and Pipeline Lateral related activity occurred during this period.

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). Only take by Level B harassment is anticipated as a result of NEG's operation and maintenance and repair activities. Anticipated take of marine mammals is associated with operation of dynamic positioning during the docking of the NEG vessels and positioning of maintenance and dive vessels, and by operations of certain machinery during maintenance and repair activities. The regasification process itself is an activity that does not rise to the level of taking, as the modeled source level for this activity is 108 dB. Certain species may have a behavioral reaction to the sound emitted during the activities. Hearing impairment is not anticipated. Additionally, vessel strikes are not anticipated, especially because of the speed restriction measures that are proposed that were described earlier in this document.

The full suite of potential impacts to marine mammals was described in detail in the “Potential Effects of the Specified Activity on Marine Mammals” section found earlier in this document. The potential effects of sound from the proposed NEG Port and Pipeline Lateral operations, maintenance and repair activities might include one or more of the following: masking of natural sounds and behavioral disturbance (Richardson et al., 1995). As discussed earlier in this document, the most common impact will likely be from behavioral disturbance, including avoidance of the ensonified area or changes in speed, direction, and/or diving profile of the animal. Hearing impairment (TTS and PTS) is highly unlikely to occur based on low noise source levels from the proposed activities that would preclude marine mammals from being exposed to noise levels high enough to cause hearing impairment.

For non-pulse sounds, such as those produced by operating DP thruster during vessel docking and supporting underwater construction and repair activities and the operations of various machineries that produces non-pulse noises, NMFS uses the 120 dB (rms) re 1 μPa isopleth to indicate the onset of Level B harassment.

The basis for Northeast Gateway and Algonquin's “take” estimate is the number of marine mammals that would be exposed to sound levels in excess of 120 dB, which is the threshold used by NMFS for non-pulse sounds. For the NEG Port and Pipeline Lateral operations and maintenance and repair activities, the take estimates are determined by multiplying the 120-dB ensonified area by local marine mammal density estimates, and then multiplying by the estimated number of days such activities would occur during a year-long period. For the NEG Port operations, the 120-dB ensonified area is 56.8 km2 for a single visit during docking when running DP system. Although two EBRV docking with simultaneous DP system running was modeled, this situation would not occur in reality. For NEG Port and Pipeline Lateral maintenance and repair activities, modeling based on the empirical measurements showed that the distance of the 120-dB radius is expected to be 3.5 km, making a maximum 120-dB ZOI of approximately 40.7 km2.

For the purposes of understanding the noise footprint of operations at the NEG Port, measurements taken to capture operational noise (docking, undocking, regasification, and EBRV thruster use) during the 2006 Gulf of Mexico field event were taken at the source. Measurements taken during EBRV transit were normalized to a distance of 328 ft (100 m) to serve as a basis for modeling sound propagation at the NEG Port site in Massachusetts Bay.

Sound propagation calculations for operational activities were then completed at two positions in Massachusetts Bay to determine site-specific distances to the 120/160/180 dB isopleths:

• Operations Position 1—Port (EBRV Operations): 70°36.261′ W. and 42°23.790′ N.; and

• Operations Position 2—Boston TSS (EBRV Transit): 70°17.621′ W. and 42°17.539′ N.

At each of these locations sound propagation calculations were performed to determine the noise footprint of the operation activity at each of the specified locations. Updated acoustic modeling was completed using Tetra Tech's underwater sound propagation program which utilizes a version of the publicly available Range Dependent Acoustic Model (RAM). Based on the U.S. Navy's Standard Split-Step Fourier Parabolic Equation, this modeling methodology considers range and depth along with a geo-referenced dataset to automatically retrieve the time of year information, bathymetry, and seafloor geoacoustic properties along the given propagation transects radiating from the sound source. The calculation methodology assumes that outgoing energy dominates over scattered energy, and computes the solution for the outgoing wave equation. An approximation is used to provide two-dimensional transmission loss values in range and depth, i.e., computation of the transmission loss as a function of range and depth within a given radial plane is carried out independently of neighboring radials, reflecting the assumption that sound propagation is predominantly away from the source. Transects were run along compass points at angular directions ranging from 0 to 360° in 5 degree increments. The received underwater sound levels at any location within the region of interest are computed from the 1/3-octave band source levels by subtracting the numerically modelled transmission loss at each 1/3-octave band center frequency and summing across all frequencies to obtain a broadband value. The resultant underwater sound pressure levels to the 120 dB isopleth is presented in Table 2.

The Mid-Atlantic Fishery Management Council and the Atlantic States Marine Fisheries Commission cooperatively manage the summer flounder, scup, and black sea bass fisheries. The Summer Flounder, Scup, and Black Sea Bass Fishery Management Plan (FMP) and its implementing regulations outline the Council's process for establishing specifications. Specifications in these fisheries include various catch and landing subdivisions, such as the commercial and recreational sector annual catch limits (ACLs), annual catch targets (ACTs), and sector-specific landing limits (i.e., the commercial fishery quota and recreational harvest limit). Annual specifications may be established for three year periods, and, in interim years, specifications are reviewed by the Council to ensure previously established multi-year specifications remain appropriate. The FMP also contains formulas to divide the specification catch limits into commercial and recreational fishery allocations, state-by-state quotas, and quota periods, depending on the species in question. Rulemaking for measures used to manage the recreational fisheries (minimum fish sizes, open seasons, and bag limits) for these three species occurs separately, and typically takes place in the spring of each year.

On December 28, 2015, NMFS published a final rule implementing the Council's recommended specifications for the summer flounder, scup, and black sea bass fisheries (80 FR 80689) for fishing years 2016 through 2018. The Council intended to reconsider the specifications set for fishing years 2017 and 2018 after reviewing any updated information. Based on updated information on the status of the summer flounder stock, the Council is now recommending adjustments to the previously established summer flounder specifications for the 2017 and 2018 fishing years. An assessment update will be available next summer and notice will be provided in the Federal Register on whether the revised 2018 specifications will remain in place or be updated further based on any new information. The scup and black sea bass specifications implemented through previous rulemaking remain unchanged by this action.

When the Council previously recommended summer flounder specifications in 2015, available scientific information indicated that the summer flounder stock size was declining and that overfishing occurred in 2014. In order to minimize disruption to the industry as much as possible, given the necessary reduction in available catch to prevent further overfishing and to increase the stock size, the Council requested its Scientific and Statistical Committee (SSC) to deviate from the standard risk policy and to phase-in the summer flounder catch reductions over the 3-year specifications cycle. The SSC complied with this request, but requested a stock assessment update in July 2016 to determine if its recommended acceptable biological catches (ABCs) remain appropriate for 2017 and 2018.

The SSC met on July 21-22, 2016, to review the stock assessment update for summer flounder compiled by the Northeast Fisheries Science Center. This 2016 update was based on the peer-review approved model from the 2013 benchmark assessment, updated to include data through 2015. More specific information about the assessment information (e.g., biomass level, fishing mortality, etc.) can be found in section 6.0 of the SEA for this action. The assessment update noted that the consistent pattern in both underestimation of fishing mortality and overestimation of spawning stock biomass is continuing, even though catches have not substantially exceeded ABC levels. This downward trend in biomass is mainly due to below average recruitment in the last five years. As a result of this information, the assessment update recalculated the 2017 and 2018 overfishing limits (OFLs) for the stock. For 2017, the recalculated OFL is 16.76 million lb (7,600 mt) and for 2018, the recalculated OFL is 18.69 million lb (8,476 mt), representing approximately a 16-percent reduction from the previously established OFLs. To keep catch below these updated OFL estimates, the SSC recommended revisions to the previously adopted 2017 and 2018 ABCs. The SSC recommended revising the ABCs by abandoning the phased-in approach and instead following the Council's standard risk policy. The SSC cited among its reasons for departing from the previously approved phased-in approach the continual overestimation of biomass and recruitment and underestimation of fishing mortality, emphasizing that continuing to overfish in a period of consistently poor recruitment represents a substantial risk to the stock. The SSC recommended a revised 2017 ABC that is approximately 30 percent lower than both the previously established 2017 ABC and the current 2016 ABC. The SSC recommended a 2018 ABC that is 16 percent lower than the previously established 2018 ABC (Table 1).

The Council's Summer Flounder Monitoring Committee met July 25, 2016, to discuss specification-related recommendations for the summer flounder fishery, to recommend offsets from the ACL to account for management uncertainty, and to discuss commercial management measure recommendations, as appropriate. The Monitoring Committee determined that no additional reductions were necessary to account for management uncertainty because the recreational fishery has had only minor overages of the recreational harvest limit in recent years, and the commercial landings monitoring and fishery closure system is timely enough to prevent commercial overages. As a result, the Monitoring Committee recommended that ACTs for the commercial and recreational sectors should equal their respective ACLs and made no recommended changes to any other summer flounder management measures.

Following the SSC and Monitoring Committee meetings, the Council and the Commission's Summer Flounder, Scup, and Black Sea Bass Management Board met jointly on August 9, 2016, to consider the recommendations of the SSC, the Monitoring Committee, and public comments, and to make their specification recommendations. More complete details on the SSC, Monitoring Committee, and Council meeting deliberations can be found on the Council's Web site (www.mafmc.org). Ultimately, the Council recommended the summer flounder commercial quotas and recreational harvest limits shown in Table 1. The recommended catch limits for 2017 are nearly 30 percent lower than those previously established.

While the Board action was finalized at the August meeting, the Council's recommendations must be reviewed by NMFS to ensure that they comply with the FMP and applicable law. NMFS also must conduct notice-and-comment rulemaking to propose and implement the final specifications.

Table 2 summarizes the Council's recommended summer flounder specifications that NMFS is proposing for 2017 and 2018, including the sector-specific estimated discards.

Consistent with the summer flounder regulations, the sum of the recreational and commercial sector ACLs is equal to the ABC for each fishing year. To derive the ACLs, the sum of the sector-specific projected discards are removed from the ABCs to derive the landing allowances. For summer flounder, 60 percent of the landing allowance for each fishing year is allocated to the commercial fishery and 40 percent to the recreational fishery. Using this method ensures that each sector is accountable for its respective discards, rather than simply apportioning the ABCs by the allocation percentages to derive the sector ACLs. Although the derived ACLs are not split exactly according to the allocations specified in the Summer Flounder, Scup, and Black Sea Bass Fishery Management Plan (FMP), the landing portions of the ACLs preserve the appropriate allocation split, consistent with the FMP.

Table 3 presents the proposed state summer flounder allocations for 2017-2018 using the commercial state quota allocations described in the FMP. Any commercial quota adjustments to account for overages will be published in the Federal Register prior to the start of the respective fishing year. The final rule for this action will include any necessary quota overage reductions for fishing year 2017.

The Council and Commission will develop recreational management measures (e.g., minimum fish sizes, open seasons, and bag limits) for summer flounder this fall and NMFS rulemaking will occur in early spring of 2017.

Pursuant to section 304(b)(1)(A) of the Magnuson-Stevens Act, the NMFS Assistant Administrator has determined that this proposed rule is consistent with the Summer Flounder, Scup, and Black Sea Bass FMP, other provisions of the Magnuson-Stevens Act, and other applicable law, subject to further consideration after public comment.

These proposed specifications are exempt from review under Executive Order 12866.

An IRFA was prepared by the Council, as required by section 603 of the Regulatory Flexibility Act (RFA), to examine the impacts of these proposed specifications on small business entities, if adopted. A description of the specifications, why they are being considered, and the legal basis for proposing and implementing specifications for the summer flounder fishery are contained in the preamble to this proposed rule. A copy of the detailed RFA analysis is available from NMFS or the Council (see ADDRESSES). The Council's analysis made use of quantitative approaches when possible. Where quantitative data on revenues or other business-related metrics that would provide insight to potential impacts were not available to inform the analyses, qualitative analyses were conducted. A summary of the 2017 and 2018 summer flounder specifications RFA analysis follows.

This action proposes management measures, including annual catch limits, for the summer flounder fishery in order to prevent overfishing and achieve optimum yield in the fishery. A complete description of the action, why it is being considered, and the legal basis for this action are contained in the specifications document, and elsewhere in the preamble to this proposed rule, and are not repeated here.

On December 29, 2015, NMFS issued a final rule establishing a small business size standard of $11 million in annual gross receipts for all businesses primarily engaged in the commercial fishing industry and $7 million in annual gross receipts for all businesses primarily engaged in for-hire fishing activity (NAICS 11411) for Regulatory Flexibility Act (RFA) compliance purposes only (80 FR 81194, December 29, 2015). The North American Industry Classification System (NAICS) is the standard used by Federal statistical agencies in classifying business establishments for the purpose of collecting, analyzing, and publishing statistical data related to the U.S. business economy.

This proposed rule affects commercial and recreational fish harvesting entities engaged in the summer flounder fishery. Individually-permitted vessels may hold permits for several fisheries, harvesting species of fish that are regulated by several different FMPs, even beyond those impacted by the proposed action. Furthermore, multiple-permitted vessels and/or permits may be owned by entities affiliated by stock ownership, common management, identity of interest, contractual relationships, or economic dependency. For the purposes of the RFA analysis, the ownership entities, not the individual vessels, are considered to be the regulated entities.

Ownership entities are defined as those entities with common ownership personnel as listed on the permit application. Only permits with identical ownership personnel are categorized as an ownership entity. For example, if five permits have the same seven persons listed as co-owners on their permit applications, those seven persons would form one ownership entity that holds those five permits. If two of those seven owners also co-own additional vessels, that ownership arrangement would be considered a separate ownership entity for the purpose of this analysis.

The current ownership data set used for this analysis is based on calendar year 2015 (the most recent complete year available) and contains average gross sales associated with those permits for calendar years 2013 through 2015.

A description of the specific permits that are likely to be impacted by this action is provided below, along with a discussion of the impacted businesses, which can include multiple vessels and/or permit types.

According to the commercial ownership database, 553 affiliate firms landed summer flounder during the 2013-2015 period, with 547 of those businesses affiliates categorized as small businesses and 6 categorized as large businesses. The ownership data for the for-hire fleet indicate that there were 411 for-hire affiliate firms generating revenues from fishing recreationally for various species during the 2013-2015 period, all of which are categorized as small businesses. Although it is not possible to derive what proportion of the overall revenues came from specific fishing activities, given the popularity of summer flounder as a recreational species, it is likely that revenues generated from summer flounder recreational fishing is important for some, if not all, of these firms.

There are no new reporting or recordkeeping requirements contained in any of the alternatives considered for this action.

NMFS is not aware of any relevant Federal rules that may duplicate, overlap, or conflict with this proposed rule.

This action proposes to set commercial quotas and recreational harvest limits for the summer flounder fishery for the 2017 and 2018 fishing years that are consistent with the best scientific information available and the most recent catch limit recommendations of the Council's SSC. The proposed landings limits for 2017 include a commercial quota of 5.66 million lb (2,567 mt) and a recreational harvest limit of 3.77 million lb (1,711 mt). For 2018, the proposed measures include a commercial quota of 6.63 million lb (3,006 mt) and a recreational harvest limit of 4.42 million lb (2,004 mt).

The only other alternatives considered in this document are status quo alternatives that are identical to the summer flounder landings limits implemented in December 2015. If these specifications remained in place, they would have greater positive socioeconomic impacts than the preferred alternatives. However, these alternatives were not selected as preferred given that they do not address the new scientific information regarding summer flounder stock status, and, therefore, would likely result in overfishing, which would be inconsistent with the FMP, National Standard 1 guidance under the Magnuson-Stevens Act, and the most recent advice of the Council's SSC. Because these alternatives are inconsistent with the purpose and need of this action, they are not considered further under this analysis.

Public comment: Written comments may be directed to Gregg Waugh, Executive Director, South Atlantic Fishery Management Council (see ADDRESSES) or electronically via the Council's Web site at: https://goo.gl/forms/QAZYglsYhWIkQZNV2. The public comment form is open for use when the briefing book is posted to the Web site on the Friday, two weeks prior to the Council meeting. Comments received by close of business the Monday before the meeting (November 28, 2016) will be compiled, posted to the Web site as part of the meeting materials, and included in the administrative record. For written comments received after the Monday before the meeting (after 11/28), individuals sending the comment must use the Council's online form available from the Web site. Comments will automatically be posted to the Web site and available for Council consideration. Comments received prior to noon on Thursday, December 8, 2016 will be a part of the meeting administrative record.

The items of discussion in the individual meeting agendas are as follows:

1. The Committee will review applications for the SEDAR Pool Advisory Panel and provide recommendations (Closed Session).

2. The Committee will review options for the structure of an advisory panel for the Council's System Management Plan addressing protected areas and provide guidance and timing for the advisory panel as necessary.

1. The Committee will receive a report on the level of commercial logbook reporting at the time of permit renewal, discuss compliance with logbook reporting requirements, and provide recommendations as appropriate.

2. The Committee will also follow up on items from the earlier joint meeting of the Law Enforcement Committee and Advisory panel provide recommendations as appropriate.

The Committee will review the SSC Conflict of Interest Policy, the SSC Public Comment Policy, and the SSC Update on complex analysis review process. The Committee will provide guidance as needed.

The Committee will receive an update from NOAA Fisheries' Protected Resources Office, review the Biological Opinion for Snapper Grouper, appoint a Council member to the Large Whale Take Reduction Team, and receive an update from the U.S. Fish & Wildlife Service.

1. The Committee will receive a report from the Habitat Protection and Ecosystem-Based Management Advisory Panel and provide recommendations as appropriate.

2. The Committee will review and approve the Council's Essential Fish Habitat Policy Statements for the Fishery Ecosystem Plan II.

3. The Committee will receive an update on the Habitat and Ecosystem Tools and Model Development, Council actions pertaining to Habitat, and a report from the Lenfest Ecosystem Task Force and proved recommendations as appropriate.

1. The Committee will discuss and provide recommendations for appointments for the following stock assessments: SEDAR 50 Blueline Tilefish; SEDAR 48 Black Grouper, SEDAR 56 Black Sea Bass, and the SEDAR Stock Identification and Meristics Workshop. (Closed Session)

2. The Committee will receive updates on SEDAR projects, review the SEDAR Steering Committee Report, and assessment priorities, including SSC prioritization recommendations and a long-term assessment plan. The Committee will provide recommendations as appropriate.

1. The Committee will receive a presentation on Spiny Lobster regulations in Florida, review recommendations from the SSC for establishing Overfishing Levels and Acceptable Biological Catch for Spiny Lobster, and provide recommendations to staff.

2. The Committee will also receive an overview of a Discussion Document on action to restrict recreational traps in the South Atlantic Exclusive Economic Zone and provide direction to staff.

1. The Committees will receive updates from NOAA Fisheries on commercial and recreational catches of Dolphin and Wahoo versus annual catch limits (ACLs), status of amendments, and the 2015 commercial landings for Yellowtail Snapper.

2. The Committee will review Dolphin Wahoo Amendment 10/Snapper Grouper Amendment 44 addressing allocations of Dolphin and Yellowtail Snapper, provide direction to staff, and recommend approval of the joint amendment for public hearings.

3. The Committees will receive an overview of draft options for a Limited Entry program for federal For-Hire Permits in the Snapper Grouper, Coastal Migratory Pelagic, and Dolphin Wahoo fisheries in the South Atlantic/Atlantic, review options, modify the document if necessary, and provide guidance as appropriate.

The Committee will receive a report from the Information and Education Advisory Panel meeting and provide guidance to staff.

1. The Committee will receive a presentation on the Final Rule for National Standard 1 Guidelines, discuss and provide guidance to staff.

2. The Committee will receive an overview of Electronic Reporting Project Proposals, discuss and take action as necessary.

3. The Committee will receive an update on the status of expenditures for Calendar Year (CY) 2016; review the Draft CY 2017 Budget; review, modify, and approve the Council Follow-up and work priorities; and provide recommendations as appropriate.

3. The Committee will discuss standards and procedures for participating in Council webinar meetings and take action as appropriate.

1. The Committee will receive updates from NOAA Fisheries on the status of commercial and recreational catches versus quotas for species under Annual Catch Limits (ACLs) and the status of amendments currently under Secretarial review.

2. The Committee will receive reports from the Snapper Grouper Advisory Panel meeting and the SSC meeting, discuss and provide recommendations as appropriate.

3. The Committee will receive presentations on the efficacy of descending devices for deepwater grouper and commercial logbook discard data for red grouper, discuss and take action as appropriate.

4. The Committee will review Snapper Grouper Amendment 41 addressing management measures for mutton snapper, modify the document as appropriate, and provide recommendations to approve/disapprove the amendment for formal Secretarial Review.

5. The Committee will receive the Annual Review of the Vision Blueprint for the Snapper Grouper Fishery addressing long-term management needs and provide recommendations as appropriate. The Committee will also review options for the Recreational Visioning Blueprint Amendment (Vision Blueprint Regulatory Amendment 26) and the Commercial Visioning Blueprint Amendment (Vision Blueprint Regulatory Amendment 27), modify the documents as appropriate, and approve for public scoping.

6. The Committee will receive a presentation of Red Snapper landings by County in Florida, receive an overview of management options for Red Snapper to be addressed in Snapper Grouper Amendment 43, modify the document as necessary, and provide recommendations to approve/disapprove the options paper for public scoping.

7. The Committee will consider an emergency rule for the 2017 season of Golden Tilefish and provide guidance to staff for amendment development.

Formal Public Comment, Wednesday, December 7, 2016, 4:30 p.m.—Public comment will be accepted on items on the Council agenda. Comment will be accepted first on items before the Council for Secretarial approval: (1) Snapper Grouper Amendment 41 (Mutton Snapper); (2) Coastal Migratory Pelagic Amendment 29 (Gulf of Mexico King Mackerel Allocations); (3) Coastal Migratory Pelagic Amendment 30 (Atlantic Cobia Fishing Year); and (4) Atlantic For-Hire Electronic Reporting Amendment. The Council Chair, based on the number of individuals wishing to comment, will determine the amount of time provided to each commenter.

The Committee will conduct the Executive Director's Performance Review.

The Committee will receive a presentation from NOAA Fisheries HMS on draft Amendment 5b to the 2006 Consolidated Atlantic HMS Fishery Management Plan addressing management measures for Dusky Shark and provide guidance to staff.

1. The Committees will receive status updates from NOAA Fisheries on commercial and recreational catches versus annual catch limits (ACLs) for species under ACLs and amendments currently under Secretarial review.

2. The Committee will receive an overview of Amendment 29 to the Coastal Migratory Pelagic (CMP) Fishery Management Plan for the Gulf of Mexico and South Atlantic Region addressing allocations of Gulf Group King Mackerel, modify as necessary, and provide recommendations to approve/disapprove the amendment for formal Secretarial Review.

3. The Committee will receive an overview of CMP Amendment 30 addressing modifications to the Fishing Year for Atlantic Cobia, review public hearing comments, modify the document as necessary, and recommend approval/disapproval of the amendment for formal Secretarial Review.

4. The Committee will review the ASMFC's Public Information Document for the Interstate Fishery Management Plan for Cobia and provide comments and guidance as appropriate.

The Committee will receive a program development update on the Council's Citizen Science Program, discuss and take action as necessary.

1. The Committee will receive an update on the status of the Bycatch Reporting Amendment and the final Standardized Bycatch Reporting Methodology (SBRM) rule from NOAA Fisheries, discuss and provide direction to staff.

2. The Committee will receive an update on the status of voluntary commercial logbook electronic reporting, discuss and take action as necessary.

3. The Committee will receive an update on the status of the Pilot For-Hire Electronic Reporting Project being conducted jointly between the Council and the Atlantic Coastal Cooperative Statistics Program, review and take action as necessary.

4. The Committee will also receive a report on the status of the Headboat Electronic Reporting Program and associated outreach, an overview of the For-Hire Reporting Amendment, review the amendment and provide recommendations for approval/disapproval of the amendment for Secretarial Review.

Public Hearing—Atlantic States Marine Fisheries Commission (ASMFC)—Public Information Document for the Interstate Fishery Management Plan (FMP) for Cobia, Thursday, December 8, 2016, 6 p.m.—The ASMFC will hold a public hearing in conjunction with the Council meeting to solicit comment on the Public Information Document addressing state management of Cobia. Stakeholders are asked to provide information about changes observed in the fishery and provide input on potential management measures as well as any additional issues that should be included in the draft FMP. The Public Information Document includes draft goals and objectives of the plan; commercial and recreational measures; coast-wide, regional, or state-by-state measures; and other issues.

The Full Council will convene on Friday morning with a Call to Order, announcements and introductions, and approve the September 2016 meeting minutes. The Council will present the Law Enforcement Officer of the Year award and make other presentations as appropriate.

The Council will receive a Legal Briefing on Litigation from NOAA General Counsel (if needed) during Closed Session.

The Council will receive a report from the Snapper Grouper Committee and approve/disapprove Snapper Grouper Amendment 41 (Mutton Snapper) for Secretarial review and approve Snapper Grouper Amendment 43 (red snapper), the Recreational Visioning Amendment, and the Commercial Visioning Amendment for public scoping. The Council will consider other Committee recommendations and take action as appropriate.

The Council will receive a report from the Mackerel Cobia Committee, approve/disapprove Coastal Migratory Pelagic Amendment 29 (Gulf of Mexico King Mackerel Allocations) and Coastal Migratory Pelagic Amendment 30 (Atlantic Cobia Fishing Year) for Secretarial review, consider other Committee recommendations, and take action as appropriate.

The Council will receive a report from the Data Collection Committee and approve/disapprove the Atlantic For-Hire Amendment (Electronic Reporting) for Secretarial Review, consider other committee recommendations, and take action as appropriate.

The Council will receive a report from the Joint Dolphin Wahoo/Snapper Grouper/Mackerel Cobia Committee, approve/disapprove Joint Dolphin Wahoo Amendment 10/Snapper Grouper Amendment 44 (Allocations for Dolphin and Yellowtail Snapper) for public hearings, consider other recommendations, and take action as appropriate.

The Council will continue to receive committee reports from Information & Education, Protected Resources, Advisory Panel Selection, SSC Selection, SEDAR, Habitat and Ecosystem-Based Management, Law Enforcement, Spiny Lobster, HMS, Citizen Science, and Executive Finance Committees, review recommendations and take action as appropriate.

The Council will receive status reports from NOAA Fisheries Southeast Office and the Southeast Fisheries Science Center; review and develop recommendations on Experimental Fishing Permits as necessary; receive agency and liaison reports; and discuss other business and upcoming meetings.

Documents regarding these issues are available from the Council office (see ADDRESSES).

Although non-emergency issues not contained in this agenda may come before these groups for discussion, those issues may not be the subject of formal action during these meetings. Action will be restricted to those issues specifically identified in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the Council's intent to take final action to address the emergency.

These meetings are physically accessible to people with disabilities. Requests for auxiliary aids should be directed to the Council office (see ADDRESSES) 3 days prior to the meeting.

Title of Collection: Application Forms for Financial Empowerment Partnerships.

OMB Control Number: 3170-XXXX.

Type of Review: New collection (Request for a new OMB Control Number).

Affected Public: Private Sector (e.g., community-based organizations and national non-profit organizations), State, Local, or Tribal Governments, and Federal Government.

Estimated Number of Respondents: 285.

Estimated Total Annual Burden Hours: 1,625.

Abstract: The Bureau's Office of Financial Empowerment (Empowerment) is responsible for developing strategies to improve the financial capability of low-income and economically vulnerable consumers, such as consumers who are unbanked or underbanked, those with thin or no credit file, and households with limited savings. To address the needs of these consumers, Empowerment has developed three initiatives that target intermediary organizations and provide tools, training, technical assistance, and other services to help them reach low-income and economically vulnerable consumers to provide them the financial empowerment tools and information that they need, when they need it, where they are. These initiatives: (1) Your Money, Your Goals, (2) Financial Coaching, and (3) Tax Time Savings all require Bureau to engage organizations to participate in our financial empowerment initiatives. The proposed information collection request consists of application forms that will be used by community-based organizations, local, State, or Federal government entities, and national non-profit organizations to indicate their desire and ability to participate in Empowerment's various initiatives. Empowerment will use the information provided in these applications to select the best qualified organizations for participation.

Request for Comments: The Bureau issued a 60-day Federal Register notice on August, 23, 2016, (81 FR 57569), Docket Number: CFPB-2016-0042. Comments were solicited and continue to be invited on: (a) Whether the collection of information is necessary for the proper performance of the functions of the Bureau, including whether the information will have practical utility; (b) The accuracy of the Bureau's estimate of the burden of the collection of information, including the validity of the methods and the assumptions used; (c) Ways to enhance the quality, utility, and clarity of the information to be collected; and (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. Comments submitted in response to this notice will be summarized and/or included in the request for Office of Management and Budget (OMB) approval. All comments will become a matter of public record.

The Department of the Army's notices for system of records subject to the Privacy Act of 1974 (5 U.S.C. 552a), as amended, have been published in the Federal Register and are available from the address in FOR FURTHER INFORMATION CONTACT or from the Defense Privacy, Civil Liberties, and Transparency Division Web site http://dpcld.defense.gov/.

The proposed systems reports, as required by 5 U.S.C. 552a(r) of the Privacy Act, as amended, were submitted on October 20, 2016, to the House Committee on Oversight and Government Reform, the Senate Committee on Homeland Security and Governmental Affairs, and the Office of Management and Budget (OMB) pursuant to paragraph 4 of Appendix I to OMB Circular No. A-130, “Federal Agency Responsibilities for Maintaining Records About Individuals,” revised November 28, 2000 (December 12, 2000 65 FR 77677).

Pursuant to 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), and Section 10(a), Public Law 92-463, as amended, notice is hereby given of a forthcoming meeting of the DACOWITS.

The purpose of the meeting is for the Committee to receive briefings and updates relating to their current work. The Designated Federal Officer (DFO) will open the meeting and give a status update on the Committee's requests for information. This will be followed with four panel discussions on the following topics: Integrated Boxing Programs at the Military Service Academies; the Services' Retention Initiatives; the Services' Efforts to Increase Propensity; and the Services' Sexual Harassment/Sexual Assault Training. This will be followed with a public comment period. The second day of the meeting will open with an awards ceremony to recognize departing members. The Committee will then receive a briefing update on DoD's Childcare Programs and Initiatives. This will be followed by a panel discussion on the Services' Family Care Plan Policies.

Pursuant to 41 CFR 102-3.140, and section 10(a)(3) of the Federal Advisory Committee Act of 1972, interested persons may submit a written statement for consideration by the DACOWITS. Individuals submitting a written statement must submit their statement to the point of contact listed at the address in FOR FURTHER INFORMATION CONTACT no later than 5:00 p.m., Wednesday, November 30, 2016. If a written statement is not received by Wednesday, November 30, 2016, prior to the meeting, which is the subject of this notice, then it may not be provided to or considered by the DACOWITS until its next open meeting. The DFO will review all timely submissions with the DACOWITS Chair and ensure they are provided to the members of the Committee. If members of the public are interested in making an oral statement, a written statement should be submitted. After reviewing the written comments, the Chair and the DFO will determine who of the requesting persons will be able to make an oral presentation of their issue during an open portion of this meeting or at a future meeting. Pursuant to 41 CFR 102-3.140(d), determination of who will be making an oral presentation is at the sole discretion of the Committee Chair and the DFO, and will depend on time available and if the topics are relevant to the Committee's activities. Five minutes will be allotted to persons desiring to make an oral presentation. Oral presentations by members of the public will be permitted only on Thursday, December 8, 2016 from 2:45 p.m. to 3:15 p.m. in front of the full Committee. The number of oral presentations to be made will depend on the number of requests received from members of the public.

Pursuant to 5 U.S.C. 552b and 41 CFR 102-3.140 through 102-3.165, this meeting is open to the public, subject to the availability of space.

Title, Associated Form and OMB Number: DoD Consolidations Facility Request for Records, CAF Form 3; OMB Control Number 0704-XXXX.

Type of Request: Existing Collection without an OMB Control Number.

Number of Respondents: 120.

Responses per Respondent: 1.

Annual Responses: 120.

Average Burden per Response: 5 minutes.

Annual Burden Hours: 10 hours.

Needs and Uses: The information collection requirement is necessary to ensure needed information is collected to positively identify individuals who request records regarding themselves that are maintained by the DoD Consolidated Adjudications Facility. These records will also be used in any Privacy Act appeals or related litigation. The Law Enforcement, Congressional Inquiries, Department of Justice for Litigation, National Archives and Records Administration, and Data Breach Remediation, and Routine Uses found at http://dpcld.defense.gov/Privacy/SORNsIndex/BlanketRoutineUses.aspx. The DoD Consolidated Adjudications Facility Request for Records form will also be used to refer records under the release authority of another Federal Agency.

Affected Public: Individuals or Households.

Frequency: On occasion.

Respondent's Obligation: Voluntary.

OMB Desk Officer: Ms. Jasmeet Seehra.

Comments and recommendations on the proposed information collection should be emailed to Ms. Jasmeet Seehra, DoD Desk Officer, at [email protected]. Please identify the proposed information collection by DoD Desk Officer and the Docket ID number and title of the information collection.

You may also submit comments and recommendations, identified by Docket ID number and title, by the following method:

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

Instructions: All submissions received must include the agency name, Docket ID number and title for this Federal Register document. The general policy for comments and other submissions from members of the public is to make these submissions available for public viewing on the Internet at http://www.regulations.gov as they are received without change, including any personal identifiers or contact information.

DOD Clearance Officer: Mr. Frederick Licari.

Written requests for copies of the information collection proposal should be sent to Mr. Licari at WHS/ESD Directives Division, 4800 Mark Center Drive, East Tower, Suite 03F09, Alexandria, VA 22350-3100.

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: Trends in International Mathematics and Science Study (TIMSS 2019) Field Test Recruitment and Pilot Test.

OMB Control Number: 1850-0695.

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

Respondents/Affected Public: Individuals or Households.

Total Estimated Number of Annual Responses: 8,594.

Total Estimated Number of Annual Burden Hours: 2,190.

Abstract: The Trends in Mathematics and Science Study (TIMSS) is an international assessment of fourth and eighth grade students' achievement in mathematics and science. Since its inception in 1995, TIMSS has continued to assess students every 4 years. The United States will participate in TIMSS 2019 to continue to monitor the progress of its students compared to that of other nations and to provide data on factors that may influence student achievement. New in 2019, TIMSS will be a technology-based assessment conducted in an electronic format. TIMSS is designed by the International Association for the Evaluation of Educational Achievement (IEA), and is conducted in the U.S. by the National Center for Education Statistics (NCES). In preparation for the TIMSS 2019 main study, in April 2017, U.S. will participate in a pilot study to assist in the development of eTIMSS and, in March through April 2018, in a field test to evaluate new assessment items and background questions. The TIMSS 2019 Main Study data collection will take place from April through May 2019. This submission is to conduct the TIMSS 2019 pilot test and to begin recruitment of schools, teachers, and students for the field test study. The pilot test data collection will begin in April 2017 and the recruitment for the field test in May 2017. Recruitment for the main study will begin in May of 2018 In May 2017, NCES will submit a request to conduct the 2018 field test and recruit schools for TIMSS 2019 Main 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: Integrated Postsecondary Education Data System (IPEDS) 2016-2019.

OMB Control Number: 1850-0582.

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

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

Total Estimated Number of Annual Responses: 76,000.

Total Estimated Number of Annual Burden Hours: 1,030,893.

Abstract: The National Center for Education Statistics (NCES) seeks authorization from OMB to make a change to the Integrated Postsecondary Education Data System (IPEDS) data collection. Current authorization expires 08/31/2019 (OMB #1850-0582). NCES is requesting a new clearance for the 2017-18, 2018-19, and 2019-20 data collections to enable us to make a change to two of the IPEDS data collection components and to continue the IPEDS collection of postsecondary data over the next 3 years. IPEDS is a web-based data collection system designed to collect basic data from all postsecondary institutions in the United States and the other jurisdictions. IPEDS enables NCES to report on key dimensions of postsecondary education such as enrollments, degrees and other awards earned, tuition and fees, average net price, student financial aid, graduation rates, student outcomes, revenues and expenditures, faculty salaries, and staff employed. The IPEDS web-based data collection system was implemented in 2000-01, and it collects basic data from approximately 7,500 postsecondary institutions in the United States and the other jurisdictions that are eligible to participate in Title IV Federal financial aid programs. All Title IV institutions are required to respond to IPEDS (Section 490 of the Higher Education Amendments of 1992 [Pub. L. 102-325]). IPEDS allows other (non-title IV) institutions to participate on a voluntary basis. About 200 elect to respond. IPEDS data are available to the public through the College Navigator and IPEDS Data Center Web sites. This clearance package includes a number of proposed changes to the data collection.

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: Principal Follow-Up Survey (PFS 2016-17) to the National Teacher and Principal Survey (NTPS 2015-16).

OMB Control Number: 1850-NEW.

Type of Review: A new information collection.

Respondents/Affected Public: Individuals or Households.

Total Estimated Number of Annual Responses: 7,240.

Total Estimated Number of Annual Burden Hours: 603.

Abstract: This request is to conduct data collection for the 2016-17 Principal Follow-up Survey (PFS), a one-year follow up of principals who responded to the 2015-16 National Teacher and Principal Survey (NTPS). PFS is conducted by the National Center for Education Statistics (NCES), of the Institute of Education Sciences (IES), within the U.S. Department of Education (ED). The PFS has been conducted two times previously: beginning in 2008-09 as a follow up to the Schools and Staffing Survey (SASS) in 2007-08 (OMB #1850-0598 v.5) and, subsequently, as a follow-up to SASS in 2012-2013 (OMB #1850-0598 v.9). During the 2015-16 school year, NCES conducted the first NTPS (OMB #1850-0598 v.11), a redesign of SASS to improve the flexibility, efficiency, and timeliness of NCES data on the nation's K-12 schools, principals, and teachers. The 2016-17 PFS will be the first to launch from the redesigned NTPS. The PFS survey design and content remain highly consistent with earlier administrations. The 2016-17 PFS, like earlier PFS collections, will measure the one-year attrition rates of principals who leave the profession and will permit comparisons of stayers, movers, and leavers. “Stayers” are principals who remain in the same school between the NTPS year of data collection and the follow-up year; “movers” are principals who stay in the profession but change schools between the NTPS year and the follow-up year; and “leavers” are NTPS respondents who leave the principal profession between the NTPS year and the follow-up year. The data collected in the 2016-17 PFS will be combined with data collected in the 2015-16 NTPS on principal characteristics, qualifications, and perceptions of the school environment. Together, NTPS and PFS provide national data on turnover in the principal workforce, including rates of entry and attrition from principalship, sources and characteristics of newly hired principals, and characteristics and destinations of leavers. The cross-sectional repeated design of PFS allows for analyses of trends related to these topics.

Purpose of the Committee: The Hydrogen and Fuel Cell Technical Advisory Committee (HTAC) was established under section 807 of the Energy Policy Act of 2005 (EPACT), Pub. L. 109-58; 119 Stat. 849.

Purpose of the Meeting: To provide advice and recommendations to the Secretary of Energy on the program authorized by Title VIII of EPACT.

Tentative Agenda: (updates will be posted on the web at: http://hydrogen.energy.gov/advisory_htac.html).

Public Participation: The meeting is open to the public. Individuals who would like to attend and/or to make oral statements during the public comment period must register no later than 5:00 p.m. on Monday, November 28, 2016 by email at [email protected]. Entry to the meeting room will be restricted to those who have confirmed their attendance in advance. Please provide your name, organization, citizenship, and contact information. Anyone attending the meeting will be required to present government-issued identification. Those wishing to make a public comment are required to register. The public comment period will take place between 9:00 a.m. and 9:30 a.m. on December 6, 2016. Time allotted per speaker will depend on the number who wish to speak but will not exceed five minutes. Those not able to attend the meeting or have insufficient time to address the committee are invited to send a written statement to [email protected].

Minutes: The minutes of the meeting will be available for public review at http://hydrogen.energy.gov/advisory_htac.html.

Background

Section 57b.(2) of the Atomic Energy Act of 1954, as amended (AEA), is implemented through the DOE/NNSA regulations under Title 10 of the Code of Federal Regulations (CPR) Part 810 (Part 810) governing exports of unclassified nuclear technology and assistance. On February 23, 2015, DOE/NNSA published its final rule (80 FR 9359) revising Part 810. The final rule came into effect on March 25, 2015. Before the Secretary of Energy authorizes certain transfers of civil nuclear technology and assistance, DOE/NNSA is required to consult with the Nuclear Regulatory Commission (NRC), the Department of Commerce (DOC), and the Department of Defense (DoD), and obtain the concurrence of the Department of State (DOS). These reviews are accomplished in a manner consistent with Part D of the Procedures Established Pursuant to the Nuclear Non-Proliferation Act of 1978 (the “Procedures”), as published in the Federal Register on June 7, 1978 (43 FR 25326), and amended by publication in the Federal Register on May 16, 1984 (49 FR 20780), and February 19, 1991 (56 FR 6701). This amendment addresses only Section 12 of Part D of the Procedures to implement the new requirements of Section 3136 of the NDAA, which mandates that the Director, ODNI, also be consulted with respect to each authorization under section 57b. of the AEA to a covered foreign country as defined in section 3136(i)(2) of the NDAA.

To provide for consultation with the ODNI on applications for specific authorization under section 57b.(2) of the AEA, as implemented by DOE/NNSA regulations at 10 CFR Part 810, Section 12 of Part D of the Procedures is amended as follows:

1. Within 10 days of receipt of an application for specific authorization for a transfer of technology controlled under 10 CFR Part 810, DOE/NNSA conducts a technical review of the application to determine whether the application is properly submitted and falls within the scope of the regulation.

1.a. Concurrent with the internal DOE/NNSA technical review, for packages involving covered foreign countries as defined in section 3136(i)(2) of the NDAA, DOE/NNSA sends the end user, equipment, supplier information, and any other relevant information to ODNI. ODNI notifies Intelligence Community (IC) elements of the application for transfer of technology as soon as possible.

1.b. Within 10 business days of initial notification, ODNI identifies, based on the details of the transfer application and availability, an IC point of contact (POC) to provide a response. DOE/NNSA provides ODNI with any technical reviews or assessments conducted by DOE/NNSA relevant to the technology transfer.

1.c. Within 30 business days of receiving the end user, equipment, and supplier information from DOE/NNSA, ODNI makes its coordinated response available to: DOE/NNSA; DOS; and NRC, DOC, and DoD (collectively herein referred to as the “Consulting Agencies”).

2. After the DOE/NNSA technical review is complete, with expected timelines of not more than 60 days for covered foreign countries and 30 days for other destinations, DOE/NNSA transmits through appropriate means the application and DOE/NNSA analysis to DoD, DOC, DOS, and NRC for review. Within 30 days after receipt, DOS and the Consulting Agencies provide their views on the application and analysis. If DOS or a Consulting Agency notifies DOE/NNSA NPAC in writing that additional information is required, NPAC will provide appropriate time for all Consulting Agencies to consider the application and a new time line will be established for reviews based on individual circumstances. Note that the U.S. Government, through DOS, requests foreign government assurances for specific authorizations, and it is the foreign government's control over how long it may take to deliver these assurances, which may lengthen the time line for interagency review beyond the expected 30 days.

3. Within 100 days following the completion of the interagency consultations, NPAC provides the Secretary of Energy with a recommendation for action on the application, including the views of DOS, the Consulting Agencies, and ODNI, if applicable. In the event that any such agencies recommend further consideration this timeline may be extended.

Information provided to DOE in connection with these procedures may be marked or otherwise identified as business proprietary and/or personally identifiable information and would be subject to protection in accordance with applicable law and Executive Orders. Such information would be made available within the respective agencies only to those personnel who have a need to know for the purpose of reviewing applications for exports of unclassified nuclear technology and assistance under section 57b.(2) of the Atomic Energy Act of 1954, as amended, and otherwise disclosed only with the express consent of DOE/NNSA or when such disclosure is required by law.

OMB Approval Number: 3060-0698.

Title: Section 25.203(i) and 73.1030(a)(2), Radio Astronomy Coordination Zone in Puerto Rico.

Form No: N/A.

Type of Review: Extension of a currently approved collection.

Respondents: Business or other for-profit, not-for-profit institutions, and State, local, or tribal Government.

Number of Respondents and Responses: 450 respondents, 4,000 responses.

Estimated Time per Response: 5-40 minutes (.0833 hours to .667 hours).

Frequency of Response: On occasion reporting requirement and third party disclosure requirement.

Obligation to Respond: Required to obtain or retain benefits. Statutory authority for this information collection is contained 47 U.S.C. 154(i), 303(f), 303(r), and 309(j)(13).

Total Annual Burden: 602 hours.

Total Annual Cost: No cost.

Privacy Impact Assessment: No impact(s).

Nature and Extent of Confidentiality: There is no need for confidentiality.

Needs and Uses: The Commission will submit this expiring information collection to the Office of Management and Budget (OMB) after this 60 day comment period to obtain the three-year clearance from them.

On October 15, 1997, the FCC released a Report and Order, ET Docket No. 96-2, RM-8165, FCC 97-347, that established a Coordination Zone for new and modified radio facilities in various communications services that cover the islands of Puerto Rico, Desecheo, Mona, Vieques, and Culebra within the Commonwealth of Puerto Rico. The coordination zone and notification procedures enable the Arecibo Radio Astronomy Observatory to receive information needed to assess whether an applicant's proposed operations will cause harmful interference to the Arecibo Observatory's operations, which also promotes efficient resolution of coordination problems between the applicants and the Arecibo Observatory.

OMB Control Number: 3060-XXXX.

Title: Improving Reporting for Submarine Cables and Enhanced Submarine Outage Data.

Form Number: FCC Form 5623.

Type of Review: New collection.

Respondents: Business or other for-profit.

Number of Respondents and Responses: 63 respondents; 50 responses.

Estimated Time per Response: 2 hours.

Frequency of Response: Recurring reporting requirement if reporting thresholds are met, we estimate each respondent will file 0.79 reports per year.

Obligation To Respond: Mandatory. Statutory authority for this information collection is contained in 47 U.S.C. 1, 4(j), 4(o), 34-39, 151, 154(i)-(j), 3 U.S.C. 301, and Executive Order No. 10530.

Total Annual Burden: 100 hours.

Total Annual Cost: No Cost.

Privacy Act Impact Assessment: No impact(s).

Nature and Extent of Confidentiality: Outage reports filed with the Commission pursuant to part 4 are presumed confidential. The information in those filings may be shared with the Department of Homeland Security only under appropriate confidential disclosure protections. Other persons seeking disclosure must follow the procedures delineated in 47 CFR 0.457 and 0.459 of the Commission's rules for requests for and disclosure of information. The information collection discussed here does not affect the confidential treatment of information provided to the FCC through NORS reports.

Needs and Uses: Section 151 of the Communications Act of 1934 (Act), as amended, requires the Commission to promote the safety of life and property through the use of wire and radio communications. Additionally, the Cable Landing License Act, Cable Landing License Act (47 U.S.C. 34-39), and Executive Order 10530, provide the Commission with authority to grant, withhold, condition and revoke submarine cable landing licenses. In concert, the Cable Landing License Act and Executive Order provide that the Commission may place conditions on the grant of a submarine cable landing license in order to assure just and reasonable rates and service in the operation and use of cables so licensed. “Just and reasonable service” entails assurance that the cable infrastructure will be reasonably available. Availability of submarine cables is also critically important for national security, and the economy, because submarine cables carry approximately 95 percent of international communications traffic, and are the primary means of connectivity for numerous U.S. states and territories. The data collection requires all submarine cable licensees to report outages through the network outage reporting system (NORS). The general purpose of NORS reporting is to gather sufficient information regarding disruptions to telecommunications to facilitate FCC monitoring, analysis, and investigation of the reliability and security of networks, and to identify and act on potential threats to our Nation's telecommunications infrastructure. The FCC uses this information collection to identify the duration, magnitude, root causes, contributing factors, and preventive measures taken with respect to significant outages, and to take swift remedial action as required in appropriate circumstances. The Commission also maintains an ongoing dialogue with reporting entities, as well as with the industry at large, generally regarding lessons learned from the information collection in order to foster better understanding of the root causes of significant outages, and to explore preventive measures in the future so as to mitigate the potential impact of such outages on the Nation and the American public.

The data will provide the Commission with greater visibility into the availability and health of these networks, allowing it to better track and analyze submarine cable resiliency, and suggest or take appropriate actions when the data so indicate, i.e. before there is a significant problem. Thus, the data will ensure that submarine cable service is just and reasonable, and that critical communications carried across submarine cables continue to promote the safety of life and property, fulfilling the aforementioned statutory obligations.

The NORS information collection (OMB Control No. 3060-0484) is administered by the FCC's Public Safety and Homeland Security Bureau (PSHSB), which maintains an Internet portal for the electronic submission of NORS reports. This electronic filing requirement entails entering the required information using Commission-approved Web-based outage report templates that are available online at the NORS Internet Web portal. The completion of these online templates results in the information being electronically entered into the Commission's NORS reporting data base in real-time.

Pursuant to Section 6(f) of the Federal Trade Commission Act, 15 U.S.C. 46(f), and FTC Rule 2.34, 16 CFR 2.34, notice is hereby given that the above-captioned consent agreement containing consent order to cease and desist, having been filed with and accepted, subject to final approval, by the Commission, has been placed on the public record for a period of thirty (30) days. The following Analysis to Aid Public Comment describes the terms of the consent agreement, and the allegations in the complaint. An electronic copy of the full text of the consent agreement package can be obtained from the FTC Home Page (for November 7, 2016), on the World Wide Web, at http://www.ftc.gov/os/actions.shtm.

You can file a comment online or on paper. For the Commission to consider your comment, we must receive it on or before December 7, 2016. Write “In the Matter of Valeant Pharmaceuticals International, Inc., File No. 1510236” on your comment. Your comment—including your name and your state—will be placed on the public record of this proceeding, including, to the extent practicable, on the public Commission Web site, at http://www.ftc.gov/os/publiccomments.shtm. As a matter of discretion, the Commission tries to remove individuals' home contact information from comments before placing them on the Commission Web site.

Because your comment will be made public, you are solely responsible for making sure that your comment does not include any sensitive personal information, like anyone's Social Security number, date of birth, driver's license number or other state identification number or foreign country equivalent, passport number, financial account number, or credit or debit card number. You are also solely responsible for making sure that your comment does not include any sensitive health information, like medical records or other individually identifiable health information. In addition, do not include any “[t]rade secret or any commercial or financial information which . . . is privileged or confidential,” as discussed in Section 6(f) of the FTC Act, 15 U.S.C. 46(f), and FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2). In particular, do not include competitively sensitive information such as costs, sales statistics, inventories, formulas, patterns, devices, manufacturing processes, or customer names.

If you want the Commission to give your comment confidential treatment, you must file it in paper form, with a request for confidential treatment, and you have to follow the procedure explained in FTC Rule 4.9(c), 16 CFR 4.9(c).1 Your comment will be kept confidential only if the FTC General Counsel, in his or her sole discretion, grants your request in accordance with the law and the public interest.

Postal mail addressed to the Commission is subject to delay due to heightened security screening. As a result, we encourage you to submit your comments online. To make sure that the Commission considers your online comment, you must file it at https://ftcpublic.commentworks.com/ftc/valeantparagonpelicanconsent by following the instructions on the web-based form. If this Notice appears at http://www.regulations.gov/#!home, you also may file a comment through that Web site.

If you file your comment on paper, write “In the Matter of Valeant Pharmaceuticals International, Inc., File No. 1510236” on your comment and on the envelope, and mail your comment to the following address: Federal Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue NW., Suite CC-5610 (Annex D), Washington, DC 20580, or deliver your comment to the following address: Federal Trade Commission, Office of the Secretary, Constitution Center, 400 7th Street SW., 5th Floor, Suite 5610 (Annex D), Washington, DC. If possible, submit your paper comment to the Commission by courier or overnight service.

Visit the Commission Web site at http://www.ftc.gov to read this Notice and the news release describing it. The FTC Act and other laws that the Commission administers permit the collection of public comments to consider and use in this proceeding as appropriate. The Commission will consider all timely and responsive public comments that it receives on or before December 7, 2016. You can find more information, including routine uses permitted by the Privacy Act, in the Commission's privacy policy, at http://www.ftc.gov/ftc/privacy.htm.

The Federal Trade Commission (“Commission”) has accepted for public comment an Agreement Containing Consent Order (“Consent Order”) with Valeant Pharmaceuticals International, Inc. (“Valeant”) to remedy the alleged anticompetitive effects resulting from Valeant's acquisition of Paragon Holdings I, Inc., including wholly-owned subsidiaries Paragon Vision Sciences, Inc. and CRT Technology, Inc. (“Paragon”).

The Complaint alleges that the acquisition violated Section 7 of the Clayton Act, as amended, 15 U.S.C. 18, and Section 5 of the Federal Trade Commission Act, as amended, 15 U.S.C. 45, by lessening competition in the markets for polymer discs, or “buttons,” used to make three different types of rigid gas permeable (“GP”) contact lenses: Orthokeratology contact lenses, large-diameter scleral contact lenses, and general vision correction contact lenses. The Consent Order would remedy the alleged violations by restoring competition in these GP button markets.

Under the terms of the Consent Order, Valeant is required to divest Paragon in its entirety, including the assets of Pelican Products LLC (“Pelican”), a manufacturer of contact lens packaging.

The proposed Consent Order has been placed on the public record for 30 days to solicit comments from interested persons. Comments received during this period will become part of the public record. After 30 days, the Commission will again review the proposed Consent Order and any comments received, and decide whether the Consent Order should be withdrawn, modified, or made final.

Valeant is a Canadian conglomerate that develops and markets prescription and non-prescription pharmaceutical products. Through its subsidiary Bausch + Lomb, Valeant is a leading producer of GP buttons used to make GP contact lenses. Prior to its acquisition by Valeant in May 2015, Paragon was a United States corporation with its principal place of business in Arizona. Paragon produces GP buttons used to make GP contact lenses and also produces finished GP lenses.

After the Paragon acquisition, Valeant also purchased Pelican, a manufacturer of contact lens packaging, and the only producer of FDA-approved vials for wet-shipping finished orthokeratology lenses. Pelican became a subsidiary of Paragon. This acquisition ensured Valeant's access to the vials, after Pelican's owner announced plans to exit the market.

Both parties engage in developing, manufacturing, and selling GP buttons in the United States. The relevant product markets in which to analyze the effects of the acquisition are the manufacture and sale of FDA-approved GP buttons for: Orthokeratology GP lenses, which are worn to reshape the cornea; large-diameter scleral GP lenses, which cover the white of the eye and are used post-surgery, for transplants, and to treat eye disease; and general vision correction GP lenses. Each type of GP lens requires a GP button with parameters unique to that lens type.

GP lenses are used, and in some cases are medically necessary, to address a variety of vision problems, including dry eyes, abnormal curvatures of the eye, corneal disease, post-eye surgery complications, and eye trauma. Optical labs use GP buttons to make GP contact lenses to fulfill prescriptions from eye care professionals. Prescriptions typically specify a particular product and brand of button, and eye care professionals invest significant capital in fitting equipment for the brands they prescribe.

The FDA requires that GP lenses must be made from FDA-approved GP buttons. Thus, there are no alternatives to FDA-approved GP buttons for making each of the types of GP lenses and the relevant geographic market is the United States.

Prior to the acquisition, Valeant and Paragon independently produced buttons for all three types of GP lenses. In the market for orthokeratology GP buttons, the combination of Valeant and Paragon was a merger to monopoly. In the market for scleral GP buttons, the combined company accounted for 70-80 percent of the market. In the market for general vision correction GP buttons, the combined company's market share was approximately 65-75 percent.

The acquisition likely caused significant competitive harm in the relevant markets. Specifically, the acquisition of Paragon eliminated actual, direct, and substantial competition between Valeant and Paragon in the relevant markets for GP buttons and allowed Valeant to unilaterally exercise market power. For instance, following the acquisition, Valeant increased prices in all three GP button markets.

Prior to the acquisition, Valeant and Paragon also competed on innovation, with the incentive to develop new GP lens buttons and improve button materials by investing in research, development, and adoption. This innovation led to broader product lines, improvements to button materials, and marketing and education funding for optical labs. The acquisition also eliminated this innovation competition between Valeant and Paragon.

Entry into the relevant market has not been, and would not be, timely, likely, or sufficient to deter or counteract the anticompetitive effects of the acquisition. Optical labs have limited short-term ability to switch from Valeant and Paragon, which supply the majority of their GP scleral buttons and GP general vision correction buttons, and 100 percent of their GP orthokeratology buttons. Optical labs might try to persuade eye care professionals to switch to a different material and brand, but ultimately the decision is made by the eye care professional, for whom such a change is costly and time-consuming.

Considerable entry barriers also arise from the FDA approval process. For GP orthokeratology buttons, the FDA premarket approval process takes several years because finished orthokeratology lenses worn overnight are Class III medical devices. For GP scleral and general vision buttons, the FDA premarket notification process likely requires at least one year, as the finished lenses incorporating such buttons are Class II medical devices.

We did not find any evidence of efficiencies that would outweigh the competitive concerns arising from the Paragon acquisition.

The proposed Consent Order requires Valeant to divest Paragon in its entirety no later than ten (10) days after the order date, to remedy the concerns raised by the acquisition and restore competition in the relevant markets by instituting Paragon as an independent, viable competitor to Valeant. The proposed Consent Order also requires Valeant to divest Pelican with Paragon to ensure continued access to FDA-approved vials for shipping its finished lenses.

The proposed Consent Order requires that Valeant must divest Paragon and Pelican to Paragon Companies LLC in an upfront transaction. Paragon Companies LLC is a newly created entity owned by Joe Sicari. Mr. Sicari was the president of Paragon prior to its acquisition by Valeant in May 2015.

The Commission may, at any time, appoint a Monitor with the power and authority to ensure that Valeant fulfills all obligations and responsibilities under the Consent Order and Divestiture Agreement.

The Consent Order will remain in effect for ten (10) years, and contains standard compliance and reporting requirements.

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 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) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) Enhance the quality, utility, and clarity of the information to be collected; (d) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology (e.g., permitting electronic submission of responses); and (e) Assess information collection costs. 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 use 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 be able to respond to a collection of information, search data sources, and complete and review the collection of information; and to transmit or otherwise disclose the information.

Reframing How We Talk About Alcohol: Public Perceptions of Excessive Alcohol Use and Related Harms—NEW—National Center on Birth Defects and Developmental Disabilities (NCBDD), Centers for Disease Control and Prevention (CDC).

Excessive alcohol consumption leads to a variety of negative health and social consequences. Those who drink heavily have an increased risk for certain chronic diseases, such as hypertension, psychological disorders, and various forms of cancer. Excessive alcohol use also can result in societal harms, such as unintentional injuries, violence, and high economic costs.

Fortunately effective prevention strategies are available to reduce excessive alcohol use and its related harms. However, it is difficult to craft public health messages and communication strategies to change alcohol-related attitudes and behaviors because the range of knowledge and beliefs about excessive alcohol use and its risks is not well understood. Despite the fact that public health experts recommend that alcohol screening and brief counseling be provided to adults in primary care settings, data indicate that only one of six U.S. adults reported ever discussing alcohol use with a health professional. To develop an effective, consistent messaging strategy, a deeper understanding of how the public thinks and talks about alcohol is required. The research will be used to inform the development of patient and provider materials and messages about excessive alcohol use and related harms.

The one-year study proposes a series of individual in-depth interviews and triads (small group discussions with three participants) with 54 participants identified by contractor staff and professional recruiting firms. Data will be collected through one-time, 90-minute in-depth interviews or triads. Up to 300 individuals will be screened to obtain 54 individuals who will participate in 90-minute in-depth interviews or triads. All data will be collected only one time. Respondents who will participate in these interviews and triads will be selected purposively to inform the development of a messaging strategy. Topics addressed may include alcohol and its related harms, language used when talking about alcohol, how people talk about alcohol with their health care providers, and sources of information about alcohol.

The information gathered through this data collection will allow CDC to develop an effective messaging strategy that reframes the way the public thinks and communicates about excessive alcohol use. Participation is voluntary, and there is no cost to respondents other than their time.

The total estimated annualized burden hours are 132.

Section 1813 of the Social Security Act (the Act) provides for an inpatient hospital deductible to be subtracted from the amount payable by Medicare for inpatient hospital services furnished to a beneficiary. It also provides for certain coinsurance amounts to be subtracted from the amounts payable by Medicare for inpatient hospital and extended care services. Section 1813(b)(2) of the Act requires us to determine and publish each year the amount of the inpatient hospital deductible and the hospital and extended care services coinsurance amounts applicable for services furnished in the following calendar year (CY).

Section 1813(b) of the Act prescribes the method for computing the amount of the inpatient hospital deductible. The inpatient hospital deductible is an amount equal to the inpatient hospital deductible for the preceding CY, adjusted by our best estimate of the payment-weighted average of the applicable percentage increases (as defined in section 1886(b)(3)(B) of the Act) used for updating the payment rates to hospitals for discharges in the fiscal year (FY) that begins on October 1 of the same preceding CY, and adjusted to reflect changes in real case-mix. The adjustment to reflect real case-mix is determined on the basis of the most recent case-mix data available. The amount determined under this formula is rounded to the nearest multiple of $4 (or, if midway between two multiples of $4, to the next higher multiple of $4).

Under section 1886(b)(3)(B)(i)(XX) of the Act, the percentage increase used to update the payment rates for FY 2017 for hospitals paid under the inpatient prospective payment system is the market basket percentage increase, otherwise known as the market basket update, reduced by 0.75 percentage points (see section 1886(b)(3)(B)(xii)(V) of the Act), and an adjustment based on changes in the economy-wide productivity (the multifactor productivity (MFP) adjustment) (see section 1886(b)(3)(B)(xi)(II) of the Act). Under section 1886(b)(3)(B)(viii) of the Act, for FY 2017, the applicable percentage increase for hospitals that do not submit quality data as specified by the Secretary of the Department of Health and Human Services (the Secretary) is reduced by one quarter of the market basket update. We are estimating that after accounting for those hospitals receiving the lower market basket update in the payment-weighted average update, the calculated deductible will not be affected, since the majority of hospitals submit quality data and receive the full market basket update. Section 1886(b)(3)(B)(ix) of the Act requires that any hospital that is not a meaningful electronic health record (EHR) user (as defined in section 1886(n)(3) of the Act) will have three-quarters of the market basket update reduced by 662/3 percent for FY 2016, 100 percent for FY 2017, and 100 percent for FY 2018 and each subsequent fiscal year. We are estimating that after accounting for these hospitals receiving the lower market basket update, the calculated deductible will not be affected, since the majority of hospitals are meaningful EHR users and are expected to receive the full market basket update.

Under section 1886 of the Act, the percentage increase used to update the payment rates for FY 2017 for hospitals excluded from the inpatient prospective payment system is as follows:

• The percentage increase for long term care hospitals is the market basket percentage increase reduced by 0.75 percentage points and the MFP adjustment (see sections 1886(m)(3)(A) and 1886(m)(4)(F) of the Act). In addition, these hospitals may also be impacted by the quality reporting adjustments and the site-neutral payment rates (see sections 1886(m)(5) and 1886(m)(6) of the Act).

• The percentage increase for inpatient rehabilitation facilities is the market basket percentage increase reduced by 0.75 percentage points and the MFP adjustment (see sections 1886(j)(3)(C) and 1886(j)(3)(D)(v) of the Act). In addition, these hospitals may also be impacted by the quality reporting adjustments (see section 1886(j)(7) of the Act).

• The percentage increase used to update the payment rate for inpatient psychiatric facilities is the market basket percentage increase reduced by 0.2 percentage points and the MFP adjustment (see sections 1886(s)(2)(A)(i), 1886(s)(2)(A)(ii), and 1886(s)(3)(E) of the Act). In addition, these hospitals may also be impacted by the quality reporting adjustments (see section 1886(s)(4) of the Act).

• The percentage increase for other types of hospitals excluded from the inpatient hospital prospective payment system (cancer hospitals, children's hospitals, and hospitals located outside the 50 States, the District of Columbia, and Puerto Rico) is the market basket percentage increase (see section 1886(b)(3)(B)(ii)(VIII) of the Act).

The Inpatient Prospective Payment System market basket percentage increase for FY 2017 is 2.7 percent and the MFP adjustment is −0.3 percentage point, as announced in the final rule that appeared in the Federal Register on August 22, 2016 entitled, “Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Fiscal Year 2017 Rates” (81 FR 56762). Therefore, the percentage increase for hospitals paid under the inpatient prospective payment system that submit quality data and are meaningful EHR users is 1.65 percent (that is, the FY 2017 market basket update of 2.7 percent less the MFP adjustment of 0.3 percentage point and less 0.75 percentage point). The average payment percentage increase for hospitals excluded from the inpatient prospective payment system is 2.0 percent. This average includes long term care hospitals, inpatient rehabilitation facilities, and other hospitals excluded from the inpatient hospital prospective payment system. Weighting these percentages in accordance with payment volume, our best estimate of the payment-weighted average of the increases in the payment rates for FY 2017 is 1.70 percent.

To develop the adjustment to reflect changes in real case-mix, we first calculated an average case-mix for each hospital that reflects the relative costliness of that hospital's mix of cases compared to those of other hospitals. We then computed the change in average case-mix for hospitals paid under the Medicare prospective payment system in FY 2016 compared to FY 2015. (We excluded from this calculation hospitals whose payments are not based on the inpatient prospective payment system because their payments are based on alternate prospective payment systems or reasonable costs.) We used Medicare bills from prospective payment hospitals that we received as of July 2016. These bills represent a total of about 7.4 million Medicare discharges for FY 2016 and provide the most recent case-mix data available at this time. Based on these bills, the change in average case-mix in FY 2016 is 2.61 percent. Based on these bills and past experience, we expect the overall case mix change to be 2.7 percent as the year progresses and more FY 2016 data become available.

Section 1813 of the Act requires that the inpatient hospital deductible be adjusted only by that portion of the case-mix change that is determined to be real. Real case-mix is that portion of case-mix that is due to changes in the mix of cases in the hospital and not due to coding optimization. Over the past several years, we have seen case mix increases of about 0.5 percent per year. (In some years there were larger increases in case mix due to much lower discharges for that year.) For 2016, we expect the increase in real case mix to continue to be 0.5 percent. Most of the observed FY 2016 case mix increase is likely due to artifacts of the implementation of ICD-10 which affects the calculated case mix level, but does not measure the actual increase in real case mix. Therefore, we expect that much of the change in average case-mix will not be real and estimate that this real change will be 0.5 percent.

Thus as stated above, the estimate of the payment-weighted average of the applicable percentage increases used for updating the payment rates is 1.70 percent, and the real case-mix adjustment factor for the deductible is 0.5 percent. Therefore, using the statutory formula as stated in section 1813(b) of the Act, we calculate the inpatient hospital deductible for services furnished in CY 2017 to be $1,316. This deductible amount is determined by multiplying $1,288 (the inpatient hospital deductible for CY 2016 (81 FR 56762)) by the payment-weighted average increase in the payment rates of 1.017 multiplied by the increase in real case-mix of 1.005, which equals $1,316.45 and is rounded to $1,316.

The coinsurance amounts provided for in section 1813 of the Act are defined as fixed percentages of the inpatient hospital deductible for services furnished in the same CY. The increase in the deductible generates increases in the coinsurance amounts. For inpatient hospital and extended care services furnished in CY 2017, in accordance with the fixed percentages defined in the law, the daily coinsurance for the 61st through 90th day of hospitalization in a benefit period will be $329 (one-fourth of the inpatient hospital deductible as stated in section 1813(a)(1)(A) of the Act); the daily coinsurance for lifetime reserve days will be $658 (one-half of the inpatient hospital deductible as stated in section 1813(a)(1)(B) of the Act); and the daily coinsurance for the 21st through 100th day of extended care services in a skilled nursing facility in a benefit period will be $164.50 (one-eighth of the inpatient hospital deductible as stated in section 1813(a)(3) of the Act).

Table 1 below summarizes the deductible and coinsurance amounts for CYs 2016 and 2017, as well as the number of each that is estimated to be paid.

The estimated total increase in costs to beneficiaries is about $740 million (rounded to the nearest $10 million) due to: (1) The increase in the deductible and coinsurance amounts; and (2) the increase in the number of deductibles and daily coinsurance amounts paid. We determine the increase in cost to beneficiaries by calculating the difference between the 2016 and 2017 deductible and coinsurance amounts multiplied by the estimated increase in the number of deductible and coinsurance amounts paid.

Section 1813(b)(2) of the Act requires publication of the inpatient hospital deductible and all coinsurance amounts—the hospital and extended care services coinsurance amounts—between September 1 and September 15 of the year preceding the year to which they will apply. These amounts are determined according to the statute as discussed above. As has been our custom, we use general notices, rather than notice and comment rulemaking procedures, to make the announcements. In doing so, we acknowledge that under the Administrative Procedure Act (APA), interpretive rules, general statements of policy, and rules of agency organization, procedure, or practice are excepted from the requirements of notice and comment rulemaking.

We considered publishing a proposed notice to provide a period for public comment. However, we may waive that procedure if we find good cause that prior notice and comment are impracticable, unnecessary, or contrary to the public interest. We find that the procedure for notice and comment is unnecessary here, because the formulae used to calculate the inpatient hospital deductible and hospital and extended care services coinsurance amounts are statutorily directed, and we can exercise no discretion in following the formulae. Moreover, the statute establishes the time period for which the deductible and coinsurance amounts will apply and delaying publication would be contrary to the public interest. Therefore, we find good cause to waive publication of a proposed notice and solicitation of public comments.

This document does not impose information collection requirements, that is, reporting, recordkeeping or third-party disclosure requirements. Consequently, there is no need for review by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

Section 1813(b)(2) of the Act requires the Secretary to publish, between September 1 and September 15 of each year, the amounts of the inpatient hospital deductible and hospital and extended care services coinsurance applicable for services furnished in the following CY.

We have examined the impact of this notice as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Review (January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354), section 1102(b) of the Social Security Act, section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 1995; Pub. L. 104-4), Executive Order 13132 on Federalism (August 4, 1999) and the Congressional Review Act (5 U.S.C., Part I, Ch. 8).

Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). A regulatory impact analysis (RIA) must be prepared for major notices with economically significant effects ($100 million or more in any 1 year). As stated in section IV of this notice, we estimate that the total increase in costs to beneficiaries associated with this notice is about $740 million due to: (1) The increase in the deductible and coinsurance amounts; and (2) the increase in the number of deductibles and daily coinsurance amounts paid. As a result, this notice is economically significant under section 3(f)(1) of Executive Order 12866 and is a major action under the Congressional Review Act. In accordance with the provisions of Executive Order 12866, this notice was reviewed by the Office of Management and Budget.

The RFA requires agencies to analyze options for regulatory relief of small entities, if a rule has a significant impact on a substantial number of small entities. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small governmental jurisdictions. Most hospitals and most other providers and suppliers are small entities, either by nonprofit status or by having revenues of less than $7.5 million to $38.5 million in any 1 year (for details, see the Small Business Administration's Web site at http://www.sba.gov/sites/default/files/files/Size_Standards_Table.pdf). Individuals and states are not included in the definition of a small entity. As discussed above, this annual notice announces the inpatient hospital deductible and the hospital and extended care services coinsurance amounts for services furnished in CY 2017 under Medicare's Hospital Insurance Program (Medicare Part A). As a result, we are not preparing an analysis for the RFA because the Secretary has determined that this notice will not have a significant economic impact on a substantial number of small entities.

In addition, section 1102(b) of the Social Security Act requires us to prepare a regulatory impact analysis if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 604 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a Metropolitan Statistical Area for Medicare payment regulations and has fewer than 100 beds. As discussed above, we are not preparing an analysis for section 1102(b) of the Act because the Secretary has determined that this notice will not have a significant impact on the operations of a substantial number of small rural hospitals.

Section 202 of the Unfunded Mandates Reform Act of 1995 also requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. For 2016, that threshold accounting for inflation is approximately $146 million. This notice does not impose mandates that will have a consequential effect of $146 million or more on state, local, or tribal governments or on the private sector.

Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on state and local governments, preempts state law, or otherwise has Federalism implications. Since this notice does not impose any costs on state or local governments, preempt state law, or have Federalism implications, the requirements of Executive Order 13132 are not applicable.

Part B is the voluntary portion of the Medicare program that pays all or part of the costs for physicians' services, outpatient hospital services, certain home health services, services furnished by rural health clinics, ambulatory surgical centers, comprehensive outpatient rehabilitation facilities, and certain other medical and health services not covered by Medicare Part A, Hospital Insurance. Medicare Part B is available to individuals who are entitled to Medicare Part A, as well as to U.S. residents who have attained age 65 and are citizens, and aliens who were lawfully admitted for permanent residence and have resided in the United States for 5 consecutive years. Part B requires enrollment and payment of monthly premiums, as described in 42 CFR part 407, subpart B, and part 408, respectively. The premiums paid by (or on behalf of) all enrollees fund approximately one-fourth of the total incurred costs, and transfers from the general fund of the Treasury pay approximately three-fourths of these costs.

The Secretary of the Department of Health and Human Services (the Secretary) is required by section 1839 of the Social Security Act (the Act) to announce the Part B monthly actuarial rates for aged and disabled beneficiaries as well as the monthly Part B premium. The Part B annual deductible is included because its determination is directly linked to the aged actuarial rate.

The monthly actuarial rates for aged and disabled enrollees are used to determine the correct amount of general revenue financing per beneficiary each month. These amounts, according to actuarial estimates, will equal, respectively, one-half of the expected average monthly cost of Part B for each aged enrollee (age 65 or over) and one-half of the expected average monthly cost of Part B for each disabled enrollee (under age 65).

The Part B deductible to be paid by enrollees is also announced. Prior to the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173), the Part B deductible was set in statute. After setting the 2005 deductible amount at $110, section 629 of the MMA (amending section 1833(b) of the Act) requires that the Part B deductible be indexed beginning in 2006. The inflation factor to be used each year is the annual percentage increase in the Part B actuarial rate for enrollees age 65 and over. Specifically, the 2017 Part B deductible is calculated by multiplying the 2016 deductible by the ratio of the 2017 aged actuarial rate to the 2016 aged actuarial rate. The amount determined under this formula is then rounded to the nearest $1.

The monthly Part B premium rate to be paid by aged and disabled enrollees is also announced. (Although the costs to the program per disabled enrollee are different than for the aged, the statute provides that they pay the same premium amount.) Beginning with the passage of section 203 of the Social Security Amendments of 1972 (Pub. L. 92-603), the premium rate, which was determined on a fiscal year basis, was limited to the lesser of the actuarial rate for aged enrollees, or the current monthly premium rate increased by the same percentage as the most recent general increase in monthly Title II social security benefits.

However, the passage of section 124 of the Tax Equity and Fiscal Responsibility Act of 1982 (TEFRA) (Pub. L. 97-248) suspended this premium determination process. Section 124 of TEFRA changed the premium basis to 50 percent of the monthly actuarial rate for aged enrollees (that is, 25 percent of program costs for aged enrollees). Section 606 of the Social Security Amendments of 1983 (Pub. L. 98-21), section 2302 of the Deficit Reduction Act of 1984 (DEFRA 84) (Pub. L. 98-369), section 9313 of the Consolidated Omnibus Budget Reconciliation Act of 1985 (COBRA 85) (Pub. L. 99-272), section 4080 of the Omnibus Budget Reconciliation Act of 1987 (OBRA 87) (Pub. L. 100-203), and section 6301 of the Omnibus Budget Reconciliation Act of 1989 (OBRA 89) (Pub. L. 101-239) extended the provision that the premium be based on 50 percent of the monthly actuarial rate for aged enrollees (that is, 25 percent of program costs for aged enrollees). This extension expired at the end of 1990.

The premium rate for 1991 through 1995 was legislated by section 1839(e)(1)(B) of the Act, as added by section 4301 of the Omnibus Budget Reconciliation Act of 1990 (OBRA 90) (Pub. L. 101-508). In January 1996, the premium determination basis would have reverted to the method established by the 1972 Social Security Act Amendments. However, section 13571 of the Omnibus Budget Reconciliation Act of 1993 (OBRA 93) (Pub. L. 103-66) changed the premium basis to 50 percent of the monthly actuarial rate for aged enrollees (that is, 25 percent of program costs for aged enrollees) for 1996 through 1998.

Section 4571 of the Balanced Budget Act of 1997 (BBA) (Pub. L. 105-33) permanently extended the provision that the premium be based on 50 percent of the monthly actuarial rate for aged enrollees (that is, 25 percent of program costs for aged enrollees).

The BBA included a further provision affecting the calculation of the Part B actuarial rates and premiums for 1998 through 2003. Section 4611 of the BBA modified the home health benefit payable under Part A for individuals enrolled in Part B. Under this section, beginning in 1998, expenditures for home health services not considered “post-institutional” are payable under Part B rather than Part A. However, section 4611(e)(1) of the BBA required that there be a transition from 1998 through 2002 for the aggregate amount of the expenditures transferred from Part A to Part B. Section 4611(e)(2) of the BBA also provided a specific yearly proportion for the transferred funds. The proportions were 1/6 for 1998, 1/3 for 1999, 1/2 for 2000, 2/3 for 2001, and 5/6 for 2002. For the purpose of determining the correct amount of financing from general revenues of the Federal Government, it was necessary to include only these transitional amounts in the monthly actuarial rates for both aged and disabled enrollees, rather than the total cost of the home health services being transferred.

Section 4611(e)(3) of the BBA also specified, for the purpose of determining the premium, that the monthly actuarial rate for enrollees age 65 and over be computed as though the transition would occur for 1998 through 2003 and that 1/7 of the cost be transferred in 1998, 2/7 in 1999, 3/7 in 2000, 4/7 in 2001, 5/7 in 2002, and 6/7 in 2003. Therefore, the transition period for incorporating this home health transfer into the premium was 7 years while the transition period for including these services in the actuarial rate was 6 years.

Section 811 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (Pub. L. 108-173, also known as the Medicare Modernization Act, or MMA), which amended section 1839 of the Act, requires that, starting on January 1, 2007, the Part B premium a beneficiary pays each month be based on their annual income. Specifically, if a beneficiary's “modified adjusted gross income” is greater than the legislated threshold amounts (for 2017, $85,000 for a beneficiary filing an individual income tax return, and $170,000 for a beneficiary filing a joint tax return) the beneficiary is responsible for a larger portion of the estimated total cost of Part B benefit coverage. In addition to the standard 25 percent premium, these beneficiaries now have to pay an income-related monthly adjustment amount. The MMA made no change to the actuarial rate calculation, and the standard premium, which will continue to be paid by beneficiaries whose modified adjusted gross income is below the applicable thresholds, still represents 25 percent of the estimated total cost to the program of Part B coverage for an aged enrollee. However, depending on income and tax filing status, a beneficiary can now be responsible for 35, 50, 65, or 80 percent of the estimated total cost of Part B coverage, rather than 25 percent. (For 2018 and subsequent years, the income thresholds are lower for the two highest income ranges, as a result of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) (Pub. L. 114-10).) The end result of the higher premium is that the Part B premium subsidy is reduced and less general revenue financing is required for beneficiaries with higher income because they are paying a larger share of the total cost with their premium. That is, the premium subsidy continues to be approximately 75 percent for beneficiaries with income below the applicable income thresholds, but will be reduced for beneficiaries with income above these thresholds. The MMA specified that there be a 5-year transition to full implementation of this provision. However, section 5111 of the Deficit Reduction Act of 2005 (DRA) (Pub. L. 109-171) modified the transition to a 3-year period.

Section 4732(c) of the BBA added section 1933(c) of the Act, which required the Secretary to allocate money from the Part B trust fund to the state Medicaid programs for the purpose of providing Medicare Part B premium assistance from 1998 through 2002 for the low-income Medicaid beneficiaries who qualify under section 1933 of the Act. This allocation, while not a benefit expenditure, was an expenditure of the trust fund and was included in calculating the Part B actuarial rates through 2002. For 2003 through 2015, the expenditure was made from the trust fund because the allocation was temporarily extended. However, because the extension occurred after the financing was determined, the allocation was not included in the calculation of the financing rates for these years. Section 211 of MACRA permanently extended this expenditure, which is included in the calculation of the Part B actuarial rates for 2016 and subsequent years.

Another provision affecting the calculation of the Part B premium is section 1839(f) of the Act, as amended by section 211 of the Medicare Catastrophic Coverage Act of 1988 (MCCA 88) (Pub. L. 100-360). (The Medicare Catastrophic Coverage Repeal Act of 1989 (Pub. L. 101-234) did not repeal the revisions to section 1839(f) of the Act made by MCCA 88.) Section 1839(f) of the Act, referred to as the “hold-harmless” provision, provides that if an individual is entitled to benefits under section 202 or 223 of the Act (the Old-Age and Survivors Insurance Benefit and the Disability Insurance Benefit, respectively) and has the Part B premium deducted from these benefit payments, the premium increase will be reduced, if necessary, to avoid causing a decrease in the individual's net monthly payment. This decrease in payment occurs if the increase in the individual's social security benefit due to the cost-of-living adjustment under section 215(i) of the Act is less than the increase in the premium. Specifically, the reduction in the premium amount applies if the individual is entitled to benefits under section 202 or 223 of the Act for November and December of a particular year and the individual's Part B premiums for December and the following January are deducted from the respective month's section 202 or 223 benefits. The “hold-harmless” provision does not apply to beneficiaries who are required to pay an income-related monthly adjustment amount.

A check for benefits under section 202 or 223 of the Act is received in the month following the month for which the benefits are due. The Part B premium that is deducted from a particular check is the Part B payment for the month in which the check is received. Therefore, a benefit check for November is not received until December, but has December's Part B premium deducted from it.

Generally, if a beneficiary qualifies for hold-harmless protection, the reduced premium for the individual for that January and for each of the succeeding 11 months is the greater of either—

• The monthly premium for January reduced as necessary to make the December monthly benefits, after the deduction of the Part B premium for January, at least equal to the preceding November's monthly benefits, after the deduction of the Part B premium for December; or

• The monthly premium for that individual for that December.

In determining the premium limitations under section 1839(f) of the Act, the monthly benefits to which an individual is entitled under section 202 or 223 of the Act do not include retroactive adjustments or payments and deductions on account of work. Also, once the monthly premium amount is established under section 1839(f) of the Act, it will not be changed during the year even if there are retroactive adjustments or payments and deductions on account of work that apply to the individual's monthly benefits.

Individuals who have enrolled in Part B late or who have re-enrolled after the termination of a coverage period are subject to an increased premium under section 1839(b) of the Act. The increase is a percentage of the premium and is based on the new premium rate before any reductions under section 1839(f) of the Act are made.

Section 1839 of the Act, as amended by section 601(a) of the Bipartisan Budget Act of 2015 (Pub. L. 114-74), specified that the 2016 actuarial rate for enrollees age 65 and older be determined as if the hold-harmless provision did not apply. The premium revenue that was lost by using the resulting lower premium (excluding the foregone income-related premium revenue) was replaced by a transfer of general revenue from the Treasury, which will be repaid over time to the general fund.

Starting in 2016, in order to repay the balance due (which includes the transfer amount and the foregone income-related premium revenue), the Part B premium otherwise determined will be increased by $3.00. These repayment amounts will be added to the Part B premium otherwise determined each year and paid back to the general fund of the Treasury and will continue until the balance due is paid back.

High-income enrollees pay an additional $1.20, $3.00, $4.80, or $6.60 as part of the income-related monthly adjustment amount (IRMAA) premium dollars, which reduce (dollar for dollar) the amount of general revenue received by Part B from the general fund of the Treasury. Because of this general revenue offset, the repayment IRMAA premium dollars are not included in the direct repayments made to the general fund of the Treasury from Part B in order to avoid a double repayment. (Only the $3.00 monthly repayment amounts are included in the direct repayments).

These repayment amounts will continue until the total amount collected is equal to the beginning balance due. (In the final year of the repayment, the additional amounts may be modified in order to avoid an overpayment.) The repayment amounts (excluding the repayment amounts for high-income enrollees) are subject to the hold harmless provision. The beginning balance due was $9,066,409,000, consisting of $1,625,761,000 in forgone income-related premium revenue plus a transfer amount of $7,440,648,000. It is estimated that $701,088,000 will have been collected for repayment to the general fund by the end of 2016.

The Medicare Part B monthly actuarial rates applicable for 2017 are $261.90 for enrollees age 65 and over and $254.20 for disabled enrollees under age 65. In section II.B. of this notice, we present the actuarial assumptions and bases from which these rates are derived. The Part B standard monthly premium rate for all enrollees for 2017 is $134.00.

Section 1839 of the Act requires the Secretary to determine the monthly actuarial rates, including an appropriate amount for a contingency margin, and the Part B premium each year. For 2017, the Secretary made the determination that a 13 percent target reserve ratio by the end of 2017 is appropriate and reasonable to balance both the level of premium increase necessary for the incurred expenditures and the reserve ratio. With the selected target reserve ratio, the Part B premium in 2017 is a 10 percent increase from 2016.

The following are the 2017 Part B monthly premium rates to be paid by (or on behalf of) beneficiaries who file an individual tax return (including those who are single, head of household, qualifying widow(er) with dependent child, or married filing separately who lived apart from their spouse for the entire taxable year), or a joint tax return.

In addition, the monthly premium rates to be paid by (or on behalf of) beneficiaries who are married and lived with their spouse at any time during the taxable year, but file a separate tax return from their spouse, are as follows:

The Part B annual deductible for 2017 is $183.00 for all beneficiaries.

Except where noted, the actuarial assumptions and bases used to determine the monthly actuarial rates and the monthly premium rates for Part B are established by the Centers for Medicare & Medicaid Services Office of the Actuary. The estimates underlying these determinations are prepared by actuaries meeting the qualification standards and following the actuarial standards of practice established by the Actuarial Standards Board.

Under section 1839 of the Act, the starting point for determining the standard monthly premium is the amount that would be necessary to finance Part B on an incurred basis. This is the amount of income that would be sufficient to pay for services furnished during that year (including associated administrative costs) even though payment for some of these services will not be made until after the close of the year. The portion of income required to cover benefits not paid until after the close of the year is added to the trust fund and used when needed.

The premium rates are established prospectively and are, therefore, subject to projection error. Additionally, legislation enacted after the financing was established, but effective for the period in which the financing is set, may affect program costs. As a result, the income to the program may not equal incurred costs. Therefore, trust fund assets must be maintained at a level that is adequate to cover an appropriate degree of variation between actual and projected costs, and the amount of incurred, but unpaid, expenses. Numerous factors determine what level of assets is appropriate to cover variation between actual and projected costs. The three most important of these factors are the: (1) Difference from prior years between the actual performance of the program and estimates made at the time financing was established; (2) likelihood and potential magnitude of expenditure changes resulting from enactment of legislation affecting Part B costs in a year subsequent to the establishment of financing for that year; and (3) expected relationship between incurred and cash expenditures. These factors are analyzed on an ongoing basis, as the trends can vary over time.

Table 1 summarizes the estimated actuarial status of the trust fund as of the end of the financing period for 2015 and 2016.

The monthly actuarial rate for enrollees age 65 and older is one-half of the sum of monthly amounts for: (1) The projected cost of benefits; and (2) administrative expenses for each enrollee age 65 and older, after adjustments to this sum to allow for interest earnings on assets in the trust fund and an adequate contingency margin. The contingency margin is an amount appropriate to provide for possible variation between actual and projected costs and to amortize any surplus assets or unfunded liabilities.

The monthly actuarial rate for enrollees age 65 and older for 2017 is determined by first establishing per-enrollee cost by type of service from program data through 2016 and then projecting these costs for subsequent years. The projection factors used for financing periods from January 1, 2014 through December 31, 2017 are shown in Table 2.

As indicated in Table 3, the projected per-enrollee amount required to pay for one-half of the total of benefits and administrative costs for enrollees age 65 and over for 2017 is $238.61. Based on current estimates, the assets associated with the aged Medicare beneficiaries at the end of 2016 are not sufficient to cover the amount of incurred, but unpaid, expenses and to provide for a significant degree of variation between actual and projected costs. Thus, a positive contingency margin is needed. The monthly actuarial rate of $261.90 provides an adjustment of $25.07 for a contingency margin and −$1.78 for interest earnings.

The contingency margin for 2017 is affected by several factors. As noted previously, for most Part B beneficiaries the hold-harmless provision prevents their benefits under Section 202 or 223 of the Act from decreasing as a result of an increase in the Part B premium. For 2016, social security benefits received no cost-of-living adjustment and therefore the majority of Part B enrollees were held harmless and paid a premium of $104.90, rather than the 2016 premium of $121.80. On October 18, 2016, the Social Security Administration announced that the increase in the benefits under Section 202 and 223 of the Act will be 0.3 percent for 2017. As a result, the average 2017 social security benefit increase will be about $4.00 and the average 2017 premium paid by Part B enrollees who are held harmless will be about $109.00. Consequently, a minority of Part B enrollees will pay (or have paid on their behalf) a larger-than-normal premium, resulting from an increased contingency margin. The Part B premium of $134.00 for 2017 will be paid by (or on behalf of) approximately 30 percent of beneficiaries (those not subject to the hold-harmless provision). (As noted previously, individuals with higher incomes would not be held harmless and would pay a 2017 premium that is higher than $134.00.)

Two other factors affect the contingency margin for 2017. Starting in 2011, manufacturers and importers of brand-name prescription drugs have paid a fee that is allocated to the Part B account of the SMI trust. For 2017, the total of these brand-name drug fees is estimated to be $3.9 billion. The contingency margin has been reduced to account for this additional revenue.

Another factor impacting the contingency margin comes from the requirement that certain payment incentives, to encourage the development and use of health information technology (HIT) by Medicare physicians, are to be excluded from the premium determination. HIT positive incentive payments or penalties will be directly offset through transfers with the general fund of the Treasury. The monthly actuarial rate includes an adjustment of −$0.13 for HIT incentive payments in 2017.

The traditional goal for the Part B reserve has been that assets minus liabilities at the end of a year should represent between 15 and 20 percent of the following year's total incurred expenditures. To accomplish this goal, a 17 percent reserve ratio has been the normal target used to calculate the Part B premium. The Secretary, who determines the Part B premium each year under section 1839 of the Act, directed the Office of the Actuary to use a target reserve ratio for the Part B premium determination of 13 percent by the end of 2017. This targets a 2017 reserve ratio that is lower than the reserve ratio expected for the end of 2016. The Office of the Actuary has estimated that a target reserve ratio of 14 percent is the minimally financially adequate level for the Part B premium determination. The target reserve ratio of 13 percent is below this level resulting in a non-trivial risk of Part B income and trust fund assets being inadequate to cover Part B costs, which would occur if experience is significantly worse than current estimates. Financing rates in future years will likely need to be increased to restore the contingency reserve to an adequate level.

The actuarial rate of $261.90 per month for aged beneficiaries, as announced in this notice for 2017, reflects that combined effect of the factors previously described and the projected assumptions listed in Table 2.

Disabled enrollees are those persons under age 65 who are enrolled in Part B because of entitlement to Social Security disability benefits for more than 24 months or because of entitlement to Medicare under the end-stage renal disease (ESRD) program. Projected monthly costs for disabled enrollees (other than those with ESRD) are prepared in a fashion parallel to the projection for the aged using appropriate actuarial assumptions (see Table 2). Costs for the ESRD program are projected differently because of the different nature of services offered by the program.

As shown in Table 4, the projected per-enrollee amount required to pay for one-half of the total of benefits and administrative costs for disabled enrollees for 2017 is $285.21. The monthly actuarial rate of $254.20 also provides an adjustment of −$2.67 for interest earnings and −$28.34 for a contingency margin, reflecting the same factors described previously for the aged actuarial rate at magnitudes appropriate to the disabled rate determination. Based on current estimates, the assets associated with the disabled Medicare beneficiaries at the end of 2016 are more-than sufficient to cover the amount of incurred, but unpaid, expenses and to provide for a significant degree of variation between actual and projected costs. Thus, a negative contingency margin is needed to decrease assets to an appropriate level.

The actuarial rate of $254.20 per month for disabled beneficiaries, as announced in this notice for 2017, reflects the combined net effect of the factors described previously for aged beneficiaries and the projection assumptions listed in Table 2.

Several factors contribute to uncertainty about future trends in medical care costs. It is appropriate to test the adequacy of the rates using alternative cost growth rate assumptions. The results of those assumptions are shown in Table 5. One set represents increases that are higher and, therefore, more pessimistic than the current estimate. The other set represents increases that are lower and, therefore, more optimistic than the current estimate. The values for the alternative assumptions were determined from a statistical analysis of the historical variation in the respective increase factors.

As indicated in Table 5, the monthly actuarial rates would result in an excess of assets over liabilities of $45,497 million by the end of December 2017 under the cost growth rate assumptions shown in Table 2 and assuming that the provisions of current law are fully implemented. This amounts to 13.7 percent of the estimated total incurred expenditures for the following year.

Assumptions that are somewhat more pessimistic (and that therefore test the adequacy of the assets to accommodate projection errors) produce a surplus of −$1,387 million by the end of December 2017 under current law, which amounts to −0.4 percent of the estimated total incurred expenditures for the following year. Under fairly optimistic assumptions, the monthly actuarial rates would result in a surplus of $89,869 million by the end of December 2017, or 31.0 percent of the estimated total incurred expenditures for the following year.

The sensitivity analysis indicates that the premium and general revenue financing established for 2017, together with existing Part B account assets would not be adequate to cover estimated Part B costs for 2017 under current law if actual costs prove to be somewhat greater than expected.

As determined in accordance with section 1839 of the Act, listed are the 2017 Part B monthly premium rates to be paid by beneficiaries who file an individual tax return (including those who are single, head of household, qualifying widow(er) with dependent child, or married filing separately who lived apart from their spouse for the entire taxable year), or a joint tax return.

In addition, the monthly premium rates to be paid by beneficiaries who are married and lived with their spouse at any time during the taxable year, but file a separate tax return from their spouse, are listed as follows:

Section 1818 of the Social Security Act (the Act) provides for voluntary enrollment in the Medicare Hospital Insurance Program (Medicare Part A), subject to payment of a monthly premium, of certain persons aged 65 and older who are uninsured under the Old-Age, Survivors, and Disability Insurance (OASDI) program or the Railroad Retirement Act and do not otherwise meet the requirements for entitlement to Medicare Part A. These “uninsured aged” individuals are uninsured under the OASDI program or the Railroad Retirement Act, because they do not have 40 quarters of coverage under Title II of the Act (or are/were not married to someone who did). (Persons insured under the OASDI program or the Railroad Retirement Act and certain others do not have to pay premiums for Medicare Part A.)

Section 1818A of the Act provides for voluntary enrollment in Medicare Part A, subject to payment of a monthly premium for certain disabled individuals who have exhausted other entitlement. These are individuals who were entitled to coverage due to a disabling impairment under section 226(b) of the Act, but who are no longer entitled to disability benefits and free Medicare Part A coverage because they have gone back to work and their earnings exceed the statutorily defined “substantial gainful activity” amount (section 223(d)(4) of the Act).

Section 1818A(d)(2) of the Act specifies that the provisions relating to premiums under section 1818(d) through section 1818(f) of the Act for the aged will also apply to certain disabled individuals as described above.

Section 1818(d)(1) of the Act requires us to estimate, on an average per capita basis, the amount to be paid from the Federal Hospital Insurance Trust Fund for services incurred in the upcoming calendar year (CY) (including the associated administrative costs) on behalf of individuals aged 65 and over who will be entitled to benefits under Medicare Part A. We must then determine the monthly actuarial rate for the following year (the per capita amount estimated above divided by 12) and publish the dollar amount for the monthly premium in the succeeding CY. If the premium is not a multiple of $1, the premium is rounded to the nearest multiple of $1 (or, if it is a multiple of 50 cents but not of $1, it is rounded to the next highest $1).

Section 13508 of the Omnibus Budget Reconciliation Act of 1993 (Pub. L. 103-66) amended section 1818(d) of the Act to provide for a reduction in the premium amount for certain voluntary enrollees (section 1818 and section 1818A of the Act). The reduction applies to an individual who is eligible to buy into the Medicare Part A program and who, as of the last day of the previous month:

• Had at least 30 quarters of coverage under Title II of the Act;

• Was married, and had been married for the previous 1-year period, to a person who had at least 30 quarters of coverage;

• Had been married to a person for at least 1 year at the time of the person's death if, at the time of death, the person had at least 30 quarters of coverage; or

• Is divorced from a person and had been married to the person for at least 10 years at the time of the divorce if, at the time of the divorce, the person had at least 30 quarters of coverage.

Section 1818(d)(4)(A) of the Act specifies that the premium that these individuals will pay for CY 2017 will be equal to the premium for uninsured aged enrollees reduced by 45 percent.

The monthly premium for the uninsured aged and certain disabled individuals who have exhausted other entitlement for the 12 months beginning January 1, 2017, is $413.

The monthly premium for the individuals eligible under section 1818(d)(4)(B) of the Act, and therefore, subject to the 45 percent reduction in the monthly premium, is $227.

As discussed in section I of this notice, the monthly Medicare Part A premium is equal to the estimated monthly actuarial rate for CY 2017 rounded to the nearest multiple of $1 and equals one-twelfth of the average per capita amount, which is determined by projecting the number of Medicare Part A enrollees aged 65 years and over as well as the benefits and administrative costs that will be incurred on their behalf.

The steps involved in projecting these future costs to the Federal Hospital Insurance Trust Fund are:

• Establishing the present cost of services furnished to beneficiaries, by type of service, to serve as a projection base;

• Projecting increases in payment amounts for each of the service types; and

• Projecting increases in administrative costs.

We base our projections for CY 2017 on—(1) current historical data; and (2) projection assumptions derived from current law and the Mid-Session Review of the President's Fiscal Year 2017 Budget.

We estimate that in CY 2017, 48,634,512 people aged 65 years and over will be entitled to (enrolled in) benefits (without premium payment) and that they will incur about $240.891 billion in benefits and related administrative costs. Thus, the estimated monthly average per capita amount is $412.76 and the monthly premium is $413. Subsequently, the full monthly premium reduced by 45 percent is $227.

The CY 2017 premium of $413 is approximately 0.5 percent higher than the CY 2016 premium of $411. We estimate that approximately 654,000 enrollees will voluntarily enroll in Medicare Part A, by paying the full premium. Note that states pay Part A premiums for persons who are enrolled in the Qualified Medicare Beneficiary Program (a Medicaid program which helps certain low-income individuals with Medicare premium and cost-sharing liability). Furthermore, the CY 2017 reduced premium of $227 is approximately 0.5 percent higher than the CY 2016 premium of $226. We estimate an additional 67,000 enrollees will pay the reduced premium. Therefore, we estimate that the total aggregate cost to enrollees paying these premiums in CY 2017, compared to the amount that they paid in CY 2016, will be about $17 million.

We use general notices, rather than notice and comment rulemaking procedures, to make announcements such as this premium notice. In doing so, we acknowledge that, under the Administrative Procedure Act (APA), interpretive rules, general statements of policy, and rules of agency organization, procedure, or practice are excepted from the requirements of notice and comment rulemaking. The agency may also waive notice and comment if there is “good cause,” as defined by the statute. We considered publishing a proposed notice to provide a period for public comment. However, under the APA, we may waive that procedure if we find good cause that prior notice and comment are impracticable, unnecessary, or contrary to the public interest.

We are not using notice and comment rulemaking in this notification of Medicare Part A premiums for CY 2017 as that procedure is unnecessary because of the lack of discretion in the statutory formula that is used to calculate the premium and the solely ministerial function that this notice serves. The APA permits agencies to waive notice and comment rulemaking when notice and public comment thereon are unnecessary. On this basis, we waive publication of a proposed notice and a solicitation of public comments.

This document does not impose information collection requirements, that is, reporting, recordkeeping or third-party disclosure requirements. Consequently, there is no need for review by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

Section 1818(d) of the Act requires the Secretary of the Department of Health and Human Services (the Secretary) during September of each year to determine and publish the amount to be paid, on an average per capita basis, from the Federal Hospital Insurance Trust Fund for services incurred in the impending CY (including the associated administrative costs) on behalf of individuals aged 65 and over who will be entitled to benefits under Medicare Part A.

We have examined the impact of this notice as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Review (January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354), section 1102(b) of the Social Security Act, section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 1995; Pub. L. 104-4), Executive Order 13132 on Federalism (August 4, 1999) and the Congressional Review Act (5 U.S.C. Part I, Ch. 8).

Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). A regulatory impact analysis (RIA) must be prepared for major notices with economically significant effects ($100 million or more in any 1 year). As stated in section IV of this notice, we estimate that the overall effect of the changes in the Part A premium will be a cost to voluntary enrollees (section 1818 and section 1818A of the Act) of about $17 million. As a result, this notice is non-economically significant under section 3(f)(1) of Executive Order 12866 and is not a major action under the Congressional Review Act. In accordance with the provisions of Executive Order 12866, this notice was reviewed by the Office of Management and Budget.

The RFA requires agencies to analyze options for regulatory relief of small entities, if a rule has a significant impact on a substantial number of small entities. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small governmental jurisdictions. Most hospitals and most other providers and suppliers are small entities, either by nonprofit status or by having revenues of less than $7.5 million to $38.5 million in any 1 year (for details, see the Small Business Administration's Web site at http://www.sba.gov/sites/default/files/files/Size_Standards_Table.pdf).

Individuals and states are not included in the definition of a small entity. As discussed above, this annual notice announces Medicare's Hospital Insurance (Part A) premium for uninsured enrollees in CY 2017. As a result, we are not preparing an analysis for the RFA because the Secretary has determined that this notice will not have a significant economic impact on a substantial number of small entities.

In addition, section 1102(b) of the Social Security Act requires us to prepare a regulatory impact analysis if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 604 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a Metropolitan Statistical Area for Medicare payment regulations and has fewer than 100 beds. As discussed above, we are not preparing an analysis for section 1102(b) of the Act, because the Secretary has determined that this notice will not have a significant impact on the operations of a substantial number of small rural hospitals.

Section 202 of the Unfunded Mandates Reform Act of 1995 also requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. In 2016, that threshold is approximately $146 million. This notice does not impose mandates that will have a consequential effect of $146 million or more on state, local, or tribal governments or on the private sector.

Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on state and local governments, preempts state law, or otherwise has Federalism implications. Since this notice does not impose any costs on state or local governments, the requirements of Executive Order 13132 are not applicable.

Section 306(a)(2)(B) of the FD&C Act (21 U.S.C. 335a(a)(2)(B)) requires debarment of an individual if FDA finds that the individual has been convicted of a felony under Federal law for conduct relating to the regulation of any drug product under the FD&C Act. On July 31, 2015, the U.S. District Court for the Eastern District of California entered judgment against Dr. Singh for one count of mail fraud, in violation of 18 U.S.C. 1341.

FDA's finding that the debarment is appropriate is based on the felony conviction referenced herein. The factual basis for this conviction is as follows: Dr. Singh was the President and Secretary of Paul S. Singh, DO, Inc., and provided obstetric and gynecological services to women. Beginning on or about May 2008, and continuing to at least on or about June 2012, within the Eastern District of California and elsewhere, Dr. Singh devised a scheme and artifice to defraud health care benefit programs, patients, and others of money and property by means of materially false and fraudulent pretenses, representations, and promises.

During the time period described, Dr. Singh provided his patients forms of birth control, including the insertion of an intrauterine device (“IUD”). IUDs are regulated by FDA. At the relevant time, FDA had only approved one IUD, which used copper as its active ingredient, the ParaGard T-380A IUD. ParaGard T-380A was sold only by its manufacturer and was not available on third-party Web sites.

The insertion of a non-FDA approved copper IUD risks a patient's health and safety. Dr. Singh knew of this risk and knew that inserting a non-FDA approved copper IUD was prohibited by FDA. Despite this, Dr. Singh obtained non-FDA approved copper IUDs by purchasing them on the Internet and inserted them in his patients. Dr. Singh failed to inform his patients that he had inserted a non-FDA approved copper IUD, and none of his patients consented to the insertion of one. On or about August 17, 2010, FDA agents met with Dr. Singh and warned him that he could not insert non-FDA approved copper IUDs, and he agreed that he would stop doing so. Notwithstanding this warning, Dr. Singh continued to insert non-FDA approved copper IUDs in his patients and falsely claimed to his patients that he was inserting FDA-approved copper IUDs.

Dr. Singh billed at least 10 different health care benefit programs for payment for the insertion of non-FDA approved copper IUDs in his patients. In submitting these claims, Dr. Singh knowingly misrepresented the type of IUD he had inserted. Dr. Singh caused the U.S. mails to be used to carry out an essential part of his scheme. At all relevant times, Dr. Singh acted with the intent to defraud. As a result of Dr. Singh's conduct, he made false claims of over $83,000 to health care benefit programs, his patients, and others.

As a result of this conviction, FDA sent Dr. Singh by certified mail on August 17, 2016, a notice proposing to permanently debar him from providing services in any capacity to a person that has an approved or pending drug product application. The proposal was based on a finding, under section 306(a)(2)(B) of the FD&C Act, that Dr. Singh was convicted of a felony under Federal law for conduct relating to the regulation of a drug product under the FD&C Act. FDA determined that Dr. Singh's felony conviction was related to the regulation of drug products because the conduct underlying his conviction undermined FDA's regulatory oversight over drug products marketed in the United States—it involved using and misrepresenting as approved unapproved IUDs that presented health risks to patients. The proposal also offered Dr. Singh an opportunity to request a hearing, providing him 30 days from the date of receipt of the letter in which to file the request, and advised him that failure to request a hearing constituted a waiver of the opportunity for a hearing and of any contentions concerning this action. The proposal was received on August 23, 2016. Dr. Singh did not request a hearing and has, therefore, waived his opportunity for a hearing and any contentions concerning his debarment (21 CFR part 12).

Therefore, the Director, Office of Enforcement and Import Operations, Office of Regulatory Affairs, under sections 306(a)(2)(B) of the FD&C Act, under authority delegated to him (Staff Manual Guide 1410.35), finds that Paul S. Singh has been convicted of a felony under Federal law for conduct relating to the regulation of a drug product under the FD&C Act. Section 306(c)(2)(A)(ii) of the FD&C Act requires that Dr. Singh's debarment be permanent.

As a result of the foregoing finding, Paul S. Singh is permanently debarred from providing services in any capacity to a person with an approved or pending drug product application under sections 505, 512, or 802 of the FD&C Act (21 U.S.C. 355, 360b, or 382), or under section 351 of the Public Health Service Act (42 U.S.C. 262), effective (see DATES) (see sections 201(dd) (21 U.S.C. 321(dd)), 306(c)(1)(B), and 306(c)(2)(A)(ii) of the FD&C Act). Any person with an approved or pending drug product application who knowingly employs or retains as a consultant or contractor, or otherwise uses the services of Paul S. Singh, in any capacity during his debarment, will be subject to civil money penalties (section 307(a)(6) of the FD&C Act (21 U.S.C. 335b(a)(6))). If Dr. Singh provides services in any capacity to a person with an approved or pending drug product application during his period of debarment he will be subject to civil money penalties (section 307(a)(7) of the FD&C Act). In addition, FDA will not accept or review any abbreviated new drug applications from Paul S. Singh during his period of debarment (section 306(c)(1)(B) of the FD&C Act).

Any application by Dr. Singh for special termination of debarment under section 306(d)(4) of the FD&C Act should be identified with Docket No. FDA-2016-N-1311 and sent to the Division of Dockets Management (see ADDRESSES). All such submissions are to be filed in four copies. The public availability of information in these submissions is governed by 21 CFR 10.20.

Publicly available submissions will be placed in the docket, and will be viewable at http://www.regulations.gov or at the Division of Dockets Management (see ADDRESSES) between 9 a.m. and 4 p.m., Monday through Friday.

Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

The 2009 Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (Pub. L. 111-31) amends the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to grant FDA authority to regulate the manufacture, marketing, and distribution of tobacco products to protect public health and to reduce tobacco use by minors. Section 1003(d)(2)(D) of the FD&C Act (21 U.S.C. 393(d)(2)(D)) supports the development and implementation of FDA public education campaigns related to tobacco use. Accordingly, FDA is currently developing and implementing a tobacco education intervention at the point of sale to reduce the public health burden of tobacco use. The campaign features advertisements intended to encourage future quit attempts among current smokers in stores that sell tobacco products.

In support of the provisions of the Tobacco Control Act that require FDA to protect the public health, FDA requests OMB approval to collect information to evaluate the effectiveness of the point of sale tobacco education campaign. Data from this outcome evaluation study will be used to examine statistical associations between exposure to the campaign and specific outcomes of interest, which include awareness of the campaign and its messaging, campaign-related attitudes, beliefs and risk perceptions, motivation to quit smoking, self-efficacy for quitting, and increased intention to quit.

Evaluation is an essential organizational practice in public health and a systematic way to account for and improve public health actions. Comprehensive evaluation of FDA's public education campaigns will be used to document whether the intended audience is aware of and understands campaign messages, and whether campaign exposure influences campaign-related attitudes, beliefs and risk perceptions, motivation to quit smoking, self-efficacy for quitting, and increased intention to quit. All of the information collected is integral to that evaluation.

Evaluation of the Point of Sale Campaign. This outcome evaluation study will consist of three longitudinal data collection periods each lasting 3-4 months at 4 month intervals between data collection periods, with the first survey (Wave 1) occurring 3 months after campaign launch. Information will be collected from adult smokers, ages 25 to 54, about awareness of and exposure to campaign advertisements, tobacco use, and knowledge, attitudes, and beliefs related to tobacco use. Information will be collected on demographic variables including age, sex, race/ethnicity, and primary language. Participants will also be offered the option to download a smartphone application that will track their exposure to the campaign, and that will ask them to respond to a brief survey about every six months over the 18 month study period.

FDA's media contractor has identified 52 potential counties for the campaign. From this list, FDA's evaluation contractor will randomly select 36 counties to be included in the evaluation. Of these, 24 counties will receive the intervention, while 12 counties will not receive it (control counties).

Data will be collected from a longitudinal cohort that will consist of an entirely new sample of adult cigarette smokers. Addresses will be randomly selected from a predetermined list of U.S. counties and merged with household data on age and demographic characteristics commonly associated with smoking status in order to identify households that are likely to contain one or more adult smokers between the ages of 25 and 54. Pre-paid pre-addressed paper screening surveys will be mailed to approximately 71,875 (23,958 annualized) households that meet this criteria. For the purpose of calculating maximum burden, we assume that all 71,875 (23,958 annualized) households will be screened in one of two ways: (1) When an adult member of the household completes and returns the 10-minute screener they received by mail, or (2) during a 10 minute in-person screening interview conducted by trained field interviewers who visit all the addresses that do not return the screener. At 10 minutes per screening, the maximum potential burden hours for the mail screener is 12,219 (4,073 annualized).

Accounting for nonresponse, we estimate that the mail and in-person screenings will result in 5,750 (1,917 annualized) adults who meet criteria for participation and complete the full Wave 1 survey. The Wave 1 survey will be completed during an in-person visit to the home, either as a stand-alone visit (for households that returned the mail screener) or immediately after the in-person screening is completed (for households that did not return the mail screener). We estimate that the Wave 1 survey will take 40 minutes to complete, resulting in 3,853 (1,284 annualized) burden hours. Adjusting for loss to follow-up between waves, we anticipate that 4,600 (1,533 annualized) participants will complete the Wave 2 survey, which will take 40 minutes and result in 3,082 (1,027 annualized) burden hours, and that 3,772 (1,257 annualized) participants will complete the Wave 3 survey, which will take 40 minutes and result in 2,527 (842 annualized) burden hours. Both the Wave 2 and 3 surveys will also be administered in person by trained interviewers. The total burden hours for all three in-person surveys will be 9,462 (3,154 annualized).

We anticipate that approximately 2/3 of the participants (3,833 people [1,278 annualized]) who complete the Wave 1 survey will download a smartphone application that will deliver additional surveys to them starting one month after the end of the first data collection. These participants will complete 3 surveys lasting 5 minutes each (every 6 months over the course of 18 months), resulting in 307 (102 annualized) burden hours per app-based survey and 921 (307 annualized) burden hours total for all of the app-based surveys. The total burden hours for the screener, 3 in-person surveys, and 3 app-based surveys is 22,600 (7,533 annualized).

Section 306(a)(2)(A) of the FD&C Act (21 U.S.C. 335a(a)(2)(A)) requires debarment of an individual if FDA finds that the individual has been convicted of a felony under Federal law for conduct relating to the development or approval, including the process for development or approval, of any drug product. Section 306(a)(2)(B) of the FD&C Act requires debarment of an individual if FDA finds that the individual has been convicted of a felony under Federal law for conduct otherwise relating to the regulation of any drug product under the FD&C Act.

On October 27, 2015, the U.S. District Court for the Eastern District of Washington entered judgment against Mr. Smith for one count of conspiracy, in violation of 18 U.S.C. 371, three counts of introducing misbranded drugs into interstate commerce with intent to defraud or mislead, in violation of section 301(a) of the FD&C Act (21 U.S.C. 331(a)), which according to section 303(a)(2) of the FD&C Act (21 U.S.C. 333(a)(2)) constitutes a felony, and one count of smuggling in violation of 18 U.S.C. 545.

The factual basis for this conviction is as follows: Mr. Smith was a managing member of PGL International, LLC (PGL), and served as the director of PGL's operations. PGL is a Nevada corporation, which marketed and sold various health-related products, including Miracle Mineral Solution (MMS), a mixture of sodium chlorite and water. Sodium chlorite is an industrial chemical used as a pesticide and for hydraulic fracking and wastewater treatment. Sodium chlorite cannot be sold for human consumption and suppliers of the chemical include a warning sheet stating that it can cause potentially fatal side effects if swallowed. Mr. Smith obtained chemicals needed to manufacture the misbranded drug MMS without revealing to regulators and suppliers the true purpose of the chemicals; used those chemicals to manufacture the misbranded drug MMS in a facility that was not disclosed to regulators; offered the misbranded drug MMS for sale on Web sites Mr. Smith had established; and sold that drug in interstate commerce.

From on or about September 11, 2004, to at least on or about July 16, 2012, in the Eastern District of Washington and elsewhere, Mr. Smith introduced, delivered for introduction into interstate commerce, and caused the introduction and delivery for introduction into interstate commerce, with the intent to defraud or mislead, misbranded drugs. In addition, he knowingly defrauded the United States and also impeded the lawful government functions of FDA, specifically, FDA's duty to protect the health and safety of the public by, among other things, ensuring that drugs marketed in the United States are safe and effective for their intended uses and are manufactured in establishments that are registered with FDA, and that the labeling of such drugs bears true and accurate information.

As a result of this conviction, FDA sent Mr. Smith by certified mail on August 5, 2016, a notice proposing to permanently debar him from providing services in any capacity to a person that has an approved or pending drug product application. The proposal was based on a finding, under section 306(a)(2) of the FD&C Act, that Mr. Smith was convicted of felonies under Federal law for conduct relating to the development or approval, including the process for development or approval, of a drug product, or conduct otherwise relating to the regulation of a drug product under the FD&C Act. The proposal also offered Mr. Smith an opportunity to request a hearing, providing him 30 days from the date of receipt of the letter in which to file the request, and advised him that failure to request a hearing constituted a waiver of the opportunity for a hearing and of any contentions concerning this action. Mr. Smith received the proposal on August 8, 2016. Mr. Smith did not request a hearing and has, therefore, waived his opportunity for a hearing and any contentions concerning his debarment (21 CFR part 12).

Therefore, the Director, Office of Enforcement and Import Operations, Office of Regulatory Affairs, under section 306(a)(2) of the FD&C Act, under authority delegated to him (Staff Manual Guide 1410.35), finds that Louis Daniel Smith has been convicted of felonies under Federal law for conduct relating to the development or approval, including the process for development or approval, of a drug product, or conduct otherwise relating to the regulation of a drug product under the FD&C Act.

As a result of the foregoing finding, Louis Daniel Smith is permanently debarred from providing services in any capacity to a person with an approved or pending drug product application under sections 505, 512, or 802 of the FD&C Act (21 U.S.C. 355, 360b, or 382), or under section 351 of the Public Health Service Act (42 U.S.C. 262), effective (see DATES) (see section 201(dd) (21 U.S.C. 321(dd)), 306(c)(1)(B), and 306(c)(2)(A)(ii) of the FD&C Act). Any person with an approved or pending drug product application who knowingly employs or retains as a consultant or contractor, or otherwise uses the services of Louis Daniel Smith, in any capacity during his debarment, will be subject to civil money penalties (section 307(a)(6) of the FD&C Act (21 U.S.C. 335b(a)(6))). If Mr. Smith provides services in any capacity to a person with an approved or pending drug product application during his period of debarment he will be subject to civil money penalties (section 307(a)(7) of the FD&C Act). In addition, FDA will not accept or review any abbreviated new drug applications from Mr. Smith during his period of debarment (section 306(c)(1)(B) of the FD&C Act).

Any application by Mr. Smith for special termination of debarment under section 306(d)(4) of the FD&C Act should be identified with Docket No. FDA-2016-N-1162 and sent to the Division of Dockets Management (see ADDRESSES). All such submissions are to be filed in four copies. The public availability of information in these submissions is governed by 21 CFR 10.20.

Publicly available submissions will be placed in the docket, and will be viewable at http://www.regulations.gov or at the Division of Dockets Management (see ADDRESSES) between 9 a.m. and 4 p.m., Monday through Friday.

Technology descriptions follow.

Available for nonexclusive licensing for research uses is the cell line, SV-k1, derived from the Organ of Corti. The line was developed from the stria vascularis, an organ localized on the lateral wall of the cochlea, adjacent to the Organ of Corti, containing cell populations specialized in the production of an endolymph very rich in K+ characteristic of the mammalian inner ear. SV-k1 cells express a set of biomarkers completely different of those expressed by OC-k3 cells (See notice for E-012-2017/0 published contemporaneously herewith), and are not sensitive to ototoxic drugs.

• Research

• Hearing research

• Materials

HHS Reference No. E-013-2017/0—Research Material.

Michael Shmilovich, Esq, CLP; 301-435-5019; [email protected].

The Advisory Council on Historic Preservation (ACHP) is an independent federal agency that promotes the preservation, enhancement, and sustainable use of our nation's diverse historic resources, and advises the President and the Congress on national historic preservation policy. The goal of the National Historic Preservation Act (NHPA), which established the ACHP in 1966, is to have federal agencies act as responsible stewards of our nation's resources when their actions affect historic properties. The ACHP is the only entity with the legal responsibility to encourage federal agencies to factor historic preservation into federal project requirements. For more information on the ACHP, please visit our Web site at www.achp.gov.

The agenda for the upcoming quarterly meeting of the ACHP is the following:

The meetings of the ACHP are open to the public. If you need special accommodations due to a disability, please contact Cindy Bienvenue, 202-517-0202 or [email protected], at least seven (7) days prior to the meeting.

This Notice relies on the authority of the Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended. An ICR is an application to OIRA seeking the approval, extension, or renewal of a Coast Guard collection of information (Collection). The ICR contains information describing the Collection's purpose, the Collection's likely burden on the affected public, an explanation of the necessity of the Collection, and other important information describing the Collection. There is one ICR for each Collection. The Coast Guard invites comments on whether this ICR should be granted based on the Collection being necessary for the proper performance of Departmental functions. In particular, the Coast Guard would appreciate comments addressing: (1) The practical utility of the Collection; (2) the accuracy of the estimated burden of the Collection; (3) ways to enhance the quality, utility, and clarity of information subject to the Collection; and (4) ways to minimize the burden of the Collection on respondents, including the use of automated collection techniques or other forms of information technology. These comments will help OIRA determine whether to approve the ICR referred to in this Notice.

We encourage you to respond to this request by submitting comments and related materials. Comments to Coast Guard or OIRA must contain the OMB Control Number of the ICR. They must also contain the docket number of this request, [USCG-2016-0262], and must be received by December 15, 2016.

We encourage you to submit comments through the Federal eRulemaking Portal at http://www.regulations.gov. If your material cannot be submitted using http://www.regulations.gov, contact the person in the FOR FURTHER INFORMATION CONTACT section of this document for alternate instructions. Documents mentioned in this notice, and all public comments, are in our online docket at http://www.regulations.gov and can be viewed by following that Web site's instructions. Additionally, if you go to the online docket and sign up for email alerts, you will be notified when comments are posted.

We accept anonymous comments. All comments received will be posted without change to http://www.regulations.gov and will include any personal information you have provided. For more about privacy and the docket, you may review a Privacy Act notice regarding the Federal Docket Management System in the March 24, 2005, issue of the Federal Register (70 FR 15086).

OIRA posts its decisions on ICRs online at http://www.reginfo.gov/public/do/PRAMain after the comment period for each ICR. An OMB Notice of Action on each ICR will become available via a hyperlink in the OMB Control Number: 1625-0066.

This request provides a 30-day comment period required by OIRA. The Coast Guard published the 60-day notice (81 FR 28089, May 9, 2016) required by 44 U.S.C. 3506(c)(2). That Notice elicited no comments. Accordingly, no changes have been made to the Collections.

Title: Vessel and Facility Response Plans (Domestic and International), and Additional Response Requirements for Prince William Sound.

OMB Control Number: 1625-0066

Summary: The Oil Pollution Act of 1990 (OPA 90) required the development of Vessel and Facility Response Plans to minimize the impact of oil spills. OPA 90 also required additional response requirements for Prince William Sound. Shipboard Oil Pollution Emergency Plans and Shipboard Marine Pollution Emergency Plans are required of other vessels to minimize impacts of oil spills.

Need: This information is needed to ensure that vessels and facilities are prepared to respond in event of a spill incident. The information will be reviewed by the Coast Guard to assess the effectiveness of the response plan.

Forms: CG-6083, Application for Approval/Revision of Vessel Pollution Response Plans and Vessel Response Plan (VRP) Express Search Tool.

Respondents: Owners and operators of vessels and facilities.

Frequency: On occasion.

Hour Burden Estimate: The estimated burden has decreased from 136,460 hours to 75,395 hours a year. The decrease in burden is primarily due to a decrease in the estimated annual number of Facility Response Plan (FRP) respondents.

Authority: The Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended.

With this notice, we make the Final LRTP for the Northeast Region of the Service available for public review. Notice of availability and request for comments on the Draft LRTP was published in the Federal Register (FR00002485) on March 7, 2016. Comments received were evaluated and incorporated, as applicable, into this Final LRTP. The Final LRTP outlines a strategy for improving and maintaining transportation assets that provide access to Service-managed lands in the Northeast Region in Maine, New Hampshire, Vermont, Massachusetts, Rhode Island, Connecticut, New York, Pennsylvania, New Jersey, Delaware, Maryland, Virginia, and West Virginia.

This final report also includes changes made in reference to the Federal multi-year transportation funding legislation. The Fixing America's Surface Transportation Act (FAST ACT) was signed in December 2015, and replaces the 2012 Moving Ahead for Progress in the 21st Century Act (MAP-21). Both require all Federal land management agencies to conduct long range transportation planning in a manner that is consistent with metropolitan planning organization and State departments of transportation planning. This LRTP was initiated within the Service to achieve the following:

• Establish a structure for sound transportation planning and decision-making.

• Establish a vision, mission, goals, and objectives for transportation planning in the Service's Northeast Region.

• Implement coordinated and cooperative transportation partnerships in an effort to improve the Service's transportation infrastructure.

• Integrate transportation planning and funding for wildlife refuges and fish hatcheries into existing and future Service management plans and strategies e.g., comprehensive conservation plans and comprehensive hatchery management plans.

• Increase awareness of Alternative Transportation Systems and associated benefits.

• Develop best management practices for transportation improvements on Service lands.

• Serve as a pilot project for the implementation of a Regional-level transportation planning process within the Service.

Through a collaborative effort, the National Wildlife Refuge System (Refuge System) and the Fish and Aquatic Conservation programs, in cooperation with the Planning Group and the Division of Refuge Field Support within the Service's Northeast Region, have contributed to defining the mission, goals, and objectives presented in this document. The resulting mission, goals, and objectives are intended to provide a systematic approach to guide the process for evaluating and selecting transportation improvements for the Service lands in the Northeast Region. These guiding principles have shaped the development, conclusions, and recommendations of this LRTP.

To support the Service's mission by connecting people to fish, wildlife, and their habitats through strategic implementation of transportation programs.

This long range transportation plan has six categories of goals: Coordinated Opportunities; Asset Management; Safety; Environmental; Access, Mobility, and Connectivity; and Visitor Experience. Under each goal, we present distinct objectives that move us to the goal.

1. Coordinated Opportunities: The program will seek joint transportation opportunities that support the Service mission, maximize the utility of Service resources, and provide mutual benefits to the Service and external partners.

Objectives:

• Identify and increase key internal and external partnerships at the national, regional, and unit levels.

• Maximize leveraged opportunities by identifying and pursuing funding for projects of mutual interest and benefit.

• Develop best practices for external engagement that illustrates success in forming and nurturing coalitions and partnerships that support the Service's mission.

• Coordinate within Service programs, including the Refuge System, Ecological Services, Migratory Birds, and Fish and Aquatic Conservation during the development of Regional long-range and project-level plans.

2. Asset Management: The program will operate and maintain a functional, financially sustainable and resilient transportation network to satisfy current and future land management needs in the face of a changing climate.

Objectives:

• Use asset management principles to maintain important infrastructure at an appropriate condition level.

• Prioritize work programs through the project selection process detailed in this plan or an adaptation thereof.

• Evaluate life cycle costs when considering new assets to determine long-term financial sustainability.

• Consider the impacts of climate change in the planning and management of transportation assets.

3. Safety: The program's network will provide a superior level of safety for all users and all modes of transportation to and within Service lands.

Objectives:

• Identify safety issue `hot-spots' within the Service's transportation system with the Safety Analysis Toolkit.

• Implement appropriate safety countermeasures to resolve safety issues and reduce the frequency and severity of crashes (also with the Safety Analysis Toolkit).

• Address wildlife-vehicle collisions with design solutions (Environmental Enhancements).

• Use cooperation and communication among the “4E's” of safety, including: Engineering, education, enforcement, and emergency medical services.

4. Environmental: Transportation infrastructure will be landscape appropriate and play a key role in the improvement of environmental conditions in and around Service lands.

Objectives:

• Follow the Roadway Design Guidelines for best practices in design, planning, management, maintenance, and construction of transportation assets.

• Reduce greenhouse gas emissions and air pollutants by increasing transportation options and use of alternative fuels.

• Protect wildlife corridors, reduce habitat fragmentation, and enhance terrestrial and aquatic organism passage on and adjacent to Service lands to conserve fish, wildlife, and plant populations.

5. Access, Mobility, and Connectivity: The program will ensure that units open to public visitation have adequate transportation options for all users including underserved, underrepresented, and mobility-limited populations.

Objectives:

• Offer a wide range of transportation modes and linkages for onsite and offsite access.

• Provide a clear way for finding information both on and off Service lands.

• Through the Urban Wildlife Conservation Program, integrate Service transportation facilities with local community transportation systems in a way that encourages local visitation and provides economic benefits to partner and gateway communities.

• Through coordinated planning, provide context-appropriate transportation facilities that address the specific needs of local visitor groups and respect the natural setting of the refuge or hatchery.

• Address congestion issues to and within Service units.

6. Visitor Experience: The program will enhance the visitation experience through improvement and investment in the transportation network.

Objectives:

• Integrate interpretation, education, and resource stewardship principles into the transportation experience.

• Evaluate the feasibility of alternative transportation systems at all stations and implement where appropriate.

• Encourage connections with existing and planned public and private transportation services.

• Design infrastructures in such a way that highlights the landscape and not the transportation facility.

We solicited comments on the Draft LRTP from March 7 to April 7, 2016 (FR00002485). During the comment period, we received two written responses. Comments received were evaluated and incorporated, as applicable, into this Final LRTP.

After considering the comments we received on the Draft LRTP, we have updated the report to highlight partnership opportunities at the Potomac River National Wildlife Refuge Complex. This final report also includes changes made in referencing the Federal multi-year transportation funding legislation. The FAST Act was signed in December 2015, and replaces the MAP-21.

We will document the Final LRTP, which will be published in the Federal Register.

A person or party who wishes to protest against any of the above surveys must file a written notice within thirty (30) calendar days from the date of this publication with the Wyoming State Director, Bureau of Land Management, at the above address, stating that they wish to protest. A statement of reasons for the protest may be filed with the notice of protest and must be filed with the Wyoming State Director within thirty (30) calendar days after the protest is filed. If a protest against the survey is received prior to the date of official filing, the filing will be stayed pending consideration of the protest. A plat will not be officially filed until the day after all protests have been dismissed or otherwise resolved. Before including your address, phone number, email address, or other personal identifying information in your protest, you should be aware that your entire protest—including your personal identifying information—may be made publicly available at any time. While you can ask us to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.

Copies of the preceding described plats and field notes are available to the public at a cost of $4.20 per plat and $.13 per page of field notes.

On April 29, 2016, the U.S. Departments of Justice (DOJ), Homeland Security (DHS), and Defense (DoD) submitted a joint report to the President outlining a strategy to expedite deployment of gun safety technology, found here: https://www.whitehouse.gov/sites/default/files/docs/final_report-smart_gun_report.pdf.

The report was published in response to Presidential Memorandum, Promoting Smart Gun Technology, found here: https://www.whitehouse.gov/the-press-office/2016/01/05/memorandum-promoting-smart-gun-technology. The report described the potential benefits of advanced gun safety technology, but noted that additional work was required before this technology is ready for widespread adoption by law enforcement agencies. In particular, the report stressed the importance of integrating this technology into a firearm's design without compromising the reliability, durability, and accuracy that officers expect from their service weapons.

To address these issues, the report called on law enforcement agencies to develop “baseline specifications,” which would outline the agencies' operational requirements for any firearms equipped with gun safety technology. By developing baseline specifications, federal, state, and municipal law enforcement agencies can make clear to private manufacturers what they expect from this technology.

DOJ and DHS recently assembled a working group of experts in firearms technology to identify operational needs and prepare a draft document that defines generic baseline specifications for law enforcement service pistols with additional technology to enhance the security of firearms. The additional security specifications that may be addressed by smart gun technology are distinguished from more familiar firearm safety mechanisms. The distinction between safety and security can be nuanced, and the additional security specifications may also function as safety features under certain circumstances. However, this distinction forms the basis of the use of the different terminology. The working group was led by NIJ and was comprised of subject matter experts from various federal law enforcement agencies. The pistols defined by this document are semi-automatic, recoil-operated, magazine-fed, striker-fired, and fire 9 mm Luger or .40 S&W ammunition. The information detailed in this document is informed in part by specifications enumerated in recent handgun solicitations by the Federal Bureau of Investigation (FBI) and Immigration and Customs Enforcement (ICE), which are publicly available on FedBizOpps (http://www.fbo.gov) under solicitation numbers RFP-OSCU-DSU1503 and HSCEMS-16-R-00003, respectively.

NIJ published a Federal Register notice (https://www.federalregister.gov/d/2016-16759) on July 15, 2016, seeking feedback from the public on the draft document that defined generic baseline specifications for law enforcement service pistols with additional technology to enhance the security of the firearms. The 60-day public comment period closed on September 13, 2016. The working group made revisions to the draft document, and the final version of the document, Baseline Specifications for Law Enforcement Service Pistols with Security Technology, is published here: http://nij.gov/topics/technology/firearms/pages/welcome.aspx.

Under the authority of Section 103 of the Federal Mine Safety and Health Act of 1977, MSHA is required to issue regulations requiring operators to maintain accurate records of employee exposures to potentially toxic materials or harmful physical agents which are required to be monitored or measured under any applicable mandatory health or safety standard promulgated under this Act.

Airborne radon and radon daughters exist in every uranium mine and in several other underground mining commodities. Radon is radioactive gas. It diffuses into the underground mine atmosphere through the rock and the ground water. Radon decays in a series of steps into other radioactive elements, which are solids, called radon daughters. Radon and radon daughters are invisible and odorless. Decay of radon and its daughters results in emissions of alpha energy.

Medical doctors and scientists have associated high radon daughter exposures with lung cancer. The health hazard arises from breathing air contaminated with radon daughters which are in turn deposited in the lungs. The lung tissues are sensitive to alpha radioactivity.

The amounts of airborne radon daughters to which most miners can be exposed with no adverse effects have been established and are expressed as working levels (WL). The current MSHA standard is a maximum personal exposure of 4 working level months (WLM) per year.

Excess lung cancer in uranium miners, just as coal workers' pneumoconiosis, silicosis, and other debilitating occupational diseases, has been recognized for many years. Thus, an adequate base of accurate exposure level data is essential to control miners' exposures and permit an evaluation of the effectiveness of existing regulations.

The standard at 30 CFR 57.5037 established the procedures to be used by the mine operator in sampling mine air for the presence and concentrations of radon daughters. Operators are required to conduct weekly sampling where concentrations of radon daughters exceed 0.3 WL. Sampling is required bi-weekly where uranium mines have readings of 0.1 WL to 0.3 WL and every 3 months in non-uranium underground mines where the readings are 0.1 WL to 0.3 WL. Mine operators are required to keep records of all mandatory samplings. Records must include the sample date, location, and results, and must be retained at the mine site or nearest mine office for at least 2 years.

The standard at 30 CFR 57.5040 requires mine operators to calculate and record individual exposures to radon daughters on MSHA Form 4000-9 “Record of Individual Exposure to Radon Daughters.” The calculations are based on the results of the weekly sampling required by 30 CFR 57.5037. Records must be maintained by the operator and submitted to MSHA annually.

MSHA is soliciting comments concerning the proposed information collection related to Radiation Sampling and Exposure Records (pertains to underground metal and nonmetal mines).

• MSHA is particularly interested in comments that:

• Evaluate whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information has practical utility;

• Evaluate the accuracy of MSHA's estimate of the burden of the collection of information, including the validity of the methodology and assumptions used;

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

• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.

The information collection request will be available on http://www.regulations.gov. MSHA cautions the commenter against providing any information in the submission that should not be publicly disclosed. Full comments, including personal information provided, will be made available on www.regulations.gov and www.reginfo.gov.

The public may also examine publicly available documents at USDOL-Mine Safety and Health Administration, 201 12th South, Suite 4E401, Arlington, VA 22202-5452. Sign in at the receptionist's desk on the 4th floor via the East elevator.

Questions about the information collection requirements may be directed to the person listed in the FOR FURTHER INFORMATION section of this notice.

This request for collection of information contains provisions for Radiation Sampling and Exposure Records (pertains to underground metal and nonmetal mines). MSHA has updated the data with respect to the number of respondents, responses, burden hours, and burden costs supporting this information collection request.

Type of Review: Extension, without change, of a currently approved collection.

Agency: Mine Safety and Health Administration.

OMB Number: 1219-0003.

Affected Public: Business or other for-profit.

Number of Respondents: 5.

Frequency: Weekly.

Number of Responses: 505.

Annual Burden Hours: 502 hours.

Annual Respondent or Recordkeeper Cost: $17,433.

MSHA Forms: MSHA Form 4000-9, Record of Individual Exposure to Radon Daughters.

Comments submitted in response to this notice will be summarized and included in the request for Office of Management and Budget approval of the information collection request; they will also become a matter of public record.

I. Notice of the Application for Expansion

The Occupational Safety and Health Administration is providing notice that MET Laboratories, Inc. (MET), is applying for expansion of its current recognition as an NRTL. MET requests the addition of five test standards to its NRTL scope of recognition.

OSHA recognition of an NRTL signifies that the organization meets the requirements specified in 29 CFR 1910.7. Recognition is an acknowledgment that the organization can perform independent safety testing and certification of the specific products covered within its scope of recognition. Each NRTL's scope of recognition includes (1) the type of products the NRTL may test, with each type specified by its applicable test standard; and (2) the recognized site(s) that has/have the technical capability to perform the product-testing and product-certification activities for test standards within the NRTL's scope. Recognition is not a delegation or grant of government authority; however, recognition enables employers to use products approved by the NRTL to meet OSHA standards that require product testing and certification.

The Agency processes applications by an NRTL for initial recognition and for an expansion or renewal of this recognition, following requirements in Appendix A to 29 CFR 1910.7. This appendix requires that the Agency publish two notices in the Federal Register in processing an application. In the first notice, OSHA announces the application and provides its preliminary finding. In the second notice, the Agency provides its final decision on the application. These notices set forth the NRTL's scope of recognition or modifications of that scope. OSHA maintains an informational Web page for each NRTL, including MET, which details the NRTL's scope of recognition. These pages are available from the OSHA Web site at http://www.osha.gov/dts/otpca/nrtl/index.html.

MET currently has one facility (site) recognized by OSHA for product testing and certification, with its headquarters located at: MET Laboratories, Inc., 914 West Patapsco Avenue, Baltimore, Maryland 21230. A complete list of MET's scope of recognition is available at https://www.osha.gov/dts/otpca/nrtl/met.html.

MET submitted five applications, four dated July 7, 2015 (OSHA-2006-0028-0026), (OSHA-2006-0028-0027), (OSHA-2006-0028-0028), (OSHA-2006-0028-0029) and one dated August 4, 2015 (OSHA-2006-0028-0025), to expand its recognition to include five additional test standards. OSHA staff performed a detailed analysis of the application packet and reviewed other pertinent information. OSHA did not perform any on-site reviews in relation to this application.

Table 1 below lists the appropriate test standards found in MET's application for expansion for testing and certification of products under the NRTL Program.

Periodically, OSHA will propose to add new test standards to the NRTL list of appropriate test standards following an evaluation of the test standard document. To qualify as an appropriate test standard, the Agency evaluates the document to (1) verify it represents a product category for which OSHA requires certification by an NRTL, (2) verify the document represents an end product and not a component, and (3) verify the document defines safety test specifications (not installation or operational performance specifications). OSHA becomes aware of new test standards through various avenues. For example, OSHA may become aware of new test standards by: (1) Monitoring notifications issued by certain SDOs; (2) reviewing applications by NRTLs or applicants seeking recognition to include a new test standard in their scopes of recognition; and (3) obtaining notification from manufacturers, manufacturing organizations, government agencies, or other parties. OSHA may determine to include a new test standard in the list, for example, if the test standard is for a particular type of product that another test standard also covers or it covers a type of product that no standard previously covered.

In this notice, OSHA proposes to add a new test standard to the NRTL Program's List of Appropriate Test Standards. Table 1, below, lists the test standard that is new to the NRTL Program. OSHA preliminarily determined that this test standard is an appropriate test standard and proposes to include it in the NRTL Program's List of Appropriate Test Standards. OSHA seeks public comment on this preliminary determination.

MET submitted an acceptable application for expansion of its scope of recognition. OSHA's review of the application file, and pertinent documentation, indicate that MET can meet the requirements prescribed by 29 CFR 1910.7 for expanding its recognition to include the addition of these five test standards for NRTL testing and certification listed above. This preliminary finding does not constitute an interim or temporary approval of MET's application.

OSHA welcomes public comment as to whether MET meets the requirements of 29 CFR 1910.7 for expansion of its recognition as an NRTL. Comments should consist of pertinent written documents and exhibits. Commenters needing more time to comment must submit a request in writing, stating the reasons for the request. Commenters must submit the written request for an extension by the due date for comments. OSHA will limit any extension to 10 days unless the requester justifies a longer period. OSHA may deny a request for an extension if the request is not adequately justified. To obtain or review copies of the exhibits identified in this notice, as well as comments submitted to the docket, contact the Docket Office, Room N-2625, Occupational Safety and Health Administration, U.S. Department of Labor, at the above address. These materials also are available online at http://www.regulations.gov under Docket No. OSHA-2006-0028.

OSHA staff will review all comments to the docket submitted in a timely manner and, after addressing the issues raised by these comments, will recommend to the Assistant Secretary for Occupational Safety and Health whether to grant MET's application for expansion of its scope of recognition. The Assistant Secretary will make the final decision on granting the application. In making this decision, the Assistant Secretary may undertake other proceedings prescribed in Appendix A to 29 CFR 1910.7.

OSHA will publish a public notice of its final decision in the Federal Register.

David Michaels, Ph.D., MPH, Assistant Secretary of Labor for Occupational Safety and Health, 200 Constitution Avenue NW., Washington, DC 20210, authorized the preparation of this notice. Accordingly, the Agency is issuing this notice pursuant to 29 U.S.C. 657(g)(2), Secretary of Labor's Order No. 1-2012 (77 FR 3912, Jan. 25, 2012), and 29 CFR 1910.7.