Title: Value-Added Producer Grants.

OMB Number: 0570-0064.

Expiration Date of Approval: March 31, 2014.

Type of Request: Extension of a currently approved information collection.

Abstract: The purpose of this information collection is to obtain information necessary to evaluate grant applications to determine the eligibility of the applicant and the project for the program and to qualitatively assess the project to determine which projects should be funded.

Estimate of Burden: Public reporting burden for this collection of information is estimated to average 79 hours per grant application.

Respondents: Independent producers, agriculture producer groups, farmer- or rancher-cooperatives, and majority-controlled producer-based business ventures.

Estimated Number of Respondents: 468.

Estimated Number of Responses per Respondent: 3.

Estimated Number of Responses: 1294.

Estimated Total Annual Burden on Respondents: 37,065 hours.

Copies of this information collection can be obtained from Jeanne Jacobs, Regulations and Paperwork Management Branch, Support Services Division at (202) 692-0040.

Comments: Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the Rural Business-Cooperative Service, including whether the information will have practical utility; (b) the accuracy of the Rural Business-Cooperative Service's estimate of the burden of the proposed collection of information including validity of the methodology and 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 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.

Comments may be sent to Jeanne Jacobs, Regulations and Paperwork Management Branch, Support Services Division, U.S. Department of Agriculture, Rural Development, STOP 0742, 1400 Independence Avenue SW., Washington, DC 20250-0742.

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

The Petitions

On September 30, 2013, the Department of Commerce (the Department) received antidumping duty (AD) petitions concerning imports of non-oriented electrical steel (NOES) from the PRC, Germany, Japan, Korea, Sweden, and Taiwan filed in proper form on behalf of AK Steel Corporation (Petitioner). The AD petitions were accompanied by three countervailing duty (CVD) petitions. 1 Petitioner is the sole domestic producer of NOES.

On October 22, 2013, and October 29, 2013, the Department requested additional information and clarification of certain areas of the Petitions. 2 Petitioner filed responses to these requests on October 25, 2013, October 28, 2013 and October 30, 2013.

In accordance with section 732(b) of the Tariff Act of 1930, as amended (the Act), Petitioner alleges that imports of NOES from the PRC, Germany, Japan, Korea, Sweden, and Taiwan are being, or are likely to be, sold in the United States at less than fair value within the meaning of section 731 of the Act and that such imports are materially injuring, or threatening material injury to, an industry in the United States. Also, consistent with section 732(b)(1) of the Act, the Petitions are accompanied by information reasonably available to Petitioner supporting its allegations.

The Department finds that Petitioner filed these Petitions on behalf of the domestic industry because Petitioner is an interested party as defined in section 771(9)(C) of the Act. The Department also finds that Petitioner has demonstrated sufficient industry support with respect to the initiation of the AD investigations that Petitioner is requesting. See the “Determination of Industry Support for the Petitions” section below.

Pursuant to 19 CFR 351.204(b)(1), because the Petitions were filed on September 30, 2013, the period of investigation (POI) for the PRC investigation is January 1, 2013, through June 30, 2013. The POI for the Germany, Japan, Korea, Sweden, and Taiwan investigations is July 1, 2012, through June 30, 2013.

The product covered by these investigations is NOES from the PRC, Germany, Japan, Korea, Sweden, and Taiwan. For a full description of the scope of the investigations, see the “Scope of the Investigations,” in Appendix I of this notice.

During our review of the Petitions, the Department issued questions to, and received responses from, Petitioner pertaining to the proposed scope to ensure that the scope language in the Petitions would be an accurate reflection of the products for which the domestic industry is seeking relief. As discussed in the preamble to the regulations, 3 we are setting aside a period for interested parties to raise issues regarding product coverage. The Department encourages all interested parties to submit such comments by 5:00 p.m. Eastern Time on November 26, 2013. All comments must be filed on the records of the PRC, Germany, Japan, Korea, Sweden, and Taiwan AD investigations as well as the concurrent PRC, Korea, and Taiwan CVD investigations.

All submissions to the Department must be filed electronically using IA ACCESS. 4 An electronically filed document must be received successfully in its entirety by the time and date noted above. Documents excepted from the electronic submission requirements must be filed manually ( i.e., in paper form) with Enforcement and Compliance's APO/Dockets Unit, Room 1870, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230, and stamped with the date and time of receipt by the deadline noted above.

The Department requests comments from interested parties regarding the appropriate physical characteristics of NOES to be reported in response to the Department's antidumping duty questionnaires. This information will be used to identify the key physical characteristics of the subject merchandise in order to report the relevant factors and costs of production accurately as well as to develop appropriate product-comparison criteria.

Interested parties may provide any information or comments that they feel are relevant to the development of an accurate list of physical characteristics. Specifically, they may provide comments as to which characteristics are appropriate to use as: (1) General product characteristics and (2) product-comparison criteria. We note that it is not always appropriate to use all product characteristics as product-comparison criteria. We base product-comparison criteria on meaningful commercial differences among products. In other words, while there may be some physical product characteristics utilized by manufacturers to describe NOES, it may be that only a select few product characteristics take into account commercially meaningful physical characteristics. In addition, interested parties may comment on the order in which the physical characteristics should be used in matching products. Generally, the Department attempts to list the most important physical characteristics first and the least important characteristics last.

In order to consider the suggestions of interested parties in developing and issuing the AD questionnaires, we must receive comments on product characteristics by November 20, 2013. Rebuttal comments must be received by November 27, 2013. All comments and submissions to the Department must be filed electronically using IA ACCESS, as referenced above.

As explained in the memorandum from the Assistant Secretary for Enforcement and Compliance, the Department has exercised its discretion to toll deadlines for the duration of the closure of the Federal Government from October 1, through October 16, 2013. 5 Therefore, all deadlines in these investigations have been tolled by 16 days. The revised deadline for the initiation of these investigations is November 6, 2013.

Section 732(b)(1) of the Act requires that a petition be filed on behalf of the domestic industry. Section 732(c)(4)(A) of the Act provides that a petition meets this requirement if the domestic producers or workers who support the petition account for: (i) At least 25 percent of the total production of the domestic like product; and (ii) more than 50 percent of the production of the domestic like product produced by that portion of the industry expressing support for, or opposition to, the petition. Moreover, section 732(c)(4)(D) of the Act provides that, if the petition does not establish support of domestic producers or workers accounting for more than 50 percent of the total production of the domestic like product, the Department shall: (i) Poll the industry or rely on other information in order to determine if there is support for the petition, as required by subparagraph (A); or (ii) determine industry support using a statistically valid sampling method to poll the industry.

Section 771(4)(A) of the Act defines the “industry” as the producers as a whole of a domestic like product. Thus, to determine whether a petition has the requisite industry support, the statute directs the Department to look to producers and workers who produce the domestic like product. The International Trade Commission (ITC), which is responsible for determining whether “the domestic industry” has been injured, must also determine what constitutes a domestic like product in order to define the industry. While both the Department and the ITC must apply the same statutory definition regarding the domestic like product, 6 they do so for different purposes and pursuant to a separate and distinct authority. In addition, the Department's determination is subject to limitations of time and information. Although this may result in different definitions of the like product, such differences do not render the decision of either agency contrary to law. 7

Section 771(10) of the Act defines the domestic like product as “a product which is like, or in the absence of like, most similar in characteristics and uses with, the article subject to an investigation under this title.” Thus, the reference point from which the domestic like product analysis begins is “the article subject to an investigation” ( i.e., the class or kind of merchandise to be investigated, which normally will be the scope as defined in the Petitions).

With regard to the domestic like product, Petitioner does not offer a definition of the domestic like product distinct from the scope of the investigations. Based on our analysis of the information submitted on the record, we have determined that NOES constitutes a single domestic like product and we have analyzed industry support in terms of that domestic like product. 8

The International Trade Administration will have a senior executive lead the Travel and Tourism Trade Mission to Taiwan, Japan and Korea, March 10-14, 2014, published at 78 FR 34344, June 7, 2013. As previously published, the notice did not specify that there would be a fee charged for each additional participant.

For these reasons, the Mission Description of the Notice of the Travel and Tourism Trade Mission to Taiwan, Japan and Korea is amended to read as follows:

After a company has been selected to participate in the mission, a payment to the Department of Commerce in the form of a participation fee is required.

This Trade Mission is organized as three separate segments (Taiwan, Korea and Japan). Companies may choose to participate in one, two or all three segments. The fee for participating in more than one segment is the sum of the individual segments.

For business-to-business meetings in Taiwan only (not traveling to an additional trade mission country), the participation fee will be $1,400 for a small or medium-sized enterprise (SME) and $1,625 for large firms.

For business-to-business meetings in Japan only (not traveling to an additional trade mission country), the participation fee will be $1,725 for a small or medium-sized enterprise (SME) and $1,925 for large firms.

For business-to-business meetings in Korea only (not traveling to an additional trade mission country), the participation fee will be $1,275 for a small or medium-sized enterprise (SME) and $1,475 for large firms.

The fee for each additional firm representative (SME or large) is $700. Expenses for travel, lodging, some meals, and incidentals will be the responsibility of each mission participant.

The Council will hold its 148th regular Council Meeting to discuss the items contained in the following agenda:

The established times for addressing items on the agenda may be adjusted as necessary to accommodate the timely completion of discussion relevant to the agenda items. To further accommodate discussion and completion of all items on the agenda, the meeting may be extended from, or completed prior to the date established in this notice.

The meetings are open to the public, and will be conducted in English. Fishers and other interested persons are invited to attend and participate with oral or written statements regarding agenda issues.

Although non-emergency issues not contained in this agenda may come before this group for discussion, those issues may not be subjects for formal action during these meetings. Actions 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 that 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. For more information or request for sign language interpretation and/other auxiliary aids, please contact Mr. Miguel A. Rolón, Executive Director, Caribbean Fishery Management Council, 270 Muñoz Rivera Avenue, Suite 401, San Juan, Puerto Rico, 00918, telephone (787) 766-5926, at least 5 days prior to the meeting date.

On September 12, 2013, notice was published in the Federal Register (78 FR 56218) that a request for a permit to conduct commercial or educational photography had been submitted by the above-named applicant. The requested permit has been issued under the authority of the Marine Mammal Protection Act of 1972, as amended (16 U.S.C. 1361 et seq. ), and the regulations governing the taking and importing of marine mammals (50 CFR part 216).

Permit No. 18171 authorizes commercial/educational underwater and vessel-based filming and photography of marine mammals in waters off Puerto Rico. Footage will be used in two documentaries, one focused on offshore sport fishing in Puerto Rico and another one focused on Puerto Rico's marine mammal and marine mammal program (i.e., Department of Natural and Environmental Resources Marine Mammal Rescue Program). The first documentary will be presented at a film festival in Puerto Rico and distributed to schools and the public throughout Puerto Rico. A maximum of 210 bottlenose, 210 spinner, and 210 striped dolphins, 60 false killer and 60 killer whales, could be approached and filmed annually. Filming may occur year-round. The permit is valid through November 7, 2015.

In compliance with the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq. ), a final determination has been made that the activity proposed is categorically excluded from the requirement to prepare an environmental assessment or environmental impact statement.

Background

Sections 101(a)(5)(A)(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 January 18, 2013, NMFS received an application from Excelerate Energy, L.P. (Excelerate) and Tetra Tech EC, Inc., on behalf of Northeast Gateway and Algonquin, for an authorization to take 14 species of marine mammals by Level B harassment incidental to operations, maintenance, and repair of an LNG 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 LNG 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 previously issued an IHA to Northeast Gateway 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 Algonquin Pipeline Lateral (72 FR 27077; May 14, 2007). Subsequently, NMFS issued four 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). The most recent IHA expired on October 6, 2012. Unlike the previous IHAs, which only covered incidental harassment during standard operations of the deepwater port, the new IHA application from Excelerate requests take coverage during standard operations, as well as during planned and unplanned maintenance and repair. Marine mammals could be affected by noise generated by operating the dynamic positioning system during the docking of LNG vessels at the NEG Port, and noises generated from maintenance and repair of the LNG Port and Pipeline Lateral facilities.

The Northeast Gateway Port is located in Massachusetts Bay and consists of a submerged buoy system to dock specially designed LNG carriers approximately 13 mi (21 km) offshore of Massachusetts in federal waters approximately 270 to 290 ft (82 to 88 m) in depth. This facility delivers regasified LNG to onshore markets via the Algonquin Pipeline Lateral (Pipeline Lateral). The Pipeline Lateral consists of a 16.1-mile (25.8-kilometer) long, 24-inch (61-centimeter) outside diameter natural gas pipeline which interconnects the Port to an offshore natural gas pipeline known as the HubLine.

The Northeast Gateway Port consists of two subsea Submerged Turret Loading TM (STL) buoys, each with a flexible riser assembly and a manifold connecting the riser assembly, via a steel Flowline, to the subsea Pipeline Lateral. Northeast Gateway utilizes vessels from its current fleet of specially designed Energy Bridge TM Regasification Vessels (EBRVs), each capable of transporting approximately 2.9 billion ft 3 (82 million m 3 ) of natural gas condensed to 4.9 million ft 3 (138,000 m 3 ) of LNG. Northeast Gateway has recently added two vessels to its fleet that have a cargo capacity of approximately 151,000 m 3 (5.3 million ft 3 ). The mooring system installed at the Northeast Gateway Port is designed to handle each class of vessel. The EBRVs would dock to the STL buoys, which would serve as both the single-point mooring system for the vessels and the delivery conduit for natural gas. Each of the STL buoys is secured to the seafloor using a series of suction anchors and a combination of chain/cable anchor lines.

During NEG Port operations, EBRVs servicing the NEG Port would utilize the International Maritime Organization (IMO)-approved Boston Traffic Separation Scheme (TSS) to delivery LNG to the NEG Port facility. When an EBRV arrives at the NEG Port, it would retrieve one of the two permanently anchored submerged STL buoys. It would make final connection to the buoy through a series of engine and bow thruster actions. The EBRV would require the use of thrusters for dynamic positioning (DP) during docking procedure. Typically, the docking procedure is completed over a 10- to 30-minute period, with the thrusters activated as necessary for short periods (bursts in seconds). During this time period thrusters would be engaged in use for docking at the NEG Port approximately 10 to 30 minutes for each vessel arrival and departure. Once connected to the buoy, the EBRV would make ready to begin vaporizing the LNG into its natural gas state using the onboard regasification system. As the LNG is regasified, natural gas would be transferred at pipeline pressures off the EBRV through the STL buoy and flexible riser via a steel flowline leading to the connecting Algonquin Pipeline Lateral. When the LNG vessel is on the buoy, wind and current effects on the vessel would be allowed to “weathervane” on the single-point mooring system; therefore, thrusters would not be used to maintain a stationary position.

According to NEG, it is estimated that the NEG Port could receive approximately 65 cargo deliveries a year, although none have been received since February 2010.

Detailed information on the operation activities can be found in the MARAD/USCG Final EIS on the Northeast Gateway Project (see ADDRESSES for availability). Detailed information on the LNG facility's operation and noise generated from operations was also published in the Federal Register for the proposed IHA for Northeast Gateway's LNG Port construction and operations on March 13, 2007 (72 FR 11328).

The specified design life of the NEG Port is about 40 years, with the exception of the anchors, mooring chain/rope, and riser/umbilical assemblies, which are based on a maintenance-free design life of 20 years. The buoy pick-up system components are considered consumable and are inspected following each buoy connection, and replaced (from inside the STL compartment during the normal cargo discharge period) as deemed necessary. The underwater components of the NEG Port are inspected once yearly in accordance with Classification Society Rules (American Bureau of Shipping) using either divers or remotely operated vehicles (ROV) to inspect and record the condition of the various STL system components. These activities are conducted using the NEG Port's normal support vessel (125-foot [38 meter], 99 gross ton, 2,700 horsepower, aluminum mono-hull vessel), and to the extent possible coincide with planned weekly visits to the NEG Port.

In addition to these routine activities, there may be instances whereby unanticipated events at the NEG Port necessitate emergency maintenance and/or repair activities. While the extent and number of such maintenance and repair activities at the NEG Port over its expected 25 year life cannot be accurately estimated, it is reasonable to assume that a worst-case maintenance and/or repair scenario would result in similar types of activities and require the use of similar support vessels and equipment as used for construction. There may also be certain unanticipated circumstances that require the presence of an EBRV at the NEG Port to support these maintenance and repair activities (e.g., 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). To assess the impact to marine mammals from the NEG port maintenance and repair, a 14-day maintenance period during one calendar is selected. This is based on evaluation of the potential marine mammal takes associated with similar maintenance and repair at the Neptune Port Facility in Massachusetts Bay, due to the fact that both the NEG and Neptune Ports are very similar in their potential need and type of maintenance and repair of port facilities.

The planned activities required for the operations and maintenance (O&M) of the Algonquin Pipeline Lateral and Flowlines over a 1-year period are limited. Similar to the inspection of the NEG Port underwater components, the only planned O&M activity is the annual inspection of the cathodic protection monitors by a ROV. The monitors are located at the ends of the Algonquin Pipeline Lateral and the adjacent Flowlines. Each inspection activity would take approximately 3 days and would utilize a ROV launched from a vessel of opportunity. The most likely vessel would be similar to the NEG Port's normal support vessel referenced earlier in the document. This vessel is self-positioning and requires no anchors or use of thrusters. The vessel would mobilize from Salem, Massachusetts, and would inspect the monitors in the vicinity of the NEG Port and at the point where the Algonquin Pipeline Lateral interconnects with Algonquin's HubLine. These activities would be performed during daylight hours and during periods of good weather.

Unplanned O&M activities may be required from time to time at a location along the Algonquin Pipeline Lateral or along one of the Flowlines should the line become damaged or malfunction. Repair activities requiring limited excavation to access the pipeline or cathodic protection maintenance are authorized by the FERC certificate.

Should repair work be required, it is likely a dive vessel would be the main vessel used to support the repair work. The type of diving spread and the corresponding vessel needed to support the spread would be dictated by the type of repair work required and the water depth at the work location. In addition, the type of vessel used may vary depending upon availability. The duration of an unplanned activity would also vary depending upon the repair work involved (e.g., repairing or replacing a section of the pipeline, connection, or valve) but can generally be assumed to take less than 40 work days to complete based on industry experience with underwater pipeline repairs.

A diving spread required to execute an unplanned activity might necessitate several vessels. Most likely the dive vessel would support a saturation diving spread and be moored at the work location using four anchors. Once secured at the work location, the dive vessel would remain on site through the completion of the work, weather permitting. A crew/supply boat would be utilized to intermittently provide labor and supply transfers. Once or twice during the work, a tug may be required to bring a material barge to and from the location. While unlikely, there is a small possibility that a second dive vessel would be required to support the main dive vessel, depending upon the work activity. The second dive vessel would be on-site for a shorter work duration. These vessels would be supported from an onshore base located between Quincy and Gloucester, Massachusetts.

The selection of a dive vessel would be driven by the technical requirements of the work. In addition, the degree of urgency required to address the work and the availability of vessels will also enter into the decision process for securing a dive vessel. It may be that a four-point moored dive vessel is either not available or doesn't meet the technical capabilities required by the work. It then becomes possible that a DP dive vessel may have to be utilized. The use of a DP dive vessel removes the need for an attendant tug to support the vessel since no anchors will be deployed. However, potential impacts related to noise are increased when a DP dive vessel is used. The noise generated by a DP dive vessel varies, and results from the use of the thrusters which run at various levels to maintain the vessel's position during the work depending upon currents, winds, waves and other forces acting on the vessel at the time of the work.

Marine mammal species that potentially occur in the vicinity of the Northeast Gateway facility include several species of cetaceans and pinnipeds:

Information on those species that may be affected by this activity is discussed in detail in the USCG Final EIS on the Northeast Gateway LNG proposal. Please refer to that document for more information on these species and potential impacts from construction and operation of this LNG facility. In addition, general information on these marine mammal species can also be found in Würsig et al. (2000) and in the NMFS Stock Assessment Reports (Waring et al., 2013). This latter document is available at: http://www.nmfs.noaa.gov/pr/sars/pdf/ao2012.pdf. An updated summary on several PSO-sighted marine mammal species distribution and abundance in the vicinity of the proposed action area is provided below.

The highest abundance for humpback whales is distributed primarily along a relatively narrow corridor following the 100-m (328 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-ft) 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 847 animals (Waring et al., 2009). Current data suggest that the Gulf of Maine humpback whale stock is steadily increasing in size, which is consistent with an estimated average trend of 3.1 percent in the North Atlantic population overall for the period 1979-1993 (Stevick et al., 2003, cited in Waring et al., 2009).

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 2,269 (Waring et al., 2009). 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 3,312 animals (Waring et al., 2009). 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, or 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, or 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 population size was estimated to be at least 345 individuals in 2005 based on a census of individual whales identified using photo-identification techniques (Waring et al., 2009). This value is a minimum and does not include animals that were alive prior to 2003 but not recorded in the individual sightings database as seen from December 1, 2003, to October 10, 2008. It also does not include calves known to be born during 2005 or any other individual whale seen during 2005 but not yet entered into the catalog (Waring et al., 2009). Examination of the minimum alive population index calculated from the individual sightings database, as it existed on October 10, 2008, for the years 1990-2005 suggests a positive trend in numbers. These data reveal a significant increase in the number of catalogued whales alive during this period but with significant variation due to apparent losses exceeding gains during 1998-1999. Mean growth rate for the period 1990-2005 was 1.8 percent (Waring et al., 2009).

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 26,535 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 63,368 (Waring et al., 2009). 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 coPSOnly seen in the vicinity of the proposed project area in Massachusetts Bay (Wiley et al., 1994; NCCOS, 2006; 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 coPSOn dolphins is 120,743 animals, and a trend analysis has not been conducted for this species (Waring et al., 2007). There are several stocks of bottlenose dolphins found along the eastern U.S. 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 7,489 animals (Waring et al., 2009). 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 20,479 animals (Waring et al., 2009). 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 89,054 animals (Waring et al., 2009). 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 99,340 animals (Waring et al., 2009). Between 1981 and 2001, the uncorrected counts of seals increased from 10,543 to 38,014, an annual rate of 6.6 percent (Gilbert et al., 2005, cited in Waring et al., 2009).

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. (2009) note that gray seal abundance in the U.S. Atlantic is likely increasing, but the rate of increase is unknown.

The proposed NEG LNG 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. Currently, NMFS considers that repeated exposure to received noise levels at 180 dB and 190 dB re 1 μPa (rms) could lead to TTS in cetaceans and pinnipeds, respectively.

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). 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 dB (more than 3 times in terms of 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 dynamic positioning (DP) thrusters, dredging and pipe laying associated with LNG Port and Pipeline Lateral maintenance and repair, and LNG 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 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 LNG regasification). For the NEG Port and Algonquin 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.

Northeast Gateway contracted with Tetra Tech EC, Inc. (Tetra Tech) to perform field investigations to document various underwater noise levels emitted during the construction of the NEG Port and Algonquin Pipeline Lateral and during the operation of NEG Port facilities (namely the operation of EBRVs). Tetra Tech conducted five offshore hydroacoustic field programs: One in 2005 and one in 2006 at the Gulf Gateway Deepwater Port located approximately 116 miles off the coast of Louisiana in the Gulf of Mexico; and three in 2007 at the NEG Port and Algonquin Pipeline Lateral Project area. The 2005 measurements were completed to determine underwater noise levels during EBRV onboard regasification and vessel movements. The data from the 2005 field program was used to support the modeling and analysis of potential acoustic effects of EBRV operations in Massachusetts Bay during the NEG Port permitting and licensing process. The data collected in 2006 was also associated with EBRV operation activities and were collected for the purpose of verifying the measurement completed in 2005 as well as to further document sound levels during additional operational and EBRV activities such as EBRV coupling and decoupling from the buoy system, transit and the use of stern and bow thrusters required for dynamic positioning. The 2007 measurements were collected during NEG Port and Algonquin Pipeline Lateral construction to obtain site-specific underwater sound-level data associated with various construction activities that were previously modeled in support of permitting and licensing. These data are used here to analyze potential noise impacts to marine mammals and to provide the basis for take calculation before new measurements are made on-site (see Proposed Monitoring Measures section below).

A detailed report describing both the 2006 and 2007 operation and construction noise measurement events and associated results have been included as Appendix B of the IHA application. The following sections describe those activities that could result in Level B harassment as they relate to NEG Port and Algonquin O&M activities.

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 feet (100 meters) 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 re 1 µPa isopleths: At LNG Port (EBRV Operations) and at Boston TSS (EBRV Transit).

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. Calculations were performed in accordance with Marsh and Schulkin (1985) and Richardson et al (1995) and took into consideration aspects of water depth, sea state, bathymetry, and seabed composition. In addition, the acoustic modeling performed specifically evaluated sound energy in 1/3-octave spectral bands covering frequencies from 12.5 hertz (Hz) to 20 kilohertz (kHz). This range encompasses the auditory frequency range of marine mammals and the range at which sound propagates beyond the immediate vicinity of the source (i.e., high frequency sounds have a much higher attenuation rate than frequencies in the low to middle range due to a higher absorption rate by seawater and boundary effects). These results were then summed across frequencies to provide the broadband received levels at receptor locations. A literature review of relevant underwater noise measurement data of offshore construction activities in similar shallow water environments were referred to for estimating typical propagation rates. Relevant here, the resulting distances to the 120 dB isopleth (180 dB re 1 µPa does not exist) was estimated to determine the maximum distance at which Level B harassment may occur.

To further understand how NEG Port activities may result in underwater noise that could harass marine mammals, Northeast Gateway has engaged scientists from Cornell University's Bioacoustics Research Program (BRP) and the Woods Hole Oceanographic Institution (WHOI) as the consultants for collecting and analyzing the acoustic data throughout the project area (see sections 13.0 and 14.0 of the IHA application). Elevated underwater sound levels within Massachusetts Bay due to this existing vessel traffic and other Bay activities may effectively mask sound generated during Port activities. Sound levels recorded by marine autonomous recording units (MARUs) within frequency bands for marine mammals have been reported to include whales, other biotic and abiotic sound sources and ambient noise that could be occurring at the time (BRP 2011).

As stated in earlier in the document, routine inspections of NEG Port mooring components occur after each buoy connection from the Port's normal support vessel. Inspections of other Port facility components such as the STL Buoy, flexible riser, mooring system, pipeline end manifold (PLEM) are conducted annually by a ROV and/or diver launched from a vessel of opportunity.

In addition to these routine activities, there may be instances whereby unanticipated events at the NEG Port necessitate emergency maintenance and/or repair activities. While the extent and number of such maintenance and repair activities at the NEG Port over its expected 25 year life cannot be accurately estimated, it is reasonable to assume that a worst-case maintenance and/or repair scenario would result in similar types of activities and require the use of similar support vessels and equipment as used for construction.

Modeling analysis conducted by TetraTech concluded that the only underwater noise of critical concern during NEG Port construction would be from vessel noises such as turning screws, engine noise, noise of operating machinery, and thruster use. To confirm these modeled results and better understand the noise footprint associated with construction activities at the NEG Port, field measurements were taken of various construction activities during the 2007 NEG Port and Algonquin Pipeline Lateral Construction period. Measurements were taken to establish the “loudest” potential construction measurement event. The location at the LNG Port was used to determine site-specific distances to the 120/180 dB re 1 µPa isopleths for NEG Port maintenance and repair activities.

As described for NEG Port operations, sound propagation calculations were performed to determine the noise footprint of the construction activity. The calculations took into consideration aspects of water depth, sea state, bathymetry, and seabed composition, and specifically evaluated sound energy in the range that encompasses the auditory frequencies of marine mammals and at which sound propagates beyond the immediate vicinity of the source. These results were then summed across frequencies to provide the broadband received levels at receptor locations. The resulting distances to the 120 dB isopleth (180 dB re 1 µPa does not exist) was estimated to determine the maximum distance at which Level B harassment may occur (Table 1).

As discussed earlier in the document, routine inspections of the Algonquin Pipeline Lateral are conducted annually by a ROV launched from a vessel of opportunity. Planned O&M activity is the annual inspection of the cathodic protection monitors by a ROV. The monitors are located at the ends of the Algonquin Pipeline Lateral and the adjacent Flowlines. Each inspection activity will take approximately 3 days and will utilize a ROV launched from a vessel of opportunity. The most likely vessel will be similar to the NEG Port's normal support vessel.

In addition to these routine activities, there may be instances whereby unanticipated events at the NEG Port and Algonquin Pipeline Lateral necessitate emergency maintenance and/or repair activities. While the extent and number of such maintenance and repair activities at the Port over its expected 25 year life cannot be accurately estimated, it is reasonable to assume that a worst-case maintenance and/or repair scenario would result in similar types of activities and require the use of similar support vessels and equipment as used for construction.

Modeling analysis conducted in support of the final EIS/EIR concluded that the only underwater noise of critical concern during NEG Port and Algonquin Pipeline Lateral construction would be from vessel noises such as turning screws, engine noise, noise of operating machinery, and thruster use. As with construction noise at the NEG Port, to confirm modeled results and better understand the noise footprint associated with construction activities along the Algonquin Pipeline Lateral, field measurements were taken of various construction activities during the 2007 NEG Port and Algonquin Pipeline Lateral Construction period. Again, measurements were taken to establish the “loudest” potential construction measurement event. Two positions within Massachusetts Bay were then used to determine site-specific distances to the 120/180 dB re 1 µPa isopleths: at PLEM and at Mid-Pipeline.

As described for NEG Port operations and maintenance and repair, at each location sound propagation calculations were performed to determine the noise footprint of the construction activity at each of the specified locations. The resulting distances to the 120 dB isopleth (180 dB re 1 µPa does not exist) was estimated to determine the maximum distance at which Level B harassment may occur (Table 1).

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 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 EBRVs occupying both 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 it cargo delivery activities at the NEG Port. However, during the operations of the NEG Port facility, it was revealed that significantly more water usage is needed from 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 feet 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 12 °C (21.6 °F) from ambient from the vessel's main condenser cooling system.

Under the requested water-use scenario, Tech 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 × 10 14 to 4.29 × 10 15 cells per year. Assuming a dry-weight biomass of 10 − 10 to 10 − 11 gram per cell (g/cell), an estimated 7.2 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 × 10 3 organisms per m 3 . Applying this density, the water withdrawal volume under the proposed activity would result in the entrainment of 2.2 × 10 10 zooplankton individuals per trip or 1.5 × 10 12 individuals per year. Assuming an average biomass of 0.63 × 10 − 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 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. Nevertheless, since the demand for natural gas and corresponding 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. 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. Therefore, NMFS believes that the prey removals by NEG Port operations resulting from water usage will have negligible impacts on marine mammal habitat.

As stated earlier, NEG LNG Port will require scheduled maintenance inspections using either divers or 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 LNG 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 waters-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 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 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 Algonquin 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 a 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 Algonquin 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 Algonquin 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. Therefore, NMFS considers that Algonquin Pipeline Lateral maintenance and repair would have negligible impacts to marine mammal habitat in the proposed activity area.

In order to issue an incidental take authorization under Section 101(a)(5)(D) of the MMPA, NMFS must set forth the permissible methods of taking pursuant to such activity, and other means of effecting the least practicable adverse impact on such species or stock and its habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance, and on the availability of such species or stock for taking for certain subsistence uses.

For the proposed NEG LNG Port operations and maintenance and repair activities, Excelerate and Tetra Tech worked with NMFS and proposed the following mitigation measures to minimize the potential impacts to marine mammals in the project vicinity as a result of the LNG Port and Algonquin 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 LNG Port facility, and to minimize the intensity of noise exposure of marine mammals in the activity area. For the proposed NEG Port and Algonquin Pipeline Lateral operations and maintenance and repair, the following mitigation measures are proposed.

(i) 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.

(ii) 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, the EBRV shall go into “Heightened Awareness” as described below.

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

(I) 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;

(II) Post a look-out to visually monitor for the presence of marine mammals;

(III) Provide the US Coast Guard (USCG) required 96-hour notification of an arriving EBRV to allow the NEG Port Manager to notify Cornell of vessel arrival.

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

(C) 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.

(D) 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:

(I) 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.

(II) The sighting shall be recorded in the sighting log by the designated look-out.

(iii) 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 (460 m) to a North Atlantic right whale and 100 yards (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 km away from any visually-detected North Atlantic right whales.

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

(A) Respond to active right whale sightings and/or 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 (50 CFR 224.105) or within the circular area centered on an area 8 nm in radius from a sighting location;

(B) 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 AB; and

(C) 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.

(v) 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:

(A) 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:

(B) 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:

(C) 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).

(D) 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.

(E) 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.

(F) 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 (8 kilometers) of any sighting location, when traveling in any of the seasonal management areas (SMAs) or when traveling in any active dynamic management area (DMA).

(b) NEG Port-Specific Operations

(i) In addition to the general marine mammal avoidance requirements identified in (5)(a) above, vessels calling on the NEG Port must comply with the following additional requirements:

(A) 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 miles (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.

(B) EBRVs that are approaching or departing from the NEG Port and are within the ATBA5 surrounding the NEG Port, shall remain at least 1 km away from any visually-detected North Atlantic right whale and at least 100 yards (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.

(C) 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.

(ii) Vessel captains shall focus on reducing dynamic positioning (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.

(c) Planned and Unplanned Maintenance and Repair Activities

(i) NEG Port

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

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

(C) 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.

(ii) Pipeline Lateral

(A) 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 miles (8 km) of any sighting location, when travelling in any of the seasonal management areas (SMAs) as defined above.

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

(C) Planned maintenance and repair activities shall be restricted to the period between May 1 and November 30.

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

(E) Algonquin shall also provide the NMFS Office of the Protected Resources, NMFS Northeast Region Ship Strike Coordinator, and Stellwagen Bank National Marine Sanctuary (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.

(F) If dynamic positioning (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 or greater, activities shall be conducted in accordance with the requirements for DP systems listed in (b)(ii) above.

(G) In the event that a whale is visually observed within 0.5 mile (0.8 kilometers) 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.

(H) 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 m) from the vessel. Repair and maintenance work may resume after the marine mammal is positively reconfirmed outside the established zones (500 yd [457 m]) 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.

(I) 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 m]) 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.

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

(I) Operations involving equipment with sound source levels 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.

(II) 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.

(III) For any material mentioned above 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.

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

(K) 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:

(I) 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.

(II) 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.

(III) 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 m 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.

(IV) 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.

(V) 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.

(i) Vessels associated with maintaining the acoustic seafloor array of Marine Autonomous Recording Units (MARUs) and the AB network operating as part of the mitigation/monitoring protocols shall adhere to the following speed restrictions and marine mammal monitoring requirements.

(A) Vessels maintaining the MARU array that are greater than 300 gross tons (GT) shall not exceed 10 knots.

(B) Vessels maintaining the MARU array that are less than 300 GT shall not exceed 15 knots at any time, but shall adhere to speeds of 10 knots or less in the following areas and seasons:

(I) In the ORP-SMA between March 1 and April 30; and

(II) In the CCB-SMA between January 1 and May 15.

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

(D) 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 to determine if there are right whales present in the operational area.

NMFS has carefully evaluated the 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.

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

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

(i) Vessel-Based monitoring for marine mammals shall be done by trained look-outs during NEG LNG Port and Pipeline Lateral operations and maintenance and repair activities. The observers shall monitor the occurrence of marine mammals near the vessels during LNG 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”.

(ii) The vessel look-outs assigned to visually monitor for the presence of marine mammals and shall be provided with the following:

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

(B) Binoculars to support observations;

(C) Marine mammal detection guide sheets; and

(D) Sighting log.

(i) 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.

(ii) 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 Area to be Avoided (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.

(iii) 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.

(iv) 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.

(i) Two (2) qualified and NMFS-approved protected species observers (PSOs) shall be assigned to each vessel that will use dynamic positioning (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 auto-detection buoy (AB) data indicates that sound levels exceed 120 dB re 1 μPa, further then 100 meters (328 feet) from these vessels.

(ii) 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.

(iii) 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:

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

(B) 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.

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

(D) Alert the vessel superintendent or construction crew supervisor of visual detections within 2 miles (3.31 kilometers) immediately.

(E) 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.

(iv) In the event that a whale is visually observed within the 2-mile (3.31-kilometers) zone of influence (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.

(i) Northeast Gateway shall monitor the noise environment in Massachusetts Bay in the vicinity of the NEG Port and Pipeline Lateral using an array of 19 MARUs that were deployed initially in April 2007 to collect data during NEG LNG Port and Pipeline Lateral related activities.

(ii) The acoustic data collected by the MARUs shall be analyzed to document the seasonal occurrences and overall distributions of whales (primarily fin, humpback and right whales) within approximately 10 nm 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.

(iii) In addition to the 19 MARUs, Northeast Gateway shall deploy 10 ABs within the Separation Zone of the TSS for the operational life of the Project.

(iv) The ABs shall be used to detect a calling North Atlantic right whale an average of 5 nm 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 in section (5) above.

(i) NEG Port Operations

(A) Ten (10) 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).

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

(ii) NEG Port and Pipeline Lateral Planned and Unplanned/Emergency Repair and Maintenance Activities

(A) 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.

(B) 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.

(C) 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.

(D) 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:

(i) 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.

(ii) 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.

(iii) 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 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:

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

(ii) 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;

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

(iv) The distance of observed marine mammals from the maintenance and repair activities;

(v) Changes, if any, in marine mammal behaviors during the observation;

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

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

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

(ix) Details of passive acoustic detections and any action taken in response to those detections.

(i) 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, at 301-427-8401 and/or by email to Jolie.Harrison@noaa.gov and Shane.Guan@noaa.gov and the Northeast Regional Stranding Coordinators ( Mendy.Garron@noaa.gov or Lanni.Hall@noaa.gov ) or by phone at 978-281-9300. The report must include the following information:

(A) time, date, and location (latitude/longitude) of the incident;

(B) the name and type of vessel involved;

(C) the vessel's speed during and leading up to the incident;

(D) description of the incident;

(E) status of all sound source use in the 24 hours preceding the incident;

(F) water depth;

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

(H) description of marine mammal observations in the 24 hours preceding the incident;

(I) species identification or description of the animal(s) involved;

(J) the fate of the animal(s); and

(K) 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 MMPA compliance. NEG and/or Algonquin may not resume their activities until notified by NMFS via letter, email, or telephone.

(ii) 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 report the incident to the Supervisor of the Incidental Take Program, Permits and Conservation Division, Office of Protected Resources, NMFS, at 301-427-8401, and/or by email to Jolie.Harrison@noaa.gov and Shane.Guan@noaa.gov and the NMFS Northeast Stranding Coordinators ( Mendy.Garron@noaa.gov or Lanni.Hall@noaa.gov ) or by phone at 978-281-9300, within 24 hours of the discovery. 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.

(iii) 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, at 301-427-8401, and/or by email to Jolie.Harrison@noaa.gov and Shane.Guan@noaa.gov and the NMFS Northeast Stranding Coordinators ( Mendy.Garron@noaa.gov or Lanni.Hall@noaa.gov ) or by phone at 978-281-9300, 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.

Based on monthly activity reports submitted to NMFS for the period between August 2010 and October 2013, there were no activities at the NEG Port during the period. Therefore, no take of marine mammals occurred or were reported 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 LNG 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 open water marine survey programs might include one or more of the following: masking of natural sounds; behavioral disturbance; non-auditory physical effects; and, at least in theory, temporary or permanent hearing impairment (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. For reasons discussed previously in this document, hearing impairment (TTS and PTS) is highly unlikely to occur based on the proposed mitigation and monitoring measures 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 dynamic positioning (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.

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 feet (100 meters) 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:

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. Calculations were performed in accordance with Marsh and Schulkin (1985) and Richardson et al. (1995) and took into consideration aspects of water depth, sea state, bathymetry, and seabed composition. In addition, the acoustic modeling performed specifically evaluated sound energy in 1/3-octave spectral bands covering frequencies from 12.5 Hz to 20 kHz. The resultant underwater sound pressure levels to the 120 dB isopleth is presented in Table 2.

Sections 101(a)(5)(A) of the MMPA (16 U.S.C. 1361 et seq. ) directs the Secretary of Commerce to allow, upon request, the incidental, but not intentional, taking of small numbers of marine mammals by U.S. citizens who engage in a specified activity (other than commercial fishing) within a specified geographical region if certain findings are made and either regulations are issued. Under the MMPA, the term “take” means to harass, hunt, capture, or kill, or attempt to harass, hunt, capture, or kill marine mammals.

Authorization for incidental takings shall be granted if NMFS finds that the taking will have a negligible impact on the identified 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 in the regulations. 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.”

Regulations governing the taking of harbor seals (Phoca vitulina), California sea lions, Steller sea lions ( Eumetopias jubatus ), harbor porpoise, Dall's porpoise, southern resident and transient killer whales, gray whales, and humpback whales, by harassment, incidental to pile driving activities in Elliott Bay, were issued on October 21, 2013 (78 FR 63396, October 24, 2013), and remain in effect until October 21, 2018. For detailed information on this action, please refer to that document. The regulations include mitigation, monitoring, and reporting requirements for the incidental take of marine mammals during pile driving activities associated with the Elliott Bay Seawall.

Pursuant to those regulations, NMFS issued an LOA, effective from October 22, 2013, through October 21, 2014, which authorizes the incidental take of the nine marine mammal species listed above that may result from construction associated with the Elliott Bay Seawall project. Take of marine mammals will be minimized through implementation of the following mitigation measures: (1) Limited impact pile driving; (2) containment of impact pile driving; (3) additional sound attenuation measures; (4) ramp-up of pile-related activities; (5) marine mammal exclusion zones; and (6) shutdown and delay procedures. SDOT will also conduct visual monitoring and underwater acoustic monitoring for mitigation and research purposes.

Reports will be submitted to NMFS at the time of request for a renewal of the LOA, and a final comprehensive report, which will summarize all previous reports and assess cumulative impacts, will be submitted before the rule expires. This LOA will be renewed based on review of the annual monitoring report and provided that NMFS makes the required findings.

The Defense Health Agency notices for systems 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 at the Defense Privacy and Civil Liberties Office Web site http://dpclo.defense.gov/privacy/SORNs/component/osd/index.html. The proposed amendments are not within the purview of subsection (r) of the Privacy Act (5 U.S.C. 552a), as amended, which would require the submission of a new or altered system report for each system. The specific changes to the record systems being amended are set forth below.

In the Department of Defense (DoD), systems of records are grouped by the DoD Component responsible for that system and its system of records notice. Each DoD Component has an assigned letter denominator for systems of records for which it is responsible. The Defense Health Agency, which was established on October 1, 2013, is assigned `E' as its letter denominator.

Pursuant to 41 CFR 102-3.105(j) and 102-3.140 and section 10(a)(3) of the Federal Advisory Committee Act of 1972, the public may submit written statements to the Board of Visitors of the DLI in response to the agenda. All written statements shall be submitted to the ADFO for DLI Board of Visitors (see FOR FURTHER INFORMATION CONTACT ). Statements must be received by the ADFO at least 10 work days prior to the meeting. Written statements received after this date may not be provided to or considered by the Board of Visitors of the DLI until its next meeting. The ADFO will review all timely submissions with the Chairperson, and ensure they are provided to the members of the respective subcommittee before the meeting. After reviewing written comments, the Chairperson and the ADFO may choose to invite the submitter of the comments to orally present their issue during open portion of this meeting or at a future meeting. The ADFO, in consultation with the Chairperson, may allot a specific amount of time for the members of the public to present their issues for review and discussion.

The Proposed Action is the transfer of approximately 624 acres of excess federal property at the former NAS Alameda from the DoN to the Department of Veterans Affairs (VA) via a Federal-to-Federal transfer. VA will be responsible for the subsequent construction and operation of an outpatient clinic (OPC), offices, and National Cemetery on approximately 112 acres of land (referred to as the “VA Development Area”).

Based on information gathered during preparation of the Final EA and based upon the findings in the Final EA, DoN finds that implementation of the Proposed Action, with the VA's implementation and monitoring of the mitigation measures identified in the FONSI, would not have a significant impact on the human environment and an Environmental Impact Statement is not required for the transfer of excess property and VA's development of an OPC, offices, cemetery, and associated infrastructure at the former NAS Alameda.

The FONSI is available for public review for 30 days before becoming final at which time the proposed action may be implemented. The FONSI public review period ends 30 days after issuance of the Notice of Availability.

Supporting documents, which explain in detail the information that the EPA will be collecting, are available in the public docket for this information collection request. The docket can be viewed online at www.regulations.gov or in person at the EPA Docket Center, WJC West Building, Room 3334, 1301 Constitution Ave. NW., Washington, DC. The telephone number for the Docket Center is (202) 566-1744. For additional information about the EPA's public docket, visit: http://www.epa.gov/dockets.

EPA ICR Number: 1663.08.

OMB Control Number: 2060-0376.

Abstract: The Clean Air Act (the CAA) contains several provisions directing EPA to require source owners to conduct monitoring to support certification as to their status of compliance with applicable requirements. These provisions are set forth in Section 504 (operating permits provisions) and Section 114 (enforcement provisions) of the CAA. Section 504(b) directs EPA to implement monitoring and certification requirements through the operating permits program. This section allows EPA to prescribe by rule, methods and procedures for determining compliance recognizing that continuous emissions monitoring systems need not be required if other procedures or methods provide sufficiently reliable and timely information for determining compliance. Under section 504(c), each operating permit must “set forth inspection, entry, monitoring, compliance, certification, and reporting requirements to assure compliance with the permit terms and conditions.” Section 114(a)(3) requires EPA to promulgate rules for enhanced monitoring and compliance certifications. Section 114(a)(1) of the provides additional authority concerning monitoring, reporting, and record keeping requirements. This section provides the Administrator with the authority to require any owner or operator of a source to install and operate monitoring systems and to record the resulting monitoring data. EPA promulgated the Compliance Assurance Monitoring (CAM) rule, 40 CFR part 64, on October 22, 1997 (62 FR 54900) to implement these authorities.

Form Numbers: None.

Respondents/affected entities: All facilities required to have an operating permit under Title V of the CAA and the state, local and tribal permitting authorities that implement the CAM program.

Respondent's obligation to respond: Mandatory under Title V of the CAA.

Estimated number of respondents: 23,235

Frequency of response: At least every 6 months per Title V and the implementing regulations at 40 CFR 70.6(a)(3)(iii)(A) and (B).

Total estimated burden: 50,473 hours (per year). Burden is defined at 5 CFR 1320.3(b).

Total estimated cost: $2,031,643 (per year), which includes no annualized capital or operation and maintenance costs.

Changes in Estimates: There is decrease of 7,403,108 hours in the total estimated respondent burden compared with the ICR currently approved by OMB. This decrease is a result of the fact that most facilities are now using electronic monitoring systems that automatically record the output of the monitor, thus, resulting in a decrease in the number of labor hours needed to record the monitoring results. Additionally, all affected facilities with existing Title V permits have now submitted their CAM monitoring approach in their permit renewal applications, therefore, significantly reducing the costs for new monitoring development. Also, we reviewed the reporting and recordkeeping requirements of the Title V permit program vis-à-vis those required under the CAM program. We found that, with the exception of sources required to develop a quality improvement plan, sources were meeting the reporting and recordkeeping requirements for CAM by complying with the requirements of the Title V program. We revised some of our assumptions to account for the additional requirements set forth under the CAM rule that are not outlined in the Title V program, while at the same time ensuring that requirements met under the Title V program were not being re-counted in this assessment. Furthermore, in order to reflect projected trends for the next 3 years, we updated some of the formulas used to calculate burden.

Supporting documents which explain in detail the information that the EPA will be collecting are available in the public docket for this ICR. The docket can be viewed online at www.regulations.gov or in person at the EPA Docket Center, EPA West, Room 3334, 1301 Constitution Ave. NW., Washington, DC. The telephone number for the Docket Center is 202-566-1744. For additional information about EPA's public docket, visit http://www.epa.gov/dockets.

EPA ICR Number: 2236.04.

OMB Control Number: 2060-0594.

Abstract: This ICR assesses the burden (in hours and dollars) of the 1997 8-hour Ozone National Ambient Air Quality Standard (NAAQS) Implementation Rule as well as the periodic reporting and record keeping necessary to maintain the rule. The rule was proposed on June 2, 2003, (68 FR 32802) and promulgated in two Phases: Phase 1 published on April 30, 2004, (69 FR 23951) and Phase 2 published on November 29, 2005 (70 FR 71612). The rule includes requirements that involve collecting information from states with areas that remain designated non-attainment for the 1997 8-hour ozone NAAQS. These information collection milestones include state submission of an attainment demonstration SIP, a RFP SIP submission, and a RACT SIP. However, not all of the milestones and associated burden and administrative costs estimates apply to every designated nonattainment area. The burden estimated is for six of the thirty-eight non-attainment areas that were reclassified to a higher classification resulting in new SIP revisions required. The remaining thirty-two non-attainment areas have either met the requirements or have their requirements suspended.

Form Numbers: None.

Respondents/affected entities: States and regional entities.

Respondent's obligation to respond: Mandatory as required by the Clean Air Act, Section 110.

Estimated number of respondents: 6 (total).

Frequency of response: Annual.

Total estimated burden: 11,667 hours (per year). Burden is defined at 5 CFR 1320.3(b).

Total estimated cost: $759,500 (per year), which includes no annualized capital or operation & maintenance costs.

Changes in the Estimates: There is an increase of 5,000 hours in the total estimated respondent burden compared with the ICR currently approved by OMB. This is due to a number of reasons that include: (1) The burden associated with one remaining non-attainment area that may receive a mandatory reclassification is estimated to be the same as areas completing the initial SIP framework because of the work they must complete to reevaluate databases, emissions inventories, legal authorities, state rule development, publication and public hearing to comply with the standards; (2) EPA's final rule of May 14, 2012 (77 FR 28423) assigning former subpart 1 ozone non-attainment areas re-designations under subpart 2, resulted in non-attainment areas with additional burden for completing SIP revisions; (3) the number of non-attainment areas has decreased as areas have come into compliance with the standards; and (4) the number of non-attainment areas with SIP revisions required has decreased as areas have either submitted the requirements or the planning requirements have been suspended with a Clean Data Determination.

Supporting documents which explain in detail the information that the EPA will be collecting are available in the public docket for this ICR. The docket can be viewed online at www.regulations.gov or in person at the EPA Docket Center, WJC West, Room 3334, 1301 Constitution Ave. NW., Washington, DC. The telephone number for the Docket Center is 202-566-1744. For additional information about EPA's public docket, visit: http://www.epa.gov/dockets.

Abstract: This ICR renewal is being submitted for the Air Emission Standards for Tanks, Surface Impoundments and Containers (40 CFR Part 264, Subpart CC and 40 CFR Part 265, Subpart CC), which were promulgated on December 6, 1994. The requirements of this subpart apply to owners and operators of all facilities that treat, store, or dispose of hazardous wastes in tanks, surface impoundments and containers that are subject to subparts I, J or K of these parts, except for Sections 264.1 and 265.1 and those management units identified at Sections 264.1080(b) and 265.1080(b). Also, the requirements of this subpart apply to large quantity generators that manage hazardous wastes in either tanks, or containers (262.34(a)(1)(i and ii)). The affected entities are subject to the General Provisions of the NSPS at 40 CFR part 60, subpart A and any changes or additions to the Provisions specified at 40 CFR part 264, subpart CC and 40 CFR part 265, subpart CC.

Form Numbers: None.

Respondents/affected entities: Facilities that treat, store, or dispose of RCRA Subtitle C hazardous waste.

Respondent's obligation to respond: Mandatory (40 CFR part 264, subpart CC and 40 CFR part 265, subpart CC)

Estimated number of respondents: 6,209 (total).

Frequency of response: Occasionally, annually, and semiannually.

Total estimated burden: 712,293 hours (per year). Burden is defined at 5 CFR 1320.3(b).

Total estimated cost: $82,092,685 (per year), includes $12,418,000 for operation & maintenance costs annualized capital and no annualized capital/start-up costs.

Changes in the Estimates: There is an adjustment increase in the respondent burden hours and costs from the most recently approved ICR. The previous ICR used rounded numbers, while this ICR uses exact values in calculating burden hours. In addition, this ICR uses updated labor rates from the Bureau of Labor Statistics to calculate burden costs.

There is also an increase of one response in this ICR due to a correction. The previous ICR did not account for the annual project report for the Sisterville Plant when calculating the total number of responses.

Supporting documents, which explain in detail the information that EPA will be collecting, are available in the public docket for this ICR. The docket can be viewed online at www.regulations.gov or in person at the EPA Docket Center, WJC West, Room 3334, 1301 Constitution Ave. NW., Washington, DC. The telephone number for the Docket Center is 202-566-1744. For further information about EPA's public docket, visit http://www.epa.gov/dockets.

ICR Information: EPA ICR Number 2375.02; OMB Control Number 2060-0648.

Abstract: This ICR includes ambient air monitoring data reporting and recordkeeping activities associated with the 40 CFR part 58, appendix A, Ambient Air Quality Surveillance Quality Assurance Regulations. These data and information are collected by state, local, and tribal air quality management agencies and reported to the EPA.

The EPA Ambient Air Quality Monitoring Program's quality assurance requirements in 40 CFR part 58, appendix A, require: “2.6 Gaseous and Flow Rate Audit Standards. Gaseous pollutant concentration standards (permeation devices or cylinders of compressed gas) used to obtain test concentrations for CO, SO 2 , NO, and NO 2 must be traceable to either a National Institute of Standards and Technology (NIST) Traceable Reference Material (NTRM), NIST Standard Reference Materials (SRM), and Netherlands Measurement Institute (NMI) Primary Reference Materials (valid as covered by Joint Declaration of Equivalence) or a NIST-certified Gas Manufacturer's Internal Standard (GMIS), certified in accordance with one of the procedures given in reference 4 of this appendix. Vendors advertising certification with the procedures provided in reference 4 of this appendix and distributing gases as “EPA Protocol Gas” must participate in the EPA Protocol Gas Verification Program or not use “EPA” in any form of advertising.”

These requirements give assurance to end users that all specialty gas producers selling EPA Protocol Gases are participants in a program that provides an independent assessment of the accuracy of their gases' certified concentrations. In 2010, EPA developed an Ambient Air Protocol Gas Verification Program that provides end users with information about participating producers and verification results. Each year, EPA will attempt to compare gas cylinders from every specialty gas producer being used by ambient air monitoring organizations. Cylinders will be verified at a pre-determined time each quarter. In order to make the appropriate selection, EPA needs to know what specialty gas producers are being used by the monitoring organizations. Therefore, EPA needs information from each primary quality assurance organization every year on specialty gas producers being used and whether the monitoring organization would like to participate in the verification for the upcoming calendar year.

Form Numbers: None.

Respondents/affected entities: State, local, and Tribal air quality management agencies.

Respondent's obligation to respond: Mandatory under 40 CFR part 58.

Estimated number of respondents: 211 (total).

Frequency of response: Yearly.

Total estimated burden: 70 hours (per year). Burden is defined at 5 CFR 1320.03(b).

Total estimated cost: $4,674 (per year). There are no annualized capital or operation & maintenance costs.

Changes in the Estimates: There is no change in the total estimated respondent burden compared with the ICR currently approved by OMB.

Title and Form Number: EIB 92-34 Application for Short-Term Letter of Credit Export Credit Insurance Policy.

OMB Number: 3048-0009.

Type of Review: Regular.

Need and Use: This form is used by a financial institution (or broker acting on its behalf) to obtain approval for coverage of a short-term letter of credit. The information allows the Ex-Im Bank staff to make a determination of the eligibility of the applicant and transaction for Ex-Im Bank assistance under its programs.

Affected Public: This form affects entities involved in the export of U.S. goods and services.

Annual Number of Respondents: 11.

Estimated Time per Respondent: 1 hr.

Annual Burden Hours: 11.

Frequency of Reporting of Use: On occasion.

Government Reviewing Time per Year: 11 hours.

Average Wages per Hour: $42.50.

Average Cost per Year: $468 (time*wages).

Benefits and Overhead: 20%.

Total Government Cost: $598.

The full text of these applications is available for inspection and copying during normal business hours in the Commission's Reference Center, 445 12th Street SW., Washington, DC 20554 or electronically via the Media Bureau's Consolidated Data Base System, http://svartifoss2.fcc.gov/prod/cdbs/pubacc/prod/cdbs_pa.htm. A copy of this application may also be purchased from the Commission's duplicating contractor, Best Copy and Printing, Inc., 445 12th Street SW., Room CY-B402, Washington, DC, 20554, telephone 1-800-378-3160 or www.BCPIWEB.com.

A. Purpose

To protect the Government's interests and to ensure timely delivery of items of the requisite quality, contracting officers, prior to award, must make an affirmative determination that the prospective contractor is responsible, i.e., capable of performing the contract. Before making such a determination, the contracting officer must have in his or her possession or must obtain information sufficient to be satisfied that the prospective contractor: (i) Has adequate financial resources, or the ability to obtain such resources; (ii) is able to comply with the required delivery schedule; (iii) has a satisfactory record of performance; (iv) has a satisfactory record of integrity; and (v) is otherwise qualified and eligible to receive an award under appropriate laws and regulations. If such information is not in the contracting officer's possession, it is obtained through a preaward survey conducted by the contract administration office responsible for the plant and/or the geographic area in which the plant is located. The necessary data is collected by contract administration personnel from available data or through plant visits, phone calls, and correspondence. This data is entered on Standard Forms 1403, 1404, 1405, 1406, 1407, and 1408 in detail commensurate with the dollar value and complexity of the procurement. These standard forms are not cumulative. The surveying activity completes only the applicable standard form(s) necessary to determine contractor responsibility in each case.

The analysis of the public comments is summarized as follows:

1. Necessity of the information collection requirement.

Comment: According to the respondent, agencies should be seeking to create savings by reducing or eliminating such information collection requirements. However, the respondent did not challenge the propriety of this underlying information collection requirement.

Response: FAR 9.106-1 requires that preaward surveys be completed only when the information on hand or readily available to the contracting officer, including information from sources other than the offeror, is not sufficient to make a determination regarding responsibility. While not all of these requirements are necessary in all cases, some are required regularly, thus preventing their reduction or elimination without negatively impacting the ability of the Government to assess contractor responsibility and protect the Government's interests in maintaining the integrity of the acquisition process.

2. OMB approval to extend the approval of this information collection requirement.

Comment: The respondent commented that the extension of the information collection would violate the fundamental purposes of the Paperwork Reduction Act because the analysis significantly underestimates the paperwork burden imposed by this requirement and has therefore not provided sufficient justification for the requested extension. The respondent further stated that the agency and OMB should assess the need to extend this information collection requirement in the context of assessing the total information collection burden. The respondent further commented that the “collective burden of compliance” required of the Government acquisition community annually totals over 30 million hours. According to the respondent, the collective burden greatly exceeds the agency's estimates and outweighs any potential utility of the extension.

Response: The criteria for extension of an information collection requirement must be based primarily on the need and use for the required information. It is essential for contractors to report requirements, regardless the number of responses. If the agencies have determined that the information is essential to protect the interests of the Government, then the extension should be approved.

3. Accuracy of data estimates.

Comment: The respondent questioned the estimated number of respondents (3,540), and how the estimated number of respondents was derived. In addition, the respondent apparently understood the renewal request to say that “preaward surveys are never justified under this information collection.” Further, the respondent asked that “OMB insist that the Agencies provide the actual number of responses received annually.”

Response: The respondent's comment that the information collection renewal request stated that preaward surveys are never justified fundamentally misunderstood the submission. While the conduct of a preaward survey is unnecessary unless other information sources are inadequate for a determination of the firm's responsibility in accordance with the requirements of FAR subpart 9.1, when a preaward survey is conducted, it is the Government that bears the burden of the effort. The Government's work in conducting a preaward survey is not the subject of this information collection, so it is not addressed in the supporting documents. That does not mean, however, that there is no such effort or that there are no preaward surveys. The information collection is focused solely on the time that a firm's employees must take to complete one or more of the forms at issue.

With regard to the estimate of 3,540 respondents, that number was clearly stated to be an estimate, not an actual number. We are unable to provide an actual number, because that information is not available through the Federal Procurement Data System (FPDS), nor is it collected in any single location.

However, the basis used for the estimate has been reconsidered due to the comment. Initially, we estimated that 30 percent of the contracts awarded in Fiscal Year 2012 (according to FPDS statistics) that were over the simplified acquisition threshold and that did not use FAR part 12 commercial acquisition procedures had a preaward survey conducted and therefore required the firm to complete at least one of the standard forms included in the information collection request. Upon reconsideration, it became obvious that a preaward survey would only be needed if the firm had not previously been a Government contractor. The revised estimate is that only 15 percent of such awards are first-time Government contract awards. This reduces the basis of the estimate from 3,540 contracts to 1,771 contracts.

4. Timing of request for extension.

Comment: The respondent noted that this information collection is soliciting comments during an emergency extension period OMB granted in March 2013. The respondent reiterated OMB's comment that the agencies should have in place an internal planning process so that completion of the public notification and comment period required by 5 CFR 1320 occurs prior to an information collection's expiration date. Regular order allows the agencies and the public to have a meaningful and on-the-record dialogue on information collection extensions.

Response: Although ideally it is preferable to complete the renewal process prior to expiration, an emergency extension may be necessary in order to allow the public the opportunity for input into the process.

5. The collective burden of compliance.

Comment: The respondent objects to the overall collective burden imposed by the Government on all respondents.

Response: The Councils cannot effectively address the broad allegations with regard to the accuracy and utility of the entire collective burden imposed on all Federal acquisitions. The Councils can only effectively address each individual information collection requirement that is under consideration for OMB approval. The Councils constantly review information collection requirements imposed by FAR regulations for ways to reduce the burdens and still achieve the objectives of the regulations, whether based on policy or statute.

A preaward survey would be needed only if the firm had not previously been a Government contractor and therefore had no record of past performance. The data from FPDS for FY 2012 showed a total of 11,805 contracts awarded Governmentwide that were over the $150,000 simplified acquisition threshold, and for which commercial acquisition procedures were not used. Initially, we estimated that preaward surveys were completed for 30 percent of the total or 3,540. After reconsideration, it became obvious that a preaward survey would only be needed if the firm had not previously been a Government contractor. The revised estimate is that only 15 percent of awards will potentially require a preaward survey. The estimate is reduced from 3,540 contracts to 1,771 contracts. Of the six Standard Forms (1403, 1404, 1405, 1406, 1407, and 1408), we estimated that Standard Form 1403 is used most frequently because it is a general form and accounts for 30 percent or 531 times, Standard Forms 1404 and 1407 account for 15 percent or 266 times, Standard Form 1408 accounts for 20 percent or 354 times, and Standard Forms 1405 and 1406 account 10 percent or 177 times.

Respondents: 531.

Responses Annually: 1.

Total Responses: 531.

Hours per Response: 24.

Total Burden Hours: 12,744.

Respondents: 266.

Responses Annually: 1.

Total Responses: 266.

Hours per Response: 24.

Total Burden Hours: 6,384.

Respondents: 177.

Responses Annually: 1.

Total Responses: 177.

Hours per Response: 24.

Total Burden Hours: 4,248.

Respondents: 177.

Responses Annually: 1.

Total Responses: 177.

Hours per Response: 24.

Total Burden Hours: 4,248.

Respondents: 266.

Responses Annually: 1.

Total Responses: 266.

Hours per Response: 24.

Total Burden Hours: 6,384.

Respondents: 354.

Responses Annually: 1.

Total Responses: 354.

Hours per Response: 24.

Total Burden Hours: 8,496.

Public comments are particularly invited on: Whether this collection of information is necessary for the proper performance of functions of the Federal Acquisition Regulations (FAR), and whether it will have practical utility; whether our estimate of the public burden of this collection of information is accurate, and based on valid assumptions and methodology; ways to enhance the quality, utility, and clarity of the information to be collected; and ways in which we can minimize the burden of the collection of information on those who are to respond, through the use of appropriate technological collection techniques or other forms of information technology.

Obtaining Copies of Proposals: Requesters may obtain a copy of the information collection documents from the General Services Administration, Regulatory Secretariat (MVCB), 1800 F Street NW., Washington, DC 20405, telephone 202-501-4755.

Please cite OMB Control Number 9000-0011, Preaward Survey Forms (Standard Forms 1403, 1404, 1405, 1406, 1407, and 1408), in all correspondence.

Proposed Project Collection of Information for Agency for Healthcare Research and Quality's (AHRQ) Consumer Assessment of Healthcare Providers and Systems (CAHPS) Health Plan Survey Comparative Database

Request for information collection approval. The Agency for Healthcare Research and Quality (AHRQ) requests that the Office of Management and Budget (OMB) reapprove, under the Paperwork Reduction Act of 1995, AHRQ's collection of information for the AHRQ Consumer Assessment of Healthcare Providers and Systems (CARPS) Database for Health Plans: OMB Control number 0935-0165, expiration July 31, 2013. The CAHPS Health Plan Database consists of data from the AHRQ CAHPS Health Plan Survey. Health plans in the U.S. are asked to voluntarily submit data from the survey to AHRQ, through its contractor, Westat. The CAHPS Database was developed by AHRQ in 1998 in response to requests from health plans, purchasers, and the Centers for Medicare & Medicaid Services (CMS) to provide comparative data to support public reporting of health plan ratings, health plan accreditation and quality improvement.

Background on the CAHPS Health Plan Survey. The CAHPS Health Plan Survey is a tool for collecting standardized information on enrollees' experiences with health plans and their services. The development of the CAHPS Health Plan Survey began in 1995, when AHRQ awarded the first set of CAHPS grants to Harvard, RTI, and RAND. In 1997 the CAHPS 1.0 survey was released by the CAHPS Consortium. The CAHPS Consortium refers to the research organizations involved in the development, dissemination, and support of CAHPS products. The current Consortium includes AHRQ, CMS, RAND, Yale School of Public Health, and Westat.

Since that time, the Consortium has clarified and updated the survey instrument to reflect field test results; feedback from industry experts; reports from health plan participants, data collection vendors, and other users; and evidence from cognitive testing and focus groups. In November 2006, the CAHPS Consortium released the latest version of the instrument: The CAHPS Health Plan Survey 4.0. The development of this update to the Health Plan Survey has been part of the “Ambulatory CAHPS (A-CAHPS) Initiative,” which arose as a result of extensive research conducted with users. AHRQ released the CAHPS Health Plan Survey 4.0, along with guidance on how to customize and administer it. The National Quality Forum endorsed the 4.0 version of the Health Plan Survey in July 2007.

Rationale for the information collection. The CAHPS Health Plan Database uses data from AHRQ's standardized CAHPS Health plan survey to provide comparative results to health care purchasers, consumers, regulators and policy makers across the country. The Database also provides data for AHRQ's annual National Healthcare Quality and National Healthcare Disparities Reports. Voluntary participants include public and private employers, State Medicaid agencies, State Children's Health Insurance Programs (SCHIP), the Centers for Medicare & Medicaid Services (CMS), and individual health plans.

This study is being conducted by AHRQ through its contractor, Westat, pursuant to AHRQ's statutory authority to conduct and support research on healthcare and on systems for the delivery of such care, including activities with respect to: The quality, effectiveness, efficiency, appropriateness and value of healthcare services; quality measurement and improvement; and database development. 42 U.S.C. 299a(a)(1), (2), and (a)(8).

Each year State Medicaid agencies, and individual health plans decide whether to participate in the database and prepare their materials and dataset for submission to the CARPS Health Plan Database. Participating organizations are typically State Medicaid agencies with multiple health plans. However, individual health plans are also encouraged to submit their data to the CARPS Database. The number of data submissions per registrant varies from participant to participant and year to year because some participants submit data for multiple health plans, while others may only submit survey data for one plan.

Each organization that decides to participate in the database must have their point-of-contact (POC) complete a registration form providing their contact information for access to the on-line data submission system, sign and submit a DUA, and provide health plan characteristics such as health plan name, product type, type of population surveyed, health plan state, and plan name to appear in the reporting of their results.

Each vendor that submits files on behalf of a Medicaid agency or individual health plan must also complete the registration form in order to obtain access to the on-line submission system. The vendor, on behalf of their client, may also complete additional information about survey administration (CAHPS survey version used, mode of survey administration, total enrollment count, description of how the sample was selected), submit a copy of the questionnaire used, and submit one data file per health plan. Commercial health plan data is received directly from NCQA. Medicare health plan data is received from CMS.

Survey data from the CAHPS Health Plan Database is used to produce four types of products: (1) An annual chartbook available to the public on the CAHPS Database Web site ( https://www.cahpsdatabase.ahrq.gov/CAHPSIDB/Public/Chartbook.aspx ); (2) individual participant comparative reports that are confidential and customized for each participating organization (e.g., health plan, Medicaid agency) that submits their data; (3) a research database available to researchers wanting to conduct additional analyses; and (4) data tables provided to AHRQ for inclusion in the National Healthcare Quality and National Healthcare Disparities Reports.

Exhibit 1 shows the estimated burden hours for the respondent to participate in the database. The burden hours pertain only to the collection of Medicaid data from State Medicaid agencies and individual Medicaid health plans because those are the only entities that submit data through the data submission process (other data are obtained directly from NCQA and CMS as noted earlier in Section 2). The 80 POCs in exhibit 1 are a combination of an estimated 60 State Medicaid agencies and individual health plans, and 20 estimated vendors.

Each State Medicaid agency, health plan or vendor will register online for submission. The online Registration form will require about 5 minutes to complete. Each submitter will also complete a Health Plan information form of information about each Health Plan such as the name of the plan, the product type (e.g., HMO, PPO), the population surveyed (e.g., adult Medicaid or child Medicaid), the health plan State, total enrollment at the time the sample frame was generated, mode of survey administration (mail, telephone, IVR) and how the sample was selected. The online Health Plan Information form takes on average 30 minutes to complete per health plan with each POC completing the form for 4 plans on average. The data use agreement will be completed by the 60 participating State Medicaid agencies or individual health plans. Vendors do not sign or submit DUAs. The DUA requires about 3 minutes to sign and return by fax or mail. Each submitter will provide a copy of their questionnaire and the survey data file in the required file format. Survey data files must conform to the data file layout specifications provide by the CAHPS Database. Since the unit of analysis is at the health plan level, submitters will upload one data file per health plan. Once a data file is uploaded the file will be automatically checked to ensure it conforms to the specifications and a data file status report will be produced and made available to the submitter. Submitters will review each report and will be expected to fix any errors in their data file and resubmit if necessary. It will take about one hour to submit the data for each plan, and each POC will submit data for 4 plans on average. The total burden is estimated to be 490 hours annually.

Exhibit 2 shows the estimated annualized cost burden based on the respondents' time to complete one submission process. The cost burden is estimated to be $20,202 annually.

In accordance with the Paperwork Reduction Act, comments on AHRQ's information collection are requested with regard to any of the following: (a) Whether the proposed collection of information is necessary for the proper performance of AHRQ health care research and health care information dissemination functions, including whether the information will have practical utility; (b) the accuracy of AHRQ's estimate of burden (including hours and costs) of the proposed collection(s) of information; (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 upon the respondents, including the use of automated collection techniques or other forms of information technology.

Comments submitted in response to this notice will be summarized and included in the Agency's subsequent request for OMB approval of the proposed information collection. All comments will become a matter of public record.

Title 5, U.S.C. 4314(c)(4) of the Civil Service Reform Act of 1978, Public Law 95-454, requires that the appointment of Performance Review Board Members be published in the Federal Register . The following persons will serve on the CDC Performance Review Boards or Panels, which will oversee the evaluation of performance appraisals of Senior Executive Service members for the Fiscal Year 2013 review period:

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

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

The “Guidance for Industry on Special Protocol Assessment” describes Agency procedures to evaluate issues related to the adequacy (e.g., design, conduct, analysis) of certain proposed studies. The guidance describes procedures for sponsors to request special protocol assessment and for the Agency to act on such requests. The guidance provides information on how the Agency interprets and applies provisions of the Food and Drug Administration Modernization Act of 1997 and the specific Prescription Drug User Fee Act of 1992 (PDUFA) goals for special protocol assessment associated with the development and review of PDUFA products. The guidance describes the following two collections of information: (1) The submission of a notice of intent to request special protocol assessment of a carcinogenicity protocol and (2) the submission of a request for special protocol assessment.

As described in the guidance, a sponsor interested in Agency assessment of a carcinogenicity protocol should notify the appropriate division in FDA's Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER) of an intent to request special protocol assessment at least 30 days prior to submitting the request. With such notification, the sponsor should submit relevant background information so that the Agency may review reference material related to carcinogenicity protocol design prior to receiving the carcinogenicity protocol.

The guidance asks that a request for special protocol assessment be submitted as an amendment to the investigational new drug application (IND) for the underlying product and that it be submitted to the Agency in triplicate with Form FDA 1571 attached. The guidance also suggests that the sponsor submit the cover letter to a request for special protocol assessment via facsimile to the appropriate division in CDER or CBER. Agency regulations (21 CFR 312.23(d)) state that information provided to the Agency as part of an IND is to be submitted in triplicate and with the appropriate cover form, Form FDA 1571. An IND is submitted to FDA under existing regulations in part 312 (21 CFR part 312), which specifies the information that manufacturers must submit so that FDA may properly evaluate the safety and effectiveness of investigational drugs and biological products. The information collection requirements resulting from the preparation and submission of an IND under part 312 have been estimated by FDA and the reporting and recordkeeping burden has been approved by OMB under OMB control number 0910-0014.

FDA suggests that the cover letter to the request for special protocol assessment be submitted via fax to the appropriate division in CDER or CBER to enable Agency staff to prepare for the arrival of the protocol for assessment. The Agency recommends that a request for special protocol assessment be submitted as an amendment to an IND for two reasons: (1) To ensure that each request is kept in the administrative file with the entire IND and (2) to ensure that pertinent information about the request is entered into the appropriate tracking databases. Use of the information in the Agency's tracking databases enables the appropriate Agency official to monitor progress on the evaluation of the protocol and to ensure that appropriate steps will be taken in a timely manner.

The guidance recommends that the following information should be submitted to the appropriate Center with each request for special protocol assessment so that the Center may quickly and efficiently respond to the request:

• Questions to the Agency concerning specific issues regarding the protocol; and

• All data, assumptions, and information needed to permit an adequate evaluation of the protocol, including: (1) The role of the study in the overall development of the drug; (2) information supporting the proposed trial, including power calculations, the choice of study endpoints, and other critical design features; (3) regulatory outcomes that could be supported by the results of the study; (4) final labeling that could be supported by the results of the study; and (5) for a stability protocol, product characterization and relevant manufacturing data.

Description of Respondents: A sponsor, applicant, or manufacturer of a drug or biologic product regulated by the Agency under the Federal Food, Drug, and Cosmetic Act or section 351 of the Public Health Service Act (42 U.S.C. 262) who requests special protocol assessment.

Burden Estimate: Table 1 of this document provides an estimate of the annual reporting burden for notifications for a carcinogenicity protocol and requests for a special protocol assessment.

Notification for a Carcinogenicity Protocol. Based on the number of notifications for carcinogenicity protocols and the number of carcinogenicity protocols currently submitted to CDER and CBER, CDER estimates that it will receive approximately 50 notifications of an intent to request special protocol assessment of a carcinogenicity protocol per year from approximately 23 sponsors. CBER estimates that it will receive approximately one notification of an intent to request special protocol assessment of a carcinogenicity protocol per year from approximately one sponsor. The hours per response, which is the estimated number of hours that a sponsor would spend preparing the notification and background information to be submitted in accordance with the guidance, is estimated to be approximately 8 hours.

Requests for Special Protocol Assessment. Based on the number of requests for special protocol assessment currently submitted to CDER and CBER, CDER estimates that it will receive approximately 300 requests for special protocol assessment per year from approximately 145 sponsors. CBER estimates that it will receive approximately14 requests from approximately 11 sponsors. The hours per response is the estimated number of hours that a respondent would spend preparing the information to be submitted with a request for special protocol assessment, including the time it takes to gather and copy questions to be posed to the Agency regarding the protocol and data, assumptions, and information needed to permit an adequate evaluation of the protocol. Based on the Agency's experience with these submissions, FDA estimates approximately 15 hours on average would be needed per response.

FDA estimates the burden of this collection as follows:

I. Background

In the Federal Register of September 18, 2013 (78 FR 57391), FDA published a notice with a 60-day comment period to request comment on a proposed collection of information related to “Food Canning Establishment Registration, Process Filing, and Recordkeeping for Acidified Foods and Thermally Processed Low-Acid Foods in Hermetically Sealed Containers.” Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval.

We have received a request to extend the comment period for the proposed collection of information. The request noted that we intend to issue a draft guidance document further explaining the forms that are the subject of the collection of information and requested that the comment period for the proposed collection of information be extended to match the comment period that will be announced in a future notice requesting comments on such a draft guidance document. The requestor expected that a likely comment period for the draft guidance would be 60 days.

We have considered the request and are extending the comment period for the information collection for 90 days, until February 18, 2014. We believe that a 90-day extension allows adequate time for interested persons to submit comments without significantly delaying our submission of the proposed collection of information to OMB for review under the PRA. We are not granting the specific request to extend the comment period to match the date when we publish a notice of availability for a related draft guidance because we cannot say with certainty when that notice will publish. However, we expect to issue that notice in a timely manner such that we would announce a comment period until approximately February 18, 2014. In addition, we note that comments are welcome on guidance documents at any time (21 CFR 10.115(g)(5)).

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

In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

Section 413(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 350b(a)) provides that at least 75 days before the introduction or delivery for introduction into interstate commerce of a dietary supplement that contains an NDI, a manufacturer or distributor of dietary supplements or of an NDI is to submit to us (as delegate for the Secretary of Health and Human Services) information upon which the manufacturer or distributor has based its conclusion that a dietary supplement containing an NDI will reasonably be expected to be safe. Part 190 (21 CFR part 190) implements these statutory provisions. Section 190.6(a) requires each manufacturer or distributor of a dietary supplement containing an NDI, or of an NDI, to submit to the Office of Nutrition, Labeling, and Dietary Supplements notification of the basis for their conclusion that said supplement or ingredient will reasonably be expected to be safe. Section 190.6(b) requires that the notification include the following: (1) The complete name and address of the manufacturer or distributor, (2) the name of the NDI, (3) a description of the dietary supplements that contain the NDI, and (4) the history of use or other evidence of safety establishing that the dietary ingredient will reasonably be expected to be safe.

The notification requirements described previously are designed to enable us to monitor the introduction into the food supply of NDIs and dietary supplements that contain NDIs, in order to protect consumers from the introduction of unsafe dietary supplements into interstate commerce. We use the information collected under these regulations to help ensure that a manufacturer or distributor of a dietary supplement containing an NDI is in full compliance with the FD&C Act. We are currently developing an electronic means for submitting this information.

Description of Respondents: The respondents to this collection of information are firms in the dietary supplement industry, including dietary supplement and dietary ingredient manufacturers, packagers and re-packagers, holders, labelers and re-labelers, distributors, warehouses, exporters, and importers.

In the Federal Register of August 26, 2013 (78 FR 52773), FDA published a 60-day notice requesting public comment on the proposed collection of information; two comments were received with one containing multiple comments. Some comments were outside the scope of the four collection of information topics being solicited and therefore will not be discussed in this document.

One comment suggested providing drop-down menus to facilitate data entry. FDA appreciates this suggestion and will continue to consider various configurations for submitting information in electronic form that are most effective and efficient for respondents. Another comment stated that FDA's estimate of 20 hours per notification is not accurate. The comment indicated that 40 to 60 hours were required to extract and summarize relevant information from the firm's files, and that an additional 20 to 40 hours was needed to format the information to meet NDI requirements. FDA deliberated over this comment, but believes that collecting and compiling data under applicable regulatory requirements for the premarket notification program places a minimal burden on respondents. As noted both in our August 26, 2013, notice and in this document, § 190.6(a) requires each manufacturer or distributor of an NDI, or dietary supplement containing an NDI, to submit notification of the basis for their conclusion that the supplement or ingredient will reasonably be expected to be safe. Because we are requesting only that information that the manufacturer or distributor should have already developed, we believe that 20 hours per submission is an appropriate burden estimate.

Both comments note that in the Federal Register of July 5, 2011 (76 FR 39111), FDA issued a draft guidance entitled “Dietary Supplements: New Dietary Ingredient Notifications and Related Issues” (available at http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/DietarySupplements/ucm257563.htm ) and suggested that FDA underestimated the reporting burden of the notification procedures under § 190.6 because we failed to take into account the provisions of the draft guidance. FDA considered this response but submits that the notification procedure requirements set forth in its regulations at § 190.6 remain unchanged. The collection of information in this instant analysis is exclusive of the draft guidance and pertains only to the subject regulations. However, as stated in the notice of availability for the draft guidance, FDA does intend to publish a 60-day notice inviting comment on the information collection burden associated with that document and will carefully evaluate all comments it receives.

FDA estimates the burden of this collection of information as follows:

We believe that there will be minimal burden on the industry to generate data to meet the requirements of the premarket notification program because we are requesting only that information that the manufacturer or distributor should already have developed to satisfy itself that a dietary supplement containing an NDI is in full compliance with the FD&C Act. In the past, commenters argued that our burden estimate is too low. Section 190.6(a) requires each manufacturer or distributor of a dietary supplement containing an NDI, or of an NDI, to submit notification of the basis for their conclusion that said supplement or ingredient will reasonably be expected to be safe. Section 190.6 requests simply the extraction and summarization of the safety data that should have already been developed by the manufacturer or distributor. Thus, we estimate that extracting and summarizing the relevant information from the company's files, and presenting it in a format that will meet the requirements of section 413 of the FD&C Act will require a burden of approximately 20 hours of work per submission.

We estimate that 55 respondents will submit one premarket notification each and that it will take a respondent 20 hours to prepare the notification, for a total of 1,100 hours. The estimated number of premarket notifications and hours per response is an average based on our experience with notifications received during the last 3 years and information from firms that have submitted recent premarket notifications.

FEMA Office of External Affairs, Public Affairs Division, is implementing the SalesForce Customer Relationship Management (CRM) system to improve the response to correspondences from individuals seeking information from a FEMA program office pursuant to Exec. Order No. 13411, which calls for improvements to the delivery of Federal disaster assistance by providing disaster survivors with “prompt and efficient access to Federal disaster assistance, as well as information regarding assistance available from State and local government and private sector sources.” The SalesForce CRM provides a centralized portal to manage frequently asked questions relating to Federal, State, local, and tribal information.

Title: The SalesForce Customer Relationship Management System Web-form allowing an Individual to Submit Correspondence to FEMA.

OMB Number: 1660-NEW.

Type of Information Collection: New information collection.

FEMA Forms: None.

Abstract: FEMA correspondence teams respond to questions from individuals covering various topics. Depending on the topic searched, the CRM queries the database of pre-approved questions and answers. If the search result does not provide the desired answer, the citizen is provided a link to the web-form to submit their inquiry (i.e. question/comment) to the proper component (i.e. program office) for a response. In general, a citizen's inquiry may range from publications requests, how to apply for grants, or reimbursement criterion. The minimal collection of Personally Identifiable Information (PII) is necessary for FEMA correspondence teams to carry out their mission of responding to citizens who seek assistance.

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

Number of Respondents: 25,000.

Number of Responses: 25,000.

Estimated Total Annual Burden Hours: 833 hours.

Estimated Cost: The estimated annual cost to respondents for the hour burden is $25,664.73. There are no annual costs to respondents operations and maintenance costs for technical services. There is no annual start-up or capital costs. The cost to the Federal Government is $645,008.00.

Comments may be submitted as indicated in the ADDRESSES caption above. Comments are solicited to (a) Evaluate whether the proposed data collection is necessary for the proper performance of the agency, including whether the information shall have practical utility; (b) evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) enhance the quality, utility, and clarity of the information to be collected; and (d) minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.

Title: FEMA Preparedness Grants: Regional Catastrophic Preparedness Grant Program (RCPGP).

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

OMB Number: 1660-0123.

Form Titles and Numbers: FEMA Form 089-19, RCPGP Investment Justification Template; FEMA Form 089-26, RCGCP (Sample) Detailed Project Plan Template; FEMA Form 089-17, RCPT Membership List.

Abstract: The RCPGP is an important tool among a comprehensive set of measures to help strengthen the Nation against risks associated with potential terrorist attacks. DHS/FEMA uses the information to evaluate applicants' familiarity with the national preparedness architecture and identify how elements of this architecture have been incorporated into regional/state/local planning, operations, and investments.

Affected Public: State, local or Tribal Government.

Estimated Number of Respondents: 10.

Estimated Total Annual Burden Hours: 1,762 hours.

Estimated Cost: The estimated annual cost to respondents for the hour burden is $88,240.96. There are no annual costs to respondents operations and maintenance costs for technical services. There is no annual start-up or capital costs. The cost to the Federal Government is $33,963.52.