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 Liliana Schiller, Support Services Specialist, at 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 Melissa Wojnaroski at mwojnaroski@usccr.gov. Persons who desire additional information may contact the Regional Programs Coordination Unit at (202) 618-4158.

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 the file sharing website, www.box.com. Persons interested in the work of this Committee are directed to the Commission's website, http://www.usccr.gov, or may contact the Regional Programs Coordination Unit at the above phone number.

Background

On October 28, 2024, pursuant to section 702(h) of the Trade Agreements Act of 1979, as amended (the Act), Commerce published the quarterly update to the annual listing of foreign government subsidies on articles of cheese subject to an in-quota rate of duty covering the period April 1, 2024, through June 30, 2024. 1 In the Second Quarter 2024 Update, we requested that any party that had information on foreign government subsidy programs that benefited articles of cheese subject to an in-quota rate of duty submit such information to Commerce. 2 We received no comments, information, or requests for consultation from any party.

Pursuant to section 702(h) of the Act, we hereby provide Commerce's update of subsidies on articles of cheese that were imported during the period July 1, 2024, through September 30, 2024. The appendix to this notice lists the country, the subsidy program or programs, and the gross and net amounts of each subsidy for which information is currently available. Commerce will incorporate additional programs which are found to constitute subsidies, and additional information on the subsidy programs listed, as the information is developed.

This determination and notice are in accordance with section 702(a) of the Act.

Each year during the anniversary month of the publication of an antidumping duty (AD) or countervailing duty (CVD) 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 AD or CVD 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 (POR). 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 AD 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 AD 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 responses.

Opportunity To Request a Review: Not later than the last day of February 2025, 2 interested parties may request administrative review of the following orders, findings, or suspended investigations, with anniversary dates in February for the following periods:

None.

In accordance with 19 CFR 351.213(b), an interested party as defined by section 771(9) of the Act may request in writing that Commerce conduct an administrative review. For both AD and CVD reviews, the interested party must specify the individual producers or exporters covered by an AD finding or an AD or CVD order or suspension agreement for which it is requesting a review. In addition, a domestic interested party or an interested party described in section 771(9)(B) of the Act must state why it desires Commerce to review those particular producers or exporters. If the interested party intends for Commerce to review sales of merchandise by an exporter (or a producer if that producer also exports merchandise from other suppliers) which was produced in more than one country of origin and each country of origin is subject to a separate order, then the interested party must state specifically, on an order-by-order basis, which exporter(s) the request is intended to cover.

Note that, for any party Commerce was unable to locate in prior segments, Commerce will not accept a request for an administrative review of that party absent new information as to the party's location. Moreover, if the interested party who files a request for review is unable to locate the producer or exporter for which it requested the review, the interested party must provide an explanation of the attempts it made to locate the producer or exporter at the same time it files its request for review, in order for Commerce to determine if the interested party's attempts were reasonable, pursuant to 19 CFR 351.303(f)(3)(ii).

As explained in Antidumping and Countervailing Duty Proceedings: Assessment of Antidumping Duties, 68 FR 23954 (May 6, 2003), and Non-Market Economy Antidumping Proceedings: Assessment of Antidumping Duties, 76 FR 65694 (October 24, 2011), Commerce clarified its practice with respect to the collection of final antidumping duties on imports of merchandise where intermediate firms are involved. The public should be aware of this clarification in determining whether to request an administrative review of merchandise subject to antidumping findings and orders. 3

Commerce no longer considers the non-market economy (NME) entity as an exporter conditionally subject to an AD administrative review. 4 Accordingly, the NME entity will not be under review unless Commerce specifically receives a request for, or self-initiates, a review of the NME entity. 5 In administrative reviews of AD orders on merchandise from NME countries where a review of the NME entity has not been initiated, but where an individual exporter for which a review was initiated does not qualify for a separate rate, Commerce will issue a final decision indicating that the company in question is part of the NME entity. However, in that situation, because no review of the NME entity was conducted, the NME entity's entries were not subject to the review and the rate for the NME entity is not subject to change as a result of that review (although the rate for the individual exporter may change as a function of the finding that the exporter is part of the NME entity). Following initiation of an AD administrative review when there is no review requested of the NME entity, Commerce will instruct CBP to liquidate entries for all exporters not named in the initiation notice, including those that were suspended at the NME entity rate.

All requests must be filed electronically in Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS) on Enforcement and Compliance's ACCESS website at https://access.trade.gov. 6 Further, in accordance with 19 CFR 351.303(f)(l)(i), a copy of each request must be served on the petitioner and each exporter or producer specified in the request. Note that Commerce has amended certain of its requirements pertaining to the service of documents in 19 CFR 351.303(f). 7

Commerce will publish in the Federal Register a notice of “Initiation of Administrative Review of Antidumping or Countervailing Duty Order, Finding, or Suspended Investigation” for requests received by the last day of February 2025. If Commerce does not receive, by the last day of February 2025, a request for review of entries covered by an order, finding, or suspended investigation listed in this notice and for the period identified above, Commerce will instruct CBP to assess antidumping or countervailing duties on those entries at a rate equal to the cash deposit of estimated antidumping or countervailing duties required on those entries at the time of entry, or withdrawal from warehouse, for consumption and to continue to collect the cash deposit previously ordered.

For the first administrative review of any order, there will be no assessment of antidumping or countervailing duties on entries of subject merchandise entered, or withdrawn from warehouse, for consumption during the relevant provisional-measures “gap” period of the order, if such a gap period is applicable to the period of review.

On September 20, 2021, Commerce published the final rule titled “ Regulations to Improve Administration and Enforcement of Antidumping and Countervailing Duty Laws” in the Federal Register . 8 On September 27, 2021, Commerce also published the notice entitled “ Scope Ruling Application; Annual Inquiry Service List; and Informational Sessions” in the Federal Register . 9 The Final Rule and Procedural Guidance provide that Commerce will maintain an annual inquiry service list for each order or suspended investigation, and any interested party submitting a scope ruling application or request for circumvention inquiry shall serve a copy of the application or request on the persons on the annual inquiry service list for that order, as well as any companion order covering the same merchandise from the same country of origin. 10

In accordance with the Procedural Guidance, for orders published in the Federal Register before November 4, 2021, Commerce created an annual inquiry service list segment for each order and suspended investigation. Interested parties who wished to be added to the annual inquiry service list for an order submitted an entry of appearance to the annual inquiry service list segment for the order in ACCESS and, on November 4, 2021, Commerce finalized the initial annual inquiry service lists for each order and suspended investigation. Each annual inquiry service list has been saved as a public service list in ACCESS, under each case number, and under a specific segment type called “AISL-Annual Inquiry Service List.”  11

As mentioned in the Procedural Guidance, beginning in January 2022, Commerce will update these annual inquiry service lists on an annual basis when the Opportunity Notice for the anniversary month of the order or suspended investigation is published in the Federal Register . 12 Accordingly, Commerce will update the annual inquiry service lists for the above-listed AD and CVD proceedings. All interested parties wishing to appear on the updated annual inquiry service list must take one of the two following actions: (1) new interested parties who did not previously submit an entry of appearance must submit a new entry of appearance at this time; (2) interested parties who were included in the preceding annual inquiry service list must submit an amended entry of appearance to be included in the next year's annual inquiry service list. For these interested parties, Commerce will change the entry of appearance status from “Active” to “Needs Amendment” for the annual inquiry service lists corresponding to the above-listed proceedings. This will allow those interested parties to make any necessary amendments and resubmit their entries of appearance. If no amendments need to be made, the interested party should indicate in the area on the ACCESS form requesting an explanation for the amendment that it is resubmitting its entry of appearance for inclusion in the annual inquiry service list for the following year. As mentioned in the Final Rule, 13 once the petitioners and foreign governments have submitted an entry of appearance for the first time, they will automatically be added to the updated annual inquiry service list each year.

Interested parties have 30 days after the date of this notice to submit new or amended entries of appearance. Commerce will then finalize the annual inquiry service lists five business days thereafter. For ease of administration, please note that Commerce requests that law firms with more than one attorney representing interested parties in a proceeding designate a lead attorney to be included on the annual inquiry service list.

Commerce may update an annual inquiry service list at any time as needed based on interested parties' amendments to their entries of appearance to remove or otherwise modify their list of members and representatives, or to update contact information. Any changes or announcements pertaining to these procedures will be posted to the ACCESS website at https://access.trade.gov.

In the Final Rule, Commerce stated that, “after an initial request and placement on the annual inquiry service list, both petitioners and foreign governments will automatically be placed on the annual inquiry service list in the years that follow.”  14 Accordingly, as stated above and pursuant to 19 CFR 351.225(n)(3), the petitioners and foreign governments will not need to resubmit their entries of appearance each year to continue to be included on the annual inquiry service list. However, the petitioners and foreign governments are responsible for making amendments to their entries of appearance during the annual update to the annual inquiry service list in accordance with the procedures described above.

This notice is not required by statute but is published as a service to the international trading community.

Every five years, pursuant to the Tariff Act of 1930, as amended (the Act), the U.S. Department of Commerce (Commerce) and the U.S. International Trade Commission automatically initiate and conduct reviews to determine whether revocation of a countervailing or antidumping duty order or termination of an investigation suspended under section 704 or 734 of the Act would be likely to lead to continuation or recurrence of dumping or a countervailable subsidy (as the case may be) and of material injury.

Pursuant to section 751(c) of the Act, the following Sunset Reviews are scheduled for initiation in March 2025 and will appear in that month's Notice of Initiation of Five-Year Sunset Reviews (Sunset Review).

No Sunset Review of suspended investigations is scheduled for initiation in March 2025.

Commerce's procedures for the conduct of Sunset Review are set forth in 19 CFR 351.218. The Notice of Initiation of Five-Year (Sunset) Review provides further information regarding what is required of all parties to participate in Sunset Review.

Pursuant to 19 CFR 351.103(c), Commerce will maintain and make available a service list for these proceedings. To facilitate the timely preparation of the service list(s), it is requested that those seeking recognition as interested parties to a proceeding contact Commerce in writing within 10 days of the publication of the Notice of Initiation.

Please note that if Commerce receives a Notice of Intent to Participate from a member of the domestic industry within 15 days of the date of initiation, the review will continue.

Thereafter, any interested party wishing to participate in the Sunset Review must provide substantive comments in response to the notice of initiation no later than 30 days after the date of initiation. Note that Commerce has amended certain of its requirements pertaining to the service of documents in 19 CFR 351.303(f). 1 An electronically filed document must be received successfully in its entirety by ACCESS by 5:00 p.m. Eastern Time on the day on which it is due.

In prior proceedings we have encouraged interested parties to provide an executive summary of their comments, including footnotes. In these sunset reviews, we request that interested parties provide at the beginning of their comments, an executive summary for each issue raised in their comments. Further, we request that interested parties limit their public executive summary of each issue to no more than 450 words, not including citations. We intend to use the public executive summaries as the basis of the comment summaries included in the decision memorandum that will accompany the notice to be published in the Federal Register . Finally, we request that interested parties include footnotes for relevant citations in the public executive summary of each issue.

This notice is not required by statute but is published as a service to the international trading community.

Commerce's procedures for the conduct of Sunset Reviews are set forth in its Procedures for Conducting Five-Year (Sunset) Reviews of Antidumping and Countervailing Duty Orders, 63 FR 13516 (March 20, 1998) and 70 FR 62061 (October 28, 2005). Guidance on methodological or analytical issues relevant to Commerce's conduct of Sunset Reviews is set forth in Antidumping Proceedings: Calculation of the Weighted-Average Dumping Margin and Assessment Rate in Certain Antidumping Duty Proceedings; Final Modification, 77 FR 8101 (February 14, 2012).

In accordance with section 751(c) of the Act and 19 CFR 351.218(c), we are initiating the Sunset Reviews of the following antidumping and countervailing duty order(s) and suspended investigation(s):

As a courtesy, we are making information related to sunset proceedings, including copies of the pertinent statute and Commerce's regulations, Commerce's schedule for Sunset Reviews, a listing of past revocations and continuations, and current service lists, available to the public on Commerce's website at the following address: https://enforcement.trade.gov/sunset/. All submissions in these Sunset Reviews must be filed in accordance with Commerce's regulations regarding format, translation, and service of documents. These rules, including electronic filing requirements via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS), can be found at 19 CFR 351.303.

In accordance with section 782(b) of the Act, any party submitting factual information in an AD/CVD proceeding must certify to the accuracy and completeness of that information. Parties must use the certification formats provided in 19 CFR 351.303(g). Commerce intends to reject factual submissions if the submitting party does not comply with applicable revised certification requirements.

Pursuant to 19 CFR 351.103(d), Commerce will maintain and make available a public service list for these proceedings. Parties wishing to participate in any of these five-year reviews must file letters of appearance as discussed at 19 CFR 351.103(d). To facilitate the timely preparation of the public service list, it is requested that those seeking recognition as interested parties to a proceeding submit an entry of appearance within 10 days of the publication of the Notice of Initiation. Because deadlines in Sunset Reviews can be very short, we urge interested parties who want access to proprietary information under administrative protective order (APO) to file an APO application immediately following publication in the Federal Register of this notice of initiation. Commerce's regulations on submission of proprietary information and eligibility to receive access to business proprietary information under APO can be found at 19 CFR 351.304-306. Note that Commerce has temporarily modified certain of its requirements for serving documents containing business proprietary information, until further notice. 1

Domestic interested parties, as defined in sections 771(9)(C), (D), (E), (F), and (G) of the Act and 19 CFR 351.102(b), wishing to participate in a Sunset Review must respond not later than 15 days after the date of publication in the Federal Register of this notice of initiation by filing a notice of intent to participate. The required contents of the notice of intent to participate are set forth at 19 CFR 351.218(d)(1)(ii). In accordance with Commerce's regulations, if we do not receive a notice of intent to participate from at least one domestic interested party by the 15-day deadline, Commerce will automatically revoke the order without further review. 2

If we receive an order-specific notice of intent to participate from a domestic interested party, Commerce's regulations provide that all parties wishing to participate in a Sunset Review must file complete substantive responses not later than 30 days after the date of publication in the Federal Register of this notice of initiation. The required contents of a substantive response, on an order-specific basis, are set forth at 19 CFR 351.218(d)(3). Note that certain information requirements differ for respondent and domestic parties. Also, note that Commerce's information requirements are distinct from the ITC's information requirements. Consult Commerce's regulations for information regarding Commerce's conduct of Sunset Reviews. Consult Commerce's regulations at 19 CFR part 351 for definitions of terms and for other general information concerning antidumping and countervailing duty proceedings at Commerce.

Note that Commerce has amended certain of its requirements pertaining to the service of documents in 19 CFR 351.303(f). 3 An electronically filed document must be received successfully in its entirety by ACCESS by 5:00 p.m. Eastern Time on the day on which it is due.

In prior proceedings we have encouraged interested parties to provide an executive summary of their comments, including footnotes. In these sunset reviews, we request that interested parties provide at the beginning of their comments, an executive summary for each issue raised in their comments. Further, we request that interested parties limit their public executive summary of each issue to no more than 450 words, not including citations. We intend to use the public executive summaries as the basis of the comment summaries included in the decision memorandum that will accompany the notice to be published in the Federal Register . Finally, we request that interested parties include footnotes for relevant citations in the public executive summary of each issue.

This notice of initiation is being published in accordance with section 751(c) of the Act and 19 CFR 351.218(c).

On December 5, 2024, Commerce published the Preliminary Results in the Federal Register . 1 We invited interested parties to comment on the Preliminary Results;   2 however, no interested party submitted comments. Accordingly, because we have made no changes to the Preliminary Results, the final results remain unchanged from the Preliminary Results and there is no decision memorandum accompanying this Federal Register notice.

On December 9, 2024, Commerce tolled the deadline to issue the final results in this administrative review by 90 days. 3 Accordingly, the deadline for these final results is now July 3, 2025. Commerce conducted this administrative review in accordance with section 751 of the Tariff Act of 1930, as amended (the Act).

The merchandise subject to the Order is thermal paper from Korea. For a complete description of the scope of the Order, see the Preliminary Results.

We determine that the following weighted-average dumping margin exists for the period November 1, 2022, through October 31, 2023:

Normally, Commerce discloses to interested parties the calculations performed in connection with the final results of review within five days of any public announcement or, if there is no public announcement, within five days of the date of publication of the notice of final results in the Federal Register , in accordance with 19 CFR 351.224(b). However, because Commerce made no changes from the Preliminary Results, there are no new calculations to disclose.

Pursuant to section 751(a)(2)(C) of the Act, and 19 CFR 351.212(b)(1), Commerce has determined, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries of subject merchandise in accordance with the final results of this review. Because the weighted-average dumping margin for Hansol Paper Company (Hansol) is zero, we will instruct CBP to liquidate the appropriate entries without regard to antidumping duties.

Commerce's “automatic assessment” practice will apply to entries of subject merchandise during the POR produced by Hansol for which the reviewed company did not know that the merchandise it sold to the intermediary ( e.g., a reseller, trading company, or exporter) was destined for the United States. In such instances, we will instruct CBP to liquidate unreviewed entries at the all-others rate ( i.e., 6.19 percent), 5 if there is no rate for the intermediate company(ies) involved in the transaction. 6

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

The following cash deposit requirements will be effective upon publication in the Federal Register of these final results of administrative review for all shipments of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the publication date, as provided by section 751(a)(2)(C) of the Act: (1) the cash deposit rate for the company listed above will be zero, as established in the final results of this review; (2) for previously reviewed or investigated companies not covered by this review, the cash deposit will continue to be the company-specific rate published for the most recently completed segment of this proceeding in which the company participated; (3) if the exporter is not a firm covered in this review, or the less-than-fair-value (LTFV) investigation, but the producer is, then the cash deposit rate will be the rate established for the most recently completed segment for the producer of the subject merchandise; and (4) the cash deposit rate for all other producers and exporters will continue to be 6.19 percent, the all-others rate established in the LTFV investigation. 7 These cash deposit requirements, when imposed, shall remain in effect until further notice.

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

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

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

The South Atlantic Council's Best Fishing Practices (BFP) Outreach Initiative was expanded in December 2022. Evaluation of the outreach efforts conducted is key in ensuring that the goal of increasing the use of BFP in the South Atlantic snapper grouper fishery is achieved. Fortunately, in recent years, there has become increased interest in exploring stakeholder perception and usage of BFP, namely barotrauma mitigation tools like descending devices. This workshop will explore the relationship between perceptions, norms, and the use of best practices, the effectiveness of best fishing practices outreach and education efforts, and how evaluation efforts can be used to support science and management processes.

These meetings are physically accessible to people with disabilities. Requests for auxiliary aids should be directed to the Council office (see ADDRESSES ) 5 days prior to the meeting.

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

The primary purpose of this online meeting is to provide a briefing for Pacific Council advisory body members and the public on the 2024-2025 California Current Ecosystem Status Report, which will be a topic on the Pacific Council's March 4-11, 2025 meeting agenda. In addition to providing this briefing, the EWG may discuss other items relevant to its work for the Pacific Council. A detailed meeting agenda will be available on the Pacific Council's website prior to the meeting.

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

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

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

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

Title: Protection of Collateral of Counterparties to Uncleared Swaps; Treatment of Securities in a Portfolio Margining Account in a Commodity Broker Bankruptcy (OMB Control No. 3038-0075). This is a request for an extension of a currently approved information collection.

Abstract: Section 4s(l) of the Commodity Exchange Act requires SDs and MSPs to notify uncleared swap counterparties that they have the right to require that any initial margin the counterparty provides in connection with such transaction be segregated, and to report quarterly to counterparties who have not requested segregated accounts that the back office procedures of the SD or MSP relating to margin and collateral comply with the agreement of the counterparties.

Regulations 23.701 and 23.704 establish reporting requirements that are mandated by Section 4s(l) and, thus, are necessary to implement the objectives of Section 4s(l). Regulation 23.701 requires that the SD or MSP notify the counterparty at the beginning of the swap trading relationship of the counterparty's right to require segregation of initial margin, and to permit the counterparty to change that election by written notice to the SD or MSP. Regulation 23.704 requires that, in certain circumstances, an SD or MSP must report to the counterparty, on a quarterly basis, that the back office procedures of the SD or MSP relating to margin and collateral requirements are in compliance with the agreement of the counterparties. The data required to be compiled and maintained pursuant to Regulations 23.701 and 23.704 would be used by uncleared swap counterparties (and, in some instances, the CFTC and self-regulatory organizations).

With respect to the collection of information, the CFTC invites comments on:

• Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information will have a practical use;

• The accuracy of the Commission's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

• Ways to enhance the quality, usefulness, and clarity of the information to be collected; and

• Ways to minimize the burden of collection of information on those who are to respond, including through the use of appropriate automated electronic, mechanical, or other technological collection techniques or other forms of information technology; e.g., permitting electronic submission of responses.

All comments must be submitted in English, or if not, accompanied by an English translation. Comments will be posted as received to https://www.cftc.gov/. You should submit only information that you wish to make available publicly. If you wish for the Commission to consider information that you believe is exempt from disclosure under the Freedom of Information Act, a petition for confidential treatment of the exempt information may be submitted according to the procedures established in § 145.9 of the Commission's regulations. 1

The Commission reserves the right, but shall have no obligation, to review, pre-screen, filter, redact, refuse or remove any or all of your submission from https://www.cftc.gov that it may deem to be inappropriate for publication, such as obscene language. All submissions that have been redacted or removed that contain comments on the merits of the Information Collection Request will be retained in the public comment file and will be considered as required under the Administrative Procedure Act and other applicable laws, and may be accessible under the Freedom of Information Act.

Burden Statement: The Commission is revising its estimate of the burden for this collection for 106 SDs. There are currently no registered MSPs. The respondents' burden for this collection is estimated to be as follows:

• Regulation 23.701:

Estimated Number of Respondents: 106.

Estimated Average Burden Hours per Respondent: 600 hours.

Estimated Total Annual Burden Hours: 63,600 hours.

Frequency of Collection: Beginning of the swap trading relationship with a counterparty.

• Regulation 23.704:

Estimated Number of Respondents: 106.

Estimated Average Burden Hours per Respondent: 806 hours.

Estimated Total Annual Burden Hours: 85,436 hours.

Frequency of Collection: Quarterly (4 times per year).

• Total Annual Burden for the Collection: 149,036 hours.

There are no capital costs or operating and maintenance costs associated with this collection.

Due to circumstances beyond the control of the Designated Federal Officer for the U.S. Army Science Board and the Department of Defense, the U.S. Army Science Board was unable to provide public notification required by 41 CFR 102-3.150(a) concerning its January 30, 2025, meeting. Accordingly, the Advisory Committee Management Officer for the Department of Defense, pursuant to 41 CFR 102-3.150(b), waives the 15-calendar day notification requirement.

The meeting will be held Pursuant to the Federal Advisory Committee Act (5 U.S.C. 1001-1014), the Government in the Sunshine Act of 1976 (5 U.S.C. 552b, as amended) and Title 41, Code of Federal Regulations (CFR) 102-3.140 through 160.

Purpose of Meeting: The purpose of the meeting is for ASB members to review, deliberate, and vote on the findings and recommendations presented for one Fiscal Year (FY) 2024 study and one FY 2025 study.

Agenda: The board will present findings and recommendations for deliberation and vote on the following studies:

“Data-Centric Command and Control (C2)”. The purpose of this FY2024 study is to assess the Army's implementation of a dynamic data-centric C2 framework in multi-domain operations. This briefing will include Controlled Unclassified Information (CUI) that contains trade secrets information exempted under 5 U.S.C. 552b(c)(4) and therefore will be presented in a closed session from 8:00 a.m.-9:00 a.m.

“An Assessment of the Army's Capability to provide Combat-Ready Forces”. The purpose of this study is to evaluate the U.S. Army's current organization and capability to provide combat-ready medical forces following the reorganization of the Department of Defense (DoD) medical enterprise under the Defense Health Agency (DHA). This FY25 study is unclassified and will be presented in an open session from 9:30 a.m.-10:30 a.m.

Public Accessibility to the Meeting: Pursuant to 5 U.S.C. 552b, as amended, and 41 CFR 102-3.140 through 102-3.165, and subject to the availability of space, this meeting is open to the public. Registration of members of the public who wish to attend the meeting will begin at 07:45 a.m. on the day of the meeting. Seating is limited and is on a first-to-arrive basis. Attendees will be asked to provide their name, title, affiliation, and contact information to include email address and daytime telephone number at registration. Any interested person may attend the meeting, file written comments or statements with the committee, or make verbal comments from the floor during the public meeting, at the times, and in the manner, permitted by the committee, as set forth below.

Special Accommodations: The meeting venue is fully handicap accessible, with wheelchair access. Individuals requiring special accommodations to access the public meeting or seeking additional information about public access procedures, should contact Mr. Vinson Bullard, the Alternate Designated Federal Official (ADFO) for the ASB, at the email addresses or telephone numbers listed in the FOR FURTHER INFORMATION CONTACT section, at least five (5) business days prior to the meeting so that appropriate arrangements can be made.

Written Comments or Statements: Pursuant to 41 CFR 102-3.105(j) and 102-3.140(c) and 5 U.S.C. 1009(a)(3), the public or interested organizations may submit written comments or statements to the ASB about its mission and/or the topics to be addressed in this public meeting. Written comments or statements should be submitted to Mr. Vinson Bullard, the ADFO of the ASB, via electronic mail, the preferred mode of submission, at the addresses listed in the FOR FURTHER INFORMATION CONTACT section in the following formats: Adobe Acrobat or Microsoft Word. The comment or statement must include the author's name, title, affiliation, address, and daytime telephone number. Written comments or statements being submitted in response to the agenda set forth in this notice must be received by the ADFO at least five (5) business days prior to the meeting so that they may be made available to the ASB for its consideration prior to the meeting. Written comments or statements received after this date may not be provided to the ASB until its next meeting. Please note that because the ASB operates under the provisions of the Federal Advisory Committee Act, as amended, all written comments will be treated as public documents and will be made available for public inspection.

Purpose: In accordance with the Government in the Sunshine Act (Sunshine Act), Public Law 94-409, as amended (5 U.S.C. 552b), the U.S. Election Assistance Commission (EAC) will conduct an open meeting on updates from the EAC's Election Supporting Technology Evaluation Program (ESTEP) and recent pilot efforts from the Field Services Program.

Agenda: During the meeting, the EAC's Commissioners will lead discussions with agency staff on updates. Other panelists will include election officials and election technology vendors.

The full agenda will be posted in advance on the EAC website: https://www.eac.gov.

The EAC will accept written comments and questions from members of the public. If you would like to participate, please email clearinghouse@eac.gov with your full name and question or comment no later than 9 a.m. ET on February 19, 2025.

Background: Under the authority of the Help America Vote Act of 2002 (HAVA), the EAC created the Election Supporting Technology Evaluation Program (ESTEP) to establish requirements and guidelines specific to election technologies that are not covered under the Voluntary Voting System Guidelines (VVSG), which includes electronic poll books, electronic ballot delivery systems, election night reporting systems, and voter registration systems.

As outlined in HAVA, the Field Services Program is derived from the EAC Testing and Certification division's Quality Monitoring Program, where the agency is positioned to assist states and local jurisdictions in the verification of EAC certified fielded systems on an ongoing basis. To best accomplish this, the program has a deployable, full-time staff of subject matter experts to proactively provide a combination of virtual and onsite services and training to help officials.

Status: This meeting will be open to the public.

This document extends the comment period for three actions published on December 3, 2024 and December 13, 2024. Comments for notice FRL-12241-02-OCSPP (89 FR 95779, December 3, 2024) now must be received on or before March 5, 2025. Comments for notices FRL-9941-02-OCSPP (89 FR 96650, December 5, 2024) and FRL-11244-01-OW (89 FR 10100, December 13, 2024) now must be received on or before April 4, 2025.

EPA may identify additional actions for reopening or extending comment periods in subsequent notices.

This document extends the public comment period for the notice “1,3-Butadiene; Draft Risk Evaluation Under the Toxic Substances Control Act (TSCA); Science Advisory Committee on Chemicals (SACC) Peer Review; Notice of SACC Meeting, Availability of Draft Documents and Request for Comment” established in the Federal Register document of December 3, 2024 (89 FR 957790) (FRL-12241-02-OCSPP), for 30 days. In that document, EPA announced the availability of and solicited public comment on the draft risk evaluation for 1,3-butadiene. The draft risk evaluation was prepared under the Toxic Substances Control Act (TSCA) and will be submitted to the Science Advisory Committee on Chemicals (SACC) for peer review. EPA also announced that there will be two virtual public meetings of the SACC: On February 4, 2025, a preparatory meeting for the SACC to consider the scope and clarity of the draft charge questions for the peer review; and on February 25 through 28, 2025, the peer review meeting for the SACC to consider the draft documents and public comments. Both public meetings will be rescheduled.

This document extends the public comment period for the notice “Atrazine; Updated Proposed Mitigation for the Interim Registration Review Decision; Notice of Availability and Request for Comment” established in the Federal Register document of December 5, 2024 (89 FR 96650) (FRL-9941-02-OCSPP), for 60 days. In that document, EPA announced the availability of and requested comment on EPA's proposed updates to the mitigation in the interim registration review decision for atrazine (Case Number 0062). The updated mitigation proposal for atrazine reflected in the memorandum released for comment incorporated the revised level of concern of 9.7 micrograms per liter (µg/L) as well as corrections to exposure modeling and feedback received during the 2022 public comment period. EPA released its updated mitigation proposal to reduce run-off/erosion, which will expand the number of options of mitigation measures growers can choose to implement to reduce potential exposure and risk to aquatic plant communities from atrazine runoff in vulnerable watersheds. The proposal includes placing mitigations on the product labeling, directing users to EPA's mitigation menu website and to the Bulletins Live! Two system. The Agency is not soliciting comment on any other aspects of the atrazine interim registration review decision.

This document extends the public comment period for the notice “National Pollutant Discharge Elimination System (NPDES) 2026 Issuance of the Multi-Sector General Permit for Stormwater Discharges Associated With Industrial Activity” established in the Federal Register document of December 12, 2024 (89 FR 101000) (FRL 11244-01-OW), for 60 days. In that document, all 10 EPA Regions proposed for public comment the 2026 National Pollutant Discharge Elimination System (NPDES) general permit for stormwater discharges associated with industrial activity, also referred to as the “2026 Multi-Sector General Permit (MSGP)” or the “proposed permit.” The proposed permit once finalized will replace the EPA's existing MSGP that expires on February 28, 2026. The EPA proposed to issue this permit for five (5) years. Once finalized, this permit will be available in areas where the EPA is the NPDES permitting authority. The EPA solicits comment on all aspects of the proposed general permit and seeks public comment on specific requests for information as described in the document. The public is encouraged to read the proposed permit fact sheet to better understand the proposed permit requirements.

EPA is extending these comment periods to allow interested parties additional time to thoroughly review and analyze how these notices may impact parties potentially subject to them. Comments previously submitted need not be resubmitted as they are already incorporated into the public record and will be considered in the final action as appropriate. Where appropriate, the Agency may consider further extending the comment period for the above referenced actions. To submit comments, or access the docket, please follow the detailed instructions provided under ADDRESSES . If you have questions, consult the technical person listed under FOR FURTHER INFORMATION CONTACT .

Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term “collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires federal agencies to publish a 30-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice that summarizes the following proposed collection(s) of information for public comment:

1. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Section 1115 Demonstration Projects Regulations at 42 CFR 431.408, 431.412, 431.420, 431.424, and 431.428; Use: This collection is necessary to ensure that states comply with regulatory and statutory requirements related to the development, implementation and evaluation of demonstration projects. States seeking waiver authority under Section 1115 are required to meet certain requirements for public notice, the evaluation of demonstration projects, and reports to the Secretary on the implementation of approved demonstrations. Form Number: CMS-10341 (OMB control number: 0938-1162); Frequency: Yearly and quarterly; Affected Public: State, Local, or Tribal Governments; Number of Respondents: 48; Total Annual Responses: 403; Total Annual Hours: 41,847. (For policy questions regarding this collection contact Raven Smith at 410-786-3731.)

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

This information collection helps implement statutory and regulatory requirements that govern the labeling of prescription drugs. FDA regulations codified in part 201 (21 CFR part 201), subpart B (§§ 201.50 through 201.58), apply to requisite labeling elements that include a statement of identity; a declaration of net quantity of contents; a statement of dosage; and specific content and formatting of information. The regulations also provide for requesting that FDA waive any requirement under §§ 201.56, 201.57, and 201.80. Since last approval of the information collection, FDA requested, and OMB approved, adding tasks provided for under § 201.25(d), requiring that manufacturers submit a written request for exemption from applicable barcode requirements, and tasks relating to exceptions or alternatives to the labeling requirements of products in the Strategic National Stockpile (SNS) as provided for in § 201.26, to the scope of the activity. Under the Public Health Service Act (PHS Act), the Department of Health and Human Services stockpiles medical products that are essential to the security of the Nation (section 319F-2 of the PHS Act (42 U.S.C. 247d-6b). Information regarding the SNS is available at the following website: www.phe.gov/about/sns/Pages/default.aspx.

Relevant information regarding applicable statutory and regulatory requirements are also discussed in topic-specific guidance documents issued consistent with 21 CFR 314.445, 21 CFR 601.29 (guidance documents), and Agency Good Guidance Practice regulations in 21 CFR 10.115, which provide for public comment at any time. The following guidance documents discuss activities included in the information collection:

“Safety Labeling Changes—Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act” (FD&C Act) (78 FR 45930, July 30, 2013). The guidance document includes instruction on communicating with FDA regarding labeling changes required under section 505(o)(4) (Section IV—Procedures) (21 U.S.C. 355(o)(4)) and is available for download from our website at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/safety-labeling-changes-implementation-section-505o4-federal-food-drug-and-cosmetic-act.

“Guidance for Industry on Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims” (76 FR 14024, March 15, 2011). The guidance document is intended to help respondents with developing labeling for cardiovascular outcome claims for drugs that are indicated to treat hypertension. The guidance document is available for download from our website at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/hypertension-indication-drug-labeling-cardiovascular-outcome-claims.

Respondents to the information collection are sponsors of product labeling subject to the applicable labeling requirements. We characterize the information collection activities as recordkeeping, consistent with 5 CFR 1320.3(m), noting that a recordkeeping requirement means a requirement to maintain specified records, including the requirement to retain and notify third parties, the Federal Government, or the public regarding such records. Regulations in part 201 govern the statement of ingredients and declaration of net quantity of contents regarding prescription drug product labeling. The regulations require that firms identify bulk or transport containers with the name of the product contained therein and that containers be accompanied by documentation that identifies the product as meeting applicable compendial standards. New drug product and biological product applicants must: (1) design and create prescription drug labeling containing “Highlights,” “Contents,” and “Full Prescribing Information”; (2) test the designed labeling (for example, to ensure that the designed labeling fits into carton-enclosed products); and (3) submit it to FDA for approval.

In the Federal Register of September 19, 2024 (89 FR 76853), we published a 60-day notice requesting public comment on the proposed collection of information. Although two comments were received, they were not responsive to the four collection of information topics solicited.

We estimate the burden of this information collection as follows:

Based on our evaluation, we have retained the currently approved estimate that 414 applicants will prepare an average of 549 prescription drug labels annually and assume it will require 3,349 hours to design, test, and submit to FDA as part of a new drug application or a biologics license application.

New medical gas containers must meet applicable requirements found in 21 CFR part 211, as well as specific labeling requirements in § 201.328. Consistent with statutory authority under the Consolidated Appropriations Act, 2017 (Pub. L. 115-31), we have revised the information collection to include burden associated new medical gas labeling requirements under § 201.161(b), established by final rule in the Federal Register of June 18, 2024 (89 FR 51738). We estimate 260 respondents will incur burden for the design, testing, production, and submission of labeling for new medical gas containers as established in § 201.328 and assume an average of 10 minutes (0.17) is required for these activities.

Based on our evaluation, few requests for exemption from barcode requirements are received, and we have therefore made no changes to the currently approved estimate for this activity. Likewise, we have also retained the currently approved estimate for information collection activities associated with safety labeling requirements established in section 505(o)(4) of the FD&C Act. Similarly, we retain the currently approved estimate for exceptions to labeling under § 201.26; however, this activity was previously approved in OMB control number 0910-0614 and is a new element to the collection, adding 1 response and 32 hours annually.

Finally, we have combined activity elements associated with labeling recommendations regarding drugs products that include a hypertension indication as discussed in the applicable March 2011 guidance referenced above, reducing the overall estimate for this element by 4 hours annually.

FDA is announcing the availability of two revised final guidances, “Recommendations to Reduce the Risk of Transmission of Disease Agents Associated with Sepsis by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)” and “Recommendations to Reduce the Risk of Transmission of Mycobacterium Tuberculosis (Mtb) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps).” These guidance documents were originally published in the Federal Register on January 7, 2025 (90 FR 1141; 90 FR 1170). Both guidances recommended that establishments making donor eligibility determinations (establishments) implement the recommendations in the guidances “as soon as feasible, but not later than 4 weeks after the guidance issue date.”

FDA is revising final guidances “Recommendations To Reduce the Risk of Transmission of Disease Agents Associated with Sepsis by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)” and “Recommendations To Reduce the Risk of Transmission of Mycobacterium Tuberculosis (Mtb) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)” to recommend implementation of the guidance recommendations on a longer timeframe, by May 4, 2025. The revised implementation date will permit FDA to consider the comments received thus far prior to the implementation date. Permitting the Agency additional time to further review and consider the guidances, including comments received, as well as seek additional comments is consistent with the President's January 20, 2025, memorandum entitled, “Regulatory Freeze Pending Review.” See paragraph 3 (directing agencies to consider postponing effective dates of certain rules “for the purpose of reviewing any questions of fact, law, and policy that the rules may raise”; “where appropriate and consistent with applicable law, consider opening a comment period to allow interested parties to provide comments about issues of fact, law, and policy raised by the rules postponed under this memorandum”; and consider further delaying such rules “where necessary to continue to review these questions of fact, law, and policy”).

FDA issued the guidance entitled “Recommendations To Reduce the Risk of Transmission of Disease Agents Associated with Sepsis by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)” to provide establishments making donor eligibility determinations with recommendations to reduce the risk of transmission of disease agents associated with sepsis for donors of human cells, tissues, and cellular and tissue-based products.

FDA issued the guidance entitled “Recommendations To Reduce the Risk of Transmission of Mycobacterium Tuberculosis (Mtb) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)” to assist establishments that make donor eligibility determinations for donors of human cells, tissues, and cellular and tissue-based products, with recommendations for screening donors for evidence of, and risk factors for, infection with Mtb, the organism that causes tuberculosis.

FDA is issuing these revised guidances consistent with our good guidance practices regulation (§ 10.115 (21 CFR 10.115)). We are implementing these revisions without prior public comment because we have determined that prior public participation is not feasible or appropriate (see § 10.115(g)(2) and section 701(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371(h)(1)(C)). We made this determination because the revisions present a less burdensome policy that is consistent with public health. Although these guidance documents are being implemented immediately, you can comment on any guidance at any time (§ 10.115(g)(5)). FDA has already received comments on the guidances discussed above, and the Agency intends to consider those comments. Please submit any additional comments regarding the guidances that you wish the Agency to consider, including whether it would be appropriate to reissue these guidances in draft form or consider a later implementation date.

While these guidance documents contain no collection of information, they do 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 21 CFR 1271 relating to HCT/Ps, including establishing and maintaining records, investigation and reporting of adverse actions and documentation of methods used in facilities related to HCT/Ps, which, includes but is not limited to donor screening, donor testing, and labeling have been approved under OMB control number 0910-0543.

Persons with access to the internet may obtain the guidances at https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

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

This information collection supports FDA's Biosimilars User Fee Program and implementation of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). The BPCI Act creates an abbreviated approval pathway for biological products shown to be biosimilar to or interchangeable with an FDA-licensed reference biological product. Section 351(k) of the Public Health Service Act (PHS Act) (42 U.S.C. 262(k)), added by the BPCI Act, allows a company to apply for licensure of a biosimilar or interchangeable biological product (351(k) application). The BPCI Act also amended section 735 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 379g) to include 351(k) applications as a type of application under “human drug application” for the purposes of the prescription drug user fee provisions. The FD&C Act as amended by the Biosimilar User Fee Amendments of 2022 (BsUFA III), reauthorizes FDA to assess and collect fees for biosimilar biological products from October 2022 through September 2027 to facilitate the development of safe and effective biosimilar products for the American public.

FDA maintains information on our website at https://www.fda.gov/industry/fda-user-fee-programs/biosimilar-user-fee-amendments regarding its BsUFA program. Also available on our website is the Biosimilars Action Plan (BAP), which discusses key actions the Agency is taking to encourage innovation and competition among biologics and the development of biosimilars. The BAP builds on progress in implementing the approval pathway for biosimilar and interchangeable products, and provides interested persons with updates on related deliverables and activities.

We have revised the information collection to reflect the currently agreed-upon performance goals established and captured in the latest reauthorization document entitled, “Biosimilar Biological Product Reauthorization Performance Goals and Procedures Fiscal Years 2023 Through 2027” (BsUFA Commitment Letter). The BsUFA Commitment Letter is available for download from our website at https://www.fda.gov/media/152279/download?attachment. The BsUFA Commitment Letter outlines current program goals, including information technology goals, discusses program effectiveness considerations, and discusses user fee resource management.

The information collection also includes Form FDA 3792, “Biosimilars User Fee Cover Sheet,” to be submitted by each new biological product development (BPD) entrant (identified via a new meeting request or investigational new drug submission) or new biologics license application (BLA) applicant. Form FDA 3792 requests the minimum information necessary to identify the request, to determine the amount of the fee to be assessed, and to account for and track user fees. Form FDA 3792 is completed electronically at https://userfees.fda.gov/OA_HTML/bsufaCAcdLogin.jsp, and a notification is emailed to the respondent that includes information regarding annual program fees. We are discontinuing use of the associated annual survey at this time.

Relatedly, Form FDA 3971 (Small Business Waiver and Refund Request), currently approved in OMB control number 0910-0297, may also be utilized. As instructed on our BsUFA web page, respondents should submit Form FDA 3971 by email to CDERCollections@fda.hhs.gov at least 4 months prior to the submission of the application to see if they qualify for a small business waiver. Finally, user fee refund and transfer requests, currently approved in OMB control number 0910- 0805, may be submitted to FDA using Forms FDA 3913 and FDA 3914, respectively.

Patent infringement notifications are also included in the scope of collection activity. Section 351(l) of the PHS Act provides for the exchange of patent information and resolution of patent disputes between a 351(k) biosimilar applicant and the holder of the 351(a) BLA reference product. If a biosimilar applicant is served with a complaint in an action for a patent infringement described in section 351(l)(6) of the PHS Act, the biosimilar applicant is required to provide the Secretary of HHS with notice and a copy of the complaint within 30 days of service. FDA is required to publish notice of a complaint received under section 351(l)(6)(C) of the PHS Act in the Federal Register .

Relevant information regarding applicable statutory requirements is discussed in topical guidance documents, issued consistent with our BsUFA Commitment Letter and Agency Good Guidance Practice regulations in 21 CFR 10.115, which provide for public comment at any time. The following draft and final guidance documents include instructional and procedural information on communicating with FDA regarding the BsUFA program:

• “Assessing User Fees Under the Biosimilar User Fee Amendments of 2022” (July 2023), available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/assessing-user-fees-under-biosimilar-user-fee-amendments-2022. The guidance document instructs respondents on requesting discontinuation from the BPD program, as well as requesting to move products to the discontinued section of the biosimilar list. The guidance document also provides information on the consequences of failing to pay BsUFA III fees as well as processes for submitting reconsideration and appeal requests.

• “Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products” (August 2023), available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/formal-meetings-between-fda-and-sponsors-or-applicants-bsufa-products-guidance-industry. The guidance document explains standardized procedures for requesting, preparing, scheduling, conducting, and documenting formal meetings with FDA, and discusses good meeting management practices.

• As listed on our Center for Drug Evaluation and Research 2023 and 2024 Annual Guidance agenda (available at: https://www.fda.gov/media/134778/download ), we are planning to issue a draft guidance for industry entitled “Pediatric Study Plans for Biosimilar Products,” to help implement provisions of the Pediatric Research Equity Act, codified in section 505B of the FD&C Act (21 U.S.C. 355c). For more information regarding FDA guidance documents, including ways to participate, please visit https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs.

Description of Respondents: Sponsors and applicants who have or intend to submit an application for a biosimilar product for licensure under section 351(k) of the PHS Act or who intend to submit an initial pediatric study plan (iPSP) as described in section 505B(e) of the FD&C Act for those products intended to be licensed under section 351(k) of the PHS Act and being developed as a proposed biosimilar to a reference product.

In the Federal Register of September 23, 2024 (89 FR 77531), we published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.

We estimate the burden of this information collection as follows:

Our estimated burden for the information collection reflects an overall increase of 13,069 hours and 105 responses annually. Although part of the increase may be attributed to the inclusion of burden associated with the submission of pediatric study plans, the majority of adjustments correspond with an increase in submissions we are receiving.

The Immigration and Nationality Act (INA) authorizes the Secretary, after consultation with appropriate U.S. Government agencies, to designate a foreign state (or part thereof) for TPS if the Secretary determines that certain country conditions exist. INA 244(b)(1), 8 U.S.C. 1254a(b)(1). 1 The determination whether to designate any foreign state (or part thereof) for TPS is discretionary, and there is no judicial review of “any determination of the [Secretary] with respect to the designation, or termination or extension of a designation, of a foreign state” for TPS. INA 244(b)(5)(A), 8 U.S.C. 1254a(b)(5)(A). The Secretary, in the Secretary's discretion, may then grant TPS to eligible nationals of that foreign state (or individual aliens having no nationality who last habitually resided in the designated foreign state). See INA 244(a)(1)(A), 8 U.S.C. 1254a(a)(1)(A).

At least 60 days before the expiration of a foreign state's TPS designation or extension, the Secretary, after consultation with appropriate U.S. Government agencies, must review the conditions in the foreign state designated for TPS to determine whether they continue to meet the conditions for the TPS designation. See INA 244(b)(3)(A), 8 U.S.C. 1254a(b)(3)(A). If the Secretary determines that the conditions in the foreign state continue to meet the conditions for TPS designation, the designation will be extended for an additional period of 6 months or, in the Secretary's discretion, 12 or 18 months. See INA 244(b)(3)(A), (C), 8 U.S.C. 1254a(b)(3)(A), (C). If the Secretary determines that the foreign state no longer meets the conditions for TPS designation, the Secretary must terminate the designation. See INA 244(b)(3)(B), 8 U.S.C. 1254a(b)(3)(B).

On March 9, 2021, Secretary Mayorkas designated Venezuela for TPS on the basis of extraordinary and temporary conditions in Venezuela that prevented nationals of Venezuela from returning in safety (2021 designation). See Designation of Venezuela for Temporary Protected Status and Implementation of Employment Authorization for Venezuelans Covered by Deferred Enforced Departure, 86 FR 13574 (Mar. 9, 2021).

On September 8, 2022, DHS extended the Venezuela 2021 TPS designation for 18 months. See Extension of the Designation of Venezuela for Temporary Protected Status, 87 FR 55024 (Sept. 8, 2022). On October 3, 2023, DHS extended the Venezuela 2021 TPS designation for another 18 months with an expiration date of September 10, 2025, and separately newly designated Venezuela, which then Secretary Mayorkas called a “redesignation,” for 18 months (the Venezuela 2023 designation) with an expiration of April 2, 2025, resulting in two separate and concurrent Venezuela TPS designations. See Extension and Redesignation of Venezuela for Temporary Protected Status, 88 FR 68130 (Oct. 3, 2023).

The Venezuela 2023 TPS designation expires on April 2, 2025, and the Secretary must make a decision by February 1, 2025. The Venezuela 2021 TPS designation expires on September 10, 2025, and the Secretary must make a decision by July 12, 2025. Notwithstanding the fact that these are both decisions that would lie with new Secretary of Homeland Security Kristi Noem, Secretary Mayorkas took action with respect to both designations.

On January 17, 2025, Secretary Mayorkas issued a notice extending the 2023 designation of Venezuela for TPS for 18 months (Mayorkas Notice). The notice was based on Secretary Mayorkas' January 10, 2025, determination that the conditions for the designation continued to be met. See INA 244(b)(3)(A), 8 U.S.C. 1254a(b)(3)(A). In the Mayorkas Notice, Secretary Mayorkas did not expressly extend or terminate the 2021 designation. Instead, the notice allowed for a consolidation of filing processes such that all eligible Venezuela TPS beneficiaries (whether under the 2021 or 2023 designations) could obtain TPS through the same extension date of October 2, 2026. See Extension of the 2023 Designation of Venezuela for Temporary Protected Status, 90 FR 5961 (Jan. 17, 2025). The notice also extended certain EADs. The effect of Secretary Mayorkas' actions, however, resulted in an extension of the 2021 Venezuela TPS designation.

The Secretary of Homeland Security is vacating the January 10, 2025 decision of Secretary Mayorkas which (1) extended the 2023 Venezuela TPS designation and (2) allowed the consolidation of filing processes for both designations, which had the effect of extending the 2021 Venezuela TPS designation, and (3) extended certain EADs. An agency has inherent (that is, statutorily implicit) authority to revisit its prior decisions unless Congress has expressly limited that authority. The TPS statute does not limit the Secretary's inherent authority under the INA to reconsider any TPS-related determination, and upon reconsideration, to vacate or amend the determination. 2

Background. —On April 14, 2009, the Department of Commerce (“Commerce”) issued an antidumping duty order on imports of steel threaded rod from China (74 FR 17154). Commerce issued a continuation of the antidumping duty order on imports of steel threaded rod from China following Commerce's and the Commission's first five-year reviews, effective August 19, 2014 (79 FR 49050) and second five-year reviews, effective March 9, 2020 (85 FR 13625). The Commission is now conducting a third five-year review pursuant to section 751(c) of the Act, as amended (19 U.S.C. 1675(c)), to determine whether revocation of the order would be likely to lead to continuation or recurrence of material injury to the domestic industry within a reasonably foreseeable time. Provisions concerning the conduct of this proceeding may be found in the Commission's Rules of Practice and Procedure at 19 CFR part 201, subparts A and B, and 19 CFR part 207, subparts A and F. The Commission will assess the adequacy of interested party responses to this notice of institution to determine whether to conduct a full or expedited review. The Commission's determination in any expedited review will be based on the facts available, which may include information provided in response to this notice.

Definitions. —The following definitions apply to this review:

(1) Subject Merchandise is the class or kind of merchandise that is within the scope of the five-year review, as defined by Commerce.

(2) The Subject Country in this review is China.

(3) The Domestic Like Product is the domestically produced product or products which are like, or in the absence of like, most similar in characteristics and uses with, the Subject Merchandise. In its original determination and its expedited first and second five-year review determinations, the Commission defined a single Domestic Like Product consisting of certain steel threaded rod, coextensive with Commerce's scope.

(4) The Domestic Industry is the U.S. producers as a whole of the Domestic Like Product, or those producers whose collective output of the Domestic Like Product constitutes a major proportion of the total domestic production of the product. In its original determination and its expedited first and second five-year review determinations, the Commission defined a single Domestic Industry consisting of all U.S. producers of certain steel threaded rod.

(5) An Importer is any person or firm engaged, either directly or through a parent company or subsidiary, in importing the Subject Merchandise into the United States from a foreign manufacturer or through its selling agent.

Participation in the proceeding and public service list. —Persons, including industrial users of the Subject Merchandise and, if the merchandise is sold at the retail level, representative consumer organizations, wishing to participate in the proceeding as parties must file an entry of appearance with the Secretary to the Commission, as provided in § 201.11(b)(4) of the Commission's rules, no later than 21 days after publication of this notice in the Federal Register . The Secretary will maintain a public service list containing the names and addresses of all persons, or their representatives, who are parties to the proceeding.

Former Commission employees who are seeking to appear in Commission five-year reviews are advised that they may appear in a review even if they participated personally and substantially in the corresponding underlying original investigation or an earlier review of the same underlying investigation. The Commission's designated agency ethics official has advised that a five-year review is not the same particular matter as the underlying original investigation, and a five-year review is not the same particular matter as an earlier review of the same underlying investigation for purposes of 18 U.S.C. 207, the post-employment statute for Federal employees, and Commission rule 201.15(b) (19 CFR 201.15(b)), 79 FR 3246 (Jan. 17, 2014), 73 FR 24609 (May 5, 2008). Consequently, former employees are not required to seek Commission approval to appear in a review under Commission rule 19 CFR 201.15, even if the corresponding underlying original investigation or an earlier review of the same underlying investigation was pending when they were Commission employees. For further ethics advice on this matter, contact Charles Smith, Office of the General Counsel, at 202-205-3408.

Limited disclosure of business proprietary information (BPI) under an administrative protective order (APO) and APO service list. —Pursuant to § 207.7(a) of the Commission's rules, the Secretary will make BPI submitted in this proceeding available to authorized applicants under the APO issued in the proceeding, provided that the application is made no later than 21 days after publication of this notice in the Federal Register . Authorized applicants must represent interested parties, as defined in 19 U.S.C. 1677(9), who are parties to the proceeding. A separate service list will be maintained by the Secretary for those parties authorized to receive BPI under the APO.

Certification. —Pursuant to § 207.3 of the Commission's rules, any person submitting information to the Commission in connection with this proceeding must certify that the information is accurate and complete to the best of the submitter's knowledge. In making the certification, the submitter will acknowledge that information submitted in response to this request for information and throughout this proceeding or other proceeding may be disclosed to and used: (i) by the Commission, its employees and Offices, and contract personnel (a) for developing or maintaining the records of this or a related proceeding, or (b) in internal investigations, audits, reviews, and evaluations relating to the programs, personnel, and operations of the Commission including under 5 U.S.C. Appendix 3; or (ii) by U.S. government employees and contract personnel, solely for cybersecurity purposes. All contract personnel will sign appropriate nondisclosure agreements.

Written submissions. —Pursuant to § 207.61 of the Commission's rules, each interested party response to this notice must provide the information specified below. The deadline for filing such responses is 5:15 p.m. on March 5, 2025. Pursuant to § 207.62(b) of the Commission's rules, eligible parties (as specified in Commission rule 207.62(b)(1)) may also file comments concerning the adequacy of responses to the notice of institution and whether the Commission should conduct an expedited or full review. The deadline for filing such comments is 5:15 p.m. on April 17, 2025. All written submissions must conform with the provisions of § 201.8 of the Commission's rules; any submissions that contain BPI must also 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. Also, in accordance with §§ 201.16(c) and 207.3 of the Commission's rules, each document filed by a party to the proceeding must be served on all other parties to the proceeding (as identified by either the public or APO service list as appropriate), and a certificate of service must accompany the document (if you are not a party to the proceeding you do not need to serve your response).

Please note the Secretary's Office will accept only electronic filings at this time. Filings must be made through the Commission's Electronic Document Information System (EDIS, https://edis.usitc.gov ). No in-person paper-based filings or paper copies of any electronic filings will be accepted until further notice.

No response to this request for information is required if a currently valid Office of Management and Budget (“OMB”) number is not displayed; the OMB number is 3117 0016/USITC No. 24-5-629, expiration date June 30, 2026. Public reporting burden for the request is estimated to average 15 hours per response. Please send comments regarding the accuracy of this burden estimate to the Office of Investigations, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436.

Inability to provide requested information. —Pursuant to § 207.61(c) of the Commission's rules, any interested party that cannot furnish the information requested by this notice in the requested form and manner shall notify the Commission at the earliest possible time, provide a full explanation of why it cannot provide the requested information, and indicate alternative forms in which it can provide equivalent information. If an interested party does not provide this notification (or the Commission finds the explanation provided in the notification inadequate) and fails to provide a complete response to this notice, the Commission may take an adverse inference against the party pursuant to § 776(b) of the Act (19 U.S.C. 1677e(b)) in making its determination in the review.

Information To Be Provided in Response to This Notice of Institution: As used below, the term “firm” includes any related firms.

Those responding to this notice of institution are encouraged, but not required, to visit the USITC's website at https://usitc.gov/reports/response_noi_worksheet, where one can download and complete the “NOI worksheet” Excel form for the subject proceeding, to be included as attachment/exhibit 1 of your overall response.

(1) The name and address of your firm or entity (including World Wide Web address) and name, telephone number, fax number, and email address of the certifying official.

(2) A statement indicating whether your firm/entity is an interested party under 19 U.S.C. 1677(9) and if so, how, including whether your firm/entity is a U.S. producer of the Domestic Like Product, a U.S. union or worker group, a U.S. importer of the Subject Merchandise, a foreign producer or exporter of the Subject Merchandise, a U.S. or foreign trade or business association (a majority of whose members are interested parties under the statute), or another interested party (including an explanation). If you are a union/worker group or trade/business association, identify the firms in which your workers are employed or which are members of your association.

(3) A statement indicating whether your firm/entity is willing to participate in this proceeding by providing information requested by the Commission.

(4) A statement of the likely effects of the revocation of the antidumping duty order on the Domestic Industry in general and/or your firm/entity specifically. In your response, please discuss the various factors specified in section 752(a) of the Act (19 U.S.C. 1675a(a)) including the likely volume of subject imports, likely price effects of subject imports, and likely impact of imports of Subject Merchandise on the Domestic Industry.

(5) A list of all known and currently operating U.S. producers of the Domestic Like Product. Identify any known related parties and the nature of the relationship as defined in section 771(4)(B) of the Act (19 U.S.C. 1677(4)(B)).

(6) A list of all known and currently operating U.S. importers of the Subject Merchandise and producers of the Subject Merchandise in the Subject Country that currently export or have exported Subject Merchandise to the United States or other countries after 2018.

(7) A list of 3-5 leading purchasers in the U.S. market for the Domestic Like Product and the Subject Merchandise (including street address, World Wide Web address, and the name, telephone number, fax number, and email address of a responsible official at each firm).

(8) A list of known sources of information on national or regional prices for the Domestic Like Product or the Subject Merchandise in the U.S. or other markets.

(9) If you are a U.S. producer of the Domestic Like Product, provide the following information on your firm's operations on that product during calendar year 2024, except as noted (report quantity data in pounds and value data in U.S. dollars, f.o.b. plant). If you are a union/worker group or trade/business association, provide the information, on an aggregate basis, for the firms in which your workers are employed/which are members of your association.

(a) Production (quantity) and, if known, an estimate of the percentage of total U.S. production of the Domestic Like Product accounted for by your firm's(s') production;

(b) Capacity (quantity) of your firm to produce the Domestic Like Product (that is, the level of production that your establishment(s) could reasonably have expected to attain during the year, assuming normal operating conditions (using equipment and machinery in place and ready to operate), normal operating levels (hours per week/weeks per year), time for downtime, maintenance, repair, and cleanup, and a typical or representative product mix);

(c) the quantity and value of U.S. commercial shipments of the Domestic Like Product produced in your U.S. plant(s);

(d) the quantity and value of U.S. internal consumption/company transfers of the Domestic Like Product produced in your U.S. plant(s); and

(e) the value of (i) net sales, (ii) cost of goods sold (COGS), (iii) gross profit, (iv) selling, general and administrative (SG&A) expenses, and (v) operating income of the Domestic Like Product produced in your U.S. plant(s) (include both U.S. and export commercial sales, internal consumption, and company transfers) for your most recently completed fiscal year (identify the date on which your fiscal year ends).

(10) If you are a U.S. importer or a trade/business association of U.S. importers of the Subject Merchandise from the Subject Country, provide the following information on your firm's(s') operations on that product during calendar year 2024 (report quantity data in pounds and value data in U.S. dollars). If you are a trade/business association, provide the information, on an aggregate basis, for the firms which are members of your association.

(a) The quantity and value (landed, duty-paid but not including antidumping duties) of U.S. imports and, if known, an estimate of the percentage of total U.S. imports of Subject Merchandise from the Subject Country accounted for by your firm's(s') imports;

(b) the quantity and value (f.o.b. U.S. port, including antidumping duties) of U.S. commercial shipments of Subject Merchandise imported from the Subject Country; and

(c) the quantity and value (f.o.b. U.S. port, including antidumping duties) of U.S. internal consumption/company transfers of Subject Merchandise imported from the Subject Country.

(11) If you are a producer, an exporter, or a trade/business association of producers or exporters of the Subject Merchandise in the Subject Country, provide the following information on your firm's(s') operations on that product during calendar year 2024 (report quantity data in pounds and value data in U.S. dollars, landed and duty-paid at the U.S. port but not including antidumping duties). If you are a trade/business association, provide the information, on an aggregate basis, for the firms which are members of your association.

(a) Production (quantity) and, if known, an estimate of the percentage of total production of Subject Merchandise in the Subject Country accounted for by your firm's(s') production;

(b) Capacity (quantity) of your firm(s) to produce the Subject Merchandise in the Subject Country (that is, the level of production that your establishment(s) could reasonably have expected to attain during the year, assuming normal operating conditions (using equipment and machinery in place and ready to operate), normal operating levels (hours per week/weeks per year), time for downtime, maintenance, repair, and cleanup, and a typical or representative product mix); and

(c) the quantity and value of your firm's(s') exports to the United States of Subject Merchandise and, if known, an estimate of the percentage of total exports to the United States of Subject Merchandise from the Subject Country accounted for by your firm's(s') exports.

(12) Identify significant changes, if any, in the supply and demand conditions or business cycle for the Domestic Like Product that have occurred in the United States or in the market for the Subject Merchandise in the Subject Country after 2018, and significant changes, if any, that are likely to occur within a reasonably foreseeable time. Supply conditions to consider include technology; production methods; development efforts; ability to increase production (including the shift of production facilities used for other products and the use, cost, or availability of major inputs into production); and factors related to the ability to shift supply among different national markets (including barriers to importation in foreign markets or changes in market demand abroad). Demand conditions to consider include end uses and applications; the existence and availability of substitute products; and the level of competition among the Domestic Like Product produced in the United States, Subject Merchandise produced in the Subject Country, and such merchandise from other countries.

(13) (OPTIONAL) A statement of whether you agree with the above definitions of the Domestic Like Product and Domestic Industry; if you disagree with either or both of these definitions, please explain why and provide alternative definitions.

Authority: This proceeding is being conducted under authority of title VII of the Tariff Act of 1930; this notice is published pursuant to § 207.61 of the Commission's rules.

Authority: The authority for institution of this investigation is contained in section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, and in section 210.10 of the Commission's Rules of Practice and Procedure, 19 CFR 210.10 (2025).

Scope of Investigation: Having considered the complaint, the U.S. International Trade Commission, on January 28, 2025, ordered that —

(1) Pursuant to subsection (b) of section 337 of the Tariff Act of 1930, as amended, an investigation be instituted to determine: whether there is a violation of subsection (a)(1)(C) of section 337 in the importation into the United States, the sale for importation, or the sale within the United States after importation of certain products identified in paragraph (2) by reason of infringement of one or more of the Asserted Trademarks, and whether an industry in the United States exists or is in the process of being established as required by subsection (a)(2) of section 337;

(2) Pursuant to section 210.10(b)(1) of the Commission's Rules of Practice and Procedure, 19 CFR 210.10(b)(1), the plain language description of the accused products or category of accused products, which defines the scope of the investigation, is “electrolyte beverages and associated packaging and labels that bear the Electrolit® Asserted Trademarks”;

(3) For the purpose of the investigation so instituted, the following are hereby named as parties upon which this notice of investigation shall be served:

(a) The complainants are:

Background. —On November 19, 2003, the Department of Commerce (“Commerce”) issued an antidumping duty order on imports of refined brown aluminum oxide from China (68 FR 65249). Commerce issued a continuation of the antidumping duty order on imports of refined brown aluminum oxide from China following Commerce's and the Commission's first five-year reviews, effective March 13, 2009 (74 FR 10884), second five-year reviews, effective October 14, 2014 (79 FR 61606), and third five-year reviews, effective March 6, 2020 (85 FR 13138). The Commission is now conducting a fourth review pursuant to section 751(c) of the Act, as amended (19 U.S.C. 1675(c)), to determine whether revocation of the order would be likely to lead to continuation or recurrence of material injury to the domestic industry within a reasonably foreseeable time. Provisions concerning the conduct of this proceeding may be found in the Commission's Rules of Practice and Procedure at 19 CFR part 201, subparts A and B, and 19 CFR part 207, subparts A and F. The Commission will assess the adequacy of interested party responses to this notice of institution to determine whether to conduct a full or expedited review. The Commission's determination in any expedited review will be based on the facts available, which may include information provided in response to this notice.

Definitions. —The following definitions apply to this review:

(1) Subject Merchandise is the class or kind of merchandise that is within the scope of the five-year review, as defined by Commerce.

(2) The Subject Country in this review is China.

(3) The Domestic Like Product is the domestically produced product or products which are like, or in the absence of like, most similar in characteristics and uses with, the Subject Merchandise. In its original determination and its expedited first, second, and third five-year review determinations, the Commission defined the Domestic Like Product as all merchandise corresponding to Commerce's scope, as well as any brown aluminum oxide where particles with a diameter greater than 3/8 inch constitute at least 50 percent of the total weight of the entire batch, as long as the product has been crushed, screened, and sorted into consistent sizes.

(4) The Domestic Industry is the U.S. producers as a whole of the Domestic Like Product, or those producers whose collective output of the Domestic Like Product constitutes a major proportion of the total domestic production of the product. In its original determination, the Commission defined the Domestic Industry as all U.S. producers of refined brown aluminum oxide, with the exception of Great Lakes Minerals, which was excluded from the domestic industry as a related party. In its expedited first, second, and third five-year review determinations, the Commission defined the Domestic Industry as consisting of all domestic producers of the Domestic Like Product.

(5) An Importer is any person or firm engaged, either directly or through a parent company or subsidiary, in importing the Subject Merchandise into the United States from a foreign manufacturer or through its selling agent.

Participation in the proceeding and public service list. —Persons, including industrial users of the Subject Merchandise and, if the merchandise is sold at the retail level, representative consumer organizations, wishing to participate in the proceeding as parties must file an entry of appearance with the Secretary to the Commission, as provided in § 201.11(b)(4) of the Commission's rules, no later than 21 days after publication of this notice in the Federal Register . The Secretary will maintain a public service list containing the names and addresses of all persons, or their representatives, who are parties to the proceeding.

Former Commission employees who are seeking to appear in Commission five-year reviews are advised that they may appear in a review even if they participated personally and substantially in the corresponding underlying original investigation or an earlier review of the same underlying investigation. The Commission's designated agency ethics official has advised that a five-year review is not the same particular matter as the underlying original investigation, and a five-year review is not the same particular matter as an earlier review of the same underlying investigation for purposes of 18 U.S.C. 207, the post-employment statute for Federal employees, and Commission rule 201.15(b) (19 CFR 201.15(b)), 79 FR 3246 (Jan. 17, 2014), 73 FR 24609 (May 5, 2008). Consequently, former employees are not required to seek Commission approval to appear in a review under Commission rule 19 CFR 201.15, even if the corresponding underlying original investigation or an earlier review of the same underlying investigation was pending when they were Commission employees. For further ethics advice on this matter, contact Charles Smith, Office of the General Counsel, at 202-205-3408.

Limited disclosure of business proprietary information (BPI) under an administrative protective order (APO) and APO service list .—Pursuant to § 207.7(a) of the Commission's rules, the Secretary will make BPI submitted in this proceeding available to authorized applicants under the APO issued in the proceeding, provided that the application is made no later than 21 days after publication of this notice in the Federal Register . Authorized applicants must represent interested parties, as defined in 19 U.S.C. 1677(9), who are parties to the proceeding. A separate service list will be maintained by the Secretary for those parties authorized to receive BPI under the APO.

Certification. —Pursuant to § 207.3 of the Commission's rules, any person submitting information to the Commission in connection with this proceeding must certify that the information is accurate and complete to the best of the submitter's knowledge. In making the certification, the submitter will acknowledge that information submitted in response to this request for information and throughout this proceeding or other proceeding may be disclosed to and used: (i) by the Commission, its employees and Offices, and contract personnel (a) for developing or maintaining the records of this or a related proceeding, or (b) in internal investigations, audits, reviews, and evaluations relating to the programs, personnel, and operations of the Commission including under 5 U.S.C. Appendix 3; or (ii) by U.S. government employees and contract personnel, solely for cybersecurity purposes. All contract personnel will sign appropriate nondisclosure agreements.

Written submissions. —Pursuant to § 207.61 of the Commission's rules, each interested party response to this notice must provide the information specified below. The deadline for filing such responses is 5:15 p.m. on March 5, 2025. Pursuant to § 207.62(b) of the Commission's rules, eligible parties (as specified in Commission rule 207.62(b)(1)) may also file comments concerning the adequacy of responses to the notice of institution and whether the Commission should conduct an expedited or full review. The deadline for filing such comments is 5:15 p.m. on April 17, 2025. All written submissions must conform with the provisions of § 201.8 of the Commission's rules; any submissions that contain BPI must also 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. Also, in accordance with §§ 201.16(c) and 207.3 of the Commission's rules, each document filed by a party to the proceeding must be served on all other parties to the proceeding (as identified by either the public or APO service list as appropriate), and a certificate of service must accompany the document (if you are not a party to the proceeding you do not need to serve your response).

Please note the Secretary's Office will accept only electronic filings at this time. Filings must be made through the Commission's Electronic Document Information System (EDIS, https://edis.usitc.gov ). No in-person paper-based filings or paper copies of any electronic filings will be accepted until further notice.

No response to this request for information is required if a currently valid Office of Management and Budget (“OMB”) number is not displayed; the OMB number is 3117 0016/USITC No. 24-5-628, expiration date June 30, 2026. Public reporting burden for the request is estimated to average 15 hours per response. Please send comments regarding the accuracy of this burden estimate to the Office of Investigations, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436.

Inability to provide requested information. —Pursuant to § 207.61(c) of the Commission's rules, any interested party that cannot furnish the information requested by this notice in the requested form and manner shall notify the Commission at the earliest possible time, provide a full explanation of why it cannot provide the requested information, and indicate alternative forms in which it can provide equivalent information. If an interested party does not provide this notification (or the Commission finds the explanation provided in the notification inadequate) and fails to provide a complete response to this notice, the Commission may take an adverse inference against the party pursuant to § 776(b) of the Act (19 U.S.C. 1677e(b)) in making its determination in the review.

Information To Be Provided in Response to This Notice of Institution: As used below, the term “firm” includes any related firms.

Those responding to this notice of institution are encouraged, but not required, to visit the USITC's website at https://usitc.gov/reports/response_noi_worksheet, where one can download and complete the “NOI worksheet” Excel form for the subject proceeding, to be included as attachment/exhibit 1 of your overall response.

(1) The name and address of your firm or entity (including World Wide Web address) and name, telephone number, fax number, and email address of the certifying official.

(2) A statement indicating whether your firm/entity is an interested party under 19 U.S.C. 1677(9) and if so, how, including whether your firm/entity is a U.S. producer of the Domestic Like Product, a U.S. union or worker group, a U.S. importer of the Subject Merchandise, a foreign producer or exporter of the Subject Merchandise, a U.S. or foreign trade or business association (a majority of whose members are interested parties under the statute), or another interested party (including an explanation). If you are a union/worker group or trade/business association, identify the firms in which your workers are employed or which are members of your association.

(3) A statement indicating whether your firm/entity is willing to participate in this proceeding by providing information requested by the Commission.

(4) A statement of the likely effects of the revocation of the antidumping duty order on the Domestic Industry in general and/or your firm/entity specifically. In your response, please discuss the various factors specified in section 752(a) of the Act (19 U.S.C. 1675a(a)) including the likely volume of subject imports, likely price effects of subject imports, and likely impact of imports of Subject Merchandise on the Domestic Industry.

(5) A list of all known and currently operating U.S. producers of the Domestic Like Product. Identify any known related parties and the nature of the relationship as defined in § 771(4)(B) of the Act (19 U.S.C. 1677(4)(B)).

(6) A list of all known and currently operating U.S. importers of the Subject Merchandise and producers of the Subject Merchandise in each Subject Country that currently export or have exported Subject Merchandise to the United States or other countries after 2018.

(7) A list of 3-5 leading purchasers in the U.S. market for the Domestic Like Product and the Subject Merchandise (including street address, World Wide Web address, and the name, telephone number, fax number, and email address of a responsible official at each firm).

(8) A list of known sources of information on national or regional prices for the Domestic Like Product or the Subject Merchandise in the U.S. or other markets.

(9) If you are a U.S. producer of the Domestic Like Product, provide the following information on your firm's operations on that product during calendar year 2024, except as noted (report quantity data in short tons and value data in U.S. dollars, f.o.b. plant). If you are a union/worker group or trade/business association, provide the information, on an aggregate basis, for the firms in which your workers are employed/which are members of your association.

(a) Production (quantity) and, if known, an estimate of the percentage of total U.S. production of the Domestic Like Product accounted for by your firm's(s') production;

(b) Capacity (quantity) of your firm to produce the Domestic Like Product (that is, the level of production that your establishment(s) could reasonably have expected to attain during the year, assuming normal operating conditions (using equipment and machinery in place and ready to operate), normal operating levels (hours per week/weeks per year), time for downtime, maintenance, repair, and cleanup, and a typical or representative product mix);

(c) the quantity and value of U.S. commercial shipments of the Domestic Like Product produced in your U.S. plant(s);

(d) the quantity and value of U.S. internal consumption/company transfers of the Domestic Like Product produced in your U.S. plant(s); and

(e) the value of (i) net sales, (ii) cost of goods sold (COGS), (iii) gross profit, (iv) selling, general and administrative (SG&A) expenses, and (v) operating income of the Domestic Like Product produced in your U.S. plant(s) (include both U.S. and export commercial sales, internal consumption, and company transfers) for your most recently completed fiscal year (identify the date on which your fiscal year ends).

(10) If you are a U.S. importer or a trade/business association of U.S. importers of the Subject Merchandise from the Subject Country, provide the following information on your firm's(s') operations on that product during calendar year 2024 (report quantity data in short tons and value data in U.S. dollars). If you are a trade/business association, provide the information, on an aggregate basis, for the firms which are members of your association.

(a) The quantity and value (landed, duty-paid but not including antidumping duties) of U.S. imports and, if known, an estimate of the percentage of total U.S. imports of Subject Merchandise from the Subject Country accounted for by your firm's(s') imports;

(b) the quantity and value (f.o.b. U.S. port, including antidumping duties) of U.S. commercial shipments of Subject Merchandise imported from the Subject Country; and

(c) the quantity and value (f.o.b. U.S. port, including antidumping duties) of U.S. internal consumption/company transfers of Subject Merchandise imported from the Subject Country.

(11) If you are a producer, an exporter, or a trade/business association of producers or exporters of the Subject Merchandise in the Subject Country, provide the following information on your firm's(s') operations on that product during calendar year 2024 (report quantity data in short tons and value data in U.S. dollars, landed and duty-paid at the U.S. port but not including antidumping duties). If you are a trade/business association, provide the information, on an aggregate basis, for the firms which are members of your association.

(a) Production (quantity) and, if known, an estimate of the percentage of total production of Subject Merchandise in the Subject Country accounted for by your firm's(s') production;

(b) Capacity (quantity) of your firm(s) to produce the Subject Merchandise in the Subject Country (that is, the level of production that your establishment(s) could reasonably have expected to attain during the year, assuming normal operating conditions (using equipment and machinery in place and ready to operate), normal operating levels (hours per week/weeks per year), time for downtime, maintenance, repair, and cleanup, and a typical or representative product mix); and

(c) the quantity and value of your firm's(s') exports to the United States of Subject Merchandise and, if known, an estimate of the percentage of total exports to the United States of Subject Merchandise from the Subject Country accounted for by your firm's(s') exports.

(12) Identify significant changes, if any, in the supply and demand conditions or business cycle for the Domestic Like Product that have occurred in the United States or in the market for the Subject Merchandise in the Subject Country after 2018, and significant changes, if any, that are likely to occur within a reasonably foreseeable time. Supply conditions to consider include technology; production methods; development efforts; ability to increase production (including the shift of production facilities used for other products and the use, cost, or availability of major inputs into production); and factors related to the ability to shift supply among different national markets (including barriers to importation in foreign markets or changes in market demand abroad). Demand conditions to consider include end uses and applications; the existence and availability of substitute products; and the level of competition among the Domestic Like Product produced in the United States, Subject Merchandise produced in the Subject Country, and such merchandise from other countries.

(13) (OPTIONAL) A statement of whether you agree with the above definitions of the Domestic Like Product and Domestic Industry; if you disagree with either or both of these definitions, please explain why and provide alternative definitions.

Authority: This proceeding is being conducted under authority of title VII of the Tariff Act of 1930; this notice is published pursuant to § 207.61 of the Commission's rules.

Pursuant to 39 CFR 3041.405, the Commission gives notice that the Postal Service filed request(s) for the Commission to consider matters related to Competitive negotiated service agreement(s). The request(s) may propose the addition of a negotiated service agreement from the Competitive product list or the modification of an existing product currently appearing on the Competitive product list.

The public portions of the Postal Service's request(s) can be accessed via the Commission's website ( http://www.prc.gov ). Non-public portions of the Postal Service's request(s), if any, can be accessed through compliance with the requirements of 39 CFR 3011.301. 1

Section II identifies the docket number(s) associated with each Postal Service request, if any, that will be reviewed in a public proceeding as defined by 39 CFR 3010.101(p), the title of each such request, the request's acceptance date, and the authority cited by the Postal Service for each request. For each such request, the Commission appoints an officer of the Commission to represent the interests of the general public in the proceeding, pursuant to 39 U.S.C. 505 and 39 CFR 3000.114 (Public Representative). Section II also establishes comment deadline(s) pertaining to each such request.

The Commission invites comments on whether the Postal Service's request(s) identified in Section II, if any, are consistent with the policies of title 39. Applicable statutory and regulatory requirements include 39 U.S.C. 3632, 39 U.S.C. 3633, 39 U.S.C. 3642, 39 CFR part 3035, and 39 CFR part 3041. Comment deadline(s) for each such request, if any, appear in Section II.

Section III identifies the docket number(s) associated with each Postal Service request, if any, to add a standardized distinct product to the Competitive product list or to amend a standardized distinct product, the title of each such request, the request's acceptance date, and the authority cited by the Postal Service for each request. Standardized distinct products are negotiated service agreements that are variations of one or more Competitive products, and for which financial models, minimum rates, and classification criteria have undergone advance Commission review. See 39 CFR 3041.110(n); 39 CFR 3041.205(a). Such requests are reviewed in summary proceedings pursuant to 39 CFR 3041.325(c)(2) and 39 CFR 3041.505(f)(1). Pursuant to 39 CFR 3041.405(c)-(d), the Commission does not appoint a Public Representative or request public comment in proceedings to review such requests.

1. Docket No(s).: MC2025-1157 and K2025-1157; Filing Title: USPS Request to Add Priority Mail Express, Priority Mail & USPS Ground Advantage Contract 1322 to the Competitive Product List and Notice of Filing Materials Under Seal; Filing Acceptance Date: January 28, 2025; Filing Authority: 39 U.S.C. 3642, 39 CFR 3035.105, and 39 CFR 3041.310; Public Representative: Almaroof Agoro; Comments Due: February 5, 2025.

2. Docket No(s).: MC2025-1158 and K2025-1158; Filing Title: USPS Request to Add Priority Mail & USPS Ground Advantage Contract 605 to the Competitive Product List and Notice of Filing Materials Under Seal; Filing Acceptance Date: January 28, 2025; Filing Authority: 39 U.S.C. 3642, 39 CFR 3035.105, and 39 CFR 3041.310; Public Representative: Elsie Lee-Robbins; Comments Due: February 5, 2025.

3. Docket No(s).: MC2025-1159 and K2025-1159; Filing Title: USPS Request to Add Priority Mail & USPS Ground Advantage Contract 606 to the Competitive Product List and Notice of Filing Materials Under Seal; Filing Acceptance Date: January 28, 2025; Filing Authority: 39 U.S.C. 3642, 39 CFR 3035.105, and 39 CFR 3041.310; Public Representative: Kenneth Moeller; Comments Due: February 5, 2025.

4. Docket No(s).: MC2025-1160 and K2025-1160; Filing Title: USPS Request to Add Priority Mail Express, Priority Mail & USPS Ground Advantage Contract 1323 to the Competitive Product List and Notice of Filing Materials Under Seal; Filing Acceptance Date: January 28, 2025; Filing Authority: 39 U.S.C. 3642, 39 CFR 3035.105, and 39 CFR 3041.310; Public Representative: Maxine Bradley; Comments Due: February 5, 2025.

5. Docket No(s).: MC2025-1161 and K2025-1161; Filing Title: USPS Request to Add Priority Mail Express, Priority Mail & USPS Ground Advantage Contract 1324 to the Competitive Product List and Notice of Filing Materials Under Seal; Filing Acceptance Date: January 28, 2025; Filing Authority: 39 U.S.C. 3642, 39 CFR 3035.105, and 39 CFR 3041.310; Public Representative: Maxine Bradley; Comments Due: February 5, 2025.

None. See Section II for public proceedings.

This Notice will be published in the Federal Register .

For Applicants' representations, legal analysis, and conditions, please refer to Applicants' second amended and restated application, dated January 15, 2025, which may be obtained via the Commission's website by searching for the file number at the top of this document, or for an Applicant using the Company name search field, on the SEC's EDGAR system. The SEC's EDGAR system may be searched at https://www.sec.gov/edgar/searchedgar/companysearch. You may also call the SEC's Office of Investor Education and Advocacy at (202) 551-8090.

Title: S Corporation Shareholder Stock and Debt Basis Limitations.

OMB Number: 1545-2302.

Document Number: Forms 7203.

Abstract: Internal Revenue Code (IRC) Section 1366 determines the shareholder's tax liability from an S corporation. IRC Section 1367 details the adjustments to basis including the increase and decrease in basis, income items included in basis, the basis of indebtedness, and the basis of inherited stock. Shareholders will use Form 7203 to calculate their stock and debt basis, ensuring the losses and deductions are accurately claimed.

Current Actions: There are no changes in the form previously approved by OMB. However, updates in the burden computation will result in a burden decrease of 51,100 hours.

Type of Review: Revision of a currently approved collection.

Affected Public: Estates and Trusts.

Estimated Number of Respondents: 70,000.

Estimated Time per Respondent: 3 hrs., 2 min.

Estimated Total Annual Burden Hours: 214,200.

The following paragraph applies to all the collections of information covered by this notice:

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

Books or records relating to a collection of information must be retained if their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.

Desired Focus of Comments: The Internal Revenue Service (IRS) is particularly interested in comments that:

• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility.

• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used.

• Enhance the quality, utility, and clarity of the information to be collected; and

• Minimize the burden of the collection of information on those who are to respond, including using appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., by permitting electronic submissions of responses.

Comments submitted in response to this notice will be summarized and/or included in the ICR for OMB approval of the extension of the information collection; they will also become a matter of public record.

Title: Credit for Employer-Provided Child Care Facilities and Services.

OMB Number: 1545-1809.

Project Number: Form 8882.

Abstract: Employers use Form 8882 to claim the credit for qualified childcare facility and resource and referral expenditures. It is part of the general business credit.

Current Actions: There is no change in the paperwork burden previously approved by OMB. This form is being submitted for renewal purposes only.

Type of Review: Extension of a currently approved collection.

Affected Public: Businesses and other for-profit organizations, and individuals.

Estimated Number of Respondents: 286.

Estimated Time per Respondent: 3 hrs. 41 min.

Estimated Total Annual Burden Hours: 1,053.

The following paragraph applies to all the collections of information covered by this notice:

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

Books or records relating to a collection of information must be retained if their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.

Desired Focus of Comments: The Internal Revenue Service (IRS) is particularly interested in comments that:

• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility.

• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used.

• Enhance the quality, utility, and clarity of the information to be collected; and

• Minimize the burden of the collection of information on those who are to respond, including using appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., by permitting electronic submissions of responses.

Comments submitted in response to this notice will be summarized and/or included in the ICR for OMB approval of the extension of the information collection; they will also become a matter of public record.

The United States Sentencing Commission is an independent agency in the judicial branch of the United States Government. The Commission promulgates sentencing guidelines and policy statements for federal courts pursuant to 28 U.S.C. 994(a). The Commission also periodically reviews and revises previously promulgated guidelines pursuant to 28 U.S.C. 994(o) and submits guideline amendments to the Congress not later than the first day of May each year pursuant to 28 U.S.C. 994(p).

Fentanyl and fentanyl analogue cases have increased substantially over the last several years. Since fiscal year 2019, fentanyl cases have increased 244.7 percent, such that they comprised 16.3 percent of all federal drug trafficking cases in fiscal year 2023. Today, fentanyl represents the third most common drug type in federal drug trafficking cases. Fentanyl analogue cases have increased 113.5 percent since fiscal year 2019, but those cases occupy a much smaller portion of the federal drug trafficking case load (1.4%).

In response to rising numbers of fentanyl and fentanyl analogue cases, the Commission previously undertook a multi-year study of synthetic controlled substances. In 2018, following that study, the Commission amended § 2D1.1 (Unlawful Manufacturing, Importing, Exporting, or Trafficking (Including Possession with Intent to Commit Those Offenses); Attempt or Conspiracy) to add an enhancement specific to fentanyl and fentanyl analogue cases. In particular, the Commission added a new specific offense characteristic at subsection (b)(13) providing a 4-level increase when the defendant knowingly misrepresented or knowingly marketed as another substance a mixture or substance containing fentanyl or a fentanyl analogue. See USSG, App. C. amend. 807 (effective Nov. 1, 2018). In adding this new specific offense characteristic, the Commission pointed to the harm attendant to cases where a user does not know the substance they are using contains fentanyl or fentanyl analogue. Id. As the Commission explained, “[b]ecause of fentanyl's extreme potency, the risk of overdose death is great, particularly when the user is inexperienced or unaware of what substance he or she is using.” Id. Thus, the Commission concluded that “it is appropriate for traffickers who knowingly misrepresent fentanyl or a fentanyl analogue as another substance to receive additional punishment.” Id.

In 2023, the Commission amended § 2D1.1(b)(13) based on the continued increase in fentanyl and fentanyl analogue distribution. See USSG, App. C. amend. 818 (effective Nov. 1, 2023). The amendment added a new subparagraph (B) with an alternative 2-level enhancement for offenses where the defendant represented or marketed as a legitimately manufactured drug another mixture or substance containing fentanyl or a fentanyl analogue, and acted with willful blindness or conscious avoidance of knowledge that such mixture or substance was not the legitimately manufactured drug. Id. As grounds for the amendment, the Commission cited data from the Drug Enforcement Agency (“DEA”) showing a substantial increase in the seizure of fake prescription pills. Id. The DEA reported seizing over 50.6 million fake pills in calendar year 2022, with 70 percent containing fentanyl. Id. Of those seized pills containing fentanyl, six out of ten contained a potentially lethal dose of the substance. Id. The Commission also pointed to the increase in drug overdose deaths—most of which involved synthetic opioids, primarily fentanyl. Id.

Since 2023, the Commission has continued to receive public comment on whether the guidelines appropriately account for factors specific to offenses involving fentanyl, fentanyl analogues, and other opioids. For example, in a recent letter to the Commission, the Department of Justice stated that, “although the Commission added [a] new two-level enhancement [at § 2D1.1(b)(13)(B)] to address the harm associated with imitation pills, the new two-level enhancement has proven not to be very useful.” Letter from Scott Meisler, Ex-Officio Member, U.S. Sent'g Comm'n, to Hon. Carlton W. Reeves, Chair, U.S. Sent'g Comm'n (July 15, 2024) at 5, available at https://www.ussc.gov/sites/default/files/pdf/amendment-process/public-comment/202407/89FR48029_public-comment_R.pdf [hereinafter “DOJ Letter”]. Commission data shows that, in fiscal year 2023, 2.1 percent of individuals sentenced for fentanyl trafficking and 1.5 percent sentenced for fentanyl analogue trafficking received the 4-level increase for knowingly misrepresenting or knowingly marketing a mixture or substance containing fentanyl or a fentanyl analogue as another substance. Because the enhancement at § 2D1.1(b)(13)(B) became effective November 1, 2023, only preliminary 2024 data is available. Based on this preliminary data, 12 individuals sentenced for fentanyl trafficking and zero individuals sentenced for fentanyl analogue trafficking received the 2-level willful blindness enhancement.

To address the harm in cases involving fentanyl, fentanyl analogues, and other opioids, the Department of Justice proposed several amendments to § 2D1.1 to enhance sentences when certain circumstances are present. See DOJ Letter at 6-8. First, the Department of Justice proposed creating an enhancement under § 2D1.1 for distribution of fentanyl, fentanyl analogues, and other opioids to individuals under the age of 21. Id. at 6. According to the Department of Justice, “[m]embers of that age group have increasingly become victims of drug overdoses.” Id. Commission data reveals 37 cases in fiscal year 2023 in which the offense involved distribution of fentanyl or a fentanyl analogue to a person under 21 years old.

Second, the Department of Justice proposed creating an enhancement under § 2D1.1 for drug-trafficking offenses using “the dark web or other anonymizing technologies to avoid detection.” DOJ Letter at 6. The Department of Justice explains that individuals “are increasingly relying on anonymizing technologies to further their illicit activity, posting advertisements for fentanyl pills on dark web marketplaces where the seller is unknown to the buyer, the transaction involves an exchange of cryptocurrency, and the product is shipped with misleading tracking information.” Id. Commission data reveals 60 cases in fiscal year 2023 in which the offense involved the use of the dark web or cryptocurrency to traffic fentanyl or a fentanyl analogue. Of these 60 cases, 39 cases involved the use of both the dark web and cryptocurrency, 17 cases involved only the use of the dark web, and four cases involved only the use of cryptocurrency.

Third, the Department of Justice asked the Commission to consider an enhancement for drug trafficking offenses involving fentanyl or another synthetic opioid adulterated with xylazine or medetomidine. DOJ Letter at 6-7. According to the Department of Justice, individuals engaged in drug trafficking “are increasingly adulterating fentanyl with these alpha-2-adrenergic agonists, which can extend a user's high and also serve as a filler and binding agent.” Id. The Department of Justice notes that the effects of these substances “have not yet been fully studied” but states that they “are profoundly dangerous because their effects cannot be reversed by life-saving medicines like naloxone (Narcan).” Id. at 7. Commission data reveals 94 cases in fiscal year 2023 in which the offense involved mixing fentanyl or a fentanyl analogue with xylazine or medetomidine. Of these 94 cases, 90 cases used xylazine as the mixing agent, and four cases used medetomidine as the mixing agent.

1. The Commission seeks comment on whether it should consider revising § 2D1.1 to add an enhancement for distribution of fentanyl, fentanyl analogues, and other opioids to individuals under the age of 21. If so, should the enhancement be defendant-based or offense-based? By how many levels should the enhancement increase base offense levels, and what is the basis for such increase? Should the Commission consider any other changes to § 2D1.1 to address the harm in these cases?

2. The Commission seeks comment on whether it should consider revising § 2D1.1 to add an enhancement for fentanyl, fentanyl analogue, and opioid offenses involving the use of the dark web or other anonymizing technologies. If so, how should the Commission define or describe what technologies qualify for the enhancement? Should the enhancement be defendant-based or offense-based? By how many levels should the enhancement increase base offense levels, and what is the basis for such increase? Should the Commission consider any other changes to § 2D1.1 to address the harm in these cases?

3. The Commission seeks comment on whether it should consider revising § 2D1.1 to add an enhancement for drug trafficking offenses involving fentanyl, a fentanyl analogue, or another synthetic opioid adulterated with xylazine or medetomidine. The Commission invites comment on xylazine and medetomidine, particularly their pharmacological effects, potential for addiction and abuse, the patterns of abuse and harms associated with their abuse, and the patterns of trafficking and harms associated with their trafficking. The Commission also invites comment on whether there are other adulterants to fentanyl, fentanyl analogues, and other synthetic opioids for which an enhancement should apply. If the Commission were to add an enhancement to § 2D1.1 for drug trafficking offenses involving fentanyl, a fentanyl analogue, or another synthetic opioid adulterated with xylazine, medetomidine, or another adulterant should the enhancement be defendant-based or offense-based? By how many levels should the enhancement increase base offense levels, and what is the basis for such increase? Should the Commission consider any other changes to § 2D1.1 to address the harm in these cases?

Authority: 28 U.S.C. 994(a), (o), (p), (x); USSC Rules of Practice and Procedure 2.2, 4.3, 4.4.

Title: Nonprofit Research and Education Corporations (NPCs)—Annual Report, Remediation Plans & Assessment Questionnaires (VA Forms 10-10073, 10-10073A, 10-10073B, and 10-10073C).

OMB Control Number: 2900-0783. https://www.reginfo.gov/public/do/PRASearch.

Type of Review: Revision of a currently approved collection.

Abstract: Title 38 U.S.C. 7366, Accountability and Oversight, states “(b) each such corporation (NPC) shall submit to the Secretary (Department of Veterans Affairs (DVA)) an annual report providing a detailed statement of its operations, activities, and accomplishments during that year.” The individual NPC annual reports are combined into one NPC Annual Report to Congress. VA oversight of NPCs includes reviews, audits, self-assessments, and remediation plans. This information collection is used for oversight of NPCs and includes the following:

Since 1988, when the enabling legislation for the NPCs was passed, annual reports have been obtained from each NPC and combined into an NPC Annual Report to Congress. Congress uses the combined NPC Annual Report to Congress to monitor the progress of the overall NPC program it created. The NPC Annual Report to Congress is also used by top-level VA executives to evaluate the program and to recommend changes where needed. VHA's Nonprofit Oversight Board and the Nonprofit Program Office (NPPO) use both the combined NPC Annual Report to Congress and the individual NPC Annual Report Templates to monitor and oversee the NPCs. Trend analyses and other financial information are analyzed for each NPC and judgments made about each NPC's progress, financial viability, stewardship of assets, and accomplishments.

The NPC Audit Action Items Remediation Plans information collection is used to review the NPCs' remedies for audit deficiencies and recommendations. The major objective of the information collection is to help ensure proper corrective action. If any of the remediation plans submitted are inadequate, then the NPPO will make recommendations for sound, workable remedies.

The NPPO Internal Control Questionnaire, or portions of it, will be used in conducting reviews, audits, and investigations of the NPCs. The major objective of the questionnaire is to uncover weaknesses and lapses in internal controls. The NPPO will then make recommendations for improved internal controls wherever there are weaknesses or lapses. The questionnaire also may be used as a voluntary self-assessment by the NPCs.

The NPPO Operations Oversight Questionnaire, or portions of it, will be used in conducting operational reviews of the NPCs. The major objective of the questionnaire is to uncover operating problems and areas that need improvement. The NPPO will then make recommendations for operations improvements wherever problems or opportunities for improvement are found. The questionnaire also may be used as a voluntary self-assessment by the NPCs.

VHA does not anticipate any changes to the total annual number of responses or burden hours for this collection. However, there are some minor updates to the forms for clarification and to comply with current guidance on standard PRA language.

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 Federal Register Notice with a 60-day comment period soliciting comments on this collection of information was published at 89 FR 93906, November 27, 2024.

Total Annual Burden: 858 hours.

Total Annual Responses: 300.

Affected Public: Private Sector (Not-for-profit).

Estimated Annual Burden:

a. NPC Annual Report Template—273 hours.

b. NPC Audit Actions Items Remediation Plans—156 hours.

c. NPPO Internal Control Questionnaire—312 hours.

d. NPPO Operations Oversight Questionnaire—117 hours.

Estimated Average Burden per Respondent:

a. NPC Annual Report Template—210 minutes.

b. NPC Audit Actions Items Remediation Plans—142 minutes.

c. NPPO Internal Control Questionnaire—240 minutes.

d. NPPO Operations Oversight Questionnaire—90 minutes.

Frequency of Response:

a. NPC Annual Report Template—Once annually.

b. NPC Audit Actions Items Remediation Plans—1.5 times annually.

c. NPPO Internal Control Questionnaire—Once annually.

d. NPPO Operations Oversight Questionnaire—Once annually.

Estimated Number of Respondents: