Background

On June 20, 2025, Commerce published in the Federal Register the preliminary results of this administrative review of the antidumping duty order on tapered roller bearings and parts thereof, finished and unfinished (TRBs) from China. 1 This review covers two companies: C&U Shanghai, preliminarily determined to be part of the China-wide entity and, Tainai, preliminarily determined to have no shipments of subject merchandise during the POR. 2 We invited parties to comment on the Preliminary Results. 3 No interested party submitted comments. Accordingly, the final results are unchanged from the Preliminary Results, and no decision memorandum accompanies this Federal Register notice. Commerce conducted this administrative review in accordance with section 751(a) of the Tariff Act of 1930, as amended (the Act).

Due to the lapse in appropriations and Federal Government shutdown, on November 14, 2025, Commerce tolled all deadlines in administrative proceedings by 47 days. 4 Additionally, due to a backlog of documents that were electronically filed via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS) during the Federal Government shutdown, on November 24, 2025, Commerce tolled all deadlines in administrative proceedings by an additional 21 days. 5 Accordingly, the deadline for these final results is now December 29, 2025. 6

The merchandise subject to the Order is TRBs from China. For a full description of the scope of the Order, see the Preliminary Results. 8

In the Preliminary Results, Commerce found that Tainai had no shipments of TRBs during the POR, based on Tainai's timely submitted no-shipment certification. As we have not received any information to contradict this preliminary finding, Commerce determines that Tanai did not have any shipments of subject merchandise during the POR and will issue appropriate instructions that are consistent with our “automatic assessment” clarification, for these final results.

Based on the above information, Commerce has not calculated any dumping margins for any companies under review, nor has Commerce granted a separate rate to any companies under review. Commerce continues to find that C&U Shanghai is part of the China-wide entity and is subject to the China-wide entity rate. Because no party requested a review of the China-wide entity, and we did not self-initiate a review, the China-wide entity rate  9 is not subject to change as a result of this review. Consequently, there are no calculations to disclose in accordance with 19 CFR 351.224(b) for these final results.

Pursuant to section 751(a)(2)(C) of the Act and 19 CFR 351.212(b)(1), Commerce has determined, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries of subject merchandise covered by this review. 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).

We have not calculated any assessment rates in this administrative review. As Commerce continues to find that Tainai did not have any shipments of subject merchandise during the POR and C&U Shanghai is part of the China-wide entity, we will instruct CBP to assess any suspended entries of subject merchandise associated with Tainai and C&U Shanghai at the China-wide rate ( i.e., 92.84 percent).

The following cash deposit requirements will be effective upon publication of the final results of this administrative review for shipments of the subject merchandise from China 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) for previously investigated or reviewed China and non-China exporters that are not under review in this segment of the proceeding but have separate rates, the cash deposit rate will continue to be the exporter's existing cash deposit rate; (2) for all China exporters of subject merchandise that have not been found to be entitled to a separate rate, the cash deposit rate will be the existing rate for the China-wide entity of 92.84 percent; and (3) for all non-China exporters of subject merchandise which have not received their own rate, the cash deposit rate will be the rate applicable to the China exporter that supplied that non-China exporter. These 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 has occurred and the subsequent assessment of double antidumping duties.

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

These final results are issued and published in accordance with sections 751(a)(1)(B) and 777(i)(1) of the Act, and 19 CFR 351.221(b)(5).

Commerce has received timely requests, in accordance with 19 CFR 351.213(b), for administrative reviews of various AD and CVD orders with October anniversary dates. All deadlines for the submission of various types of information, certifications, comments, or actions by Commerce discussed below refer to the number of calendar days from the applicable starting time.

In the event that 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 either on U.S. Customs and Border Protection (CBP) data for U.S. imports during the period of review (POR) or questionnaires in which we request the quantity and value (Q&V) of sales, shipments, or exports during the POR. Where Commerce selects respondents based on CBP data, we intend to place the CBP data on the record within five days of publication of the initiation notice. Where Commerce selects respondents based on Q&V data, Commerce intends to place the Q&V questionnaire on the record of the review within five days of publication of the initiation notice. In either case, we intend to make our respondent selection decision within 35 days of the Federal Register publication of the initiation notice. Comments regarding the CBP data (and/or Q&V data (where applicable)) and respondent selection should be submitted within seven days after the placement of the CBP data/submission of the Q&V data on the record of the review. Parties wishing to submit rebuttal comments should submit those comments within five days after the deadline for the initial comments.

In the event that Commerce decides it is necessary to limit individual examination of respondents and conduct respondent selection under section 777A(c)(2) of the Tariff Act of 1930, as amended (the Act), the following guidelines regarding collapsing of companies for purposes of respondent selection will apply. In general, Commerce has found that determinations concerning whether particular companies should be “collapsed” ( e.g., 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 the 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 the AD proceeding ( e.g., investigation, administrative review, new shipper review, or changed circumstances review). For any company subject to the 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 the Q&V 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 the proceeding where Commerce considered collapsing that entity, complete Q&V data for that collapsed entity must be submitted.

With respect to AD administrative reviews, we intend to rescind the review where there are no suspended entries for a company or entity under review and/or where there are no suspended entries under the company-specific case number for that company or entity. Where there may be suspended entries, if a producer or exporter named in this notice of initiation had no exports, sales, or entries during the POR, it may notify Commerce of this fact within 30 days of publication of this initiation notice in the Federal Register for Commerce to consider how to treat suspended entries under that producer's or exporter's company-specific case number.

Pursuant to 19 CFR 351.213(d)(1), a party that has requested 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 a 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 responses to section D of the questionnaire.

In proceedings involving non-market economy (NME) countries, Commerce begins with a rebuttable presumption that all companies within the country are subject to government control and, thus, should be assigned a single AD deposit rate. It is Commerce's policy to assign all exporters of merchandise subject to an administrative review in an NME country this single rate unless an exporter can demonstrate that it is sufficiently independent so as to be entitled to a separate rate.

To establish whether a firm is sufficiently independent from government control of its export activities to be entitled to a separate rate, Commerce analyzes each entity exporting the subject merchandise. In accordance with the separate rates criteria, Commerce assigns separate rates to companies in NME cases only if respondents can demonstrate the absence of both de jure and de facto government control over export activities.

All firms listed below that wish to qualify for separate rate status in the administrative reviews involving NME countries must complete, as appropriate, either a Separate Rate Application or Certification, as described below. In addition, all firms that wish to qualify for separate rate status in the administrative reviews of AD orders in which a Q&V questionnaire is issued must complete, as appropriate, either a Separate Rate Application or Certification, and respond to the Q&V questionnaire.

For these administrative reviews, in order to demonstrate separate rate eligibility, Commerce requires entities for whom a review was requested, that were assigned a separate rate in the most recent segment of this proceeding in which they participated, to certify that they continue to meet the criteria for obtaining a separate rate. The Separate Rate Certification form will be available on Commerce's website at https://access.trade.gov/Resources/nme/nme-sep-rate.html on the date of publication of this Federal Register notice. In responding to the certification, please follow the “Instructions for Filing the Certification” in the Separate Rate Certification. Separate Rate Certifications are due to Commerce no later than 14 calendar days after publication of this Federal Register notice. In addition to filing a Separate Rate Certification with Commerce no later than 14 calendar days after publication of this Federal Register notice. The deadline and requirement for submitting a Separate Rate Certification applies equally to NME-owned firms, wholly foreign-owned firms, and foreign sellers who purchase and export subject merchandise to the United States.

Entities that currently do not have a separate rate from a completed segment of the proceeding  2 should timely file a Separate Rate Application to demonstrate eligibility for a separate rate in this proceeding. In addition, companies that received a separate rate in a completed segment of the proceeding that have subsequently made changes, including, but not limited to, changes to corporate structure, acquisitions of new companies or facilities, or changes to their official company name, 3 should timely file a Separate Rate Application to demonstrate eligibility for a separate rate in this proceeding. The Separate Rate Application will be available on Commerce's website at https://access.trade.gov/Resources/nme/nme-sep-rate.html on the date of publication of this Federal Register notice. In responding to the Separate Rate Application, refer to the instructions contained in the application. Separate Rate Applications are due to Commerce no later than 14 calendar days after publication of this Federal Register notice. The deadline and requirement for submitting a Separate Rate Application applies equally to NME-owned firms, wholly foreign-owned firms, and foreign sellers that purchase and export subject merchandise to the United States.

Exporters and producers must file a timely Separate Rate Application or Certification if they want to be considered for individual examination. Furthermore, exporters and producers who submit a Separate Rate Application or Certification and subsequently are selected as mandatory respondents will no longer be eligible for separate rate status unless they respond to all parts of the questionnaire as mandatory respondents.

Commerce may establish a certification process for companies whose exports to the United States could contain both subject and non-subject merchandise. Companies under review that were deemed to not be eligible to participate in the certification program of that proceeding may submit a Certification Eligibility Application to establish that they maintain the necessary systems to track their sales to the United States of subject and non-subject goods.

All firms listed below that are not currently eligible to certify but wish to establish certification eligibility are required to submit a Certification Eligibility Application. The Certification Eligibility Application will be available on Commerce's website at https://access.trade.gov/Resources/Certification-Eligibility-Application.pdf.

Certification Eligibility Applications must be filed according to Commerce's regulations and are due to Commerce no later than 30 calendar days after the publication of the Federal Register notice.

Exporters and producers that are not currently eligible to certify, who submit a Certification Eligibility Application, and are subsequently selected as mandatory respondents must respond to all parts of the questionnaire as mandatory respondents for Commerce to consider their Certification Eligibility Application.

In accordance with 19 CFR 351.221(c)(1)(i), we are initiating administrative reviews of the following AD and CVD orders and findings. We intend to issue the final results of these reviews not later than October 31, 2026.

None.

During any administrative review covering all or part of a period falling between the first and second or third and fourth anniversary of the publication of an AD order under 19 CFR 351.211 or a determination under 19 CFR 351.218(f)(4) to continue an order or suspended investigation (after sunset review), Commerce, if requested by a domestic interested party within 30 days of the date of publication of the notice of initiation of the review, will determine whether antidumping duties have been absorbed by an exporter or producer subject to the review if the subject merchandise is sold in the United States through an importer that is affiliated with such exporter or producer. The request must include the name(s) of the exporter or producer for which the inquiry is requested.

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 “gap” period of the order ( i.e., the period following the expiry of provisional measures and before definitive measures were put into place), if such a gap period is applicable to the POR.

Interested parties must submit applications for disclosure under administrative protective orders in accordance with the procedures outlined in Commerce's regulations at 19 CFR 351.305. Those procedures apply to administrative reviews included in this notice of initiation. Parties wishing to participate in any of these administrative reviews should ensure that they meet the requirements of these procedures ( e.g., the filing of separate letters of appearance as discussed at 19 CFR 351.103(d)).

Commerce's regulations identify five categories of factual information in 19 CFR 351.102(b)(21), which are summarized as follows: (i) evidence submitted in response to questionnaires; (ii) evidence submitted in support of allegations; (iii) publicly available information to value factors under 19 CFR 351.408(c) or to measure the adequacy of remuneration under 19 CFR 351.511(a)(2); (iv) evidence placed on the record by Commerce; and (v) evidence other than factual information described in (i)-(iv). These regulations require any party, when submitting factual information, to specify under which subsection of 19 CFR 351.102(b)(21) the information is being submitted and, if the information is submitted to rebut, clarify, or correct factual information already on the record, to provide an explanation identifying the information already on the record that the factual information seeks to rebut, clarify, or correct. The regulations, at 19 CFR 351.301, also provide specific time limits for such factual submissions based on the type of factual information being submitted. Please review the Final Rule, 8 available at https://www.govinfo.gov/content/pkg/FR-2013-07-17/pdf/2013-17045.pdf, prior to submitting factual information in this segment. Note that Commerce has amended certain of its requirements pertaining to the service of documents in 19 CFR 351.303(f). 9

Any party submitting factual information in an AD or CVD proceeding must certify to the accuracy and completeness of that information using the formats provided at the end of the Final Rule. 10 Commerce intends to reject factual submissions in any proceeding segments if the submitting party does not comply with applicable certification requirements.

Parties may request an extension of time limits before a time limit established under Part 351 expires, or as otherwise specified by Commerce. 11 In general, an extension request will be considered untimely if it is filed after the time limit established under Part 351 expires. For submissions which are due from multiple parties simultaneously, an extension request will be considered untimely if it is filed after 10:00 a.m. on the due date. Examples include, but are not limited to: (1) case and rebuttal briefs, filed pursuant to 19 CFR 351.309; (2) factual information to value factors under 19 CFR 351.408(c), or to measure the adequacy of remuneration under 19 CFR 351.511(a)(2), filed pursuant to 19 CFR 351.301(c)(3) and rebuttal, clarification and correction filed pursuant to 19 CFR 351.301(c)(3)(iv); (3) comments concerning the selection of a surrogate country and surrogate values and rebuttal; (4) comments concerning CBP data; and (5) Q&V questionnaires. Under certain circumstances, Commerce may elect to specify a different time limit by which extension requests will be considered untimely for submissions which are due from multiple parties simultaneously. In such a case, Commerce will inform parties in the letter or memorandum setting forth the deadline (including a specified time) by which extension requests must be filed to be considered timely. This policy also requires that an extension request must be made in a separate, standalone submission, and clarifies the circumstances under which Commerce will grant untimely-filed requests for the extension of time limits. Please review the Final Rule, available at https://www.gpo.gov/fdsys/pkg/FR-2013-09-20/html/2013-22853.htm, prior to submitting factual information in these segments.

These initiations and this notice are in accordance with section 751(a) of the Act (19 U.S.C. 1675(a)) and 19 CFR 351.221(c)(1)(i).

On September 29, 2025, the U.S. Department of Commerce (Commerce) received antidumping duty (AD) petitions concerning imports of chromium trioxide from India and Türkiye, filed in proper form on behalf of American Chrome & Chemicals, Inc. (ACC) (the petitioner), a domestic producer of chromium trioxide. 1 The AD Petitions were accompanied by a countervailing duty (CVD) petition concerning imports of chromium trioxide from India. 2

Due to the lapse in appropriations and Federal Government shutdown, on November 14, 2025, Commerce tolled all deadlines in administrative proceedings by 47 days. 3 Additionally, due to a backlog of documents that were electronically filed via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS) during the Federal Government shutdown, on November 24, 2025, Commerce tolled all deadlines in administrative proceedings by an additional 21 days. 4 The revised deadline for the initiation of these investigations is now December 29, 2025. 5

Between November 14 and December 9, 2025, Commerce requested supplemental information pertaining to certain aspects of the Petitions in supplemental questionnaires. 6 Between November 18 and December 11, 2025, the petitioner filed timely responses to these requests for additional information. 7

In accordance with section 732(b) of the Tariff Act of 1930, as amended (the Act), the petitioner alleges that imports of chromium trioxide from India and Türkiye are being, or are likely to be, sold in the United States at less than fair value (LTFV) within the meaning of section 731 of the Act, and that imports of such products are materially injuring, or threatening material injury to, the chromium trioxide industry in the United States. Consistent with section 732(b)(1) of the Act, the Petitions were accompanied by information reasonably available to the petitioner supporting its allegations.

Commerce finds that the petitioner filed the Petitions on behalf of the domestic industry, because the petitioner is an interested party, as defined in section 771(9)(C) of the Act. Commerce also finds that the petitioner demonstrated sufficient industry support for the initiation of the requested LTFV investigations. 8

Because the Petitions were filed on September 29, 2025, pursuant to 19 CFR 351.204(b)(1), the period of investigation (POI) for the India and Türkiye LTFV investigations is July 1, 2024, through June 30, 2025.

The product covered by these investigations is chromium trioxide from India and Türkiye. For a full description of the scope of these investigations, see the appendix to this notice.

On November 17, 2025, Commerce requested information and clarification from the petitioner regarding the proposed scope to ensure that the scope language in the Petitions is an accurate reflection of the products for which the domestic industry is seeking relief. 9 On November 20, 2025, the petitioner provided clarifications and revised the scope. 10 The description of merchandise covered by these investigations, as described in the appendix to this notice, reflects these clarifications.

As discussed in the Preamble to Commerce's regulations, we are setting aside a period for interested parties to raise issues regarding product coverage ( i.e., scope). 11 Commerce will consider all scope comments received from interested parties and, if necessary, will consult with interested parties prior to the issuance of the preliminary determinations. If scope comments include factual information, all such factual information should be limited to public information. 12 Commerce requests that interested parties provide at the beginning of their scope comments a public executive summary for each comment or issue raised in their submission. Commerce further requests that interested parties limit their public executive summary of each comment or issue to no more than 450 words, not including citations. Commerce intends to use the public executive summaries as the basis of the comment summaries included in the analysis of scope comments. To facilitate preparation of its questionnaires, Commerce requests that scope comments be submitted by 5:00 p.m. Eastern Time (ET) on January 20, 2026, which is the next business day after 20 calendar days from the signature date of this notice. 13 Any rebuttal comments, which may include factual information, and should also be limited to public information, must be filed by 5:00 p.m. ET on January 30, 2026, which is 10 calendar days from the initial comment deadline.

Commerce requests that any factual information that parties consider relevant to the scope of these investigations be submitted during that period. However, if a party subsequently finds that additional factual information pertaining to the scope of the investigations may be relevant, the party must contact Commerce and request permission to submit the additional information. All scope comments must be filed simultaneously on the records of the concurrent LTFV and CVD investigations.

All submissions to Commerce must be filed electronically via Enforcement and Compliance's Antidumping Duty and Countervailing Duty Centralized Electronic Service System (ACCESS), unless an exception applies. 14 An electronically filed document must be received successfully in its entirety by the time and date it is due.

On September 29, 2025, the U.S. Department of Commerce (Commerce) received a countervailing duty (CVD) petition concerning imports of chromium trioxide from India, filed in proper form on behalf of American Chrome & Chemicals, Inc. (the petitioner), a domestic producer of chromium trioxide. 1 The CVD Petition was accompanied by antidumping duty (AD) petitions concerning imports of chromium trioxide from India and the Republic of Türkiye. 2

Due to the lapse in appropriations and Federal Government shutdown, on November 14, 2025, Commerce tolled all deadlines in administrative proceedings by 47 days. 3 Additionally, due to a backlog of documents that were electronically filed via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS) during the Federal Government shutdown, on November 24, 2025, Commerce tolled all deadlines in administrative proceedings by an additional 21 days. 4 The revised deadline for the initiation of this investigation is now December 29, 2025. 5

Between November 17 and December 9, 2025, Commerce requested supplemental information pertaining to certain aspects of the Petition in supplemental questionnaires. 6 Between November 20 and December 11, 2025, the petitioner filed timely responses to these requests for additional information. 7

In accordance with section 702(b)(1) of the Tariff Act of 1930, as amended (the Act), the petitioner alleges that the Government of India (GOI) is providing countervailable subsidies, within the meaning of sections 701 and 771(5) of the Act, to producers of chromium trioxide from India, and that such imports are materially injuring, or threatening material injury to, the domestic industry producing chromium trioxide in the United States. Consistent with section 702(b)(1) of the Act and 19 CFR 351.202(b), for those alleged programs on which we are initiating a CVD investigation, the Petition was accompanied by information reasonably available to the petitioner supporting its allegations.

Commerce finds that the petitioner filed the Petition on behalf of the domestic industry, because the petitioner is an interested party, as defined in section 771(9)(C) of the Act. Commerce also finds that the petitioner demonstrated sufficient industry support with respect to the initiation of the requested CVD investigation. 8

Because the Petition was filed on September 29, 2025, the POI is January 1, 2024, through December 31, 2024. 9

The product covered by this investigation is chromium trioxide from India. For a full description of the scope of this investigation, see the appendix to this notice.

On November 17, 2025, Commerce requested information and clarification from the petitioner regarding the proposed scope to ensure that the scope language in the Petition is an accurate reflection of the products for which the domestic industry is seeking relief. 10 On November 20, 2025, the petitioner provided clarifications and revised the scope. 11 The description of merchandise covered by this investigation, as described in the appendix to this notice, reflects these clarifications.

As discussed in the Preamble to Commerce's regulations, we are setting aside a period for interested parties to raise issues regarding product coverage ( i.e., scope). 12 Commerce will consider all scope comments received from interested parties and, if necessary, will consult with interested parties prior to the issuance of the preliminary determination. If scope comments include factual information, all such factual information should be limited to public information. 13 Commerce requests that interested parties provide at the beginning of their scope comments a public executive summary for each comment or issue raised in their submission. Commerce further requests that interested parties limit their public executive summary of each comment or issue to no more than 450 words, not including citations. Commerce intends to use the public executive summaries as the basis of the comment summaries included in the analysis of scope comments. To facilitate preparation of its questionnaires, Commerce requests that scope comments be submitted by 5:00 p.m. Eastern Time (ET) on January 20, 2026, which is the next business day after 20 calendar days from the signature date of this notice. 14 Any rebuttal comments, which may include factual information, and should also be limited to public information, must be filed by 5:00 p.m. ET on January 30, 2026, which is 10 calendar days from the initial comment deadline.

Commerce requests that any factual information that parties consider relevant to the scope of this investigation be submitted during that period. However, if a party subsequently finds that additional factual information pertaining to the scope of the investigation may be relevant, the party must contact Commerce and request permission to submit the additional information. All scope comments must be filed simultaneously on the records of the concurrent AD and CVD investigations.

All submissions to Commerce must be filed electronically via ACCESS, unless an exception applies. 15 An electronically filed document must be received successfully in its entirety by the time and date it is due.

Pursuant to sections 702(b)(4)(A)(i) and (ii) of the Act, Commerce notified the GOI of the receipt of the Petition and provided an opportunity for consultations with respect to the Petition. 16 The GOI did not request consultations.

Section 702(b)(1) of the Act requires that a petition be filed on behalf of the domestic industry. Section 702(c)(4)(A) of the Act provides that a petition meets this requirement if the domestic producers or workers who support the petition account for: (i) at least 25 percent of the total production of the domestic like product; and (ii) more than 50 percent of the production of the domestic like product produced by that portion of the industry expressing support for, or opposition to, the petition. Moreover, section 702(c)(4)(D) of the Act provides that, if the petition does not establish support of domestic producers or workers accounting for more than 50 percent of the total production of the domestic like product, Commerce shall: (i) poll the industry or rely on other information in order to determine if there is support for the petition, as required by subparagraph (A); or (ii) determine industry support using a statistically valid sampling method to poll the “industry.”

Section 771(4)(A) of the Act defines the “industry” as the producers as a whole of a domestic like product. Thus, to determine whether a petition has the requisite industry support, the statute directs Commerce to look to producers and workers who produce the domestic like product. The U.S. International Trade Commission (ITC), which is responsible for determining whether “the domestic industry” has been injured, must also determine what constitutes a domestic like product in order to define the industry. While both Commerce and the ITC must apply the same statutory definition regarding the domestic like product, 17 they do so for different purposes and pursuant to a separate and distinct authority. In addition, Commerce's determination is subject to limitations of time and information. Although this may result in different definitions of the like product, such differences do not render the decision of either agency contrary to law. 18

Section 771(10) of the Act defines the domestic like product as “a product which is like, or in the absence of like, most similar in characteristics and uses with, the article subject to an investigation under this title.” Thus, the reference point from which the domestic like product analysis begins is “the article subject to an investigation” ( i.e., the class or kind of merchandise to be investigated, which normally will be the scope as defined in the petition).

With regard to the domestic like product, the petitioner does not offer a definition of the domestic like product distinct from the scope of the investigation. 19 Based on our analysis of the information submitted on the record, we have determined that chromium trioxide, as defined in the scope, constitutes a single domestic like product, and we have analyzed industry support in terms of that domestic like product. 20

In determining whether the petitioner has standing under section 702(c)(4)(A) of the Act, we considered the industry support data contained in the Petition with reference to the domestic like product as defined in the “Scope of the Investigation,” in the appendix to this notice. To establish industry support, the petitioner provided its own production of the domestic like product in 2024. 21 The petitioner identified itself as the sole producer of the domestic like product; therefore, the Petition is supported by 100 percent of the U.S. industry. 22 We relied on data provided by the petitioner for purposes of measuring industry support. 23

Our review of the data provided in the Petition, the General Issues Supplement, and other information readily available to Commerce indicates that the petitioner has established industry support for the Petition. 24 First, the Petition established support from domestic producers (or workers) accounting for more than 50 percent of the total production of the domestic like product and, as such, Commerce is not required to take further action in order to evaluate industry support ( e.g., polling). 25 Second, the domestic producers (or workers) have met the statutory criteria for industry support under section 702(c)(4)(A)(i) of the Act because the domestic producers (or workers) who support the Petition account for at least 25 percent of the total production of the domestic like product. 26 Finally, the domestic producers (or workers) have met the statutory criteria for industry support under section 702(c)(4)(A)(ii) of the Act because the domestic producers (or workers) who support the Petition account for more than 50 percent of the production of the domestic like product produced by that portion of the industry expressing support for, or opposition to, the Petition. 27 Accordingly, Commerce determines that the Petition was filed on behalf of the domestic industry within the meaning of section 702(b)(1) of the Act. 28

Because India is a “Subsidies Agreement Country” within the meaning of section 701(b) of the Act, section 701(a)(2) of the Act applies to this investigation. Accordingly, the ITC must determine whether imports of the subject merchandise from India materially injure, or threaten material injury to, a U.S. industry.

The petitioner alleges that imports of the subject merchandise are benefiting from countervailable subsidies and that such imports are causing, or threaten to cause, material injury to the U.S. industry producing the domestic like product. In addition, the petitioner alleges that subject imports exceed the negligibility threshold provided for under section 771(24)(A) of the Act. 29

The petitioner contends that the industry's injured condition is illustrated by a significant increase in the volume of subject imports; increased market share of subject imports; lost sales and revenues; underselling and price suppression; declines in production, capacity utilization, and U.S. shipments; and negative impact on financial performance. 30 We assessed the allegations and supporting evidence regarding material injury, threat of material injury, causation, as well as negligibility, and we have determined that these allegations are properly supported by adequate evidence, and meet the statutory requirements for initiation. 31

Based upon the examination of the Petition and supplemental responses, we find that they meet the requirements of section 702 of the Act. Therefore, we are initiating a CVD investigation to determine whether imports of chromium trioxide from India benefit from countervailable subsidies conferred by the GOI. In accordance with section 703(b)(1) of the Act and 19 CFR 351.205(b)(1), unless postponed, we will make our preliminary determination no later than 65 days after the date of this initiation.

Based on our review of the Petition, we find that there is sufficient information to initiate a CVD investigation on 48 programs alleged by the petitioner. For a full discussion of the basis for our decision to initiate on each program, see the India CVD Initiation Checklist. A public version of the initiation checklist for this investigation is available on ACCESS.

In the Petition, the petitioner identified one company ( i.e., Vishnu Chemicals Limited (Vishnu)) in India as a producer/exporter of chromium trioxide and provided independent third-party information as support. 32 We currently know of no additional producers/exporters of chromium trioxide from India.

Accordingly, Commerce intends to individually examine the only known producer/exporter in the investigation from India ( i.e., Vishnu). We invite interested parties to comment on this issue. Such comments may include factual information within the meaning of 19 CFR 351.102(b)(21). Parties wishing to comment must do so within three business days of the publication of this notice in the Federal Register . Comments must be filed electronically using ACCESS. An electronically filed document must be received successfully in its entirety via ACCESS by 5:00 p.m. ET on the specified deadline. Because we intend to examine the only known producer/exporter in India, if no comments are received or if comments received further support the existence of only this producer/exporter in India, we do not intend to conduct respondent selection and will proceed to issuing the initial CVD questionnaire to the company identified. However, if comments are received which create a need for a respondent selection process, we intend to finalize our decisions regarding respondent selection within 20 days of publication of this notice.

In accordance with section 702(b)(4)(A) of the Act and 19 CFR 351.202(f), a copy of the public version of the Petition has been provided to the GOI via ACCESS. To the extent practicable, we will attempt to provide a copy of the public version of the Petition to each exporter named in the Petition, as provided under 19 CFR 351.203(c)(2).

Commerce will notify the ITC of its initiation, as required by section 702(d) of the Act.

The ITC will preliminarily determine no later than December 30, 2025, whether there is a reasonable indication that imports of chromium trioxide from India are materially injuring, or threatening material injury to, a U.S. industry. 33 A negative ITC determination will result in the investigation being terminated. 34 Otherwise, this CVD investigation will proceed according to statutory and regulatory time limits.

Factual information is defined in 19 CFR 351.102(b)(21) as: (i) evidence submitted in response to questionnaires; (ii) evidence submitted in support of allegations; (iii) publicly available information to value factors of production under 19 CFR 351.408(c) or to measure the adequacy of remuneration under 19 CFR 351.511(a)(2); (iv) evidence placed on the record by Commerce; and (v) evidence other than factual information described in (i)-(iv). Section 351.301(b) of Commerce's regulations requires any party, when submitting factual information, to specify under which subsection of 19 CFR 351.102(b)(21) the information is being submitted  35 and, if the information is submitted to rebut, clarify, or correct factual information already on the record, to provide an explanation identifying the information already on the record that the factual information seeks to rebut, clarify, or correct. 36 Time limits for the submission of factual information are addressed in 19 CFR 351.301, which provides specific time limits based on the type of factual information being submitted. Interested parties should review the regulations prior to submitting factual information in this investigation.

Parties may request an extension of time limits before the expiration of a time limit established under 19 CFR 351.301, or as otherwise specified by Commerce. In general, an extension request will be considered untimely if it is filed after the expiration of the time limit established under 19 CFR 351.301, or as otherwise specified by Commerce. 37 For submissions that are due from multiple parties simultaneously, an extension request will be considered untimely if it is filed after 10:00 a.m. ET on the due date. Under certain circumstances, Commerce may elect to specify a different time limit by which extension requests will be considered untimely for submissions which are due from multiple parties simultaneously. In such a case, we will inform parties in a letter or memorandum of the deadline (including a specified time) by which extension requests must be filed to be considered timely. An extension request must be made in a separate, standalone submission; under limited circumstances we will grant untimely filed requests for the extension of time limits, where we determine, based on 19 CFR 351.302, that extraordinary circumstances exist. Parties should review Commerce's regulations concerning the extension of time limits and the Time Limits Final Rule prior to submitting factual information in this investigation. 38

Any party submitting factual information in an AD or CVD proceeding must certify to the accuracy and completeness of that information. 39 Parties must use the certification formats provided in 19 CFR 351.303(g). 40 Commerce intends to reject factual submissions if the submitting party does not comply with the applicable certification requirements.

Notification to Interested Parties

Interested parties must submit applications for disclosure under APO in accordance with 19 CFR 351.305. Parties wishing to participate in this investigation should ensure that they meet the requirements of 19 CFR 351.103(d) ( e.g., by filing the required letters of appearance). Note that Commerce has amended certain of its requirements pertaining to the service of documents in 19 CFR 351.303(f). 41

This notice is issued and published pursuant to sections 702 and 777(i) of the Act, and 19 CFR 351.203(c).

This preliminary determination is made in accordance with section 733(b) of the Tariff Act of 1930, as amended (the Act). Commerce published the notice of initiation of this investigation on April 23, 2025. 1 On August 19, 2025, Commerce postponed the preliminary determination of this investigation. 2

Due to the lapse in appropriations and Federal Government shutdown on November 14, 2025, Commerce tolled all deadlines in administrative proceedings by 47 days. 3 Additionally, due to a backlog of documents that were electronically filed via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS) during the Federal Government shutdown, on November 24, 2025, Commerce tolled all deadlines in administrative proceedings by an additional 21 days. 4 Accordingly, the deadline for this determination is now December 30, 2025.

For a complete description of the events that followed the initiation of this investigation, see the Preliminary Decision Memorandum. 5 A list of topics included in the Preliminary Decision Memorandum is included as Appendix II to this notice. The Preliminary Decision Memorandum is a public document and is on file electronically via ACCESS. ACCESS is available to registered users at https://access.trade.gov. In addition, a complete version of the Preliminary Decision Memorandum can be accessed directly at https://access.trade.gov/public/FRNoticesListLayout.aspx.

The products covered by this investigation are monomers and oligomers from Korea. For a complete description of the scope of this investigation, see Appendix I.

In accordance with the Preamble to Commerce's regulations, 6 in the Initiation Notice, Commerce set aside a period of time for parties to raise issues regarding product coverage ( i.e., scope). 7 No interested party commented on the scope of the investigation as it appeared in the Initiation Notice. Commerce is not preliminarily modifying the scope language as it appeared in the Initiation Notice. The complete description of the scope is provided in Appendix I to this notice.

In accordance with 19 CFR 351.225(d)(3), we are notifying the public of the following scope ruling applications related to AD and CVD orders and findings filed in or around the month of October 2025. This notification includes, for each scope application: (1) identification of the AD and/or CVD orders at issue (19 CFR 351.225(c)(1)); (2) concise public descriptions of the products at issue, including the physical characteristics (including chemical, dimensional and technical characteristics) of the products (19 CFR 351.225(c)(2)(ii)); (3) the countries where the products are produced and the countries from where the products are exported (19 CFR 351.225(c)(2)(i)(B)); (4) the full names of the applicants; and (5) the dates that the scope applications were filed with Commerce and the name of the ACCESS scope segment where the scope applications can be found. 1 This notice does not include applications which have been rejected and not properly resubmitted. The scope ruling applications listed below are available on Commerce's online e-filing and document management system, Antidumping and Countervailing Duty Electronic Service System (ACCESS), at https://access.trade.gov.

Hardwood Plywood from The People's Republic of China (China) (A-570-051/C-570-052); Birch Plywood;  2 produced in Indonesia and exported from Indonesia; submitted by Woodstock Supplies LLC (Woodstock); October 1, 2025; ACCESS scope segment “SCO—Woodstock Birch Plywood”

This list of scope ruling applications is not an identification of scope inquiries that have been initiated. In accordance with 19 CFR 351.225(d)(1), if Commerce has not rejected a scope ruling application nor initiated the scope inquiry within 30 days after the filing of the application, the application will be deemed accepted and a scope inquiry will be deemed initiated the following day—day 31. 3 Commerce's practice generally dictates that where a deadline falls on a weekend, Federal holiday, or other non-business day, the appropriate deadline is the next business day. 4 Accordingly, if the 30th day after the filing of the application falls on a non-business day, the next business day will be considered the “updated” 30th day, and if the application is not rejected or a scope inquiry initiated by or on that particular business day, the application will be deemed accepted and a scope inquiry will be deemed initiated on the next business day which follows the “updated” 30th day. 5

In accordance with 19 CFR 351.225(m)(2), if there are companion AD and CVD orders covering the same merchandise from the same country of origin, the scope inquiry will be conducted on the record of the AD proceeding. Further, please note that pursuant to 19 CFR 351.225(m)(1), Commerce may either apply a scope ruling to all products from the same country with the same relevant physical characteristics, (including chemical, dimensional, and technical characteristics) as the product at issue, on a country-wide basis, regardless of the producer, exporter, or importer of those products, or on a company-specific basis.

For further information on procedures for filing information with Commerce through ACCESS and participating in scope inquiries, please refer to the Filing Instructions section of the Scope Ruling Application Guide, at https://access.trade.gov/help/Scope_Ruling_Guidance.pdf. Interested parties, apart from the scope ruling applicant, who wish to participate in a scope inquiry and be added to the public service list for that segment of the proceeding must file an entry of appearance in accordance with 19 CFR 351.103(d)(1) and 19 CFR 351.225(n)(4). Interested parties are advised to refer to the case segment in ACCESS as well as 19 CFR 351.225(f) for further information on the scope inquiry procedures, including the timelines for the submission of comments.

Please note that this notice of scope ruling applications filed in AD and CVD proceedings may be published before any potential initiation, or after the initiation, of a given scope inquiry based on a scope ruling application identified in this notice. Therefore, please refer to the case segment on ACCESS to determine whether a scope ruling application has been accepted or rejected and whether a scope inquiry has been initiated.

Interested parties who wish to be served scope ruling applications for a particular AD or CVD order may file a request to be included on the annual inquiry service list during the anniversary month of the publication of the AD or CVD order in accordance with 19 CFR 351.225(n) and Commerce's procedures. 6

Interested parties are invited to comment on the completeness of this monthly list of scope ruling applications received by Commerce. Any comments should be submitted to Scot Fullerton, Acting Deputy Assistant Secretary for AD/CVD Operations, Enforcement and Compliance, International Trade Administration, via email to CommerceCLU@trade.gov.

This notice of scope ruling applications filed in AD and CVD proceedings is published in accordance with 19 CFR 351.225(d)(3).

The NOAA's Science Advisory Board (SAB) was originally established by a Decision Memorandum dated September 25, 1997. In 2017, the SAB became a non-discretionary committee when Congress mandated that the SAB shall continue to maintain two specific subcommittees [Weather Research and Forecasting Innovation Act of 2017 (Pub. L. 115-25) §§ 401, 508]. The SAB is the only Federal Advisory Committee with responsibility to advise the Under Secretary of Commerce for Oceans and Atmosphere on long- and short-range strategies for research, education and the application of science to resource management and environmental assessment and prediction. SAB activities and advice provide necessary input to ensure that National Oceanic and Atmospheric Administration (NOAA) science programs are of the highest quality and provide optimal support to resource management.

Status: The March 10-11, 2026, meeting will be open to public participation with a 20-minute public comment period at time allocated on the published agenda. Public statements presented at the meeting should not be repetitive of previously submitted verbal or written statements. In general, each individual or group making a verbal presentation will be limited to a total time of three minutes. Written comments for the March 10-11, 2026 meeting should be received by the SAB Executive Director's Office ( noaa.scienceadvisoryboard@noaa.gov ) by February 22, 2026 to provide sufficient time for SAB review. Written comments received by the SAB Executive Director after this date will be distributed to the SAB, but may not be reviewed prior to the meeting date.

Special Accommodations: This meeting is physically accessible to people with disabilities. Requests for special accommodations may be directed to the SAB Executive Director no later than 12:00 p.m. EDT on February 22, 2026.

Matters To Be Considered: The meeting on March 10-11, 2026, will include the following topic(s): (1) A consent calendar for approval of Working Groups Membership and Terms of References, (2) Working groups reports on several different topics for approval and submission to NOAA, (3) NOAA Science Update and NOAA responses to previous SAB reports, and (4) Working Groups Updates.

Meeting materials, including work products, will also be available on the SAB website: https://sab.noaa.gov/current-meetings/.

Agenda

The Scientific and Statistical Committee (SSC) will meet to consider the Council's request to reconsider the SSC recommendations for the white hake overfishing limits and acceptable biological catches for fishing years 2026-2030 based on setting the fishing mortality rate at 75 percent of the rate at maximum sustainable yield (F MSY ; 75 percent F MSY ). They also plan to review and discuss initial plans for an SSC workshop in 2026 on integrating dynamic reference points into fisheries management. Also, on the agenda is to review and discuss other aspects of the 2026 SSC work plan. Other business will be discussed as necessary.

Although non-emergency issues not contained on the agenda may come before this Council for discussion, those issues may not be the subject of formal action during this meeting. Council action will be restricted to those issues specifically listed in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Act, provided the public has been notified of the Council's intent to take final action to address the emergency. The public also should be aware that the meeting will be recorded. Consistent with 16 U.S.C. 1852, a copy of the recording is available upon request.

This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Cate O'Keefe, Executive Director, at 978-465-0492, at least 5 days prior to the meeting date.

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

Sections 101(a)(5)(A) and (D) of the MMPA (16 U.S.C. 1361 et seq. ) direct the Secretary of Commerce to allow, upon request, the incidental, but not intentional, taking of small numbers of marine mammals by U.S. citizens who engage in a specified activity (other than commercial fishing) within a specified geographical region if certain findings are made and either regulations are issued or, if the taking is limited to harassment, a notice of a proposed authorization is provided to the public for review.

An authorization for incidental takings shall be granted if NMFS finds that the taking will have a negligible impact on the species or stock(s), will not have an unmitigable adverse impact on the availability of the species or stock(s) for subsistence uses (where relevant), and if the permissible methods of taking and requirements pertaining to the mitigation, monitoring and reporting of such takings are set forth. NMFS has defined “negligible impact” in 50 CFR 216.103 as an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival.

Except with respect to certain activities not pertinent here, the MMPA defines “harassment” as: any act of pursuit, torment, or annoyance which (i) has the potential to injure a marine mammal or marine mammal stock in the wild (Level A harassment); or (ii) has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering (Level B harassment).

On January 19, 2021, we issued a final rule with regulations to govern the unintentional taking of marine mammals incidental to geophysical survey activities conducted by oil and gas industry operators, and those persons authorized to conduct activities on their behalf (collectively “industry operators”), in U.S. waters of the GOA  1 over the course of 5 years (86 FR 5322, January 19, 2021). The rule was based on our findings that the total taking from the specified activities over the 5-year period will have a negligible impact on the affected species or stock(s) of marine mammals and will not have an unmitigable adverse impact on the availability of those species or stocks for subsistence uses, and became effective on April 19, 2021.

The regulations at 50 CFR 217.180 et seq. allow for the issuance of LOAs to industry operators for the incidental take of marine mammals during geophysical survey activities and prescribe the permissible methods of taking and other means of effecting the least practicable adverse impact on marine mammal species or stocks and their habitat (often referred to as mitigation), as well as requirements pertaining to the monitoring and reporting of such taking. Under 50 CFR 217.186(e), issuance of an LOA shall be based on a determination that the level of taking will be consistent with the findings made for the total taking allowable under these regulations and a determination that the amount of take authorized under the LOA is of no more than small numbers.

NMFS subsequently discovered that the 2021 rule was based on erroneous take estimates. We conducted another rulemaking using correct take estimates and other newly available and pertinent information relevant to the analyses supporting some of the findings in the 2021 final rule and the taking allowable under the regulations. We issued a final rule in April 2024 (89 FR 31488, April 24, 2024), effective May 24, 2024, through April 19, 2026.

The 2024 final rule made no changes to the specified activities or the specified geographical region in which those activities would be conducted, nor to the original 5-year period of effectiveness. In consideration of the new information, the 2024 rule presented new analyses supporting affirmance of the negligible impact determinations for all species, and affirmed that the existing regulations, which contain mitigation, monitoring, and reporting requirements, are consistent with the “least practicable adverse impact” standard of the MMPA.

NMFS issued a LOA to WesternGeco on March 7, 2025, for the taking of marine mammals incidental to a three-dimensional ocean bottom node survey over 240 lease blocks in the Green Canyon and Walker Ridge areas, effective March 7, 2025, through December 31, 2025. Please see the Federal Register notice of issuance (90 FR 11947, March 13, 2025) for additional detail regarding the LOA and the survey activity.

On March 20, 2025, WesternGeco informed NMFS that they shifted the planned survey area westward and, accordingly, they requested a modification to the LOA to reflect this adjustment. The updated survey plan maintained a total of 100 days of sound source operation, with the distribution shifted to include 57 days in zone 7, 31 days in zone 5, and 12 days in zone 6. Since the number of survey days per zone changed, we updated the take numbers accordingly based on this new information. There were no other changes to the planned survey. On March 31, 2025, NMFS issued a modified LOA to WesternGeco (90 FR 14789, April 4, 2025).

On November 18, 2025, WesternGeco notified NMFS that the survey commenced later than was originally planned ( i.e., May/June instead of March), mainly due to vessel scheduling and availability constraints. WesternGeco requested that NMFS extend the end of the LOA effective period from December 31, 2025, to February 28, 2026, to provide sufficient time to complete the survey. To account for any potential additional delays, NMFS recommended extending the LOA effective period through April 19, 2026 ( i.e., the expiration date for the rule). The overall survey plan remains the same ( i.e., 100 total days of sound source operation). However, given the survey timing now involves months for which take was not previously assessed, we have updated WesternGeco's take estimates based on the revised schedule (table 1). The monthly distribution of survey days is not known in advance, though we assume that the planned 100 days of source operation would occur contiguously. Take estimates for each species are based on the period that produces the greatest value.

For the Rice's whale, take estimates based on the modeling yielded results that are not realistically likely to occur when considered in light of other relevant information concerning Rice's whale habitat preferences considered during the rulemaking process. NMFS' 2024 final rule provided detailed discussion regarding Rice's whale habitat ( e.g., 89 FR 31508, 31519, April 24, 2024). In summary, recent survey data, sightings, and acoustic data support Rice's whale occurrence in waters throughout the GOA between approximately 100 and 400 meters (m) depth along the continental shelf break, and associated habitat-based density modeling has identified similar habitat ( i.e., approximately 100 to 400 m water depths along the continental shelf break) as being Rice's whale habitat (Garrison et al., 2023; Soldevilla et al., 2022, 2024).

Although Rice's whales may occur outside of the general depth range expected to provide suitable habitat, we expect that any such occurrence would be rare. WesternGeco's planned activities will occur in water depths of approximately 700 to 3,400 m in the central GOA. Thus, NMFS does not expect there to be the reasonable potential for take of Rice's whale in association with this survey and, accordingly, does not authorize take of Rice's whale through the LOA.

Based on the results of our analysis, NMFS has determined that the level of taking expected for this survey and authorized through the LOA is consistent with the findings made for the total taking allowable under the regulations. See table 1 in this notice and table 6 of the rule (89 FR 31488, April 24, 2024).

Under the rule, NMFS may not authorize incidental take of marine mammals in an LOA if it will exceed “small numbers.” In short, when an acceptable estimate of the individual marine mammals taken is available, if the estimated number of individual animals taken is up to, but not greater than, one-third of the best available abundance estimate, NMFS will determine that the numbers of marine mammals taken of a species or stock are small (89 FR 31535, May 24, 2024). For more information please see NMFS' discussion of small numbers in the 2021 final rule (86 FR 5438, January 19, 2021).

The take numbers for authorization are determined as described in the Federal Register notice of issuance (90 FR 11947, March 13, 2025). Subsequently, the total incidents of harassment for each species are multiplied by scalar ratios to produce a derived product that better reflects the number of individuals likely to be taken within a survey (as compared to the total number of instances of take), accounting for the likelihood that some individual marine mammals may be taken on more than 1 day (86 FR 5404, January 19, 2021). The output of this scaling, where appropriate, is incorporated into adjusted total take estimates that are the basis for NMFS' small numbers determinations, as depicted in table 1.

This product is used by NMFS in making the necessary small numbers determinations through comparison with the best available abundance estimates (see discussion at 86 FR 5391, January 19, 2021). For this comparison, NMFS' approach is to use the maximum theoretical population, determined through review of current stock assessment reports (SAR; https://www.fisheries.noaa.gov/national/marine-mammal-protection/marine-mammal-stock-assessments ) and model-predicted abundance information ( https://seamap.env.duke.edu/models/Duke/GOM ). Information supporting the small numbers determinations is provided in table 1.

Based on the analysis contained herein of WesternGeco's proposed survey activity described in its LOA application and the anticipated take of marine mammals, NMFS finds that small numbers of marine mammals will be taken relative to the affected species or stock sizes ( i.e., less than one-third of the best available abundance estimate); therefore, the taking is of no more than small numbers.

NMFS has determined that the level of taking for this LOA request is consistent with the findings made for the total taking allowable under the incidental take regulations and that the amount of take authorized under the LOA is of no more than small numbers. Accordingly, we have issued a modified LOA to WesternGeco authorizing the take of marine mammals incidental to its geophysical survey activity, as described above.

The Board, which consists of a balanced representation from academia, industry, state government and citizens groups, was established in 1976 by Section 209 of the Sea Grant Improvement Act (Pub. L. 94-461, 33 U.S.C. 1128). The Board advises the Secretary of Commerce and the Director of the National Sea Grant College Program with respect to operations under the Act, and such other matters as the Secretary refers to them for review and advice. Race or sex shall not be considered in the selection of the committee's membership.

Privacy Act Statement: Authority. The collection of information concerning nominations to the NSGAB FAC is authorized under the FACA, as amended, 5 U.S.C. App. and its implementing regulations, 41 CFR part 102-3, and in accordance with the Privacy Act of 1974, as amended, (Privacy Act) 5 U.S.C. 552a. Purpose. The collection of names, contact information, resumes, professional information, and qualifications is required in order for the Under Secretary to appoint members to the NSGAB FAC. Routine Uses. NOAA will use the nomination information for the purpose set forth above. The Privacy Act of 1974 authorizes disclosure of the information collected to NOAA staff for work-related purposes and for other purposes only as set forth in the Privacy Act and for routine uses published in the Privacy Act System of Records Notice COMMERCE/DEPT-11, Candidates for Membership, Members, and Former Members of Department of Commerce Advisory Committees, available at https://www.osec.doc.gov/opog/PrivacyAct/SORNs/dept-11.html, and the System of Records Notice COMMERCE/DEPT-18, Employees Personnel Files Not Covered by Notices of Other Agencies, available at https://www.osec.doc.gov/opog/PrivacyAct/SORNs/DEPT-18.html .

Disclosure. Furnishing the nomination information is voluntary; however, if the information is not provided, the individual would not be considered for appointment as a member of the NSGAB FAC.

The subject permit is requested under the authority of the Marine Mammal Protection Act of 1972, as amended (MMPA; 16 U.S.C. 1361 et seq. ) and the regulations governing the taking and importing of marine mammals (50 CFR part 216).

The applicant requests a 5-year research permit to import non-listed and non-MMPA depleted marine mammal parts from Denmark to study anatomy of ear and vocal apparatus. Parts from up to 10 cetaceans and 10 pinnipeds, excluding walrus, would be imported annually.

In compliance with the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq. ), an initial determination has been made that the activity proposed is categorically excluded from the requirement to prepare an environmental assessment or environmental impact statement.

Concurrent with the publication of this notice in the Federal Register , NMFS is forwarding copies of the application to the Marine Mammal Commission and its Committee of Scientific Advisors.

Title and OMB Number: Defense Federal Acquisition Regulation Supplement (DFARS) Part 225, Foreign Acquisition, and Defense Contractors Performing Private Security Functions Outside the United States; OMB Control Number 0704-0549.

Type of Request: Revision of a currently approved collection.

Affected Public: Businesses entities.

Respondent's Obligation: Required to obtain or retain benefits.

Frequency: On Occasion.

Number of Respondents: 10.

Responses per Respondent: 4.

Annual Responses: 40.

Average Burden per Response: 0.5 hours.

Annual Burden Hours: 20.

Needs and Uses: Geographic combatant commanders are required by statute to establish procedures and assign responsibilities for ensuring that contractors and contractor personnel report certain security incidents when performing private security functions in covered operational areas. The clause at DFARS 252.225-7039, Defense Contractors Performing Private Security Functions Outside the United States, requires contractors and subcontractors performing private security functions in designated operational areas outside the United States to comply with 32 CFR 159 and any orders, directives, and instructions contained in the contract on reporting the following types of incidents to the geographic combatant commander if and when they occur:

(a) A weapon is discharged by personnel performing private security functions.

(b) Personnel performing private security functions are attacked, killed, or injured.

(c) Persons are killed or injured, or property is destroyed as a result of conduct by contractor personnel.

(d) A weapon is discharged against personnel performing private security functions or personnel performing such functions believe a weapon was so discharged.

(e) Active, non-lethal countermeasures (other than the discharge of a weapon) are employed by personnel performing private security functions in response to a perceived immediate threat.

DoD Clearance Officer: Mr. Reginald T. Lucas. Requests for copies of the information collection proposal should be sent to Mr. Lucas at whs.mc-alex.esd.mbx.dd-dod-information-collections@mail.mil.

Title and OMB Number: Defense Federal Acquisition Regulation Supplement (DFARS) Part 237, Service Contracting and Associated Clauses at 252.237-7025 and 252.237-7026; OMB Control Number 0750-0006.

Affected Public: Businesses or other for-profit and not-for-profit institutions.

Respondent's Obligation: Required to obtain or retain benefits.

Frequency: On occasion.

Number of Respondents: 12.

Responses per Respondent: 35.

Annual Responses: 420.

Average Burden per Response: 0.062 hour.

Annual Burden Hours: 26.

Needs and Uses: This information collection is required to implement section 1006 of the National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2019 (Pub. L. 115-232), as amended by section 1011 of the NDAA for FY 2020 (Pub. L. 116-92). Section 1006 applies to accounting firms that provide financial statement auditing to DoD in support of the audit under 31 U.S.C. 3521 or audit remediation services in support of the Financial Improvement and Audit Remediation Plan described in 10 U.S.C. 240b. Such firms, when responding to a solicitation or awarded a contract for the acquisition of covered services, must disclose to DoD before any contract action (including award, renewals, and amendments) the details of any disciplinary proceedings with respect to the accounting firm or its associated persons before any entity with the authority to enforce compliance with rules or laws applying to audit services offered by the accounting firm. DoD, as a matter of policy to provide a level playing field between firms that provide audit services to support certain DoD audits, is extending this requirement to firms other than accounting firms that provide such services. Section 1011 amended section 1006 to require any disclosures to be treated as confidential to the extent required by the court or agency in which the proceeding occurred and to be treated in a manner consistent with any protections or privileges established by any other provision of Federal law.

a. The provision at DFARS 252.237-7025, Preaward Transparency Requirements for Firms Offering to Support Department of Defense Audits—Representation and Disclosure, is prescribed at DFARS 237.270(e)(3) for use in solicitations for the acquisition of financial statement auditing or audit remediation services.

b. The clause at 252.237-7026, Postaward Transparency Requirements for a Firm that Supports Department of Defense Audits, is prescribed at DFARS 237.270(e)(4) for use in solicitations and contracts for the acquisition of financial statement auditing or audit remediation services.

DoD Clearance Officer: Mr. Reginald T. Lucas. Requests for copies of the information collection proposal should be sent to Mr. Lucas at whs.mc-alex.esd.mbx.dd-dod-information-collections@mail.mil.

Title and OMB Number: Safeguarding Covered Defense Information, Cyber Incident Reporting, and Cloud Computing; OMB Control Number 0704-0478.

Affected Public: Businesses or other for-profit and not-for-profit institutions.

Respondent's Obligation: Required to obtain or retain benefits.

Reporting Frequency: On occasion.

Number of Respondents: 1,971.

Responses per Respondent: 8.2, approximately.

Annual Responses: 16,223.

Average Burden per Response: 0.42 hours.

Annual Burden Hours: 6,770.

Needs and Uses: Offerors and contractors must report cyber incidents on unclassified networks or information systems, within cloud computing services, and when they affect contractors designated as providing operationally critical support, as required by statute.

a. The clause at DFARS 252.204-7012, Safeguarding Covered Defense Information and Cyber Incident Reporting, covers cyber incident reporting requirements for incidents that affect a covered contractor information system or the covered defense information residing therein, or that affects the contractor's ability to perform the requirements of the contract that are designated as operationally critical support and identified in the contract.

b. The provision at DFARS 252.204-7008, Compliance with Safeguarding Covered Defense Information Controls, requires an offeror that proposes to vary from any of the security controls of National Institute of Standards and Technology (NIST) Special Publication (SP) 800-171 in effect at the time the solicitation is issued to submit to the contracting officer a written explanation of how the specified security control is not applicable or an alternative control or protective measure is used to achieve equivalent protection.

c. The provision at DFARS 252.239-7009, Representation of Use of Cloud Computing, requires offerors to report that they “anticipate” or “do not anticipate” utilizing cloud computing service in performance of a contract resulting from a solicitation containing the provision. The representation will notify contracting officers of the applicability of the cloud computing requirements of the DFARS 252.239-7010 clause of the contract.

d. The clause at DFARS 252.239-7010, Cloud Computing Services, requires reporting of cyber incidents that occur when DoD is purchasing cloud computing services.

These DFARS provisions and clauses facilitate mandatory cyber incident reporting requirements in accordance with statutory regulations. When reports are submitted, DoD will analyze the reported information for cyber threats and vulnerabilities in order to develop response measures as well as improve U.S. Government understanding of advanced cyber threat activity. In addition, the security requirements in NIST SP 800-171 are specifically tailored for use in protecting sensitive information residing in contractor information systems and generally reduce the burden placed on contractors by eliminating Federal-centric processes and requirements. The information provided will inform DoD in assessing the overall risk to DoD covered defense information on unclassified contractor systems and networks.

Comments and recommendations on the proposed information collection should be sent to Ms. Susan Minson, DoD Desk Officer, at Oira_submission@omb.eop.gov. Please identify the proposed information collection by DoD Desk Officer and the Docket ID number and title of the information collection.

You may also submit comments, identified by docket number and title, by the following method: Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments.

DoD Clearance Officer: Mr. Reginald T. Lucas. Requests for copies of the information collection proposal should be sent to Mr. Lucas at whs.mc-alex.esd.mbx.dd-dod-information-collections@mail.mil.

Title and OMB Number: Defense Federal Acquisition Regulation Supplement (DFARS) Part 228, Bonds and Insurance, and related clauses at 252.228; OMB Control Number 0704-0216.

Type of Request: Extension of a currently approved collection.

Affected Public: Businesses or other for-profit and not-for-profit institutions.

Respondent's Obligation: Required to obtain or retain benefits.

Frequency: On Occasion.

Number of Respondents: 385.

Responses per Respondent: 1.

Annual Responses: 385.

Average Burden per Response: Approximately 1.57 hours.

Annual Burden Hours: 603.

Needs and Uses: DoD uses the information obtained through this collection to determine (1) the allowability of a contractor's costs of providing war-hazard benefits to its employees; (2) the need for an investigation regarding an accident that occurs in connection with a contract; and (3) whether a non-Spanish contractor performing a service or construction contract in Spain has adequate insurance coverage. DFARS 252.228-7000, Reimbursement for War- Hazard Losses, requires the contractor to provide notice and supporting documentation to the contracting officer regarding potential claims, open claims, and settlements providing war-hazard benefits to contractor employees. DFARS 252.228-7005, Accident Reporting and Investigation Involving Aircraft, Missiles, and Space Launch Vehicles, requires the contractor to report promptly to the administrative contracting officer all pertinent facts relating to each accident involving an aircraft, missile, or space launch vehicle being manufactured, modified, repaired, or overhauled in connection with the contract. DFARS 252.228-7006, Compliance with Spanish Laws and Insurance, requires the contractor to provide the contracting officer with a written representation that the contractor has obtained the required types of insurance in the minimum amounts specified in the clause, when performing a service or construction contract in Spain.

DoD Clearance Officer: Mr. Reginald T. Lucas. Requests for copies of the information collection proposal should be sent to Mr. Lucas at whs.mc-alex.esd.mbx.dd-dod-information-collections@mail.mil.

This action is directed to the general public. This action may also be of interest to those involved in the manufacture, processing, distribution, and disposal of chemical substances and mixtures, and/or those interested in the assessment of risks involving chemical substances and mixtures. Since other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action.

If you have any questions regarding the applicability of this action to a particular entity, consult the DFO listed under FOR FURTHER INFORMATION CONTACT .

1. Submitting CBI. Do not submit CBI or other sensitive information to EPA through email. If your nomination contains any information that you consider to be CBI or otherwise protected, please contact the DFO listed under FOR FURTHER INFORMATION CONTACT to obtain special instructions before submitting your nomination. Information properly marked as CBI will not be disclosed except in accordance with the procedures set forth in 40 CFR part 2.

2. Request for nominations. As part of a broader process for developing a pool of candidates for the SACC membership, the EPA Science Advisory Committee Branch (SACB) staff solicits the public stakeholder communities for nominations of prospective candidates. Sources such as list serv and website announcements in addition to this notice will be utilized to solicit nominations and identify candidates. Any interested person or organization may nominate qualified individuals to be considered as prospective candidates. Individuals also may self-nominate.

The SACC is a federal advisory committee, established in December 2016 pursuant to TSCA section 2525(o), and chartered under the Federal Advisory Committee Act (FACA), 5 U.S.C. 1001-1014. EPA established the SACC to provide independent advice and recommendations to the EPA Administrator on the scientific aspects of risk evaluations, methodologies, and approaches for chemicals regulated under TSCA. The SACC members serve as Special Government Employees (SGEs) or Regular Government Employees (RGEs). The SACC expects to meet approximately 4 to 6 times per year, or as needed and approved by the DFO. Currently, there are 19 SACC members with ten membership terms that will expire over the next year.

Nominations should include candidates who have demonstrated high levels of competence, knowledge, and expertise in scientific/technical fields relevant to chemical safety and risk assessment. In particular, nominees should include specific expertise and perspectives representing the sectors of science, government, labor, public health, public interest, animal protection, industry, and other groups, including representatives that have specific scientific expertise in the relationship of chemical exposures to women, children, and other potentially exposed or susceptible subpopulations. Nominees should demonstrate expertise from the following disciplines, including, but not limited to: human health and ecological risk assessment, biostatistics, epidemiology, pediatrics, physiologically-based pharmacokinetics (PBPK), toxicology and pathology (including neurotoxicology, developmental/reproductive toxicology, environmental toxicology, computational toxicology and carcinogenesis), cancer hazard and risk assessment, aggregate exposure, exposure assessment, bioinformatics/statics, inhalation exposure, inhalation toxicology, occupational exposure/industrial hygiene, and the relationship of chemical exposures to women, children, and other potentially exposed or susceptible subpopulations.

Each nomination should include the following information:

• Current contact information for the person making the nomination;

• Name, affiliation, and contact information for the nominee;

• The disciplinary and specific areas of expertise of the nominee; and

• Any additional information indicating current position; educational background; research activities; and recent service on other federal advisory committees and national or international professional organization.

Persons having questions about the nomination process should contact the DFO listed under FOR FURTHER INFORMATION CONTACT .

The DFO will acknowledge receipt of nominations. The names and biographical sketches of all nominees identified by respondents to this Federal Register notice, other sources for nominations, and any additional candidates identified by EPA Staff, will be posted in a List of Candidates in the docket at http://www.regulations.gov and will be available through the SACC website at http://www.epa.gov/tsca-peer-review. The availability of the list also will be announced through the Office of Chemical Safety and Pollution Prevention's listservs. You may subscribe to these listservs at the following website: https://public.govdelivery.com/accounts/USAEPAOPPT/subscriber/new?topic_id=USAEPAOPPT_101. Public comments on the List of Candidates will be requested to provide relevant information or other documentation on nominees that the EPA should consider in evaluating candidates. The final list of selected candidates to the SACC (names, professional affiliations) will be posted on the SACC website and announced through the OCSPP's listservs.

In addition to scientific expertise, in selecting members, EPA will consider the breadth and balance of different perspectives and the collective experience needed to address EPA's prospective charges to the SACC, including the following:

• Background and experiences that would contribute to the diversity of scientific viewpoints on the committee, including professional experiences in government, labor, public health, public interest, animal protection, industry, and other groups, as the EPA Administrator determines to be advisable ( e.g., geographical location, professional affiliations, etc.);

• Skills and experience working on committees and advisory panels including demonstrated ability to work constructively and effectively in a committee setting;

• Information on financial conflicts of interest or the appearance of a loss of impartiality. Prospective candidates will be asked to submit confidential financial information which shall fully disclose, among other financial interests, the candidate's employment, stocks, and bonds, and where applicable, sources of research support. EPA will evaluate the candidate's financial disclosure forms to assess the possibility of financial conflicts of interest, appearance of a loss of impartially, or any prior involvement with the development of documents likely to be under consideration by the SACC (including previous scientific peer reviews) before the candidate is considered further;

• Willingness to commit adequate time for the thorough review of materials provided to the committee; and

• Availability to participate in committee meetings.

This action is directed to the public in general and may be of particular interest to those involved in the manufacture (defined under TSCA section 3(9) to include import), processing, distribution, use, and disposal of 1,3-butadiene, related industry trade organizations, non-governmental organizations with an interest in human and environmental health, State and local governments, Tribal Nations, and/or those interested in the assessment of risks involving chemical substances and mixtures regulated under TSCA. As such, the Agency has not attempted to describe all the specific entities that this action might apply to. If you need help determining applicability, consult the technical contact listed under FOR FURTHER INFORMATION CONTACT .

The Agency conducted this risk evaluation under TSCA section 6, (15 U.S.C. 2605), which requires that EPA conduct risk evaluations on chemical substances and identifies the minimum components EPA must include in the risk evaluations. Each risk evaluation must be conducted consistent with the best available science, be based on the weight of the scientific evidence, and consider reasonably available information, and not consider costs or non-risk factors. 15 U.S.C. 2625(h), (i), and (k). See also the implementing procedural regulations at 40 CFR part 702 and for more information about the TSCA risk evaluation process for existing chemicals, go to https://www.epa.gov/assessing-and-managing-chemicals-under-tsca.

EPA is announcing the availability of the final risk evaluation under TSCA for 1,3-butadiene. The purpose of risk evaluations under TSCA is to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment under the conditions of use, including unreasonable risk to potentially exposed or susceptible subpopulations identified as relevant to the risk evaluation by EPA, and without consideration of costs or non-risk factors. EPA has used the best available science to prepare this final risk evaluation and ensured that this action is consistent with Executive Order 14303 “Restoring Gold Standard Science,” (May 23, 2025). Based on the weight of scientific evidence, the Agency determined that 1,3-butadiene poses unreasonable risk to human health driven by specific conditions of use. EPA will now initiate risk management action as required pursuant to TSCA section 6(a) (15 U.S.C 2605(a)), to address the unreasonable risk.

1,3-Butadiene is a colorless gas with a total production volume (PV) in the United States between 1 and 5 billion pounds. 1,3-Butadiene is produced from petrochemical processing and is also used to aid in petrochemical manufacturing but is primarily used as a monomer to produce plastic and rubber products. This involves polymerization of 1,3-butadiene with itself or with other monomers, which are then incorporated into various rubber and plastic articles. These synthetic rubbers, resins, and latex are used to manufacture tires, other rubber components and plastic materials. 1,3-Butadiene polymers are also used as viscosity agents in several formulations for adhesives, lubricants, and paints and coatings. These polymerization products which are polymeric forms of 1,3-butadiene are also referred to as 1,3-butadiene by some chemical safety data sheets (SDSs). This risk assessment covers only the monomer form of 1,3-butadiene.

On December 30, 2019, EPA announced its designation of 1,3-butadiene as a high priority substance for risk evaluation under TSCA (84 FR 71924 (FRL-10003-15)). On April 9, 2020, EPA sought public comment on the draft scope of the 1,3-butadiene risk evaluation (85 FR 19941(FRL-10007-11)) and, after considering public comments, issued the final scope on September 4, 2020 (85 FR 55281 (FRL-10013-90)). On December 3, 2024, EPA released the draft risk evaluation for public comment and external peer review by the Science Advisory Committee on Chemicals (SACC) (89 FR 95779 (FRL-12241-02-OCSPP)).

These documents, other supporting documents, and public comments are in dockets EPA-HQ-OPPT-2018-0451 and EPA-HQ-OPPT-2024-0425. The following documents are being released with this notice:

• A response to comments document titled, “Summary of and Response to External Peer Review and Public Comments on the Risk Evaluation for 1,3-Butadiene”;

• A non-technical summary of the final risk evaluation titled, “Non-technical Summary of the TSCA Risk Evaluation for 1,3-Butadiene”; and

• The final risk evaluation titled, “Risk Evaluation for 1,3-Butadiene,” along with multiple supporting documents.

EPA has determined that 1,3-butadiene, under the conditions of use (COUs), presents an unreasonable risk of injury to human health. EPA has determined that the unreasonable risk to human health presented by 1,3-butadiene is driven by 11 of the 30 COUs. The 11 COUs that significantly contribute to the unreasonable risk determination for 1,3-butadiene are based on identified non-cancer and cancer risk to workers, including 1 COU that contributes to unreasonable risk of injury to occupational non-users, from inhalation exposure:

• Manufacturing—domestic manufacturing;

• Manufacturing—importing;

• Processing as a reactant—intermediate (adhesive manufacturing; all other basic organic chemical manufacturing; fuel binder for solid rocket fuels; organic fiber manufacturing; petrochemical manufacturing; plastic material and resin manufacturing; propellant manufacturing; synthetic rubber manufacturing; paint and coating manufacturing);

• Processing as a reactant—monomer used in polymerization process (Synthetic rubber manufacturing; plastic material and resin manufacturing);

• Processing—incorporation into formulation, mixture, or reaction product—monomers (plastic product manufacturing; plastic material and resin manufacturing; synthetic rubber manufacturing);

• Processing—incorporation into formulation, mixture, or reaction product—plasticizer (asphalt paving, roofing, and coating materials manufacturing);

• Processing—incorporation into article—monomer (rubber product manufacturing);

• Processing—use-non-incorporative activities—fuel (petroleum refineries);

• Processing—repackaging—(wholesale and retail trade fuel; synthetic rubber manufacturing; petrochemical manufacturing);

• Processing—recycling; and

• Disposal.

Consistent with TSCA section 6(a), EPA will propose a risk management regulatory action, to the extent necessary, so that 1,3-butadiene no longer presents an unreasonable risk. EPA expects to focus its risk management action on the conditions of use that significantly contribute to the unreasonable risk. In proposing a rule and selecting among requirements, consistent with TSCA section 6(c)(2), EPA will consider and factor in, to the extent practicable: (i) the effects of 1,3-butadiene on health and the environment, (ii) the magnitude of exposure to 1,3-butadiene of human beings and the environment, (iii) the benefits of 1,3-butadiene for various uses, and (iv) the reasonably ascertainable economic consequences of the rule. Additional information received may inform the risk management of 1,3-butadiene and, like the prioritization and risk evaluation processes, there will be opportunity for public comment on any proposed risk management actions.

The EPA approved eleven Requests for Coverage under the CA-GDF General Permit  1 submitted by the Permittees. The Requests for Coverage under the CA-GDF General Permit were approved on the dates listed in Table 1. These approvals pertain to the construction and operation of the Sources, all of which are gasoline dispensing facilities, located or to be located in Indian country in California. The EPA issued the approvals pursuant to the provisions of Clean Air Act sections 110(a) and 301(d) and the EPA's Tribal Minor NSR Program at 40 CFR 49.151-49.164. The EPA based its approvals on its determinations that the Sources met the criteria qualifying them for coverage and that the Sources were eligible for coverage under the CA-GDF General Permit.

This action provides information that is directed to the public in general.

EPA is publishing this document in the Federal Register as required by sections 5 of the Toxic Substances Control Act (TSCA), 15 U.S.C. 2601 et seq., and corresponding EPA regulations.

Under TSCA, a chemical substance may be either an “existing” chemical substance or a “new” chemical substance, see https://www.epa.gov/chemicals-under-tsca. Any chemical substance that is not on EPA's TSCA Inventory of Chemical Substances (TSCA Inventory) is classified as a “new chemical substance,” while a chemical substance that is listed on the TSCA Inventory is classified as an “existing chemical substance.” See TSCA section 3(2) and (11). For more information about the TSCA Inventory, see https://www.epa.gov/inventory.

Any person who intends to manufacture (including import) a new chemical substance for a non-exempt commercial purpose, or to manufacture or process a chemical substance in a non-exempt manner for a use that EPA has determined is a significant new use, is required by TSCA section 5 to provide EPA with a PMN, MCAN, or SNUN, as appropriate, before initiating the activity. EPA will review the notice, make a risk determination on the new chemical substance or significant new use, and take appropriate action as described in TSCA section 5(a)(3).

TSCA section 5(h)(1) authorizes EPA to allow persons, upon application and under appropriate restrictions, to manufacture a new chemical substance, or manufacture or process a chemical substance subject to a significant new use rule (SNUR) issued under TSCA section 5(a)(2), for “test marketing” purposes, upon a showing that the manufacture, processing, distribution in commerce, use, and disposal of the chemical substances will not present an unreasonable risk of injury to health or the environment. This is referred to as a test marketing exemption, or TME.

Premanufacture notification procedures for review of certain new microbial products of biotechnology are established in 40 CFR part 725. These pertain to MCANs and biotechnology exemptions, including TSCA experimental release applications (TERAs), TMEs for microorganisms, and Tier I and Tier II exemptions.

This document provides notice of receipt and status reports for the covered period and certain submissions under TSCA section 5 and provides an opportunity to comment on this information. The Agency is providing information about the receipt of PMNs, SNUNs, MCANs, and amendments to a previously submitted notice; test information; biotechnology exemption applications under 40 CFR part 725; TME applications; NOCs for new chemical substances; and a periodic status report on chemical substances that are currently under EPA review or have recently concluded review.

1. Submitting CBI. Do not submit CBI to EPA through https://www.regulations.gov or email. If you wish to include CBI in your comment, please follow the instructions at https://www.epa.gov/dockets/commenting-epa-dockets#rules and clearly mark the information that you claim to be CBI. In addition to one complete version of the comment that includes CBI, a copy of the comment without CBI must be submitted for inclusion in the public docket. Information marked as CBI will not be disclosed except in accordance with procedures set forth in 40 CFR parts 2 and 703.

2. Tips for preparing your comments. When preparing and submitting your comments, see the commenting tips at https://www.epa.gov/dockets/commenting-epa-dockets.

The tables in this document provide the following information on the TSCA section 5 submissions received by EPA during this period and determined to be complete consistent with 40 CFR 720.70(a).

• Case number. The EPA number assigned to the TSCA section 5 submissions. Please note that a case number may be listed more than once in the table when the submission involves a subsequent amendment.

• Chemical substance. Name of the chemical substance, or generic name if the specific name is claimed as CBI.

• Manufacturer. Name of the submitting manufacturer, to the extent that such information is not subject to a CBI claim. The term “manufacturer” is defined by statute to include importer.

• Use(s). Potential uses identified by the manufacturer.

• Received. Date the submission was received by EPA.

• Commencement. Date of commencement provided by the submitter in the NOC.

• Test information. For test information received, the type of test information submitted to EPA based on the attachment type and subtype data selected by the submitter.

As used in each of the tables, the following explanations apply:

• (S) indicates that the information in the table is the specific information provided by the submitter.

• (G) indicates that the information in the table is generic information because the specific information provided by the submitter was claimed as CBI.

EPA provides information on its website about cases reviewed under TSCA section 5, including the PMNs, SNUNs, MCANs, and exemption applications received; the date of receipt; the final EPA determination on the submission; and the effective date of EPA's determination. See https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/status-pre-manufacture-notices. In addition, information EPA receives about chemical substances under TSCA, including non-CBI new chemical submissions, can be accessed in ChemView at https://chemview.epa.gov/chemview.

Table 1 provides non-CBI information for the PMNs, SNUNs and MCANs received by EPA that have passed an initial screening and determined to be complete consistent with 40 CFR 720.70(a) during this period.

Table 2 provides non-CBI information on the NOCs received by EPA that have passed an initial screening during this period.

Table 3 provides non-CBI information on the test information that has been received by EPA that have passed an initial screening during this period.

Information about the TSCA section 5 PMNs, SNUNs, MCANs, and exemption applications received, including the date of receipt, the status of EPA's review, the final EPA determination, and the effective date of EPA's determination, is available online at: https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/pre-manufacture-notices .

This action is directed to the public in general. Although this action may be of particular interest to applicants seeking to amend their pesticide registration. Since other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action.

1. Submitting CBI. Do not submit this information to EPA through regulations.gov or email. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

2. Tips for preparing your comment s. When preparing and submitting your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.

A copy of the draft PR notice is available in the docket under docket identification (ID) number EPA-HQ-OPP-2025-2863.

This draft PR Notice provides updated guidance to registrants and applicants (both of which are referred to in this notice as “registrants”) concerning the process for notifications, non-notifications and minor formulation amendments. This proposed notice updates and clarifies the scope of changes accepted by notification, non-notification and minor formulation amendment for all pesticide products. This PR Notice, when final, will supersede PR Notice 98-10, entitled “Notification, Non-notification, Minor Formulation Amendments” dated October 22, 1998, in its entirety. In addition, the guidance in this draft PR Notice allowing for additions, modifications, or deletions of mandatory or advisory statements will supersede the contrary guidance in section II of PR Notice 2000-5, dated May 10, 2000, that requires such changes be submitted by amendment.

The changes in procedure presented in this draft PR Notice are updates to clarify the scope of all registration changes accepted by notification, non-notification, and minor formation amendment for all pesticide products. The draft PR Notice adds several new minor modifications, moves some existing minor modifications to a more streamlined process ( e.g., from notification to non-notification), and provides more details in the minor modification and process descriptions to enhance clarity. For example, a new minor modification in the draft PR Notice includes the use of placeholder text for certain symbols, pictures, logos, and graphics, including distributor product logos, which can be added to the master label via notification and then, once the placeholder text is on the stamped master label, the actual symbols, pictures, logos, or graphics can be added to the master label via non-notification. These changes will help reduce the burden associated with completing, submitting and processing these applications for both pesticide registrants and the Agency and provide improved efficiencies without the extra burden.

EPA is particularly interested in receiving feedback on the following proposed changes in the draft PR Notice: updated requirements under Section II.E, which refers to symbols, pictures, logos, and graphics or placeholder text for symbols, pictures, logos, and graphics being added to the master label by notification; use of a placeholder for adding state-required fertilizer restrictions; specific 100% repack product label revisions; the addition of referral statements and marketing claims; and changes to sources for certain inert ingredients, addition of certain product packaging graphics and statements, changes in state registration status, changes in warranty statement, and adjustments to certain Endangered Species Act (ESA)-related labeling language that are now being proposed to be made via non-notification.

No, the draft PR Notice discussed in this document is intended to provide guidance to EPA personnel and decision makers and to pesticide registrants. While the requirements in the statutes and Agency regulations are binding on EPA and the applicants, this PR Notice, when final would not be binding on either EPA or pesticide registrants, and EPA may depart from the guidance where circumstances warrant and without prior notice. Likewise, pesticide registrants may assert that the guidance is not appropriate generally or not applicable to a specific pesticide or situation.

Additional information about these statutes and Executive Orders can be found at https://www.epa.gov/laws-regulations/laws-and-executive-orders.

This action is not a significant regulatory action under Executive Order 12866 (58 FR 51735; October 4, 1993) and was therefore not submitted to the Office of Management and Budget (OMB) for review under Executive Orders 12866 and 13563 (76 FR 3821, January 21, 2011).

This guidance does not create any paperwork burdens that require additional approval by OMB under the PRA, 44 U.S.C. 3501 et seq. The information collection activities associated with pesticide registration are already approved by OMB under OMB Control No. 2070-0226, entitled “Consolidated Pesticide Registration Submission Portal” (EPA ICR No. 2624).

I. Executive Summary A. Does this action apply to me?

This action provides information that is directed to the public in general.

This document lists the statements of findings made by EPA after review of submissions under TSCA section 5(a) that certain new chemical substances or significant new uses are not likely to present an unreasonable risk of injury to health or the environment. This document presents statements of findings made by EPA during the applicable period.

TSCA section 5(a)(3) requires EPA to review a submission under TSCA section 5(a) and make specific findings pertaining to whether the substance may present unreasonable risk of injury to health or the environment. Among those potential findings is that the chemical substance or significant new use is not likely to present an unreasonable risk of injury to health or the environment per TSCA Section 5(a)(3)(C).

TSCA section 5(g) requires EPA to publish in the Federal Register a statement of its findings after its review of a submission under TSCA section 5(a) when EPA makes a finding that a new chemical substance or significant new use is not likely to present an unreasonable risk of injury to health or the environment. Such statements apply to PMNs, MCANs, and SNUNs submitted to EPA under TSCA section 5.

Anyone who plans to manufacture (which includes import) a new chemical substance for a non-exempt commercial purpose and any manufacturer or processor wishing to engage in a use of a chemical substance designated by EPA as a significant new use must submit a notice to EPA at least 90 days before commencing manufacture of the new chemical substance or before engaging in the significant new use.

The submitter of a notice to EPA for which EPA has made a finding of “not likely to present an unreasonable risk of injury to health or the environment” may commence manufacture of the chemical substance or manufacture or processing for the significant new use notwithstanding any remaining portion of the applicable review period.

In this unit, EPA identifies the PMNs, MCANs and SNUNs for which EPA has made findings under TSCA section 5(a)(3)(C) that the new chemical substances or significant new uses are not likely to present an unreasonable risk of injury to health or the environment. For the findings made during this period, the following list provides the EPA case number assigned to the TSCA section 5(a) submission and the chemical identity (generic name if the specific name is claimed as confidential).

• P-24-0139, Maleic acid, dibutyl ester, reaction products with isophoronediamine-5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethylcyclohexane-trimethylolpropane triacrylate polymer, di-Bu maleate and di-Et maleate (Generic Name).

• P-24-0145, 2-Butenedioic acid (2Z)-, 1,4-bis(2-ethylhexyl) ester, reaction products with 5-amino-1,3,3-trimethylcyclohexanemethanamine-hexamethylene diacrylate-isophorone diisocyanate polymer and di-Bu maleate (Generic Name).

To access EPA's decision document describing the basis of the “not likely to present an unreasonable risk” finding made by EPA under TSCA section 5(a)(3)(C), lookup the specific case number at https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca/determined-not-likely.

Authority: 15 U.S.C. 2601 et seq.

This action is directed to organizations who administer soil and water conservation programs and organizations/individuals with expertise in the reduction of erosion and runoff on agricultural land who advise or offer consulting services to growers/landowners. Additionally, growers and commercial applicators who apply pesticides and the general public may be interested in this action. Since a potentially broad range of entities may be interested in this action, the Agency has not attempted to describe all the specific entities that may be interested. If you have any questions regarding the applicability of this guidance to a particular entity or registration action, contact the person listed under FOR FURTHER INFORMATION CONTACT .

EPA is issuing this guidance pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (7 U.S.C. 136a, et seq. ).

The Agency is announcing the availability of a draft PR Notice entitled “Process to Become an EPA Qualified Conservation Program (QCP) and Qualified External Party (QEP).” PR Notices are issued by OPP to inform pesticide registrants and other interested persons about important policies, procedures, and registration related decisions, and serve to provide guidance to pesticide registrants and OPP personnel. EPA is announcing the availability of and seeking public comment on this draft PR Notice.

This draft PR Notice seeks to inform interested parties of (1) the proposed process of becoming an EPA QCP or EPA QEP and to solicit public comment on the proposed process, and (2) communicate the estimated paperwork burden that this process would create for the public and to solicit public comment on these estimates pursuant to the Paperwork Reduction Act.

For this draft PR Notice, interested parties primarily include conservation programs, growers and other members of the agricultural community who support or consult growers when utilizing pesticides.

EPA seeks comment on the following:

• The EPA would like feedback on the two applications described in the draft PR Notice. Specifically, are the instructions and questions in the applications clear? If not, please feel free to provide suggestions of how to clarify the instructions or questions.

• Do any questions appear redundant or otherwise unnecessary for EPA to judge the quality of the program or organization/individual?

• The Agency is considering expanding this process to also qualify conservation programs and external parties that support non-agricultural ( e.g., turf, nursery/ornamentals, forestry, rights of way) uses. Additionally, the EPA intends to develop a mitigation menu for non-agricultural uses. However, this menu has not yet been developed. Are there conservation programs that cover non-agricultural use sites that could want to be qualified? Would there be value to qualify external parties for non-agricultural use sites? If yes to either of these questions, would the applications in their current form be relevant for these programs or parties seeking qualification?

• Is there other or additional information that EPA should request to judge the program?

• What amount of time would it take you or staff members in your organization to complete the application (please assign number of hours for each staff level involved—manager type, technical type and clerical type)?

• EPA has estimated the burden to complete these applications to be 56 hours total time, see Information Collection Request Supporting Statement for more details of this estimate. If your estimate is significantly different from this estimate, please explain why yours is different and if you anticipate your estimate is more likely to represent the typical entity who may apply or not.

• How many programs/organizations/individuals provide these services in your area? Please provide separate estimates for each group.

• Given the burden that it would take to complete the applications, how likely is it that you or your program organization will apply to become an QCP or QEP?

• Do you think other organizations/individuals like yours would find it worth the effort to also apply?

• Please provide comments on the proposed re-review process. Should it occur? Is the process as described clear?

• Is 5-years an appropriate length of time for approvals to remain valid? If not, what time frame would be more appropriate for a re-review process and why?

• Please comment on the proposed process to revoke status as QCP and QEP? Are there additional elements the Agency should consider?

• The Agency would like to receive detailed input as to the extent states should be involved in any element of the proposed process.

• What elements of the process should the states be included and why? If they should be included, please estimate how much time would be involved in reviewing or helping to prepare applications for the associated paperwork burden to account for state involvement.

The requirements in the relevant statutes and Agency regulations may be binding, however, this PR Notice is not binding on either EPA or potential QCP or QEP applicants. The EPA may depart from the process where circumstances warrant and without prior notice. Likewise, relevant stakeholders may assert that the process is not appropriate generally or not applicable to their work or situation.

According to the PRA, 44 U.S.C. 3501 et seq., an agency may not conduct or sponsor, and a person is not required to respond to a collection of information that requires approval under the PRA, unless it has been approved by the Office of Management and Budget (OMB) and displays a currently valid OMB control number. The information collection activities described in this draft PR Notice are being addressed in the new ICR entitled “Process to Become an EPA Qualified Conservation Program (QCP) and Qualified External Party (QEP),” identified as EPA ICR No. 7807.01, that is included in the docket for public review and comment. EPA welcomes comment and will review public comments received on all materials including (1) the ICR (including public estimates of burden), (2) the draft PR Notice, and (3) the two applications. EPA will consider all public comments received and update all materials as appropriate for a second public review and comment period. After the second comment period, the Agency will provide a summary response and may make final updates to all relevant materials, if deemed necessary. Finally, EPA will submit all relevant materials for OMB for review and approval under the PRA and issue a final PR Notice.

This action is directed to the public in general. This action may, however, be of interest to those involved in the manufacture, processing, distribution, and disposal of chemical substances and mixtures, and/or those interested in the assessment of risks involving chemical substances and mixtures. Since other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action.

1. Submitting CBI. Do not submit CBI or other sensitive information to EPA through email. If your nomination contains any information that you consider to be CBI or otherwise protected, please contact the DFO in FOR FURTHER INFORMATION CONTACT to obtain special instructions before submitting that information.

2. Request for Nominations to Serve as ad hoc Expert Reviewers to Assist the SACC. As part of a broader process for developing a pool of candidates for SACC peer reviews, EPA is asking the public and stakeholders for nominations of scientific and technical experts that EPA can consider as prospective candidates to serve as ad hoc reviewers assisting the SACC with peer reviews. Any interested person or organization may nominate qualified individuals for consideration as prospective candidates for this review by following the instructions provided in this document. Individuals may also self-nominate.

Those selected from the pool of prospective candidates will be invited to attend the public meeting and to participate in the discussion of key issues and assumptions at the meeting. In addition, they will be asked to review chemical evaluation documents and to help finalize the meeting minutes and final report.

Individuals nominated for the two SACC peer reviews anticipated for early and mid-2026 should have expertise in one or more of the chemicals and/or areas of expertise identified below.

Early-2026 Chemicals Undergoing Risk Evaluation that EPA is Considering for SACC Review:

• 1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-hexamethylcyclopenta [g]-2-benzopyran (HHCB)

• Phthalic anhydride (PAD)

• o-Dichlorobenzene (o-DCB)

• p-Dichlorobenzene (p-DCB)

Individuals nominated for peer review for the early-2026 chemical review should also have expertise in one or more of the following areas:

Aquatic exposure modeling; aquatic exposures from ships/ports; cancer mechanism of action (MOA); cancer weight-of-evidence (WoE); chemical engineering; chemical transport and fate; computational toxicology; consumer exposure; dermal exposure modeling (including probabilistic modeling) and estimation for workers; dermal sensitization; dose-response modeling; epidemiology; inhalation toxicology; metabolism; physiologically based pharmacokinetics (PBPK); probabilistic modeling for environmental exposures; read-across; respiratory sensitization; risk assessment; sediment dynamics; toxicokinetics; transcriptomics; and worker exposure.

Mid-2026 Chemicals Undergoing Risk Evaluation that EPA is Considering for SACC Review:

• 1,2-Dichloropropane (1,2-DCP)

• 1,1,2-Trichloroethane (1,1,2-TCA)

• trans-1,2-Dichloroethylene (trans-DCE)

• Ethylene dibromide (EDB)

• 4,4′-(1-Methylethylidene)bis[2, 6-dibromophenol] (TBBPA)

• Phosphoric acid, triphenyl ester (TPP)

Individuals nominated for peer review for the mid-2026 chemical review should have expertise in one or more of the following areas:

Aquatic exposure modeling; aquatic toxicology; amphibian toxicology; avian toxicology; cancer mechanism of action (MOA); cancer weight-of-evidence (WoE); chemical engineering (processing as a reactant and processing as a plastic processes); chemical transport and fate; computational toxicology; consumer exposure; dermal exposure modeling (including probabilistic modeling) and estimation for workers; dermal sensitization; dose-response modeling; epidemiology; exposure modeling-releases from industrial and commercial facilities; exposures to firefighters; industrial hygiene; inhalation exposure modeling and estimation for workers; inhalation toxicology; metabolism; physiologically based pharmacokinetics (PBPK); respiratory sensitization; risk assessment; sediment dynamics; toxicokinetics; and worker exposure.

Nominees should be scientific experts who have sufficient professional qualifications, including training and experience, to be capable of providing expert comments on the scientific issues for these reviews. Each nomination should include the following information:

• Contact information for the person making the nomination;

• Name, affiliation, and contact information for the nominee; and

• The disciplinary and specific areas of expertise of the nominee.

Submit your nomination as directed under ADDRESSES by the deadline indicated under DATES .

Those who are selected from the pool of prospective candidates will be invited to attend a public SACC meeting and participate in the discussion of key issues and assumptions. In addition, they will be asked to review and to help finalize the meeting minutes and final report.

SACC members and ad hoc reviewers are subject to the provisions of the Standards of Ethical Conduct for Employees of the Executive Branch at 5 CFR part 2635, conflict of interest statutes in Title 18 of the United States Code and related regulations. In anticipation of this requirement, prospective candidates for service on the SACC will be asked to submit confidential financial information which shall fully disclose, among other financial interests, the candidate's employment, stocks, and bonds, and where applicable, sources of research support. EPA will evaluate the candidates' financial disclosure forms to assess whether there are financial conflicts of interest, appearance of a loss of impartiality, or any prior involvement with the development of the documents under consideration (including previous scientific peer review) before the candidate is considered further for service on the SACC. Selected candidates are required to complete an ethics training prior to conducting their reviews.

The selection of scientists to serve as ad hoc reviewers for the SACC is based on the function of the Committee and the expertise needed to address the Agency's charge to the Committee. No interested scientists shall be ineligible to serve by reason of their membership on any other advisory committee to a federal department or agency or their employment by a federal department or agency, except EPA. Other factors considered during the selection process include availability of the prospective candidate to fully participate in the Committee's reviews, ability to be hired as an EPA Special Government Employee (SGE), absence of any conflicts of interest or appearance of loss of impartiality, independence with respect to the matters under review, and lack of bias. Although financial conflicts of interest, the appearance of loss of impartiality, lack of independence, and bias may result in non-selection, the absence of such concerns does not assure that a candidate will be selected to serve on the SACC. Numerous qualified candidates are often identified for SACC reviews. Therefore, selection decisions involve carefully weighing several factors including the candidates' areas of expertise and professional qualifications and achieving an overall balance of different scientific perspectives across reviewers.

At this time, EPA is seeking nominations to create a pool of ad hoc experts who can be available to the SACC to assist in reviews conducted by the Committee. EPA anticipates selecting experts from this pool, as needed, to assist the SACC in their review of the chemicals listed in Units II B1. and II.B2. The Agency will consider all nominations of prospective candidates for service as ad hoc reviewers for the SACC that are received on or before February 4, 2026. However, final selection of ad hoc reviewers is a discretionary function of the Agency.

EPA plans to make a list of candidates under consideration as prospective ad hoc reviewers for these reviews available for public comment. The list will be available in the docket at https://www.regulations.gov (docket identification number EPA-HQ-OPPT-2025-3358) and through the SACC website at https://www.epa.gov/tsca-peer-review.

The SACC provides independent advice and recommendations to the EPA on the scientific and technical aspects of risk assessments, methodologies, and pollution prevention measures and approaches for chemicals regulated under TSCA. The SACC is comprised of experts in toxicology; environmental risk assessment; exposure assessment; and related sciences ( e.g., synthetic biology, pharmacology, biotechnology, nanotechnology, biochemistry, biostatistics, physiologically based pharmacokinetic (PBPK) modeling, computational toxicology, epidemiology, environmental fate, environmental engineering and sustainability). The SACC currently consists of 19 members. When needed, the committee will be assisted by ad hoc reviewers with specific expertise in the topics under consideration.

• 1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-hexamethylcyclopenta [g]-2-benzopyran (HHCB): HHCB is a synthetic polycyclic musk used in fragrances found in cleaners, detergents, and personal care products. EPA designated it as a High-Priority Substance for risk evaluation under TSCA in 2019. HHCB is released primarily via wastewater pathways and may persist in aquatic and sediment environments. EPA's risk evaluation will address ecological toxicity, environmental fate, bioaccumulation, general population exposures, and human health impacts across conditions of use.

• Phthalic Anhydride (PAD): PAD is an industrial intermediate used to manufacture alkyd resins, plasticizers, polyester resins, pigments, and coatings. EPA designated it as a High-Priority Substance for risk evaluation under TSCA in 2019. The draft risk evaluation will examine industrial releases, occupational inhalation and dermal exposures (including sensitization), consumer exposures, environmental fate, and human health hazards.

• o-Dichlorobenzene (o-DCB): o-DCB is used as a solvent, degreasing agent, and chemical intermediate. EPA designated it as a High-Priority Substance for risk evaluation under TSCA in 2019. Its evaluation will focus on inhalation exposures to workers and consumers, multimedia environmental transport, and potential health risks associated with acute and chronic exposures.

• p-Dichlorobenzene (p-DCB): p-DCB is used in deodorant blocks, air fresheners, repellents, and other industrial applications. EPA designated it as a High-Priority Substance for risk evaluation under TSCA in 2019. It presents inhalation exposure concerns due to its volatility and widespread consumer uses. EPA's risk evaluation will address health hazards, exposure pathways, environmental fate, and risks associated with indoor and ambient exposures.

• 1,2-Dichloropropane (1,2-DCP): 1,2-DCP is a chlorinated solvent used in consumer and industrial cleaning, chemical synthesis, and as an intermediate. EPA designated it as a High-Priority substance due to concerns for inhalation and dermal exposure and potential carcinogenicity. EPA's draft risk evaluation will assess general population, occupational and consumer exposures, environmental releases, fate and transport, and human health and environmental hazards.

• 1,1,2-Trichloroethane (1,1,2-TCA): 1,1,2-TCA is used as a solvent and chemical intermediate. EPA designated it as a High-Priority Substance for risk evaluation under TSCA in 2019. Its evaluation will address general population, occupational and consumer exposures via inhalation and dermal exposure pathways; environmental releases from industrial use; and potential human and environmental health hazards including systemic toxicity and carcinogenicity.

• trans-1,2-Dichloroethylene (trans-DCE): trans-DCE is a highly flammable, colorless liquid. It is a synthetic chemical with no known natural sources, and it is used as a solvent in processing and in formulaitons for cleaning and degreasing, among other uses. EPA designated it as a High-Prioroty Substance for risk evaluation under TSCA in 2019. EPA's risk evaluation will address potentially exposed or susceptible subpopulations (PESS), environmental and human health hazards, and exposures and impacts across conditions of use.

• Ethylene Dibromide (EDB): EDB is primarily used in chemical synthesis and as a fuel additive. It was historically used as a fumigant. EDB has known toxicity and potential carcinogenic effects. EPA designated it as a High-Priority Substance under TSCA. EPA's draft evaluation will consider inhalation and dermal exposures during manufacturing, processing and use, environmental fate, ecological effects, and health hazards associated with occupational, consumer, and general population exposures.

• Tetrabromobisphenol A (TBBPA): TBBPA is a brominated flame retardant used in printed circuit boards, resins, and polymer systems. EPA designated it as a High-Priority Substance due to potential ecological hazards, persistence, and possible endocrine-related effects. The risk evaluation will address aquatic and sediment exposure pathways, environmental fate, bioaccumulation, and human health risks associated with occupational and consumer uses.

• Triphenyl Phosphate (TPP): TPP is used as a flame retardant and plasticizer in polymers, electronics, and consumer products. EPA designated it as a High-Priority Substance under TSCA. TPP may be released to air, water, or dust during use and disposal. EPA's risk evaluation will consider exposure to workers and consumers, environmental fate, ecological effects, and potential risks across conditions of use.

The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug or biological product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.

A regulatory review period consists of two periods of time: a testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).

FDA has approved for marketing the human drug product, AUGTYRO (repotrectinib), is indicated for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). Subsequent to this approval, the USPTO received a patent term restoration application for AUGTYRO (U.S. Patent No. 9,714,258) from Turning Point Therapeutics, Inc. and the USPTO requested FDA's assistance in determining the patent's eligibility for patent term restoration. In a letter dated June 27, 2025, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of AUGTYRO represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.

FDA has determined that the applicable regulatory review period for AUGTYRO is 2,574 days. Of this time, 2,340 days occurred during the testing phase of the regulatory review period, while 234 days occurred during the approval phase. These periods of time were derived from the following dates:

1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective: October 30, 2016. The applicant claims October 29, 2016, as the date the investigational new drug application (IND) became effective. However, FDA records indicate that the IND effective date was, October 30, 2016, which was 30 days after FDA receipt of the IND.

2. The date the application was initially submitted with respect to the human drug product under section 505 of the FD&C Act: March 27, 2023. FDA has verified the applicant's claim that the new drug application (NDA) for AUGTYRO (NDA 218213) was initially submitted on March 27, 2023.

3. The date the application was approved: November 15, 2023. FDA has verified the applicant's claim that NDA 218213 was approved on November 15, 2023.

This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application(s) for patent extension, this applicant seeks 1,027 days of patent term extension.

Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see DATES ). Furthermore, as specified in § 60.30 (21 CFR 60.30), any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must comply with all the requirements of § 60.30, including but not limited to: must be timely (see DATES ), must be filed in accordance with § 10.20, must contain sufficient facts to merit an FDA investigation, and must certify that a true and complete copy of the petition has been served upon the patent applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30.

Submit petitions electronically to https://www.regulations.gov at Docket No. FDA-2013-S-0610. Submit written petitions (two copies are required) to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug or biological product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.

A regulatory review period consists of two periods of time: a testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).

FDA has approved for marketing the human drug product, BRENZAVVY (bexagliflozin), indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Subsequent to this approval, the USPTO received patent term restoration applications for BRENZAVVY (U.S. Patent Nos. 7,838,499; 8,802,637; 10,533,032; 10,981,942) from THERACOSBIO, LLC and the USPTO requested FDA's assistance in determining the patents' eligibility for patent term restoration. In a letter dated June 27, 2025, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of BRENZAVVY represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.

FDA has determined that the applicable regulatory review period for BRENZAVVY is 5,098 days. Of this time, 4,642 days occurred during the testing phase of the regulatory review period, while 456 days occurred during the approval phase. These periods of time were derived from the following dates:

1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective: February 6, 2009. FDA has verified the applicant's claim that the date the investigational new drug application became effective was on February 6, 2009.

2. The date the application was initially submitted with respect to the human drug product under section 505 of the FD&C Act or section: October 22, 2021. FDA has verified the applicant's claim that the new drug application (NDA) for BRENZAVVY (NDA 214373) was initially submitted on October 22, 2021.

3. The date the application was approved: January 20, 2023. FDA has verified the applicant's claim that NDA 214373 was approved on January 20, 2023.

This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application(s) for patent extension, this applicant seeks 548, 779, 1,769, or 1,826 days of patent term extension.

Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see DATES ). Furthermore, as specified in § 60.30 (21 CFR 60.30), any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must comply with all the requirements of § 60.30, including but not limited to: must be timely (see DATES ), must be filed in accordance with § 10.20, must contain sufficient facts to merit an FDA investigation, and must certify that a true and complete copy of the petition has been served upon the patent applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30.

Submit petitions electronically to https://www.regulations.gov at Docket No. FDA-2013-S-0610. Submit written petitions (two copies are required) to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

I. Background

The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug or biological product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.

A regulatory review period consists of two periods of time: a testing phase and an approval phase. For human drug products, the testing phase begins when the exemption to permit the clinical investigations of the drug becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human drug product and continues until FDA grants permission to market the drug product.

Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a human drug product will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).

FDA has approved for marketing the human drug product, IZERVAY (avacincaptad pegol sodium), indicated for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). Subsequent to this approval, the USPTO received patent term restoration applications for IZERVAY (U.S. Patent Nos. 7,579,456; 8,236,773; 9,617,546; 11,273,171) from IVERIC bio, Inc. and the USPTO requested FDA's assistance in determining the patents' eligibility for patent term restoration. In a letter dated June 27, 2025, FDA advised the USPTO that this human drug product had undergone a regulatory review period and that the approval of IZERVAY represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that FDA determine the product's regulatory review period.

FDA has determined that the applicable regulatory review period for IZERVAY is 6,383 days. Of this time, 6,154 days occurred during the testing phase of the regulatory review period, while 229 days occurred during the approval phase. These periods of time were derived from the following dates:

1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective: February 13, 2006. The applicant claims June 29, 2008, as the date the investigational new drug application (IND) became effective. However, FDA records indicate that the IND effective date was February 13, 2006, which was 30 days after FDA receipt of an earlier IND

2. The date the application was initially submitted with respect to the human drug product under section 505 of the FD&C Act: December 19, 2022. FDA has verified the applicant's claim that the new drug application (NDA) for IZERVAY (NDA 217225) was initially submitted on December 19, 2022.

3. The date the application was approved: August 4, 2023. FDA has verified the applicant's claim that NDA 217225 was approved on August 4, 2023.

This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application(s) for patent extension, this applicant seeks 369, 1,268, or 5 years of patent term extension.

Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see DATES ). Furthermore, as specified in § 60.30 (21 CFR 60.30), any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must comply with all the requirements of § 60.30, including but not limited to: must be timely (see DATES ), must be filed in accordance with § 10.20, must contain sufficient facts to merit an FDA investigation, and must certify that a true and complete copy of the petition has been served upon the patent applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30.

Submit petitions electronically to https://www.regulations.gov at Docket No. FDA-2013-S-0610. Submit written petitions (two copies are required) to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. L. 100-670) generally provide that a patent may be extended for a period of up to 5 years so long as the patented item (human drug product, animal drug product, medical device, food additive, or color additive) was subject to regulatory review by FDA before the item was marketed. Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.

A regulatory review period consists of two periods of time: A testing phase and an approval phase. For medical devices, the testing phase begins with a clinical investigation of the device and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the device and continues until permission to market the device is granted. Although only a portion of a regulatory review period may count toward the actual amount of extension that the Director of USPTO may award (for example, half the testing phase must be subtracted as well as any time that may have occurred before the patent was issued), FDA's determination of the length of a regulatory review period for a medical device will include all of the testing phase and approval phase as specified in 35 U.S.C. 156(g)(3)(B).

FDA has approved for marketing the medical device, MEDIBEACON. MEDIBEACON is intended to assess the Glomerular Filtration Rate (GFR) in adult patients with impaired or normal renal function by noninvasively monitoring fluorescent light emission from an exogenous tracer agent over time. This device has been validated in patients with stable renal function. The MediBeacon® TGFR is not approved for use in patients with GFR <15 ml/min/1.73 m2, GFR >120 ml/min/1.73m2, patients on dialysis, or anuric patients. The use of this device in patients with dynamic and rapidly changing renal function has not been validated. This device is not intended to diagnose acute kidney injury (AKI). The MediBeacon® TGFR Sensor and exogenous tracer agent, Lumitrace® injection, are single use and are only used with the MediBeacon® TGFR. The MediBeacon® TGFR Sensor is a single use device intended to attach to the patient's skin and excite fluorescence in Lumitrace® injection, the tracer agent, and measure the returning light intensity. The data is sent to the MediBeacon® TGFR Monitor. Lumitrace® is an injectable exogenous fluorescent tracer indicated for use with the MediBeacon® Transdermal GFR System (TGFR) for Glomerular Filtration Rate assessment. Subsequent to this approval, the USPTO received patent term restoration applications for MEDIBEACON (U.S. Patent Nos. 8,115,000; RE47,413) from Medibeacon Inc., and the USPTO requested FDA's assistance in determining this patents' eligibility for patent term restoration. In a letter dated June 27, 2025, FDA advised the Patent and Trademark Office that this medical device had undergone a regulatory review period and that the approval of MEDIBEACON represented the first permitted commercial marketing or use of the product. Thereafter, the USPTO requested that the FDA determine the product's regulatory review period.

FDA has determined that the applicable regulatory review period for MEDIBEACON is 4,175 days. Of this time, 3,598 days occurred during the testing phase of the regulatory review period, while 577 days occurred during the approval phase. These periods of time were derived from the following dates:

1. The date an exemption under section 520(g) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360j(g)) involving this device became effective: August 15, 2013. FDA has verified the applicant's claim that the date the investigational device exemption (IDE) required under section 520(g) of the act for human tests to begin became effective August 15, 2013.

2. The date an application was initially submitted with respect to the device under section 515 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e): June 21, 2023. FDA has verified the applicant's claim that the premarket approval application (PMA) for MEDIBEACON (PMA P230019) was initially submitted June 21, 2023.

3. The date the application was approved: January 17, 2025. FDA has verified the applicant's claim that PMA P230019 was approved on January 17, 2025.

This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application(s) for patent extension, this applicant seeks 5 years of patent term extension.

Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and, under 21 CFR 60.24, ask for a redetermination (see DATES ). Furthermore, as specified in § 60.30 (21 CFR 60.30), any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must comply with all the requirements of § 60.30, including but not limited to: must be timely (see DATES ), must be filed in accordance with § 10.20, must contain sufficient facts to merit an FDA investigation, and must certify that a true and complete copy of the petition has been served upon the patent applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should be in the format specified in 21 CFR 10.30.

Submit petitions electronically to https://www.regulations.gov at Docket No. FDA-2013-S-0610. Submit written petitions (two copies are required) to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

Under the Patient Protection and Affordable Care Act, Public Law 111-148, the preventive care and screenings set forth in the Guidelines are required to be covered without cost-sharing by certain group health plans and health insurance issuers. HRSA established the Guidelines in 2011 based on expert recommendations by the Institute of Medicine, now known as the National Academy of Medicine, developed under a contract with HHS. Since 2016, HRSA has funded cooperative agreements for WPSI to convene a coalition representing clinicians, academics, and consumer-focused health professional organizations to conduct a rigorous review of current scientific evidence, solicit and consider public input, and make recommendations to HRSA regarding updates to the Guidelines to improve adult women's health across the lifespan. HRSA then determines whether to support, in whole or in part, the recommended updates to the Guidelines.

For clarity, note that the Implementation Considerations address aspects of clinical and practical application of the Clinical Recommendations. Research Recommendations are provided to highlight areas where further research and clinical trials are needed to inform the development of Clinical Recommendations. The Implementation Considerations and Research Recommendations sections are not a part of the Clinical Recommendations accepted by the HRSA Administrator and therefore have no impact on health insurance coverage without cost-sharing. In the description of responses to the public comments below, the term “recommendation” is sometimes used in place of “Clinical Recommendation.”

Recommended updates to the Guidelines are based on review and synthesis of existing clinical guidelines and new scientific evidence, following robust standards for establishing foundations for and rating strengths of recommendations, articulation of recommendations, and external reviews. Additionally, HRSA provides opportunity for public comment, including participation by patients and consumers, in the development of the Guidelines.

As is standard practice, HRSA published a Federal Register Notice seeking public comment regarding the proposed updates to the Guidelines for Screening for Cervical Cancer (90 FR 47313 (Oct. 1, 2025)). All public comments were reviewed and considered as part of the deliberative process. A total of 42 responses were received, with each response containing one or more distinct comments.

WPSI recommended retaining the existing Guideline on Screening for Cervical Cancer, with several updates to the language. Language of the final Clinical Recommendation is set out at the end of this Notice.

• The first change is the use of the full form of Women's Preventive Services Initiative, instead of the acronym WPSI, in the first sentence of the Guideline.

• The second change occurs in the second sentence of the Guideline and only restructures the sentence for clarity and does not provide any changes to the recommendation.

• Next, the abbreviation “hrHPV” was added after the term “human papillomavirus” for consistency and increased clarity that the recommendation is specific to high-risk HPV types. Corresponding revisions using the abbreviation are provided throughout the remaining text of the updated recommendation.

• The word “co-testing” was previously unhyphenated in the recommendation; a hyphen was added in the latest version of the recommendation.

• WPSI updated the Guideline regarding cervical cancer testing for women aged 30-65 and added “primary hrHPV testing every 5 years (preferred) or cytology and hrHPV testing (co-testing) every 5 years. If hrHPV testing is not available, continue screening with cytology alone every 3 years.” This update reflects current evidence-based practice on testing and interval screening.

• Next, a new sentence was added (“Patient-collected hrHPV testing is an appropriate method and should be offered as an option for cervical cancer screening in women aged 30 to 65 years at average risk.”) to reflect the new evidence and developments supporting the expansion of options for cervical cancer screening through patient-collected hrHPV testing.

• The last update to the Guideline adds language on additional testing to complete the cervical cancer screening process (“Additional testing may be required to complete the screening process and follow-up findings on the initial screening. If additional testing ( e.g., cytology, biopsy colposcopy, extended genotyping, dual stain) and pathologic evaluation are indicated, these services also are recommended to complete the screening process for malignancies.”). This update ensures the screening process for malignancies is complete should additional testing services ( e.g., cytology, biopsy colposcopy, extended genotyping, dual stain) and pathologic evaluation be clinically indicated. Additional testing to complete the screening process covers all cases of cervical cancer screening, regardless of whether the test was collected by the patient or clinician.

HRSA received 42 responses on these proposed updates, with each response containing one or more distinct comments. Public comments were largely positive about the updated Guideline, with an overwhelming majority of respondents expressing support for at least one component of the recommendation. The comments have been reviewed and organized into categories, with overview summaries of comments and responses provided below:

• Adjusting Screening by Risk-Level/Defining Average Risk:

○ Comments: Thirteen comments suggested adjustments to screening by risk, socioeconomic group, or age with some requesting screening past 65, before age 20, and others requesting screening begin at age 25 in alignment with other guidelines. Four of these comments requested a definition for average risk.

○ Response: The evidence review did not determine a need to change the age for the start or stop of screening. Among the five major guidelines for average-risk women examined in the evidence review, four aligned on the same starting age, and all five recommended concluding screening at age 65. These guidelines are meant for average-risk women, a definition of which is available in the full evidence review ( https://www.hrsa.gov/sites/default/files/hrsa/about/cervical-cancer-screening-update.pdf ); the Implementation Considerations also provides notes around how WPSI defines average-risk. Screening approaches for those at high-risk are outside the scope of these recommendations. At present, the evidence does not support tailoring screening approaches based on socioeconomics. Accordingly, these comments were not accepted and no change was made in response to these comments.

• Uniform Data System/Healthcare Effectiveness and Data Information Set Alignment:

○ Comments: Ten comments noted that the addition of self-collection for cervical cancer screening provides the opportunity for HRSA to collect information through its Uniform Data System (UDS) for health centers for “member-collected samples” for cervical cancer screening that would align with an existing measure noted in the 2024 Healthcare Effectiveness and Data Information Set (HEDIS) General Guidelines used by health plans; one of these commentors requested UDS be revised to adopt the HEDIS measure language.

Another comment recommended that specific language be added to the recommendation to improve data collection in the UDS by socioeconomic subgroups as well as metrics regarding issues with screening (such as “never-screened,” “delayed-initiation,” etc.).

○ Response: While these comments go beyond the scope of this evidence review and recommendation, and thus no changes were made to the recommendation, HRSA has shared these observations and suggestions with HRSA staff that administer the Health Center Program, including UDS.

• Supporting Implementation, Follow-up Care, and Public Education:

○ Comments: Seven comments were provided that focused on supporting implementation, follow-up, and public education on the updated recommendation. Six of these comments requested more support/systems to address follow-up of positive results for home-based self-collection, particularly given concerns around loss to follow-up and access for underserved populations. One of these comments specifically requested expansion of community-based services and language on patient navigation for follow-up.

○ Response: While these comments go beyond the scope of this evidence review and recommendation, it should be noted that starting January 1, 2026, the evidence-based WPSI Patient Navigation Services for Breast and Cervical Cancer Screening Guideline, 89 FR 106522 (Dec. 30, 2024), takes effect, providing person-to-person navigation services without patient copay. A reminder of this recommendation has been added to the Implementation Considerations and additional research on the impact of patient navigation on follow-up care is already noted in the Research Recommendations.

○ Comments: Two comments requested more language delineating all necessary follow-up procedures/care or circumstances for additional testing; one of these requested specific language on an in-person follow-up visit for positive self-collected test results.

○ Response: While specific follow-up procedures and management of abnormal results are beyond the scope of the evidence review and recommendation, a note has been added to the Implementation Considerations stating follow-up for abnormal test results should follow established clinical guidelines.

○ Comments: Three of the seven comments suggested more robust outreach and education efforts, with one of the three asking for education to be tailored to highest need.

○ Response: While these comments go beyond the scope of this evidence review and recommendation, additional language has been added to the Implementation Considerations on the importance of patient-centered discussion and education, as well as the WPSI Patient Navigation Services for Breast and Cervical Cancer Screening Guideline, as noted above.

• Equal Preference for hrHPV, Cytology, and Co-Testing/Adjusting Preferences:

○ Comments: Seven comments requested equal weight be given to cytology, hrHPV, and co-testing, removing the preference for primary hrHPV testing; a number of these comments mentioned a desire to align with the draft 2024 U.S. Preventive Services Task Force (USPSTF) guideline. One comment requested cytology be used in conjunction with hrHPV testing.

○ Response: As per the 2025 WPSI evidence review, newer evidence released since the 2024 USPSTF evidence review informs primary hrHPV based screening for the 30 to 65 year age group as the preferred method, with increased detection of precancer compared with cytology-based screening and lower rates of precancer with subsequent screening seen with this modality. As such, these comments were not accepted and no change was made in response to these comments.

• FDA Intended Use for Self-Collection and Other:

○ Comments: Six comments mentioned concerns related to FDA approvals, and included concern that the FDA intended use for self-collected samples is only for situations when a clinician-collected sample cannot be obtained, a desire to note in the recommendation that FDA approvals are required for use, or other perceived FDA-related/regulatory limitations.

○ Response: In May 2025, the FDA approved the first at-home cervical cancer screening self-collection kit; this follows their earlier May 2024 approval of in-clinic self-collection kits for the same purpose. To provide additional clarity, a note was added to the Implementation Considerations on FDA approved methods.

• Self-Collection Screening Frequency Changed to Shorter Interval:

○ Comments: Five comments requested a shorter screening frequency for self-collected samples.

○ Response: No changes were made to the recommendation as self-collected samples had a similar test accuracy as clinician-collected samples and WPSI's evidence review did not support changing to an increased frequency of screening. A Research Recommendation has been added to address this.

• Self-Collections as a Secondary Option:

○ Comments: Five comments recommended self-collection as a secondary option or that it be considered only for select populations.

○ Response: The WPSI evidence review concluded that self-collected vaginal hrHPV has similar test accuracy for precancer when compared to clinician-collected samples, yielding similar proportions of positive screening results. Self-collection can also increase screening uptake, which facilitates earlier detection of cervical disease. Earlier detection is associated with improved treatment outcomes and, ultimately, the potential to prevent more cervical cancer-related deaths. Accordingly, these comments were not accepted and no change was made in response to these comments.

• Lack of U.S. Data:

○ Comments: Three commentors mentioned a concern over the use of European studies or the lack of U.S. data around self-collection or preference for primary hrHPV testing.

○ Response: The studies used in the WPSI evidence review were comparable to the broader U.S. population for the research questions examined. Most comparative screening studies used in the WPSI Evidence Review's analysis were conducted in countries with organized screening programs similar to the U.S., along with one large population cohort study conducted in a U.S. health setting with an organized screening program representing a diverse group of patients. Accordingly, these comments were not accepted and no change was made to the recommendation in response to these comments.

• Clarifications on Additional Screening to Complete the Screening Process:

○ Comments: Two comments requested defining “additional screening” and what constitutes the end of screening, particularly for the purposes of billing and coding, with one of these comments requesting information on what to do about inconclusive results and two comments requesting guidance on coding and billing for the additional tests.

○ Response: This change to the recommendation was made in alignment with similar language in the breast cancer screening guideline, added in 2024, which also recommended additional testing to complete the screening process for malignancies. While billing and coding are not specifically addressed by the Clinical Recommendation, the Center for Consumer Information and Insurance Oversight and the tri-department committee, made up of the Department of Labor, the Department of the Treasury, and HHS, makes determinations regarding coverage and can be approached for assistance with billing and coding. As reflected in the recommendation, an inconclusive result would require additional testing to complete the screening process. As such, no change to the recommendation was made in response to these comments.

• For and Against Extended Genotyping During Primary Screening:

○ Comments: One commenter noted that they do not recommend routine extended genotyping with primary screening and appreciated the addition of “hr” in front of HPV to help indicate this, while another two comments requested including extended genotyping as part of primary screening.

○ Response: No changes were made to the recommendation as there was no evidence to support extended genotyping during primary screen for average risk populations.

• Additional Technical Details Requested Comments and Responses:

○ Three comments requested additional technical details.

One of these comments requested additional technical details including a need to test patients/partners for anal and oropharyngeal HPV, which was outside the scope of this recommendation and thus no change was made.

One comment requested exit screening protocols, which is already mentioned in the Implementation Considerations.

An additional comment supported hrHPV as the preferred method of testing but suggested including language indicating that other forms of screening, such as co-testing, are also effective. This language is reflected in the existing recommendation, thus no additional changes were made.

• Single Comments and Responses:

○ Single comments were received on the following topics:

One commenter requested the evidence review, which can be accessed by visiting HRSA's Women's Preventive Services Guidelines pages https://www.hrsa.gov/womens-guidelines ). No change was made to the recommendation in response to this comment.

One comment was concerned the recommendation may lead to women having fewer gynecologic exams and potential increases in associated cancers. No changes were made as this recommendation does not change existing WPSI recommendations around the annual well-woman visit or any existing preventive cancer screenings connected to ongoing well-woman care.

One comment shared a concern that the recommendation will weaken reimbursement and institutional support. This comment was beyond the scope of the evidence review and recommendation, and no change was made.

One comment stressed the need to ensure scientific integrity for the development of the recommendation, which is a shared priority for HHS and HRSA. The evidence-based guideline development process is described elsewhere in this notice. No change was made to the recommendation in response to this comment.

One comment requested more inclusive language. No change was made based on this comment, as the guideline relates to all women at average risk of cervical cancer.

One comment requested a Research Recommendation to better assess age for first screening, which was added to the Research Recommendations.

Another comment requested more research on the best ways for providers to communicate to underserved groups. No change was made in response to this comment, as this goes beyond the scope of this evidence review and recommendation.

One commenter suggested adding a comma between “biopsy” and “colposcopy” in the final recommendation. The guideline was updated to include this grammatical edit, which does not change the substance or intent of the recommendation.

On December 29, 2025, the HRSA Administrator accepted WPSI's recommendation, which is revised as described above, and, as such, updated the HRSA-supported Women's Preventive Services Guidelines. The final Guideline for this topic reads as follows:

“The Women's Preventive Services Initiative recommends cervical cancer screening for average-risk women aged 21 to 65 years. For women aged 21 to 29 years, cervical cancer screening using cervical cytology (Pap test) every 3 years is recommended. Co-testing with cytology and human papillomavirus (hrHPV) testing is not recommended for women younger than 30 years. Women aged 30 to 65 years should be screened with primary hrHPV testing every 5 years (preferred) or cytology and hrHPV testing (co-testing) every 5 years. If hrHPV testing is not available, continue screening with cytology alone every 3 years. Women who are at average risk should not be screened more than once every 3 years. Patient-collected hrHPV testing is an appropriate method and should be offered as an option for cervical cancer screening in women aged 30 to 65 years at average risk. Additional testing may be required to complete the screening process and follow-up findings on the initial screening. If additional testing ( e.g., cytology, biopsy, colposcopy, extended genotyping, dual stain) and pathologic evaluation are indicated, these services also are recommended to complete the screening process for malignancies.”

Non-grandfathered group health plans and health insurance issuers offering group or individual health insurance coverage must cover without cost-sharing the services and screenings listed on the updated Women's Preventive Services Guidelines for plan years (in the individual market, policy years) that begin 1 year after this date. Thus, for most plans, this update will take effect for purposes of the Section 2713 coverage requirement in 2027. Additional information regarding the Women's Preventive Services Guidelines can be accessed at the following link: https://www.hrsa.gov/womens-guidelines.

Authority: Section 2713(a)(4) of the Public Health Service Act, 42 U.S.C. 300gg-13(a)(4).

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

The 2026 aggregate production quotas (APQ) and assessment of annual needs (AAN) represent those quantities of schedule I and II controlled substances and the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine that may be manufactured in the United States in 2026 in order to provide for the estimated medical, scientific, research, and industrial needs of the U.S., lawful export requirements, and the establishment and maintenance of reserve stocks. These quotas include imports of ephedrine, pseudoephedrine, and phenylpropanolamine, but do not include imports of controlled substances for use in industrial processes.

On November 28, 2025, a notice titled “Proposed Aggregate Production Quotas for Schedule I and II Controlled Substances and Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2026” was published in the Federal Register . 1 This notice proposed the 2026 APQs for each basic class of controlled substance listed in schedules I and II and the 2026 AANs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine. All interested persons were invited to comment on or object to the proposed APQs and the proposed AANs on or before December 15, 2025.

Within the public comment period, DEA received 5,044 comments from DEA registrants, chronic pain patients, patients with attention deficit/hyperactivity disorder (ADHD), pain advocacy associations, U.S. professional associations, U.S. doctors and nurses, and others. The comments included concerns about perceived domestic opioid drug shortages due to further quota reductions; patient difficulty filling authorized opioid and stimulant prescriptions; increases in drug overdose deaths despite a continued decrease in production quotas; concerns that medical professionals might be impeded from exercising their medical expertise regarding opioid prescriptions; concerns of ADHD medication efficacy and shortages based on quotas associated with isomer ratios; ordering thresholds for pharmacies, data collection and methodology; tools used to determine diversion estimates; adequate quotas for research purposes, stake holder collaboration; requests for a public hearing; requests for an extension to the comment period; and comments not pertaining to DEA-regulated activities. While all comments were posted to regulations.gov , DEA restricted the attachments to 22 comments from public view due to confidential business information and/or confidential personal identifying information.

Issue (Medication Out of Stock at Pharmacy Level): Many commenters expressed that due to the decreases in the aggregate production quotas for oxycodone and hydrocodone, they have had difficulty filling legitimate prescriptions. They stated they often experienced delays or have to visit multiple pharmacies to get their prescriptions filled. These issues have negatively impacted their quality of life and caused mental health-related issues, possibly leading to suicide. Additionally, commenters expressed concerns over the cardiovascular effects they experienced when pain is left untreated for an extended period of time due to the delay in getting medications.

DEA Response: DEA is committed to ensuring an adequate and uninterrupted supply of controlled substances in order to meet legitimate medical, scientific, and export needs of the United States. DEA utilizes the available, reliable data and information received by the agency at the time APQs are proposed and proactively monitors drug production, distribution and supply during the year. However, drug shortages may occur due to factors outside of DEA's control such as manufacturing and quality problems, processing delays, supply chain disruptions, or discontinuations. In such circumstances, if the drug manufacturer notifies the Food and Drug Administration (FDA) Drug Shortage Staff, FDA will coordinate with DEA to address and minimize the impact of drug shortages if both agencies believe action is warranted. Currently, FDA has not listed on its Drug Shortage website any nationwide shortages of oxycodone and hydrocodone products. Additionally, if a patient is faced with a delay in receiving their medications, the patient may request a one-time transfer of initial dispensing of an electronic prescription for Schedules II-V controlled substances from one retail pharmacy to another retail pharmacy if authorized under state law. If the medication is a controlled substance in Schedules III-V and includes authorized refills, the refills can also be transferred with the initial prescription to the receiving pharmacy.

Issue: (Shortage of injectable opioid products): DEA received comments from palliative care associations, healthcare companies, and manufacturers regarding the listing of injectable opioid medications including fentanyl, hydromorphone, and morphine on the FDA's Drug Shortage website and the proposed reduction of the APQs for fentanyl, hydromorphone, and morphine.

DEA Response: DEA is committed to ensuring an adequate and uninterrupted supply of controlled substances in order to meet the estimated legitimate medical, scientific, research, and industrial needs of the United States, for lawful export requirements, and for the establishment and maintenance of reserve stocks. Opioid injectable products utilize less than 5% of the relevant APQ. The remainder of the APQ is used to manufacture other opioid dosage forms. Therefore, injectable shortages do not usually require changes to the relevant APQ. Based on the data that DEA is required to consider for setting the APQs, DEA has determined that the established APQs for opioids are sufficient to meet all legitimate needs for 2026. As mentioned above, DEA proactively monitors drug production, distribution and supply during the year. Additionally, DEA and FDA are required to, and routinely do, coordinate efforts to prevent or alleviate drug shortages pursuant to 21 U.S.C. 826(h). Such efforts may include adjusting the APQ, adjusting individual domestic manufacturers' quotas, FDA approval of additional market competitors, and coordination between the agencies to allow importation of foreign-manufactured drug products that meet FDA approval.

Issue (Opioid Prescribing Hesitancy): Many self-identified chronic pain patients expressed that they are obtaining opioid pain medications legally and taking them as prescribed. Commenters stated that many chronic pain patients experience a decreased quality of life, and some have died by suicide, due to the inability to get prescriptions from their providers, which they allege is directly related to the APQ reductions made by DEA. Many commenters also stated that restrictions imposed by DEA have caused opioid medications to be under-prescribed due to fear of prosecution. Commenters said doctors should have latitude in making treatment decisions to prescribe opioid pain medications based on individual patient needs.

DEA Response: DEA's regulations do not impose restrictions on the amount and the type of medication that licensed practitioners can prescribe. DEA has consistently emphasized and supported the authority of individual practitioners under the CSA to administer, dispense, and prescribe controlled substances for the legitimate treatment of pain within acceptable medical standards, as outlined in DEA's policy statement “Dispensing Controlled Substances for the Treatment of Pain” published in the Federal Register on September 6, 2006. 2

Issue (Patients Switching to Illicit Fentanyl or Medications Obtained from Illegal Sources): Several commenters expressed concerns that chronic pain sufferers will turn to illegal fentanyl or medications obtained from illegitimate sources for relief if they are unable to fill their legitimate prescriptions due to the reduction of quotas for opioids. They stated that overdose deaths in the United States continue to rise as a result of illegal fentanyl or illegitimate medications, rather than from legally prescribed medications for the treatment of chronic pain.

DEA Response: DEA considered various factors such as the estimation of legitimate medical need provided by the Department of Health and Human Services (HHS), as well as the extent of any diversion, when proposing and establishing the APQs for opioids to ensure there is an adequate supply to meet legitimate medical demand while preventing diversion (21 CFR 1303.11(b)). Pursuant to the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities (SUPPORT) Act (Pub. L. 115-271), DEA is mandated to estimate diversion for fentanyl, hydrocodone, hydromorphone, oxycodone and oxymorphone, and this estimation includes the consideration of rates of overdose deaths. While overdose deaths may still occur from the use of illicit substances, DEA implemented quota regulations such that the occurrences of overdose and death caused by the misuse and diversion of pharmaceutical controlled substances are reduced. Patients are encouraged to work closely with their licensed healthcare practitioners to utilize FDA-approved medications for their conditions and to fill their prescriptions only from DEA-registered pharmacies. Medications received from unregistered internet sources may, in fact, be manufactured or laced with illicit substances including illicit fentanyl, which contribute to rates of overdose deaths.

Issue (isomer ratio): Several self-identified ADHD patients claimed that they have been negatively impacted by the poor quality and ineffectiveness of their prescribed Adderall or amphetamine mixed salt products. They claimed that the manufacturing of Adderall dosages requires a 3:1 isomeric ratio of d-amphetamine to l-amphetamine, and that dosage form manufacturers are unable to procure the proper ratio of isomers because DEA is allocating d-amphetamine and l-amphetamine to dosage manufacturers in a fixed one-to-one ratio, thus affecting the effectiveness and quality of the medication and a shortage of the medication.

Response: The FDA is a regulatory agency under HHS that has the authority to oversee and regulate the safety, efficacy and manufacturing quality of drugs sold in the United States. The FDA monitors and ensures manufacturers' compliance with all applicable requirements, including Current Good Manufacturing Practices (cGMP) regulations. Patients should raise concerns with their licensed healthcare provider or pharmacist if they find that their prescribed medications are ineffective in treating their conditions.

DEA does not allocate d-amphetamine and l-amphetamine quotas in a fixed one-to-one ratio because the manufacturers do not request d-amphetamine and l-amphetamine quotas in a 1:1 ratio. When DEA upgraded the quota application process from paper to electronic, DEA noticed that manufacturers did not request quota for l-amphetamine but, preferred to request quota for d,l-amphetamine. The d,l-amphetamine APQ represents the racemic mixture of d- and l-amphetamine expressed as base. A racemic mixture is considered a 50:50 ratio of left and right-handed mirror images, in this instance, the 50:50 ratio is of d-amphetamine and l-amphetamine. Therefore, the currently established and proposed aggregate production quotas of d,l-amphetamine and d-amphetamine are allocated to manufacturers in a proper ratio such that amphetamine mixed salt products can be manufactured in accordance with the drug's approval, following cGMP standards and quality control practices as required by FDA.

Issue: Commenters mentioned that as a result of the national opioid settlements, wholesale drug distributors have increasingly imposed ordering thresholds or limits on pharmacies, thereby impacting patient access to opioids. According to the commenters, distributors often flag an increase in controlled substance orders by pharmacies as suspicious, which can lead to denials or contract termination. Pharmacies with a record of distributor-initiated contract terminations may then face difficulties in securing new contracts with other distributors, as prior terminations are viewed as red flags. Therefore, pharmacies may be unwilling to increase their purchasing orders to meet legitimate medical need for fear that doing so could trigger distributors to cancel their contract. A commenter also expressed concerns that valid prescriptions to patients in hospice may not be fulfilled because pharmacies are unwilling to increase their controlled substances orders in fear of contract cancellations. The commenters encourage DEA to ensure that distributors are properly identifying and evaluating suspicious orders, and to allow pharmacies that were unintentionally suspended or terminated by their distributors to undergo a voluntary DEA inspection to verify that the prescriptions they filled were legitimate.

DEA Response: The APQs established by DEA set a limit to the total quantity of a controlled substance that may be produced by all manufacturers in a calendar year, and do not impose any ordering thresholds or limits to pharmacies purchasing controlled substance medications from distributors.

Issue: DEA received a comment from a healthcare company suggesting DEA establish the annual APQs in terms of pharmaceutical dosage forms.

DEA Response: Pursuant to 21 U.S.C. 826(a)(1), “production quotas shall be established in terms of quantities of each basic class of controlled substance and not in terms of individual pharmaceutical dosage forms prepared from or containing such a controlled substance.” DEA sets APQ in a manner to support legitimate domestic medical need, exports, scientific research and product development, as well as maintaining reserve stocks. In turn, the APQ takes into consideration all FDA approved dosage forms to meet the estimated medical needs of the United States. 21 U.S.C. 826(a)(2) provides an exception to that general rule by allowing, but not requiring, DEA to grant quotas in terms of dosage forms if DEA determines that doing so will assist in avoiding the overproduction, shortage, or diversion of controlled substances. DEA has utilized this authority to issue individual manufacturing quotas in terms of dosage form when necessary, where it can be more effective in averting potential shortages. Since quotas set at the individual dosage-form manufacturing level are more directly connected to distributions of FDA-approved drug products, DEA can use its dosage-form authority to alleviate any potential shortage in a more timely manner at the individual manufacturing quota level than at the aggregate production quota level. By issuing a single APQ covering all dosage forms of the basic class, rather than estimating an APQ for each dosage form, DEA retains the flexibility to alleviate potential shortages and to react to unforeseen emergencies by adjusting the individual quotas granted to manufacturers under that APQ.

Issue (Lack of Real-Time Data): A few commenters opined that DEA lacks real-time data on opioid inventory, production and distribution. They suggested this lack of real-time data makes it difficult for DEA to accurately assess legitimate medical needs of patients and ensure adequate supply of opioid pain medications.

DEA Response: DEA has access to current sales data provided by manufacturers from the Quota and Year-end Reporting Management System (QMS), Automation of Reports and Consolidated Orders System (ARCOS) reports, and monthly IQVIA data when determining legitimate medical needs to ensure an adequate supply of medications containing schedule II-controlled substances. While manufacturers and distributors have a choice on reporting their distributions monthly or quarterly under 21 CFR 1304.33, at the DEA Annual Supply Chain Conferences in April 2024 and April 2025, DEA requested manufacturers and distributors to report sales data into the ARCOS database on a monthly basis, which improves the timeliness and accuracy of data points DEA uses to estimate legitimate medical needs.

Issue (over-reliance on historical trends): Several commenters opined that the quota-setting process overly relies on historical trends that do not adequately reflect patient population changes and new prescribing trends, stating that DEA relies on data that is outdated and incomplete, resulting in arbitrary cuts to the APQs of opioids and suppression of APQs for ADHD medications.

DEA Response: When developing the annual APQs, DEA routinely evaluates data from multiple sources to ensure that all the legal factors specified in 21 CFR 1303.11(b) are adequately addressed. DEA's quota process not only relies on current and historical trends, but it also incorporates the most up to date information provided by the FDA and registered manufacturers. For example, DEA utilizes information provided by quota applicants to derive the estimates of scientific, research, and industrial needs, lawful export requirements, as well as current reserve stocks. The information DEA receives from FDA includes the observed and projected domestic usage of schedule II-controlled substances, new drug application and abbreviated new drug application approvals, manufacturers discontinuing production, product shortages, and clinical trials for schedule I and II controlled substances. FDA utilizes a variety of data sources in developing its estimates and describes certain caveats regarding the forecasts it provides. The data provided by FDA, as well as the data obtained from registered manufacturers, DEA's internal databases, and third party prescription data from IQVIA and MIDAS, all contributed to DEA's proposed APQs to meet legitimate estimated domestic manufacturing needs for the controlled substances listed in the table.

Issue (red flags): Commenters raised concerns with DEA's methodology for estimating diversion using PDMP “red flags” data. Commenters state that the data captured in these “red flags” metrics can also represent legitimate patient care such as changing doctors, doctors retiring, multi-specialty care, and paying cash due to loss of health insurance.

DEA Response: DEA has worked with investigators and subject matter experts to select potential indicators of diversion. DEA's Diversion Control Division identified over-prescribing, doctor shopping, and cash payments as risk indicators related to its quota setting function. While it is possible that a legitimate prescription for an opioid might meet one of these criteria, in DEA's experience the number of such legitimate prescriptions would be minimal and unlikely to significantly impact the diversion calculation.

Issue (Request for Data Sharing): DEA received a comment from a pharmaceutical manufacturer stating that the data DEA utilizes to determine quotas should be shared with manufacturers.

DEA Response: DEA considers ARCOS data which is provided by registered manufacturers and distributors. DEA provides access to manufacturers and distributors of this data through the use of the “ARCOS lookup” tool available to DEA registrants on DEA's website. Additionally, DEA cannot provide access to the underlying data used in calculating the manufacturing, procurement, or import quotas because it includes confidential business information.

While DEA has stated it considers prescription data from IQVIA, a third party, DEA purchases this data under contract and is not permitted to share the data. Any pharmaceutical company can contract to purchase data from IQVIA or any other company that supplies prescription data.

Issue (APQ adjustment for research): DEA received comments from pharmaceutical companies regarding advanced research and clinical trials of several schedule I controlled substances, requesting the APQs be established at sufficient levels to allow for their manufacturing to meet research and scientific needs.

DEA Response: DEA considered these comments and matched them to the contracted DEA-registered manufacturers and determined that the specific schedule I controlled substance APQs are sufficient to support the legitimate research and scientific efforts toward an FDA-approved drug product.

Issue: Several commenters including palliative care associations and a healthcare company suggested that DEA should collaborate with a broad range of stakeholders on how DEA can address the opioid crisis while ensuring legitimate medical needs are met.

DEA Response: DEA has and will continue to collaborate with federal agencies, industry, and medical associations to combat the opioid crisis, prevent diversion, and set appropriate manufacturing quantities of controlled substances and chemicals to meet legitimate need and preparedness for unforeseen circumstances within the United States. In addition, DEA has engaged with pharmaceutical manufacturers and private sector entities with relevant pharmaceutical information through roundtable discussions and data sharing efforts. DEA is willing to meet with relevant private organizations upon request when presented with good cause.

Issue: Sixty commenters suggested that DEA consider holding a public hearing to provide patient testimony regarding the APQs and AANs economic impact on public health.

DEA Response: The decision whether to grant a hearing on the issues raised by the commenters lies solely within the discretion of the Administrator. While hearings are required when requested by states in certain situations, these requests were not submitted by states. These requests did not include any evidence that would lead to the conclusion that a hearing is necessary or warranted. DEA appreciates the written comments provided by patients and has addressed specific points raised by the commenters in the issues and responses above.

Issue: DEA received 15 comments questioning why the comment period was compressed to 15 calendar days and 10 comments requesting an extension of the comment period.

DEA Response: The comment period was compressed to 15 calendars days in part due to the government shutdown from October 1 to November 12, 2025. DEA provides the opportunity for comment on the 2026 proposed APQ and AAN as required by 21 CFR 1303.11(c) and 1315.11(d), which establish that the Administrator shall permit any interested person to file written comments on or objections to the proposal and shall designate in the notice the time during which such filings may be made.

DEA received comments that are outside the scope of this order. The comments were general in nature and included but not limited to issues such as specific medical illnesses, medical treatments, perceived ineffectiveness of suboxone and its potential side effects, and medication costs. These comments are outside the scope of this Final Order and do not impact the analysis involved in establishing the 2026 APQs.

In determining the established 2026 APQs and AANs, DEA has considered the above comments along with the factors set forth in 21 CFR 1303.11 and 21 CFR 1315.11, in accordance with 21 U.S.C. 826(a). These factors include, but are not limited to, the 2025 manufacturing quotas, current 2025 sales and inventories, anticipated 2026 export requirements, industrial use, additional applications for 2026 quotas, and information on research and product development requirements.

On July 25, 2025, DEA established a specific listing for dipentylone in schedule I of the Controlled Substances Act (CSA) because it is a positional isomer of N-ethylpenthylone, which is a schedule I hallucinogen (90 FR 38396), making all regulatory controls pertaining to schedule I controlled substances applicable to the manufacture of this substance, including the requirement to establish an aggregate production quota pursuant to 21 U.S.C. 826 and 21 CFR part 1303. This final order establishes an aggregate production quota for this substance.

On August 15, 2025, DEA published a temporary scheduling order placing N-pyrrolidino metonitazene and N-pyrrolidino protonitazene in schedule I of the CSA (90 FR 39314), making all regulatory controls pertaining to schedule I controlled substances applicable to the manufacture of these substances, including the requirement to establish an aggregate production quota pursuant to 21 U.S.C. 826 and 21 CFR part 1303. This final order establishes an aggregate production quota for these substances.

On October 15, 2025, DEA published a temporary scheduling order placing Ethyleneoxynitazene, Methylenedioxynitazene, 5-methyl etodesnitazene, N-desethyl etonitazene, N-desethyl protonitazene, N,N-dimethylamino etonitazene, and N-pyrrolidino isotonitazene in schedule I of the CSA (90 FR 48259), making all regulatory controls pertaining to schedule I controlled substances applicable to the manufacture of these substances, including the requirement to establish an aggregate production quota pursuant to 21 U.S.C. 826 and 21 CFR part 1303. This final order establishes an aggregate production quota for these substances.

DEA published a final rule on September 18, 2025 placing beta- methylacetyl fentanyl, meta- fluorofuranyl fentanyl, ortho- chlorofentanyl, ortho- methylcyclopropyl fentanyl, para- chlorofentanyl, para -fluoro valeryl fentanyl, and tetrahydrothiofuranyl fentanyl in schedule I of the CSA (90 FR 44979), and also published a final rule on November 17, 2025 placing 4-Chloromethcathinone in schedule I of the CSA (90 FR 51102), making all regulatory controls pertaining to the schedule I controlled substances applicable to the manufacture of these substances, including the requirement to establish an aggregate production quota pursuant to 21 U.S.C. 826 and 21 CFR part 1303. This final order establishes an aggregate production quota for these substances.

Based on all of the above, the Administrator establishes the 2026 APQs for d, l-amphetamine, d-amphetamine (for conversion), dimethyltryptamine, lisdexamfetamine, morphine (for sale), oripavine, psilocybin, and psilocyn at higher levels than were proposed.

As specified in the proposal, and as required by 21 U.S.C. 826(i), DEA calculated a national diversion estimate for each of the five covered controlled substances. This data, which remains unchanged, was published in the Proposed Aggregate Production Quotas for Schedule I and II Controlled Substances and Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2026. 4

In accordance with 21 U.S.C. 826, 21 CFR 1303.11, and 21 CFR 1315.11, the Administrator hereby establishes the 2026 APQs for the following schedule I and II controlled substances and the 2026 AANs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine, expressed in grams of anhydrous acid or base, as follows: