In light of a changed pattern and level of oil and gas activity from what was anticipated in the 1997 ROD, there is a need to reevaluate our 1997 Oil and Gas Leasing Analysis that identified NFS lands available for federal oil and gas leasing on the PNG. The purpose of the analysis is to consider and disclose any new circumstances or information relevant to environmental effects that may not have been anticipated in the 1997 FEIS to determine if additional management direction and/or leasing stipulations are necessary to protect National Forest System lands. The need for this action is to allow the PNG to verify that specific lands nominated by industry for leasing are adequately addressed in a NEPA document before providing consent to the BLM to offer such lands at a lease sale.

The PNG proposes to validate what lands are available for federal oil and gas leasing; what constraints are needed (lease stipulations) to minimize impacts to surface resources; and make any needed changes to management direction in the LRMP.

Glenn Casamassa, Forest Supervisor of the Arapaho and Roosevelt National Forests and Pawnee National Grassland.

Based on the analysis and information contained in the EIS, the Forest Supervisor will validate which lands will be available for lease, which lands will be adminstratively unavailable for lease, whether or not additional management direction would be incorporated into the Arapaho and Roosevelt National Forests and Pawnee National Grassland LRMP, and if that would require a plan amendment.

The meeting is open to the public. Board discussion is limited to Forest Service staff and Board members.

The Federal Recreation Lands Enhancement Act (Title VII, Pub. L. 108-447) directed the Secretary of Agriculture to publish a six month advance notice in the Federal Register whenever new recreation fee areas are established. Once public involvement is complete, these new fees will be reviewed by a Recreation Resource Advisory Committee prior to a final decision and implementation. People wanting reserve these sites at Lake Canyon Recreation Area would need to do so through the National Recreation Reservation Service, at www.recreation.gov or by calling 1-877-444-6777 when it becomes available.

In accordance with the Federal Advisory Committee Act (FACA) (Title 5, United States Code, Appendix 2, Section 10), notice is hereby given to announce an open virtual meeting of the CSAC. The CSAC will meet in a virtual session on April 18, 2013. A virtual meeting of the CSAC provides a cost savings to the government while still offering a venue that allows for public participation and transparency, as required by the FACA.

This virtual meeting will take place by webinar and audio-video conferencing technology. All meeting participants, whether attending virtually or in person, should please register by April 10, 2013. The webinar will be limited to 200 participants. You may access the online registration form with the following link: http://www.regonline.com/csacapr2013. Web and audio instructions to participate in this meeting will be provided to all registered participants.

Members of the public are encouraged to attend the meeting virtually. For members of the public wishing to attend in person, a listening room will be made available. Please see the ADDRESSES section of this notice for the location of the listening room.

The agenda may be updated should priority items come before the Committee between the time of this publication and the scheduled date of the CSAC meeting.

These meetings are physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to the Committee Liaison Officer as soon as possible, preferably two weeks prior to the meeting. If attending in person, due to increased security and for access to the meeting, please call 301-763-9906 upon arrival at the Census Bureau on the day of the meeting. A photo ID must be presented in order to receive your visitor's badge. Visitors are not allowed beyond the first floor.

Any member of the public who wishes to file written data or comments pertaining to the agenda may do so by sending the data or comments via email to: Jeri.Green@census.gov (subject line “Virtual CSAC Meeting”), or by letter submission to the Committee Liaison Officer, Department of Commerce, U.S. Census Bureau, Room 8H182, 4600 Silver Hill Road, Washington, DC 20233. Such submissions will be included in the record for the meeting if received by Wednesday, April 10, 2013.

The primary purpose of the meeting is to provide the CSAC with an opportunity to discuss the following items:

• Executive Remarks.

• ACS Group Quarters Working Group.

• Optimizing Self-Response in the 2020 Census.

• Adaptive Design Case Study.

All meetings are open to the public. A brief period will be set aside at the meeting for public comment on April 18. However, individuals with extensive questions or statements (exceeding two minutes) must submit them in writing to Ms. Jeri Green by April 10, 2013.

Background

Section 117 of the MMPA (16 U.S.C. 1361 et seq. ) requires NMFS and the U.S. Fish and Wildlife Service (FWS) to prepare SARs for each stock of marine mammals occurring in waters under the jurisdiction of the United States. These reports contain information regarding the distribution and abundance of the stock, population growth rates and trends, the stock's Potential Biological Removal (PBR) level, estimates of annual human-caused mortality and serious injury from all sources, descriptions of the fisheries with which the stock interacts, and the status of the stock. Initial reports were completed in 1995.

The MMPA requires NMFS and FWS to review the SARs at least annually for strategic stocks and stocks for which significant new information is available, and at least once every 3 years for non-strategic stocks. NMFS and FWS are required to revise a SAR if the status of the stock has changed or can be more accurately determined. NMFS, in conjunction with the Alaska, Atlantic, and Pacific Scientific Review Groups (SRGs), reviewed the status of marine mammal stocks as required and revised reports in each of the three regions.

As required by the MMPA, NMFS updated SARs for 2012, and the revised reports were made available for public review and comment for 90 days (77 FR 47043, August 7, 2012). NMFS received comments on the draft SARs and has revised the reports as necessary. Subsequent to soliciting public comment on the draft 2012 SARs, NMFS revised the 2011 abundance estimates for ten Atlantic marine mammal stocks and the 2010 northeast sink gillnet serious injury and mortality estimates for several others. This new information prompted the agency to revise the SARs for the following marine mammal stocks: fin whale, western North Atlantic stock; sei whale, Nova Scotia stock; minke whale Canadian east coast stock; sperm whale, North Atlantic stock; Cuvier's beaked whale, western North Atlantic stock; Gervais' beaked whale, western North Atlantic stock; Sowerby's beaked whale, western North Atlantic stock; Risso's dolphin, western North Atlantic stock; Atlantic white-sided dolphin, western North Atlantic stock; and harbor porpoise, Gulf of Maine/Bay of Fundy stock. NMFS solicited public comment on the revised draft 2012 SARs for these ten stocks (78 FR 3399, January 16, 2013). The public comment period on the revised reports closes on April 16, 2013 and the reports will subsequently be finalized. This notice announces the availability of the final 2012 reports for the 114 stocks that are currently finalized. These reports are available on NMFS' Web site (see ADDRESSES ).

NMFS received letters containing comments on the draft 2012 SARs from the Marine Mammal Commission (Commission), the U.S. Navy (Pacific Fleet), nine non-governmental organizations (The Humane Society of the United States, Center for Biological Diversity, Garden State Seafood Association, Maine Lobstermen's Association, Inc., Cape Cod Commercial Hook Fishermen's Association, Hawaii Longline Association, Alaska Seafood Cooperative, Pacific Seafood Processors Association, and Groundfish Forum), the Western Pacific Regional Fisheries Management Council, and one individual.

Many comments recommended initiation or repetition of large data collection efforts, such as abundance surveys, observer programs, or other efforts to estimate mortality. Many comments, including those from the Commission, recommending additional data collection (e.g., additional abundance surveys or observer programs) have been addressed in previous years. Although NMFS agrees that additional information would improve the SARs and inform conservation decisions, resources for surveys and observer programs are fully utilized, and no new large surveys or other programs may be initiated until additional resources are available. Such comments on the 2012 SARs, and responses to them, may not be included in the summary below because the responses have not changed. Comments on actions not related to the SARs (e.g., listing a marine mammal species under the Endangered Species Act (ESA)) are not included below. Comments suggesting editorial or minor clarifying changes were incorporated in the reports but are not included in the summary of comments and responses below.

In some cases, NMFS' responses state that comments would be considered or incorporated in future revisions of the SARs rather than being incorporated into the final 2012 SARs. These delays are due to the schedule of the review of the reports by the regional SRGs. NMFS provides preliminary copies of updated SARs to SRGs prior to release for public review and comment. If a comment on the draft SAR suggests a substantive change to the SAR, NMFS may discuss the comment and prospective change with the SRG at its next meeting.

Comment 1: The Commission recommends that NMFS convene a workshop or series of workshops to explore novel ideas for detecting entanglements and ship strikes, improving information on their frequency and trends, reducing the bias in estimates of large whale mortality and serious injury caused by these interactions, and considering possible options for addressing these risk factors.

Response: NMFS recognizes and is attempting to address the concerns raised by the Commission through a variety of staff actions, discussed below. NMFS recognizes the threats to recovery of large whales posed by entanglements with fishing gear and collisions with ships and has implemented several regulations aimed at reducing these threats. The agency continues to conduct extensive research to quantify these threats and develop mitigation measures to reduce them. In 2010, NMFS convened a ship strike reduction workshop on reducing vessel strikes of large whales in California. In 2012, NMFS staff served on the steering committee of an international workshop on maritime transport and biodiversity conservation, aimed at developing a plan to reduce the risk of whale ship strikes. NMFS staff are members of the International Whaling Commission's (IWC) Ship Strike Subcommittee and are involved in the planning of an upcoming IWC workshop on ship strike reduction. NOAA continues to work closely with the U.S. Coast Guard on developing routing measures to reduce the risk of ship strikes in United States waters. With respect to reducing fishing gear entanglements, NMFS continues to fund and conduct gear research aimed at reducing the risk of large whale entanglements and is developing new regulations to reduce the entanglement risk associated with vertical lines.

In 2012, NMFS finalized its procedure for determining serious injury for marine mammals, which includes quantitative methods for accounting for injury cases where the outcome cannot be determined, methods for accounting for successful post-interaction mitigation efforts, and injury determination processes specific to large cetaceans, small cetaceans and pinnipeds. This is expected to provide a more accurate estimate of total human-caused serious injury and mortality to marine mammals.

Comment 2: The Commission recommends that NMFS, in conjunction with the FWS, more completely assess human effects on marine mammals by (1) developing a framework for describing the full effects, both direct and indirect, of all human activities that may cause serious injury or mortality of marine mammals and then (2) incorporating that framework into stock assessment reports so that decision-makers are informed not only about the known information on a stock but also about the degree of uncertainty regarding the other risk factors that may be affecting the stock's status and what would be required to reduce that uncertainty.

Response: The SARs discuss the potential effects of human activities on marine mammals to an extent (e.g., effects of sonar), but NMFS acknowledges that this could be more thoroughly and consistently discussed in the reports and will strive to do so. The Guidelines for Assessing Marine Mammal Stocks (GAMMS III) workshop participants recommended to NMFS that SARs describe uncertainties in key factors such as human-caused mortality and serious injury and include a statement on whether existing data would be sufficient to detect a precipitous decline if one was occurring. The draft revised GAMMS include a characterization of uncertainty in the reports.

Comment 3: The Commission recommends that NMFS consider the feasibility and advisability of providing explicit technical guidance on trend analysis and, for each stock assessment with no trend analysis, require an explicit explanation for why such an analysis could not be completed.

Response: NMFS acknowledges that the SARS for many stocks currently do not have trend analyses and the reports often do not explicitly provide the reason for this absence. In such cases where trend analyses are not available, NMFS will include in the reports an explanation for why the analysis could not be completed. Two recent papers (Moore and Barlow 2011, and Moore and Barlow 2013) provide quantitative methods for marine mammal trend analysis, which NMFS intends to apply to other stocks where there is sufficient information to do so.

Comment 4: The Commission recommends that NMFS establish an internal review process to standardize the updating of the SARs within and across regions and consider using a copy editor to check for completeness, errors, and consistency.

Response: NMFS strives to produce reports that are complete and error-free and will continue to work to standardize the reports within and across regions.

Comment 5: The Commission recommends that NMFS expand Table 2 in the North Atlantic right whale report to include right whale #3903 as a serious injury and the unidentified dead right whale seen on 18 May 2006 as an entanglement-related mortality, and recalculate the five-year average of entanglement-related mortality and serious injury.

Response: Cause of death for the 18 May 2006 event is unknown. The last sentence from the Cassoff et al. (2011) paper on this event ( http://www.int-res.com/articles/feature/d096p175.pdf ) indicates that there is still too much doubt about cause of death to make a determination; therefore, #3903 was not included in the serious injury list. “Although there was insufficient information to determine cause of death, entanglement was a probable factor, especially since there were no external injuries from a ship strike or predation, although blunt trauma with no external signs could not be ruled out.” Because there is too much doubt to make a determination of cause of death for #3903, this right whale will not be added to the list of human-caused serious injury and mortality records.

Comment 6: The Commission recommends that NMFS expand the section of the North Atlantic right whale report on fishery-related mortality and serious injury to include the total number of entanglements between 2006 and 2012.

Response: The GAMMS call for the presentation of serious injury and mortality in 5-year data periods. We recognize the increased interest in this particular stock, but feel it is outside the scope of the SAR to present more than 5 years of serious injury and entanglement records. Total numbers of entanglement cases reviewed for the applicable 5-year period are presented in the Mortality and Serious Injury Determination reports (see http://www.nefsc.noaa.gov/publications/crd/crd1211/ for the most recent reports). Only those cases that have been found to be confirmed human-caused serious injury and mortality are presented in Table 2 of the SAR.

Comment 7: The Commission recommends that NMFS expand the report for the Gulf of Maine harbor porpoise either to include a trend analysis and explanation or to describe the reasons that the analysis and explanation cannot be provided. If the latter, then the Service also should explain how it plans to rectify the problem(s).

Response: NMFS agrees that a trend analysis would be a useful addition to the harbor porpoise SAR as well as many of the other reports. We are working toward that goal with increased modeling efforts, but it may still be several years before trend analysis is available.

Comment 8: The Commission recommends that NMFS contact Canadian officials to (1) determine the feasibility of an analysis of port catch levels to estimate the number of harbor porpoises caught in the Canadian Bay of Fundy sink gillnet fishery since 2002, and (2) pursue the development of a reliable means for estimating harbor porpoise bycatch in the Canadian Bay of Fundy.

Response: NMFS agrees with these recommendations and has initiated communication with Canadian officials and hopes in the near future to improve upon the Canadian statistics provided in the SAR.

Comment 9: The MMC recommends that NMFS conduct the required surveys of the western North Atlantic harbor and gray seal stocks, incorporate the results into the stock assessment reports, and use that information in its management of those stocks and the risk factors affecting them.

Response: NMFS agrees there is a pressing need for updated abundance estimates for harbor and gray seals in United States waters. Counting of digital aerial images from our 2012 Gulf of Maine harbor seal abundance survey, our seasonal southeastern Massachusetts and gray and harbor seal monitoring surveys, and our 2010-2012 gray seal pupping surveys is underway. The resulting data will be used to develop a new abundance estimate for harbor seals. The seasonal surveys will provide an index of harbor seal and gray seal numbers and information from the pupping surveys will be used to develop a gray seal population growth model. The modeling project, however, is dependent on funding.

Comment 10: The SAR fails to provide even the most basic stock information on the western Atlantic gray seal population and, instead, lists all its stock parameters as unknown. This complete lack of data is particularly disturbing considering the indisputable explosion in gray seal numbers that has occurred on Cape Cod in recent years.

Response: NMFS concurs that the gray seal population in New England waters has been increasing, particularly in the Cape Cod region. The Northeast Fisheries Science Center (NEFSC) has been monitoring the New England gray seal pupping colonies and conducting seasonal surveys of southeast Massachusetts haul-out sites since 2005. The NEFSC expects to complete the counting of the archived digital survey images by spring 2013. These data will provide an index of harbor seal and gray seal numbers, and can be used to develop a gray seal population growth model. The completion of the modeling project, however, is dependent on funding.

Comment 11: We are encouraged to see a continued increase in the minimum population estimate, now at 444 animals, for North Atlantic right whales. It would be informative if the SAR could include an estimate of the number of those whales not included in this estimate because they were not re-sighted since 2008.

Response: It would be outside the bounds and focus of the SAR to report the number of whales not used in the estimate. That is a random number subject to varying recapture rates and as such we disagree that it is an informative number.

Comment 12: The Draft 2012 humpback whale SAR attributes all serious injury and mortality observed in the southeast and mid-Atlantic region to the Gulf of Maine stock unless a whale is definitively identified to another stock. Photo-identification research conducted in 2002 determined that less than 50% of the (humpback whales photographed in the) southeastern and mid-Atlantic states were identified as Gulf of Maine stock and that it is likely that Canadian whales were under-represented. While this is somewhat outdated, it should be used to inform assumptions on the population identity of these whales rather than attributing 100% of serious injury and mortality to the Gulf of Maine stock as was done in the draft 2012 SAR. We urge use of a more representative pro-rated method for assigning mid-Atlantic serious injury and mortality to the Gulf of Maine stock.

Response: The current approach of assigning serious injuries and mortalities to the stock of humpback whales, when known, and assigning all unknown stock injuries and mortalities to the Gulf of Maine stock provides some measure of precaution with respect to the impact of serious injuries and mortalities on the Gulf of Maine stock. However, the tally of observed serious injuries and mortalities almost certainly underestimates the actual number, given that some fraction of serious injuries and mortalities are not observed. Therefore, the possible inclusion of non-Gulf of Maine whales is unlikely to exceed the true mortality of the Gulf of Maine stock.

Comment 13: The SARs attribute the annual North Atlantic right whale human-caused serious injury and mortality data for entanglements and ship strikes to either the United States or Canada. We do not believe that United States fisheries should be held responsible for serious injury or mortality that occurs in Canadian fisheries since those fisheries are not part of our management plan. Therefore, understanding where the human-caused serious injury or mortality takes place is extremely important in more accurately assessing progress against PBR.

Response: NMFS agrees that understanding the geographic source of fishery interactions is important for management needs. However, in many cases gear is recovered after having been on the animal for some time, and it is difficult to determine where the actual interaction/entanglement occurred geographically because the animal has likely moved since the original interaction. In cases where gear is recovered, the lack of a universal marking system hampers determination of gear source.

Comment 14: The North Atlantic right whale SAR acknowledges that the location where the animal was first sighted and the date of the sighting do not necessarily indicate where or when the serious injury or mortality occurred. Yet this exact information is used to assign the serious injury or mortality to either the United States or Canada. Additional information sources must be consulted in making these determinations such as the NMFS analysis of gear removed from whales, data from Center for Coastal Studies, and necropsy data.

Response: NMFS uses all reliable available information to try to determine if the location of the entanglement differs from the location of the initial observation.

Comment 15: The summary information presented in Table 1 shows the same figure for both Nmin and Nbest for both North Atlantic right and humpback whales. Since the minimum population estimate for right whales is based on a census of individual whales, a separate estimate of Nbest should be included for this species. Similarly, Nbest should be included for humpback whales.

Response: Stock assessment guidelines require only an Nmin for calculation of PBR. Nbest is not required but is often available when an abundance estimate is derived from a sampling process. For the census count, as is used for the North Atlantic right whale and humpback whale estimate, there is only a minimum number generated with no associated range. We have considered using line-transect or mark-recapture estimators to produce an Nmin, but these approaches are likely to lead to a less accurate estimate of Nmin than the current approach.

Comment 16: Appendix III includes a description of the Northeast/Mid-Atlantic American Lobster trap/pot fishery. The section on temporal and spatial distribution of the fishery states that “fishing effort is intense and increasing throughout the range of the resource.” This statement should be corrected to reflect that effort in the lobster fishery is not increasing throughout the range of the resource.

Response: NMFS concurs. This statement has been removed from the report.

Comment 17: Table 2 of the North Atlantic right whale SAR lists mortalities and serious injuries. We believe that an animal was omitted from the list of animals entangled in 2009 that appears to have been seriously injured as a result of entanglement: Right whale #1019 (Radiator) was seen and photographed entangled in July 2009 well south of Nantucket.

Response: The extent and configuration of the gear entanglement of North Atlantic right whale #1019 is unknown. The fate of the animal is also unknown, so this interaction was not included in the list of serious injuries.

Comment 18: In the section on Annual Human-Caused Serious Injury and Mortality for North Atlantic right whales, NMFS makes an inaccurate (or at best misleading) statement regarding the number of entangled whales between 2006-2010. First, unless there are clear gear markings to indicate where the entangling gear was set, there is no way to be sure where an animal became entangled so attributing entanglements to United States (versus Canadian) gear is seldom possible. Second, there were more than “8 entanglements” during this 5-year time period. Third, even if NMFS erroneously wrote “entanglement” rather than “fishery-related serious injury and mortality,” this too would be incorrect, as Table 2 of the SAR lists 9 fishery-related serious injuries and entanglements, not eight. Fourth, each year there are a number of “floaters” for which cause of death is never established. As a result of these numerous problems with the new verbiage trying to estimate the number of animals either entangled or presumed dead pre- and post-take reduction plan, we suggest simply removing this new language regarding the number of entanglements.

Response: In response to attributing serious injuries and mortalities to nationality, we state in footnote `a' of the serious injury and mortality table: “The date sighted and location provided in the table are not necessarily when or where the serious injury or mortality occurred; rather, this information indicates when and where the whale was first reported beached, entangled, or injured.” NMFS agrees that accurately attributing entanglements to United States (versus Canadian) gear is seldom possible.

The new verbiage added dividing the entanglement and ship strike cases into pre- and post-reduction plan/ship strike rule periods was suggested by the SRG at the February 2012 review meeting. NMFS has revised the sentence to read: “Of the 8 reported fisheries entanglements from United States waters during this 5-year time period that were classified as serious injury or mortality, 5 were reported before the Atlantic Large Whale Take Reduction Plan's sinking-groundline rule went into effect in April 2009, and 3 were reported after enactment of the rule.” The 8 from United States waters is correct. However, we did find an erroneous 8, which we have corrected to 9, in the fishery-related serious injury and mortality section, as that number refers to both United States and Canadian records.

Comment 19: We reiterate a perennial request for information with less than a 2-year time lag for North Atlantic right whales. Since the estimates of mortality are minimums and based solely on sightings and strandings of dead whales, there is no need for extra time in reporting to allow for extrapolation of effort as is the case with small cetacean bycatch. It would be useful to have up-do-date information.

Response: The abundance estimate for North Atlantic right whales is at most one year behind that for other stocks in the Atlantic and Gulf of Mexico SAR. The accounting process to obtain the minimum number alive requires two years of sightings to get a stable count, after which the data are analyzed and entered into the SAR in the third year. All animals are not seen every year; waiting two years assures that greater than 90% of the animals still alive will be included in the count.

Comment 20: We believe that there are humpback whales on the large whale disentanglement Web site last seen trailing significant amounts of gear that could qualify them as seriously injured based on criteria S6 of the NMFS guidelines (NMFS Instruction, 2012).

Response: The new NMFS Serious Injury Determination Policy will not be applied until the 2013 SAR. The 2012 SAR uses the previous guidelines for determination of serious injury.

Comment 21: For multiple stocks of Atlantic coastal bottlenose dolphin, the SARs were not updated, even though most are strategic stocks. There has been additional annual fishery-related mortality since the prior update in 2010 both in commercial fisheries and recreational fishing gear and additional strandings, some with signs of human interaction. New information on strandings and entanglements should have triggered an update in the SAR for any of these strategic stocks of bottlenose dolphins. We note that the Southeast region provided updates on at least the stranding and fishery-related mortality data for bottlenose stocks in the Gulf of Mexico, and the same should be done as well for all strategic stocks of bottlenose dolphins in the Atlantic.

Response: NMFS focused efforts for the 2012 SARS on stocks in the Gulf of Mexico due to the Deepwater Horizon oil spill (that began on 20 April 2010) and the unprecedented Northern Gulf of Mexico Unusual Mortality Event that began February 1, 2010 and was ongoing as of November 18, 2012. All Atlantic bottlenose dolphin SARs will be updated for 2013.

Comment 22: Although long-finned pilot whales are listed as a strategic stock in the NMFS SARs table and fishery-related mortality has been documented in pelagic fisheries, the SAR was not updated. Annual updates are required for strategic stocks, particularly in the face of new information on mortality. Further, though NMFS has separated SARs for long- and short-finned pilot whales in the Atlantic and provided PBRs for each, mortality estimates are still “lumped,” which makes it impossible to determine whether fishery-related mortality is disproportionately affecting one species more than the other. The agency should update fishery-related mortality for all strategic stocks on an annual basis and should prioritize efforts to assign mortality to either one of these species or the other.

Response: NMFS has been working towards splitting mortality estimates for pilot whale species in the Atlantic. Because abundance estimates are made during the summer but historically most fishery-related mortality takes place in the fall and early winter, the distribution of the two species during the times of greatest mortality has been poorly understood. NMFS conducted a ship-based survey in fall 2011 to help address this issue. Both pilot whale SARs will be updated in 2013 using the information from the fall 2011 survey, and mortality estimates will be split between the two pilot whale species.

Comment 23: In the SAR for the Northern Gulf of Mexico bay, sound and estuarine bottlenose dolphin stocks in Table 1, most have not been assessed for abundance for 20 years. Since they were last assessed, there have been several declarations of Unusual Mortality Events in their ranges, and the effects of the Deepwater Horizon spill reached into quite a number of these bays. We also note that the table listing the multiple stocks in this complex of bay, sound and estuarine dolphins contains stocks for which there are also separate stock assessments (e.g., the Barataria Bay and Choctawhatchee Bay stocks are among several in the list in Table 1 that also have their own SAR). Any stock that has its own SAR should be removed from the table in the SAR for bay, sound and estuarine bottlenose dolphins to avoid confusing readers.

Response: NMFS is working towards a method to prioritize the many Gulf of Mexico bay, sound and estuary stocks of bottlenose dolphins for assessment purposes. As most of these stocks are not amenable to standard aerial or ship-based abundance survey using line- transect methods, NMFS first convened a workshop, partially funded by the Marine Mammal Commission, in 2010 to discuss and compile best practices for mark-recapture abundance estimation methods specifically aimed at bottlenose dolphins in estuarine habitats. With stocks prioritized and a robust method for abundance estimation in place, it will be possible to begin targeting specific stocks. In 2012 NMFS conducted necessary field work to start stock structure analyses for several estuarine stocks in Texas.

NMFS would like to retain the information for all the bottlenose dolphins in the multiple bay, sound and estuary stocks SAR but will note in Table 1 those stocks that have an individual SAR (e.g., Barataria Bay).

Comment 24: The Humane Society of the United States and Center for Biological Diversity commend the agency for providing more in depth information on effects from the Deepwater Horizon oil spill and subsequent declarations of Unusual Mortality Events.

Response: NMFS acknowledges this comment.

Comment 25: Given records of ongoing takes of bottlenose dolphins from several stocks in the menhaden fishery (including fisher self-reports, research-related takes and NMFS records from the 1990s), NMFS must prioritize added observer coverage of this fishery given the co-occurrence of the menhaden fishery with dolphins and the sporadic self-reports of lethal takes (which the agency acknowledges to be under-reports).

Response: NMFS agrees and, as such, implemented a pilot observer program for the Gulf of Mexico menhaden fishery during the 2011 fishing season. The goal of the pilot program was to characterize protected species bycatch, specifically sea turtles and bottlenose dolphins. During the pilot program we learned there are challenges associated with observing this fishery. For example, observing from the main ship (for safety reasons) provided limited visibility for protected species bycatch. In addition, the small number of participants triggers confidentiality requirements. We are evaluating the potential for additional observer coverage and/or methods for observing this fishery, provided resources become available. Meanwhile, we will continue monitoring fishermen self-reports and stranding data.

Comment 26: The MMC recommends that NMFS first verify that compliance with the measures of the 1997 take reduction plan for sperm whales remains at a high level and monitor any changes in fishery effort that might systematically affect entanglement risk and then reconvene the take reduction team only if either of those efforts reveals deficiencies.

Response: NMFS analyzed data from this fishery recently, including compliance with acoustic pinger use and extender lengths (Carretta and Barlow 2011). Pinger use compliance was >99% in all observed sets dating back to 1998. A small fraction of sets (3.7%) experienced some pinger failure during this study, but the recent entanglement of two sperm whales occurred in a set where all pingers were functioning. The entanglement of sperm whales in this fishery is an extremely rare event (10 entanglements observed in 8,000 sets), and NMFS continues to investigate potential factors responsible for such events.

Comment 27: The MMC recommends that NMFS continue to plan and request funding for the necessary surveys to estimate abundance of Pacific Coast harbor seals but also consider alternative assessment approaches to update stock assessment reports for harbor seals along the Pacific coast.

Response: A survey of Washington Inland waters harbor seals is planned for 2014. There are currently no funds available for conducting surveys of harbor seals on the outer coasts and Washington and Oregon.

Comment 28: The MMC recommends that NMFS review all available information on stock structure for Pacific Island stocks of melon-headed whales, pantropical spotted dolphins, and rough-toothed dolphins and update the stock assessment reports accordingly.

Response: All Hawaii SARs will be updated with new stock structure, abundance, and mortality information in 2013. New science relating to the stock structure of melon-headed whales, spotted dolphins, and rough-toothed dolphins will be reviewed and new stock boundaries may be implemented as appropriate.

Comment 29: The Hawaiian monk seal is critically endangered, and the PBR should be zero—not undetermined. With a declining population trend and an already critically low abundance, the PBR should be zero. Hawaiian monk seals are critically endangered and are on a trajectory toward extinction. An “undetermined” PBR is misleading and can be misinterpreted.

Response: The GAMMS are clear on this issue: “In unusual situations, the formula Congress added to the MMPA to calculate PBR (Nmin*0.5Rmax*Fr) results in a number that is not consistent with the narrative definition of PBR (the maximum number of animals, not including natural mortality, that may be removed from a marine mammal stock while allowing that stock to reach or maintain its OSP). An underlying assumption in the application of the PBR equation is that marine mammal stocks exhibit certain dynamics. Specifically, it is assumed that a depleted stock will naturally grow toward OSP and that some surplus growth may be removed while still allowing recovery. Such a situation arises when a stock is below its OSP and is declining or stable, yet human-caused mortality is not a major factor in the population's trend. Thus, for unknown reasons, the stock's dynamics do not conform to the underlying model for calculating PBR. For example, Hawaiian monk seals are endangered, declining, and below OSP (based upon the abundance prior to the 1970s), yet human-caused mortality is insufficient to account for the decline or a failure to increase. A limited removal would not reduce the population's ability to reach or maintain its OSP after the major factors affecting the stock have been identified and addressed. Therefore, in these unusual situations, NMFS may report PBR as undetermined.

Comment 30: The Hawaiian monk seal SAR should be updated to include the four seals slain within the past year in the Main Hawaiian Islands under suspicious circumstances, including some that may have been shot or bludgeoned. Additionally, the SAR should be updated to include the increased incidents of hooking.

Response: The 2012 SAR updates information through 2010 and contains the slain and hooked Hawaiian monk seal information through 2010 only. The draft 2013 SAR will report on more recent data.

Comment 31: Some of the areas of the Hawaiian monk seal SAR lag in reporting current information on threats. For example, ciguatoxins, potent algal neurotoxins that concentrate in fish preyed upon by monk seals, have been reported in Hawaiian monk seals, which could pose a significant threat to the seals (Bottein et al. 2011). There should also be updated information on Hawaiian monk seal diet, as well as more recent data on plastic entanglements and shark predation based upon information gathered by NMFS. There was also a problem in the past year with an aggressive monk seal killing other seals.

Response: The 2012 Hawaiian monk seal SAR updates information through 2010. This SAR was drafted in 2011 and thus only contains complete information through the previous year, 2010. Regarding ciguatoxin, the Bottein et al. (2011) paper represents an advance in detection of these compounds. However, whether and to what degree they may influence monk seal mortality is not known, and the focus of stock assessments is on human-caused mortality. More recent information will be included in the 2013 draft SAR.

Comment 32: The draft long-beaked dolphin report notes that dolphins of this species have died as a result of past Navy training exercises. The new stock assessment report should provide more information on the impacts of sonar and other training exercises given the proposed continuation and/or expansion of those activities for the Southern California and Hawaii Training Ranges. Additionally, along California's coast, mortality of long-beaked dolphins has been documented due to domoic acid toxicity, a neurotoxin associated with algal blooms. Although domoic acid toxicity is mentioned in the SAR, it may be important to note that this risk is likely to increase. Studies suggest that the toxicity of these algal blooms will increase up to 5-fold due to ocean acidification (Tatters et al. 2012).

Response: While observed impacts to long-beaked common dolphin from Navy training exercises (such as those noted in the SAR) are relatively straightforward to quantify, undetected impacts of these activities are difficult to quantify. Currently only qualitative statements about the impacts of such activities are included in the SAR, as discussed by Danil and St. Leger (2011). Language related to potential increases in the toxicity of algal blooms responsible for domoic acid mortality events has been added to the SAR.

Comment 33: The southern resident killer whale population evaluation should be restricted to evaluating the more relevant population growth trends since 1987, to discount impacts from the aquarium trade removals in the 1960s. Looking at a more limited time period, the population is actually declining, not growing.

Response: Since the first complete census of this stock in 1974 when 71 animals were identified, the number of southern resident killer whales has fluctuated annually. There have been periods of increases and declines over this time, and there is no justification in choosing any particular starting year in determining if this stock is declining or growing. The population size as of the 2010/2011 census season was 87 animals. Text in this section of the SAR has been modified to reflect the variability in population size since the first census was conducted until present.

Comment 34: The southern resident killer whale SAR should also describe the threat to the killer whales from limited prey availability. The 2011 SAR notes that “this population appears to be Chinook salmon specialists (Ford and Ellis 2006, Hanson et al. 2010), and there is some evidence that changes in coast-wide Chinook abundance has affected this population (Ford et al. 2009).” NMFS' recent biological opinions confirm that evidence.

Response: The SAR currently contains language and references regarding potential effects of limited prey availability on this population of killer whales.

Comment 35: The new records of movements of the western stock of gray whales to the United States waters (Weller et al. 2012) suggests that the SAR should obtain more information and consider calculating PBR for this stock of whales as they are at risk of being caught by United States fisheries and would be at risk from a proposed Makah tribal hunt of gray whales.

Response: NMFS plans on preparing a separate stock assessment report for the western stock of gray whales in 2013.

Comment 36: At least two cases of apparent human-related injury do not appear to have been accounted in the gray whale SAR. Two gray whales with apparent trauma were examined by Cascadia Research in April 2009 and a gray whale that stranded in California in April 2009 had apparent propeller cuts along one side. This section should be checked to update mortalities.

Response: One of the two gray whales examined by Cascadia Research in April 2009 is already listed in the draft SAR. The April 27 record has the geographic attribution of Whidbey Island, although the animal was first seen floating off Camano Island. The carcass was towed to nearby Whidbey Island for necropsy. The second record was reviewed in the preparation of the draft SAR, and the source of the trauma was not definitively human-related. The California stranding from Sunset Beach is listed in the draft SAR (April 5, 2009 whale with apparent propeller cuts).

Comment 37: Though the region may have reviewed the stock assessments for the ESA-listed stocks (e.g., blue whales, humpback whales, etc.), there is no mention made of this. This assurance should be provided to reassure reviewers that the region was diligent in monitoring these stocks. New information on abundance or mortality triggers the requirement to revise the SAR for a strategic stock. The SARs for ESA-listed stocks should be updated annually in the face of annual mortality.

Response: Strategic stocks are reviewed annually, but revisions to the stock assessment may not necessarily be made unless new information on mortality would change the status of that stock. NMFS will add language to the preface of future Pacific region SARs that will inform reviewers and public commenters of this action each year.

Comment 38: NMFS should work to obtain more data on Hawaii spinner dolphin stocks. The military exercises planned in the range of spinner dolphins pose a threat to them and should be discussed here. The takes predicted in the Southern California and Hawaii Training Range for 2014-2019 are extremely large numbers.

Response: NMFS has added a statement of the potential impact of naval activities on spinner dolphins in Hawaii due to the proximity of naval training exercises for main Hawaiian Islands stocks. NMFS is working with its research partners to collect additional information on spinner dolphin stocks in Hawaii. Significant progress has been made in recent years with recognition of five distinct island-associated stocks within the main and Northwestern Hawaiian Islands and a sixth pelagic stock. As additional information becomes available on stock abundance and movements, it will be reflected in the SAR and considered as part of incidental harassment and other take authorizations. Such authorizations are analyzed through the NMFS permitting process.

Comment 39: While we commend the region for including literature as recent as 2012 to inform the false killer whale SAR, there is updated literature used in consideration of the proposed listing of the insular stock that is not considered in the SAR that may provide further insight into stock movements and boundaries (e.g., Chivers et al 2011). It also may be worth noting that there is currently no mechanism to address the excessive levels of fishery-related mortality. NMFS still has not published the take reduction plan for false killer whales and has indicated that portions of the plan recommended by the take reduction team will likely not be part of any final plan. As such, we are concerned that there will be continued depredation of stocks by fisheries.

Response: Chivers et al. 2011 and Baird et al. In press were added to the text and list of citations to better reflect the breadth of support for the separation of the Hawaii insular stock, now known as the Main Hawaiian Islands insular stock, from other false killer whale populations. The final take reduction plan outlining regulatory and non-regulatory measures intended to reduce false killer whale bycatch in Hawaii's longline fisheries was published on November 29, 2012. Requirements such as longline area closures and measures to improve captain and crew response to hooked and entangled marine mammals went into effect on December 31, 2012, and gear requirements for the deep-set longline fishery take effect on February 27, 2013. Nearly all take reduction measures recommended by the take reduction team were implemented as part of the final plan (77 FR 71260, 29 November, 2012). The reference in the SAR has been updated to reflect the recent publication of the new fishery rules and summarize the implemented measures.

Comment 40: There appear to be at least two populations of melon-headed whales in the Hawaiian archipelago. There is a small population resident off the northwest region of the island of Hawaii and a larger population that ranges throughout the main Hawaiian Islands (Aschettino 2010). As melon-headed whales may be susceptible to impacts from navy training exercises, the presence of a small population with a restricted range in an area adjacent to where naval exercises may be undertaken should be noted. Aschettino (Id.) also notes evidence of fisheries interactions for both the Big Island resident population and the Main Hawaiian Islands population. This should be updated in the next SARs.

Response: All Hawaii SARs will be updated with new stock structure, abundance, and mortality information in 2013. New science relating to the stock structure of melon-headed whales, spotted dolphins, and rough-toothed dolphins will be reviewed, and new stock boundaries may be implemented as appropriate.

Comment 41: Hawaii spotted dolphins should be split into management stocks and managed to protect local populations that may be adversely impacted by commercial and recreational fisheries. Recent genetic analyses support the separation of pantropical spotted dolphins found in the Hawai`i, O`ahu, and 4-islands area regions into different populations (Courbis 2011). This should be updated in the next SARs.

Response: See response to comment 40.

Comment 42: There are new genetic studies indicating that there should be separate SARs for rough-toothed dolphins. There is high site fidelity and small populations of these dolphins that appear to warrant separate management approaches (Baird et al. 2008, Albertson 2011, poster). This should be updated in the next SARs.

Response: See response to comment 40.

Comment 43: The Western Pacific Regional Fishery Management Council finds inconsistencies in NMFS' interpretation of population trend data for different stocks of false killer whales. The Council agrees that changes in survey methodology and oceanographic conditions preclude using the 2002 and 2010 abundance estimates as a direct measure of population trend for the pelagic stock of false killer whales. However, we find that NMFS has not consistently applied the above reasoning in evaluating the insular stock population trend. The Council therefore requests that NMFS apply consistent scientific reasoning in inferring population trends for the insular and pelagic stocks of false killer whales.

Response: Considerably more data are available to evaluate trends of main Hawaiian Islands insular false killer whales than are available for the pelagic stock. Only two abundance estimates are available for the pelagic stock, each with overlapping coefficients of variation (CV), and it is not possible to assess whether this stock may be increasing, decreasing, or stable. In contrast, data on insular stock trends include aerial survey data from the 1980s, 1990s and early 2000s, and recent estimates of abundance from small vessel surveys resulting in identification of a large portion of the population. These data together allow for a robust assessment of population trend for the insular stock. Uncertainties in the trend assessment were tested in sensitivity trials in Oleson et al. (2010), with the outcome of all plausible models indicating a declining population.

Comment 44: The Western Pacific Regional Fishery Management Council finds the declining population trend attributed to the insular stock to be inconsistent with observed data since 2000. The draft 2012 SAR cites the Status Review of Hawaiian insular false killer whales to show that the current decline of the insular stock is occurring at an average rate of 9% since 1989. The SAR also reports that the population estimate for the insular stock based on a photographic mark-recapture study during 2000-2004 was 123 animals. Applying the 9% annual decline to the 123 insular false killer whales in 2000, the population in 2012 would be estimated at approximately 40 animals. Alternatively, starting with 123 animals in 2004 would result in approximately 58 animals in 2012. However, the current best estimate of the insular false killer whales according to the draft 2012 SAR is 151 animals, significantly higher than would be expected based on the quantified population trend. This simple exercise highlights possible inaccuracies in NMFS' assumptions regarding the insular stock population trend. The Council therefore requests that NMFS reanalyze the insular stock population trend based on the best available information.

Response: NMFS thanks the Council for pointing out an omission in the draft 2012 SAR. The 2000-2004 estimate used in the Population Viability Analysis (PVA) presented in the Hawaiian insular false killer whale Status Review was 162 (CV=0.23) animals, rather than the older estimate of 123 (CV=0.72) animals listed in the SAR. The updated abundance estimate for the 2000-2004 period has now been included within the SAR. All estimates are described in detail in Oleson et al. (2010). However, the exercise conducted by the Council does not correctly consider the time period of the two estimates (from 2000-2004 to 2006-2009) and does not incorporate uncertainty in the estimates of population abundance and trend. Also, it does not provide an accurate evaluation of the trend analyses conducted as part of the Status Review. NMFS is required to use many factors in calculating the abundance trend, as carefully described in Oleson et al. (2010)—we attempt to summarize those factors here. The PVA used all available data, including minimum counts, encounter rates, and abundance estimates, as well as estimates of environmental stochasticity, the impact of Allee effects, and catastrophic events. The Status Review explicitly acknowledged the relatively small change in population size from the 2000-2004 estimate of 162 individuals and the 2006-2009 estimate of either 151 or 170 individuals, suggesting that a two-stage model may also be appropriate. Most iterations of the PVA were parameterized with the higher 2006-2009 abundance of 170 individuals that is now considered an overestimate, as animals seen near Kauai now known to associate with the Northwest Hawaiian Islands (NWHI) stock were included in that estimate. Thus, the second rate of change could be seen as overly optimistic, as it attempted to incorporate the higher 2006-2009 abundance. The impact of using the lower 2006-2009 estimate on the risk of extinction can be seen in Appendix 2 (model 9) of Oleson et al. (2010).

Comment 45: Based on the new abundance estimate and all other available evidence, the Western Pacific Regional Fishery Management Council believes that the Hawaii longline fishery has had significantly less impact on the false killer whale population than has been implied over the last decade. According to NMFS, incidental take of false killer whales in the Hawaii deep-set longline fishery has exceeded PBR since 2000 when a SAR for Hawaii false killer whales was first produced. Given that take exceeding PBR in the long-term is considered unsustainable, the false killer whale population interacting with the longline fishery would be expected to show a decline. However, available data do not suggest that the pelagic stock has experienced a decline, and a stable or increasing trend is much more likely for the pelagic stock than a declining trend. This calls into question the assumptions used in marine mammal stock assessments, the calculation of PBR, and evaluation of fishery impacts on marine mammal populations. Given the lack of evidence indicating a population decline of the pelagic stock of false killer whales, NMFS should consider setting the recovery factor higher than 0.5.

Response: NMFs concurs with the Council's comment on the 2012 draft SARs that acknowledges that environmental variability and lack of information on the entire range of the pelagic false killer whale stock precludes any trend analysis for this stock. In this comment, the Council is implying that such trend analyses may be appropriate. At this time, inadequate data exist to assess trends in abundance for this stock, and it is inappropriate to assume the fishery has had no effect when surveys covered only a fraction of the range of the population, without any information on the dependence of the distribution of this stock on environmental conditions. The population remains at unknown status such that use of a recovery factor equal to 0.5 is appropriate and warranted.

Comment 46: The draft 2012 SAR for the Hawaiian Islands stock complex of spinner dolphins description under the human-caused mortality and serious injury section in nearly all Hawaii dolphin SARs is irrelevant and represents an inaccurate interpretation of the cited study. Furthermore, NMFS observer data from the Main Hawaiian Islands bottomfish fishery between 2003 and 2005 indicate that there has been no observed incidental take of cetaceans in this fishery. The Council believes the observer program data represent the best available information on human-caused mortality and serious injury for the bottomfish fishery and requests that NMFS include these as a measure of interactions in the fishery rather than using the target catch damage rates currently used in the SARs.

Response: The information on interaction rates from the 1995 study will continue to be included as it represents the best available historical data for the bottomfish fishery. NMFS appreciates the Council's reference to more recent data from the Observer Program from 2003 to 2005, a short period when the NWHI fishery was observed at 18-25% coverage. This information is now included in the SAR. The Main Hawaiian Islands bottomfish fishery has never been observed.

Comment 47: The draft 2012 SAR for Hawaiian monk seals includes descriptions of recent intentional killings in the Main Hawaiian Islands, followed by the claim that “more seals are likely intentionally killed than are reported or discovered.” However, no scientific justification or reference is provided to support this claim, and it appears to be speculative. NMFS should avoid such speculation and use the best available scientific information in the SARs as required under Section 117(a) of the MMPA.

Response: The intentional killing of monk seals in the Main Hawaiian Islands is well-documented, although it is extremely unlikely that all carcasses of seals killed intentionally are discovered and reported. Studies of the recovery rates of carcasses of marine mammal species have shown that the probability of detecting and documenting all deaths (whether from human or natural causes) is quite low (Peltier et al. 2012; Williams et al. 2011; Perrin et al. 2010; Punt and Wade 2010). Text to address this uncertainty has been incorporated in the SAR.

Comment 48: The SARs annually contain descriptions of United States commercial fisheries in Appendix I. No revisions were proposed in the draft 2012 SAR for the Pacific Ocean. However, upon review of the fishery descriptions in the Final 2011 SARs, the Council notes that descriptions for Hawaii Category III fisheries (Hawaii gillnet, lobster trap, inshore handline, deep sea bottomfish handline & jig, and tuna handline and jig fisheries) are outdated and require revisions. Necessary revisions include, but are not limited to, the following: (1) Number of active permit holders and total effort for the Hawaii Category III fisheries have not been updated since 2000; (2) there are currently no lobster and bottomfish fisheries in the NWHI due to the establishment of the Papahanaumokuakea Marine National Monument that prohibited unpermitted removal of monument resources; (3) the Main Hawaiian Islands bottomfish fishery in federal waters is managed under the Fishery Ecosystem Plan for the Hawaiian Archipelago and operates under an annual catch limit. The fishery is co-managed with the State of Hawaii, which has adopted complementary measures in state waters.

Response: NMFS will update all fishery descriptions in the 2013 SARs and will consult with local Council staff regarding whether other updates may be warranted.

Comment 49: The Hawaii Longline Association appreciates that NMFS has updated the abundance estimate for the Hawaii pelagic false killer whale stock (“Pelagic Stock”) based on the best available scientific information. However, certain aspects of the Draft SAR's characterization of the 2010 Hawaii EEZ survey data are inaccurate and, accordingly, we propose language that accurately reflects the available information. The Draft SAR is not consistent with the best available scientific information in two additional respects: (i) the Draft SAR's statement that no population trend data are available for the Pelagic Stock and (ii) the use of a 0.5 recovery factor value in the calculation of the Pelagic Stock's potential biological removal.

Response: The Hawaii Longline Association proposed revisions to the text in the Hawaii pelagic false killer whale stock SAR regarding the possibility of positive bias in sightings as a result of vessel attraction; this language has been incorporated with a few changes. Including additional bootstrap variance on the various parameters in the 2010 estimate would not inform this issue (other than showing that most of the variance comes from the encounter rate) and would seem to be superfluous information for a SAR. It remains that the bootstrap CV on the density (and abundance) estimates resulted in an estimate with confidence intervals that overlap with those of the 2002 estimate. That alone negates our ability to make a trend estimate as infinite scenarios (including a decline) are possible (lognormal 95% CIs for the two estimates are 484 (103-2274) and 1,503 (462-4884)). The population remains at unknown status, such that use of a recovery factor equal to 0.5, given the CV on the mortality and serious injury estimate, is appropriate and warranted.

Comment 50: The certainty with which NMFS has confirmed a new, separate false killer whale stock in the NWHI stock is not scientifically justified. This decision was made on a very limited data set and the agency's rush to judgment about the separateness of this new “stock” appears to reflect an aversion to attributing new sightings of hundreds of whales to already established stocks, not the best available information.

Response: NMFS disagrees that the designation of new stocks is not scientifically justified. The separation of the NWHI stock and the Hawaii insular and pelagic stocks is sound and based on multiple lines of evidence including genetic analyses indicating significant differentiation in both mtDNA and nucDNA, photo-ID indicating separation from the tight social network of the Main Hawaiian Islands animals, and satellite telemetry data suggesting island and atoll association within the NWHI. The data on false killer whale stock structure, including the new NWHI stock, have been evaluated both for demographic independence, the benchmark for separation under the MMPA, and for evolutionary separation, the more stringent standard for separation under the ESA.

Comment 51: NMFS's serious injury determinations regarding the deep-set fishery's interactions with the Pelagic Stock are not accurate. NMFS's contention that the deep-set fishery has caused serious injuries in excess of PBR for a period of years cannot be reconciled with the best available evidence, which shows that false killer whale populations in the Hawaii EEZ have increased, or at a minimum remained stable, during the same time that the deep-set fishery has supposedly caused serious injuries at an unsustainable rate. NMFS should implement changes in the process through which serious injuries are determined.

Response: At this time, the available data do not provide sufficient information to statistically determine trends in abundance, particularly since only a portion of the range of this stock has been surveyed. It is therefore incorrect to conclude the population is stable or increasing. The MMPA clearly states that a stock for which mortality and serious injury exceeds the PBR is strategic, and false killer whales have consistently met this definition since the first SAR for Hawaiian false killer whales in 2000.

The process by which injuries are determined to be serious or not serious has been developed and peer-reviewed over many years by experts in marine mammal biology and health, and is based on the best available science (see Andersen et al. 2008; NOAA 2012a; NOAA 2012b). Prorating is done in accordance with NMFS guidelines using appropriate statistical techniques, and has been peer-reviewed by the Pacific SRG and other qualified scientists.

Comment 52: Several of the draft SAR's conclusions regarding the Hawaii insular false killer whale stock (the “Insular Stock”) are not correct. Specifically, the best available scientific information does not (i) suggest that the Insular Stock has declined in abundance or (ii) support the allocation of a deep-set fishery interaction to the Insular Stock. In addition, the use of a 0.1 recovery factor is inappropriate until, if, and when the Insular Stock is listed as an endangered species.

Response: This stock was listed as endangered under the ESA as of December 28, 2012 (77 FR 70915). The name of this stock has been changed to the “Main Hawaiian Islands insular stock” throughout the SAR to reflect the name given during the ESA listing. Prior to listing, NMFS conducted an ESA status review of Hawaii insular false killer whales (Oleson et al. 2010) that represents the best available scientific information on the status of this stock. The PVA conducted by the Biological Review Team (BRT) indicates with high certainty that the population has declined. No new information is available since the 2010 Status Review that negates the findings of the BRT. The BRT concluded that Hawaiian insular false killer whales are at high risk of extinction as a result of either small scale incremental impacts over time or a single catastrophic event. The combination of a decline in abundance, a high risk of extinction, and a small population size warranted a recovery factor of 0.1 for this stock prior to their listing, which was supported by the Pacific SRG.

The partial allocation of a single 2006 take within the Main Hawaiian Islands insular-pelagic overlap zone is supported by the best available data on the range of the insular and pelagic stocks. The reference to the NMFS statement that there are “no documented serious injuries or mortalities of [Insular Stock] animals incidental to Hawaii's longline fisheries” (75 FR 2853, 19 January, 2010) does not include the entire sentence from the Federal Register notice, which clearly states that the provided information comes from the 2008 and 2009 SARs, prior to reevaluation of the insular stock boundary and the implementation of the insular-pelagic overlap zone.

Comment 53: The US Navy would request for the final long-beaked common dolphin SAR deletion of the sentence as unwarranted: “Exposure to blast trauma resulting from underwater detonations is a habitat concern for this stock and the cumulative impacts of these detonations at the population level is unknown (Danil and St. Leger 2011)”, and deletion of the blast trauma statement “* * * and mortality resulting from blast trauma (0.8 animals per year for the 5-yr period 2007 to 2011).”

Response: Danil and St. Leger (2011) state that the population-level impacts of such blast-trauma events require careful consideration. This acknowledges that while this was the first such event documented by the Navy in this region, not all blast trauma events are necessarily detected. NMFS supports the mitigation measures that the Navy implemented following this event and acknowledges that such measures will reduce the probability of future events. NMFS acknowledges that this type of activity represents a local threat to dolphins in the testing area, unlike habitat threats that could have much larger spatial and quantitative impacts. Language in the SAR has been changed from “habitat concern” to “local concern.”

Calculation of an average annual mortality based on various human-caused sources is required under Section 117 of the MMPA, which states that NMFS must “estimate the annual human-caused mortality and serious injury of the stock by source and, for a strategic stock, other factors that may be causing a decline or impeding recovery of the stock, including effects on marine mammal habitat and prey.” The use of a 5-year average annual mortality for past human-caused mortality and serious injury is standard in stock assessment reports and is used for all sources of human-caused mortality. The language in the SAR is not intended to imply that future blast trauma events will occur every year at a level of 0.8 animals per year but rather is an annual average of the most recent past 5-year period over which human-caused mortality is evaluated from each source. Conversely, an absence of detected blast trauma events in a given year does not constitute “evidence of absence” of these events.

Comment 54: I would like to suggest that the CA-OR-WA minke whale stock extends north into British Columbia, Southeast Alaska, Prince William Sound and along the Gulf of Alaska coast to about Unimak Pass in the Aleutian Islands. I base this assertion on the similar spatial distribution patterns in these northern regions to that in the CA-OR-WA stock. My suggestions would be a CA-OR-WA-BC-AK stock, although I know that BC waters are not under the purview of NMFS.

Response: While the distribution of minke whales may be concentrated in shelf waters within the large area described, there are no data that support the lumping of CA-OR-WA stock minke whales with animals from Canada and Alaska. In the absence of such evidence, the GAMMS recommend defining management units at a smaller spatial scale to avoid local depletion, particularly as the source and magnitude of anthropogenic impacts may vary regionally.

Comment 55: The Commission recommends that NMFS meet with the Commission to discuss the impending changes in the Arctic and consider the development of (a) a long-term assessment strategy to characterize population abundance, stock status, and ecological and human interactions as climate disruption continues and (b) a long-term management strategy that anticipates the risks to ice seals and develops pro-active measures to avoid or minimize those risks.

Response: NMFS appreciates the Marine Mammal Commission's interest and would welcome the opportunity to discuss these and other issues of mutual concern.

Comment 56: The Commission recommends that NMFS continue its efforts to (1) collaborate with the Alaska Native community to monitor the abundance and distribution of ice seals and (2) use seals taken in the subsistence harvest to obtain data on demography, ecology, life history, behavior, health status, and other pertinent topics; among other things, subsistence harvests provide opportunities to collect valuable data on ice seal populations in many parts of their ranges while minimizing the logistical requirements and costs.

Response: NMFS continues to work with Alaska Native partners to obtain data on ice seal stocks, including information on abundance and distribution, demography, ecology, life history, subsistence harvest, and other data pertinent to assessing the status of these stocks.

Comment 57: The Commission recommends that NMFS revise its stock assessments for the north Kodiak, south Kodiak, and Cook Inlet harbor seal stocks by (1) Reducing the recovery factor to be consistent with the Service's 2005 guidelines, (2) recalculating their PBR values, (3) updating the stock assessment reports accordingly, including changing the status of the north Kodiak stock, and (4) working with Native communities to ensure that harvest numbers, when combined with other human-related serious injuries and deaths, do not exceed the PBR for the north Kodiak stock.

Response: The GAMMS state that, “stocks that are not known to be decreasing, taken primarily by aboriginal subsistence hunters, could have higher Fr values, up to and including 1.0, provided that there have not been recent increases in the levels of takes.” In the case of these 3 stocks, the trend is unknown, there are no additional indications the stocks are decreasing, they are taken primarily by aboriginal subsistence hunters, and there is no apparent increase in the level of takes. NMFS is currently developing new methods for analysis of abundance and trend for each of the stocks. Results from this new analysis will inform future decisions regarding the determination of recovery factor. Additionally, the assignment of subsistence harvest and fisheries mortalities to a particular stock is imprecise, because the stocks are mixed during most of the year, when harbor seals are not tied to their breeding locations. As noted in response to other comments, NMFS continues to work with Alaska Native partners to obtain subsistence harvest data.

Comment 58: The Commission recommends that NMFS conduct the research needed to (1) analyze and describe the risks to North Pacific right whales associated with increasing shipping traffic in the Bering Sea and North Pacific, paying particular attention to Unimak Pass, and of entanglement in fishing gear and (2) use that information to design management measures that will minimize the risk of ship strikes and entanglement, and that it ensure its activities do not significantly increase the risk faced by the whales.

Response: NMFS is also concerned about the North Pacific right whale population. With a current estimate of 31 animals in the eastern population, the population is critically endangered. At the present time, there is no evidence that entanglement in fishing gear is a major problem for this population; photographs of right whales in the National Marine Mammal Laboratory catalogue show no entanglement scars. In addition, the Alaska Fisheries Science Center is working with the Marine Conservation Alliance, a fishing industry group, to examine the overlap of fixed gear with right whales in the Bering Sea, and will produce a report on this analysis in the coming year. With regard to shipping, it will be difficult to reliably quantify the risk of ship strikes to right whales in Unimak Pass or elsewhere because we have very little information on seasonal right whale distribution. NMFS is considering the emerging issue of increased shipping in the Arctic with various management bodies and stakeholders, and is working toward a coordinated, proactive approach to this topic. In addition, the research needs identified by the Commission are part of the recently published draft Recovery Plan for North Pacific right whales (78 FR 4835, January 23, 2013).

Comment 59: The Commission recommends that NMFS make every effort to expedite the analysis of all passive acoustic, satellite telemetry, and other data available for North Pacific right whales, update the stock assessment report accordingly, and use those data to develop protective measures for this population.

Response: NMFS has already conducted and published results of some of this work, including papers on a low-latitude match and an aerial acoustics technique together with new data on the past illegal Soviet catches (the primary reason for the eastern population's critically endangered status). Other papers summarizing the distribution, acoustic research, and satellite tagging data are in preparation. NMFS is currently seeking funding for a study clarifying whether the northern limit of the right whale's range in the Bering Sea extends to and above the Bering Strait.

Comment 60: The Commission recommends that NMFS revise the stock assessment report for the North Pacific right whale stock to indicate that based on knowledge of migratory patterns of similar species, Hawaii and Mexico could be low latitude habitats used more regularly by North Pacific right whales than currently recognized.

Response: As noted by Brownell et al. (2001) and Clapham et al. (2004), there is very little evidence from historical whaling and sighting data, or from archaeology, that either Hawai'i or Baja California were ever a significant habitat for right whales. There has been no new information since those publications that would significantly alter that conclusion.

Comment 61: There is an acknowledgement in the Steller seal lion (Western stock) SAR that there is a marked difference in trends of abundance for this stock depending on the specific trend site. Yet the gains in some portions of the range have been assumed to compensate for the losses in other portions of the range with a PBR calculated for the entire stock from the western Aleutians to the eastern Gulf of Alaska. This seems inappropriately risk prone. The region should consider managing Steller sea lions on a finer scale to more appropriately illustrate the need for conservative management in portions of the species' range where declines are ongoing.

Response: The Alaska Regional Office has been considering options for more fine-scale management of Steller sea lions for some time (with areas such as those in the Recovery Plan). For example, we considered fine-scale population trends in the 2010 Biological Opinion on the effects of the Alaska groundfish fisheries on the Western distinct population segment (DPS), and we are examining trends in portions of the Eastern DPS as we consider possible delisting. NMFS Alaska Regional Office will continue to investigate this approach.

Comment 62: Steller sea lions (Western stock) is one of several stocks for which there is an acknowledgement that fisheries known to interact with the stock are not being monitored by observers and may not have been monitored in over a decade. In this case, the SAR states that “observer data on state fisheries dates as far back as 1990; however, these are the best data available to estimate takes in these fisheries. No observers have been assigned to several fisheries that are known to interact with this stock.” This must be remedied to provide a better understanding of fishery-related impacts, particularly in areas where there are ongoing declines.

Response: NMFS has previously responded to this comment (see 77 FR 29969, May 21, 2012, comment 62) as follows: “NMFS is working with fishing industry and Alaska state partners on implementing adaptive sampling in the federal observer program that covers fisheries managed by the State of Alaska. The adaptive sampling methods are designed to increase data collection efficiency. NMFS has recently directed funds to observer effort in nearshore drift gillnet fisheries in southeast Alaska.”

Comment 63: This Steller sea lions (Western stock) SAR is one of many SARs for pinnipeds in Alaska stating that “[a]s of 2009, data on community subsistence harvests are no longer being collected. Therefore the most recent 5-years of data (2004-2008) will be retained and used for estimating annual mortality * * *” This is a deplorable approach to management of a stock that is declining in inhabited portions of its range and/or where hunting of this endangered species may be ongoing. NMFS must correct this data deficit as soon as possible.

Response: NMFS agrees that it is important to understand the magnitude of Steller sea lion subsistence harvest. A successful marine mammal harvest monitoring program cannot be developed exclusively in the federal domain and must be supported by Alaska Native hunters and communities. In December 2010 and March 2011 NMFS partnered with the Indigenous People's Council on Marine Mammals to convene two workshops of marine mammal hunters and Alaska Native Organization (ANO) representatives to begin to develop a statewide program for monitoring subsistence hunting and harvests. NMFS continues to work with our ANO partners on harvest monitoring programs within the annual ANO co-management funding program.

Comment 64: The need for better accounting of mortality is particularly poignant for Steller sea lions (Western stock) because there is every reason to believe that human-related mortality exceeds the PBR. The section on “status of the stock” states that the current levels of anthropogenic mortality and serious injury are below the PBR simply because anthropogenic mortality is at a level a few dozen animals less than the PBR. This does not account for the fact that (as acknowledged in the SAR) fishery-related mortality data are absent; and, thus, the estimate of fishery impacts is likely an under-estimate. Nor does it take into consideration the complete lack of effort to collect data on native subsistence take. Thus the statement that the average annual mortality of 231.8 is below the PBR of 275 is overly optimistic and likely inaccurate.

Response: Previous responses (75 FR 12498, March 16, 2010, Comment 19; 76 FR 34054, June 10, 2011, Comment 11) have addressed comments pertaining to the need for current and accurate estimates of subsistence takes for pinnipeds in Alaska, including the western stock of Steller sea lions. Observer coverage in the Federal groundfish fisheries remains relatively high, and serious injury and mortality (SI/M) estimates from these fisheries are estimated based on observed SI/M. The best available data are used to estimate SI/M for Alaska state fisheries and included in the total SI/M estimate.

Comment 65: We believe NMFS should consider whether the ongoing declines of Northern fur seals warrant listing this stock as threatened under the Endangered Species Act. Fur seals were listed as depleted in 1988, as a consequence of a decline to less than 50 percent of its population of the 1950's. See: 53 FR 17888 (May18, 1988). Since that time, just in the past 20 years, the stock has once again lost approximately 50 percent of its abundance (i.e., estimated at 182,437 in 1992 and 93,627 in 2010).

Response: The Eastern Pacific stock of northern fur seals is composed of breeding aggregations on St. Paul Island, St. George Island, and Bogoslof Island. NMFS concurs with the commenter in the estimated percent reduction in abundance; however, the actual abundance is about 4.5 times higher than presented for St. Paul Island alone. The commenter is incorrect in the description of the estimated abundance of the stock of northern fur seals as 93,627; in fact that is the estimate of pups born on St. Paul Island in 2010. The estimated population abundance is 611,617 for the eastern Pacific Stock. While NMFS is concerned about the statistically significant decline in pup production on the Pribilof Islands, we do not believe the entire stock is threatened with extinction. The protections afforded northern fur seals under the MMPA are adequate to implement management measures to promote increases in overall stock abundance. NMFS has invested significantly in a vital rates study by tagging annual cohorts and adult female northern fur seals over the past three years. The continuation of this study to mark and re-sight individuals will allow NMFS to estimate survival and reproductive rates on St. Paul and St. George and determine where management measures will be most effective towards stock recovery. The results of this work will not be realized until a series of annual cohorts have been re-sighted and individual cohort survival and reproductive rates can be estimated.

Comment 66: Lake Iliamna seals should be separated and recognized as a separate stock (reasons detailed in comment letter). Whether the Iliamna Lake seal is a stock of harbor seal or if the Iliamna Lake seal is a stock of spotted seal, or a separate species of Phoca, extirpation of the Iliamna Lake seal would result in a gap in the range of harbor seal or spotted seal.

Response: NMFS and co-management partners in the Alaska Native community designated 12 stocks of harbor seals based on local knowledge, as well as historical and recent data. NMFS is in the process of evaluating the evidence for discreteness of the harbor seals in Lake Iliamna, including their genetic relatedness to other harbor seals and seasonal variation in numbers of seals in the lake. NMFS recently received a petition to list Iliamna harbor seals as threatened or endangered under the ESA. If NMFS determines that the petition presents substantial information indicating that listing may be warranted, NMFS will undertake a status review, which would include a thorough evaluation of whether these seals constitute a population that is eligible for listing.

Comment 67: The table showing abundance and trends in harbor seals shows some management stocks with declining trends and others stabilized. Neither the text nor Table 9a, that provides minimum abundance estimates for each of the management stocks, provide CVs for the estimates of abundance. If available, these should be provided to elucidate the appropriateness of the recovery factor that was provided. Using the same recovery factor (0.5) in calculating PBR for all of the management stocks, whether stable or declining and with no CV provided for the estimates, seems risk prone.

Response: Table 9a in the SAR provides Nmin estimates for each of the 12 harbor seal stocks. CVs for the estimates of abundance have been added to the final SAR.

Comment 68: NMFS should determine a PBR for beluga whales based on a conservative estimate as proposed in the revisions of the stock assessment guidelines.

Response: The revised GAMMS III have not been finalized; therefore, the PBR calculation is based upon the current guidelines (GAMMS II).

Comment 69: The Cook Inlet beluga population is not increasing, and we agree that setting a PBR allowing take of the species is inappropriate. The PBR should be set at zero to avoid a misconception that an undetermined PBR places no limit on take. Further, there are continuing proposals for oil and gas exploration and port expansion in their habitat. While NMFS continues to assert that there is no significant impact from each of these proposed projects, many of them subject these belugas to harmful sound levels and ensonification of their habitat (e.g., NMFS, 2012). NMFS must prioritize necropsy of any dead belugas found in Cook Inlet. We believe that the continued insult to their habitat has been given short shrift in the discussion of habitat impact and recent litigation has asserted that NMFS has not properly considered and mitigated impacts.

Response: Similar to Hawaiian monk seals (see response to comment #29) and as stated in the SAR, the Cook Inlet beluga stock does not meet the assumptions inherent to the use of PBR. NMFS has decided it would not be appropriate to calculate a maximum number that may be removed while allowing the population to achieve OSP; therefore, PBR for Cook Inlet beluga whales is undetermined. NMFS has previously responded to similar comments pertaining to Cook Inlet beluga habitat (75 FR 12498, March 16, 2010, Comment 1 and 6), and specifically to the “habitat concerns” section of the Cook Inlet beluga SAR (76 FR 34054, June 10, 2011, Comment 22).

Comment 70: NMFS must update abundance estimates for harbor porpoises that are over 8 years old, many of which are even 15 years old. To the extent that these data are currently unavailable, NMFS should apply the new GAMMS strategy for determining PBR when data is old. These abundance data need to be collected for better management.

Response: The revised guidelines for assessing marine mammal stocks (GAMMS III) have not been finalized; therefore, the PBR calculation is based upon the current guidelines (GAMMS II).

Comment 71: The Dall's porpoise SAR should be updated with more current population estimates. Rather than undetermined PBR for stocks with data more than 8 years old, the worst-case scenario should be assumed for establishing PBR as proposed in the draft GAMMS III.

Response: NMFS is in the process of analyzing abundance and trends of Dall's porpoise in Southeast Alaska; however, these data are currently not available and include only a portion of the range for this stock. Once this analysis is complete, NMFS will update the Dall's porpoise SAR with new information.

Comment 72: NMFS should obtain a reliable estimate of the sperm whale population size and set a PBR.

Response: NMFS agrees that an abundance estimate, trend, and PBR are needed for sperm whales in Alaska and will continue to seek resources for necessary surveys (77 FR 29969, June 10, 2011, Comment 71).

Comment 73: The humpback whale SAR Appendix 8 only provides information on mortality through 2007 despite the fact that more updated information is available in individual SARs. This appendix should be updated through 2010.

Response: NMFS is currently working on a technical memorandum summarizing all Alaska marine mammal injury assessments for 2007-2011, including humpback whales, using guidance provided in the Marine Mammal Serious Injury Policy and Procedural Directives that became effective 27 January 2012. These data will be available in the Tech Memo in 2013 and will no longer be included as an Appendix in the SAR.

Comment 74: NMFS should update the SARs for the ice seals—spotted, bearded, ringed and ribbon seals. The ice seals should be classified as strategic, and accordingly their SARs should be updated every year. Additionally, given the limited understanding of stock abundance and trends and the lack of CVs surrounding abundance estimates, the formula provided for calculating PBRs for all of these seals errs in utilizing an inappropriate recovery factor of 0.5. A more precautionary recovery factor should be used for these stocks following the most recent final GAMMS that suggest lower recovery factors for stocks with greater uncertainty in estimates of abundance (NMFS, 2005). We are particularly alarmed that several SARs for ice seals contain language acknowledging that “[a]s of 2009, data on community subsistence harvests are no longer being collected…” This warrants an explanation. Why are anthropogenic impacts not being tracked on a timely basis for these intentional harvests? This is particularly important for these stocks for which no abundance or trend information is available and that depend on habitat that the SARs acknowledge to be degraded.

Response: NMFS agrees that information on subsistence harvest is necessary for ice-associated seals. A successful marine mammal harvest monitoring program cannot be developed exclusively in the federal domain and must be supported by Alaska Native hunters and communities. In December 2010 and March 2011, NMFS partnered with the Indigenous People's Council on Marine Mammals to convene two workshops of marine mammal hunters and ANO representatives to begin to develop a statewide program for monitoring subsistence hunting and harvests. NMFS continues to work with our ANO partners by prioritizing harvest monitoring programs within the annual ANO co-management funding program. Even so, the subsistence harvest of ice-associated seals in Alaska appears to be sustainable, and the significant concerns about the future status of ice seals stem from climate change and associated habitat loss, not subsistence harvest.

Comment 75: The draft 2012 reports on Steller sea lions do not reflect the most current or accurate information regarding total population and trend for the United States Western DPS or the entire Western DPS. For example, the draft SAR does not provide any population trend for the total population of the U.S. Western DPS Steller sea lion stock in its entirety. The total population of the U.S. Western DPS has increased to 52,209 in 2011, an increase of 41% from 2000. The best estimate for Steller sea lions in Russia is 25,000 to 28,000 animals. Therefore the best estimate of the entire Western DPS population in 2011 would be 77,000-80,000 (with 52,000 in the U.S. Western DPS and 25,000-28,000 in Russia). From 2000 to 2011, the total population estimate for the entire Western DPS has increased 54% to 60%. The SAR should provide the best total estimate of the total population for the entire U.S Western DPS stock and the entire Western DPS. The disclaimer concerning the pup multiplier and the reference to Holmes 2007 should be deleted as Holmes 2007 (and the hypothesized reduced natality in Central gulf of Alaska and extension to the entire Western DPS) does not represent the best available or current science.

Response: NMFS agrees with the estimate of 52,000 for the U.S. Western DPS Steller sea lion population in 2011, and agrees that the best current estimate (i.e., 2011) for Steller sea lion abundance in Russia is between 25,000 and 28,000, and that the total western DPS population is between 77,000 and 80,000. However, NMFS does not agree with how the commenter calculated the percent change in the western DPS population between estimates derived in 2000 and 2011. NMFS' estimate of percent change based on pup counts at western DPS rookeries that were surveyed in both years in the United States (N=31) indicates a 17% increase between 2001-02 (8,639 pups) and 2011 (10,139 pups). These two pup counts are not estimates of the total pup production in these years but sums of counts at the 31 largest rookeries; in 2011, the 31 largest rookeries had the vast majority (87%=10,139/11,600) of all pups born in the western DPS in the United States. NMFS does not have a similar estimate of total pup production for 2001-02 since aerial surveys were not used to count pups then; and, consequently, several major haul-outs and some smaller rookeries that have been consistently surveyed during aerial surveys since 2005 were not counted during the 2001-02 surveys. Estimates of change in abundance of non-pups in the western DPS in the United States between 2000 and 2011 are based on counts at two groups of trend sites. The 1990s trend sites (N=161) had a total of 23,836 non-pups in 2000 and 27,168 in 2008, an increase of 14%; the 2000s trend sites (N=232) had 25,251 non-pups in 2000 and 30,147 in 2008, an increase of 19%. Consequently, estimates for the change in western Steller sea lion abundance in the United States between 2000 and 2011 range between 14% and 19%, less than half the 41% cited by the commenter.

While the western Steller sea lion SAR provides information about abundance in Russia, only information about the portion of the stock residing in United States waters is used to estimate Nmin and to calculate PBR. The GAMMS instructs that for stocks that span international boundaries, the PBR for United States fisheries is calculated based on the abundance estimate of the stock residing in United States waters.

Comment 76: The minimum population for the Western DPS of Steller sea lions should be revised upward as it excludes known counts. Exclusion of these additional counts ignores the best available scientific information.

Response: In order for Steller sea lion non-pup counts (from aerial photographs) to represent a consistent index of the total non-pup population from year to year, only animals on land are counted. During the breeding season, only a small fraction of non-pups are at sea; non-pups spend most of their time on land. Animals in the water are counted only when it is known they were disturbed from the land to the water during the survey. In those circumstances, every effort is made to only count those animals that entered the water and are still relatively close to shore. Surveys are designed to occur during the season and time of day when non-pups are most likely to be hauled out on land, which maximizes the opportunity of obtaining a consistent index count of non-pups each year.

Comment 77: The Western DPS of Steller sea lion SAR should be revised to include the population trend for the total U.S. Western DPS and the entire Western DPS. The current draft only contains estimates for fragmented sections of the population in sub-areas (and sections of sub-areas as in the Central Aleutian Islands), but the SAR inexplicably provides no overall trend for the total population for the U.S. Western DPS and Western DPS. If sub-area trends for non-pups are to be included, the SAR should be more explicit as to how non-pup trends to 2011 are being derived—when the 2011 non-pup survey only covered 75% of the non-pup survey sites.

Response: NMFS is currently working on estimating trends for the entire U.S. Western DPS of Steller sea lions through 2012, as well as for each of the sub-areas. These results will be included in the 2013 SAR.

Comment 78: The draft Western DPS of Steller sea lion SAR should be revised to include the most recent total population estimate for the Russian population (25,000-28,000).

Response: The most recent estimate for the Russian population of Steller sea lion (25,000 to 28,000) referenced by the commenter is based on a presentation at the Alaska Marine Science Symposium in January 2012. These data became available after the draft 2012 SAR was prepared, and the SRG has not reviewed them in the context of the SAR. NMFS intends to update the draft 2013 SAR with this information once it has undergone expert review.

Comment 79: The draft Western DPS of Steller sea lion SAR should consider revising the recovery factor from 0.1 to 0.3 as the U.S. Western DPS stock is steadily increasing with known human take (subsistence and fishery interactions). The U.S. Western DPS has increased +41% from 2000 to 2011 and is 98% of the downlisting population threshold. Revision of the recovery factor for an increasing population is consistent with the GAMMS.

Response: The GAMMS instruct that the default recovery factor for stocks of endangered species should be 0.1. Changes to recovery factors for listed stocks can be made after careful consideration and SRG review. However, given that the current annual level of incidental U. S. Commercial fishery-related mortality exceeds 10% of the PBR and cannot be considered insignificant and approaching a zero mortality and serious injury rate, combined with the relatively high CVs for commercial fishery mortality estimates, it is prudent that NMFS be conservative in managing this endangered stock. Therefore, NMFS will not increase the recovery factor at this time.

Comment 80: The Western DPS of Steller sea lion SAR should be revised to accurately describe the extent (range and magnitude) of movement of Western DPS and Eastern DPS SSLs, both males and females. The reference to “a few migrants” (p. 2) should be deleted. The reference to Phillips 2011 does not support this assertion. A more thorough evaluation of the effects of observed movement by males and females on stock structure should be conducted.

Response: Phillips et al. (2011) is a phylogeographic study of Steller sea lions and is not cited in reference to movements between the western and eastern stocks of Steller sea lions in the SARs. There are documented movements of a few individuals between the geographic division of the eastern and western stocks; however, these cases are minimal and are not significant enough to affect stock structure. Demographics of these migrant individuals is being examined further, and the SAR will be reviewed and updated as appropriate in the draft 2013 SARs.

Comment 81: Given the Center for Independent Experts (CIE) review and Independent Scientific Review Panel findings and conclusions, the 2012 Western DPS of Steller sea lion SAR should not include the scientifically flawed information or constructs that were found to have little scientific basis in the 2010 Biological Opinion. Our detailed comments are provided in Attachment 1 to this letter.

Response: The CIE review was conducted in August 2012, after the draft 2012 Western DPS of Steller sea lion SAR was released for public comment. NMFS will consider incorporating any significant findings and new information resulting from the CIE review in the draft 2013 SARs.

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

1. Discuss and provide recommendations for Mackerel Amendment 19, which addresses bag limit sales of king and Spanish mackerel, reduces inactive king mackerel permits, and addresses income requirements for commercial king and Spanish mackerel permits.

2. Discuss and provide recommendations for Mackerel Amendment 20, which pertains to: changes in Gulf group zones; transit provisions in Florida waters; and allocations for king and Spanish mackerel in North Carolina. The amendment also addresses framework procedure modifications as well as updated Annual Catch Limits (ACLs) for cobia.

3. Discuss and provide recommendations for South Atlantic Framework Actions, which considers: a change in the king mackerel minimum size limit; modifications to transfer-at-sea provisions for the Spanish mackerel gillnet fishery; changes in the king mackerel commercial trip limits; and modifications to the Spanish mackerel quota and trip limit system.

1. Receive an update on the April, 2013 Scientific and Statistical Committee (SSC) Meeting, including: the application of the Only Reliable Catch Stocks (ORCS) methodology to specify Acceptable Biological Catches (ABCs) for unassessed snapper grouper species included in the Comprehensive ACL Amendment; and the black sea bass stock assessment.

2. Receive an update on both future and completed snapper grouper amendments.

3. Receive presentations on: Vessel Monitoring Systems (VMS); an electronic monitoring (EM) pilot study on snapper grouper bandit vessels; and the Fishery Independent Reef Fish Survey.

4. Receive an overview of Snapper Grouper Amendment 30, pertaining to the consideration of VMS for the commercial snapper grouper fishery. Discuss the amendment and provide recommendations.

5. Receive an overview on Regulatory Amendment 14, which addresses management measures for the following snapper grouper species: greater amberjack; mutton snapper; gray triggerfish; hogfish; black sea bass; vermilion snapper; and gag grouper. Discuss the amendment and provide recommendations.

6. Receive overviews on: regional allocations for black sea bass; and Visioning and Strategic Planning for the snapper grouper complex. Discuss the overviews and provide recommendations.

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

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

The Committee, composed of external, knowledgeable representatives of stakeholder groups, was established by the Department of Commerce (DOC) to provide advice to the Secretaries of Commerce and the Interior on implementation of Section 4 of Executive Order 13158, on marine protected areas.

Matters to be Considered: The focus of the Committee's meeting is reporting on the Subcommittee workplans and their implementation (Jobs, Recreation and Tourism Subcommittee and Stakeholder Engagement Subcommittee) to address the Committee's charge. The Committee will also hear updates from the National Oceanic and Atmospheric Administration and the Department of the Interior. The agenda is subject to change. The latest version will be posted at http://www.mpa.gov.

Background: On February 23, 2012, the White House released Consumer Data Privacy in a Networked World: A Framework for Protecting Privacy and Promoting Innovation in the Global Digital Economy (the “Privacy Blueprint”). 1 The Privacy Blueprint directs NTIA to convene multistakeholder processes to develop legally enforceable codes of conduct that specify how the Consumer Privacy Bill of Rights applies in specific business contexts. 2 On June 15, 2012, NTIA announced that the goal of the first multistakeholder process is to develop a code of conduct to provide transparency in how companies providing applications and interactive services for mobile devices handle personal data. 3 On July 12, 2012, NTIA convened the first meeting of the first privacy multistakeholder process, followed by additional meetings through March 2013.

Matters to Be Considered: The April 30, 2013; May 23, 2013; and June 11, 2013, meetings are a continuation of a series of NTIA-convened multistakeholder discussions concerning mobile application transparency. Stakeholders will engage in an open, transparent, consensus-driven process to develop a code of conduct regarding mobile application transparency. The April 30, 2013; May 23, 2013; and June 11, 2013, meetings will build on stakeholders' previous work. More information about stakeholders' work is available at: http://www.ntia.doc.gov/other-publication/2012/privacy-multistakeholder-process-mobile-application-transparency.

Time and Date: NTIA will convene meetings of the privacy multistakeholder process on April 30, 2013; May 23, 2013; and June 11, 2013 from 1:00 p.m. to 5:00 p.m., Eastern Time. The meeting times are subject to change. The meetings are subject to cancellation if stakeholders complete their work developing a code of conduct. Please refer to NTIA's Web site, http://www.ntia.doc.gov/other-publication/2012/privacy-multistakeholder-process-mobile-application-transparency, for the most current information.

Place: The meetings will be held in the Boardroom at the American Institute of Architects, 1735 New York Avenue NW., Washington, DC 20006. The location of the meetings is subject to change. Please refer to NTIA's Web site, http://www.ntia.doc.gov/other-publication/2012/privacy-multistakeholder-process-mobile-application-transparency, for the most current information.

Other Information: The meetings are open to the public and the press. The meetings are physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to John Verdi at (202) 482-8238 or jverdi@ntia.doc.gov at least seven (7) business days prior to each meeting. The meetings will also be webcast. Requests for real-time captioning of the webcast or other auxiliary aids should be directed to John Verdi at (202) 482-8238 or jverdi@ntia.doc.gov at least seven (7) business days prior to each meeting. There will be an opportunity for stakeholders viewing the webcast to participate remotely in the meetings through a moderated conference bridge, including polling functionality. Access details for the meetings are subject to change. Please refer to NTIA's Web site, http://www.ntia.doc.gov/other-publication/2012/privacy-multistakeholder-process-mobile-application-transparency, for the most current information.

The United States Patent and Trademark Office (USPTO) is giving notice of an amendment to a system of records that is subject to the Privacy Act of 1974. This system of records maintains information related to testimony that may be given by current and former USPTO employees in accordance with 37 CFR part 104, 15 CFR part 15, and the Manual of Patent Examining Procedure (MPEP) Chapter 1700. The Privacy Act notice is being updated with the current address information for the system location and system manager. The description of the routine uses of records maintained in the system has been updated to include use in law enforcement, audits and oversight activities, and distribution to contractors, all uses commonly published in other agency system of records notices. The rule references for the notification procedure and contesting record procedures have been updated to correspond to the current statutes and rules for those items as related to the USPTO.

The amended Privacy Act system of records notice, “COMMERCE/PAT-TM-11 Patent Examiner Testimony Files,” is published in its entirety below.

The United States Patent and Trademark Office (USPTO) is giving notice of an amendment to a system of records that is subject to the Privacy Act of 1974. This system of records maintains information on patent applicants and their authorized representatives who request a license to file a patent application in a foreign country. The Privacy Act notice is being updated with the current address and departmental information for the system location and system manager. The routine uses of records maintained in the system have been updated to include use in law enforcement, audits and oversight activities, and distribution to contractors, all uses commonly published in other agency system of records notices. The descriptions of storage, retrievability, and safeguards have been revised to reflect current database practices. The rule references for the notification procedure and contesting record procedures have been updated to correspond to the current statutes and rules for those items as related to the USPTO.

The amended Privacy Act system of records notice, “COMMERCE/PAT-TM-13 Petitioners for License to File for Foreign Patents,” is published in its entirety below.

Summary of Information Collection

Respondents are individuals or representatives of Federal and non-Federal government agencies, community groups, for-profit and non-profit organizations, and civic organizations requesting Armed Forces support for patriotic events conducted in the civilian domain. DD Forms 2535 and 2536 record the type of military support requested, event data, and sponsoring organization information. The completed forms provide the Armed Forces the minimum information necessary to determine whether an event is eligible for military participation and whether the desired support is permissible and/or available. If the forms are not provided, the review process is greatly increased because the Armed Forces must make additional written and telephonic inquiries with the event sponsor. In addition, use of the forms reduces the event sponsor's preparation time because the forms provide a detailed outline of information required, eliminate the need for a detailed letter, and contain concise information necessary for determining appropriateness of military support. Use of the forms is essential to reduce preparation and processing time, increase productivity, and maximize responsiveness to the public.

Respondents are UOCAVA citizens who desire to vote in a Federal election but did not receive an absentee ballot from their State of residency with enough time to vote and return it. The information provided by these citizens is used by the States to determine if the citizen is a resident of a jurisdiction within that State, has previously requested an absentee ballot (when applicable) and therefore eligible for the enclosed ballot to be counted. In States that allow the form to be used as a voter registration form, the information provided is used by the States to determine if the citizen is a resident of a jurisdiction within that State, and therefore eligible to vote within that jurisdiction and to provide absentee ballots to these citizens for Federal elections held within each calendar year. This form is mandated by 42 U.S.C. 1973ff. The Department of Defense does not receive, collect nor maintain any data provided on the form by these citizens; this data is collected and maintained by the individual States. The burden in the collection of this data resides in the individual States. If the form is not provided, UOCAVA citizens would not have access to the emergency backup ballot and thus, may be disenfranchised from their right as a U.S. citizen to participate in the electoral process. The previous Federal Write-In Absentee Ballot is the edition dated 08-2011. The form has been updated for usability and consistency. The most significant changes on the form are as follows: The Agency Disclosure Statement has been added to the instruction page of the form as per OMB guidance. Block 2 classification has been clarified to include activated National Guard members on State orders and U.S. citizens who have never resided in the United States. These individuals had previously been listed as U.S. citizens otherwise granted military/overseas voting rights. The overseas citizen selection previously described as “I am a U.S. citizen residing outside the U.S., and I do not intend to return” has been reworded for citizens who are unsure of their future plans or are hesitant to sign that they do not intend to return to the country. The intent to return language remains on the form due to the October 2008 National Association Secretaries of State (NASS) Survey of State Statues that shows the majority of States have intent as a prerequisite for obtaining a State ballot. Block 7 has been reworded back to the 2005 form language of “my voting residence address” to ensure military voters with more than one potential U.S. address are not registering in the wrong jurisdiction. Block 8 has been reworded to “where to send my voting materials” to ensure voters are using their mailing address and not their U.S. voting address. The Affirmation has been modified so that voters do not have to reaffirm information already found on the form. The signature block has been highlighted and the text previously found on the signature and date lines has been moved below it so local election officials can easily read signatures and dates. The mailing envelope has been modified to include a space to identify which election their ballot is being submitted for. This will ensure local election officials do not accidently count a general election ballot for a primary election and disenfranchise a voter because their ballot was not counted in their preferred election. The mailing envelope instructions have been clarified to highlight that the ballot security envelope and mailing envelope are not the same and two envelopes are required.

Summary of Information Collection

Respondents are UOCAVA citizens who desire to apply for voter registration and/or request an absentee ballot from their state of residency. The information provided by these citizens is used by the states to determine if the citizen is a resident of a jurisdiction within that state, and therefore eligible to vote within that jurisdiction and to provide absentee ballots to these citizens for Federal elections held within each calendar year. This form is mandated by 42 U.S.C. 1973ff. The Department of Defense does not receive, collect nor maintain any data provided on the form by these citizens; this data is collected and maintained by the individual states. The burden in the collection of this data resides in the individual States. If the form is not provided, UOCAVA citizens may not be able to register to vote in their State of residency nor be able to request absentee ballots and thus may be disenfranchised from their right as a U.S. citizen to participate in the electoral process. The previous Federal Post Card Application is the edition dated 08-2011. The form has been updated for usability and consistency. The most significant changes on the form are as follows: Block 1 classification has been clarified to include activated National Guard members on State orders and U.S. citizens who have never resided in the United States. These individuals had previously been listed as U.S. citizens otherwise granted military/overseas voting rights. The overseas citizen selection previously described as “I am a U.S. citizen residing outside the U.S., and I do not intend to return” has been reworded for citizens who are unsure of their future plans or are hesitant to sign that they do not intend to return to the country. The intent-to-return language remains on the form due to the October 2008 National Association Secretaries of State (NASS) Survey of State Statues that shows the majority of States have intent as a prerequisite for obtaining a State ballot. Block 7 has been reworded back to the 2005 FPCA language of “my voting residence address” to ensure military voters with more than one potential U.S. address are not registering in the wrong jurisdiction. Block 8 has been reworded to “where to send my ballot” to ensure voters are using their mailing address and not their U.S. voting address. The Affirmation has been modified so that voters do not have to reaffirm information already found on the form. The signature block has been highlighted and the text previously found on the signature and date lines has been moved below it so local election officials can easily read signatures and dates. The Agency Disclosure Statement has been added to the instruction page of the form as per OMB guidance.

Title, Associated Form, and OMB Number: Defense Federal Acquisition Regulation Supplement (DFARS), Appendix I, DoD Pilot Mentor-Protege Program; OMB Control Number 0704-0332.

Needs and Uses: DoD needs this information to evaluate whether the purposes of the DoD Pilot Mentor-Protege Program have been met. The purposes of the Program are to (1) provide incentives to major DoD contractors to assist protege firms in enhancing their capabilities to satisfy contract and subcontract requirements; (2) increase the overall participation of protege firms as subcontractors and suppliers; and (3) foster the establishment of long-term business relationships between protege firms and major DoD contractors. This Program implements Section 831 of the National Defense Authorization Act for Fiscal Year 1991 (Pub. L. 101-510) and Section 811 of the National Defense Authorization Act for Fiscal Year 2000 (Public Law 106-65) (10 U.S.C. 2302 note). Participation in the Program is voluntary.

Affected Public: Businesses or other for-profit and not-for profit institutions.

Number of Respondents: 115.

Responses per Respondent: 1.96.

Annual responses: 225.

Average Burden per Response: Approximately 1 hour.

Annual Burden Hours for Responses: 225.

Total Recordkeeping Hours: 357.

Annual Burden Hours: 582.

Frequency: Semiannually (mentor); Annually (protégé).

DFARS Appendix I-112.2(a)-(d) requires mentor firms to report on the progress made under active mentor-protege agreements semiannually for the periods ending March 31st and September 30th. The September 30th report must address the entire fiscal year. Reports must include—

(1) Data on performance under the mentor-protege agreement, including dollars obligated, expenditures, credit taken under the Program, applicable subcontract awards under DoD contracts, developmental assistance provided, impact of the agreement, and progress of the agreement; and

(2) For each contract where developmental assistance was credited toward an SDB subcontracting goal, a copy of the Individual Subcontracting Report (ISR) or SF 294, and/or the Summary Subcontracting Report (SSR) or SF 295, with a statement identifying—

(i) The amount of dollars credited to the applicable subcontracting goal as a result of developmental assistance provided to protege firms under the Program; and

(ii) The number and dollar value of subcontracts awarded to the protege firm(s), broken out per protege.

DFARS Appendix I-112.2(e) requires the protege firm to annually provide data by October 31st on the progress made by the protege firm in employment, revenues, and participation in DoD contracts during each fiscal year of the Program participation term and each of the two fiscal years following the expiration of the Program participation term. During the Program participation term, the firms may provide this data as part of the mentor report required by I-112.2(a) for the period ending September 30th.

Requests to make oral comments or to provide written comments to NAC/GAC should be sent to Oscar Carrillo at carrillo.oscar@epa.gov by Wednesday, April 17, 2013. The meeting is open to the public, with limited seating on a first-come, first-served basis. Members of the public wishing to participate in the teleconference should contact Oscar Carrillo at carrillo.oscar@epa.gov or (202) 564-0347 by April 17, 2013.

Meeting Access: For information on access or services for individuals with disabilities, please contact Oscar Carrillo at 202-564-0347 or carrillo.oscar@epa.gov. To request accommodation of a disability, please contact Oscar Carrillo, preferably at least 10 days prior to the meeting, to give EPA as much time as possible to process your request.

OMB Control Number: 3060-0804.

Title: Universal Service—Rural Health Care Program.

Form Numbers: FCC Forms 460, 461, 462, 463 (new); 465, 466, 466-A, and 467.

Type of Review: Revision of a currently approved collection.

Respondents: Business or other for-profit; not-for-profit institutions; federal government; and state, local, or Tribal governments.

Number of Respondents and Responses: 10,400 respondents; 38,745 responses.

Estimated Time per Response: 1.69 hours.

Frequency of Response: On occasion, one time, annual, quarterly, and monthly reporting requirements.

Obligation to Respond: Required to obtain or retain benefits. Statutory authority for this collection of information is contained in 47 U.S.C. sections 151, 154(i), 154(j), 201-205, 214, 254 and 403.

Total Annual Burden: 65,614 hours.

Total Annual Cost: $60,000.

Privacy Impact Assessment: No Impact(s).

Nature and Extent of Confidentiality: The Commission is not requesting that the respondents submit confidential information to the FCC. Respondents may, however, request confidential treatment for information they believe to be confidential under 47 CFR 0.459 of the Commission's rules. We note that the universal service administrator must preserve the confidentiality of all data obtained from respondents and contributors to the universal service support program mechanism; must not use the data except for purposes of administering the universal service support program; and must not disclose data in company-specific form unless directed to do so by the Commission.

Needs and Uses: The Federal Communications Commission (hereinafter referred to as the Commission or FCC) seeks Office of Management and Budget (OMB) approval of revisions (change in reporting and recordkeeping requirements) of an information collection (IC) previously approved by OMB under this OMB Control Number 3060-0804, which is utilized for the rural health care (RHC) support mechanism of the Commission's universal service fund (USF). The purpose of the revision is to seek approval for: (1) New information collection requirements associated with the Healthcare Connect Fund, a new RHC fund created by the Commission's Report and Order, Rural Health Care Support Mechanism, WC Docket No. 02-60, FCC 12-150 (released Dec. 21, 2012) (Healthcare Connect Fund Order); (2) new information collection requirements associated with a skilled nursing facilities pilot program (SNF Pilot) created in the Healthcare Connect Fund Order; (3) revisions to the annual reporting requirement for participants in the Commission's existing rural health care Pilot Program (2006 Pilot Program), created in 2006; and (4) extend the information collection requirements for the existing RHC programs (the Telecommunications Program and the Internet Access Program, as well as the 2006 Pilot Program).

The Commission issued a Notice of Proposed Rulemaking (NPRM) in July 2010 (FCC 10-125) that led to the Healthcare Connect Fund Order, and received OMB pre-approval for the information collection requirements proposed in the NPRM. The Healthcare Connect Fund Order, however, adopted information collection requirements that are in some ways significantly different from those proposed in the NPRM, based on the comments received in the rulemaking proceeding. Many of the proposed requirements have been modified in light of commenters' recommendations on streamlining and simplifying the information collection burden, especially on smaller health care providers.

The information collections described in this notice are contained in new rules adopted in the Healthcare Connect Fund Order (47 CFR 54.601(b), 54.631(a), 54.631(c), 54.632, 54.633(c), 54.634(b), 54.636, 54.639(d), 54.640(b), 54.642, 54.643, 54.645, 54.646, 54.647, 54.648(b), 54.675(d), and 54.679), and existing rules as amended by the Healthcare Connect Fund Order (47 CFR 54.603(a), 54.603(b), 54.609(d)(2), 54.615(c), 54.619(a)(1), 54.619(d), and 54.623(a)).

Beginning in Funding Year 2012, its filing process to provide a simple, web-based, user-friendly interface for submission of the Telecommunications and Internet Access Program information collections. Applicants are also able to upload required documentation (such as a bill) as they complete the online form. The interface is designed to provide online storage of applications and related materials for health care providers, in order to ease compliance with recordkeeping requirements and possible audits. Furthermore, the system is designed to carry forward information already provided by an applicant to future filings ( i.e. pre-populate data), in order to further reduce the filing burden. Respondents in the Telecommunications and Internet Access Programs can also send their forms and other documents to USAC via mail or electronic mail. Respondents in the 2006 Pilot Program can send forms and documents via electronic mail, and invoices via mail.

USAC will implement the information collection for the new Healthcare Connect Fund through an online-only interface on the USAC Web site. Health care providers who lack sufficient Internet access will be able to contact USAC's help desk over the telephone to obtain assistance with filing.

Revised Information Collection Requirements: (1) HEALTHCARE CONNECT FUND: In December 2012, the Commission established the Healthcare Connect Fund, which reforms, expands, and modernizes the RHC program based on lessons learned from the 2006 Pilot Program. The Healthcare Connect Fund is separate from the Telecommunications Program and the 2006 Pilot Program. The Healthcare Connect Fund provides support, in part, for services similar to those supported under the Internet Access Program. Therefore, the Commission will stop providing support under the Internet Access Program for services received after June 30, 2014.

The following are the new Healthcare Connect Fund information collection requirements:

(a) Authorization for Third Parties To Submit Forms on Behalf of HCP/Consortium. Third parties (for example, consultants) may submit forms and other documentation on behalf of eligible health care providers if USAC receives, prior to submission of the forms or documentation, a written, dated, and signed authorization from the relevant officer, director, or other authorized employee stating that the HCP or Consortium Leader accepts all potential liability from any errors, omissions, or misrepresentations on the forms and/or documents being submitted by the third party.

(b) Form 460—Eligibility Determination and Consortium Information. Healthcare Connect Fund participants would be required to file a new FCC Form 460 in order to certify that they are eligible to receive support from the Fund. Applicants will be required to provide the HCP's address and contact information, identify the eligible HCP type, provide an address for each physical location that will receive supported connectivity, provide a brief explanation for why the HCP is eligible under the Act and the Commission's rules and orders, and certify to the accuracy of this information under penalty of perjury. They may also be required to provide a unique health care provider identifying number, such as a National Provider Identifier code and/or taxonomy code. Consortium applicants may file FCC Form 460 on behalf of member HCPs if they have a letter of agency (discussed below). Applicants must also register off-site administrative offices and off-site data centers for which they are receiving support.

FCC Form 460 will also be used to provide certain basic information about consortia to USAC: (1) The lead entity (“Consortium Leader”); (2) the individual contact person within the lead entity (the “Project Coordinator”); and (3) HCP sites that will participate in a consortium, including sites ineligible to receive support.

(c) Form 460 Attachment: Letter of Agency. Each Consortium Leader must also obtain a letter of agency (LOA) from each HCP participant that is independent of the Consortium Leader (i.e. HCP sites that are not owned or otherwise controlled by the Consortium Leader). The LOA is submitted as an attachment to FCC Form 460. The purposes of the LOA are to provide authority for the Consortium Leader to submit FCC Forms 460, 461, and/or 462 on behalf of the HCP site. Consortium leaders are required to obtain supporting information and/or documents to support eligibility for each HCP when they collect the LOAs, and may be asked for this information during a future audit or investigation.

(d) Form 460 Attachment: State/Non-Profit Entities That Want To Serve as Both Vendor and Consortium Leader/Consultant. In general, an entity may not simultaneously (1) serve as a Consortium Leader or provide consulting assistance to a consortium, and (2) participate as a potential vendor during the competitive bidding process. State organizations, public sector entities, or non-profit entities who wish to obtain an exemption from this prohibition may make a showing to USAC that they have set up an organizational and functional separation. The exemption must be obtained before the consortium begins preparing its FCC Form 461 (request for services) and associated documents.

(e) Form 460 Attachment—Agreement Regarding Legal and Financial Responsibility for Consortium Activities. Consortia may allocate legal and financial responsibility for supported program activities as they see fit, except for certain responsibilities specified in the Healthcare Connect Fund Order, provided that this allocation is memorialized in a formal written agreement between the affected parties (i.e. the Consortium Leader, and the consortium as a whole and/or its individual members). The written agreement must submitted to USAC for approval with or prior to the submission of FCC Form 461. The agreement should clearly identify the party(ies) responsible for repayment if USAC is required, at a later date, to recover disbursements to the consortium due to violations of program rules.

(f) Form 461—Request for Services (Competitive Bidding). All HCPs, unless their funding request is subject to a competitive bidding exemption, must submit a request for services (new Form 461 and associated documents) for posting by USAC, wait at least 28 days before selecting a service provider, and select the most cost-effective bid. On FCC Form 461, applicants will provide basic information regarding the HCP(s) on the application (including contact information for potential bidders), a brief description of the desired services, and evaluation criteria for bids. Each applicant must also certify that (1) it is authorized to submit the request and that all statements of fact in the application are true to the best of the signatory's knowledge; (2) it has followed any applicable state or local procurement rules; (3) the supported services and/or equipment will be used solely for purposes reasonably related to the provision of health care service or instruction that the HCP is legally authorized to provide under the law of the state in which the services are provided and will not be sold, resold, or transferred in consideration for money or any other thing of value; (4) the HCP or consortium satisfies all program requirements and will abide by all such requirements; and (5) all statements of facts contained therein are true to the best of their knowledge, information, and belief, and that under federal law, persons willfully making false statements on the form can be punished by fine, forfeiture, or imprisonment.

(g) Form 461 Attachment—Network Planning for Consortia. Consortium applicants must also submit a narrative attachment with FCC Form 461 that includes: (1) Goals and objectives of the proposed network; (2) strategy for aggregating the specific needs of HCPs (including providers that serve rural areas) within a state or region; (3) strategy for leveraging existing technology to adopt the most efficient and cost effective means of connecting those providers; (4) how the broadband services will be used to improve or provide health care delivery; (5) any previous experience in developing and managing health IT (including telemedicine) programs; and (6) a project management plan outlining the project's leadership and management structure, and a work plan, schedule, and budget.

(h) Form 461 Attachment—Request for Proposals (RFP). Submission of a separate RFP document with Form 461 is required for (1) applicants who are required to issue an RFP under applicable state, Tribal, or local procurement rules or regulations; (2) consortium applications that seek more than $100,000 in program support in a funding year; and (3) consortium applications that seek support for infrastructure (i.e. HCP-owned facilities) as well as services. In addition, any applicant is free to submit an RFP to USAC for posting. All applicants who utilize an RFP in conjunction with their competitive bidding process must submit the RFP to USAC for posting. RFPs must provide sufficient information to enable an effective competitive bidding process, including describing the HCP's service needs; specify the period during which bids will be accepted; and include the scoring criteria that will be used to evaluate bids for cost-effectiveness. In addition, certain additional requirements apply to RFPs if the applicant seeks support for long-term capital investments (such as HCP-constructed infrastructure or fiber indefeasible rights-of-use); dark fiber; services or equipment that include an ineligible component; or HCP-owned and constructed network facilities.

(i) FCC Form 462—Request for Funding. Once a service provider is selected, applicants will submit a “Funding Request” on FCC Form 462 (and supporting documentation) to provide information about the services and service providers (vendors) selected and certify that the services were the most cost-effective offers received. FCC Form 462 is the means by which an applicant identifies the service(s), rates, service provider(s), and date(s) of service provider selection. Applicants will also certify on FCC Form 462 that: (1) The person signing the application is authorized to submit the application on behalf of the applicant, and has examined the form and all attachments, and to the best of his or her knowledge, information, and belief, all statements of fact contained therein are true; (2) each service provider selected is, to the best of the applicant's knowledge, information, and belief, the most cost-effective service provider available, as defined in the Commission's rules; (3) all Healthcare Connect Fund support will be used only for the eligible health care purposes, as described in this Order and consistent with the Act and the Commission's rules; (4) the applicant is not requesting support for the same service from both the Healthcare Connect Fund and from other RHC programs; (5) the applicant satisfies all of the requirements under section 254 of the Act and applicable Commission rules, and understands that any letter from USAC that erroneously commits funds for the benefit of the applicant may be subject to rescission; (6) the applicant has reviewed all applicable requirements for the program and will comply with those requirements; and (7) the applicant will maintain complete billing records for the service for five years (and for long-term capital investments, for five years after the end of the useful life of the facility).

(j) FCC Form 462 Attachment—Contracts or Similar Documentation. All applicants must submit a contract or other documentation that clearly identifies (1) the vendor(s) selected and the HCP(s) who will receive the services; (2) the service, bandwidth, and costs for which support is being requested; (3) the term of the service agreement(s) if applicable ( i.e. if services are not being provided on a month-to-month basis).

(k) FCC Form 462 Attachment—Cost Allocation Method for Ineligible Entities or Components. Applicants who seek to include ineligible entities within a consortium, or to obtain support for services or equipment that include both eligible and ineligible components, should submit a written description of their allocation method(s) to USAC with their funding requests. If ineligible entities participate in a network, the allocation method must be memorialized in writing, such as a formal agreement among network members, a master services contract, or for smaller consortia, a letter signed and dated by all (or each) ineligible entity and the Consortium Leader. Applicants should also submit with their funding requests any agreements that memorialize cost-sharing arrangements with ineligible entities.

(l) FCC Form 462 Attachment—Competitive Bidding Documents. Applicants must submit documentation to support their certifications that they have selected the most cost-effective option. Relevant documentation includes a copy of each bid received (winning, losing, and disqualified), the bid evaluation criteria, and any other related documents, such as bid evaluation sheets; a list of people who evaluated bids (along with their title/role/relationship to the applicant organization); memos, board minutes, or similar documents related to the vendor selection/award; copies of notices to winners; and any correspondence with service providers during the bidding/evaluation/award phase of the process. If the application is exempt from competitive bidding, the applicant should submit sufficient documentation to allow USAC to verify that the applicant is eligible for the exemption.

(m) FCC Form 462 Attachment—Updated Network Planning for Consortia. Consortium applicants should submit any revisions to the project management plan, work plan, schedule, and budget previously submitted with the Request for Services (Form 461). If not previously provided with the project management plan, applicants should also provide (or update) a narrative description of how the network will be managed, including all administrative aspects of the network (including but not limited to invoicing, contractual matters, and network operations.) If the consortium is required to provide a sustainability plan (see below), the revised budget should include the budgetary factors discussed in the sustainability plan requirements.

(n) FCC Form 462 Attachment—List of Participating HCPs and Relevant Information. Consortium applicants will be required to provide electronically (via a spreadsheet or similar method) a list of the participating HCPs (both those eligible for support and those ineligible) and all of their relevant information, including eligible (and ineligible, if applicable) cost information for each participating HCP.

(o) FCC Form 462 Attachment—Evidence of Viable Source for 35 Percent Contribution. All consortium applicants must submit, with their funding requests, evidence of a viable source for their 35 percent contribution.

(p) FCC Form 462 Attachment—Sustainability Plans for Applicants Requesting Support for Long-Term Capital Expenses. Consortia who seek funding to construct and own their own facilities or obtain indefeasible rights of use (IRUs) or capital lease interests must submit a sustainability plan with their funding requests demonstrating how they intend to maintain and operate the facilities that are supported over the relevant time period. Although participants are free to include additional information to demonstrate a project's sustainability, the sustainability plan must, at a minimum, address the following points: (1) Projected sustainability period; (2) principal factors considered to demonstrate sustainability; (3) terms of membership in the network; ownership structure for the network; sources of future support; management structure of the network. Applicants will be required to later submit revised sustainability plans if there is a material change in sources of future support or management, a change that would impact projected income or expenses by the greater of 20 percent or $100,000 from the previous submission, or if the applicant submits a funding request based on a new Form 461 (i.e., a new competitively bid contract).

(q) FCC Form 463—Invoicing. Service providers will bill HCPs directly for services that they have provided. Upon receipt of a service provider's bill, the HCP will create and approve an invoice for USAC on FCC Form 463 for the services it has received. On the invoice, (1) the HCP or Consortium Leader must certify to USAC that it has paid its 35 percent contribution directly to the service provider; and (2) the HCP and service provider must certify that they have reviewed the invoice and that it is accurate. USAC will pay the service provider directly based on the invoice. For consortia, the Consortium Leader is responsible for the invoicing process, including certifying that the participant contribution has been paid and that the invoice is accurate.

(r) Extension Request for Lighting Fiber. Fiber must be lit during the funding year for non-recurring charges associated with such fiber to be eligible. Applicants may receive up to a one-year extension to light fiber, however, if they provide documentation to USAC that construction was unavoidably delayed due to weather or other reasons.

(s) Recordkeeping. Program participants and vendors in the Healthcare Connect Fund must maintain required documentation for five years after the service has been delivered (or after the end of the useful life of a facility for which the participant has received support to make a long-term capital investment) and produce these records upon request of the Commission, any auditor appointed by the Administrator or the Commission, or of any other state or federal agency with jurisdiction. For a consortium, the Consortium Leader is responsible for compliance with the Commission's recordkeeping requirements.

(t) Annual Reporting Requirement for Consortium Participants. Consortium participants in the Healthcare Connect Fund will be required to submit annual reports to assist the Commission in measuring progress toward the three program goals for the Healthcare Connect Fund. Additionally, applicants may request support for upfront, non-recurring charges for long-term capital investments, such as constructing their own network facilities, or obtaining an indefeasible right-of-use (IRU) or prepaid lease interest in existing network facilities such as dark fiber. In such a case, the applicant may be obtaining access to facilities that have a useful life extending many years after program funds have been disbursed, but would not need to submit requests for funding on an annual basis once access to the facility is obtained. In order to ensure that such facilities continue to be used for eligible purposes throughout their useful life, the Commission will require such applicants to submit, during the useful life of the facility, additional information identifying the health care providers utilizing the network, and the services they are receiving from the supported network. Much of the data to be collected from participants in the Healthcare Connect Fund, as discussed in the Healthcare Connect Order, is already collected through FCC Forms 460, 461, 462, and 463. In order to minimize the burden posed by the annual report, the Commission and USAC will develop a simple and streamlined, electronic reporting system that integrates data collected through the application process, thereby eliminating the need to resubmit (in the annual report) any information that has previously been provided.

(2) SKILLED NURSING FACILITIES PILOT: Also in December 2012, the Commission adopted the Skilled Nursing Facilities Pilot (SNF Pilot) to test how to support broadband connections for skilled nursing facilities. The SNF Pilot will focus on how the Commission can best utilize program support to assist skilled nursing facilities that are using broadband connectivity to work with eligible health care providers through the use of electronic health records, telemedicine, and other broadband-enabled health care applications. The Commission intends to utilize Healthcare Connect Fund forms for the Skilled Nursing Facilities Pilot Program ( e.g. to register skilled nursing facility locations with USAC, invoicing, etc.) to the extent feasible, except with respect to the application and reporting requirements described below.

The following new information collection requirements are associated with the SNF Pilot:

(u) Application for Skilled Nursing Facilities Pilot. Participants in the SNF Pilot will be selected using a competitive process. It is anticipated that applications for the SNF Pilot will likely be in a narrative format, and may include the following elements: (1) Project description, budget and goals, including technologies to be used and patient population(s) to be targeted; (2) explanation of the need for broadband connectivity and anticipated health IT uses of supported connectivity; (3) anticipated health care cost savings and/or improvements in the quality of health care enabled through use of broadband-enabled health IT; (4) a detailed explanation of the design, data gathering and evaluation component of the project; (5) a description of the sites to be connected and the network design; and (6) certifications to ensure compliance with program requirements.

The Commission will be developing scoring criteria for applications for the SNF Pilot with the input of relevant stakeholders (such as the U.S. Department of Health and Human Services (HHS)), consistent with the program goals for the Healthcare Connect Fund. Once the scoring criteria are developed, the Commission will release a Public Notice announcing the application procedures and deadlines. Applicants will include in their applications a demonstration of how they satisfy the scoring criteria.

(v) Reporting Requirements for Skilled Nursing Facilities Pilot Participants. The SNF Pilot Program will seek to collect data on a number of variables related to the broadband connections supported and their health care uses. Applicants must commit to robust data gathering as well as analysis and sharing of the data and to submitting an annual report. Applicants will be expected to explain what types of data they intend to gather and how they intend to gather that data in their applications. At the conclusion of the Pilot, applicants should be prepared to demonstrate with objective, observable metrics the health care cost savings and/or improved quality of patient care that have been realized through greater use of broadband to provide telemedicine to treat the residents of SNFs. The Commission plans to make this data public for the benefit of all interested parties, including third parties that may use such information for their own studies and observations.

(3) REVISIONS TO 2006 PILOT PROGRAM REPORTING REQUIREMENTS: Participants in the 2006 Pilot Program are currently required to submit to USAC and the Commission quarterly reports containing data listed in the Rural Health Care Pilot Program Selection Order, Appendix D.

(w) Revised Reporting Requirements for 2006 Pilot Program Participants. In the Healthcare Connect Fund Order, the Commission modified the 2006 Pilot Program reporting requirements to: (1) Extend through and include the last funding year in which a Pilot project received Pilot support, or, for Pilot Projects that received large upfront payments, for the life of the supported facility; (2) file annually instead of quarterly, filing their first annual report on September 30, 2013 and submitting the report to USAC, rather than USAC and the Commission; and (3) conform their reports with the Healthcare Connect Fund annual reports for consortia, where participants will be required to submit annual reports to assist the Commission in measuring progress toward the three program goals: increase access to broadband for health care providers; develop and deploy of broadband healthcare networks; and measure the cost-effectiveness of the program.

Previously Approved Collection Requirements: The Telecommunications, Internet Access, and 2006 Pilot Programs use forms and instructions that have been previously approved by OMB as part of this information collection. The Commission is seeking renewal of these forms and instructions for a new three-year period.

All eligible health care providers applying for discounts under the Telecommunications, Internet Access, and 2006 Pilot Programs must file FCC Forms 465, 466 and/or 466-A, and 467. Eligible health care providers file FCC Form 465 with USAC to make a bona fide request for supported services. Next, after a period of not less than 28-days after filing FCC Form 465, a health care provider that has selected a vendor submits FCC Form 466 and/or 466-A to indicate the type(s) and cost(s) of services ordered, information about the service provider, and the terms of the service agreement. Eligible health care providers must also certify on the applicable FCC Forms 466 and 466-A that the health care provider has selected the most cost-effective method of providing the selected service(s). The last form eligible health care providers submit is FCC Form 467, which is used by the entity to notify USAC that the service provider has begun providing supported services. As part of this information collection, OMB has also previously approved certain templates, samples, and spreadsheets provided to program participants to facilitate the reporting and record keeping requirements under this collection.

Under the PRA, 44 U.S.C. 3501-3521, federal agencies must obtain approval from OMB for each collection of information they conduct or sponsor. “Collection of information” means agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. 44 U.S.C. 3502(3); 5 CFR 1320.3(c). As required by section 3506(c)(2)(A) of the PRA, the FTC is providing this opportunity for public comment before requesting that OMB extend the existing paperwork clearance for the TSR, 16 CFR part 310 (OMB Control Number 3084-0097).

The TSR, 16 CFR 310, implements the Telemarketing and Consumer Fraud and Abuse Prevention Act, 15 U.S.C. 6101-6108 (“Telemarketing Act”), as amended by the Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism Act (“USA PATRIOT Act”), Public Law 107056 (Oct. 25, 2001). The Act seeks to prevent deceptive or abusive telemarketing practices in telemarketing, which, pursuant to the USA PATRIOT Act, includes calls made to solicit charitable contributions by third-party telemarketers. The Telemarketing Act mandated certain disclosures by telemarketers, and directed the Commission to include recordkeeping requirements in promulgating a rule to prohibit such practices. As required by the Telemarketing Act, the TSR mandates certain disclosures for telephone sales and requires telemarketers to retain certain records regarding advertising, sales, and employees. The required disclosures provide consumers with information necessary to make informed purchasing decisions. The required records are to be made available for inspection by the Commission and other law enforcement personnel to determine compliance with the Rule. Required records may also yield information helpful to measuring and redressing consumer injury stemming from Rule violations.

In 2003, the Commission amended the TSR to include certain new disclosure requirements and to expand the Rule in other ways. See 68 FR 4580 (Jan. 29, 2003). Specifically, the Rule was amended to cover upsells  1 (not only in outbound calls, but also in inbound calls) and additional transactions were included under the Rule's purview. For example, the Rule was extended to the solicitation by telephone of charitable donations by third-party telemarketers in response to the mandate of the USA PATRIOT Act. Finally, the amendments established the National Do Not Call Registry (“Registry”), permitting consumers to register, via either a toll-free telephone number or the Internet, their preference not to receive certain telemarketing calls. 2 Accordingly, under the TSR, most sellers and telemarketers are required to refrain from calling consumers who have placed their numbers on the Registry. 3 Moreover, sellers and telemarketers must periodically access the Registry to remove from their telemarketing lists the telephone numbers of those consumers who have registered. 4

In 2008, the Commission promulgated amendments to the TSR regarding prerecorded calls, 16 CFR 310.4(b)(1)(v), and call abandonment rate calculations, 16 CFR 310.4(b)(4)(i). 5 The amendment regarding prerecorded calls added certain information collection requirements. 6 Specifically, the amendment expressly authorized sellers and telemarketers to place outbound prerecorded telemarketing calls to consumers only if: (1) The seller has obtained written agreements from those consumers to receive prerecorded telemarketing calls after a clear and conspicuous disclosure of the purpose of the agreement; and (2) the call discloses and provides an automated telephone keypress or voice-activated opt-out mechanism at the outset of the call. 7 Although the opt-out mechanism requirement took effect on December 1, 2008, the written agreement requirement did not take effect until September 1, 2009. 8

In 2010, the Commission published additional amendments taking effect that year to require specific new disclosures in the sale of a “debt relief service,” as that term is defined in Section 310.2(m) to include for-profit credit counseling services, debt settlement, and debt negotiation services. The amendments result in PRA burden for all covered entities—both new and existing respondents—that engage in telemarketing of these services. The amendments, among other things: (1) Applied the TSR to inbound telemarketing of debt relief services;  9 and (2) added new required disclosures and prohibited representations to curb deceptive practices prevalent in the telemarketing of debt relief services.

Estimated Annual Hours Burden: 1,319,984 hours.

The estimated burden for recordkeeping is 15,610 hours for all industry members affected by the Rule. The estimated burden for the disclosures that the Rule requires for both the live telemarketing call provisions of the TSR and those regarding prerecorded calls is 1,304,374 hours for all affected industry members. Thus, the total PRA burden is 1,319,984 hours. These estimates are explained below.

Number of Respondents: As a preliminary matter, only telemarketers and sellers, not telefunders (third-party telemarketers soliciting contributions on behalf of charities), are subject to the Registry provisions of the Rule, and only sellers, not telemarketers or telefunders, are subject to the new express agreement obligations attributable to the prerecorded call disclosure requirements. 10 The Registry data does not separately account for telefunders; they are a subset of the overall number of telemarketing entities known to access the Registry for any given year. 11

In calendar year 2012, 28,601 telemarketing entities accessed the Registry. Of these entities, 641 were “exempt” entities obtaining access to data. 12 By definition, none of the exempt entities are subject to the TSR. In addition, 22,321 sellers and 5,639 telemarketers accessed the Registry. Of those, however, 15,854 sellers and 3,996 telemarketers with independent access to the Registry obtained data for just one state. Staff assumes that these entities are operating solely intrastate, and thus would not be subject to the TSR. 13 Applying this Registry data, staff estimates that 8,110 telemarketing entities (28,601—641—15,854—3,996) are currently subject to the TSR, of which 6,467 (22,321—15,854) are sellers and 1,643 (5,639—3,996) are telemarketers. 14

Staff estimates that the above-noted 8,110 telemarketing entities subject to the Rule each require approximately one hour per year to file and store records required by the TSR for an annual total of 8,110 burden hours. The Commission staff also estimates that 75 new entrants per year would need to spend 100 hours each developing a recordkeeping system that complies with the TSR for an annual total of 7,500 burden hours. 15 These figures, based on prior estimates, are consistent with staff's current knowledge of the industry. Thus, the total estimated annual recordkeeping burden for new and existing telemarketing entities, including those offering debt relief services and making prerecorded calls, 16 is 15,610 hours.

Scope of the problem: Less than half (48%) of all U.S. adults (1) meet the 2008 Physical Activity Guidelines, which will be included in the docket as a supporting document, and less than 3 in 10 high school students get at least 60 minutes of physical activity every day (2). Only 13 percent of children walk or bike to school, compared with 44 percent a generation ago (3). More than a quarter of trips made by car are within one mile of home (4). Observed differences in physical activity levels among some population groups include: physical activity levels decline with age (5); activity levels are lower in low-income communities and among racial/ethnic miniorities (6); and, in general, persons with disabilities are less active than those without disabilities (7). Causes for lower physical activity levels vary but may in part be due to a lack of available and/or accessible places for safe and enjoyable physical activity. Walking can be an enjoyable recreational, occupational or purposeful (e.g., for transportation) physical activity in which many Americans can engage. It can enhance health and quality of life and can also serve as a gateway to other enjoyable types of physical activity.

Approach: HHS/CDC works to increase health-related physical activity through population-based approaches. The agency also conducts physical activity related surveillance, applied research and evaluation, and translates and disseminates associated best practices to inform efforts to improve opportunities and support for physical activity. Consistent with these activities, HHS/CDC is assisting the Office of the Surgeon General in the Department of Health and Human Services to issue a call to action to increase attention to the promotion of walking and walkability to help Americans become more physically active. The intent of the Surgeon General's call to action is to identify opportunities and actions that can be taken by all levels of government, civic organizations, health care providers, educational institutions, worksites, industry, service providers, individuals and others to increase walking and walkability throughout the nation by providing access to safe, attractive and convenient places to walk (and wheelchair roll) and creating a culture that supports walking for Americans of all ages and abilities.

We invite comments and information on environmental or systems strategies; interventions that increase walkability of communities and walking for individuals; and national-, state-, tribal-, territorial-, community-, organizational-, and individual-level actions. We are particularly interested in strategies that consider individuals with developmental and chronic disease-related disabilities, and groups having health and physical activity disparities or lack resources and opportunities to be physically active.

Areas of Focus: Many factors can contribute to low levels of walking and physical inactivity, including lack of access to safe and convenient places to walk, lack of signage and directional information, long distances to destinations, lack of public transportation, and lack of the inclusion of persons with mobility limitations in walking campaigns and programs. HHS/CDC and the Office of the Surgeon General are interested in receiving information on the following topics:

(1) Barriers to walking for youth; adults; seniors; persons with developmental, injury, and chronic disease-related disabilities; racial and ethnic minorities; and low-income individuals.

(2) Evidence-based strategies for overcoming those barriers and their reach and impact to increase physical activity at the population level and among the above mentioned subpopulations.

FDA is announcing the availability of a draft guidance for industry entitled “Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants.” This draft guidance provides recommendations to industry on formal meetings between FDA and sponsors or applicants relating to the development and review of biosimilar biological products regulated by CDER and CBER. For the purposes of this draft guidance, “formal meeting” includes any meeting that is requested by a sponsor or applicant following the request procedures provided in this draft guidance and includes meetings conducted in any format (i.e., face-to-face meeting, teleconference, or videoconference).

The Biologics Price Competition and Innovation Act of 2009 amended the Public Health Service (PHS) Act and other statutes to create an abbreviated licensure pathway in section 351(k) of the PHS Act (42 U.S.C. 262(k)) for biological products shown to be biosimilar to, or interchangeable with, an FDA-licensed biological product (see sections 7001 through 7003 of the Patient Protection and Affordable Care Act (Pub. L. 111-148)). The Biosimilar User Fee Act of 2012 (BsUFA), enacted as part of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144), amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to authorize a new user fee program for biosimilar biological products. FDA has committed to meeting certain performance goals in connection with the new user fee program. The performance goals, which are set forth in a letter from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, 1 include meeting management goals for formal meetings that occur between FDA and sponsors or applicants during the development phase of a biosimilar biological product. This draft guidance describes the Agency's current thinking on how it intends to interpret and apply certain provisions of BsUFA, and also provides information on specific performance goals for the management of meetings associated with the development and review of biosimilar biological products.

This draft guidance reflects a unified approach to all formal meetings between sponsors or applicants and FDA for biosimilar biological product development (BPD) programs. It is intended to assist sponsors and applicants in generating and submitting a meeting request and the associated meeting package to FDA for biosimilar biological products. This draft guidance does not apply to new drug or abbreviated new drug applications under section 505 of the FD&C Act or to biologics license applications (BLAs) under section 351(a) of the PHS Act.

FDA expects that review staff will participate in many meetings with biosimilar biological product sponsors or applicants who seek guidance relating to the development and review of biosimilar biological products. Because these meetings often will represent critical points in the regulatory process, it is important that there are efficient, consistent procedures for the timely and effective conduct of such meetings. The good meeting management practices in this draft guidance are intended to provide consistent procedures that will promote well-managed meetings and to ensure that such meetings are scheduled within a reasonable time, conducted efficiently, and documented appropriately. The following five meeting types that occur between sponsors or applicants and FDA staff during the biosimilar BPD phase are described in the draft guidance: (1) Biosimilar Initial Advisory meeting; (2) BPD Type 1 meeting; (3) BPD Type 2 meeting; (4) BPD Type 3 meeting; and (5) BPD Type 4 meeting.

This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the Agency's current thinking on formal meetings between FDA and sponsors or applicants regarding biosimilar biological products. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.

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.

Under the Paperwork Reduction Act of 1995 (PRA), 44 U.S.C. 3501-3520, Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “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: (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 draft guidance on the procedures for formal meetings between FDA and biosimilar biological product sponsors or applicants describes procedures for requesting, scheduling, conducting, and documenting such formal meetings.

The draft guidance describes two types of collections of information: (1) The submission of a meeting request containing certain information and (2) the submission of an information package that accompanies the meeting request. The draft guidance also refers to previously approved collections of information found in FDA regulations. The collections of information for 21 CFR 312.48 have been approved under OMB control number 0910-0014.

Under the draft guidance, a sponsor or applicant interested in meeting with CDER or CBER should submit a meeting request to the sponsor's or applicant's application (e.g., investigational new drug application, BLA) through the controlled document system. If there is no application, the request should be submitted to either the appropriate CDER division director with a copy sent to the division's chief of project management staff or to the division director of the appropriate product office within CBER. Before submitting any meeting request by fax or email when there is no application, the sponsor or applicant should contact the appropriate review division or the Biosimilars Program staff, CDER, Office of New Drugs, to determine to whom the request should be directed, how the request should be submitted, and the appropriate format for the request, and to arrange for confirmation of receipt of the request.

FDA recommends that a request be submitted in this manner to prevent the possibility of faxed or emailed requests being overlooked because of the volume of emails received daily by FDA staff. Faxed or emailed requests should be sent during official business hours (8 a.m. to 4:30 p.m. EST/EDT) Monday through Friday (except Federal government holidays). Processing and receipt may be delayed for requests where confirmation of receipt has not been prearranged.

Under the draft guidance, FDA requests that sponsors and applicants include in meeting requests certain information about the proposed meeting. This information includes:

1. Product Name.

2. Application Number (if applicable).

3. Proposed Proper Name (or proper name if post-licensure).

4. Structure (if applicable).

5. Reference Product Name.

6. Proposed Indication(s) or Context of Product Development.

7. Meeting Type Being Requested (i.e., Biosimilar Initial Advisory meeting, BPD Type 1, 2, 3, or 4 meeting). The rationale for requesting the meeting type should be included.

8. A Brief Statement of the Purpose of the Meeting. This statement should include a brief background of the issues underlying the agenda. It also can include a brief summary of completed or planned studies and clinical trials or data that the sponsor or applicant intends to discuss at the meeting, the general nature of the critical questions to be asked, and where the meeting fits in overall development plans. Although the statement need not provide detailed documentation of trial designs or completed studies and clinical trials, it should provide enough information to facilitate understanding of the issues, such as a small table that summarizes major results.

9. A List of the Specific Objectives/Outcomes the Requester Expects from the Meeting.

10. A Proposed Agenda, Including Estimated Times Needed for Each Agenda Item.

11. A List of Questions, Grouped by Discipline. For each question there should be a brief explanation of the context and purpose of the question.

12. A List of Ill Individuals with Their Titles and Affiliations Who Will Attend the Requested Meeting from the Sponsor's or Applicant's Organization and Consultants.

13. A List of FDA Staff, if Known, or Disciplines, Asked to Participate in the Requested Meeting.

14. Suggested Dates and Times (e.g., morning or afternoon) for the Meeting Which are Within or Beyond the Appropriate Time Frame of the Meeting Type Being Requested.

15. The Proposed Format of the Meeting (i.e., face-to-face meeting, teleconference, or videoconference).

This information will be used by FDA to determine the utility of the meeting, to identify FDA staff necessary to discuss proposed agenda items, and to schedule the meeting.

FDA requests that a sponsor or applicant submit a meeting package to the appropriate review division with the meeting request. FDA recommends that information packages generally include:

1. Product Name and Application Number (if applicable).

2. Proposed Proper Name (or proper name if postlicensure).

3. Structure (if applicable).

4. Reference Product Name.

5. Proposed Indication(s) or Context of Product Development.

6. Dosage Form, Route of Administration, Dosing Regimen (frequency and duration), and Presentation(s).

7. A List of Sponsor or Applicant Attendees, Affiliations, and Titles.

8. A Background Section that Includes the Following:

a. A brief history of the development program.

b. The status of product development (e.g., chemistry, manufacturing, and controls; nonclinical; and clinical, including any development outside the United States, as applicable).

9. A Brief Statement Summarizing the Purpose of the Meeting.

10. A Proposed Agenda.

11. A List of Questions for Discussion Grouped by Discipline and with a Brief Summary for Each Question to Explain the Need or Context for the Question.

12. Data to Support Discussion Organized by Discipline and Question. The level of detail of the data should be appropriate to the meeting type requested and the product development stage.

The purpose of the information package is to provide FDA staff the opportunity to adequately prepare for the meeting, including the review of relevant data concerning the product.

Description of Respondents: A sponsor or applicant for a biosimilar biological product who requests a formal meeting with FDA regarding the development and review of a biosimilar biological product.

Burden Estimate: Provided below is an estimate of the annual reporting burden for the submission of meeting requests and information packages under the draft guidance.

The estimated number of respondents submitting meeting requests and information packages is based on the current workload and development expectations for biosimilar biological products. The burden hour estimate includes any time that may be needed by sponsors or applicants for rescheduling and canceling meetings, for premeetings and other communications with FDA about the meetings, and for resolution of disputes about meeting minutes.

Based on the current workload and development expectations, FDA estimates that approximately 15 sponsors and applicants (respondents) may request approximately a total of 30 formal meetings, and submit approximately 30 information packages, with CDER annually, and approximately 1 respondent may request approximately 2 formal meetings, and submit approximately 2 information packages, with CBER annually.

For a meeting request, the hours per response, which is the estimated number of hours that a respondent would spend preparing the information to be submitted with a meeting request in accordance with the draft guidance, is estimated to be approximately 15 hours. Based on FDA's experience, we expect it will take respondents this amount of time to gather and copy brief statements about the product and a description of the purpose and details of the meeting.

For an information package, the hours per response, which is the estimated number of hours that a respondent would spend preparing the information package in accordance with the draft guidance, is estimated to be approximately 30 hours. Based on FDA's experience, we expect it will take respondents this amount of time to gather and copy brief statements about the product, a description of the details for the anticipated meeting, and data and information that generally would already have been compiled for submission to FDA. In total, we expect sponsors to spend 480 hours preparing meeting requests and 960 hours preparing information packages each year.

I. Background

FDA is announcing the availability of a SUPAC draft guidance for industry entitled “SUPAC: Manufacturing Equipment Addendum.” This revised draft document combines and supersedes the following guidances for industry: (1) “SUPAC IR/MR: Immediate Release and Modified Release Solid Oral Dosage Forms: Manufacturing Equipment Addendum,” published on January 1, 1999, and (2) “SUPAC-SS: Nonsterile Semisolid Dosage Forms; Manufacturing Equipment Addendum,” published as draft on December 1, 1998. When published, these guidances included tables that listed specific equipment that were misinterpreted as a list of FDA required equipment. In addition, FDA is concerned that the equipment addenda may no longer reflect current practices and may be limiting, instead of encouraging, manufacturers to continually evaluate and update practices. FDA has removed the tables listing specific manufacturing equipment from these guidances and combined them into a single addendum. FDA has also made some changes to clarify the types of processes being referenced.

This guidance should be used with the following guidances for industry to determine what documentation should be submitted to FDA regarding equipment changes: (1) “SUPAC-IR: Immediate Release Solid Oral Dosage Forms—Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation” ( http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070636.pdf ), (2) “SUPAC-MR: Modified Release Solid Oral Dosage Forms Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls; In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation” ( http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070640.pdf ), and (3) “SUPAC-SS: Nonsterile Semisolid Dosage Forms, Scale-Up and Post Approval Changes: Chemistry Manufacturing and Controls; In Vitro Release Testing and In Vivo Bioequivalence Documentation” ( http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070930.pdf ).

As part of a greater effort, FDA is thoroughly reviewing the SUPAC guidance series to determine how these guidances fit with current manufacturing practices, including, but not limited to, risk-based assessment approaches and quality by design principles. These efforts will also be considered part of the finalization process for this guidance.

This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the Agency's current thinking on manufacturing equipment. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.

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 .

Persons with access to the Internet may obtain the document at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov .

Background

For the purposes of this request for information (RFI), neurotoxicity means adverse outcomes to the nervous system resulting from exposure during any life stage. Special emphasis is placed on identifying assay systems that interrogate cellular and molecular events that are critical to the development and/or function of the nervous system. The NTP is also interested in receiving recommendations on molecular targets within critical cellular toxicity pathways in biochemical- or cell-based assays or alternative animal models that assess the potential ability of compounds to act as toxicants to the developing or adult nervous systems.

1. Information on technologies/assays currently available for screening critical pathways involved in neurotoxicity where the endpoint is associated with a phenotypic manifestation of toxicity in vivo (adverse outcome).

a. The referred technologies/assays should have the ability to batch screen sets of at least 20 compounds to produce a concentration response curve suitable for defining the potency and efficacy of a response and have been demonstrated to be both reliable and relevant.

b. Specific information requested for each assay includes the robustness of the assay, dose-response and time-course toxicity profiles, as well as to what extent the assay informs on specific neurotoxicity life-stage windows (i.e., developmental, juvenile, ageing).

2. Information on assays that can be used to measure the activity of a compound on a molecular initiating event or key event within a neurotoxicity adverse outcome pathway.

3. Information on the best molecular or cellular targets that accurately characterize the activity of a compound within a specific pathway resulting in an adverse neurotoxic outcome.

4. Information on assays, technologies, or methods that will aid in identifying neurotoxic compounds, which are activated or deactivated by metabolic activity.

Respondents to this RFI are asked to provide the following: the Data Universal Numbering System or DUNS® number, organization name, address, technical and administrative points of contact (including names, titles, addresses, telephone and fax numbers, and email address), the North American Industry Classification System (NAICS) code, and size and type of business (e.g., 8(a), HUBZone, WOSB, SDVOSB, etc.). Information packages should not exceed one (1) page in length, excluding standard brochures. Telephone and facsimile responses will not be accepted. Electronic information should be submitted in Microsoft Office (Word, PowerPoint, Excel), Adobe PDF, or compatible formats sufficient to clearly read the information provided. Please include a cover page identifying the technical and administrative points of contact for the organization, including names, titles, addresses, telephone and fax numbers, email addresses, and organization name. The deadline for receipt of the requested information is May 1, 2013.

Responses to this request are voluntary. This notice does not obligate the U.S. Government to award a contract or otherwise pay for the information provided in response to this request. The U.S. Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this request should ensure that its response is complete and sufficiently detailed. Respondents are advised that the U.S. Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. No proprietary, classified, confidential, or sensitive information should be included in your response.

The NTP is an interagency program established in 1978 (43 FR 53060) to coordinate toxicology research and testing across the Department of Health and Human Services. Other activities of the program focus on strengthening the science base in toxicology, developing and validating improved testing methods, and providing information about potentially toxic chemicals to health regulatory and research agencies, scientific and medical communities, and the public. Information about the NTP is found at http://ntp.niehs.nih.gov.

The Mandatory Guidelines were initially developed in accordance with Executive Order 12564 and section 503 of Public Law 100-71. The “Mandatory Guidelines for Federal Workplace Drug Testing Programs”, as amended in the revisions listed above, requires strict standards that Laboratories and Instrumented Initial Testing Facilities (IITF) must meet in order to conduct drug and specimen validity tests on urine specimens for Federal agencies.

To become certified, an applicant Laboratory/IITF must undergo three rounds of performance testing plus an on-site inspection. To maintain that certification, a Laboratory/IITF must participate in a quarterly performance testing program plus undergo periodic, on-site inspections.

Laboratories and Instrumented Initial Testing Facilities (IITF) in the applicant stage of certification are not to be considered as meeting the minimum requirements described in the HHS Mandatory Guidelines. A Laboratory/ IITF must have its letter of certification from HHS/SAMHSA (formerly: HHS/NIDA) which attests that it has met minimum standards.

In accordance with the Mandatory Guidelines dated November 25, 2008 (73 FR 71858), the following Laboratories and Instrumented Initial Testing Facilities (IITF) meet the minimum standards to conduct drug and specimen validity tests on urine specimens:

None.

ACL Laboratories, 8901 W. Lincoln Ave., West Allis, WI 53227, 414-328-7840/800-877-7016, (Formerly: Bayshore Clinical Laboratory)

ACM Medical Laboratory, Inc., 160 Elmgrove Park, Rochester, NY 14624, 585-429-2264

Advanced Toxicology Network, 3560 Air Center Cove, Suite 101, Memphis, TN 38118, 901-794-5770/888-290-1150

Aegis Analytical Laboratories, 345 Hill Ave., Nashville, TN 37210, 615-255-2400, (Formerly: Aegis Sciences Corporation, Aegis Analytical Laboratories, Inc.)

Alere Toxicology Services, 1111 Newton St., Gretna, LA 70053, 504-361-8989/800-433-3823, (Formerly: Kroll Laboratory Specialists, Inc., Laboratory Specialists, Inc.)

Alere Toxicology Services, 450 Southlake Blvd., Richmond, VA 23236, 804-378-9130, (Formerly: Kroll Laboratory Specialists, Inc., Scientific Testing Laboratories, Inc.; Kroll Scientific Testing Laboratories, Inc.)

Baptist Medical Center-Toxicology Laboratory, 11401 I-30, Little Rock, AR 72209-7056, 501-202-2783, (Formerly: Forensic Toxicology Laboratory Baptist Medical Center)

Clinical Reference Lab, 8433 Quivira Road, Lenexa, KS 66215-2802, 800-445-6917

Doctors Laboratory, Inc., 2906 Julia Drive, Valdosta, GA 31602, 229-671-2281

DrugScan, Inc., 200 Precision Road, Suite 200, Horsham, PA 19044, 800-235-4890

ElSohly Laboratories, Inc., 5 Industrial Park Drive, Oxford, MS 38655, 662-236-2609

Fortes Laboratories, Inc., 25749 SW Canyon Creek Road, Suite 600, Wilsonville, OR 97070, 503-486-1023

Gamma-Dynacare Medical Laboratories*, A Division of the Gamma-Dynacare Laboratory Partnership, 245 Pall Mall Street, London, ONT, Canada N6A 1P4, 519-679-1630

Laboratory Corporation of America Holdings, 7207 N. Gessner Road, Houston, TX 77040, 713-856-8288/800-800-2387

Laboratory Corporation of America Holdings, 69 First Ave., Raritan, NJ 08869, 908-526-2400/800-437-4986, (Formerly: Roche Biomedical Laboratories, Inc.)

Laboratory Corporation of America Holdings, 1904 Alexander Drive, Research Triangle Park, NC 27709, 919-572-6900/800-833-3984, (Formerly: LabCorp Occupational Testing Services, Inc., CompuChem Laboratories, Inc.; CompuChem Laboratories, Inc., A Subsidiary of Roche Biomedical Laboratory; Roche CompuChem Laboratories, Inc., A Member of the Roche Group)

Laboratory Corporation of America Holdings, 1120 Main Street, Southaven, MS 38671, 866-827-8042/800-233-6339, (Formerly: LabCorp Occupational Testing Services, Inc.; MedExpress/National Laboratory Center)

LabOne, Inc. d/b/a Quest Diagnostics, 10101 Renner Blvd., Lenexa, KS 66219, 913-888-3927/800-873-8845, (Formerly: Quest Diagnostics Incorporated; LabOne, Inc.; Center for Laboratory Services, a Division of LabOne, Inc.,)

MedTox Laboratories, Inc., 402 W. County Road D, St. Paul, MN 55112, 651-636-7466/800-832-3244

MetroLab-Legacy Laboratory Services, 1225 NE 2nd Ave., Portland, OR 97232, 503-413-5295/800-950-5295

Minneapolis Veterans Affairs Medical Center, Forensic Toxicology Laboratory, 1 Veterans Drive, Minneapolis, MN 55417, 612-725-2088

National Toxicology Laboratories, Inc., 1100 California Ave., Bakersfield, CA 93304, 661-322-4250/800-350-3515

One Source Toxicology Laboratory, Inc., 1213 Genoa-Red Bluff, Pasadena, TX 77504, 888-747-3774, (Formerly: University of Texas Medical Branch, Clinical Chemistry Division; UTMB Pathology-Toxicology Laboratory)

Pacific Toxicology Laboratories, 9348 DeSoto Ave., Chatsworth, CA 91311, 800-328-6942, (Formerly: Centinela Hospital Airport Toxicology Laboratory)

Pathology Associates Medical Laboratories, 110 West Cliff Dr., Spokane, WA 99204, 509-755-8991/800-541-7891x7

Phamatech, Inc., 10151 Barnes Canyon Road, San Diego, CA 92121, 858-643-5555

Quest Diagnostics Incorporated, 1777 Montreal Circle, Tucker, GA 30084, 800-729-6432, (Formerly: SmithKline Beecham Clinical Laboratories; SmithKline Bio-Science Laboratories)

Quest Diagnostics Incorporated, 400 Egypt Road, Norristown, PA 19403, 610-631-4600/877-642-2216, (Formerly: SmithKline Beecham Clinical Laboratories; SmithKline Bio-Science Laboratories)

Quest Diagnostics Incorporated, 8401 Fallbrook Ave., West Hills, CA 91304, 818-737-6370, (Formerly: SmithKline Beecham Clinical Laboratories)

Redwood Toxicology Laboratory, 3650 Westwind Blvd., Santa Rosa, CA 95403, 707-570-4434

South Bend Medical Foundation, Inc., 530 N. Lafayette Blvd., South Bend, IN 46601, 574-234-4176 x1276

Southwest Laboratories, 4625 E. Cotton Center Boulevard, Suite 177, Phoenix, AZ 85040, 602-438-8507/800-279-0027

STERLING Reference Laboratories, 2617 East L Street, Tacoma, Washington 98421, 800-442-0438

Toxicology & Drug Monitoring Laboratory, University of Missouri Hospital & Clinics, 301 Business Loop 70 West, Suite 208, Columbia, MO 65203, 573-882-1273

US Army Forensic Toxicology Drug Testing Laboratory, 2490 Wilson St., Fort George G. Meade, MD 20755-5235, 301-677-7085

*The Standards Council of Canada (SCC) voted to end its Laboratory Accreditation Program for Substance Abuse (LAPSA) effective May 12, 1998. Laboratories certified through that program were accredited to conduct forensic urine drug testing as required by U.S. Department of Transportation (DOT) regulations. As of that date, the certification of those accredited Canadian laboratories will continue under DOT authority. The responsibility for conducting quarterly performance testing plus periodic on-site inspections of those LAPSA-accredited laboratories was transferred to the U.S. HHS, with the HHS' NLCP contractor continuing to have an active role in the performance testing and laboratory inspection processes. Other Canadian laboratories wishing to be considered for the NLCP may apply directly to the NLCP contractor just as U.S. laboratories do.

Upon finding a Canadian laboratory to be qualified, HHS will recommend that DOT certify the laboratory ( Federal Register , July 16, 1996) as meeting the minimum standards of the Mandatory Guidelines published in the Federal Register on April 30, 2010 (75 FR 22809). After receiving DOT certification, the laboratory will be included in the monthly list of HHS-certified laboratories and participate in the NLCP certification maintenance program.

This Notice relies on the authority of the Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended. An ICR is an application to OIRA seeking the approval, extension, or renewal of a Coast Guard collection of information (Collection). The ICR contains information describing the Collection's purpose, the Collection's likely burden on the affected public, an explanation of the necessity of the Collection, and other important information describing the Collections. There is one ICR for each Collection.

The Coast Guard invites comments on whether these ICRs should be granted based on the Collections being necessary for the proper performance of Departmental functions. In particular, the Coast Guard would appreciate comments addressing: (1) The practical utility of the Collections; (2) the accuracy of the estimated burden of the Collections; (3) ways to enhance the quality, utility, and clarity of information subject to the Collections; and (4) ways to minimize the burden of the Collections on respondents, including the use of automated collection techniques or other forms of information technology. In response to your comments, we may revise these ICRs or decide not to seek approval of revisions of the Collections. We will consider all comments and material received during the comment period.

We encourage you to respond to this request by submitting comments and related materials. Comments must contain the OMB Control Number of the ICR and the docket number of this request, [USCG-2013-0164], and must be received by May 31, 2013. We will post all comments received, without change, to http://www.regulations.gov. They will include any personal information you provide. We have an agreement with DOT to use their DMF. Please see the “Privacy Act” paragraph below.

If you submit a comment, please include the docket number [USCG-2013-0164], indicate the specific section of the document to which each comment applies, providing a reason for each comment. You may submit your comments and material online ( via http://www.regulations.gov ), by fax, mail, or hand delivery, but please use only one of these means. If you submit a comment online via www.regulations.gov, it will be considered received by the Coast Guard when you successfully transmit the comment. If you fax, hand deliver, or mail your comment, it will be considered as having been received by the Coast Guard when it is received at the DMF. We recommend you include your name, mailing address, an email address, or other contact information in the body of your document so that we can contact you if we have questions regarding your submission.

You may submit your comments and material by electronic means, mail, fax, or delivery to the DMF at the address under ADDRESSES; but please submit them by only one means. To submit your comment online, go to http://www.regulations.gov, and type “USCG-2013-0164” in the “Keyword” box. If you submit your comments by mail or hand delivery, submit them in an unbound format, no larger than 8 1/2 ; by 11 inches, suitable for copying and electronic filing. If you submit comments by mail and would like to know that they reached the Facility, please enclose a stamped, self-addressed postcard or envelope. We will consider all comments and material received during the comment period and will address them accordingly.

Viewing comments and documents: To view comments, as well as documents mentioned in this Notice as being available in the docket, go to http://www.regulations.gov, click on the “read comments” box, which will then become highlighted in blue. In the “Keyword” box insert “USCG-2013-0164” and click “Search.” Click the “Open Docket Folder” in the “Actions” column. You may also visit the DMF in Room W12-140 on the ground floor of the DOT West Building, 1200 New Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

Anyone can search the electronic form of comments received in dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review a Privacy Act statement regarding Coast Guard public dockets in the January 17, 2008, issue of the Federal Register (73 FR 3316).

1. Title: Waterfront Facilities Handling Liquefied Natural Gas (LNG) and Liquefied Hazardous Gas (LHG).

OMB Control Number: 1625-0049.

Summary: Liquefied Natural Gas (LNG) and other Liquefied Hazardous Gases (LHG) present a risk to the public when handled at waterfront facilities. These rules should either prevent accidental releases at waterfront facilities or mitigate their results. They are necessary to promote and verify compliance with safety standards.

Need: Title 33 CFR part 127 prescribe safety standards for the design, construction, equipment, operations, maintenance, personnel training, and fire protection at waterfront facilities handling LNG or LHG.

Forms: None.

Respondents: Owners and operators of waterfront facilities that transfer LNG or LHG.

Frequency: On occasion.

Burden Estimate: The estimated burden has decreased from 9,504 hours to 6,425 hours a year.

2. Title: Marine Occupational Health and Safety Standards for Benzene—46 CFR 197 Subpart C.

OMB Control Number: 1625-0063.

Summary: To protect marine workers from exposure to toxic Benzene vapor, the Coast Guard implemented Title 46 CFR part 197 subpart C.

Need: This information collection is vital to verifying compliance.

Forms: None.

Respondents: Owners and operators of vessels.

Frequency: On occasion.

Burden Estimate: The estimated burden has decreased from 59,766 hours to 38,165 hours a year due to a correction in the method of calculating burden.

This Notice relies on the authority of the Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended. An ICR is an application to OIRA seeking the approval, extension, or renewal of a Coast Guard collection of information (Collection). The ICR contains information describing the Collection's purpose, the Collection's likely burden on the affected public, an explanation of the necessity of the Collection, and other important information describing the Collection. There is one ICR for each Collection. The Coast Guard invites comments on whether this ICR should be granted based on the Collection being necessary for the proper performance of Departmental functions. In particular, the Coast Guard would appreciate comments addressing: (1) The practical utility of the Collection; (2) the accuracy of the estimated burden of the Collection; (3) ways to enhance the quality, utility, and clarity of information subject to the Collection; and (4) ways to minimize the burden of the Collection on respondents, including the use of automated collection techniques or other forms of information technology. In response to your comments, we may revise this ICR or decide not to seek approval of revisions of the Collection. We will consider all comments and material received during the comment period.

We encourage you to respond to this request by submitting comments and related materials. Comments must contain the OMB Control Number of the ICR and the docket number of this request, [USCG-2013-0045], and must be received by May 31, 2013. We will post all comments received, without change, to http://www.regulations.gov . They will include any personal information you provide. We have an agreement with DOT to use their DMF. Please see the “Privacy Act” paragraph below.

If you submit a comment, please include the docket number [USCG-2013-0045], indicate the specific section of the document to which each comment applies, providing a reason for each comment. You may submit your comments and material online ( via http://www.regulations.gov ), by fax, mail, or hand delivery, but please use only one of these means. If you submit a comment online via www.regulations.gov, it will be considered received by the Coast Guard when you successfully transmit the comment. If you fax, hand deliver, or mail your comment, it will be considered as having been received by the Coast Guard when it is received at the DMF. We recommend you include your name, mailing address, an email address, or other contact information in the body of your document so that we can contact you if we have questions regarding your submission.

You may submit your comments and material by electronic means, mail, fax, or delivery to the DMF at the address under ADDRESSES ; but please submit them by only one means. To submit your comment online, go to http://www.regulations.gov, and type “USCG-2013-0045” in the “Keyword” box. If you submit your comments by mail or delivery, submit them in an unbound format, no larger than 8-1/2 by 11 inches, suitable for copying and electronic filing. If you submit them by mail and would like to know that they reached the Facility, please enclose a stamped, self-addressed postcard or envelope. We will consider all comments and material received during the comment period and will address them accordingly.

To view comments, as well as documents mentioned in this Notice as being available in the docket, go to http://www.regulations.gov, click on the “read comments” box, which will then become highlighted in blue. In the “Keyword” box insert “USCG-2013-0045” and click “Search.” Click the “Open Docket Folder” in the “Actions” column. You may also visit the DMF in Room W12-140 on the ground floor of the DOT West Building, 1200 New Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

Anyone can search the electronic form of comments received in dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review a Privacy Act statement regarding Coast Guard public dockets in the January 17, 2008, issue of the Federal Register (73 FR 3316).

Title: U.S. Coast Guard International Ice Patrol (IIP) Customer Survey.

OMB Control Number: 1625-0087.

Summary: This information collection provides feedback on the processes of delivery and products distributed to the mariner by the International Ice Patrol.

Need: In accordance with Executive Order 12862, the U.S. Coast Guard is directed to conduct surveys (both qualitative and quantitative) to determine the kind and quality of services our customers want and expect, as well as their satisfaction with USCG's existing services. This survey will be limited to data collections that solicit strictly voluntary opinions and will not collect information that is required or regulated.

Forms: CG-16700.

Respondents: Owners and operators of vessels transiting the North Atlantic.

Frequency: Annually.

Burden Estimate: The estimated burden is estimated to be 120 hours.

Public Participation and Request for Comments.

This Notice relies on the authority of the Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended. An ICR is an application to OIRA seeking the approval, extension, or renewal of a Coast Guard collection of information (Collection). The ICR contains information describing the Collection's purpose, the Collection's likely burden on the affected public, an explanation of the necessity of the Collection, and other important information describing the Collection. There is one ICR for each Collection. The Coast Guard invites comments on whether this ICR should be granted based on the Collection being necessary for the proper performance of Departmental functions. In particular, the Coast Guard would appreciate comments addressing: (1) The practical utility of the Collection; (2) the accuracy of the estimated burden of the Collection; (3) ways to enhance the quality, utility, and clarity of information subject to the Collection; and (4) ways to minimize the burden of the Collection on respondents, including the use of automated collection techniques or other forms of information technology. In response to your comments, we may revise this ICR or decide not to seek approval of revisions of the Collection. We will consider all comments and material received during the comment period.

We encourage you to respond to this request by submitting comments and related materials. Comments must contain the OMB Control Number of the ICR and the docket number of this request, [USCG-2013-0133], and must be received by May 31, 2013. We will post all comments received, without change, to http://www.regulations.gov. They will include any personal information you provide. We have an agreement with DOT to use their DMF. Please see the “Privacy Act” paragraph below.

If you submit a comment, please include the docket number [USCG-2013-0133], indicate the specific section of the document to which each comment applies, providing a reason for each comment. You may submit your comments and material online ( via http://www.regulations.gov ), by fax, mail, or hand delivery, but please use only one of these means. If you submit a comment online via www.regulations.gov, it will be considered received by the Coast Guard when you successfully transmit the comment. If you fax, hand deliver, or mail your comment, it will be considered as having been received by the Coast Guard when it is received at the DMF. We recommend you include your name, mailing address, an email address, or other contact information in the body of your document so that we can contact you if we have questions regarding your submission.

You may submit your comments and material by electronic means, mail, fax, or delivery to the DMF at the address under ADDRESSES ; but please submit them by only one means. To submit your comment online, go to http://www.regulations.go v, and type “USCG-2013-0133” in the “Keyword” box. If you submit your comments by mail or delivery, submit them in an unbound format, no larger than 8 1/2 by 11 inches, suitable for copying and electronic filing. If you submit them by mail and would like to know that they reached the Facility, please enclose a stamped, self-addressed postcard or envelope. We will consider all comments and material received during the comment period and will address them accordingly.

To view comments, as well as documents mentioned in this Notice as being available in the docket, go to http://www.regulations.gov, click on the “read comments” box, which will then become highlighted in blue. In the “Keyword” box insert “USCG-2013-0133” and click “Search.” Click the “Open Docket Folder” in the “Actions” column. You may also visit the DMF in Room W12-140 on the ground floor of the DOT West Building, 1200 New Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

Anyone can search the electronic form of comments received in dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review a Privacy Act statement regarding Coast Guard public dockets in the January 17, 2008, issue of the Federal Register (73 FR 3316).

Title: Labeling Required in 33 CFR Parts 181 and 183 and 46 CFR 25.10-3.

OMB Control Number: 1625-0056.

Summary: Parts 181 and 183 of Title 33, Code of Federal Regulations and 46 CFR 25.10-3 contain the regulations and safety standards authorized by the statutes which apply to manufacturers of recreational boats, un-inspected commercial vessels and associated equipment. The regulations and safety standards contain information collections, which require boat and associated equipment manufacturers, importers and the boating public to apply for serial numbers and to display various labels evidencing compliance: Hull Identification Numbers; U.S. Coast Guard Maximum Capacities Label; Gasoline Fuel Tank Label; USCG Type Fuel Hose Label; and Certified Navigation Light Label.

Need: Title 46 U.S.C. 4302(a)(3) gives the Coast Guard the authority to require the display of seals, labels, plates, insignia, or other devices for certifying or evidencing compliance with safety regulations and standards of the United States Government for recreational vessels and associated equipment.

Forms: None.

Respondents: Manufacturers of boats, fuel tanks, fuel hoses and navigation lights.

Frequency: Once.

Burden Estimate: 156,170 hours annually.

We are publishing this meeting notice under provisions of the Federal Advisory Committee Act (FACA), 5 U.S.C. Appendix. NBSAC provides advice and recommendations to the Department of Homeland Security on matters relating to recreational boating safety. See 33 U.S.C. 13110.

The agenda for April 25, 2013 includes:

(1) Discussion of progress made on the objectives and strategies of the 2012-2016 national recreational boating safety program strategic plan.

(2) Public comment.

A final agenda will be available on http://homeport.uscg.mil/NBSAC NLT April 11, 2013.

We have scheduled the last fifteen minutes of the meeting, from 2:45 to 3 p.m., for oral comments from the public. If you wish to make an oral comment, please contact Mr. Jeff Ludwig, listed in the FOR FURTHER INFORMATION CONTACT section, either before the meeting or at the meeting when the members of the audience are requested to state their interest in commenting. We request that you limit your oral comments to 3 minutes. Please note that this public comment period may start before 2:45 p.m. if all other agenda items have been covered and may end before 3 p.m. if all of those wishing to comment have done so.

For information on facilities or services for individuals with disabilities or to request special assistance at the teleconference, please contact the individuals listed in the FOR FURTHER INFORMATION CONTACT section, as soon as possible.

We are publishing this meeting notice under provisions of the Federal Advisory Committee Act (FACA), 5 U.S.C. Appendix. NBSAC provides advice and recommendations to the Department of Homeland Security on matters relating to recreational boating safety. See 33 U.S.C. 13110.

The agenda for April 29, 2013 includes:

(1) Discussion of issues related to improving safety of recreational boating through the development of safer boating practices.

(2) Public comment.

A final agenda will be available on http://homeport.uscg.mil/NBSAC NLT April 15, 2013.

We have scheduled the last fifteen minutes of the meeting, from 2:45 to 3 p.m., for oral comments from the public. If you wish to make an oral comment, please contact Mr. Jeff Ludwig, listed in the FOR FURTHER INFORMATION CONTACT section, either before the meeting or at the meeting when the members of the audience are requested to state their interest in commenting. We request that you limit your oral comments to 3 minutes. Please note that this public comment period may start before 2:45 p.m. if all other agenda items have been covered and may end before 3 p.m. if all of those wishing to comment have done so.

For information on facilities or services for individuals with disabilities or to request special assistance at the teleconference, please contact the individuals listed in the FOR FURTHER INFORMATION CONTACT section, as soon as possible.

We are publishing this meeting notice under provisions of the Federal Advisory Committee Act (FACA), 5 U.S.C. Appendix. NBSAC provides advice and recommendations to the Department of Homeland Security on matters relating to recreational boating safety. See 33 U.S.C. 13110.

The agenda for April 16, 2013 includes:

(1) Discussion of issues related to the required carriage of safety equipment and compliance with standards and regulations in the manufacture of recreational boats.

(2) Public comment.

A final agenda will be available on http://homeport.uscg.mil/NBSAC NLT April 2, 2013.

We have scheduled the last fifteen minutes of the meeting, from 2:45 to 3 p.m., for oral comments from the public. If you wish to make an oral comment, please contact Mr. Jeff Ludwig, listed in the FOR FURTHER INFORMATION CONTACT section, either before the meeting or at the meeting when the members of the audience are requested to state their interest in commenting. We request that you limit your oral comments to 3 minutes. Please note that this public comment period may start before 2:45 p.m. if all other agenda items have been covered and may end before 3 p.m. if all of those wishing to comment have done so.

For information on facilities or services for individuals with disabilities or to request special assistance at the teleconference, please contact the individuals listed in the FOR FURTHER INFORMATION CONTACT section, as soon as possible.

This notice informs the public that HUD has submitted to OMB a request for approval of the Information collection described below. This notice is soliciting comments from members of the public and affecting agencies concerning the proposed collection of information to: (1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information; (3) Enhance the quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the collection of information on those who are to respond; including through the use of appropriate automated collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.

This notice also lists the following information:

Title of Proposed: Public Housing Authority Executive Compensation Information.

OMB Approval Number: 2577-0272.

Form Numbers: HUD-52725, HUD 52723.

Description of the need for the information and proposed use: Pursuant to PIH Notice 2011-48, HUD has been collecting information on the compensation provided by public housing authorities (PHAs) to their five most highly compensated employees, similar to the information that nonprofit organizations receiving federal tax exemptions are required to report to the IRS annually. Since PHAs receive significant direct federal funds, such compensation information has been collected by HUD to enhance oversight by HUD and by state and local authorities. After HUD began this information collection, Congress included a provision in its fiscal year 2012 appropriations legislation that placed a specific cap on the use of Section 8 and Section 9 funds to pay the salaries of PHA officials. To obtain information that will help HUD determine PHA compliance with this and future legislation, and to achieve the same overall objectives of the original information collection, HUD is revising the data collection instrument to collect information on base salary, and bonus and incentive compensation, and the extent to which such payments are made with federal funds. Changes include obtaining data on total cash compensation paid for with Section 8 and Section 9 funds. The new elements replace several segments such as “Reportable Compensation from PHA and Related Organizations” and “Contributions to Employee Benefit Plans and Deferred Compensation from the PHA and Related Organizations and “Contributions to Employee Benefit Plans and Deferred Compensation from the PHA and Related Organizations”.

Total Estimated Burden Hours: 1,372.

Status: Revision of a currently approved collection.

HUD is submitting the proposed information collection to OMB for review, as required by the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35, as amended).

This Notice is soliciting comments from members of the public and affected agencies concerning the proposed collection of information to: (1) Evaluate whether the proposed collection is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information; (3) Enhance the quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the collection of information on those who are to respond; including the use of appropriate automated collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.

This Notice also lists the following information:

Title of Proposal: Capital Needs Assessment (CNA).

OMB Control Number, if applicable: 2502-0505.

Description of the need for the information and proposed use: Collecting this information is required for compliance with the statute. In addition, this information allows the project owner and HUD to assess current project resources and determine future financial resources required to meet the needs of the project.

Agency form numbers, if applicable: None: CNAs are required to be prepared by qualified third party entities and provided to the loan originator or servicer for review. The originator or servicer then provides the completed document to the owner, who must provide a copy to HUD.

Estimation of the total numbers of hours needed to prepare the information collection including number of respondents, frequency of response, and hours of response: The number of burden hours is 72,720. The number of respondents is 1,818, the number of responses is 1,818, the frequency of response is on occasion, and the burden hour per response is 40.

Status of the proposed information collection: This is an extension of a currently approved collection.

Subsequent to the republication on February 6, 2013, HUD discovered that the Prefatory Statement of General Routine Uses inadvertently reported repeated information that HUD proposes to exclude from that publication. In addition, this notice updates and corrects the proposed number of Prefatory Statements of Routine Uses published for that notice to 17.

In conclusion, in the Federal Register on February 6, 2013, in FR Doc. 2013-02672, on page 8554, the second column, this notice removes the “Action” caption for routine use number 10: To appropriate Federal, state, local, tribal, or governmental agencies or multilateral governmental organizations responsible for investigating or prosecuting the violations of, or for enforcing or implementing, a statute, rule, regulation, order, or license, where HUD determines that the information would assist in the enforcement of civil or criminal laws; and, routine use number 11: To third parties during the course of a law enforcement investigation to the extent necessary to obtain information pertinent to the investigation, provided disclosure is appropriate to the proper performance of the official duties of the officer making the disclosure.

Under the Act (16 U.S.C. 1531 et seq. ), we maintain Lists of Endangered and Threatened Wildlife and Plants (which we collectively refer to as the List) in the Code of Federal Regulations (CFR) at 50 CFR 17.11 (for animals) and 17.12 (for plants). Section 4(c)(2)(A) of the Act requires us to review each listed species' status at least once every 5 years. Our regulations at 50 CFR 424.21 require that we publish a notice in the Federal Register announcing those species under active review. For additional information about 5-year reviews, go to http://www.fws.gov/endangered/what-we-do/recovery-overview.html, scroll down to “Learn More about 5-Year Reviews,” and click on our factsheet.

A 5-year review considers all new information available at the time of the review. In conducting these reviews, we consider the best scientific and commercial data that have become available since the listing determination or most recent status review, such as:

(A) Species biology, including but not limited to population trends, distribution, abundance, demographics, and genetics;

(B) Habitat conditions, including but not limited to amount, distribution, and suitability;

(C) Conservation measures that have been implemented that benefit the species;

(D) Threat status and trends in relation to the five listing factors (as defined in section 4(a)(1) of the Act); and

(E) Other new information, data, or corrections, including but not limited to taxonomic or nomenclatural changes, identification of erroneous information contained in the List, and improved analytical methods.

Any new information will be considered during the 5-year review and will also be useful in evaluating the ongoing recovery programs for the species.

This notice announces our active review of the species listed in the table below.