In accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), USAID is providing the general public and Federal agencies with an opportunity to comment on the proposed collection of information. USAID is requesting a general clearance to provide and conduct workforce surveys, interviews, and focus groups with a diverse workforce consisting of numerous hiring mechanisms, including, but not limited to, U.S. direct hires, fellows, interns, Personal Services Contractors, Institutional Support Contractors, Coordinating Country Nationals, and Third Country Nationals. The goal of data collection under this generic clearance is to collect workforce feedback on organizational health, operations, workforce culture, and work environment necessary to strengthen mission readiness and better achieve its development objectives. USAID will only collect data from the approximately 11,000 members of the USAID workforce with minimal collection of personally identifiable information. The total estimated number of annual burden hours for these workforce population surveys is 41,250 hours. USAID will limit analysis and reporting to summary level statistics that will only be available to the internal workforce.

OMB Control Number: TBD.

The regulations in 9 CFR part 93, subpart D (§§ 93.400 through 93.442, referred to below as part 93 or the subpart), contain requirements for the importation of ruminants into the United States to address the risk of introducing or disseminating diseases of livestock within the United States. Part 93 currently contains provisions that address the risk that imported bovines (cattle or bison) may introduce or disseminate bovine tuberculosis within the United States. Within part 93, § 93.437 contains the requirements for classification of foreign regions for bovine tuberculosis and § 93.438 contains the process for requesting regional classification for bovine tuberculosis.

In accordance with § 93.437(f), the Animal and Plant Health Inspection Service (APHIS) maintains lists of all Level I, Level II, Level III, Level IV, and Level V regions for bovine tuberculosis and makes changes to the lists in accordance with § 93.438. In accordance with § 93.437(e), regions that do not have a program that meets APHIS requirements for bovine tuberculosis classification, have a prevalence of bovine tuberculosis in their domestic bovine herds equal to or greater than 0.5 percent, or are unassessed by APHIS with regard to bovine tuberculosis are considered to be Level V.

Paragraph (d) of § 93.438 provides that a region may be required to allow APHIS to conduct additional information collection activities in order for that region to maintain its classification for bovine tuberculosis. If APHIS determines that a region's classification is no longer accurate, APHIS will publish a notice in the Federal Register announcing the revised classification and setting forth the reasons for the reclassification.

In March 2023, APHIS conducted an onsite review of the bovine tuberculosis control and eradication program in Nuevo León. At the time of this review, APHIS recognized the Nuevo León region as Level IV status for bovine tuberculosis. The review determined that the region no longer has a program that meets APHIS minimum requirements for Level IV status due to deficiencies in the following areas: Veterinary control and oversight; epidemiological investigations; management of affected herds; regulatory controls on the movement of livestock; and surveillance. These findings support reclassifying Nuevo León as Level V for bovine tuberculosis.

With the publication of this notice, we are announcing the revised classification of the Nuevo León region of Mexico to Level V for bovine tuberculosis, effective December 1, 2023. This notice serves as an official record and public notification of this action.

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. 1622 and 8301-8317; 21 U.S.C. 136 and 136a; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.4.

On April 20, 2010, the mobile offshore drilling unit Deepwater Horizon, which was being used to drill a well for BP Exploration and Production, Inc. (BP), in the Macondo prospect (Mississippi Canyon 252-MC252), experienced a significant explosion, fire, and subsequent sinking in the Gulf of Mexico, resulting in an unprecedented volume of oil and other discharges from the rig and from the wellhead on the seabed. The DWH oil spill is the largest offshore oil spill in U.S. history, discharging millions of barrels of oil over a period of 87 days. In addition, well over 1 million gallons of dispersants were applied to the waters of the spill area in an attempt to disperse the spilled oil. An undetermined amount of natural gas was also released into the environment as a result of the spill.

The DWH Federal and State natural resource trustees (DWH Trustees) conducted NRDA for the DWH oil spill under OPA (33 U.S.C. 2701-2720). Pursuant to OPA, Federal, and State agencies act as trustees on behalf of the public, to assess natural resources injuries and losses and to determine the actions required to compensate the public for those injuries and losses. OPA further instructs the designated trustees to develop and implement a plan for the restoration, rehabilitation, replacement, or acquisition of the equivalent of the injured natural resources under their trusteeship to baseline (the resource quality and conditions that would exist if the spill had not occurred). This includes the loss of use and services provided by those resources from the time of injury until the completion of restoration.

The DWH Trustees are:

• U.S. Department of the Interior (DOI), as represented by the National Park Service, U.S. Fish and Wildlife Service, and Bureau of Land Management;

• National Oceanic and Atmospheric Administration (NOAA), on behalf of the U.S. Department of Commerce;

• USDA;

• U.S. Environmental Protection Agency (EPA);

• State of Louisiana Coastal Protection and Restoration Authority, Oil Spill Coordinator's Office, Department of Environmental Quality, Department of Wildlife and Fisheries, and Department of Natural Resources;

• State of Mississippi Department of Environmental Quality;

• State of Alabama Department of Conservation and Natural Resources and Geological Survey of Alabama;

• State of Florida Department of Environmental Protection and Fish and Wildlife Conservation Commission; and

• State of Texas: Texas Parks and Wildlife Department, Texas General Land Office, and Texas Commission on Environmental Quality.

On April 4, 2016, the United States District Court for the Eastern District of Louisiana entered a Consent Decree resolving civil claims by the DWH Trustees against BP arising from the DWH oil spill: United States v. BPXP et al., Civ. No. 10-4536, centralized in MDL 2179, In re: Oil Spill by the Oil Rig “Deepwater Horizon” in the Gulf of Mexico, on April 20, 2010 (E.D. La.) ( https://www.justice.gov/enrd/deepwater-horizon ). Pursuant to the Consent Decree, restoration projects in the Mississippi Restoration Area are chosen and managed by MS TIG. MS TIG is composed of the following Trustees: State of Mississippi Department of Environmental Quality; DOI; NOAA; EPA; and USDA.

On February 7, 2022, MS TIG posted public notice requesting natural resource restoration project ideas by March 7, 2022, for the Mississippi Restoration Area. The notice stated that MS TIG was seeking project ideas for the following restoration types:

(1) Wetlands, Coastal, and Nearshore Habitat;

(2) Nutrient Reduction; and

(3) Provide and Enhance Recreational Opportunities.

On October 11, 2022, the MS TIG announced that it had initiated drafting of the RP4 and EA ( https://www.gulfspillrestoration.noaa.gov/2022/10/notice-initiation-restoration-planning-mississippi ) and that the plan may include proposed projects for some or all of the three restoration types.

MS TIG released the Draft RP4 and EA for public review and comment announced through a notice published in the Federal Register on August 31, 2023 (88 FR 60174-60176). The 30-day comment period for the notice closed on October 2, 2023. To facilitate public understanding of the document, MS TIG released a pre-recorded webinar on September 12, 2023, which had been announced in the August notice. In addition, the Draft RP and EA was made available to the public through a web story posted on MS TIG's website ( www.gulfspillrestoration.noaa.gov ). Informally, MS TIG accepted additional public comments through October 13, 2023, as announced on the MS TIG's website. MS TIG received three comments from the public. MS TIG reviewed the comments received, prepared responses to those comments, finalized the RP4 and EA, and prepared a FONSI.

In the Final RP4 and EA, MS TIG analyzes a reasonable range of 10 restoration alternatives and, pursuant to NEPA, a no action alternative for each of the restoration types. MS TIG selected seven preferred alternatives for funding and implementation, which are listed in the table below:

The documents comprising the Administrative Record for the Final RP4 and EA can be viewed electronically at https://www.doi.gov/deepwaterhorizon/adminrecord under the folder 6.5.6.2.4.

The authorities for this action are OPA, its implementing NRDA regulations in 15 CFR part 990; and NEPA (42 U.S.C. 4321—4347) and its implementing regulations in 40 CFR parts 1500-1508.

The PECSEA was originally established on June 1, 1976, as a subordinate committee of the President's Export Council (PEC), and the PECSEA charter was renewed biennially until the PECSEA terminated in 2019. The PECSEA is being reestablished under agency authority as a subordinate committee of the PEC and in accordance with section 1-205 of Executive Order (E.O.) 12131, “The President's Export Council” (May 4, 1979), as amended and as continued by successive E.O.s, most recently by E.O. 14109, “Continuance of Certain Federal Advisory Committees and Amendments to Other Executive Orders,” September 29, 2023, and in accordance with the provisions of the Federal Advisory Committee Act, as amended (FACA) (5 U.S.C. 1001 et seq. ).

The PECSEA is a discretionary committee and will function solely as an advisory body, complying with the provisions of FACA.

PECSEA members will be appointed by the Secretary of Commerce and serve at the Secretary's discretion. Members will generally serve two-year appointments and may be reappointed for membership by the Secretary. PECSEA members must be able to qualify for a Secret security clearance or a security clearance at a level sufficient to perform their work on PECSEA. The PECSEA will meet approximately three times per year. Members of PECSEA who are not otherwise paid a salary by the federal government shall receive no compensation from the U.S. by virtue of their service on the PECSEA, but may, upon their request, be allowed travel expenses, as authorized by 5 U.S.C. 5701 et seq.

PECSEA will be composed of members selected from industry and other non-governmental organizations, drawn from among members of the PEC and other representatives of industry and other non-governmental organizations who are exporters of or otherwise engaged in activities related to items that are presently controlled under the Export Administration Regulations or are proposed for such control, balanced to the extent possible among large and small firms. The PECSEA is seeking private-sector members who are preferably senior executives with strategic authority within their companies and with significant operational control around production, supply chains, research and development activities, and/or international sales and should have an understanding of the impact of export controls on these functions and the broader marketplace.

PECSEA will draw on the experiences and perspectives of its members to provide advice and make recommendations on protecting U.S. national security and foreign policy concerns through the administration of export controls while protecting U.S. technology leadership and commercial trade to ensure a strong U.S. defense industrial base. The diverse membership of the PECSEA assures perspectives reflecting the breadth of the PECSEA's responsibilities, and, where possible, the Department will also consider the ethnic, racial, and gender diversity and various abilities of the U.S. population.

To Apply: If you are interested in nominating someone or yourself to become a member of the PECSEA, please provide full name, title, employer name, and any other information you believe relevant to the nomination (2 pages maximum). Third-party nominations should state that the candidate agrees to the nomination.

Please do not send organization brochures or any other information.

All applications should be submitted in pdf or MS Word format via email to the email address listed in ADDRESSES above by the deadline noted in DATES above.

The collection, maintenance, and disclosure of this information is governed by the Privacy Act of 1974 (5 U.S.C. 552a). The Department of Commerce is authorized to collect this information pursuant to authorities that include, but are not limited to, E.O. 12131, “The President's Export Council” (May 4, 1979), as amended and as continued by successive E.O.s, most recently by E.O. 14109, “Continuance of Certain Federal Advisory Committees and Amendments to Other Executive Orders,” September 29, 2023, and in accordance with the provisions of the FACA. The principal purpose for which the Department will use the information is to assist in choosing members for the PECSEA. Information received will be maintained in a Privacy Act system of records, COMMERCE/DEPT-11, entitled “Candidates for Membership, Members, and Former Members of Department of Commerce Advisory Committees.” A notice describing that system, including a complete set of routine disclosures, has been published both in the Federal Register and on the Department's website at: https://osec.doc.gov/opog/PrivacyAct/SORNs/dept-11.html. Although providing this information is voluntary, an individual cannot be considered for membership without an application submission, whether self-nominated or nominated by a third-party.

Background: The CINTAC was established under the discretionary authority of the Secretary of Commerce and in accordance with the Federal Advisory Committee Act (5 U.S.C. 1001 et seq. ), in response to an identified need for consensus advice from U.S. industry to the U.S. Government regarding the development and administration of programs to expand U.S. exports of civil nuclear goods and services in accordance with applicable U.S. laws and regulations, including advice on how U.S. civil nuclear goods and services export policies, programs, and activities affect the U.S. civil nuclear industry's competitiveness and ability to participate in the international market.

Topics to be considered: The agenda for the Thursday, January 11, 2024, CINTAC meeting will include discussions of CINTAC priorities for its 2022-2024 charter term and activities related to the U.S. Department of Commerce's Civil Nuclear Trade Initiative.

Members of the public wishing to attend the meeting must notify Mr. Jonathan Chesebro at the contact information above by 5 p.m. EST on Monday, January 8, 2024, in order to pre-register. Please specify any requests for reasonable accommodation at least five business days in advance of the meeting.

A limited amount of time will be available for brief oral comments from members of the public attending the meeting. To accommodate as many speakers as possible, the time for public comments will be limited to two (2) minutes per person, with a total public comment period of 20 minutes. Individuals wishing to reserve speaking time during the meeting must contact Mr. Jonathan Chesebro and submit a brief statement of the general nature of the comments and the name and address of the proposed participant by 5 p.m. EST on Monday, January 8, 2024. If the number of registrants requesting to make statements is greater than can be reasonably accommodated during the meeting, ITA may conduct a lottery to determine the speakers.

Any member of the public may submit written comments concerning the CINTAC's affairs at any time before and after the meeting. Comments may be submitted to Mr. Jonathan Chesebro in the International Trade Administration's Office of Energy & Environmental Industries. For consideration during the meeting, and to ensure transmission to the Committee prior to the meeting, comments must be received no later than 5:00 p.m. EST on Monday, January 8, 2024. Comments received after that date will be distributed to the members but may not be considered at the meeting.

Copies of CINTAC meeting minutes will be available within 90 days of the meeting.

Background: The Secretary of Commerce established the REEEAC pursuant to discretionary authority and in accordance with the Federal Advisory Committee Act, as amended (5 U.S.C. 1001 et seq. ), on July 14, 2010. The REEEAC was re-chartered most recently on May 27, 2022. The REEEAC provides the Secretary of Commerce with advice from the private sector on the development and administration of programs and policies to expand the export competitiveness of U.S. renewable energy and energy efficiency products and services. More information about the REEEAC, including the list of appointed members for this charter, is published online at http://trade.gov/reeeac.

On January 25, 2024, the REEEAC will hold the sixth meeting of its current charter term. The Committee will deliberate on approval of several recommendations. The REEEAC will also be briefed on recent ITA accomplishments of relevance to the U.S. renewable energy and energy efficiency industries, including the delegation to COP28, the launch of the Clean Tech Top Export Markets website, and the establishment of the Supply Chain Center. The agenda will be made available by January 22, 2024 upon request to Cora Dickson, and the most current version of the agenda will also be made available on the REEEAC website.

The meeting will be open to the public and will be accessible to people with disabilities. All guests are required to register in advance by the deadline identified under the DATES caption. Requests for auxiliary aids must be submitted by the registration deadline. Last minute requests will be accepted but may not be possible to fill.

A limited amount of time before the close of the meeting will be available for oral comments from members of the public attending the meeting. Members of the public attending virtually who wish to speak during the public comment period must give the DFO advance notice in order to facilitate their access. To accommodate as many speakers as possible, the time for public comments will be limited to two to five minutes per person (depending on number of public participants). Individuals wishing to reserve speaking time during the meeting must contact Cora Dickson using the contact information above and submit a brief statement of the general nature of the comments, as well as the name and address of the proposed participant, by 5 p.m. EDT on Monday, January 22, 2024. If the number of registrants requesting to make statements is greater than can be reasonably accommodated during the meeting, the International Trade Administration may conduct a lottery to determine the speakers. Speakers are requested to submit a copy of their oral comments by email to Cora Dickson for distribution to the participants in advance of the meeting.

Any member of the public may submit written comments concerning the REEEAC's affairs at any time before or after the meeting. Comments may be submitted via email to the Renewable Energy and Energy Efficiency Advisory Committee, c/o: Cora Dickson, Designated Federal Officer, Office of Energy and Environmental Industries, U.S. Department of Commerce; Cora.Dickson@trade.gov. To be considered during the meeting, public comments must be transmitted to the REEEAC prior to the meeting. As such, written comments must be received no later than 5 p.m. EDT on Monday, January 22, 2024. Comments received after that date will be distributed to the members but may not be considered at the meeting.

Copies of REEEAC meeting minutes will be available within 30 days following the meeting.

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 IHA 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.

On June 28, 2022, NMFS received a request from DOT&PF for an IHA to take marine mammals incidental to the Hydaburg Seaplane Base Refurbishment Project in Hydaburg, Alaska. Following NMFS' review of the application, and multiple discussions between DOT&PF and NMFS, DOT&PF submitted responses to NMFS questions on December 15, 2022 and a revised application on February 22, 2023. The application was deemed adequate and complete on March 13, 2023. DOT&PF's request is for take of nine species of marine mammals by Level B harassment and, for a subset of 6 of these species, Level A harassment. Neither DOT&PF nor NMFS expect serious injury or mortality to result from this activity and, therefore, an IHA is appropriate.

DOT&PF, in cooperation with the Federal Aviation Administration, is planning maintenance improvements to the existing Hydaburg Seaplane Base as part of the Hydaburg Seaplane Base Refurbishment Project. The existing facility has experienced deterioration in recent years, and DOT&PF has conducted several repair projects. The facility is near the end of its useful life, and replacement of the existing float structures is required to continue safe operation in the future. The in-water portion of the project will include the removal of five existing steel piles and installation of eight permanent steel piles to support replacement of the floating dock structure (Table 1). Up to 10 temporary steel piles will be installed to support permanent pile installation and will be removed following completion of permanent pile installation (Table 1). Activities included as part of the project with potential to affect marine mammals include vibratory removal, down-the-hole (DTH) installation, and vibratory and impact installation of steel pipe piles. Pile installation and removal will occur intermittently over 26 nonconsecutive days within a 2-month construction window, and is anticipated to begin in fall 2024.

A detailed description of the planned construction project is provided in the Federal Register notice for the proposed IHA (88 FR 45774, June 17, 2023). Since that time, no changes have been made to the planned activities. Therefore, a detailed description is not provided here. Please refer to that Federal Register notice for the description of the specific activity.

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

A notice of NMFS' proposal to issue an IHA to the DOT&PF was published in the Federal Register on July 17, 2023 (88 FR 45774). That notice described, in detail, the DOT&PF's activities, the marine mammal species that may be affected by the activities, and the anticipated effects on marine mammals. In that notice, we requested public input on the request for authorization described therein, our analyses, the proposed authorization, and any other aspect of the notice of proposed IHA, and requested that interested persons submit relevant information, suggestions, and comments. This proposed notice was available for a 30-day public comment period.

In the Federal Register notice of the proposed IHA, NMFS presented our assessment of DTH systems, which differed from DOT&PF's assessment. Specifically, the DOT&PF and NMFS disagreed about some of the source levels and transmission loss (TL) coefficients that should be used as proxies to estimate the ensonified area resulting from certain DTH activities. NMFS also disagreed with the DOT&PF's assessment that sounds resulting from the DTH installation of 8 inch anchor piles should only be considered as continuous sound sources when calculating Level A and Level B harassment rather than as having both impulsive and continuous components as recommended by NMFS (2022) ( https://media.fisheries.noaa.gov/2022-11/PUBLIC%20DTH%20Basic%20Guidance_November%202022.pdf ). Available data does not support DOT&PF's evaluation. NMFS' recommendations regarding analysis of sound produced through use of DTH techniques is based on the best available science and interpretation of available data by subject matter experts, and is publicly available online. NMFS explained these issues in the notice of the proposed IHA, and specifically requested public comment on its DTH-related recommendations in context of DOT&PF's alternative interpretation.

During the 30-day public comment period, NMFS received comments from the Marine Mammal Commission (MMC). The MMC expressed support for NMFS' assessment and evaluation of DTH systems. Specifically, the MMC agrees with NMFS that DTH installation of all sized piles, including 8-inch tension anchors, should be considered an impulsive, continuous source and that NMFS should the use proxy source levels recommended by NMFS (2022) instead of those proposed by the DOT&PF to estimate associated ensonified areas. In addition, the MMC agrees with NMFS' determination that applying proxy TL coefficients measured in other locations in Hydaburg is inappropriate, because transmission loss is dependent on sediment characteristics, bathymetry/water depth, and sound speed profiles in a given area. The MMC supports NMFS' decision to require the DOT&PF to use practical spreading loss models ( i.e., 15 log R) when calculating ensonified areas resulting from DTH pile installation at Hydaburg, and recommends that NMFS continue to require action proponents to use practical spreading unless site-specific transmission loss data are available from the proposed project site. The comments and recommendations are available online at: https://www.fisheries.noaa.gov/national/marine-mammal-protection/incidental-take-authorizations-construction-activities. Please see the comment submission for full details regarding the recommendations and supporting rationale.

Since the Federal Register notice of the proposed IHA was published (88 FR 45774, July 17, 2023), NMFS published the 2022 Alaska and Pacific Stock Assessment Reports (SARs), which provide updates to the humpback whale stock structure and Southeast Alaska harbor porpoise stock structure (Carretta et al., 2023; Young et al, 2023). Updates have been made to the species descriptions for these species (see Description of Marine Mammals in the Area of Specified Activities) as well as to our analysis of take (see Estimated Take) and small numbers determinations (see Small Numbers).

In addition, based on the comment letter received from the MMC in support of NMFS' assessment of DTH systems, the Estimated Take section in this notice only considers source levels and transmission loss coefficients recommended by NMFS (2022) for DTH systems as proxies to estimate associated ensonified areas (in contrast to including a discussion regarding the DOT&PF's assessment of DTH systems). Specifically, DTH installation of all sized piles are considered to be an impulsive, continuous source; proxy source levels follow NMFS's recommendations for DTH systems (NMFS, 2022); and transmission loss of sounds produced by DTH systems in the Hydaburg project area are modelled assuming practical spreading loss.

Lastly, a typographical error identified in Table 1 in the Federal Register notice of the proposed IHA has been corrected in this Federal Register notice. Specifically, the number of estimated days of installation and removal of 24-inch steel piles included in the Table was incorrect. No other changes have been made from the proposed IHA to the final IHA.

Sections 3 and 4 of the DOT&PF's 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, referenced here, 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 2 lists all species or stocks for which take is expected and 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 expected to occur, PBR and annual serious injury and mortality from anthropogenic sources are included here as gross indicators of the status of the species or stocks 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 stocks managed under the MMPA in this region are assessed in NMFS' U.S. Alaska and Pacific SARs ( e.g., Carretta, et al., 2023; Young et al., 2023). All values presented in Table 2 are the most recent available at the time of publication and are available online at: www.fisheries.noaa.gov/national/marine-mammal-protection/marine-mammal-stock-assessments .

A detailed description of the species likely to be affected by the construction project, including a brief introduction to the affected stock as well as available information regarding population trends and threats, and information regarding local occurrence, were provided in the Federal Register notice for the proposed IHA (88 FR 41920, June 28, 2023). Since that time, the structure of the harbor porpoise and humpback whale stocks have been updated; therefore, a detailed description of those species updated stock structure is provided here. Please refer to the Federal Register notice of the proposed IHA (88 FR 41920, June 28, 2023) for the full description for all species. Please also refer to NMFS' website ( https://www.fisheries.noaa.gov/find-species ) for generalized species accounts.

In the 2022 Alaska SAR, stock structure was revised for the Southeast Alaska harbor porpoise stock, which was split into three stocks: the Northern Southeast Alaska Inland Waters, Southern Southeast Alaska Inland Waters, and Yakutat/Southeast Alaska Offshore Waters harbor porpoise stocks (Young et al., 2023). This update better aligns harbor porpoise stock structure with genetics, trends in abundance, and information regarding discontinuous distribution trends (Young et al., 2023). Harbor porpoises found in Hydaburg are assumed to be members of the Southern Southeast Alaska Inland Waters stock based on the geographical range of the stock, which encompasses Sumner Strait, including areas around Wrangell and Zarembo Islands, Clarence Strait, and adjacent inlets and channels within the inland waters of Southeast Alaska north-northeast of Dixon Entrance.

The 2022 Alaska and Pacific SARs include an update to the humpback whale stock structure which modifies the previously MMPA-designated humpback stocks to align more closely with the ESA-designated distinct population segments (DPSs) (Caretta et al., 2023; Young et al., 2023). Specifically, the three existing North Pacific humpback whale stocks (Central and Western North Pacific stocks and a CA/OR/WA stock) were replaced by five stocks, largely corresponding with the ESA-designated DPSs. These include Western North Pacific and Hawaii stocks and a Central America/Southern Mexico-CA/OR/WA stock (which corresponds with the Central America DPS). The remaining two stocks, corresponding with the Mexico DPS, are the Mainland Mexico-CA/OR/WA and Mexico-North Pacific stocks (Carretta et al., 2023; Young et al., 2023). In the notice of the proposed IHA, NMFS assumed that humpbacks in the proposed action area were members of the Central North Pacific Stock. Based on these new delineations, humpback whales in the proposed action area are now assumed to be members of either the Hawaii stock or the Mexico-North Pacific stock.

The Hawaii stock consists of one demographically independent population (DIP) (Hawaii-Southeast Alaska/Northern British Columbia DIP) and the Hawaii-North Pacific unit, which may or may not be composed of multiple DIPs (Wade et al., 2021). The DIP and unit are managed as a single stock at this time, due to the lack of data available to separately assess them and lack of compelling conservation benefit to managing them separately (NMFS, 2019; NMFS, 2022b; NMFS 2023). The DIP is delineated based on two strong lines of evidence: genetics and movement data (Wade et al., 2021). Whales in the Hawaii-Southeast Alaska/Northern British Columbia DIP winter off Hawaii and largely summer in Southeast Alaska and Northern British Columbia (Wade et al., 2021). The group of whales that migrate from Russia, western Alaska (Bering Sea and Aleutian Islands), and central Alaska (Gulf of Alaska excluding Southeast Alaska) to Hawaii have been delineated as the Hawaii-North Pacific unit (Wade et al., 2021). There are a small number of whales that migrate between Hawaii and southern British Columbia/Washington, but current data and analyses do not provide a clear understanding of which unit these whales belong to (Wade et al., 2021; Caretta et al., 2023; Young et al., 2023)

The Hawaii stock of humpback whales is equivalent to the Hawaii DPS of humpback whales, which is not listed under the ESA (Bettridge et al., 2015; Wade et al., 2021). Humpback whales were previously considered to be depleted species-wide under the MMPA solely on the basis of the species' ESA listing. After the evaluation of the listing status of DPSs of humpback whales, humpback whale DPSs that are not listed as threatened or endangered were not considered to have depleted status under the MMPA (81 FR 62259, September 8, 2016). However, because the Central North Pacific stock, which is what humpback whales in Hydaburg were presumed to be members of in the notice of the proposed IHA, included some whales from the ESA-listed Mexico and Western North Pacific DPSs, the stock was considered to be endangered and depleted, and as a result, was classified as a strategic stock. The newly defined Hawaii stock of humpback whales does not include whales from any listed DPSs and, therefore, is not currently considered depleted under the MMPA, and is also not a strategic stock due to its ESA status.

The Mexico-North Pacific unit is likely composed of multiple DIPs, based on movement data (Martien et al., 2021; Wade, 2021, Wade et al., 2021). However, because currently available data and analyses are not sufficient to delineate or assess DIPs within the unit, it was designated as a single stock (NMFS, 2019; NMFS, 2022c; NMFS, 2023a). Whales in this stock winter off Mexico and the Revillagigedo Archipelago and summer primarily in Alaska waters (Martien et al., 2021) (Carretta et al., 2023; Young et al., 2023). The Mexico-North Pacific stock of humpback whales is one of two stocks that make up the “Mexico DPS” of humpback whales, which are listed as threatened under the ESA (Bettridge et al. 2015; Martien et al., 2021), and is therefore considered “depleted” and “strategic” under the MMPA.

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 or hear over the same frequency range ( 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 3.

The pinniped 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 et al., 2013).

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

The underwater noise produced by the DOT&PF's construction activities has the potential to result in behavioral harassment of marine mammals in the vicinity of the survey area. The Federal Register notice of the proposed IHA (88 FR 45774, July 17, 2023) included a discussion of the effects of anthropogenic noise on marine mammals and the potential effects of underwater noise from the DOT&PF' construction activities on marine mammals and their habitat. That information and analysis is incorporated by reference into this final IHA determination and is not repeated here; please refer to the notice of the proposed IHA (88 FR 45774, July 17, 2023).

This section provides an estimate of the number of incidental takes authorized through the 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 will primarily be by Level B harassment, as use of the acoustic source ( i.e., vibratory pile driving, impact pile driving, and DTH systems) has the potential to result in disruption of behavioral patterns for individual marine mammals. There is also some potential for auditory (Level A harassment) to result, primarily for mysticetes and high frequency species and phocids because predicted auditory injury zones are larger than for mid-frequency species and otariids. Auditory injury is unlikely to occur for mid-frequency species or otariids. The 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 authorized for this activity. Below we describe how the 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 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 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. Generally speaking, Level B harassment take estimates based on these behavioral harassment thresholds are expected to include any likely takes by TTS as, in most cases, the likelihood of TTS occurs at distances from the source less than those at which behavioral harassment is likely. TTS of a sufficient degree can manifest as behavioral harassment, as reduced hearing sensitivity and the potential reduced opportunities to detect important signals (conspecific communication, predators, prey) may result in changes in behavior patterns that would not otherwise occur.

The DOT&PF's activity includes the use of continuous (vibratory pile driving) and intermittent (impact pile driving) sources, and therefore the RMS SPL thresholds of 120 and 160 dB re 1 μPa are applicable. DTH systems have both continuous, non-impulsive, and impulsive components. When evaluating Level B harassment, NMFS recommends treating DTH as a continuous source and applying the RMS SPL thresholds of 120 dB re 1 μPa.

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). The DOT&PF's construction includes the use of impulsive (impact pile driving) and non-impulsive (vibratory pile driving) sources. As described above, DTH includes both impulsive and non-impulsive characteristics. When evaluating Level A harassment, NMFS recommends treating DTH as an impulsive source.

The thresholds used to identify the onset of PTS are provided in Table 4. 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 area is the existing background noise plus additional construction noise from the project. Marine mammals are expected to be affected via sound generated by the primary components of the project ( i.e., impact pile installation, vibratory pile installation, vibratory pile removal, and DTH).

Sound Source Levels of Construction Activities —The intensity of pile driving sounds is greatly influenced by factors such as the type of piles (material and diameter), hammer type, and the physical environment ( e.g., sediment type) in which the activity takes place (Table 5). A description of the assessment and appropriateness of proxy sound source levels and TL measurements for the DOT&PF's activities can be found in the notice of proposed IHA (88 FR 45774, July 17, 2023). This includes a discussion regarding the analyses of noise from DTH systems that follows NMFS' recommendations ( i.e., https://media.fisheries.noaa.gov/2022-11/PUBLIC%20DTH%20Basic%20Guidance_November%202022.pdf; NMFS, 2022a). Please refer to the notice of the proposed IHA (88 FR 45774, July 17, 2023) for full details.

Estimated Harassment Isopleths —All Level B harassment isopleths are reported in Table 7 considering RMS SPLs and the default TL coefficient for practical spreading loss ( i.e., 15*Log10(range)). Land forms (including causeways, breakwaters, islands, and other land masses) impede the transmission of underwater sound and create shadows behind them where sound from construction is not audible. At Hydaburg, Level B harassment isopleths from the project will be blocked by Sukkwan Island, Spook Island, Mushroom Island, and the coastline along Prince of Wales Island both southeast and northwest of the project site. The maximum distance that a harassment isopleth can extend due to these land masses is 5,162 m.

The ensonified area associated with Level A harassment is 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 (2018) 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 from impact pile driving, vibratory pile driving, and DTH), 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. Inputs used in the optional User Spreadsheet tool are reported in Table 6 and the resulting estimated isopleths are reported in Table 7.

Title; Associated Form; and OMB Number: Student Information Management System (SIMS); OMB Control Number: 0701-SIMS.

Needs and Uses: The information is required to enroll and track students in flight training courses. Contact information is necessary to ensure students can be informed of last-minute changes in their schedules and emergency contact info is necessary in the event of a training accident. Employment, Position/Rank, flight physical, and security clearance information, among other types of information, is necessary to ensure students meet the prerequisites for their training.

Affected Public: Individuals or households (foreign military personnel).

Annual Burden Hours: 45.

Number of Respondents: 45.

Responses per Respondent: 1.

Annual Responses: 45.

Average Burden per Response: 1 hour.

Frequency: On occasion.

Title; Associated Form; and OMB Number: Restructure or Realignment of Military Medical Treatment Facilities; OMB Control Number: 0720-RMTF.

Type of Request: New.

Number of Respondents: 53,100.

Responses per Respondent: 2.

Annual Responses: 106,200.

Average Burden per Response: 10 minutes.

Annual Burden Hours: 17,700.

Needs and Uses: The National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2017 (NDAA FY 2017—Pub. L. 114-328), section 703 “Military Medical Treatment Facilities” (MTFs) states that, there shall be an update on the study ( i.e., a report) from the 2015 Military Health System Modernization Study that addresses the realignment or restructuring of MTFs. As part of the report on the implementation plan to restructure or realign all MTFs, this survey will provide valuable data on TRICARE beneficiary's experience with the transition from receiving their care at an MTF to now receiving care in the private-sector with a network provider/facility. The collection of this information will be from TRICARE prime enrollees empaneled at MTFs undergoing MTF restructuring as a result of NDAA FY 2017, section 703. The survey will be given two times, the first iteration given two weeks after transition to collect immediate information regarding the transition and access to care experience; a second survey will be released six months after transition to review progress. These TRICARE prime enrollees will be responding to questions relating to how their transition from the MTF to either a Network (private-sector care), Primary Care Manager (PCM), or TRICARE select resulted. This information will assist the DHA with assessing this restructuring effort as well as future efforts to ensure beneficiaries receive high-quality care. Specifically, survey findings will show what problems beneficiaries faced during the transition from their MTF PCM to a network PCM, details on access to care now with a network PCM, satisfaction with their new network PCM, and communications about the transition overall.

Affected Public: Individuals or households.

Frequency: On occasion.

Respondent's Obligation: Voluntary.

OMB Desk Officer: Mr. Matt Eliseo.

You may also submit comments and recommendations, identified by Docket ID number and title, by the following method:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments.

Instructions: All submissions received must include the agency name, Docket ID number, and title for this Federal Register document. The general policy for comments and other submissions from members of the public is to make these submissions available for public viewing on the internet at http://www.regulations.gov as they are received without change, including any personal identifiers or contact information.

DOD Clearance Officer: Ms. Angela Duncan.

Requests for copies of the information collection proposal should be sent to Ms. Duncan at whs.mc-alex.esd.mbx.dd-dod-information-collections@mail.mil.

Title; Associated Form; and OMB Number: Women's Reproductive Health Care Provider Survey (WRHCPS); OMB Control Number: 0720-WRHS.

Needs and Uses: Health care provider knowledge, beliefs, and practices may have an impact on active-duty service women's (ADSW) access to contraception and overall reproductive health. The proposed survey is devised to be a sufficiently large and representative sample of the diverse professionals who provide reproductive and contraceptive care to ADSW at health care visits ( e.g., readiness visits, pre-deployment, and during deployment). The survey will be designed to capture provider self-reported beliefs, clinical knowledge on reproductive health care (including contraceptive counseling) and prescription of contraception care for and during deployment. Data and analysis from the survey will enable DoD to evaluate, enhance, and where needed, improve reproductive services delivery and educational interventions; provide a strong basis for planning policy and services related to ADSW's reproductive and contraceptive health; and provide data, programs, and details necessary for replication and peer review. In addition, the proposed one-time survey meets a Congressional mandate and serves as an appropriate follow-up to the WRHS by determining whether identified gaps in contraceptive access are the result of provider knowledge and attitudes. The 116-48 SASC Report for FY2020 required DoD to conduct a survey to better understand provider knowledge and beliefs related to provision of contraceptives to ADSW. The target population of the survey includes uniformed (active component only) and civilian MHS personnel.

Affected Public: Federal Government employees.

Annual Burden Hours: 709.

Number of Respondents: 2,128.

Responses per Respondent: 1.

Annual Responses: 2,128.

Average Burden per Response: 20 minutes.

Frequency: Once.

Title; Associated Form; and OMB Number: Personnel Accountability and Assessment for a Public Health Emergency; DD Form 3112; OMB Control Number: 0720-0067.

Type of Request: Extension.

Number of Respondents: 100,000.

Responses per Respondent: 1.

Annual Responses: 100,000.

Average Burden per Response: 5 minutes.

Annual Burden Hours: 8,333.3 hours.

Needs and Uses: The principal purpose of the DD Form 3112, “Personnel Accountability and Assessment Notification for a Public Health Emergency,” is to collect information used to protect the health and safety of individuals working in, residing on, or assigned to DoD installations, facilities, field operations, and commands, and to protect the DoD mission. When authorized by DoD, this form may be used to provide information about individuals who are infected or otherwise impacted by a public health emergency or similar occurrence or when there is an isolated incident in which an individual learns they have been exposed to a contagious disease or hazardous substance/agent. The form will also be used to document personnel accountability for and status of DoD-affiliated personnel in a natural or man-made disaster, or when directed by the Secretary of Defense. Such events could include severe weather events, acts of terrorism or severe destruction. The collection of this information is necessary to support the DoD in protecting the health and safety of DoD-affiliated individuals and maintain the DoD mission.

The information collected will inform decisions made about the status of DoD facilities and spaces that Affected Individuals have entered. This information may be used to make decisions to protect the health and safety of DoD personnel and facilities. It may also be used to notify other individuals who may have contacted the Affected Individual to make informed decisions about the status of the DoD facility and office space that subject individuals exposed to communicable diseases or hazardous substances/agents have entered. This information may be used to make Health Protection Condition (HPCON) level decisions. It may also be used to notify other individuals who may have been in contact with the subject individual(s).

Affected Public: Individuals or households.

Frequency: On occasion.

Respondent's Obligation: Voluntary.

OMB Desk Officer: Mr. Matt Eliseo.

You may also submit comments and recommendations, identified by Docket ID number and title, by the following method:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments.

Instructions: All submissions received must include the agency name, Docket ID number, and title for this Federal Register document. The general policy for comments and other submissions from members of the public is to make these submissions available for public viewing on the internet at http://www.regulations.gov as they are received without change, including any personal identifiers or contact information.

DOD Clearance Officer: Ms. Angela Duncan.

Requests for copies of the information collection proposal should be sent to Ms. Duncan at whs.mc-alex.esd.mbx.dd-dod-information-collections@mail.mil.

Title; Associated Form; and OMB Number: Military Experiences, Risk and Protective Factors, and Adolescent Health and Well-Being Survey; OMB Control Number: 0704-0635.

Needs and Uses: This study is designed to assess the direct and indirect association of military experiences with adolescents' psychosocial adjustment and physical health, academic achievement, and educational and career aspirations to identify risk and protective factors that may promote or inhibit positive outcomes among military-connected adolescents and their families.

Affected Public: Individuals or households.

Annual Burden Hours: 1,888.

Number of Respondents: 3,776.

Responses per Respondent: 1.

Annual Responses: 3,776.

Average Burden per Response: 30 minutes.

Frequency: On occasion.

Military-connected adolescents surveyed every 18-24 months until age 25.

The Department, in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. The Department is soliciting comments on the proposed information collection request (ICR) that is described below. The Department is especially interested in public comment addressing the following issues: (1) is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.

Title of Collection: Migrant Student Information Exchange User Application Form.

OMB Control Number: 1810-0686.

Type of Review: An extension without change of a currently approved ICR.

Respondents/Affected Public: State, local, and Tribal governments.

Total Estimated Number of Annual Responses: 732.

Total Estimated Number of Annual Burden Hours: 366.

Abstract: Regulations for the Migrant Information Exchange (MSIX), effective on June 9, 2016, were issued by the U.S. Department of Education (the Department). The MSIX, a nationwide, electronic records exchange mechanism mandated under Title I, Part C of the Elementary and Secondary Education Act (ESEA), as amended. As a condition of receiving a grant of funds under the Migrant Education Program (MEP), each State educational agency (SEA) is required to collect, maintain, and submit minimum health and education-related data to MSIX within established timeframes. MSIX is designed to facilitate timely school enrollment, grade and course placement, accrual of secondary course credits and participation in the MEP for migratory children. Additionally, the regulations help the Department to determine accurate migratory child counts and meet other MEP reporting requirements. The MEP is authorized under sections 1301-1309 in title I, part C of the ESEA, as amended. MSIX and the minimum data elements (MDEs) are authorized specifically under section 1308(b) of the ESEA, as amended.

The Department is requesting approval to extend the 1810-0686 information collection that supports statutory requirements for data collection under title I, part C—MEP. The purpose of the MSIX User Application Form is to collect user directory data to verify the identity of users in order to grant access to the MSIX system for the purpose of transferring migratory student data. The application collects information on an MSIX users' identity, title/position, work address, work telephone, email, and role in MSIX.

President Biden called for net-zero emissions, economy-wide, by 2050 and a 100% clean energy electricity sector by 2035. 1 The building sector currently contributes more than one-third of U.S. greenhouse gases. Within the building sector, the Biden-Harris Administration has set the goal to make zero emissions resilient new construction and retrofits common practice by 2030. Accomplishing these goals will require increasing efficiency and expanding clean energy capacity. Zero emissions buildings will plug into a grid that is rapidly becoming cleaner. All buildings, both new and existing, have a critical role to play in achieving a clean energy economy. A clean energy economy advances the goals of tackling the climate crisis, and protecting public health and the environment, including local communities' health and well-being. Executive Order 14096, “Revitalizing Our Nation's Commitment to Environmental Justice for All,” directs every Federal agency to advance environmental justice for all, including work to better protect communities with environmental justice concerns from the increasing impacts of climate change. It is also vital that the Administration is implementing Executive Order 14096 and the historic Justice40 Initiative, which set the goal that 40 percent of the overall benefits of certain Federal investments in climate and other key areas flow to disadvantaged communities.

A broadly accepted common minimum definition for a zero emissions building, as well as a pathway for verification, is foundational to efforts by public and private entities to transition the building sector to zero emissions. 2 The intent of Part 1 of the National Definition for a Zero Emissions Building is to create a standardized, consistent, measurable basis for zero operating emissions buildings. This clear market signal and consistent target is intended to help move the building sector to zero emissions. The definition may serve as a framework that users can achieve through multiple pathways to influence the design and operation of buildings to substantially reduce building sector emissions.

The minimum criteria included to define a zero operating emissions building is a building that is:

• Highly energy efficient,

• Free of on-site emissions from energy use, and

• Powered solely from clean energy.

Part 1 of the draft National Definition for a Zero Emissions Building focuses on operational emissions which have well-established measurement protocols. Reducing the whole life cycle emissions of a building also requires minimizing the embodied carbon of the building, as well as minimizing the impacts of refrigerants. Such emissions are not within scope for Part 1 and may be considered in subsequent parts to the National Definition for a Zero Emission Building.

This definition can be applied to existing buildings and new construction of non-federally owned buildings. This definition is not intended for federally owned buildings, which are governed as a portfolio through statutory and executive guidance.

Part 1 of the draft definition in full, which includes details on the criteria above, is available here: https://www.energy.gov/eere/buildings/national-definition-zero-emissions-building. This RFI is intended to collect broader technical input on Part 1 of the draft definition. DOE will consider responses to this RFI before finalizing version 1.00 of Part 1 of the National Definition for a Zero Emissions Building.

DOE issued a RFI in 2015 for zero energy buildings. 3 While the 2015 RFI was informative, the National Definition for a Zero Emissions Building in this RFI has different parameters.

The purpose of this RFI is to solicit feedback from industry, academia, research laboratories, government agencies, and other stakeholders on Part 1 of a draft National Definition for a Zero Emissions Building.

This RFI is not a Funding Opportunity Announcement (FOA); therefore, EERE is not accepting applications at this time. EERE may issue a FOA in the future based on or related to the content and responses to this RFI; however, EERE may also elect not to issue a FOA. There is no guarantee that a FOA will be issued as a result of this RFI. Responding to this RFI does not provide any advantage or disadvantage to potential applicants if EERE chooses to issue a FOA regarding the subject matter. Final details, including the anticipated award size, quantity, and timing of EERE funded awards, will be subject to Congressional appropriations and direction. Any information obtained as a result of this RFI is intended to be used by the Government on a non-attribution basis for planning and strategy development; this RFI does not constitute a formal solicitation for proposals or abstracts. Your response to this notice will be treated as information only. EERE will review and consider all responses in its formulation of program strategies for the identified materials of interest that are the subject of this request. EERE will not provide reimbursement for costs incurred in responding to this RFI. Respondents are advised that EERE is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted under this RFI. Responses to this RFI do not bind EERE to any further actions related to this topic.

Pursuant to 10 CFR 1004.11, any person submitting information that he or she believes to be confidential and exempt by law from public disclosure should submit via email, postal mail, or hand delivery two well-marked copies: one copy of the document marked “confidential” including all the information believed to be confidential, and one copy of the document marked “non-confidential” with the information believed to be confidential deleted. Submit these documents via email or on a CD, if feasible. DOE will make its own determination about the confidential status of the information and treat it according to its determination.

Federal employees are subject to the non-disclosure requirements of a criminal statute, the Trade Secrets Act, 18 U.S.C. 1905. The Government may seek the advice of qualified non-Federal personnel. The Government may also use non-Federal personnel to conduct routine, nondiscretionary administrative activities. The respondents, by submitting their response, consent to EERE providing their response to non-Federal parties. Non-Federal parties given access to responses must be subject to an appropriate obligation of confidentiality prior to being given access. Submissions may be reviewed by support contractors and private consultants.

Please reference the linked full draft of Part 1 of the National Definition for a Zero Emissions Building when responding to these questions.

A. Are the draft criteria clear and appropriate for the definition for a zero emissions building? Should any other criteria be considered for Part 1? Please provide specific feedback about this draft definition.

B. Energy efficiency criteria.

○ Should energy efficiency be considered a criteria for the definition of a zero emissions building?

○ If the efficiency of an existing building should be considered, do you agree that requiring energy performance in the top 25% of similar buildings is an appropriate measure of energy efficiency for this definition? (ENERGY STAR® score of 75 or above.) Should it be higher or lower?

Are there other benchmarks or approaches that should be considered?

For an existing building, is one year of measured energy performance an appropriate requirement for demonstrating efficiency or is another approach appropriate?

Are the draft criteria appropriate for single-family homes? Are there other benchmarks that should be considered for single-family homes?

○ For new construction, are the draft criteria appropriate? The modeled building performance is at least 10% lower than the energy use according to the latest version of IECC or ASHRAE 90.1 ( e.g., model energy code) and the building is designed to achieve an ENERGY STAR score of at least 90 (for eligible buildings). Are there other benchmarks that should be considered?

Are the draft criteria appropriate for single family homes? Are there other benchmarks that should be considered for single family homes?

C. On-site emissions from energy use.

• Should there be an exemption allowed for emission producing emergency generation? Are any other exemptions needed?

• Should biofuels consumed on-site be allowed? If so, how?

D. Clean energy generation and procurement.

• Are the clean energy criteria provided appropriate for this definition? Are there other clean energy criteria that should be considered? Should community solar qualify for this requirement? If so, how?

• Should there be a proximity requirement for off-site power used to meet the clean power criterion? If so, how should a proximity requirement be implemented ( e.g., regional definition, phase-in, etc.)?

E. Documentation is important for effective implementation.

• Should organizations leveraging the definition be able to determine whether buildings have to meet it annually, one time, or on a different frequency?

• If the definition is extended to single-family homes, what documentation should be required?

• Are licensed professional and third-party certification bodies the appropriate parties to independently verify the documentation that a building has met the definition? Beyond existing government resources such as EPA's ENERGY STAR Portfolio Manager, are there other methods to verify meeting the zero emissions building definition?

• What time frame should be used for greenhouse gas (GHG) calculations ( i.e. hourly, monthly by year, annually)? Explain how this would be implemented effectively across the market.

• What other verification criteria are necessary to make this definition useful for the marketplace?

• Are there any issues regarding conflict or synergy with regional, state or local energy and climate programs that ought to be addressed?

F. Use cases.

• Is it important for a national definition to cover all building types, including commercial, multifamily, and single-family?

• Are there any other recommendations that would help clarify and improve the definition?

• While Part 1 of the definition focuses on operating emissions, what other areas should be considered in future parts of the definition, such as embodied carbon, refrigerant, and grid interactivity?

Responses to this RFI must be submitted electronically at https://forms.office.com/g/Y0Ss3UFdL3. Only responses to this web form will be accepted.

Respondents may answer as many or as few questions as they wish.

EERE will not respond to individual submissions or publish publicly a compendium of responses. A response to this RFI will not be viewed as a binding commitment to develop or pursue the project or ideas discussed.

Respondents are requested to provide the following information at the start of their response to this RFI:

• Company/institution name;

• Company/institution contact;

• Contact's address, phone number, and email address.

Virtual Listening Sessions may be held additional information will be posted at: https://www.energy.gov/eere/buildings/national-definition-zero-emissions-building.

This document of the Department of Energy was signed on December 28, 2023, by Jeffrey Marootian, Principal Deputy Assistant Secretary for Energy Efficiency and Renewable Energy, pursuant to delegated authority from the Secretary of Energy. That document with the original signature and date is maintained by DOE. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DOE Federal Register Liaison Officer has been authorized to sign and submit the document in electronic format for publication, as an official document of the Department of Energy. This administrative process in no way alters the legal effect of this document upon publication in the Federal Register .

This action is directed to the public in general. This notice may be of specific interest to persons who are or may be interested in risk assessments of new chemical substances under TSCA ( e.g., submitters of TSCA 5 notices, industry, non-governmental organizations (NGOs), and academia). Since other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action.

EPA is announcing the availability of a new decision framework for use by the New Chemicals Division (NCD) of the Office of Pollution Prevention and Toxics (OPPT) for identification of eye irritation or corrosion hazards for new chemical substances based on prioritization of reproducible, human-relevant data. The document supports EPA's efforts to develop NAMs that do not require vertebrate animal testing and furthers the agency's commitment to reduce and replace the use of vertebrate animals in the testing of chemical substances and mixtures.

TSCA section 4(h)(2)(A) directs EPA to “promote the development and implementation of alternative test methods and strategies to reduce, refine, or replace vertebrate animal testing and provide information of equivalent or better scientific quality and relevance for assessing risks of injury to health or the environment.”

To incorporate alternative test methods and strategies, or NAMs, data for eye irritation and corrosion hazard identification into the new chemicals program risk assessment process, NCD developed a framework for new chemical risk assessments that prioritizes reproducible, human-relevant in vitro data. The Framework is based upon existing peer-reviewed literature, accepted Organization for Economic Cooperation and Development (OECD) test guidelines, and other existing accepted risk assessment approaches.

NCD is responsible for conducting risk assessments for new chemical substances submitted under TSCA section 5 authority. NCD expects multiple benefits from the incorporation of this proposed Framework in its assessment including: (1) progress towards fulfilling TSCA section 4(h)(2) statutory requirements; (2) transparency for stakeholders regarding EPA's process of hazard identification of eye irritation and corrosion for new chemical submissions; (3) clear scientific rationale for identification of eye irritation and corrosion hazards for human health assessors leading to improved consistency across final new chemical risk assessments; and (4) use of the most reproducible, human-relevant scientific data for decision-making.

This document is not binding on the Agency or any outside parties, and the Agency may depart from it where circumstances warrant and without prior notice. While EPA has made every effort to ensure the accuracy of the discussion in the Framework, the obligations of EPA and the regulated community are determined by statutes, regulations, or other legally binding documents. In the event of a conflict between the discussion in the Framework document and any statute, regulation, or other legally binding document, the Framework document will not be controlling.

This action does not contain any new or revised information collections or burden subject to additional OMB approval under the PRA, 44 U.S.C. 3501 et seq. Burden is defined in 5 CFR 1320.3(b). Information collection activities contained in the TSCA new chemicals program are already approved by OMB under the PRA and are assigned OMB Control No. 2070-0038 (EPA ICR No. 1188.14).

Authority: 15 U.S.C. 2604 et seq.

Following is a summary of the use and burden associated with the subject information collection(s). More detailed information can be found in the collection's supporting statement and associated materials (see ADDRESSES ).

1. Title of Information Collection: Certified Community Behavioral Health Clinic (CCBHC) Cost Report; Type of Information Collection Request: Revision of an active collection of information request; Use: The CCBHC cost report allows clinics in the demonstration to calculate Prospective Payment System (PPS) rates using clinic-specific cost and visit data associated with delivery of the nine statutory services as outlined under the authorizing Protecting Access to Medicare Act (PAMA) (Pub. L. 113-93) at section 223(D) Scope of Services. Currently CCBHCs use the cost report to calculate rates based on the existing CC PPS-1 daily, or CC PPS-2 monthly rate that do not include separate crisis rate options. Calculation of the new daily and monthly special crisis services PPS rates required CMS to revise the existing CCBHC cost report to include addition worksheets to address the new crisis rate offerings being finalized in the CCBHC Technical Guide. SCS rates would be effective beginning January 1, 2024, for any existing states that may be interested in implementing either CC PPS-3 or CC PPS-4, and new states entering the program by July 2024 will have the option to choose from among the four PPS rate options made available under the updated Technical Guide and CCBHC cost report.

States and clinics selecting either the CC PPS-3 or CC PPS-4 crisis rate methodology will require additional time to separate costs and visit data for up to three special crisis services rates. CCBHCs in states that choose CC PPS-2 rate methodology will require additional time to gather data for special populations and account for outlier thresholds.

Because use of this cost report involves participation in the CCBHC demonstration program, the information is expected to be collected annually, assuming rates are trended forward for the second year of the program using the Medicare Economic Index (MEI), rebased in the third year of the demonstration and trended forward for the fourth year of the demonstration using the MEI. However, if the state requires CCBHCs to rebase rates for other years of the demonstration using CCBHC cost report data, the provider would be required to complete the cost report each time the state rebases the rate. CMS does also require CCBHC demonstration states to submit cost reports in trended years although rates may only reflect changes based on MEI adjustment for inflationary changes. Form Number: CMS-10398 #43 (OMB control number: 0938-1148); Frequency: Annual; Affected Public: Private Sector (Businesses or other for profits and Not for profit institutions) and State, Local, or Tribal Governments; Number of Respondents: 60; Total Annual Responses: 60; Total Annual Hours: 3,389. (For policy questions regarding this collection contact: Beverly Boston at 410-786-4186.)

2. Title of Information Collection: Certified Community Behavioral Health Clinic (CCBHC) 2024 State Proposal Demonstration Application; Type of Information Collection Request: Revision of an active collection of information request; Use: Based on recent extension and expansion of the CCBHC Demonstration under section 11001 of Bipartisan Safer Communities Act  1 (BSCA) of 2022, the State Proposal Demonstration Application is required to be completed by existing CCBHC grantee states and submitted to the Centers for Medicare & Medicaid Services (CMS) and the Substance Abuse and Mental Health Services Administration (SAMHSA) to determine state readiness and eligibility to be selected as one of the 10 new states added to the CCBHC demonstration in 2024 and every two years thereafter per the BSCA legislation. The awarding of Planning Grants to states was the first phase of a two-phase process. Phase II will consist of participation in the demonstration. Form Number: CMS-10398 #45 (OMB control number: 0938-1148); Frequency: One time and On occasion; Affected Public: State, Local, or Tribal Governments; Number of Respondents: 30; Total Annual Responses: 30; Total Annual Hours: 1,790. (For policy questions regarding this collection contact: Beverly Boston at 410-786-4186.)

3. Title of Information Collection: Behavioral Health Clinic Quality Data Reporting; Type of Information Collection Request: Revision of an active collection of information request; Use: This Information Collection concerns the Behavioral Health Clinic Quality Data Reporting Template (hereinafter “Reporting Template” or “Template”), developed in partnership with the Substance Abuse and Mental Health Services Administration (SAMHSA) and the Assistant Secretary for Planning and Evaluation (ASPE) (collectively, “the Agencies”). The Reporting Template is designed to collect quality measure data and to report at the clinic level. The Agencies developed the Template to provide states and clinics with a streamlined and structured tool to report quality measures data. The Reporting Template aims to eliminate the time required for states or clinics to develop their own reporting templates for quality measure data reporting and minimizes inconsistencies in reporting. Furthermore, the Reporting Template, with its accompanying instructions, support an innovative approach to improve behavioral health, a key focus of health care reform. Form Number: CMS-10398 (#48) (OMB control number: 0938-1148); Frequency: Annual; Affected Public: Private Sector (Businesses or other for profits and Not for profit institutions) and State, Local, or Tribal Governments; Number of Respondents: 429; Total Annual Responses: 1,009; Total Annual Hours: 6,814. (For policy questions regarding this collection contact: Beverly Boston at 410-786-4186.)

FDA is announcing the issuance of a priority review voucher to the sponsor of an approved rare pediatric disease product application. Under section 529 of the FD&C Act (21 U.S.C. 360ff), FDA will award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA has determined that CASGEVY (exagamglogene autotemcel), manufactured by Vertex Pharmaceuticals, Inc., meets the criteria for a priority review voucher.

CASGEVY (exagamglogene autotemcel) is indicated for treatment of sickle cell disease in patients 12 years of age and older with recurrent vaso-occlusive crises.

For further information about the Rare Pediatric Disease Priority Review Voucher Program and for a link to the full text of section 529 of the FD&C Act, go to https://www.fda.gov/industry/developing-products-rare-diseases-conditions/rare-pediatric-disease-rpd-designation-and-voucher-programs. For further information about CASGEVY (exagamglogene autotemcel), go to the Center for Biologics Evaluation and Research's Approved Cellular and Gene Therapy Products website at https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/approved-cellular-and-gene-therapy-products.

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 Food and Drug Administration (FDA, us, or we) programs. Under section 1003(d)(2)(D) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 393(d)(2)(D)), FDA is authorized to conduct educational and public information programs.

In conducting studies relating to the regulation and communications related to tobacco products, FDA will need to employ formative qualitative research including but not limited to focus groups, usability and/or psychometric testing, indepth interviews (IDIs), cognitive interviews and asynchronous qualitative discussions ( e.g., online journaling or web-based discussion boards), naturalistic observation and ethnographic studies to assess knowledge and perceptions about tobacco-related topics with specific target audiences. The information collected will serve four major purposes. First, foundational research will provide critical knowledge and insights about intended audiences. FDA must first understand people's knowledge of, perceptions of, and reactions to tobacco related topics prior to developing survey/research questions as well as stimuli for experimental studies. Second, formative research will provide information about people's responses, thoughts, and feelings regarding potential creative messaging, or stimuli. Third, by collecting communications usability information, FDA will be able to serve and respond to the ever-changing demands of consumers of tobacco products. Additionally, we will be able to determine the best way to communicate with intended audiences around tobacco prevention and cessation. Fourth, cognitive testing will allow FDA to assess consumer understanding of survey/research questions and study stimuli. Focus groups and/or IDIs with a sample of the intended audience will allow FDA to refine the survey/research questions and study stimuli while they are still in the developmental stage. FDA will collect, and interpret information gathered through this generic clearance to: (1) better understand characteristics of the intended audience—its perceptions, knowledge, attitudes, beliefs, and behaviors—and use these in the development of appropriate survey/research questions, study stimuli, or communications; (2) more efficiently and effectively design survey/research questions and study stimuli; and (3) more efficiently and effectively design experimental studies.

FDA is requesting approval of an extension of this generic clearance for collecting information using qualitative methods ( e.g., interviews, focus groups, asynchronous discussion boards, etc.) for studies involving all tobacco products regulated by FDA. This information will be used to explore concepts of interest and assist in the development of quantitative study proposals, complementing other important research efforts in the Agency. This information may also be used to help identify and develop communication messages, which may be used in education campaigns. Qualitative research plays an important role in gathering information because it allows for an indepth understanding of individuals' attitudes, beliefs, motivations, and feelings. Qualitative research serves the narrowly defined need for direct and informal public opinion on a specific topic.

The number of respondents to be included in each new study may vary, depending on the nature of the study ( e.g., foundational, formative, etc.), approach (synchronous vs. asynchronous, or virtual vs. in person) and the intended audience. Table 1 provides examples of the types of studies that may be administered and estimated burden levels during the 3-year period. Time to read, view, or listen to the message being tested is built into the “Average Burden per Response” figures. FDA estimates the burden of this collection of information as follows:

Our estimated burden for the information collection reflects an overall increase of 384,258 hours and a corresponding increase of 314,926 responses. We attribute this adjustment to the number of study responses used during the current approval and now estimated for the next 3 years. A greater number of qualitative studies will be conducted over the next 3 years due to the need to develop new creative messages and content. Recent years have seen a dramatic change in media. With the shift to digital media, FDA must adapt to communicate effectively in a digital environment. As digital tobacco use prevention/interventions are still in their infancy, we must better understand the types of digital channels available. To impact public health outcomes, we need to understand how to reach our intended audience. New foundational studies are needed (including those on digital metrics, measurement, and implementation). As a result, we have adjusted our burden estimate and revised the number of respondents to the information collection.

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 supports FDA implementation of section 512 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360b), which governs new animal drugs. Agency regulations in 21 CFR part 530 permit FDA, if we find that there is a reasonable probability that the extralabel use of an animal drug may present a risk to public health, to establish a safe level for a residue from the extralabel use of the drug, and to require the development of an analytical method for the detection of residues above that established safe level. This requirement is codified at § 530.22(b) (21 CFR 530.22(b)).

Although to date, we have not established a safe level for a residue from the extralabel use of any new animal drug and, therefore, have not required the development of analytical methodology, we believe that there may be instances when analytical methodology will be required. We are, therefore, estimating the reporting burden based on two methods being required annually. The requirement to establish an analytical method may be fulfilled by any interested person. We believe that the sponsor of the drug will be willing to develop the method in most cases. Alternatively, FDA, the sponsor, and perhaps a third party may cooperatively arrange for method development. Respondents to the information collection are private sector drug sponsors or veterinary associations, or veterinarians, State, local, and tribal governments, and Federal Agencies.

In the Federal Register of August 31, 2023 (88 FR 60213), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.

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

Based on a review of the information collection since our last request for OMB approval, we have made no adjustments to our burden estimate.

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 supports FDA fellowship and traineeship programs. Sections 1104, 1302, 3301, 3304, 3320, 3361, 3393, and 3394 of Title 5 of the United States Code authorize Federal Agencies to rate applicants for Federal jobs. The information collection involves brief online applications completed by applicants applying to FDA's Fellowship and Traineeship programs. These voluntary online applications will allow the Agency to easily and efficiently elicit and review information from students and healthcare professionals who are interested in becoming involved in FDA-wide activities. The process will reduce the time and cost of submitting written documentation to the Agency and lessen the likelihood of applications being misrouted within the Agency mail system. It will assist the Agency in promoting and protecting the public health by encouraging outside persons to share their expertise with FDA.

In the Federal Register of September 19, 2023 (88 FR 64438), FDA published a 60-day notice requesting public comment on the proposed collection of information. We received two comments, which were not PRA related and will not be addressed in this document.

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, we have made no adjustments to our burden estimate.

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 regulations governing FDA expedited programs for serious conditions. These provisions are set forth in 21 CFR part 312, subpart E and are intended to speed the availability of new therapies to patients with serious conditions, especially when there are no satisfactory alternative therapies, while preserving appropriate standards for safety and effectiveness. The regulations call for earlier attention to drugs that have promise in treating such conditions, including early consultation with FDA for sponsors of such products. Respondents to the information collection are sponsors of drug or biologic product applications submitted to FDA.

To assist respondents with the information collection, we developed Agency guidance entitled “Guidance for Industry Expedited Programs for Serious Conditions—Drugs and Biologics” (May 2014). The guidance is a resource for information on FDA's policies and procedures related to the following expedited programs for serious conditions: (1) fast track designation, (2) breakthrough therapy designation, (3) accelerated approval, and (4) priority review designation, and describes threshold criteria generally applicable to expedited programs, including what is meant by serious condition, unmet medical need, and available therapy. The guidance addresses the applicability of expedited programs to rare diseases, clarification on available therapy, and additional detail on possible flexibility in manufacturing and product quality. It also clarifies the qualifying criteria for breakthrough therapy designation, provides examples of surrogate endpoints and intermediate clinical endpoints used to support accelerated approval, and priority review.

In addition, we developed Agency guidance entitled “Expedited Programs for Regenerative Medicine Therapies for Serious Conditions,” (February 2019) describing the criteria for participation in the Regenerative Medicine Advanced Therapy (RMAT) program. The RMAT expedited program was approved as part of the 21st Century CURES Act, signed December 13, 2016. An RMAT product is intended to treat, modify, reverse, or cure serious or life-threatening diseases or conditions, and preliminary clinical evidence indicate that the drug has the potential to address unmet medical needs for such diseases or conditions. This is a Center Biologics Evaluation and Research (CBER) program and is included as an expedited program available for serious conditions.

For a sponsor or applicant who seeks fast track, priority, breakthrough, RMAT or accelerated approval designation review, approval is required to submit a request showing that the drug product: (1) is intended for a serious or life-threatening condition and (2) has the potential to (a) address an unmet medical need, (b) demonstrate substantial improvement over available therapy, or (c) fill an unmet need to be approved based on a surrogate endpoint. We expect that most information to support a designation request will have been gathered under existing requirements for preparing an investigational new drug (IND), new drug application (NDA), or biologics license application (BLA). If such information has already been submitted to us, the information may be summarized in the designation request. A designation request should include, where applicable, additional information not specified elsewhere by statute or regulation. For example, additional information may be needed to show that a product has the potential to address an unmet medical need where an approved therapy exists for the serious or life-threatening condition to be treated. Such information may include clinical data, published reports, summaries of data and reports, and a list of references. The amount of information and discussion in a designation request should be sufficient to permit a reviewer to assess whether the criteria for fast track, priority, breakthrough, RMAT or accelerated approval designation have been met.

After we make an expedited programs designation, a sponsor or applicant may submit a premeeting package that may include additional information supporting a request to participate in certain expedited programs. The premeeting package serves as background information for the meeting and should support the intended objectives of the meeting. As with the request for expedited programs designation, we expect that most sponsors or applicants will have gathered such information to meet existing requirements for preparing an IND, NDA, or BLA. These may include descriptions of clinical safety and efficacy trials not conducted under an IND ( e.g., foreign studies) and information to support a request for accelerated approval. If such information has already been submitted to us, the information may be summarized in the premeeting package.

The guidance documents are available on our website at www.fda.gov/regulatory-information/search-fda-guidance-documents and were 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 this collection of information as follows:

Based on FY 2022 receipts, we estimate that for Center for Drug Evaluation and Research (CDER) products, 81 respondents will submit 124 requests for priority review designation annually, and we assume 30 hours are needed to prepare such a request. We estimate 71 respondents will submit 77 requests for breakthrough designation annually, and we assume 70 hours are needed to prepare such a request. We estimate that 235 respondents will submit 277 requests for fast-track designation requests annually, and we assume 60 hours are required to prepare such a request. We estimate 26 respondents will submit 33 accelerated approval designation requests annually and we assume 100 hours are required to prepare such a request. Finally, CDER received 165 pre-meeting package submissions from 163 respondents. We assume 100 hours are needed to prepare a pre-meeting package.

Similarly, also based on FY 2022 receipts, we estimate that for CBER products, 8 applicants will submit 8 requests for priority review designation annually, and we assume 30 hours are required to prepare such a request. We estimate 15 respondents will submit 17 requests for breakthrough designation annually, and we assume 70 hours are needed to prepare such a request. We estimate that 64 respondents will submit 78 requests for fast-track designation annually, and we assume 60 hours is required to prepare such a request. We also estimate 33 respondents will submit 35 requests for RMAT designation annually and assume that 60 hours are needed to prepare each RMAT designation request. Finally, CBER received 283 pre-meeting package submissions from 146 respondents. We assume 100 hours are needed to prepare a pre-meeting package.

Based on a review of the information collection since our last request for OMB approval, we have increased our burden estimate by 143 responses and 10,350 hours to reflect actual submissions we have received. We attribute these changes to increased interest in the expedited programs, new expedited programs, and an increase in the number of submissions we received over the last few years.

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

Information Collection Request Title: Bureau of Health Workforce Performance Data Collection, OMB No. 0915-0061—Revision.

Abstract: Over 50 Bureau of Health Workforce (BHW) programs award grants to health professions schools and training programs across the United States to develop, expand, and enhance training, and to strengthen the distribution of the health workforce. These programs are governed by titles III, VII, and VIII of the Public Health Service Act. Performance information is collected in the HRSA Performance Report for Grants and Cooperative Agreements. Data collection activities consisting of an annual progress report and an annual performance report satisfy statutory and programmatic requirements for performance measurement and evaluation (including specific title III, VII and VIII requirements), as well as Government Performance and Results Act of 1993, the Government Performance and Results Act Modernization Act of 2010, and the Foundations for Evidence-Based Policymaking Act of 2018 requirements. The performance measures were last revised in 2022 to ensure they addressed programmatic changes, met evolving program management needs, and responded to emerging workforce concerns. As these changes were successful, BHW will continue with its current performance management strategy and make additional changes that reduce burden, simplify reporting, reflect new Department of Health and Human Services and HRSA priorities, and enable longitudinal analysis of program performance. Specifically, an Excel upload feature was implemented for all programs to reduce burden. Questions on partnerships were revised and standardized across forms to understand the type and purposes of partnerships associated with grant funding. Employment-related questions were standardized across programs and forms to provide consistent outcomes on employment location, type of employment, and hiring organization. New questions were added for programs using apprenticeships. Specifically, questions were added to measure additional employment outcomes including role at the employment site and vulnerable populations served and to measure program satisfaction and types of competencies graduates were ready to perform.

A 60-day notice published in the Federal Register on October 19, 2023, 88 FR 72086-87. There was one public comment. The commenter was complementary of BHW's efforts to consolidate performance data into one collection and raised questions related to collaborating with other departments on the data collection, defining apprenticeships, and making individual-level data publicly available. Specifically, the commenter asked how HRSA collaborates on data collection with agencies outside of the Department of Health and Human services. Our response to the commenter explained the data collected via this OMB package are performance metrics specific to HRSA grant programs and the data are used to meet obligations for performance budgeting. This is in alignment with the Government's authorization to collect data to meet reporting requirements. The commenter also asked how HRSA defines apprenticeships and how it aligns with definitions from other agencies. HRSA responded that it uses the Department of Labor's definition of apprentices and that it included questions from the Department of Labor's Employment and Training Administration instrument to reduce reporting burden and made data comparable across the agencies. Lastly, the commenter requested that HRSA make more individual-level data available, but statute prohibits HRSA from doing so (see 42 U.S.C. 292 et seq. ). There was a follow-up comment from the same commenter regarding HRSA working with external researchers to analyze data on workforce program participants. HRSA's response was that HRSA does not work with external researchers to analyze data collected on workforce programs. Aggregated data is publicly available to external researchers via HRSA's data warehouse.

Need and Proposed Use of the Information: The purpose of the proposed data collection is to continue analysis and reporting of grantee training activities and education, identify details about the practice locations where trainees work (or plan to work) after program completion, and report outcomes of funded initiatives. Data collected from these grant programs will also provide a description of the program activities of approximately 1,828 reporting grantees to inform policymakers on the barriers, opportunities, and outcomes involved in health care workforce development. The proposed measures focus on four key outcomes:

(1) increasing the workforce supply of well-educated practitioners in needed professions,

(2) increasing the number of practitioners that practice in underserved and rural areas,

(3) enhancing the quality of education, and

(4) supporting educational infrastructure to increase the capacity to train more health professionals in high demand areas.

Likely Respondents: Respondents are awardees of BHW health professions grant programs.

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

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

ACHDNC provides advice and recommendations to the Secretary of Health and Human Services (Secretary) on the development of newborn screening activities, technologies, policies, guidelines, and programs for effectively reducing morbidity and mortality in newborns and children having, or at risk for, heritable disorders. ACHDNC reviews and reports regularly on newborn and childhood screening practices, recommends improvements in the national newborn and childhood screening programs, and fulfills requirements stated in the authorizing legislation. In addition, ACHDNC's recommendations regarding inclusion of additional conditions for screening on the Recommended Uniform Screening Panel (RUSP), following adoption by the Secretary, are evidence-informed preventive health services provided for in the comprehensive guidelines supported by HRSA pursuant to section 2713 of the Public Health Service Act (42 U.S.C. 300gg-13). Under this provision, non-grandfathered group health plans and health insurance issuers offering non-grandfathered group or individual health insurance are required to provide insurance coverage without cost-sharing (a co-payment, co-insurance, or deductible) for preventive services for plan years ( i.e., policy years) beginning on or after the date that is one year from the Secretary's adoption of the condition for screening.

During the January 29-30, 2024, meeting, ACHDNC will hear from experts in the fields of public health, medicine, heritable disorders, rare disorders, and newborn screening. Agenda items include the following topics:

(1) A possible presentation on qualitative research that focuses on family perspectives;

(2) Updates from Committee ad hoc topic groups. Potential topics include: the nomination process and revisions to the decision matrix;

(3) An update on the evidence review of Duchenne muscular dystrophy nomination; and

(4) Presentation of the final evidence-based review report on the Krabbe disease condition nomination for possible inclusion on the RUSP. Following this report presentation, the ACHDNC expects to vote on the second meeting day, on January 30, 2024, whether to recommend to the Secretary adding Krabbe disease to the RUSP (with potential implications under section 2713 of the Public Health Service Act, as noted above).

The agenda for this meeting includes a potential vote to recommend a nominated condition (Krabbe disease) be added by the Secretary to the RUSP. Agenda items are subject to change as priorities dictate. Information about the ACHDNC, including a roster of members and past meeting summaries, is also available on the ACHDNC website.

Members of the public also will have the opportunity to provide comments on any or all of the above agenda items. Public participants may request to provide general oral comments and may submit written statements in advance of the scheduled meeting. Oral comments will be honored in the order they are requested and may be limited as time allows. Subject to change: members of the public registered to submit oral public comments on Krabbe disease are tentatively scheduled to provide their statements on Tuesday, January 30, 2024. Members of the public registered to provide oral public comments on all other newborn screening related topics are tentatively scheduled to provide their statements on Monday, January 29, 2024. Requests to provide a written statement or make oral comments to ACHDNC must be submitted via the registration website by 12 p.m. ET on Tuesday, January 17, 2024. Written comments will be shared with the Committee prior to the meeting so that they have an opportunity to consider them in advance of the meeting. Individuals who need special assistance or another reasonable accommodation should notify Kim Morrison at the address and phone number listed above at least 10 business days prior to the meeting.

Since this meeting occurs in a federal government building, attendees must go through a security check to enter the building. Non-United States Citizen attendees must notify HRSA of their planned attendance at least 15 business days prior to the meeting in order to facilitate their entry into the building. All attendees are required to present government-issued identification prior to entry.

The patent rights in these inventions have been assigned and/or exclusively licensed to the government of the United States of America.

The prospective exclusive license territory may be worldwide, and the field of use may be limited to the following:

“Thermally controlled autologous T cell therapy products for the treatment of HPV-positive cancer in humans.”

The E-176-2014 patent family is primarily directed to an isolated TCR reactive to HPV 16 E7 antigen in the context of HLA-A*02:01 (the “E7 TCR”). HPV describes a group of human viruses known to cause malignancy. Of the group, HPV-16 is the most prevalent strain. Approximately 90% of adults are estimated to have been exposed at some point in their lifetime. HPV drives transformation of infected cells through the expression of certain oncoproteins, chiefly E5, E6 and E7. The latter two are constitutively expressed in malignant cells and are necessary to maintain a transformed state, rendering them attractive therapeutic targets.

The E7 TCR may be useful in the development of certain diagnostics and/or therapeutics for the treatment of cancers which express both the HPV 16 E7 oncoprotein and HLA-A*02:01. Potential therapeutic applications of the E7 TCR may include, but are not limited to, engineered autologous or allogeneic immune cell therapies ( e.g., T cell or natural killer cell-based) and TCR fusion proteins and conjugates ( e.g., soluble TCR bi-specifics or TCR-drug conjugates). The exclusive field of use which may be granted to Port applies to “thermally controlled” autologous T cell products, which is a subset of engineered immune cell therapies.

This Notice is made in accordance with 35 U.S.C. 209 and 37 CFR part 404. The prospective exclusive license will be royalty bearing, and the prospective exclusive license may be granted unless within fifteen (15) days from the date of this published Notice, the National Cancer Institute receives written evidence and argument that establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR part 404.

In response to this Notice, the public may file comments or objections. Comments and objections, other than those in the form of a license application, will not be treated confidentially and may be made publicly available.

License applications submitted in response to this Notice will be presumed to contain business confidential information and any release of information from these license applications will be made only as required and upon a request under the Freedom of Information Act, 5 U.S.C. 552.

Section 1113 of the Consolidated Appropriations Act, 2023 (Pub. L. 117-328) requires the HHS Secretary to establish a Task Force on Maternal Mental Health or incorporate the duties, public meetings, and reports specified into existing relevant Federal committees or working groups. The Task Force consists of representatives of specific federal agencies and non-federal individuals and entities who represent diverse disciplines and views. The Task Force will evaluate and make recommendations to the ACWS for further deliberation regarding improvements and coordination for Federal activities that address maternal mental health and co-occurring substance use disorders. The ACWS will make final recommendations to the Secretary of Health and Human Services and to Congress.

The Task Force invites members of the public to comment on any issues or concerns they believe are relevant or appropriate to the state of maternal mental health programs at the Federal level, and identification of best practices with respect to maternal mental health and substance use. Specifically, the Task Force requests public comment on the following questions:

1. Data, Research and Quality Improvement:

• What are the priority outcomes for pregnant and postpartum individuals with substance use disorder and/or mental health conditions?

• How would you define quality care for pregnant and postpartum individuals with substance use disorders and/or mental health conditions?

• What are the priority research questions and gaps related to maternal substance use disorder and/or mental health conditions that must be addressed to improve services and outcomes for individuals while pregnant and postpartum?

2. Prevention, Screening and Diagnosis:

• What is lacking and what is working to support maternal emotional health, and substance use and well-being during pregnancy and after?

• What steps should be taken to ensure that approaches to detecting maternal emotional health issues and substance use challenges are culturally appropriate?

• What can be done to help pregnant and postpartum individuals feel more comfortable to open up about how they are feeling? Who, where, and how might pregnant and postpartum individuals feel safest about disclosing their experience?

3. Evidence-based Intervention and Treatment:

• What are key evidence-based intervention and treatment models that should be broadly implemented to address maternal mental health and substance use?

i. Do providers have the training and resources to appropriately provide evidenced-based intervention and treatment or referral?

ii. Are community-based resources being utilized to bridge the gap in education, evidence-based screening, and treatment or referral? If not, what are the challenges of incorporating culturally competent community-based health care workers?

• What are the barriers/gaps to evidence-based intervention for maternal mental health and substance use among reproductive age individuals? How do access and engagement differ between people who have already received mental health and/or substance use treatment prior to pregnancy versus those who never have?

• Are underserved populations represented in the research and subsequent guidelines developed from the research for screening and treatment? What evidence is still needed to inform guidelines for screening and treatment, including for underrepresented, underserved populations?

i. Underserved populations may include Black, Latino, and Indigenous and American Indian/Alaska Native persons, Asian Americans and Pacific Islanders and other persons of color; members of religious minorities; lesbian, gay, bisexual, transgender, queer, and intersex (LGBTQI+) persons; persons with disabilities; persons who live in rural areas; and persons otherwise adversely affected by persistent poverty or inequality.

4. Evidence-Based Community Practices:

• What are the most pressing needs related to maternal mental health and maternal substance use in your community? For the purposes of this question, please define “community” however it most resonates with you ( e.g., geography, race, ethnicity, sexual orientation, and gender identity, disability status, American Indian/Alaska Native status, veteran status, etc.)

• What strategies have been the most successful, transformative, and/or sustainable in addressing maternal mental health and maternal substance use needs in your community? What strategies have been the least successful, transformative, and/or sustainable, and why?

• What innovations are needed to better address maternal mental health and substance use needs in your community ( i.e., how can community-based organizations and entrepreneurs partner to address gaps and provide support for areas of identified need)?

5. Communications and Community Engagement:

• What do ideal services and resources look like for a pregnant or postpartum individual in your community? And what are barriers to access to these services?

• What steps should be taken to ensure that approaches to detecting maternal emotional health issues and substance use challenges are culturally appropriate?

• What can be done to help mothers and pregnant and postpartum people feel more comfortable to open up about how they are feeling? Who, where, and how might mothers and pregnant and postpartum people feel safest about disclosing their experience?

How to submit a response: All submissions must be submitted in the Docket ID HHS- for “Solicitation for Public Comments on Questions from the Task Force on Maternal Mental Health.” Comments are encouraged from the public and will be accepted through January 31, 2024. The https://www.regulations.gov electronic filing system will accept electronic comments until midnight eastern time at the end of January 31, 2024. Comments received by mail/courier will be considered if they are postmarked or the delivery service acceptance receipt date is on or before that date. Written comments via mail will be uploaded into https://www.regulations.gov and are under the same limitations as for those directly submitted electronically into https://www.regulations.gov: 5,000 character limit for text box, and maximum number (10) of attached files and maximum size (10 MB) of each attached file.

This RFI is for informational and planning purposes only and is not a solicitation for applications or an obligation on the part of the Government to provide support for any ideas identified in response to it. Please note that the Government will not pay for the preparation of any information submitted or for use of that information.

Notice of this meeting is in compliance with the Federal Advisory Committee Act, (Pub. L. 117-286, 5 U.S.C., ch. 10). The Committee is authorized, by section 601 of the Frank LoBiondo Coast Guard Authorization Act of 2018, Public Law 115-282, 132 Stat. 4192, and is codified in 46 U.S.C. 70112. The Committee operates under the provisions of the Federal Advisory Committee Act and 46 U.S.C. 15109. The National Maritime Security Advisory Committee provides advice, consults with, and makes recommendations to the Secretary of Homeland Security, via the Commandant of the U.S. Coast Guard, on matters relating to national maritime security.

(1) Call to Order.

(2) Introduction.

(3) Designated Federal Officer Remarks.

(4) Roll call of Committee members and determination of quorum.

(5) Remarks from Committee Leadership.

(6) Discussion of Task T-2023-01: Update of NVIC 03-03, “Implementation Guidance for the Regulations Mandated by the Maritime Transportation Security Act of 2002 for Facilities.”

(7) Public Comment Period.

(8) Adjournment of Meeting.

(1) Call to Order.

(2) Introduction.

(3) Roll call of Committee members and determination of quorum.

(4) Discussion of Task T-2023-02: Active Shooter/Active Threat in the Maritime Environment.

(5) Public Comment Period.

(6) Adjournment of Meeting.

(1) Call to Order.

(2) Introduction.

(3) Roll call of Committee members and determination of quorum.

(4) Discussion of Task T-2023-03: Unmanned Systems in the Maritime Environment.

(5) Public Comment Period.

(6) Adjournment of Meeting.

A copy of all meeting documentation will be available at https://homeport.uscg.mil/NMSAC no later than February 4, 2024. Alternatively, you may contact Mr. Ryan Owens as noted in the FOR FURTHER INFORMATION CONTACT section above.

There will be a public comment period at the end of meetings. Speakers are requested to limit their comments to 3 minutes. Please note that the public comment period may end before the period allotted, following the last call for comments. Please contact the individual listed in the FOR FURTHER INFORMATION CONTACT section above to register as a speaker.

The Federal Emergency Management Agency (FEMA) hereby gives notice that pursuant to the authority vested in the Administrator, under Executive Order 12148, as amended, E. Craig Levy Sr., of FEMA is appointed to act as the Federal Coordinating Officer for this disaster.

This action terminates the appointment of John E. Brogan as Federal Coordinating Officer for this disaster.

The Federal Emergency Management Agency (FEMA) hereby gives notice that pursuant to the authority vested in the Administrator, under Executive Order 12148, as amended, Robert Little III, of FEMA is appointed to act as the Federal Coordinating Officer for this disaster.

This action terminates the appointment of DuWayne Tewes Casper as Federal Coordinating Officer for this disaster.

Notice is hereby given that, in a letter dated November 21, 2023, the President issued a major disaster declaration under the authority of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the “Stafford Act”), as follows:

The Federal Emergency Management Agency (FEMA) hereby gives notice that pursuant to the authority vested in the Administrator, under Executive Order 12148, as amended, Andrew F. Grant, of FEMA is appointed to act as the Federal Coordinating Officer for this major disaster.

The following areas of the State of California have been designated as adversely affected by this major disaster: