The Dairy Tariff-Rate Quota Import Licensing Regulation promulgated by the Department of Agriculture and codified at 7 CFR 6.20-6.36 provides for the issuance of licenses to import certain dairy articles that are subject to TRQs set forth in the HTS. Those dairy articles may only be entered into the United States at the in-quota TRQ tariff-rates by or for the account of a person or firm to whom such licenses have been issued and only in accordance with the terms and conditions of the regulation.

Licenses are issued on a calendar year basis, and each license authorizes the license holder to import a specified quantity and type of dairy article from a specified country of origin. The use of such licenses is monitored by the Import Program within the Foreign Agricultural Service, U.S. Department of Agriculture, and U.S. Customs and Border Protection, U.S. Department of Homeland Security.

The regulation at 7 CFR 6.33(a) provides that a fee will be charged for each license issued to a person or firm by the Licensing Authority to defray the Department of Agriculture's costs of administering the licensing system under this regulation.

The regulation at 7 CFR 6.33(a) also provides that the Licensing Authority will announce the annual fee for each license and that such fee will be set out in a notice to be published in the Federal Register . Accordingly, this notice sets out the fee for the licenses to be issued for the 2023 calendar year.

The total cost to the Department of Agriculture of administering the licensing system for 2023 has been estimated to be $789,068.00 and the estimated number of licenses expected to be issued is 2,250. Of the total cost, $572,200.00 represents staff and supervisory costs directly related to administering the licensing system, and $216,868.00 represents other miscellaneous costs, including travel, publications, forms, and Automatic Data Processing (ADP) system support.

Accordingly, notice is hereby given that the fee for each license issued to a person or firm for the 2023 calendar year, in accordance with 7 CFR 6.33, will be $350 per license.

Title: CCC Facility Guarantee Program (FGP).

OMB Number: 0551-0032.

Expiration Date of Approval: November 30, 2022.

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

Abstract: Under the FGP, CCC provides payment guarantees to facilitate the financing of manufactured goods and U.S. services to improve or establish agriculture-related facilities in emerging markets. By supporting such goods and services exports, the FGP is designed to enhance sales of U.S. agricultural commodities and products to emerging markets where the demand for such commodities and products may be limited due to inadequate storage, processing, handling, or distribution capabilities for such products.

The FGP is currently available in 84 countries. Under 7 CFR part 1493, U.S. sellers, foreign financial institutions (FFI), and U.S. financial institutions (USFI) are required to submit the following: (1) information about the seller, FFI, and USFI for program participation; (2) applications for payment guarantees; (3) environmental impact statement/assessment; (4) notice of assignment of payment guarantee; (5) evidence of performance; (6) notice of default and claims for loss; and (7) documents supporting dispute resolution and appeals. In addition, each seller and seller's assignee (U.S. financial institution) must maintain records on all information submitted to CCC and in connection with sales made under FGP. The information collected is used by CCC to manage, plan, evaluate, and account for government resources. The reports and records are required to ensure the proper and judicious use of public funds.

Estimate of Burden: The public reporting burden for these collections is estimated to average 1.282 hours per response.

Type of Respondents: U.S. exporters (sellers), U.S. financial institutions, and foreign financial institutions.

Estimated Number of Respondents: 18 per year.

Estimated Number of Responses per Respondent: 15.6 per year.

Estimated Total Annual Burden of Respondents: 360.5 hours.

Copies of this information collection can be obtained from Dacia Rogers, the Agency Information Collection Coordinator, at Dacia.Rogers@usda.gov.

Request for Comments: Send comments regarding (a) whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) the accuracy of the agency's estimate of the burden of the collection of information including validity of the methodology and assumption used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on those who are to respond, including through the use of automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

All comments received in response to this notice, including names and addresses when provided, will be a matter of public record. Comments will be available without change, including any personal information provided, for inspection online at http://www.regulations.gov and at the mail address listed above between 8:00 a.m. and 4:30 p.m., Monday through Friday, except holidays.

Comments will be summarized and included in the submission for Office of Management and Budget approval.

Persons with disabilities who require an alternative means for communication of information (Braille, large print, audiotape, etc.) should contact FAS-ReasonableAccommodation@usda.gov or Cynthia Stewart (RA Coordinator), cynthia.stewart@usda.gov.

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 stock assessments for each stock of marine mammals occurring in waters under the jurisdiction of the United States, including the U.S. Exclusive Economic Zone (EEZ). These SARs must contain information regarding the distribution and abundance of the stock, population growth rates and trends, estimates of annual human-caused mortality and serious injury (M/SI) from all sources, descriptions of the fisheries with which the stock interacts, and the status of the stock. Initial SARs 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. The term “strategic stock” means a marine mammal stock: (A) for which the level of direct human-caused mortality exceeds the potential biological removal level or potential biological removal rate PBR (defined by the MMPA as the maximum number of animals, not including natural mortalities, that may be removed from a marine mammal stock while allowing that stock to reach or maintain its optimum sustainable population); (B) which, based on the best available scientific information, is declining and is likely to be listed as a threatened species under the Endangered Species Act (ESA) within the foreseeable future; or (C) which is listed as a threatened species or endangered species under the ESA or is designated as depleted under the MMPA. NMFS and FWS are required to revise a SAR if the status of the stock has changed or can be more accurately determined.

In order to ensure that marine mammal SARs constitute the best scientific information available, the updated SARs under NMFS's jurisdiction are peer-reviewed within NOAA Fisheries Science Centers and by members of three regional independent Scientific Review Groups (SRGs), established under the MMPA to independently advise NMFS and FWS. Because of the time it takes to review, revise, and assess available data, the period covered by the 2021 Final SARs is 2015 through 2019. While this results in a time lag, the extensive peer review process ensures the best scientific information is available in the SARs.

NMFS reviewed the status of all marine mammal strategic stocks and considered whether significant new information was available for all other stocks under NMFS' jurisdiction. As a result of this review, NMFS revised a total of 50 SARs in the Alaska, Atlantic, and Pacific regions to incorporate new information. The 2021 revisions to the SARs consist primarily of updated or revised human-caused M/SI estimates and updated abundance estimates. No stocks changed in status from “non-strategic” to “strategic.” Three stocks (all Northern Gulf of Mexico Bay, Sound, and Estuary Common Bottlenose Dolphin stocks—Galveston Bay, East Bay, Trinity Bay stock; Mississippi River Delta stock; and Sabine Lake stock) changed in status from “strategic” to “non-strategic.”

NMFS received comments on the draft 2021 SARs from the Marine Mammal Commission (Commission); the Department of Fisheries and Oceans Canada (DFO); the Makah Indian Tribe (Makah); the Washington Department of Fish and Wildlife (WDFW); the Oregon Department of Fish and Wildlife (ODFW); three fishing industry associations (Hawaii Longline Association (HLA), Maine Lobstermen's Association (MLA), and United Southeast Alaska Gillnetters (USAG)), and a coalition comment letter from two non-governmental organizations (Center for Biological Diversity and Whale and Dolphin Conservation, hereafter referred to as “CBD and WDC”). Responses to substantive comments are below. Responses to comments not related to the SARs are not included. Comments suggesting editorial or minor clarifying changes were incorporated in the reports, but they are not included in the summary of comments and responses. 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 2021 SARs.

[Comment 1]: The Commission continues to be concerned about NMFS' performance in meeting several of the requirements of section 117 of the MMPA. Including the SARs revised in 2021, an Nmin estimate is lacking for 77 of the 252, or 31 percent, of identified stocks. The primary hindrance to full assessment of all stocks continues to be an ongoing lack of resources, including lack of access to vessel and aerial platforms from which population surveys are conducted. The Commission encourages NMFS' continued engagement and collaboration with other federal agencies that require basic information on marine mammal stocks, and the Commission reiterates its recommendation that these marine assessment programs continue to include appropriate personnel, logistical capability, and vessel time to allow for photo-identification, biopsy sampling, satellite tagging, acoustic monitoring and other efforts to increase the value of the core line-transect survey data collected.

Response: NMFS acknowledges the Commission's comment and will continue to prioritize our efforts for the collection of data to address outdated Nmin estimates, as resources allow.

[Comment 2]: The Commission comments that regarding trend analyses, guidance is needed on how population trend analyses should be performed, and how key uncertainties should be addressed. To address the reporting inconsistencies and lack of analyses, the Commission recommends that NMFS convene a workshop to develop guidelines for data requirements and best practices for population trend analyses pursuant to section 117 of the MMPA. The Commission recommends that invited participants include scientists from the NMFS Science Centers, SRG members, and non-NMFS statisticians who might provide guidance and different perspectives.

Response: NMFS agrees that long-term time series trend analyses are useful, while also acknowledging that it is difficult to achieve the appropriate precision and accuracy needed to detect trends (Authier et al. 2020). NMFS will work to improve consistency across regions and provide best practices for trend analyses in the SARs. We plan to address this topic in a future GAMMS revision. In the short term, we appreciate the Commission's offer to help with a workshop and will consider the possibility of convening one, as resources allow.

[Comment 3]: NMFS' process for distinguishing serious from non-serious injury requires reporting information on human-caused events that result in injury to the animal. This includes detailed documentation of strikes of marine mammals by vessels. These data are listed in technical memoranda, which typically include summaries of human-caused mortalities and injuries. Data is stored within different NMFS programs, offices, and databases, such that there is no single source to query for all vessel strike data. This impedes the compilation of accurate data summaries and makes cross-regional comparisons of data challenging. Given that these data are being summarized separately by each region for reporting under the NMFS injury determination process, the Commission recommends that NMFS develop a system for centralizing all data on vessel strikes of marine mammals into a single, queryable source. This resource would have regional, national, and global value in understanding and mitigating risk of vessel strikes.

Response: NMFS agrees with the value of a centralized database for vessel strikes. We are working to create this and will keep the Commission updated on our progress.

[Comment 4]: The Commission is concerned about the references made to publications that are “in review” to support information in 12 of the draft SARs, particularly when addressing annual human-caused serious injury and mortality. Labeling a report as “in review” suggests that the underlying analysis has been completed and submitted for publication, but analyses could change prior to publication. Therefore, the Commission recommends that NMFS carefully consider whether it should base draft revisions to the SARs being considered for public comment on analyses that are still “in review.” At a minimum, NMFS should make every attempt to make the underlying reports/publications available to the public during the comment period.

Response: Because SARs are considered to be influential scientific assessments, all scientific information used in support of the SARs should meet the peer review requirements described in the Office of Management and Budget (OMB) Bulletin on peer review and NOAA Information Quality Act guidelines to ensure the information is not only high quality but is available for management decisions in a timely fashion. The best scientific information available for any given time period covered in a SAR may not necessarily have been published or subjected to professional peer review prior to inclusion in a draft SAR, as this process can take months or years to complete. In other cases, data such as annual human-caused serious injury and mortality pertinent to assessments of stocks are routinely collected and analyzed, and while not always suitable for journal publication, we publish them as technical memoranda, annual reports, or memos to the record. These data, and methods are annually reviewed by the SRG, and NMFS considers this review to constitute peer review and to meet the requirements of the OMB Peer Review Bulletin and NOAA IQA guidelines.

[Comment 5]: The Commission has repeatedly recommended that NMFS, in collaboration with its co-management partners, improve its monitoring and reporting of subsistence hunting in Alaska. The Commission notes that take levels are lacking for the majority of communities that hunt or may hunt ice seals and harbor seals and continues to recommend that NMFS find ways to gather reliable information on the numbers of marine mammals taken for subsistence and handicraft purposes through partnerships with existing and emerging co-management partners and the state of Alaska. Further, the Commission encourages NMFS to continue to provide updated information in the SARs whenever it becomes available, even if it pertains only to a few villages or a subset of years.

Response: NMFS agrees that it is important to collect reliable information on the numbers of marine mammals taken for subsistence and handicraft purposes. Funding for subsistence use surveys remains limited. In most cases, the best available data are not comprehensive. Nevertheless, we continue to work with our Alaska Native co-management partners (and the State of Alaska in some cases) to conduct surveys of subsistence use as resources allow, including animals struck and lost, and we incorporate that information into the SARs as it becomes available. In particular, we have encouraged the Alaska Department of Fish & Game to explore the feasibility of obtaining harvest information and biological samples of subsistence-harvested seals in communities where such data collection has not recently occurred. The Alaska Department of Fish & Game is pursuing this.

[Comment 6]: The Commission understands that the final 2020 SAR for the Eastern Bering Sea (EBS) stock of beluga whales was withdrawn to allow for Tribal consultation. That SAR was not included in the draft reports for 2021. We await further word from NMFS on whether that SAR will be included in the final 2021 SARs for Alaska.

Response: The EBS beluga whale SAR was not revised in 2021. After ongoing consultations with NMFS co-management partner, the Alaska Beluga Whale Committee (ABWC), NMFS has withdrawn the final 2020 EBS beluga whale SAR and anticipates releasing a revised draft SAR for the 2022 or 2023 SAR cycle. This has been noted on the NMFS SAR web page ( https://www.fisheries.noaa.gov/national/marine-mammal-protection/marine-mammal-stock-assessment-reports-species-stock#cetaceans--small-whales ). Additionally, NMFS temporarily withdrew the final 2020 Beaufort Sea, Chukchi Sea, and Bristol Bay beluga whale SARs to review potential implications of the ABWC recommendations on the Eastern Bering Sea beluga whale SAR but republished them with an explanatory note indicating that any changes resulting from such a review will be reflected in a future SAR. As is our practice, we will include the most recently revised version of each Alaska SAR in the compiled final Alaska SARs. The most recent EBS beluga whale SAR is the final 2017 SAR.

NMFS is providing this information for awareness only and is not seeking public comment on the NMFS-ABWC co-management agreement nor the final 2020 EBS beluga whale SAR.

[Comment 7]: USAG is concerned that the areas of highest densities of harbor porpoises have not been surveyed and suggests that a more thorough survey would involve track lines that followed the edges of the straits, in shallower water, and include larger bays and inlets. Since the stock boundaries for SEAK extend from west of Yakutat to Dixon Entrance, USAG wonders why the outside waters were not surveyed in 2019. This would indicate that the population estimate could be biased low. USAG comments that population survey would be best for the region if it included the coastal waters that were not included in 2019.

Response: In the 2019 survey, NMFS developed a protocol to sample the study area more thoroughly than ever before and to account for biases not previously considered in previous analyses. This protocol focused on: Sampling the habitats in the main channels of SEAK where harbor porpoise has been historically documented, including shallower (close to shore) and deeper (middle of the channel) waters. Because sampling in these areas was proportional to the area of each habitat, estimates of density within these habitats are expected to be unbiased.

Approximately 40% of the area of inlets and small bays were sampled in response to previous criticism that NMFS' SEAK surveys did not cover these habitats. The results showed that only a small fraction (approximately 5-10%) of the population occurs in these areas in the summer.

Applying a correction factor to account for animals missed (“g(0) correction”) developed with data from previous surveys in SEAK inland waters.

The fact that the 2019 survey had nearly 200 sightings of harbor porpoise suggests that the design implemented during the cruise did sample the species habitat within inland waters.

The SAR acknowledges that the estimate of abundance from inland waters is an underestimate for the whole stock because the outer coast between Cape Suckling and Dixon Entrance has not been sampled. The survey was limited to inside waters due to logistical and funding constraints. Sampling the outer coast is needed to develop a stock-wide estimate. Additional sampling for stock structure ( e.g., environmental DNA (eDNA)) is also needed to assess the relationship of animals in the outer coast with those within inland waters.

[Comment 8]: USAG points out that the SARs include evidence of sub-populations of harbor porpoises. This is based on eDNA samples, with a notable difference between northern and southern parts of the region. Since the SEAK stock includes a large area, eDNA should be procured from all areas to further define sub-populations. There should also be eDNA collected in the Gulf of Alaska stock for comparison with the unique stocks in SEAK that may have been identified. USAG would question whether the samples were collected in a fashion that could have eliminated the possibility of familial relationships.

Response: The evidence supporting population differentiation among regions throughout coastal Alaska waters and within the currently recognized SEAK stock is based on genetic data generated from both eDNA samples and tissue samples collected from fisheries bycatch and beachcast strandings. Nuclear genetic data suggest a degree of genetic relatedness among harbor porpoises sampled within a region that is greater than we would expect by chance, suggesting genetic structure and likely natal philopatry. Mitochondrial genetic data, generated from both tissue and eDNA samples, indicate significant genetic differences between Gulf of Alaska and SEAK, as well as within SEAK. The majority of the samples represent nearshore coastal waters; however, some coastal regions are poorly represented, or unrepresented ( e.g., between Copper River and Yakutat).

Environmental DNA samples were collected as surface seawater in the fluke prints of submerging harbor porpoises from small boats in SEAK inshore waters. At this time, determining familial relationships is not feasible with eDNA samples. As a result, a conservative approach was adopted, counting each “discovered” unique genetic sequence from each eDNA sample only once. This strategy avoids over-representing mitochondrial haplotypes based on sequencing read depth but may underestimate genetic differentiation metrics if multiple related porpoises comprising the same mitochondrial haplotype co-occur, as multiple related porpoises represented by genetic material in a single eDNA sample will only be counted as a singleton. The Gulf of Alaska stock is well represented by tissue samples throughout nearshore waters ( e.g., Cook Inlet and Copper River); however, coastal regions between SEAK and the Gulf of Alaska are unsampled and collecting samples from these regions will be very valuable for identifying key regions delimiting harbor porpoise stocks within SEAK and beyond.

[Comment 9]: USAG comments that the SAR notes that entanglement in fishing gear is the only known human cause of mortality, but there are other industrial fisheries being prosecuted in the region. To make the assumption that only one gear type interacts with a species that exists in the same habitat seems arbitrary. Charter boats, sport fishing, yachters, cruise ships, both large and small, and other water related outdoor excursions, have all increased substantially, and the USAG notes that ship strikes are a cause of mortality.

Response: NMFS agrees that harbor porpoise are difficult to see in the wild. We take the characteristics of the species into consideration when we design and execute our surveys. For example, we search for porpoise using binoculars, which allows for early detection. We only search in good visibility and oceanographic conditions. Before analysis, we inspect the data to assess whether there is evidence that animals are reacting to the boat. We only analyze data collected in relatively good observation conditions ( e.g., Beaufort sea state 3 or less). The elusive nature of harbor porpoises often results in animals or groups of animals being missed by observers. We therefore estimate the proportion of porpoise missed and add that to the estimates of density and abundance to minimize or eliminate any negative bias in the estimates.

The estimates of population size indicate abundance is stable in the northern portion of SEAK inland waters ( e.g., around Cross Sound, Icy Strait, and Glacier Bay), but there is evidence of declines in the southern range of the species more towards the south, around Wrangell and Zarembo Island.

Other types of fisheries can result in M/SI; but, as noted in the comment, they have not been documented in SEAK. In other parts of the world, harbor porpoises are known to be extremely vulnerable to gillnets, and there is no reason to believe the situation is different in SEAK. This is one of the reasons the concern with this type of gillnet fishery is greater.

[Comment 10]: USAG emphasizes that the SEAK gillnet fishery has been fishing the same statistical waters since statehood, and those areas are a relatively small portion of the region. Portions of the areas SEAK gillnetters are permitted to fish are often closed to gillnetting for salmon management concerns, and other portions of those areas are not fished due to lack of productivity. Since 1975, with the inception of Limited Entry, USAG effort has been static. Given the lifespan of a harbor porpoise, USAG feels that it is safe to assume that any impact the gillnet fleet has had on the stock has likely happened. USAG notes there are no population estimates pre-statehood, so it would be impossible to determine just what impact commercial fishing has had on these animals since its inception.

Response: It is still unclear whether the population is stable in part of the range (near Wrangell and Zarembo Island). NMFS agrees that there is uncertainty with respect to the potential impact of fisheries to harbor porpoise and believes that additional data are needed to address this question.

[Comment 11]: In 2012 and 2013, the SEAK gillnet salmon fishery was observed in districts 6, 7, and 8. In 2012, there were 0 observed interactions with harbor porpoise. There were 2006.5 boat days for that particular season. In 2013, there were four observed interactions with harbor porpoises, two released alive, and two released, judged by the observer as significantly injured, likely resulting in a mortality. There were 2,708.6 boat days in 2013. This makes 2013 an anomaly in that USAG had several multi-day openings and more boats than normal fishing in the districts observed. USAG thinks this inflates the mortality associated with the gillnet fishery artificially.

Response: NMFS takes fishing effort into account when calculating a bycatch rate and estimating M/SI. This minimizes bias in the estimates given potential differences in effort across years ( e.g., between 2012 and 2013, as suggested in the comment). NMFS agrees that rare events, when observed, inflate the mortality estimate. However, the capture of four porpoise in a single year (2013) suggests that bycatch events, while rare, may be occurring at a frequency large enough to impact the population, particularly in areas where harbor porpoise occur in relatively large numbers such as around the Alaska Department of Fish & Game fishing districts 6, 7, and 8 in SEAK.

[Comment 12]: Department of Fisheries and Oceans Canada (DFO) believes the reference number provided for electronic submission of comments on the draft SARs (NOAA-NMFS-2021-0130) is incorrect as it leads to the wrong docket.

Response: Thank you. Because of a technical error, we extended the public comment period two weeks and published a correction notice in the FR with the correct link for the appropriate docket.

[Comment 13]: The Commission remains concerned that numerous known serious injuries of gray seals are not being accounted for in estimates of total M/SI. The 2021 draft SAR reports a PBR level of 1,458. Total reported annual M/SI in U.S. waters is 1,179 (1,169 of which were deaths caused by U.S. commercial fisheries). The Commission recommends that NMFS use the best available science when calculating the total estimated annual M/SI to account for these entanglements. Further, the Commission encourages NMFS to work diligently to address this welfare issue and greatly reduce gray seal injuries and deaths in U.S. fisheries.

Response: NMFS recognizes that estimates of gray seal bycatch mainly reflect mortalities because observers rarely document live animals. Therefore, data derived from observer coverage do not reflect the numerous animals that are seen living with entanglements and that may eventually die as a result. Currently, there is not a system in place to document seals that are living with entanglements in the NMFS National Stranding database (live entangled cetaceans are recorded, but not pinnipeds). This policy decision was made primarily due to the inability to distinguish between individuals, resulting in uncertainty over whether an observed entangled animal was a unique case, or one seal observed multiple times over many years. NMFS is working to address this issue, including developing a customized database for tracking entanglements rather than the National Stranding database. We are also preliminarily planning to conduct entanglement surveys, as resources allow. The goal is to quantify the number of entangled animals at various haul-outs in a given day so that, at a minimum, we may add these to the bycatch estimates.

[Comment 14]: DFO comments that right whale #3893 was assigned as a Canadian mortality and was observed in U.S. waters on January 22, 2018, before being found dead on January 28, 2018. Prior to this, it was seen gear free in Canadian waters on July 29, 2017. No pictures or information about the gear analysis have been provided to assist in the Canadian analysis. DFO emphasizes this whale should be XU.

Right whale #3694 was “unidentified” prior to the 2020 SAR. Upon inquiry to NOAA, DFO received the following response: “Gear from #3694 was identified as Canadian snow crab by the NMFS Greater Atlantic Regional Fisheries Office, and this result was announced through an email to the Atlantic Large Whale Take Reduction Team in April 2018.” No information on this was provided to Canadian officials for review.

Response: The U.S. gear team reports that the recovered gear from right whale #3893 and #3694 are inconsistent with legal U.S. gear and are consistent with offshore Canadian trap/pot gear. Without new incident documentation or bilateral analysis, under longstanding NMFS protocols, NMFS would not change the current attribution. NMFS believes bilateral gear investigation of gear retrieved from entangled large whales in U.S. and Canadian waters would be invaluable to improve our understanding of at least that subset of entanglements that are observed and documented. NMFS will continue to pursue collaborative bilateral efforts on gear analysis and other fronts, toward improving science and management to help the U.S. and Canada develop additional solutions to reduce the impacts of our fisheries on endangered right whales.

[Comment 15]: For Right whale #4094, the gear was identified as Canadian crab pot in Daoust et al. Upon review of this report, no information was included to support this finding. Additionally, the DFO Marine Mammal Response archives have the following, “A live entangled North Atlantic right whale (NARW) was reported on July 19th, 2017 by NOAA Fisheries in the Gulf of St. Lawrence. No response was performed as no action was permitted. No subsequent sightings were completed after this date.” It is unclear how a determination was made if no response was performed. DFO believes this whale should be XC and NR.

DFO would like to suggest that the “points” for the serious injury associated with right whale #4057 be equally split (.5/.5) between Canada and the U.S. On August 13, 2016, #4057 was disentangled by the Campobello Whale Rescue Team. In their report they noted that the entanglement responded to impacted and exasperated old wounds from 2014. On February 16, 2014, #4057 was found near Florida dragging over 100 yards (91.44 meters) of heavy 9/16 ″ diameter fishing rope. Responders from the Florida Fish and Wildlife Conservation Commission disentangled the whale the following day.

The gear for Right whale #3125 is attributed to Canada. DFO requests that the U.S. provide information on how the conclusive origin of the gear was determined in this case. If no review of the gear has been conducted, DFO concludes this whale should be XC.

Right whale #1226 is currently assigned “CN.” DFO comments that this whale should be XC. The whale was sighted anchored alive in Canadian waters, and the carcass was later found without gear present.

Response: NMFS notes that #4094's gear attribution was based on identification of gear in the Daoust et al. report, which was co-authored by DFO staff. We would consider changing it to XC if the published incident report that identified the gear as Canadian snow crab is revised.

#4057—The two events are evaluated separately in keeping with longstanding NMFS protocols. The 2014 incident was deemed not serious, assigned a 0 against PBR, and does not impact the current SARs because the time frame for the data is 2015-2019. The 2016 incident was deemed serious based on severe health decline despite disentanglement. U.S. gear experts report that Parks Canada confirmed the recovered gear to be Canadian snow crab.

#3125—The U.S. gear team reports that the recovered gear from this event is inconsistent with legal U.S. gear and is consistent with Canadian snow crab gear. Without new incident documentation or bilateral analysis, under longstanding NMFS protocols, we would not change the current attribution.

#1226—This whale was seen without gear in the Gulf of St Lawrence (GoSL) from June 9-July 21, 2019. The entanglement was observed in GoSL on August 6, 2019, when the whale was anchored alive. In keeping with longstanding NMFS protocols, anchoring in place is considered evidence of incident location so this incident was assigned as a Canadian injury. Though no gear was present on the carcass on September 16, 2019, the documented fatal injuries on the carcass line up with the entanglement configuration documented on August 6, 2019. Injury was attributed to the August 6, 2019 entanglement.

[Comment 16]: MLA states that the Draft SAR fails to disclose key limits of the Pace model. The Pace model remains sensitive to new data, and its output is highly variable. Further, the period from 2011-2015, during which time NARW shifted their geographic distribution to areas lacking survey effort, may be producing an underestimate of the population.

MLA notes that the Draft SAR underweight the existence of natural predation as demonstrated by Taylor (2013), Curtis (2014), and Sharp (2019). MLA comments the SAR must cite relevant literature on natural mortality and discuss how the treatment of this significant factor affects population models. This estimate of total annual human-caused mortality may be somewhat positively biased ( i.e., a slight overestimate) given that some calf mortality is likely not human-caused.” Although the Draft SAR acknowledges this is likely a “slight overestimate,” its conclusion that all mortality is human-caused is not supported by Taylor (2013), Curtis (2014), and Sharp (2019). With natural causes constituting a total of 14.5 percent of all examined individuals and 25 percent of those incidents where cause was confirmed, this is more than a “slight overestimate,” and the best available scientific information does not support attributing all calf and adult mortalities of unknown cause to human activity. MLA comments that the assumption that natural mortality is limited to newborn calves is without empirical justification and results in an overestimation of anthropogenic mortality.

Finally, Pace (2021) incorrectly assumes an equal sex ratio and probability of mortality. Neither of these assumptions are supported by the best available data. Hamilton (2020) reports that through 2017, 94 percent of males have been entangled at least once compared to 87 percent of females. Males are known to make up a larger portion of the population and statistically more likely to encounter and become entangled in a vertical line. This, too, must be corrected or, at a minimum, disclosed to the public.

Response: The Pace et al. 2017 and slightly updated Pace 2021 Mark- Recapture-Resight MRR model has been reviewed and re-reviewed by both journal peer review process for publication as well as more than 6 years of Atlantic SRG meetings with rotating membership, meaning an additional 20 experts have reviewed the model and its contents are publicly available to review as the documents are cited within the SAR.

The MRR model published by Pace et al. 2017 uses standard well-verified methods of using sighting histories of individuals to estimate interval (in this case annual) capture probabilities which are allowed to vary at each interval. Indeed the estimated capture probabilities since 2011 of NARWs have shown considerable variation compared with the previous decade. The statistical methodology employed simultaneously estimates survival and capture rates to estimate the number of whales still alive thereby accommodating variable annual capture rates. Beyond that the MRR model used, unlike some of its predecessors, allows for individual animals to have unique catchability parameters thus reducing biases in capture rate found in simpler MRR models. Although there is no accommodation for permanent emigration, so far there has been no evidence that even modest numbers of NARW have permanently left all of the areas surveyed. Hence, the conservation conclusion is that the estimated survival rates presented in the SAR and reflected in the abundance estimates represent actual survival rates of the stock and not merely apparent survival rates.

On the issue of natural mortality, NMFS and the SAR acknowledge that some natural mortality of calves exists. However, there are no observations of adult mortality from natural causes. NMFS reviewed relevant data, existing models and the literature with the Atlantic SRG on Sept 2, 2021 and requested guidance. The Atlantic SRG recommended NMFS continue to assign 100 percent of the mortalities of non-calf NARW to anthropogenic origins (Atlantic SRG letter to NMFS September 16, 2021).

[Comment 17]: The Draft 2021 SAR includes new text speculating that the probability of carcass recovery is higher for vessel strike events than entanglement events. MLA comments that there is presently no evidence to support such a finding, and the literature cited in the Draft SAR are not the results of empirical studies to inform this issue. MLA thinks it is equally, if not more likely, that the observed data with respect to carcass status as discussed in Pace (2021) are correct—that entanglements and vessel strikes kill whales in roughly equal proportions. MLA requests that NMFS remove this entire section until empirical data are available to inform the probability of carcass recovery for different modes of death.

Response: NMFS agrees that there is no empirical study showing that the bodies of whales dying from vessel strikes are more likely to be detected than the bodies of whales dying from entanglement. However, it is the intention of this stock assessment report to provide information on our current understanding of the right whale population, including trends in strandings data, and we will therefore continue to include this empirical information relevant to the probability of carcass recovery. We believe that including hypotheses that may explain the disparity between the proportion of detected entanglement and vessel strike serious injuries compared to the proportions by cause diagnosed for dead whales is relevant and informative. The Moore et al. (2020) hypothesis is founded in the physics of buoyancy on marine mammal bodies under different conditions. However, we agree that there is not currently sufficient basis to conclude that the proportion of observed serious injuries that were the result of entanglement reflect the correct apportionment of total mortalities. We also agree that there may be factors that increase the likelihood of detection of entanglement serious injuries. We do not believe there is currently sufficient basis to assert that right whales struck by vessels are more likely to sink.

NMFS proposed many alternative scenarios to the Atlantic SRG (ASRG) on how best to apportion cryptic mortality (NMFS intersessional September 21, 2021). The ASRG recommended that the ratio between entangled and vessel struck NARW, calculated from documented observations of Serious Injuries and Mortalities over the last five years, be used to apportion cause. NMFS scientists will continue to work on improving our methods for apportioning these sources of mortality, and the ASRG will continue to consider better alternatives as they are developed.

[Comment 18]: MLA is concerned that the Draft SAR only reports total observed M/SI data without apportioning those observations between the U.S. and Canada. The Draft SAR does not present the annual mortality and serious injury estimates by each “fishery.” MLA believes it is arbitrary for NMFS to ignore these data demonstrating that many more M/SI are occurring in Canadian fisheries than U.S. fisheries. MLA reiterates that NMFS should not rely on limited data to conclude that all cryptic mortality results from anthropogenic sources and that vessel strike carcass recovery is more likely than for entanglements.

Response: NMFS seeks to provide the maximum precision and resolution in apportioning all M/SI to cause—whether fishery, vessel or other. However, there continues to be a distinct lack of information available to the agency to assign entanglement to fisheries based upon recovered gear. We believe expansion of gear marking and reporting requirements will assist us in this area moving forward. In addition, because right whales are able to travel thousands of miles in short periods of time, even when trailing gear, it is very difficult to attribute entanglement based upon the region of initial sighting.

NMFS has invested considerable effort developing better methods for apportioning M/SI to appropriate sources in light of increased mortality overall, including increasing observations in Canada. We are also working to improve our ability to quantify unseen mortality with consideration of if and how to apportion natural versus anthropogenic mortality. As part of this effort, the agency convened a special session of the Atlantic SRG in September 2021 for scientific and technical input. The Atlantic SRG supported its prior position that 100 percent of the mortalities of noncalf NARW should be considered to be of anthropogenic origin. The Atlantic SRG also considered the various approaches provided by NMFS for apportioning SIM between U.S. and Canada but did not have enough information to provide a robust scientific alternative. They suggested alternatively, a fully fleshed out co-occurrence model for both U.S. and Canadian waters could be used, but this is also not presently available. Given this data limitation, it would be arbitrary for NMFS to assign proportions without better data to support conclusions.

[Comment 19]: MLA notes that the NARW Draft SAR contains none of the statutorily required-information from Section 117 of the MMPA regarding entanglements in fishing gear. As a result, the public has no information about the fisheries that interact with the NARW and the levels, types, and seasonal and geographic patterns of entanglement that occur within and among those fisheries. MLA notes that the Draft SAR presents only M/SI entanglement data—non-serious injury entanglements are omitted. MLA requests that the SAR also include data on the severity of entanglements. MLA requests a more detailed table included in the SAR, since this information is important for assessing individual fisheries.

The Draft SAR cites three studies concluding that NARW mitigation measures implemented prior to 2009 have not worked and that the effectiveness of measures implemented since 2009 have not yet been evaluated. MLA comments that the SAR should report data showing that there has been a 90 percent decline in instances of lobster gear removed from entangled NARW since 2010 based on observed data. There were four known cases of lobster gear removed from NARW from 1997 to 2000, six from 2000 to 2010, and one from 2010 to 2019. The only confirmed M/SI resulting from entanglement in lobster gear occurred in 2002. MLA requests that NMFS present information about the fact that the scarring data suggests most entanglements are minor.

Response: The fisheries are summarized in Appendix 3—Fishery Descriptions. NMFS cites our annual M/SI report for reported injuries during the time frame encompassed by the SAR. However, because only a small fraction of entanglements have gear recovered and a smaller fraction of those are traceable to the fishery, the agency has not been able to estimate the annual M/SI to the resolution of fishery/region. Given recommendations from the Atlantic SRG and additional analysis resulting from Pace et al. (2021), the agency is working to improve our understanding of this issue to the resolution requested above in future SARs. For now, this topic is addressed to the extent that data can support in table three of the SAR.

The issue of non-serious injuries is discussed in the third paragraph of the section titled “Fishery-Related Mortality and Serious Injury.” The draft cites Knowlton et al. (2012), which reported 26 percent of the population being entangled each year and now includes Hamilton et al. (2019), which reports 30 percent of the population receiving non-serious injuries annually. This is an increasing trend. Despite roughly 100 injuries per year in recent years, they are almost never observed, but the wounds persist for periods of weeks to months/years during which time animals may travel thousands of miles. Therefore, the agency takes a conservative approach to not apportion injury by fishery or area where data are not available. Additional language to address this concern has been added to the first paragraph of the “Fishery-Related Mortality and Serious Injury” section of the SAR.

Regarding the “decline” in lobster gear removed from NARW, the SAR does not address this because it is not a metric supported by a rigorous sampling design with high probability of detection. Rather, it is anecdotal in nature with detection rates subject to numerous biases described above. The comment raises the similar “observed decline” in entanglements observed to be connected with groundline. However, despite some reason for optimism with both these observations, they are anecdotal in nature, and also in juxtaposition with the dramatic increase in mortality that has subsequently occurred. The SAR acknowledges these are from multiple sources across multiple regions. Because of this, the SAR focuses on the more appropriate metrics of total M/SI and cryptic mortality. In response that most injuries are “minor”—it should be noted that NMFS uses similar but slightly different criteria for the assignment of injury severity than New England Aquarium. The SAR does report the number of injuries which meet the criteria for “serious” under the NMFS criteria, and there has been an increase in serious injuries including entanglement for the past decade. The SAR addresses these “non-serious” injuries in the previous section, acknowledging that collectively they “should be considered to fully understand anthropogenic impacts to the population, especially in cases where females' fecundity may be affected.”

[Comment 20]: MLA believes the SAR should include additional available scientific information about NARW behavior that affects its risk of harm from fishing gear. Recent scientific literature confirms that NARW have shifted their habitat usage away from the Maine lobster fishery. These findings were most recently summarized and reported in Meyer-Gutbrod (2021), which MLA expresses must be referenced and discussed in the Draft SAR.

Response: NMFS appreciates this comment and agrees with the distribution changes and observations characterized above. The Meyer-Gutbrod reference and some additional language have been added to the habitat section. However, NMFS believes there is a flawed assumption that right whales are only subject to mortality when they are densely aggregated in foraging areas, and those areas are the only regions that should be managed for right whale conservation. In reality, portions of the NARW population are only aggregated in a few small regions during some parts of the year, and we are recognizing that our management measures need to be spatially resilient to reflect the documented acoustic presence of right whales across their entire range through much of the year, including the Gulf of Maine. Furthermore, given the high degree of surveillance in the areas of high aggregation and the comparative lack of surveillance in many other regions (aside from acoustics, which only detect vocalizing whales, and cannot detect mortality/injury), the agency is increasingly concerned that much of the unseen mortality is likely to be happening in areas where there is a high degree of risk from either fishing or vessel activity for solitary whales transiting through those regions. We have added additional language to reflect this in the habitat section.

[Comment 21]: MLA is concerned that the 2021 draft SAR omits important details describing NARW stock definition and geographic range. MLA believes the multiple references to right whale feeding grounds located in New England waters must specify that these important areas are located in southern New England. MLA thinks the Draft SAR incompletely cites the available data on mortality in Canadian waters and calving. MLA recommends the Draft SAR add a reference to Hamilton (2022), which provides important “insight into right whale calf survival, growth rates, and association patterns.” MLA comments that the section summarizing M/SI from vessel strikes has the heading “Other Mortality” and also reiterates that the text and reference to Frazier (2005) be removed.

Response: The description of NARW feeding grounds reflects our current understanding and best available scientific information. Acoustic and visual monitoring in the central Gulf of Maine indicates right whales are present in areas besides southern New England.

All mortalities are accounted for in Table 3. The spike of right whale mortalities in 2017 noted in the text is including all carcasses found that year in both U.S. and Canadian waters. The 2019 calf detection is included in the SAR text. The years 2020-2021 fall outside the reporting period for the 2021 SARs and are therefore not included in this report. The 2022 Hamilton paper was not available during the 2021 stock assessment report timeframe, but the findings will be incorporated into the 2022 report.

The “Other Mortality” heading has been a standard heading for stock assessment reports for all species. This suggestion will be forwarded to the editorial board for consideration. As the section opens with the sentence, “Vessel strikes are a major cause of mortality and injury to right whale” and discusses no other sources of mortality, NMFS has been diligent in informing the public of this threat to right whales.

NMFS appreciates the MLA catching this transcription error. Although NMFS believes that Fitzgerald (2018) best represents the current understanding of pedigree-informed abundance estimation, as noted in previous responses, Frasier (2005) has not been conclusively refuted. NMFS has restored Frasier (2005), and added Frasier et al. (2007), to the text and references of the final 2021 SAR.

NMFS believes the description of right whale distribution and movement in the SAR is as comprehensive and accurate as the data and available analyses currently allow.

[Comment 22]: MLA reiterates that Kenney (2018) should not be cited in the SAR. Specifically, the methods used in this study fail to account for basic biological processes—namely, natural death. Further, calves have natural mortality rates that are ignored during scenarios when they are included in this model. Additionally, Kenney (2018) assumes a constant calving rate of one calf per 5 years (0.2/yr), which is a vast oversimplification of the life history process of NARW, and the Kenney (2018) value of the calving rate is far higher than the “best” current estimate of 0.04 in the Draft SAR. For these reasons, Kenney (2018) should not be cited in the SAR. If NMFS is going to continue to include citations of this study, then it must address these scientific points.

Response: The Kenney (2018) reference is a relevant, peer-reviewed study that helps provide context to the impacts of fishery-related mortality on the right whale population. The study does account for other mortality, removing only confirmed fishery-related deaths and serious injuries (likely to lead to death). Several scenarios are provided with varying levels of hypothetically-reduced entanglement mortality rates corresponding to degrees of compliance to MMPA regulations. While the paper presents a simple representation of complex processes, the model parameters are reasonable and the results are informative for the reader to appreciate the cumulative impact of entanglement on the population. Any element of natural mortality or other processes affecting the population other than documented entanglement mortality are accounted for by using the time series of abundance estimates as a baseline.

Inclusion of the unrealized calves in the paper is an acknowledgment of basic population biology, and the outsized effect of removing productive females on a population's trajectory cannot be ignored. Kenny (2018) treats this effect conservatively. Proven female calving intervals have varied between 3 and 10 years, but are primarily in the 3- to 7-year range, so the choice of a 5-year calving interval is well founded. The paper's total of 26 calves lost due to the deaths of 15 females over 27 years equals an unrealised population increase of much less than 0.01/yr (1 divided by the average annual population size), and this undoubtedly underrepresents the actual value given that only known females documented as mortalities or serious injuries were used in the analysis.

[Comment 23]: CBD and WDC take issue with the statement which currently reads “In addition, right whales apparently abandoned the central Gulf of Maine in winter (see Cole et al. 2013) . . . .” CBD and WDC do not believe it is accurate to indicate that right whales have abandoned the central Gulf of Maine during winter months. In fact, acoustic detections in the central Gulf of Maine have been documented during the winter for the past several years. In addition, CBD and WDC recommend the section regarding high resolution genetic profiling as it relates to parentage and relatedness be updated using Hamilton et al. 2022.

Response: NMFS agrees that new, widespread acoustic monitoring has changed our assessment of right whale presence and will adjust the text to reflect this fact. We will evaluate Hamilton et al. 2022 in the subsequent SAR cycle since its publication occurred during the finalization of the 2021 SARs.

[Comment 24]: CBD and WDC ask NMFS to include the findings in the recently published NARW ( Eubalaena glacialis ) Vessel Speed Rule Assessment which concluded that voluntary measures did not have a meaningful impact, small vessel collisions can seriously injure right whales, and the current SMAs should be modified.

Response: In general, NMFS limits the content of the SARs to the statutory requirements of section 117. The SAR is not intended to evaluate or discuss the merits of specific management activities. The SAR acknowledges that vessel strikes remain a serious issue for right whales; and, for transparency, the vessel size class involved in lethal strike events is always noted, if known. In addition, the NARW ( Eubalaena glacialis ) Vessel Speed Rule Assessment is posted on the NMFS website and easily accessible to the public.

[Comment 25]: While CBD and WDC appreciate the extensive updates to the 2020 Gulf of Mexico Bryde's whale SAR, this species was not updated in the recent 2021 draft. CBD and WDC remind NMFS that, as an ESA-listed species, the SAR for these whales should be updated every year. CBD and WDC also reiterate introductory comments on the general timing of review and public comment for the SARs and the substantial delay in including new information, as it is now known that these whales have been designated a new species: Rice's whales. CBD and WDC request that this new designation be recognized and the 2021 SAR updated accordingly.

Response: The statutory requirement does not require the SAR to be updated every year, but to be reviewed annually. In regard to the updated designation, on August 23, 2021, NMFS published a direct final rule to update the taxonomic classification, description, and common name of species included in the list of endangered species maintained at 50 CFR 224.101 to reflect the updated science (86 FR 47022). The direct final rule changed the common name of the listed entity from Bryde's whale (Gulf of Mexico subspecies) to Rice's whale, the scientific name from B. edeni (unnamed subspecies) to B. ricei, and the description of the listed entity from Bryde's whales that breed and feed in the Gulf of Mexico to the entire species. The direct final rule and these changes became effective on October 22, 2021. This change became effective too late for an update to the draft 2021 SARs, but the draft 2022 SAR has been updated accordingly to reflect the revised taxonomy.

[Comment 26]: CBD and WDC oppose NMFS categorizing fisheries interactions with Hawaiian monk seals as non-serious when the national guidelines would recommend the “serious injury” category. This is a problem especially because NMFS does not adequately consider the cumulative and chronic impacts of entanglements on Hawaiian monk seals. The draft SARs rely on Mercer 2021, which gives details on the two cases. Reclassifying these injuries from fishing gear as non-serious fails to account for the cumulative impacts of chronic entanglements. Entanglements make marine mammals more vulnerable to other sources of mortality, including disease. It is premature to deviate from the serious injury guidelines to reclassify incidents as non-serious before NMFS adequately assesses cumulative and chronic entanglement impacts for Hawaiian monk seals.

Response: NMFS appreciates this comment and notes that determinations follow the NMFS' policy and procedural directive for distinguishing serious from non-serious injuries.

[Comment 27]: HLA appreciates NMFS' acknowledgment that “timely publication of results that inform SARs is important” and hopes that similar delays will not occur in the future. HLA reiterates that the Draft 2021 SAR shows that the deep-set fishery's M/SI rate for the Hawaii Pelagic False Killer Whale (FKW) Stock (Pelagic Stock) is well below the stock's PBR. HLA believes the Pelagic Stock has never been “strategic” because the deep-set fishery's M/SI rate has never exceeded a PBR based on those abundances. HLA comments there is no legal basis to include the Pelagic Stock within the scope of the Take Reduction team (TRT).

In addition, NMFS did state in response to comments on the Draft 2020 SAR that NMFS cannot determine trend information for the Pelagic Stock based upon the three comprehensive surveys it has performed in the EEZ over a 15-year timeframe, along with multiple modeling exercises (performed over periods of years). HLA emphasizes that there are no data available supporting the notion that the stock has declined over time.

Response: NMFS uses the best available science at the time it is available to inform each SAR and support management actions. Subsequent years of data collection and analysis effort and refinement produce newer estimates of pelagic false killer whale abundance. These current estimates now represent the best available science. However, at the time the False Killer Whale Take Reduction Team (FKWTRT) was established in 2010, the pelagic stock of false killer whales was strategic and met the trigger for convening a take reduction team per MMPA section 118(f).

NMFS maintains that a temporal trend in the estimates of pelagic stock abundance cannot be determined because of the confounding effect of random variation in the encounter rate. As explained in Bradford et al. (2020), the model-based approach minimizes the effect of annual sampling variability but assumes that there are no underlying temporal trends in abundance aside from those predicted by habitat changes. While model-based methods can be used to estimate population trends, more data are needed to do so for pelagic false killer whales. Since a trend cannot be estimated, there is no basis to definitively state that the population is not declining. Anecdotal accounts cannot be used to infer population status. Metrics that can be quantitatively derived ( e.g., depredation rates) would need to control for other factors ( e.g., cultural transmission rates) for which there are currently no data.

[Comment 28]: HLA disagrees with NMFS' assignment of a recovery factor of 0.5 to the Pelagic Stock, which is the value typically assigned to depleted or threatened stocks, or stocks of unknown status, with a mortality estimate Coefficient of Variation of 0.3 or less. HLA comments that the Pelagic Stock is not depleted or threatened, its status is not unknown, and it has never qualified as a “strategic stock.” Accordingly, all of the available data contradict any hypothesis that the Pelagic Stock is decreasing or otherwise not at its optimum sustainable population. HLA believes NMFS' assignment of a recovery factor of 0.5 to the stock is therefore arbitrary and not consistent with the best available scientific information.

Response: The status of the pelagic false killer whale population relative to its optimum sustainable population size is unknown, and a temporal trend cannot be estimated as explained in the previous response. The Guidelines for Assessing Marine Mammal Stocks indicate that stocks of unknown status should use a recovery factor of 0.5 based on results of previous simulation studies (Wade 1998) designed to evaluate the ability of the PBR management scheme to achieve the conservation goals of the MMPA in the face of uncertainty. The guidelines further state that for stocks of unknown status, recovery factors of 1.0 should be reserved for cases where there is assurance that the minimum population estimate (N min ), the maximum net productivity rate (R max ), and the estimates of mortality and serious injury are unbiased and where the stock structure is unequivocal, which is not the case for pelagic false killer whales. NMFS notes that more recent simulation work supports these guidelines (Punt et al. 2020) and that the recovery factor is not linked to a specific abundance level or a stock designation of “strategic” or “depleted.”

[Comment 29]: HLA comments that the population estimate for the Main Hawaiian Islands insular FKW stock inappropriately reflects the abundance of animals in only a portion of the Insular Stock's range. The 2021 Draft SAR estimates the Main Hawaiian Islands insular FKW stock (“Insular Stock”) abundance to be 167 animals, based upon Bradford et al. (2018), which found that the population size of the Insular Stock in certain study areas has consistently ranged between 144 and 187 animals over a 16-year period. Bradford et al. (2018) concludes that (1) the study on which the Insular Stock abundance estimate is based did not sample the entire range of the stock and (2) the population estimate underestimates the abundance to an unknown degree.

The MMPA requires the SAR to “describe the geographic range of the affected stock” and to provide minimum population estimate for “such stock” (not a “portion of such stock”). 6 U.S.C. 1386(a). NMFS has made no attempt to estimate the abundance of the Insular Stock across its range or to apply “appropriate correction factors” to do so.

Response: Mark-recapture estimation does not require the full range of a population to be sampled. Thus, Bradford et al. (2018) indicated that the partial sample of main Hawaiian Island insular false killer whales would not be problematic if all distinctive individuals in the population used the sampled area at some point. This assumption could not be evaluated, so Bradford et al. (2018) indicated that the true abundance of distinctive individuals in each year may be underestimated. The text from Bradford et al. (2018) that was omitted from the second paragraph ( i.e., “. . . it is likely that all individuals in the population have been exposed to sampling efforts at some point during the study period . . .”) is not speculation, but rather inference from movement analyses of satellite-tagged false killer whales (Baird et al. 2010, 2012). The number of satellite tag deployments on main Hawaiian Islands insular false killer whales has almost doubled since the Baird et al. (2012) study, and movement tracks from these individuals and fitted utilization distributions continue to reflect a lack of spatially-restricted use, such that individuals could be subject to sampling at some point during the sampling period. These utilization distributions are currently being used in an updated analysis of main Hawaiian Island insular false killer whale abundance that accounts for animal availability and the spatial bias in sampling.

[Comment 30]: HLA disagrees with NMFS' decision to apportion a small amount of “take” by the deep-set fishery to the Insular Stock despite the fact that there has never been a recorded interaction between the deep-set fishery and the (the “Insular Stock”) and the fact that the fishery operates almost exclusively outside the Insular Stock's range. HLA continues to disagree with this approach for the reasons it has previously stated and incorporates those previous comments by reference.

HLA also reiterates its position that this type of overly conservative decision, which has no support in the best available science, undermines the integrity of the TRT process and decreases the fishing industry's motivation for participation in that process. Finally, in its responses to comments on the Draft 2020 SAR, NMFS agreed that it “can more explicitly state that no confirmed MHI insular false killer whales have been observed as taken in [the deep-set] fishery.” 86 FR 38991 (July 23, 2021). HLA requests that NMFS do so in the final SAR.

Response: NMFS reiterates its response to this same comment from the 2020 Draft SARs. NMFS' Observer Program does not observe every deep-set trip. With ~20 percent coverage, some statistical extrapolation/approximation of what is observed is required. False killer whale takes are relatively rare. The rarity of observed takes together with the sampling design mean that the lack of observation does not equate to the lack of actual interactions. NMFS is not attributing interactions that occur outside of the MHI insular stock area to the MHI insular stock. We are prorating the estimated portion of the take to account for fishing effort that occurs within the MHI insular stock range and based on the relative density of the false killer whale stocks in this area. In reality, if an MHI insular false killer whale were taken by the fishery, we would very likely be underestimating the impact on this stock given our current proration method.

Further, although NMFS noted that we can more explicitly state that no confirmed MHI insular false killer whales have been observed as taken in this fishery, the overlap between the 2020 SAR comment period and the preparation of the 2021 draft SAR precluded this change. We will add this note, with previously noted caveat that very few of the observed takes are identified to stock due to the lack of tissue samples or adequate photographs.

[Comment 31]: CBD and WDC reiterate that NMFS update its protocol of using a July deadline for its annual census. We once again ask NMFS to update the protocol to reflect this shift in timing and to capture the most complete population count possible in a year by setting a December date and remind NMFS again that a July deadline reflects a number more than a year and a half out of date currently, and six months out of date for the SAR.

There are two updated regulatory measures that should be included in this SAR: the final rule for the revision of critical habitat should be noted in place of the reference to the proposed rule, and Washington State has issued new vessel guidelines requiring a distance of 300 yards (274 meters) from the sides and 400 yards (365.76 meters) in front or behind a group of SRKWs, and a vessel speed of 7 knots within a 1/2 mile (0.8 km) of the whales.

New research on the SRKW population should be included in this SAR. Additional data from Hanson et al. (2018) is available on passive acoustic monitoring in coastal waters. Updated analysis on coastal prey sampling has been completed and is no longer “in press”—Hanson et al. (2021). New studies on body condition (Fearnbach et al. 2018) and adult sizes (Groskreutz et al. 2019) provide additional information on the impacts of prey depletion on the health of SRKWs. NMFS and the Washington Department of Fish and Wildlife have also completed a report on Priority Chinook Stocks that should be noted.

Response: With regard to the timing and reporting of census numbers, NMFS has previously addressed this same public comment (86 FR 38991, July 23, 2021). The Hanson et al. (in press) reference has been updated to Hanson et al. (2021). We will update the revision of critical habitat as well as the updated information on body condition and prey in the subsequent SAR cycle.

[Comment 32]: WDFW, Washington Dungeness Crab Fishermen's Association (WDCFA), and the Makah Tribe note the characterization of the distinct population segment (DPS) composition of humpback whales occurring in the stock is inconsistent with other NOAA reports. Regarding the text in the Draft 2021 SAR that describes the proportion of DPSs designated under the ESA for humpback whales by breeding grounds that utilize feeding grounds off the coast of Washington and southern British Columbia: The Draft 2021 SAR states, as previous SARs have stated, “The northern Washington and southern British Columbia feeding group includes primarily threatened Mexico DPS whales, with smaller numbers from the unlisted Hawaii DPS and endangered Central America DPS.” It is not clear where this characterization was originally derived from, as no reference is provided. This characterization of most of the whales in Washington coming from the threatened Mexico DPS is inconsistent with estimates provided by NOAA scientists to the International Whaling Commission. Furthermore, this statement is in conflict with a memo released by NMFS in July 2021, which states that the proposed approach for evaluating impacts to listed DPSs in ESA section 7 consultations (and in all relevant ESA analyses) would consider DPS proportions for humpback whales foraging off of northern Washington and southern BC derived from Wade (2021). The numbers included in the memo do not align with the characterization in the Draft 2021 SAR. The text in the report should be updated to reflect Wade as the best available science on the migratory destination of North Pacific humpback whales.

Response: NMFS will replace the following language “The northern Washington and southern British Columbia feeding group includes primarily threatened Mexico DPS whales, with smaller numbers from the unlisted Hawaii DPS and endangered Central America DPS” with findings from Wade (2021): “Based on a Pacific-wide photo-ID effort in 2004-2006, Wade (2021) reported that of 180 unique whale identifications from the Southern British Columbia—Washington stratum (“SBC/WA”), 28 were matched to Mexico wintering areas, 19 to Hawai'i, and 3 to Central America. Wade (2021) also estimated movement probabilities from the SBC/WA stratum to each wintering area. The highest movement probabilities were between SBC/WA and Hawai'i (0.688), followed by SBC/WA and Mexico (0.254), and SBC/WA and Central America (0.059).”

[Comment 33]: WDFW and the Makah Tribe comment that the draft 2021 SAR relies heavily on Calambokidis and Barlow (2020) to provide the minimum population (stock) abundance estimate ( i.e., 4,776 animals) and will be used for practical/regulatory purposes ( e.g., assessing the impacts of anthropogenic activities). Our primary concern with respect to the use of Calambokidis and Barlow (2020) for providing an authoritative minimum abundance estimate for the stock comes from the fact that it does not consider sightings data collected off the coast of Washington. This is especially concerning because the genetic makeup of the feeding aggregation (in terms of DPSs or Demographically Independent Populations—DIPs) off of WA and SBC is significantly different from that of the CA/OR feeding aggregation. A minimum abundance estimate for the entire CA/OR/WA stock should include an estimate of animals found off the coast of Washington (animals that belong to the WA/SBC feeding group).

WDFW respectfully requests a comparative analysis of the assumptions and precision of each of these estimates, as this would increase transparency and improve the public's understanding of this important process for determining the best available science. WDFW also requests NMFS find some way to derive N min that more precisely accounts for humpback whales found off the coast of Washington.

Response: NMFS cites and compares two abundance estimates (Becker et al. 2020, Calambokidis and Barlow 2020) in the draft humpback whale SAR. The Becker et al. (2020) estimate is based on line-transect survey efforts that included Washington state waters (Becker et al. 2020), and for which the estimate is approximately 200 whales lower than the Calambokidis and Barlow (2020) estimate. While the lower estimate of Becker et al. (2020) could be used to represent CA + OR + WA abundance in this SAR, the mark-recapture estimate of Calambokidis and Barlow (2020) is used, for reasons given in the SAR.

[Comment 34]: WDFW staff, in coordination with Oregon and California Departments of Fish and Wildlife (ODFW and CDFW) staff, reviewed the Draft 2021 SAR alongside the 2021 M&SI Report (Carretta et al. 2021) and the most up-to-date version of the West Coast Region entanglement database currently available to state agencies. Multiple inconsistencies were identified, and WDFW concurs with the comments provided by ODFW regarding these inconsistencies.

Response: NMFS reviewed the draft SAR and M/SI report and revised the values consistent between the SAR narrative and M/SI report totals. Totals that appear in the M/SI report may not agree with West Coast Region entanglement reports, as the latter is released months in advance of the preparation of the annual M/SI report. During that period, additional details or evidence regarding entanglements may come to light that result in addition or deletion of cases.

[Comment 35]: CBD and WDC request that NMFS revise the CA/OR/WA humpback stock so as not to aggregate two demographically independent populations that do not interbreed when mature. The current draft 2021 SAR does not reference these papers or provide hypothetical stocks if each were separate stocks. The draft SAR misleadingly includes information from Calambokidis and Barlow (2020) about an apparent increase in abundance from 2014 to 2018. Including appropriate caveats to the apparent increase in the CA/OR/WA stock is important because they explain that the increase may not apply to the DIPs. The draft SARs do not include scientific information regarding the accuracy of determining to which DIP or DPS a whale belongs based on photographic identification. There is genetic evidence that animals that are photographically identified as wintering in mainland Mexico-feeding off California/Oregon are not representative of that herd. It is not clear that photo identification will accurately assess the ESA-listed Central America DPS and Mexico DPS. CBD and WDC request adequate funding to meet the MMPA mandates for completing stock assessment reports.

Response: The draft 2021 SARs were prepared before the referenced Technical Memoranda were published. New information on multiple demographically independent humpback populations and their status in U.S. west coast waters will be addressed in the 2022 draft SARs.

[Comment 36]: CBD and WDC recognize that one important function of the SARs is enumerating serious injury and mortality for each stock, and this is especially critical for ESA-listed humpback whales vulnerable to vessel collisions off California. The draft SAR includes Rockwood et al. (2017) but not more recent research available. A 2019 follow-up to Rockwood et al. (2017) concluded that even the 2017 study estimates were an underestimate, particularly in relation to humpback whale mortality during winter months. Table 1 of the Rockwood et al. (2021) paper allows the results from the 2017 paper to be comparable to the results of the paper. This information on ship strike mortality and injury should be updated in the humpback whale SAR.

Response: Rockwood et al. (2021) did not estimate vessel strike deaths for the entire U.S. EEZ as they did in the 2017 publication, though they compare estimates for Southern California between the two studies. The increase in estimates for Southern California between the two studies does not translate to an increase over the whole study area, thus it is unclear how the new estimates for Southern California (including new winter estimates) may be incorporated into the SAR, when estimates from the remainder of the U.S. EEZ are lacking. It is also unclear how winter/spring estimates of humpback whale vessel strike deaths can be higher than summer/autumn estimates for the same region, when humpback whales are more abundant in this region in summer and autumn. NMFS will consult with the authors on how the new results may directly apply to future SARs.

[Comment 37]: CBD and WDC recommend that the SAR should also note the impacts from marine heat waves and changing ocean conditions under Habitat Concerns. Warmer ocean temperatures influence primary prey choice by humpback whales and creates shifts in distribution and habitat use, which may increase risk of human interaction.

Response: NMFS has added language to the Habitat Concerns section with regard to marine heat waves. “The impacts of marine heatwaves on the foraging activities of humpback whales, including changes in the abundance and distribution of prey and whale foraging locations, may increase risk of human interactions (Santora et al. 2020).”

[Comment 38]: WDCFA and the Makah Tribe are concerned that the abundance of SBC/WA populations is not included in the west coast abundance estimates. The excluded population of the SBC/WA population is in the order of 1,593 distinct animals and is not factored into the total of what the 2021 SAR characterizes as coast wide abundance estimated at 4,973, which produces an N min of 4,776. While a portion of the SBC/WA population is international in range a significant portion of that population occurs off of WA and should be accounted for in the west coast (CA/OR/WA) population. A more accurate abundance estimate would benefit from and be more reflective of population abundance from a proportional inclusion of SBC/WA populations.

Response: NMFS notes that whales summering in NBC/WA waters are not considered a separate “stock” under the MMPA, as stated by the commenter. With respect to the estimate of 4,973 (CV=0.048) whales for CA + OR + WA waters by Calambokidis and Barlow (2020), they state: “While this estimate was calculated using identifications from California and Oregon, it likely incorporates the smaller number of Washington animals since there is some level of interchange with that area and adding our estimate for Washington-Southern British Columbia would likely be biased high both for that reason as well as because it would inappropriately (for purpose of calculating an N min for US waters) include whales outside US waters.” The only other independent estimate of abundance for CA + OR + WA waters combined is 4,784 (CV=0.31) (Becker et al. 2020), and it is lower than the mark-recapture estimate of Calambokidis and Barlow (2020). The Becker et al. (2020) estimate could be used in the SAR, but the mark-recapture estimate is considered the best estimate for management purposes for reasons given in the SAR.

[Comment 39]: The data for consideration in this SARs report on Pacific coast Humpback activity was gathered in 2018. WDCFA is concerned about how long it takes to get data processed and analyzed so that stakeholders and fisheries managers can make timely and well-informed decisions on practices that may impact the well being of stakeholders who make a living from the sea and the well being of the marine species that share ocean space with us.

Response: Data on the abundance of humpback whales were collected during a line-transect and mark-recapture survey in the past several years. It takes 1-2 years to analyze and publish these data for use in SARs. Guidelines for preparing marine mammal stock assessments note that abundance estimates are considered valid for use in SARs for an 8-year period after being collected.

[Comment 40]: The Makah Tribe has two concerns with the use of 8 percent for the maximum net productivity rate. First, the 8 percent is determined based on the observed rate of increase of humpback whales on the U.S. west coast and is not the maximum net productivity rate required by the formula for PBR. In the absence of a model with anthropogenic mortality included, the best available science indicates that an 11.8 percent growth rate should be used as the maximum theoretical or estimated net productivity rate in calculating PBR for the CA/OR/WA stock of humpback whales. The Makah Tribe also note that Calambokidis and Barlow calculated an observed growth rate of 8.2 percent per year from the 1980s to the current best estimate of CA/OR humpback whales. Thus, even if NOAA decides to use an observed growth rate for purposes of the SAR, the rate should be increased to 8.2 percent.

Response: Guidelines for preparing marine mammal stock assessments note that default rates of Rmax should be used in the absence of stock-specific measured rates. The guidelines also note that “to be consistent with a risk-averse approach, these default values should be near the lower range of measured or theoretical values.” The Rmax of 11.8 percent noted in the comment is taken from the upper 99th quantile of the results reported by Zerbini et al. (2010) which does not reflect the lower range of the theoretical values reported. It also does not represent a stock-specific estimate of increase. The impacts of anthropogenic removals on estimates of Rmax has not been estimated for humpback whales; thus, observed rates of increase have been used in the SARs. The commenter is correct that Calambokidis and Barlow (2020) note that an 8.2 percent growth rate is implied for U.S. west coast humpback whales, based on rates of increase shown since the late 1980s. NMFS has updated the Rmax estimate to 8.2 percent in the final 2021 SAR.

[Comment 41]: The Makah Tribe notes that the assumption that the stock spends 50 percent of its time outside of US waters is too low. Modeled ship strikes should not be counted against the potential biological removal. The Makah Tribe suggests that it is best to compare the PBR to observed rates of ship strikes because the actual reports can be validated, whereas the modeled rates may not be accurate.

Response: NMFS will review the available data with regard to how much time this stock spends outside of U.S. west coast waters, as resources allow. The 50 percent proration factor has been used in the SAR for many years but can be improved. The vessel strike estimates of Rockwood et al. are considered as any other published estimates of anthropogenic removals might be in a SAR, including bycatch estimates. The commenter does not make a defensible case for why estimates of vessel strike deaths should be excluded from the SAR.

[Comment 42]: CBD and WDC comment that the changes NMFS proposes to the section on “Current Population Trend” do not seem to reflect the concern among the Pacific SRG regarding the large declining trend in the species distribution model (SDM) abundance estimates. Also, CBD and WDC are concerned that the draft SAR does not adequately explain the choice to adopt the mark-recapture estimate (1,898, CV=0.085) rather than the SDM estimate (670, CV=0.43). The results of the SDM show a declining trend and a worrisome low estimate of abundance for blue whales, which could easily be explained by an actual decline in the blue whale population. The lack of consideration of the blue whale SDM estimate stands in contrast to the adoption of the SDM results for fin whale abundances estimates. If the agency's explanation is that it favors mark-recapture estimates over line-transect or SDM for transboundary stocks, this should be more fully developed in the draft SARs.

Response: NMFS has been consistent in favoring mark-recapture abundance estimates over line-transect estimates (or SDM estimates derived from line-transect surveys) in SARs when (1) the precision of the mark-recapture estimate is superior and data were collected over a sufficient time period; (2) the line-transect survey effort is spatially-reduced compared with previous surveys, as was the case in 2018 (Becker et al. 2020); or (3) the line-transect estimate is outdated. When available, the mark-recapture estimates have been used in the blue whale SAR since 2009. In the case of fin whales, the SDM estimate of Becker et al. (2020) is used because it represents the only recent estimate, compared with the older line-transect trend estimates from Moore and Barlow (2011) and Nadeem et al. (2016), and there are no mark-recapture estimates for fin whales in this region. For blue whales, use of the Calambokidis and Barlow (2020) mark-recapture estimate is explained in the draft SAR as being due to its superior precision over the SDM estimate and the fact that the SDM estimate is spatially and seasonally constrained: “The mark-recapture estimate (1,898) is considered the best estimate of abundance for 2018 due to its higher precision and because estimates based on line-transect data reflect only animal densities within the study area at the time surveys are conducted.” Given that spatially-constrained line-transect abundance estimates have declined while mark-recapture estimates have increased, it is not irrational to assume that some portion of the blue whale population is outside of the U.S. EEZ during summer/autumn surveys or that their distribution has shifted north over time, as the SAR outlines with multiple published references. One of these references (Monnahan et al. 2015) notes that this blue whale population may have been near carrying capacity in 2013. Given the uncertainty from all of these sources, the SAR conservatively states that “the current population trend is unknown.”

[Comment 43]: ODFW notes that Table 1 in the blue whale Draft SAR shows 2 serious injuries attributed to CA Dungeness crab gear (2 M&SI total). The M&SI Report shows 3 entanglements involving CA Dungeness crab gear that resulted in 2.75 serious injuries (2.75 M&SI total). This also results in a different total M&SI from human-related interactions in the Draft SAR (10.75 M&SI total) and the M&SI Report (11.5 M&SI total).

Response: Totals have been corrected in the final SAR.

Many communities across the country face environmental injustices. These communities have been overburdened by pollution and underserved by critical infrastructure and services, leading to negative health impacts and outcomes. Communities that suffer from environmental injustices include low income communities, communities of color, and Tribal Nations. Furthermore, these same communities are too often left out of decision making that directly impacts their health and well-being. President Biden has committed to charting a new and better course, one that puts environmental and economic justice for communities at the center of the Federal Government's work.

Within his first days in office, President Biden signed Executive Order 14008 on Tackling the Climate Crisis at Home and Abroad, stating that agencies must make achieving environmental justice part of their missions by developing programs, policies, and activities to address the disproportionately high and adverse human health, environmental, climate-related, and other cumulative impacts on disadvantaged communities, as well as the accompanying economic challenges of such impacts.

The Executive Order mandates the development of performance measures for an annual Environmental Justice Scorecard, which will aim to detail the efforts of the Federal Government to address historic and current environmental injustices.

As outlined in the Executive Order, the Environmental Justice Scorecard will be developed in collaboration with the Executive Office of the President and with the White House Environmental Justice Interagency Council (IAC). It will be guided by recommendations by the White House Environmental Justice Advisory Council (WHEJAC), with input by environmental justice stakeholders. The WHEJAC's Phase One Recommendations on the Environmental Justice Scorecard informed the development of this RFI, and will continue to inform the vision, scale, and scope of the Environmental Justice Scorecard.

The Environmental Justice Scorecard will be the first government-wide assessment of Federal agencies' efforts to advance environmental justice. The Environmental Justice Scorecard will evolve over time, with the goal of creating a robust and comprehensive assessment of the Federal Government's efforts to secure environmental justice for all. It eventually will be located on a public, web-based platform that is easy to use.

The first version of the Environmental Justice Scorecard will provide a baseline assessment of the Federal Government's efforts to secure environmental justice. It will focus on and describe the processes and progress that Federal agencies have made starting in 2021. This baseline is critical to establish because it will enable the measurement of progress over time. The Federal Government will then build on and improve the Scorecard, year after year.

Initially, the Environmental Justice Scorecard will focus on three main categories. It will highlight activities by Federal agencies to: (1) reduce harms and burdens borne disproportionately by communities, (2) deliver investment benefits, and (3) undertake institutional reform to center community voices in decision making. This framework reflects the Administration's commitment to begin repairing historic wrongs, to strive towards delivering tangible benefits to communities, and to work towards ensuring that the voices and needs of communities are elevated and centered in decision making.

As part of this broader effort to assess progress on environmental justice, the Environmental Justice Scorecard also will measure progress made towards the Justice40 Initiative. In Executive Order 14008, President Biden set of a goal of ensuring that 40 percent of the overall benefits of certain Federal investments—those made in climate, clean energy and energy efficiency, clean transit, affordable and sustainable housing, training and workforce development, the remediation and reduction of legacy pollution, and the development of critical clean water infrastructure—flow to disadvantaged communities that are marginalized and overburdened by pollution and underinvestment in basic services.

This RFI is part of the Administration's commitment to ensuring that environmental justice efforts within the Federal Government, including the development of the Environmental Justice Scorecard, are informed by the priorities and perspectives of communities that face environmental injustices. By soliciting input through this RFI, CEQ seeks to provide transparency about the Federal Government's vision, goals, and process so that the public is better able to monitor the government's progress and hold the government accountable for delivering results.

i. The vision for the Environmental Justice Scorecard is as a robust and comprehensive assessment of the Federal Government's efforts to address current and historic environmental injustice, including the Justice40 Initiative.

ii. Question

1. Does this vision reflect the needs and priorities of communities that face environmental injustices?

i. In the first version of the Environmental Justice Scorecard, Federal Government activities will be organized in three reporting categories.

1. Reducing Burdens and Harms in Communities: This category would measure the regulatory, enforcement, and other actions taken to reduce harms and environmental injustices.

2. Benefits to Communities: This category would measure the Administration's progress on implementation of the Justice40 Initiative, among other environmental justice efforts.

3. Centering Justice in Decision Making: This category would capture measures taken to reform agency decision making to incorporate the perspectives, priorities, and lived experiences of environmental justice communities.

ii. Questions

1. Do these categories broadly reflect the needs, priorities, and impacts that communities are facing from environmental injustices?

2. For the first version of the Environmental Justice Scorecard, what processes and markers of progress should be reflected in each of these categories?

3. In the long term, what are the desired outcomes that could be included in each of these categories?

i. Please provide recommendations on how to improve engagement with, and around, the Environmental Justice Scorecard. In particular, what are ways to improve sharing information about the Environmental Justice Scorecard?

ii. For a future website, what are some usability and accessibility features that should be considered for an online platform?

i. Please provide additional feedback on the vision, framework, and outcomes of the Environmental Justice Scorecard. Feedback on the vision for the first version, and on future versions, is welcome.

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

Title of Collection: Charter School Programs Application: State Entity Grants, Developer Grants, and Charter Management Organization Grants.

OMB Control Number: 1810-0767.

Type of Review: Extension of an information collection.

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

Total Estimated Number of Annual Responses: 365.

Total Estimated Number of Annual Burden Hours: 21,900.

Abstract: The Expanding Opportunity Through Quality Charter Schools Program (CSP) is authorized under Title IV, Part C of the Elementary and Secondary Education Act of 1965, as amended by the Every Student Succeeds Act (20 U.S.C. 7221-7221j). On March 14, 2022, the Department published in the Federal Register a Notice of Proposed Priorities, Requirements, Definitions, and Selection Criteria for CSP Grants to State Entities (SE Grants), Grants to Charter Management Organizations for the Replication and Expansion of High-Quality Charter Schools (CMO Grants), and Grants to Charter School Developers for the Opening of New Charter Schools and for the Replication and Expansion of High-Quality Charter Schools (Developer Grants) (Vol. 87, No. 49, pages 14197-14210) (CSP NPP). Specifically, the Department proposed new priorities, application requirements, assurances, definitions, and selection criteria to create results-driven policies to help promote positive student outcomes, student and staff diversity, educator and community empowerment, promising practices, and accountability, including fiscal transparency and responsibility, in charter schools supported with CSP funds, which can serve as models for other charter schools. Based on the CSP NPP and public comments, the Department issued a notice of final priorities, requirements, definitions, and selection criteria for CSP SE Grants, CMO Grants and Developer Grants (CSP NFP), which published in the Federal Register on July 1, 2022. The final priorities, requirements, definitions, and selection criteria in the CSP NFP are intended to supplement existing statutory and regulatory requirements governing CSP SE Grants, CMO Grants, and Developer Grants. The Charter School Programs Office of the Department is requesting continued approval of this information collection for CSP SE Grants, CMO Grants, and Developer Grants generally; and for the CSP NFP, which requires the submission of a needs analysis and information regarding contracts with for-profit management organizations. The CSP (Assistance Listing Numbers (ALN) 84.282, including SE Grants (84.282A), CMO Grants (84.282M), and Developer Grants (84.282B and 84.282E)) is a competitive discretionary grant program. The grant applications submitted for this program are evaluated based on how well an applicant addresses the selection criteria (and any competitive preference priorities) and are used to determine applicant eligibility and award amounts for projects selected for funding.

This Notice amends the list of covered facilities under EEOICPA by removing the designation of Sciaky Brothers, Inc. in Chicago, Illinois; Swenson Evaporator Co. in Harvey, Illinois; and the Museum of Science and Industry in Chicago, Illinois, as AWE facilities. Previous lists or revisions were published by DOE on February 17, 2016 (81 FR 8060); July 16, 2015 (80 FR 42094); February 11, 2013 (78 FR 9678); February 6, 2012 (77 FR 5781); May 26, 2011 (76 FR 30695); August 3, 2010 (75 FR 45608); April 9, 2009 (74 FR 16191); June 28, 2007 (72 FR 35448); November 30, 2005 (70 FR 71815); August 23, 2004 (69 FR 51825); July 21, 2003 (68 FR 43095); December 27, 2002 (67 FR 79068); June 11, 2001 (66 FR 31218); and January 17, 2001 (66 FR 4003).

EEOICPA established a program to provide compensation to individuals who developed illnesses because of their employment in nuclear weapons production-related activities of the DOE or its predecessor agencies. Covered employees include, among others, current or former employees of an “atomic weapons employer” or “AWE”, also as defined by the Act. On December 7, 2000, the President issued Executive Order 13179, “Providing Compensation to America's Nuclear Weapons Workers,” which directed DOE to list covered AWE facilities, DOE facilities, and beryllium vendor facilities in the Federal Register . The Department's initial listing was published on January 17, 2001 (66 FR 4003), and DOE has periodically updated the listing as new information has become available.

Section 3621(4) of EEOICPA (42 U.S.C. 7384l(4)) defines an AWE as “an entity, other than the United States, that—(A) processed or produced, for use by the United States, material that emitted radiation and was used in the production of an atomic weapon, excluding uranium mining and milling; and (B) is designated by the Secretary of Energy as an [AWE] for purposes of the compensation program.” Section 3621(5) of the Act (42 U.S.C. 7384l(5)) defines an “atomic weapons employer facility” as “a facility, owned by an [AWE], that is or was used to process or produce, for use by the United States, material that emitted radiation and was used in the production of an atomic weapon, excluding uranium mining or milling.”

DOE has determined that Sciaky Brothers, Inc. in Chicago, Illinois; Swenson Evaporator Co. in Harvey, Illinois; and the Museum of Science and Industry in Chicago, Illinois, do not meet the statutory definition of AWE facilities because none of these entities processed or produced, for use by the United States, material that emitted radiation and was used in the production of an atomic weapon. Therefore, the designation of these three facilities as AWE facilities was erroneous.

This Notice formally makes the changes to the listing of covered facilities as indicated below:

• Sciaky Brothers, Inc., Chicago, Illinois, is no longer designated as an AWE facility.

• Swenson Evaporator Co., Harvey, Illinois, is no longer designated as an AWE facility.

• Museum of Science and Industry, Chicago, Illinois, is no longer designated as an AWE facility.

This document of the Department of Energy was signed on July 27, 2022, by Jennifer Granholm, Secretary of Energy. That document with the original signature and date is maintained by DOE. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DOE Federal Register Liaison Officer has been authorized to sign and submit the document in electronic format for publication, as an official document of the Department of Energy. This administrative process in no way alters the legal effect of this document upon publication in the Federal Register .

DOE's mission includes advancing the energy, environmental, and nuclear security of the United States (U.S.) and promoting scientific and technological innovation in support of that mission. DOE's 2014 to 2018 Strategic Plan states that DOE will “support a more economically competitive, environmentally responsible, secure and resilient U.S. energy infrastructure.” The plan further indicates that DOE will continue to explore advanced concepts in nuclear energy. The advanced concepts may lead to new types of reactors that improve safety, lower environmental impacts, and reduce proliferation concerns.

Advanced reactors that operate in the fast-neutron  1 spectrum offer the potential to have inherent safety characteristics incorporated into their designs. They can operate for long periods without refueling and reduce the volume of newly generated nuclear waste. Effective testing and development of advanced reactor technologies requires the use of fast neutrons comparable to those that would occur in actual advanced reactors. A high flux of fast neutrons allows accelerated testing, meaning that a comparatively short testing period would accomplish what would otherwise require many years to decades of exposure in a test environment with lower energy neutrons, a lower flux, or both. This accelerated testing would contribute to the development of materials and fuels for advanced reactors and generate data allowing advanced reactor developers, researchers, DOE, and regulatory agencies to improve performance, understand material properties, qualify improved materials and fuels, evaluate reliability, and ensure safety. Accelerated testing capabilities would also benefit these same areas for the current generation of light-water reactors.

Many commercial organizations and universities are pursuing advanced nuclear energy fuels, materials, and reactor designs that complement DOE and its laboratories' efforts to advance nuclear energy. These designs include thermal  2 and fast-spectrum reactors that target improved fuel resource utilization and waste management, and the use of materials other than water for cooling. Their development requires an adequate infrastructure for experimentation, testing, design evolution, and component qualification. Available irradiation test capabilities are aging (most are over 50 years old). These capabilities are focused on testing materials, fuels, and components in the thermal neutron spectrum and do not have the ability to support the needs for fast reactors ( i.e., reactors that operate using fast neutrons). Only limited fast-neutron-spectrum testing capabilities, with restricted availability, exist outside the U.S.

A number of studies evaluating the needs and options for a fast-neutron spectrum test reactor have been conducted. The Advanced Demonstration and Test Reactor Options Study identified a strategic objective to “provide an irradiation test reactor to support development and qualification of fuels, materials, and other important components/items ( e.g., control rods, instrumentation) of both thermal and fast neutron-based . . . advanced reactor systems.” The DOE Nuclear Energy Advisory Committee (NEAC) issued an Assessment of Missions and Requirements for a New U.S. Test Reactor, confirming the need for fast-neutron testing capabilities in the U.S. and acknowledging that no such facility is readily available domestically or internationally. Developing the capability for large-scale testing, accelerated testing, and qualifying advanced nuclear fuels, materials, instrumentation, and sensors is essential for the U.S. to modernize its nuclear energy infrastructure and to develop transformational nuclear energy technologies that re-establish the U.S. as a world leader in nuclear technology commercialization.

DOE's Mission Need Statement for the Versatile Test Reactor (VTR) Project, A Major Acquisition Project embraces the development of a well-instrumented, sodium-cooled, fast-neutron-spectrum test reactor in the 300 megawatt-thermal power level range. The deployment of a sodium-cooled, fast-neutron-spectrum test reactor is consistent with the conclusions of the test reactor options study and the NEAC recommendation.

As required by the Nuclear Energy Innovation Capabilities Act of 2017 (NEICA) (Pub. L. 115-248), DOE assessed the mission need for a VTR-based fast-neutron source to serve as a national user facility. Having identified the need for the VTR, NEICA directs DOE “to the maximum extent practicable, complete construction of, and approve the start of operations for, the user facility by not later than December 31, 2025.” The Energy Act of 2020, within the Consolidated Appropriations Act (Pub. L. 116-68), directs the Secretary of Energy to provide a fast-neutron testing capability, authorizes the necessary funding, and revises the completion date from 2025 to 2026. To this end, DOE prepared an EIS in accordance with NEPA and the Council on Environmental Quality (CEQ) and DOE NEPA regulations (40 CFR parts 1500 through 1508  3 and 10 CFR part 1021, respectively).

The purpose of this DOE action is to establish a domestic, versatile, reactor-based fast-neutron source and associated facilities that meet identified user needs ( e.g., providing a high neutron flux of at least 4 × 10  15 neutrons per square centimeter per second and related testing capabilities). Associated facilities include those for the preparation of VTR driver fuel and test/experimental fuels and materials and those for the ensuing examination of the test/experimental fuels and materials; existing facilities would be used to the extent possible. The U.S. has not had a viable domestic fast-neutron-spectrum testing capability for almost three decades. DOE needs to develop this capability to establish the U.S. testing capability for next-generation nuclear reactors—many of which require a fast-neutron spectrum for operation—thus enabling the U.S. to regain technology leadership for the next generation nuclear fuels, materials, and reactors. The lack of a versatile fast-neutron-spectrum testing capability is a significant national strategic risk affecting the ability of DOE to fulfill its mission to advance the energy, environmental, and nuclear security interests of the U.S. and promote scientific and technological innovation. This testing capability is essential for the U.S. to modernize its nuclear energy industry. Further, DOE needs to develop this capability on an accelerated schedule to avoid further delay in the U.S. ability to develop and deploy advanced nuclear energy technologies. If this capability is not available to U.S. innovators as soon as possible, the ongoing shift of nuclear technology dominance to other nations will accelerate, to the detriment of the U.S. nuclear industrial sector.

DOE proposes to construct and operate the VTR at a suitable DOE site. DOE would use or expand existing, co-located, post-irradiation examination capabilities as necessary to accomplish the mission. DOE would also use or expand existing facility capabilities to produce VTR driver fuel and to manage radioactive wastes and spent nuclear fuel. The DOE facilities would be capable of receiving test articles from the user community, as well as fabricating test articles for insertion in the VTR. 4

Candidate sites for construction and operation of the VTR include the INL Site near Idaho Falls, Idaho, and the Oak Ridge National Laboratory (ORNL), near Oak Ridge, Tennessee. DOE would perform most post-irradiation examination in existing, modified, or new facilities near the VTR, although there may be instances when test items would be sent to another location for evaluation. DOE would produce VTR driver fuel at the INL Site or SRS near Aiken, South Carolina.

DOE proposes to use the GE Hitachi Nuclear Energy (GEH) Power Reactor Innovative Small Module (PRISM), a pool-type reactor, as the basis for VTR's design under both action alternatives. The PRISM design would require several changes, notably the elimination of electricity production and the accommodation for experimental locations within the core. The PRISM design  5 of a sodium-cooled, pool-type reactor satisfies the need to use a mature technology. The VTR would be an approximately 300-megawatt (thermal) reactor based on and sharing many of the design and passive safety features of the GEH PRISM. It also would incorporate technologies adapted from previous sodium-cooled fast reactors ( e.g., the Experimental Breeder Reactor II [EBR-II] and the Fast Flux Test Facility). The VTR's reactor, primary heat removal system, and safety systems would be similar to those of the PRISM design. VTR, like PRISM, would use metallic alloy fuels. The conceptual design for the first VTR driver fuel core is an alloy of 70 percent uranium (uranium enriched to 5 percent uranium-235  6 ), 20 percent plutonium, and 10 percent zirconium (by weight).

The major facilities in the VTR complex include an electrical switchyard, the reactor facility, 10 large sodium-to-air heat exchangers, and an operational support facility. The reactor facility would be about 180 feet by 280 feet. The reactor vessel, containing the core of the VTR, would extend 90 feet below grade. Other below-grade elements of the facility include the reactor head access area (over the core), secondary coolant equipment rooms, test assembly storage areas, and fuel cask pits. The reactor and experiment hall operating area that extends 90 feet above grade would allow the receipt and movement of fuel and experiments into and out of the core and storage areas.

The VTR core design would differ from that of PRISM because it needs to meet the requirement for a high-flux test environment that accommodates several test and experimental assemblies. Experiments would be placed in some locations normally occupied by driver fuel in the PRISM. Heat generated by the VTR during operation would be dissipated through a heat rejection system consisting of intermediate heat exchangers within the reactor vessel, a secondary sodium-cooling loop, and air-cooled heat exchangers. This system and the Reactor Vessel Auxiliary Cooling System (RVACS) would provide shutdown and emergency cooling. The RVACS would remove decay heat from the sodium pool by transferring the thermal energy through the reactor vessel and guard vessel walls to naturally circulating air being drawn down through the inlets of four cooling chimneys, through risers on the exterior of the guard vessel, and up through the outlets of the cooling chimneys. The RVACS chimneys would be about 100 feet tall, extending above the experiment support area. No water would be used in either of the reactor cooling systems.

The core of the VTR would comprise 66 driver fuel assemblies. The core would be surrounded by rows of reflector assemblies (114 total assemblies), which would be surrounded by rows of shield assemblies (114 total assemblies). Non-instrumented experiments (containing test specimens) could be placed in multiple locations in the reactor core or in the reflector region, by replacing a driver fuel or reflector assembly (test pins may also be placed within a driver fuel assembly). Instrumented experiments, which would provide real-time information while the reactor is operating, would require a penetration in the reactor cover for the instrumentation stalk and could only be placed in six fixed locations. One of these six locations can accommodate a “rabbit” test apparatus that would allow samples to be inserted and/or removed while the reactor is in operation. The number of instrumented test locations, plus the flexibility in the number and location of non-instrumented tests would strengthen the versatility of the reactor as a test facility.

The VTR mission requires capabilities to examine the test specimens after irradiation in the VTR to determine the effects of a high flux of fast neutrons. Highly radioactive test specimens would be removed from the VTR after a period of irradiation ranging from days to years. Test specimens would then be transferred to a fully enclosed, radiation-shielded facility where they could be remotely disassembled, analyzed, and evaluated. The examination facilities are “hot cell” facilities. These hot cells include concrete walls and multi-layered, leaded-glass windows several feet thick. Remote manipulators allow operators to perform a range of tasks on test specimens within the hot cell while protecting them from radiation exposure. An inert atmosphere is required in some hot cells. An inert atmosphere of argon would be used  7 in the hot cell to which test assemblies are initially transferred after removal from the VTR. The inert atmosphere may be necessary to prevent test specimen degradation or unacceptable reactions ( e.g., pyrophoric) that could occur in an air atmosphere. The post-irradiation hot cell facilities would be in close proximity to the VTR. After initial disassembly and examination in the inert atmosphere hot cell, test specimens may be transferred to other post-irradiation examination facilities for additional analysis.

The VTR would generate up to 45 spent nuclear fuel assemblies per year. 8 DOE would use existing or new facilities at the locations identified in the site-specific alternatives for the management of spent driver fuel. DOE will not separate, purify, or recover fissile material from VTR spent nuclear fuel. Spent driver fuel assemblies would be temporarily stored within the reactor vessel for about 1 year. Upon removal from the reactor vessel, surface sodium coolant would be washed off the assembly, and the assembly would be transported in a transfer cask to a new onsite spent fuel pad. After several years (at least 3 years), during which time the radioactive constituents would further decay, the assemblies would be transferred in a cask to a spent nuclear fuel conditioning facility. The sodium that was enclosed within the spent driver fuel pins to enhance heat transfer would be removed using a melt-distill-package process. The spent nuclear fuel would be chopped, and the chopped material consolidated, melted, and vacuum distilled to separate the sodium from the fuel. To meet safeguards requirements, diluent would be added to the remaining spent fuel to reduce the fissile material concentration. The resulting material would be packaged in containers and temporarily stored in casks on the spent fuel pad, pending transfer to an offsite storage or disposal facility. Currently, there is not a repository for disposal of spent nuclear fuel, but the conditioned spent driver fuel from the VTR is expected to be compatible with the acceptance criteria for any interim storage facility or permanent repository.

Under the No Action Alternative, DOE would not pursue the construction and operation of a VTR. To the extent they are capable and available for testing in the fast-neutron-flux spectrum, DOE would continue to make use of the limited capabilities of existing facilities, both domestic and foreign. Domestic facilities that would likely be used, without modification, would include the INL Advanced Test Reactor and the ORNL High Flux Isotope Reactor. DOE would not construct new or modify any existing post-irradiation examination or spent nuclear fuel conditioning facilities to support VTR operation. Existing post-irradiation examination and spent nuclear fuel conditioning facilities would continue to support operation of the existing reactors. Because there would not be a VTR under the No Action Alternative, there would be no need to produce VTR driver fuel. Therefore, no new VTR driver fuel production capabilities would be pursued. The No Action Alternative would not meet the purpose and need identified for the VTR.

Under the INL VTR Alternative, DOE would site the VTR adjacent to and east of the Materials and Fuels Complex (MFC) at the INL Site and use existing hot cell and other facilities at the MFC for post-irradiation examination and conditioning spent nuclear fuel ( i.e., preparing it for disposal). The VTR complex would occupy about 25 acres. Additional land would be disturbed during the construction of the VTR complex for such items as temporary staging of VTR components, construction equipment, and worker parking. In total, construction activities (anticipated to last 51 months) would result in the disturbance of about 100 acres, inclusive of the 25 acres occupied by the completed VTR complex.

The MFC is the location of the Hot Fuel Examination Facility (HFEF), the Irradiated Materials Characterization Laboratory (IMCL), and the Fuel Conditioning Facility (FCF). The HFEF and IMCL (and other analytical laboratory facilities) would be used for post-irradiation examination and the FCF for spent nuclear fuel conditioning. The existing Perimeter Intrusion Detection and Assessment System (PIDAS) security fencing around the Fuel Manufacturing Facility (FMF) and the Zero Power Physics Reactor (ZPPR) would be extended to encompass most of the VTR facility.

Following irradiation, test and sample articles would be transferred to the HFEF first. The HFEF, a Hazard Category 2 nuclear facility, 9 contains two large hot cells. HFEF hot cells provide shielding and containment for remote examination (including destructive and non-destructive testing), processing, and handling of highly radioactive materials.

The IMCL, a Hazard Category 2 nuclear facility, has a modular design that provides flexibility for future examination of nuclear fuel and materials. The IMCL would be used for the study and characterization of radioactive fuels and materials at the micro- and nanoscale to assess irradiation damage processes.

Existing facilities within the MFC would need minor modifications to support fabrication of test articles or to support post-irradiation examination of irradiated test specimens withdrawn from the VTR. These types of activities are ongoing within the MFC.

A new spent fuel pad would be constructed within the VTR site. The spent fuel pad would consist of an approximately 11,000-square foot concrete slab with a 2,500-square foot approach pad. Spent driver fuel would be temporarily stored at the VTR within the reactor vessel, followed by a period of storage on the spent fuel pad. After the fuel cools sufficiently, it would be transferred in a cask to FCF. FCF is a Hazard Category 2 nuclear facility located within a PIDAS. At FCF, the fuel would be conditioned using a melt-distill-package process. The fuel would be chopped, using existing equipment at the FCF. The chopped material would be consolidated, melted, and vacuum distilled to separate the sodium from the fuel. Following addition of a diluent, the mixture would be packaged in containers, placed in storage casks, and temporarily stored on the new spent fuel pad until shipped to an offsite location (an interim storage facility or a permanent repository when either becomes available for VTR fuel).

Under the conceptual design, the existing infrastructure, including utilities and waste management facilities, would be used to support construction and operation of the VTR. The current infrastructure is adequate to support the VTR with minor upgrades and modifications. Radioactive wastes would be shipped off site for treatment and/or disposal.

Under the ORNL VTR Alternative, the VTR would be sited at ORNL at a site previously considered for other projects, about a mile east of the ORNL main campus. The major structures for the VTR would be the same as those described for the INL VTR Alternative. At ORNL, a new hot cell, a joint post-irradiation examination and spent nuclear fuel conditioning facility, would be constructed adjacent to the VTR. Although there are facilities with hot cells at ORNL that would be used for post-irradiation examination of test materials, none of the available hot cells operates with an inert atmosphere. A new spent fuel pad of the same dimensions as described under INL VTR Alternative would also be constructed.

The new hot cell facility would be approximately 172 feet by 154 feet, four levels, and would rise to about 84 feet above grade. The facility would house four hot cells: two for post-irradiation examinations and two for spent nuclear fuel conditioning. Construction would occur in parallel with the construction of the VTR and be completed in the same 51-month period. Construction activities would result in disturbance of about 150 acres, with the completed VTR complex, including the hot cell facility, occupying less than 50 acres. The VTR facility, hot cell facility, and spent fuel pad would be located within a single PIDAS.

In addition to the new hot cell facility, existing facilities at ORNL within the Irradiated Fuels Examination Laboratory (Building 3525) and the Irradiated Material Examination and Testing Facility (Building 3025E) would be used to supplement the capabilities of the new post-irradiation examination facility. The Irradiated Fuels Examination Laboratory is a Hazard Category 2 nuclear facility and contains hot cells that are used for examination of a wide variety of fuels. The Irradiated Material Examination and Testing Facility is a Hazard Category 3 nuclear facility and contains hot cells that are used for mechanical testing and examination of highly irradiated structural alloys and ceramics. In addition, the Low Activation Materials Design and Analysis Laboratory would be used for the examination of materials with low radiological content that do not require remote manipulation.

Spent driver fuel would be managed the same as described under the INL VTR Alternative—temporarily stored at the VTR reactor vessel, stored on the spent fuel pad, then conditioned and packaged. Conditioning spent nuclear fuel in preparation for disposal would occur in an inert atmosphere hot cell located in the new hot cell facility adjacent to VTR. Containerized spent nuclear fuel would be placed in storage casks and temporarily stored on the new spent fuel pad until shipped to an offsite location (an interim storage facility or a permanent repository when either becomes available for VTR fuel).

Under the conceptual design, the existing ORNL infrastructure would be extended to the VTR site. The location selected for the VTR is relatively undeveloped and does not have sufficient infrastructure ( e.g., roads, utilities, security) to support construction and operation of the VTR. Radioactive waste would be shipped off site for treatment and/or disposal. Waste management capabilities provided by the project ( e.g., treatment or packaging of radioactive liquid waste) and facilities within ORNL would be used to support waste management during construction and operation of the VTR.

The VTR design envisions the use of metallic fuel. The initial VTR core would consist of a uranium/plutonium/zirconium alloy (U/Pu/Zr) fuel that would be 70 percent uranium (uranium enriched to 5 percent uranium-235), 20 percent plutonium, and 10 percent zirconium—a blend identified as U-20Pu-10Zr. VTR driver fuel used in later operations could consist of these elements in different ratios and could use plutonium with uranium of varying enrichments, including depleted uranium or uranium enriched up to 19.75 percent. Annual heavy metal requirements would be approximately 1.8 metric tons of fuel material (between 1.3 metric tons and 1.4 metric tons of uranium and between 0.4 and 0.54 metric tons of plutonium, depending on the ratio of uranium to plutonium). 10 Feedstock for this fuel could be acquired from several existing sources.

DOE's plan for providing uranium for fabricating VTR driver fuel is to acquire metallic uranium from a domestic commercial supplier. If another source of uranium were to be selected, DOE would conduct a review to determine if additional NEPA analysis would be needed. Other possible sources are DOE managed inventories of excess uranium acquired from many sources, including U.S. defense programs and the former DOE uranium enrichment enterprise. Some of the uranium is enriched and could be down-blended for use in VTR driver fuel.

Existing sources of U.S. excess plutonium  11 managed by DOE and the National Nuclear Security Administration (NNSA) would be sufficient to meet the needs of the VTR project. Potential DOE/NNSA plutonium materials include surplus pit  12 plutonium ( i.e., metal), other plutonium metal, oxide, and plutonium from other sources. If the U.S. sources cannot be made available for the VTR project or to supplement the domestic supply, DOE has identified potential sources of plutonium in Europe.

VTR driver fuel production evaluated in the EIS involves two steps or phases: feedstock preparation and fuel fabrication. Depending on the impurities of the source material, a polishing process, or a combination of processes, would be required. These processes would be performed in a series of gloveboxes  13 to limit worker radiological exposure.

Three potential feedstock preparation processes are under consideration: an aqueous capability, a pyrochemical capability, and a combination of the two. In the aqueous process, the plutonium feed (containing impurities) is dissolved in a nitric acid solution and through a series of extraction and precipitation steps, a polished plutonium oxide is produced. The oxide is converted to a metal in a direct oxide reduction process. In one form of the pyrochemical process (molten salt extraction), the metallic plutonium feed is combined with a salt and the mixture raised to the melting point. Impurities ( e.g., americium) react with the salt, and the polished plutonium is collected at the bottom of the reaction crucible. If the pyrochemical process were selected, a direct oxide reduction process would also be required to convert plutonium dioxide feeds to plutonium metal. If a combination of the two processes were to be selected, a smaller aqueous line to prepare this fuel could be incorporated into the pyrochemical process.

Fuel fabrication would use an injection casting process to combine and convert the metallic ingots into fuel slugs. In a glovebox, a casting furnace would be used to melt and blend the three fuel components: uranium, plutonium, and zirconium. The molten alloy then would be injected into quartz fuel slug molds. After cooling, the molds would be broken, and the fuel slugs retrieved. Fuel pins would be created, using stainless steel tubes (cladding) into which a slug of solid sodium would be inserted, followed by the alloy fuel slugs. The fuel slugs and sodium would occupy about half of the volume of the fuel pin with the remainder containing argon gas at near atmospheric pressure. The ends of the tubes would be closed with top and bottom end plugs. These activities would take place in gloveboxes with inert atmospheres. Once fully assembled, the fuel pins would be heated sufficiently to melt the sodium and create the sodium bond with the fuel. The sodium-bonded fuel would fill about half the length of the fuel pin. Fuel pins would be assembled into a fuel assembly with each fuel assembly containing 217 fuel pins. Sodium bonding and producing the fuel assemblies would be performed in an open environment. No gloveboxes would be required.

Operationally, the feedstock preparation and fuel fabrication capabilities would need to generate about 66 fuel assemblies for the initial VTR core. Thereafter, the capabilities would need to produce up to 45 fuel assemblies per year.

The EIS evaluates the INL Site and SRS as potential locations for performing the activities necessary for driver fuel production for the VTR. Independently, DOE would establish and operate all or part of the fuel fabrication capability at either site. DOE is not making a decision regarding driver fuel production in this ROD.

Implementation of either the INL VTR Alternative or the ORNL VTR Alternative would generally have small environmental consequences. Overall, the environmental consequences would be smaller at the INL Site for several reasons. The total area that would be temporarily disturbed and the area that would be permanently occupied by the VTR complex would be smaller at the INL Site because of the need to build a new hot cell facility if the VTR were located at ORNL. Unlike the INL Site, the ORNL location abuts wetlands that would have to be avoided or managed in accordance with Clean Water Act and State of Tennessee regulations. The removal of trees at the ORNL location would also result in the loss of roosting habitat for sensitive bat species. The potential radiological impacts would be small at both locations but would be smaller at the INL Site because the VTR would be further from the site boundary and the population density is lower near the INL Site than near ORNL.

Implementation of the reactor fuel production options at either the INL Site or SRS would generally have small environmental consequences. At both locations, existing facilities would be modified or adapted to provide capabilities for feedstock preparation and fuel fabrication. Disturbance of a minimal area (up to 3 acres) would occur at SRS. Because there is existing staff at the INL Fuel Manufacturing Facility, fewer new employees would need to be hired for fuel fabrication at the INL Site. Potential radiological impacts would be small at both sites, but due to differences in population density and distribution, potential impacts would be somewhat smaller at the INL Site.

The No Action Alternative would be the Environmentally Preferable Alternative. Under the No Action Alternative, DOE would not pursue the construction and operation of a VTR. To the extent they are capable and available for testing in the fast-neutron-flux spectrum, DOE would continue to make use of the limited capabilities of existing facilities, both domestic and foreign. Construction and operation of a VTR and associated support facilities would not occur, resulting in less impacts than under the Action Alternatives. However, the No Action Alternative would not meet the purpose and need for a domestic fast-neutron-spectrum testing capability.

DOE made more than 1,850 notifications of the completion and availability of the Final VTR EIS to Congressional members and committees; states, including Idaho, Tennessee, and South Carolina; Tribal governments and organizations; local governments; other Federal agencies; non-governmental organizations; and individuals. Following issuance of the Final VTR EIS, DOE received four letters and/or emails. DOE considered the comments received following issuance of the Final VTR EIS and finds that they do not present “significant new circumstances or information relevant to environmental concerns and bearing on the proposed action or its impacts” within the meaning of 40 CFR 1502.9(c) and 10 CFR 1021.314(a), and therefore do not require preparation of a supplement analysis or a supplemental EIS.

DOE addressed two of the emails received—a press inquiry and a process question—directly with the people who submitted them.

A third email/letter received included multiple comments on a variety of topics. One related to the author's Freedom of Information Act request and has no bearing on or relevance to the environmental impacts evaluated in the EIS. It also contained another question of whether the Office of Nuclear Energy would have the ability and funds to establish a VTR fuel fabrication project at SRS. As appropriate, the VTR EIS evaluated the potential environmental impacts of a fuel fabrication capability at SRS; the administrative and funding items are factors DOE would consider when it makes a decision regarding fuel fabrication.

Other comments posed questions about the plutonium for VTR driver fuel fabrication, a nonproliferation assessment, and management of transuranic waste resulting from fuel fabrication activities. Similar topics were raised in comments on the Draft VTR EIS. DOE responded to these comment topics in Volume 3 of the Final VTR EIS and revised the EIS as necessary to fully address these topics commensurate with the stage of project development.

This third letter/email also incorrectly stated that the VTR had been “terminated” and the “EIS [was] improperly issued after termination.” Additionally, it requested “that no Record of Decision (ROD) be issued on the project.” While it is correct that Congress did not appropriate funds for VTR in fiscal year 2022, the Energy Act of 2020, included in the Consolidated Appropriations Act (Pub. L. 116-68), authorized full funding for the VTR project. DOE is following Council on Environmental Quality guidance to integrate NEPA into the planning process early to ensure planning and decisions reflect environmental values, to avoid delays, and to head off potential conflicts. By issuing the Final VTR EIS and ROD, DOE is taking important steps, consistent with the Energy Act of 2020, by deciding whether and where to construct the VTR. In accordance with its authorization in the Energy Act of 2020, DOE will work with Congress to obtain the funding needed to execute this important project.

The fourth letter/email recommended that DOE clarify management approaches for spent driver fuel beyond January 1, 2035. As indicated in the response to comments received from the State of Idaho and as revised in the Final VTR EIS, prior to issuing this ROD, DOE committed to exploring potential approaches with the State of Idaho to clarify and, as appropriate, address potential issues concerning management of VTR spent nuclear fuel beyond January 1, 2035; those discussions are ongoing. Spent driver fuel from the VTR, regardless of whether it was generated before or after January 1, 2035, would be stored within the VTR reactor vessel until decay heat generation is reduced to a level that would allow fuel transfer and storage of the fuel assemblies with passive cooling. After allowing time for additional radioactive decay, the spent fuel would be transferred to a spent nuclear fuel conditioning facility. At the facility, the spent fuel would be chopped, melted, and vacuum distilled to remove the sodium, after which the fuel would be diluted and placed in canisters ready for future disposal. The canisters would be placed in dry storage casks and stored on site in compliance with all regulatory requirements and agreements. This VTR spent nuclear fuel would be managed at the site until it is transported off site to an interim storage facility or a permanent repository.

DOE has decided to implement its Preferred Alternative as described in the Final VTR EIS. DOE's Preferred Alternative is to construct and operate a VTR at INL, and to establish, through modification and construction, co-located facilities for post-irradiation examination of test products and for management of spent VTR driver fuel at INL.

DOE has not decided whether to establish VTR driver fuel production capabilities for feedstock preparation and fuel fabrication at the INL Site, SRS, or a combination of the two sites. Once a preferred alternative/option for VTR driver fuel production is identified, DOE will announce its preference in an FR notice. DOE would publish a record of decision no sooner than 30 days after its announcement of a preferred alternative/option for VTR driver fuel production.

The Final VTR EIS provided the DOE decision-maker with important information regarding potential environmental impacts of alternatives and options for satisfying the purpose and need. In addition to environmental information, DOE considered other factors including public comments, statutory responsibilities, strategic objectives, technology needs, safeguards and security, cost, and schedule, when making its decision.

No potential adverse impacts were identified that would require additional mitigation measures beyond those required by regulation and agreements or achieved through design features or best management practices. However, the INL VTR Alternative has the potential to affect one or more resource areas. If during implementation, mitigation measures above and beyond those required by regulations are identified to reduce impacts, they would be developed, documented, and executed.

This document of the Department of Energy was signed on July 22, 2022, by Robert Boston, Manager, Idaho Operations Office, Office of Nuclear Energy, pursuant to delegated authority from the Secretary of Energy. That document with the original signature and date is maintained by DOE. For administrative purposes only, and in compliance with the requirements of the Office of the Federal Register, the undersigned DOE Federal Register Liaison Officer has been authorized to sign and submit the document in electronic format for publication, as an official document of the Department of Energy. The administrative process in no way alters the legal effect of this document upon publication in the Federal Register .

Title: FERC-725Z (Mandatory Reliability Standards: IRO Reliability Standards).

OMB Control No.: 1902-0276.

Type of Request: Extension to this currently approved information collection.

Abstract: On August 8, 2005, The Electricity Modernization Act of 2005, which is Title XII of the Energy Policy Act of 2005 (EPAct 2005), was enacted into law. 1 Under section 215 of the Federal Power Act (FPA) implemented in 18 CFR 40, the Commission requires a Commission-certified Electric Reliability Organization (ERO) to develop mandatory and enforceable Reliability Standards  2 , which are subject to Commission review and approval. In 2006, the Commission established a process to select and certify an ERO and, subsequently, certified the North American Electric Reliability Corporation (NERC) as the ERO. 3

The ERO develops proposed Reliability Standards  4 and, if approved by NERC, submits them to the Commission for review and approval. When the standards are approved by the Commission, the Reliability Standards become mandatory and must be enforced by the ERO, subject to Commission oversight.

NERC established the following IRO standards within FERC-725Z:

IRO-001-4 purpose is to establish the responsibility of Reliability Coordinators to act or direct other entities to act.

In a joint petition dated May 30, 2019, the North American Electric Reliability Corporation (“NERC”) and Western Electricity Coordinating Council (“WECC”) requested Commission approval for Reliability Standard IRO-002-6 (now IRO-002-7) (Reliability Coordination, Monitoring and Analysis). NERC and WECC stated that the “Reliability Standard IRO-002-7 reflects the addition of a regional Variance containing additional requirements applicable to Reliability Coordinators providing service to entities in the Western Interconnection.” NERC maintains that the data exchange capability requirement in Reliability Standard IRO-002-7, Requirement R1 is covered by Reliability Standard IRO-008-2, Requirement R1, which obligates the reliability coordinator to perform operational planning analyses to assess whether the planned operations for the next-day will exceed System Operating Limits and Interconnection Reliability Operating Limits within its Wide Area. NERC asserts that “to perform the required operational planning analyses, the Reliability Coordinator must have the data it deems necessary from those entities that possess it.”

Currently effective IRO-009-2 applicable to reliability coordinators and the purpose of the standard is to prevent instability, uncontrolled separation, or cascading outages that adversely impact the reliability of the interconnection by ensuring prompt action to prevent or mitigate instances of exceeding Interconnection Reliability Operating Limits (IROLs).

Additionally, regarding data exchange, NERC cites Reliability Standard IRO-010-2 (Reliability Coordinator Data Specification and Collection) and its stated purpose of preventing instability, uncontrolled separation, or cascading outages “by ensuring the Reliability Coordinator has the data it needs to monitor and assess the operation of its Reliability Coordinator Area.” NERC states that under Reliability Standard IRO-010-2, Requirements R1, R2 and R3, the reliability coordinator must specify the data necessary for it to perform its operational planning analyses and provide the specifications to the entities from which it needs data who then must comply with the data request using a mutually agreeable format and security protocols.

IRO-014-3 purpose is to ensure that each Reliability Coordinator's operations are coordinated such that they will not adversely impact other Reliability Coordinator Areas and to preserve the reliability benefits of interconnected operations.

IRO-017-1 (Outage Coordination) purpose is to ensure that outages are properly coordinated in the Operations Planning time horizon and Near-Term Transmission Planning Horizon. Reliability coordinators, planning coordinators, balancing authorities, transmission owners and transmission planners are applicable entities for IRO-017-1.

IRO-018-1 (Reliability Coordinator Real-time Reliability Monitoring and Analysis Capabilities), submitted by North American Electric Reliability Corporation (NERC). Requirement R3 requires reliability coordinators to have an alarm process monitor that provides notification to system operators when the failure of a real-time monitoring alarm processor has occurred. In this order, the Reliability Standards build on monitoring, real-time assessments and support effective situational awareness. The Reliability Standards accomplish this by requiring applicable entities to: (1) provide notification to operators of real-time monitoring alarm failures; (2) provide operators with indications of the quality of information being provided by their monitoring and analysis capabilities; and (3) address deficiencies in the quality of information being provided by their monitoring and analysis capabilities.

NERC observes that the performance of the requirements it cites is premised on the existence of data exchange capabilities, regardless of whether a separate requirement expressly requires the reliability coordinator to have data exchange capabilities in place. In review the 725Z collection for the IRO Reliability Standards, the number of entities/respondents was checked and broken down into the appliable type of entity for each reliability standard. In the past combining reliability standards caused the same reliability standard to be accounted for multiple times, resulting in the previously recorded 6,686 responses. These numbers were revised and updated to be the new calculated total of 953 responses. Staff looked at each reliability standard as its own unique project and in doing so eliminated the multiple entity count by making a more accurate representation of the number of responses.

Type of Respondents: Reliability coordinators (RC), planning coordinators (PC), balancing authorities (BA), transmission owners (TO), transmission planners (TP), Transmission Operators (TOP) are included entities for Estimate of Annual Burden:   5 The Commission estimates the changes in the annual public reporting burden and cost  6 as follows.

Comments: Comments are invited on: (1) whether the collection of information is necessary for the proper performance of the functions of the Commission, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of the burden and cost of the collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility and clarity of the information collection; and (4) ways to minimize the burden of the collection of information on those who are to respond, including the use of automated collection techniques or other forms of information technology.

Title: FERC-725P1 (Mandatory Reliability Standards: PRC-005-6 Reliability Standard).

OMB Control No.: 1902-0280.

Abstract: The Commission requires the information collected by the FERC-725P1 to implement the statutory provisions of section 215 of the Federal Power Act (FPA). On August 8, 2005, Congress enacted into law the Electricity Modernization Act of 2005, which is Title XII, Subtitle A, of the Energy Policy Act of 2005 (EPAct 2005). EPAct 2005 added a new section 215 to the FPA, which required a Commission-certified Electric Reliability Organization (ERO) to develop mandatory and enforceable Reliability Standards, which are subject to Commission review and approval. Once approved, the Reliability Standards may be enforced by the ERO subject to Commission oversight, or the Commission can independently enforce Reliability Standards.

On February 3, 2006, the Commission issued Order No. 672, implementing section 215 of the FPA. Pursuant to Order No. 672, the Commission certified one organization, North American Electric Reliability Corporation (NERC), as the ERO. The Reliability Standards developed by the ERO and approved by the Commission apply to users, owners and operators of the Bulk-Power System as set forth in each Reliability Standard.

On November 13, 2015, the North American Electric Reliability Corporation filed a petition for Commission approval of proposed Reliability Standard PRC-005-6 (Protection System, Automatic Reclosing, and Sudden Pressure Relaying Maintenance).

NERC also requested approval of the proposed implementation plan for PRC-005-6, and the retirement of previous versions of Reliability Standard PRC-005.

NERC explained in its petition that Reliability Standard PRC-005-6 represented an improvement upon the most recently-approved version of the standard, PRC-005-4.

FERC approved the proposed Reliability Standard PRC-005-6 on December 18, 2015.

Type of Respondent: Transmission Owner (TO), Distribution Provider (DP), and Generator Owners (GOs).

Estimate of Annual Burden:   1 The Commission estimates the annual public reporting burden for the information collection as:  2

Comments: Comments are invited on: (1) whether the collection of information is necessary for the proper performance of the functions of the Commission, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of the burden and cost of the collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility and clarity of the information collection; and (4) ways to minimize the burden of the collection of information on those who are to respond, including the use of automated collection techniques or other forms of information technology.

On April 16, 2009, FERC approved and confirmed the Sierra Nevada Region Washoe Project, Stampede Division's non-firm power formula rate, Rate Schedule SNF-7, under Rate Order No. WAPA-136, on a final basis through July 31, 2013. 1 FERC subsequently approved two consecutive 5-year rate extensions, extending the rate through September 30, 2022. 2 This rate schedule applies to the Washoe Project, Stampede Division. Western Area Power Administration (WAPA) published a Federal Register notice (Proposed FRN) on April 5, 2022 (87 FR 19678), proposing no changes from the existing Washoe Project, Stampede Division non-firm power formula rate in Rate Schedule SNF-7, which expires on September 30, 2022. The Proposed FRN also initiated a public consultation and comment period and set forth the date and location of the public information and public comment forums.

By Delegation Order No. S1-DEL-RATES-2016, effective November 19, 2016, the Secretary of Energy delegated: (1) the authority to develop power and transmission rates to the WAPA Administrator; (2) the authority to confirm, approve, and place such rates into effect on an interim basis to the Deputy Secretary of Energy; and (3) the authority to confirm, approve on a final basis, remand, or disapprove such rates, to FERC. By Delegation Order No. S1-DEL-S3-2022-2, effective June 13, 2022, the Secretary of Energy also delegated the authority to confirm, approve, and place such rates into effect on an interim basis to the Under Secretary for Infrastructure. By Redelegation Order No. S3-DEL-WAPA1-2022, effective June 13, 2022, the Under Secretary for Infrastructure redelegated the authority to confirm, approve, and place such rates into effect on an interim basis to WAPA's Administrator. This rate action is issued under Redelegation Order No. S3-DEL-WAPA1-2022 and Department of Energy procedures for public participation in rate adjustments outlined in 10 CFR part 903. 3

Following a review of the Sierra Nevada Region's proposal, I hereby confirm, approve, and place Rate Order No. WAPA-201, which provides the non-firm power formula rate for the Washoe Project, Stampede Division into effect on an interim basis. WAPA will submit Rate Order No. WAPA-201 to FERC for confirmation and approval on a final basis.

In the Matter of: Western Area Power Administration, Sierra Nevada Region, Rate Adjustment for the Washoe Project, Stampede Division, Non-Firm Power Formula Rate.

The non-firm power formula rate in Rate Order No. WAPA-201 is established following section 302 of the Department of Energy (DOE) Organization Act (42 U.S.C. 7152). 4

By Delegation Order No. S1-DEL-RATES-2016, effective November 19, 2016, the Secretary of Energy delegated: (1) the authority to develop power and transmission rates to the WAPA Administrator; (2) the authority to confirm, approve, and place such rates into effect on an interim basis to the Deputy Secretary of Energy; and (3) the authority to confirm, approve, and place into effect on a final basis, or to remand or disapprove such rates, to FERC. By Delegation Order No. S1-DEL-S3-2022-2, effective June 13, 2022, the Secretary of Energy also delegated the authority to confirm, approve, and place such rates into effect on an interim basis to the Under Secretary for Infrastructure. By Redelegation Order No. S3-DEL-WAPA1-2022, effective June 13, 2022, the Under Secretary for Infrastructure further redelegated the authority to confirm, approve, and place such rates into effect on an interim basis to WAPA's Administrator. This rate action is issued under Redelegation Order No. S3-DEL-WAPA1-2022 and DOE procedures for public participation in rate adjustments set forth at 10 CFR part 903. 5

As used in this Rate Order, the following acronyms, terms, and definitions apply:

The Provisional Formula Rate Schedule WSH-1 will take effect on the first day of the first full billing period beginning on or after October 1, 2022, and will remain in effect through September 30, 2027, pending approval by FERC on a final basis or until superseded.

Sierra Nevada Region followed the Procedures for Public Participation in Power and Transmission Rate Adjustments and Extensions, 10 CFR part 903, in developing this non-firm power formula rate. Following are the steps Sierra Nevada Region took to involve interested parties in the rate process:

1. On April 5, 2022, a Federal Register notice (87 FR 19678) (Proposed FRN) announced the proposed non-firm power formula rate and launched a 60-day public consultation and comment period.

2. On April 5, 2022, the Sierra Nevada Region notified Preference Customers and interested parties of the proposed rate and provided a copy of the published Proposed FRN.

3. On April 22, 2022, the Sierra Nevada Region held a public information forum via Webex. Sierra Nevada Region's representatives explained the proposed non-firm power formula rate, answered questions, and gave notice that more information was available in the Customer Rate Brochure.

4. On April 22, 2022, the Sierra Nevada Region held a public comment forum to provide an opportunity for customers and other interested parties to comment for the record.

5. Sierra Nevada Region published a website that contains all dates, customer letters, presentations, comments, FRNs, Customer Rate Brochure, and other information about this rate process. The website is located at www.wapa.gov/regions/SN/rates/Pages/Rate-Case-2022-WAPA-201.aspx.

6. During the 60-day consultation and comment period, which ended on June 6, 2022, the Sierra Nevada Region received no oral comments and no written comments.

Stampede Dam and Reservoir are located on the Little Truckee River in Sierra County, California, about 11 miles northeast of the town of Truckee. The Washoe Project was designed to improve the regulation of runoff from the Truckee and Carson River system and to provide supplemental irrigation water and drainage, as well as water for municipal, industrial, fishery use, flood protection, fish and wildlife benefits, and recreation. The Stampede Powerplant provides the economic equivalent of project-use power to Lahontan and Marble Bluff fish facilities.

When the Stampede Dam and Reservoir project was first authorized, under Public Law 84-858, on August 1, 1956, hydroelectric power development was included. During the period 1966 to 1970, when Stampede Dam was built, power facilities were not constructed because the power function was not economically justified. Provisions were made to facilitate the addition of power facilities at a later date.

In July 1976, a preliminary reevaluation of a powerplant at Stampede was conducted and published in a special U.S. Department of Interior, Bureau of Reclamation (Reclamation) report, Adding Powerplants at Existing Federal Dams in California. In the report, Reclamation recommended the construction of a Stampede Powerplant. As a result, definitive plan studies were initiated in Fiscal Year 1977, and construction of the powerplant was completed in 1987. A one-half-mile, 60-kilovolt transmission line, owned by Sierra Pacific Power Company (Sierra Pacific), interconnects the Stampede power facilities with Sierra Pacific's transmission system.

Under section 205(c) of the Fallon Paiute Shoshone Indian Tribes Water Rights Settlement Act of 1990, Congress declared all Washoe Project costs non-reimbursable except the Stampede Powerplant. 6 This was necessary because a 1982 court order requires that Stampede be operated for the benefit of endangered or threatened fish at Pyramid Lake. 7 The energy generated by the powerplant has a priority reservation for designated Washoe Project loads. All remaining energy generation is sold on a non-firm basis under the conditions outlined in the Sierra Nevada Region's contract with a third-party contractor. Energy generated at Stampede Powerplant is dependent on the run of the river and is therefore considered non-firm.

Since the Washoe Project has no Federally owned transmission lines, Sierra Nevada Region contracted with Truckee Donner Public Utility District and the City of Fallon (TDF) to accept Stampede generation and serve project use loads. Energy in excess of project use loads is marketed with the Central Valley Project (CVP) under the 2004 and 2025 Power Marketing Plans. Under the provisional Rate Schedule WSH-1, each year any remaining reimbursable expenses that exceed the revenue collected under the TDF contract are transferred to the CVP and incorporated into the CVP power revenue requirement (PRR). CVP customers that participate in the Renewable Energy Credit (REC) program receive a share of the annual Stampede RECs based on the annual percentage of CVP revenue transferred to the Washoe Project.

There are no changes from the existing formula rate to the Provisional Formula Rate. The Provisional Formula Rate for Stampede's non-firm power is designed to recover an annual revenue requirement that includes investment repayment, interest, purchase power, reimbursable operation and maintenance expenses, and other expenses. The Provisional Formula Rate for Stampede power is:

The SEEA is an annual energy exchange account for Stampede energy. Under the contract, TDF accepts delivery of all energy generated from Stampede and integrates this generation into its resource portfolio. The monthly calculation of revenue from Stampede energy received by TDF is credited into the SEEA. WAPA can use the SEEA revenue to benefit project use facilities and market energy from Stampede to CVP preference entities.

In the SEEA, the revenues from sales (generation revenues) are reduced by the project use costs, station service power costs, and SEEA administrative costs. WAPA applies the ratio of project use cost to the generation revenue recorded in the SEEA to determine a non-reimbursable percentage. One hundred percent minus the non-reimbursable percentage establishes a reimbursable percentage. This reimbursable percentage is then applied to the appropriate power-related costs to determine the reimbursable costs for repayment. The reimbursable costs are then netted against generation revenues made at the SEEA rate.

Sierra Nevada Region received no oral or written comments during the public consultation and comment period.

I have certified that the Provisional Formula Rate for the Washoe Project, Stampede Division under Rate Schedule WSH-1 is the lowest possible rate, consistent with sound business principles. The Provisional Formula Rate was developed following administrative policies and applicable laws.

Information about this rate adjustment, including the Customer Rate Brochure, PRS, comments, letters, memorandums, and other supporting materials that were used to develop the Provisional Formula Rate, is available for inspection and copying at the Sierra Nevada Regional Office, 114 Parkshore Drive, Folsom, California. Many of these documents are also available on WAPA's website at www.wapa.gov/regions/SN/rates/Pages/Rate-Case-2022-WAPA-201.aspx.

WAPA has determined that this action fits within the following categorical exclusions listed in appendix B to subpart D of 10 CFR part 1021.410: B4.3 (Electric power marketing rate changes) and B4.4 (Power marketing services and activities). Categorically excluded projects and activities do not require the preparation of either an environmental impact statement or an environmental assessment. 8 Specifically, WAPA has determined that this rulemaking is consistent with activities identified in B4, Categorical Exclusions Applicable to Specific Agency Actions (see 10 CFR part 1021, appendix B to subpart D, part B4). A copy of the categorical exclusion determination is available on WAPA's website at www.wapa.gov/regions/SN/rates/Pages/Rate-Case-2022-WAPA-201.aspx.

Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each new proposed collection, each proposed extension of existing collection of information, and each reinstatement of previously approved information collection before submitting the collection to the OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below.

The OMB is particularly interested in comments that will help:

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, including the validity of the methodology and assumptions used;

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

4. Minimize the burden of the collection of information on those who are to respond, including using appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submissions of responses; and

5. Assess information collection costs.

Energy Employees Occupational Illness Compensation Program Act of 2000 (EEOICPA) Special Exposure Cohort Petitions. (OMB Control No. 0920-0639, Exp. 01/31/2023)—Extension—National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC).

On October 30, 2000, the Energy Employees Occupational Illness Compensation Program Act of 2000 (EEOICPA), 42 U.S.C. 7384-7385 [1994, supp. 2001] was enacted. The Act established a compensation program to provide a lump sum payment of $150,000 and medical benefits as compensation to covered employees suffering from designated illnesses incurred because of their exposure to radiation, beryllium, or silica while in the performance of duty for the Department of Energy and certain of its vendors, contractors, and subcontractors. This legislation also provided for payment of compensation for certain survivors of these covered employees. This program has been mandated to be in effect until Congress ends the funding.

Among other duties, the Department of Health and Human Services (HHS) was directed to establish and implement procedures for considering petitions by classes of nuclear weapons workers to be added to the “Special Exposure Cohort” (the “Cohort”). In brief, EEOICPA authorizes HHS to designate such classes of employees for addition to the Cohort when NIOSH lacks sufficient information to estimate with sufficient accuracy the radiation doses of the employees, and if HHS also finds that the health of members of the class may have been endangered by the radiation dose the class potentially incurred. HHS must also obtain the advice of the Advisory Board on Radiation and Worker Health (the “Board”) in establishing such findings. On May 28, 2004, HHS issued a rule that established procedures for adding such classes to the Cohort (42 CFR part 83). The rule was amended on July 10, 2007.

The HHS rule authorizes a variety of respondents to submit petitions. Petitioners are required to provide the information specified in the rule to qualify their petitions for a complete evaluation by HHS and the Board. HHS has developed two forms to assist the petitioners in providing this required information efficiently and completely. Form A is a one-page form to be used by EEOICPA claimants for whom NIOSH has attempted to conduct dose reconstructions and has determined that available information is not sufficient to complete the dose reconstruction. Form B, accompanied by separate instructions, is intended for all other petitioners. Forms A and B can be submitted electronically as well as in hard copy. Respondent/petitioners should be aware that HHS is not requiring respondents to use the forms. Respondents can choose to submit petitions as letters or in other formats, but petitions must meet the informational requirements stated in the rule. NIOSH expects, however, that all petitioners for whom Form A would be appropriate will use the form, since NIOSH will provide it to them upon determining that their dose reconstruction cannot be completed and encourage them to submit the petition. NIOSH expects most petitioners for whom Form B would be appropriate will also use the form, since it provides a simple, organized format for addressing the informational requirements of a petition.

NIOSH will use the information obtained through the petition for the following purposes: (a) identify the petitioner(s), obtain their contact information, and establish that the petitioner(s) is qualified and intends to petition HHS; (b) establish an initial definition of the class of employees being proposed to be considered for addition to the Cohort; (c) determine whether there is justification to require HHS to evaluate whether or not to designate the proposed class as an addition to the Cohort (such an evaluation involves potentially extensive data collection, analysis, and related deliberations by NIOSH, the Board, and HHS); and (d) target an evaluation by HHS to examine relevant potential limitations of radiation monitoring and/or dosimetry-relevant records and to examine the potential for related radiation exposures that might have endangered the health of members of the class.

Finally, under the rule, petitioners may contest the proposed decision of the Secretary to add or deny adding classes of employees to the cohort by submitting evidence that the proposed decision relies on a record of either factual or procedural errors in the implementation of these procedures. NIOSH estimates that the average time to prepare and submit such a challenge is five hours. Because of the uniqueness of this submission, NIOSH is not providing a form. The submission will typically be in the form of a letter to the Secretary.

CDC requests OMB approval for an estimated 43 annual burden hours. There are no costs to respondents other than their time to participate, unless a respondent/petitioner chooses to purchase the services of an expert in dose reconstruction, an option provided for under the rule.

Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each new proposed collection, each proposed extension of existing collection of information, and each reinstatement of previously approved information collection before submitting the collection to the OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below.

The OMB is particularly interested in comments that will help:

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, including the validity of the methodology and assumptions used;

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

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

5. Assess information collection costs.

Assessing Fatigue and Fatigue Management in U.S. Onshore Oil and Gas Extraction Industry—New—National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC).

Oil and gas extraction (OGE) workers play an important role in supporting the United States economy and help fulfill the energy needs of Americans and American businesses. OGE workers have significant risks for a variety of exposures at oil and gas well sites. There has been no significant fatigue research in the United States onshore upstream OGE sector. This proposed project will characterize relationships between sleep, fatigue, fatigue management, and related factors, within the onshore OGE industry.

Primary data will be collected using three approaches. First, researchers will collect direct measurements of sleep and alertness among OGE workers. Second, researchers will use questionnaires to collect information on OGE worker demographics, occupation, general heath, normal working hours, commute times, home life, physical sleeping environment, and typical sleep quality. Third, researchers will collect qualitative information through interviews with workers, front-line supervisors, health and safety leaders, as well as subject matter experts, to understand challenges and opportunities related to fatigue management in the OGE industry.

CDC requests OMB approval for an estimated 305 annual burden hours. There is no cost to respondents other than their time to participate.

In the Federal Register of June 11, 2010 (75 FR 33311), FDA announced the availability of a guidance for industry entitled “Bioequivalence Recommendations for Specific Products” that explained the process that would be used to make product-specific guidances available to the public on FDA's website at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs.

As described in that guidance, FDA adopted this process as a means to develop and disseminate product-specific guidances and provide a meaningful opportunity for the public to consider and comment on those guidances. Under that process, draft guidances are posted on FDA's website and announced periodically in the Federal Register . The public is encouraged to submit comments on those recommendations within 60 days of their announcement in the Federal Register . FDA considers any comments received and either publishes final guidances or publishes revised draft guidances for comment. Guidances were last announced in the Federal Register on May 20, 2022 (87 FR 30962). This notice announces draft product-specific guidances, either new or revised, that are posted on FDA's website.

FDA is announcing the availability of new draft product-specific guidances for industry for drug products containing the following active ingredients:

FDA is announcing the availability of revised draft product-specific guidances for industry for drug products containing the following active ingredients:

For a complete history of previously published Federal Register notices related to product-specific guidances, go to https://www.regulations.gov and enter Docket No. FDA-2007-D-0369.

These draft guidances are being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). These draft guidances, when finalized, will represent the current thinking of FDA on, among other things, the product-specific design of BE studies to support ANDAs. They do not establish any rights for any person and are not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.

FDA tentatively concludes that these draft guidances contain no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.

Persons with access to the internet may obtain the draft guidance at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

Pursuant to 41 CFR 102-3.65 and approval by the Department of Health and Human Services and by the General Services Administration, FDA is announcing the renewal of the Blood Products Advisory Committee (the Committee). The Committee is a discretionary Federal advisory committee established to provide advice to the Commissioner. The Committee advises the Commissioner or designee in discharging responsibilities as they relate to helping to ensure safe and effective drugs for human use and, as required, any other product for which FDA has regulatory responsibility.

The Committee reviews and evaluates available data concerning the safety, effectiveness, and appropriate use of blood, products derived from blood and serum or biotechnology which are intended for use in the diagnosis, prevention, or treatment of human diseases, and, as required, any other product for which the Food and Drug Administration has regulatory responsibility. The Committee also advises the Commissioner of Food and Drugs of its findings regarding screening and testing (to determine eligibility) of donors and labeling of the products, on clinical and laboratory studies involving such products, on the affirmation or revocation of biological products licenses, and on the quality and relevance of FDA's research program which provides the scientific support for regulating these agents. The Committee will function at times as a medical device panel under the Federal Food, Drug, and Cosmetic Act Medical Device Amendments of 1976. As such, the Committee: (1) recommends classification of devices subject to its review into regulatory categories; (2) recommends the assignment of a priority for the application of regulatory requirements for devices classified in the standards or premarket approval category; (3) advises on formulation of product development protocols and reviews premarket approval applications for those devices to recommend changes in classification as appropriate; (4) recommends exemption of certain devices from the application of portions of the Medical Device Amendments of 1976; (5) advises on the necessity to ban a device; and (6) responds to requests from the Agency to review and make recommendations on specific issues or problems concerning the safety and effectiveness of devices.

The Committee shall consist of a core of 17 voting members including the Chair. Members and the Chair are selected by the Commissioner or designee from among authorities knowledgeable in the fields of clinical and administrative medicine, hematology, immunology, blood banking, surgery, internal medicine, biochemistry, engineering, biological and physical sciences, biotechnology, computer technology, statistics, epidemiology, sociology/ethics, and other related professions. Members will be invited to serve for overlapping terms of up to 4 years. Non-Federal members of this committee will serve as Special Government Employees, representatives, or Ex-Officio members. Federal members will serve as Regular Government Employees or Ex-Officios. The core of voting members may include one technically qualified member, selected by the Commissioner or designee, who is identified with consumer interests and is recommended by either a consortium of consumer-oriented organizations or other interested persons. In addition to the voting members, the Committee may include one non-voting representative member who is identified with industry interests. There may also be an alternate industry representative.

The Commissioner or designee shall have the authority to select members of other scientific and technical FDA advisory committees (normally not to exceed 10 members) to serve temporarily as voting members and to designate consultants to serve temporarily as voting members when: (1) expertise is required that is not available among current voting standing members of the Committee (when additional voting members are added to the Committee to provide needed expertise, a quorum will be based on the combined total of regular and added members); or (2) to comprise a quorum when, because of unforeseen circumstances, a quorum is or will be lacking. Because of the size of the Committee and the variety in the types of issues that it will consider, FDA may, in connection with a particular committee meeting, specify a quorum that is less than most of the current voting members. The Agency's regulations (21 CFR 14.22(d)) authorize a committee charter to specify quorum requirements.

If functioning as a medical device panel, an additional non-voting representative member of consumer interests and an additional non-voting representative member of industry interests will be included in addition to the voting members.

Further information regarding the most recent charter and other information can be found at https://www.fda.gov/advisory-committees/blood-vaccines-and-other-biologics/blood-products-advisory-committee or by contacting the Designated Federal Officer (see FOR FURTHER INFORMATION CONTACT ). In light of the fact that no change has been made to the committee name or description of duties, no amendment will be made to 21 CFR 14.100.

This notice is issued under the Federal Advisory Committee Act (5 U.S.C. App.). For general information related to FDA advisory committees, please visit us at http://www.fda.gov/AdvisoryCommittees/default.htm.

I. Background

The United States is a party to the 1971 Convention on Psychotropic Substances (Psychotropic Convention). Article 2 of the Psychotropic Convention provides that if a party to the convention or WHO has information about a substance, which in its opinion may require international control or change in such control, it shall so notify the Secretary-General of the United Nations (U.N. Secretary-General) and provide the U.N. Secretary-General with information in support of its opinion.

Section 201(d)(2)(A) of the CSA (21 U.S.C. 811(d)(2)(A)) (Title II of the Comprehensive Drug Abuse Prevention and Control Act of 1970) provides that when WHO notifies the United States under Article 2 of the Psychotropic Convention that it has information that may justify adding a drug or other substances to one of the schedules of the Psychotropic Convention, transferring a drug or substance from one schedule to another, or deleting it from the schedules, the Secretary of State must transmit the notice to the Secretary of Health and Human Services (Secretary of HHS). The Secretary of HHS must then publish the notice in the Federal Register and provide opportunity for interested persons to submit comments that will be considered by HHS in its preparation of the scientific and medical evaluations of the drug or substance.

The Secretary of HHS received the following notice from WHO (nonrelevant text removed):

ADB-BUTINACA is a synthetic cannabinoid that has been sold online and is used to mimic the biological effects of tetrahydrocannabinol, the main psychoactive constituent in marijuana. Research and clinical reports have demonstrated that synthetic cannabinoids are applied onto plant material so that the material may be smoked as users attempt to obtain a euphoric and psychoactive “high.” Synthetic cannabinoids have been marketed under the guise of “herbal incense,” and promoted by drug traffickers as legal alternatives to marijuana. According to the National Forensic Laboratory Information System (NFLIS-Drug) database, 1 ADB-BUTINACA was first reported in 2020, and there were 4,358 reports in 2021. There are toxicology reports identifying ADB-BUTINACA in at least six deaths and eight non-fatal emergency room visits. There are no commercial or approved medical uses for ADB-BUTINACA. As a positional isomer of AB-PINACA, ADB-BUTINACA is controlled in schedule I of the CSA.

Adinazolam is a designer benzodiazepine ( i.e., a structural or functional analog of other drugs in the benzodiazepine class) and is expected to have central nervous system (CNS) depressant-like effects similar to that of other known benzodiazepines. Adinazolam was first reported to NFLIS-Drug in 2019, and there were 87 reports in 2021. Adinazolam has appeared in toxicology reports in the United States. Adinazolam is not currently controlled in the United States.

Bromazolam is a designer benzodiazepine and is expected to have CNS depressant-like effects similar to that of other known benzodiazepines. Bromazolam was first reported to NFLIS-Drug in 2016, and there were 743 reports in 2021. Bromazolam has appeared in at least two overdose death reports in the United States and adverse effects associated with the use of bromazolam have been reported. Bromazolam is not currently controlled in the United States.

Protonitazene (propoxynitazene), etazene (etodesnitazene), and etonitazepyne ( N -pyrrolidino etonitazene) are novel synthetic opioid receptor agonists of the benzimidazole structural class. Law enforcement data indicates that these substances have appeared on the U.S. illicit markets as evidenced by their identification in forensic drug seizures and biological samples. Etazene was first reported to NFLIS-Drug in 2020, and there were 41 reports in 2021. Protonitazene and etonitazepyne were both first reported to NFLIS-Drug in 2021 with 20 and 129 reports in that year, respectively. The abuse of these benzimidazole opioids are similar to other synthetic opioids. Protonitazene, etazene, and etonitazepyne have been identified in toxicology and several post-mortem cases. The public health risks attendant to the abuse of mu-opioid receptor agonists are well established. These risks included large numbers of drug treatment admissions, emergency department visits, and fatal overdoses. On April 12, 2022, the U.S. Drug Enforcement Administration issued a temporary order to control these substances as schedule I substances under the CSA.

2-Methyl-AP-237 is a novel synthetic mu-opioid receptor agonist. It was first reported to NFLIS-Drug in 2019, and there were 45 reports in 2021. Abuse of 2-methyl-AP-237 is similar to other synthetic opioids, and has been associated with adverse health effects, including death. In the United States, there are at least 10 confirmed reports of fatal poisonings and several reports of emergency room visits, and non-fatal poisonings associated with 2-methyl-AP-237. 2-Methyl-AP-237 is not currently controlled in the United States. There are no commercial or approved medical uses of 2-methyl-AP-237.

Alpha-PiHP is a synthetic stimulant designer drug structurally similar to other schedule I synthetic cathinones. Alpha-PiHP is a monoamine transporter (dopamine transporter and norepinephrine transporter) uptake inhibitor. Adverse effects associated with synthetic cathinones abuse include agitation, hypertension, tachycardia, and death. Alpha-PiHP was first reported to NFLIS-Drug in 2017, and there were 332 reports in 2021. Alpha-PiHP has been confirmed to have played a role in fatal and non-fatal overdose events in the United States. Alpha-PiHP has no approved medical uses in the United States. As a positional isomer of alpha-PHP, alpha-PiHP is controlled in schedule I of the CSA.

3-Methylmethcathinone (3-MMC) is a designer drug of the phenethylamine class, which is structurally and pharmacologically similar to amphetamine, 3,4-methylenedioxymethamphetamine, cathinone and other related substances. 3-MMC is a monoamine transporter (dopamine transporter, serotonin transporter, and norepinephrine transporter) uptake inhibitor. Like other schedule I synthetic cathinones, 3-MMC is abused for its psychoactive effects. Adverse effects associated with synthetic cathinones abuse include agitation, hypertension, tachycardia, and death. 3-MMC was first reported to NFLIS-Drug in 2012, and there were three reports in 2021. 3-MMC has no approved medical uses in the United States. As a positional isomer of mephedrone, 3-MMC is controlled in schedule I of the CSA.

Zopiclone is a nervous system depressant drug used in the treatment of insomnia. Its mechanism of action is based on modulating benzodiazepine receptors. Zopiclone is approved for medical use in the United States as (S)-zopiclone (or eszopiclone), the active (S) isomer of zopiclone. Zopiclone has abuse potential and may be misused due to its ability to produce euphoric effects at high doses. Amnesia and hallucinations have been reported with higher doses. Zopiclone is controlled in schedule IV of the CSA.

As required by section 201(d)(2)(A) of the CSA, FDA, on behalf of HHS, invites interested persons to submit comments regarding the 10 drug substances. Any comments received will be considered by HHS when it prepares a scientific and medical evaluation for drug substances that is responsive to the WHO Questionnaire for these drug substances. HHS will forward such evaluation of these drug substances to WHO, for WHO's consideration in deciding whether to recommend international control/decontrol of any of these drug substances. Such control could limit, among other things, the manufacture and distribution (import/export) of these drug substances and could impose certain recordkeeping requirements on them.

Although FDA is, through this notice, requesting comments from interested persons, which will be considered by HHS when it prepares an evaluation of these drug substances, HHS will not now make any recommendations to WHO regarding whether any of these drugs should be subjected to international controls. Instead, HHS will defer such consideration until WHO has made official recommendations to the Commission on Narcotic Drugs, which are expected to be made in late 2022. Any HHS position regarding international control of these drug substances will be preceded by another Federal Register notice soliciting public comments, as required by section 201(d)(2)(B) of the CSA.

FDA is announcing the availability of a draft guidance for industry entitled “Electronic Submission of Expedited Safety Reports from IND-Exempt BA/BE Studies.” This guidance provides instructions for the electronic submission of expedited ICSRs from IND-exempt BA/BE studies through the FAERS database. An ICSR captures information necessary to support the reporting of an adverse event related to an individual subject that is associated with the use of an FDA-regulated product. 1 The electronic submission of the ICSRs from IND-exempt BA/BE studies is a voluntary option.

In the Federal Register of September 29, 2010 (75 FR 59935), FDA published a final rule that revised the IND safety reporting requirements for human drug and biological products under 21 CFR 312 and added safety reporting requirements for persons conducting IND-exempt BA/BE studies under 21 CFR 320.31. 2 A serious adverse event experienced by a study subject during the conduct of an IND-exempt BA/BE study must be submitted on Form FDA 3500A or in an electronic format that FDA can process, review, and archive. 3

Previously, to meet the requirements under § 320.31(d)(3) applicable to IND-exempt BA/BE studies, submitters sent expedited premarket safety reports directly to the Office of Generic Drugs (OGD) by email, telephone, or facsimile. This guidance provides recommendations on how to electronically submit ICSRs to the FAERS database as an alternate avenue for submitting reports to OGD once these enhancements are activated.

This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on “Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.

While this guidance contains no collection of information, it does refer to previously approved FDA collections of information. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not required for this guidance. The previously approved collections of information are subject to review by OMB under the PRA. The collections of information in 21 CFR part 312 for IND applications and 21 CFR 320.31 for IND-exempt BA/BE safety reporting requirements for human drug and biological products have been approved under OMB control number 0910-0014. The collections of information in 21 CFR 314 for safety report submissions for applications for FDA approval new drug application have been approved under OMB control number 0910-0001.

Persons with access to the internet may obtain the draft guidance at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs , https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov .

Agenda: The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. The committee will discuss new drug application (NDA) 216660, for sodium phenylbutyrate/taurursodiol (AMX0035) powder for oral suspension, submitted by Amylyx Pharmaceuticals Inc., for the treatment of amyotrophic lateral sclerosis.

FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available on FDA's website at the time of the advisory committee meeting. Background material and the link to the online teleconference meeting room will be available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting link. The meeting will include slide presentations with audio components to allow the presentation of materials in a manner that most closely resembles an in-person advisory committee meeting.

Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. All electronic and written submissions submitted to the Docket (see ADDRESSES ) on or before August 23, 2022, will be provided to the committee. Oral presentations from the public will be scheduled between approximately 3:15 p.m. and 4:15 p.m. Eastern Time. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before August 15, 2022. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by August 16, 2022.

For press inquiries, please contact the Office of Media Affairs at fdaoma@fda.hhs.gov or 301-796-4540.

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

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

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

The Program provides a system of no-fault compensation for certain individuals who have been injured by specified childhood vaccines. Subtitle 2 of Title XXI of the PHS Act, 42 U.S.C. 300aa-10 et seq., provides that those seeking compensation are to file a petition with the United States Court of Federal Claims and to serve a copy of the petition to the Secretary of HHS, who is named as the respondent in each proceeding. The Secretary has delegated this responsibility under the Program to HRSA. The Court is directed by statute to appoint special masters who take evidence, conduct hearings as appropriate, and make initial decisions as to eligibility for, and amount of, compensation.

A petition may be filed with respect to injuries, disabilities, illnesses, conditions, and deaths resulting from vaccines described in the Vaccine Injury Table (the Table) set forth at 42 CFR 100.3. This Table lists for each covered childhood vaccine the conditions that may lead to compensation and, for each condition, the time period for occurrence of the first symptom or manifestation of onset or of significant aggravation after vaccine administration. Compensation may also be awarded for conditions not listed in the Table and for conditions that are manifested outside the time periods specified in the Table, but only if the petitioner shows that the condition was caused by one of the listed vaccines.

Section 2112(b)(2) of the PHS Act, 42 U.S.C. 300aa-12(b)(2), requires that “[w]ithin 30 days after the Secretary receives service of any petition filed under section 2111 the Secretary shall publish notice of such petition in the Federal Register .” Set forth below is a list of petitions received by HRSA on June 1, 2022, through June 30, 2022. This list provides the name of petitioner, city and state of vaccination (if unknown then city and state of person or attorney filing claim), and case number. In cases where the Court has redacted the name of a petitioner and/or the case number, the list reflects such redaction.

Section 2112(b)(2) also provides that the special master “shall afford all interested persons an opportunity to submit relevant, written information” relating to the following:

1. The existence of evidence “that there is not a preponderance of the evidence that the illness, disability, injury, condition, or death described in the petition is due to factors unrelated to the administration of the vaccine described in the petition,” and

2. Any allegation in a petition that the petitioner either:

a. “[S]ustained, or had significantly aggravated, any illness, disability, injury, or condition not set forth in the Vaccine Injury Table but which was caused by” one of the vaccines referred to in the Table, or

b. “[S]ustained, or had significantly aggravated, any illness, disability, injury, or condition set forth in the Vaccine Injury Table the first symptom or manifestation of the onset or significant aggravation of which did not occur within the time period set forth in the Table but which was caused by a vaccine” referred to in the Table.

In accordance with Section 2112(b)(2), all interested persons may submit written information relevant to the issues described above in the case of the petitions listed below. Any person choosing to do so should file an original and three (3) copies of the information with the Clerk of the United States Court of Federal Claims at the address listed above (under the heading “For Further Information Contact”), with a copy to HRSA addressed to Director, Division of Injury Compensation Programs, Health Systems Bureau, 5600 Fishers Lane, 08N146B, Rockville, Maryland 20857. The Court's caption (Petitioner's Name v. Secretary of HHS) and the docket number assigned to the petition should be used as the caption for the written submission. Chapter 35 of title 44, United States Code, related to paperwork reduction, does not apply to information required for purposes of carrying out the Program.