The regulations in 9 CFR part 94 (referred to below as the regulations) govern the importation of certain animals and animal products into the United States to prevent the introduction of various animal diseases, including Newcastle disease and highly pathogenic avian influenza (HPAI). The regulations prohibit or restrict the importation of live poultry, poultry meat, and other poultry products from regions where these diseases are considered to exist.

Section 94.6 of the regulations contains requirements governing the importation into the United States of carcasses, meat, parts or products of carcasses, and eggs (other than hatching eggs) of poultry, game birds, or other birds from regions of the world where HPAI exists or is reasonably believed to exist. HPAI is an extremely infectious and potentially fatal form of avian influenza in birds and poultry that, once established, can spread rapidly from flock to flock. The Animal and Plant Health Inspection Service (APHIS) maintains a list of restricted regions it considers affected with HPAI of any subtype on the APHIS website at https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/animal-and-animal-product-import-information/animal-health-status-of-regions.

APHIS receives notice of HPAI outbreaks from veterinary officials of the exporting country, from the World Organization for Animal Health (WOAH), 1 or from other sources the Administrator determines to be reliable.

On May 31, 2021, the veterinary authorities of the Kingdom of Lesotho reported to the WOAH an HPAI occurrence in that country. On June 8, 2021, after confirming that the HPAI occurred in commercial birds or poultry, APHIS added the Kingdom of Lesotho to the list of regions where HPAI exists. On that same day, APHIS issued an import alert notifying stakeholders that APHIS imposed restrictions on the importation of poultry, commercial birds, other types of birds (research, performing), ratites, any avian hatching eggs, unprocessed avian products and byproducts, and certain fresh poultry products from the Kingdom of Lesotho to mitigate risk of HPAI introduction into the United States.

On August 20, 2021, the veterinary authorities of the Republic of Benin reported to the WOAH an HPAI occurrence in that country. On August 26, 2021, after confirming that the HPAI occurred in commercial birds or poultry, APHIS added the Republic of Benin to the list of regions where HPAI exists. On that same day, APHIS issued an import alert notifying stakeholders that APHIS imposed restrictions on the importation of poultry, commercial birds, other types of birds (research, performing), ratites, any avian hatching eggs, unprocessed avian products and byproducts, and certain fresh poultry products from the Republic of Benin to mitigate risk of HPAI introduction into the United States.

On September 6, 2021, the veterinary authorities of the Republic of Botswana reported to the WOAH an HPAI occurrence in that country. On September 10, 2021, after confirming that the HPAI occurred in commercial birds or poultry, APHIS added the Republic of Botswana to the list of regions where HPAI exists. On that same day, APHIS issued an import alert notifying stakeholders that APHIS imposed restrictions on the importation of poultry, commercial birds, other types of birds (research, performing), ratites, any avian hatching eggs, unprocessed avian products and byproducts, and certain fresh poultry products from the Republic of Botswana to mitigate risk of HPAI introduction into the United States.

With the publication of this notice, we are informing the public that we added: The Kingdom of Lesotho to the list of regions APHIS considers affected with HPAI of any subtype, effective June 8, 2021; the Republic of Benin to the list of regions APHIS considers affected with HPAI of any subtype, effective August 26, 2021; and the Republic of Botswana to the list of regions APHIS considers affected with HPAI of any subtype, effective September 10, 2021. This notice serves as an official record and public notification of these actions.

Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq. ), the Office of Information and Regulatory Affairs designated this action as not a major rule, as defined by 5 U.S.C. 804(2).

Authority: 7 U.S.C. 1633, 7701-7772, 7781-7786, and 8301-8317; 21 U.S.C. 136 and 136a; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.4.

These meetings are available to the public through the WebEx 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 the call-in number found through registering at the web link provided for these meetings.

Members of the public are entitled to make comments during the open period at the end of the meetings. Members of the public may also submit written comments; the comments must be received in the Regional Programs Unit within 30 days following the meeting. Written comments may be emailed to Liliana Schiller at lschiller@usccr.gov. Persons who desire additional information may contact the Regional Programs Unit at (202) 539-8246. Records and documents discussed during the meetings 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.

Committee meetings are available to the public through the conference link above. Any interested member of the public may listen to the meeting. An open comment period will be provided to allow members of the public to make a statement as time allows. If joining via phone, callers can expect to incur regular charges for calls they initiate over wireless lines, according to their wireless plan. 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 (800) 877-8339 and providing the Service with the conference details found through registering at the web link above. To request additional accommodations, please email kfajota@usccr.gov at least ten (10) days prior to the meeting.

Members of the public are also entitled to submit written comments; the comments must be received in the regional office within 30 days following the meeting. Written comments may be emailed to Liliana Schiller at lschiller@usccr.gov. Persons who desire additional information may contact the Regional Programs Coordination Unit at (312) 353-8311.

Records generated from this meeting may be inspected and reproduced at the Regional Programs Coordination Unit Office, as they become available, both before and after the meeting. Records of the meeting will be available via www.facadatabase.gov under the Commission on Civil Rights, Wyoming Advisory Committee link. Persons interested in the work of this Committee are directed to the Commission's website, http://www.usccr.gov, or may contact the Regional Programs Coordination Unit at the above phone number.

Background

On June 28, 2022, Commerce published in the Federal Register the final results of the 2019-2020 administrative review of the AD order on crystalline silicon photovoltaic cells, whether or not assembled into modules, from China. 1 On July 5, 2022, the American Alliance for Solar Manufacturing (the petitioner) alleged that Commerce made a ministerial error in its calculations in the final results of review. 2 On July 11, 2022, Risen  3 rebutted the petitioner's ministerial error comments. 4

Pursuant to 19 CFR 351.224(e), Commerce will analyze any ministerial error comments received and, if appropriate, correct any ministerial error by amending the final results of review. According to section 751(h) of the Tariff Act of 1930, as amended (the Act), and 19 CFR 351.224(f), a ministerial error is an error “in addition, subtraction, or other arithmetic function, clerical errors resulting from inaccurate copying, duplication, or the like, and any other type of unintentional error which {Commerce} considers ministerial.”

After analyzing interested parties' comments, we have determined that we made a ministerial error in the final results by inadvertently using the incorrect average unit value for the Malaysian Harmonized Tariff Schedule subheading that we selcted to value the mandatory respondents' aluminum frames, profiles, keys, and extrusions. For details regarding the ministerial error, see the Ministerial Error Memorandum. 5

Accordingly, we are amending our calculations of the mandatory respondents' dumping margins in the final results to reflect our correction of this error. 6 Because the dumping margins of the non-individually examined respondents to which we granted a separate rate are based on the weighted-average dumping margins that we calculated for the mandatory respondents, we also have amended the dumping margin that we assigned to these non-individually examined respondents. 7

After correcting the ministerial error referenced above, we have determined that the following weighted-average dumping margins exist for the period of review, December 1, 2019 through November 30, 2020:

Pursuant to 19 CFR 351.224(b), within five days of the publication of this notice in the Federal Register , we will disclose to the parties to this proceeding, the calculations that we performed for these amended final results of review.

Pursuant to section 751(a)(2)(C) of the Act and 19 CFR 351.212(b)(1), Commerce has determined, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries of subject merchandise covered by the amended final results of review. Commerce intends to issue assessment instructions to CBP no earlier than 35 days after the date of publication of these amended final results of 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).

Where a mandatory respondent's weighted-average dumping margin is zero or de minimis, or where an importer-specific ad valorem or per-unit dumping margin is zero or de minimis, Commerce will instruct CBP to liquidate appropriate entries without regard to antidumping duties. 8 For U.S. entries that were not reported in a mandatory respondent's U.S. sales data, but that were entered under the case number of that respondent ( i.e., at the individually-examined exporter's cash deposit rate), Commerce will instruct CBP to liquidate such entries at the cash deposit rate for the China-wide entity ( i.e., 238.95 percent).

We calculated importer or customer-specific ad valorem assessment rates for the mandatory respondents by dividing the total amount of dumping duties for reviewed sales of subject merchandise imported by an importer, or for reviewed sales of subject merchandise to a customer, as appropriate, by the total sales value of those transactions.

For the companies not individually examined in this administrative review that qualified for a separate rate, the assessment rate will be equal to the weight average of the weighted-average dumping margins calculated for the mandatory respondents in these amended final results of review.

The following cash deposit requirements will be effective for shipments of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the date of publication of this notice of the amended final results of review in the Federal Register , as provided by section 751(a)(2)(C) of the Act: (1) for the companies listed in the table above, the cash deposit rate will be equal to the weighted-average dumping margin listed for the company in the table; (2) for previously investigated or reviewed China and non-China exporters that are not under review in this segment of the proceeding that have a separate rate, the cash deposit rate will continue to be their existing exporter-specific rate; (3) for all China exporters of subject merchandise that do not have a separate rate, their cash deposit rate will be the cash deposit rate previously established for the China-wide entity, which is 238.95 percent; and (4) for all non-China exporters of subject merchandise that do not have a separate rate, the cash deposit rate will be the cash deposit rate applicable to the China exporter that supplied the non-China exporter.

These cash 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 review period. Failure to comply with this requirement could result in Commerce's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of double 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(a)(3), which continues to govern business proprietary information in this segment of the proceeding. 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 which is subject to sanction.

We are issuing and publishing this notice in accordance with sections 751(h) and 777(i)(1) of the Act, and 19 CFR 351.224(e).

The MEP Advisory Board is authorized under 15 U.S.C 278k(m), in accordance with the provisions of the Federal Advisory Committee Act (FACA), as amended, 5 U.S.C. app. The Hollings Manufacturing Extension Partnership Program (Program) is a unique program consisting of Centers in all 50 states and Puerto Rico with partnerships at the federal, state and local levels. By statute, the MEP Advisory Board provides the NIST Director with: (1) advice on the activities, plans and policies of the Program; (2) assessments of the soundness of the plans and strategies of the Program; and (3) assessments of current performance against the plans of the Program.

Background information on the MEP Advisory Board is available at http://www.nist.gov/mep/about/advisory-board.cfm.

Pursuant to the Federal Advisory Committee Act, as amended, 5 U.S.C. app., notice is hereby given that the MEP Advisory Board will hold an open meeting on Tuesday, September 20, 2022, from 12:30 p.m. to 6:00 p.m. Central time. The meeting agenda will include an update on the MEP programmatic operations, as well as provide guidance and advice on current activities related to both the current MEP National Network TM 2017-2022 Strategic Plan and upcoming MEP National Network 2023-2028 Strategic Plan. The agenda may change to accommodate Board business. The final agenda will be posted on the MEP Advisory Board website at http://www.nist.gov/mep/about/advisory-board.cfm. Individuals and representatives of organizations who would like to offer comments and suggestions related to the MEP Advisory Board's business are invited to request a place on the agenda. Approximately 15 minutes will be reserved for public comments at the end of the meeting. Speaking times will be assigned on a first-come, first-served basis. The amount of time per speaker will be determined by the number of requests received but is likely to be no more than three to five minutes each. Requests must be submitted by email to cheryl.gendron@nist.gov and must be received by September 14, 2022, to be considered. The exact time for public comments will be included in the final agenda that will be posted on the MEP Advisory Board website at http://www.nist.gov/mep/about/advisory-board.cfm. Questions from the public will not be considered during this period. Speakers who wish to expand upon their oral statements, those who wished to speak but could not be accommodated on the agenda or those who are/were unable to attend the meeting are invited to submit written statements electronically by email to cheryl.gendron@nist.gov.

Admittance Instructions: Anyone wishing to attend the MEP Advisory Board meeting must submit their name, organization, email address and phone number to Cheryl Gendron ( Cheryl.Gendron@nist.gov or 301-975-2785) no later than Wednesday, September 14, 2022, 5:00 p.m. Eastern time.

The MMPA prohibits the “take” of marine mammals, with certain exceptions. Sections 101(a)(5)(A) and (D) of the MMPA (16 U.S.C. 1361 et seq. ) direct the Secretary of Commerce (as delegated to NMFS) 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 proposed or, if the taking is limited to harassment, a notice of a proposed incidental harassment authorization is provided to the public for review.

Authorization for incidental takings shall be granted if NMFS finds that the taking will have a negligible impact on the species or stock(s) and will not have an unmitigable adverse impact on the availability of the species or stock(s) for taking for subsistence uses (where relevant). Further, NMFS must prescribe the permissible methods of taking and other “means of effecting the least practicable adverse impact” on the affected species or stocks and their habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance, and on the availability of the species or stocks for taking for certain subsistence uses (referred to in shorthand as “mitigation”); and requirements pertaining to the mitigation, monitoring and reporting of the takings are set forth. The definitions of all applicable MMPA statutory terms cited above are included in the relevant sections below.

To comply with the National Environmental Policy Act of 1969 (NEPA; 42 U.S.C. 4321 et seq. ) and NOAA Administrative Order (NAO) 216-6A, NMFS must review our proposed action ( i.e., the issuance of an IHA) with respect to potential impacts on the human environment.

This action is consistent with categories of activities identified in Categorical Exclusion B4 (IHAs with no anticipated serious injury or mortality) of the Companion Manual for NOAA Administrative Order 216-6A, which do not individually or cumulatively have the potential for significant impacts on the quality of the human environment and for which we have not identified any extraordinary circumstances that would preclude this categorical exclusion. Accordingly, NMFS has preliminarily determined that the issuance of the proposed IHA qualifies to be categorically excluded from further NEPA review.

We will review all comments submitted in response to this notice prior to concluding our NEPA process or making a final decision on the IHA request.

On February 15, 2022, NMFS received a request from WSDOT for an IHA to take marine mammals incidental to the Bainbridge Island Ferry Terminal Overhead Loading Replacement Project (the Bainbridge Project) and Eagle Harbor Maintenance Facility Slip F Improvement Projects (the Eagle Harbor Project) in Bainbridge Island, Washington. The application was deemed adequate and complete on July 25, 2022. WSDOT's request is for take of 12 species of marine mammal by Level B harassment and, for a subset of these species (harbor seal ( Phoca vitulina ), harbor porpoise ( Phocoena phocoena ), and Dall's porpoise ( Phocoenoides dalli )), Level A harassment. Neither WSDOT nor NMFS expect serious injury or mortality to result from this activity and, therefore, an IHA is appropriate.

The Washington State Department of Transportation (WSDOT) Ferries Division (WSF) operates and maintains 19 ferry terminals and one maintenance facility, all of which are located in either Puget Sound or the San Juan Islands. Two projects are proposed to be conducted: replacement of the Bainbridge Island Ferry Terminal overhead loading structure, and improvement of the Eagle Harbor Maintenance Facility Slip F. Both of the projects are located within Eagle Harbor on Bainbridge Island, Washington, would be completed within the same in-water work season, would have overlapping ensonified areas, and use the same datasets to estimate marine mammal takes. Therefore, WSDOT has submitted one application for a single IHA to cover both projects.

The purpose of the Bainbridge Project is to replace the seismically vulnerable timber trestle and fixed steel portions of the overhead loading structure at the Bainbridge Island Ferry Terminal. The purpose of the Eagle Harbor Project is to improve the maintenance efficiency of the facility. The facility has six vessel slips whose purpose is to maintain the Washington State Ferry (WSF) system's vessels.

Due to in-water work timing restrictions established by NMFS and the U.S. Army Corps of Engineers, construction in the projects area is limited each year from August 1 through February 15. Both the Bainbridge Project and the Eagle Harbor Project would be constructed during the August 1, 2022 to February 15, 2023 in-water work season. For the Bainbridge Project, in-water construction is expected to occur on up to 57 days (Table 1). For the Eagle Harbor Project, in-water construction is expected to occur on up to 31 days (Table 2).

Both projects are located within Eagle Harbor on Bainbridge Island, Washington, approximately 9 miles (mi; 14.5 kilometers (km)) west of Seattle, Washington. The Eagle Harbor Maintenance Facility is approximately 1/4 mi (0.4 km) southwest of the Bainbridge Island Ferry Terminal. Eagle Harbor contains a mix of commercial docks, public marinas, private docks, and undeveloped waterfront properties. The harbor extends 2 mi (1.2 km) west from the mouth of the harbor, which is approximately 900 feet (ft; 274.3 meters (m)) wide and is bounded by Wing Point to the north and Bill Point to the south. A large underwater sand bar extends to the southeast from Wing Point. Water depths within Eagle Harbor range are up to 50 ft (15.2 m) but outside the harbor, water depths between Bainbridge Island and Seattle can be over 700 ft (213.4 m).

The existing overhead loading fixed walkway at the Bainbridge Island Ferry Terminal consists of two major components: a timber trestle, constructed in 1972, which is approximately 345 ft (105.2 m) long and supported on timber batter piles; and a steel truss, constructed in 1988, which is approximately 78 ft (23.8 m) long and supported on a concrete shaft at each end. The walkway is elevated approximately 40 ft (12.2 m) above ground.

The proposed project elements for the Bainbridge Project include:

1. Installation of temporary work platforms: two temporary work platforms would support construction equipment. A total of 31 24-inch (in) steel pipe piles would support the structures, which would be installed first using a vibratory hammer to within 5 ft (1.5 m) of tip elevation, and then driven with an impact hammer to verify bearing capacity.

2. Installation of temporary walkway: a temporary walkway would be constructed to maintain overhead loading operations while the new walkway is constructed. This would allow the inshore portion of the existing walkway to be demolished so the new walkway can be constructed. The offshore portion of the existing walkway would remain to allow passenger loading until the new walkway is completed. The temporary walkway would be supported on four 24-inch diameter steel piles, which would be installed first using a vibratory hammer to within 5 ft (1.5 m) of tip elevation, and then driven with an impact hammer to verify bearing capacity.

3. Installation of new permanent walkway: the new walkway would be supported by 14 30-in and 12 36-in steel pipe piles, which would be installed first using a vibratory hammer to within 5 ft (1.5 m) of tip elevation, and then driven with an impact hammer to verify bearing capacity.

4. Removal of existing overhead loading walkway: the existing overhead loading walkway, including 76 creosote-treated 12-in timber piles and one 4.5 ft (1.4 m) diameter concrete drill shaft, would be removed. The piles would be removed using a vibratory hammer and the concrete drill shaft would be removed by cutting it with a saw at the mudline.

5. Removal of temporary walkway and work platform: after the new walkway is constructed, all piles associated with the temporary walkway and work platform would be removed with a vibratory hammer.

The construction schedule would be coordinated to allow work to occur around ferry boats that may be present in the Bainbridge Island Ferry Terminal slips.

The last seven vessels built for the WSF fleet have evacuation slides on the passenger deck. These require the use of a vehicle drive-on slip to allow changing out these slides. Currently, only two of the six slips are vehicle drive-on slips. This results in delays when more than two vessels are undergoing maintenance. A new vehicle drive-on slip would be constructed to reduce maintenance delays, and provide more flexibility in accomplishing the various maintenance activities on the vessels that is crucial to making the WSF system as reliable as possible.

The proposed project elements for the Eagle Harbor Project include:

1. Trestle and transfer span: The vehicle transfer span is the link for vehicles to load and unload from the fixed trestle to the vehicle deck of the ferry vessel. At Eagle Harbor, the existing Slip F gangplank system would be replaced with a new pile supported trestle and a transfer span adjustable with a mechanical system. The new trestle would be approximately 15-ft (4.6 m) wide and 80 ft (24.4 m) long, and will be supported by nine 24-in steel pipe piles and two 36-in steel pipe piles which would each be installed first using a vibratory hammer to within 5 ft (1.5 m) of tip elevation, and then driven with an impact hammer to verify bearing capacity.

2. Wingwalls and dolphins: The existing pair of timber dolphins would be replaced with a new pair of steel wingwalls. Two new fixed pile dolphins would be constructed adjacent to the Trask Pier. The wingwalls design would consist of four 36-inch diameter steel reaction piles and two 36-inch diameter fender piles. Two fixed dolphins would be constructed adjacent to the Trask Pier to provide protection to the pier and mooring lines for tie-up. The dolphin design would consist of four 30-inch diameter steel reaction piles and one 36-inch diameter fender pile. Wingwall and dolphin piles would be installed using a vibratory hammer only.

3. Removal of timber walkway, timber dolphins, and U-float: the project would also include the removal of a currently existing timber walkway/trestle, four timber pile dolphins, and a U-float. The timber trestle removal includes 52 12-inch diameter timber piles, the four dolphins include a total of 134 12-inch diameter timber piles, and the U-float consists of four 18-inch diameter steel piles, all of which would be removed using a vibratory hammer.

Proposed mitigation, monitoring, and reporting measures are described in detail later in this document (please see Proposed Mitigation and Proposed Monitoring and Reporting).

Sections 3 and 4 of the application summarize available information regarding status and trends, distribution and habitat preferences, and behavior and life history of the potentially affected species. NMFS fully considered all of this information, and we refer the reader to these descriptions, incorporated here by reference, instead of reprinting the information. Additional information regarding population trends and threats may be found in NMFS' Stock Assessment Reports (SARs; www.fisheries.noaa.gov/national/marine-mammal-protection/marine-mammal-stock-assessments ) and more general information about these species ( e.g., physical and behavioral descriptions) may be found on NMFS' website ( https://www.fisheries.noaa.gov/find-species).

Table 3 lists all species or stocks for which take is expected and proposed to be authorized for this activity, and summarizes information related to the population or stock, including regulatory status under the MMPA and Endangered Species Act (ESA) and potential biological removal (PBR), where known. PBR is defined by the MMPA as the maximum number of animals, not including natural mortalities, that may be removed from a marine mammal stock while allowing that stock to reach or maintain its optimum sustainable population (as described in NMFS' SARs). While no serious injury or mortality is anticipated or authorized here, PBR and annual serious injury and mortality from anthropogenic sources are included here as gross indicators of the status of the species and other threats.

Marine mammal abundance estimates presented in this document represent the total number of individuals that make up a given stock or the total number estimated within a particular study or survey area. NMFS' stock abundance estimates for most species represent the total estimate of individuals within the geographic area, if known, that comprises that stock. For some species, this geographic area may extend beyond U.S. waters. All managed stocks in this region are assessed in NMFS' U.S. Pacific and Alaska SARs. All values presented in Table 3 are the most recent available at the time of publication and are available in the 2020 SARs (Carretta et al., 2021, Muto et al., 2021) and draft 2021 SARs (available online at: https://www.fisheries.noaa.gov/national/marine-mammal-protection/draft-marine-mammal-stock-assessment-reports ).

As indicated above, all 12 species (with 12 managed stocks) in Table 3 temporally and spatially co-occur with the activity to the degree that take is reasonably likely to occur. While humpback whales ( Megaptera novaeangliae ) and killer whales from the Southern Resident stock are known to occur in Puget Sound, in consideration of the proposed requirements described in the Proposed Mitigation and Proposed Monitoring and Reporting sections of this notice, WSDOT has determined that take of these species is unlikely to occur and has therefore not requested take of humpback whales or Southern Resident killer whales. NMFS has concurred with this determination and no take of these species is anticipated or proposed to be authorized.

Gray whales generally spend the summer and fall in Arctic feeding grounds and winter to early spring in Mexican breeding areas. Between October and February, the species migrates south along the U.S. West Coast, returning north between February and July (Carretta et al., 2021). A subpopulation of the Eastern North Pacific stock, referred to as the Pacific Coast Feeding Group (PCFG), remains along the Washington and Oregon coast to feed for extended periods while the rest of the stock continues along their migratory path (Calambokidis et al., 2018). Occurrence of gray whales in Puget Sound has been steadily increasing in recent years and is generally highest between February and May. Most gray whales remain further north in Puget Sound, concentrating in the waters around Whidbey Island, but some venture south, including into Elliott Bay near WSDOT's proposed activities (Orca Network, 2021). During 372 total days of construction at the Washington State Ferries Multimodal Project at Colman Dock in Seattle between 2017 and 2021, a total of 4 gray whales were observed, with a maximum of 1 individual observed on a single day.

Biologically Important Areas (BIAs) for feeding gray whales along the coasts of Washington, Oregon, and California have been identified, including northern Puget Sound, Northwestern Washington, and Grays Harbor in Washington, Depoe Bay and Cape Blanco and Orford Reef in Oregon, and Point St. George in California; most of these areas are of importance from late spring through early fall (Calambokidis et al., 2015). BIAs have also been identified for migrating gray whales along the entire coasts of Washington (including the inland waters of Puget Sound), Oregon, and California; although most whales travel within 10 km from shore, the BIAs were extended out to 47 km from the coastline (Calambokidis et al., 2015).

On May 30, 2019, NMFS declared an unusual mortality event (UME) for gray whales after elevated numbers of strandings occurred along the U.S. west coast. As of January 7, 2022, a total of 502 stranded gray whales have been reported, including 256 in the United States (117 in Alaska, 56 in Washington, 12 in Oregon, and 71 in California), 225 in Mexico, and 21 in Canada. Full or partial necropsy examinations were conducted on a subset of the whales. Preliminary findings in several of the whales have shown evidence of emaciation. These findings are not consistent across all of the whales examined, so more research is needed. The UME is ongoing, and NMFS continues to investigate the cause(s). Additional information about the UME is available at https://www.fisheries.noaa.gov/national/marine-life-distress/2019-2020-gray-whale-unusual-mortality-event-along-west-coast.

The International Whaling Commission (IWC) recognizes three stocks of minke whales in the North Pacific: The Sea of Japan/East China Sea, the rest of the western Pacific west of 180° N, and the remainder of the Pacific (Donovan 1991). Minke whales are relatively common in the Bering and Chukchi seas and in the Gulf of Alaska, but are not considered abundant in any other part of the eastern Pacific (Brueggeman et al., 1990). In the far north, minke whales are thought to be migratory, but they are believed to be year-round residents in coastal waters off the west coast of the United States (Dorsey et al., 1990).

Minke whales are reported in Washington inland waters year-round, although few are reported in the winter ( i.e., during the anticipated in-water work window for these projects; Calambokidis and Baird 1994). They are relatively common in the San Juan Islands and Strait of Juan de Fuca (especially around several of the banks in both the central and eastern Strait), but are relatively rare in Puget Sound and the Orca Network has no sighting records of minke whales in the project areas. During 372 total days of construction at the Washington State Ferries Multimodal Project at Colman Dock in Seattle between 2017 and 2021, a single minke whale was observed.

Long-beaked common dolphins are commonly found along the U.S. West Coast, from Baja California, Mexico (including the Gulf of California), northward to about central California (Carretta et al., 2020). The Salish Sea is not considered part of their typical range (Carretta et al., 2020), but there have been reports of long-beaked common dolphins in inland waters. Two individual common dolphins were observed in August and September of 2011 (Whale Museum, 2015). The first record of a pod of long-beaked common dolphins in this area came in the summer of 2016. Beginning on June 16, 2016 long-beaked common dolphins were observed near Victoria, B.C. Over the following weeks, a pod of 15 to 20 (including a calf) was observed in central and southern Puget Sound. They were positively identified as long-beaked common dolphins (Orca Network 2016). Two long-beaked common dolphins were observed by Washington State Department of Transportation (WSDOT) marine mammal monitors during construction at Washington State Ferries Multimodal Project at Colman Dock in Seattle during the 2017-18 construction window (WSDOT 2019).

Bottlenose dolphins are distributed worldwide from approximately 45° N to 45° S. Bottlenose dolphins inhabiting west coast U.S. waters are considered to be in either the California coastal stock, which ranges from Mexico to the San Francisco area within approximately 1 kilometer of shore, or the California/Oregon/Washington offshore stock, which is most commonly found along the California coast, northward to about the Oregon border. NMFS offshore surveys from 1991 to 2014 resulted in no sightings during study transects off the Oregon or Washington coasts (Carretta et al., 2019). In September 2017, however, multiple sightings of a bottlenose dolphin throughout the Puget Sound and in Elliott Bay were reported to Cascadia Research Collective and Orca Network. One of the individuals was identified as belonging to the California coastal stock (Cascadia Research Collective, 2017). Bottlenose dolphins are considered rare in Puget Sound but occasional sightings have continued since the initial reports in 2017 (Orca Network, 2021). During 372 total days of construction at the Washington State Ferries Multimodal Project at Colman Dock in Seattle between 2017 and 2021, a total of 6 bottlenose dolphins were observed, with a maximum of 2 individuals observed on a single day.

The Pacific white-sided dolphin is found in cool temperate waters of the North Pacific from the southern Gulf of California to Alaska. Across the North Pacific, it appears to have a relatively narrow distribution between 38° N and 47° N (Brownell et al., 1999). In the eastern North Pacific Ocean, the Pacific white-sided dolphin is one of the most common cetacean species, occurring primarily in shelf and slope waters (Green et al., 1993; Barlow 2003, 2010). It is known to occur close to shore in certain regions, including (seasonally) southern California (Brownell et al., 1999). Results of aerial and shipboard surveys strongly suggest seasonal north-south movements of the species between California and Oregon/Washington; the movements apparently are related to oceanographic influences, particularly water temperature (Green et al., 1993; Forney and Barlow 1998; Buchanan et al., 2001). During winter, this species is most abundant in California slope and offshore areas; as northern waters begin to warm in the spring, it appears to move north to slope and offshore waters off Oregon/Washington (Green et al., 1992, 1993; Forney 1994; Forney et al., 1995; Buchanan et al., 2001; Barlow 2003). The highest encounter rates off Oregon and Washington have been reported during March-May in slope and offshore waters (Green et al., 1992). Large groups of Pacific white-sided dolphins have been observed in San Juan Channel (Orca Network 2012), north of Puget Sound, and may rarely occur in Central Puget Sound. During 372 total days of construction at the Washington State Ferries Multimodal Project at Colman Dock in Seattle between 2017 and 2021, a total of 2 Pacific white-sided dolphins were observed on one day of construction.

There are three distinct ecotypes, or forms, of killer whales recognized in the north Pacific: resident, transient, and offshore. The three ecotypes differ morphologically, ecologically, behaviorally, and genetically. Resident killer whales exclusively prey upon fish, with a clear preference for salmon (Ford and Ellis 2006; Hanson et al., 2010; Ford et al., 2016), while transient killer whales exclusively prey upon marine mammals (Caretta et al., 2019). Less is known about offshore killer whales, but they are believed to consume primarily fish, including several species of shark (Dahlheim et al., 2008). Currently, there are eight killer whale stocks recognized in the U.S. Pacific (Carretta et al., 2021; Muto et al., 2021). Of those, individuals from the West Coast Transient stock may occur in the project areas and be taken incidental to WSDOT's proposed activities.

Within Puget Sound, transient killer whales primarily hunt pinnipeds and porpoises, though some groups will occasionally target larger whales. The West Coast Transient stock of killer whales occurs from California through southeast Alaska (Muto et al., 2021). The seasonal movements of transients are largely unpredictable, although there is a tendency to investigate harbor seal haulouts off Vancouver Island more frequently during the pupping season in August and September (Baird 1994; Ford 2014). Transient killer whales have been observed in central Puget Sound in all months (Orca Network 2021). During 372 total days of construction at the Washington State Ferries Multimodal Project at Colman Dock in Seattle between 2017 and 2021, a total of 47 transient killer whales were observed, with a maximum of 20 individuals observed on a single day.

In the eastern North Pacific Ocean, harbor porpoise are found in coastal and inland waters from Point Barrow, along the Alaskan coast, and down the west coast of North America to Point Conception, California (Gaskin 1984). Harbor porpoise are known to occur year-round in the inland trans-boundary waters of Washington and British Columbia, Canada (Osborne et al., 1988), and along the Oregon/Washington coast (Barlow 1988, Barlow et al., 1988, Green et al., 1992). There was a significant decline in harbor porpoise sightings within southern Puget Sound between the 1940s and 1990s but sightings have increased seasonally in the last 10 years (Carretta et al., 2019). Annual winter aerial surveys conducted by the Washington Department of Fish and Wildlife from 1995 to 2015 revealed an increasing trend in harbor porpoise in Washington inland waters, including the return of harbor porpoise to Puget Sound. The data suggest that harbor porpoise were already present in Juan de Fuca, Georgia Straits, and the San Juan Islands from the mid-1990s to mid-2000s, and then expanded into Puget Sound and Hood Canal from the mid-2000s to 2015, areas they had used historically but abandoned. Changes in fishery-related entanglement was suspected as the cause of their previous decline and more recent recovery, including a return to Puget Sound (Evenson et al., 2016). Seasonal surveys conducted in spring, summer, and fall 2013-2015 in Puget Sound and Hood Canal documented substantial numbers of harbor porpoise in Puget Sound. Observed porpoise numbers were twice as high in spring as in fall or summer, indicating a seasonal shift in distribution of harbor porpoise (Smultea 2015). The reasons for the seasonal shift and for the increase in sightings is unknown. During 372 total days of construction at the Washington State Ferries Multimodal Project at Colman Dock in Seattle between 2017 and 2021, a total of 413 harbor porpoises were observed, with a maximum of 40 individuals observed on a single day.

Dall's porpoises are endemic to temperate waters of the North Pacific Ocean. Off the U.S. West Coast, they are commonly seen in shelf, slope, and offshore waters (Morejohn 1979). Sighting patterns from aerial and shipboard surveys conducted in California, Oregon, and Washington (Green et al., 1992, 1993; Forney and Barlow 1998; Barlow 2016) suggest that north-south movement between these states occurs as oceanographic conditions change, both on seasonal and inter-annual time scales. Dall's porpoise are considered rare in Puget Sound. During 372 total days of construction at the Washington State Ferries Multimodal Project at Colman Dock in Seattle between 2017 and 2021, a total of 8 Dall's porpoises were observed, with a maximum of 5 individuals observed on a single day.

The California sea lion is the most frequently sighted pinniped found in Washington waters and uses haul-out sites along the outer coast, Strait of Juan de Fuca, and in Puget Sound. Haul-out sites are located on jetties, offshore rocks and islands, log booms, marina docks, and navigation buoys. This species also may be frequently seen resting in the water, rafted together in groups in Puget Sound. Only male California sea lions migrate into Pacific Northwest waters, with females remaining in waters near their breeding rookeries off the coast of California and Mexico. The California sea lion was considered rare in Washington waters prior to the 1950s. More recently, peak numbers of 3,000 to 5,000 animals move into the Salish Sea during the fall and remain until late spring, when most return to breeding rookeries in California and Mexico (Jeffries et al., 2000).

California sea lions are often observed in the area of potential effects and are known to be comfortable and seemingly curious around human activities. The nearest documented California sea lion haulout is 2.3 mi (3.7 km) southeast of the project sites on Blakely Rocks. Jeffries et al. (2000) estimated less than 100 California sea lions occupy the Blakely Rocks haulout site. California sea lions are not commonly observed in Eagle Harbor but are regularly observed in Elliott Bay, especially around two navigational buoys near Alki Point, at the southwest edge of Elliott Bay. During 372 total days of construction at the Washington State Ferries Multimodal Project at Colman Dock in Seattle between 2017 and 2021, a maximum of 38 California sea lions were observed on a single day.

Steller sea lions range along the North Pacific Rim from northern Japan to California (Loughlin et al., 1984). There are two separate stocks of Steller sea lions, the Eastern U.S. stock, which occurs east of Cape Suckling, Alaska (144° W), and the Western U.S. stock, which occurs west of that point. Only the Western stock of Steller sea lions, which is designated as the Western DPS of Steller sea lions, is listed as endangered under the ESA (78 FR 66139; November 4, 2013). Unlike the Western U.S. stock of Steller sea lions, there has been a sustained and robust increase in abundance of the Eastern U.S. stock throughout its breeding range. The eastern stock of Steller sea lions has historically bred on rookeries located in Southeast Alaska, British Columbia, Oregon, and California. However, within the last several years a new rookery has become established on the outer Washington coast (at the Carroll Island and Sea Lion Rock complex), with more than 100 pups born there in 2015 (Muto et al., 2020).

Steller sea lions use haul-out locations in Puget Sound, and may occur at the same haul-outs as California sea lions, but are considered rare visitors to the waters around Bainbridge Island. Few Steller sea lions have been observed during monitoring of recent construction projects in the Seattle area; typically fewer than 5 total observations per year ( e.g., Anchor QEA 2018, 2019). During 372 total days of construction at the Washington State Ferries Multimodal Project at Colman Dock in Seattle between 2017 and 2021, a total of 100 Steller sea lions were observed, with a maximum of 10 Steller sea lions observed on a single day.

Harbor seals inhabit coastal and estuarine waters off Baja California, north along the western coasts of the continental U.S., British Columbia, and Southeast Alaska, west through the Gulf of Alaska and Aleutian Islands, and in the Bering Sea north to Cape Newenham and the Pribilof Islands (Carretta et al., 2014). They haul out on rocks, reefs, beaches, and drifting glacial ice and feed in marine, estuarine, and occasionally fresh waters. Harbor seals generally are non-migratory, with local movements associated with such factors as tides, weather, season, food availability, and reproduction (Scheffer and Slipp 1944; Fisher 1952; Bigg 1969, 1981). Within U.S. west coast waters, five stocks of harbor seals are recognized: (1) Southern Puget Sound (south of the Tacoma Narrows Bridge); (2) Washington Northern Inland Waters (including Puget Sound north of the Tacoma Narrows Bridge, the San Juan Islands, and the Strait of Juan de Fuca); (3) Hood Canal; (4) Oregon/Washington Coast; and (5) California. Harbor seals in the project areas would be from the Washington Northern Inland Waters stock.

Harbor seals are the only pinniped species that occurs year-round and breeds in Washington waters (Jeffries et al., 2000). Pupping seasons vary by geographic region, with pups born in coastal estuaries (Columbia River, Willapa Bay, and Grays Harbor) from mid-April through June; Olympic Peninsula coast from May through July; San Juan Islands and eastern bays of Puget Sound from June through August; southern Puget Sound from mid-July through September; and Hood Canal from August through January (Jeffries et al., 2000). The most recent estimate for the Washington Northern Inland Waters Stock is 11,036 based on surveys conducted in 1999. There are no current estimates of abundance for this stock but the population is thought to be stable (Carretta et al., 2014).

There is one documented harbor seal haulout area near Bainbridge Island at Blakely Rocks, approximately 2.3 mi (3.7 km) southeast of the project sites. The haulout, which is estimated at less than 100 animals, consists of intertidal rocks and reef areas (Jefferies et al., 2000). Harbor seals are a commonly observed marine mammal in the area of potential effects and are known to be comfortable and seemingly curious around human activities. Observations of harbor seals were reported during many recent construction projects along the Seattle waterfront. During 372 total days of construction at the Washington State Ferries Multimodal Project at Colman Dock in Seattle between 2017 and 2021, a maximum of 43 harbor seals were observed on a single day.

Northern elephant seals breed and give birth in California (U.S.) and Baja California (Mexico), primarily on offshore islands (Stewart et al., 1994), from December to March (NOAA 2015). Males migrate to the Gulf of Alaska and western Aleutian Islands along the continental shelf to feed on benthic prey, while females migrate to pelagic areas in the Gulf of Alaska and the central North Pacific Ocean to feed on pelagic prey (Le Boeuf et al., 2000). Adults return to land between March and August to molt, with males returning later than females. Adults return to their feeding areas again between their spring/summer molting and their winter breeding seasons (Carretta et al., 2015).

During 372 total days of construction at the Washington State Ferries Multimodal Project at Colman Dock in Seattle between 2017 and 2021, a single northern elephant seal was observed. Elephant seals are generally considered rare in Puget Sound. However, a female elephant seal has been reported hauled-out in Mutiny Bay on Whidbey Island periodically since 2010. She was observed alone for her first three visits to the area, but in March 2015, she was seen with a pup. Since then, she has produced two more pups, born in 2018 and 2020. Northern elephant seals generally give birth in January but this individual has repeatedly given birth in March. She typically returns to Mutiny Bay in April and May to molt. Her pups have also repeatedly returned to haul-out on nearby beaches (Orca Network 2020).

Hearing is the most important sensory modality for marine mammals underwater, and exposure to anthropogenic sound can have deleterious effects. To appropriately assess the potential effects of exposure to sound, it is necessary to understand the frequency ranges marine mammals are able to hear. Not all marine mammal species have equal hearing capabilities ( e.g., Richardson et al., 1995; Wartzok and Ketten, 1999; Au and Hastings, 2008). To reflect this, Southall et al. (2007, 2019) recommended that marine mammals be divided into hearing groups based on directly measured (behavioral or auditory evoked potential techniques) or estimated hearing ranges (behavioral response data, anatomical modeling, etc.). Note that no direct measurements of hearing ability have been successfully completed for mysticetes ( i.e., low-frequency cetaceans). Subsequently, NMFS (2018) described generalized hearing ranges for these marine mammal hearing groups. Generalized hearing ranges were chosen based on the approximately 65 decibel (dB) threshold from the normalized composite audiograms, with the exception for lower limits for low-frequency cetaceans where the lower bound was deemed to be biologically implausible and the lower bound from Southall et al. (2007) retained. Marine mammal hearing groups and their associated hearing ranges are provided in Table 4.

The pinniped functional hearing group was modified from Southall et al. (2007) on the basis of data indicating that phocid species have consistently demonstrated an extended frequency range of hearing compared to otariids, especially in the higher frequency range (Hemilä et al., 2006; Kastelein et al., 2009; Reichmuth and Holt, 2013).

For more detail concerning these groups and associated frequency ranges, please see NMFS (2018) for a review of available information.

This section includes a discussion of the ways that components of the specified activity may impact marine mammals and their habitat. The Estimated Take section later in this document includes a quantitative analysis of the number of individuals that are expected to be taken by this activity. The Negligible Impact Analysis and Determination section considers the content of this section, the Estimated Take section, and the Proposed Mitigation section, to draw conclusions regarding the likely impacts of these activities on the reproductive success or survivorship of individuals and whether those impacts are reasonably expected to, or reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival.

Acoustic effects on marine mammals during the specified activities can occur from impact pile driving and vibratory driving and removal. The effects of underwater noise from WSDOT's proposed activities have the potential to result in Level A or Level B harassment of marine mammals in the action areas.

The marine soundscape is comprised of both ambient and anthropogenic sounds. Ambient sound is defined as the all-encompassing sound in a given place and is usually a composite of sound from many sources both near and far (ANSI 1995). The sound level of an area is defined by the total acoustical energy being generated by known and unknown sources. These sources may include physical ( e.g., waves, wind, precipitation, earthquakes, ice, atmospheric sound), biological ( e.g., sounds produced by marine mammals, fish, and invertebrates), and anthropogenic sound ( e.g., vessels, dredging, aircraft, construction).

The sum of the various natural and anthropogenic sound sources at any given location and time—which comprise “ambient” or “background” sound—depends not only on the source levels (as determined by current weather conditions and levels of biological and shipping activity) but also on the ability of sound to propagate through the environment. In turn, sound propagation is dependent on the spatially and temporally varying properties of the water column and sea floor, and is frequency-dependent. As a result of the dependence on a large number of varying factors, ambient sound levels can be expected to vary widely over both coarse and fine spatial and temporal scales. Sound levels at a given frequency and location can vary by 10-20 decibels (dB) from day to day (Richardson et al., 1995). The result is that, depending on the source type and its intensity, sound from the specified activities may be a negligible addition to the local environment or could form a distinctive signal that may affect marine mammals.

In-water construction activities associated with the projects would include impact and vibratory pile driving and removal. The sounds produced by these activities fall into one of two general sound types: impulsive and non-impulsive. Impulsive sounds ( e.g., explosions, sonic booms, impact pile driving) are typically transient, brief (less than 1 second), broadband, and consist of high peak sound pressure with rapid rise time and rapid decay (ANSI, 1986; NIOSH, 1998; NMFS, 2018). Non-impulsive sounds ( e.g., machinery operations such as drilling or dredging, vibratory pile driving, underwater chainsaws, and active sonar systems) can be broadband, narrowband or tonal, brief or prolonged (continuous or intermittent), and typically do not have the high peak sound pressure with raid rise/decay time that impulsive sounds do (ANSI 1995; NIOSH 1998; NMFS 2018). The distinction between these two sound types is important because they have differing potential to cause physical effects, particularly with regard to hearing ( e.g., Ward 1997 in Southall et al., 2007).

Two types of hammers would be used on these projects, impact and vibratory. Impact hammers operate by repeatedly dropping and/or pushing a heavy piston onto a pile to drive the pile into the substrate. Sound generated by impact hammers is considered impulsive. Vibratory hammers install piles by vibrating them and allowing the weight of the hammer to push them into the sediment. Vibratory hammers produce non-impulsive, continuous sounds. Vibratory hammering generally produces SPLs 10 to 20 dB lower than impact pile driving of the same-sized pile (Oestman et al., 2009). Rise time is slower, reducing the probability and severity of injury, and sound energy is distributed over a greater amount of time (Nedwell and Edwards, 2002; Carlson et al., 2005).

The likely or possible impacts of WSDOT's proposed activities on marine mammals could be generated from both non-acoustic and acoustic stressors. Potential non-acoustic stressors include the physical presence of the equipment, vessels, and personnel; however, we expect that any animals that approach the project site(s) close enough to be harassed due to the presence of equipment or personnel would be within the Level B harassment zones from pile driving and would already be subject to harassment from the in-water activities. Therefore, any impacts to marine mammals are expected to primarily be acoustic in nature. Acoustic stressors are generated by heavy equipment operation during pile installation and removal ( i.e., impact and vibratory pile driving and removal).

The introduction of anthropogenic noise into the aquatic environment from pile driving equipment is the primary means by which marine mammals may be harassed from WSDOT's specified activities. In general, animals exposed to natural or anthropogenic sound may experience physical and psychological effects, ranging in magnitude from none to severe (Southall et al., 2007). Generally, exposure to pile driving and removal and other construction noise has the potential to result in auditory threshold shifts and behavioral reactions ( e.g., avoidance, temporary cessation of foraging and vocalizing, changes in dive behavior). Exposure to anthropogenic noise can also lead to non-observable physiological responses such as an increase in stress hormones. Additional noise in a marine mammal's habitat can mask acoustic cues used by marine mammals to carry out daily functions such as communication and predator and prey detection. The effects of pile driving and demolition noise on marine mammals are dependent on several factors, including, but not limited to, sound type ( e.g., impulsive vs. non-impulsive), the species, age and sex class ( e.g., adult male vs. mother with calf), duration of exposure, the distance between the pile and the animal, received levels, behavior at time of exposure, and previous history with exposure (Wartzok et al., 2004; Southall et al., 2007). Here we discuss physical auditory effects (threshold shifts) followed by behavioral effects and potential impacts on habitat. No physiological effects other than PTS are anticipated or proposed to be authorized, and therefore are not discussed further.

NMFS defines a noise-induced threshold shift (TS) as a change, usually an increase, in the threshold of audibility at a specified frequency or portion of an individual's hearing range above a previously established reference level (NMFS, 2018). The amount of threshold shift is customarily expressed in dB. A TS can be permanent or temporary. As described in NMFS (2018), there are numerous factors to consider when examining the consequence of TS, including, but not limited to, the signal temporal pattern ( e.g., impulsive or non-impulsive), likelihood an individual would be exposed for a long enough duration or to a high enough level to induce a TS, the magnitude of the TS, time to recovery (seconds to minutes or hours to days), the frequency range of the exposure ( i.e., spectral content), the hearing and vocalization frequency range of the exposed species relative to the signal's frequency spectrum ( i.e., how animal uses sound within the frequency band of the signal; e.g., Kastelein et al., 2014), and the overlap between the animal and the source ( e.g., spatial, temporal, and spectral).

Permanent Threshold Shift (PTS) —NMFS defines PTS as a permanent, irreversible increase in the threshold of audibility at a specified frequency or portion of an individual's hearing range above a previously established reference level (NMFS 2018). Available data from humans and other terrestrial mammals indicate that a 40 dB threshold shift approximates PTS onset (see Ward et al., 1958, 1959; Ward, 1960; Kryter et al., 1966; Miller, 1974; Ahroon et al., 1996; Henderson et al., 2008). PTS levels for marine mammals are estimates, because there are limited empirical data measuring PTS in marine mammals ( e.g., Kastak et al., 2008), largely due to the fact that, for various ethical reasons, experiments involving anthropogenic noise exposure at levels inducing PTS are not typically pursued or authorized (NMFS, 2018).

Temporary Threshold Shift (TTS) —TTS is a temporary, reversible increase in the threshold of audibility at a specified frequency or portion of an individual's hearing range above a previously established reference level (NMFS, 2018). Based on data from cetacean TTS measurements (see Southall et al., 2007), a TTS of 6 dB is considered the minimum threshold shift clearly larger than any day-to-day or session-to-session variation in a subject's normal hearing ability (Schlundt et al., 2000; Finneran et al., 2000, 2002). As described in Finneran (2016), marine mammal studies have shown the amount of TTS increases with cumulative sound exposure level (SEL cum ) in an accelerating fashion: At low exposures with lower SEL cum , the amount of TTS is typically small and the growth curves have shallow slopes. At exposures with higher SEL cum , the growth curves become steeper and approach linear relationships with the noise SEL.

Depending on the degree (elevation of threshold in dB), duration ( i.e., recovery time), and frequency range of TTS, and the context in which it is experienced, TTS can have effects on marine mammals ranging from discountable to serious (similar to those discussed in auditory masking, below). For example, a marine mammal may be able to readily compensate for a brief, relatively small amount of TTS in a non-critical frequency range that takes place during a time when the animal is traveling through the open ocean, where ambient noise is lower and there are not as many competing sounds present. Alternatively, a larger amount and longer duration of TTS sustained during time when communication is critical for successful mother/calf interactions could have more serious impacts. We note that reduced hearing sensitivity as a simple function of aging has been observed in marine mammals, as well as humans and other taxa (Southall et al., 2007), so we can infer that strategies exist for coping with this condition to some degree, though likely not without cost.

Currently, TTS data only exist for four species of cetaceans (bottlenose dolphin, beluga whale ( Delphinapterus leucas ), harbor porpoise, and Yangtze finless porpoise ( Neophocoena asiaeorientalis )) and five species of pinnipeds exposed to a limited number of sound sources ( i.e., mostly tones and octave-band noise) in laboratory settings (Finneran, 2015). TTS was not observed in trained spotted ( Phoca largha ) and ringed ( Pusa hispida ) seals exposed to impulsive noise at levels matching previous predictions of TTS onset (Reichmuth et al., 2016). In general, harbor seals and harbor porpoises have a lower TTS onset than other measured pinniped or cetacean species (Finneran, 2015). The potential for TTS from impact pile driving exists. After exposure to playbacks of impact pile driving sounds (rate 2,760 strikes/hour) in captivity, mean TTS increased from 0 dB after 15 minute exposure to 5 dB after 360 minute exposure; recovery occurred within 60 minutes (Kastelein et al., 2016). Additionally, the existing marine mammal TTS data come from a limited number of individuals within these species. No data are available on noise-induced hearing loss for mysticetes. Nonetheless, what we considered is the best available science. For summaries of data on TTS in marine mammals or for further discussion of TTS onset thresholds, please see Southall et al. (2007), Finneran and Jenkins (2012), Finneran (2015), and Table 5 in NMFS (2018).

WSDOT proposes to use impact pile driving to install some piles for these projects. There would likely be pauses in activities producing the sound ( e.g., impact pile driving) during each day. Given these pauses and the fact that many marine mammals are likely moving through the project areas and not remaining for extended periods of time, the potential for TS declines.

Behavioral Harassment —Exposure to noise from pile driving and removal also has the potential to behaviorally disturb marine mammals. Available studies show wide variation in response to underwater sound; therefore, it is difficult to predict specifically how any given sound in a particular instance might affect marine mammals perceiving the signal. If a marine mammal does react briefly to an underwater sound by changing its behavior or moving a small distance, the impacts of the change are unlikely to be significant to the individual, let alone the stock or population. However, if a sound source displaces marine mammals from an important feeding or breeding area for a prolonged period, impacts on individuals and populations could be significant ( e.g., Lusseau and Bejder, 2007; Weilgart, 2007; NRC, 2005).

Disturbance may result in changing durations of surfacing and dives, number of blows per surfacing, or moving direction and/or speed; reduced/increased vocal activities; changing/cessation of certain behavioral activities (such as socializing or feeding); visible startle response or aggressive behavior (such as tail/fluke slapping or jaw clapping); or avoidance of areas where sound sources are located. Pinnipeds may increase their haul-out time, possibly to avoid in-water disturbance (Thorson and Reyff, 2006). Behavioral responses to sound are highly variable and context-specific and any reactions depend on numerous intrinsic and extrinsic factors ( e.g., species, state of maturity, experience, current activity, reproductive state, auditory sensitivity, time of day), as well as the interplay between factors ( e.g., Richardson et al., 1995; Wartzok et al., 2004; Southall et al., 2007; Weilgart, 2007; Archer et al., 2010). Behavioral reactions can vary not only among individuals but also within an individual, depending on previous experience with a sound source, context, and numerous other factors (Ellison et al., 2012), and can vary depending on characteristics associated with the sound source ( e.g., whether it is moving or stationary, number of sources, distance from the source). In general, pinnipeds seem more tolerant of, or at least habituate more quickly to, potentially disturbing underwater sound than do cetaceans, and generally seem to be less responsive to exposure to industrial sound than most cetaceans. Please see Appendices B and C of Southall et al. (2007) for a review of studies involving marine mammal behavioral responses to sound.

Disruption of feeding behavior can be difficult to correlate with anthropogenic sound exposure, so it is usually inferred by observed displacement from known foraging areas, the appearance of secondary indicators ( e.g., bubble nets or sediment plumes), or changes in dive behavior. As for other types of behavioral response, the frequency, duration, and temporal pattern of signal presentation, as well as differences in species sensitivity, are likely contributing factors to differences in response in any given circumstance ( e.g., Croll et al., 2001; Nowacek et al., 2004; Madsen et al., 2006; Yazvenko et al., 2007). A determination of whether foraging disruptions incur fitness consequences would require information on or estimates of the energetic requirements of the affected individuals and the relationship between prey availability, foraging effort and success, and the life history stage of the animal.

In 2016, the Alaska Department of Transportation and Public Facilities (ADOT&PF) documented observations of marine mammals during construction activities ( i.e., pile driving) at the Kodiak Ferry Dock (see 80 FR 60636, October 7, 2015). In the marine mammal monitoring report for that project (ABR 2016), 1,281 Steller sea lions were observed within the Level B disturbance zone during pile driving or drilling ( i.e., documented as Level B harassment take). Of these, 19 individuals demonstrated an alert behavior, 7 were fleeing, and 19 swam away from the project site. All other animals (98 percent) were engaged in activities such as milling, foraging, or fighting and did not change their behavior. In addition, two sea lions approached within 20 m of active vibratory pile driving activities. Three harbor seals were observed within the disturbance zone during pile driving activities; none of them displayed disturbance behaviors. Fifteen killer whales and three harbor porpoise were also observed within the Level B harassment zone during pile driving. The killer whales were travelling or milling while all harbor porpoises were travelling. No signs of disturbance were noted for either of these species. Given the similarities in species, activities, and habitat ( e.g., cool-temperate waters, industrialized area), we expect similar behavioral responses from the same and similar species affected by WSDOT's specified activities. That is, disturbance, if any, is likely to be temporary and localized ( e.g., small area movements).

Stress responses —An animal's perception of a threat may be sufficient to trigger stress responses consisting of some combination of behavioral responses, autonomic nervous system responses, neuroendocrine responses, or immune responses ( e.g., Seyle 1950; Moberg 2000). In many cases, an animal's first and sometimes most economical (in terms of energetic costs) response is behavioral avoidance of the potential stressor. Autonomic nervous system responses to stress typically involve changes in heart rate, blood pressure, and gastrointestinal activity. These responses have a relatively short duration and may or may not have a significant long-term effect on an animal's fitness.

Neuroendocrine stress responses often involve the hypothalamus-pituitary-adrenal system. Virtually all neuroendocrine functions that are affected by stress—including immune competence, reproduction, metabolism, and behavior—are regulated by pituitary hormones. Stress-induced changes in the secretion of pituitary hormones have been implicated in failed reproduction, altered metabolism, reduced immune competence, and behavioral disturbance ( e.g., Moberg 1987; Blecha 2000). Increases in the circulation of glucocorticoids are also equated with stress (Romano et al., 2004).

The primary distinction between stress (which is adaptive and does not normally place an animal at risk) and “distress” is the cost of the response. During a stress response, an animal uses glycogen stores that can be quickly replenished once the stress is alleviated. In such circumstances, the cost of the stress response would not pose serious fitness consequences. However, when an animal does not have sufficient energy reserves to satisfy the energetic costs of a stress response, energy resources must be diverted from other functions. This state of distress will last until the animal replenishes its energetic reserves sufficient to restore normal function.

Relationships between these physiological mechanisms, animal behavior, and the costs of stress responses are well-studied through controlled experiments and for both laboratory and free-ranging animals ( e.g., Holberton et al., 1996; Hood et al., 1998; Jessop et al., 2003; Krausman et al., 2004; Lankford et al., 2005). Stress responses due to exposure to anthropogenic sounds or other stressors and their effects on marine mammals have also been reviewed (Fair and Becker 2000; Romano et al., 2002b) and, more rarely, studied in wild populations ( e.g., Romano et al., 2002a). For example, Rolland et al. (2012) found that noise reduction from reduced ship traffic in the Bay of Fundy was associated with decreased stress in North Atlantic right whales. These and other studies lead to a reasonable expectation that some marine mammals will experience physiological stress responses upon exposure to acoustic stressors and that it is possible that some of these would be classified as “distress.” In addition, any animal experiencing TTS would likely also experience stress responses (NRC, 2003), however distress is an unlikely result of these projects based on observations of marine mammals during previous, similar projects in the area.

Masking —Sound can disrupt behavior through masking, or interfering with, an animal's ability to detect, recognize, or discriminate between acoustic signals of interest ( e.g., those used for intraspecific communication and social interactions, prey detection, predator avoidance, navigation) (Richardson et al., 1995). Masking occurs when the receipt of a sound is interfered with by another coincident sound at similar frequencies and at similar or higher intensity, and may occur whether the sound is natural ( e.g., snapping shrimp, wind, waves, precipitation) or anthropogenic ( e.g., pile driving, shipping, sonar, seismic exploration) in origin. The ability of a noise source to mask biologically important sounds depends on the characteristics of both the noise source and the signal of interest ( e.g., signal-to-noise ratio, temporal variability, direction), in relation to each other and to an animal's hearing abilities ( e.g., sensitivity, frequency range, critical ratios, frequency discrimination, directional discrimination, age or TTS hearing loss), and existing ambient noise and propagation conditions. Masking of natural sounds can result when human activities produce high levels of background sound at frequencies important to marine mammals. Conversely, if the background level of underwater sound is high ( e.g., on a day with strong wind and high waves), an anthropogenic sound source would not be detectable as far away as would be possible under quieter conditions and would itself be masked. The Puget Sound area contains active commercial shipping, ferry operations, and commercial fishing as well as numerous recreational and other commercial vessels, and background sound levels in the area are already elevated.

Airborne Acoustic Effects —Pinnipeds that occur near the project site could be exposed to airborne sounds associated with pile driving and removal that have the potential to cause behavioral harassment, depending on their distance from pile driving activities. Cetaceans are not expected to be exposed to airborne sounds that would result in harassment as defined under the MMPA.

Airborne noise would primarily be an issue for pinnipeds that are swimming or hauled out near the project site within the range of noise levels elevated above the acoustic criteria. We recognize that pinnipeds in the water could be exposed to airborne sound that may result in behavioral harassment when looking with their heads above water. Most likely, airborne sound would cause behavioral responses similar to those discussed above in relation to underwater sound. For instance, anthropogenic sound could cause hauled-out pinnipeds to exhibit changes in their normal behavior, such as reduction in vocalizations, or cause them to temporarily abandon the area and move further from the source. However, these animals would likely previously have been `taken' because of exposure to underwater sound above the behavioral harassment thresholds, which are generally larger than those associated with airborne sound. There are no haulouts near the project sites. Thus, the behavioral harassment of these animals is already accounted for in these estimates of potential take. Therefore, we do not believe that authorization of incidental take resulting from airborne sound for pinnipeds is warranted, and airborne sound is not discussed further here.

WSDOT's proposed construction activities could have localized, temporary impacts on marine mammal habitat, including prey, by increasing in-water sound pressure levels and slightly decreasing water quality. Increased noise levels may affect acoustic habitat (see masking discussion above) and adversely affect marine mammal prey in the vicinity of the project areas (see discussion below). During impact and vibratory pile driving or removal, elevated levels of underwater noise would ensonify the project areas where both fishes and mammals occur and could affect foraging success. Additionally, marine mammals may avoid the area during construction, however, displacement due to noise is expected to be temporary and is not expected to result in long-term effects to the individuals or populations. Construction activities are of short duration and would likely have temporary impacts on marine mammal habitat through increases in underwater and airborne sound.

A temporary and localized increase in turbidity near the seafloor would occur in the immediate area surrounding the area where piles are installed or removed. In general, turbidity associated with pile installation is localized to about a 25-ft (7.6-m) radius around the pile (Everitt et al., 1980). The sediments of the project site will settle out rapidly when disturbed. Cetaceans are not expected to be close enough to the pile driving areas to experience effects of turbidity, and any pinnipeds could avoid localized areas of turbidity. Local currents are anticipated to disburse any additional suspended sediments produced by project activities at moderate to rapid rates depending on tidal stage. Therefore, we expect the impact from increased turbidity levels to be discountable to marine mammals and do not discuss it further.

The area likely impacted by the project is relatively small compared to the available habitat in Puget Sound. The area is highly influenced by anthropogenic activities. The total seafloor area affected by pile installation and removal is a small area compared to the vast foraging area available to marine mammals in the area. At best, the impact area provides marginal foraging habitat for marine mammals and fishes. Furthermore, pile driving and removal at the project site would not obstruct long-term movements or migration of marine mammals.

Avoidance by potential prey ( i.e., fish or, in the case of transient killer whales, other marine mammals) of the immediate area due to the temporary loss of this foraging habitat is also possible. The duration of fish and marine mammal avoidance of this area after pile driving stops is unknown, but a rapid return to normal recruitment, distribution, and behavior is anticipated. Any behavioral avoidance by fish or marine mammals of the disturbed area would still leave significantly large areas of fish and marine mammal foraging habitat in the nearby vicinity.

In-Water Construction Effects on Potential Prey —Sound may affect marine mammals through impacts on the abundance, behavior, or distribution of prey species ( e.g., crustaceans, cephalopods, fish, zooplankton, other marine mammals). Marine mammal prey varies by species, season, and location. Here, we describe studies regarding the effects of noise on known marine mammal prey other than other marine mammals (which have been discussed earlier).

Fish utilize the soundscape and components of sound in their environment to perform important functions such as foraging, predator avoidance, mating, and spawning ( e.g., Zelick and Mann, 1999; Fay, 2009). Depending on their hearing anatomy and peripheral sensory structures, which vary among species, fishes hear sounds using pressure and particle motion sensitivity capabilities and detect the motion of surrounding water (Fay et al., 2008). The potential effects of noise on fishes depends on the overlapping frequency range, distance from the sound source, water depth of exposure, and species-specific hearing sensitivity, anatomy, and physiology. Key impacts to fishes may include behavioral responses, hearing damage, barotrauma (pressure-related injuries), and mortality.

Fish react to sounds which are especially strong and/or intermittent low-frequency sounds, and behavioral responses such as flight or avoidance are the most likely effects. Short duration, sharp sounds can cause overt or subtle changes in fish behavior and local distribution. The reaction of fish to noise depends on the physiological state of the fish, past exposures, motivation ( e.g., feeding, spawning, migration), and other environmental factors. Hastings and Popper (2005) identified several studies that suggest fish may relocate to avoid certain areas of sound energy. Additional studies have documented effects of pile driving on fish; several are based on studies in support of large, multiyear bridge construction projects ( e.g., Scholik and Yan, 2001, 2002; Popper and Hastings, 2009). Several studies have demonstrated that impulse sounds might affect the distribution and behavior of some fishes, potentially impacting foraging opportunities or increasing energetic costs ( e.g., Fewtrell and McCauley, 2012; Pearson et al., 1992; Skalski et al., 1992; Santulli et al., 1999; Paxton et al., 2017). However, some studies have shown no or slight reaction to impulse sounds ( e.g., Pena et al., 2013; Wardle et al., 2001; Jorgenson and Gyselman, 2009; Popper et al., 2015).

SPLs of sufficient strength have been known to cause injury to fish and fish mortality. However, in most fish species, hair cells in the ear continuously regenerate and loss of auditory function likely is restored when damaged cells are replaced with new cells. Halvorsen et al. (2012a) showed that a TTS of 4-6 dB was recoverable within 24 hours for one species. Impacts would be most severe when the individual fish is close to the source and when the duration of exposure is long. Injury caused by barotrauma can range from slight to severe and can cause death, and is most likely for fish with swim bladders. Barotrauma injuries have been documented during controlled exposure to impact pile driving (Halvorsen et al., 2012b; Casper et al., 2013).

The most likely impact to fishes from pile driving and removal and construction activities at the project areas would be temporary behavioral avoidance of the area. The duration of fish avoidance of this area after pile driving stops is unknown, but a rapid return to normal recruitment, distribution, and behavior is anticipated.

Construction activities, in the form of increased turbidity, have the potential to adversely affect forage fish in the project areas. Forage fish form a significant prey base for many marine mammal species that occur in the project areas. Increased turbidity is expected to occur in the immediate vicinity (on the order of 10 ft (3 m) or less) of construction activities. However, suspended sediments and particulates are expected to dissipate quickly within a single tidal cycle. Given the limited area affected and high tidal dilution rates any effects on forage fish are expected to be minor or negligible. Finally, exposure to turbid waters from construction activities is not expected to be different from the current exposure; fish and marine mammals in Eagle Harbor are routinely exposed to substantial levels of suspended sediment from natural and anthropogenic sources.

In summary, given the short daily duration of sound associated with individual pile driving events and the relatively small areas being affected, pile driving activities associated with the proposed actions are not likely to have a permanent, adverse effect on any fish habitat, or populations of fish species. Any behavioral avoidance by fish of the disturbed area would still leave significantly large areas of fish and marine mammal foraging habitat in the nearby vicinity. Thus, we conclude that impacts of the specified activities are not likely to have more than short-term adverse effects on any prey habitat or populations of prey species. Further, any impacts to marine mammal habitat are not expected to result in significant or long-term consequences for individual marine mammals, or to contribute to adverse impacts on their populations.

This section provides an estimate of the number of incidental takes proposed for authorization through this IHA, which will inform both NMFS' consideration of “small numbers” and the negligible impact determinations.

Harassment is the only type of take expected to result from these activities. Except with respect to certain activities not pertinent here, section 3(18) of 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).

Authorized takes would primarily be by Level B harassment (in the form of behavioral disturbance and TTS), as use of the acoustic sources ( i.e., vibratory or impact pile driving and removal) have the potential to result in disruption of behavioral patterns and cause a temporary loss in hearing sensitivity for individual marine mammals. There is also some potential for auditory injury (Level A harassment) to result for porpoises and harbor seals because predicted auditory injury zones are larger. The proposed mitigation and monitoring measures are expected to minimize the severity of the taking to the extent practicable.

As described previously, no serious injury or mortality is anticipated or proposed to be authorized for this activity. Below we describe how the proposed take numbers are estimated.

For acoustic impacts, generally speaking, we estimate take by considering: (1) Acoustic thresholds above which NMFS believes the best available science indicates marine mammals will be behaviorally harassed or incur some degree of permanent hearing impairment; (2) the area or volume of water that will be ensonified above these levels in a day; (3) the density or occurrence of marine mammals within these ensonified areas; and, (4) the number of days of activities. We note that while these factors can contribute to a basic calculation to provide an initial prediction of potential takes, additional information that can qualitatively inform take estimates is also sometimes available ( e.g., previous monitoring results or average group size). Below, we describe the factors considered here in more detail and present the proposed take estimates.

NMFS recommends the use of acoustic thresholds that identify the received level of underwater sound above which exposed marine mammals would be reasonably expected to be behaviorally harassed (equated to Level B harassment) or to incur PTS of some degree (equated to Level A harassment).

Level B Harassment —Though significantly driven by received level, the onset of behavioral disturbance from anthropogenic noise exposure is also informed to varying degrees by other factors related to the source or exposure context ( e.g., frequency, predictability, duty cycle, duration of the exposure, signal-to-noise ratio, distance to the source), the environment ( e.g., bathymetry, other noises in the area, predators in the area), and the receiving animals (hearing, motivation, experience, demography, life stage, depth) and can be difficult to predict ( e.g., Southall et al., 2007, 2021, Ellison et al., 2012). Based on what the available science indicates and the practical need to use a threshold based on a metric that is both predictable and measurable for most activities, NMFS typically uses a generalized acoustic threshold based on received level to estimate the onset of behavioral harassment. NMFS generally predicts that marine mammals are likely to be behaviorally harassed in a manner considered to be Level B harassment when exposed to underwater anthropogenic noise above root-mean-squared pressure received levels (rms SPL) of 120 dB (referenced to 1 micropascal (re 1 μPa)) for continuous ( e.g., vibratory pile-driving, drilling) and above rms SPL 160 dB re 1 μPa for non-explosive impulsive ( e.g., seismic airguns) or intermittent ( e.g., scientific sonar) sources.

WSDOT's proposed activities includes the use of continuous (vibratory hammer) and impulsive (impact hammer) sources, and therefore the 120 and 160 dB re 1 μPa (rms) thresholds are applicable.

Level A harassment —NMFS' Technical Guidance for Assessing the Effects of Anthropogenic Sound on Marine Mammal Hearing (Version 2.0) (Technical Guidance, 2018) identifies dual criteria to assess auditory injury (Level A harassment) to five different marine mammal groups (based on hearing sensitivity) as a result of exposure to noise from two different types of sources (impulsive or non-impulsive). WSDOT's activities include the use of impulsive (impact hammer) and non-impulsive (vibratory hammer) sources.

These thresholds are provided in the table below. The references, analysis, and methodology used in the development of the thresholds are described in NMFS' 2018 Technical Guidance, which may be accessed at: www.fisheries.noaa.gov/national/marine-mammal-protection/marine-mammal-acoustic-technical-guidance.

Here, we describe operational and environmental parameters of the activity that are used in estimating the area ensonified above the acoustic thresholds, including source levels and transmission loss coefficient.

The sound field in the project areas is the existing background noise plus additional construction noise from the proposed project. Marine mammals are expected to be affected by sound generated by the primary components of the project ( i.e., impact and vibratory pile driving).

In order to calculate distances to the Level A harassment and Level B harassment thresholds for the methods and piles being used in these projects, NMFS used acoustic monitoring data from previous pile driving at the Bainbridge Island Ferry Terminal (impact installation of 24-in steel piles) and Eagle Harbor Maintenance Facility (impact installation of 30-in steel piles), as well as pile driving at other locations within Puget Sound to develop source levels for the various pile types, sizes, and methods for the two projects (Table 6). A source level for vibratory driving of 18-in steel piles is not available so it is conservatively assumed to be equivalent to the source level for 24-in steel piles.

Transmission loss (TL) is the decrease in acoustic intensity as an acoustic pressure wave propagates out from a source. TL parameters vary with frequency, temperature, sea conditions, current, source and receiver depth, water depth, water chemistry, and bottom composition and topography. The general formula for underwater TL is:

The recommended TL coefficient for most nearshore environments is the practical spreading value of 15. This value results in an expected propagation environment that would lie between spherical and cylindrical spreading loss conditions, which is the most appropriate assumption for WSDOT's proposed activities in the absence of specific modelling. The Level B harassment zones for WSDOT's proposed activities are shown in Table 7.

The ensonified area associated with Level A harassment is more technically challenging to predict due to the need to account for a duration component. Therefore, NMFS developed an optional User Spreadsheet tool to accompany the Technical Guidance that can be used to relatively simply predict an isopleth distance for use in conjunction with marine mammal density or occurrence to help predict potential takes. We note that because of some of the assumptions included in the methods underlying this optional tool, we anticipate that the resulting isopleth estimates are typically going to be overestimates of some degree, which may result in an overestimate of potential take by Level A harassment. However, this optional tool offers the best way to estimate isopleth distances when more sophisticated modeling methods are not available or practical. For stationary sources such as pile installation and removal, the optional User Spreadsheet tool predicts the distance at which, if a marine mammal remained at that distance for the duration of the activity, it would be expected to incur PTS. The isopleths generated by the User Spreadsheet used the same TL coefficient as the Level B harassment zone calculations ( i.e., the practical spreading value of 15). Inputs used in the User Spreadsheet ( e.g., number of piles per day, duration and/or strikes per pile) are presented in Tables 1 and 2, and the resulting isopleths are reported below in Table 7.

In this section we provide information about the occurrence of marine mammals, including density or other relevant information, that will inform the quantitative estimate of the take that is reasonably likely to occur and proposed for authorization. Unless otherwise specified, the term “pile driving” in this section, and all following sections, may refer to either pile installation or removal. WSDOT first estimated take for both projects using the areas ensonified above the Level B harassment threshold and density estimates for marine mammals in Puget Sound. Density estimates for all species except harbor porpoises were from the U.S. Navy's Marine Species Density Database (MSDD) for the Northwest Training and Testing (NWTT) Study Area (U.S. Navy, 2019). For harbor porpoises, WSDOT used the density estimate from Evenson (2016) as it was considered more conservative than the density estimate for harbor porpoises from the NWTT MSDD. However, for all species except harbor seals and harbor porpoises, WSDOT did not consider the resulting take estimates to be realistic ( i.e., either over- or underestimated take). Instead, WSDOT compiled monitoring results from pile driving between August 2017 and February 2021 at the Seattle Ferry Terminal Multimodal Project at Colman Dock (WSDOT 2021) (Table 8). Because the Level B harassment zones from vibratory pile driving at Colman Dock extended to or near the Bainbridge Island shoreline, and because the Level B harassment zones from vibratory pile driving at the Bainbridge Ferry Terminal and Eagle Harbor Maintenance Facility extend to the shoreline, WSDOT considered the monitoring results from the Seattle Multimodal Project to be the most relevant and comprehensive sightings data available for the project areas. Based on the Seattle Multimodal Project monitoring results, WSDOT used their best professional judgement to estimate the number of marine mammals that may be taken incidental to the proposed activities.

NMFS has carefully reviewed WSDOT's analysis and concludes that it represents an appropriate and accurate method for estimating incidental take caused by WSDOT's activities.

WSDOT estimated that up to 20 gray whales could be taken by Level B harassment from each project, for a total of 40 takes of gray whales by Level B harassment. In consideration of the infrequent occurrence of gray whales in the project areas, the proposed mitigation and monitoring measures that WSDOT would be required to comply with, including marine mammal monitoring and coordination with Orca Network that would alert WSDOT to the presence of large whales in the project area (see Proposed Mitigation), and given the size and visibility of gray whales, WSDOT would be able to detect gray whales and stop work before gray whales could enter the Level A harassment zones. Therefore, it is unlikely that any gray whales would be taken by Level A harassment. No take of gray whales by Level A harassment is requested or proposed to be authorized.

WSDOT estimated that up to 20 minke whales could be taken by Level B harassment from each project, for a total of 40 takes of minke whales by Level B harassment. Like gray whales, in consideration of the infrequent occurrence of minke whales in the project areas, the proposed mitigation and monitoring measures that WSDOT would be required to comply with, including marine mammal monitoring and coordination with Orca Network (see Proposed Mitigation), and given the size and visibility of minke whales, WSDOT would be able to detect minke whales and stop work before minke whales could enter the Level A harassment zones. Therefore, it is unlikely that any minke whales would be taken by Level A harassment. No take of minke whales by Level A harassment is requested or proposed to be authorized.

WSDOT estimated that up to 20 long-beaked common dolphins could be taken by Level B harassment from each project, for a total of 40 takes of long-beaked common dolphins by Level B harassment. The Level A harassment zones for mid-frequency cetaceans are all less than 50 m. Given the visibility of long-beaked common dolphins, WSDOT would be able to cease pile driving before long-beaked common dolphins could enter the Level A harassment zone. No take of long-beaked common dolphins by Level A harassment is requested or proposed to be authorized.

WSDOT estimated that up to 20 bottlenose dolphins could be taken by Level B harassment from each project, for a total of 40 takes of bottlenose dolphins by Level B harassment. The Level A harassment zones for mid-frequency cetaceans are all less than 50 m. Given the visibility of bottlenose dolphins, WSDOT would be able to cease pile driving before bottlenose dolphins could enter the Level A harassment zone. No take of bottlenose dolphins by Level A harassment is requested or proposed to be authorized.

WSDOT estimated that up to 20 Pacific white-sided dolphins could be taken by Level B harassment from each project, for a total of 40 takes of Pacific white-sided dolphins by Level B harassment. The Level A harassment zones for mid-frequency cetaceans are all less than 50 m. Given the visibility of long-beaked common dolphins, WSDOT would be able to cease pile driving before long-beaked common dolphins could enter the Level A harassment zone. No take of long-beaked common dolphins by Level A harassment is requested or proposed to be authorized.

WSDOT estimated that up to 60 transient killer whales could be taken by Level B harassment from each project, for a total of 120 takes of killer whales by Level B harassment. The Level A harassment zones for mid-frequency cetaceans are all less than 50 m. Given the visibility of killer whales, WSDOT would be able to cease pile driving before killer whales could enter the Level A harassment zone. No take of killer whales by Level A harassment is requested or proposed to be authorized.

As stated above, no take of Southern Resident killer whales is expected or proposed to be authorized.

To estimate the number of harbor porpoises that may be taken by Level B harassment from the two projects, WSDOT calculated the area ensonified above the Level B harassment threshold for each pile size, type, and method for both projects. WSDOT then multiplied the estimated density of harbor porpoises in the area (0.58 per km 2 ; Evenson 2016) by the ensonified area and the expected days of work for each project element (Table 9).

The areas ensonified above the Level A harassment threshold for high-frequency cetaceans has been omitted from the areas ensonified above the Level B harassment threshold presented in Table 9. For impact installation of 30-in steel piles, the Level A harassment zone for high-frequency cetaceans is approximately 1,620 m. To estimate the number of harbor porpoises that may be present within the Level A harassment zone, WSDOT used the average sightings rate from the Seattle Multimodal Project at Colman Dock (0.691 harbor porpoises per day; Table 8) multiplied by the days of impact pile driving expected for each project (27 days for the Bainbridge Project and 8 days for the Eagle Harbor Project) to estimate that 19 and 6 harbor porpoises may be taken by Level A harassment from the Bainbridge Project and Eagle Harbor Project, respectively, for a total of 25 takes of harbor seals by Level A harassment.

WSDOT estimated that up to 20 Dall's porpoises could be taken by Level B harassment from each project, for a total of 40 takes of Dall's porpoises by Level B harassment.

For impact installation of 30-in steel piles, the Level A harassment zone for high-frequency cetaceans is approximately 1,620 m. Dall's porpoises are considered rare in the project area and are unlikely to be present within the Level A harassment zones but WSDOT conservatively estimates that no more than 5 Dall's porpoises could enter the Level A harassment zones of each project, for a total of 10 takes of Dall's porpoises by Level A harassment.

Over the course of 372 days of monitoring for the Seattle Multimodal Project at Colman Dock, the average number of California sea lions observed per day was 7.05 (Table 8). WSDOT used that average sightings rate multiplied by the days of work for each project (57 days for the Bainbridge Project and 31 days for the Eagle Harbor Project) to estimate that 402 and 219 California sea lions may be taken by Level B harassment from the Bainbridge Project and Eagle Harbor Project, respectively, for a total of 621 takes of California sea lions by Level B harassment.

The largest Level A harassment zone for otariid pinnipeds is 53 m. WSDOT would be required to implement a 60 m shutdown zone for otariids for all pile driving activities. At that close range, WSDOT would be able to detect California sea lions and implement the required shutdown measures before California sea lions could enter the Level A harassment zone. Therefore, no takes of California sea lions by Level A harassment are requested or proposed to be authorized.

WSDOT estimated that 180 Steller sea lions could be taken by Level B harassment from each project, for a total of 360 takes of Steller sea lions by Level B harassment. The largest Level A harassment zone for otariid pinnipeds is 53 m. WSDOT would be required to implement a 60 m shutdown zone for otariids for all pile driving activities. At that close range, WSDOT would be able to detect Steller sea lions and implement the required shutdown measures before Steller sea lions could enter the Level A harassment zone. Therefore, no takes of Steller sea lions by Level A harassment are requested or proposed to be authorized.

To estimate the number of harbor seals that may be taken by Level B harassment from the two projects, WSDOT calculated the area ensonified above the Level B harassment threshold for each pile size, type, and method for both projects. WSDOT then multiplied the estimated density of harbor seals in the area (3.91 per km 2 ; Navy 2019) by the ensonified area and the expected days of work for each project element (Table 10). In total, WSDOT estimates that 3,450 harbor seals may be taken by Level B harassment.

The areas ensonified above the Level A harassment threshold for high-frequency cetaceans has been omitted from the areas ensonified above the Level B harassment threshold presented in Table 10. For impact installation of 30-in steel piles, the Level A harassment zone for phocid pinnipeds is approximately 728 m. To estimate the number of harbor seals that may be present within the Level A harassment zone, WSDOT used the average sightings rate from the Seattle Multimodal Project at Colman Dock (5.21 harbor seals per day; Table 8) multiplied by the days of impact pile driving expected for each project (27 days for the Bainbridge Project and 8 days for the Eagle Harbor Project) to estimate that 141 and 42 harbor seals may be taken by Level A harassment from the Bainbridge Project and Eagle Harbor Project, respectively, for a total of 183 takes of harbor seals by Level A harassment.

Individual elephant seals have occasionally been reported in central Puget Sound ( e.g., Orca Network, 2020) but are considered rare in the project areas. WSDOT estimated that up to 10 northern elephant seals could be taken by Level B harassment from each project, for a total of 20 takes of northern elephant seals by Level B harassment. The largest Level A harassment zone (728 m) occurs during impact installation of 30-in steel pipe piles (Table 7). It is unlikely that northern elephant seals would be found within this zone, and even more unlikely that northern elephant seals would be found within the Level A harassment zones for vibratory pile driving (up to 295 m). However, even if northern elephant seals were encountered in the project areas, at that close range, WSDOT would be able to detect them and implement the required shutdown measures before any northern elephant seals could enter the Level A harassment zones. Therefore, no take of northern elephant seals by Level A harassment is requested or proposed to be authorized.

The primary purpose of this online meeting is to discuss and potentially develop work products and recommendations for the Pacific Council's September 2022 meeting. Topics will include changes to Council Operating Procedure 23, ecosystem initiatives, and Council processes and efficiencies. Other items on the Pacific Council's September agenda may be discussed as well. The meeting agenda will be available on the Pacific Council's website in advance of the meeting.

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.

This request is for revision and extension of a currently approved collection. The subsistence use of northern fur seals is cooperatively managed by the National Oceanic and Atmospheric Administration's (NOAA) National Marine Fisheries Service (NMFS) and the Tribal Governments of St. Paul and St. George Islands under § 119 of the Marine Mammal Protection Act, 16 U.S.C. 1388 (MMPA) and governed by regulations found in 50 CFR part 216 subpart F, Taking for Subsistence Purposes under the Fur Seal Act (16 U.S.C. 1155). The regulations, laws, and cooperative agreements are focused on conserving northern fur seals through cooperative effort and consultation regarding effective management of human activities related to the subsistence harvests of northern fur seals and Steller sea lions. In 2014, NMFS obtained a collection of information control number (79 FR 65327; November 4, 2014), reviewed the control number in 2017 (82 FR 51218; November 3, 2017), updated the control number in 2019 (84 FR 52372; October 2, 2019, and corrected in 2020 (85 FR 15948; March 20, 2020).

This an information collection for the annual subsistence use male northern fur seals by Alaska Natives (Pribilovians) residing in the communities of St. Paul and St. George, Alaska (Pribilof Islands) under 50 CFR 216 part 216 subpart F. NMFS established regulations regarding the maximum levels for the annual subsistence needs of the Pribilovians after direct consultation with the Tribal Governments of St. Paul and St. George Islands in Alaska and their respective local Native corporations (Tanadgusix and Tanaq). NMFS regulation creates independent northern fur seal subsistence seasons on St. Paul and St. George islands to include male fur seals less than 7 years old, limits on accidental mortality of female northern fur seals, monitoring and reporting through co-management processes established under their respective cooperative agreements. The regulations at 50 CFR 216.72 state that Pribilovians are responsible for reporting their subsistence needs and actual level of subsistence take. NMFS receives electronic copies of the northern fur seal subsistence use reports from the tribal governments of St. Paul and St. George annually. NMFS subsequently posts these reports online ( https://www.fisheries.noaa.gov/alaska/marine-mammal-protection/northern-fur-seal-subsistence-harvest-estimates-and-reports ) and includes the relevant data in the annual Alaska Marine Mammal Stock Assessment Report.

The only change requested to the collection of information at this time is the changing of the collection title from “Annual Northern Seal Subsistence Harvest Reporting” to “Pribilof Islands, Taking for Subsistence Purposes.”

NMFS receives electronic copies of the northern fur seal subsistence use reports from the tribal governments of St. Paul and St. George annually via email.

OMB Control Number: 0648-0699.

Form Number(s): None.

Type of Review: Regular submission (revision of a current information collection).

Affected Public: Individuals or households, and State, Local or Tribal Government.

Estimated Number of Respondents: 2.

Estimated Time per Response: Subsistence use report submitted via email estimated to take 40 hours per response for each respondent. The St. George Island Traditional Council submits two reports annually and the Aleut Community of St. Paul Island submits three reports annually.

Estimated Total Annual Burden Hours: 200 hours.

Estimated Total Annual Cost to Public: $80.

Respondent's Obligation: Required to Obtain or Retain Benefits.

Legal Authority: Fur Seal Act (16 U.S.C. 1155).

We are soliciting public comments to permit the Department/Bureau to: (a) Evaluate whether the proposed information collection is necessary for the proper functions of the Department, including whether the information will have practical utility; (b) Evaluate the accuracy of our estimate of the time and cost burden for this proposed collection, including the validity of the methodology and assumptions used; (c) Evaluate ways to enhance the quality, utility, and clarity of the information to be collected; and (d) Minimize the reporting burden on those who are to respond, including the use of automated collection techniques or other forms of information technology.

Comments that you submit in response to this notice are a matter of public record. We will include or summarize each comment in our request to OMB to approve this ICR. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you may ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.

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. ), the regulations governing the taking and importing of marine mammals (50 CFR part 216), the Endangered Species Act of 1973, as amended (ESA; 16 U.S.C. 1531 et seq. ), the regulations governing the taking, importing, and exporting of endangered and threatened species (50 CFR parts 222-226), and the Fur Seal Act of 1966, as amended (16 U.S.C. 1151 et seq. ).

The applicant proposes to receive, import, and export teeth from marine mammal species to perform age analysis including 500 harbor seals ( Phoca vitulina ), 1,000 each of bearded ( Erignathus barbatus ) and spotted seals ( P. largha ), 2,000 ringed seals ( P. hispida ), 500 unidentified pinnipeds (species other than those already mentioned, excluding walrus), and 300 unidentified cetaceans. Sources of foreign and domestic teeth may include subsistence harvests, other authorized researchers or curated collections, law enforcement, and foreign stranded animals. No live animal takes are requested. The requested duration of the permit is five years.

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.

The primary purpose of this meeting is for the GAP to receive information about potential fishery management changes regarding non-trawl rockfish conservation area management and to begin reviewing materials and preparing recommendations on groundfish matters for the September 2022 Pacific Council meeting. The GAP may also discuss other items on the Pacific Council's September agenda, particularly Pacific halibut, ecosystem, and administrative matters.

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 Committee was created from Public Law 117-121 signed on May 12, 2022. The Committee meets no more than twice annually and membership is comprised of 22 individuals appointed by the Secretary with the following geographic representation: Region 1 consisting of Alaska, Hawaii, the Commonwealth of the Northern Mariana Islands, and the Territories of Guam and American Samoa; Region 2 consisting of Maine, New Hampshire, Massachusetts, Rhode Island, and Connecticut; Region 3 consisting of Texas, Alabama, Louisiana, Mississippi, Florida, Arkansas, Puerto Rico, and the Territory of the Virgin Islands of the United States; Region 4 consisting of California, Washington, Oregon, and Idaho; Region 5 consisting of New Jersey, New York, Delaware, Maryland, Virginia, North Carolina, South Carolina, and Georgia; and Region 6 consisting of Michigan, Minnesota, Wisconsin, Illinois, Indiana, Ohio, and Pennsylvania. Membership for each region will be composed of highly qualified, diverse individuals with experience in one or more of the following areas of expertise, and in as many seafood species as possible: seafood harvesting or processing; recreational or commercial fishing; growing seafood; fisheries science; and/or food distribution, marketing, retail, or food service.

Four at-large members shall also be appointed by the Secretary as follows: one individual with experience in food distribution, marketing, retail, or food service; one individual with experience in the recreational fishing industry supply chain, such as fishers, manufacturers, retailers, and distributors; one individual with experience in the commercial fishing industry supply chain, such as fishers, manufacturers, retailers, and distributors; and one individual who is an employee of NMFS with expertise in fisheries research.

Committee membership is voluntary and, except for reimbursable travel and related expenses per federal travel regulations, service is without compensation.

Each nominee must submit a cover letter and a resume/curriculum vitae (CV) in PDF format. The cover letter shall include a brief statement as to their interest in serving on the Committee and their qualifications. The resume/CV shall detail the applicant's contact information (address, telephone number, email address) and specific qualifications/experience/expertise as referenced in Public Law 117-121. Any applicants selected for Committee membership shall be required to complete a financial disclosure/conflict of interest form. The first Committee meeting will take place within the first two weeks of December 2022.

Nominations shall be submitted by email to nmfs.afac.nominations@noaa.gov, and must be received by September 24, 2022 to be considered. The full text of Public Law 117-121 and other relevant documents can be viewed at the following link: https://www.fisheries.noaa.gov/national/funding-and-financial-services/saltonstall-kennedy-research-and-development-program

Statutory Authority and Function: NACIE is authorized by Section 6141 of the Elementary and Secondary Education Act of 1965 (ESEA), as amended (20 U.S.C. 7471). The work of NACIE was expanded per Executive Order 14049. In accordance with Section 6141 of the ESEA, NACIE shall advise the Secretary of Education and the Secretary of Interior on the funding and administration (including the development of regulations and administrative policies and practices) of any program, including any program established under Title VI, Part A of the ESEA, with respect to which the Secretary of Education has jurisdiction and (1) that includes Indian children or adults as participants or (2) that may benefit Indian children or adults. Also in accordance with Section 6141 of the ESEA, NACIE shall make recommendations to the Secretary of Education for filling the position of Director of Indian Education whenever a vacancy occurs and shall submit to the Congress, no later than June 30 of each year, a report on its activities that includes recommendations that are considered appropriate for the improvement of Federal education programs that include Indian children or adults as participants or that may benefit Indian children or adults, and recommendations concerning the funding of any such program. In accordance with Section 3 of Executive Order 14049, NACIE shall advise the Co-Chairs of the White House Initiative on Advancing Educational Equity, Excellence and Economic Opportunity for Native Americans and Strengthening Tribal Colleges and Universities (Initiative), in consultation with the Initiative, on (1) what is needed for the development, implementation, and coordination of educational programs and initiatives to improve educational opportunities and outcomes for Native Americans, (2) how to promote career pathways for in-demand jobs for Native American students, including registered apprenticeships as well as internships, fellowships, mentorships, and work-based learning initiatives, (3) ways to strengthen Tribal Colleges and Universities and increase their participation in agency programs, (4) how to increase public awareness of and generate solutions for the educational and training challenges and equity disparities that Native American students face and the causes of these challenges and disparities, (5) approaches to establish local and national partnerships with public, private, philanthropic, and nonprofit stakeholders to advance the policy set forth in Section 1 of Executive Order 14049, consistent with applicable law, and (6) actions for promoting, improving, and expanding educational opportunities for Native languages, traditions, and practices to be sustained through culturally responsive education. Also, in accordance with Section 3 of Executive Order 14049, NACIE and the Executive Director of the Initiative (Executive Director) shall, as appropriate and consistent with applicable law, facilitate frequent collaborations between the Initiative and Tribal Nations, Alaska Native Entities, and other Tribal organizations. Finally, in accordance with Section 3 of Executive Order 14049, NACIE shall consult with the Executive Director so that the Executive Director can address NACIE's efforts pursuant to Section 3(a) of Executive Order 14019 in the annual report of the Initiative submitted to the President.

Meeting Agenda: The purpose of this meeting is to convene NACIE to conduct the following business: (1) discussion, deliberation, and approval of the 2022 Annual Report to Congress, (2) for the Office of Indian Education (OIE) to conduct an overview and seek recommendations related to the activities of the OIE, and (3) for the Initiative to seek recommendations from NACIE.

Instructions for Accessing the Meeting: Members of the public may access the NACIE meeting via teleconference and the web. Up to 350 lines will be available on a first come, first serve basis for those who wish to join via teleconference. The dial-in listen only phone number for the meeting is 1-669-254-5252, Meeting ID: 161 715 5166. The web link to register to access the meeting via Zoom.gov is https://www.zoomgov.com/meeting/register/vJIsceCuqjMuGJyzwCIWSDTJ0q5S1djwrsE .

Public Comment: Members of the public interested in submitting written comments may do so via email to Donna Sabis-Burns at donna.sabis-burns@ed.gov by 11:59 p.m. on August 14, 2022. Please note, written comments should pertain to the work of NACIE.

Reasonable Accommodations: The virtual meeting is accessible to individuals with disabilities. If you will need an auxiliary aid or service for the meeting ( e.g., interpreting service, assistive listening device, or materials in an alternate format), notify the contact person listed in this notice no later than August 19, 2022. Although we will attempt to meet a request received after that date, we may not be able to make available the requested auxiliary aid or service because of insufficient time to arrange it.

Access to Records of the Meeting: The Department will post the official open meeting report of this meeting on the OESE website, https://oese.ed.gov/offices/office-of-indian-education/national-advisory-council-on-indian-education-oie/ , 21 days after the meeting. Pursuant to the FACA, the public may also inspect NACIE records at the Office of Indian Education, United States Department of Education, 400 Maryland Avenue SW, Washington, DC 20202, Monday-Friday, 8:30 a.m. to 5:00 p.m. Eastern Standard Time. Please email Donna Sabis-Burns at Donna.Sabis-Burns@ed.gov to schedule an appointment.

Electronic Access to this Document: The official version of this document is the document published in the Federal Register . Free internet access to the official edition of the Federal Register and the Code of Federal Regulations is available via the Federal Digital System at: www.gpo.gov/fdsys. At this site you can view this document, as well as all other documents of this Department published in the Federal Register , in text or Adobe Portable Document Format (PDF). To use PDF, you must have Adobe Acrobat Reader, which is available free at the site. You also may access documents of the Department published in the Federal Register by using the article search feature at: www.federalregister.gov. Specifically, through the advanced search feature at this site, you can limit your search to documents published by the Department.

Authority: Section 6141 of the ESEA, as amended (20 U.S.C. 7471).

The construction, operation, maintenance, and connection of facilities at the international border of the United States for the transmission of electric energy between the United States and a foreign country is prohibited in the absence of a Presidential permit issued pursuant to Executive Order (E.O.) 10485, as amended by E.O. 12038.

On May 18, 2022, ESJ filed an application with the Office of Electricity of the Department of Energy (DOE), as required by regulations at 10 CFR 205.320 et seq., requesting that DOE amend Presidential Permit No. PP-334 to increase the rate of transmission over ESJ's operating electric power generation tie line (ESJ Tie Line).

On August 31, 2012, DOE issued Presidential Permit No. PP-334, authorizing ESJ to construct, operate, maintain, and connect the ESJ Project (Project). As described in PP-334, the Project is a double-circuit 230-kV electric transmission line originating at San Diego Gas and Electric Company's planned East County (ECO) Substation in San Diego County, interconnecting with the Imperial Valley-Miguel segment of the Southwest Powerlink, extending approximately 0.65 miles southward, crossing the U.S.-Mexico border near Jacumba, California. At the border, the ESJ Tie Line transitions to a generation tie line constructed and operated by Energia Sierra Juarez, S. de R. L. de C.V. (ESJ Mexico), a Mexican affiliate of ESJ, which extends approximately 1 mile farther south to an interconnection point for a wind generating facility in Mexico (ESJ Wind Project) owned and operated by ESJ Mexico.

The ESJ Tie Line commenced commercial operation in June of 2015, and ESJ has been operating the ESJ Tie Line in accordance with PP-334 since that time to transmit power from the initial phase of the ESJ Wind Project generating facilities in Mexico to the electric grid in California at the ECO Substation. The ESJ Tie Line has the thermal capacity to transmit up to 1250 megawatts (MW of electricity, corresponding to the total potential generating capacity of the ESJ Wind Project. The ESJ Wind Project was to be developed in several phases. At the time PP-334 was issued in 2012, the California Independent System Operator (CAISO) had completed a generation interconnection study only for the first 400 MW of generation from the ESJ Wind Project. As a result, PP-334 included a provision limiting the maximum non-simultaneous rate of transmission over the ESJ Tie Line to 400 MW.

Article 4 of PP-334 stated that ESJ may apply for a modification to the permit to increase the authorized rate of transmission at such time as CAISO completes interconnection studies for power generated by the ESJ Wind Project greater than 400 MW.

In accordance with Article 4 of PP-334, ESJ is now requesting a modification to the permit to increase the maximum authorized rate of transmission over the ESJ Tie Line to 700 MW based on the CAISO interconnection study for Cimarron Wind, which is expected to add another 300 MW of generation. The proposed increase in the rate of transmission requires no physical modifications to the ESJ Tie Line.

Procedural Matters: Any person may comment on this application by filing such comment at the address provided above. Each comment should be clearly marked with OE Docket No. PP-334-1. Consideration of comments is limited to those addressing the subject of the proposed amendment. Any person seeking to become a party to this proceeding must file a motion to intervene at the address provided above in accordance with Rule 214 of FERC's Rules of Practice and Procedure (18 CFR 385.214). Two copies of each comment or motion to intervene should be filed with DOE on or before the date listed above.

Additional copies of such comments and motions to intervene also should be filed directly with: Emily C. Shults, Senior Vice President—Development, Energia Sierra Juarez U.S., LLC, 488 8th Avenue, San Diego, CA 92101, eshults@sempraglobal.com, and

Eric J. Murdock, Partner, Hunter Andrews Kurth LLP, N 2200 Pennsylvania Ave. NW, Washington, DC 20037, emurdock@hunton.com.

Before a Presidential permit may be issued or amended, DOE must determine that the proposed action is in the public interest. In making that determination, DOE may consider the environmental impacts of the proposed action ( i.e., granting the Presidential permit or amendment, with any conditions and limitations, or denying the permit), determine the proposed project's impact on electric reliability by ascertaining whether the proposed project would adversely affect the operation of the U.S. electric power supply system under normal and contingency conditions, and weigh any other factors that it may also deem relevant to the public interest. DOE also must obtain the favorable recommendation of the Secretary of State and the Secretary of Defense before taking final action on a Presidential permit application.

This application may be reviewed or downloaded electronically at https://www.energy.gov/oe/pending-applications.

On June 15, 2013, Plaintiffs filed suit in the Federal district court for the District of Idaho against the Fish and Wildlife Service and the National Marine Fisheries Service (collectively, “the Services”). The complaint alleged that the Services unreasonably delayed or unlawfully withheld completion of Endangered Species Act (“ESA”) consultation with EPA regarding new and revised water quality standards that were submitted in 1996 and/or 1997. On September 24, 2013, Plaintiffs filed an amended complaint adding various CWA and ESA claims against EPA regarding dozens of Idaho water quality standard submissions dating back to 1994. Broadly speaking, Plaintiffs' claims fell into two categories: claims that EPA failed to consult with the Services on various water quality standard approval actions and claims that EPA failed to complete its mandatory duties under the CWA with respect to various new and revised water quality standards adopted by the State. In April 2015, the Services entered a stipulated dismissal with Plaintiffs by which they agreed to complete certain ESA obligations. This left EPA as the sole defendant in the case.

On February 28, 2019, the Court partially granted EPA's motion to dismiss a number of claims on statute of limitations grounds. On January 21, 2021, the Court entered a stipulated order of partial dismissal, which resolved all but one remaining claim against EPA: that EPA failed to act under section 303(c)(4) of the CWA to promulgate aquatic life mercury criteria following EPA's December 12, 2008, disapproval of State revisions to its existing mercury criteria. On July 19, 2021, the Court held that, under the circumstances of this case, EPA's disapproval created a mandatory duty for the Agency to promulgate new criteria for the State. See Nw. Env't Advocs. v. United States Env't Prot. Agency, 549 F. Supp. 3d 1218 (D. Idaho 2021).

The parties have negotiated a settlement framework regarding an appropriate remedy in the form of a stipulated order on remedy. Pursuant to the agreed-upon terms, EPA would sign for publication in the Federal Register proposed aquatic life mercury criteria for the State of Idaho within 18 months of entry of the Proposed Order with the Court. EPA would have nine months after publication to (1) determine whether ESA section 7 consultation with the Services is required and (2) initiate any such consultation. If consultation occurs, EPA would have to finalize the criteria within eight months of the conclusion of that consultation. Alternatively, if EPA determines that consultation is not required, EPA would have to notify the Plaintiffs and finalize the criteria within eight months of that determination. As part of the agreement, EPA would include in its proposal water column concentrations, or default water column values that can be modified on a case-by-case basis, if EPA determines there are sufficient data available to support this form of criteria. If EPA declines to propose water column concentrations or default water column values, then it would explain and take comment on its reasoning for not doing so. EPA's commitment to promulgate these criteria will be null and void if the State adopts and EPA approves new aquatic life mercury criteria.

For a period of thirty (30) days following the date of publication of this notice, EPA will accept written comments relating to the Proposed Order from persons who are not parties to the litigation. EPA also may hold a public hearing on whether to enter into the Proposed Order. EPA or the Department of Justice may withdraw or withhold consent to the Proposed Order if the comments received disclose facts or considerations that indicate that such consent is inappropriate, improper, inadequate, or inconsistent with the requirements of the Clean Water Act.

The official public docket for this action (identified by Docket ID No. EPA-HQ-OGC-2022-0683) contains a copy of the Proposed Order. The official public docket is available for public viewing at the Office of Environmental Information (OEI) Docket in the EPA Docket Center, EPA West, Room 3334, 1301 Constitution Ave. NW, Washington, DC. The EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OEI Docket is (202) 566-1752.

The electronic version of the public docket for this action contains a copy of the Proposed Order and is available through https://www.regulations.gov. You may use https://www.regulations.gov to submit or view public comments, access the index listing of the contents of the official public docket, and access those documents in the public docket that are available electronically. Once in the system, key in the appropriate docket identification number then select “search.”

Submit your comments, identified by Docket ID No. EPA-HQ-OGC-2022-0683 via https://www.regulations.gov. Once submitted, comments cannot be edited or removed from this docket. EPA may publish any comment received to its public docket. Do not submit to EPA's docket at https://www.regulations.gov any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. EPA will generally not consider comments or comment contents located outside of the primary submission ( i.e., on the web, cloud, or other file sharing system). For additional submission methods, the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets. For additional information about submitting information identified as CBI, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section of this document.

If you submit an electronic comment, EPA recommends that you include your name, mailing address, and an email address or other contact information in the body of your comment. This ensures that you can be identified as the submitter of the comment and allows EPA to contact you in case EPA cannot read your comment due to technical difficulties or needs further information on the substance of your comment. Any identifying or contact information provided in the body of a comment will be included as part of the comment that is placed in the official public docket and made available in EPA's electronic public docket. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment.

Use of the https://www.regulations.gov website to submit comments to EPA electronically is EPA's preferred method for receiving comments. The electronic public docket system is an “anonymous access” system, which means EPA will not know your identity, email address, or other contact information unless you provide it in the body of your comment.

Please ensure that your comments are submitted within the specified comment period. Comments received after the close of the comment period will be marked “late.” EPA is not required to consider these late comments.

OMB Control Number: 3060-1192.

Title: Survey of Urban Rates, DA 13-598.

Form Number: N/A.

Type of Review: Extension of a currently approved collection.

Respondents: Business or other for-profit.

Number of Respondents and Responses: 2,275 respondents; 2,275 responses.

Estimated Time per Response: 3 hours.

Frequency of Response: Annual reporting requirement.

Obligation to Respond: Required to obtain or retain benefits. Statutory authority for this information collection is contained in 47 U.S.C. 254(b).

Total Annual Burden: 6,825 hours.

Total Annual Cost: No cost.

Privacy Act Impact Assessment: No impact(s).

Nature and Extent of Confidentiality: The Commission is not requesting that respondents submit confidential information to the Commission. Also, respondents may request materials or information submitted to the Commission be withheld from public inspection under 47 CFR 0.459 of the Commission's rules.

Needs and Uses: In April 2013, the Wireline Competition Bureau of the Federal Communications Commission adopted an Order (Order), in WC Docket No. 10-90; DA 13-598, 78 FR 29063, Connect America Fund. The Order adopted the form and content for a survey of urban rates for fixed voice and fixed broadband residential services for purposes of implementing various reforms adopted as part of the USF/ICC Transformation Order, 76 FR 73830, November 29, 2011. The information collected in this survey will be used to help ensure that universal service support recipients offering fixed voice and broadband services do so at reasonably comparable rates to those in urban areas. The comparability requirements are important components of the Commission's overall effort to improve accountability for the use of universal service funding. The comparability requirements will ensure that rates are reasonably comparable for voice as well as broadband service, between urban and rural, insular, and high cost areas. Rates must be reasonably comparable so that consumers in rural, insular, and high cost areas have meaningful access to these services. This Order requires a statistically valid sample of urban providers to complete a survey with information regarding the types and prices of their offerings. The Commission conducts this survey through an online reporting form accessible to those urban providers of fixed voice and broadband services that are chosen to participate.

On June 15, 2022, CDC published a document announcing a notice of award of a single-source cooperative agreement to fund India Council of Medical Research (ICMR) and ICMR institutions: National Institute of Virology (NIV), Pune and National Institute of Epidemiology (NIE), Chennai (87 FR 36133). On July 1, 2022, CDC published another document that announced a corrected funding amount to that amount published on June 15, 2022 (87 FR 39521).

This document announces a cancellation of the notice of award to fund the ICMR Institutions: NIV, Pune and NIE, Chennai. These awards are cancelled in their entirety. CDC still plans to fund the ICMR in the amount of $24,495,000 with an expected total funding of approximately $122,475,000.

Amount of Award: $24,495,000 in Federal Fiscal Year (FFY) 2022, with a total estimated $122,475,000 for the 5-year period of performance, subject to availability of funds. Please note, the Notice of Funding Opportunity funding strategy is as follows: $1,980,000 for Core Component 1, and $22,515,000 in Approved but Unfunded (ABU) Components for the recipient.

The Advisory Panel for Outreach and Education (APOE) (the Panel) is governed by the provisions of the Federal Advisory Committee Act (FACA) (Pub. L. 92-463), as amended (5 U.S.C. appendix 2), which sets forth standards for the formation and use of federal advisory committees. The Panel is authorized by section 1114(f) of the Social Security Act (the Act) (42 U.S.C. 1314(f)) and section 222 of the Public Health Service Act (42 U.S.C. 217a).

The Secretary of the U.S. Department of Health and Human Services (HHS) (the Secretary) signed the charter establishing the Citizen's Advisory Panel on Medicare Education  1 (the predecessor to the APOE) on January 21, 1999 (64 FR 7899) to advise and make recommendations to the Secretary and the Administrator of the Centers for Medicare & Medicaid Services (CMS) on the effective implementation of national Medicare education programs, including with respect to the Medicare+Choice (M+C) program added by the Balanced Budget Act of 1997 (Pub. L. 105-33).

The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173) expanded the existing health plan options and benefits available under the M+C program and renamed it the Medicare Advantage (MA) program. CMS has had substantial responsibilities to provide information to Medicare beneficiaries about the range of health plan options available and better tools to evaluate these options. The successful MA program implementation required CMS to consider the views and policy input from a variety of private sector constituents and to develop a broad range of public-private partnerships.

In addition, Title I of the MMA authorized the Secretary and the Administrator of CMS (by delegation) to establish the Medicare prescription drug benefit. The drug benefit allows beneficiaries to obtain qualified prescription drug coverage. In order to effectively administer the MA program and the Medicare prescription drug benefit, we have substantial responsibilities to provide information to Medicare beneficiaries about the range of health plan options and benefits available, and to develop better tools to evaluate these plans and benefits.

The Patient Protection and Affordable Care Act (Pub. L. 111-148) and Health Care and Education Reconciliation Act of 2010 (Pub. L. 111-152) (collectively referred to as the Affordable Care Act) expanded the availability of other options for health care coverage and enacted a number of changes to Medicare as well as to Medicaid and CHIP. Qualified individuals and qualified employers are now able to purchase private health insurance coverage through a competitive marketplace, called an Affordable Insurance Exchange (also called Health Insurance Marketplace® or Marketplace®  2 ). In order to effectively implement and administer these changes, we must provide information to consumers, providers, and other stakeholders through education and outreach programs regarding how existing programs will change and the expanded range of health coverage options available, including private health insurance coverage through the Marketplace®. The APOE (the Panel) allows us to consider a broad range of views and information from interested audiences in connection with this effort and to identify opportunities to enhance the effectiveness of education strategies concerning the Affordable Care Act.

The scope of this Panel also includes advising on issues pertaining to the education of providers and stakeholders with respect to the Affordable Care Act and certain provisions of the Health Information Technology for Economic and Clinical Health (HITECH) Act enacted as part of the American Recovery and Reinvestment Act of 2009 (ARRA) (Pub. L. 111-5).

On January 21, 2011, the Panel's charter was renewed and the Panel was renamed the Advisory Panel for Outreach and Education. The Panel's charter was most recently renewed on January 19, 2021, and will terminate on January 19, 2023 unless renewed by appropriate action.

In accordance with the January 19, 2021 charter, the APOE will advise HHS and CMS on developing and implementing education programs that support individuals who are enrolled in or eligible for Medicare, Medicaid, CHIP, or coverage available through the Health Insurance Marketplace® and other CMS programs. The scope of this FACA group also includes advising on education of providers and stakeholders with respect to health care reform and certain provisions of the HITECH Act enacted as part of the ARRA.

The charter will terminate on January 19, 2023, unless renewed by appropriate action. The APOE was chartered under 42 U.S.C. 217a, section 222 of the Public Health Service Act, as amended. The APOE is governed by provisions of Pub. L. 92-463, as amended (5 U.S.C. Appendix 2), which sets forth standards for the formation and use of advisory committees.

In accordance with the renewed charter, the APOE will advise the Secretary and the CMS Administrator concerning optimal strategies for the following:

• Developing and implementing education and outreach programs for individuals enrolled in, or eligible for, Medicare, Medicaid, the CHIP, and coverage available through the Health Insurance Marketplace® and other CMS programs.

• Enhancing the federal government's effectiveness in informing Medicare, Medicaid, CHIP, or the Health Insurance Marketplace® consumers, issuers, providers, and stakeholders, pursuant to education and outreach programs of issues regarding these programs, including the appropriate use of public-private partnerships to leverage the resources of the private sector in educating beneficiaries, providers, partners and stakeholders.

• Expanding outreach to minority and underserved communities, including racial and ethnic minorities, in the context of Medicare, Medicaid, CHIP, and the Health Insurance Marketplace® education programs and other CMS programs as designated.

• Assembling and sharing an information base of “best practices” for helping consumers evaluate health coverage options.

• Building and leveraging existing community infrastructures for information, counseling, and assistance.

• Drawing the program link between outreach and education, promoting consumer understanding of health care coverage choices, and facilitating consumer selection/enrollment, which in turn support the overarching goal of improved access to quality care, including prevention services, envisioned under the Affordable Care Act.

The current members of the Panel as of June 23, 2022, are as follows:

• Julie Carter, Senior Federal Policy Associate, Medicare Rights Center.

• Scott Ferguson, Psychotherapist, Scott Ferguson Psychotherapy.

• Jean-Venable Robertson Goode, Professor, Department of Pharmacotherapy and Outcomes Science, School of Pharmacy, Virginia Commonwealth University.

• Ted Henson, Director of Health Center Performance and Innovation, National Association of Community Health Centers.

• Joan Ilardo, Director of Research Initiatives, Michigan State University, College of Human Medicine.

• Daisy Kim, Policy Manager, Asian & Pacific Islander American Health Forum.

• Cheri Lattimer, Executive Director, National Transitions of Care Coalition.

• Cori McMahon, Vice President, Tridiuum.

• Alan Meade, Director of Rehabilitation Services, Holston Medical Group.

• Neil Meltzer, President and CEO, LifeBridge Health.

• Michael Minor, National Director, H.O.P.E. HHS Partnership, National Baptist Convention USA, Incorporated.

• Jina Ragland, Associate State Director of Advocacy and Outreach, AARP Nebraska.

• Morgan Reed, Executive Director, Association for Competitive Technology.

• Carrie Rogers, Associate Director, Community Catalyst.

• Margot Savoy, Senior Vice President, American Academy of Family Physicians.

• Congresswoman Allyson Schwartz, Senior Advisor, FTI Consulting.

• Matthew Snider, JD, Senior Policy Analyst, Unidos US.

• Tia Whitaker, Statewide Director, Outreach and Enrollment, Pennsylvania Association of Community Health Centers.

In accordance with section 10(a) of the FACA, this notice announces a meeting of the APOE. The agenda for the September 15, 2022 meeting will include the following:

Individuals or organizations that wish to make a 5-minute oral presentation on an agenda topic should submit a written copy of the oral presentation to the DFO at the address listed in the ADDRESSES section of this notice by the date listed in the DATES section of this notice. The number of oral presentations may be limited by the time available. Individuals not wishing to make an oral presentation may submit written comments to the DFO at the address listed in the ADDRESSES section of this notice by the date listed in the DATES section of this notice.

The meeting is open to the public, but attendance is limited to registered participants. Persons wishing to attend this meeting must register at the website https://www.eventbrite.com/e/apoe-september-15-2022-virtual-meeting-tickets-380357628907 or contact the DFO at the address or number listed in the FOR FURTHER INFORMATION CONTACT section of this notice by the date specified in the DATES section of this notice. This meeting will be held virtually. Individuals who are not registered in advance will be unable to attend the meeting.

This document does not impose information collection requirements, that is, reporting, recordkeeping, or third-party disclosure requirements. Consequently, there is no need for review by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35).

The Administrator of the Centers for Medicare & Medicaid Services (CMS), Chiquita Brooks-LaSure, having reviewed and approved this document, authorizes Lynette Wilson, who is the Federal Register Liaison, to electronically sign this document for purposes of publication in the Federal Register .

Under the PRA (44 U.S.C. 3501-3521), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

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

This information collection is intended to support FDA-conducted research. Understanding patients, consumers, and healthcare professionals' perceptions and behaviors plays an important role in improving FDA's regulatory decision-making processes and communications that affect various stakeholders. FDA uses the following methods to achieve these goals: (1) individual indepth interviews, (2) general public focus group interviews, (3) intercept interviews, (4) self-administered surveys, (5) gatekeeper surveys, and (6) focus group interviews. These methods serve the narrowly defined need for direct and informal opinion on a specific topic and serve as a qualitative and quantitative research tool having two major purposes:

• Obtaining useful information for the development of variables and measures for formulating the basic objectives of social and behavioral research and

• successfully communicating and addressing behavioral changes with intended audiences to assess the potential effectiveness of FDA communications, behavioral interventions, and other materials.

While FDA will use these methods to test and refine its ideas and help develop communication and behavioral strategies research, the Agency will generally conduct further research before making important decisions (such as adopting new policies and allocating or redirecting significant resources to support these policies).

FDA's Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, Office of the Commissioner, and any other Centers will use this mechanism to test communications and social and behavioral methods about regulated drug products on a variety of subjects related to consumer, patient, or healthcare professional perceptions, beliefs, attitudes, behaviors, and use of drug and biological products and related materials. These subjects include social and behavioral research, decision-making processes, and communication and behavioral change strategies.

Annually, FDA projects about 25 social and behavioral studies using the variety of test methods listed in this document. FDA is revising this burden to account for the number of studies we have received in the last 3 years and to better reflect the scope of the information collection.

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

Based on a review of the information collection since our last request for OMB approval, our burden estimate for this information collection reflects an overall increase of 35,886 responses with a corresponding increase of 8,972 hours. We attribute this adjustment to an increase in the funding in specific areas, particularly substance abuse (for example, opioids and stimulants) and COVID-19.

Under the PRA (44 U.S.C. 3501-3521), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

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

This information collection supports Agency regulations. FDA's patent extension activities are conducted under the authority of section 505(j) of the Federal, Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(j)) and the Generic Animal Drug and Patent Term Restoration Act of 1988 ((Pub. L. 100-670) (21 U.S.C. 301 et seq)). The regulations are codified in part 60 (21 CFR part 60), Patent Term Restoration. New human drug, animal drug, human biological, medical device, food additive, or color additive products regulated by FDA must undergo FDA safety, or safety and effectiveness review before marketing is permitted. If the product is covered by a patent, part of the patent's term may be consumed during this review, which diminishes the value of the patent.

In enacting section 505(j) of the FD&C Act and the Generic Animal Drug and Patent Term Restoration Act of 1988, Congress sought to encourage development of new, safer, and more effective medical and food additive products. It did so by authorizing the U.S. Patent and Trademark Office (USPTO) to extend the patent term by a portion of the time during which FDA's safety and effectiveness review prevented marketing of the product. The length of the patent term extension is generally limited to a maximum of 5 years and is calculated by USPTO based on a statutory formula. When a patent holder submits an application for patent term extension to USPTO, USPTO requests information from FDA, including the length of the regulatory review period for the patented product. If USPTO concludes that the product is eligible for patent term extension, FDA publishes a notice that describes the length of the regulatory review period and the dates used to calculate that period. Interested parties may request, under §  60.24, revision of the length of the regulatory review period, or may petition under §  60.30 to reduce the regulatory review period by any time where marketing approval was not pursued with “due diligence.”

Section 60.36(a) defines due diligence as “that degree of attention, continuous directed effort, and timeliness as may reasonably be expected from, and are ordinarily exercised by, a person during a regulatory review period.” As provided in §  60.30(c), a due diligence petition “shall set forth sufficient facts, including dates if possible, to merit an investigation by FDA of whether the applicant acted with due diligence.” Upon receipt of a due diligence petition, FDA reviews the petition and evaluates whether any change in the regulatory review period is necessary. If so, the corrected regulatory review period is published in the Federal Register . A due diligence petitioner not satisfied with FDA's decision regarding the petition may, under § 60.40, request an informal hearing for reconsideration of the due diligence determination. Petitioners are likely to include persons or organizations having knowledge that FDA's marketing permission for that product was not actively pursued throughout the regulatory review period. The information collection for which an extension of approval is being sought is the use of the statutorily created due diligence petition.

During the calendar years 2019 through 2022, 15 requests for revision of the regulatory review period were submitted under §  60.24(a). In addition, a total of one due diligence petition was submitted under §  60.30. There have been no requests for hearings under §  60.40; however, for purposes of this information collection approval, we estimate that we may receive one submission annually.

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

Our estimated burden for the information collection reflects a small decrease (-1 response) associated with submissions received under §  60.24 in previous years.

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

On June 22, 2009, the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (Pub. L. 111-31) was signed into law. The Tobacco Control Act amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) by adding a chapter granting FDA important authority to regulate the manufacture, marketing, and distribution of tobacco products to protect the public health generally and to reduce tobacco use by minors.

The Consolidated Appropriations Act of 2022 (Pub. L. 117-103) (the Appropriations Act), enacted on March 15, 2022, amended the definition of the term “tobacco product” in section 201(rr) of the FD&C Act (21 U.S.C. 321(rr)) to include products that contain nicotine from any source. As a result, non-tobacco nicotine (NTN) products that were not previously subject to the FD&C Act ( e.g., products containing synthetic nicotine) are now subject to all of the tobacco product provisions in the FD&C Act beginning on April 14, 2022, including the requirement of premarket review for new tobacco products.

The FD&C Act, as amended by the Tobacco Control Act, requires that before a new tobacco product may be introduced or delivered for introduction into interstate commerce, the new tobacco product must undergo premarket review by FDA. FDA must issue an order authorizing the commercial distribution of the new tobacco product or find the product exempt from the requirements of substantial equivalence under section 910(a)(2)(A) of the FD&C Act (21 U.S.C. 387j(a)(2)(A)), before the product may be introduced into commercial distribution.

FDA has established a pathway for manufacturers to request exemptions from the substantial equivalence requirements of the FD&C Act in §  1107.1 (21 CFR 1107.1) of the Agency's regulations. As described in §  1107.1(a), FDA may exempt tobacco products that are modified by adding or deleting a tobacco additive, or increasing or decreasing the quantity of an existing tobacco additive, from the requirement of demonstrating substantial equivalence if the Agency determines that: (1) the modification would be a minor modification of a tobacco product that can be sold under the FD&C Act; (2) a report demonstrating substantial equivalence is not necessary to ensure that permitting the tobacco product to be marketed would be appropriate for the protection of public health; and (3) an exemption is otherwise appropriate.

Section 1107.1(b) states that a request for exemption under section 905(j)(3) of the FD&C Act (21 U.S.C. 387e(j)(3)) may be made only by the manufacturer of a legally marketed tobacco product for a minor modification to that tobacco product and that the manufacturer must submit the request and all information supporting it to FDA. The request must be made in an electronic format that FDA can process, review, and archive (or a written request must be made by the manufacturer explaining in detail why the manufacturer cannot submit the request in an electronic format and requesting an alternative means of submission to the electronic format).

An exemption request must contain: (1) the manufacturer's address and contact information; (2) identification of the tobacco product(s); (3) a detailed explanation of the purpose for the modification; (4) a detailed description of the modification, including a statement as to whether the modification involves adding or deleting a tobacco additive, or increasing or decreasing the quantity of the existing tobacco additive; (5) a detailed explanation of why the modification is a minor modification of a tobacco product that can be sold under the FD&C Act; (6) a detailed explanation of why a report under section 905(j)(1) of the FD&C Act intended to demonstrate substantial equivalence is not necessary to ensure that permitting the tobacco product to be marketed would be appropriate for protection of the public health; (7) a certification ( i.e., a signed statement by a responsible official of the company) summarizing the supporting evidence and providing the rationale for the official's determination that the modification does not increase the tobacco product's appeal to or use by minors, toxicity, addictiveness, or abuse liability; (8) other information justifying an exemption; and (9) an environmental assessment (EA) under part 25 (21 CFR part 25; 42 U.S.C. 4332(2)) prepared in accordance with the requirements of § 25.40 (21 CFR 25.40)).

The National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4347) states national environmental objectives and imposes upon each Federal Agency the duty to consider the environmental effects of its actions. Section 102(2)(C) of NEPA requires the preparation of an environmental impact statement for every major Federal action that will significantly affect the quality of the human environment.

The FDA NEPA regulations are contained in part 25. All applications for exemption from substantial equivalence require the submission of an EA. An EA provides information that is used to determine whether an FDA action could result in a significant environmental impact. Section 25.40(a) and (c) specifies the content requirements for EAs for non-excluded actions.

The information required by §  1107.1(b) is submitted to FDA so FDA can determine whether an exemption from substantial equivalence to the product is appropriate for the protection of the public health. Section 1107.1(c) states that FDA will review the information submitted and determine whether to grant or deny an exemption based on whether the criteria in section 905(j)(3) of the FD&C Act are met. FDA may request additional information if necessary, to make a determination and may consider the exemption request withdrawn if the information is not provided within the requested timeframe.

This collection of information also contains a requirement that a manufacturer submit a report (referred to as an “abbreviated report”) at least 90 days prior to making an introduction or delivery for introduction into interstate commerce for commercial distribution of a tobacco product. Section 905(j)(1)(A)(ii) of the FD&C Act states that if an exemption has been requested and granted, the manufacturer must submit to FDA a report that demonstrates that the tobacco product is modified within the meaning of section 905(j)(3), the modifications are to a product that is commercially marketed and in compliance with the requirements of the FD&C Act, and all the modifications are covered by exemptions granted by the Secretary under section 905(j)(3).

Description of Respondents: The respondents to this collection of information are tobacco product manufacturers defined as any person, including any repacker or relabeler, who: (1) manufactures, fabricates, assembles, processes, or labels a tobacco product; or (2) imports a finished tobacco product for sale or distribution in the United States.

Section 1107.1(b) requires that the exemption request and supporting information be submitted in an electronic format that FDA can process, review, and archive. The exemption request and supporting information must be legible and in English. These requirements ensure that FDA can review the exemption request expeditiously and appropriately. FDA provides information on its website on how manufactures may provide electronic submissions and regulatory correspondence, such as the exemption request and supporting information, as well as the abbreviated report, to FDA ( e.g., information on electronic media and methods of transmission). Steps on how to prepare and the recommended structure of an exemption request and abbreviated report can be found at: https://www.fda.gov/tobacco-products/market-and-distribute-tobacco-product/exemption-substantial-equivalence. Information on how to submit exemption requests and abbreviated reports to the CTP Portal can be found here: https://www.fda.gov/tobacco-products/manufacturing/submit-documents-ctp-portal.

FDA does not anticipate any need to submit an exemption request or supporting information in a non-electronic format. However, a company that is not able to submit the documentation in an electronic format may submit a written request to the Center for Tobacco Products document control center ( https://www.fda.gov/tobacco-products/about-center-tobacco-products-ctp/contact-ctp ).

In the Federal Register of February 25, 2022 (87 FR 10797), FDA published a 60-day notice requesting public comment on the proposed collection of information. One comment responsive to the four information collection topics solicited was received. The comment stated that the Agency should consider making the exemption request pathway (section 905(j)(3) of the FD&C Act) more flexible for new products, devices, and technology innovations.

FDA appreciates the comment and notes that although we may consider the comment, these types of actions may necessitate guidance (as noted in the comment). Currently, we believe that the exemption pathway is providing applicants an efficient pathway to make additive changes to their products and receive a marketing order. If the Agency decides to consider revising the suggested actions, these types of actions would need to be done pursuant to separate notice and comment procedures.

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

FDA estimates that we will receive 812 exemption requests under § 1107.1(b) for 24 hours per response including EA for a total of 19,488 hours. Since an EA is required for each § 1107.1(b) (Optional Preparation of Tobacco Product Exemption From Substantial Equivalence Request), the burden per response for EAs (12 hours) has been combined with the 12 hours for an exemption request for a total of 24 hours per response.

FDA further estimates, that we will receive 150 submissions requiring additional information in support of the initial exemption request, and it is expected that it will take an average of 3 hours to prepare the additional information for a total of 450 hours.

FDA estimates that 1,217 respondents will prepare 1,217 responses and each response will take approximately 2 hours to prepare an abbreviated report, as required by section 905(j)(1)(A)(ii), for a total of 2,434 hours. The estimates reflect a decrease of 1,217 hours to account for a reduction in average response time for preparing an abbreviated report. FDA provides a recommended format for applicants in the exemption order letter that significantly reduces the burden hours for preparing the abbreviated report. Therefore, FDA now estimates that the hours for the collection of information associated with exemptions from substantial equivalence requirements total 22,372 hours.

Although there may be year-to-year variability in the absolute number of exemption requests submitted, FDA considers any trends in our analysis, and the overall number of extension requests from manufacturers of tobacco products has remained consistent. Additionally, although manufacturers of NTN products are now subject to all of the tobacco product provisions in the FD&C Act, including the need to submit premarket submissions to FDA and obtain authorization from the Agency to market their product, FDA expects to receive premarket tobacco product applications for most currently marketed NTN products. FDA does not expect to receive many exemption requests for currently marketed NTN products. Thus, no additional adjustments to the number of respondents in our burden estimate are needed for NTN products as the current estimate accounts for some year-to-year variability in the absolute number of exemption requests submitted.

Section 204 of the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-115) amended section 514 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360d). Amended section 514 of the FD&C Act allows FDA to recognize consensus standards developed by international and national organizations for use in satisfying portions of device premarket review submissions or other requirements.

In the Federal Register of September 14, 2018 (83 FR 46738), FDA announced the availability of a guidance entitled “Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices.” The guidance describes how FDA has implemented its standards recognition program and is available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-voluntary-consensus-standards-premarket-submissions-medical-devices. Modifications to the initial list of recognized standards, as published in the Federal Register , can be accessed at https://www.fda.gov/medical-devices/standards-and-conformity-assessment-program/federal-register-documents.

These notices describe the addition, withdrawal, and revision of certain standards recognized by FDA. The Agency maintains on its website HTML and PDF versions of the list of FDA Recognized Consensus Standards, available at https://www.fda.gov/medical-devices/standards-and-conformity-assessment-program/federal-register-documents. Additional information on the Agency's Standards and Conformity Assessment Program is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/standards-and-conformity-assessment-program.

FDA is announcing the addition, withdrawal, correction, and revision of certain consensus standards the Agency is recognizing for use in premarket submissions and other requirements for devices. FDA is incorporating these modifications to the list of FDA Recognized Consensus Standards in the Agency's searchable database. FDA is using the term “Recognition List Number: 058” to identify the current modifications.

In table 1, FDA describes the following modifications: (1) the withdrawal of standards and their replacement by others, if applicable; (2) the correction of errors made by FDA in listing previously recognized standards; and (3) the changes to the supplementary information sheets of recognized standards that describe revisions to the applicability of the standards.

In section III, FDA lists modifications the Agency is making that involve new entries and consensus standards added as modifications to the list of recognized standards under Recognition List Number: 058.

In table 2, FDA provides the listing of new entries and consensus standards added as modifications to the list of recognized standards under Recognition List Number: 058. These entries are of standards not previously recognized by FDA.

FDA maintains the current list of FDA Recognized Consensus Standards in a searchable database that may be accessed at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm. Such standards are those that FDA has recognized by notice published in the Federal Register or that FDA has decided to recognize but for which recognition is pending (because a periodic notice has not yet appeared in the Federal Register ). FDA will announce additional modifications and revisions to the list of recognized consensus standards, as needed, in the Federal Register once a year, or more often if necessary.

Any person may recommend consensus standards as candidates for recognition under section 514 of the FD&C Act by submitting such recommendations, with reasons for the recommendation, to CDRHStandardsStaff@fda.hhs.gov. To be considered, such recommendations should contain, at a minimum, the information available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/standards-and-conformity-assessment-program#process.

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

This information collection helps support implementation of the National Environmental Policy Act (NEPA), consistent with FDA's authority under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Public Health Service Act. All applications or petitions requesting FDA action require the submission of an environmental assessment (EA) or a claim of categorical exclusion (CE). A CE applies to Agency actions that usually have little or no potential to cause significant environmental effects and are excluded from the requirements to prepare an EA or environmental impact statement (EIS). Regulations in part 25 (21 CFR part 25) set forth FDA procedures with regard to NEPA requirements (part 25, subpart A); identify actions that require the preparation of an EA (part 25, subpart B); explain CEs (part 25, subpart C); and discuss the preparation of documents (part 25, subpart D). The regulations also supplement procedural provisions of NEPA that were published by the Council on Environmental Quality (CEQ) in 40 CFR parts 1500 through 1508 and the procedures included in the “HHS General Administration Manual, part 30: Environmental Protection” (45 FR 76519 to 76534, November 19, 1980).

In the Federal Register of August 25, 2021 (86 FR 47501), we published a 60-day notice requesting public comment on the proposed collection of information. Although one comment was received, it was not responsive to the four collection of information topics solicited. On our own initiative and for efficiency of Agency operations, we are revising the information collection to account for burden that may result from recommendations found in Agency guidance and currently approved in OMB control number 0910-0541. The guidance document entitled, “Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for Food Safety and Applied Nutrition” identifies, interprets, and clarifies existing requirements imposed by applicable statutes and regulations, consistent with the CEQ regulations (40 CFR 1507.3). It consists of recommendations that do not themselves create requirements; rather, they are explanatory guidance for FDA's own procedures in order to ensure full compliance with the purposes and provisions of NEPA. The guidance document is available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-preparing-claim-categorical-exclusion-or-environmental-assessment-submission-cfsan, and was issued consistent with our Good Guidance Practice regulations in 21 CFR 10.115, which provide for public comment at any time.

We estimate the burden of the information collection as follows:

CDER:

Under §§ 312.23(a)(7)(iv)(e), 314.50(d)(1)(iii), and 314.94(a)(9)(i) (21 CFR 312.23(a)(7)(iv)(e), 314.50(d)(1)(iii), and 314.94(a)(9)(i)), each investigational new drug application (IND), new drug application (NDA), and abbreviated new drug application (ANDA) must contain a claim for CE under § 25.30 or § 25.31, or an EA under § 25.40.

CDRH:

Under § 814.20(b)(11) (21 CFR 814.20(b)(11)), premarket approvals (PMAs) (original PMAs and supplements) must contain a claim for CE under § 25.30 or § 25.34 or an EA under § 25.40.

CBER:

Under 21 CFR 601.2(a), biologic license applications (BLAs) as well as INDs (§ 312.23), NDAs (§ 314.50), ANDAs (§ 314.94), and PMAs (§ 814.20) must contain either a claim of CE under § 25.30 or § 25.32 or an EA under § 25.40.

CVM:

Under 21 CFR 514.1(b)(14), new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs); 21 CFR 514.8(a)(1) supplemental NADAs and ANADAs; 21 CFR 511.1(b)(10) investigational new animal drug applications and generic investigational new animal drug applications, and 21 CFR 571.1(c) food additive petitions must contain a claim for CE under § 25.30 or § 25.32 or an EA under § 25.40.

CTP:

Under sections 905, 910, and 911 of the FD&C Act (21 U.S.C. 387e, 387j, and 387k), product applications and supplements, premarket tobacco applications (PMTAs), substantial equivalences (SEs), exemption from SEs, and modified risk tobacco product applications must contain a claim for a CE or an EA. Upon evaluation, we have concluded that the majority of the EA burden for tobacco products is accounted for in other information collections currently approved by OMB. The burden we attribute to SEs is currently approved in OMB control number 0910-0673; the burden we attribute to PMTAs is currently approved in OMB control number 0910-0768; and the burden we attribute to SE exemptions is currently approved in OMB control number 0910-0684.

CFSAN:

The estimates for respondents and numbers of responses are based on the annualized numbers of petitions and notifications qualifying for CEs listed under § 25.32(i) and (q) that the Agency has received in the past 3 years. To avoid counting the burden attributed to § 25.32(o) as zero, we have estimated the burden for this claim of CE at one respondent making one submission a year for a total of one annual submission. The burden for submitting a claim of CE is captured under § 25.15(a) and (d).

As a result of revising the information collection to include submissions made to CFSAN, it reflects an increase in burden of 108 responses and 10,668 hours annually.

Under the PRA (44 U.S.C. 3501-3521), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

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

The Mammography Quality Standards Act (Pub. L. 102-539) requires the establishment of a Federal certification and inspection program for mammography facilities; standards for accreditation and certification bodies for mammography facilities; and standards for mammography equipment, personnel, and practices, including quality assurance. Implementing regulations are found in part 900 (21 CFR part 900). The regulations are intended to assure safe, reliable, and accurate mammography on a nationwide level. Under the regulations, as a first step in becoming certified, mammography facilities must become accredited by an FDA-approved accreditation body (AB). This requires undergoing a review of their clinical images and providing the AB with information showing that they meet the equipment, personnel, quality assurance, and quality control standards, and have a medical reporting and recordkeeping program, a medical outcomes audit program, and a consumer complaint mechanism. On the basis of this accreditation, facilities are then certified by FDA or an FDA-approved State certification agency and must prominently display their certificate. These actions are taken to ensure safe, accurate, and reliable mammography on a nationwide basis.

FDA meets with its National Mammography Quality Assurance Advisory Committee (NMQAAC) for the purposes of advising FDA's mammography program on advances in mammography technology and procedures and on appropriate quality standards for mammography facilities. NMQAAC is made up of representatives of the mammography community, consumer and industry groups, and government. The meetings are open to the public and time is allotted for public statements on issues of concern in the mammography field. The chairperson may also call upon attendees to contribute to the committee discussions.

FDA also regularly meets or holds teleconferences with its approved accreditation bodies and State certification agencies to discuss issues of mutual concern. We also engage with the Conference of State Radiation Program Directors (CRCPD), a professional organization of State agencies concerned with radiation protection. The CRCPD has established a standing Mammography Committee, which meets with FDA mammography staff at least once a year.

Finally, in recent years, FDA mammography staff have met several times with representatives of manufacturers working on the new applications of digital technology in mammography to resolve problems preventing the making of that technology generally available. FDA mammography staff have also worked with representatives of the manufacturers to develop quality assurance manuals for full field digital mammography units.

We estimate the burden of this collection of information as follows:

Respondents use the Mammography Program Reporting and Information System to submit information. Our estimated burden for the information collection reflects an overall increase of 28,664 hours and a corresponding increase of 9,137,449 responses/records. We attribute this adjustment to an increase in the number of submissions we received over the last few years. We do not include burden for §§ 900.12(c)(1) and (3), 900.3(f)(1), and 900.24(c) because if a certifying State had its approval withdrawn, FDA would take over certifying authority for the affected facilities. Because FDA already has all the certifying State's electronic records, we assume no additional reporting burden.

Subpart M—Medical Review Officer (MRO), Section 13.2 of the Mandatory Guidelines, “How are nationally recognized entities or subspecialty boards that certify MROs approved?” states as follows: “All nationally recognized entities or subspecialty boards which seek approval by the Secretary to certify physicians as MROs for federal workplace drug testing programs must submit their qualifications, a sample examination, and other necessary supporting examination materials ( e.g., answers, previous examination statistics or other background examination information, if requested). Approval will be based on an objective review of qualifications that include a copy of the MRO applicant application form, documentation that the continuing education courses are accredited by a professional organization, and the delivery method and content of the examination. Each approved MRO certification entity must resubmit their qualifications for approval every two years. The Secretary shall publish at least every two years a notice in the Federal Register listing those entities and subspecialty boards that have been approved. This notice is also available on the internet at http://www.samhsa.gov/workplace/drug-testing .”

HHS has completed its review of entities that certify MROs, in accordance with requests submitted by such entities to HHS. The Assistant Secretary for Mental Health and Substance Use approves the following MRO certifying entities that offer MRO certification through examination:

The information collection notice was previously published in the Federal Register on May 16, 2022, at 87 FR 29759, allowing for a 60-day public comment period. USCIS did not receive comments in connection with the 60-day notice.

You may access the information collection instrument with instructions, or additional information by visiting the Federal eRulemaking Portal site at: http://www.regulations.gov and enter USCIS-2009-0024. in the search box. The comments submitted to USCIS via this method are visible to the Office of Management and Budget and comply with the requirements of 5 CFR 1320.12(c). All submissions will be posted, without change, to the Federal eRulemaking Portal at http://www.regulations.gov, and will include any personal information you provide. Therefore, submitting this information makes it public. You may wish to consider limiting the amount of personal information that you provide in any voluntary submission you make to DHS. DHS may withhold information provided in comments from public viewing that it determines may impact the privacy of an individual or is offensive. For additional information, please read the Privacy Act notice that is available via the link in the footer of http://www.regulations.gov.

Written comments and suggestions from the public and affected agencies should address one or more of the following four points:

(1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

(2) Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

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

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

(1) Type of Information Collection Request: Extension, Without Change, of a Currently Approved Collection.

(2) Title of the Form/Collection: MyAppointment.

(3) Agency form number, if any, and the applicable component of the DHS sponsoring the collection: No Form Number; USCIS.

(4) Affected public who will be asked or required to respond, as well as a brief abstract: Primary: Individuals or households. The MyAppointment system allows an applicant or petitioner to schedule an interview appointment with USCIS through USCIS' internet website.

(5) An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: The estimated total number of respondents for the information collection MyAppointment is 1,043,319 and the estimated hour burden per response is .1 hours.

(6) An estimate of the total public burden (in hours) associated with the collection: The total estimated annual hour burden associated with this collection is 104,332 hours.

(7) An estimate of the total public burden (in cost) associated with the collection: There is no estimated total annual cost burden associated with this collection of information, all costs are captured in the information collections that require an appointment.

We, the U.S. Fish and Wildlife Service (Service), have received an application from San Diego Gas & Electric (SDG&E) for an incidental take permit (ITP) through the year 2050 that would cover 41 species, pursuant to section 10(a)(1)(B) of the Endangered Species Act of 1973, as amended (Act; 16 U.S.C. 1531 et seq. ). SDG&E has prepared the Public Review Draft San Diego Gas & Electric Company Habitat Conservation Plan Amendment 2022 (HCP amendment), which would amend their 1995 Subregional Natural Community Conservation Plan and Habitat Conservation Plan (subregional HCP) pursuant to section 10(a)(1)(B) of the Act. The HCP Amendment includes 41 covered species, and the applicant is requesting the authorization of incidental take of the 25 covered wildlife species that could result from activities covered under the HCP amendment. The HCP amendment includes a conservation program to avoid, minimize, and mitigate for covered activities.

The HCP amendment also includes an eagle conservation plan (ECP) that SDG&E developed with the Service. The ECP provides the information required by the Bald and Golden Eagle Protection Act (BGEPA; 16 U.S.C. 668 and 50 CFR 22) and the Service's final rule revising the regulations that govern the Service's eagle take permit program (50 CFR 13; 50 CFR 22; and 81 FR 91494, December 16, 2016) to continue including bald eagle ( Haliaeetus leucocephalus ) and golden eagle ( Aquila chrysaetos ) as covered species under the HCP amendment.

In connection with the application, we have prepared a draft environmental assessment (draft EA) under the National Environmental Policy Act of 1967, as amended (42 U.S.C. 4321 et seq.; NEPA), and its implementing regulations in the Code of Federal Regulations (CFR) at 40 CFR 1506.6.

We are requesting comments on the permit application and on the draft EA.

Section 9 of the Act and its implementing Federal regulations prohibit the “take” of animal species listed as endangered or threatened. Take is defined under the Act as to “harass, harm, pursue, hunt, shoot, wound, kill, trap, capture, or collect, or to attempt to engage in such conduct” (16 U.S.C. 1538). “Harm” includes significant habitat modification or degradation that actually kills or injures listed wildlife by significantly impairing essential behavioral patterns such as breeding, feeding, or sheltering (50 CFR 17.3). However, under section 10(a) of the Act, the Service may issue permits to authorize incidental take of listed species. “Incidental taking” is defined as “any taking otherwise prohibited, if such taking is incidental to, and not the purpose of, the carrying out an otherwise lawful activity” (50 CFR 17.3). Regulations governing incidental take permits for endangered and threatened species, respectively, are found at 50 CFR 17.22 and 50 CFR 17.32.

The Service would issue an ITP to SDG&E for the amendment to its subregional HCP for certain covered activities. SDG&E has requested an ITP for 41 covered species, including 25 animals and 16 plants, of which 31 are currently listed as threatened or endangered under the Act. Implementation of the HCP amendment may result in 400 acres (ac) of permanent impacts, 210 ac of temporary impacts, and 210 ac of wildfire fuels management impacts to habitat supporting covered species. The impacts anticipated are in addition to the 400 ac of habitat impacts authorized and mitigated under ITP No. PRT-809637 for the subregional HCP. The original ITP for the subregional HCP was set to expire in 2050, and the ITP for the HCP amendment is anticipated to have the same expiration date.

The HCP amendment plan area has been expanded from that for the subregional HCP to include all of SDG&E's 2,815,930-ac service area in all of San Diego County and portions of Orange and Riverside Counties. The plan area includes all of SDG&E's gas and electric transmission and distribution facilities, rights-of-way, buffer lands, areas owned by SDG&E and/or subject to SDG&E easements, access routes, and those areas acquired as mitigation to offset the impacts resulting from covered activities. The total plan area includes approximately 2,021,745 ac (72 percent) of natural land cover types and 794,185 ac (28 percent) of other land cover types ( e.g., agriculture, disturbed habitat, eucalyptus woodland, and urban/developed).

The proposed section 10 ITP would allow take of covered wildlife species resulting from covered activities in the proposed HCP amendment plan area. SDG&E is requesting incidental take authorization for covered species that could be affected by activities identified in the HCP amendment. The HCP amendment covers all SDG&E operations and maintenance (O&M), minor new construction, and wildfire fuels management that may result in take of covered species in the plan area. O&M activities occur throughout SDG&E's existing network of facilities and would occur at or near the existing facilities. Minor new construction activities include installing new or replacement structures to upgrade facilities or to extend service to new customers. Minor new construction, when in preserves or proposed preserves, is limited to 1.75 acres per project. Impacts greater than 1.75 acres from minor new construction in preserves or proposed preserves would require a minor amendment approved by the Service as described in the HCP amendment. Minor amendments are permissible without amending the underlying section 10(a)(l)(B) permit, provided that the Service determines that the changes do not (1) result in additional incidental take of/impacts to covered species not analyzed in connection with the original HCP amendment; (2) result in operations under the HCP amendment that are significantly different from those analyzed in connection with the original HCP amendment; or (3) have adverse effects on the environment that are new or significantly different from those analyzed in connection with the original HCP amendment.

Covered species are those species addressed in the HCP amendment for which conservation actions will be implemented and for which SDG&E is seeking an ITP. Proposed covered species include the following wildlife species that are listed as threatened (T) or endangered (E) under the Act: San Diego fairy shrimp ( Branchinecta sandiegonensis, E), Riverside fairy shrimp ( Streptocephalus woottoni, E), Laguna Mountains skipper ( Pyrgus ruralis lagunae, E), Hermes copper butterfly ( Lycaena hermes, T), arroyo toad ( Anaxyrus californicus, E), California red-legged frog ( Rana draytonii, E), western snowy plover (Pacific Coast Population Distinct Population Segment (DPS) [ Charadrius nivosus nivosus ( C. alexandrinus n. ), T], western yellow-billed cuckoo ( Coccyzus americanus occidentalis, E), southwestern willow flycatcher ( Empidonax traillii extimus, E), coastal California gnatcatcher ( Polioptila californica californica, T), light-footed Ridgway's (=clapper) rail [ Rallus obsoletus (= longirostris ) levipes, E], California least tern [ Sternula antillarum browni ( Sterna a. b. ), E], least Bell's vireo ( Vireo bellii pusillus, E), Stephens' kangaroo rat ( Dipodomys stephensi, T), peninsular bighorn sheep ( Ovis canadensis nelson, E), and Pacific pocket mouse ( Perognathus longimembris pacificus, E).

The golden eagle ( Aquila chrysaetos ) and the bald eagle ( Haliaeetus leucocephalus ) are also covered species in the HCP amendment, along with other regionally sensitive wildlife species, including western spadefoot ( Spea hammondii ), western pond turtle ( Actinemys marmorata ), coast horned lizard ( Phrynosoma blainvillii ), tricolored blackbird ( Agelaius tricolor ), burrowing owl ( Athene cunicularia ), coastal cactus wren ( Campylorhynchus brunneicapillus sandiegensis ) and the Belding's savannah sparrow ( Passerculus sandwichensis beldingi ).

The definition of “take” in the Act does not apply to plants. However, SDG&E proposes to include federally listed plant species in recognition of the conservation benefits provided for them under the HCP amendment. For the purposes of the HCP amendment, federally listed plant species are further included to meet regulatory obligations under section 7 of the Act. SDG&E would receive assurances for all species included on the ITP under Service's “No Surprises” regulations found at 50 CFR 17.22(b)(5) and 50 CFR 17.32(b)(5). The following federally listed plant species are included as covered species in the HCP amendment: San Diego thorn-mint ( Acanthomintha ilicifolia, T), San Diego ambrosia ( Ambrosia pumila, E), Del Mar manzanita ( Arctostaphylos glandulosa ssp. crassifolia, E) Encinitas baccharis ( Baccharis vanessae, T), thread-leaved brodiaea (Brodiaea filifolia ), Salt marsh bird's-beak ( Chloropyron maritimum ssp. maritimum, E), Orcutt's spineflower ( Chorizanthe orcuttiana, E), Otay tarplant ( Deinandra conjugens, T), San Diego button-celery ( Eryngium aristulatum var. parishii, E), willowy monardella ( Monardella viminea, E), spreading navarretia ( Navarretia fossalis, T), California Orcutt grass ( Orcuttia californica, E), San Diego mesa mint ( Pogogyne abramsii, E), and Otay Mesa mint ( Pogogyne nudiuscula, E).

The draft EA was prepared to analyze the impacts of issuing an ITP based on the HCP amendment and to inform the public of the proposed action, alternatives, and associated impacts and disclose any irreversible commitments of resources. The proposed ITP issuance triggers the need for compliance with NEPA. The proposed action presented in the draft EA is compared to the no-action alternative. The no-action alternative represents estimated future conditions to which the proposed action's estimated future conditions can be compared.

We will evaluate the proposed HCP amendment and comments we receive to determine whether the permit application meets the requirements and issuance criteria under section 10(a) of the Act (16 U.S.C. 1531 et seq. ). We will also evaluate whether issuance of a section 10 ITP would comply with section 7 of the Act by conducting an intra-Service consultation. We will use the results of this consultation, in combination with the above findings, in our final analysis to determine whether or not to issue an ITP. If the requirements and issuance criteria under section 10(a) are met, we will issue the ITP to SDG&E for incidental take of covered species.

If you wish to comment on the permit application, proposed HCP amendment, and associated documents, you may submit comments by any of the methods noted in the ADDRESSES section.

Before including your name, address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you may ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.

We provide this notice under section 10 of the Act (16 U.S.C. 1531 et seq. ) and NEPA regulations (40 CFR 1506.6).

The Las Vegas Field Office announces the temporary closures of certain public lands under its administration. This action is being taken to help ensure public safety and prevent unnecessary environmental degradation during the official permitted running of the 2022 Rise Lantern Festival. The public lands affected by this closure are described as follows:

The properties listed in this notice are being considered for listing or related actions in the National Register of Historic Places. Nominations for their consideration were received by the National Park Service before July 30, 2022. Pursuant to Section 60.13 of 36 CFR part 60, comments are being accepted concerning the significance of the nominated properties under the National Register criteria for evaluation.

Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.

Nominations submitted by State or Tribal Historic Preservation Officers:

Additional documentation has been received for the following resources:

Nominations submitted by Federal Preservation Officers:

The State Historic Preservation Officer reviewed the following nominations and responded to the Federal Preservation Officer within 45 days of receipt of the nominations and supports listing the properties in the National Register of Historic Places.

Authority: Section 60.13 of 36 CFR part 60

The Commission instituted this investigation on February 18, 2022, based on a complaint filed by Proven Networks, LLC of Los Angeles, CA (“Proven”). 87 FR 9382 (Feb. 18, 2022). The complaint, as supplemented, alleges violations of section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, in the importation into the United States, the sale for importation, or the sale within the United States after importation of certain networking devices, computers, and components thereof and systems containing the same by reason of infringement of claims 1-37 of U.S. Patent No. 8,687,573. Id. The complaint further alleges that a domestic industry exists. Id. The Commission's notice of investigation named as respondent NetApp, Inc. of San Jose, CA (“NetApp”). Id. The Office of Unfair Import Investigations is not participating in the investigation. Id.

On May 5, 2022, NetApp moved, “[p]ursuant to Commission Rule 210.21(a) [19 CFR 210.21(a)] . . . for termination of the instant investigation based on [Proven's] clear and unequivocal waiver of the sole basis on which Proven alleges it satisfies the domestic industry requirement.” Certain Networking Devices, Computers, and Components Thereof and Sys. Containing the Same, Inv. No. 337-TA-1298, Respondent's Mot. to Terminate Based on Waiver of Domestic Indus., 1 (May 5, 2022). Proven filed a response in opposition to the motion to terminate on May 16, 2022. The CALJ held oral argument on the motion on June 1, 2022. At the outset of the argument, the CALJ characterized the pending motion as one “to terminate the investigation for good cause.” Tr. at 4 (EDIS Doc. ID 772805).

On July 5, 2022, the CALJ issued the subject ID granting NetApp's motion and terminating the investigation in its entirety. The ID relies on the “good cause” language of Commission Rule 210.21(a)(1) as the basis for granting the motion. ID at 4, 12. Substantively, the ID finds that “Proven expressly waived its ability to rely on [third-party] Extreme's products and activities to demonstrate a domestic industry in this investigation,” and that “[w]ithout the ability to rely on Extreme's products and services, Proven cannot satisfy the domestic industry requirement of section 337 and no violation of section 337 can be found.” ID at 12. The Commission has determined not to review the subject ID.

The Commission has also determined to deny as moot a motion filed by NetApp to strike Proven's untimely petition for review. Proven filed an untimely petition for review of the ID, which NetApp moved to strike. Proven's request that its petition for review be received out of time was denied by the Chair. See EDIS Doc. ID 776332 (July 27, 2022). As such, Proven's petition for review is not on the record and therefore NetApp's motion to strike the petition from the record is moot.

The investigation is hereby terminated in its entirety.

The Commission vote for this determination took place on August 4, 2022.

The authority for the Commission's determination is contained in section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and in part 210 of the Commission's Rules of Practice and Procedure (19 CFR part 210).

On November 4, 2021, the Commission instituted this investigation based on a complaint filed on behalf of Honeywell International Inc., Hand Held Products, Inc., and Metrologic Instruments, Inc. (collectively, “Complainants”), all of Charlotte, North Carolina. 86 FR 60915 (Nov. 4, 2021). The complaint alleges violations of section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, based upon the importation into the United States, the sale for importation, and the sale within the United States after importation of certain bar code scanners, mobile computers with bar code scanning capabilities, scan engines, and components thereof that infringe one of more claims of U.S. Patent Nos. 8,794,520 (“the '520 patent”); 7,568,628 (“the '628 patent”); 7,770,799 (“the '799 patent”); 9,576,169 (“the '169 patent”); and 10,721,429 (“the '429 patent”). Id. The complaint also alleges that a domestic industry exists or is in the process of being established. Id. The Commission's notice of investigation named Zebra Technologies Corporation of Lincolnshire, Illinois and Symbol Technologies, Inc. of Holtsville, New York (collectively, “Respondents”) as respondents. Id. The Office of Unfair Import Investigations is participating in this investigation. Id.

The Commission previously terminated the investigation as to the '520 patent and certain claims of the '628, '799, '169, and '429 patents. Order No. 13 (Apr. 7, 2022), unreviewed by Notice (Apr. 25, 2022); Order No. 19 (May 27, 2022), unreviewed by Notice (June 13, 2022).

On July 11, 2022, Complainants and Respondents filed a joint motion to terminate the investigation based on a license and settlement agreement between the parties. No opposition to the motion was filed.

On July 12, 2022, the ALJ issued the subject ID (Order No. 23), granting the joint motion to terminate the investigation based on settlement. The ID finds that the motion for termination satisfies Commission Rule 210.21(b) (19 CFR 210.21(b), and that no extraordinary circumstances exist that would prevent the requested termination. No petitions for review were filed.

The Commission has determined not to review the subject ID. The investigation is terminated in its entirety.

The Commission vote for this determination took place on August 4, 2022.

The authority for the Commission's determination is contained in section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and in part 210 of the Commission's Rules of Practice and Procedure (19 CFR part 210).

The Commission instituted this investigation on November 2, 2021, based on a complaint filed and supplemented by Easton Diamond Sports, LLC of Thousand Oaks, California (“Easton”). 86 FR 60468-469 (Nov. 2, 2021). The complaint alleges a violation of section 337 of the Tariff Act, as amended, 19 U.S.C. 1337, based on the importation, sale for importation, or sale in the United States after importation of certain composite baseball and softball bats and components thereof by reason of infringement of one or more asserted claims of U.S. Patent No. 6,997,826. Id. The complaint further alleges the existence of a domestic industry. Id. The Commission's notice of investigation names Juno of Aventura, Florida; Monsta Athletics LLC of Calimesa, California (“Monsta”); and Proton Sports Inc. of Scottsdale, Arizona (“Proton”) as respondents. Id. at 60469. The Office of Unfair Import Investigations is not a party to this investigation. Id.

On January 25, 2022, the Commission amended the complaint and notice of investigation to add TianChang Zhengmu Aluminum Technology Co., Ltd. of Tianching City, China (“TZA”) as a respondent. Order No. 8 (Dec. 28, 2021), unreviewed by Comm'n Notice (Jan. 25, 2022).

On February 16, 2022, the Commission terminated TZA from the investigation based on withdrawal of the complaint. Order No. 11 (Jan. 28, 2022), unreviewed by Comm'n Notice (Feb. 16, 2022).

On April 12, 2022, the Commission found respondent Proton in default. Order No. 13 (March 30, 2022), unreviewed by Comm'n Notice (April 12, 2022).

On July 25, 2022, the Commission terminated Monsta from the investigation based on withdrawal of the complaint. Order No. 21 (June 27, 2022), unreviewed by Comm'n Notice (July 25, 2022).

On July 8, 2022, Easton and Juno filed a joint motion to terminate the investigation with respect to Juno based on a settlement agreement. Easton further requested issuance of a limited exclusion order (“LEO”) against the defaulting respondent, Proton. Joint Motion to Terminate the Investigation as to Respondent Juno Athletics LLC Based on Settlement and Motion to Stay the Investigation as to Juno Athletics LLC at 3 (July 11, 2022).

On July 11, 2022, the presiding ALJ issued the subject ID granting the motion to terminate the investigation with respect to Juno. Order No. 23 (July 11, 2022). The subject ID finds that the joint motion complies with the requirements of Commission Rule 210.21(a), (b) (19 CFR 210.21(a), (b)), in that the settlement agreement completely resolves the dispute between Easton and Juno, and there are no other agreements, oral or written, express or implied, between the parties regarding the subject matter of the investigation. The ID also finds that terminating Juno serves the public interest by avoiding litigation and conserving public and private resources. The ID further finds that terminating Juno is not contrary to the public health and welfare, competitive conditions in the U.S. economy, the production of like or directly competitive articles in the United States, or U.S. consumers. The ID also finds there are no extraordinary circumstances that weigh against termination. No party filed a petition for review of the subject ID.

Upon review of the subject ID, the Commission has determined not to review, and thereby adopts, the subject ID. The investigation is hereby terminated with respect to Juno.

As Juno was the last active respondent in this investigation, only Proton, who was previously found in default, remains. As noted above, Easton seeks an LEO against Proton.

In connection with the final disposition of this investigation, the statute authorizes issuance of an order that could result in the exclusion of the subject articles from entry into the United States. Accordingly, the Commission is interested in receiving written submissions that address the form of remedy, if any, that should be ordered. If a party seeks exclusion of an article from entry into the United States for purposes other than entry for consumption, the party should so indicate and provide information establishing that activities involving other types of entry either are adversely affecting it or likely to do so. For background, see Certain Devices for Connecting Computers via Telephone Lines, Inv. No. 337-TA-360, USITC Pub. No. 2843, Comm'n Op. at 7-10 (December 1994).

The statute requires the Commission to consider the effects of any remedy upon the public interest. The public interest factors the Commission will consider include the effect that an exclusion order and/or cease-and-desist order would have on: (1) the public health and welfare; (2) competitive conditions in the U.S. economy; (3) U.S. production of articles that are like or directly competitive with those that are subject to investigation; and (4) U.S. consumers. The Commission is therefore interested in receiving written submissions that address the aforementioned public interest factors in the context of this investigation.

If the Commission orders some form of remedy, the U.S. Trade Representative, as delegated by the President, has 60 days to approve, disapprove, or take no action on the Commission's action. See Presidential Memorandum of July 21, 2005. 70 FR 43251 (July 26, 2005). During this period, the subject articles would be entitled to enter the United States under bond, in an amount determined by the Commission and prescribed by the Secretary of the Treasury. The Commission is therefore interested in receiving submissions concerning the amount of the bond that should be imposed if a remedy is ordered.

Written Submissions: Parties to this investigation, interested government agencies, and any other interested parties are requested to file written submissions on the issues of remedy, the public interest, and bonding.

In its initial submission, Complainant is requested to identify the remedy sought and to submit proposed remedial orders for the Commission's consideration. Complainant is also requested to provide the HTSUS subheadings under which the accused products are imported. Complainant is further requested to supply the names of known importers of a respondent's products at issue in this investigation. Complainant is also requested to identify and explain, from the record, articles that it contends are “components of” the subject products, and thus potentially covered by the proposed remedial orders, if imported separately from the subject products. See 86 FR 60468-469. Failure to provide this information may result in waiver of any remedy directed to “components of” the subject products, in the event any violation may be found.

The parties' written submissions and proposed remedial orders must be filed no later than the close of business on August 26, 2022. Reply submissions must be filed no later than the close of business on September 5, 2022. Opening submissions are limited to 30 pages. Reply submissions are limited to 25 pages. No further submissions on any of these issues will be permitted unless otherwise ordered by the Commission.

Persons filing written submissions must file the original document electronically on or before the deadlines stated above. The Commission's paper filing requirements in 19 CFR 210.4(f) are currently waived. 85 FR 15798 (Mar. 19, 2020). Submissions should refer to the investigation number (“Inv. No. 337-TA-1283”) in a prominent place on the cover page and/or first page. ( See Handbook for Electronic Filing Procedures, https://www.usitc.gov/documents/handbook_on_filing_procedures.pdf. ) Persons with questions regarding filing should contact the Secretary (202-205-2000).

Any person desiring to submit a document to the Commission in confidence must request confidential treatment by marking each document with a header indicating that the document contains confidential information. This marking will be deemed to satisfy the request procedure set forth in Commission Rules 201.6(b) and 210.5(e)(2) (19 CFR 201.6(b), 210.5(e)(2)). Documents for which confidential treatment by the Commission is properly sought will be treated accordingly. All information, including confidential business information and documents for which confidential treatment is properly sought, submitted to the Commission for purposes of this Investigation may be disclosed to and used: (i) By the Commission, its employees and Offices, and contract personnel (a) for developing or maintaining the records of this or a related proceeding, or (b) in internal investigations, audits, reviews, and evaluations relating to the programs, personnel, and operations of the Commission including under 5 U.S.C. Appendix 3; or (ii) by U.S. government employees and contract personnel, solely for cybersecurity purposes. All contract personnel will sign appropriate nondisclosure agreements. All non-confidential written submissions will be available for public inspection at the Office of the Secretary and on EDIS.

The Commission voted to approve this determination on August 4, 2022.

The authority for the Commission's determinations is contained in Section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and in part 210 of the Commission's Rules of Practice and Procedure (19 CFR part 210).

In accordance with 21 CFR 1301.34(a), this is notice that on June 13, 2022, Lipomed, 150 Cambridgepark Drive, Suite 705, Cambridge, Massachusetts 02140, applied to be registered as an importer of the following basic class(es) of controlled substance(s):

The company plans to import analytical reference standards for distribution to its customers for research and analytical purposes. No other activity for this drug code is authorized for this registration.

Approval of permit applications will occur only when the registrant's business activity is consistent with what is authorized under 21 U.S.C. 952(a)(2). Authorization will not extend to the import of Food and Drug Administration-approved or non-approved finished dosage forms for commercial sale.

In accordance with 21 CFR 1301.33(a), this is notice that on May 9, 2022, Cambrex Charles City, 1205 11th Street, Charles City, Iowa 50616-3466, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s):

The company plans to manufacture the listed controlled substances in bulk for conversion to other controlled substances and sales to its customers for dosage form development, clinical trials and use in stability qualification studies.

In reference to drug codes 7360 (Marihuana), and 7370 (Tetrahydrocannabinols), the company plans to bulk manufacture these drugs as synthetic. No other activities for these drug codes are authorized for this registration.

In accordance with 21 CFR 1301.34(a), this is notice that on June 9, 2022, VA Cooperative Studies Program, 2401 Centre Avenue SE, Albuquerque, New Mexico 87106, applied to be registered as an importer of the following basic class(es) of controlled substance(s):

The company plans to import finished dosage unit products containing Tetrahydrocannabinols drug code (7370) for research and clinical trial studies. No other activity for this drug code is authorized for this registration.

Approval of permit applications will occur only when the registrant's business activity is consistent with what is authorized under 21 U.S.C. 952(a)(2). Authorization will not extend to the import of Food and Drug Administration-approved or non-approved finished dosage forms for commercial sale.

In accordance with 21 CFR 1301.34(a), this is notice that on July 19, 2022, Epic Pharma, LLC, 22715 North Conduit Avenue, Laurelton, New York 11413-3134, applied to be registered as an importer of the following basic class(es) of controlled substance(s):

The company plans to import the listed controlled substance for research and development purposes. No other activity for this drug code is authorized for this registration.

Approval of permit applications will occur only when the registrant's business activity is consistent with what is authorized under 21 U.S.C. 952(a)(2). Authorization will not extend to the import of Food and Drug Administration-approved or non-approved finished dosage forms for commercial sale.