On September 21, 2018, Encore Wire Corporation and Southwire Company LLC filed petitions seeking the imposition of AD and CVD duties on imports of AWC from China. 1 Following Commerce's affirmative determinations of dumping and countervailable subsidies, 2 and the U.S. International Trade Commission's (ITC) finding of material injury, 3 Commerce issued the Orders. 4

The merchandise subject to the Orders is AWC from China, which is defined as “an assembly of one or more electrical conductors made from 8000 Series Aluminum Alloys (defined in accordance with ASTM B800), Aluminum Alloy 1350 (defined in accordance with ASTM B230/B230M or B609/B609M0), and/or Aluminum Alloy 6201 (defined in accordance with ASTM B398/B398M), provided that: (1) at least one of the electrical conductors is insulated; (2) each insulated electrical conductor has a voltage rating greater than 80 volts and not exceeding 1000 volts; and (3) at least one electrical conductor is stranded and has a size not less than 16.5 thousand circular mil (kcmil) and not greater than 1000 kcmil.” For a full description of the scope of the Orders, see the Appendix to this notice.

The scope and circumvention inquiries cover AWC assembled and completed in the third countries, using Chinese-origin AWC inputs ( e.g., stranded wire and cables or unfinished AWC), that is subsequently exported from the third countries to the United States. Specifically, Commerce placed information on the administrative record, as attachments to its Initiation Memorandum, that AWC inputs produced in China undergo further processing in the third countries before being exported to the United States. 5

Section 351.225(b) of Commerce's regulations states that if Commerce “determines from available information that an inquiry is warranted to determine whether a product is covered by the scope of an order,” then Commerce “may initiate a scope inquiry and publish a notice of initiation in the Federal Register .”

Additionally, 19 CFR 351.226(b) states that if Commerce “determines from available information that an inquiry is warranted into the question of whether the elements necessary for a circumvention determination under section 781 of the Act exist,” Commerce “may initiate a circumvention inquiry and publish a notice of initiation in the Federal Register .” Section 781(b)(1) of the Act provides that Commerce may find circumvention of an AD or CVD order when merchandise of the same class or kind subject to the order is completed or assembled in a foreign country other than the country to which the order applies. In conducting circumvention inquiries, under section 781(b)(1) of the Act, Commerce considers the following criteria: (A) the merchandise imported into the United States is of the same class or kind as any merchandise produced in a foreign country that is the subject of an antidumping or countervailing duty order or finding; (B) before importation into the United States, such imported merchandise is completed or assembled in another foreign country from merchandise which is subject to the order or merchandise which is produced in the foreign country that is subject to the order; (C) the process of assembly or completion in the foreign country referred to in section (B) is minor or insignificant; (D) the value of the merchandise produced in the foreign country to which the AD or CVD order applies is a significant portion of the total value of the merchandise exported to the United States; and (E) the administering authority determines that action is appropriate to prevent evasion of such order or finding.

In determining whether or not the process of assembly or completion in a third country is minor or insignificant under section 781(b)(1)(C) of the Act, section 781(b)(2) of the Act directs Commerce to consider: (A) the level of investment in the foreign country; (B) the level of research and development in the foreign country; (C) the nature of the production process in the foreign country; (D) the extent of production facilities in the foreign country; and (E) whether or not the value of processing performed in the foreign country represents a small proportion of the value of the merchandise imported into the United States. However, no single factor, by itself, controls Commerce's determination of whether the process of assembly or completion in a third country is minor or insignificant. 6 Accordingly, it is Commerce's practice to evaluate each of these five factors as they exist in the third country, based on the particular circumvention scenario presented by the facts collected during the inquiry. 7

In addition, section 781(b)(3) of the Act sets forth additional factors to consider in determining whether to include merchandise assembled or completed in a third country within the scope of an antidumping and/or countervailing duty order. Specifically, Commerce shall take into account such factors as: (A) the pattern of trade, including sourcing patterns; (B) whether the manufacturer or exporter of the merchandise is affiliated with the person who, in the third country, uses the merchandise to complete or assemble the merchandise which is subsequently imported into the United States; and (C) whether imports of the merchandise into the third country have increased after the initiation of the investigation that resulted in the issuance of such order or finding.

Commerce is self-initiating these scope inquiries to determine if AWC inputs produced in China and further processed in the third countries before being exported to the United States meet the scope description. 8 We are seeking to determine whether in-scope AWC inputs leave China and undergo minor processing in the third countries before being exported to the United States. If the Chinese-origin, in-scope merchandise that undergoes minor processing in the third countries results in merchandise that still corresponds to the description of in-scope merchandise outlined in the Orders, Commerce will find that the merchandise meeting the scope description is covered by the Orders. For those products for which Commerce finds that the merchandise is covered by the Orders, Commerce may rescind the circumvention inquiries, pursuant to 19 CFR 351.226(f)(6).

Based on available information, we also determine that initiation of these circumvention inquiries is warranted to determine whether certain imports of AWC, completed in the third countries using AWC inputs manufactured in China, are circumventing the Orders. 9 Commerce has made this determination in accordance with its analysis of the factors set forth in section 781(b) of the Act and 19 CFR 351.226(i). 10

Commerce has determined that it is appropriate to first determine whether the merchandise is subject to the scope of the Orders through scope inquiries, before considering whether the merchandise is circumventing the Orders. Accordingly, Commerce will initially conduct its scope inquiries of the merchandise at issue, and then once it has made a determination as to the scope coverage status of the merchandise, it will determine whether to continue with the circumvention inquiries. Commerce may apply its scope determinations, in accordance with 19 CFR 351.225(m)(1), on a producer-specific, exporter-specific, or importer-specific basis, or on a country-wide basis, regardless of the producer, exporter, or importer of the products being exported from the third countries to the United States.

If Commerce determines that AWC inputs produced in China and further processed in the third countries before being exported to the United States are not subject to the scope of the Orders, in whole or in part, Commerce intends to continue with the circumvention inquiries of that merchandise. If, as a result of the circumvention inquiries, Commerce determines that the products subject to the inquiries are circumventing the Orders, then in accordance with 19 CFR 351.226(m)(1), Commerce may apply its determination on a producer-specific, exporter-specific, or import-specific basis, or on a country-wide basis, regardless of the producer, exporter, or importer of the products being exported from the third countries to the United States.

Pursuant to 19 CFR 351.225(f)(7) and 226(f)(7), Commerce may “alter or extend” time limits under the scope and circumvention inquiries as necessary to make certain all parties to each or both segments of the proceedings are able to file comments and factual information as necessary.

Consistent with the approach taken in prior scope and circumvention inquiries that Commerce initiated on a country-wide basis, we intend to solicit information from certain companies in the third countries concerning their production of AWC and their shipments thereof to the United States. A company's failure to completely respond to Commerce's requests for information may result in the application of partial or total facts available, pursuant to section 776(a) of the Act, which may include adverse inferences, pursuant to section 776(b) of the Act.

Commerce intends to base respondent selection on responses to quantity and value questionnaires. Commerce intends to identify the companies to which it will issue the quantity and value questionnaire, in part, based on U.S. Customs and Border Protection (CBP) data. Parties to which Commerce does not issue the quantity and value questionnaire may also respond to the quantity and value questionnaire, which will be available in ACCESS, by the applicable deadline. Commerce intends to place the CBP data on the record within five days of publication of the initiation notice. Comments regarding the CBP data and respondent selection should be submitted within seven days after placement of the CBP data on the record of the relevant inquiry.

Pursuant to 19 CFR 351.225(l)(1), when Commerce self-initiates a scope inquiry under 19 CFR 351.225(b), Commerce will notify CBP of the initiation and direct CBP to continue the suspension of liquidation of entries of products subject to the scope inquiry that were already subject to the suspension of liquidation, and to apply the cash deposit rate that would be applicable if the product were determined to be covered by the scope of the order. Accordingly, Commerce will notify CBP of the initiation of the scope inquiries and direct CBP to continue to suspend (unliquidated) entries of the products subject to the scope inquiries that were already covered by the suspension of liquidation. In addition, Commerce will direct CBP to apply the cash deposit rate that would be applicable if the products were determined to be covered by the scope of the Orders.

Should Commerce issue preliminary or final scope rulings, Commerce will follow the suspension of liquidation rules under 19 CFR 351.225(l)(2)-(4). In the event that Commerce issues preliminary or final scope rulings that the products are covered by the scope of the Orders, Commerce will instruct CBP to continue the suspension of liquidation of previously suspended entries and to apply the applicable cash deposit rate. Commerce will also instruct CBP to begin the suspension of liquidation and application of cash deposits for any unliquidated entries not yet suspended, entered, or withdrawn from warehouse, for consumption, on or after the date of initiation of the scope inquiries pursuant to paragraphs (l)(2)(ii) and (l)(3)(ii). In addition, pursuant to paragraphs (l)(2)(iii)(A) and (l)(3)(iii)(A), Commerce normally will instruct CBP to begin the suspension of liquidation and application of cash deposits for any unliquidated entries not yet suspended, entered, or withdrawn from warehouse, for consumption, prior to the date of initiation of the scope inquiry, but not for such entries prior to November 4, 2021, the effective date of these provisions in the Final Rule. 11 These rules will not affect CBP's authority to take any additional action with respect to the suspension of liquidation or related measures for these entries, as stated in 19 CFR 351.225(l)(5).

Pursuant to 19 CFR 351.226(l)(1), when Commerce self-initiates a circumvention inquiry under 19 CFR 351.226(b), Commerce will notify CBP of the initiation and direct CBP to continue the suspension of liquidation of entries of products covered by the circumvention inquiry that were already covered by the suspension of liquidation, and to apply the cash deposit rate that would be applicable if the product were determined to be circumventing the order. Accordingly, Commerce will notify CBP of the initiation of the circumvention inquiries and direct CBP to continue to suspend (unliquidated) entries of the products covered by the circumvention inquiries that were already covered by the suspension of liquidation. In addition, Commerce will direct CBP to apply the cash deposit rate that would be applicable if the products were determined to be circumventing the Orders.

Should Commerce issue preliminary or final circumvention determinations, Commerce will follow the suspension of liquidation rules under 19 CFR 351.226(l)(2)-(4). In the event that Commerce issues affirmative preliminary or final circumvention determinations that the products are circumventing the Orders, Commerce will instruct CBP to continue the suspension of liquidation of previously suspended entries and to apply the applicable cash deposit rate. Commerce will also instruct CBP to begin the suspension of liquidation and application of cash deposits for any unliquidated entries not yet suspended, entered, or withdrawn from warehouse, for consumption, on or after the date of publication of the notice of initiation of the circumvention inquiries pursuant to paragraphs (l)(2)(ii) and (l)(3)(ii). In addition, pursuant to paragraphs (l)(2)(iii)(A) and (l)(3)(iii)(A), Commerce may instruct CBP to begin the suspension of liquidation and application of cash deposits for any unliquidated entries not yet suspended, entered, or withdrawn from warehouse, for consumption, prior to the date of initiation of the circumvention inquiry, but not for such entries prior to November 4, 2021, the effective date of these provisions in the Final Rule. 12 These rules will not affect CBP's authority to take any additional action with respect to the suspension of liquidation or related measures for these entries, as stated in 19 CFR 351.226(l)(5).

In accordance with 19 CFR 351.225(b) and 226(b), and section 781(b) of the Act, Commerce determines that available information supports initiating both scope and circumvention inquiries to determine whether certain imports of AWC, completed in and exported from the third countries using AWC inputs manufactured in China, are subject to or circumventing the Orders. Accordingly, Commerce is notifying all interested parties of the initiation of scope and circumvention inquiries. In addition, we have included a description of the products that are the subject of these inquiries, and an explanation of the reasons for Commerce's decision to initiate these inquiries as provided above and in the accompanying Initiation Memo. Pursuant to 19 CFR 351.225(e)(3) and 226(e)(3), due to the interrelated nature of the scope and circumvention inquiries, Commerce is aligning the deadlines for the scope inquiries with the circumvention inquiries and will conduct the scope inquiries first for the reasons explained above.

Pursuant to 19 CFR 351.225(f)(1), interested parties have until 30 days after publication of this notice in the Federal Register to submit one set of comments and factual information addressing the self-initiation of the scope inquiries.

Under 19 CFR 351.225(l)(2)(iii)(B) and (l)(3)(iii)(B), interested parties may timely request that Commerce adopt an alternative date to begin the suspension of liquidation and application of cash deposits under paragraphs (l)(2)(ii)(A) and (l)(3)(iii)(A). A request for Commerce to adopt an alternative date must be based on a specific argument supported by evidence establishing the appropriateness of that alternative date. 13 If parties wish to make such a request, that request must be included with the set of comments and factual information submitted to Commerce pursuant to 19 CFR 351.225(f)(1).

Within 14 days of the filing of such comments, any interested party is permitted one opportunity to submit comments and factual information to rebut, clarify, or correct factual information submitted by the other interested parties (including rebuttal in response to any requests made under 19 CFR 351.225(l)(2)(iii)(B) and (l)(3)(iii)(B)). At this time, we are not soliciting or accepting comments on the self-initiation of the circumvention inquiries. Should Commerce determine to proceed with the circumvention inquiries after finalizing its scope determinations, Commerce will notify interested parties on the segment-specific service list of an opportunity to comment.

In accordance with section 19 CFR 351.225(e), unless the scope inquiries are rescinded, in whole or in part, Commerce intends to issue its final scope rulings within 120 days after the date on which the scope inquiries were initiated. Furthermore, in accordance with section 781(f) of the Act and 19 CFR 351.226(e)(2), unless the circumvention inquiries are rescinded, in whole or in part, Commerce intends to issue its final circumvention determinations within 300 days from the date of publication of the notice of initiation of a circumvention inquiries in the Federal Register .

The ETTAC is mandated by section 2313(c) of the Export Enhancement Act of 1988, as amended, 15 U.S.C. 4728(c), to advise the Environmental Trade Working Group of the Trade Promotion Coordinating Committee, through the Secretary of Commerce, on the development and administration of programs to expand U.S. exports of environmental technologies, goods, services, and products. The ETTAC was most recently re-chartered through August 16, 2024.

On Tuesday, November 14, 2023 from 9:30 a.m. to 3:00 p.m. EST, the ETTAC will hold the fourth meeting of its current charter term. During the meeting, committee members will participate in breakout discussions to discuss issues of interest to specific environmental technology sectors and to deliberate on potential recommendation topics. The committee will also hear briefings on U.S. government resources and programs to support U.S. environmental technology exporters, including the U.S. National Export Strategy. An agenda will be made available one week prior to the meeting upon request to Megan Hyndman.

The meeting will be open to the public and time will be permitted for public comment before the close of the meeting. Members of the public seeking to attend the meeting are required to register by Friday, November 3, 2023, at 5:00 p.m. EST, via the contact information provided above. This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to OEEI at Megan.Hyndman@trade.gov or (202) 823-1839 no less than one week prior to the meeting. Requests received after this date will be accepted, but it may not be possible to accommodate them.

Written comments concerning ETTAC affairs are welcome any time before or after the meeting. To be considered during the meeting, written comments must be received by Friday, November 3, 2023, at 5:00 p.m. EST to ensure transmission to the members before the meeting. Draft minutes will be available within 30 days of this meeting.

On August 16, 2018, Commerce published in the Federal Register the AD orders on low melt PSF from Korea and Taiwan. 1 On July 3, 2023, Commerce published the Initiation Notice of the first sunset reviews of the Orders pursuant to section 751(c) of the Tariff Act of 1930, as amended (the Act). 2 In accordance with 19 CFR 351.218(d)(1)(i) and (ii), Commerce received notices of intent to participate in these sunset reviews from Huvis Indorama Advanced Materials, LLC and Nan Ya Plastics Corporation, America (collectively, the domestic interested parties) within 15-days after the date of publication of the Initiation Notice. 3 The domestic interested parties claimed interested party status under section 771(9)(C) of the Act as producers of a domestic like product in the United States.

Commerce received timely, adequate substantive responses to the Initiation Notice from the domestic interested parties within the 30-day period specified in 19 CFR 351.218(d)(3)(i). 4 Commerce did not receive substantive responses from any other interested parties, and no party requested a hearing.

On August 22, 2023, Commerce notified the U.S. International Trade Commission that it did not receive an adequate substantive response from other interested parties. 5 As a result, in accordance with section 751(c)(3)(B) of the Act and 19 CFR 351.218(e)(1)(ii)(C)(2), Commerce conducted expedited, i.e., 120-day, sunset reviews of the Orders.

The merchandise subject to the Orders is synthetic staple fibers, not carded or combed, specifically bi-component polyester fibers having a polyester fiber component that melts at a lower temperature than the other polyester fiber component (low melt PSF). For a complete description of the scope of the Orders, see the Issues and Decision Memorandum. 6

All issues raised in these sunset reviews are addressed in the Issues and Decision Memorandum, including the likelihood of continuation or recurrence of dumping and the magnitude of the margins of dumping likely to prevail if the Orders were revoked. 7 A list of topics discussed in the Issues and Decision Memorandum is included as an appendix to this notice. The Issues and Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at http://access.trade.gov. In addition, a complete version of the Issues and Decision Memorandum can be accessed at http://access.trade.gov/public/FRNoticesListLayout.aspx.

Pursuant to sections 751(c)(1) and 752(c)(1) and (3) of the Act, Commerce determines that revocation of the Orders would likely lead to the continuation or recurrence of dumping and that the magnitude of the dumping margins likely to prevail would be at a rate up to 16.27 percent for Korea and up to 49.93 percent for Taiwan.

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

We are issuing and publishing the results in accordance with sections 751(c), 752(c), and 771(i)(1) of the Act and 19 CFR 351.218.

An AOA is a defined geographic area that NOAA has evaluated through both spatial analysis and a programmatic National Environmental Policy Act (NEPA) process and determined to be environmentally, socially, and economically appropriate to support multiple commercial aquaculture operations. On June 1, 2023, NOAA announced the beginning of the process to identify AOAs in partnership with the State of Alaska in Alaska state waters. This is the beginning of a multi-year process in which NOAA and the State of Alaska will work to analyze locations and identify AOAs in Alaska state waters to help sustainably advance invertebrate ( e.g., shellfish, sea cucumber) and seaweed ( e.g., macroalgae, kelp) aquaculture. NOAA will not consider finfish aquaculture during identification of AOAs in Alaska because it is prohibited by state law.

NOAA has directives to preserve ocean sustainability and facilitate domestic aquaculture in the U.S., including through the National Aquaculture Act of 1980, the NOAA Marine Aquaculture Policy, and the Executive Order 1321, Promoting American Seafood Competitiveness and Economic Growth (May 7, 2020). NOAA has a variety of proven science-based tools and strategies that can support these directives and help communities thoughtfully consider how and where to sustainably develop aquaculture that will complement wild-capture fisheries, working waterfronts, and our nation's seafood processing and distribution infrastructure.

The areas identified as AOAs will have characteristics that are expected to be able to support multiple aquaculture farm sites of varying types; however, all portions of the AOA may not be appropriate for aquaculture or for all types of aquaculture. Identifying AOAs is an opportunity to use the best available science, which includes Indigenous Knowledge, and supports the “triple bottom line” of environmental, economic, and social sustainability. This approach has been refined and utilized widely within states and by other countries with robust, sustainable aquaculture sectors.

The Secretary of Commerce will identify AOAs in consultation with the Secretary of Defense, the Secretary of the Interior, the Secretary of Agriculture, the Secretary of Homeland Security, the Administrator of the Environmental Protection Agency, other appropriate Federal officials, and appropriate Regional Fishery Management Councils, and in coordination with appropriate State and Tribal governments.

NOAA held a 60-day public comment period in 2020 (85 FR 67519, October 23, 2020) to collect input on where in the country to focus the science-based, inclusive process to identify AOAs. During that comment period, NOAA received letters of support from individuals, industry, Alaska Native organizations, state agencies, and the state legislature to begin the process in Alaska state waters.

NOAA cannot conduct spatial modeling on the scale of the entire coast of Alaska, and will narrow down to study areas that will be the focus moving forward. This will be done using a combination of spatial mapping, scientific review, public input gathered through this RFI, and other relevant information. NOAA's National Centers for Coastal Ocean Science will use public input and the best available data, which includes Indigenous Knowledge, to account for key environmental, economic, social, and cultural considerations to identify areas that may support sustainable aquaculture development. NOAA will then combine those data with input from other State and Federal agencies, Fishery Management Councils, Marine Fisheries Commissions, Alaska Native Tribes and organizations, and the general public to identify areas that will be considered in more depth through the NEPA process. Through this notice, NOAA is requesting data, comments, views, information, analysis, or suggestions from the public to support the identification of AOAs in Alaska state waters, including siting parameters that can be used to select potential study areas for further analysis. The public input provided in response to this request for information will inform NOAA as it works with Federal, State, and Local agencies, appropriate Regional Fishery Management Councils, and in coordination with appropriate Alaska Native Tribes and organizations to identify AOAs. Additional opportunities for public input will be provided during the NEPA process.

NOAA may use the information received through this notice in the NEPA process. The information could inform the development of potential NEPA alternatives, such as different locations, different aquaculture types in each location ( e.g., seaweed in one location, shellfish in another location), and different configurations of farm locations or farming gear. NOAA expects to publish a notice of intent (NOI) to prepare a programmatic NEPA document. Public notices announcing the NOI and announcing the availability of a draft NEPA document will provide future opportunities for public comment on the identification of AOAs in Alaska state waters.

AOA identification is a planning process, and does not result in areas permitted for aquaculture. Future aquaculture operations proposed within an AOA would be subject to the same Federal and State permitting and authorization requirements as an aquaculture operation proposed anywhere else and would be required to comply with all applicable Federal and State laws and regulations. Site-specific environmental surveys may be required for the permitting process. Additional NEPA analysis beyond that completed for identification of AOA(s) may be necessary as a part of permitting and authorization processes for individual operations.

Additional information on identifying AOAs in Alaska, including frequently asked questions, is available on NOAA's website at: https://www.fisheries.noaa.gov/alaska/aquaculture/identifying-aquaculture-opportunity-areas-alaska.

NOAA requests data, comments, views, information, analysis, or suggestions from the public to support the identification of AOAs in Alaska state waters, including siting parameters that can be used to select potential study areas for further analysis.

NOAA proposes using the following parameters to select study areas in Alaska state waters:

a. State waters within a 25-mile (40-kilometer) radius of coastal community population centers (based on 2010 census data) as a proxy for needed infrastructure to support aquaculture development in Alaska.

b. State waters that do not regularly experience significant sea ice cover (based on the 10 year aggregate maximum sea ice cover reported by the U.S. National Ice Center).

Figures showing the potential AOA study areas that would result from use of these parameters can be found on the NOAA's National Centers for Coastal Ocean Science Alaska AOA study area website: https://coastalscience.noaa.gov/news/alaska-aquaculture-opportunity-areas/.

These parameters are proposed starting points, from which NOAA will select study areas using a combination of spatial mapping approaches, scientific review, public input, Indigenous Knowledge, and any other relevant information.

Specifically, NOAA is soliciting information and feedback on:

1. Are the preliminary parameters (noted above) useful? Are there other parameters NOAA should consider in identifying initial study areas for the aquaculture siting analysis? Are there other distances from population centers/local infrastructure that should be considered, and why?

2. Are there size limitations NOAA should consider for AOAs in Alaska? How many farms should fit within an AOA? Should the size of AOAs be aligned with state economic development goals for shellfish and seaweed aquaculture?

3. Are there specific locations within Alaska state waters that should be considered or avoided for AOAs? Please be as specific as possible and include latitude and longitude or defining landmarks. Please indicate why such areas should be considered or avoided, for example, favorable biological parameters, water quality ( e.g., nutrients or other constituents that might make an area favorable), proximity to infrastructure ( e.g., ports, testing or processing facilities, or hatcheries that could supply seed for grow-out), relationship to other planned initiatives, etc.

4. Are there subsistence harvest locations, fishing areas, and other traditionally and culturally important locations or sacred sites that should be avoided? Is there available spatial data or geographic information system (GIS) layers, or a point of contact for these data or information?

5. Are there specific locations within Alaska state waters where the presence of aquaculture gear may overlap with sensitive habitats or biologically important areas for protected species ( e.g., whales, sea otters, sea lions, etc. )?

6. Are there specific locations within Alaska state waters that should be avoided because of concerns about harmful algal blooms (HABs) or impaired water quality?

7. Is there ongoing environmental, economic, or social science research that would assist in the identification of AOAs in Alaska state waters? If so, please describe in as much detail as is available.

8. Is there information that may not be readily available or accessible online that would be useful for AOA planning processes in Alaska state waters? This includes spatial data or GIS layers representing subsistence, environmental, and socioeconomic considerations, or a point of contact for these data, for the following categories:

a. Biophysical/oceanographic (ice cover, temperature, ocean acidification indices, wave climate, currents, bathymetry),

b. Natural resources (minerals, energy resources, fishes and other aquatic organisms, protected species and habitats, marine mammals, kelp beds, eelgrass beds, biodiversity),

c. Social, historical, and cultural resources (cultural and subsistence harvest, community subsistence hunting, subsistence fishing, culturally important sites to encourage or avoid, shipwrecks),

d. Government boundaries,

e. Industry (fishing, energy production, transportation, communication cables),

f. Military,

g. Navigation, and

h. Recreational resources (fishing, hunting, etc. ).

9. Are there aquaculture species or gear considerations that may result in optimized growth in Alaska state waters? This might include (but is not limited to): species or aquaculture gear depth thresholds, water current thresholds, temperature thresholds, salinity thresholds, etc. Are there any species or gear not currently being used in Alaska state waters that you would like to see in the future? Do they extend any of these (or other) thresholds? Please be as specific as possible.

10. Is there any additional information NOAA should consider?

When providing input, please specify:

• The question number(s) you are responding to; and

• Whether your comments are related to specific type(s) of aquaculture (macroalgae, invertebrates, or a combination of species).

Responses to this request are voluntary. Respondents need not reply to all questions.

Authority: E.O. 13921.

Background

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, regulations are promulgated (when applicable), and public notice and an opportunity for public comment are provided.

An authorization for incidental takings shall be granted if NMFS finds that the taking will have a negligible impact on the species or stock(s) and will not have an unmitigable adverse impact on the availability of the species or stock(s) for taking for subsistence uses (where relevant). If such findings are made, NMFS must prescribe the permissible methods of taking; “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 as “mitigation”); and requirements pertaining to the monitoring and reporting of such takings. The MMPA defines “take” to mean harass, hunt, capture, or kill, or attempt to harass, hunt, capture, or kill any marine mammal (16 U.S.C. 1362(13); 50 CFR 216.103). Level A harassment is defined as any act of pursuit, torment, or annoyance which has the potential to injure a marine mammal or marine mammal stock in the wild (16 U.S.C. 1362(18); 50 CFR 216.3). Level B harassment is defined as any act of pursuit, torment, or annoyance which 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 (16 U.S.C. 1362(18); 50 CFR 216.3). Section 101(a)(5)(A) of the MMPA and the implementing regulations at 50 CFR part 216, subpart I authorize NMFS to propose and, if appropriate, promulgate regulations and issue an associated LOA(s). NMFS promulgated regulations on September 13, 2023 (88 FR 62898) for the taking of marine mammals incidental to the construction of the Ocean Wind 1 Project offshore of New Jersey. The LOA authorizes Ocean Wind and those persons it authorizes or funds to conduct activities on its behalf to take marine mammals incidental to specified activities during the construction of the Project and requires them to implement mitigation, monitoring, and reporting requirements.

On September 13, 2023, NMFS promulgated a final rule (88 FR 62898) responding to a request from Ocean Wind for authorization to take marine mammals (17 species comprising 18 stocks) by Level B harassment (all 18 stocks) and by Level A harassment (10 stocks) incidental to construction activities occurring in Federal and State waters off of New Jersey, specifically within and around the Bureau of Ocean Energy Management (BOEM) Commercial Lease of Submerged Lands for Renewable Energy Development on the Outer Continental Shelf (OCS) Lease Area OCS-A 0498 (Lease Area) and along 2 export cable routes to sea-to-shore transition points (collectively referred to as the “Project Area”), over the course of 5 years (October 13, 2023 through October 12, 2028). The activities covered under the final rule include: the installation of 98 wind turbine generators (WTGs) and 3 offshore substations (OSSs) on monopile foundations by impact pile driving; the installation and subsequent removal of nearshore temporary cofferdams and goal posts by vibratory pile driving at the cable landfall sites in Ocean County, New Jersey and Cape May County, New Jersey; high-resolution geophysical (HRG) marine site characterization surveys using active acoustic sources; the detonation of up to 10 unexploded ordnance or munitions and explosives of concern (UXOs/MECs) of different charge weights; fishery and ecological monitoring surveys; the placement of scour protection; the installation of the export cable route from OSSs to shore-based converter stations and inter-array cables between turbines by trenching, laying, and burial activities; vessel transits within the specified geographical region to transport crew, supplies, and materials to support construction and operation.

Marine mammals exposed to elevated noise levels during impact driving, or UXO/MEC detonations may be taken by Level A harassment, and marine mammals exposed to elevated noise levels during impact and vibratory pile driving, site characterization surveys, or UXO/MEC detonations may be taken by Level B harassment. No Level A harassment of North Atlantic right whales, blue whales, sperm whales, Atlantic spotted dolphins, Atlantic white-sided dolphins, common dolphins, long-finned or short-finned pilot whales, or Risso's dolphins is anticipated or authorized. No mortality or serious injury of any marine mammal is anticipated or authorized.

In accordance with the final rule (88 FR 62898, September 13, 2023, see 50 CFR 217.266), we have issued a LOA to Ocean Wind authorizing the take, by harassment, of marine mammals incidental to specified construction activities within the specified geographical region. No mortality or serious injury of any marine mammal species is anticipated or authorized. The incidental takes authorized herein are the same as those analyzed and authorized in the final rule (88 FR 62898, September 13, 2023). Takes of marine mammals will be minimized through the following planned mitigation and monitoring measures, as applicable for each specified activity: (1) implementation of seasonal/time of day work restrictions; (2) use of multiple NMFS-approved Protected Species Observers (PSOs) to visually observe for marine mammals (with any detection within specifically designated zones triggering a delay or shutdown, as applicable); (3) use of NMFS-approved passive acoustic monitoring (PAM) operators to acoustically detect marine mammals, with a focus on detecting baleen whales (with any detection within designated zones triggering a delay or shutdown, as applicable); (4) implementation of clearance and shutdown zones; (6) use of soft-start prior to the start of impact pile driving; (7) use of noise attenuation technology during impact pile driving and UXO/MEC detonations; (8) use of situational awareness monitoring for marine mammal presence; (9) use of sound field verification monitoring; (10) use of soft-start impact pile driving and ramp-up acoustic sources during HRG surveys; (11) implementation of vessel separation zones between marine mammals and project vessels; (12) use of PAM within the vessel transit corridor for Project vessels to travel over 10 knots (11.5 miles per hour); and (13) implementation of additional Vessel Strike Avoidance measures to reduce the risk of a vessel collision with a marine mammal. Additionally, NMFS may modify the LOA's mitigation, monitoring, or reporting measures, based on new information, when appropriate ( see also 50 CFR 217.267(c)). Ocean Wind is also required to submit reports, as specified in the final rule.

Based on the findings and information discussed in the preamble of the final rule, the take authorized in the LOA will have a negligible impact on marine mammal stocks, will not have an unmitigable adverse impact on the availability of the affected marine mammal stock for subsistence uses, and the mitigation measures provide a means of affecting the least practicable adverse impact on the affected stocks and their habitat.

Nellis AFB is proposing to develop the east side of the Installation. The purpose of the Proposed Action is to optimize Nellis AFB's current operational capabilities and capacity for future warfighting training and testing. The Proposed Action is needed because the current Nellis and United States Air Force Warfare Center mission sets are outpacing the ability to expand resources and capacity. In addition, the Air Force anticipates that facility requirements are likely to increase over time through normal attrition and the arrival of new missions and that the number of active duty and civilian personnel would also increase. The existing infrastructure does not meet current and future mission needs; mission capability at Nellis AFB is nearing physical capacity, and additional flightline support facilities and infrastructure are needed to meet anticipated future growth. The Proposed Action is also needed to relieve stress on facility and infrastructure constraints on the west side of the Installation. Flying units are currently sharing hangar space, which is not conducive to future mission growth. Presently, the Installation's infrastructure and utilities are a limitation to operational expansion and growth; utilities and the west-side ramp are reaching full operational capacity and must be expanded to accommodate future operations. Without expansion, the existing facilities and infrastructure at Nellis AFB would be insufficient to meet Air Force and Department of Defense current and future mission requirements.

The Proposed Action is development of the east side of Nellis AFB to address current mission constraints and future mission growth because the majority of the land available to construct facilities and infrastructure is located in the undeveloped area on the east side of the Installation. Constructed facilities and infrastructure will be grouped by functional land use category, and facilities with similar uses and mission functions will be located in the same general area. For planning purposes, the Air Force grouped similar mission activities into eight categories based on facility and infrastructure function and conservatively estimated the anticipated amount of impervious surface coverage typical of each functional category. The eight functional categories are Airfield Operations/Industrial/Light Industrial; Administrative/Small-scale Administrative; Medical/Community Services/Community Commercial/Small-scale Retail and Service; Lodging/Residential (Accompanied and Unaccompanied); Outdoor Recreation/Open Space/Training Space; Transportation; Utilities/Infrastructure; and Existing Pavements.

In order to address facility requirements needed to support current and future mission structure changes and the associated increase in mission personnel, the Air Force is proposing two alternatives to gain functional capacity and support future mission growth at Nellis AFB: Alternative 1, complete build-out covering approximately 2,000 acres, and Alternative 2, partial build-out covering approximately 1,486 acres. The Air Force will also evaluate a No Action Alternative in the EIS. The Air Force is early in the planning process and has not yet identified a Preferred Alternative.

The EIS will provide analysis to inform decision-makers, as well as the public and tribal partners, of the potential environmental consequences and any associated mitigation, and will provide interested persons or agencies opportunities to provide their input. The environmental impacts analysis is expected to focus on potential impacts related to air emissions from construction, potential threatened and endangered species impacts from construction and habitat reduction, soil and water quality impacts from soil compaction and erosion, stormwater impacts from the increase in impervious surfaces, and potential impacts to cultural resources. Impacts to transportation may include increased traffic on and off the Installation. Permitting actions for construction, air emissions, and stormwater pollution prevention may be required. The Air Force will also consult with appropriate resource agencies and Native American tribes to determine the potential for significant impacts. Consultation will be incorporated into the preparation of the EIS and will include, but not be limited to, consultation under Section 7 of the Endangered Species Act and consultation under Section 106 of the National Historic Preservation Act. Additional analysis will be provided in the Draft EIS.

Scoping and Agency Coordination: To effectively define the full range of issues to be evaluated in the EIS, the Air Force is soliciting comments from interested local, state, and federal officials and agencies; Native American tribes; and interested members of the public and other stakeholders. Comments are requested on potential alternatives and impacts, and identification of any relevant information, studies, or analyses of any kind concerning impacts affecting the quality of the natural and/or human environment. Concurrent with the publication of this Notice of Intent, public scoping notices will be announced locally.

Due to circumstances beyond the control of the Department of Defense and the Designated Federal Officer, the BoR USUHS was unable to provide sufficient public notification required by 41 CFR 102-3.150(a) regarding the change in location of its October 20, 2023 meeting. Accordingly, the Advisory Committee Management Officer for the Department of Defense, pursuant to 41 CFR 102-3.150(b), waives the 15-calendar day notification requirement.

The proposed changes to the MCM are being made available on the internet at http://www.regulations.gov, Docket ID: DoD-2023-OS-0099 rather than being printed in the Federal Register .

These proposed changes have not been coordinated within the DoD under DoD Directive 5500.01, “Preparing, Processing and Coordinating Legislation, Executive Orders, Proclamations, Views Letters, and Testimony,” June 15, 2007, and do not constitute the official position of the DoD, the Military Departments, or any other Government agency.

This notice is provided in accordance with DoD Instruction 5500.17, “Role and Responsibilities of the Joint Service Committee on Military Justice (JSC),” February 21, 2018.

The JSC invites members of the public to comment on the proposed changes; such comments should address specific recommended changes and provide supporting rationale.

This notice also sets forth the date, time, and location for a public meeting of the JSC to discuss the proposed changes.

This notice is intended only to improve the internal management of the Federal Government. It is not intended to create any right or benefit, substantive or procedural, enforceable at law by any party against the United States, its agencies, its officers, or any person.

Subsection (e)(2)(D)(i) of the American Innovation and Manufacturing Act of 2020 (AIM Act) directs the Environmental Protection Agency (EPA) to determine, by October 1 of each calendar year, the quantity of allowances for the production and consumption of regulated substances that may be used for the following calendar year. EPA has codified the production and consumption baselines and phasedown schedules for regulated substances in 40 CFR 84.7. Under the phasedown schedule, for 2024, total production allowances may not exceed 229,521,263 metric tons of exchange value equivalent (MTEVe) and total consumption allowances may not exceed 181,522,990 MTEVe.

EPA regulations at 40 CFR part 84, subpart A, outline the process by which the Agency determines the number of allowances each entity is allocated. EPA allocated allowances consistent with this process for calendar year 2024, and has posted entity-specific allowance allocations on its website at https://www.epa.gov/climate-hfcs-reduction. An allowance allocated under the AIM Act does not constitute a property right and is a limited authorization for the production or consumption of a regulated substance.

Note that while allowances may be transferred or conferred once they are allocated, they can only be expended to cover imports and production in the calendar year for which they are allocated. In other words, calendar year 2024 allowances may only be expended for production and import of bulk HFCs between January 1, 2024, and December 31, 2024.

EPA established the methodology for issuing application-specific allowances in the 2021 final rule titled Phasedown of Hydrofluorocarbons: Establishing the Allowance Allocation and Trading Program Under the American Innovation and Manufacturing Act (86 FR 55116) and codified the methodology for issuing allowance allocations in 40 CFR 84.13. Because application-specific allowances can be expended to either produce or import HFCs, and application-specific allowances must be provided from within the overall annual production and consumption caps, EPA subtracts the amount of application-specific allowances allocated from both the production and consumption general allowance pools. EPA issues application-specific allowances to end users in five applications established by the AIM Act: propellants in metered dose inhalers (MDIs), defense sprays, structural composite preformed polyurethane foam for marine use and trailer use, etching of semiconductor material or wafers and the cleaning of chemical vapor deposition chambers within the semiconductor manufacturing sector, and onboard aerospace fire suppression. Additionally, EPA issues application-specific allowances to the U.S. Department of Defense for mission-critical military end uses.

EPA's 2023 final rule titled Phasedown of Hydrofluorocarbons: Allowance Allocation Methodology for 2024 and Later Years (88 FR 46836), updated the methodology for how the Agency would issue production and consumption allowances for 2024 through 2028. These updates are codified in 40 CFR 84.9 (production) and 40 CFR 84.11 (consumption), and EPA is issuing allowances to entities who meet the criteria in the regulations, including those who were previously issued consumption allowances as new market entrants pursuant to 40 CFR 84.15.

EPA's final calculations for allocation of allowances for each entity on September 29, 2023, follows below. EPA followed the methodology from the applicable regulations in determining allocations, i.e., 40 CFR 84.13 for application-specific allowances, 40 CFR 84.9 for production allowances, and 40 CFR 84.11 for consumption allowances.

Applying the methodology codified in 40 CFR 84.13, EPA allocated the number of application-specific allowances shown in Table 1.

EPA has denied requests for application-specific allowances from Apple Inc. and Zarc International, Inc. because they are ineligible under 40 CFR 84.13. The requests were ineligible for at least one of the following reasons:

(1) Did not report purchases of regulated substances in the past three years; or

(2) Failed to submit a request by the deadline.

Applying the methodology codified in 40 CFR 84.9, EPA allocated the number of production allowances shown in Table 2.

Applying the methodology codified in 40 CFR 84.11, EPA allocated the number of consumption allowances shown in Table 3.

Separate from the allocation of calendar year 2024 allowances, EPA also took administrative consequences against certain entities. Each administrative consequence is an independent stand-alone action, but for administrative efficiency EPA is providing notice of these independent actions through this notice as well. The requirements surrounding administrative consequences are codified in 40 CFR 84.35. Using this authority, EPA can retire, revoke, or withhold the allocation of allowances, or ban an entity from receiving, transferring, or conferring allowances. A retired allowance is one that must go unused and expire at the end of the year; a revoked allowance is one that EPA takes back from an allowance holder and redistributes to all the other allowance holders; and a withheld allowance is one that is retained by the Agency until an allowance holder that has failed to meet a regulatory requirement comes back into compliance, at which point EPA allocates it to the allowance holder. A withheld allowance could become a revoked allowance if the allowance holder fails to meet the regulatory requirement at issue within the timeframe specified by EPA. 1 More information on EPA's approach to administrative consequences can be found at 86 FR 55168.

EPA finalized administrative consequences for certain entities that were allocated consumption allowances, listed in Table 3 for calendar year 2024, effective concurrently with the issuance of calendar year 2024 allowances. Specifically, the following entities failed to submit complete HFC reports as required in 40 CFR 84.31 and therefore EPA has withheld a portion of their consumption allowances until the missing reports are filed and verified by EPA: Air Liquide USA; Creative Solution; and Matheson Tri-gas, Inc.

The following entities imported regulated HFCs without expending the requisite number of consumption allowances at the time of import and therefore EPA has retired and/or revoked consumption allowances commensurate with the quantities of regulated substances imported without allowances: American Air Components; AFK & Co.; Artsen; Bluon, Inc.; Electronic Fluorocarbons; Fluorofusion Specialty Chemicals; and Resonac America, Inc. Lastly, Honeywell International produced and imported regulated substances without expending the requisite number of consumption allowances at the time of production or import.

In some of these cases, EPA finalized administrative consequences that totaled more than was allocated to an entity. For example, American Air Components, Bluon, Inc., and Resonac America, Inc. imported regulated HFCs without the necessary allowances at the time of import in such quantities that exceed their initial allocation of calendar year 2024 allowances. With respect to one entity, the Agency decided to apply the administrative consequence across multiple years. EPA made this determination given the size of the administrative consequence and as a result of considerations related to the step reduction in 2024 and implications for the market as a whole regarding access to chemicals that are anticipated to be impacted by EPA HFC regulations. A summary of these administrative consequences is included in Table 4.

The allowance adjustments by way of withholding, retiring, and/or revoking a portion of entities' calendar year 2024 allowances effective September 29, 2023, are reflected below in Table 5.

The official public docket for this action (identified by Docket ID No. EPA-HQ-OGC-2023-0500) contains a copy of the proposed consent decree. The official public docket is available for public viewing at the Office of Environmental Information (OEI) Docket in the EPA Docket Center, EPA West, Room 3334, 1301 Constitution Ave. NW, Washington, DC. The EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OEI Docket is (202) 566-1752.

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

On December 14, 2020, EPA issued a final rule approving two revisions to Pennsylvania's state implementation plan (SIP) to address certain reasonably available control technology requirements, specifically those related to control techniques guidelines for volatile organic compounds and the addition of regulations controlling volatile organic compounds emissions from industrial cleaning solvents. That final rule was titled “Air Plan Approval; Pennsylvania; Reasonably Available Control Technology (RACT) for Volatile Organic Compounds (VOC) Under the 2008 Ozone National Ambient Air Quality Standards (NAAQS),” and published at 85 FR 80616 (December 14, 2020) (“Final Rule”).

On February 12, 2021, Plaintiff petitioned the United States Court of Appeals for the Third Circuit to review the Final Rule. 1 On August 2, 2021, EPA filed a motion for voluntary remand without vacatur in Third Circuit Case No. 21-1279 so that the Agency could reconsider the Final Rule. On September 3, 2021, the Third Circuit granted EPA's motion for voluntary remand without vacatur. To date, EPA has not completed its reconsideration of the Final Rule. The proposed consent decree would establish a deadline for EPA to complete its reconsideration of the Final Rule. Further, if that reconsideration process results in rulemaking, EPA shall, within 15 business days of signature of a notice of a final rule, send the rulemaking package to the Office of the Federal Register for review and publication in the Federal Register .

In accordance with section 113(g) of the CAA, for a period of thirty (30) days following the date of publication of this document, the Agency will accept written comments relating to the proposed consent decree. EPA or the Department of Justice may withdraw or withhold consent to the proposed consent decree if the comments disclose facts or considerations that indicate that such consent is inappropriate, improper, inadequate, or inconsistent with the requirements of the Act.

Submit your comments, identified by Docket ID No. EPA-HQ-OGC-2023-0500, via https://www.regulations.gov. Once submitted, comments cannot be edited or removed from this docket. EPA may publish any comment received to its public docket. Do not submit to EPA's docket at https://www.regulations.gov any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. EPA will generally not consider comments or comment contents located outside of the primary submission ( i.e., on the web, cloud, or other file sharing system). For additional submission methods, the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets. For additional information about submitting information identified as CBI, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section of this document. Note that written comments containing CBI and submitted by mail may be delayed and deliveries or couriers will be received by scheduled appointment only.

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

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

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

In accordance with 5 U.S.C. 4314(c)(4), the names and position of the EEOC PRB members are set forth below:

This notice serves to update and modify FCC/WTB-1, as a result of various necessary changes and updates. The substantive changes and modifications to the previously published version of the FCC/WTB-1 system of records include:

1. Updating the language in the Security Classification to follow OMB guidance;

2. Updating the language in the Purposes section for clarity and for consistency with the language and phrasing currently used in the FCC's SORNs and to include collecting and maintaining information to allow staff access to documents necessary for key activities discussed in this SORN, including analyzing effectiveness and efficiency of FCC programs, informing future rule-making and policy-making activity, and improving staff efficiency;

3. Modifying the language in the Categories of Individuals and Categories of Records for clarity and for consistency with the language and phrasing currently used in the FCC's SORNs;

4. Updating and/or revising language in six routine uses (listed by current routine use number): (1) Public Access; (2) Litigation and (3) Adjudication (now two separate routine uses); (5) Law Enforcement and Investigation; (6) Congressional Inquiries; and (7) Government-wide Program Management and Oversight;

5. Adding four new routine uses (listed by current routine use number): (4) FCC Enforcement Actions; (8) Breach Notification, the addition of which is as required by OMB Memorandum No. M-17-12; (9) Assistance to Federal Agencies and Entities Related to Breaches, the addition of which is required by OMB Memorandum No. M-17-12; and (10) Non-Federal Personnel;

6. Deleting one prior routine use (listed by former routine use number) (2) Financial Obligations Under the Debt Collection Acts, which does not reflect how the FCC has used or disclosed records from this system;

7. Updating the SORN to include the records schedule “Universal Licensing System” Records Schedule, Number N1-173-08-001.

The system of records is also updated to reflect various administrative changes related to the system managers and system addresses; policy and practices for storage and retrieval of the information; administrative, technical, and physical safeguards; and updated notification, records access, and contesting records procedures.

This notice serves to update and modify FCC/EB-5. The sole modification to the previously published version of the FCC/EB-5 system of records notice is revising the language in routine use (6) Law Enforcement and Investigation to include disclosures to international and multinational regulatory and/or law enforcement agencies.

This notice serves to update and modify FCC/WTB-6, as a result of various necessary changes and updates. The substantive changes and modifications to the previously published version of the FCC/WTB-6 system of records include:

1. Updating the language in the Security Classification to follow OMB guidance.

2. Updating the language in the Purposes section to be consistent with the language and phrasing currently used in the FCC's SORNs.

3. Modifying the language in the Categories of Individuals and Categories of Records to be consistent with the language and phrasing currently used in the FCC's SORNs.

4. Deleting two routine uses (listed by former routine use number) (2) Employment, Clearances, Licensing, Contract, Grant, or other Benefits Decisions by the agency; and (3) Employment, Clearances, Licensing, Contract, Grant, or other Benefits Decisions by other than the agency—neither of which reflects how the FCC has used or disclosed records from this system.

5. Updating and/or revising language in the following routine uses (listed by current routine use number): (1) Public Access; (2) Litigation and Adjudication which is now two separate routine uses—(2) Litigation and (3) Adjudication; (5) Law Enforcement and Investigation; (6) Congressional Inquiries; and (7) Government-wide Program Management and Oversight.

6. Adding the following new routine uses (listed by current routine use number): (4) FCC Enforcement Actions; (8) Breach Notification, the addition of which is as required by OMB Memorandum No. M-17-12; (11) Assistance to Federal Agencies and Entities Related to Breaches, the addition of which is required by OMB Memorandum No. M-17-12; and (10) Non-Federal Personnel to allow contractors, vendors, grantees, or volunteers performing or working on a contract, grant, or cooperative agreement for the Federal Government to have access to needed information.

7. Updating the SORN to include the records schedule N1-173-94-002, “Wireless Telecommunications Bureau—Licensing Division Records.”

The system of records is also updated to reflect various administrative changes related to the system managers and system addresses; policy and practices for storage and retrieval of the information; administrative, technical, and physical safeguards; and updated notification, records access, and contesting records procedures.

Proposal to renew the following currently approved collection of information:

1. Title: Recordkeeping and Disclosure Requirements in Connection with Regulation M (Consumer Leasing).

OMB Number: 3064-0083.

Affected Public: State nonmember banks and state savings associations engaging in consumer leasing.

Burden Estimate:

General Description of Collection: Regulation M (12 CFR 1013), issued by the Bureau of Consumer Financial Protection, implements the consumer leasing provisions of the Truth in Lending Act. Regulation M requires lessors of personal property to provide consumers with meaningful disclosures about the costs and terms of the leases for personal property. Lessors are required to retain evidence of compliance with Regulation M for twenty-four months. There is no change in the methodology or substance of this information collection. The change in burden is due solely to the decrease in the estimated number of respondents from 19 in 2021 to 17.

2. Title: Retail Foreign Exchange Transactions.

OMB Number: 3064-0182.

Forms: None.

Affected Public: Insured state nonmember banks and state savings associations.

Burden Estimate:

General Description of Collection: This information collection implements section 742(c)(2) of the Dodd-Frank Act (7 U.S.C. 2(c)(2)(E)) and FDIC regulations governing retail foreign exchange transactions as set forth at 12 CFR part 349, subpart B. The regulation allows banking organizations under FDIC supervision to engage in off-exchange transactions in foreign currency with retail customers provided they comply with various reporting, recordkeeping and third-party disclosure requirements specified in the rule. If an institution elects to conduct such transactions, compliance with the information collection is mandatory. Reporting Requirements—part 349, subpart B requires that, prior to initiating a retail foreign exchange business; a banking institution must provide the FDIC with a notice certifying that the institution has written policies and procedures, and risk measurement and management systems and controls in place to ensure that retail foreign exchange transactions are conducted in a safe and sound manner. The institution must also provide information about how it intends to manage customer due diligence, new product approvals and haircuts applied to noncash margin. Recordkeeping Requirements—part 349 subpart B requires that institutions engaging in retail foreign exchange transactions keep full, complete and systematic records of account, financial ledger, transaction, memorandum orders and post execution allocations of bunched orders. In addition, institutions are required to maintain records regarding their ratio of profitable accounts, possible violations of law, records of noncash margin and monthly statements and confirmations issued. Disclosure Requirements—The regulation requires that, before opening an account that will engage in retail foreign exchange transactions, a banking institution must obtain from each retail foreign exchange customer an acknowledgement of receipt and understanding of a written disclosure specified in the rule and of disclosures about the banking institution's fees and other charges and of its profitable accounts ratio. The institution must also provide monthly statements to each retail foreign exchange customer and must send confirmation statements following every transaction. The customer dispute resolution provisions of the regulation require certain endorsements, acknowledgements and signature language as well as the timely provision of a list of persons qualified to handle a customer's request for arbitration.

After reviewing the requirements in Subpart B and the similar ICRs currently approved by OMB for the OCC and the Federal Reserve, the FDIC has determined that subpart B imposes more recordkeeping requirements than those listed in the 2021 ICR. While the 2021 ICR listed 12 CFR 349.19 as the only recordkeeping requirement in Subpart B, 1 the FDIC notes that the requirement in 12 CFR 349.21(b)(2)  2 also meets the definition of a recordkeeping requirement, as does the requirement in 12 CFR 349.25(a). 3 The OCC and the Federal Reserve each listed requirements that are analogous to those in 12 CFR 349.21(b)(2) and 12 CFR 349.25(a) as recordkeeping requirements in their similar ICRs, 4 in addition to recordkeeping requirements that are analogous to those in 12 CFR 349.19. 5 The FDIC is revising its information collection to include this burden.

3. Title: Generic Information Collection for Qualitative Research.

OMB Number: 3064-0198.

Affected Public: General public including FDIC insured depository institutions.

Burden Estimate:

General Description of Collection: The FDIC is requesting renewal of this approved collection to use occasional qualitative surveys to gather information from the public to inform qualitative research. While the subject and nature of the surveys to be deployed under this information collection are yet to be determined, based on prior experience it is expected that the number or respondents will range from a few to, at times, several thousands, but, in general, these surveys are expected to involve an average of 500 respondents. Likewise, the time to respond to the surveys can range from a few minutes to several hours, but, it is expected that the average time to respond to a survey is approximately one hour. These surveys are completely voluntary in nature. FDIC estimates that approximately 20 such surveys will be conducted in any given year. Currently, the FDIC has a variety of methods to collect quantitative information from consumers and institutions ( e.g., Call Reports, FDIC National Survey of Unbanked and Underbanked Households, etc.). Qualitative data would provide complementary information on insights, opinions, and perceptions that will inform how the FDIC approaches its mission to safeguard financial stability of the banking system and promote consumer protection and economic inclusion. This clearance would allow the FDIC to engage with consumers and other relevant stakeholders through qualitative research methods such as focus groups, in-depth interviews, cognitive testing, and/or qualitative virtual methods. The purpose of the surveys is, in general terms, to obtain anecdotal information about regulatory burden, problems or successes in the bank supervisory process (including both safety-and-soundness and consumer related exams), the perceived need for regulatory or statutory change, and similar concerns. The information in these surveys is anecdotal in nature, that is, samples are not necessarily random, the results are not necessarily representative of a larger class of potential respondents, and the goal is not to produce a statistically valid and reliable database. Rather, the surveys are expected to yield anecdotal information about the particular experiences and opinions of members of the public, primarily staff at respondent banks or bank customers. The collection is noncontroversial and does not raise issues of concern to other Federal agencies; with the exception of information needed to provide remuneration for participants of focus groups and cognitive laboratory studies, personally identifiable information (PII) is collected only to the extent necessary and is not retained. Participation in this information collection will be voluntary and conducted in-person, by phone, or using other methods, such as virtual technology. The types of collections that this generic clearance covers include, but are not limited to: Small discussion groups; focus groups of consumers, financial industry professionals, or other stakeholders; cognitive laboratory studies, such as those used to refine questions or assess usability of a website; qualitative customer satisfaction surveys ( e.g., post- transaction surveys; opt-out web surveys); and in-person observation testing ( e.g., website or software usability tests).

There is no change in the substance or methodology of this information collection.

Comments are invited on: (a) Whether the collections of information are necessary for the proper performance of the FDIC's functions, including whether the information has practical utility; (b) the accuracy of the estimates of the burden of the information collections, including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collections of information on respondents, including through the use of automated collection techniques or other forms of information technology. All comments will become a matter of public record.

Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from 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) to include agency requests or requirements that ten or more persons submit information to a third party. FHFA's collection of information set forth in this document is titled “Federal Home Loan Bank Capital Stock” (assigned control number 2590-0002 by OMB). To comply with the PRA requirement, FHFA is publishing notice of a proposed three-year extension of this collection of information, which is due to expire on November 30, 2023.

The Federal Home Loan Bank System consists of eleven regional Federal Home Loan Banks (Banks) and the Office of Finance (a joint office that issues and services the Banks' debt securities). The Banks are wholesale financial institutions, organized under authority of the Federal Home Loan Bank Act (Bank Act) to serve the public interest by enhancing the availability of residential housing finance and community lending credit through their member institutions and, to a limited extent, through certain eligible nonmembers. Each Bank is structured as a regional cooperative that is owned and controlled by member institutions located within its district, which are also its primary customers. An institution that is eligible for membership in a particular Bank must purchase and hold a prescribed minimum amount of the Bank's capital stock in order to become and remain a member of that Bank. With limited exceptions, only an institution that is a member of a Bank may obtain access to low cost secured loans, known as advances, or other products provided by that Bank.

Section 6 of the Bank Act establishes capital requirements for the Banks and requires FHFA to issue regulations prescribing uniform capital standards applicable to all of the Banks. 1 Section 6 also establishes parameters relating to the Banks' capital structures and requires that each Bank adopt a “capital structure plan” (capital plan) to establish, within those statutory parameters, its own capital structure and to establish requirements for, and govern transactions in, the Bank's capital stock. 2 FHFA's regulations on Bank Capital Requirements, Capital Stock, and Capital Plans are located at 12 CFR part 1277.

Both the Bank Act and FHFA's regulations state that a Bank's capital plan must require its members to maintain a minimum investment in the Bank's capital stock, but both permit each Bank to determine for itself what that minimum investment is and how each member's required minimum investment is to be calculated. 3 Although each Bank's capital plan establishes a slightly different method for calculating the required minimum stock investment for its members, each Bank's method is tied to some degree to both the level of assets held by the member institution (typically referred to as a “membership stock purchase requirement”) and the amount of advances or other business engaged in between the member and the Bank (typically referred to as an “activity-based stock purchase requirement”).

A Bank must collect information from its members to determine the minimum capital stock investment each member is required to maintain at any point in time. Although the information needed to calculate a member's required minimum investment and the precise method through which it is collected differ somewhat from Bank to Bank, the Banks typically collect two types of information. First, in order to calculate and monitor compliance with its membership stock purchase requirement, a Bank typically requires each member to provide and/or confirm an annual report on the amount and types of assets held by that institution. Second, each time a Bank engages in a business transaction with a member, the Bank typically confirms with the member the amount of additional Bank capital stock, if any, the member must acquire in order to satisfy the Bank's activity-based stock purchase requirement and the method through which the member will acquire that stock.

The OMB number for the information collection is 2590-0002, which is due to expire on November 30, 2023. The likely respondents include current and former Bank members and institutions applying for Bank membership.

FHFA has analyzed the time burden imposed on respondents by the two collections under this control number and estimates that the average total annual hour burden imposed on all respondents over the next three years will be 20,245 hours. The estimate for each collection was calculated as follows:

FHFA estimates that the average annual number of current and former members and applicants for membership required to report information needed to calculate a membership stock purchase requirement will be 6,550, and that each institution will submit one report per year, resulting in an estimated total of 6,550 submissions annually. The estimate for the average time required to prepare, review, and submit each report is 0.7 hours. Accordingly, the estimate for the annual hour burden associated with membership stock purchase requirement submissions is (6,550 reports × 0.7 hours per report) = 4,585 hours.

FHFA estimates that the average number of daily transactions between Banks and members that will require the exchange of information to confirm the member's activity-based stock purchase requirement will be 300, and that there will be an average of 261 working days per year, resulting in an estimated 78,300 submissions annually. The estimate for the average preparation time per submission is 0.2 hours. Accordingly, the estimate for the annual hour burden associated with activity-based stock purchase requirement submissions is (78,300 submissions × 0.2 hours per submission) = 15,660 hours.

In accordance with the requirements of 5 CFR 1320.8(d), FHFA published an initial notice and request for public comments regarding this information collection in the Federal Register on August 8, 2023. 4 The 60-day comment period closed on October 10, 2023. FHFA received no substantive comments.

FHFA requests written comments on the following: (1) whether the collection of information is necessary for the proper performance of FHFA functions, including whether the information has practical utility; (2) the accuracy of FHFA's estimates of the burdens of the collection of information; (3) ways to enhance the quality, utility, and clarity of the information collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.

The enforcement policy described in this guidance applies to modified devices where the original device was a legally marketed, noninvasive remote monitoring device listed in the guidance that measures or detects common physiological parameters and that is used to support patient monitoring. The guidance is intended to describe the enforcement policy for limited modifications to the indications, functionality, or hardware or software of device types in the scope of the guidance without prior submission of a premarket notification under section 510(k) of the FD&C Act (21 U.S.C. 360(k)) (see 21 CFR 807.81) where such submission would be required. This guidance supersedes “Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency” issued in March 2020 and updated in June 2020, October 2020, and March 2023.

In the Federal Register of March 13, 2023 (88 FR 15417), FDA announced that that guidance was being revised to continue in effect for 180 days after the expiration of the COVID-19 public health emergency (PHE) declaration issued under section 319 of the Public Health Service Act, during which time, FDA intended to further revise the guidance. Consistent with what we said in the Federal Register of March 13, 2023, FDA is therefore issuing this revised final guidance.

Leveraging the perspective gained during the COVID-19 pandemic, FDA is updating the policy reflected in the “Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency” guidance to exercise certain enforcement policies for certain devices beyond the expiration of the COVID-19 PHE (which expired on May 11, 2023) and the 180-day period announced in the March 13, 2023 Federal Register notice, including by removing clinical thermometers and pulse oximeters from the scope of the guidance, revising the policy with respect to certain device types subject to special controls, and removing use of the term “claims.”

This guidance is being implemented without prior public comment because FDA has determined that prior public participation for this guidance is not feasible or appropriate (see section 701(h)(1)(C) of the FD&C Act (21 U.S.C. 371(h)(1)(C)) and §  10.115(g)(2) (21 CFR 10.115(g)(2)). FDA has determined that this guidance document presents a less burdensome policy that is consistent with public health. Although this policy is being implemented immediately without prior comment, it remains subject to comment in accordance with FDA's good guidance practices regulation (§  10.115(g)(3)(i)(D)). FDA will consider all comments received and revise the guidance document as appropriate.

This guidance is being issued consistent with FDA's good guidance practices regulation (§ 10.115). The guidance represents the current thinking of FDA on “Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.

Persons interested in obtaining a copy of the guidance may do so by downloading an electronic copy from the internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also available at https://www.regulations.gov, https://www.fda.gov/regulatory-information/search-fda-guidance-documents. Persons unable to download an electronic copy of “Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring” may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number GUI00007017 and complete title to identify the guidance you are requesting.

While this guidance contains no new collection of information, it does refer to previously approved FDA collections of information. The previously approved collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections of information in the following FDA regulations, guidance, and forms have been approved by OMB as listed in the following table:

The applicants listed in the table have informed FDA that these drug products are no longer marketed and have requested that FDA withdraw approval of the applications under the process described in § 314.150(c) (21 CFR 314.150(c)). The applicants have also, by their requests, waived the opportunity for a hearing. Withdrawal of approval of an application or abbreviated application under § 314.150(c) is without prejudice to refiling.

Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of November 20, 2023. Approval of each entire application is withdrawn, including any strengths and dosage forms inadvertently missing from the table. Introduction or delivery for introduction into interstate commerce of products listed in the table without an approved new drug application or abbreviated new drug application violates sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(a) and 331(d)). Drug products that are listed in the table that are in inventory on November 20, 2023 may continue to be dispensed until the inventories have been depleted or the drug products have reached their expiration dates or otherwise become violative, whichever occurs first.

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

FDA conducts focus groups and in-depth individual interviews on a variety of topics involving FDA-regulated products, including drugs, biologics, devices, food, tobacco products, and veterinary medicine.

Focus groups are an important role in gathering information because they allow for a better understanding of consumers' attitudes, beliefs, motivations, and feelings than do quantitative studies and encourages interaction between participants.

Individual interviews allow for a more comprehensive, in-depth information exchange where more insights are likely to be collected.

Both focus groups and in-depth individual interviews serve the narrowly defined need for direct and informal opinion on a specific topic and, as a qualitative research tool, have three major purposes:

• To obtain consumer information that is useful for developing variables and measures for quantitative studies,

• To better understand consumers' attitudes and emotions in response to topics and concepts, and

• To further explore findings obtained from quantitative studies.

FDA will use findings to test and refine ideas but will generally conduct further research before making important decisions, such as adopting new policies and allocating or redirecting significant resources to support these policies.

Respondents to this collection of information will include members of the general public, healthcare professionals, the industry, and other stakeholders who are related to a product under FDA's jurisdiction. Inclusion and exclusion criteria will vary depending on the research topic.

In the Federal Register of April 11, 2023 (88 FR 21680), FDA published a 60-day notice requesting public comment on the proposed collection of information. Three comments were received, two in support of the information collection, and one that did not address the elements of the PRA.

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

The estimated burden for the information collection reflects an overall increase of 5,600 hours and a corresponding increase of 3,200 responses. We have added individual in-depth interviews as a method of information gathering. In addition, we are consolidating ICR 0910-0677, “Focus Groups About Drug Products as Used by the Food and Drug Administration” into this request for extension.

As part of FDA's commitment to providing timely guidance to support response efforts to the Coronavirus Disease 2019 (COVID-19)  1 pandemic, the Agency published on the FDA website the guidance for industry entitled “Notifying FDA of Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act” in March 2020, and announced its availability in the Federal Register on April 6, 2020 (85 FR 18247), (Notifying FDA Guidance); and in January 2021, the Agency published on the FDA website the guidance for industry entitled “COVID-19: Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting SARS-CoV-2 Infectivity” and announced its availability in the Federal Register February 19, 2021 (86 FR 10285), (Potency Assay Guidance). The Notifying FDA Guidance explained that during the COVID-19 pandemic FDA had been closely monitoring the medical supply chain with the expectation that it may be impacted by the COVID-19 outbreak, potentially leading to supply disruptions or shortages of drug and biological products in the United States. The Notifying FDA Guidance, therefore, communicated the Agency's recommendations for providing timely, informative notifications about changes in the production of certain drugs and biological products to help the Agency in its efforts to prevent or mitigate shortages of such products. The Potency Assay Guidance communicated information to assist sponsors in the development of mAbs and other therapeutic proteins for use as COVID-19 therapeutics and described how potency assay methods required for release and stability testing can be shown to assess known or potential mechanism(s) of action of the product. The guidance also described methods that applicants should use to ensure the potency of mAbs and other therapeutic proteins proposed for use in as anti-infective agents for COVID-19. FDA issued both guidances to communicate its recommendations for the duration of the COVID-19 PHE declared by the Secretary of Health and Human Services (HHS) on January 31, 2020, including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the Public Health Service Act (42 U.S.C. 247d(a)(2)). We also said in both guidances that we expected their recommendations would continue to apply in circumstances outside the context of the PHE and that following the end of the COVID-19 PHE, FDA intended to revise and replace the guidances with updated guidances that incorporated any appropriate changes based on comments received and the Agency's experience with implementation. Furthermore, in the Federal Register of March 13, 2023 (88 FR 15417), FDA listed the COVID-19-related guidance documents that will no longer be in effect with the expiration of the COVID-19 PHE declaration on May 11, 2023, guidances that FDA revised to continue in effect for 180 days after the expiration of the COVID-19 PHE declaration to provide a period for stakeholder transition and then would no longer be in effect, and guidances that FDA revised to continue in effect for 180 days after the expiration of the PHE declaration during which time FDA planned to further revise the guidances. The Notifying FDA Guidance and the Potency Assay Guidance were included in the latter category and were revised to remain in effect for 180 days post expiration of the PHE declaration.

FDA also stated in the Federal Register of March 13, 2023, that the Agency “continues to assess the needs and circumstances related to the policies in our COVID-19-related guidances, and we may alter our approach for individual guidances listed in this notice.” (88 FR 15417 at 15418). Following the expiration of the COVID-19 PHE declaration on May 11, 2023, FDA has reviewed the Notifying FDA Guidance and the Potency Assay Guidance and determined that these two guidances are no longer needed because new draft guidances are available.

In March 2023 (88 FR 13126), the Agency issued the draft guidance document entitled “Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting Viral Pathogens,” which provides information to assist in the development of mAbs and other therapeutic proteins directly targeting viral proteins or host cell proteins mediating pathogenic mechanisms of infection. The draft guidance also provides detailed recommendations for drug developers with the goal of helping to ensure that drug developers provide adequate information to assess potency at each stage of a product's life cycle. FDA believes that many of the recommendations set forth in the 2021 Potency Assay Guidance are applicable outside the context of the COVID-19 PHE and are applicable to mAbs and other therapeutic protein directly targeting any viral surfaces (glycol) proteins mediating pathogenic mechanisms of infection, not just those that directly target SARS-CoV-2. In preparing the draft guidance, FDA considered comments received regarding the 2021 Potency Assay Guidance as well as the Agency's experience with SARS-CoV-2 and other viruses.

In April 2023 (88 FR 20526), the Agency issued the draft guidance for industry entitled “Notification of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act” to assist applicants and manufacturers in providing FDA timely, informative notifications about changes in the production of certain finished drugs and biological products as well as certain active pharmaceutical ingredients (API) that may, in turn, help the Agency in its effort to prevent and mitigate shortages. The draft guidance discusses the notification requirements under section 506C of the Federal Food, Drug and Cosmetic Act (FD&C Act) (21 U.S.C. 356c), including requirements added by the Coronavirus Aid, Relief, and Economic Security Act (CARES Act)  2 related to notifying FDA about finished product and API manufacturing discontinuances and interruptions. The draft guidance provides recommendations for applicants and manufacturers to provide additional details and follow additional procedures to ensure FDA has the specific information it needs to help prevent or mitigate shortages. In addition, the draft guidance explains how FDA communicates information about products in shortage to the public. In preparing the draft guidance, FDA considered comments received on the 2020 Notifying FDA Guidance.

For the reasons discussed above, FDA is announcing the guidance entitled “Notifying FDA of Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act” (March 2020) and the guidance entitled “COVID-19: Potency Assay Consideration for Monoclonal Antibodies and Other Therapeutic Proteins Targeting SARS-CoV-2 Infectivity” (January 2021) will expire on November 7, 2023.

The expiration date for the guidance documents in this document is November 7, 2023.

Information Collection Request Title: Rapid Uptake of Disseminated Interventions (RUDI) Evaluation, OMB No. 0906-xxxx—New.

Abstract: HRSA dedicated significant resources and effort to developing novel intervention strategies aimed at eliminating disparities and improving HIV-related health outcomes for people with HIV. HRSA encourages and supports Ryan White HIV/AIDS Program (RWHAP) providers to implement interventions developed through its RWHAP Part F Special Projects of National Significance program and technical assistance initiatives that have been found to be effective, with adaptations for priority populations served as applicable. HRSA disseminates its RWHAP Part F Special Projects of National Significance and technical assistance initiative resources and products across a variety of dissemination channels, hoping to reach a maximum number of RWHAP recipients and subrecipients for whom these resources may meet an important need. This mixed-methods RUDI evaluation will use a web-based survey and virtual site visits to collect information from RWHAP recipients and subrecipients on the uptake, utility, and efficacy of the resources and products HRSA disseminates; the effectiveness of its dissemination processes; and the reach of its dissemination channels. HRSA will use the information to identify opportunities for strengthening its dissemination channels and resources to improve care and health outcomes for program participants. A 60-day notice was published in the Federal Register on July 12, 2023, Vol. 88, No. 132, pp. 44371-44373 (88 FR 44371). HRSA received no comments.

Need and Proposed Use of the Information: Currently, HRSA does not systematically gather information about the resources accessed by RWHAP providers, RWHAP recipients, or AIDS Education and Training Center (AETC) staff and the extent to which they use those resources to inform implementation of interventions.

The mixed-methods RUDI evaluation will help HRSA systematically assess and understand (1) how, where, and why recipients of RWHAP funding access and use its disseminated resources and products; and (2) the utility and effectiveness of the disseminated resources and products in caring for and treating people with HIV. HRSA will use the findings from the RUDI evaluation to develop strategies to maximize the uptake and impact of its disseminated resources and products, contributing to ending the HIV epidemic in the United States.

Likely Respondents: The mixed-methods RUDI evaluation includes a web-based survey of all RWHAP recipients and subrecipients nationally, individual and small group interviews with a sample of RWHAP recipients, virtual site visits with a sample of RWHAP providers, and individual interviews with all AETCs. The RUDI web-based survey design includes two versions of the survey that will be administered to non-overlapping respondents—the RUDI Recipients Survey for RWHAP Part A and B recipient administrative entities—and the RUDI Providers Survey for Part A and B subrecipients and Part C, D, and F recipients who provide direct care. Both versions ask about respondents' use of HRSA-disseminated resources, how they were helpful, what could be improved, and reasons for non-use where applicable. In addition, the RUDI Recipients Survey asks about the recipients' role in guiding their subrecipients to needed resources, and the RUDI Providers Survey asks about the providers' experience implementing interventions for which they used the resources. Both surveys are designed to be followed up with additional sets of interviews with a sample of the survey respondents to provide deeper understanding of their experience to support development of actionable recommendations pertaining to dissemination. Virtual site visits to RWHAP providers include interviews with an average of three staff within each provider organization that were part of an intervention implementation with assistance from HRSA resources. Individual interviews for Part A and B recipient administrative entities and AETCs will generate a complete picture of how those organizations use HRSA resources and how the resources or their dissemination could be improved for the future, especially when considered together with the survey responses and virtual site visit data from the RWHAP providers.

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.

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 (GPRA), the GPRA 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.

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.

Total Estimated Annualized Burden Hours:

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.

Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects: (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.

Title of the Collections: Project/Performance Site Location(s), Project Abstract, and Key Contacts forms.

Type of Collection: Revision.

OMB No. 4040-0010.

Abstract: The Project/Performance Site Location(s), Project Abstract, and Key Contacts forms provide the Federal grant-making agencies an alternative to the Standard Form 424 data set and form. Agencies may use Project/Performance Site Location(s), Project Abstract, and Key Contacts forms for grant programs not required to collect all the data that is required on the SF-424 core data set and form.

Type of respondent: Project/Performance Site Location(s), Project Abstract, and Key Contacts forms are used by organizations to apply for Federal financial assistance in the form of grants. This form is submitted to the Federal grant-making agencies for evaluation and review. Previously, 26 Federal grant-making entities were using this information collection. This information collection will now be utilized by 51 Federal grant-making agencies and additional grant-making entities. To improve the transparency of reading and enhance user-friendliness of the supporting statement A, language modifications were implemented within sections 3 through 16. For section 14, Cost to the Federal Government was adjusted to the 2023 base general schedule. Grants.gov is requesting a revision of this collection to allow for data reporting and publication by agencies requesting to use the common form. The information collection (IC) expires on November 30, 2025. Grants.gov seeks a three-year clearance of these collections.

The following represents the intellectual property to be licensed under the prospective agreement: U.S. provisional application (63/308,898), filed on February 19, 2022, and the PCT application (PCT/US2023/062324), filed on February 9, 2023, entitled “Human Monoclonal Antibodies that Broadly Target Coronaviruses” (HHS Reference No. E-047-2022). All rights in these inventions have been assigned to the Government of the United States of America.

The prospective exclusive patent commercialization license territory may be worldwide, and the field of use may be limited to: Prevention and treatment of coronavirus infection, illness, and transmission through mucosal delivery to the respiratory tract of products, comprised of COV44-62 (fusion peptide), COV44-79 (fusion peptide), COV89-22 (stem helix), and/or COV72-37 (stem helix), including products that may be obtained from the genetic sequence of the same and derivatives thereof. The prospective exclusive patent commercialization license may include two products (preventative and therapeutic) in the field of use.

An abstract for this invention was published in the Federal Register on June 10, 2022. The family of coronaviruses cause upper respiratory tract disease in humans and have caused three major disease outbreaks in recent history: the 2003 SARS outbreak, the 2012 MERS outbreak, and the current SARS-CoV-2 pandemic. There is an urgent need for strategies that broadly target coronaviruses, both to deal with new SARS-CoV-2 variants and future coronavirus outbreaks.

Scientists at NIAID have developed several novel human monoclonal antibodies that bind to conserved parts of the SARS-CoV-2 spike protein. These antibodies can neutralize SARS- CoV-2 variants of concern including Omicron BA.1 and BA.2, as well as neutralize at least one other betacoronavirus. Further, these antibodies limit disease in animal models. Broadly reactive antibodies against coronaviruses are useful tools to identify conserved sites on the coronavirus spike protein, which could be investigated for the development of broad coronavirus vaccines that aim to prevent future pandemics. Potent neutralizers that target these sites could also be useful for prevention of disease caused by diverse coronaviruses, including those that may emerge in the future.

This notice is made in accordance with 35 U.S.C. 209 and 37 CFR part 404. The prospective exclusive patent commercialization license will be royalty bearing, and may be granted unless within fifteen (15) days from the date of this published notice, the National Institute of Allergy and Infectious Diseases 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.

Complete applications for a license in the prospective field of use that are timely filed in response to this notice will be treated as objections to the grant of the contemplated exclusive patent commercialization license. Comments and objections submitted in response to this notice will not be made available for public inspection and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 522.

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) Presentation and discussion of final recommendations to Task T-2022-5: Working

Group on Cybersecurity Information Sharing.

(7) Public Comment Period.

(8) Adjournment of Meeting.

A copy of all meeting documentation will be available at https://homeport.uscg.mil/NMSAC no later than December 4, 2023. Alternatively, you may contact Mr. Ryan Owens as noted in the FOR FURTHER INFORMATION section above.

There will be a public comment period at the end of meeting. 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.

FEMA proposes to make flood hazard determinations for each community listed below, in accordance with section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR 67.4(a).

These proposed flood hazard determinations, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own or pursuant to policies established by other Federal, State, or regional entities. These flood hazard determinations are used to meet the floodplain management requirements of the NFIP.

The communities affected by the flood hazard determinations are provided in the tables below. Any request for reconsideration of the revised flood hazard information shown on the Preliminary FIRM and FIS report that satisfies the data requirements outlined in 44 CFR 67.6(b) is considered an appeal. Comments unrelated to the flood hazard determinations also will be considered before the FIRM and FIS report become effective.

Use of a Scientific Resolution Panel (SRP) is available to communities in support of the appeal resolution process. SRPs are independent panels of experts in hydrology, hydraulics, and other pertinent sciences established to review conflicting scientific and technical data and provide recommendations for resolution. Use of the SRP only may be exercised after FEMA and local communities have been engaged in a collaborative consultation process for at least 60 days without a mutually acceptable resolution of an appeal. Additional information regarding the SRP process can be found online at https://www.floodsrp.org/pdfs/srp_overview.pdf.

The watersheds and/or communities affected are listed in the tables below. The Preliminary FIRM, and where applicable, FIS report for each community are available for inspection at both the online location https://hazards.fema.gov/femaportal/ prelimdownload and the respective Community Map Repository address listed in the tables. For communities with multiple ongoing Preliminary studies, the studies can be identified by the unique project number and Preliminary FIRM date listed in the tables. Additionally, the current effective FIRM and FIS report for each community are accessible online through the FEMA Map Service Center at https://msc.fema.gov for comparison.

The Federal Emergency Management Agency (FEMA) makes the final determinations listed below for the new or modified flood hazard information for each community listed. Notification of these changes has been published in newspapers of local circulation and 90 days have elapsed since that publication. The Deputy Associate Administrator for Insurance and Mitigation has resolved any appeals resulting from this notification.

This final notice is issued in accordance with section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR part 67. FEMA has developed criteria for floodplain management in floodprone areas in accordance with 44 CFR part 60.

Interested lessees and owners of real property are encouraged to review the new or revised FIRM and FIS report available at the address cited below for each community or online through the FEMA Map Service Center at https://msc.fema.gov.

The flood hazard determinations are made final in the watersheds and/or communities listed in the table below.