This action is not a rule as defined by the Regulatory Flexibility Act (5 U.S.C. 601-612) and thus is exempt from the provisions of that Act.

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3507), no recordkeeping or reporting requirements have been included that are subject to approval from the Office of Management and Budget.

The affected programs are listed in the Assistance Listings ( https://sam.gov/ ) under No. 10.553, No. 10.555, No. 10.556, No. 10.558, and No. 10.559 and are subject to the provisions of Executive Order 12372, which requires intergovernmental consultation with State and local officials. (See 2 CFR part 415).

Pursuant to sections 9(b)(1), 13A(h)(2), and 17(c)(4) of the Richard B. Russell National School Lunch Act (42 U.S.C. 1758(b)(1), 42 U.S.C. 1762(h)(2), and 42 U.S.C. 1766(c)(4)), and sections 3(a)(6) and 4(e)(1)(A) of the Child Nutrition Act of 1966 (42 U.S.C. 1772(a)(6) and 1773(e)(1)(A)), the Department annually issues the Income Eligibility Guidelines for free and reduced price meals for the National School Lunch Program (7 CFR part 210), the Commodity School Program (7 CFR part 210), School Breakfast Program (7 CFR part 220), Summer Food Service Program (7 CFR part 225), Child and Adult Care Food Program (7 CFR part 226), free milk in the Special Milk Program for Children (7 CFR part 215), and program benefits in the Summer EBT Program (7 CFR part 292). These eligibility guidelines are based on the Federal income poverty guidelines and are stated by household size. The guidelines are used to determine eligibility for free and reduced price meals, free milk, and Summer EBT benefits in accordance with applicable program rules.

In accordance with the Department's policy as provided in the Food and Nutrition Service publication Eligibility Manual for School Meals, “income,” as the term is used in this notice, means income before any deductions such as income taxes, Social Security taxes, insurance premiums, charitable contributions, and bonds. It includes the following: (1) monetary compensation for services, including wages, salary, commissions or fees; (2) net income from nonfarm self-employment; (3) net income from farm self-employment; (4) Social Security; (5) dividends or interest on savings or bonds or income from estates or trusts; (6) net rental income; (7) public assistance or welfare payments; (8) unemployment compensation; (9) government civilian employee or military retirement, or pensions or veterans payments; (10) private pensions or annuities; (11) alimony or child support payments; (12) regular contributions from persons not living in the household; (13) net royalties; and (14) other cash income. Other cash income would include cash amounts received or withdrawn from any source including savings, investments, trust accounts and other resources that would be available to pay the price of a child's meal.

“Income”, as the term is used in this notice, does not include any income or benefits received under any Federal programs that are excluded from consideration as income by any statutory prohibition. Furthermore, the value of meals, milk, or EBT benefits to children shall not be considered as income to their households for other benefit programs in accordance with the prohibitions in section 12(e) of the Richard B. Russell National School Lunch Act and section 11(b) of the Child Nutrition Act of 1966 (42 U.S.C. 1760(e) and 1780(b)).

The following are the Income Eligibility Guidelines to be effective from July 1, 2025 through June 30, 2026. The Department's guidelines for free meals and milk and reduced price meals were obtained by multiplying the year 2025 Federal income poverty guidelines by 1.30 and 1.85, respectively, and by rounding the result upward to the next whole dollar.

This notice displays only the annual Federal poverty guidelines issued by the Department of Health and Human Services because the monthly and weekly Federal poverty guidelines are not used to determine the Income Eligibility Guidelines. The chart details the free and reduced price eligibility criteria for monthly income, income received twice monthly (24 payments per year), income received every two weeks (26 payments per year) and weekly income.

Income calculations are made based on the following formulas: monthly income is calculated by dividing the annual income by 12; twice monthly income is computed by dividing annual income by 24; income received every two weeks is calculated by dividing annual income by 26; and weekly income is computed by dividing annual income by 52. All numbers are rounded upward to the next whole dollar. The numbers reflected in this notice for a family of four in the 48 contiguous States, the District of Columbia, Guam and the territories represent an increase of 3.0 percent over last year's level for a family of the same size.

Authority: Section 9(b)(1) of the Richard B. Russell National School Lunch Act (42 U.S.C. 1758(b)(1)(A)).

On February 25, 2025, the President issued Executive Order 14220, Addressing the Threat to National Security From Imports of Copper (90 FR 11001), instructing the Secretary of Commerce (“Secretary”) to initiate an investigation under section 232 of the Trade Expansion Act (19 U.S.C. 1862) to determine the effects on national security of imports of copper in all forms including, but not limited to, raw mined copper; copper concentrates; refined copper; copper alloys; scrap copper; and derivative products. On March 10, 2025, the Secretary initiated the section 232 investigation.

This investigation is being undertaken in accordance with part 705 of the National Security Industrial Base Regulations (15 CFR parts 700 to 709) (“NSIBR”). Interested parties are invited to submit written comments, data, analyses, or information pertinent to this investigation to the Office of Strategic Industries and Economic Security, U.S. Department of Commerce (“the Department”), no later than April 1, 2025. The Department is particularly interested in comments and information directed to the criteria listed in § 705.4 of the regulations as they affect national security, including the following: (i) the current and projected demand for copper in United States defense, energy, and critical infrastructure sectors; (ii) the extent to which domestic production, smelting, refining, and recycling can meet demand; (iii) the role of foreign supply chains, particularly from major exporters, in meeting United States demand; (iv) the concentration of United States copper imports from a small number of suppliers and the associated risks; (v) the impact of foreign government subsidies, overcapacity, and predatory trade practices on United States industry competitiveness; (vi) the economic impact of artificially suppressed copper prices due to dumping and state-sponsored overproduction; (vii) the potential for export restrictions by foreign nations, including the ability of foreign nations to weaponize their control over refined copper supplies; (viii) the feasibility of increasing domestic copper mining, smelting, and refining capacity to reduce import reliance; and (ix) the impact of current trade policies on domestic copper production and whether additional measures, including tariffs or quotas, are necessary to protect national security.

Material submitted by members of the public that is business confidential information will be exempted from public disclosure as provided for by § 705.6 of the regulations. See the ADDRESSES section of this notice. Communications from agencies of the United States Government will not be made available for public inspection. The Bureau of Industry and Security does not maintain a separate public inspection facility. Requesters should first view the Bureau's web page, which can be found at https://efoia.bis.doc.gov/ (see “Electronic FOIA” heading). If requesters cannot access the website, they may call 202-482-0795 for assistance. The records related to this assessment are made accessible in accordance with the regulations published in part 4 of title 15 of the Code of Federal Regulations (15 CFR 4.1 et seq. ).

On March 1, 2025, the President Issued Executive Order 14223, Addressing the Threat to National Security from Imports of Timber, Lumber (90 FR 11359), instructing the Secretary of Commerce (Secretary) to initiate an investigation under section 232 of the Trade Expansion Act (19 U.S.C. 1862) to determine the effects on national security of imports of wood products: timber, lumber, and their derivative products. On March 10, 2025, the Secretary initiated the 232 investigation.

This investigation is being undertaken in accordance with part 705 of the National Security Industrial Base Regulations (15 CFR parts 700 to 709) (“NSIBR”). Interested parties are invited to submit written comments, data, analyses, or information pertinent to this investigation to the Office of Strategic Industries and Economic Security, U.S. Department of Commerce (“the Department”), no later than April 1, 2025. The Department is particularly interested in comments and information directed to the criteria listed in § 705.4 of the regulations as they affect national security, including the following: (i) the current and projected demand for timber and lumber in the United States; (ii) the extent to which domestic production of timber and lumber can meet domestic demand; (iii) the role of foreign supply chains, particularly of major exporters, in meeting United States timber and lumber demand; (iv) the impact of foreign government subsidies and predatory trade practices on United States timber, lumber, and derivative product industry competitiveness; (v) the feasibility of increasing domestic timber and lumber capacity to reduce imports; (vi) the impact of current trade policies on domestic timber, lumber, and derivative product production, and whether additional measures, including tariffs or quotas, are necessary to protect national security; and (vii) any other relevant factors.

Material submitted by members of the public that is business confidential information will be exempted from public disclosure as provided for by § 705.6 of the regulations. See the ADDRESSES section of this notice. Communications from agencies of the United States Government will not be made available for public inspection. The Bureau of Industry and Security does not maintain a separate public inspection facility. Requesters should first view the Bureau's web page, which can be found at https://efoia.bis.doc.gov/ (see “Electronic FOIA” heading). If requesters cannot access the website, they may call 202-482-0795 for assistance. The records related to this assessment are made accessible in accordance with the regulations published in part 4 of title 15 of the Code of Federal Regulations (15 CFR 4.1 et seq. ).

On April 26, 2019, Commerce published its Final Results in the 2016-2017 AD administrative review of passenger tires from China. Commerce calculated a rate of 64.57 percent for Zhaoqing Junhong Co., Ltd. (Junhong) and relied on that rate to establish the rate for the separate rate respondents. 1

In its August 29, 2022, opinion, the U.S. Court of Appeals for the Federal Circuit (Federal Circuit) remanded the Final Results, concluding that Commerce erred in restricting its examination to a single mandatory respondent and in applying the single mandatory respondent's rate to the separate rate respondents. 2 Therefore, on remand, Commerce sought to select an additional mandatory respondent to review and selected Kenda as a mandatory respondent. 3 In March and May 2023, Kenda submitted responses to sections A through D of Commerce's AD questionnaire. 4 In June 2023, Kenda submitted responses to Commerce's supplemental questionnaire. 5 In the first remand redetermination, issued in October 2023, Commerce: (1) recalculated Kenda's estimated weighted-average dumping margin to be 18.15 percent based on its reported data; (2) recalculated the separate rate and applied it to Shandong Linglong Tyre Co. (Linglong); and (3) continued to find Shandong Wanda Boto Tyre Co., Ltd. (Wanda Boto), Mayrun Tyre (Hong Kong) Limited (Mayrun), Shandong Hengyu Science & Technology Co., Ltd. (Hengyu), and Winrun Tyre Co., Ltd. (Winrun) to be part of the China-wide entity. 6 The Court remanded for a second time, concluding that Commerce: (1) may have erred in the order in which it selected a second respondent; (2) did not support with substantial evidence its denial of separate rate status for Mayrun, Hengyu, Winrun, and Wanda Boto; and (3) did not sufficiently explain its denial of the new withdrawal requests submitted during the first remand. 7

In its second remand redetermination, issued in October 2024, pursuant to the Remand Order, Commerce reexamined the U.S. Customs and Border Protection (CBP) data and determined that the correct order of selection for a second mandatory respondent was: (1) Wanda Boto; (2) Hengyu; (3) Mayrun; (4) Winrun; (5) Linglong, and (6) Kenda. Thus, on remand, Commerce selected Linglong as an additional mandatory respondent; however, because Linglong refused to participate, Commerce continued to rely on Kenda as the second mandatory respondent. In addition, Commerce found that: (1) Wanda Boto, Mayrun, Hengyu, Winrun, and Linglong failed to establish their entitlement to a separate rate and thus were part of the China-wide entity; and (2) that it is inappropriate to accept the untimely review withdrawal requests filed by Mayrun, Hengyu, Winrun, and Linglong. Finally, Commerce recalculated the cash deposit rate applicable to the China-wide entity to account for combined export subsidies and estimated domestic subsidy pass-through of 11.13 percent. 8 In response to a motion by Kenda for partial judgement, the Court issued a partial judgment sustaining Commerce's final redetermination with respect to Kenda's dumping margin calculation. 9

On December 19, 2018, Commerce issued its Final Scope Rulings  1 that certain door thresholds imported by Worldwide and Columbia fall within the scope of the Orders. 2 Worldwide and Columbia appealed Commerce's Final Scope Ruling. On December 23, 2020, pursuant to the CIT's first remand orders in Worldwide I and Columbia I, 3 Commerce issued its First Remand Redeterminations, in which Commerce continued to find that Worldwide's and Columbia's door thresholds were subassemblies included in the scope of the Orders and, therefore, failed to satisfy the requirements for the finished merchandise exclusion. 4

In Worldwide II and Columbia II, the CIT determined that Commerce impermissibly based its analysis in the First Remand Redeterminations on inferences that were contradicted or unsupported by other information on the record. 5 The CIT directed Commerce to reconsider whether Worldwide's and Columbia's door thresholds required cutting or machining prior to incorporation into another product, and to determine whether Worldwide's and Columbia's door thresholds qualified for the finished merchandise exclusion. 6 On December 13, 2021, Commerce issued its Second Remand Redeterminations, in which Commerce determined that Worldwide's and Columbia's door thresholds were excluded from the Orders as finished merchandise. 7

In Worldwide III and Columbia III, the CIT held that Commerce's Second Remand Redeterminations misconstrued aspects of the CIT's decision in Worldwide II and Columbia II and were not submitted in a form the CIT could sustain upon judicial review. 8 The CIT directed Commerce to issue a new determination, in a form that would go into effect if sustained upon judicial review, determining whether the extruded aluminum components of Worldwide's and Columbia's door thresholds are within the scope of the Orders. 9

In the Third Remand Redeterminations, Commerce continued to find, in accordance with the CIT's holdings, that Worldwide's and Columbia's door thresholds are outside the scope of the Orders based on the finished merchandise exclusion; Commerce also provided further explanation for the basis of that finding and clarified that Commerce did not intend to issue any other scope ruling or other agency determination subsequent to the CIT's order. 10 The CIT subsequently sustained Commerce's remand redeterminations in Worldwide IV and Columbia IV. 11 On December 29, 2022, Commerce published a notice of court decisions not in harmony with its final scope ruling and notice of amended final scope ruling. 12

On October 8, 2024, the Federal Circuit reversed and the CIT and sustained the non-protested portions of Commerce's First Remand Redeterminations and vacated the CIT's subsequent opinions and orders. 13 The Federal Circuit held that Commerce's finding in the First Remand Redeterminations that the Worldwide and Columbia door thresholds at issue are subassemblies covered by the scope of the Orders is supported by substantial evidence. 14

Because there is now a final and conclusive court decision reinstating Commerce's scope rulings in the First Remand Redeterminations, we are amending the First Amended Final Scope Rulings with respect to Worldwide and Columbia's door thresholds. 15 In accordance with the Federal Circuit's decision in Worldwide Federal Circuit, the Worldwide and Columbia door thresholds at issue in the Final Scope Rulings are subject to the Orders.

Accordingly, Commerce will instruct U.S. Customs and Border Protection (CBP) to continue to suspend liquidation of Worldwide and Columbia's door thresholds until appropriate liquidation instructions are sent. As of the date of publication of this notice in the Federal Register , the cash deposit rate for entries of Worldwide and Columbia's door thresholds will be the applicable cash deposit rate of the exporters of the merchandise from China to the United States.

This notice is issued and published in accordance with sections 516A(c)(1) and (e)(1), and 777(i)(1) of the Tariff Act of 1930, as amended.

The Executive/Finance Committee will meet in closed session to discuss internal administrative matters.

The SSC agenda will include the following issues:

The agenda is subject to change, and the latest version will be posted at https://meetings.npfmc.org/Meeting/Details/3081 prior to the meeting, along with meeting materials.

In addition to providing ongoing scientific advice for fishery management decisions, the SSC functions as the Council's primary peer review panel for scientific information, as described by the Magnuson-Stevens Act section 302(g)(1)(e), and the National Standard 2 guidelines (78 FR 43066). The peer-review process is also deemed to satisfy the requirements of the Information Quality Act, including the OMB Peer Review Bulletin guidelines.

The Advisory Panel agenda will include the following issues:

The Council agenda will include the following issues. The Council may take appropriate action on any of the issues identified.

You can attend the meeting online using a computer, tablet, or smart phone; or by phone only. Connection information will be posted online at: https://www.npfmc.org/upcoming-council-meetings . For technical support, please contact our administrative staff, email: npfmc.admin@noaa.gov .

Public comment letters will be accepted and should be submitted electronically through the links at https://www.npfmc.org/upcoming-council-meetings . The Council strongly encourages written public comment for this meeting, to avoid any potential for technical difficulties to compromise oral testimony. The written comment period is open from March 7, 2025 to March 28, 2025, and closes at 12 p.m., Alaska Time on Friday, March 28, 2025.

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

The May 2025 FMAC agenda will include review of the 2024 Observer Annual report; NMFS updates, including budget, and other business.

The agenda is subject to change, and the latest version will be posted at https://meetings.npfmc.org/Meeting/Details/3079 prior to the meeting, along with meeting materials.

You can attend the meeting online using a computer, tablet, or smartphone; or by phone only. Connection information will be posted online at: https://meetings.npfmc.org/Meeting/Details/3079 .

Public comment letters will be accepted and should be submitted electronically to https://meetings.npfmc.org/Meeting/Details/3079 .

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

Atlantic highly migratory species (HMS) fisheries (tunas, swordfish, sharks, and billfish) are managed under the 2006 Consolidated HMS Fishery Management Plan (FMP) and its amendments pursuant to the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act; 16 U.S.C. 1801 et seq. ) and consistent with the Atlantic Tunas Convention Act (16 U.S.C. 971 et seq. ). HMS implementing regulations are at 50 CFR part 635. Section 635.8 describes the requirements for the Atlantic Shark Identification Workshops and Safe Handling, Release, and Identification Workshops. The workshop schedules, registration information, and a list of frequently asked questions regarding the Atlantic Shark Identification and Safe Handling, Release, and Identification workshops are available online at: https://www.fisheries.noaa.gov/atlantic-highly-migratory-species/atlantic-shark-identification-workshops and https://www.fisheries.noaa.gov/atlantic-highly-migratory-species/safe-handling-release-and-identification-workshops.

Since January 1, 2008, Atlantic shark dealers have been prohibited from receiving, purchasing, trading, or bartering for Atlantic sharks unless a valid Atlantic Shark Identification Workshop certificate is on the premises of each business listed under the shark dealer permit that first receives Atlantic sharks (71 FR 58057, October 2, 2006). Dealers who attend and successfully complete a workshop are issued a certificate for each place of business that is permitted to receive sharks. These certificate(s) are valid for 3 years. Thus, certificates that were initially issued in 2022 will expire in 2025.

Currently, permitted dealers may send a proxy to an Atlantic Shark Identification Workshop. However, if a dealer opts to send a proxy, the dealer must designate a proxy for each place of business covered by the dealer's permit that first receives Atlantic sharks. Only one certificate will be issued to each proxy. A proxy must be a person who is currently employed by a place of business covered by the dealer's permit; is a primary participant in the identification, weighing, and/or first receipt of fish as they are offloaded from a vessel; and who fills out dealer reports. Atlantic shark dealers are prohibited from renewing a Federal shark dealer permit unless a valid Atlantic Shark Identification Workshop certificate for each business location that first receives Atlantic sharks has been submitted with the permit renewal application. Additionally, a copy of a valid dealer or proxy Atlantic Shark Identification Workshop certificate must be in any trucks or other conveyances that are extensions of a dealer's place of business.

1. April 17, 2025, 12 p.m.-4 p.m., Comfort Inn Medford, 2695 Route 112, Medford, NY 11763.

2. May 15, 2025, 12 p.m.-4 p.m., Holiday Inn Manahawkin, 151 Route 72 East, Manahawkin, NJ 08050.

3. June 20, 2025, 12 p.m.-4 p.m., Hampton Inn Cypress Creek, 720 E Cypress Creek Road, Fort Lauderdale, FL 33334.

To register for a scheduled Atlantic Shark Identification Workshop, please contact Eric Sander at ericssharkguide@yahoo.com or at 386-852-8588. Pre-registration is highly recommended, but not required.

To ensure that workshop certificates are linked to the correct permits, participants will need to bring the following specific items to the workshop:

• Atlantic shark dealer permit holders must bring proof that the attendee is an owner or agent of the business (such as articles of incorporation), a copy of the applicable permit, and proof of identification.

• Atlantic shark dealer proxies must bring documentation from the permitted dealer acknowledging that the proxy is attending the workshop on behalf of the permitted Atlantic shark dealer for a specific business location, a copy of the appropriate valid permit, and proof of identification.

The Atlantic Shark Identification Workshops are designed to reduce the number of unknown and improperly identified sharks reported in the dealer reporting form and increase the accuracy of species-specific dealer-reported information. Reducing the number of unknown and improperly identified sharks will improve quota monitoring and the data used in stock assessments. These workshops will train shark dealer permit holders or their proxies to properly identify Atlantic shark carcasses.

Since January 1, 2007, shark limited access and swordfish limited access permit holders who fish with longline or gillnet gear have been required to submit a copy of their Safe Handling, Release, and Identification Workshop certificate in order to renew either permit (71 FR 58057, October 2, 2006). These certificate(s) are valid for 3 years. Certificates issued in 2022 will expire in 2025. As such, vessel owners who have not already attended a workshop and received a NMFS certificate, or vessel owners whose certificate(s) will expire prior to the next permit renewal, must attend a workshop to fish with, or renew, their swordfish and shark limited access permits. Additionally, new shark and swordfish limited access permit applicants who intend to fish with longline or gillnet gear must attend a Safe Handling, Release, and Identification Workshop and submit a copy of their workshop certificate before either of the permits will be issued.

In addition to vessel owners, at least one operator on board vessels issued a limited access swordfish or shark permit that uses longline or gillnet gear is required to attend a Safe Handling, Release, and Identification Workshop and receive a certificate. Vessels that have been issued a limited access swordfish or shark permit and that use longline or gillnet gear may not fish unless both the vessel owner and operator have valid workshop certificates on board at all times. Vessel operators who have not already attended a workshop and received a NMFS certificate, or vessel operators whose certificate(s) will expire prior to their next fishing trip, must attend a workshop to operate a vessel with swordfish and shark limited access permits on which longline or gillnet gear is used.

1. April 4, 2025, 9 a.m.-2 p.m., Hilton Garden Inn, 300 Wingo Way, Mount Pleasant, SC 29464.

2. May 5, 2025, 9 a.m.-2 p.m., Hilton Garden Inn, 1297 Miracle Strip Parkway SE, Fort Walton Beach, FL 32448.

3. June 18, 2025, 9 a.m.-2 p.m., Hilton Garden Inn, 3485 Veterans Memorial Highway, Ronkonkoma, NY 11779.

To register for a scheduled Safe Handling, Release, and Identification Workshop, please contact Angler Conservation Education at 386-682-0158. Pre-registration is highly recommended, but not required.

To ensure that workshop certificates are linked to the correct permits, participants will need to bring the following specific items with them to the workshop:

• Individual vessel owners must bring a copy of the appropriate swordfish and/or shark permit(s), a copy of the vessel registration or documentation, and proof of identification;

• Representatives of a business-owned or co-owned vessel must bring proof that the individual is an agent of the business (such as articles of incorporation), a copy of the applicable swordfish and/or shark permit(s), and proof of identification; and

• Vessel operators must bring proof of identification.

The Safe Handling, Release, and Identification Workshops are designed to teach the owner and operator of a vessel that fishes with longline or gillnet gear the required techniques for the safe handling and release of entangled and/or hooked protected species, such as sea turtles, marine mammals, smalltooth sawfish, Atlantic sturgeon, and prohibited sharks. In an effort to improve reporting, the proper identification of protected species and prohibited sharks will also be taught at these workshops. Additionally, individuals attending these workshops will gain a better understanding of the requirements for participating in these fisheries. The overall goal of these workshops is to provide participants with the skills needed to reduce the mortality of protected species and prohibited sharks, which may prevent additional regulations on these fisheries in the future.

NMFS implemented an online option for shark dealers and owners and operators of vessels that fish with longline and gillnet gear to renew their certificates in December 2021. To be eligible for online recertification workshops, dealers and vessel owners and operators need to have previously attended an in-person workshop. Information about the courses is available online at https://www.fisheries.noaa.gov/atlantic-highly-migratory-species/atlantic-shark-identification-workshops and https://www.fisheries.noaa.gov/atlantic-highly-migratory-species/safe-handling-release-and-identification-workshops. To access the course please visit: https://hmsworkshop.fisheries.noaa.gov/start.

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, effective May 24, 2024 (89 FR 31488, April 24, 2024).

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.

WesternGeco plans to conduct a three-dimensional (3D) ocean bottom node (OBN) survey over 240 lease blocks in the Green Canyon and Walker Ridge areas, with water depths ranging from approximately 1,600 to 3,000 meters (m). See section F of the LOA application for a map of the area.

WesternGeco anticipates using three source vessels, and would use one of the following source configurations: a conventional airgun array source consisting of 28 elements with a total volume of 5,000 cubic inches (in 3 ) or a combination of the conventional airgun array source and a low-frequency tuned pulse source (TPS). Please see WesternGeco's application for additional detail.

The TPS was not included in the acoustic exposure modeling developed in support of the rule. However, the TPS was previously described and evaluated in support of previous LOAs and we rely on those analyses here (86 FR 37309, 37310, July 15, 2021; see also 87 FR 55790, 55791, September 12, 2022). For additional detail regarding sources, see section C of the LOA application. Based on this information we have determined there will be no effects of a magnitude or intensity different from those evaluated in support of the rule. NMFS therefore expects that use of modeling results supporting the final rule relating to use of airgun arrays are expected to be conservative as a proxy for use in evaluating potential impacts of use of the TPS.

Consistent with the preamble to the final rule, the survey effort proposed by WesternGeco in its LOA request was used to develop LOA-specific take estimates based on the acoustic exposure modeling results described in the preamble (89 FR 31488, April 24, 2024). In order to generate the appropriate take number for authorization, the following information was considered: (1) survey type; (2) location (by modeling zone  2 ); (3) number of days; (4) source; and (5) month. 3 In this case, because WesternGeco may also elect to use the specified 28-element, 5,000 in 3 airgun array source, the 5,110 in 3 airgun array proxy was selected. The acoustic exposure modeling performed in support of the rule provides 24-hour exposure estimates for each species, specific to each modeled source and survey type in each zone and month.

No 3D OBN surveys were included in the modeled survey types, and use of existing proxies ( i.e., two-dimensional (2D), 3D narrow-azimuth (NAZ), 3D wide-azimuth (WAZ), Coil) is generally conservative for use in evaluation of 3D OBN survey effort, largely due to the greater area covered by the modeled proxies. Summary descriptions of these modeled survey geometries are available in the preamble to the proposed rule (83 FR 29212, 29220, June 22, 2018). Coil was selected as the best available proxy survey type in this case because the spatial coverage of the planned survey is most similar to the coil survey pattern. The planned OBN survey will involve three source vessels sailing along closely spaced survey lines, with daily survey area coverage of approximately 125 kilometers squared (km 2 ) per day, similar to that assumed for the coil survey proxy. Among the different parameters of the modeled survey patterns ( e.g., area covered, line spacing, number of sources, shot interval, total simulated pulses), NMFS considers area covered per day to be most influential on daily modeled exposures exceeding Level B harassment criteria. Although WesternGeco is not proposing to perform a survey using the coil geometry, the coil proxy is most representative of the effort planned by WesternGeco in terms of predicted Level B harassment exposures.

The survey will take place over approximately 130 days with 100 days of sound source operation, with 20 days planned in Zone 5 and 80 days planned in Zone 7. 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 time 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 (see, 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 m and 400 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 1,600 to 3,000 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 (see 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 above in the Summary of Request and Analysis section. 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 (see 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.

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

An incidental take authorization 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.

The MMPA states that the term “take” means to harass, hunt, capture, kill or attempt to harass, hunt, capture, or kill any marine mammal.

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 July 18, 2024, NMFS received application from the IBRP requesting authorization for take of marine mammals incidental to construction activities related to the Interstate Bridge Replacement Project on I-5 between Portland, OR and Vancouver, WA. After the IBRP responded to our questions on October 12, 2024 and January 14, 2025, we determined the application was adequate and complete on January 16, 2025. The requested regulations would be valid for five years, from September 15, 2027 through September 14, 2032. The IBRP plans to conduct necessary work, including pile driving (impact and vibratory) and rotary drilling, to construct replacement bridges for the I-5 roadway over the Columbia River and North Portland Harbor. The proposed action may incidentally expose marine mammals occurring in the vicinity to elevated levels of underwater sound, thereby resulting in incidental take, by Level A and Level B harassment. Therefore, the IBRP requests authorization to incidentally take marine mammals.

The purpose of the proposed IBR project is to improve I-5 corridor mobility by addressing present and future travel demand and mobility needs in the program area. Relative to the replacement bridges portion of the larger transportation project, the proposed action is intended to achieve the following objectives: improve travel safety and traffic operations on the I-5 river crossing and associated interchanges; and improve the I-5 river crossing's structural integrity (seismic stability). The entire IBR project, including demolition and removal of the existing bridges, is anticipated to take approximately nine years to construct. The IBRP's ITR request is for the first five years. Within the first five years, construction work is expected to take approximately 1,725 non-consecutive days over the course of five years, and involve the installation and or removal of 1,560 steel pipe piles (24-inch [in] or 48-in diameter) and 1,500 linear feet (ft) of steel sheet piles.

Interested persons may submit information, suggestions, and comments concerning the IBRP's request (see ADDRESSES ). NMFS will consider all information, suggestions, and comments related to the request during the development of proposed regulations governing the incidental taking of marine mammals by the IBRP, if appropriate.

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

An incidental take authorization 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. The MMPA states that the term “take” means to harass, hunt, capture, kill or attempt to harass, hunt, capture, or kill any marine mammal.

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 October 30, 2024, NMFS received an application from Hilcorp requesting authorization for take of marine mammals incidental to oil and gas exploration, development, production, and decommissioning activities in Cook Inlet, Alaska. NMFS determined that the application was adequate and complete on February 10, 2024. The requested regulations would be valid for five years, from the date of issuance through December 31, 2029. Hilcorp plans to conduct necessary work, including tugs towing, holding, or positioning a jack-up rig, pile driving, and pipeline replacement/installation activities. The exposure of marine mammals occurring in the vicinity to underwater noise generated by the activities could result in incidental take, by Level A and Level B harassment. Therefore, Hilcorp requests authorization to incidentally take marine mammals.

Hilcorp plans to continue oil and gas exploration, development, production, and decommissioning activities in Cook Inlet, Alaska, for the reasonably foreseeable future. The work expected to span five years includes up to 54 days of tugs towing, holding, or positioning a jack-up rig in support of production drilling at existing platforms in middle Cook Inlet and Trading Bay; up to 70 days of pile driving in support of production well development at the Tyonek platform in middle Cook Inlet; up to 6 days of tugs towing, holding, or positioning a jack-up rig and up to 18 days of pile driving in support of exploration drilling at two locations in the Middle Ground Shoal Unit in middle Cook Inlet and one location between the Anna and Bruce platforms on the northern border of Trading Bay; and up to 22 days of pipeline replacement/installation, involving either pipe pulling or anchor handling or a combination of both, at up to two locations in middle Cook Inlet and/or Trading Bay. Hilcorp requests take of marine mammals by Level B harassment for twelve marine mammal species (including Cook Inlet beluga whales ( Delphinapterus leucas )), and take by Level A harassment of nine marine mammal species.

Interested persons may submit information, suggestions, and comments concerning the Hilcorp's request (see ADDRESSES ). NMFS will consider all information, suggestions, and comments related to the request during the development of proposed regulations governing the incidental taking of marine mammals by Hilcorp, if appropriate.

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

Authorization for incidental takings shall be granted if NMFS finds that the taking will have a negligible impact on the species or stock(s) and will not have an unmitigable adverse impact on the availability of the species or stock(s) for taking for subsistence uses (where relevant). Further, NMFS must prescribe the permissible methods of taking and other “means of effecting the least practicable adverse impact” on the affected species or stocks and their habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance, and on the availability of the species or stocks for taking for certain subsistence uses (referred to in shorthand as “mitigation”); and requirements pertaining to the monitoring and reporting of the takings. The definitions of all applicable MMPA statutory terms used above are included in the relevant sections below and can be found in section 3 of the MMPA (16 U.S.C. 1362) and NMFS regulations at 50 CFR 216.103.

To comply with the National Environmental Policy Act of 1969 (NEPA; 42 U.S.C. 4321 et seq. ) and NOAA Administrative Order (NAO) 216-6A, NMFS must review our proposed action ( i.e., the issuance of an IHA) with respect to potential impacts on the human environment.

This action is consistent with categories of activities identified in Categorical Exclusion B4 (IHAs with no anticipated serious injury or mortality) of the Companion Manual for NAO 216-6A, which do not individually or cumulatively have the potential for significant impacts on the quality of the human environment and for which we have not identified any extraordinary circumstances that would preclude this categorical exclusion. Accordingly, NMFS has preliminarily determined that the issuance of the proposed IHA qualifies to be categorically excluded from further NEPA review.

We will review all comments submitted in response to this notice prior to concluding our NEPA process or making a final decision on the IHA request.

On May 15, 2023, NMFS received an application from USACE on behalf of USAF for an IHA to take marine mammals incidental to construction associated with the EAS Fuel Pier repair in Alcan Harbor on Shemya Island, Alaska. NMFS published a notice of a proposed IHA and request for comments in the Federal Register on October 10, 2023 (88 FR 74451). On March 5, 2024, NMFS issued an IHA that was effective from April 1, 2024 through March 31, 2025 (89 FR 17423, March 11, 2024). In-water work associated with the project was expected to be completed between April and October 2024.

On September 23, 2024, USAF informed NMFS that work on the project had experienced significant delays due to piling production delays and weather and would not be completed during the 2024 IHA time period USAF completed a portion of the construction work that was covered by the 2024 IHA and submitted a monitoring report demonstrating that the required mitigation and monitoring requirements were satisfied, no impacts of a scale or nature not previously analyzed or authorized occurred as a result of the activities conducted, and the IHA holder did not exceed the authorized levels of take under that IHA.

On September 23, 2024, NMFS received a letter from USAF requesting renewal of the 2024 IHA (2024 request) to conduct nearly identical construction activities that were previously analyzed under the 2024 IHA. On May 3, 2024, NMFS published (89 FR 36762) and solicited public comment on its draft updated Technical Guidance for Assessing the Effects of Anthropogenic Sound on Marine Mammal Hearing Underwater and In-Air Criteria for Onset of Auditory Injury and Temporary Threshold Shifts (Version 3.0) (2024 Technical Guidance), which includes updated thresholds and weighting functions to inform auditory injury (AUD INJ) estimates. The public comment period ended on June 17th, 2024, and the 2024 Technical Guidance was finalized on October 24, 2024. While USAF's planned activity would ordinarily qualify for a renewal of the IHA, NMFS determined that a renewal of the 2024 IHA is not appropriate in this case because application of the updated Guidance indicates that substantial modification of the prescribed shutdown zones and updates to authorized take numbers for certain species is appropriate.

On December 16, 2024, USAF revised their request to indicate that all work completed during the 2024 season would need to be redone, due to shifting sediments and improperly functioning piles. As such, the same work analyzed under the 2024 IHA is planned for the current IHA, across the same number of construction days. This includes the (1) installation of 208 42-inch round steel interlocking pipe piles (2) the installation of 60 30-inch steel template piles and, (3) the removal of 64 30-inch steel template piles, which includes the removal of 4 additional piles that were installed under the 2024 IHA.

Additionally, USAF also requested to reduce the size of the shutdown zones established for low-frequency cetaceans due to practicability concerns associated with excessive fog. Under this proposed IHA, USAF would conduct pile driving activities between the in water work window dates of April 2025 through October 2025. The proposed activities are nearly identical to those analyzed under the 2024 IHA, but the mitigation zones and number of authorized takes have been adjusted to account for the isopleths calculated using the 2024 Technical Guidance and the request to adjust the shutdown zone for low frequency cetaceans. The USAF request was deemed adequate and complete on January 23, 2024. In evaluating the request, and where applicable, NMFS relies on the information previously presented in notices associated with issuance of the 2024 IHA (88 FR 74451, October 31, 2023; 89 FR 17423, March 11, 2024).

USAF is conducting long-term repairs on the only existing fuel pier at EAS on Shemya Island, Alaska. The 2024 IHA was based on the installation and removal of sixty 30-inch piles and the installation of 208 42-inch round steel interlocking pipe piles over an estimated 160 days of pile driving and removal (table 1), between April and October, 2024. USAF did not complete most of the work in 2024, and work that was attempted will need to be redone. Between August 23, 2024 and September 19, 2024: (1) six out of sixty 30-inch temporary steel pipe piles were installed, (2) two out of sixty 30-inch temporary steel piles were removed, (3) five out of 208 42-inch round steel interlocking pipe piles were installed, and (4) unplanned, all five 42-inch round steel interlocking pipe piles were removed because they were interlocking improperly. As such, USAF requests that this proposed IHA cover take incidental to the same activity analyzed under the 2024 IHA: (1) installation of 208 42″ round steel interlocking pipe piles (2) installation of 60 30-inch steel template pipe piles and (3) removal of 64 30″ template pipe piles, which includes the removal of 4 additional piles that were installed under the 2024 IHA, (table 1) across the same number of construction days (n = 160) between April and October 2025.

To support public review and comment on the IHA that NMFS is proposing to issue here, we refer to the documents related to the previously issued IHA and discuss any new or changed information here. These previous documents include the Federal Register notice of the issuance of the 2024 IHA for USAF's Fuel Pier Repair project (89 FR 17423, March 11, 2024), and the Federal Register notice of the proposed IHA (88 FR 74451, October 31, 2023) and all associated references and documents. The descriptions and analyses contained in those documents remain accurate with the exception of the minor modifications described herein. A detailed description of the proposed vibratory removal and vibratory and impact pile driving and down-the-hole (DTH) activities at the fuel pier repair project is found in these documents. We also refer the reader to USAF's previous application and final monitoring report for the 2024 construction activities, which can be found at https://www.fisheries.noaa.gov/national/marine-mammal-protection/incidental-take-authorizations-construction-activities .

A detailed description of the proposed construction activities is found in these previous documents. Excepting the piles that have already been driven, the location, timing, and nature of the activities, including the types of equipment planned for use, are identical to those described in the previous notices (table 1). Remaining piles will be installed (and removed, as needed) over the course of 160 construction days between April and October, 2025.

A detailed description of the species likely to be affected by USAF's Fuel Pier Repair project, including brief introductions to the species and relevant stocks, available information regarding population trends and threats, and information regarding local occurrence, were provided in the Federal Register notice for the proposed IHA (88 FR 74451, October 21, 2023); since that time, we are not aware of any changes in the status of these species and stocks; therefore, detailed descriptions are not provided here. NMFS reviewed the most recent SARs (found on NMFS' website at https://www.fisheries.noaa.gov/national/marine-mammal-protection/marine-mammal-stock-assessments ), up-to-date information on relevant Unusual Mortality Events (UMEs; https://www.fisheries.noaa.gov/national/marine-mammal-protection/marine-mammal-unusual-mortality-events ), and recent scientific literature and determined that the new information does not change our original analysis of impacts under the 2024 IHA. Please refer to that Federal Register notice for these descriptions. Please also refer to NMFS' website ( https://www.fisheries.noaa.gov/find-species ) for generalized species accounts.

Hearing is the most important sensory modality for marine mammals underwater, and exposure to anthropogenic sound can have deleterious effects. To appropriately assess the potential effects of exposure to sound, it is necessary to understand the frequency ranges marine mammals are able to hear. Not all marine mammal species have equal hearing capabilities ( e.g., Richardson et al., 1995; Wartzok and Ketten, 1999; Au and Hastings, 2008). To reflect this, Southall et al. (2007, 2019) recommended that marine mammals be divided into hearing groups based on directly measured (behavioral or auditory evoked potential techniques) or estimated hearing ranges (behavioral response data, anatomical modeling, etc. ). Subsequently, NMFS (2018, 2024) described generalized hearing ranges for these marine mammal hearing groups. Generalized hearing ranges were chosen based on the approximately 65-decibel (dB) threshold from the normalized composite audiograms, with the exception for lower limits for low-frequency cetaceans where the lower bound was deemed to be biologically implausible and the lower bound from Southall et al. (2007) retained. Note that since the issuance of the 2024 IHA, NMFS' 2024 Technical Guidance was finalized and has been incorporated into this analysis. The re-named marine mammal hearing groups that have been incorporated into this proposed 2025 IHA are presented in table 3. The references, analysis, and methodology used in the development of the thresholds are described in the 2024 Technical Guidance, which may be accessed at: https://www.fisheries.noaa.gov/national/marine-mammal-protection/marine-mammal-acoustic-technical-guidance.

For more detail concerning these groups and associated frequency ranges, please see NMFS (2024) for a review of available information.

The effects of underwater noise from USAF's construction activities have the potential to result in the harassment of marine mammals in the vicinity of the project area. The notice of proposed 2024 IHA (88 FR 74451, October 31, 2024) included a discussion of the effects of anthropogenic noise on marine mammals and the potential effects of underwater noise from USAF's construction on marine mammals and their habitat. That information and analysis is not repeated here; please refer to the notice of proposed 2024 IHA (88 FR 74451, October 31, 2024).

A detailed description of the methods and inputs used to estimate authorized take is found in these previous documents. The methods of estimating take by Level B harassment for the proposed 2025 IHA are identical to those used in the 2024 IHA. The source levels and days of operation remain unchanged from the previously issued IHA. Data reported in the marine mammal monitoring report suggest a greater occurrence of harbor seal than estimated for the 2024 IHA. To account for the revised isopleths, mitigation zones, and marine mammal occurrence information, take by Level A and Level B harassment has been revised for six species.

Level A Harassment —NMFS' 2024 Technical Guidance (NMFS, 2024) identifies dual criteria to assess auditory injury (Level A harassment) to five different marine mammal groups (based on hearing sensitivity) as a result of exposure to noise from two different types of sources (impulsive or non-impulsive). Between the issuance of the 2024 IHA and this proposed 2025 IHA, NMFS' 2024 Technical Guidance was updated and has been incorporated into this analysis. USAF's activity includes the use of impulsive (impact pile driving and DTH) and non-impulsive (continuous pile driving and DTH) sources. The updated thresholds, which identify the Onset of AUD INJ based on the 2024 Technical Guidance, have been incorporated in this proposed IHA are presented in table 4. The references, analysis, and methodology used in the development of the thresholds are described in the 2024 Technical Guidance, which may be accessed at: https://www.fisheries.noaa.gov/national/marine-mammal-protection/marine-mammal-acoustic-technical-guidance. NMFS defines AUD INJ as “damage to the inner ear that can result in destruction of tissue . . . which may or may not result in PTS” (NMFS 2024). NMFS defined PTS as a permanent, irreversible increase in the threshold of audibility at a specified frequency or portion of an individual's hearing range above a previously established reference level (NMFS, 2024).

Here, we describe operational and environmental parameters of the activity that are used in estimating the area ensonified above the acoustic thresholds, including source levels and transmission loss coefficient.

The sound field in the project area is the existing background noise plus additional construction noise from the planned project. Marine mammals are expected to be affected via sound generated by the primary components of the project ( i.e., pile driving and removal).

The project includes vibratory pile installation and removal, impact pile driving, and DTH. Source levels for these activities are based on reviews of measurements of the same or similar types and dimensions of piles available in the literature. Source levels for each pile size and activity each year are presented in table 5. Source levels for vibratory installation and removal of piles of the same diameter are assumed to be the same.

Sections 101(a)(5)(A) and (D) of the Marine Mammal Protection Act (MMPA; 16 U.S.C. 1361 et seq. ) direct the Secretary of Commerce (as delegated to NMFS) to allow, upon request, the incidental, but not intentional, taking of small numbers of marine mammals by U.S. citizens who engage in a specified activity (other than commercial fishing) within a specified geographical region if certain findings are made and either regulations are 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.

The MMPA states that the term “take” means to harass, hunt, capture, kill or attempt to harass, hunt, capture, or kill any marine mammal.

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 November 24, 2023, NMFS published final notification of our issuance of an IHA authorizing take of marine mammals incidental to the USACE Unalaska (Dutch Harbor) Channel Deepening Project (88 FR 82326). The effective dates of that IHA were January 1, 2024 through December 31, 2024. On December 20, 2024, USACE submitted a request that we reissue an identical IHA that would be effective from January 1, 2025 through December 31, 2025, in order to conduct the construction work that was analyzed and authorized through the previously issued IHA. In the request they described that the project had been delayed. None of the work identified in the initial IHA ( e.g., dredging and confined underwater blasting) has occurred. Therefore, re-issuance of the IHA is appropriate.

The planned activities (including mitigation, monitoring, and reporting), authorized incidental take, and anticipated impacts on the affected stocks are the same as those analyzed and authorized through the previously issued IHA.

The USACE plans to deepen the entrance channel of Iliuliuk Bay by means of dredging and (if necessary) confined blasting of a 42-foot (ft) (12.8 meter (m)) deep “bar” which currently restricts access to the port of Dutch Harbor, Alaska. Dutch Harbor is the only deep draft, year-round ice-free port along the 1,200-mile (1,931 km) Aleutian Island chain, providing vital services to vessels operating in both the North Pacific and the Bering Sea, and the depth of the bar currently restricts access for large vessels that may need to enter the port, particularly during extreme weather. The purpose of the project is to increase navigational safety and improve economic efficiencies into and out of Dutch Harbor via Iliuliuk Bay. The location, timing, and nature of the activities, including the types of equipment planned for use, are within scope of those described in the initial IHA. The mitigation and monitoring are also as prescribed in the initial IHA.

Species that are expected to be taken by the planned activity include humpback whale ( Megaptera novaeangliae ), harbor porpoise ( Phocoena phocoena ), Steller sea lion ( Eumetopias jubatus ), and harbor seal ( Phoca vitulina ). A description of the methods and inputs used to estimate take anticipated to occur and, ultimately, the take that was authorized is found in the previous documents referenced above. The data inputs and methods of estimating take are identical to those used in the initial IHA. NMFS has reviewed recent stock assessment reports, information on relevant unusual mortality events, and recent scientific literature, and determined that our original analysis of impacts and take estimate under the initial IHA remain valid.

We refer to the documents related to the previously issued IHA, which include the Federal Register notice of the issuance of the initial 2024 IHA for USACE's construction work (88 FR 82326), USACE's application, the Federal Register notice of the proposed IHA (88 FR 21630), and all associated references and documents.

USACE will conduct activities as analyzed in the initial 2024 IHA. As described above, the number of authorized takes of the same species and stocks of marine mammals are identical to the numbers that were found to meet the negligible impact and small numbers standards and authorized under the initial IHA and no new information has emerged that would change those findings. The re-issued 2025 IHA includes identical required mitigation, monitoring, and reporting measures as the initial IHA, and there is no new information suggesting that our analysis or findings should change.

Based on the information contained here and in the referenced documents, NMFS has determined the following: (1) the required mitigation measures will effect the least practicable impact on marine mammal species or stocks and their habitat; (2) the authorized takes will have a negligible impact on the affected marine mammal species or stocks; (3) the authorized takes represent small numbers of marine mammals relative to the affected stock abundances; and (4) USACE's activities will not have an unmitigable adverse impact on taking for subsistence purposes as no relevant subsistence uses of marine mammals are implicated by this action.

This action is consistent with categories of activities identified in Categorical Exclusion B4 (incidental take authorizations with no anticipated serious injury or mortality) of the Companion Manual for NOAA Administrative Order 216-6A, which do not individually or cumulatively have the potential for significant impacts on the quality of the human environment and for which we have not identified any extraordinary circumstances that would preclude this categorical exclusion. Accordingly, NMFS determined that the issuance of the initial IHA qualified to be categorically excluded from further National Environmental Policy Act review. NMFS has determined that the application of this categorical exclusion remains appropriate for this reissued IHA.

Section 7(a)(2) of the ESA of 1973 (16 U.S.C. 1531 et seq. ) requires that each Federal agency insure that any action it authorizes, funds, or carries out is not likely to jeopardize the continued existence of any endangered or threatened species or result in the destruction or adverse modification of designated critical habitat. To ensure ESA compliance for the issuance of IHAs, NMFS consults internally whenever we propose to authorize take for endangered or threatened species, in this case with the NMFS' Alaska Regional Office (AKRO).

NMFS is authorizing take of the Mexico-North Pacific stock of humpback whale, and Western DPS of Steller sea lion, which are listed as threatened or endangered under the ESA. The NMFS AKRO issued a Biological Opinion under section 7 of the ESA on the issuance of an IHA to USACE under section 101(a)(5)(D) of the MMPA by NMFS OPR. The biological opinion concluded that the action is not likely to jeopardize the continued existence of the listed species.

NMFS has issued an IHA to USACE for in-water construction activities associated with the specified activity from March 15, 2025 through March 14, 2026. All previously described mitigation, monitoring, and reporting requirements from the initial 2024 IHA are incorporated.

To give stakeholders additional time to review materials and prepare comments, EPA is hereby reopening the comment period established in the Federal Register document of January 7, 2025, at 90 FR 1125 (FRL-12481-01-OCSPP) for 60 days. More information on the action can be found in the Federal Register of January 7, 2025.

To submit comments or access the docket, please follow the detailed instructions provided under ADDRESSES . If you have questions, consult the technical person listed under FOR FURTHER INFORMATION CONTACT .

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

Section 309(g)(1)(A) of the Clean Water Act (CWA or Act) empowers the EPA to assess an administrative civil penalty whenever, on the basis of any information available, the EPA finds that a person has violated certain sections of the Act or any permit condition or limitation implementing any such section in a permit issued under section 402 or 404 of the Act. 33 U.S.C. 1319(g)(1)(A). However, before issuing an order assessing an administrative civil penalty under section 309(g), the EPA is required by the CWA and the Consolidated Rules of Practice Governing the Administrative Assessment of Civil Penalties and the Revocation/Termination or Suspension of Permits (Rules of Practice) to provide public notice of and reasonable opportunity to comment on the proposed issuance of such order. 33 U.S.C. 1319(g)(4); 40 CFR 22.45(b)(1).

Any person who comments on the proposed assessment of a penalty is then entitled to receive notice of any hearing held under section 309(g) of the CWA and at such hearing is entitled to a reasonable opportunity to be heard and to present evidence. 33 U.S.C. 1319(g)(4)(B); 40 CFR 22.45(c)(1). If no hearing is held before issuance of an order assessing a penalty under section 309(g) of the CWA, such as where the administrative penalty action in question is settled pursuant to a consent agreement and final order, any person who commented on the proposed assessment may petition to set aside the order on the basis that material evidence was not considered and to hold a hearing on the penalty. 33 U.S.C. 1319(g)(4)(C); 40 CFR 22.45(c)(4)(ii).

The CWA requires that if the evidence presented in support of the petition is material and was not considered in the issuance of the order, the Administrator shall immediately set aside such order and provide a hearing in accordance with section 309(g). 33 U.S.C. 1319(g)(4)(C). Conversely, if the Administrator denies a hearing, the Administrator shall provide to the petitioner, and publish in the Federal Register , notice of and reasons for such denial. Id.

The authority to decide petitions by commenters to set aside final orders entered without a hearing and provide copies and/or notice of the decision has been delegated to Regional Administrators in administrative penalty actions brought by regional offices of the EPA. Memorandum from the EPA Administrator to Regional Administrators Regarding Delegation of Authority 2-52A (January 18, 2017) (available at: https://intranet.epa.gov/ohr/rmpolicy/ads/dm/2-52A.pdf ). The Rules of Practice require that where a commenter petitions to set aside a consent agreement and final order in an administrative penalty action brought by a regional office of the EPA, the Regional Administrator shall assign a Petition Officer to consider and rule on the petition. 40 CFR 22.45(c)(4)(iii). Upon review of the petition and any response filed by the complainant, the Petition Officer shall then make written findings as to: (A) the extent to which the petition states an issue relevant and material to the issuance of the consent agreement and proposed final order; (B) whether the complainant adequately considered and responded to the petition; and (C) whether the resolution of the proceeding by the parties is appropriate without a hearing. 40 CFR 22.45(c)(4)(v).

If the Petition Officer finds that a hearing is appropriate, the Presiding Officer shall order that the consent agreement and proposed final order be set aside and establish a schedule for a hearing. 40 CFR 22.45(c)(4)(vi). Conversely, if the Petition Officer finds that resolution of the proceeding without a hearing is appropriate, the Petition Officer shall issue an order denying the petition and stating reasons for the denial. 40 CFR 22.45(c)(4)(vii). The Petition Officer shall then file the order with the Regional Hearing Clerk, serve copies of the order on the parties and the commenter, and provide public notice of the order. Id.

In March 2024, the Director of the Enforcement and Compliance Assurance Division of EPA Region 3 (Complainant) and the Frederick-Winchester Service Authority and the Frederick County Sanitation Authority (Respondents) agreed to enter into a Consent Agreement and Final Order (Proposed CAFO) in the matter styled as In the Matter of Frederick-Winchester Service Authority and Frederick County Sanitation Authority, Docket No. CWA-03-2024-0036. The Proposed CAFO sought to simultaneously commence and conclude an administrative penalty action under section 309(g) of the CWA against the Respondents for alleged violations of effluent limitations found in a permit issued to the Respondents under section 402 of the CWA that occurred between June 30, 2019, and January 31, 2024, at the Respondents' Crooked Run Wastewater Treatment Plant. Pursuant to the agreement, the Respondents agreed to pay a civil penalty of $12,000 to settle the alleged violations and waived their right to otherwise contest the allegations or appeal the Final Order. Pursuant to section 309(a)(3) of the CWA, the parties separately entered into an Administrative Order of Consent, which required the Respondents to provide the EPA with an Injunctive Relief Framework detailing plans to implement infrastructure upgrades needed to come into compliance with their permit's effluent limitations.

The Complainant posted a public notice expressing an intent to file the Proposed CAFO and advising that anyone wishing to comment on the Proposed CAFO could do so. Alan Randolph Holland, Jr. (Petitioner) was among a number of people that filed a timely comment on the Proposed CAFO. The Complainant then sent a letter to each commenter declaring an intent to finalize the Proposed CAFO as originally planned, attaching a copy of the Proposed CAFO and advising commenters that they had 30 days from its receipt to petition the Regional Administrator to set aside the Proposed CAFO. On July 16, 2024, the Petitioner timely submitted a petition seeking to set aside the Proposed CAFO and have a public hearing held thereon (Petition).

On September 17, 2024, having decided not to withdraw the Proposed CAFO after considering the arguments in the Petition, the Regional Administrator for Region 3 requested that the Office of Administrative Law Judges assign an Administrative Law Judge to consider the Petition in accordance with 40 CFR 22.45(c)(4)(iii). On October 25, 2024, an order issued in which the undersigned was assigned to consider and rule on the Petition, and the Complainant was directed to present a written response to the Petition. The Complainant timely filed a response, along with exhibits in support, on November 25, 2024.

On February 14, 2025, the undersigned issued an Order Denying Petition to Set Aside Consent Agreement and Proposed Final Order (Order), holding that resolution of the proceeding without a hearing is appropriate. The Order concluded that none of the three issues raised in the Petition presented relevant and material evidence that had not been adequately considered and responded to by the Complainant.

First, the Petitioner argued that the civil penalty was incorrectly calculated based on the Respondents' false statement that they received no economic benefit. According to the Petitioner, the Respondents' assertion to the Complainant that revenue generated by the community served by the Crooked Run Wastewater Treatment Plant covered the cost of operating the facility was contradicted by previous statements that operating costs outstripped revenue. The undersigned, however, found that the purportedly false statement was not material because it would not change the economic benefit analysis.

Second, the Petitioner argued that the Respondents falsely claimed to have acted in good faith by telling the Complainant that their policies included stringent pollution control requirements at the time of the violations when, according to the Petitioner, the Respondents adopted the measures only after the violations were discovered. The undersigned concluded that the Respondents' alleged statement was not materially false because the evidence provided by the Petitioner directly supported the Respondents' claim.

Third, the Petitioner argued that, based on the two allegedly false statements that he identified, the Respondents falsely certified to the Complainant that all of their statements were complete and accurate. The undersigned concluded that this argument was merely a repackaging of the Petitioner's first two arguments and that any allegedly false certification will not itself be material and relevant if the allegedly false statements underlying the certification were not themselves material and relevant.

Because the Petitioner did not identify any material and relevant issues not considered by the Complainant when setting the civil penalty, the undersigned therefore issued the Order denying the Petition. The Order may be viewed online at http://yosemite.epa.gov/oarm/alj/alj_web_docket.nsf/Dockets/CWA-03-2024-0036.

Authority: 33 U.S.C. 1319(g); 40 CFR part 22.

The EPA received a petition from the Chesapeake Bay Foundation, Mothers Out Front, Sierra Club, Falls of the James Group, and Virginia Interfaith Power & Light dated July 19, 2024, requesting that the EPA object to the issuance of operating permit no. PRO 50232, issued by VADEQ to AdvanSix Resins and Chemicals LLC, Hopewell Plant in the City of Hopewell, Prince George County, Virginia.

On December 16, 2024, the EPA Administrator issued an order granting in part and denying in part the petition. The order itself explains the bases for the EPA's decision.

Sections 307(b) and 505(b)(2) of the CAA provide that a petitioner may request judicial review of those portions of an order that deny issues in a petition. Any petition for review shall be filed in the United States Court of Appeals for the appropriate circuit no later than May 12, 2025.

OMB Control Number: 3060-0474.

Title: Section 74.1263, Time of Operation.

Form Number: N/A.

Type of Review: Extension of a currently approved collection.

Respondents: Business and other for profit entities; not-for-profit institutions.

Number of Respondents and Responses: 110 respondents; 110 responses.

Estimated Time per Response: 0.5 hours.

Frequency of Response: On occasion reporting requirement.

Obligation to Respond: Statutory authority for this collection of information collection is contained in Sections 154(i), 303 and 308 of the Communications Act of 1934, as amended.

Total Annual Burden: 55 hours.

Total Annual Costs: None.

Needs and Uses: The information collection requirements contained in 47 CFR 74.1263(c) require a licensee of an FM translator or booster station to notify the Commission of its intent to discontinue operations for 30 or more consecutive days. In addition, a licensee must notify the Commission within 48 hours of the station's return to operation. The information collection requirements contained in 47 CFR 74.1263(d) require an FM translator or booster station licensee to notify the Commission of its intent to discontinue operations permanently and to forward the station license to the FCC for cancellation.

9000-0075, Government Property, Standard Forms 1428, and 1429.

This clearance covers the information that offerors and contractors must submit to comply with the following FAR requirements:

1. FAR clause 52.245-1, Government Property.

a. Paragraph (f)(1)(ii) requires contractors to document the receipt of Government property.

b. Paragraph (f)(1)(ii)(A) requires contractors to submit a written statement to the Property Administrator containing all relevant facts, such as cause or condition and a recommended course(s) of action, if overages, shortages, or damages and/or other discrepancies are discovered upon receipt of Government-furnished property.

c. Paragraph (f)(1)(iii) requires contractors to create and maintain records of all Government property accountable to the contract, including Government-furnished and Contractor-acquired property. Property records shall, unless otherwise approved by the Property Administrator, contain the following:

i. The name, part number and description, National Stock Number (if needed for additional item identification tracking and/or disposition), and other data elements as necessary and required in accordance with the terms and conditions of the contract.

ii. Quantity received (or fabricated), issued, and balance-on-hand.

iii. Unit acquisition cost.

iv. Unique-item identifier or equivalent (if available and necessary for individual item tracking).

v. Unit of measure.

vi. Accountable contract number or equivalent code designation.

vii. Location.

viii. Disposition.

ix. Posting reference and date of transaction.

x. Date placed in service (if required in accordance with the terms and conditions of the contract).

When approved by the Property Administrator, contractors may maintain, in lieu of formal property records, a file of appropriately cross-referenced documents evidencing receipt, issue, and use of material that is issued for immediate consumption.

d. Paragraph (f)(1)(iv) requires contractors to periodically perform, record, and disclose physical inventory results during contract performance, including upon completion or termination of the contract.

e. Paragraph (f)(1)(vii)(B) requires contractors, unless otherwise directed by the Property Administrator, to investigate and report all incidents of Government property loss as soon as the facts become known. Such reports shall, at a minimum, contain the following information:

i. Date of incident (if known).

ii. The data elements required under paragraph (f)(1)(iii)(A) of FAR 52.245-1.

iii. Quantity.

iv. Accountable contract number.

v. A statement indicating current or future need.

vi. Unit acquisition cost, or if applicable, estimated sales proceeds, estimated repair or replacement costs.

vii. All known interests in commingled material of which includes Government material.

viii. Cause and corrective action taken or to be taken to prevent recurrence.

ix. A statement that the Government will receive compensation covering the loss of Government property, in the event the Contractor was or will be reimbursed or compensated.

x. Copies of all supporting documentation.

xi. Last known location.

xii. A statement that the property did or did not contain sensitive, export controlled, hazardous, or toxic material, and that the appropriate agencies and authorities were notified.

f. Paragraph (f)(1)(viii) requires contractors to promptly disclose and report Government property in its possession that is excess to contract performance.

g. Paragraph (f)(1)(ix) requires contractors to disclose and report to the Property Administrator the need for replacement and/or capital rehabilitation.

h. Paragraph (f)(1)(x) requires contractors to perform and report to the Property Administrator contract property closeout.

i. Paragraph (f)(2) requires contractors to establish and maintain Government accounting source data, particularly in the areas of recognition of acquisitions, loss of Government property, and disposition of material and equipment.

j. Paragraphs (j)(2) and (3) require contractors to submit inventory disposal schedules to the Plant Clearance Officer using the Standard Form (SF) 1428, Inventory Disposal Schedule and if needed the SF 1429, Inventory Disposal Schedule-Continuation Sheet. Paragraph (j)(2)(iv) requires contractors to provide the following information:

i. Any additional information that may facilitate understanding of the property's intended use.

ii. For work-in-progress, the estimated percentage of completion.

iii. For precious metals in raw or bulk form, the type of metal and estimated weight.

iv. For hazardous material or property contaminated with hazardous material, the type of hazardous material.

v. For metals in mill product form, the form, shape, treatment, hardness, temper, specification (commercial or Government) and dimensions (thickness, width, and length).

2. FAR 52.245-9, Use and Charges. Paragraph (d)(1) of this clause requires contractors submitting a government property rental request to: identify the property for which rental is requested, propose a rental period, and compute an estimated rental charge by using the Contractor's best estimate of rental time in the formulae described in paragraph (e) of FAR clause 52.245-9.

This information is used to facilitate the management of Government property in the possession of the contractor.

Respondents/Recordkeepers: 4,702.

Total Annual Responses: 9,433,560.

Total Burden Hours: 4,662,001 (2,405,041 reporting hours + 2,256,960 recordkeeping hours).

Obtaining Copies: Requesters may obtain a copy of the information collection documents from the GSA Regulatory Secretariat Division by calling 202-501-4755 or emailing GSARegSec@gsa.gov . Please cite OMB Control No. 9000-0075, Government Property.

9000-0007, Subcontracting Plans.

This clearance covers the information that offerors and contractors must submit to comply with the requirements in Federal Acquisition Regulation (FAR) 52.219-9, Small Business Subcontracting Plans, regarding subcontracting plans as follows:

1. Subcontracting plan. In accordance with section 8(d) of the Small Business Act (15 U.S.C. 637(d)), contractors receiving a contract that is expected to exceed, or a contract modification that causes a contract to exceed, $750,000 ($1.5 million for construction of a public facility) and has subcontracting possibilities, shall submit an acceptable subcontracting plan that provides maximum practicable opportunities for small business, veteran-owned small business, service-disabled veteran-owned small business, HUBZone small business, small disadvantaged business, and women-owned small business concerns. Specific elements required to be included in the plan are specified in section 8(d) of the Small Business Act and implemented in FAR subpart 19.7 and the clause at FAR 52.219-9.

2. Summary Subcontract Report (SSR). In conjunction with the subcontracting plan requirements, contractors with subcontracting plans must submit an annual summary of subcontracts awarded as prime and subcontractors for each specific Federal Government agency. Contractors submit the information in an SSR through the Electronic Subcontracting Reporting System (eSRS). This is required for all contractors with subcontracting plans regardless of the type of plan ( i.e., commercial or individual).

3. Individual Subcontract Report (ISR). In conjunction with the subcontracting plan requirements, contractors with individual subcontracting plans must submit semi-annual reports of their small business subcontracting progress. Contractors submit the information through eSRS in an ISR, the electronic equivalent of the Standard Form (SF) 294, Subcontracting Report for Individual Contracts. Contractors with contracts that are not reported in the Federal Procurement Data System (FPDS), in accordance with FAR 4.606(c)(5), do not submit ISRs in eSRS; instead, they will continue to use the SF 294 to submit the information to the agency.

4. Written explanation for not using a small business subcontractor as specified in the proposal or subcontracting plan. Section 1322 of the Small Business Jobs Act of 2010 (Jobs Act), Public Law 111-240, amends the Small Business Act (15 U.S.C. 637(d)(6)) to require, as part of a subcontracting plan, that a prime contractor make a good faith effort to utilize a small business subcontractor during performance of a contract to the same degree the prime contractor relied on the small business in preparing and submitting its bid or proposal. If a prime contractor does not utilize a small business subcontractor as described above, the prime contractor is required to explain, in writing, to the contracting officer the reasons why it is unable to do so.

Respondents: 30,365.

Total Annual Responses: 49,296.

Total Burden Hours: 112,704.

A 60-day notice was published in the Federal Register at 89 FR 97004, on December 6, 2024. Comments were received from a respondent; however, they did not change the estimate of the burden.

Comment: The respondent recommended removing the requirement for subcontracting plans in Federal contracting. The respondent stated that the “process of creating, maintaining, and reporting subcontracting plans imposes significant administrative burdens without a corresponding benefit that cannot already be achieved through existing reporting mechanisms.”

Response: The respondent's input is appreciated. Subcontracting plans and subcontracting plan reporting are required by section 8(d) of the Small Business Act (15 U.S.C. 637(d)). Therefore, changes to the information collected would require a change to the underlying statute.

Obtaining Copies: Requesters may obtain a copy of the information collection documents from the GSA Regulatory Secretariat Division by calling 202-501-4755 or emailing GSARegSec@gsa.gov. Please cite OMB Control No. 9000-0007, Subcontracting Plans.

9000-0189, Certain Federal Acquisition Regulation Part 4 Requirements.

This clearance covers the information that offerors and contractors must submit to comply with the following FAR requirements:

1. FAR 52.204-3, and 52.212-3(l)—Taxpayer Identification Number (TIN) Information. When there is not a requirement to be registered in the System for Award Management (SAM), offerors are required to submit their TIN information by the provision at FAR 52.204-3, Taxpayer Identification, for other than commercial acquisitions, and by paragraph (l) of the provision at FAR 52.212-3, Offeror Representations and Certifications—Commercial Products and Commercial Services, for commercial acquisitions.

The TIN information may be used by the Government to collect and report on any delinquent amounts arising out of the offeror's relationship with the Government (31 U.S.C. 7701(c)(3)). If a contract is subject to the payment reporting requirements in FAR 4.904, the TIN may be matched with the Internal Revenue Service records to verify the accuracy of the TIN submitted by the offeror.

2. FAR 52.204-6, 52.212-1(j), and 52.204-12—Unique Entity Identifier. When there is not a requirement to be registered in SAM, offerors are required to submit their unique entity identifier by the provision at FAR 52.204-6, Unique Entity Identifier, for other than commercial acquisitions, and by paragraph (j) of the provision at FAR 52.212-1, Instructions to Offerors—Commercial Products and Commercial Services, for commercial acquisitions. The clause at FAR 52.204-12, Unique Entity Identifier Maintenance, requires contractors to maintain their unique entity identifier with the organization designated in SAM to issue such identifiers, for the life of the contract. The clause also requires contractors to notify contracting officers of any changes to the unique entity identifier.

The Government uses the unique entity identifier to identify contractors in reporting to the Federal Procurement Data System (FPDS). FPDS provides a comprehensive mechanism for assembling, organizing, and presenting contract placement data for the Federal Government. Contracting officers use a notification provided under FAR 52.204-12 regarding any change to the unique entity identifier to modify contracts to reflect the updated unique entity identifier.

3. FAR 52.204-7, 52.204-13, and 52.212-3(b)—SAM Registration and Maintenance. The provision at FAR 52.204-7, System for Award Management, requires offerors to be registered in SAM when submitting an offer or quotation and at time of award, except in certain limited cases, and to continue to be registered through final payment of any award that results from such offer. The clause at FAR 52.204-13, System for Award Management Maintenance, requires contractors to make sure their SAM data is kept current, accurate, and complete throughout contract performance and final payment; this maintenance is, at a minimum, to be done through an annual review and update of the contractor's SAM registration. Paragraph (b) of the provision at FAR 52.212-3 contains the equivalent of FAR 52.204-7 and 52.204-13, for commercial acquisitions.

The Government use the collected information to establish a common source of vendor data to increase visibility of vendor sources (including their geographical locations) for specific supplies and services.

4. FAR 52.204-14, and 52.204-15—Service Contract Reporting Requirements. The clauses at FAR 52.204-14, Service Contract Reporting Requirements, and FAR 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts, require contractors to report the following information in SAM annually:

(a) Contract number and, as applicable, order number.

(b) The total dollar amount invoiced for services performed during the previous Government fiscal year under each contract.

(c) The number of contractor direct labor hours expended on the services performed during the previous Government fiscal year.

(d) Data reported by each first-tier subcontractor providing services under the contract if required to do so.

Section 743 of Division C of the Consolidated Appropriations Act, 2010 (Pub. L. 111-117) requires executive agencies covered by the Federal Activities Inventory Reform Act (Pub. L. 105-270), except DoD, to submit to OMB an annual inventory of activities performed by service contractors. DoD is exempt from this reporting requirement because 10 U.S.C. 4505(c) already require DoD to develop an annual service contract inventory. Civilian agencies use the service contract information provided by FAR clauses 52.204-14 and 52.204-15 to supplement agency annual service contract reporting requirements with the contractor-provided service contract reporting information.

5. FAR 52.204-16 and 52.204-18, Commercial and Government Entity (CAGE) Code Reporting and Maintenance. The provision at FAR 52.204-16, Commercial and Government Entity Code Reporting, require offerors to provide their CAGE code, including name and location address, with their offer. The CAGE code must be for that name and location address. The CAGE code is required prior to award. The clause at FAR 52.204-18, Commercial and Government Entity Code Maintenance, requires contractors to maintain their CAGE code throughout the life of the contract for each location of contract, including subcontract, performance.

For contractors registered in SAM, the Defense Logistics Agency (DLA) CAGE Branch shall only modify data received from SAM in the CAGE master file if the contractor initiates those changes via update of its SAM registration. Contractors undergoing a novation or change-of-name agreement shall notify the contracting officer in accordance with FAR subpart 42.12. The contractor shall communicate any change to the CAGE code to the contracting officer within 30 days after the change, so that a modification can be issued to update the CAGE code on the contract. Contractors located in the U.S. or its outlying areas that are not registered in SAM shall submit written change request to the DLA CAGE Branch. Contractors located outside the U.S. and its outlying areas that are not registered in SAM shall contact the appropriate National Codification Bureau points of contact to request CAGE changes.

6. FAR 52.204-17, Ownership or Control of Offeror. This provision requires offerors to represent whether they are owned or controlled by another entity, and if so, to provide the CAGE code and name of such entity.

The CAGE code system may be used, among other things, to—

(a) Exchange data with another contracting activity, including contract administration activities and contract payment activities;

(b) Exchange data with another system that requires the unique identification of a contractor entity; or

(c) Identify when offerors are owned or controlled by another entity.

7. FAR 52.204-20, Predecessor of Offeror. This provision requires offerors to identify if the offeror is, within the last three years, a successor to another entity that received a Federal Government award and, if so, to provide the CAGE code and legal name of the predecessor.

The information on predecessors is used to identify such entities in the Federal Awardee Performance and Integrity Information System (FAPIIS) to allow retrieval of integrity and performance data on the most recent predecessor of an apparent successful offeror to whom award is anticipated. FAR 9.104-6 requires contracting officers to consult FAPIIS before awarding a contract that exceeds the simplified acquisition threshold.

8. FAR 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab Covered Entities. This clause requires contractors to report, in writing, to the contracting officer or, in the case of DoD, to the website at https://dibnet.dod.mil, any instance when the contractor identifies a covered article provided to the Government during contract performance, or if contractors are notified of such an event by subcontractors at any tier or any other source.

Agency personnel will use the collected information to identify and remove prohibited hardware, software, or services from Government use. This information collection is required to comply with section 1634 of Division A of the National Defense Authorization Act for Fiscal Year 2018 (Pub. L. 115-91).

Respondents: 353,291.

Total Annual Responses: 843,253.

Total Burden Hours: 387,083.

A 60-day notice was published in the Federal Register at 89 FR 104154, on December 20, 2024. No comments were received.

Obtaining Copies: Requesters may obtain a copy of the information collection documents from the GSA Regulatory Secretariat Division by calling 202-501-4755 or emailing GSARegSec@gsa.gov. Please cite OMB Control No. 9000-0189, Certain Federal Acquisition Regulation Part 4 Requirements.

9000-0152, Service Contracting.

This clearance covers the information that offerors must submit to comply with the FAR requirements at FAR 52.237-10, Identification of Uncompensated Overtime. This provision requires offerors, when professional or technical services are acquired on the basis of the number of hours to be provided, to identify uncompensated overtime hours in excess of 40 hours per week, whether at the prime or subcontract level. This includes uncompensated overtime hours that are in indirect cost pools for personnel whose regular hours are normally charged direct.

The contracting officer will use the collected information to perform an adequate cost realism analysis of the offerors' proposed labor rates. Proposals which include unrealistically low labor rates, or which do not otherwise demonstrate cost realism, will be considered by the contracting officer in a risk assessment and evaluated appropriately. The primary purpose for obtaining the information and using it during the source selection process is to discourage the use of uncompensated overtime.

Respondents: 20,076.

Total Annual Responses: 20,076.

Total Burden Hours: 10,038.

Obtaining Copies: Requesters may obtain a copy of the information collection documents from the GSA Regulatory Secretariat Division by calling 202-501-4755 or emailing GSARegSec@gsa.gov. Please cite OMB Control No. 9000-0152, Service Contracting.

9000-0027, Value Engineering Requirements.

This clearance covers the information that contractors must submit to comply with the following Federal Acquisition Regulation (FAR) requirements:

• FAR 52.248-1, Value Engineering; 52.248-2, Value Engineering-Architect-Engineer; and 52.248-3, Value Engineering-Construction. These clauses require contractors submitting Value Engineering Change Proposals (VECP's) to the Government to provide such details as: a description of the differences between the existing contract requirement and the proposed requirement, and the comparative advantages and disadvantages of each; a list and analysis of contract requirements that must be changed if the VECP is accepted; a detailed cost estimate showing anticipated reductions associated with the VECP; a statement of the time a modification accepting the VECP must be issued to achieve maximum cost reduction, and the effect on contract completion time; and identification of any previous submissions of the VECP; the agencies and contract numbers involved and previous Government actions, if known.

The Government will use the collected information to evaluate the VECP and, if accepted, to arrange for an equitable sharing plan.

Respondents: 90.

Total Annual Responses: 180.

Total Burden Hours: 2,700.

Obtaining Copies: Requesters may obtain a copy of the information collection documents from the GSA Regulatory Secretariat Division by calling 202-501-4755 or emailing GSARegSec@gsa.gov. Please cite OMB Control No. 9000-0027, Value Engineering Requirements.

9000-0059, North Carolina Sales Tax Certification.

This clearance covers the information that contractors must submit to comply with the requirements of the Federal Acquisition Regulation clause at 52.229-2, North Carolina State and Local Sales and Use Tax. This clause requires contractors for construction or vessel repair to be performed in North Carolina to provide certified statements of the cost of the property purchased from each vendor and the amount of sales or use taxes paid. The North Carolina Sales and Use Tax Act authorizes counties and incorporated cities and towns, to obtain each year from the Commissioner of Revenue of the State of North Carolina, a refund of sales and use taxes indirectly paid on building materials, supplies, fixtures, and equipment that become a part of or are annexed to any building or structure in North Carolina. However, to substantiate a refund claim for sales or use taxes paid on purchases of building materials, supplies, fixtures, or equipment by a contractor, the Government must secure from the contractor certified statements setting forth the cost of the property purchased from each vendor and the amount of sales or use taxes paid. Similar certified statements by subcontractors must be obtained by the general contractor and furnished to the Government.

The Government will use the information as evidence to establish exemption from State and local taxes.

Respondents: 182.

Total Annual Responses: 182.

Total Burden Hours: 227.5.

A 60-day notice was published in the Federal Register at 89 FR 92126, on November 21, 2024. No comments were received.

Obtaining Copies: Requesters may obtain a copy of the information collection documents from the GSA Regulatory Secretariat Division by calling 202-501-4755 or emailing GSARegSec@gsa.gov. Please cite OMB Control No. 9000-0059, North Carolina Sales Tax Certification.

9000-0048, Certain Federal Acquisition Regulation Part 15 Requirements.

This clearance covers the information that offerors and contractors must submit to comply with the following FAR requirements:

1. FAR 15.407-2(e), Make-or-buy programs. When prospective contractors are required to submit proposed make-or-buy program plans for negotiated acquisitions, paragraph (e) requires the following information in their proposal:

(a) A description of each major item or work effort;

(b) Categorization of each major item or work effort as “must make,” “must buy,” or “can either make or buy”;

(c) For each item or work effort categorized as “can either make or buy,” a proposal either to “make” or to “buy”;

(d) Reasons for categorizing items and work efforts as “must make” or “must buy,” and proposing to “make” or to “buy” those categorized as “can either make or buy”;

(e) Designation of the plant or division proposed to make each item or perform each work effort, and a statement as to whether the existing or proposed new facility is in or near a labor surplus area;

(f) Identification of proposed subcontractors, if known, and their location and size status;

(g) Any recommendations to defer make-or-buy decisions when categorization of some items or work efforts is impracticable at the time of submission; and

(h) Any other information the contracting officer requires in order to evaluate the program.

2. FAR 52.215-1(c)(2)(iv)—Authorized Negotiators. This provision requires firms offering supplies or services to the Government under negotiated solicitations to provide the names, titles, and telephone and facsimile numbers (and electronic addresses if available) of authorized negotiators to assure that discussions are held with authorized individuals.

Contracting officers use this information during contract negotiations and it becomes part of the official contract file.

3. FAR 52.215-9, Changes or Additions to Make-or-Buy Program. This clause requires the contractor to submit, in writing, for the contracting officer's advance approval a notification and justification of any proposed change in the make-or-buy program incorporated in the contract.

Contracting officers use the information collected regarding make-or-buy programs at FAR 15.407-2(e) and 52.215-9 to ensure negotiation of reasonable contract prices, satisfactory performance, or implementation of socioeconomic policies.

4. FAR 52.215-14—Integrity of Unit Prices. This clause requires offerors and contractors under negotiated solicitations and contracts to identify those supplies which they will not manufacture or to which they will not contribute significant value, if requested by the contracting officer or when contracting without adequate price competition.

When a contract action is priced on the basis of a cost estimate, contracting officers use this information to determine whether the intrinsic value of an item has been distorted through allocation of overhead costs and whether such items should be considered for breakout.

5. FAR 52.215-19—Notification of Ownership Changes. This clause requires contractors to notify the administrative contracting officer when the contractor becomes aware that a change in its ownership has occurred, or is certain to occur, that could result in changes in the valuation of its capitalized assets in the accounting records.

The notification of ownership change enables the Government to adequately administer the cost principle at FAR 31.205-52, Asset valuations resulting from business combinations, which addresses the allowability of certain costs resulting from asset valuations following business combinations.

6. FAR 52.215-22, Limitations on Pass-Through Charges—Identification of Subcontract Effort. This provision requires offerors submitting a proposal for a contract, task order, or delivery order to provide the following information with their proposal:

(a) The total cost of the work to be performed by the offeror, and the total cost of the work to be performed by each subcontractor;

(b) If the offeror intends to subcontract more than 70 percent of the total cost of work to be performed, the amount of the offeror's indirect costs and profit/fee applicable to the work to be performed by the subcontractor(s), and a description of the value added by the offeror as related to the work to be performed by the subcontractor(s); and

(c) If any subcontractor proposed intends to subcontract to a lower-tier subcontractor more than 70 percent of the total cost of work to be performed, the amount of the subcontractor's indirect costs and profit/fee applicable to the work to be performed by the lower-tier subcontractor(s) and a description of the added value provided by the subcontractor as related to the work to be performed by the lower-tier subcontractor(s).

7. FAR 52.215-23, Limitations on Pass-Through Charges. This clause requires contractors to provide a description of the value added by the contractor or subcontractor, as applicable, as related to the subcontract effort if the effort changes from the amount identified in the proposal such that it exceeds 70 percent of the total cost of work to be performed.

Contracting officers use the information collected at FAR 52.215-22 and 52.215-23 to assess the value added by a contractor or subcontractor in relation to proposed, billed, or claimed indirect costs or profit/fee on work performed by a subcontractor. This information is required to ensure that pass-through charges under contracts and subcontracts are not excessive.

Respondents: 122,097.

Total Annual Responses: 139,074.

Total Burden Hours: 43,027 (43,022 reporting hours + 5 recordkeeping hours).

A 60-day notice was published in the Federal Register at 89 FR 92127, on November 21, 2024. No comments were received.

Obtaining Copies: Requesters may obtain a copy of the information collection documents from the GSA Regulatory Secretariat Division by calling 202-501-4755 or emailing GSARegSec@gsa.gov. Please cite OMB Control No. 9000-0048, Certain Federal Acquisition Regulation Part 15 Requirements.

9000-0079, Travel Costs.

This clearance covers the information that contractors must submit to comply with the following FAR requirements:

1. FAR 31.205-46(a)(3)—In special or unusual situations, costs incurred by a contractor for lodging, meals, and incidental expenses, may exceed the per diem rates in effect as set forth in the Federal Travel Regulation (FTR) for travel in the contiguous 48 United States. The actual costs may be allowed only if the contractor provides the following:

a. FAR 31.205-46(a)(3)(ii)—A written justification for use of the higher amounts approved by an officer of the contractor's organization or designee to ensure that the authority is properly administered and controlled to prevent abuse.

b. FAR 31.205-46(a)(3)(iii)—Advance approval from the contracting officer if it becomes necessary to exercise the authority to use the higher actual expense method repetitively or on a continuing basis in a particular area.

c. FAR 31.205-46(a)(3)(iv)—Documentation to support actual costs incurred including a receipt for each expenditure of $75.00 or more.

2. FAR 31.205-46(c) requires firms to maintain and make available manifest/logs for all flights on company aircraft. As a minimum, the manifest/log must indicate:

a. Date, time, and points of departure;

b. Destination, date, and time of arrival;

c. Name of each passenger and relationship to the contractor

d. Authorization for trip; and

e. Purpose of trip.

The information required by (1) and (2) and the name of each passenger (required by (3)) are recordkeeping requirements already established by Federal Aviation Administration regulations. This information, plus the additional required information, is needed to ensure that costs of owned, chartered, or leased aircraft are properly charged against Government contracts and that directly associated costs of unallowable activities are not charged to Government contracts.

The contracting officer will use the information to ensure that the Government does not reimburse contractors for excessive travel costs. Also, the information is used by Government auditors to identify allowable and unallowable costs under Government contracts.

Respondents/Recordkeepers: 1,854.

Total Annual Responses: 12,680.

Total Burden Hours: 6,686 (3,170 reporting hours + 3,516 recordkeeping hours).

Obtaining Copies: Requesters may obtain a copy of the information collection documents from the GSA Regulatory Secretariat Division by calling 202-501-4755 or emailing GSARegSec@gsa.gov. Please cite OMB Control No. 9000-0079, Travel Costs.

9000-0149, Subcontract Consent and Contractors' Purchasing System Review.

This clearance covers the information that contractors must submit to comply with the requirements in the Federal Acquisition Regulation (FAR) clause at 52.244-2, Subcontracts, regarding consent to subcontract, advance notification, and contractors' purchasing system review as follows:

1. Consent to subcontract. This is the contracting officer's written consent for the prime contractor to enter into a particular subcontract. In order for the contracting officer responsible for consent to make an informed decision, the prime contractor must submit adequate information to ensure that the proposed subcontract is appropriate for the risks involved and consistent with current policy and sound business judgment. Paragraph (e)(1) of the FAR clause at 52.244-2, requires prime contractors to submit the following information:

(i) A description of the supplies or services to be subcontracted.

(ii) Identification of the type of subcontract to be used.

(iii) Identification of the proposed subcontractor.

(iv) The proposed subcontract price.

(v) The subcontractor's current, complete, and accurate certified cost or pricing data and Certificate of Current Cost or Pricing Data, if required by other contract provisions.

(vi) The subcontractor's Disclosure Statement or Certificate relating to Cost Accounting Standards when such data are required by other provisions of the contract.

(vii) A negotiation memorandum reflecting—

(A) The principal elements of the subcontract price negotiations;

(B) The most significant considerations controlling establishment of initial or revised prices;

(C) The reason certified cost or pricing data were or were not required;

(D) The extent, if any, to which the Contractor did not rely on the subcontractor's certified cost or pricing data in determining the price objective and in negotiating the final price;

(E) The extent to which it was recognized in the negotiation that the subcontractor's certified cost or pricing data were not accurate, complete, or current; the action taken by the Contractor and the subcontractor; and the effect of any such defective data on the total price negotiated;

(F) The reasons for any significant difference between the Contractor's price objective and the price negotiated; and

(G) A complete explanation of the incentive fee or profit plan when incentives are used. The explanation shall identify each critical performance element, management decisions used to quantify each incentive element, reasons for the incentives, and a summary of all trade-off possibilities considered.

If the contractor has an approved purchasing system, consent is required for subcontracts specifically identified by the contracting officer in paragraph (d) of the FAR clause at 52.244-2. The contracting officer may require consent to subcontract if the contracting officer has determined that an individual consent action is required to protect the Government adequately because of the subcontract type, complexity, or value, or because the subcontract needs special surveillance. These can be subcontracts for critical systems, subsystems, components, or services.

If the contractor does not have an approved purchasing system, consent to subcontract is required for cost-reimbursement, time-and-materials, labor-hour, or letter contracts, and also for unpriced actions under fixed-price contracts that exceed the simplified acquisition threshold.

Contracting Officers use the information to ensure contractors' compliance with Government policy when subcontracting.

2. Advance notification. Paragraph (e)(1) of the FAR clause at 52.244-2 requires contractors to notify the contracting officer reasonably in advance of placing any subcontract or modification thereof for which consent is required under paragraph (b), (c), or (d) of the clause.

Contracting Officers use the information to ensure compliance with the statutory requirements in 10 U.S.C. 3322(c) and 41 U.S.C. 3905.

3. Contractors' Purchasing System Review. Paragraph (i) of FAR clause 52.244-2 specifies that the Government reserves the right to review the contractor's purchasing system as set forth in FAR subpart 44.3. This clause is the mechanism through which the requirements of FAR subpart 44.3 are applied to contractors.

FAR 44.302 requires the administrative contracting officer (ACO) to determine the need for a Contractors' Purchasing System Review (CPSR) based on, but not limited to, the past performance of the contractor, and the volume, complexity and dollar value of subcontracts. If a contractor's sales to the Government (excluding competitively awarded firm-fixed-price and competitively awarded fixed-price with economic price adjustment contracts and sales of commercial products and commercial services pursuant to part 12) are expected to exceed $25 million during the next 12 months, the ACO will perform a review to determine if a CPSR is needed. Sales include those represented by prime contracts, subcontracts under Government prime contracts, and modifications. Generally, a CPSR is not performed for a specific contract. Rather, CPSRs are conducted on contractors based on the factors identified above. For example, the Defense Contract Management Agency Contractor Purchasing System Review Group is a group dedicated to conducting CPSRs for the Department of Defense. The head of the agency responsible for contract administration may raise or lower the $25 million review level if it is considered to be in the Government's best interest. Once an initial determination has been made to conduct a review, at least every three years the ACO shall determine whether a purchasing system review is necessary. If necessary, the cognizant contract administration office will conduct a purchasing system review.

The cognizant ACO is responsible for granting, withholding, or withdrawing approval of a contractor's purchasing system and for promptly notifying the contractor of same (FAR 44.305-1). Related administrative requirements are as follows:

• FAR 44.305-2(c) requires that when recommendations are made for improvement of an approved system, the contractor shall be requested to reply within 15 days with a position regarding the recommendations.

• FAR 44.305-3(b) requires when approval of the contractor's purchasing system is withheld or withdrawn, the ACO shall within 10 days after completing the in-plant review (1) inform the contractor in writing, (2) specify the deficiencies that must be corrected to qualify the system for approval, and (3) request the contractor to furnish within 15 days a plan for accomplishing the necessary actions. If the plan is accepted, the ACO shall make a follow-up review as soon as the contractor notifies the ACO that the deficiencies have been corrected.

Contracting Officers use the information to evaluate the efficiency and effectiveness with which a contractor spends Government funds.

Respondents: 2,515.

Total Annual Responses: 7,065.

Total Burden Hours: 49,635.

A 60-day notice was published in the Federal Register at 89 FR 93291, on November 26, 2024. No comments were received.

Obtaining Copies: Requesters may obtain a copy of the information collection documents from the GSA Regulatory Secretariat Division by calling 202-501-4755 or emailing GSARegSec@gsa.gov. Please cite OMB Control No. 9000-0149, Subcontract Consent and Contractors' Purchasing System Review.

9000-0073, Certain Federal Acquisition Regulation Part 32 Requirements

This justification supports the extension of OMB Control No. 9000-0073. This clearance covers the information that offerors and contractors must submit to comply with the following FAR requirements:

FAR 32.408, Application for advance payments. The authorities behind advance payments are 41 U.S.C. chapter 45; 10 U.S.C. chapter 277; Public Law 85-804 (50 U.S.C. 1431-1435); and Executive Order 10789, November 14, 1958. In accordance with FAR 32.408(b), contractors requesting advance payments must submit their request in writing to the contracting officer and provide the following information:

• A reference to the contract if the request concerns an existing contract, or a reference to the solicitation if the request concerns a proposed contract.

• A cash flow forecast showing estimated disbursements and receipts for the period of contract performance.

• The proposed total amount of advance payments.

• The name and address of the financial institution at which the contractor expects to establish a special account as depository for the advance payments.

• A description of the contractor's efforts to obtain unguaranteed private financing or a V-loan under eligible contracts.

• Other information appropriate to an understanding of

• the contractor's financial condition and need,

• the contractor's ability to perform the contract without loss to the Government, and

• financial safeguards needed to protect the Government's interest.

The information is used to determine if advance payments should be provided to the contractor. If advance payments are authorized, the information is used to ensure proper procedures are followed to protect the Government's interest.

FAR 52.232-1 through 52.232-4, 52.232-6, 52.232-7, and 52.232-10—Payments. The basic authority for the contract financing that is implemented in these clauses is contained in 41 U.S.C. chapter 45, Contract Financing, 10 U.S.C. chapter 277, and Title III of the Defense Production Act of 1950 (50 U.S.C. App.2091). The following FAR clauses require the contractor to (as appropriate to the payment terms specified in the contract) provide a proper invoice or voucher.

• 52.232-1, Payments.

• 52.232-2, Payments under Fixed-Price Research and Development Contracts.

• 52.232-3, Payments under Personal Services Contracts.

• 52.232-4, Payments under Transportation Contracts and Transportation-Related Services Contracts.

• 52.232-6, Payment under Communication Service Contracts with Common Carriers.

• 52.232-7, Payments under Time-and-Materials and Labor-Hour Contracts.

• 52.232-10, Payments under Fixed-Price Architect-Engineer Contracts.

“Proper invoice” is defined in FAR part 2 as an invoice that meets the minimum standards specified in FAR 32.905(b), which include the following items:

• Name and address of the contractor.

• Invoice date and invoice number.

• Contract number or other authorization for supplies delivered or services performed (including order number and line item number).

• Description, quantity, unit of measure, unit price, and extended price of supplies delivered or services performed.

• Shipping and payment terms.

• Name and address of contractor official to whom payment is to be sent.

• Name (where practicable), title, phone number, and mailing address of person to notify in the event of a defective invoice.

• Taxpayer Identification Number (TIN) if required by agency procedures.

• Electronic funds transfer (EFT) banking information if required by agency procedures.

• Any other information or documentation required by the contract ( e.g., evidence of shipment).

The information is used to determine the proper amount of payments to Federal contractors.

FAR 52.232-5, Payments under Fixed-Price Construction Contracts. This clause requires the contractor's request for progress payments to include the following substantiation:

• An itemization of the amounts requested, related to the various elements of work required by the contract covered by the payment requested.

• A listing of the amount included for work performed by each subcontractor under the contract.

• A listing of the total amount of each subcontract under the contract.

• A listing of the amounts previously paid to each such subcontractor under the contract.

• Additional supporting data in a form and detail required by the contracting officer.

Paragraph (c) of FAR clause 52.232-5 requires contractors to provide a certification with each request for progress payment certifying that—

• The amounts requested are only for performance in accordance with the specifications, terms, and conditions of the contract;

• All payments due to subcontractors and suppliers from previous payments received under the contract have been made, and timely payments will be made from the proceeds of the payment covered by the certification;

• The request for progress payment does not include any amounts which the prime contractor intends to withhold or retain from a subcontractor or supplier in accordance with the terms and conditions of the subcontract; and

• The certification is not to be construed as final acceptance of a subcontractor's performance.

Paragraph (d) of FAR clause 52.232-5 requires contractors to notify contracting officers, if the contractor, after making a certified request for progress payments, discovers that a portion or all of the request constitutes a payment for performance by the contractor that fails to conform to the specifications, terms, and conditions of the contract. Contractors must notify the contracting officer that the performance deficiency has been corrected.

The information is used to determine the proper amount of payments to Federal contractors for construction contracts.

FAR 52.232-12, Advance Payments. For authority behind this clause, see the authority for advance payments cited in the narrative above for FAR 32.408. If advance payments are authorized, this clause requires contractors to submit the following:

• Per paragraph (g)—The financial institution agreement, in the form prescribed by the administering office, establishing the special account, and clearly setting forth the special character of the account and the responsibilities of the financial institution under the account.

• Per paragraph (i)(3)—Notification of a lien in favor of the Government to a third person receiving any items or materials on which the Government has a lien, and a receipt from that third person acknowledging the existence of the lien. Contractors are also required to provide a copy of each receipt to the contracting officer.

• Per paragraph (m)—(1) Monthly, signed or certified balance sheets and profit and loss statements together with a report on the operation of the special account in the form prescribed by the administering office; and (2) If requested, other information concerning the operation of the contractor's business. (This same requirement is at paragraph (j) of the clause with its Alternate V.)

If advance payments are authorized, the information is used to ensure proper procedures are followed to protect the Government's interest.

FAR 52.232-20 and 52.232-22—Limitation of Costs or Funds. FAR clause 52.232-20, Limitation of Cost, requires the contractor to notify the contracting officer in writing whenever it has reason to believe that—

• The costs the contractors expect to incur under the contract in the next 60 days, when added to all costs previously incurred, will exceed 75 percent of the estimated cost of the contracts; or

• The total cost for the performance of the contract will be greater or substantially less than estimated.

As part of the notification, the contractor must provide a revised estimate of the total cost of performing the contract.

FAR clause 52.232-22, Limitation of Funds, requires the contractor to notify the contracting officer in writing whenever it has reason to believe that the costs it expects to incur under the contract in the next 60 days, when added to all costs previously incurred, will exceed 75 percent of (1) the total amount so far allotted to the contract by the Government or, (2) if this is a cost-sharing contract, the amount then allotted to the contract by the Government plus the contractor's corresponding share. The notice must state the estimated amount of additional funds required to continue performance for the contract period. Sixty days before the end of the contract period, the contractor must notify the contracting officer in writing of the estimated amount of additional funds, if any, required to continue performance under the contract, and when the funds will be required.

The information is used to avoid cost overruns and to ensure that funding is available to complete work under Federal contracts.

FAR 52.232-27, Prompt Payment for Construction Contracts. The authority for this FAR clause are the OMB prompt payment regulations at 5 CFR part 1315, which in turn implements the Prompt Payment statute. Paragraph (a)(6)(ii) of FAR clause 52.232-27 requires contractors making a written demand to the designated payment office for additional penalty payment to support their demand with the following data:

• Specifically assert that late payment interest is due under a specific invoice, and request payment of all overdue late payment interest penalty and such additional penalty as may be required;

• Attach a copy of the invoice on which the unpaid late payment interest was due; and

• State that payment of the principal has been received, including the date of receipt.

Paragraph (e)(5) of FAR clause 52.232-27 requires contractors to notify contracting officers upon—

• Reduction of the amount of any subsequent certified application for payment; or

• Payment to the subcontractor of any withheld amounts of a progress payment, specifying: the amounts withheld; and the dates that the withholding began and ended.

Paragraph (g) of FAR clause 52.232-27 requires contractors to issue a written notice of any withholding to a subcontractor (with copy to the contracting officer), specifying—

• The amount to be withheld;

• The specific causes for the withholding under the terms of the subcontract; and

• The remedial actions to be taken by the subcontractor in order to receive payment of the amounts withheld.

Paragraph (l) of FAR clause 52.232-27 requires contractors to remit overpayments to the payment office cited in the contract along with a description that includes the following:

• Circumstances of the overpayment ( e.g., duplicate payment, erroneous payment, liquidation errors, date(s) of overpayment);

• Affected contract number and delivery order number if applicable;

• Affected line item or subline item, if applicable; and

• Contractor point of contact.

Contractors are required to provide a copy of the remittance and supporting documentation to the contracting officer.

The information is used to understand when the contractor withholds amounts from subcontractors and suppliers after the Government has already paid the contractor the amounts withheld.

FAR 52.232-33, Payment by Electronic Funds Transfer—System for Award Management. FAR clause 52.232-33 requires contractors to provide updated EFT information in the System for Award Management (SAM) if their information changes. According to the SAM Entity Registration Checklist, the registration/renewal process asks entities to provide the account type, routing number, and account number for EFT. The burden associated with this clause is reflected under OMB Control Number 9000-0189, Certain Federal Acquisition Regulation Part 4 Requirements. OMB Control Number 9000-0189 accounts for new registrations and renewals in SAM, which includes providing EFT information as part of the registration and renewal process.

FAR 52.232-34, Payment by Electronic Funds Transfer—Other than System for Award Management. This clause requires contractors to provide the following information to enable the Government to make payments under the contract by EFT:

• The contract number (or other procurement identification number).

• The contractor's name and remittance address.

• The signature, title, and telephone number of the contractor official authorized to provide this information.

• The name, address, and 9-digit Routing Transit Number of the contractor's financial agent.

• The contractor's account number and the type of account.

• If applicable, the Fedwire Transfer System telegraphic abbreviation of the contractor's financial agent.

• If applicable, the contractor must provide the name, address, telegraphic abbreviation, and 9-digit Routing Transit Number of the correspondent financial institution receiving the wire transfer payment if the contractor's financial agent is not directly on-line to the Fedwire Transfer System.

31 U.S.C.3332 requires, subject to implementing regulations of the Secretary of the Treasury at 31 CFR part 208, that EFT be used to make all contract payments.

The information is used to enable the Government to make contract payments by EFT.

Respondents: 273,518.

Total Annual Responses: 1,789,889.

Total Burden Hours: 462,859.

Obtaining Copies: Requesters may obtain a copy of the information collection documents from the GSA Regulatory Secretariat Division by calling 202-501-4755 or emailing GSARegSec@gsa.gov. Please cite OMB Control No. 9000-0073, Certain Federal Acquisition Regulation Part 32 Requirements.

9000-0198, Certain Federal Acquisition Regulation Part 9 Requirements.

This clearance covers the information that offerors and contractors must submit to comply with the following FAR requirements:

1. FAR 52.209-1, Qualification Requirements. This clause requires offerors to provide with their proposal: Their name, the manufacturer's name, source's name, item's name, service identification, and test number (if known) for a proposed product or service that has already been determined to meet the qualification standards. If an offeror, manufacturer, source, product or service has met the qualification requirement but is not yet on a qualified products list, qualified manufacturers list, or qualified bidders list, this clause requires the offeror to submit evidence of qualification prior to award of a contract.

2. FAR 52.209-2, 52.209-10, and 52.212-3(n), Prohibition on Contracting with Inverted Domestic Corporations. FAR provision 52.209-2, Prohibition on Contracting with Inverted Domestic Corporations-Representation, and its equivalent for commercial acquisitions at FAR 52.212-3(n), requires each offeror to represent whether it is, or is not, an inverted domestic corporation or a subsidiary of an inverted domestic corporation.

FAR clause 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations, requires contractors to promptly notify the contracting officer in the event the contractor becomes an inverted domestic corporation or a subsidiary of an inverted domestic corporation during the period of performance of the contract.

3. FAR 52.209-5, 52.209-6, and 52.212-3(h), Debarment, Suspension, and other Responsibility Matters. FAR provision 52.209-5, Certification Regarding Responsibility Matters, and its equivalent for commercial acquisitions at FAR 52.212-3(h), require the disclosure of the following critical information by an offeror to be considered by the contracting officer in making a responsibility determination:

• Whether the offeror or any of its principals have been—

○ Debarred, suspended, proposed for debarment, declared ineligible for contract award;

○ Within a three-year period preceding their offer:

• Convicted of or had a civil judgment rendered against them or indicted for commission of a fraud or a criminal offense in connection with obtaining, attempting to obtain, or performing a public (Federal, State, or local) contract or subcontract, violation of Federal or State antitrust statutes relating to the submission of offers, or commission of embezzlement, theft, forgery, bribery, falsification or destruction of records, making false statements, tax evasion, violating Federal criminal tax laws, or receiving stolen property;

• Notified of any delinquent Federal taxes in an amount that exceeds $10,000 for which the liability remains unsatisfied;

• Had one or more contracts terminated for default by any Federal agency; or

• Are presently indicted for, or otherwise criminally or civilly charged by a governmental entity with commission of any of the offenses identified above.

If the offeror has responded affirmatively to the certifications in the FAR provisions at 52.209-5 or 52.212-3(h), the offeror shall provide additional information if requested by the contracting officer.

The offeror shall also provide immediate written notice to the contracting officer if, at any time prior to contract award, the offeror learns that its certification was erroneous when submitted or has become erroneous by reason of changed circumstances.

Paragraph (c) of the FAR clause at 52.209-6, Protecting the Government's Interest When Subcontracting with Contractor's Debarred, Suspended, or Proposed for Debarment, requires the contractor to require each proposed subcontractor whose subcontract will exceed $35,000, other than a subcontractor providing a commercially available off-the-shelf (COTS) item, to disclose to the contractor in writing, whether as of the time of award of the subcontract, the subcontractor, or its principals, is or is not debarred, suspended, or proposed for debarment by the Government.

Paragraph (d) of the FAR clause at 52.209-6 requires a corporate officer or designee of the contractor to notify the contracting officer, in writing, before entering into a subcontract (for other than COTS items) with a party that is debarred, suspended, or proposed for debarment. The written notice must include: The name of the subcontractor; why the subcontractor is debarred, suspended, or ineligible; the compelling reason(s) for doing business with the subcontractor; and how the contractor will protect the Government's interests when dealing with such subcontractor. For any subcontract subject to Government consent, contracting officers shall not consent to such subcontracts unless the agency head or a designee states in writing the compelling reasons for approving such subcontract.

4. FAR 52.209-7 and 52.209-9, Information Regarding Responsibility Matters and Updates to that Publicly Available Information. FAR provision 52.209-7, Information Regarding Responsibility Matters, requires each offeror to represent whether it has current active Federal contracts and grants with a total value greater than $10 million. The provision also requires each offeror to post in the Federal Awardee Performance and Integrity Information System (FAPIIS), as required by maintaining an active registration in the System for Award Management (SAM), information on whether the offeror and/or any of its principals has, or has not, within the past five years, in connection with the award to or performance by the offeror of a federal contract or grant, been the subject of a proceeding, at the Federal or State level, that resulted in:

(a) A criminal conviction in the case of a criminal proceeding;

(b) The finding of fault and liability in a civil proceeding resulting in the payment of $5,000 or more in damages, restitution, reimbursement, fine or penalty;

(c) The finding of fault and liability in an administrative proceeding resulting in the payment of a monetary fine or penalty of $5,000 or more, or the payment of a reimbursement, restitution, or damages in excess of $100,000; or

(d) In a criminal, civil, or administrative proceeding, a disposition of the matter by consent or compromise with an acknowledgement of fault by the contractor if the proceeding could have led to any of the outcomes specified in (4)(a) through (c) above.

Paragraph (a) of the FAR clause 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters, requires contractors to update the information in FAPIIS on a semiannual basis, throughout the life of the contract, by posting the information in SAM. Paragraph (c) of the FAR clause 52.209-9 informs contractors of their ability to provide feedback on information posted by the Government in FAPIIS and the procedure to follow in the event information exempt from public disclosure is slated to become publicly available information in FAPIIS.

5. FAR 52.209-11, 52.209-12, and 52.212-3(q), Prohibition on Contracting With Corporations with Delinquent Taxes or a Felony Conviction. FAR provision 52.209-11, Representation by Corporations Regarding Delinquent Tax Liability or a Felony Conviction under any Federal Law, and its equivalent for commercial acquisitions at FAR 52.212-3(q), require offerors to represent whether the offeror is a corporation that—

• Has any unpaid Federal tax liability that has been assessed, for which all judicial and administrative remedies have been exhausted or have lapsed, and that is not being paid in a timely manner pursuant to an agreement with the authority responsible for collecting the tax liability; and

• Was convicted of a felony criminal violation under a Federal law within the preceding 24 months.

FAR provision 52.209-12, Certification Regarding Tax Matters, require offerors proposing a total contract price that will exceed $5.5 million (including options) to certify that, to the best of the offeror's knowledge and belief, it—

• Has filed all Federal tax returns required during the three years preceding the certification;

• Has not been convicted of a criminal offense under the Internal Revenue Code of 1986; and

• Has not, more than 90 days prior to certification, been notified of any unpaid Federal tax assessment for which the liability remains unsatisfied, unless the assessment is the subject of an installment agreement or offer in compromise that has been approved by the Internal Revenue Service and is not in default, or the assessment is the subject of a non-frivolous administrative or judicial proceeding.

6. FAR 52.209-13, Violations of Arms Control Treaties or Agreements with the United States. Unless the offeror is providing evidence of a waiver or determination in accordance with paragraph (b)(2) of the FAR provision at 52.209-13, Violation of Arms Control Treaties or Agreements—Certification, paragraph (b)(1) of the provision requires offerors to certify that—

• The offeror does not engage and has not engaged in any activity that contributed to or is a significant factor in the President's or Secretary of State's determination that a foreign country is in violation of its obligations undertaken in any arms control, nonproliferation, or disarmament agreement to which the United States is a party, or is not adhering to its arms control, nonproliferation, or disarmament commitments in which the United States is a participating state. The determinations are described in the most recent unclassified annual report provided to Congress pursuant to section 403 of the Arms Control and Disarmament Act (22 U.S.C. 2593a); and

• No entity owned or controlled by the offeror is an entity organized under the laws of such country, that engages or has engaged in any activity that contributed to or is a significant factor in the President's or Secretary of State's determination that a foreign country is in violation of its obligations undertaken in any arms control, nonproliferation, or disarmament agreement to which the United States is a party, or is not adhering to its arms control, nonproliferation, or disarmament commitments in which the United States is a participating state.

Contracting officers use the collected information described above to determine an offeror's responsibility for contract award.

Respondents: 1,973,803.

Total Annual Responses: 2,177,511.

Total Burden Hours: 1,125,803. (589,703 reporting hours + 536,100 recordkeeping hours).

A 60-day notice was published in the Federal Register at 89 FR 102145, on December 17, 2024. No comments were received.

Obtaining Copies: Requesters may obtain a copy of the information collection documents from the GSA Regulatory Secretariat Division by calling 202-501-4755 or emailing GSARegSec@gsa.gov. Please cite OMB Control No. 9000-0198, Certain Federal Acquisition Regulation Part 9 Requirements.

Section 306(b)(1)(D) of the FD&C Act permits debarment of an individual from importing or offering for import any drug into the United States if FDA finds, as required by section 306(b)(3)(C) of the FD&C Act, that the individual has been convicted of a felony for conduct relating to the importation into the United States of any drug or controlled substance.

On July 30, 2024, Mr. Cosie was convicted as defined in section 306(l)(1) of the FD&C Act in the U.S. District Court for the Middle District of Florida-Jacksonville Division when the court accepted his plea of guilty and entered judgment against him for two counts of introducing misbranded drugs into interstate commerce with the intent to defraud and mislead in violation of sections 301(a) and 303(a)(2) of the FD&C Act (21 U.S.C. 331(a) and 21 U.S.C. 333(a)(2)). The underlying facts supporting the conviction are as follows: As contained in the Information and Plea Agreement from Mr. Cosie's case, from approximately 2016 through 2020, he owned and operated several businesses including HCGRK LLC a/k/a Health Conscious Group Rx LLC (HCGRX). According to its website, HCGRX advertised itself as a national distributor of competition quality weight loss, body building and sports supplements. The website also advertised products for the treatment of erectile dysfunction, which were described as generic versions of the prescription drugs VIAGRA (sildenafil) and CIALIS (tadalafil). Among other supplements, Mr. Cosie sold a number of products containing Human Chorionic Gonadotropin (“HCG”). HCG is a hormone produced by the placenta during pregnancy. FDA has approved several prescription drugs containing HCG for the treatment of female infertility and for other medical conditions. FDA has not approved any HCG-containing products for weight loss, nor for any purpose without a prescription. Mr. Cosie falsely claimed on his website that his company was cooperating with international pharmacies to ship orders out. In fact, Mr. Cosie obtained unapproved prescription drugs containing HCG from foreign manufacturers and other sources. Then, after importing those drugs, Mr. Cosie would apply to the vials his own counterfeit labels which he created and printed and which contained false and misleading information. Mr. Cosie then knowingly and intentionally sold the drugs to consumers without a prescription or the supervision of a licensed medical practitioner. From October 28, 2017, through December 24, 2020, Mr. Cosie received approximately $626,202.77 in proceeds from distribution of misbranded prescription drugs, and $20,000 for the sale of HCGRX.

FDA sent Mr. Cosie, by certified mail, on December 3, 2024, a notice proposing to debar him for a 10-year period from importing or offering for import any drug into the United States. The proposal was based on a finding under section 306(b)(3)(C) of the FD&C Act that Mr. Cosie's felony convictions under Federal law for introducing misbranded drugs into interstate commerce with the intent to defraud and mislead in violation of sections 301(a) and 303(a)(2) of the FD&C Act, was for conduct relating to the importation of any drug or controlled substance into the United States because Mr. Cosie illegally imported and introduced misbranded prescription drug products into interstate commerce. In proposing a debarment period, FDA weighed the considerations set forth in section 306(c)(3) of the FD&C Act that it considered applicable to Mr. Cosie's offense and concluded that the offense warranted the imposition of a 10-year period of debarment.

The proposal informed Mr. Cosie of the proposed debarment and offered him an opportunity to request a hearing, providing him 30 days from the date of receipt of the letter in which to file the request, and advised him that failure to request a hearing constituted a waiver of the opportunity for a hearing and of any contentions concerning this action. Mr. Cosie received the proposal and notice of opportunity for a hearing on December 7, 2024. Mr. Cosie failed to request a hearing within the timeframe prescribed by regulation and has, therefore, waived his opportunity for a hearing and waived any contentions concerning his debarment (21 CFR part 12).

Therefore, the Division of Field Enforcement Director, Office of Inspections and Investigations, under section 306(b)(3)(C) of the FD&C Act, under authority delegated to the Director, Division of Enforcement, finds that Mr. Jonathan Corbett Cosie has been convicted of felonies under Federal law for conduct relating to the importation into the United States of any drug or controlled substance. FDA finds that the offenses should be accorded a debarment period of 10 years as provided by section 306(c)(2)(A)(iii) of the FD&C Act.

As a result of the foregoing finding, Mr. Cosie is debarred for a period of 10 years from importing or offering for import any drug into the United States, effective (see DATES ). Pursuant to section 301(cc) of the FD&C Act, the importing or offering for import into the United States of any drug by, with the assistance of, or at the direction of Mr. Cosie is a prohibited act.

In the Federal Register of December 30, 2024 (89 FR 106519), FDA published a notice of availability with a 60-day period to provide comments on the draft guidance entitled “E6(R3) Good Clinical Practice: Annex 2.” The draft guidance provides guidance on good clinical practices for trial design and conduct, with a focus on trials with decentralized and pragmatic elements as well as trials that utilize real-world data. Since the original E6 guidance was published in 1996, clinical trials have evolved significantly with new designs and technological innovations. Annex 2 provides additional considerations to the previously published draft guidance entitled “E6(R3) Good Clinical Practice (GCP),” which includes a Principles document and Annex 1. This draft guidance, entitled “E6(R3) Good Clinical Practice: Annex 2,” is intended to be read and implemented with E6(R3) Principles and Annex 1.

Interested persons were originally given until February 28, 2025, to submit comments to the docket. FDA has received requests to extend the comment period to allow sufficient time to develop and submit meaningful comments. FDA has considered the requests and is reopening the comment period until March 31, 2025. The Agency believes that reopening the comment period until March 31, 2025, allows adequate additional time for interested persons to submit comments.

Section 306(b)(1)(D) of the FD&C Act (21 U.S.C. 335a(b)(1)(D)) permits debarment of an individual from importing or offering for import any drug into the United States if FDA finds, as required by section 306(b)(3)(C) of the FD&C Act, that the individual has been convicted of a felony for conduct relating to the importation into the United States of any drug or controlled substance.

On May 21, 2024, Mr. Singh was convicted as defined in section 306(l)(1) of the FD&C Act in the United States District Court for the Eastern District of New York when the court accepted his plea of guilty and entered judgment against him for multiple felony offenses that are conspiracy to possess with intent to distribute cathinone, tapentadol, tramadol, and carisoprodol, in violation of 21 U.S.C. 846 and 841(b)(1)(C); one felony count under Federal law for fraudulent importation and transportation of goods in violation of 18 U.S.C. 545; one felony count under Federal law for conspiracy to launder money in violation of 18 U.S.C. 1956(a) and 1956(h); and one felony count under Federal law for conspiracy to obstruct justice in violation of 18 U.S.C. 1512(c) and 1512(k). The underlying facts supporting the conviction are as follows: as contained in the Information from his case, between January 2017 and September 2019, Mr. Singh knowingly, intentionally and with intent to defraud the United States, smuggled, and clandestinely introduced and attempted to smuggle and clandestinely introduced into the United States misbranded drugs, which should had been invoiced, and made out and passed, and attempted to pass, through the customhouse one or more false, forged and fraudulent invoices, and other documents and papers; and knowingly, intentionally and fraudulently imported and brought into the United States merchandise contrary to law, and receive, conceal, buy, sell and facilitate the transportation, concealment and sale of the misbranded drugs, knowing that the drugs to have been imported and brought into the United States contrary to law. In addition, Mr. Singh together with others, did knowingly and intentionally conspire to distribute and possess with intent to distribute one or more controlled substances that are cathinone, a schedule I controlled substance; tapentadol, a schedule II controlled substance; and tramadol and carisoprodol, schedule IV controlled substances. Also, together with others, Mr. Singh knowingly and intentionally conspired: (a) to conduct one or more financial transactions affecting interstate and foreign commerce, to wit: interstate and foreign transfers of funds and payments of Federal Express bills, which transactions in fact involved the proceeds of specified unlawful activity, to wit: the crimes charged in counts one and two of the Information, knowing that the property involved in the financial transactions represented the proceeds of some form of unlawful activity, with the intent to promote the carrying on of specified unlawful activity, in violation of 18 U.S.C. 1956(a)(1)(A)(i); and (b) to conduct one or more financial transactions affecting interstate and foreign commerce, to wit: interstate and foreign transfers of funds and payments of Federal Express bills, which transactions in fact involved the proceeds of the crimes charged in counts one and two of the Information, knowing that the property involved in the financial transactions represented the proceeds of some form of unlawful activity, and knowing that the transactions were designed in whole and in part to conceal and disguise the nature, location, source, ownership and control of the proceeds of specified unlawful activity, in violation of 18 U.S.C. 1956(a)(1)(B)(i).

As further contained in the Information from Mr. Singh's case, between approximately August 2019 and September 2019, Mr. Singh, together with others, knowingly and intentionally conspired to corruptly alter, destroy, mutilate and conceal records, documents and other objects with the intent to impair the objects' integrity and availability for use in an official proceeding, to wit: a grand jury investigation in the Eastern District of New York, in violation of 18 U.S.C. 1512(c)(1) and 1512(k).

FDA sent Mr. Singh, by certified mail, on October 3, 2024, a notice proposing to debar him for a 10-year period from importing or offering for import any drug into the United States. The proposal was based on a finding under section 306(b)(3)(C) of the FD&C Act that Mr. Singh's felony convictions under Federal law for conspiracy to possess with intent to distribute cathinone, tapentadol, tramadol, and carisoprodol, fraudulent importation and transportation of goods, conspiracy to launder money, and conspiracy to obstruct justice, was for conduct relating to the importation of any drug or controlled substance into the United States because Mr. Singh illegally imported and then introduced misbranded drug products into interstate commerce. He then laundered money gained from that illegal activity and conspired to obstruct justice by destroying documents and other objects to prevent their use in a criminal investigation.

In proposing a debarment period, FDA weighed the considerations set forth in section 306(c)(3) of the FD&C Act that it considered applicable to Mr. Singh's offense and concluded that the offense warranted the imposition of a 10-year period of debarment.

The proposal informed Mr. Singh of the proposed debarment and offered him an opportunity to request a hearing, providing him 30 days from the date of receipt of the letter in which to file the request, and advised him that failure to request a hearing constituted a waiver of the opportunity for a hearing and of any contentions concerning this action. Mr. Singh received the proposal and notice of opportunity for a hearing on October 21, 2024. Mr. Singh failed to request a hearing within the timeframe prescribed by regulation and has, therefore, waived his opportunity for a hearing and waived any contentions concerning his debarment (21 CFR part 12).

Therefore, the Division of Field Enforcement Director, Office of Inspections and Investigations, under section 306(b)(3)(C) of the FD&C Act, under authority delegated to the Division of Field Enforcement Director, finds that Mr. Harpreet Singh has been convicted of multiple felonies under Federal law for conduct relating to the importation into the United States of any drug or controlled substance. FDA finds that the offenses should be accorded a debarment period of 10 years as provided by section 306(c)(2)(A)(iii) of the FD&C Act.

As a result of the foregoing finding, Mr. Singh is debarred for a period of 10 years from importing or offering for import any drug into the United States, effective (see DATES ). Pursuant to section 301(cc) of the FD&C Act (21 U.S.C. 331(cc)), the importing or offering for import into the United States of any drug by, with the assistance of, or at the direction of Mr. Singh is a prohibited act.

Section 306(a)(2)(B) of the FD&C Act (21 U.S.C. 335a(a)(2)(B)) requires debarment of an individual from providing services in any capacity to a person that has an approved or pending drug product application including, but not limited to, a BLA if FDA finds that the individual has been convicted of a felony under Federal law for conduct relating to the regulation of any drug product under the FD&C Act. On September 30, 2024, Mr. Kosolcharoen was convicted as defined in section 306(l)(1) of the FD&C Act in the United States District Court for the Central District of California when the court accepted his plea of guilty and entered judgment against him for the offense of introducing an unapproved new drug into interstate commerce with intent to defraud in violation of 21 U.S.C. 331(d), 333(a)(2), and 355(a). The underlying facts supporting the conviction are as follows:

As described in the plea agreement from his case, Mr. Kosolcharoen was the chief executive officer and sole owner of Liveyon, LLC (Liveyon). Genetech, Inc. (Genetech) was a company incorporated by another individual who described it as a “research lab” in the public filing. Mr. Kosolcharoen directed that other person to operate Genetech for the purpose of manufacturing ReGen, an injectable stem cell product made from human umbilical cord blood, for exclusive distribution by Liveyon to physicians to administer to patients to purportedly treat a variety of human diseases and illnesses. Mr. Kosolcharoen knew that Genetech and Liveyon were essentially formed and operated in concert solely to manufacture and distribute ReGen.

Beginning around May 2016, and continuing through April 2019, Mr. Kosolcharoen, together with others, fraudulently introduced ReGen and other stem cell derived Liveyon products into interstate commerce. Around July 2016, Mr. Kosolcharoen retained legal counsel and was advised that ReGen could not be manufactured or distributed without FDA's premarket approval. Nonetheless, Mr. Kosolcharoen sold ReGen and other stem cell derived Liveyon products without premarket approval. In November 2016, an FDA regulatory expert advised Mr. Kosolcharoen that ReGen could only be distributed for research use or for specific therapeutic applications that FDA had approved. Mr. Kosolcharoen then directed Liveyon's purchase orders to falsely state that the stem cell products were being sold “for research purposes only for investigational use.”

Mr. Kosolcharoen began selling ReGen around November 2016. From November 2016 until October 2017, Mr. Kosolcharoen manufactured and distributed more than $5,000,000 worth of ReGen. However, Liveyon did not file its required annual registration with FDA until on or about October 9, 2017. In that registration submission Mr. Kosolcharoen caused a Liveyon employee to include numerous false statements to mislead FDA. These false statements included that Liveyon was not a labeling product, that Liveyon products were not human cells, tissues, or cellular or tissue-based products (HCT/Ps) “regulated as drugs or biological drugs,” that Liveyon was distributing HCT/Ps that met certain criteria that exempted them from FDA pre-market approval requirements, and that Liveyon was engaged in “satellite distribution only” of human umbilical cord blood products for allogenic use. In fact, Liveyon was the sole distributor of ReGen, which Genetech manufactured exclusively for Liveyon to be distributed to Liveyon's clinician-customers for treatment of their patients. Around September 12, 2018, Mr. Kosolcharoen introduced and delivered for introduction into interstate commerce, ReGen, an unapproved new drug, for non-research, clinical use for commercial profit, with a purchase order that falsely stated “Liveyon cells are sold for research purposes only.” This conduct was undertaken knowingly and with intent to defraud as to material matters.

Mr. Kosolcharoen and others misrepresented in marketing materials that ReGen was suitable for the treatment of a variety of conditions, such as lung and heart diseases, autoimmune disorders, Alzheimer's disease, Parkinson's disease and other conditions. Liveyon marketed the products throughout the United States until about April 2019, using advertising materials that contained multiple false and misleading statements about their purported safety and effectiveness. Mr. Kosolcharoen and others fraudulently induced Liveyon customers into purchasing other stem cell derived Liveyon products that were ReGen's successors, by falsely reporting and concealing material facts regarding the outcome of an FDA inspection of Liveyon and nationwide recall of ReGen, by misleading the public about the severity and cause of adverse events suffered by Liveyon patients who were administered ReGen, and by hosting seminars to promote ReGen's successor products that were functionally identical to ReGen and that also were not FDA approved.

ReGen was administered to well more than 10 patients to whom Mr. Kosolcharoen and others mass marketed via internet and social media advertisements that falsely claimed ReGen was a safe and effective, cheaper, and less invasive treatment alternative to surgery or other procedures for severe, serious, and chronic diseases and disorders that had left patients feeling they had no options.

As a result of this conviction, FDA sent Mr. Kosolcharoen, by certified mail, on November 20, 2024, a notice proposing to permanently debar him from providing services in any capacity to a person that has an approved or pending drug product application including, but not limited to, a BLA. The proposal was based on a finding, under section 306(a)(2)(B), that Mr. Kosolcharoen was convicted of a felony under Federal law for conduct relating to the regulation of a drug product under the FD&C Act. The proposal informed Mr. Kosolcharoen of the proposed debarment and offered him an opportunity to request a hearing, providing him 30 days from the date of receipt of the letter in which to file the request, and advised him that failure to request a hearing constituted a waiver of the opportunity for a hearing and of any contentions concerning this action. Mr. Kosolcharoen received the proposal and notice of opportunity for a hearing on November 26, 2024. Mr. Kosolcharoen failed to request a hearing within the timeframe prescribed by regulation and has, therefore, waived his opportunity for a hearing and waived any contentions concerning his debarment (21 CFR part 12).

Therefore, the Division of Field Enforcement Director, Office of Inspections and Investigations, under section 306(a)(2)(B) of the FD&C Act, under authority delegated to the Director, Division of Enforcement finds that Mr. John Warrington Kosolcharoen has been convicted of a felony under Federal law for conduct relating to the regulation of a drug product under the FD&C Act.

As a result of the foregoing finding, Mr. Kosolcharoen is permanently debarred from providing services in any capacity to a person with an approved or pending drug product application including, but not limited to, a BLA, effective (see DATES ) (see sections 306(a)(2)(B) and 306(c)(2)(A)(ii) of the FD&C Act, (21 U.S.C. 335a(a)(2)(B) and 335a(c)(2)(A)(ii))). Any person with an approved or pending drug product application including, but not limited to, a BLA, who knowingly employs or retains as a consultant or contractor, or otherwise uses in any capacity the services of Mr. Kosolcharoen during his debarment, will be subject to civil money penalties (section 307(a)(6) of the FD&C Act (21 U.S.C. 335b(a)(6))). If Mr. Kosolcharoen provides services in any capacity to a person with an approved or pending drug product application including, but not limited to, a BLA during his period of debarment he will be subject to civil money penalties (section 307(a)(7) of the FD&C Act (21 U.S.C. 335b(a)(7))). In addition, FDA will not accept or review any abbreviated new drug application from Mr. Kosolcharoen during his period of debarment, other than in connection with an audit under section 306 of the FD&C Act (section 306(c)(1)(B) of the FD&C Act (21 U.S.C. 335a(c)(1)(B))). Note that, for purposes of sections 306 and 307 of the FD&C Act (21 U.S.C. 335a and 335b), a “drug product” is defined as a “drug subject to regulation under section 505, 512, or 802 of this FD&C Act [(21 U.S.C. 355, 360b, 382)] or under section 351 of the Public Health Service Act [(42 U.S.C. 262)]” (section 201(dd) of the FD&C Act (21 U.S.C. 321(dd))).

Section 306(b)(1)(D) of the FD&C Act permits debarment of an individual from importing or offering for import any drug into the United States if FDA finds, as required by section 306(b)(3)(C) of the FD&C Act, that the individual has been convicted of a felony for conduct relating to the importation into the United States of any drug or controlled substance.

On June 18, 2024, Mr. Punjani was convicted, as defined in section 306(l)(1) of the FD&C Act, in the U.S. District Court for Northern District of Georgia-Atlanta Division, when the court accepted his plea of guilty and entered judgment against him for the offense of conspiracy to deliver and introduce unapproved drugs in violation of 18 U.S.C. 371 and 21 U.S.C. 331(c) and 333(a)(2) (sections 301(c) and 303(a)(2) of the FD&C Act). The underlying facts supporting the conviction are as follows:

As contained in the information, filed on January 18, 2024, in or about March 2019, and continuing until in or about September 2022, Mr. Punjani imported thousands of AUROGRA 100 mg tablets, VIGORE 100 mg tablets, and CENFORCE 100 mg tablets, which were male enhancement pills manufactured in India, but not authorized for sale in the United States by FDA. These pills contained the active pharmaceutical ingredient (API) sildenafil. Sildenafil is the same API used in the prescription drug VIAGRA. The FDA approved drugs containing the active ingredient sildenafil are only available by prescription and may cause serious side effects for those suffering from cardiovascular disease, hypertension, bleeding disorders, and other related health conditions. The drugs Mr. Punjani imported and resold had not been approved by FDA meaning that they did not have the same assurance of safety or efficacy as FDA approved drugs. Per the information, Mr. Punjani used commercial shippers to ship the tablets from India to multiple locations in Georgia where he, with the intent to defraud and mislead, organized them for resell in the state of Georgia. The labeling on the drugs Mr. Punjani resold did not contain adequate directions for use.

FDA sent Mr. Punjani, by certified mail, on September 26, 2024, a notice proposing to debar him for a 5-year period from importing or offering for import any drug into the United States. The proposal was based on a finding under section 306(b)(3)(C) of the FD&C Act that Mr. Punjani's felony conviction under Federal law for conspiracy to deliver and introduce unapproved drugs in violation of 18 U.S.C. 371 and sections 301(c) and 303(a)(2) of the FD&C Act, was for conduct relating to the importation into the United States of any drug or controlled substance into the United States because Mr. Punjani illegally imported and introduced unapproved and misbranded prescription drug products into interstate commerce in the United States. In proposing a debarment period, FDA weighed the considerations set forth in section 306(c)(3) of the FD&C Act that it considered applicable to Mr. Punjani's offense and concluded that the offense warranted the imposition of a 5-year period of debarment.

The proposal informed Mr. Punjani of the proposed debarment and offered him an opportunity to request a hearing, providing him 30 days from the date of receipt of the letter in which to file the request, and advised him that failure to request a hearing constituted a waiver of the opportunity for a hearing and of any contentions concerning this action. Mr. Punjani received the proposal and notice of opportunity for a hearing on October 11, 2024. Mr. Punjani failed to request a hearing within the timeframe prescribed by regulation and has, therefore, waived his opportunity for a hearing and waived any contentions concerning his debarment (21 CFR part 12).

Therefore, the Division of Field Enforcement Director, Office of Inspections and Investigations, under section 306(b)(3)(C) of the FD&C Act, under authority delegated to the Director, Division of Enforcement, finds that Mr. Alnashir Alibhai Punjani has been convicted of a felony under Federal law for conduct relating to the importation into the United States of any drug or controlled substance. FDA finds that the offense should be accorded a debarment period of 5 years as provided by section 306(c)(2)(A)(iii) of the FD&C Act.

As a result of the foregoing finding, Mr. Punjani is debarred for a period of 5 years from importing or offering for import any drug into the United States, effective (see DATES ). Pursuant to section 301(cc) of the FD&C Act, the importing or offering for import into the United States of any drug by, with the assistance of, or at the direction of Mr. Punjani is a prohibited act.

Section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)) allows the submission of an ANDA to market a generic version of a previously approved drug product. To obtain approval, the ANDA applicant must show, among other things, that the generic drug product: (1) has the same active ingredient(s), dosage form, route of administration, strength, conditions of use, and (with certain exceptions) labeling as the listed drug, which is a version of the drug that was previously approved and (2) is bioequivalent to the listed drug. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA).

Section 505(j)(7) of the FD&C Act requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the “Approved Drug Products With Therapeutic Equivalence Evaluations,” which is known generally as the “Orange Book.” Under FDA regulations, drugs are removed from the list if the Agency withdraws or suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162).

A person may petition the Agency to determine, or the Agency may determine on its own initiative, whether a listed drug was withdrawn from sale for reasons of safety or effectiveness. This determination may be made at any time after the drug has been withdrawn from sale, but must be made prior to approving an ANDA that refers to the listed drug (§ 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that does not refer to a listed drug.

RIOMET (metformin hydrochloride) Oral Solution, 500 mg/5 mL, is the subject of NDA 021591, held by Ranbaxy Signature LLC, and initially approved on September 11, 2003. RIOMET is a biguanide indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus.

In a letter dated November 14, 2022, Ranbaxy Signature LLC notified FDA that RIOMET (metformin hydrochloride) Oral Solution, 500 mg/5 mL had been withdrawn from sale as of November 2019. RIOMET (metformin hydrochloride) Oral Solution, 500 mg/5 mL is currently listed in the “Discontinued Drug Product List” section of the Orange Book.

Oryza Pharmaceuticals, Inc. submitted a citizen petition dated March 9, 2023 (Docket No. FDA-2023-P-0884), under 21 CFR 10.30, requesting that the Agency determine whether RIOMET (metformin hydrochloride) Oral Solution, 500 mg/5 mL, was withdrawn from sale for reasons of safety or effectiveness. Bionpharma, Inc. submitted a citizen petition dated December 22, 2023 (Docket No. FDA-2023-P-5687) under 21 CFR 10.30, also requesting that the Agency determine whether RIOMET (metformin hydrochloride) Oral Solution, 500 mg/5 mL, was withdrawn from sale for reasons of safety or effectiveness.

After considering the citizen petition and reviewing Agency records and based on the information we have at this time, FDA has determined under § 314.161 that RIOMET (metformin hydrochloride) Oral Solution, 500 mg/5 mL, has not been withdrawn from sale for reasons of safety or effectiveness. The petitioners have identified no data or other information suggesting that RIOMET (metformin hydrochloride) Oral Solution, 500 mg/5 mL, was withdrawn from sale for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of RIOMET (metformin hydrochloride) Oral Solution, 500 mg/5 mL, from sale. We have also independently evaluated relevant literature and data for possible postmarketing adverse events. We have reviewed the available evidence and determined that this drug product was not withdrawn from sale for reasons of safety or effectiveness.

Accordingly, the Agency will continue to list RIOMET (metformin hydrochloride) Oral Solution, 500 mg/5 mL, in the “Discontinued Drug Product List” section of the Orange Book. The “Discontinued Drug Product List” delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. FDA will not begin procedures to withdraw approval of approved ANDAs that refer to this drug product. Additional ANDAs for this drug product may also be approved by the Agency as long as they meet all other legal and regulatory requirements for the approval of ANDAs. If FDA determines that labeling for this drug product should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling.

FDA is announcing the issuance of a priority review voucher to the sponsor of an approved rare pediatric disease product application. Under section 529 of the FD&C Act (21 U.S.C. 360ff), FDA will award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA has determined that GOMEKLI (mirdametinib), manufactured by SpringWorks Therapeutics, Inc., meets the criteria for a priority review voucher. GOMEKLI (mirdametinib) tablet is indicated for adults and pediatric patients 2 years of age and older with neurofibromatosis type 1 who have symptomatic plexiform neurofibromas.

For further information about the Rare Pediatric Disease Priority Review Voucher Program and for a link to the full text of section 529 of the FD&C Act, go to https://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/RarePediatricDiseasePriorityVoucherProgram/default.htm. For further information about GOMEKLI (mirdametinib), go to the “Drugs@FDA” website at https://www.accessdata.fda.gov/scripts/cder/daf/.

On February 19, 2025, the President issued Executive Order (E.O.) 14217, Commencing the Reduction of the Federal Bureaucracy, the order states within 30 days of the date of the order, the Assistant to the President for National Security Affairs, the Assistant to the President for Economic Policy, and the Assistant to the President for Domestic Policy shall identify and submit to the President additional unnecessary governmental entities and Federal Advisory Committees that should be terminated on grounds that they are unnecessary.

The Secretary of Homeland Security terminates these committees under the provisions of the Federal Advisory Committee Act (FACA) of 1972 (5 U.S.C., Ch.10), as well as 6 U.S.C. 451 effective March 7, 2025.

Background.—On December 9, 2024, the Commission determined that responses to its notice of institution of the subject five-year review were such that a full review should proceed (90 FR 6010, January 17, 2025); accordingly, a full review is being scheduled pursuant to section 751(c)(5) of the Tariff Act of 1930 (19 U.S.C. 1675(c)(5)). A record of the Commissioners' votes, the Commission's statement on adequacy, and any individual Commissioner's statements are available from the Office of the Secretary and at the Commission's website.

Participation in the review and public service list.—Persons, including industrial users of the subject merchandise and, if the merchandise is sold at the retail level, representative consumer organizations, wishing to participate in this review as parties must file an entry of appearance with the Secretary to the Commission, as provided in § 201.11 of the Commission's rules, by 45 days after publication of this notice. A party that filed a notice of appearance following publication of the Commission's notice of institution of the review need not file an additional notice of appearance. The Secretary will maintain a public service list containing the names and addresses of all persons, or their representatives, who are parties to the review.

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

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

Limited disclosure of business proprietary information (BPI) under an administrative protective order (APO) and BPI service list.—Pursuant to § 207.7(a) of the Commission's rules, the Secretary will make BPI gathered in this review available to authorized applicants under the APO issued in the review, provided that the application is made by 45 days after publication of this notice. Authorized applicants must represent interested parties, as defined by 19 U.S.C. 1677(9), who are parties to the review. A party granted access to BPI following publication of the Commission's notice of institution of the review need not reapply for such access. A separate service list will be maintained by the Secretary for those parties authorized to receive BPI under the APO.

Staff report.—The prehearing staff report in the review will be placed in the nonpublic record on August 21, 2025, and a public version will be issued thereafter, pursuant to § 207.64 of the Commission's rules.

Hearing.—The Commission will hold an in-person hearing in connection with the review beginning at 9:30 a.m. on September 11, 2025. Requests to appear at the hearing should be filed in writing with the Secretary to the Commission on or before 5:15 p.m. on September 4, 2025. Any requests to appear as a witness via videoconference must be included with your request to appear. Requests to appear via videoconference must include a statement explaining why the witness cannot appear in person; the Chairman, or other person designated to conduct the review, may in their discretion for good cause shown, grant such a request. Requests to appear as remote witness due to illness or a positive COVID-19 test result may be submitted by 3:00 p.m. the business day prior to the hearing. Further information about participation in the hearing will be posted on the Commission's website at https://www.usitc.gov/calendarpad/calendar.html.

A nonparty who has testimony that may aid the Commission's deliberations may request permission to present a short statement at the hearing. All parties and nonparties desiring to appear at the hearing and make oral presentations should attend a prehearing conference, if deemed necessary, to be held at 9:30 a.m. on September 10, 2025. Parties shall file and serve written testimony and presentation slides in connection with their presentation at the hearing by no later than noon on September 10, 2025. Oral testimony and written materials to be submitted at the public hearing are governed by § 201.6(b)(2), 201.13(f), and 207.24 of the Commission's rules. Parties must submit any request to present a portion of their hearing testimony in camera no later than 7 business days prior to the date of the hearing.

Written submissions.—Each party to the review may submit a prehearing brief to the Commission. Prehearing briefs must conform with the provisions of § 207.65 of the Commission's rules; the deadline for filing is 5:15 p.m. on September 3, 2025. Parties shall also file written testimony in connection with their presentation at the hearing, and posthearing briefs, which must conform with the provisions of § 207.67 of the Commission's rules. The deadline for filing posthearing briefs is 5:15 p.m. on September 19, 2025. In addition, any person who has not entered an appearance as a party to the review may submit a written statement of information pertinent to the subject of the review on or before 5:15 p.m. on September 19, 2025. On October 10, 2025, the Commission will make available to parties all information on which they have not had an opportunity to comment. Parties may submit final comments on this information on or before 5:15 p.m. on October 15, 2025, but such final comments must not contain new factual information and must otherwise comply with § 207.68 of the Commission's rules. All written submissions must conform with the provisions of § 201.8 of the Commission's rules; any submissions that contain BPI must also conform with the requirements of §§ 201.6, 207.3, and 207.7 of the Commission's rules. The Commission's Handbook on Filing Procedures, available on the Commission's website at https://www.usitc.gov/documents/handbook_on_filing_procedures.pdf, elaborates upon the Commission's procedures with respect to filings.

Additional written submissions to the Commission, including requests pursuant to § 201.12 of the Commission's rules, shall not be accepted unless good cause is shown for accepting such submissions, or unless the submission is pursuant to a specific request by a Commissioner or Commission staff.

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

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

Authority: This review is being conducted under authority of title VII of the Tariff Act of 1930; this notice is published pursuant to § 207.62 of the Commission's rules.

In accordance with 21 CFR 1301.34(a), this is notice that on January 17, 2025, Meridian Medical Technologies, LLC, 2555 Hermelin Drive, Saint Louis, Missouri 63144, applied to be registered as an importer of the following basic class(es) of controlled substance(s):

The company plans to import the listed controlled substance for analytical purposes only. No other activity for this drug code is authorized for this registration.

Approval of permit applications will occur only when the registrant's business activity is consistent with what is authorized under 21 U.S.C. 952(a)(2). Authorization will not extend to the import of Food and Drug Administration-approved or non-approved finished dosage forms for commercial sale.

In accordance with 21 CFR 1301.33(a), this is notice that on February 4, 2025, Patheon Pharmaceuticals Inc., 2110 East Galbraith Road, Cincinnati, Ohio 45237-1625 applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s):

The company plans to manufacture the above listed controlled substance as Active Pharmaceutical Ingredient that will be further synthesized into Food and Drug Administration-approved dosage forms. No other activity for this drug code is authorized for this registration.

In accordance with 21 CFR 1301.34(a), this is notice that on January 29, 2025, Fisher Clinical Services, Inc., 700A-C Nestle Way, Breinigsville, Pennsylvania 18031-1522, applied to be registered as an importer of the following basic class(es) of controlled substance(s):

The company plans to import the listed controlled substances for use in clinical trials only. No other activities for these drug codes are authorized for this registration.

Approval of permit applications will occur only when the registrant's business activity is consistent with what is authorized under 21 U.S.C. 952(a)(2). Authorization will not extend to the import of Food and Drug Administration-approved or non-approved finished dosage forms for commercial sale.

In accordance with 21 CFR 1301.33(a), this is notice that on December 23, 2024, Sigma Aldrich Research Biochemicals Inc., 400-600 Summit Drive, Burlington, Massachusetts 01803, applied to be registered as a bulk manufacturer of the following basic class(es) of controlled substance(s):

The company plans to manufacture the listed controlled substances as reference standards. No other activities for these drug codes are authorized for this registration.