The meetings are available to the public through the web link above. If joining only via phone, callers can expect to incur charges for calls they initiate over wireless lines, and the Commission will not refund any incurred charges. Individuals who are deaf, deafblind and hard of hearing may also follow the proceedings by first calling the Federal Relay Service at 1-800-877-8339 and providing the Service with conference details found through registering at the web link above. To request other accommodations, please email mtrachtenberg@usccr.gov at least 7 days prior to each meeting for which accommodations are requested.

Members of the public are entitled to make comments during the open period at the end of each meeting. Members of the public may also submit written comments; the comments must be received in the Regional Programs Unit within 30 days following the meetings. Written comments may be emailed to Mallory Trachtenberg at mtrachtenberg@usccr.gov. Persons who desire additional information may contact the Regional Programs Unit at (202) 809-9618. Records and documents discussed during the meeting will be available for public viewing as they become available at www.facadatabase.gov. Persons interested in the work of this advisory committee are advised to go to the Commission's website, www.usccr.gov, or to contact the Regional Programs Unit at the above phone number or email address.

Agenda: Mondays: December 13, 2021; January 10, 2022; February 14, 2022; at 3:30 p.m. (CT).

In July 2006, Congress amended the Voting Rights Act of 1965, now codified at title 52, United States Code (U.S.C.), 10301 et seq. (See Pub. L. 109-246, 120 Stat. 577 (2006)). Among other changes, the sunset date for minority language assistance provisions set forth in section 203 of the Act was extended to August 5, 2032.

Section 203 mandates that a state or political subdivision must provide language assistance to voters if more than five (5) percent of voting-age citizens are members of a single-language minority group and do not “speak or understand English adequately enough to participate in the electoral process,” and if the rate of those citizens who have not completed the fifth grade is higher than the national rate of voting-age citizens who have not completed the fifth grade. When a state is covered for a particular language minority group, an exception is made for any political subdivision in which less than five (5) percent of the voting-age citizens are members of the minority group and are limited in English proficiency, unless the political subdivision is covered independently. A political subdivision is also covered if more than 10,000 of the voting-age citizens are members of a single-language minority group, do not “speak or understand English adequately enough to participate in the electoral process,” and the rate of those citizens who have not completed the fifth grade is higher than the national rate of voting-age citizens who have not completed the fifth grade.

Finally, if more than five (5) percent of the American Indian or Alaska Native voting-age citizens residing within an American Indian Area, as defined for the purposes of the decennial census, are members of a single language minority group, do not “speak or understand English adequately enough to participate in the electoral process,” and the rate of those citizens who have not completed the fifth grade is higher than the national rate of voting-age citizens who have not completed the fifth grade, any political subdivision, such as a county, which contains all or any part of that American Indian Area, is covered by the minority language assistance provision set forth in Section 203. For the 2020 Census, American Indian areas and Alaska Native Regional Corporations were identified by the federally recognized tribal governments, Bureau of Indian Affairs, and state governments. The Census Bureau worked with American Indians and Alaska Natives to identify statistical areas, such as Oklahoma Tribal Statistical Areas (OTSA), Tribal Designated Statistical Areas (TDSA), State Designated Tribal Statistical Areas (SDTSA), and Alaska Native Village Statistical Areas (ANVSA).

Pursuant to Section 203, the Census Bureau Director has the responsibility to determine which states and political subdivisions are subject to the minority language assistance provisions of Section 203. The Section 203 determinations are generated using data from the American Community Survey, or comparable census data, as directed by the Act. To find more detailed information, please see the documentation on the 2021 tab of the Section 203 Language Determinations internet site at https://www.census.gov/programs-surveys/decennial-census/about/voting-rights/voting-rights-determination-file.html. The state and political subdivisions obligated to comply with the requirements are listed in this Notice.

Section 203 also provides that the “determinations of the Director of the Census under this subsection shall be effective upon publication in the Federal Register and shall not be subject to review in any court.” Therefore, as of this date, those jurisdictions that are listed as covered by Section 203 have a legal obligation to provide the minority language assistance prescribed in Section 203 of the Act. In the cases where a state is covered, those counties or county equivalents not displayed in the attachment are exempt from the obligation. Those jurisdictions subject to Section 203 of the Act previously, but not included on the list in this Notice, are no longer obligated to comply with Section 203.

Ron S. Jarmin, Acting Director, Census Bureau, approved the publication of this Notice in the Federal Register .

On November 26, 2021, the Department of Commerce (Commerce) inadvertently published duplicate copies of the final results of the 2019-2020 antidumping duty administrative review of large residential washers from Mexico. 1 The first version of this notice (86 FR 67444) incorrectly listed the applicable date of this notice, which is listed correctly as the publication date ( i.e., November 26, 2021) in the second version of this notice (86 FR 67446). The inadvertent duplicate publication of this notice does not constitute redetermination of this proceeding. This notice serves as a notification of, and correction to, this inadvertent duplicate publication.

Commerce regulations provide that it will publish in the Federal Register a list of scope rulings on a quarterly basis. 1 Our most recent notification of scope rulings was published on August 25, 2021. 2 This current notice covers all scope rulings and anti-circumvention determinations made by Enforcement and Compliance between July 1, 2021 and September 30, 2021.

Requestor: AYM Syntex Ltd. Flat bulk continuous filament (BCF) yarn produced from polybutylene terephthalate (PBT) is outside the scope of the antidumping duty (AD) and countervailing duty (CVD) orders on polyester textured yarn from India based on the plain language of the scope, which states that subject merchandise consists of “synthetic multifilament yarn” that is manufactured from polyester (polyethylene terephthalate); September 15, 2021.

Requestor: Midwest Diversified Technologies, Inc. Fifteen self-drilling anchor bolt systems couplers are not covered by the scope of the AD and CVD orders on forged steel fittings from China because they are not designed to connect pipes and cannot convey fluid at high pressure; July 1, 2021.

Requestor: Rimco, Inc. (Rimco). Rimco's passenger vehicle wheel model number X45477 is outside the scope of the AD and CVD orders because it is physically distinguishable from subject steel wheels based on: (1) A different hub bore size; (2) a different offset measurement; and (3) a lower load rating; July 9, 2021.

Requestor: SMA Surfaces, Inc. SMA Surfaces' crushed glass products are covered by the scope of the AD and CVD orders on quartz surface products from China because they do not meet the language of the crushed glass scope exclusion; July 15, 2021.

Requestor: Trinity Distribution Inc. (Trinity). Based on our analysis of Trinity's Request, and in accordance with 19 CFR 351.225(d) and 351.225(k)(1), we determined that Trinity's individually quick frozen (IQF) garlic cloves from China are within the scope of the AD order; July 21, 2021.

Requestor: Fastenal Company Purchasing (Fastenal). Fastenal's zinc and nylon masonry anchors, which consist of a zinc, steel, or nylon body component and a steel pin component, are outside the scope of the AD order. Consistent with the U.S. Court of Appeals for the Federal Circuit's reasoning in OMG, Inc. v. United States, we find that Fastenal's masonry anchors are unitary articles of commerce, and that they are not nails because they require pre-drilled holes for installation. This is a revision, based on litigation, to our previous scope ruling. See Certain Steel Nails from the People's Republic of China: Notice of Court Decision Not in Harmony With Final Scope Ruling and Notice of Amended Final Scope Ruling Pursuant to Court Decision, 86 FR 38675 (July 22, 2021).

Requestor: Midwest Fastener Corp. (Midwest). Midwest's strike pin anchors, which consist of four components—a steel pin, a threaded body, a nut, and a flat washer—are outside the scope of the AD order. Consistent with the U.S. Court of Appeals for the Federal Circuit's reasoning in OMG, Inc. v. United States, we find that Midwest's anchors are unitary articles of commerce, and that they are not nails because they require pre-drilled holes for installation. This is a revision, based on litigation, to our previous scope ruling. See Certain Steel Nails from the People's Republic of China: Notice of Court Decision Not in Harmony With Final Scope Ruling and Notice of Amended Final Scope Ruling Pursuant to Court Decision, 86 FR 38979 (July 23, 2021).

Requestor: Trinity Distribution Inc. (Trinity). In accordance with 19 CFR 351.225(d) and 351.225(k)(1), we determined that Trinity's individually quick frozen (IQF) 1/8 -inch diced garlic and IQF garlic puree, are not within the scope of the AD order; July 22, 2021.

Requestor: D&F Consolidated, Inc., DBA Car-Mel Products Inc. Three label tapes are covered by the scope of the AD and CVD orders on narrow woven ribbon with woven selvedge from China because they meet the physical specifications outlined by the scope and do not qualify for an exclusion; July 27, 2021.

Requestor: Simpson Strong-Tie Company (Simpson). Simpson's split-drive masonry anchors are outside the scope of the AD order. Consistent with the U.S. Court of Appeals for the Federal Circuit's reasoning in OMG, Inc. v. United States, we find that Simpson's masonry anchors are not nails because the anchors require pre-drilled holes for installation. This is a revision, based on litigation, to our previous scope ruling. See Certain Steel Nails from the People's Republic of China: Notice of Court Decision Not in Harmony With Final Scope Ruling and Notice of Amended Final Scope Ruling Pursuant to Court Decision, 86 FR 43994 (August 11, 2021).

Requestor: Simpson Strong-Tie Company (Simpson). Simpson's crimp drive anchors are outside the scope of the AD order. Consistent with the U.S. Court of Appeals for the Federal Circuit's reasoning in OMG, Inc. v. United States, we find that Simpson's masonry anchors are not nails because the anchors require pre-drilled holes for installation. This is a revision, based on litigation, to our previous scope ruling. See Certain Steel Nails from the People's Republic of China: Notice of Court Decision Not in Harmony With Final Scope Ruling and Notice of Amended Final Scope Ruling Pursuant to Court Decision, 86 FR 43993 (August 11, 2021).

Requestor: Sunbeam Products Inc. Stamped circular disc blanks are not covered by the scope of the AD and CVD orders on common alloy aluminum sheet from China because stamped circular disc blanks are stamped or punched from aluminum sheet in China, are in non-rectangular shapes and are no longer in coils or cut-to-length sheets when exported from China, and the punching of these stamped circular disc blanks has the functional purpose of preparing the discs to be pressed into circular vessels such as pots and pans; August 20, 2021.

Requestor: Maryland Mosaics, LLC. Decorative ceramic tile mosaic pieces in heart, star, circle, and petal shapes are covered by the scope of the AD and CVD orders on ceramic tile from China because they are tiles made from porcelain and fall within the tile sizes covered by the scope; August 31, 2021.

Requestor: Greenbrier International, Inc. and Family Dollar Services, LLC. Craft dowels are covered by the scope of the AD and CVD orders on wood mouldings and millwork products from China because they are dowels made of wood and continuously shaped; September 7, 2021.

Interested parties are invited to comment on the completeness of this list of completed scope inquiries and anti-circumvention determinations made during the period July 1, 2021 through September 30, 2021. Any comments should be submitted to the Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations, Enforcement and Compliance, International Trade Administration, via email to CommerceCLU@trade.gov.

This notice is published in accordance with 19 CFR 351.225(o).

On June 8, 2021, Commerce published the preliminary results of the 2019-2020 administrative review of the antidumping duty order on circular welded carbon steel pipes and tubes from Thailand. 1 The review covers 29 producers and/or exporters of subject merchandise. We invited interested parties to comment on the Preliminary Results. A full description of the events since the Preliminary Results is contained in the Issues and Decision Memorandum. 2 Commerce conducted this review in accordance with section 751(a) of the Tariff Act of 1930, as amended (the Act).

The products covered by the antidumping duty Order are circular welded carbon steel pipes and tubes. A full description of the scope of the Order is contained in the Issues and Decision Memorandum.

All issues raised in the case and rebuttal briefs are listed in the appendix to this notice and addressed in the Issues and Decision Memorandum. The Issues and Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at https://access.trade.gov. In addition, a complete version of the Issues and Decision Memorandum can be accessed directly at https://access.trade.gov/public/FRNoticesListLayout.aspx.

We preliminarily found that Blue Pipe Steel Center (Blue Pipe) and K Line Logistics (Thailand) Ltd. (K-Line) each had no shipments of subject merchandise during the POR. 4 Based on the comments received, we continue to find that Blue Pipe had no shipments. 5 Moreover, no party commented on the Preliminary Results regarding the no-shipments decision with respect to K-Line. Therefore, for these final results, we continue to find that each of these companies had no shipments of subject merchandise during the POR and will issue appropriate instructions to U.S. Customs and Border Protection (CBP) based on these final results.

Based on a review of the record and comments received from interested parties regarding our Preliminary Results, and for the reasons explained in the Issues and Decision Memorandum, we made revisions to our calculations in the Preliminary Results of the weighted-average dumping margin for the mandatory respondent, Saha Thai Steel Pipe Public Co., Ltd., also known as Saha Thai Steel Pipe (Public) Co., Ltd. (collectively, Saha Thai), and the weighted-average dumping margin assigned to the non-examined companies.

In the Preliminary Results, we determined the weighted-average dumping margin for Saha Thai that is not zero, de minimis or based entirely on facts available. For the other mandatory respondent, Blue Pipe, we determined that Blue Pipe had no shipments during the POR and accordingly we did not determine a weighted-average dumping margin for Blue Pipe for these final results. Following the guidelines for calculating the “all-others” rate in a less-than-fair-value investigation, we accordingly determined that the weighted-average dumping margin for each of the companies not selected for individual examination to be equal to the weighted-average dumping margin calculated for Saha Thai.

Commerce determines that the following weighted-average dumping margins exist for the period March 1, 2019, through February 29, 2020:

Commerce intends to disclose the calculations performed for these final results within five days of the date of publication of this notice, in accordance with 19 CFR 351.224(b).

Pursuant to section 751(a)(2)(A) of the Act and 19 CFR 351.212(b), Commerce shall determine, and CBP shall assess, antidumping duties on all appropriate entries of subject merchandise in accordance with the final results of this review. Commerce intends to issue assessment instructions to CBP no earlier than 35 days after the date of publication of the final results of this review in the Federal Register . If a timely summons is filed at the U.S. Court of International Trade, the assessment instructions will direct CBP not to liquidate relevant entries until the time for parties to file a request for a statutory injunction has expired ( i.e., within 90 days of publication).

For Saha Thai, we calculated importer-specific antidumping duty assessment rates on the basis of the ratio of the total amount of dumping calculated for each importer's examined sales and the total entered value of those sales in accordance with 19 CFR 351.212(b)(1). If an importer-specific assessment rate is zero or de minimis, then we will instruct CBP to liquidate the entries for that importer without regard to antidumping duties.

For entries of subject merchandise during the POR produced by Saha Thai for which it did not know its merchandise was destined for the United States, and for Blue Pipe and K-Line, the two companies which we find had no shipments during the POR, we will instruct CBP to liquidate unreviewed entries at the all-others rate if there is no rate for the intermediate company(ies) involved in the transaction.

The assessment rate for antidumping duties for each of the companies not selected for individual examination, will be equal to the weighted-average dumping margin listed above in the final results of review.

The following cash deposit requirements will be effective upon publication of the final results of these reviews for shipments of the subject merchandise from China entered, or withdrawn from warehouse, for consumption on or after the publication date, as provided by section 751(a)(2)(C) of the Act: (1) The cash deposit rate for the companies listed above in the final results of review will be equal to the company-specific weighted-average dumping margin established in the final results of this review; (2) for previously reviewed or investigated companies not listed above in the “Final Results of Administrative Review,” above, including companies for which Commerce may determine to have had no shipments during the POR, the cash deposit rate will continue to be the company-specific rate published for the most recently completed segment of this proceeding; (3) if the exporter is not a firm covered in this review or another completed segment of this proceeding, but the producer is, then the cash deposit rate will be the rate established for the most recently completed segment of this proceeding for the producer of the merchandise; and (4) if neither the exporter nor the producer is a firm covered in this or any previously completed segment of this proceeding, then the cash deposit rate will be the all-others rate of 15.67 percent established in the less-than-fair-value investigation. 6

These deposit requirements, when imposed, shall remain in effect until further notice.

This notice serves as a final reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this POR. Failure to comply with this requirement could result in Commerce's presumption that reimbursement of the antidumping duties occurred and the subsequent assessment of doubled antidumping duties.

This notice also serves as a reminder to parties subject to administrative protective order (APO) of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305. Timely written notification of the return or destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a violation subject to sanction.

Commerce is issuing and publishing this notice in accordance with sections 751(a)(1) and 777(i)(1) of the Act and 19 CFR 351.221(b)(5).

The subject permit is requested under the authority of the Marine Mammal Protection Act of 1972, as amended (MMPA; 16 U.S.C. 1361 et seq. ) and the regulations governing the taking of marine mammals (50 CFR part 216).

The applicant proposes to film humpback whales off the coast of Maui, Hawaii to obtain footage for a television series. Up to 1,120 humpback whales may be harassed during filming from vessels, an unmanned aircraft system, and underwater divers. The permit would expire April 30, 2022.

It has come to the agency's attention that the 2016 interim final humpback approach rule (50 CFR 216.19; 81 FR 62010, September 8, 2016) does not explicitly exempt permits issued under section 104(c)(6) of the MMPA from its prohibitions. It is not the agency's intent to preclude the issuance of permits or authorizations consistent with the requirements of the MMPA. We interpret the rule to allow issuance of these permits. Consistent with this interpretation, it has been our practice to continue to issue section 104(c)(6) permits that are in compliance with the Act's requirements and our review procedures, as evidenced by issuance of four such permits since the rule's effective date. However, to eliminate any potential ambiguity, we intend to revise the rule to explicitly clarify that photography permits issued under section 104(c)(6) of the MMPA are exempt from the prohibitions on approach.

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

Concurrent with the publication of this notice in the Federal Register , NMFS is forwarding copies of the application to the Marine Mammal Commission and its Committee of Scientific Advisors.

Sections 101(a)(5)(A) and (D) of the MMPA (16 U.S.C. 1361 et seq. ) direct the Secretary of Commerce to allow, upon request, the incidental, but not intentional, taking of small numbers of marine mammals by U.S. citizens who engage in a specified activity (other than commercial fishing) within a specified geographical region if certain findings are made and either regulations are issued or, if the taking is limited to harassment, a notice of a proposed authorization is provided to the public for review.

An authorization for incidental takings shall be granted if NMFS finds that the taking will have a negligible impact on the species or stock(s), will not have an unmitigable adverse impact on the availability of the species or stock(s) for subsistence uses (where relevant), and if the permissible methods of taking and requirements pertaining to the mitigation, monitoring and reporting of such takings are set forth. NMFS has defined “negligible impact” in 50 CFR 216.103 as an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival.

Except with respect to certain activities not pertinent here, the MMPA defines “harassment” as: Any act of pursuit, torment, or annoyance which (i) has the potential to injure a marine mammal or marine mammal stock in the wild (Level A harassment); or (ii) has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering (Level B harassment).

On January 19, 2021, we issued a final rule with regulations to govern the unintentional taking of marine mammals incidental to geophysical survey activities conducted by oil and gas industry operators, and those persons authorized to conduct activities on their behalf (collectively “industry operators”), in Federal waters of the U.S. Gulf of Mexico (GOM) over the course of 5 years (86 FR 5322; January 19, 2021). The rule was based on our findings that the total taking from the specified activities over the 5-year period will have a negligible impact on the affected species or stock(s) of marine mammals and will not have an unmitigable adverse impact on the availability of those species or stocks for subsistence uses. The rule became effective on April 19, 2021.

Our regulations at 50 CFR 217.180 et seq. allow for the issuance of LOAs to industry operators for the incidental take of marine mammals during geophysical survey activities and prescribe the permissible methods of taking and other means of effecting the least practicable adverse impact on marine mammal species or stocks and their habitat (often referred to as mitigation), as well as requirements pertaining to the monitoring and reporting of such taking. Under 50 CFR 217.186(e), issuance of an LOA shall be based on a determination that the level of taking will be consistent with the findings made for the total taking allowable under these regulations and a determination that the amount of take authorized under the LOA is of no more than small numbers.

Shell plans to conduct two separate geophysical surveys, and submitted an LOA request for each survey. The first survey is a 3D ocean bottom node (OBN) survey of Mississippi Canyon Lease Block 809 and portions of the surrounding approximately 143 lease blocks in the Ursa development area (Ursa survey). The second survey would also be a 3D OBN survey, and would cover Mississippi Canyon Lease Block 890 and Atwater Canyon and portions of the surrounding approximately 36 lease blocks (Europa survey). See Section F of the respective LOA applications for maps of these areas.

For both surveys, Shell anticipates using an airgun array consisting of 32 elements, with a total volume of 5,110 cubic inches (in 3 ). Please see Shell's applications for additional detail.

Consistent with the preamble to the final rule, the survey effort proposed by Shell in its LOA requests was used to develop LOA-specific take estimates based on the acoustic exposure modeling results described in the preamble (86 FR 5322, 5398; January 19, 2021). In order to generate the appropriate take number for authorization, the following information was considered: (1) Survey type; (2) location (by modeling zone  1 ); (3) number of days; and (4) season. 2 The acoustic exposure modeling performed in support of the rule provides 24-hour exposure estimates for each species, specific to each modeled survey type in each zone and season.

No 3D OBN surveys were included in the modeled survey types, and use of existing proxies ( i.e., 2D, 3D NAZ, 3D WAZ, Coil) is generally conservative for use in evaluation of 3D OBN survey effort, largely due to the greater area covered by the modeled proxies. Summary descriptions of these modeled survey geometries are available in the preamble to the proposed rule (83 FR 29212, 29220; June 22, 2018). Coil was selected as the best available proxy survey type for both surveys in this case, because the spatial coverage of the planned surveys is most similar to the coil survey pattern. The planned 3D OBN surveys will each involve a single source vessel sailing along closely spaced survey lines that are 100 m apart and approximately 30 km in length. The path taken by the vessel to cover these lines will mean that consecutive survey lines sailed will be 400 m apart. The coil survey pattern was assumed to cover approximately 144 kilometers squared (km 2 ) per day (compared with approximately 795 km 2 , 199 km 2 , and 845 km 2 per day for the 2D, 3D NAZ, and 3D WAZ survey patterns, respectively). Among the different parameters of the modeled survey patterns ( e.g., area covered, line spacing, number of sources, shot interval, total simulated pulses), NMFS considers area covered per day to be most influential on daily modeled exposures exceeding Level B harassment criteria. Although Shell is not proposing specifically to perform surveys using the coil geometry, its planned 3D OBN surveys are expected to cover approximately 15.7 km 2 per day, meaning that the coil proxy is most representative of the effort planned by Shell in terms of predicted Level B harassment exposures.

In addition, all available acoustic exposure modeling results assume use of a 72-element, 8,000 in 3 array. Thus, estimated take numbers for this LOA are considered conservative due to differences in both the airgun array (32 elements, 5,110 in 3 ) and the daily survey area planned by Shell (15.7 km 2 ), as compared to those modeled for the rule.

The Ursa survey will take place over 61 days, including 45 days of sound source operation. The Europa survey will take place over 122 days, including 20 days of sound source operation. Both surveys will occur within Zone 5. For both surveys, the seasonal distribution of survey days is not known in advance. Therefore, the take estimates for each species are based on the season that produces the greater value.

Additionally, for some species, take estimates based solely on the modeling yielded results that are not realistically likely to occur when considered in light of other relevant information available during the rulemaking process regarding marine mammal occurrence in the GOM. Thus, although the modeling conducted for the rule is a natural starting point for estimating take, our rule acknowledged that other information could be considered (see, e.g., 86 FR 5322, 5442 (January 19, 2021), discussing the need to provide flexibility and make efficient use of previous public and agency review of other information and identifying that additional public review is not necessary unless the model or inputs used differ substantively from those that were previously reviewed by NMFS and the public). For this survey, NMFS has other relevant information reviewed during the rulemaking that indicates use of the acoustic exposure modeling to generate a take estimate for certain marine mammal species produces results inconsistent with what is known regarding their occurrence in the GOM. Accordingly, we have adjusted the calculated take estimates for those species as described below.

Rice's whales (formerly known as GOM Bryde's whales)  3 are generally found within a small area in the northeastern GOM in waters between 100-400 m depth along the continental shelf break (Rosel et al., 2016). Whaling records suggest that Rice's whales historically had a broader distribution within similar habitat parameters throughout the GOM (Reeves et al., 2011; Rosel and Wilcox, 2014), and a NOAA survey reported observation of a Rice's whale in the western GOM in 2017 (NMFS, 2018). Habitat-based density modeling identified similar habitat ( i.e., approximately 100-400 m water depths along the continental shelf break) as being potential Rice's whale habitat (Roberts et al., 2016), although a “core habitat area” defined in the northeastern GOM (outside the scope of the rule) contained approximately 92 percent of the predicted abundance of Rice's whales. See discussion provided at, e.g., 83 FR 29212, 29228, 29280 (June 22, 2018); 86 FR 5322, 5418 (January 19, 2021).

Although it is possible that Rice's whales may occur outside of their core habitat, NMFS expects that any such occurrence would be limited to the narrow band of suitable habitat described above ( i.e., 100-400 m). Shell's planned activities will occur in water depths of approximately 600-1,800 m and 800-1,400 (Ursa and Europa, respectively) in the central GOM. Thus, NMFS does not expect there to be the reasonable potential for take of Rice's whale in association with this survey and, accordingly, does not authorize take of Rice's whale through this LOA.

Killer whales are the most rarely encountered species in the GOM, typically in deep waters of the central GOM (Roberts et al., 2015; Maze-Foley and Mullin, 2006). The approach used in the acoustic exposure modeling, in which seven modeling zones were defined over the U.S. GOM, necessarily averages fine-scale information about marine mammal distribution over the large area of each modeling zone. NMFS has determined that the approach results in unrealistic projections regarding the likelihood of encountering killer whales.

As discussed in the final rule, the density models produced by Roberts et al. (2016) provide the best available scientific information regarding predicted density patterns of cetaceans in the U.S. GOM. The predictions represent the output of models derived from multi-year observations and associated environmental parameters that incorporate corrections for detection bias. However, in the case of killer whales, the model is informed by few data, as indicated by the coefficient of variation associated with the abundance predicted by the model (0.41, the second-highest of any GOM species model; Roberts et al., 2016). The model's authors noted the expected non-uniform distribution of this rarely-encountered species (as discussed above) and expressed that, due to the limited data available to inform the model, it “should be viewed cautiously” (Roberts et al., 2015).

NOAA surveys in the GOM from 1992-2009 reported only 16 sightings of killer whales, with an additional three encounters during more recent survey effort from 2017-18 (Waring et al., 2013; www.boem.gov/gommapps ). Two other species were also observed on less than 20 occasions during the 1992-2009 NOAA surveys (Fraser's dolphin and false killer whale  4 ). However, observational data collected by protected species observers (PSOs) on industry geophysical survey vessels from 2002-2015 distinguish the killer whale in terms of rarity. During this period, killer whales were encountered on only 10 occasions, whereas the next most rarely encountered species (Fraser's dolphin) was recorded on 69 occasions (Barkaszi and Kelly, 2019). The false killer whale and pygmy killer whale were the next most rarely encountered species, with 110 records each. The killer whale was the species with the lowest detection frequency during each period over which PSO data were synthesized (2002-2008 and 2009-2015). This information qualitatively informed our rulemaking process, as discussed at 86 FR 5322, 5334 (January 19, 2021), and similarly informs our analysis here.

The rarity of encounter during seismic surveys is not likely to be the product of high bias on the probability of detection. Unlike certain cryptic species with high detection bias, such as Kogia spp. or beaked whales, or deep-diving species with high availability bias, such as beaked whales or sperm whales, killer whales are typically available for detection when present and are easily observed. Roberts et al. (2015) stated that availability is not a major factor affecting detectability of killer whales from shipboard surveys, as they are not a particularly long-diving species. Baird et al. (2005) reported that mean dive durations for 41 fish-eating killer whales for dives greater than or equal to 1 minute in duration was 2.3-2.4 minutes, and Hooker et al. (2012) reported that killer whales spent 78 percent of their time at depths between 0-10 m. Similarly, Kvadsheim et al. (2012) reported data from a study of four killer whales, noting that the whales performed 20 times as many dives to 1- 30 m depth than to deeper waters, with an average depth during those most common dives of approximately 3 m.

In summary, killer whales are the most rarely encountered species in the GOM and typically occur only in particularly deep water. While this information is reflected through the density model informing the acoustic exposure modeling results, there is relatively high uncertainty associated with the model for this species, and the acoustic exposure modeling applies mean distribution data over areas where the species is in fact less likely to occur. NMFS' determination in reflection of the data discussed above, which informed the final rule, is that use of the generic acoustic exposure modeling results for killer whales would result in high estimated take numbers that are inconsistent with the assumptions made in the rule regarding expected killer whale take (86 FR 5322, 5403; January 19, 2021).

In past authorizations, NMFS has often addressed situations involving the low likelihood of encountering a rare species such as killer whales in the GOM through authorization of take of a single group of average size ( i.e., representing a single potential encounter). See 83 FR 63268, December 7, 2018. See also 86 FR 29090, May 28, 2021; 85 FR 55645, September 9, 2020. For the reasons expressed above, NMFS determined that a single encounter of killer whales is more likely than the model-generated estimates and has authorized take associated with a single killer whale group encounter ( i.e., up to 7 animals) for the Ursa LOA.

For the Europa LOA, use of the exposure modeling produces an estimate of 7 killer whale exposures. Given the foregoing, it is unlikely that even one killer whale would be encountered during this 20-day survey, and accordingly no take of killer whales is authorized through the Europa LOA.

Based on the results of our analysis, NMFS has determined that the level of taking authorized through the LOAs is consistent with the findings made for the total taking allowable under the regulations. See Tables 1 and 2 in this notice and Table 9 of the rule (86 FR 5322; January 19, 2021).

Under the GOM rule, NMFS may not authorize incidental take of marine mammals in an LOA if it will exceed “small numbers.” In short, when an acceptable estimate of the individual marine mammals taken is available, if the estimated number of individual animals taken is up to, but not greater than, one-third of the best available abundance estimate, NMFS will determine that the numbers of marine mammals taken of a species or stock are small. For more information please see NMFS' discussion of the MMPA's small numbers requirement provided in the final rule (86 FR 5322, 5438; January 19, 2021).

The take numbers for authorization are determined as described above in the Summary of Request and Analysis section. Subsequently, the total incidents of harassment for each species are multiplied by scalar ratios to produce a derived product that better reflects the number of individuals likely to be taken within a survey (as compared to the total number of instances of take), accounting for the likelihood that some individual marine mammals may be taken on more than one day (see 86 FR 5322, 5404; January 19, 2021). The output of this scaling, where appropriate, is incorporated into an adjusted total take estimate that is the basis for NMFS' small numbers determinations, as depicted in Table 1 for Shell's Ursa survey and in Table 2 for the Europa survey.

This product is used by NMFS in making the necessary small numbers determinations, through comparison with the best available abundance estimates (see discussion at 86 FR 5322, 5391; January 19, 2021). For this comparison, NMFS' approach is to use the maximum theoretical population, determined through review of current stock assessment reports (SAR; www.fisheries.noaa.gov/national/marine-mammal-protection/marine-mammal-stock-assessments ) and model-predicted abundance information ( https://seamap.env.duke.edu/models/Duke/GOM/ ). For the latter, for taxa where a density surface model could be produced, we use the maximum mean seasonal ( i.e., 3-month) abundance prediction for purposes of comparison as a precautionary smoothing of month-to-month fluctuations and in consideration of a corresponding lack of data in the literature regarding seasonal distribution of marine mammals in the GOM. Information supporting the small numbers determinations is provided in Tables 1 and 2.

Based on the analysis contained herein of Shell's proposed survey activity described in its LOA applications and the anticipated take of marine mammals, NMFS finds that small numbers of marine mammals will be taken relative to the affected species or stock sizes and therefore is of no more than small numbers.

NMFS has determined that the level of taking for these LOA requests is consistent with the findings made for the total taking allowable under the incidental take regulations and that the amount of take authorized under the LOAs is of no more than small numbers. Accordingly, we have issued two LOAs to Shell authorizing the take of marine mammals incidental to its geophysical survey activity, as described above.

The primary purpose of the online meeting is to prepare and develop recommendations for the 2022 International Pacific Halibut Commission's (IPHC) annual meeting held online from January 24 through January 28, 2022. Recommendations generated from the 2A managers meeting will be communicated to the IPHC by the Pacific Council's representatives. Attendees may also address other topics relating to Pacific halibut management.

Although non-emergency issues not contained in the meeting agenda may be discussed, those issues may not be the subject of formal action during this meeting. Action will be restricted to those issues specifically listed in this document and any issues arising after publication of this document that require emergency action under section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the intent to take final action to address the emergency.

Requests for sign language interpretation or other auxiliary aids should be directed to Mr. Kris Kleinschmidt ( kris.kleinschmidt@noaa.gov; (503) 820-2412) at least 10 days prior to the meeting date.

Authority: 16 U.S.C. 1801 et seq.

The MMPA requires NMFS to authorize the incidental take of ESA-listed marine mammals in commercial fisheries provided it can make the following determinations: (1) The incidental mortality and serious injury (M/SI) from commercial fisheries will have a negligible impact on the affected species or stocks; (2) a recovery plan for all affected species or stocks of threatened or endangered marine mammals has been developed or is being developed; and (3) where required under MMPA section 118, a take reduction plan has been developed or is being developed, a monitoring program is implemented, and vessels participating in the fishery are registered. NMFS has determined that the WA/OR/CA sablefish pot fishery meets these three requirements and is issuing a permit to the fishery to authorize the incidental take of ESA-listed marine mammal species or stocks under the MMPA for a period of 3 years.

The MMPA LOF classifies each commercial fishery as a Category I, II, or III fishery based on the level of mortality and injury of marine mammals occurring incidental to each fishery as defined in 50 CFR 229.2. Category I and II fisheries must register with NMFS and are subsequently authorized to incidentally take marine mammals during commercial fishing operations. However, that authorization is limited to those marine mammals that are not listed as threatened or endangered under the ESA. Section 101(a)(5)(E) of the MMPA, 16 U.S.C. 1371, states that NMFS, as delegated by the Secretary of Commerce, for a period of up to three years shall allow the incidental, but not intentional, taking of marine mammal stocks designated as depleted because of their listing as an endangered species or threatened species under the ESA, 16 U.S.C. 1531 et seq., by persons using vessels of the United States and those vessels which have valid fishing permits issued by the Secretary in accordance with section 204(b) of the Magnuson-Stevens Fishery Conservation and Management Act, 16 U.S.C. 1824(b), while engaging in commercial fishing operations, if NMFS makes certain determinations. NMFS must determine, after notice and opportunity for public comment, that: (1) Incidental M/SI from commercial fisheries will have a negligible impact on the affected species or stock; (2) a recovery plan has been developed or is being developed for such species or stock under the ESA; and (3) where required under section 118 of the MMPA, a monitoring program has been established, vessels engaged in such fisheries are registered in accordance with section 118 of the MMPA, and a take reduction plan has been developed or is being developed for such species or stock.

The LOF includes a list of marine mammal species or stocks incidentally killed or injured in each commercial fishery. The WA/OR/CA sablefish pot fishery is classified as a Category II fishery on the final 2021 LOF (86 FR 3028; January 14, 2021) based on occasional incidental M/SI of the CA/OR/WA stock of humpback whales. We evaluated ESA-listed stocks or species included on the 2021 MMPA LOF as killed or seriously injured following NMFS' Procedural Directive 02-238 “Process for Distinguishing Serious from Non-Serious Injury of Marine Mammals.” Based on this evaluation, NMFS proposed to issue a permit under MMPA section 101(a)(5)(E) to vessels registered in the Category II WA/OR/CA sablefish pot fishery, as classified on the final 2021 MMPA LOF, to incidentally kill or seriously injure the CA/OR/WA stock of humpback whale (86 FR 58641; October 22, 2021).

NMFS will regularly evaluate other commercial fisheries for purposes of making a negligible impact determination (NID) and issuing MMPA section 101(a)(5)(E) authorizations with the annual LOF as new information becomes available. More information about the WA/OR/CA sablefish pot fishery is available in the 2021 MMPA LOF (86 FR 3028; January 14, 2021) and on the internet at: https://www.fisheries.noaa.gov/national/marine-mammal-protection/list-fisheries-summary-tables.

We reviewed the best available scientific information to determine if the WA/OR/CA sablefish pot fishery met the three requirements of MMPA section 101(a)(5)(E) for issuing a permit for the incidental taking of ESA-listed marine mammals. This information is included in the 2021 MMPA LOF (86 FR 3028; January 14, 2021), the SAR for CA/OR/WA stock of humpback whale (available at: https://www.fisheries.noaa.gov/national/marine-mammal-protection/marine-mammal-stock-assessment-reports ), the humpback whale recovery plan (available at: https://www.fisheries.noaa.gov/national/endangered-species-conservation/recovery-species-under-endangered-species-act ), and other relevant information, as detailed further in the document describing the preliminary and final determinations supporting the permit (available at: https://www.regulations.gov/docket/NOAA-NMFS-2021-0092 ).

NMFS is in the process of revising humpback whale stock structure under the MMPA in light of the 14 Distinct Population Segments (DPSs) established under the ESA (81 FR 62259, September 8, 2016), based on the recently finalized “Procedural Directive 02-204-03: Reviewing and Designating Stocks and Issuing Stock Assessment Reports under the Marine Mammal Protection Act” (NMFS 2019). The DPSs that occur in waters under the jurisdiction of the United States do not align with the existing MMPA stocks. Some of the listed DPSs partially coincide with the currently defined stocks. Because we cannot manage one portion of an MMPA stock as ESA-listed and another portion of a stock as not ESA-listed, until such time as the MMPA stock designations are revised in light of the ESA DPSs, NMFS continues to use the existing MMPA stock structure for MMPA management purposes ( e.g., selection of a recovery factor, stock status) and treats such stocks as ESA-listed if a component of that stock is listed under the ESA and overlaps with the analyzed commercial fishery. Therefore, for the purpose of this MMPA 101(a)(5)(E) authorization, NMFS considered the CA/OR/WA stock of humpback whale to be ESA-listed as it overlaps with two ESA-listed DPSs (Mexico and Central America).

Prior to issuing a MMPA 101(a)(5)(E) permit to take ESA-listed marine mammals incidental to commercial fishing, NMFS must determine that the M/SI incidental to commercial fisheries will have a negligible impact on the affected marine mammal species or stocks. NMFS satisfies this requirement by making a NID. Although the MMPA does not define “negligible impact,” NMFS has issued regulations providing a qualitative definition of “negligible impact,” defined in 50 CFR 216.103 as “an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to adversely affect the species or stock through effects on annual rates of recruitment or survival.”

NMFS relies on a quantitative approach for determining negligible impact detailed in NMFS Procedural Directive 02-204-02 (directive), “Criteria for Determining Negligible Impact under MMPA section 101(a)(5)(E),” which became effective on June 17, 2020 (NMFS 2020). The procedural directive is available online at: https://www.fisheries.noaa.gov/national/laws-and-policies/protected-resources-policy-directives. This directive describes NMFS' process for determining whether incidental M/SI from commercial fisheries will have a negligible impact on ESA-listed marine mammal species/stocks (the first requirement necessary for issuing a MMPA section 101(a)(5)(E) permit as noted above).

The directive first describes the derivation of two Negligible Impact Thresholds (NIT), which represent levels of removal from a marine mammal species or stock. The first, Total Negligible Impact Threshold (NIT t ), represents the total amount of human-caused M/SI that NMFS considers negligible for a given stock. The second, lower threshold, Single NIT (NIT s ) represents the level of M/SI from a single commercial fishery that NMFS considers negligible for a stock. NIT s was developed in recognition that some stocks may experience non-negligible levels of total human-caused M/SI but one or more individual fisheries may contribute a very small portion of that M/SI, and the effect of an individual fishery may be considered negligible.

The directive describes a detailed process for using these NIT values to conduct a NID analysis for each fishery classified as a Category I or II fishery on the MMPA LOF. The NID process uses a two-tiered analysis. The Tier 1 analysis first compares the total human-caused M/SI for a particular stock to NIT t . If NIT t is not exceeded, then all commercial fisheries that kill or seriously injure the stock are determined to have a negligible impact on the particular stock. If NIT t is exceeded, then the Tier 2 analysis compares each individual fishery's M/SI for a particular stock to NIT s . If NIT s is not exceeded, then the commercial fishery is determined to have a negligible impact on that particular stock. For transboundary, migratory stocks, because of the uncertainty regarding the M/SI that occurs outside of U.S. waters, we assume that total M/SI exceeds NIT t and proceed directly to the Tier 2 NIT s analysis. If a commercial fishery has a negligible impact across all ESA-listed stocks, then the first of three findings necessary for issuing a MMPA 101(a)(5)(E) permit to the commercial fishery has been met ( i.e., a negligible impact determination). If a commercial fishery has a non-negligible impact on any ESA-listed stock, then NMFS cannot issue a MMPA 101(a)(5)(E) permit for the fishery to incidentally take ESA-listed marine mammals.

These NID criteria rely on the best available scientific information, including estimates of a stock's minimum population size and human-caused M/SI levels, as published in the most recent SARs and other supporting documents, as appropriate. Using these inputs, the quantitative negligible impact thresholds allow for straightforward calculations that lead to clear negligible or non-negligible impact determinations for each commercial fishery analyzed. In rare cases, robust data may be unavailable for a straightforward calculation, and the directive provides instructions for completing alternative calculations or assessments where appropriate.

NMFS evaluated the impact of the WA/OR/CA sablefish pot fishery using the process outlined in the directive, and, based on the best available scientific information, made a NID.

The CA/OR/WA stock of humpback whale is a transboundary stock. As noted above, because of the uncertainty regarding M/SI that occurs outside of U.S. waters for transboundary stocks, we assumed that total M/SI exceeds NIT t and proceeded directly to the Tier 2 NIT s analysis. The proposed NID relied on the final 2019 CA/OR/WA humpback whale SAR. Since the publication of the proposed MMPA 101(a)(5)(E) permit for the WA/OR/CA sablefish pot fishery, the draft 2021 SAR for the CA/OR/WA stock of humpback whales was published (86 FR 58887; October 25, 2021). The M/SI estimates in the draft 2021 CA/OR/WA humpback whale SAR for the WA/OR/CA sablefish pot fishery remain the same as the M/SI estimates in the final 2019 SAR and the draft 2021 SAR was used for the final NID analysis (see response to comment #7 below).

The CA/OR/WA stock of humpback whale has documented incidental M/SI with this fishery in the most recent (2021) draft CA/OR/WA humpback whale SAR (Carretta et al. 2021). The estimated annual M/SI of humpback whales (CA/OR/WA stock) in the WA/OR/CA sablefish pot fishery is 1.9, based on observer data. Since this M/SI (1.9) is less than NIT s (2.48), NMFS determined that the WA/OR/CA sablefish pot fishery has a negligible impact on the CA/OR/WA stock of humpback whales (see accompanying MMPA 101(a)(5)(E) determination document linked above for NIT calculations).

The draft 2021 SAR includes mean annual total commercial fishery-related M/SI (≥25.2) for the CA/OR/WA stock of humpback whale. This comprises M/SI from all commercial fisheries, including the WA/OR/CA sablefish pot fishery, as well as fishery-related M/SI for the stock not assigned to a specific commercial fishery. This unattributed fishery-related M/SI could be from any number of commercial, recreational or tribal fisheries, including the WA/OR/CA sablefish pot fishery. Because data are not currently available to assign the unattributed fishery-related M/SI to a specific commercial fishery, we did not include unattributed mortality in the calculations for the NID Tier 2 analysis. In addition, because the CA/OR/WA humpback whale stock is considered to be a transboundary stock, NMFS assumed NIT t is exceeded and conducted the more conservative Tier 2 analysis with the lower NIT s criterion. NMFS is actively monitoring the WA/OR/CA sablefish pot fishery through a fishery observer program. Further, most of the information on large whale entanglements on the West Coast is reported to and documented by the West Coast Large Whale Entanglement Response Program. If additional fishery-related M/SI of the CA/OR/WA stock of humpback whale is documented through the observer program or West Coast Large Whale Entanglement Response Program that indicates additional M/SI of the CA/OR/WA stock of humpback whale in the WA/OR/CA sablefish pot fishery, then NMFS will re-evaluate the NID and the permit.

The NID analysis is presented in the accompanying MMPA 101(a)(5)(E) determination document that provides summaries of the information used to evaluate each ESA-listed stock documented on the 2021 MMPA LOF as killed or injured incidental to the fishery. The final MMPA 101(a)(5)(E) determination document is available at: https://www.fisheries.noaa.gov/action/negligible-impact-determination-and-mmpa-section-101a5e-authorization-wa-or-ca-sablefish-pot or https://www.regulations.gov/docket/NOAA-NMFS-2021-0092. Based on the criteria outlined in the directive, the most recent SAR, and the best available scientific information, NMFS has determined that the M/SI incidental to the Category II WA/OR/CA sablefish pot fishery will have a negligible impact on the associated ESA-listed marine mammal stock (CA/OR/WA stock of humpback whale). Accordingly, this MMPA 101(a)(5)(E) requirement is satisfied for the commercial fishery.

The humpback whale recovery plan has been completed (see https://www.fisheries.noaa.gov/national/endangered-species-conservation/recovery-species-under-endangered-species-act ). Accordingly, the requirement to have a recovery plan in place or being developed is satisfied.

Subject to available funding, MMPA section 118 requires the development and implementation of a Take Reduction Plan (TRP) for each strategic stock that interacts with a Category I or II fishery. The stock considered for this permit is designated as a strategic stock under the MMPA because the stock, or a component of the stock, is listed as threatened or endangered under the ESA (MMPA section 3(19)(C)).

The short- and long-term goals of a TRP are to reduce M/SI of marine mammals incidental to commercial fishing to levels below the Potential Biological Removal (PBR) level for stocks and to an insignificant threshold, defined by NMFS as 10 percent of PBR, respectively. The obligations to develop and implement a TRP are subject to the availability of funding. MMPA section 118(f)(3) (16 U.S.C. 1387(f)(3)) contains specific priorities for developing TRPs when funding is insufficient. NMFS has insufficient funding available to simultaneously develop and implement TRPs for all strategic stocks that interact with Category I or Category II fisheries. As provided in MMPA section 118(f)(6)(A) and (f)(7), NMFS uses the most recent SAR and LOF as the basis to determine its priorities for establishing Take Reduction Teams (TRT) and developing TRPs. Information about NMFS' marine mammal TRTs and TRPs may be found at: https://www.fisheries.noaa.gov/national/marine-mammal-protection/marine-mammal-take-reduction-plans-and-teams.

Based on NMFS' priorities, implementation of a TRP for the WA/OR/CA sablefish pot fishery is currently deferred under MMPA section 118 as other stocks/fisheries are a higher priority for any available funding. Accordingly, the requirement under MMPA section 118 to have TRPs in place or in development is satisfied (see determination supporting the permit available on the internet at https://www.fisheries.noaa.gov/action/negligible-impact-determination-and-mmpa-section-101a5e-authorization-wa-or-ca-sablefish-pot or https://www.regulations.gov/docket/NOAA-NMFS-2021-0092 ).

Under MMPA section 118(d), NMFS is to establish a program for monitoring incidental M/SI of marine mammals from commercial fishing operations. The WA/OR/CA sablefish pot fishery is the subject of a NMFS fishery observer program. Accordingly, the requirement under MMPA section 118 to have a monitoring program in place is satisfied.

MMPA section 118(c) requires that vessels participating in Category I and II fisheries register to obtain an authorization to take marine mammals incidental to fishing activities. NMFS has integrated the MMPA registration process, implemented through the Marine Mammal Authorization Program, with existing state and Federal fishery license, registration, or permit systems for Category I and II fisheries on the LOF. Therefore, the requirement for vessel registration is satisfied.

Based on the above evaluation for the WA/OR/CA sablefish pot fishery as it relates to the three requirements of MMPA 101(a)(5)(E), we are issuing a MMPA 101(a)(5)(E) permit to the WA/OR/CA sablefish pot fishery to authorize the incidental take of ESA-listed species or stocks during commercial fishing operations. If, during the 3-year authorization, there is a significant change in the information or conditions used to support the determinations, NMFS will re-evaluate whether to amend or modify the authorization, after notice and opportunity for public comment.

ESA section 7(a)(2) requires Federal agencies to ensure that actions they authorize, fund, or carry out do not jeopardize the existence of any species listed under the ESA, or destroy or adversely modify designated critical habitat of any ESA-listed species. The effects of the WA/OR/CA sablefish pot fishery on ESA-listed marine mammals were analyzed in an October 2020 ESA section 7 Biological Opinion.

Under section 7 of the ESA, Biological Opinions analyze the effects of the proposed action on ESA-listed species and their critical habitat and, where appropriate, exempt anticipated future take of ESA-listed species as specified in the incidental take statement. Under MMPA section 101(a)(5)(E), NMFS analyzes previously documented M/SI incidental to commercial fisheries through the negligible impact determination process, and when the necessary findings can be made, issues a MMPA section 101(a)(5)(E) permit that allows for an unspecified amount of incidental taking of specific ESA-listed marine mammal stocks while engaging in commercial fishing operations. Thus, the applicable standards and resulting analyses under the MMPA and ESA differ, and as such, may not always align.

The National Environmental Policy Act (NEPA) requires Federal agencies to evaluate the impacts of alternatives for their actions on the human environment. Because this permit would not modify any fishery operation and the effects of the fishery operations have been evaluated in accordance with NEPA, no additional NEPA analysis beyond that conducted for the associated Fishery Management Plans is required for the permit. Issuing the permit would have no additional impact on the human environment or effects on threatened or endangered species beyond those analyzed in these documents.

On October 22, 2021, NMFS published a notice and request for comments in the Federal Register for the proposed issuance of permit under MMPA section 101(a)(5)(E) to vessels registered in the Category II WA/OR/CA sablefish pot fishery (86 FR 58641). The public comment period closed on November 8, 2021. NMFS received seven comment letters on the proposed issuance of the permit and underlying preliminary negligible impact determination. The Center for Biological Diversity (CBD) and a joint letter from Whale and Dolphin Conservation and Natural Resources Defense Council (WDC/NRDC) oppose issuing the permit while Langford Walton & Associates, Sablefish and Halibut Pot Association, and a member of the public support issuing the permit. In addition, the Fishing Vessels Owner's Association supports issuing the permit and commented on several ways the ESA section 7 Biological Opinion supported the determinations in the proposed MMPA 101(a)(5)(E) permit. NMFS also received a joint letter from Whale and Dolphin Conservation, Defenders of Wildlife and Natural Resources Defense Council (WDC et al.) requesting NMFS extend the public comment period for the proposed permit. Only responses to substantive comments pertaining to the proposed permit and preliminary determination under MMPA section 101(a)(5)(E) are addressed below.

Comment 1: WDC et al. requested NMFS extend the comment period by 15-days for the proposed issuance of a MMPA 101(a)(5)(E) permit to authorize the incidental take of the CA/OR/WA stock of humpback whales in the WA/OR/CA sablefish pot fishery.

Response: NMFS did not grant an extension to the comment period, as the information presented in the proposed determination was not new but rather is based on the M/SI data from the most recent final humpback whale stock assessment report, published in 2020. On June 17, 2020, NMFS finalized Procedure 02-204-02 (Criteria for Determining Negligible Impact under MMPA section 101(a)(5)(E)). The procedural directive describes NMFS' process for determining whether incidental M/SI from commercial fisheries will have a negligible impact on ESA-listed marine mammal species/stocks. The criteria and process from that procedural directive, including the calculation for developing a negligible impact threshold, was used in order to determine that the WA/OR/CA sablefish pot fishery has a negligible impact on the CA/OR/WA stock of humpback whales. The NID determination and proposed MMPA 101(a)(5)(E) permit was based on the best available science on the stock's minimum population estimate, recovery factor, and the most recent estimates of M/SI in the WA/OR/CA sablefish pot fishery.

Comment 2: CBD incorporates their previous comments submitted on both the NMFS' draft “Criteria for Determining Negligible Impact under MMPA Section 101(a)(5)(E)” and the proposed MMPA 101(a)(5)(E) authorizations published on October 5, 2020 (85 FR 62709).

Response: CBD's comments on the draft “Criteria for Determining Negligible Impact under MMPA Section 101(a)(5)(E)” were previously addressed by NMFS and are available at: https://www.fisheries.noaa.gov/action/criteria-determining-negligible-impact-under-mmpa-section-101a5e. Comments on the proposed MMPA 101(a)(5)(E) authorizations published on October 5, 2020 (85 FR 62709) were addressed in the Federal Register notice for the final MMPA 101(a)(5)(E) authorizations (86 FR 24384; May 6, 2021).

Comment 3: CBD asserts that because NMFS has not revised the CA/OR/WA humpback whale stock structure following the designation of 14 DPS under the ESA the assumptions of the negligible impact thresholds do not hold true. CBD raises two issues with applying NIT t and NIT s to the CA/OR/WA stock of humpback whale: (1) The CA//OR/WA stock is not ESA-listed, and (2) the stock does not conform to the assumptions of PBR. CBD states that NMFS cannot assume that M/SI levels are below NIT t and NIT s for the WA/OR/CA stock will not prevent recovery of the ESA-listed DPSs, especially the Central America DPS. They further note that the CA/OR/WA stock of humpback whale abundance estimate is based on mark-recapture models for closed populations, ignoring the designation of the ESA DPSs. CBD points to NMFS' “Criteria for Determining Negligible Impact under MMPA Section 101(a)(5)(E) guidance” and recommends a NID analysis be conducted for an ESA-listed stock that does not conform to the underlying assumptions of PBR and consider if there is an alternate approach to determining negligible impact. They request NMFS use an alternate approach, revise the draft NID, and make it available for public comment.

Response: Humpback whales were listed globally as endangered under the ESA in 1970 (35 FR 18319). On September 8, 2016, NMFS published a final rule dividing the globally listed endangered humpback whale into 14 DPSs and categorizing four DPSs as endangered and one as threatened (81 FR 62259). NMFS is in the process of revising humpback whale stock structure under the MMPA in light of the 2016 final rule on humpback whale DPSs as established under the ESA. In doing so, NMFS is following the process laid out in “Procedural Directive 02-204-03: Reviewing and Designating Stocks and Issuing Stock Assessment Reports under the Marine Mammal Protection Act” (NMFS 2019). As noted by the commenters, the CA/OR/WA stock of humpback whales does not align with the DPSs established under the ESA and comprises animals from the endangered Central American DPS, the threatened Mexico DPS, and the unlisted Hawaii DPS.

Because we cannot manage one portion of an MMPA stock as ESA-listed and another portion of a stock as not ESA-listed, until humpback whale stock structure has been revised, NMFS continues to use the existing MMPA stock structure for MMPA management purposes, including NIDs and 101(a)(5)(E) authorizations. Therefore, for purposes of evaluating the impact of the WA/OR/CA sablefish pot fishery under the MMPA, NMFS used the current MMPA designation of the CA/OR/WA stock of humpback whales. In the case of the CA/OR/WA stock of humpback whales, for the purposes of this NID analysis, NMFS considers the entire stock to be endangered under the ESA and depleted under the MMPA. In addition, because the CA/OR/WA humpback whale stock is considered to be transboundary, NMFS assumed NIT t is exceeded and conducted the more conservative Tier 2 analysis with the lower NIT s criterion.

Given this approach and ongoing efforts to revise humpback whale stock structure in the Pacific, NMFS has proceeded with a final NID for the WA/OR/CA sablefish pot gear fishery with respect to the CA/OR/WA stock of humpback whales and is issuing a 101(a)(5)(E) permit for this fishery. Nevertheless, if, during the 3-year authorization, there is a significant change in the information or conditions used to support any of these determinations, including a change in MMPA stock structure and associated estimates of abundance and M/SI incidental to commercial fisheries, NMFS will re-evaluate the NID.

Comment 4: Both CBD and WDC/NRDC note that the humpback whale recovery plan included in the proposed permit is for the world-wide population that was finalized in 1991. They state that NMFS identified 14 DPSs of humpback whales in 2016, and updated recovery plans have not been developed for the 14 DPSs. Therefore, the 1991 humpback whale recovery plan does not meet the requirement of MMPA section 101(a)(5)(E).

Response: Given that the 1991 NMFS Recovery Plan for humpback whales was written for the taxonomic species, it is still applicable to humpback whale DPSs within the species and still serves as a guide for recovery actions for the currently listed DPSs that occur in U.S. waters. As noted in the final rule designating humpback whale critical habitat (86 FR 21082, April 21, 2021), some of the objectives of the 1991 Recovery Plan are still relevant today for the Mexico and Central America, and Western North Pacific DPSs. Furthermore, NMFS is working to develop updated humpback DPS recovery plans as resources allow. However, the 1991 Recovery Plan satisfies the recovery plan need for the purposes of MMPA 101(a)(5)(E), while new recovery plans are developed.

Comment 5: CBD states that NMFS has not established a program to monitor incidental marine mammal M/SI in the WA/OR/CA sablefish pot fishery. They note that the observer program that observes a portion of this fishery was not established to monitor marine mammal M/SI but to monitor groundfish catch composition. Therefore, the monitoring program does not meet the requirements of MMPA section 118(d).

Response: The observer program in the sablefish pot fishery collects data on all target and non-target species, including the incidental M/SI of marine mammals. Data from the observer program is used by NMFS scientists to generate statistically valid estimates of entanglements and mortality/serious injury that are represented in the most recent SAR for the CA/OR/WA stock of humpback whales. As such, it satisfies the requirement in MMPA section 101(a)(5)(E)(i)(III). Given that estimates of entanglements produced from observer data are used in the NID analysis, it is incorrect to state the NID analysis relies only upon confirmed entanglement reports.

Comment 6: CBD states that NMFS is not developing and has not developed a TRP for humpback whales in the WA/OR/CA sablefish pot fishery, noting NMFS' response that developing a TRP for the WA/OR/CA sablefish pot trap fishery and other similar Category II fisheries has been deferred under MMPA section 118 as other stocks/fisheries are a higher priority for any available funding for establishing new TRPs. They acknowledge that NMFS updated the list of priorities for establishing TRTs in September 2021, and the CA/WA/OR stock of humpback whale remains a low priority for establishing a TRT. CBD disagrees with NMFS that the NMFS priorities for establishing TRTS meets the MMPA section 101(a)(5)(E) requirement and asserts that MMPA section 101(a)(5)(E) requires a TRP be in place or in development prior to authorizing incidental take of these ESA-listed marine mammals.

Response: As we have noted previously (86 FR 58641; October 22, 2021), MMPA section 118(f)(3) contains specific priorities for developing TRPs if insufficient funding is available to further develop and implement TRPs for all applicable stocks and fisheries. NMFS has insufficient funding available to simultaneously develop and implement TRPs for all strategic stocks that interact with Category I or Category II fisheries. Thus, NMFS prioritizes which stocks and fisheries to address under a TRP. MMPA section 118(f) provides that if there is insufficient funding available to develop and implement a take reduction plan for stocks that interact with Category I and II fisheries, the Secretary shall give highest priority to the development of TRPs for species or stocks whose level of incidental mortality and serious injury exceeds PBR, that have a small population size, and those that are declining most rapidly. As noted in the Federal Register notice announcing NMFS's proposed intent to issue a 101(a)(5)(e) permit for the WA/OR/CA sablefish pot fishery, the CA/OR/WA stock of humpback whale authorized to be incidentally taken under this permit is currently a lower priority for developing a TRP because of the low levels of M/SI incidental to commercial fishing compared to other marine mammal stocks and commercial fisheries.

Comment 7: WDC/NRDC comments that the proposed permit is based on the 2019 CA/OR/WA humpback whale SAR and the 2019 SAR does not include up-to-date data on confirmed entanglements in the WA/OR/CA sablefish pot fishery reported in Carretta et al. 2021a. They also state that NMFS did not include confirmed unattributed humpback whale entanglements in the NID analysis and, by doing so, NMFS has underestimated humpback whale M/SI in the WA/OR/CA sablefish pot fishery.

Response: Since the publication of the proposed MMPA 101(a)(5)(E) permit for the WA/OR/CA sablefish pot fishery, the draft 2021 SAR for the CA/OR/WA stock of humpback whales published and is available for public comment (86 FR 58887; October 25, 2021). The M/SI estimates in the draft 2021 CA/OR/WA humpback whale SAR for the WA/OR/CA sablefish pot fishery remain the same as the M/SI estimates in the final 2019 SAR. The 2014 humpback whale mortality and the 2016 humpback whale serious injuries in the WA/OR/CA sablefish pot fishery reported in Carretta et al. 2021a are included in the M/SI estimates in the 2019 CA/OR/WA humpback whale SAR that was used in the analysis for the proposed permit. Carretta et al. 2021a also includes a non-serious injury of a humpback whale in the WA/OR/CA sablefish pot fishery that occurred in 2017. As noted in Carretta et al. 2021a, this non-serious injury is not counted against PBR and is not included in the M/SI estimates for the fishery. The accompanying MMPA 101(a)(5)(E) determination document has been updated to reflect the draft 2021 CA/OR/WA humpback whale SAR.

As noted above, the CA/OR/WA humpback whale SAR also includes unattributed fishery-related M/SI for the stock, which is not assigned to a specific commercial fishery. This unattributed fishery-related M/SI could be from any number of commercial, recreational or tribal fisheries, including the WA/OR/CA sablefish pot fishery. Because data are not currently available to assign the unattributed fishery-related M/SI to a specific commercial fishery, we did not include it in the calculations for the NID Tier 2 analysis. In addition, because the CA/OR/WA humpback whale stock is considered to be transboundary stock, NMFS assumed NIT t is exceeded and conducted the more conservative Tier 2 analysis with the lower NIT s criterion.

Comment 8: WDC/NRDC notes that the proposed permit uses a different abundance estimate for the CA/OR/WA stock of humpback whale than the abundance estimate in the final 2019 SAR. They state that NMFS has identified the Central America DPS as a demographically independent population (DIP) under the MMPA, and PBR should be calculated for the Central America DIP separately.

Response: See response to Comment #3 and #7 above. The abundance estimates for the CA/OR/WA stock of humpback whales used in the analysis for the proposed permit are consistent with the final 2019 SAR and the recent 2021 draft SAR. As noted in the response to comment #3, NMFS is in the process of revising humpback whale stock structure following the process laid out in NMFS (2019). This process includes evaluating the lines of evidence to support the delineation of DIPs, including whether such evidence supports the delineation of the Central America DPS as a DIP. Martien et al. (2019) does not serve as the DIP delineation document for the Central America DPS. In the analysis supporting issuance of this permit and the NID, NMFS relied on the existing MMPA designation of the CA/OR/WA stock of humpback whales. Nevertheless, if, during the 3-year authorization, there is a significant change in the information or conditions used to support any of these determinations, including a change in MMPA stock structure, NMFS will re-evaluate the permit.

Comment 9: WDC/NRDC reiterate their previous comments submitted on the NMFS' draft “Criteria for Determining Negligible Impact under MMPA Section 101(a)(5)(E).” They restate that the approach to negligible impact determinations undermines the protections for marine mammals protected as threatened or endangered under the ESA, and assessing the impacts of a single fishery when total M/SI exceeds PBR is an inadequate standard. WDC/NRDC requests NMFS consider total human-caused M/SI for the humpback whale DPSs, and if all fisheries-related M/SI exceeds PBR for the Central America or Mexico DPS, that NMFS delay issuing the permit until mitigation measures are implemented.

Response: As previously stated (86 FR 24384; May 6, 2021), NMFS received several comments on the draft “Criteria for Determining Negligible Impact under MMPA Section 101(a)(5)(E)” stating the directive was either overly precautionary or not precautionary enough. These comments were previously addressed in the response to comments (see Comment #4) on the draft “Criteria for Determining Negligible Impact under MMPA Section 101(a)(5)(E).” The full response to comments on the procedural directive is available at: https://www.fisheries.noaa.gov/action/criteria-determining-negligible-impact-under-mmpa-section-101a5e.

As described in the “Criteria for Determining Negligible Impact under MMPA Section 101(a)(5)(E),” due to the uncertainty regarding the M/SI that occurs outside of U.S. waters, we assume that total M/SI exceeds NIT t for transboundary, migratory stocks and proceed directly to the Tier 2 NIT s analysis. The CA/OR/WA stock of humpback whale is considered a transboundary stock and using the “Criteria for Determining Negligible Impact under MMPA Section 101(a)(5)(E)” a Tier 2 NIT s analysis was conducted.

The subject permit is requested under the authority of the Marine Mammal Protection Act of 1972, as amended (MMPA; 16 U.S.C. 1361 et seq. ), and the regulations governing the taking and importing of marine mammals (50 CFR part 216).

The applicant proposes to film humpback whales and dolphins to produce a documentary to celebrate Jean-Michel Cousteau's 75 years of diving and educate the public about the protection, conservation, and management of humpback whales and other cetaceans in Hawaii waters. Filmmakers would annually harass up to 105 humpback whales, 700 bottlenose dolphins, 700 pantropical spotted dolphins, and 700 spinner dolphins for photography/videography (aerial, topside and underwater) using two vessels, divers, and two unmanned aircraft systems. Filming is expected to occur within a two-week period in February or March each year. The permit would be valid for two years.

It has come to the agency's attention that the 2016 interim final humpback approach rule (50 CFR 216.19; 81 FR 62010, September 8, 2016) does not explicitly exempt permits issued under section 104(c)(6) of the MMPA from its prohibitions. It is not the agency's intent to preclude the issuance of permits or authorizations consistent with the requirements of the MMPA. We interpret the rule to allow issuance of these permits. Consistent with this interpretation, it has been our practice to continue to issue section 104(c)(6) permits that are in compliance with the MMPA's requirements and our review procedures, as evidenced by issuance of four such permits since the rule's effective date. However, to eliminate any potential ambiguity, we intend to revise the rule to explicitly clarify that photography permits issued under section 104(c)(6) of the MMPA are exempt from the prohibitions on approach.

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

Concurrent with the publication of this notice in the Federal Register , NMFS is forwarding copies of the application to the Marine Mammal Commission and its Committee of Scientific Advisors.

EPA uses RAMS to store and maintain information related to requests from individuals for reasonable accommodations from the Agency, as necessary to ensure compliance with applicable laws and regulations. Previously, RAMS covered information on requests for accommodation based on disability. EPA is amending the SORN so that in addition to these disability-related requests, the SORN also explicitly covers requests based on an individual's religious belief, practice, or observance. Additionally, EPA is adding coverage for certain specific accommodation requests based on medical conditions that may not qualify as a disability when such accommodations are authorized ( e.g. requests for temporary accommodation for a broken leg, or a delay from the COVID-19 vaccination requirement). EPA is additionally updating the SORN to reflect new requirements in Executive Orders and federal guidance. Accordingly, EPA is updating the following sections of the RAMS SORN: For Further Information Contact; Supplementary Information; System Location; System Manager; Authority; Purpose; Categories of Individuals Covered; Categories of Records; Record Source Categories; Routine Uses; Policies and Practices for Storage of Records; Policies And Practices For Retention And Disposal Of Records; Administrative, Technical, And Physical Safeguards; Record Access Procedure; Contesting Records Procedures, and Notification Procedure.

The updates will allow the Agency to manage all reasonable accommodation request information under the single updated RAMS SORN. EPA will maintain information under the RAMS SORN in two sections—one for medical accommodation request information and one for religious accommodation request information. Medical information is maintained separately from other personnel records.

OMB Control Number: 3060-0076.

Title: Common Carrier Annual Employment Report.

Form Number: FCC Form 395.

Type of Review: Extension of a currently approved collection.

Respondents: Business or other for-profit entities.

Number of Respondents and Responses: 521 respondents; 521 responses.

Estimated Time per Response: 1 hour.

Frequency of Response: Annual reporting requirement and recordkeeping requirement.

Obligation to Respond: Required to obtain or retain benefits. Statutory authority for this information collection is contained in 47 U.S.C. 154(i), 303, and 307-310 of the Communications Act of 1934, as amended.

Total Annual Burden: 521 hours.

Total Annual Cost: No cost.

Privacy Act Impact Assessment: No impact(s).

Nature and Extent of Confidentiality: The respondents are instructed on the appropriate procedures to follow to safeguard information deemed confidential under 47 CFR 0.457 of the Commission's rules, which details the type of records that are not routinely available for public inspection. Section 0.459 of the Commission's rules contains procedures for requesting that material and information submitted to the Commission be withheld from public inspection.

Needs and Uses: FCC Report 395, Common Carrier Annual Employment Report, is a data collection mechanism to implement the FCC's Equal Employment Opportunity (EEO) rules. All common carrier licensees or permittees with sixteen (16) or more full-time employees are required to file the Annual Employment Report. Each common carrier is also obligated to file with this Commission copies of all exhibits, letters, and documents pertaining to all equal employment opportunity statements and annual reports on complaints regarding violations of equal employment provisions of Federal, State, Territorial, or local law. Section 22.321(f), 47 CFR, requires each licensee to maintain these documents for a period of two years. The Annual Employment Report identifies each filer's staff by gender, race, color, and/or national origin in each of ten major job categories. The report and all other EEOC documents are filed with the Commission to detail the applicant's compliance with the Commission's EEO rules. Data from these reports are available online so that users can easily locate data for a particular carrier and/or specific reporting years.

The Board invites comment on a proposal to extend for three years, without revision, the Uniform Application for Municipal Securities Principal or Municipal Securities Representative Associated with a Bank Municipal Securities Dealer and the Uniform Termination Notice for Municipal Securities Principal or Municipal Securities Representative Associated with a Bank Municipal Securities Dealer. 1

On June 15, 1984, OMB delegated to the Board authority under the Paperwork Reduction Act (PRA) to approve and assign OMB control numbers to collections of information conducted or sponsored by the Board. In exercising this delegated authority, the Board is directed to take every reasonable step to solicit comment. In determining whether to approve a collection of information, the Board will consider all comments received from the public and other agencies.

During the comment period for this proposal, a copy of the proposed PRA OMB submission, including the draft reporting form and instructions, supporting statement, and other documentation, will be made available on the Board's public website at https://www.federalreserve.gov/apps/reportforms/review.aspx or may be requested from the agency clearance officer, whose name appears above. Final versions of these documents will be made available at https://www.reginfo.gov/public/do/PRAMain, if approved.

The Board invites public comment on the following information collections, which are being reviewed under authority delegated by the OMB under the PRA. Comments are invited on the following:

a. Whether the proposed collections of information is necessary for the proper performance of the Board's functions, including whether the information has practical utility;

b. The accuracy of the Board's estimate of the burden of the proposed information collections, including the validity of the methodology and assumptions used;

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

d. Ways to minimize the burden of information collections on respondents, including through the use of automated collection techniques or other forms of information technology; and

e. Estimates of capital or startup costs and costs of operation, maintenance, and purchase of services to provide information.

At the end of the comment period, the comments and recommendations received will be analyzed to determine the extent to which the Board should modify the proposal.

Report title: Uniform Application for Municipal Securities Principal or Municipal Securities Representative Associated with a Bank Municipal Securities Dealer.

Agency form number: Form MSD-4.

OMB control number: 7100-0100.

Frequency: Event generated.

Respondents: Each municipal securities dealer (MSD) that is a state member bank (SMB), bank holding company (BHC), or a savings and loan holding company (SLHC), certain subsidiaries of such firms, or a foreign dealer bank. 2

Estimated number of respondents: Reporting, 13; Recordkeeping, 13.

Estimated average hours per response: Reporting, 0.92; Recordkeeping, 0.08.

Estimated annual burden hours: Reporting, 11.96; Recordkeeping, 1.04.

General description of report: The Municipal Securities Rulemaking Board (MSRB) rule G-7, Information Concerning Associated Persons, requires persons who are or seek to be an associated person of an MSD, either as a municipal securities principal (a person performing supervisory functions) or representative (a person engaged in underwriting, trading, or sales of municipal securities or furnishing financial advice to issuers in connection with the issuance of municipal securities) or in any other manner set forth under the rule, to provide certain background information to the MSD. The rule also requires MSDs to obtain and report this information. MSDs for which the Board is the appropriate regulatory agency (ARA) must report to the Board information required by MSRB rule G-7 using Form MSD-4. Generally, the information required by Form MSD-4 relates to employment history and professional background, including any disciplinary sanctions, as well as any claimed basis for exemption from MSRB examination requirements. Certain information reported on Form MSD-4 is filled out by the employee, with the rest completed by the MSD. As required by MSRB rule G-7, bank municipal securities dealers must retain copies of Form MSD-4 for each associated person during the entire term of employment.

Report title: Uniform Termination Notice for Municipal Securities Principal or Municipal Securities Representative Associated with a Bank Municipal Securities Dealer.

Agency form number: Form MSD-5.

OMB control number: 7100-0101.

Frequency: Event generated.

Respondents: Each MSD that is an SMB, BHC, or an SLHC, certain subsidiaries of such firms, or a foreign dealer bank. 3

Estimated number of respondents: Reporting, 21; Recordkeeping, 21.

Estimated average hours per response: Reporting, 0.16; Recordkeeping; 0.08.

Estimated annual burden hours: Reporting, 3.36; Recordkeeping 1.68.

General description of report: An MSD for which the Board is the ARA must file Form MSD-5 with the Board when any employee previously registered as a municipal securities principal or representative is terminated for any reason. Form MSD-5 requires information such as the reason for termination and whether any investigations or actions by agencies or self-regulatory organizations (SROs) involving the associated person occurred during the period of employment.

Any SMB, BHC, or SLHC, as well as certain subsidiaries of such firms, and any foreign dealer bank that is an MSD is required to file Forms MSD-4 and MSD-5 with the Board with respect to its employees. As required by MSRB rule G-7, an MSD must retain both Form MSD-4 and Form MSD-5 for three years from the date of termination of employment.

Legal authorization and confidentiality: The Securities Exchange Act of 1934 (Exchange Act) authorizes the Securities and Exchange Commission (SEC) and MSRB to promulgate rules requiring MSDs to file reports about associated persons with the SEC and ARAs, 4 and the Board is the ARA for most Form MSD-4 and Form MSD-5 respondents. 5 The Exchange Act further authorizes the Board to enforce compliance with the SEC's and MSRB's rules, 6 and make rules and regulations to implement the portions of the Exchange Act for which it is responsible. 7

Several additional statutes also authorize the Board to require submission of the Forms MSD-4 and MSD-5 by specific entities, including the Federal Reserve Act (for SMBs and their affiliates), 8 the International Banking Act (for branches and agencies of foreign banks), 9 the Bank Holding Company Act of 1956 (for BHCs and their subsidiaries), 10 and the Home Owners' Loan Act (for SLHCs and their subsidiaries). 11

Filing of the Forms MSD-4 and MSD-5 is mandatory. Information provided on Forms MSD-4 and MSD-5 may be kept confidential pursuant to exemption 6 of the Freedom of Information Act (FOIA) to the extent disclosure of such information “would constitute a clearly unwarranted invasion of personal privacy.”  12 Information contained on Forms MSD-4 and MSD-5 may also be kept confidential under FOIA exemption 4 if it is confidential commercial or financial information that is both customarily and actually treated as private  13 or under FOIA exemption 8 if it is obtained as part of an examination or supervision of a financial institution. 14

On June 15, 1984, OMB delegated to the Board authority under the Paperwork Reduction Act (PRA) to approve and assign OMB control numbers to collections of information conducted or sponsored by the Board. Board-approved collections of information are incorporated into the official OMB inventory of currently approved collections of information. The OMB inventory, as well as copies of the PRA Submission, supporting statements, and approved collection of information instrument(s) are available at https://www.reginfo.gov/public/do/PRAMain. These documents are also available on the Federal Reserve Board's public website at https://www.federalreserve.gov/apps/reportforms/review.aspx or may be requested from the agency clearance officer, whose name appears above.

Report title: Financial Statements for Holding Companies.

Agency form number: FR Y-9C, FR Y-9LP, FR Y-9SP, FR Y-9ES, and FR Y-9CS.

OMB control number: 7100-0128.

Effective Date: December 31, 2021.

Frequency: Quarterly, semiannually, and annually.

Respondents: Bank holding companies (BHCs), savings and loan holding companies (SLHCs), securities holding companies, and U.S. intermediate holding companies (IHCs) (collectively, holding companies). 1

Estimated number of respondents:

FR Y-9C (non-advanced approaches holding companies with less than $5 billion in total assets): 119; FR Y-9C (non-advanced approaches holding companies with $5 billion or more in total assets): 221; FR Y-9C (advanced approaches holding companies): 9; FR Y-9LP: 412; FR Y-9SP: 3,708; FR Y-9ES: 78; FR Y-9CS: 236.

FR Y-9C: 349; FR Y-9LP: 412; FR Y-9SP: 3,708; FR Y-9ES: 78; FR Y-9CS: 236.

Estimated average hours per response:

FR Y-9C (non-advanced approaches holding companies with less than $5 billion in total assets): 35.74; FR Y-9C (non-advanced approaches holding companies with $5 billion or more in total assets): 44.94; FR Y-9C (advanced approaches holding companies): 50.16; FR Y-9LP: 5.27; FR Y-9SP: 5.45; FR Y-9ES: 0.50; FR Y-9CS: 0.50.

FR Y-9C: 1; FR Y-9LP: 1; FR Y-9SP: 0.50; FR Y-9ES: 0.50; FR Y-9CS: 0.50.

Estimated annual burden hours:

FR Y-9C (non-advanced approaches holding companies with less than $5 billion in total assets): 17,012; FR Y-9C (non-advanced approaches holding companies with $5 billion or more in total assets): 39,727; FR Y-9C (advanced approaches holding companies): 1,806; FR Y-9LP: 8,685; FR Y-9SP: 40,417; FR Y-9ES: 39; FR Y-9CS: 472.

FR Y-9C: 1,396; FR Y-9LP: 1,648; FR Y-9SP: 3,708; FR Y-9ES: 39; FR Y-9CS: 472.

General description of report: The FR Y-9 family of reporting forms continues to be the primary source of financial data on holding companies that examiners rely on in the intervals between on-site inspections. The Board requires holding companies to provide standardized financial statements to fulfill the Board's statutory obligation to supervise these organizations. Financial data from these reporting forms are used to detect emerging financial problems, to review performance and conduct pre-inspection analysis, to monitor and evaluate capital adequacy, to evaluate holding company mergers and acquisitions, and to analyze a holding company's overall financial condition to ensure the safety and soundness of its operations. The FR Y-9C, FR Y-9LP, and FR Y-9SP serve as standardized financial statements for the holding companies. The FR Y-9ES is a financial statement for holding companies that are Employee Stock Ownership Plans. The Board uses the voluntary FR Y-9CS (a free-form supplement) to collect additional information deemed to be critical and needed in an expedited manner. Holding companies file the FR Y-9C on a quarterly basis, the FR Y-9LP quarterly, the FR Y-9SP semiannually, the FR Y-9ES annually, and the FR Y-9CS on a schedule that is determined when this supplement is used.

Legal authorization and confidentiality: The reporting and recordkeeping requirements associated with the Y-9 series of reports are authorized for BHCs pursuant to section 5 of the Bank Holding Company Act (BHC Act);  2 for SLHCs pursuant to section 10(b)(2) and (3) of the Home Owners' Loan Act;  3 for IHCs pursuant to section 5 of the BHC Act, as well as pursuant to sections 102(a)(1) and 165 of the Dodd-Frank Wall Street and Consumer Protection Act (Dodd-Frank Act);  4 and for securities holding companies pursuant to section 618 of the Dodd-Frank Act. 5

Except for the FR Y-9CS report, which is collected on a voluntary basis, the obligation to submit the remaining reports in the FR Y-9 series of reports and to comply with the recordkeeping requirements set forth in the respective instructions to each of the other reports is mandatory.

Certain information collected on the FR Y-9C and FR Y-9SP Reports is kept confidential by the Board. The following items are kept confidential under exemption 4 of the Freedom of Information Act (FOIA) because these data items reflect commercial and financial information that is both customarily and actually treated as private by the respondent:  6

• FR Y-9C, Schedule HI, memoranda item 7(g), “FDIC deposit insurance assessments;”

• FR Y-9C, Schedule HC-P, item 7(a) “Representation and warranty reserves for 1-4 family residential mortgage loans sold to U.S. government agencies and government sponsored agencies;”

• FR Y-9C, Schedule HC-P, item 7(b) “Representation and warranty reserves for 1-4 family residential mortgage loans sold to other parties;”

• FR Y-9C, Schedule HC-C, Part I, Memorandum items 16.a and 16.b, for eligible loan modifications under Section 4013 of the 2020 Coronavirus Aid, Relief, and Economic Security Act; and

• FR Y-9C, Schedule HC and FR Y-9SP, Schedule SC, Memoranda item 2.b., the name and email address of the external auditing firm's engagement partner. 7

In some circumstances, disclosing these data items may also reveal confidential examination and supervisory information protected from disclosure under exemption 8 of the FOIA. 8 The Board has previously assured submitters that these data items will be treated as confidential.

In addition, the Chief Executive Officer Contact Information section of both the FR Y-9C and FR Y-9SP is kept confidential pursuant to FOIA exemption 6, which applies to personnel and medical files the disclosure of which would constitute a clearly unwarranted invasion of personal privacy, 9 and exemption 8, which applies to information contained in or related to examination, operating, or condition reports prepared by, on behalf of, or for the use of an agency responsible for the regulation or supervision of financial institutions. 10

Aside from the data items described above, data collected by the FR Y-9 reports generally are not accorded confidential treatment. As provided in the Board's Rules Regarding Availability of Information, 11 however, a respondent may request confidential treatment for any data items the respondent believes should be withheld pursuant to a FOIA exemption. The Board will review any such request to determine if confidential treatment is appropriate and will inform the respondent if the request for confidential treatment has been granted or denied.

To the extent that the instructions to the FR Y-9 reports direct the financial institution to retain the workpapers and related materials used in preparation of each report, such material would only be obtained by the Board as part of the examination or supervision of the financial institution. Accordingly, such information may be considered confidential pursuant to exemption 8 of the FOIA. 12 In addition, the workpapers and related materials may also be protected by exemption 4 of the FOIA, to the extent such financial information is customarily and actually treated as private by the respondent. 13

Current actions: On September 8, 2021, the Board published a notice in the Federal Register (86 FR 50354) requesting public comment for 60 days on the extension for three years of the Financial Statements for Holding Companies (FR Y-9 Reports), with revision.

The Federal Reserve periodically needs to communicate directly with the CEOs of holding companies via email; however, the Federal Reserve currently does not have a complete list of CEO email addresses. To streamline communications to CEOs, the Board proposed to collect the name, email address, and phone number of the holding company's CEO on the FR Y-9C and FR Y-9SP reports. CEO communications would be initiated or approved by the Board's senior management and would involve topics such as new initiatives and policy notifications.

The proposed CEO contact information would have been for the confidential use of the Federal Reserve and would not have been released to the public. In the proposal, the Board stated that it would use the collected CEO email addresses and phone numbers judiciously and only for significant matters requiring CEO-level attention. Having a comprehensive database of holding companies' CEO contact information, including email addresses and phone numbers, would allow the Federal Reserve to have current information to communicate important and time-sensitive information to CEOs. This information was proposed to be collected quarterly on the FR Y-9C report for consistency with the Call Report and semiannually on the FR Y-9SP report. The information would have been collected from top tier holding companies only.

Consistent with the Interagency Policy Statement Establishing Joint Standards for Assessing the Diversity Policies of Entities Regulated by the Agencies, 14 which was issued as required by section 342 of the Dodd-Frank Act, the Board's Office of Minority and Women Inclusion (OMWI) conducts an annual survey of entities the Board regulates. In this voluntary survey, the Board collects a self-assessment report on diversity policies and practices from Board-regulated entities with 100 or more full-time equivalent employees.

Currently, to identify those entities that should be invited to participate in the survey, the Board's OMWI relies on the FR Y-9C and Call Report, which collect data on the number of full-time equivalent employees for the consolidated entity. Because these data are not collected on the parent-only FR Y-9SP or the nonbank subsidiary reports, 15 the Board cannot accurately identify the FR Y-9SP reporters with 100 or more full-time equivalent employees on a consolidated basis that should be invited to participate in this survey.

Therefore, the Board proposed to add a new check box, Memorandum item 5, “Does your holding company have 100 or more full-time equivalent employees on a consolidated basis?” to Schedule SI, Income Statement of the FR Y-9SP report. The addition of this item on the FR Y-9SP would enable OMWI to have a comprehensive list of the Board-regulated holding companies with full-time equivalent employees of 100 or more on a consolidated basis. The proposed data item would have been collected only from top-tier holding companies and would have been collected only on the report for the December 31 as-of date. Given that the additional information to be reported should be easily obtainable, the Board expects that this revision would cause a small burden increase for reporters.

The FR Y-9C instructions Glossary defines “Brokered Deposits” and “Brokered Retail Deposits” consistent with section 29(g) of the Federal Deposit Insurance Act (FDI Act) and the FDIC's brokered deposits regulation. 16 Under these definitions, the meaning of the term “brokered deposit” references the defined term “deposit broker.” On January 22, 2021, the FDIC published in the Federal Register a final rule to amend its brokered deposits regulation (brokered deposits final rule), 17 which established a new framework for analyzing certain provisions of the “deposit broker” definition in the FDI Act. 18 The brokered deposits final rule clarified the term “deposit broker” and the analysis of whether entities are engaged in the business of placing, or facilitating the placement of, deposits. The revised FDIC regulation describes exceptions to the definition of “deposit broker” including when the primary purpose of an agent's or nominee's business relationship with its customers is not the placement of funds with depository institutions (primary purpose exception). The brokered deposits final rule introduced in the FDIC's regulation a list of business relationships that are designated as meeting the primary purpose exception. In February 2021, the Federal Financial Institutions Examination Council proposed changes to the Call Reports forms and instructions consistent with the brokered deposits final rule and proposed conforming clarifications in the Call Reports Glossary.

To provide clarity for respondents, the Board proposed to revise the FR Y-9C Glossary instructions to incorporate changes under the brokered deposits final rule consistent with the proposed Call Report revisions. Specifically, the Board proposed to reorder the content of the Glossary entries for “Brokered Deposits” and “Brokered Retail Deposits,” to incorporate the revised content of the FDIC regulation, and to update reference to the FDIC insurance limit of $250,000. The Board did not propose otherwise to revise the FR Y-9C form or instructions in respect to brokered deposits.

On January 24, 2020, the agencies issued a final rule  19 (SA-CCR final rule) that amends the regulatory capital rule to implement a new approach for calculating the exposure amount for derivatives contracts for purposes of calculating the total risk-weighted assets (RWA), which is called SA-CCR. The final rule also incorporates SA-CCR into the determination of the exposure amounts of derivatives for total leverage exposure under the supplementary leverage ratio and the cleared transaction framework under the capital rule.

Holding companies that are not advanced approaches banking organizations  20 may elect to use SA-CCR to calculate standardized total RWA by notifying the Board. 21 Advanced approaches holding companies are required to use SA-CCR to calculate standardized total RWA starting on January 1, 2022. Advanced approaches holding companies may adopt SA-CCR prior to January 1, 2022, but must notify the Board of their early adoption. 22

The Board proposed to revise the FR Y-9C forms and instructions by adding new line item 31.b, “Standardized Approach for Counterparty Credit Risk opt-in election.” The Board proposed to add this new item to identify holding companies that have chosen to early adopt or voluntarily elect SA-CCR, which would allow for enhanced comparability of the reported derivative data and for better supervision of the implementation of the framework at these holding companies. Due to the inherent complexity of adopting SA-CCR, identification of non-advanced approaches institutions that choose to voluntarily adopt SA-CCR is particularly important for their supervision.

Under the proposal, a non-advanced approaches holding company that adopts SA-CCR would have entered “1” for “Yes” in line item 31.b. All other non-advanced approaches holding companies would have left this item blank. If a non-advanced approaches holding company has elected to use SA-CCR, the holding company may change its election only with prior approval of the Board. 23 An advanced approaches holding company that elects to early adopt SA-CCR prior to the January 1, 2022, mandatory compliance date would have entered “1” for “Yes” in line item 31.b. After January 1, 2022, an advanced approaches holding company would have left this item blank. This proposed reporting change would have taken effect starting with the December 31, 2021, FR Y-9C report. This item would have no longer been applicable to advanced approaches holding companies starting with the March 31, 2022, report date. There would have been no material change in burden to the FR Y-9C report related to this revision.

The comment period for this notice expired on Monday, November 8, 2021. The Board did not receive any comments. The revisions will be implemented as proposed.

A comment was received on a comparable proposal involving the Consolidated Reports of Condition and Income (Call Report) (FFIEC 031, FFIEC 041and FFIEC 051; OMB Control Number 7100-0036). The comment was generally supportive of the proposed new line item related to the SA-CCR final rule. The Board has taken the comments from the proposed changes to the Call Report into consideration in finalizing the proposed FR Y-9C changes and the Board intends to add the new item for SA-CCR, as proposed.

In accordance with 5 U.S.C. 4314(c)(4), the persons named below have been selected to serve on the PRB:

As of June 13, 2021, nursing homes have reported 656,336 confirmed cases of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and coronavirus disease 2019 (COVID-19), resulting in over 132,000 COVID-19-related deaths. The U.S. Department of Health and Human Services (HHS) has distributed funds to nursing homes and launched several initiatives to improve nursing home safety and infection control. AHRQ's National Nursing Home COVID-19 Action Network ( https://www.ahrq.gov/nursing-home/about/index.html) (the Network) is a cornerstone of HHS's response, intended to provide training and assistance to nursing homes on best practices to minimize transmission of SARS-CoV-2. The Network expands AHRQ's programmatic efforts to address quality and safety in long-term care, and aligns with other agency efforts to provide COVID-19 guidance to nursing homes. As the pandemic continues, nursing homes require easy access and implementation support for up-to-date best practices on SARS-CoV-2 infection control, COVID-19 care and management, and safety measures to protect residents and staff.

AHRQ's National Nursing Home COVID-19 Coordinating Center plays a complementary role to the Network, serving as a bridge between AHRQ's Network initiatives and the nursing home quality improvement (QI) community. The Coordinating Center is tasked with (1) coordinating engagement with scientific and policy stakeholders to identify safety needs and best practices, (2) ensuring coordinated development and dissemination of QI tools and other resources, and (3) assessing the effectiveness of the Network in providing training and mentorship to support nursing homes in responding to the COVID-19 pandemic.

As part of the Coordinating Center activities, AHRQ seeks to conduct an assessment of whether and how the Network activities aided the nursing homes' efforts to mitigate the challenges posed by the COVID-19 pandemic. The goals of the performance assessment are to:

1. Assess the reach, retention, and engagement of the Network;

2. study the implementation approach, gaps and barriers;

3. study the long-term impact, sustainability, and replicability of the training program and Network activities.

This study is being conducted by AHRQ through its Coordinating Center contractor, NORC at the University of Chicago (NORC), pursuant to AHRQ's statutory authority to conduct and support training and technical assistance on health care and on systems for the delivery of such care. 42 U.S.C. 299a.

To further achieve the goals of this performance assessment, AHRQ is requesting OMB approval for new data collection. More specifically, the new data collection activities intend to collect systematic information from nursing homes on the following:

• Motivations for participation and non-participation in the Network.

• Context of participation (including state and local context, and participation in other COVID-19 related-initiatives).

• Perceptions on recruitment, engagement, and retention, including facilitators and barriers of engagement and retention.

• Perceptions on the Network training and mentorship resources, including access to and utility of the Network training and resources.

• Gaps in knowledge, skills, and resources required for identifying residents and staff infected with COVID-19.

• Impacts on the prevention and spread of SARS-CoV-2, implementation of best practice safety measures; improvement of quality of care for residents with mild and asymptomatic cases; and reduction of social isolation for residents, families, and staff.

The primary data collection includes the following activities:

Survey of all (approximately 15,000) nursing homes eligible for the COVID-19 Provider Relief Fund. Separate survey instruments will be used for Network participants (“Participant Survey”) and non-participants (“Non-Participant Survey”). The Participant Survey will be conducted primarily via a secure web-based platform. The Non-Participant Survey will be conducted via web and telephone.

Key informant interviews with up to 96 individuals from 32 nursing homes participating in the Network across all assessment domains, conducted virtually on a secure platform.

Information collected will inform whether and how the Network activities aided the nursing homes' efforts to mitigate the challenges posed by the COVID-19 pandemic. This data collection effort will also provide information on why nursing homes may not have been able to participate in the Network (Non-Participant Survey). Findings from the assessment will allow AHRQ to:

• Assess the Network's reach and the effectiveness of the retention and engagement strategies;

• Study implementation of the Network's training sessions, mentorship and technical assistance activities, and dissemination of the safety and quality improvement tools;

• Study the Network's impact on ensuring availability of protective equipment, rapid identification of nursing home residents and staff infected with SARS-CoV-2, entry and transmission of COVID-19, and improving health outcomes; and

• Study the long-term impact, sustainability, and replicability of the training program and Network activities to address other patient safety and quality improvement priorities.

Survey. The nursing home survey will have two survey instruments:

For the Participant Survey we expect that 1,804 participants (20% response rate) will agree to participate on behalf of their facilities and that the survey will take about 20 minutes to complete. For the Non-Participant Survey, we expect that 1,264 participants will agree to participate (20% response rate) on behalf of their facilities and that the survey will take about 5 minutes to complete. This estimate is based on prior provider survey experience and the response rate for an earlier customer satisfaction survey, which was approximately 20%.

Key Informant Interviews. Key informant interviews will be conducted with up to 32 nursing homes (up to 3 staff from each nursing home in each interview, for a total of 96 staff) involved in the Network. All interviews are expected to last 30 minutes, including time for respondents to provide verbal consent for participation and ask any questions at the start.

The total annual burden hours for the survey and key informant interviews are estimated to be 744 hours, as shown in Exhibit 1.

Exhibit 2 shows the estimated annual cost burden associated with the respondents' time to participate in this information collection, which comes to $45,242.64.

In accordance with section 10 (a)(2) of the Federal Advisory Committee Act (5 U.S.C. App. 2), AHRQ announces meetings of the above-listed scientific peer review groups, which are subcommittees of AHRQ's Health Services Research Initial Review Group Committee. The subcommittee meetings will be closed to the public in accordance with the provisions set forth in 5 U.S.C. App. 2 section 10(d), 5 U.S.C. 552b(c)(4), and 5 U.S.C. 552b(c)(6). The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

Agenda items for these meetings are subject to change as priorities dictate.

FDA is announcing the availability of a draft guidance for sponsor-investigators entitled “IND Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases: Clinical Recommendations.” FDA is publishing this draft guidance to provide sponsor-investigators (hereafter referred to as sponsors) who are interested in developing individualized ASO drug products for a rapidly progressive SDLT genetic disease (caused by a unique genetic variant or variants), with clinical recommendations for submission of INDs. These recommendations specifically address the following clinical considerations: Ethical and human subject protection, diagnostic and genetic, dosing, administration, safety, and assessment of clinical response to treatment.

This draft guidance describes clinical considerations and, when applicable, important information to include in IND submissions for such ASO drug products for a small number of participants (typically one to two) with SDTL diseases. In general, ASO drug products referred to in this draft guidance belong to a well-characterized chemical class and for which there is considerable nonclinical and clinical experience that is publicly available or to which the sponsor has a right of reference. The draft guidance discusses considerations and information to submit in an IND regarding: (1) Confirmation of the participant's genetic diagnosis and genetic variant(s) targeted by the ASO drug product, (2) the requirements and procedures for informed consent of the participant, (3) appropriate and safe dosing and administration procedures that are detailed and supported by relevant nonclinical evidence, (4) the nature and schedule of the specific safety assessments (adverse events and laboratory testing) to be conducted, and (5) methods for continuous clinical monitoring ( e.g., via clinical outcome assessments, pharmacodynamic biomarkers) of the participant to evaluate and document their clinical response(s) and to allow for an informed benefit-risk determination. This draft guidance is expected to facilitate the preparation of adequate and complete IND submissions for investigational ASO drug products for participants with SDLT diseases targeted by the specified ASO drug product.

This draft guidance represents one guidance in a series of guidances that FDA intends to publish to advise and help sponsors planning to use individualized ASO drug products for SDLT diseases caused by unique genetic variant(s) and for whom there are no alternative therapies available to treat their disease.

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 “IND Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases: Clinical Recommendations.” 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 new 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 have been approved under OMB control number 0910-0014. The collections of information in 21 CFR parts 50 and 56 for obtaining informed consent for prospective patients have been approved under OMB control number 0910-0130.

Persons with access to the internet may obtain the draft guidance at either 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.

FDA is announcing the availability of a draft guidance for industry entitled “IND Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases: Chemistry, Manufacturing, and Controls Recommendations.” The purpose of this draft guidance is to provide FDA's current thinking on the recommended CMC data and information to support an IND submitted by a sponsor-investigator developing an ASO drug product for a small number of individuals (typically one or two) with an SDLT disease. This draft guidance also explains FDA's recommendations around compliance with current good manufacturing practice, including the applicability of 21 CFR part 211, to support investigational use of an ASO drug product in a small number of individuals with an SDLT disease.

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 “IND Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases: Chemistry, Manufacturing, and Controls Recommendations.” 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 parts 312 and 314 have been approved under OMB control numbers 0910-0014 and 0910-0001, respectively. The collections of information in 21 CFR 211 for manufacture of drug product is approved under OMB control number 0910-0139. The collections of information for oversight of clinical investigations and safety reporting have been approved under OMB control number 0910-0733.

Persons with access to the internet may obtain the draft guidance at either 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.

When submitting comments or requesting information, please include the information collection request title for reference.

Information Collection Request Title: Environmental Information and Documentation (EID), OMB No. 0915-0324, Extension.

Abstract: HRSA is requesting approval of an extension for the EID checklist which consists of information that the agency is required to obtain to comply with the National Environmental Policy Act of 1969 (NEPA). NEPA establishes the federal government's national policy for protection of the environment. HRSA has developed the EID for applicants of funding that would potentially impact the environment and to ensure that their decision-making processes are consistent with NEPA.

Need and Proposed Use of the Information: Applicants must provide information and assurance of compliance with NEPA on the EID checklist. This information is reviewed in the Pre-Award stage (and/or prior to the implementation of the project). The information is reviewed in the Post-Award stage for project changes and the information is reviewed before the implementation of the project changes.

Likely Respondents: HRSA applicants applying for federal loan guarantees, federal construction grants, and cooperative agreements.

Burden Statement: Burden in this context means the time expended by persons to generate, maintain, retain, disclose or provide the information requested. This includes the time needed to review instructions; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information; to search data sources; to complete and review the collection of information; and to transmit or otherwise disclose the information. The total annual burden hours estimated for this ICR are summarized in the table below.

HRSA specifically requests comments on (1) the necessity and utility of the proposed information collection for the proper performance of the agency's functions, (2) the accuracy of the estimated burden, (3) ways to enhance the quality, utility, and clarity of the information to be collected, and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

When submitting comments or requesting information, please include the information request collection title for reference.

Information Collection Request Title: Rural Communities Opioid Response Program (RCORP) Performance Measures, OMB No. 0906-0044, Revised.

Abstract: RCORP is authorized by Section 711(b)(5) of the Social Security Act (42 U.S.C. 912(b)(5)) and is a multi-initiative program that aims to: (1) Support treatment for and prevention of substance use disorder (SUD), including opioid use disorder (OUD); and (2) reduce morbidity and mortality associated with SUD, to include OUD, by improving access to and delivering prevention, treatment, and recovery support services to high-risk rural communities. To support this purpose, RCORP grant initiatives include:

• RCORP-Implementation grants to fund established networks and consortia to deliver SUD/OUD prevention, treatment, and recovery activities in high-risk rural communities;

• RCORP-Medication Assisted Treatment Expansion grants to enhance access to medication-assisted treatment within eligible hospitals, health clinics, or tribal organizations in high-risk rural communities;

• RCORP-Neonatal Abstinence Syndrome grants to reduce the incidence and impact of Neonatal Abstinence Syndrome in rural communities by improving systems of care, family supports, and social determinants of health;

• RCORP-Psychostimulant Support grants to strengthen and expand prevention, treatment, and recovery services for individuals in rural areas who misuse psychostimulants; to enhance their ability to access treatment and move towards recovery; and

• Note that additional grant programs may be added pending Fiscal Year 2022 and future Fiscal Year appropriations.

Additionally, all RCORP grant award recipients are supported by eight cooperative agreements: RCORP-Technical Assistance, which provides extensive technical assistance to award recipients; RCORP-Evaluation, which evaluates the impact of the RCORP initiative on rural communities; three RCORP-Behavioral Health Care Workforce Centers, which provide workforce training and education initiatives in the region served by the Northern Border Regional Commission; and three RCORP-Centers of Excellence, which disseminate best practices related to the treatment for and prevention of substance use disorders within rural communities.

Need and Proposed Use of the Information: Due to the growth in the number of grant programs included in the RCORP initiative, as well as emerging SUD and other behavioral health trends in rural communities, HRSA is submitting a revised package that includes changes to existing RCORP performance measures as well as new performance measures that better demonstrate the impact of the initiative on rural communities and reduce burden on the grant recipients.

For this program, performance measures were developed to provide data on each RCORP initiative and to enable HRSA to provide aggregate program data required by Congress under the Government Performance and Results Act of 1993. These measures cover the principal topic areas of interest to the Federal Office of Rural Health Policy, including: (a) Provision of, and referral to, rural behavioral health care services, including SUD prevention, treatment and recovery support services; (b) behavioral health care, including SUD prevention, treatment, and recovery, process and outcomes; (c) education of health care providers and community members; (d) emerging trends in rural behavioral health care needs and areas of concern; and (e) consortium strength and sustainability. All measures will speak to the Federal Office of Rural Health Policy's progress toward meeting the goals set.

Likely Respondents: The respondents will be the grant award recipients of the RCORP initiatives.

Burden Statement: Burden in this context means the time expended by persons to generate, maintain, retain, disclose, or provide the information requested. This includes the time needed to review instructions; to develop, acquire, install, and utilize technology and systems for the purpose of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information; to search data sources; to complete and review the collection of information; and to transmit or otherwise disclose the information. The total annual burden hours estimated for this ICR are summarized in the table below. Please note that since RCORP-Psychostimulant Support includes substantially different measures than the other RCORP grant programs, HRSA calculated that program's burden hours separately.

HRSA specifically requests comments on: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

Information Collection Request Title: COVID-19 Provider Relief Programs Application and Attestation Portal, and Claims Reimbursement Submission Activities, OMB No. 0906-XXXX—NEW.

Abstract: HRSA administers the Provider Relief Programs (which includes the Provider Relief Fund (PRF), the American Rescue Plan Act Rural (ARP-R) payments, the COVID-19 Coverage Assistance Fund (CAF), and the COVID-19 Claims Reimbursement to Health Care Providers and Facilities for Testing, Treatment, and Vaccine Administration for the Uninsured (Uninsured Program or UIP)). The Provider Relief Programs disbursed, and are continuing to disburse funds to eligible healthcare providers through two pathways: (1) Direct provider payments via the PRF and ARP-R payments, and (2) claims reimbursement via the CAF and the UIP. This information collection includes four components: (1) The PRF and ARP-R application portal; (2) the PRF and ARP-R attestation portal; (3) the CAF application portal; and (4) the UIP application portal. To date, information for these programs has been collected under a Paperwork Reduction Act waiver executed pursuant to public health emergency authorities. HRSA is seeking comments regarding the CAF and the UIP for the first time. These information collections support administration of the Provider Relief Programs including the PRF, the Uninsured Program, and the CAF (funds for these three programs were appropriated under the Coronavirus Aid, Relief, and Economic Security Act (Pub. L. 116-136), Paycheck Protection Program and Health Care Enhancement Act (Pub. L. 116-139), Coronavirus Response and Relief Supplemental Appropriations Act (Division M of Pub. L. 116-260)), and the ARP-R payments (funds were appropriated under the American Rescue Plan Act of 2021, Pub. L. 117-2, as well as funds for the Uninsured Program).

A 60-day notice was published in the Federal Register , 86 FR 47119 (August 23, 2021). There were no public comments.

Need and Proposed Use of the Information: Providers who apply for Provider Relief Programs ( i.e., PRF, ARP-R, CAF, and UIP payments) must apply for direct provider payments or claims reimbursement and attest to a set of Terms and Conditions to enable HRSA's appropriate disbursement and oversight of recipients' use of funds. Information collected will allow for (1) assessing if recipients have met statutory and programmatic requirements; (2) conducting audits; (3) gathering data required to calculate, disburse, and report on PRF, ARP-R, CAF, and UIP payments; and (4) program evaluation. HRSA staff may also use information collected to identify and report on trends in the effect of the COVID-19 pandemic on health care providers and uninsured or underinsured patients throughout the United States. HHS makes publicly available the names of payment recipients and the aggregate amounts received, for all providers who attest to receipt of a payment and acceptance of the Terms and Conditions or who retain payments for more than 90 days and are deemed to have accepted the Terms and Conditions. By accepting funds, the recipient consents to HHS publicly disclosing the payments that recipient has received.

Likely Respondents: Health care providers that apply to receive, or have applied to receive, PRF, ARP-R, CAF, or UIP payments, and attested to the associated Terms and Conditions.

Burden Statement: Burden in this context means the time expended by persons to generate, maintain, retain, disclose or provide the information requested. This includes the time needed to review instructions; to develop, acquire, install, and utilize technology and systems for the purpose of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information; to search data sources; to complete and review the collection of information; and to transmit or otherwise disclose the information. The total annual burden hours estimated for this ICR are summarized in the table below.

HRSA specifically requests comments on (1) the necessity and utility of the proposed information collection for the proper performance of the agency's functions, (2) the accuracy of the estimated burden, (3) ways to enhance the quality, utility, and clarity of the information to be collected, and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

Section 4003(e) of the 21st Century Cures Act (Pub. L. 114-255) establishes the Health Information Technology Advisory Committee (referred to as the “HITAC”). The HITAC will be governed by the provisions of the Federal Advisory Committee Act (FACA) (Pub. L. 92-463), as amended, (5 U.S.C. App.), which sets forth standards for the formation and use of federal advisory committees.

The HITAC is comprised of at least 25 members, of which:

• No fewer than 2 members are advocates for patients or consumers of health information technology;

• 3 members are appointed by the HHS Secretary

○ 1 of whom shall be appointed to represent the Department of Health and Human Services and

○ 1 of whom shall be a public health official;

• 2 members are appointed by the majority leader of the Senate;

• 2 members are appointed by the minority leader of the Senate;

• 2 members are appointed by the Speaker of the House of Representatives;

• 2 members are appointed by the minority leader of the House of Representatives; and

• Other members are appointed by the Comptroller General of the United States.

Members serve for one-, two-, or three-year terms. All members may be reappointed for a subsequent three-year term. Each member is limited to two three-year terms, not to exceed six years of service. Members serve without pay, but will be provided per-diem and travel costs for committee services, if warranted.

The HITAC recommendations to the National Coordinator are publicly available at https://www.healthit.gov/topic/federal-advisory-committees/recommendations-national-coordinator-health-it.

The schedule of meetings to be held in 2022 is as follows:

All meetings are open to the public. Additional meetings may be scheduled as needed. For web conference instructions and the most up-to-date information, please visit the HITAC calendar on the ONC website, www.healthit.gov/topic/federal-advisory-committees/hitac-calendar.

Contact Person for Meetings: Michael Berry, Michael.Berry@hhs.gov. A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Please email Michael Berry for the most current information about meetings.

Agenda: As outlined in the 21st Century Cures Act, the HITAC will develop and submit recommendations to the National Coordinator on the topics of interoperability, privacy and security, patient access, and use of technologies that support public health. In addition, the committee will also address any administrative matters and hear periodic reports from ONC. ONC intends to make background material available to the public no later than 24 hours prior to the meeting start time. If ONC is unable to post the background material on its website prior to the meeting, the material will be made publicly available on ONC's website after the meeting, at www.healthit.gov/hitac.

Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person prior to the meeting date. An oral public comment period will be scheduled at each meeting. Time allotted for each commenter will be limited to three minutes. If the number of speakers requesting to comment is greater than can be reasonably accommodated during the scheduled public comment period, ONC will take written comments after the meeting.

All HITAC meetings in 2022 will be virtual until further notice. Please refer to future Federal Register Notices for updated information on in-person meetings. ONC welcomes the attendance of the public at its HITAC meetings. If you require special accommodations due to a disability, please contact Michael Berry at least seven (7) days in advance of the meeting.

Notice of these meetings are given under the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App. 2).