A proposed update to the existing form is available for public comment before M/OAA/PSC will decide to publish the revised form. The authorities for the collection of information are: Foreign Assistance Act, Public Law 87-165, as amended; 48 CFR 37.104, Personal services contracts; and 48 CFR ch. 7, app. D, Direct USAID Contracts with a U.S. Citizen or a U.S. Resident Alien for Personal Services Abroad; and 48 CFR ch. 7, App. J, Direct USAID Contracts with a Cooperating Country National and with a Third Country National for Personal Services Abroad.

Title: Walnuts Grown in California, Marketing Order No. 984.

OMB Number: 0581-NEW.

Expiration Date of Approval: This is a NEW Collection.

Type of Request: Approval of New Information Collection.

Abstract: The Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act,” authorizes the Secretary of Agriculture to issue marketing orders that regulate the handling of any agricultural commodity specified in the Act, and to consider recommendations submitted by the administrative committees that manage the operations of such marketing orders. The individuals serving on an administrative committee are nominated by each commodity industry, are familiar with the handling of such commodity in their local area and are thus in a position to make recommendations to the Secretary.

The information requirements in this notice are essential to administer the Federal marketing order for walnuts grown in California, as amended, (7 CFR part 984), hereinafter referred to as the “Order”. The Order authorizes quality regulations, research and promotion, and provides for the establishment of the Board, which locally administers the Order.

On October 28, 2021, the Board recommended multiple proposed amendments to the Secretary, including the elimination of mandatory inspection and certification of walnuts and the creation of a new mechanism for determining and collecting handler assessments. After reviewing the proposals and other information submitted by the Board, USDA concluded the Board's proposals will tend to effectuate the declared policy of the Act and conducted a public hearing on April 19-20, 2022. During the hearing, USDA proposed that § 984.67 be amended to include exemptions that were inadvertently omitted in a previous revision. On August 21, 2023, the Final Rule published in the Federal Register [88 FR 56745], with an effective date September 20, 2023.

Under the Order handler assessment obligations are incurred at the time of certification, and provisions under § 984.67 exempt certain walnut sales from assessments and quality regulations. Therefore, walnuts considered exempt are not inspected, certified, and assessed. Under the new mechanism of determining and collecting assessments, handler assessments would be based on walnuts received rather than walnuts certified. Accordingly, effective September 20, 2023, walnut receipts for deliveries that previously would have been exempt, as those walnuts would not be inspected and certified, may now be subject to assessment. To ensure that those walnuts continue to be exempt from assessment and/or that handlers can receive a refund against their current year assessments for walnut deliveries exempt under § 984.67, the Board recommended the establishment of the new information collection form described below. The form designated as OMB No. 0581-NEW is voluntary and is titled (CWB Form No. 2) Report of Walnuts Exempt from Assessments. Depending on when handlers submit the form, submission would either ensure that walnuts that are exempt from assessment are not assessed or if they are assessed, handlers would be able to receive a refund. Once approved by OMB, USDA will request permission to merge the form into OMB No. 0581-0178 Vegetable and Specialty Crops collection that includes other forms related to the Order.

Estimate of Burden: Public reporting burden for this collection of information is estimated to average 5 minutes per response.

Respondents: Walnut handlers.

Estimated Number of Respondents: 14.

Estimated Number of Responses: 14.

Estimated Number of Responses per Respondent: 1.

Estimated Total Annual Burden on Respondents: 1.16 hours.

Comments are invited on: (1) Whether the proposed collection of the information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of the burden of the proposed collection of information; (3) ways to enhance the quality, utility and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record.

Authority: 44 U.S.C. Chapter 35.

This Committee meeting is available to the public through the registration link above. Any interested member of the public may attend this meeting. An open comment period will be provided to allow members of the public to make oral statements as time allows. Pursuant to the Federal Advisory Committee Act, public minutes of the meeting will include a list of persons who are present at the meeting. If joining via phone, callers can expect to incur regular charges for calls they initiate over wireless lines, according to their wireless plan. The Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Closed captioning is available by selecting “CC” in the meeting platform. To request additional accommodations, please email svillanueva@usccr.gov at least 10 business days prior to the meeting.

Members of the public are entitled to submit written comments; the comments must be received in the regional office within 30 days following the scheduled meeting. Written comments may be emailed to Ivy Davis at ero@usccr.gov. Persons who desire additional information may contact the Regional Programs Coordination Unit at 1-202-809-9618.

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

This committee meeting is available to the public through the registration link above. Any interested member of the public may listen to the meeting. An open comment period will be provided to allow members of the public to make a statement as time allows. Per the Federal Advisory Committee Act, public minutes of the meeting will include a list of persons who are present at the meeting. If joining via phone, callers can expect to incur regular charges for calls they initiate over wireless lines, according to their wireless plan. The Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Closed captioning will be available for individuals who are deaf, hard of hearing, or who have certain cognitive or learning impairments. To request additional accommodations, please email lschiller@usccr.gov at least 10 business days prior to the meeting.

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

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

Exceptional Circumstance: Pursuant to 41 CFR 102-3.150, the notice for this meeting is given less than 15 calendar days prior to the meeting due to the availability of staff and the Committee.

On May 4, 2023, Commerce published the Preliminary Results of this administrative review and invited parties to comment on the Preliminary Results. 1 This administrative review covers 114 companies. 2 Commerce selected Kanika Exports (Kanika) and R K Fasteners (India) (RKF) as the two respondents for individual examination. 3 On August 17, 2023, Commerce extended the deadline for the final results of this review until October 31, 2023. 4 For a complete description of the events that followed the Preliminary Results, see the Issues and Decision Memorandum. 5

Commerce conducted this administrative review in accordance with section 751(a) of the Tariff Act of 1930, as amended (the Act).

The merchandise covered by the scope of this Order is carbon and alloy steel threaded rod from India. A complete description of the scope of the Order is provided in the Issues and Decision Memorandum. 7

All issues raised in the case and rebuttal briefs that were submitted by interested parties in this review are addressed in the Issues and Decision Memorandum. A list of the issues is attached to this notice at Appendix I. The Issues and Decision Memorandum is a public document and is made available to the public 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 is available at https://access.trade.gov/public/FRNoticesListLayout.aspx.

Based on our analysis of the comments received, we made certain changes to the margin calculations for Kanika in these final results. We did not make any change to RKF's margin calculations. For a discussion of these changes, see the “Discussion of the Issues” section of the Issues and Decision Memorandum.

The Act and Commerce's regulations do not address the establishment of a rate to be applied to companies not selected for examination when Commerce limits its examination in an administrative review pursuant to section 777A(c)(2) of the Act. Generally, Commerce looks to section 735(c)(5) of the Act, which provides instructions for calculating the all-others rate in a market economy investigation, for guidance when calculating the rate for companies which were not selected for individual examination in an administrative review. Under section 735(c)(5)(A) of the Act, the all-others rate is normally “an amount equal to the weighted average of the estimated weighted-average dumping margins established for exporters and producers individually investigated, excluding any zero and de minimis margins, and any margins determined entirely {on the basis of facts available}.”

Where the dumping margin for individually examined respondents are all zero, de minimis, or based entirely on facts available, section 735(c)(5)(B) of the Act provides that Commerce may use “any reasonable method to establish the estimated all-others rate for exporters and producers not individually investigated, including averaging the estimated weighted average dumping margins determined for the exporters and producers individually investigated.”

In this review, we have calculated a weighted-average dumping margins of 2.37 percent for RKF and zero percent for Kanika. Therefore, in accordance with section 735(c)(5)(A) of the Act, we are applying RKF's weighted average dumping margin of 2.37 percent to the non-examined companies ( see Appendix II for a full list of these companies), because this is the only rate that is not zero, de minimis, or based entirely on facts available.

Commerce determines that the following estimated weighted-average dumping margins exist during the period April 1, 2021, through March 31, 2022:

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

Pursuant to section 751(a)(2)(C) of the Act and 19 CFR 351.212(b)(1), Commerce shall determine, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries of subject merchandise in accordance with the final results this review. 9

For RKF, we calculated importer-specific assessment rates based on the ratio of the total amount of dumping calculated for the importer's examined sales to the total entered value of those same sales in accordance with 19 CFR 351.212(b)(1). Where an importer-specific assessment rate is either zero or de minimis ( i.e., less than 0.5 percent), the entries by that importer will be liquidated without regard to antidumping duties. Because the weighted-average dumping margin for Kanika has been determined to be zero percent, we intend to instruct CBP to liquidate Kanika's entries without regard to antidumping duties in accordance with 19 CFR 351.106(c)(2).

In accordance with Commerce's “automatic assessment” practice, for entries of subject merchandise during the POR produced by Kanika or RKF for which these companies did not know that the merchandise was destined for the United States, we will instruct CBP to liquidate those entries at the all-others rate established in the original less-than-fair-value (LTFV) investigation of 0.00 percent, 10 if there is no rate for the intermediate company(ies) involved in the transaction. 11

For the companies that were not selected for individual examination, we will instruct CBP to liquidate entries at the rate established in these final results of review.

We intend to issue instructions to CBP no earlier than 35 days after the publication date of the final results of this review in the Federal Register . If a timely summons is filed at the U.S. Court of International Trade, the assessment instructions will direct CBP not to liquidate relevant entries until the time for parties to file a request for a statutory injunction has expired ( i.e., within 90 days of publication).

The following cash deposit requirements will be effective for all shipments of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the publication date of these final results of review in the Federal Register , as provided by section 751(a)(2)(C) of the Act: (1) the cash deposit rate for the companies listed in these final results will be equal to the weighted-average dumping margin established in the final results of this administrative review; (2) for merchandise exported by producers or exporters not covered in this review but covered in a prior segment of the proceeding, the cash deposit rate will continue to be the company-specific rate published for the most recently-completed segment of this proceeding in which they were reviewed; (3) if the exporter is not a firm covered in this review, a prior review, or the original investigation but the producer is, then the cash deposit rate will be the rate established for the most recently completed segment of this proceeding for the producer of the merchandise; (4) the cash deposit rate for all other producers or exporters will continue to be 0.00 percent, the all-others rate established in the LTFV investigation, adjusted for the export-subsidy rate in the companion countervailing duty investigation. 12 These cash deposit requirements, when imposed, shall remain in effect until further notice.

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

This notice also serves as a reminder to parties subject to administrative protective order (APO) of their responsibility concerning the disposition of proprietary information disclosed under the APO in accordance with 19 CFR 351.305(a)(3), which continues to govern business proprietary information in this segment of the proceeding. Timely written notification of the return or destruction of APO materials, or conversion to judicial protective order, is hereby requested. Failure to comply with the regulations and the terms of an APO is a sanctionable violation.

This notice is being issued and published in accordance with sections 751(a)(1) and 777(i)(1) of the Act, and 19 CFR 351.213(h) and 351.221(b)(5).

On May 4, 2023, Commerce published the Preliminary Results of this administrative review in the Federal Register . 1 For a complete description of the events that occurred since the Preliminary Results, see the Issues and Decision Memorandum. 2

The product covered by the scope of the Order is aluminum foil from China. A full description of the scope of the Order is contained in the Issues and Decision Memorandum.

All issues raised by the interested parties in their case and rebuttal briefs are addressed in the Issues and Decision Memorandum. A list of topics discussed in the Issues and Decision Memorandum is provided in the 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 https://access.trade.gov. In addition, a complete version of the Issues and Decision Memorandum can be accessed directly at https://access.trade.gov/public/FRNoticesListLayout.aspx.

Based on our analysis of comments from interested parties and the evidence on the record, we revised the calculation of the net countervailable subsidy rates for Jiangsu Zhongji Lamination Materials Co., Ltd. (f/k/a Jiangsu Zhongji Lamination Materials Stock Co., Ltd.) (Zhongji). For a discussion of these changes, see the Issues and Decision Memorandum.

Commerce conducted this administrative review in accordance with section 751(a)(1)(A) of the Tariff Act of 1930, as amended (the Act). For each of the subsidy programs found to be countervailable, we find that there is a subsidy, i.e., a government-provided financial contribution that gives rise to a benefit to the recipient, and that the subsidy is specific. 4 For a complete description of the methodology underlying all of Commerce's conclusions, including our reliance, in part, on facts otherwise available, including adverse facts available, pursuant to sections 776(a) and (b) of the Act, see the Issues and Decision Memorandum.

The statute and Commerce's regulations do not address the establishment of a rate to be applied to companies not selected for individual examination when Commerce limits its examination in an administrative review pursuant to section 777A(e)(2) of the Act. However, Commerce normally determines the rates for non-selected companies in reviews in a manner that is consistent with section 705(c)(5) of the Act, which provides the basis for calculating the all-others rate in an investigation. Section 705(c)(5)(A)(i) of the Act instructs Commerce, as a general rule, to calculate the all-others rate equal to the weighted average of the countervailable subsidy rates established for exporters and producers individually investigated, excluding any zero or de minimis countervailable subsidy rates, and any rates determined entirely on the basis of facts available.

There are 10 companies for which a review was requested and not rescinded, and which were not selected as mandatory respondents or found to be cross-owned with Zhongji, the mandatory respondent. For these non-selected companies, because the rate calculated for the only participating mandatory respondent in this review, Zhongji, was above de minimis and not based entirely on facts available, we are applying Zhongji's subsidy rate to the 10 non-selected companies.

This is the same methodology Commerce applied in the Preliminary Results for determining a rate for companies not selected for individual examination. However, due to changes in the calculation for Zhongji, we revised the non-selected rate accordingly. Consequently, for the 10 non-selected companies for which a review was requested and not rescinded, we are applying an ad valorem subsidy rate of 25.32 percent. 5

We determine the following net countervailable subsidy rates exist for the period January 1, 2021, through December 31, 2021:

Each year during the anniversary month of the publication of an antidumping or countervailing duty order, finding, or suspended investigation, an interested party, as defined in section 771(9) of the Tariff Act of 1930, as amended (the Act), may request, in accordance with 19 CFR 351.213, that the U.S. Department of Commerce (Commerce) conduct an administrative review of that antidumping or countervailing duty order, finding, or suspended investigation.

All deadlines for the submission of comments or actions by Commerce discussed below refer to the number of calendar days from the applicable starting date.

In the event Commerce limits the number of respondents for individual examination for administrative reviews initiated pursuant to requests made for the orders identified below, Commerce intends to select respondents based on U.S. Customs and Border Protection (CBP) data for U.S. imports during the period of review. We intend to release the CBP data under administrative protective order (APO) to all parties having an APO within five days of publication of the initiation notice and to make our decision regarding respondent selection within 35 days of publication of the initiation Federal Register notice. Therefore, we encourage all parties interested in commenting on respondent selection to submit their APO applications on the date of publication of the initiation notice, or as soon thereafter as possible. Commerce invites comments regarding the CBP data and respondent selection within five days of placement of the CBP data on the record of the review.

In the event Commerce decides it is necessary to limit individual examination of respondents and conduct respondent selection under section 777A(c)(2) of the Act:

In general, Commerce finds that determinations concerning whether particular companies should be “collapsed” ( i.e., treated as a single entity for purposes of calculating antidumping duty rates) require a substantial amount of detailed information and analysis, which often require follow-up questions and analysis. Accordingly, Commerce will not conduct collapsing analyses at the respondent selection phase of a review and will not collapse companies at the respondent selection phase unless there has been a determination to collapse certain companies in a previous segment of this antidumping proceeding ( i.e., investigation, administrative review, new shipper review or changed circumstances review). For any company subject to a review, if Commerce determined, or continued to treat, that company as collapsed with others, Commerce will assume that such companies continue to operate in the same manner and will collapse them for respondent selection purposes. Otherwise, Commerce will not collapse companies for purposes of respondent selection. Parties are requested to: (a) identify which companies subject to review previously were collapsed; and (b) provide a citation to the proceeding in which they were collapsed. Further, if companies are requested to complete a quantity and value questionnaire for purposes of respondent selection, in general each company must report volume and value data separately for itself. Parties should not include data for any other party, even if they believe they should be treated as a single entity with that other party. If a company was collapsed with another company or companies in the most recently completed segment of a proceeding where Commerce considered collapsing that entity, complete quantity and value data for that collapsed entity must be submitted.

Pursuant to 19 CFR 351.213(d)(1), a party that requests a review may withdraw that request within 90 days of the date of publication of the notice of initiation of the requested review. The regulation provides that Commerce may extend this time if it is reasonable to do so. Determinations by Commerce to extend the 90-day deadline will be made on a case-by-case basis.

Section 504 of the Trade Preferences Extension Act of 2015 amended the Act by adding the concept of particular market situation (PMS) for purposes of constructed value under section 773(e) of the Act. 1 Section 773(e) of the Act states that “if a particular market situation exists such that the cost of materials and fabrication or other processing of any kind does not accurately reflect the cost of production in the ordinary course of trade, the administering authority may use another calculation methodology under this subtitle or any other calculation methodology.” When an interested party submits a PMS allegation pursuant to section 773(e) of the Act, Commerce will respond to such a submission consistent with 19 CFR 351.301(c)(2)(v). If Commerce finds that a PMS exists under section 773(e) of the Act, then it will modify its dumping calculations appropriately.

Neither section 773(e) of the Act nor 19 CFR 351.301(c)(2)(v) set a deadline for the submission of PMS allegations and supporting factual information. However, in order to administer section 773(e) of the Act, Commerce must receive PMS allegations and supporting factual information with enough time to consider the submission. Thus, should an interested party wish to submit a PMS allegation and supporting new factual information pursuant to section 773(e) of the Act, it must do so no later than 20 days after submission of initial section D questionnaire responses.

Opportunity to Request a Review: Not later than the last day of November 2023, 2 interested parties may request administrative review of the following orders, findings, or suspended investigations, with anniversary dates in November for the following periods:

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

Topics to be considered: The agenda for the Thursday, November 16, 2023, CINTAC meeting will include discussions of CINTAC priorities for its 2022-2024 charter term and activities related to the U.S. Department of Commerce's Civil Nuclear Trade Initiative.

Members of the public wishing to attend the meeting must notify Mr. Jonathan Chesebro at the contact information above by 5:00 p.m. EST on Monday, November 13, 2023, in order to pre-register. Please specify any requests for reasonable accommodation at least five business days in advance of the meeting.

A limited amount of time will be available for brief oral comments from members of the public attending the meeting. To accommodate as many speakers as possible, the time for public comments will be limited to two (2) minutes per person, with a total public comment period of 20 minutes. Individuals wishing to reserve speaking time during the meeting must contact Mr. Jonathan Chesebro and submit a brief statement of the general nature of the comments and the name and address of the proposed participant by 5:00 p.m. EST on Monday, November 13, 2023. If the number of registrants requesting to make statements is greater than can be reasonably accommodated during the meeting, ITA may conduct a lottery to determine the speakers.

Any member of the public may submit written comments concerning the CINTAC's affairs at any time before and after the meeting. Comments may be submitted to Mr. Jonathan Chesebro in the International Trade Administration's Office of Energy & Environmental Industries. For consideration during the meeting, and to ensure transmission to the Committee prior to the meeting, comments must be received no later than 5:00 p.m. EST on Monday, November 13, 2023. Comments received after that date will be distributed to the members but may not be considered at the meeting.

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

Background: NIST supports the United States in developing standards around emerging technologies, including artificial intelligence and related systems. The NIST AI Risk Management Framework (AI RMF) provides a foundational set of approaches for holistically assessing risk for the use of AI systems. However, in deploying this framework, specific improvements in our ability to evaluate and validate AI systems are necessary, as detailed in the AI RMF roadmap, available at https://www.nist.gov/itl/ai-risk-management-framework/roadmap-nist-artificial-intelligence-risk-management-framework-ai. In addition, The Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence Executive Order articulated a broad set of priorities relevant to and directive of NIST's work related to AI safety and trust. NIST seeks to leverage the additional resources and capabilities made available through this consortium to meet the requirements of the Executive Order and fulfill those priorities in the future.

Process: NIST is soliciting responses from all sources of relevant technical capabilities (see below) to enter into a consortium Cooperative Research and Development Agreement (CRADA) to provide technical expertise and products, data, and/or models to enable safe and trustworthy artificial intelligence (AI) systems. The Consortium will help enable the identification of proven, scalable, and interoperable techniques and metrics to promote development of trustworthy AI and its responsible use. The full project can be viewed at: https://www.nist.gov/artificial-intelligence/artificial-intelligence-safety-institute. The project is in support of the AI RMF roadmap https://www.nist.gov/itl/ai-risk-management-framework/roadmap-nist-artificial-intelligence-risk-management-framework-ai and The Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence Executive Order.

Interested parties can submit a letter of interest by visiting the project website at https://www.nist.gov/artificial-intelligence/artificial-intelligence-safety-institute and completing the letter of interest webform; alternatively, parties can answer the questions detailed in LETTER OF INTEREST, below, and send via email or hardcopy (for reference, see ADDRESSES section above). NIST will contact interested parties if there are questions regarding the responsiveness of the letters of interest to the project objective or requirements identified below. NIST will select participants who have submitted complete letters of interest on a first come, first served basis. There may be continuing opportunity to participate even after initial activity commences for participants who were not selected initially or have submitted the letter of interest after the selection process. Selected participants will be required to enter into a consortium CRADA with NIST. At NIST's discretion, entities which are not permitted to enter into CRADAs pursuant to law may be allowed to participate in the Consortium pursuant to separate non-CRADA agreement.

Project Objective: Artificial Intelligence (AI) tools and applications are growing at an unprecedented pace, changing our way of life, and having significant impacts on society and all sectors of the economy. Yet, the potential technical and societal benefits and risks of AI require much closer examination and a more complete understanding. Aligning AI with our societal norms and values and keeping the public safe requires a broad human-centered focus, specific policies, processes, and guardrails informed by community stakeholders across various levels of our society, and bold commitment from the public sector.

To manage the broad risks of AI technologies, help to protect the public and our planet, reduce market uncertainties, and encourage even more extraordinary AI technological innovations, the National Institute of Standards and Technology (NIST) is expanding its AI measurement efforts by harnessing the broader community's interests and capabilities. NIST aims to help enable the identification of proven, scalable, and interoperable measurements and methodologies to promote development of trustworthy AI and its responsible use. This is a critical challenge at a pivotal time—not only for AI technologists but for society.

Building upon its long track record of working with the private and public sectors and its history of reliable and practical measurement and standards-oriented solutions, NIST seeks research collaborators who can support this vital undertaking. Specifically, NIST looks to

• Create a convening space for collaborators to have an informed dialogue and enable sharing of information and knowledge

• Engage in collaborative research and development through shared projects

• Enable assessment and evaluation of test systems and prototypes to inform future AI measurement efforts

To create a lasting approach for continued joint research and development, NIST will engage stakeholders via this consortium. The work of the consortium will be open and transparent and provide a hub for interested parties to work together in building and maturing a measurement science for Trustworthy and Responsible AI. Consortium members will be expected to contribute:

• Technical expertise in one or more of the following areas

This project is in service of the priorities and taskings defined in The Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence Executive Order. Additionally, some of the outcomes of this project will be in support of research and development to advance the AI RMF roadmap ( https://www.nist.gov/itl/ai-risk-management-framework/roadmap-nist-artificial-intelligence-risk-management-framework-ai ). The consortium will be responsible for an array of efforts related to safe and trustworthy AI, including to:

1. Develop new guidelines, tools, methods, protocols and best practices to facilitate the evolution of industry standards for developing or deploying AI in safe, secure, and trustworthy ways

2. Develop guidance and benchmarks for identifying and evaluating AI capabilities, with a focus on capabilities that could potentially cause harm

3. Develop approaches to incorporate secure-development practices for generative AI, including special considerations for dual-use foundation models, including

a. guidance related to assessing and managing the safety, security, and trustworthiness of models and related to privacy-preserving machine learning;

b. guidance to ensure the availability of testing environments

4. Develop and ensure the availability of testing environments

5. Develop guidance, methods, skills and practices for successful red-teaming and privacy-preserving machine learning

6. Develop guidance and tools for authenticating digital content

7. Develop guidance and criteria for AI workforce skills, including risk identification and management, test, evaluation, validation, and verification (TEVV), and domain-specific expertise

8. Explore the complexities at the intersection of society and technology, including the science of how humans make sense of and engage with AI in different contexts

9. Develop guidance for understanding and managing the interdependencies between and among AI actors along the lifecycle

Requirements for Letters of Interest:

Each responding organization's letter of interest should include the address, point of contact, and following information:

1. The role(s) the organization will play in the consortium efforts.

2. The specific expertise will they intend to bring to the consortium.

3. The products, services, data, or other technical capabilities will they use in consortium activities.

Letters of interest should not include proprietary information. NIST will not treat any information provided in response to this notice as proprietary information.

NIST cannot guarantee that all submissions will be utilized, or the products proposed by respondents will be used in consortium activities. Each prospective participant will be expected to work collaboratively with NIST staff and other project participants under the terms of the consortium CRADA.

In 2009, Congress passed the Credit Card Accountability Responsibility and Disclosure Act of 2009 (CARD Act or Act). 1 The Act made substantial changes to the credit card market. The CARD Act mandated new disclosures and underwriting standards, curbed certain fees, and restricted interest rate increases on existing balances. Among the CARD Act's many provisions was a requirement that the Board of Governors of the Federal Reserve System (Board) report every two years on the state of the consumer credit card market. With the passage of the Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act) in 2010, that requirement transferred to the CFPB alongside broader responsibility for administering most of the CARD Act's provisions. This is the sixth report published pursuant to that obligation, building on prior reports published by the CFPB in 2013, 2015, 2017, 2019, and 2021. 2

In addition to being delivered to Congress, the full report is available to the public on the CFPB's website at https://files.consumerfinance.gov/f/documents/cfpb_consumer-credit-card-market-report_2023.pdf.

The full 2023 report reviews the state of the consumer credit card market as of the end of 2022. In addition to mandating the CFPB's biennial review and report on the market, the Act also requires the CFPB to “solicit comment from consumers, credit card issuers, and other interested parties” in connection with its review. 3 As in past years, the CFPB has done so through a Request for Information (RFI) published in the Federal Register , and the CFPB discusses specific evidence or arguments provided by commenters throughout the report. 4

This study represents the CFPB's sixth biennial report on the state of the consumer credit card market and continues the approach of the CFPB's previous reports. The CFPB revisits similar baseline indicators to track key market developments and consumer risks as well as the adequacy of consumer protections. Throughout this report, we continue to examine trends by card type and credit score tier, but further segment consumers with the highest scores into two new groups, prime plus (720 to 799) and superprime (800 and above). In a new section, this report examines the market dynamics, concentration, and profitability of the credit card industry in detail, complementing other regulators' examination of the safety and soundness of card issuers. We explore new topics that have become more important as the market continues to evolve. For example, the current report explores the prevalence and cost of installment plan features and the dollar value of credit card rewards. Additionally, we discuss issuer practices related to dispute resolution, minimum payments, and servicemember rate reductions.

• Use of credit: Credit card debt at the end of 2022 surpassed $1 trillion for the first time in our data, but total outstandings remain below pre-pandemic levels when adjusted for inflation. Spending grew to new highs of $846 billion in the fourth quarter of 2022. At the same time, total payments rose, and cardholders paid significantly more of their monthly balances with a greater share of accounts entirely paid off each month. Delinquency and charge-off rates in 2022 were at lower levels than 2019 but increasing, presumably rising with the expiration of COVID-19 related financial relief.

• Overall market size and structure: Nearly 4,000 issuers, together with dozens of co-brand merchant partners and four major networks, provide cards to over 190 million consumers. The top ten credit card issuers still represent over four-fifths of consumer credit card loans, but the next 20 biggest issuers' market share has grown since 2016.

• Competition and profitability: For companies involved in credit card issuance, servicing, and debt collection, the industry remains profitable. Issuers' profitability fell in 2020 but spiked in 2021 and remained at or above 2019-levels in 2022 with an average return on assets of six percent for general purpose cards and two percent on private label portfolios. Point-of-sale; Buy Now, Pay Later (BNPL); and fintech personal loans as well as “pay-by-bank” options increasingly compete with traditional credit cards for purchase volume and balances.

• Cost of credit: By some measures, credit cards have never been this expensive, as issuers charged more than $130 billion in interest and fees in 2022 alone. By the end of 2022, interest and fees as an annualized percentage of balances, or the total cost of credit, was almost 18 percent on general purpose cards and over 21 percent on private label accounts. Many cardholders with subprime scores are now paying 30 to 40 cents in interest and fees per dollar borrowed each year. Federal Reserve rate increases triggered upward repricing on most general purpose cards, and issuers continue to price well above the prime rate, with an average annual percentage rate (APR) margin of 15.4 percentage points. Fee volume now exceeds pre-pandemic levels. Annual fees grew in 2021 and 2022, while late fees returned to 2019 levels at $14.5 billion as did the cardholder cost of balance transfers and cash advances.

• Rewards: The dollar value of rewards earned by general purpose cardholders exceeded $40 billion for mass market issuers in 2022. Transacting accounts, or those where the cardholder pays the full statement balance each month, are increasingly benefitting from credit card use. But, when a consumer revolves a balance on their credit card, the cost of interest and fees almost always exceeds the value of rewards the consumer may have earned. Cardholders' rewards redemptions have increased, but consumers still forfeit hundreds of millions of dollars in rewards value each year.

• New features and products: Installment plan features which permit cardholders to convert a credit card purchase to a lower-cost, fixed-rate loan comprise a small but growing segment of the market designed to compete with BNPL. These issuer plans often offer lower finance charges than on revolving debt, but consumers may struggle to make higher monthly payments. “Credit card-as-a-service” platforms from fintechs to traditional banks have streamlined co-brand partnerships to improve user experience and offer novel rewards with smaller retailers. Some issuers are now approving consumers with only soft inquires on consumers' credit reports; others are underwriting consumers without credit scores using new datasets and modeling techniques outside the traditional credit reporting system. Issuers are providing cardholders with more flexible repayment terms and new payment options, including through a growing number of digital wallets.

• Persistent debt: With the average minimum payment due increasing to over $100 on revolving general purpose accounts in 2022, more users are incurring late fees and facing higher costs on growing debt. We find one in ten general purpose accounts are charged more in interest and fees than they pay toward the principal each year, indicating a pattern of persistent indebtedness that could become increasingly difficult for some consumers to escape. Public relief programs in 2020 and 2021 enabled some consumers to pay down credit card balances, but the number of cardholders facing persistent debt has begun to climb.

• Availability of credit: Most measures of credit card availability grew in 2021 and 2022 after a sharp decrease in access during 2020. Application volume for general purpose credit cards reached a new peak in 2022, as issuers increased acquisition efforts and consumer demand grew. For retail cards, in contrast, application volume fell from 2020 to 2022. Approval rates more than rebounded for all card types. The recent upticks in marketing, applications, and approvals led to significant growth in credit card originations in 2021 with even more activity in 2022. Consumers with below-prime scores opened more than 80 million new credit card accounts in 2021 and 2022 combined compared to 63 million over the two year period from 2019 through 2020. Total credit line across all consumer credit cards increased to over $5 trillion in 2022 but remained below 2017 levels in real terms. After declining in 2020, issuers initiated credit line increases more frequently in 2021 and 2022 than they did prior to the pandemic but decreased lines or closed accounts at rates similar to those seen over the past decade.

• Disputes: Credit card disputes spiked with pandemic-related cancellations and supply chain issues in mid-2020, declined in 2021, but then rose in 2022 as spending grew. Disputed transaction volume for mass market issuers was up 50 percent from 2019 levels to almost $10 billion in 2022, and chargebacks increased more than 80 percent from $3.2 billion to $5.9 billion.

• Account servicing: Cardholders increasingly use and service their cards through digital portals, including those accessed via mobile devices. Three in four general purpose accountholders are now enrolled in issuers' mobile apps, and adoption is increasing, notably for those under 65. The use of automatic payments has likewise continued to climb. New artificial intelligence (AI)/machine learning (ML) technologies are changing how providers service accounts, but concerns regarding the use and sharing of consumer data remain significant, particularly among older cardholders.

• Debt collection: Compared to prior surveys, the use of email in collections continued to increase in 2022, with consumers opening about one-third of messages. Issuers seemed to leverage the text messaging (or SMS) channel significantly more in 2022 than in prior years with a relatively low opt-out rate at 1.3 percent. New enrollments in loss mitigation programs and total inventory in those programs declined. Post-charge-off settlements fell significantly from their previous peaks during the pandemic. All issuers who sold debt reported deleting the charged-off tradelines from credit reports upon sale, potentially resulting in an incomplete view of consumers' debt burden, likelihood of default, and history in the credit reporting system.

Throughout this report, we highlight potential areas of concern in the consumer credit card market. Given rising balances and credit costs, more cardholders may struggle to pay their credit card bill on time, especially with amounts past-due, overlimit, or under an installment plan added to the minimum payment due. As such, the CFPB will continue to monitor assessments of late fees, reliance upon penalty repricing, and debt collection practices, alongside the disclosure of minimum payments in accordance with CARD Act requirements. Issuers' margins are increasing as they price APRs further above the prime rate, potentially signaling a lack of price competition. Instead, companies offer more generous rewards and sign-up bonuses to win new accounts, largely benefitting those with higher scores who pay their balances in full each month. The CFPB will explore ways to promote comparison shopping on purchase APRs—a major cost of credit cards that is often unknown to consumers prior to card issuance. We will also monitor changes in rewards value if issuers look to cut costs in response to lower revenue. We encourage new entrants—both bank and non-bank—to work on providing consumers with more transparency, better experiences, and greater access to credit, so long as they comply with existing consumer finance laws.

Over the past two years, the CFPB has been actively engaged in the credit card market and has taken measures to address regulatory uncertainty, identify compliance deficiencies, and research new, emerging technologies and products to ensure the adequacy of consumer protection and a transparent and competitive marketplace for all consumers. The CFPB is continuing to study and consider actions to address the areas of concern noted in the full report. Aside from a current rulemaking related to credit card penalty fees, however, the CFPB is not currently proposing to add or revise regulations related to the topics covered in the 2023 Consumer Credit Card Market Report.

Section 106(a) of the Consumer Product Safety Improvement Act of 2008 (CPSIA), mandated that ASTM F963-07ε1, Standard Consumer Safety Specifications for Toy Safety, shall be considered a mandatory consumer product safety standard issued by the CPSC. 1 15 U.S.C. 2056b(a). After compliance with ASTMF963 became mandatory in 2009, there were revisions to the voluntary standard in 2008, 2011, 2016, and 2017. Currently, ASTM F963-17, with certain exceptions, is considered a consumer product safety standard issued by the Commission under section 9 of the Consumer Product Safety Act (CPSA). 16 CFR part 1250.

On October 23, 2023, ASTM notified CPSC of ASTM's approval and publication of revisions to ASTM F963 in a revised standard, numbered ASTM F963-23, approved on August 1, 2023. Under section 106(g) of the CPSIA, if ASTM proposes revisions to ASTM F963, ASTM must notify the Commission. 15 U.S.C. 2056b(g). The revised standard shall be considered a consumer product safety standard issued by the CPSC under section 9 of the CPSA (15 U.S.C. 2058), effective 180 days after the date on which ASTM notifies the Commission of the revision, unless, within 90 days after receiving that notice, the Commission notifies ASTM that it has determined that the proposed revision does not improve the safety of toys. 15 U.S.C. 2056b(g).

CPSC is assessing the revised voluntary standard to determine whether the revisions in ASTM F963-23 meet the requirements of CPSIA section 106(g). The Commission invites public comment on that question, to inform staff's assessment and any subsequent Commission consideration of the revisions in ASTM F963-23. 2

ASTM F963-23 is available for review in several ways. ASTM has provided on its website (at https://www.astm.org/CPSC.htm ), at no cost, a read-only copy of the 2023 revisions to ASTM F963 including a red-lined version that identifies the changes made to ASTM F963-17. A read-only copy of the existing mandatory standard (ASTM F963-17) is available for viewing, at no cost, on the ASTM website at: https://www.astm.org/READINGLIBRARY/. Interested parties can download copies of the standards by purchasing them from ASTM International, 100 Barr Harbor Drive, P.O. Box C700, West Conshohocken, PA 19428-2959; phone: 610-832-9585; https://www.astm.org. Alternatively, interested parties can schedule an appointment to inspect copies of the standards at CPSC's Office of the Secretary, U.S. Consumer Product Safety Commission, 4330 East West Highway, Bethesda, MD 20814; telephone: 301-504-7479.

Comments must be received by November 16, 2023. Because of the short statutory time frame Congress established for the Commission to consider revised voluntary standards under section 106(g) of the CPSIA, CPSC will not consider comments received after this date.

Attending the Meeting: The meeting will be open to the general public. The meeting agenda and information on how to register for and attend the meeting online will be provided on EPA's website at: https://www.epa.gov/ndwac prior to the meeting.

Oral Statements: EPA will allocate one hour for the public to present oral comments during the meeting. Oral statements will be limited to three minutes per person during the public comment period. It is preferred that only one person present a statement on behalf of a group or organization. Persons interested in presenting an oral statement should send an email to NDWAC@epa.gov by noon, eastern time, on November 21, 2023.

Written Statements: Any person who wishes to file a written statement can do so before or after the Council meeting. Send written statements by email to NDWAC@epa.gov or see the FOR FURTHER INFORMATION CONTACT section if sending statements by mail. Written statements received by noon, eastern time, on November 21, 2023, will be distributed to all members of the Council prior to the meeting. Statements received after that time will become part of the permanent file for the meeting and will be forwarded to the Council members after conclusion of the meeting. Members of the public should be aware that their personal contact information, if included in any written comments, may be posted to the NDWAC website. Copyrighted material will not be posted without the explicit permission of the copyright holder.

Accessibility: For information on access or services for individuals with disabilities, or to request accommodations for a disability, please contact Elizabeth Corr by email at corr.elizabeth@epa.gov, or by phone at (202) 564-3798, preferably at least 10 days prior to the meeting to allow as much time as possible to process your request.

National Drinking Water Advisory Council: The NDWAC was created by Congress on December 16, 1974, as part of the Safe Drinking Water Act (SDWA) of 1974, Public Law 93-523, 42 U.S.C. 300j-5, and is operated in accordance with the provisions of the Federal Advisory Committee Act (FACA), 5 U.S.C. app. 2. The NDWAC was established to advise, consult with, and make recommendations to the EPA Administrator on matters relating to activities, functions, policies, and regulations under the SDWA. General information concerning the NDWAC is available at: https://www.epa.gov/ndwac.

Entities potentially regulated by this action include a wide variety of privately owned CII facilities such as shopping centers, supermarkets, office complexes, hotels, warehouses, manufacturers, cargo and trucking terminals, schools, hospitals, and nursing homes. Entities potentially regulated by this action also include privately operated CII facilities at the Ports of Long Beach and Los Angeles. Entities affected by this action are located within either of two watersheds in Los Angeles County, in California: the Los Cerritos Channel/Alamitos Bay Watershed or the Dominquez Channel/Los Angeles/Long Beach Harbor Watershed. This description of affected activities is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. This description of affected activities includes the types of entities that EPA is now aware could potentially be affected by this action. Other types of entities not included could also be affected. To determine whether your entity is affected by this action, you should also review the description of EPA's action in documents online at the website listed in the ADDRESSES section above. If you have questions regarding the applicability of this action to a particular entity, consult the person listed in the FOR FURTHER INFORMATION CONTACT section.

CWA section 402(p)(2)(E) and (6) and EPA's implementing regulations at 40 CFR 122.26(a)(9)(i) authorize EPA to designate stormwater discharges for regulation under the NPDES permitting program. Those provisions authorize the Agency to regulate stormwater discharges that contribute to a water quality standard violation or that are a significant contributor of pollutants to waters of the United States, or where controls are needed based on wasteload allocations that are part of total maximum daily loads. This authority is often referred to as “residual designation authority” or RDA. EPA is providing notice of and soliciting comment on its preliminary designation for NPDES permitting of unregulated stormwater discharges from certain commercial, industrial and institutional (CII) facilities in the Los Cerritos Channel/Alamitos Bay and Dominquez Channel/Los Angeles/Long Beach Harbor Watersheds in Los Angeles County, including privately operated CII facilities at the Ports of Long Beach and Los Angeles. EPA is also taking comment on whether privately operated CII facilities at municipal airports located within the watersheds should be included.

This preliminary designation is in response to a 2018 District Court order in Los Angeles Waterkeeper v. Pruitt, as well as two September 15, 2015 petitions entitled “Petition For A Determination That Stormwater Discharges From Commercial, Industrial, And Institutional Sites Contribute To Water Quality Standards Violations in Dominguez Channel and the Los Angeles/Long Beach Inner Harbor (Los Angeles County, California) and Require Clean Water Act Permits,” and “Petition For A Determination That Stormwater Discharges From Commercial, Industrial, And Institutional Sites Contribute To Water Quality Standards Violations in the Alamitos Bay/Los Cerritos Watershed (Los Angeles County, California) And Require Clean Water Act Permits.”

Submit comments by the deadline identified in this Federal Register notice. Information on how to submit comments and documents related to this preliminary designation are available for public inspection online at ADDRESSES above. If you need assistance in a language other than English or if you are a person with disabilities who needs a reasonable accommodation at no cost to you, please reach out by email or telephone to the FURTHER INFORMATION CONTACT listed above in this notice.

Once submitted, comments cannot be edited or removed from the administrative record. The EPA may publish any comment received as part of documentation ( e.g., response to comments document) associated with its final decision. Do not submit in your comment any information you consider to be Confidential Business Information (CBI), Proprietary Business Information (PBI), 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. The 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).

Reference: AP089513XX.

Purpose and Use:

Brief description of the purpose of the transaction: To support the export of U.S.-manufactured commercial aircraft to Ethiopia.

Brief non-proprietary description of the anticipated use of the items being exported: To be used for passenger and cargo air transport services between Ethiopia and other countries.

To the extent that EXIM is reasonably aware, the items being exported are not expected to produce exports or provide services in competition with the exportation of goods or provision of services by a United States industry.

Parties:

Principal Supplier: The Boeing Company.

Obligor: Ethiopian Airlines Group.

Guarantor(s): N/A.

Description of Items Being Exported: Boeing commercial jet aircraft.

Information on Decision: Information on the final decision for this transaction will be available in the “Summary Minutes of Meetings of Board of Directors” on https://www.exim.gov/news/meeting-minutes .

Confidential Information: Please note that this notice does not include confidential or proprietary business information; information which, if disclosed, would violate the Trade Secrets Act; or information which would jeopardize jobs in the United States by supplying information that competitors could use to compete with companies in the United States.

Authority: Section 3(c)(10) of the Export-Import Bank Act of 1945, as amended (12 U.S.C. 635a(c)(10)).

Proposal to renew the following currently approved collection of information:

1. Title: Interagency Bank Merger Application.

OMB Number: 3064-0015.

Form Number: 6220/01

Affected Public: FDIC-insured depository institutions.

Burden Estimate:

General Description of Collection: Section 18(c) of the Federal Deposit Insurance Act (FDI Act) requires an insured depository institution (IDI) that wishes to merge or consolidate with any other IDI or, either directly or indirectly, acquire the assets of, or assume liability to pay any deposits made in, any other IDI, to apply for the prior written approval of the responsible agency (the FDIC; the Board of Governors of the Federal Reserve (FRB); or the Office of the Comptroller of the Currency (OCC)). 1 Section 18(c) further requires FDIC approval in connection with any merger transaction involving an IDI and a non-insured entity.

The Interagency Bank Merger Act Application Form (Application Form) is used by the FDIC, the FRB, and the OCC for applications under section 18(c) of the FDI Act. The Application Form may be used for any merger transaction subject to section 18(c). There is a different level of burden for each of the two types of merger transactions, nonaffiliated and affiliated. An affiliate transaction refers to a merger, consolidation, other combination, or transfer of any deposit liabilities, between an IDI and another entity controlled by the same parent company, regardless of whether the other entity is FDIC-insured. It includes a business combination between an IDI and an affiliated interim institution. Applicants proposing affiliate transactions are not required to complete questions 12 through 14 of the Application Form. If the merging entities are not controlled by the same parent company, the merger transaction is considered nonaffiliated, and the applicant must complete the entire application form.

The FDIC Supplement to the Interagency Bank Merger Act Application Form (Supplement) requires each applicant to provide information that delineates the relevant geographic market(s) and describes the competition in the relevant geographic market(s). The information collected focuses on the relevant geographic market(s) where the applicant and the entity to be acquired provide banking products or services. The Supplement includes specific instructions to facilitate a comprehensive competitive analysis relative to transactions between nonaffiliated entities.

There is no change in the method or substance of the collection. The 62-hour decrease in burden hours is the result of updated data available.

Comments are invited on: (a) whether the collection of information is necessary for the proper performance of the FDIC's functions, including whether the information has practical utility; (b) the accuracy of the estimate of the burden of the information collection, 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 collection 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.

The Agency for Healthcare Research and Quality has commissioned the Evidence-based Practice Centers (EPC) Program to complete a review of the evidence for Trauma Informed Care. AHRQ is conducting this review pursuant to Section 902 of the Public Health Service Act, 42 U.S.C. 299a.

The EPC Program is dedicated to identifying as many studies as possible that are relevant to the questions for each of its reviews. In order to do so, we are supplementing the usual manual and electronic database searches of the literature by requesting information from the public ( e.g., details of studies conducted). We are looking for studies that report on Trauma Informed Care. The entire research protocol is available online at: https://effectivehealthcare.ahrq.gov/products/trauma-informed-care/protocol .

This is to notify the public that the EPC Program would find the following information on Trauma Informed Care helpful:

A list of completed studies that your organization has sponsored for this topic. In the list, please indicate whether results are available on ClinicalTrials.gov along with the ClinicalTrials.gov trial number.

For completed studies that do not have results on ClinicalTrials.gov, a summary, including the following elements, if relevant: study number, study period, design, methodology, indication and diagnosis, proper use instructions, inclusion and exclusion criteria, primary and secondary outcomes, baseline characteristics, number of patients screened/eligible/enrolled/lost to follow-up/withdrawn/analyzed, effectiveness/efficacy, and safety results.

A list of ongoing studies that your organization has sponsored for this topic. In the list, please provide the ClinicalTrials.gov trial number or, if the trial is not registered, the protocol for the study including, if relevant, a study number, the study period, design, methodology, indication and diagnosis, proper use instructions, inclusion and exclusion criteria, and primary and secondary outcomes.

Description of whether the above studies constitute ALL Phase II and above clinical trials sponsored by your organization for this topic and an index outlining the relevant information in each submitted file.

Your contribution is very beneficial to the Program. Materials submitted must be publicly available or able to be made public. Materials that are considered confidential; marketing materials; study types not included in the review; or information on topics not included in the review cannot be used by the EPC Program. This is a voluntary request for information, and all costs for complying with this request must be borne by the submitter.

The draft of this review will be posted on AHRQ's EPC Program website and available for public comment for a period of 4 weeks. If you would like to be notified when the draft is posted, please sign up for the email list at: https://www.effectivehealthcare.ahrq.gov/email-updates.

The review will answer the following questions. This information is provided as background. AHRQ is not requesting that the public provide answers to these questions.

• KQ 1. What is the evidence of benefits and/or harms of TIC on outcomes for patients/clients?

• KQ 2. What is the evidence of benefits and/or harms of TIC on outcomes for patients/clients?

Description: State child support agencies are required to establish and operate a federally approved statewide Automated Data Processing (ADP) and information retrieval system to assist in child support services. The APD process, established at 45 CFR part 95, subpart F, is the procedure by which states request and obtain approval for Federal Financial Participation (FFP) in their cost of acquiring ADP equipment and services. The ACF OCSS Division of State and Tribal Systems (DSTS) oversees this process.

States are required to submit an initial APD, containing information to assist the Secretary of the Department of Health and Human Services (HHS) in determining if the state computerized support enforcement project planning and implementation meets Federal certification requirements needed for the approval of FFP. States are then required to submit annual APD updates to HHS to report project status and request ongoing FFP for systems development, enhancements, operations, and maintenance. As-needed APDs are also submitted to acquire FFP when major milestones are missed or significant changes to project schedules occur. Based on an assessment of the information provided in the APD, states that do not meet the Federal requirements necessary for approval are required to conduct periodic independent verification and validation services for high-risk project oversight.

In addition to the APDs providing HHS/ACF/OCSS with the information necessary to determine the allowable level of Federal funding for state systems projects, states also submit associated procurement and data security documents, such as requests for proposals (RFPs), contracts, contract amendments, and the biennial security review reports.

Respondents: State child support agencies.

Estimated Total Annual Burden Hours: 9,158.50.

Comments: The Department specifically requests comments on (a) whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) 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. Consideration will be given to comments and suggestions submitted within 60 days of this publication.

Authority: 45 CFR part 95, subpart F.

Description: A State Plan is a required comprehensive narrative description of the nature and scope of a state's or Replacement Designee's (RD) Refugee Resettlement Program and provides assurances that the program will be administered in conformity with the specific requirements stipulated in 45 CFR 400.4-400.9. The State Plan must include all applicable state or RD procedures, designations, and certifications for each requirement as well as supporting documentation. The plan assures ORR that the state or RD is capable of administering refugee assistance and coordinating employment and other social services for eligible caseloads in conformity with specific requirements.

ORR proposes the following changes to the previously approved State Plan for Grants to States for Refugee Resettlement:

Respondents: State agencies and RDs under 45 CFR 400.301(c) administering or supervising the administration of programs.

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

The Committee provides advice to the Commissioner of Food and Drugs or designee on complex scientific, issues relating to medical devices, the regulation of devices, and their use by patients. Agency guidance and policies, clinical trial or registry design, patient preference study design, benefit-risk determinations, device labeling, unmet clinical needs, available alternatives, patient reported outcomes, and device-related quality of life measures or health status issues are among the topics that may be considered by the Committee. The Committee provides relevant skills and perspectives to improve communication of benefits, risks, and clinical outcomes, and increase integration of patient perspectives into the regulatory process for medical devices. It performs its duties by identifying new approaches, promoting innovation, recognizing unforeseen risks or barriers, and identifying unintended consequences that could result from FDA policy.

Pursuant to its Charter, the Committee shall consist of a core of nine voting members, including the Chair. Members and the Chair are selected by the Commissioner or designee from among authorities who are knowledgeable in areas such as clinical research, patient experience, and healthcare needs of patient groups in the United States, or who are experienced in the work of patient and health professional organizations, methodologies for patient reported outcomes and eliciting patient preferences, and strategies for communicating benefits, risks, and clinical outcomes to patients and research subjects, as well as other relevant areas. Members will be invited to serve for overlapping terms of up to 4 years. Non-Federal members of this committee will serve as either as Special Government Employees or non-voting representatives. Federal members will serve as Regular Government Employees. The core of voting members may include one technically qualified member, selected by the Commissioner or designee, who serves as an individual, but who is identified with consumer interests and is recommended by either a consortium of consumer-oriented organizations or other interested persons. The Commissioner or designee shall also have the authority to select from a group of individuals nominated by industry to serve temporarily as nonvoting members who are identified with industry interests. The number of temporary members selected for a particular meeting will depend on the meeting topic.

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

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

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

FDA is announcing the availability of a final guidance entitled “Enforcement Policy for Certain Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions.” This guidance describes FDA's general recommendations for limited modifications to devices required to have an approved PMA or HDE to help address manufacturing limitations or supply chain disruptions. This guidance supersedes “Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (Revised)”, issued in May 2020 and updated in May 2022 (COVID-19 PMA/HDE guidance). In the Federal Register of March 13, 2023 (88 FR 15417), FDA announced that COVID-19 PMA/HDE guidance was being revised to continue in effect for 180 days after the expiration of the COVID-19 PHE declaration issued under the Public Health Service Act, during which time FDA intended to further revise the guidance.

Following expiration of the PHE declaration on May 11, 2023, FDA has continued to observe supply chain challenges and shortages of medical devices remain widespread. Therefore, consistent with the Federal Register of March 13, 2023, FDA is issuing this final guidance. Although this guidance has been revised to remove any expiration date for the enforcement policy, the Agency will continue to monitor the situation and may make further revisions to the guidance, withdraw the guidance, or pursue other regulatory actions, as appropriate.

FDA has determined that this guidance document presents a less burdensome policy that is consistent with public health. This guidance is being implemented without prior public comment because FDA has determined that prior public participation for this less burdensome policy is neither feasible nor appropriate (see section 701(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 371(h)(1)(C)) and 21 CFR 10.115(g)(2)) because delaying this policy is likely to exacerbate ongoing supply chain issues. This guidance document is being implemented immediately, but it remains subject to comment in accordance with the Agency's good guidance practices.

This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on “Enforcement Policy for Certain Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions.” 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 or https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics . Persons unable to download an electronic copy of “Enforcement Policy for Certain Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions” may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number GUI00020028 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 (PRA) (44 U.S.C. 3501-3521). The collections of information in the following table have been approved by OMB:

Title 5 U.S.C. 4314(c)(4) of the Civil Service Reform Act of 1978, Public Law 95-454, requires that the appointment of Performance Review Board Members be published in the Federal Register . The following individuals are being appointed to a roster, from which the PRB members will be appointed to serve on the HHS PRB from CY 2023 through CY 2025. The PRB provides performance rating and rating-based compensation recommendations to the HHS Secretary based on the individual performance appraisals for Senior Executive Service, Senior Level/Senior Technical, and Title 42 executive equivalent employees and the organizational assessments of the Operating and Staff Divisions they serve.

The patent rights in these inventions have been either assigned and/or exclusively licensed to the government of the United States of America and the University of North Carolina at Chapel Hill.

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

“Use of mutant isocitrate dehydrogenase 1 (mIDH1) inhibitors, as claimed in the licensed patent rights, for the treatment of cancers (such as acute myeloid leukemia, glioma, cholangiocarcinoma, glioblastoma multiforme (GBM) and other solid tumors) and rare diseases.”

The inventions relate to a series of novel compounds that potently and selectively inhibit mIDH1. These compounds reduce 2-HG levels in cell lines in vitro as well as in human cancer cells grown in mouse xenografts in vivo.

These compounds show greater than 250-fold selectivity for the mutant enzyme over the wild-type, show favorable in vitro stability (in mouse, rat, dog and human hepatocyte exposure studies), are AMES negative, and exhibit no significant metabolic CYP liabilities. These compounds possess very favorable in vivo rodent pharmacokinetics and bioavailability and are well tolerated in rodents, even when dosed at high levels.

Thus, the compounds of the subject inventions can be used individually or in combination to develop new therapies to treat diseases which result from mutant IDH1 activity. The diseases caused by mutant IDH1 activity include cancer ( e.g., acute myeloid leukemia, glioma, cholangiocarcinoma and potentially other solid tumors) and selected rare diseases, such as Ollier Disease.

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

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

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

The Coast Guard announces the availability of CG-CVC Policy Letter 23-03. The new policy clarifies the Coast Guard's interpretation of several regulatory changes promulgated in the interim rule titled, Fire Safety of Small Passenger Vessels, published December 27, 2021 (86 FR 73160).

The interim rule implemented requirements mandated by the Elijah E. Cummings Coast Guard Authorization Act of 2020, which amended title 46 U.S. Code section 3306(n). Section 3306(n) directs the Secretary of Homeland Security to prescribe fire safety regulations for “covered small passenger vessels,” defined as small passenger vessels with overnight accommodations for passengers or operating on an oceans or coastwise route, excluding fishing vessels and ferries. Topics in the new policy include means of escape, special consideration by the Officer in Charge, Marine Inspection, and excursion permits.

In particular, the interim rule eliminated the option for “existing vessels” (as defined in 46 CFR subchapters K and T) to comply with the means of escape requirements applicable to them on March 10, 1996, bringing all covered small passenger vessels, regardless of age, up to current standards for means of escape design and arrangement. CG-CVC developed Policy Letter 23-03 in response to numerous inquiries requesting clarification on the correct application of the interim rule to the wide variety of small passenger vessel arrangements.

A copy of CG-CVC Policy Letter 23-03 issued on October 26, 2023 is available in the docket where indicated in the ADDRESSES section of this document and on CG-CVC's website, at https://www.dco.uscg.mil/Our-Organization/Assistant-Commandant-for-Prevention-Policy-CG-5P/Inspections-Compliance-CG-5PC-/Commercial-Vessel-Compliance/CG-CVC-Policy-Letters/.

This notice is issued under authority of 5 U.S.C. 552(a) and 46 U.S.C. 3306(n).

Telecommunications Service Priority (TSP) is authorized by E.O. 12472, E.O. 13618 and 47 CFR part 64. The Emergency Communications Division (ECD) of the Department of Homeland Security (DHS) Cybersecurity and Infrastructure Security Agency (CISA), uses the TSP Program to authorize national security and emergency preparedness organizations to receive priority treatment for vital voice and data circuits or other telecommunications service, under National Security or Emergency Preparedness telecommunications (NS/EP). The TSP Program provides service vendors a Federal Communications Commission (FCC) mandate to prioritize requests by identifying those services critical to national security and emergency preparedness. A TSP assignment ensures that it will receive priority attention by the service vendor before any non-TSP service.

Four broad categories serve as guidelines for determining whether a circuit or telecommunications service is eligible for priority provisioning or restoration. TSP service user organizations may be in the Federal, State, local, or tribal government, critical infrastructure sectors in industry, non-profit organizations that perform critical NS/EP functions, or foreign governments. Typical TSP service users are responsible for the command-and-control functions critical to management of and response to NS/EP situations, particularly during the first 24 to 72 hours following an event.

Information to request a priority, to obtain a sponsor for requesting a priority, and for other administrative requirements of the program is required from any person or organization having an NS/EP service for which they wish priority restoration from the vendor providing the service. Information is also required to allow immediate installation of a new service to support NS/EP requirements. Information is required from vendors to allow the ECD to track and identify the telecommunications services that are being provided priority treatment.

The forms used are the SF314 (Revalidation for Service Users), SF315 (TSP Request for Service Users), SF317 (TSP Action Appeal for Service Users), SF318 (TSP Service Confirmation for Service Vendors), and the SF319 (TSP Service Reconciliation for Service Vendors).

The SF314 is for users to request that their existing TSP codes be revalidated for three more years.

The SF315 is used to request restoration and/or provisioning for an organization's critical circuits.

The SF317 is for organizations to appeal the denial of TSP restoration and/or provisioning.

The SF318 is for service vendors to provide circuit ID information associated with TSP codes they've been given by their customers.

The SF319 is for service vendors to provide data to the program office in order to reconcile their TSP data with the TSP database.

Participants request TSP priorities via email in order to reduce the use of the paper forms. The paper forms will also be available for download via the CISA website.

There have been no changes to the information being collected. The annual government cost has increased due to increased wage rates/compensation factors and IT system security requirements.

This is a reinstatement of an approved information collection that was approved on 7/31/2020. The initial 60-Day Notice and request for comments was published on 4/10/2023. No comments were received.

Agency: Cybersecurity and Infrastructure Security Agency (CISA), Department of Homeland Security (DHS).

Title: Telecommunications Service Priority System.

OMB Number: 1670-0005.

Frequency: Information is required when an organization decides they want TSP priority on their critical circuits. These requests are situational and made at the discretion of the telecommunications user therefore the program office is not able to determine when or how often such requests will occur.

Affected Public: State, Local, Tribal, and Territorial Governments and Private Sector.

Number of Respondents: 25,911.

Estimated Time per Respondent: 0.28 hours.

Total Annualized Burden Hours: 7,165 hours.

Total Annualized Respondent Opportunity Cost: $372,408.

Total Annualized Government Cost: $1,145,896.

This notice announces HUD's intention to sell in HVLS 2024-1 due and payable Secretary-held reverse mortgage loans. HUD is offering 1,610 reverse mortgage notes with a loan balance of approximately $395 million. The mortgage loans consist of first liens secured by single family, vacant residential properties, where all borrowers are deceased, and no borrower is survived by a non-borrowing spouse.

In this offering, HUD also intends to awarda single asset pool consisting of a reverse mortgage loan secured by a New York single family property (“Mark House”) in Albany County that was listed on the National Register of Historic Places on August 29, 2022. This single asset pool has a loan balance of approximately $325 thousand. For the single asset pool, HUD will only accept bids from nonprofit organizations or units of State or local government with a housing mission that qualify as Priority Bidders in this sale.

A listing of the mortgage loans will be included in the due diligence materials made available to eligible bidders. The mortgage loans will be sold without FHA insurance and with servicing released. HUD will offer eligible bidders an opportunity to bid competitively on the mortgage loans.

The BIP describes in detail the procedure for bidding in HVLS 2024-1. The BIP also includes the applicable standardized non-negotiable Conveyance, Assignment and Assumption Agreements for HVLS 2024-1 (CAAs). The CAAs will contain first look requirements and mission outcome goals.

HUD will evaluate the bids submitted and determine the successful bids, in terms of the best value to HUD, in its sole and absolute discretion. If a bidder is successful, it will be required to submit a deposit which will be calculated based upon the total dollar value of the bidder's potential award. Award will be contingent on receiving the deposit in the timeframe outlined in the deposit letter. The deposit amount will be applied towards the purchase price at settlement.

This notice provides some of the basic terms of sale. The CAAs will be released in the BIP or BIP Supplement, as applicable. These documents provide comprehensive contractual terms and conditions to which eligible bidders will acknowledge and agree. To ensure a competitive bidding process, the terms of the bidding process and the CAAs are not subject to negotiation.

The BIP describes how eligible bidders may access the due diligence materials remotely via a high-speed internet connection.

HUD reserves the right to remove mortgage loans from a sale at any time prior to the Award Date and the settlement date for the mortgage loans. HUD also reserves the right to reject any and all bids, in whole or in part, and include any reverse mortgage loans in a later sale. Deliveries of mortgage loans will occur in conjunction with settlement and servicing transfer no later than 60 days after the Award Date.

The reverse mortgage loans offered for sale were insured by and were assigned to HUD pursuant to section 255 of the National Housing Act, as amended. The sale of the reverse mortgage loans is pursuant to HUD's authority in section 204(g) of the National Housing Act.

HUD selected an open competitive whole-loan sale as the method to sell the reverse mortgage loans for this specific sale transaction. For the HVLS 2024-1 sale, HUD has determined that this method of sale optimizes HUD's return on the sale of these reverse mortgage loans, affords the greatest opportunity for all eligible bidders to bid on the reverse mortgage loans, and provides the quickest and most efficient vehicle for HUD to dispose of the due and payable reverse mortgage loans.

In order to bid in HVLS 2024-1 as an eligible bidder, a prospective bidder must complete, execute, and submit a Confidentiality Agreement, a Qualification Statement (HUD-9611), and an Addendum for Nonprofit and Government Pools and Sub-pools (HUD-9612), as applicable (collectively, for these bidders, the Qualification Statement (HUD-9611) and Addendum for Nonprofit and Government Pools and Sub-pools (HUD-9612), as applicable, shall be defined as the Qualification Statement) that is acceptable to HUD. Eligible bidders seeking to be awarded loans on a priority basis must submit the Confidentiality Agreement, Qualification Statement (HUD-9611), and Addendum for Nonprofit and Government Pools and Sub-pools (HUD-9612), and Housing Mission Supplemental Certification (collectively, for these bidders, the Qualification Statement (HUD-9611) and Addendum for Nonprofit and Government Pools and Sub-pools (HUD-9612), and Housing Mission Supplemental Certification shall be defined as the Qualification Statement), that is acceptable to HUD. In the Qualification Statement, the prospective bidder must provide certain representations and warranties regarding the prospective bidder, including (i) the prospective bidder's board of directors, (ii) the prospective bidder's direct parent, (iii) the prospective bidder's subsidiaries, (iv) any related entity with which the prospective bidder shares a common officer, director, subcontractor or sub-contractor who has access to Confidential Information as defined in the Confidentiality Agreement or is involved in the formation of a bid transaction (collectively the “Related Entities”), and (v) the prospective bidder's repurchase lenders. The prospective bidder is ineligible to bid on any of the reverse mortgage loans included in HVLS 2024-1 if the prospective bidder, its Related Entities, or its repurchase lenders, are any of the following, unless other exceptions apply as provided for in the Qualification Statement.

1. An individual or entity that is currently debarred, suspended, or excluded from doing business with HUD pursuant to the Governmentwide Suspension and Debarment regulations at 2 CFR parts 180 and 2424;

2. An individual or entity that is currently suspended, debarred, or otherwise restricted by any department or agency of the Federal Government or of a State government from doing business with such department or agency;

3. An individual or entity that is currently debarred, suspended, or excluded from doing mortgage related business, including having a business license suspended, surrendered or revoked, by any Federal, State, or local government agency, division, or department;

4. An entity that has had its right to act as a Government National Mortgage Association (“Ginnie Mae”) issuer terminated and its interest in mortgages backing Ginnie Mae mortgage-backed securities extinguished by Ginnie Mae;

5. An individual or entity that is in violation of its neighborhood stabilizing outcome obligations or post-sale reporting requirements under a Conveyance, Assignment and Assumption Agreement executed for any previous mortgage loan sale of HUD;

6. An employee of HUD's Office of Housing, a member of such employee's household, or an entity owned or controlled by any such employee or member of such an employee's household with household to be inclusive of the employee's father, mother, stepfather, stepmother, brother, sister, stepbrother, stepsister, son, daughter, stepson, stepdaughter, grandparent, grandson, granddaughter, father-in-law, mother-in-law, brother-in-law, sister-in-law, son-in-law, daughter-in-law, first cousin, the spouse of any of the foregoing, and the employee's spouse;

7. A contractor, subcontractor, and/or consultant or advisor (including any agent, employee, partner, director, or principal of any of the foregoing) who performed services for or on behalf of HUD in connection with the sale;

8. An individual or entity that knowingly acquired or will acquire prior to the sale date material non-public information, other than that information which is made available to Bidder by HUD pursuant to the terms of this Qualification Statement, about mortgage loans offered in the sale;

9. An individual or entity which knowingly employs or uses the services of an employee of HUD's Office of Housing (other than in such employee's official capacity); or

10. An individual or entity that knowingly uses the services, directly or indirectly, of any person or entity ineligible under 1 through 10 to assist in preparing any of its bids on the mortgage loans.

The Qualification Statement has additional representations and warranties which the prospective bidder must make, including but not limited to the representation and warranty that the prospective bidder or its Related Entities are not and will not knowingly use the services, directly or indirectly, of any person or entity that is, any of the following (and to the extent that any such individual or entity would prevent the prospective bidder from making the following representations, such individual or entity has been removed from participation in all activities related to this sale and has no ability to influence or control individuals involved in formation of a bid for this sale):

(1) An entity or individual is ineligible to bid on any included reverse mortgage loan or on the pool containing such reverse mortgage loan because it is an entity or individual that:

(a) Serviced or held such reverse mortgage loan at any time during the six-month period prior to the bid, or

(b) Is any principal of any entity or individual described in the preceding sentence;

(c) Any employee or subcontractor of such entity or individual during that six-month period; or

(d) Any entity or individual that employs or uses the services of any other entity or individual described in this paragraph in preparing its bid on such reverse mortgage loan.

In addition, for those eligible bidders seeking to be awarded mortgage loans on a priority basis and signing the Housing Mission Supplemental Certification, each prospective bidder must provide documentation and certify that its charitable or government purpose has a qualifying housing mission and that its participation in the sale is a furtherance of that housing mission.

HUD reserves the right, in its sole and absolute discretion, to disclose information regarding HVLS 2024-1, including, but not limited to, the identity of any successful qualified bidder and its bid price or bid percentage for any pool of loans or individual loan, upon the closing of the sale of all the mortgage loans. Even if HUD elects not to publicly disclose any information relating to HVLS 2024-1, HUD will disclose any information that HUD is obligated to disclose pursuant to the Freedom of Information Act and all regulations promulgated thereunder.

This notice applies to HVLS 2024-1 and does not establish HUD's policy for the sale of other mortgage loans.

In accordance with the Paperwork Reduction Act (PRA; 44 U.S.C. 3501 et seq. ) and its implementing regulations in the Code of Federal Regulations (CFR) at 5 CFR 1320, all information collections require approval under the PRA. We may not conduct or sponsor and you are not required to respond to a collection of information unless it displays a currently valid OMB control number.

As part of our continuing effort to reduce paperwork and respondent burdens, we invite the public and other Federal agencies to comment on new, proposed, revised, and continuing collections of information. This helps us assess the impact of our information collection requirements and minimize the public's reporting burden. It also helps the public understand our information collection requirements and provide the requested data in the desired format.

We are especially interested in public comment addressing the following:

(1) Whether or not the collection of information is necessary for the proper performance of the functions of the agency, including whether or not the information will have practical utility;

(2) The accuracy of our estimate of the burden for this collection of information, including the validity of the methodology and assumptions used;

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

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

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

Abstract: The Endangered Species Act of 1973 (ESA; 16 U.S.C. 1531 et seq. ) and the Marine Mammal Protection Act of 1972 (16 U.S.C. 1361 et seq. ) place importance on public education and outreach regarding manatee conservation. Researchers conducting noninvasive surveys can raise awareness about manatees and the importance of responsible ecotourism. Furthermore, the data collected from noninvasive surveys can inform management decisions and policies related to manatee conservation and ecotourism. Authorities and policymakers can also use this data to develop evidence-based strategies that balance the interests of stakeholders while safeguarding the well-being of manatees and their habitats.

Ecotourism is broadly defined as traveling to an undisturbed area with the objective of admiring and studying the wildlife (Wallace and Pierce 1996). Tourism-based activities can provide economic benefits for the community, improve conservation, and be used as a tool for education (Ambe, Tsi, Chi, Siri, and Tita 2010; Hill and Gale 2009; Honey 2008; Masud, Aldakhil, Nassani, and Azam 2017; Snyman 2014; Stronza and Gordillo 2008; Cardenas et al. 2021). For ecotourism to be sustainable, it should encompass the dynamics between recreation and conservation of wildlife (Catlin et al. 2011). A conceptual framework provides managers and researchers a tool to assist them in achieving the best outcomes for both environmental conservation and the provision of wildlife tourism experiences (Catlin et al. 2011). The conceptual framework developed by Duffus and Dearden (1990) is referenced as nonconsumptive wildlife tourism in which “a human recreational engagement with wildlife wherein the focal organism is not purposefully removed or permanently affected by the engagement” (Duffus and Dearden 1990, p. 215). Their framework identifies three major dimensions of wildlife tourism interaction: the wildlife user, the focal species and its habitat, and the historical relationships between them (Duffus and Dearden 1990; Catlin et al. 2011). This study will focus on the wildlife user, which encompasses the visitor, the tourism operators, and the surrounding community that engage in ecotourism with manatees in Crystal River, Florida.

Crystal River is a coastal city located in Citrus County, Florida. The City of Crystal River is adjacent to Kings Bay and the Kings Bay Springs Group, also referred to as the Crystal River/Kings Bay spring complex (Florida Department of Environmental Protection 2018). The Crystal River/Kings Bay spring complex (Springs Complex) is a first magnitude spring system composed of more than 70 springs; these 70 springs account for 99 percent of the freshwater entering Kings Bay (Hammett et al. 1996). The most notable spring in the complex is Three Sisters Springs, which is located within the Crystal River National Wildlife Refuge, referred to hereon as the Refuge (Howard T. Odum Florida Springs Institute 2016). The Refuge was established in 1983 for the protection of the then endangered Florida Manatee, which gather in larger numbers at several of the spring vents during the wintertime to thermoregulate (Hartman 1979). Manatees also rely on the warm, calm, clear waters of Kings Bay to forage, rest, mate, and nurse. Due to the importance of this area for manatee survival, the Service designated this area as critical habitat for manatees under the ESA. During the colder months of the year, from November to March, several areas within the Refuge are roped off, and access to the public is restricted (manatee refuges) or completely prohibited (manatee sanctuaries).

Manatee ecotourism has been a significant part of the Crystal River community for over 50 years. This ecotourism takes many forms, including but not limited to swim-with programs, guided kayak tours, boat tours, and guests who visit the Refuge on foot to view manatees gathered at the springs. Swim-with-manatee tours are by far the most popular ecotourism activity in Crystal River, with tours running from the early morning until sunset each day. To operate a tour within the Refuge, commercial operators must apply for a Special Use Permit (SUP; OMB Control No. 1018-0102). As of 2022, there were 27 permitted operators in Crystal River, and the Refuge estimates that they manage over 400,000 guests recreating within Refuge waters each year (FWS 2022). Despite the popularity of manatee ecotourism in the area growing over the last few decades, only one study has investigated the perceptions surrounding ecotourism in Crystal River. Sorice et al. (2006) interviewed State and wildlife employees, the business community, resource managers, and advocacy groups. The study revealed overriding concerns from all stakeholders regarding water quality, overcrowding, education, harassment, and enforcement (Sorice et al. 2006). However, the study also reported the lack of agreement between stakeholders on each issue. One of the suggestions to resolve conflict was to create a participatory management approach, to organize tour operators into an association that would work with governing officials to establish best practices for ecotourism (Sorice et al. 2006). As such, the Manatee Ecotourism Association was created in Crystal River in 2011 to create standardization for swim-with tours, mainly by practicing passive observation with the goal of following Refuge regulations and reducing manatee harassment.

The purpose of the surveys is to interview manatee tour operators, kayak and paddlecraft outfitters, boat rental companies, their employees, visitors, and the Crystal River community, to obtain their perspectives on manatee ecotourism in Crystal River. We propose to collect the following information to determine the effect of tour operations on the manatee population:

This online survey gathers general information from business owners and tour operators regarding the preparation, size, frequency, nature, and content of “swim-with-manatee” tours, including specific questions about interactions with manatees. No sensitive or non-sensitive personally identifiable information is requested from respondents.

This online survey gathers general information from business owners and tour operators regarding the preparation, size, frequency, nature, and content of guided kayak tours. Questions also work to build an understanding of how these tour firms view their business and the regulations surrounding them in relation to manatees. No sensitive or non-sensitive personally identifiable information is requested from respondents.

This online survey gathers general information from tour firm owners regarding their business practices, preparation, frequency, nature, and content of unguided boat or kayak tours. Questions also work to build an understanding of how these tour firms view their business and the regulations surrounding them in relation to manatees. No personally identifiable information is requested from respondents.

This online survey gathers general information from tour consumers regarding their experiences on guided boat tours. Questions include respondents' motivations, preparations, and overall satisfaction with their tour experiences. Apart from zip/postal code, no other sensitive or non-sensitive personally identifiable information is requested from respondents.

This survey gathers general information from tour consumers regarding their experiences on guided kayak tours. Questions include respondents' motivations, preparations, and overall satisfaction with their tour experiences. Apart from zip/postal code, no other sensitive or non-sensitive personally identifiable information is requested from respondents.

This survey gathers general information from tour consumers regarding their experiences on unguided/self-guided “swim-with-manatee” tours. Questions include respondents' motivations, preparations, and overall satisfaction with their tour experiences. Apart from zip/postal code, no other sensitive or non-sensitive personally identifiable information is requested from respondents.

This survey gathers general information from Crystal River National Wildlife Refuge visitors regarding their experience and perceptions of ecotourism and local tour operations. Questions also directly address respondents' feelings towards manatee conservation and education programs. Apart from zip/postal code, no other sensitive or non-sensitive personally identifiable information is requested from respondents.

This survey gathers general information from the Crystal River community regarding their perceptions of ecotourism, manatee education, and local tour operations' impact on both manatees in general as well as on Crystal River residents and businesses specifically. Apart from zip/postal code, no other sensitive or non-sensitive personally identifiable information is requested from respondents.

The data collected from tour operators, guests, and Crystal River residents will be utilized for several purposes. First, the information will be analyzed to gain insight into the perspectives of tour operators. This understanding will enable the identification of areas for improvement and the development of sustainable practices in ecotourism. Secondly, the perceptions of guests participating in ecotours will be evaluated to gather valuable feedback. This feedback will serve as a crucial resource for tour operators to incorporate into their operations. By considering guest feedback, operators can establish best practices for activities conducted during ecotours.

Moreover, a comprehensive framework for sustainable ecotourism should not solely focus on the interests and perceptions of guests and tour boat operators. It is equally important to involve the local community, including businesses such as hotels, restaurants, and gift shops, as well as Crystal River residents. This inclusive approach aims to ensure that the benefits of ecotourism are balanced with the concerns and needs of the local community. This comprehensive approach will contribute to the development of sustainable ecotourism practices that benefit all stakeholders involved.

The public may request copies of any form or document contained in this information collection by sending a request to the Service Information Collection Clearance Officer (see ADDRESSES ).

Title of Collection: Perspectives on Manatee Ecotourism.

OMB Control Number: 1018-New.

Form Number: None.

Type of Review: New.

Respondents/Affected Public: Individuals/households and private sector.

Respondent's Obligation: Voluntary.

Frequency of Collection: On occasion.

Total Estimated Annual Nonhour Burden Cost: None.

An agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.

The authority for this action is the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

In accordance with the Paperwork Reduction Act of 1995, BOEM provides the general public and other Federal agencies with an opportunity to comment on new, proposed, revised, and continuing collections of information. This helps BOEM assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand BOEM's information collection requirements and provide the requested data in the desired format.

BOEM is soliciting comments on the proposed ICR described below. BOEM is especially interested in public comments addressing the following issues: (1) is the collection necessary to the proper functions of BOEM; (2) what can BOEM do to ensure that this information is processed and used in a timely manner; (3) is the burden estimate accurate; (4) how might BOEM enhance the quality, utility, and clarity of the information to be collected; and (5) how might BOEM minimize the burden of this collection on the respondents, including minimizing the burden through the use of information technology?

Comments submitted in response to this notice are a matter of public record. BOEM will include or summarize each comment in its ICR to OMB for approval of this information collection. You should be aware that your entire comment—including your address, phone number, email address, or other personally identifiable information included in your comment—may be made publicly available at any time. Even if BOEM withholds your information in the context of this ICR, your comment is subject to the Freedom of Information Act (FOIA). If your comment is requested under the FOIA, your information will only be withheld if BOEM determines that one of the FOIA exemptions to disclosure applies. Such a determination will be made in accordance with the Department's FOIA regulations and applicable law.

In order for BOEM to consider withholding from disclosure your personally identifiable information, you must identify, in a cover letter, any information contained in your comment that, if released, would constitute a clearly unwarranted invasion of your privacy. You must also briefly describe any possible harmful consequences of the disclosure of information, such as embarrassment, injury, or other harm. Note that BOEM will make available for public inspection, in their entirety, all comments submitted by organizations and businesses, or by individuals identifying themselves as representatives of organizations or businesses.

BOEM protects proprietary information in accordance with FOIA and the Department's implementing regulations. Items of a sensitive nature are not intended to be collected.

Title of Collection: “Piloting an Approach to Community-Informed Characterization of Communities with Environmental Justice Concerns.”

Abstract: Various Federal statutes, including the National Environmental Policy Act (NEPA), require BOEM to examine the social and economic impacts of BOEM-authorized activities at the community level. Additionally, Federal policy and guidance state that agencies should meaningfully engage communities with environmental justice (EJ) concerns in their decision making. (Executive Orders 12898, 13985, and 14008).

BOEM plans to pilot an approach to community-informed characterization of communities with EJ concerns potentially impacted by BOEM-authorized activities by selecting nine communities to participate in the study. The goal of this initiative is to improve BOEM's decision making through more detailed environmental analyses that include information on the communities with EJ concerns that may be affected by BOEM-authorized activities. Sections within NEPA documents currently discuss potential EJ impacts in a general sense. To improve its analyses, BOEM proposes to obtain information about specific potential impacts, unique contextual considerations, and the potential for detailed mitigation measures designed based on the affected community.

Baseline information to support community characterization is available but could be better applied in analyses to identify local contexts and reflect local input. BOEM plans to prepare community characterization summaries using information obtained from members of selected communities with EJ concerns to pilot such an approach. Community characterizations would summarize a community's history, demographics, economic conditions, coastal and marine resource use, coastal land use, identification of key leaders and organizations, and other baseline conditions and trends. With these summaries readily accessible, BOEM analysts will continue improving their understanding of the selected affected communities with EJ concerns and the potential impacts from BOEM-approved activities.

As appropriate, these summaries may be included in the relevant environmental analyses that inform BOEM's decisions. Furthermore, conducting community-informed research could advance earlier community awareness of BOEM activities and increase trust. Gaining first-hand information will help “ground-truth” some of the existing information that would be collated into the selected community characterization summaries.

BOEM plans to use various methods, such as interviews and focus groups, to collect information from members of approximately three communities with EJ concerns in each of the three chosen study areas. BOEM seeks comments on, and suggestions of, appropriate information collection methods and study areas.

BOEM proposes to collect information on topics such as those listed below in order to inform community characterization summaries highlighting vulnerabilities, themes, issues, or concerns of each selected community. Each community summary would include relevant history, demographics, economics, coastal and marine resource use, coastal land use including existing facilities, outreach approaches that are locally appropriate for that specific community with EJ concerns, identification of key community leaders and organizations, and other baseline conditions that will enable BOEM analysts to better incorporate specific community interests into environmental reviews and the decision-making process. BOEM is also seeking comments on whether other topics should be included in the selected community characterization summaries.

OMB Control Number: 1010-NEW.

Form Number: None.

Type of Review: New.

Respondents/Affected Public: 9-15 Selected Communities (including community leaders, key informants, and community organizations).

Total Estimated Number of Annual Responses: 135-225 community responses.

Total Estimated Number of Annual Burden Hours: 540-900 hours.

Respondent's Obligation: Voluntary.

Frequency of Collection: On occasion.

Total Estimated Annual Non-Hour Burden Cost: None.

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid OMB control number.

The authority for this action is the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

In the Federal Register of October 27, 2023 (88 FR 73873) in FR Doc. 2023-23774, on page 73873, in the first column, in the Dates section, the date should be October 23, 2023.

Background. —On October 6, 2023, the Commission determined that the domestic interested party group response to its notice of institution (88 FR 42753, July 3, 2023) of the subject five-year reviews was adequate and that the respondent interested party group response was inadequate. The Commission did not find any other circumstances that would warrant conducting full reviews. 1 Accordingly, the Commission determined that it would conduct expedited reviews pursuant to section 751(c)(3) of the Act (19 U.S.C. 1675(c)(3)). 2

For further information concerning the conduct of these reviews and rules of general application, consult the Commission's Rules of Practice and Procedure, part 201, subparts A and B (19 CFR part 201), and part 207, subparts A, D, E, and F (19 CFR part 207).

Staff report. —A staff report containing information concerning the subject matter of the reviews has been placed in the nonpublic record, and will be made available to persons on the Administrative Protective Order service list for these reviews on November 21, 2023. A public version will be issued thereafter, pursuant to § 207.62(d)(4) of the Commission's rules.

Written submissions. —As provided in § 207.62(d) of the Commission's rules, interested parties that are parties to the reviews and that have provided individually adequate responses to the notice of institution, 3 and any party other than an interested party to the reviews may file written comments with the Secretary on what determination the Commission should reach in the reviews. Comments are due on or before 5:15 p.m. on November 30, 2023, and may not contain new factual information. Any person that is neither a party to the five-year reviews nor an interested party may submit a brief written statement (which shall not contain any new factual information) pertinent to the reviews by November 30, 2023. However, should the Department of Commerce (“Commerce”) extend the time limit for its completion of the final results of its reviews, the deadline for comments (which may not contain new factual information) on Commerce's final results is three business days after the issuance of Commerce's results. If comments contain business proprietary information (BPI), they must conform with the requirements of §§ 201.6, 207.3, and 207.7 of the Commission's rules. The Commission's Handbook on Filing Procedures, available on the Commission's website at https://www.usitc.gov/documents/handbook_on_filing_procedures.pdf, elaborates upon the Commission's procedures with respect to filings.

In accordance with §§ 201.16(c) and 207.3 of the rules, each document filed by a party to the reviews must be served on all other parties to the reviews (as identified by either the public or BPI service list), and a certificate of service must be timely filed. The Secretary will not accept a document for filing without a certificate of service.

Determination. —The Commission has determined these reviews are extraordinarily complicated and therefore has determined to exercise its authority to extend the review period by up to 90 days pursuant to 19 U.S.C. 1675(c)(5)(B).

Please note that all comments received in response to this docket are considered part of the public record. They will, unless reasonable cause is given, be made available by the Drug Enforcement Administration (DEA) for public inspection online at http://www.regulations.gov. Such information includes personal identifying information (such as your name, address, etc.) voluntarily submitted by the commenter.

The Freedom of Information Act applies to all comments received. If you want to submit personal identifying information (such as your name, address, etc.) as part of your comment, but do not want it to be made publicly available, you must include the phrase “PERSONAL IDENTIFYING INFORMATION” in the first paragraph of your comment. You must also place all the personal identifying information you do not want made publicly available in the first paragraph of your comment and identify what information you want redacted.

If you want to submit confidential business information as part of your comment, but do not want it to be made publicly available, you must include the phrase “CONFIDENTIAL BUSINESS INFORMATION” in the first paragraph of your comment. You must also prominently identify confidential business information to be redacted within the comment.

Comments containing personal identifying information or confidential business information identified and located as directed above will generally be made available in redacted form. If a comment contains so much confidential business information or personal identifying information that it cannot be effectively redacted, all or part of that comment may not be made publicly available. Comments posted to http://www.regulations.gov may include any personal identifying information (such as name, address, and phone number) included in the text of your electronic submission that is not identified as directed above as confidential.

An electronic copy of this document is available at http://www.regulations.gov for easy reference.

Section 306 of the Controlled Substances Act (21 U.S.C. 826) requires the Attorney General to establish production quotas for each basic class of controlled substances listed in schedules I and II, and for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine. The Attorney General has delegated this function to the Administrator of DEA pursuant to 28 CFR 0.100.

The proposed 2024 aggregate production quotas (APQ) and assessment of annual needs (AAN) represent those quantities of schedule I and II controlled substances, and the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine, to be manufactured in the United States (U.S.) in 2024 to provide for the estimated medical, scientific, research, and industrial needs of the United States, lawful export requirements, and the establishment and maintenance of reserve stocks. These quotas include imports of ephedrine, pseudoephedrine, and phenylpropanolamine, but do not include imports of controlled substances for use in industrial processes.

In determining the proposed 2024 APQ, the Administrator has taken into account the criteria of 21 U.S.C. 826(a) and 21 CFR 1303.11, including the following seven factors:

(1) Total net disposal of the class by all manufacturers during the current and two preceding years;

(2) Trends in the national rate of net disposal of the class;

(3) Total actual (or estimated) inventories of the class and of all substances manufactured from the class, and trends in inventory accumulation;

(4) Projected demand for such class as indicated by procurement quotas requested pursuant to [21 CFR] 1303.12;

(5) The extent of any diversion of the controlled substance in the class;

(6) Relevant information obtained from the Department of Health and Human Services (HHS), including from the Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), and the Centers for Medicare and Medicaid Services (CMS), and relevant information obtained from the states; and

(7) Other factors affecting medical, scientific, research, and industrial needs in the United States and lawful export requirements, as the Administrator finds relevant, including changes in the currently accepted medical use in treatment with the class or the substances manufactured from it, the economic and physical availability of raw materials for use in manufacturing and for inventory purposes, yield and stability problems, potential disruptions to production (including possible labor strikes), and recent unforeseen emergencies such as floods and fires.

DEA formally solicited input from FDA and CDC in February of 2023 and from the states in April 2023, as required by 21 U.S.C. 826 and 21 CFR part 1303. DEA did not solicit input from CMS for reasons discussed in previous notices. 1 DEA requested information on trends in the legitimate use of select schedule I and II controlled substances from FDA and rates of overdose deaths for covered controlled substances from CDC. DEA's request for information from the states was made directly to the Prescription Drug Monitoring Program (PDMP) Administrators in each state as well as through the National Association of State Controlled Substances Authorities (NASCSA).

In similar fashion, in determining the proposed 2024 AAN for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine, the Administrator has taken into account the criteria of 21 U.S.C. 826(a) and 21 CFR 1315.11, including the five following factors:

(1) Total net disposal of the chemical by all manufacturers and importers during the current and two preceding years;

(2) Trends in the national rate of net disposal of each chemical;

(3) Total actual (or estimated) inventories of the chemical and of all substances manufactured from the chemical, and trends in inventory accumulation;

(4) Projected demand for each chemical as indicated by procurement and import quotas requested pursuant to [21 CFR] 1315.32; and

(5) Other factors affecting medical, scientific, research, and industrial needs in the United States, lawful export requirements, and the establishment and maintenance of reserve stocks, as the Administrator finds relevant, including changes in the currently accepted medical use in treatment with the chemicals or the substances manufactured from them, the economic and physical availability of raw materials for use in manufacturing and for inventory purposes, yield and stability problems, potential disruptions to production (including possible labor strikes), and recent unforeseen emergencies such as floods and fires.

In determining the proposed 2024 AAN, DEA used the calculation methodology previously described in the 2010 and 2011 assessments of annual needs (74 FR 60294, Nov. 20, 2009, and 75 FR 79407, Dec. 20, 2010, respectively).

In accordance with 21 CFR part 1303, 21 U.S.C. 826, and 42 U.S.C. 242, HHS continues to provide DEA with estimates of the quantities of select schedule I and II controlled substances and three list I chemicals that will be required to meet the legitimate medical needs of the United States for a given calendar year. The responsibility to provide these estimates of legitimate domestic medical needs resides with FDA. FDA provides DEA with predicted estimates of domestic medical usage for selected controlled substances based on information available to them at a specific point in time in order to meet statutory requirements.

FDA predicts that levels of medical need for schedule II opioids in the United States in calendar year 2024 will decline on average 7.9 percent from calendar year 2023 levels. These declines are expected to occur across a variety of schedule II opioids including fentanyl, hydrocodone, hydromorphone, oxycodone, and oxymorphone. DEA considered the potential for diversion of schedule II opioids, as required by 21 CFR 1303.11(b)(5), as well as a potential increase in demand for certain opioids identified as being necessary to support the previously postponed elective surgeries now that the COVID-19 public health emergency has ended, pursuant to 21 CFR 1303.11(b)(7), in developing the proposed 2024 APQ.

FDA predicted an average of a 3.1 percent increase in domestic medical use of the schedule II stimulants amphetamine, methylphenidate (including dexmethylphenidate), and lisdexamfetamine, which are prescribed to treat patients with attention deficit hyperactivity disorder (ADHD) and more recently prescribed off-label to treat patients diagnosed with long-COVID symptoms commonly known as brain fog where fatigue and cognitive impairment persist 4 to 12 weeks after a COVID infection. 2 FDA also raised concerns over drug shortage notifications it received from patients for specific ADHD medications containing methylphenidate and amphetamine. FDA's stated reasons for these specific shortages include increased prescribing potentially related to the growth in telemedicine, supply chain issues, manufacturing and quality issues, and business decisions of manufacturers. DEA considered FDA's concerns when determining the APQ for these substances. DEA believes that manufacturers will be able to meet the increase in domestic medical need with the APQs proposed in this notice.

There has been a significant increase in the use of schedule I hallucinogenic controlled substances for research and clinical trial purposes. DEA has received and subsequently approved new registration applications for schedule I researchers and new applications for registration from manufacturers to grow, synthesize, extract, and prepare dosage forms containing specific schedule I hallucinogenic substances for research and clinical trial purposes. DEA supports regulated research with schedule I controlled substances, as evidenced by the higher APQ proposed for 2024 as compared with APQ for these substances in 2023. Further, DEA published the final rule, “Controls to Enhance the Cultivation of Marihuana for Research in the United States” in December 2020, and the Medical Marijuana and Cannabidiol Research Expansion Act (Pub. L. 117-215) was enacted in December 2022. The agency continues to review and approve applications for schedule I manufacturers of marihuana that conform to the federal requirements contained in the CSA. See 21 CFR part 1318.

Thus, DEA is proposing APQ for ibogaine, psilocyn, psilocybin, delta-9-tetrahydrocannabinol (d-9-THC), and all other tetrahydrocannabinols to support manufacturing activities related to the increased level of research and clinical trials with these schedule I controlled substances. Additionally, DEA proposes APQs for d-9-THC and all other tetrahydrocannabinols for 2024 to reflect the relocation of manufacturing of these controlled substances from abroad to the United States.

For the factors listed in 21 CFR 1303.11(b)(3) and (4), DEA registered manufacturers of controlled substances in schedules I and II provide information such as inventory, distribution, manufacturing, sales forecasts and quota requests to the DEA database systems. See 21 CFR 1303.12, 1303.22, and part 1304.

The regulation at 21 CFR 1303.11(b)(5) requires DEA to consider the extent of diversion of controlled substances. 3 Diversion is defined as all distribution, dispensing, or other use of controlled substances for other than legitimate medical purposes. In order to consider the extent of diversion, DEA analyzed reports of diversion of controlled substances from 2022 submitted to its Theft Loss Report database. This database is comprised of DEA registrant reports documenting diversion from the legitimate distribution chain, including employee thefts, break-ins, armed robberies, and material lost in transit. The data was categorized by basic drug class, and the amount of active pharmaceutical ingredient (API) in the dosage form was delineated with an appropriate metric for use in proposing aggregate production quota values ( i.e., weight).

In this proposed 2024 APQ, DEA also considered the lingering effects of the COVID-19 pandemic on the global supply chain, pursuant to 21 CFR 1303.11(b)(7), and specifically the continued impacts on the availability of raw materials for use in the domestic manufacturing process. Additionally, DEA considered the impact of the demand for surgical care for elective surgeries that were deferred during the COVID-19 public health emergency.

In establishing any quota . . . , or any procurement quota established by [DEA] by regulation, for fentanyl, oxycodone, hydrocodone, oxymorphone, or hydromorphone (in this subsection referred to as a “covered controlled substance”), [DEA] shall estimate the amount of diversion of the covered controlled substance that occurs in the United States.

In estimating diversion under that provision, DEA:

(i) shall consider information . . . , in consultation with the Secretary of Health and Human Services, [it] determines reliable on rates of overdose deaths and abuse and overall public health impact related to the covered controlled substance in the United States; and

(ii) may take into consideration whatever other sources of information [it] determines reliable.

The statute further mandates that DEA “make appropriate quota reductions, as determined by [DEA], from the quota [it] would have otherwise established had such diversion not been considered.”  4

In estimating the amount of diversion of each covered controlled substance that occurs in the United States, DEA considered information from state PDMP Administrators and from legitimate distribution chain participants.

Pursuant to 21 CFR 1303.11(b)(6), DEA requested state PDMP data for the purpose of establishing its APQ. DEA believes state PDMPs to be an essential, reliable source of information for use in effectively estimating diversion of the five covered controlled substances. In April 2023, DEA sent a letter to NASCSA requesting its assistance in obtaining aggregated PDMP data for the five covered controlled substances from each state covering the years 2020-2022. The letter indicated that DEA was specifically interested in an analysis of prescription data from each state's PDMP that would assist DEA in estimating diversion and setting appropriate quotas in compliance with 21 U.S.C. 826(i). In its request, DEA provided specific questions, discussed in detail below, based on common indicia of potential diversion known as “red flags” by physicians, pharmacists, manufacturers, distributors, and federal and state regulatory and law enforcement agencies. 5 DEA investigators and administrative prosecutors also rely on Agency case law in which these red flags of diversion have been upheld as indicia of potential diversion. 6 Certain state regulations now include red flag circumstances as potential indicators of illegitimate prescriptions, and thus of potential abuse and diversion of controlled substances. 7 See The Pharmacy Place Order, 86 FR 21008, 21012 (Apr. 21, 2021) (citing 22 Tex. Admin. Code 291.29(c)(4), specifying the geographical distance between the practitioner and the patient or between the pharmacy and the patient as a red flag).

DEA requested responses from state PDMP Administrators by June 15, 2023. NASCSA disseminated DEA's request to its PDMP Administrators and provided them with a report tool to ensure that responses to DEA's questions were extracted consistently across all responsive states. Thirty states and two territories provided DEA with summarized PDMP data between May 3, and June 15, 2023, utilizing the standardized report developed by NASCSA. 8 See Table 1a below.

Pharmacies are required by state law to enter controlled substance dispensing data into the state's PDMP database, including the prescriber's name, registered address and DEA number; prescription information (such as drug name); dispensing date; dosage dispensed; pharmacy registered address; and patient name and address. DEA considers PDMP data to be an accurate representation of dispensing activities in states. DEA received data for the following red-flag metrics:

• The total number of patients who saw three or more prescribers in a 90-day period and were dispensed an opioid following each visit. For this metric, DEA requested and was provided the number of prescriptions for the five covered controlled substances dispensed to these patients, as a percentage of the total prescriptions dispensed for that particular covered controlled substance, as well as the corresponding quantity of the covered controlled substance dispensed. This metric (patients being prescribed covered controlled substances from three or more prescribers in a 90-day period) is used to identify potential doctor shopping, a common technique to obtain a high number of controlled substances, which may lead to abuse or diversion of controlled substances. DEA has long considered doctor shopping to be an indicator of potential diversion. 9

• The number of patients that were dispensed prescriptions for each of the five covered controlled substances that exceeded 240 morphine milligram equivalents (MME) daily. States provided the raw number of such prescriptions dispensed, the number of prescriptions as a percentage of the total covered controlled substance prescriptions dispensed, and the corresponding quantity of the covered controlled substance dispensed. DEA believes that accounting for quantities in excess of 240 MME daily allows for consideration of oncology patients with legitimate medical needs for covered controlled substance prescriptions with high MME. Higher dosages place individuals at higher risk of overdose and death. Prescriptions involving dosages exceeding 240 MME daily may indicate diversion, such as illegal distribution of controlled substances or prescribing outside the usual course of professional practice.

• The number of patients that paid cash for covered controlled substance prescriptions, without submitting for insurance reimbursement. 10 States also provided the number of prescriptions paid entirely with cash as a percentage of the total prescriptions for the five covered controlled substances dispensed, as well as the corresponding quantity of the covered controlled substances dispensed. When investigating potential diversion, cash payments are one element considered in identifying prescriptions filled for nonmedical purposes. Unusually high percentages of cash payments made to a prescriber or pharmacy for controlled substances may indicate diversion. 11

DEA received PDMP data from the states in a standardized format that allowed DEA to aggregate the data. The PDMP data sample represents a population of approximately 150.7 million people, which is approximately 45 percent of the U.S. population. DEA believes this sample is sufficient to derive a reasonable nationwide estimate.

While PDMP data is useful in estimating diversion, it is not conclusive. Further investigation would be required before concluding that any of the subject prescriptions were actually diverted. DEA continues to evaluate its methodologies in estimating diversion in an effort to adjust quotas more efficiently. State participation is crucial to accurate data analysis, and DEA anticipates working closely with states, as well as other federal and state entities, in future quota determinations.

To calculate a national diversion estimate for each of the covered controlled substances from the responses received from state PDMP Administrators, DEA relied upon the number of individuals who received a prescription for a covered controlled substance that met any of the three red-flag metrics for each of calendar years 2020-2022. Using the population of the states responding to DEA's request, DEA then calculated the percentage of the population issued a prescription with a red flag. Using this estimated percentage for 2020-2022, DEA analyzed trends in the data to predict the estimated percentage of patients who would be expected to be included in these red-flag metrics for 2024.

DEA also reviewed aggregate sales data for each of the covered controlled substances, which it extracted from IQVIA's National Sales Perspective. 12 IQVIA sales data was selected to help quantify diversion at the national level because it reflects the best national estimate for all prescriptions written and filled, including the total quantity available for diversion or misuse. DEA analyzed trends in IQVIA sales data from January 2020—April 2023, in order to predict the estimated national sales for 2024.

To estimate diversion for each of the covered controlled substances, DEA multiplied the forecasted percentage of patients likely to receive a prescription for a covered controlled substance that meet any of the three red-flag metrics in 2024 by the forecasted sales data from IQVIA for 2024. The resulting estimate of diversion from data submitted by state PDMP Administrators is summarized below in Table 1b. This data contributed to the final diversion estimate set forth in Table 3.

DEA extracted data from its Theft Loss Report database and categorized it by each basic drug class. DEA calculated the estimated amount of diversion by multiplying the quantity of API in each finished dosage form by the total amount of units reported stolen or lost to estimate the metric weight in grams of the controlled substance being diverted. This estimate of diversion from the legitimate supply chain for each of the covered controlled substances is displayed in Table 2. This data contributed to the final diversion estimates set forth in Table 3.

In accordance with 21 U.S.C. 826(i), DEA's estimate of diversion for the five controlled substances was calculated by combining the values in Tables 1b and 2. DEA reduced the APQ for each covered controlled substance by the quantities listed in Table 3.

DEA is committed to ensuring that all Americans can access appropriately prescribed medications. As part of this commitment, DEA undertook work to understand the supply chain dynamics for controlled substances subject to quotas over the last year and a half, especially in highly genericized markets. Based on that review, DEA observed various challenges in the quota allocation process stemming from the lack of real-time inventory and sales data accessible to DEA, the lack of information on manufacturers' production lead times, and issues of timeliness in ARCOS reporting.

Relatedly, beginning in the latter half of 2022, the DEA and FDA observed an increase in the number of drug shortages reported by manufacturers of schedule II stimulants including mixed-salt amphetamine products starting in April 2022 and lisdexamfetamine and methylphenidate starting in July 2023. As DEA and FDA stated in their open letter, 13 we remain committed to doing all we can to prevent stimulant drug shortages, limit their impact, and resolve them as quickly as possible.

DEA commissioned two reports by IQVIA  14 in order to understand the demographic shifts impacting the prescribing of schedule II stimulants. The reports provided valuable insights. Chief among those insights was the observed increase in prescriptions dispensed for mixed-salt amphetamine products to adults between the ages of 31-40 years, particularly women, and older patients (71-80 years old), particularly during the COVID-19 pandemic ( i.e. 2020 and 2021). In contrast, during 2022, dispensed prescriptions for products containing methylphenidate HCl and dexmethylphenidate HCl had a higher annual increase in 2022 (than in 2021) as compared to mixed-salt amphetamine products which may be indicative of product switching from amphetamine to methylphenidate and dexmethylphendiate. Neither DEA nor FDA anticipated these changes.

In addition to these demographic shifts in prescribing, DEA also evaluated inventory, manufacturing, and sales data submitted by manufacturers through ARCOS and through reports submitted to DEA's Quota Management System. That analysis revealed that dosage manufacturers of amphetamine did not utilize the full extent of their authorized quotas. DEA authorized amphetamine medication dosage form manufacturers across the entire market to purchase and use 38,418 kilograms of amphetamine but those manufacturers initially  15 reported the purchase of only 31,539 kg. Of that quantity, dosage manufacturers only shipped 26,953 kg of amphetamine medications.

This ongoing work has led DEA to conclude that changes to its regulations likely will be useful in developing more precise quotas that will provide for the estimated medical, scientific, research, and industrial needs of the United States, for lawful export requirements, and for the establishment and maintenance of reserve stocks, while also reducing opportunities for diversion. For instance, DEA believes that changes to reporting requirements are necessary to improve both the type of data collected and the timeliness of that data, allowing DEA to be more nimble in its administration of the quota program. Future regulatory changes may seek to address the lack of real-time inventory and sales data accessible to DEA, the lack of information on production lead times, and issues of timeliness in ARCOS reporting, by considering, for example, requiring manufacturers to provide anticipated production timelines and monthly ARCOS reporting. DEA is not seeking comments on these concepts through this notice, but will publish detailed proposals for comment in the future.

DEA also will seek additional information that will assist the agency to more accurately forecast export requirements, especially for those substances that are not controlled internationally. 16 DEA understands that manufacturers have contractual obligations that dictate business decisions regarding the quantities of finished dosage forms they will produce under a single DEA-issued quota, which applies to products manufactured with an active ingredient, whether for domestic or foreign markets. DEA also is exploring the purchase of third-party data to improve its understanding of the dynamic changes in foreign markets. Building off the recently issued quota management rule, 17 DEA also intends to add new subcategories to individual manufacturing quotas and procurement quotas, to distinguish between domestic requirements and export requirements.

DEA also is considering methods by which it might increase transparency in its quota setting process. Future regulatory proposals may define additional steps, including such concepts as public notification and an opportunity for public input when prescribing rates for controlled substances deviate substantially from FDA's estimate of future use. Furthermore, DEA is considering regulatory changes which will authorize it to reduce a manufacturer's individual manufacturing or procurement quota in order to apportion it to another manufacturer. As with the regulatory changes mentioned above, DEA will welcome comment on detailed proposals in the future, and is not requesting comment on these general concepts in this notice.

The abovementioned regulatory changes will take time. In the meantime, for the 2024 quota year, DEA intends to allocate procurement quotas to DEA-registered manufacturers of schedule II controlled substances on a quarterly basis. In order to address domestic drug shortages of controlled substances, procurement quota allocations for schedule II controlled substances will be divided between quantities authorized for domestic sales and quantities authorized for export sales. DEA will be sending a letter to each manufacturer with instructions on the data that will be necessary to allow DEA to process subsequent quarterly procurement quota allocations. DEA may publish or post how many companies have been allocated quota in a given calendar year, and how many of those companies have utilized their allocated quota. Further, DEA may publish or post the names of the companies that have been allocated quota.

The Administrator, therefore, proposes to establish the 2024 APQ for certain schedule I and II controlled substances and AAN for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine, expressed in grams of anhydrous acid or base, as follows: