Farm Service Agency
Federal Crop Insurance Corporation
Food and Nutrition Service
Rural Business-Cooperative Service
International Trade Administration
National Oceanic and Atmospheric Administration
National Telecommunications and Information Administration
Federal Energy Regulatory Commission
Community Living Administration
Food and Drug Administration
National Institutes of Health
Coast Guard
Federal Emergency Management Agency
Transportation Security Administration
U.S. Citizenship and Immigration Services
Geological Survey
Land Management Bureau
National Park Service
Mine Safety and Health Administration
Federal Aviation Administration
National Highway Traffic Safety Administration
Community Development Financial Institutions Fund
Comptroller of the Currency
Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, and notice of recently enacted public laws.
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U.S. Citizenship and Immigration Services (USCIS), Department of Homeland Security (DHS).
Final rule; correction.
USCIS is correcting a final rule that published in the
Effective August 28, 2024.
Rená Cutlip-Mason, Office of Policy and Strategy, U.S. Citizenship and Immigration Services, Department of Homeland Security, 5900 Capital Gateway Dr., Camp Springs, MD 20746; telephone 240-721-3000 (this is not a toll-free number).
On April 30, 2024, the Department of Homeland Security (DHS) published a final rule in the
This document, in the section titled “Correction of Errors and Technical Amendments,” identifies and corrects several technical and typographical errors in the final rule. The provisions in this document are effective as if they had been included in the final rule that published in the
Accordingly, the corrections are effective on August 28, 2024 at 12 a.m. Eastern Time. This document does not change how DHS will apply the final rule,
At 8 CFR 214.208(b), the final rule discusses what constitutes “minimum contact” with law enforcement for purposes of meeting the requirement that an applicant comply with any reasonable request for assistance from law enforcement. In one sentence in the preamble, the rule mistakenly refers to a minimum “conduct” requirement, rather than “contact.”
This document corrects an inadvertently omitted phrase in the regulatory text describing the “any credible evidence” provision.
At 8 CFR 214.204(c)(2), the final rule states an Application for T Nonimmigrant Status must include any credible evidence supporting any of the eligibility requirements set out in §§ 214.206 through 214.208. The eligibility requirements, however, extend through 8 CFR 214.209 (Extreme Hardship).
DHS inadvertently omitted this reference to extreme hardship as one of the eligibility requirements to be proven by any credible evidence,
DHS noted several technical and typographical errors in the portion of the final rule that creates a modified BFD process that generally applies only to applications that are filed on or after the effective date of the rule, August 28, 2024.
In the preamble to the final rule, DHS indicated that this BFD process applies to cases filed “on or after the effective date” of the final rule.
This document corrects an erroneously omitted reference in the section describing the automatic conversion for previously filed applications for employment authorization to applications for the newly created BFD EAD classification.
The final rule inadvertently omitted a reference to the Application for T Nonimmigrant Status in the section describing bona fide determinations for applicants in removal proceedings, which applies to individuals with Applications for T Nonimmigrant Status or Applications for Derivative T Nonimmigrant Status.
This document corrects an erroneously omitted change to regulatory text for consistency and clarity. The final rule contained new 8 CFR 214.211(e)(3), on page 34939, first column, which stated that the age-out protections apply to a derivative child applicant who is under age 21 at the time the principal filed the Application for T Nonimmigrant Status, but turns 21 during the pendency of the principal's Application for T Nonimmigrant Status. This change conformed the regulatory provisions with INA section 214(o)(4), 8 U.S.C. 1184(o)(4), which only applies the age-out protections if the child turns 21 after the principal's Application for T Nonimmigrant Status is filed, but while it is pending.
Section 553(b) of the Administrative Procedure Act (APA) generally requires agencies to publish a notice of proposed rulemaking in the
DHS believes there is good cause for publishing this document without prior notice and opportunity for public comment and with an effective date of less than 30 days because such procedures are unnecessary. This document corrects technical and typographic errors in the preamble and regulatory text and does not make substantive changes to the policies in the final rule. This document merely conforms erroneous portions of the final rule to the agency's clearly expressed contemporaneous intent. Therefore, DHS believes that it has good cause to waive the notice and comment and effective date requirements of section 553 of the APA.
Accordingly, the publication final rule at 89 FR 34864 (FR Doc. 2024-09022) is corrected as follows:
1. On page 34875, in the second column, lines 35-36, the language “8 CFR 274a.12(a)(16) and (25)” is corrected to read “8 CFR 274a.12(a)(16) and (c)(25).”
2. On page 34882, in the second column, line 36, remove the word “conduct” and add in its place the word “contact.”
3. On page 34886, in the first column, lines 50-52, remove the sentence “DHS has also amended new 8 CFR 214.211(e)(3) to state that the age-out protections apply to a child who may turn 21 during the pendency of the principal's application for T nonimmigrant status” and add in its place the sentence “DHS has also amended new 8 CFR 214.211(e)(2) and (3) to state that the age-out protections apply to a child (principal or derivative) who may turn 21 during the pendency of the principal's application for T nonimmigrant status.”
(c) * * *
(2) Any credible evidence that supports any of the eligibility requirements set out in §§ 214.206 through 214.209.
(a)
(f)
(e) * * *
(2)
Nuclear Regulatory Commission.
Policy statement; issuance.
The U.S. Nuclear Regulatory Commission (NRC) is issuing an Interim Enforcement Policy that allows staff to exercise enforcement discretion for certain violations of regulations involving robust structures containing category 1 or category 2 quantities of radioactive material, or to large components containing category 1 or 2 quantities of radioactive material, provided the licensee meets certain conditions.
The policy statement is effective on August 23, 2024.
Please refer to Docket ID NRC-2023-0030 when contacting the NRC about the availability of information for this action. You may obtain publicly available information related to this action by any of the following methods:
•
•
•
David Furst, Office of Enforcement; U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, telephone: 301-287-9087; email:
On June 15, 2010 (75 FR 33901), the NRC issued the proposed rule “Physical Protection of Byproduct Material,” for an initial public comment period. The agency subsequently published an extension notice on October 8, 2010 (75 FR 62330), which extended the public comment period until January 18, 2011.
Several commenters expressed concern about extending applicability for the proposed rule beyond byproduct material licensees to power reactor licensees. Specifically, the commenters stated that extending the requirements to large components or radioactive storage facilities located at power reactor plant sites appeared unwarranted. Accordingly, they recommended limiting the applicability of the rule to exclude large components and radioactive storage facilities and developing an appropriate threshold to exempt single items or items of aggregated quantities of large volume or weight, such that exemption requests would not be necessary and the security provisions of part 37 of title 10 of the
The NRC agreed, in part, with the commenters and determined that it is appropriate to include a partial exemption in the regulation instead of treating exemption requests on a case-by-case basis. The staff added paragraph (c) to § 37.11, “Specific exemptions,” to address radioactive waste materials. The provision does require the application of some security measures to waste exempted under § 37.11, but the majority of 10 CFR part 37 requirements would not apply. Security measures include the use of continuous physical
On March 19, 2013 (78 FR 16922), the NRC issued a final rule establishing 10 CFR part 37. The rule establishes physical protection requirements for licensees in possession of aggregated quantities of category 1 or category 2 radioactive material listed in Appendix A, “Category 1 and Category 2 Radioactive Materials,” to 10 CFR part 37. These requirements are similar to those previously imposed by orders from the NRC and Agreement States after September 11, 2001. The NRC licensees were required to be in compliance with the rule by March 19, 2014.
On March 13, 2014, before the compliance date for 10 CFR part 37, the NRC issued Enforcement Guidance Memorandum (EGM)-14-001, “Interim Guidance for Dispositioning 10 CFR part 37 Violations with Respect to Large Components or Robust Structures Containing Category 1 or Category 2 Quantities of Material at Power Reactor Facilities Licensed Under 10 CFR parts 50 and 52 (RIN 3150-AI12)” (ML14056A151). This EGM allows the staff to exercise enforcement discretion with respect to large components (
On June 12, 2014, the Nuclear Energy Institute (NEI) submitted a Petition for Rulemaking (PRM)-37-1, identifying three issues and requesting that the NRC amend 10 CFR part 37 to clarify and expand current exemptions in § 37.11 for when the physical protection measures for category 1 and category 2 quantities of radioactive material do not apply to a power reactor licensee. NEI stated that both licensees and the NRC have encountered significant problems with § 37.11 that can only practically be remedied with a rulemaking. Specifically, NEI requested that the NRC revise the exemptions in § 37.11(b) and (c) and add a new paragraph (d) to address the issues identified in EGM-14-001. NEI indicated that the exemption in § 37.11(c) only addresses waste material, and therefore large components and non-waste material stored in robust structures that present a similar or lower risk for theft or diversion are not exempt from the 10 CFR part 37 requirements. NEI stated that a rulemaking to codify EGM-14-001's rationale would recognize the practicalities mitigating the actual risk of theft or diversion and would avoid the long-term use of enforcement discretion and case-by-case exemption in this area.
On June 12, 2015 (80 FR 33450), the NRC issued a
In January 2022, regional management requested that the Office of Enforcement revise EGM-14-001 to incorporate a few minor editorial changes and to remove the requirement to bring these enforcement actions to an enforcement panel before allowing the staff to exercise enforcement discretion under the EGM. Additionally, the staff considered the potential risks presented by extended reliance on an EGM absent a clearly defined plan to restore compliance through the regulatory process.
EGM-14-001 has been executed approximately 20 times since its inception and has been in place longer than originally envisioned, primarily because of the lower priority of this rulemaking compared to other work and rulemaking activities. The staff is currently developing a rulemaking plan that would request Commission approval to initiate a rulemaking that would amend 10 CFR part 37 to address requirements for unescorted access, notification of legal actions, and coordination with law enforcement at temporary sites; specify time periods for advance license verifications; and require the development of implementing procedures associated with the shipment of radioactive materials. This rulemaking would also address the issues raised by NEI in PRM-37-1.
EGMs are intended to provide temporary guidance and are typically put in place for relatively short periods of time. Pending the active pursuit of the Part 37 rulemaking, it would be appropriate and advantageous to issue an Interim Enforcement Policy (IEP) to allow continued enforcement discretion until the underlying technical issue is dispositioned through rulemaking or other regulatory action. IEPs provide an avenue to establish policy, allowing them to be in place for longer periods of time than EGMs and providing for increased regulatory clarity because they are approved by the Commission as a policy matter. IEPs also offer enhanced openness because they are published in the
After a review of how 10 CFR part 37 requirements apply to large components and category 1 or category 2 quantities of radioactive material stored in robust structures, and after interactions with stakeholders in public meetings, the staff has determined that enforcement discretion, under certain conditions, is appropriate for some violations of part 37 at power reactor facilities while rulemaking or appropriate regulatory action is considered.
For this Interim Enforcement Policy (IEP), a large component is defined as an item weighing 2,000 kilograms or more but not containing either discrete sources or ion-exchange resins. In this context, large components typically include steam generators, steam dryers, turbine rotors, reactor vessels, reactor vessel heads, reactor coolant pumps, and shielding blocks. Due to their size and weight, these large components are not easily moved without cranes, rigging, and heavy equipment. In addition, these large components are not easily concealed during loading or when they are in motion, and the amount of time required to steal or divert these large components is such that it is reasonable to expect that the licensee would detect these activities.
For this IEP, a robust structure is defined as a closed concrete bunker or modular vault, for which the radioactive materials contained within can only be accessed using heavy equipment to
Under this IEP, the staff will typically exercise enforcement discretion and not issue a notice of violation pursuant to § 37.11(c)(1) and (2), “Specific exemptions,” or 10 CFR part 37 Subpart B, “Background Investigations and Access Authorization Program,” Subpart C, “Physical Protection Requirements During Use,” and Subpart D, “Physical Protection in Transit,” except for violations of 10 CFR 37.43(c), “General security program requirements—Training”; 10 CFR 37.45, “LLEA coordination”; 10 CFR 37.49(b), “Monitoring, detection, and assessment”; 10 CFR 37.49(d), “Response”; 10 CFR 37.57, “Reporting of events”; and 10 CFR 37.81, “Reporting of events,” involving robust structures containing category 1 or category 2 quantities of radioactive material, or to large components containing category 1 or 2 quantities of radioactive material.
Discretion will be typically exercised if the licensee meets these conditions: (1) has identified in writing those large components and robust structures that contain category 1 or category 2 quantities of radioactive material, for which it is not in compliance with 10 CFR part 37, (2) has an approved 10 CFR part 73 security plan or a written 10 CFR part 37 security plan that provides security measures adequate to detect, assess, and respond to actual or attempted theft or diversion, as well as a written analysis that considers the time needed to accomplish these activities given the proximity and mobility of the equipment available for those large components and robust structures identified above, and (3) has a written analysis documenting that the measures above do not decrease the effectiveness of the 10 CFR part 73 security plan.
An enforcement panel (
Licensees must comply with all other requirements, as applicable, unless explicitly replaced or amended through this interim policy.
Licensees can submit a request for a specific exemption, as described in § 37.11(a), for material that may not be included in the definitions above. If a licensee submits such a request for a component weighing 2,000 kilograms or more that does not contain either discrete sources or ion-exchange resins, or for a structure sufficiently robust that it would take significant time to access the material inside, and the request is submitted before the NRC inspects the licensee's facility, the NRC will postpone an enforcement decision until the NRC staff completes its review of the exemption request. If the NRC grants the exemption request, it will also consider enforcement discretion for any prior violation remedied by the exemption. If the NRC denies, or the licensee withdraws, the exemption request, the NRC will disposition the violation through the enforcement process.
The NRC intends to keep this interim policy in place until the underlying technical issue is dispositioned through rulemaking or other regulatory action.
Accordingly, the NRC has revised its Enforcement Policy to read as follows:
This section sets forth the IEP that the NRC will use to exercise enforcement discretion for certain noncompliances with the requirements of 10 CFR part 37, “Physical Protection of Category 1 and Category 2 Quantities of Radioactive Material,” involving large components containing category 1 or category 2 quantities of radioactive material, or category 1 or category 2 quantities of radioactive material stored in robust structures at power reactor facilities licensed under 10 CFR part 50, “Domestic Licensing of Production and Utilization Facilities,” or 10 CFR part 52, “Licenses, Certifications, and Approvals for Nuclear Power Plants.”
For this IEP, a large component is defined as an item weighing 2,000 kilograms or more that does not contain either discrete sources or ion-exchange resins. In this context, large components typically include steam generators, steam dryers, turbine rotors, reactor vessels, reactor vessel heads, reactor coolant pumps, and shielding blocks. Due to their size and weight, these large components are not easily moved without cranes, rigging, and heavy equipment. In addition, these large components are not easily concealed during loading or when they are in motion, and the amount of time required to steal or divert these large components is such that it is reasonable to expect that the licensee would detect these activities.
For this IEP, a robust structure is defined as a closed concrete bunker or modular vault for which the radioactive materials contained within the structure can only be accessed using heavy equipment to remove structural components or large access blocks weighing 2,000 kilograms or more. Access to these robust structures requires significant execution time. Typically, routine work activities, observation by licensees' authorized individuals located within or close to these robust structures, or observation by licensees' authorized individuals conducted in accordance with 10 CFR 73.55(i)(5)(ii) requirements make it likely that any actual or attempted theft and diversion would be detected, considering the time needed to accomplish these activities. This IEP's definitions of “large component” and “robust structure” are identical to those used successfully for several years under Enforcement Guidance Memorandum (EGM)-14-001, “Interim Guidance for Dispositioning 10 CFR part 37 Violations with Respect to Large Components or Robust Structures Containing Category 1 or Category 2 Quantities of Material at Power Reactor Facilities Licensed Under 10 CFR parts 50 and 52 (RIN 3150-AI12),” dated March 13, 2014 (Agencywide Document Access and Management System (ADAMS) Accession No. ML14056A151), and to date have proven sufficient to address past or future violations until the underlying technical issue is dispositioned through rulemaking or other regulatory action.
Under this IEP, the NRC will typically exercise enforcement discretion and not issue a notice of violation pursuant to 10 CFR 37.11(c)(1) and (2), “Specific
• The licensee has identified in writing those large components and robust structures that contain category 1 or category 2 quantities of radioactive material for which it is not in compliance with 10 CFR part 37.
• The licensee has an approved 10 CFR part 73 security plan or a written 10 CFR part 37 security plan that provides security measures adequate to detect, assess, and respond to actual or attempted theft or diversion, as well as a written analysis that considers the time needed to accomplish these activities given the proximity and mobility of the equipment available for those large components and robust structures identified above.
• The licensee has a written analysis documenting that the measures above do not decrease the effectiveness of the 10 CFR part 73 security plan.
An enforcement panel is not required to disposition a noncompliance using this discretion; however, each time discretion is granted, an enforcement action number will be assigned to document the use of discretion under this IEP. This discretion is not limited to the initial inspection identifying a noncompliance and can be applied to subsequent inspections, provided that all the criteria continue to be met.
Licensees must comply with all other requirements, as applicable, unless explicitly replaced or amended through this interim policy.
Licensees can submit a request for a specific exemption, as described in 10 CFR 37.11(a), for material that may not be included in the definitions above. If a licensee submits such a request for a component weighing 2,000 kilograms or more that does not contain either discrete sources or ion-exchange resins, or for a structure sufficiently robust that it would take significant time to access the material inside, and the request is submitted before the NRC inspects the licensee's facility, the NRC will postpone an enforcement decision until the NRC staff completes its review of the exemption request. If the NRC grants the exemption request, it will also consider enforcement discretion for any prior violation remedied by the exemption. If the NRC denies, or the licensee withdraws, the exemption request, the NRC will disposition the violation through the enforcement process.
This interim policy will remain in place until the underlying technical issue is dispositioned through rulemaking or other regulatory action.
This revision to the Policy does not contain any new or amended collections of information subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
The NRC may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the document requesting or requiring the collection displays a currently valid OMB control number.
This policy is a rule as defined in the Congressional Review Act (5 U.S.C. 801-808). However, the Office of Management and Budget has not found it to be a major rule as defined in the Congressional Review Act.
For the Nuclear Regulatory Commission.
Consumer Financial Protection Bureau.
Advisory opinion.
This advisory opinion affirms the current applicability of consumer protections and creditor obligations under the Truth in Lending Act (TILA) and its implementing Regulation Z to transactions in which a consumer purchases a home under a “contract for deed.” When a creditor sells a home to a buyer under a contract for deed, that transaction will generally meet TILA and Regulation Z's definition of credit. Where the transaction is secured by the buyer's dwelling, the buyer will also generally be entitled to the protections associated with residential mortgage loans under TILA.
This advisory opinion is applicable as of August 23, 2024.
George Karithanom, Regulatory Implementation & Guidance Program Analyst, Office of Regulations, at 202-435-7700 or at:
The Consumer Financial Protection Bureau (CFPB) is issuing this advisory opinion through the procedures for its Advisory Opinions Policy.
The CFPB is issuing this advisory opinion to affirm the applicability of certain consumer protections under the Truth in Lending Act (TILA) and its implementing Regulation Z to transactions in which a consumer purchases a home under a “contract for deed.” Broadly speaking, TILA protects consumers engaged in credit transactions by requiring creditors to disclose information about the costs and terms of the credit, and, where the credit is secured by the consumer's dwelling, provides additional protections. The CFPB has previously identified certain contracts for deed as consumer credit under the Consumer Financial Protection Act (CFPA),
A contract for deed is a type of home loan, alternatively called a “land contract,” “land installment contract,” “land sales contract,” “bond for deed,”
Another common feature is a forfeiture clause that can be triggered if the borrower fails to meet the terms of the contract. In these scenarios, the contract is canceled, the seller retakes possession of the property, and the buyer generally forfeits their entire investment—including their downpayment, principal payments, and any increase in home equity, including home equity that the buyer generated by making property improvements.
Congress first enacted TILA, 15 U.S.C. 1601
In 1994, Congress amended TILA by enacting the Home Ownership and Equity Protection Act (HOEPA) to require special disclosures and restrictions for high-cost mortgage loans secured by the consumer's principal dwelling.
New TILA sections added by the Dodd-Frank Act required creditors to make good-faith assessments of consumers' ability to repay loans secured by their dwellings, imposed new standards on mortgage disclosures, and prohibited certain practices, including mandatory arbitration clauses and waivers of Federal causes of action in consumer credit transactions secured by a dwelling.
1.
TILA's definition of “credit” includes the typical contract for deed. TILA and Regulation Z define credit as “the right granted [by a creditor to a debtor] to defer payment of debt or to incur debt and defer its payment.”
In a typical contract-for-deed transaction, as discussed above, a debt is created by the buyer receiving exclusive possession of the property, along with certain ownership obligations, at the outset of the contract in exchange for the obligation to repay the agreed-upon value of that property over time.
Where the property acquired under a contract for deed is purchased by a consumer primarily for personal, family, or household purposes, as it generally is when a purchaser buys a home using a contract for deed, the transaction is “consumer credit” under Regulation Z.
In 2020, the CFPB settled with an entity selling property under contracts for deed, requiring penalties for violations of the CFPA.
2.
Several provisions of TILA and Regulation Z apply specifically to credit transactions secured by the consumer's dwelling or by real property.
Regulation Z defines a “security interest” as “an interest in property that
The CFPB is additionally aware of many instances nationwide in which a seller's retention of legal title to the property has been characterized as securing payment of the contract for deed, either by State statute
3.
Contract for deed sellers have important obligations under TILA and Regulation Z depending on the nature of the contract for deed and whether they are “creditors.”
Third, a creditor is a person that regularly extends credit.
In general, when a person extends consumer credit more than 25 times, or more than 5 times for transactions secured by a dwelling, in the preceding calendar year, that person is a creditor under TILA.
If the contract for deed is considered to be secured by a dwelling by the applicable law in the relevant jurisdiction but is not a high-cost mortgage loan, the seller will qualify as a creditor if the seller has extended credit secured by a dwelling more than five times in the preceding or current calendar year and all other elements of the “creditor” definition are met.
If the contract for deed is secured by a dwelling and qualifies as a high-cost mortgage,
High-cost mortgage transactions will also trigger HOEPA requirements and protections, including required disclosures.
This advisory opinion is an interpretive rule issued under the CFPB's authority to interpret TILA and Regulation Z, including under section 1022(b)(1) of the Consumer Financial Protection Act of 2010, which authorizes guidance as may be necessary or appropriate to enable the CFPB to administer and carry out the purposes and objectives of Federal consumer financial laws.
By operation of TILA section 130(f), no provision of TILA sections 130, 108(b), 108(c), 108(e), or section 112 imposing any liability applies to any act done or omitted in good faith in conformity with this interpretive rule, notwithstanding that after such act or omission has occurred, the interpretive rule is amended, rescinded, or determined by judicial or other authority to be invalid for any reason.
Pursuant to the Congressional Review Act,
The CFPB has determined that this advisory opinion does not impose any new or revise any existing recordkeeping, reporting, or disclosure requirements on covered entities or members of the public that would be collections of information requiring approval by the Office of Management and Budget under the Paperwork Reduction Act.
U.S. Small Business Administration.
Interim final rule.
This interim final rule lengthens the required records retention for lenders that made loans under the Paycheck Protection Program (PPP) to ten years. PPP was established under the Coronavirus Aid, Relief, and Economic Security Act as a temporary emergency guaranteed loan program to provide economic relief to small businesses nationwide adversely impacted by the Coronavirus Disease 2019 (COVID-19), as amended. SBA has issued a number of final rules implementing the PPP Program. This interim final rule harmonizes the PPP lender records retention requirements with subsequent legislation extending the statute of limitations for criminal charges and civil enforcement actions for alleged PPP borrower fraud to ten years after the offense.
You may submit comments, identified by docket number SBA-2024-0006 through the Federal eRulemaking Portal:
SBA will post all comments on
A Call Center Representative at 833-572-0502 or the local SBA Field Office; the list of offices can be found at
On March 27, 2020, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) (Pub. L. 116-136) was enacted to provide emergency assistance and health care response for individuals, families, and businesses affected by the Coronavirus Disease 2019 (COVID-19) pandemic. Section 1102 of the CARES Act temporarily permitted the Small Business Administration (SBA) to guarantee 100 percent of 7(a) loans made by participating lenders under a new program titled the “Paycheck Protection Program” (PPP), pursuant to section 7(a)(36) of the Small Business Act (15 U.S.C. 636(a)(36)) (First Draw PPP Loans). Section 1102(F)(ii)(I) of the CARES Act stated that all PPP lenders were deemed to have been delegated authority by the SBA Administrator to make and approve PPP loans (15 U.S.C. 636(a)(36)(F)(ii)(I)). Section 1106 of the CARES Act provided for forgiveness of up to the full principal amount of qualifying loans guaranteed under the PPP. On April 24, 2020, the Paycheck Protection Program and Health Care Enhancement Act (Pub. L. 116-139) was enacted, which provided additional funding and authority for the PPP Program.
On June 5, the Paycheck Protection Program Flexibility Act of 2020 (PPP Flexibility Act) (Pub. L. 116-142) was enacted, which changed provisions of the PPP relating to the maturity of PPP loans, the deferral of PPP loan payments, and the forgiveness of PPP loans. On July 4, 2020, Public Law 116-147 extended SBA's authority to guarantee PPP loans to August 8, 2020.
On December 27, 2020, the Economic Aid to Hard-Hit Small Businesses, Nonprofits and Venues Act (Economic Aid Act) (Pub. L. 116-260) was enacted. The Economic Aid Act reauthorized lending under the PPP through March 31, 2021. The Economic Aid Act added a new temporary section 7(a)(37) to the Small Business Act, which authorized SBA to guarantee additional PPP loans (Second Draw PPP Loans) to certain eligible borrowers that previously received a First Draw PPP Loan under generally the same terms and conditions available under section 7(a)(36) of the Small Business Act. The Economic Aid Act also redesignated section 1106 of the CARES Act as section 7A of the Small Business Act, to appear after section 7 of the Small Business Act.
On March 11, 2021, the American Rescue Plan Act (ARPA) (Pub. L. 117-2) was enacted, and among other things, expanded eligibility for First Draw PPP Loans and Second Draw PPP Loans. On March 30, 2021, the PPP Extension Act of 2021 (Pub. L. 117-6) was enacted, extending SBA's PPP program authority through June 30, 2021.
From April 3, 2020, through August 8, 2020, when the 2020 round of PPP expired, SBA guaranteed over 5.2 million PPP loans made by over 5,000 PPP lenders under delegated authority. Of the approximately 5,000 lenders that participated in the PPP Program, approximately 4,900 were federally regulated lenders and several hundred were SBA Supervised Lenders (as defined in 13 CFR 120.10). From January 11, 2021, when the PPP reopened, through June 30, 2021, when the PPP program authority expired, SBA guaranteed over 6.6 million additional PPP loans made by PPP lenders under delegated authority. Thus, the total number of PPP loans guaranteed by SBA exceeds 11.8 million.
Because the approximately 5,000 PPP lenders processed PPP loans under the delegated authority provided by the CARES Act, the PPP lenders were responsible for obtaining loan applications and supporting documentation and preparing the loan note and other closing documentation. The PPP lenders were not required to provide SBA with copies of the loan origination and closing documentation, but instead when the PPP lenders applied to SBA for the issuance of a PPP loan number, the PPP lenders were required to certify that they would retain those documents in their files. See, SBA Form 2484 (Lender's Application—Paycheck Protection Program Loan Guaranty) and SBA Form 2484-SD (Lender's Application—Second Draw Loan Guaranty). The forms did not specify the length of time required to retain documents in their files.
SBA posted the first interim final rule implementing the PPP on SBA's website on April 2, 2020, and published the rule in the
On August 5, 2022, President Biden signed the PPP and Bank Fraud Enforcement Harmonization Act of 2022 (Harmonization Act) (Pub. L. 117-166). The Harmonization Act amends section 7(a) of the Small Business Act to provide, for both First Draw PPP Loans and Second Draw PPP Loans, that notwithstanding any other provision of law, any criminal charge or civil enforcement action alleging that a borrower engaged in fraud with respect to a PPP loan guaranteed by SBA shall be filed not later than 10 years after the offense was committed. The Harmonization Act was necessitated by the unprecedented volume of PPP loans, law enforcement estimates of the amount of fraud associated with these loans, and the tremendous strain on law enforcement resources in dealing not only with PPP Program fraud, but fraud in the other COVID-19 pandemic assistance programs administered by SBA and other Federal agencies.
SBA, with support from the Department of Justice (DOJ) and SBA's Office of Inspector General (OIG), which
As of December 31, 2023, U.S. Attorneys' Offices had criminally charged approximately 3,500 defendants in 2,388 pandemic fraud related cases, of which approximately 2,005 defendants had pleaded guilty or been convicted at trial.
To date, the DOJ Civil Frauds Division has opened more than 800 new investigations relating to potential civil fraud enforcement in connection with the PPP Program. These include investigations implicating more than 5,000 individuals and entities and billions of dollars in pandemic relief funds. To date, DOJ has obtained more than 450 civil settlements and judgments relating to the PPP Program, totaling more than $200 million. The number of civil fraud investigations relating to PPP borrowers has grown in volume every year since 2020, and DOJ believes that trend is likely to continue.
Extending the PPP lender records retention requirements will ensure that PPP loan records remain available to law enforcement while they continue to investigate and prosecute PPP fraud during the expanded ten-year statute of limitations period authorized by the Harmonization Act.
The Consolidated Forgiveness and Loan Review IFR sets forth the current SBA records retention requirements for PPP lenders as follows:
Lenders must comply with applicable SBA requirements for records retention, which for federally regulated lenders means compliance with the requirements of their federal financial institution regulator and for SBA supervised lenders (as defined in 13 CFR 120.10 and including PPP lenders with authority under SBA Form 3507) means compliance with 13 CFR 120.461. (86 FR 8283, 8295). These records retention requirements apply to all PPP loan records, including First Draw PPP Loans and Second Draw PPP Loans.
The records retention requirements in 13 CFR 120.461 for SBA Supervised Lenders provide as follows:
•
All applications for financing;
Lending, participation, and escrow agreements;
Financing instruments; and
○ All other documents and supporting material relating to such loans, including correspondence.
As noted previously, several hundred SBA Supervised Lenders participated in the PPP Program. An SBA Supervised Lender is defined in 13 CFR 120.10 as a 7(a) Lender that is either a Small Business Lending Company or a NFRL. A 7(a) Lender is defined in 13 CFR 120.10 as an institution that has executed a participation agreement with SBA under the guaranteed loan program.
The overwhelming majority of lenders that participated in the PPP Program are not SBA Supervised Lenders. Instead, they are federally regulated lenders. The approximately 4,900 federally regulated lenders that participated in the PPP Program included those PPP lenders regulated by the Federal Deposit Insurance Corporation, the Federal Reserve, the Office of the Comptroller of the Currency, the National Credit Union Administration, and the Farm Credit Administration. Many of these federally regulated lenders participated in PPP under their existing SBA Form 750 (Loan Guaranty Agreement (Deferred Participation)). Other federally regulated lenders participated in PPP by signing an SBA Form 3506 (CARES Act Section 1102 Lender Agreement).
Under the Consolidated Forgiveness and Loan Review IFR, federally regulated lenders that participated in the PPP Program are currently required to retain their PPP loan records in accordance with the records retention requirements imposed by their federal financial institution regulator. SBA has determined that there do not appear to be any consistent or specific time requirements imposed by federal financial institution regulators that are applicable to PPP records retention as a whole. Instead, federally regulated PPP lenders may implement and follow general internal records retention policies that are acceptable to their regulators. It is likely that many of these general internal records retention policies allow for periodic destruction of certain records after a loan is paid in full, which for PPP would include payment in full through forgiveness or otherwise.
This interim final rule extends the records retention requirements for all PPP lenders to ten years from the date of final disposition of each individual PPP loan.
This interim final rule is being issued without advance notice and public comment because section 1114 of the CARES Act and section 303 of the Economic Aid Act authorize SBA to issue regulations to implement the PPP Program without regard to notice requirements. Congress designed the PPP as a temporary emergency program, and the issuance of this interim final rule under the statutory rulemaking
SBA finds good cause for forgoing the advance notice-and-public-comment procedure because that procedure would be impracticable. The earliest PPP loan was made in April 2020 and SBA began forgiving PPP loans in late 2020, so it is urgent that the PPP lender records retention requirements be extended to prevent the lapse of records retention requirements for and potential destruction of PPP records by federally regulated lenders that could result in the loss of records that need to be preserved for law enforcement purposes. As noted previously, the overwhelming majority of PPP lenders are federally regulated lenders. Under the Consolidated Forgiveness and Loan Review IFR, those approximately 4,900 lenders are currently required to follow the records retention requirements of their federal financial institution regulators. SBA has determined that there do not appear to be any consistent or specific time requirements imposed by federal financial institution regulators that are applicable to PPP records retention as a whole. Instead, federally regulated PPP lenders may implement and follow general internal records retention policies that are acceptable to their regulators. It is likely that many of these general internal records retention policies allow for periodic destruction of certain records after a loan is paid in full, which for PPP would include payment in full through forgiveness or otherwise. Since SBA began making forgiveness payments to PPP lenders starting in late 2020, it is urgent that the current PPP records retention requirements be extended to prevent the destruction of PPP loan records.
Additionally, advising PPP lenders of the extended records retention requirement expeditiously will allow those lenders to adjust their systems and processes as soon as possible in order to comply with the newly extended records retention period. If SBA were to follow the advance notice-and-public-comment process, that would delay issuance of the rule by at least three months, during which time records that need to be preserved for law enforcement purposes are at risk of loss.
For related reasons, SBA has determined that there is good cause to make this rule effective immediately. 5 U.S.C. 553(d)(3). An immediate effective date will prevent potential loss of records that need to be preserved for law enforcement purposes. Given the urgent need to preserve PPP loan records for law enforcement purposes, SBA has determined that it is impractical and not in the public interest to provide a delayed effective date. An immediate effective date will allow PPP lenders to adjust their systems and processes to prevent the loss of PPP loan records that need to be preserved for law enforcement purposes. In this rule, SBA is not imposing a new requirement on PPP lenders, rather SBA is extending an existing requirement of records retention. The systems and process that will need to be adjusted are those that prevent the periodic destruction of records, and SBA believes that PPP lenders do not need a delayed effective date to make these adjustments.
Although this interim final rule is effective immediately, comments are solicited from interested members of the public on all aspects of the interim final rule. These comments must be submitted on or before September 23, 2024. SBA will consider these comments and the need for making any revisions as a result of these comments.
To harmonize the PPP lender records retention requirements with the ten-year PPP fraud statute of limitations in the Harmonization Act, SBA is extending the records retention requirements for all PPP lenders to ten years from the date of final disposition of each individual PPP loan. The extended records retention requirements apply equally to federally regulated lenders (including lenders that executed an SBA Form 3506) and SBA Supervised Lenders (including lenders that executed an SBA Form 3507).
Therefore, the following change is made to the Consolidated Forgiveness and Loan Review IFR:
The last paragraph of Part V.1.c. of the Consolidated Forgiveness and Loan Review IFR (86 FR 8283, 8295) is revised to read as follows:
1. SBA Reviews of Individual PPP Loans
* * *
c. When will SBA undertake a loan review?
* * *
All PPP lenders must preserve for at least 10 years following final disposition of each individual PPP loan:
i. All applications for financing (including applications for withdrawn, approved, declined and cancelled loans);
ii. Lending, participation, and escrow agreements;
iii. Financing instruments; and
iv. All other documents and supporting material relating to such loans, including correspondence.
SBA may provide further guidance, if needed, through SBA notices that will be posted on SBA's website at
OMB's Office of Information and Regulatory Affairs (OIRA) has determined that this interim final rule is significant for the purposes of Executive Orders 12866 and 13563. SBA, however, is proceeding under the emergency provision at Executive Order 12866 section 6(a)(3)(D) based on the need to move expeditiously to preserve the PPP lender records for law enforcement purposes.
This rule is necessary to prevent the loss of PPP loan records during the expanded statute of limitations period under the Harmonization Act. SBA anticipates that this rule will result in substantial benefits to law enforcement. As discussed above, as of December 31, 2023, DOJ has prosecuted thousands of cases of pandemic-related criminal fraud involving over a billion dollars in fraud loss. DOJ has a similar number of investigations that are open and yet to be charged. There have also been over a billion dollars in seizures and forfeitures issued in connection with stolen CARES Act funds. Further, the DOJ Civil Frauds Division has over 800 pending investigations for civil fraud enforcement actions related to the PPP Program, involving thousands of individuals and entities and billions of dollars in losses. DOJ believes that the numbers of these civil fraud investigations will continue to grow.
Extending the records retention requirements for PPP loan records will provide a substantial benefit to the government and the public by preserving records to allow law enforcement to continue to investigate and prosecute these criminal and civil fraud cases and recover taxpayer funds that were wrongfully obtained by these individuals and entities.
In this rule, SBA is not imposing new records retention requirements on the PPP lenders. Instead, SBA is extending existing records retention requirements
The Congressional Review Act, 5 U.S.C. 801
As explained above, SBA has found good cause to bypass the Administrative Procedure Act's notice-and-comment and 30-day effective date delay requirements. 5 U.S.C. 553(b)(B), (d)(3).
SBA has drafted this rule, to the extent practicable, in accordance with the standards set forth in section 3(a) and 3(b)(2) of Executive Order 12988, to minimize litigation, eliminate ambiguity, and reduce burden. The rule has no preemptive or retroactive effect.
SBA has determined that this rule will not have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various layers of government. Therefore, SBA has determined that this rule has no federalism implications warranting preparation of a federalism assessment.
SBA has determined that this rule will require revisions to existing recordkeeping or reporting requirements of the PPP Program information collection, OMB Control Number 3245-0407. The revisions will have a
The Regulatory Flexibility Act (RFA) generally requires that when an agency issues a proposed rule, or a final rule pursuant to section 553(b) of the Administrative Procedure Act or another law, the agency must prepare a regulatory flexibility analysis that meets the requirements of the RFA and publish such analysis in the
Rules that are exempt from notice and comment are also exempt from the RFA requirements, including conducting a regulatory flexibility analysis, when among other things the agency for good cause finds that notice and public procedure are impracticable, unnecessary, or contrary to the public interest. SBA Office of Advocacy guide: How to Comply with the Regulatory Flexibility Act, Ch.1. p.9. Since this rule is exempt from notice and comment, SBA is not required to conduct a regulatory flexibility analysis.
15 U.S.C. 636(a)(36); 15 U.S.C. 636(a)(37); and 15 U.S.C. 636m; Coronavirus Aid, Relief, and Economic Security Act, Pub. L. 116-136, section 1114, and Economic Aid to Hard-Hit Small Businesses, Nonprofits, and Venues Act, Pub. L. 116-260, section 303; PPP and Bank Fraud Enforcement Harmonization Act of 2022, Pub. L. 117-166.
Federal Aviation Administration (FAA), Department Of Transportation (DOT).
Direct final rule; request for comments.
The Federal Aviation Administration (FAA) is amending its regulations to allow aircraft to operate either with “No Smoking” signs continuously illuminated or with “No Smoking” signs a crewmember can turn on and off. Currently, crewmembers must be able to manually turn aircraft “No Smoking” signs on and off. However, the current regulations were drafted when the Department of Transportation (DOT) permitted smoking at times on commercial flights. These amendments bring FAA regulations into alignment with current practice for aircraft manufacturing and operations.
This direct final rule is effective October 22, 2024.
Submit comments on or before September 23, 2024. If the FAA receives an adverse comment, the FAA will advise the public by publishing a document in the
Send comments identified by docket number FAA-2024-2052 using any of the following methods:
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Catherine Burnett, Flight Standards Implementation and Integration Group, Air Transportation Division, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591; telephone (202) 267-8166; email
Currently, crewmembers must be able to manually turn aircraft “No Smoking” signs on and off. This requirement was implemented prior to the prohibition on smoking in passenger cabins during all phases of flight. As a general matter, there is no longer a need for the signs to indicate two different states of smoking permissibility because smoking is not typically permitted at any time on most transport category aircraft operated commercially in the United States. However, when smoking is permitted on
Aircraft manufacturers will benefit from relieving changes in title 14 of the Code of Federal Regulations (14 CFR) part 25. In addition, pilots and aircraft operators will benefit from relieving changes to regulations in parts 91, 121, and 125. The revisions to these five sections of the CFR will allow for “No Smoking” signs to be illuminated continuously without the requirement for a physical or software switch to be built into the aircraft at the factory or used by a crewmember during an aircraft operation. Specifically, the revision to part 25 imposes no new requirements on manufacturers; they may continue to make aircraft with manually operated “No Smoking” signs. However, as an alternative, the revision to part 25 allows aircraft on which the “No Smoking” signs remain illuminated continuously to receive type certification from the FAA without having to request relief from the current regulations. Similarly, with this direct final rule, operators will be able to operate aircraft where signs can either be manually operated by crewmembers or remain continuously illuminated.
The FAA has long recognized the incongruity between the prohibition on smoking in most commercial aircraft and the requirement for manufacturers to construct, and operators to operate, aircraft with “No Smoking” signs that can be turned on and off. For almost 30 years, the FAA has addressed this incongruity through equivalent level of safety (ELOS) findings
An agency typically uses direct final rulemaking when it anticipates that a proposed rule is unnecessary as the rule is considered noncontroversial.
Section 553(b)(3)(B) of the Administrative Procedure Act (APA) (5 U.S.C. 551
The FAA is providing notice to and seeking comment from the public prior to effectuating these changes.
For purposes of this direct final rule, an adverse comment is one that explains (1) why the rule is inappropriate, including challenges to the rule's underlying premise or approach; or (2) why the direct final rule will be ineffective or unacceptable without a change.
Under the direct final rule process, the FAA does not consider a comment to be adverse if that comment recommends an amendment to a different regulation beyond the regulations in the direct final rule at issue. The FAA also does not consider a frivolous or insubstantial comment to be adverse.
If the FAA receives no adverse comments, the FAA will publish a confirmation notice in the
The FAA's authority to issue rules on aviation safety is found in title 49 of the United States Code (U.S.C.). Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. Under section 44701, the FAA is charged with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce.
This rulemaking is promulgated under 49 U.S.C. 41706, which prohibits smoking on passenger flights and grants the FAA authority to “prescribe such regulations as are necessary” to enforce that prohibition. Regulations requiring “No Smoking” signs and prescribing specific standards for required “No Smoking” signs fall within that grant of authority. This rulemaking, which removes a previously required standard for the construction of “No Smoking” signs, also falls within that authority.
This rulemaking is also promulgated under the authority granted to the Administrator in 49 U.S.C. subtitle VII, part A, subpart iii, chapter 401, section 40113 (prescribing general authority of the Administrator of the FAA with respect to aviation safety duties and powers to prescribe regulations) and subpart III, chapter 447, sections 44701 (general authority of the Administrator to promote safe flight of civil aircraft in air commerce by prescribing regulations and setting minimum standards for other practices, methods, and procedures necessary for safety in air commerce and national security), 44702 (general authority of the Administrator to issue certificates, including airworthiness certificates), 44704 (general authority of the Administrator to prescribe regulations for the issuance of certificates), and 44705 (authority to issue air carrier operating certificates). These authorities provide the means by which the Administrator enforces the prohibition on smoking. As the Administrator has broad discretion over certification and aviation safety, the Administrator has broad discretion over how a ban on smoking is enforced.
In 1973, the Civil Aeronautics Board (CAB) required the separation of smoking and non-smoking passengers onboard flights.
In 1992, the FAA promulgated regulations requiring “No Smoking” signs to be on when an airplane is taxiing.
Today, aircraft manufactured to the airworthiness standards of § 25.791(a) must have “No Smoking” signs that a member of the flightcrew can turn on and off, and that are legible while turned on to each person seated in the cabin under all cabin lighting configurations. Additionally, pilots and crewmembers who conduct flights operated under §§ 91.517(a), 121.317(a), 125.207(a)(3), or 125.217(a) are required to be able to turn on and off the “No Smoking” signs on an aircraft with either a software or hardware action.
In 1992, in response to smoking becoming prohibited on most scheduled flight segments in the United States, the FAA coordinated with an aircraft manufacturer to develop an ELOS finding in accordance with § 21.21(b)(1) addressing lighted “No Smoking” signs. The manufacturer requested that the FAA allow it to install lighted “No Smoking” signs that remain continuously illuminated on specific aircraft models. The FAA concluded that continuously lighted “No Smoking” signs provide an ELOS to “No Smoking” placards on the requested aircraft. The FAA has since developed four other ELOS findings in accordance with § 21.21(b)(1) with manufacturers to allow the installation of “No Smoking” signs that are continuously illuminated on other models of aircraft. Even with an ELOS finding in accordance with § 21.21(b)(1), aircraft operators who elect to operate aircraft with the continuously illuminated “No
Delta Air Lines, Inc. (Delta) became the first aircraft operator to request an exemption from the then-current regulations in 1995.
Currently, the FAA requires aircraft manufacturers to show that the aircraft meets an ELOS findings in accordance with § 21.21(b)(1) before it will certify aircraft with continuously illuminated “No Smoking” signs. Aircraft operators require exemptions to operate such aircraft. This rulemaking revises the “No Smoking” sign regulations so that all manufacturers and operators will no longer need to expend resources to receive regulatory relief through ELOS findings and exemptions. Since continuously illuminated signs generally provide an ELOS to placards and operable signs, there is no benefit to continuing to require manufacturers and operators to prove this in each individual case.
The FAA is revising its regulations to provide an additional option regarding the manufacture and operation of “No Smoking” signs and placards on aircraft. Specifically, this rulemaking permits aircraft manufacturers to manufacture aircraft with lighted “No Smoking” signs that are continuously illuminated and cannot be turned off and permits crews to operate aircraft with “No Smoking” signs that remain continuously illuminated. No new requirements are imposed; for example, manufacturers may still produce aircraft with placards stating smoking is prohibited. Since air carriers may not allow smoking during most operations conducted in the United States, outdated language stating “If smoking is to be allowed . . .” has been removed.
To address the current requirement that aircraft be manufactured only with “No Smoking” signs that can be turned on and off, the FAA is revising § 25.791(a) to permit an aircraft manufacturer to manufacture an aircraft with “No Smoking” signs that can be turned on and off, with placards stating smoking is prohibited, or with lighted “No Smoking” signs that are continuously illuminated. Revised sections 91.517(a), 121.317(a), 125.207(a)(3), and 125.217(a) will allow operators to continuously illuminate “No Smoking” signs or, as before, to continue operating aircraft with “No Smoking” signs that can be controlled by a crewmember.
With these changes, the FAA is providing an alternative to existing regulatory requirements and not creating any new requirements. Even though smoking is prohibited, there are still passengers who may wish to smoke despite the prohibition, and the FAA continues to believe the sign or placard requirement provides a continuous reminder to passengers of the ban on smoking.
Section 25.791(a), as it is written currently, does not differentiate between requirements for the construction of “No Smoking” signs on aircraft where smoking is to be prohibited and on aircraft where smoking is to be allowed. However, prior to publication of the Revision of Airworthiness Standards for Normal, Utility, Acrobatic, and Commuter Category Airplanes final rule,
Similarly, the FAA is not revising regulations in part 135 related to “No Smoking” signs as these regulations do not include the prescriptive requirements found in parts 91, 121, and 125 related to crew operation of “No Smoking” signs. Finally, this rulemaking action does not revise any placarding requirements in part 25.
Federal agencies consider the impacts of regulatory actions under a variety of executive orders and other requirements. First, Executive Order 12866 and Executive Order 13563, as amended by Executive Order 14094 (“Modernizing Regulatory Review”), direct that each Federal agency shall propose or adopt a regulation only upon a reasoned determination that the benefits of the intended regulation justify the costs. Second, the Regulatory Flexibility Act of 1980 (Pub. L. 96-354) requires agencies to analyze the economic impact of regulatory changes on small entities. Third, the Trade Agreements Act (Pub. L. 96-39) prohibits agencies from setting standards that create unnecessary obstacles to the foreign commerce of the United States. Fourth, the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4) requires agencies to prepare a written assessment of the costs, benefits, and other effects of proposed or final rules that include a Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any one year. The current threshold after adjustment for inflation is $183 million using the most current (2023) Implicit Price Deflator for the Gross Domestic Product. This portion of the preamble presents the FAA's analysis of the economic impacts of this rule.
In conducting these analyses, the FAA has determined that this direct final rule: will not exceed the economic impact threshold for a “significant regulatory action” set in section 3(f)(1) of Executive Order 12866, as amended by Executive Order 14094; will not have a significant economic impact on a substantial number of small entities; will not create unnecessary obstacles to the foreign commerce of the United States; and will not impose an unfunded mandate on State, local, or tribal governments, or on the private sector.
On June 4, 2000, the FAA banned smoking for all U.S. scheduled flights. At the time of the ban, several rules required “No Smoking” signs to be constructed so that they were “operable” (14 CFR 25.171) or could be turned on and off (14 CFR 91.571, 121.317, 125.207, and 125.217) by a crewmember by means of an on-off switch.
As noted previously, the FAA recognizes the incongruity of these rules given the industry-wide ban on
Over a period of nearly 30 years, the FAA has made several ELOS findings and issued 57 exemptions.
This direct final rule provides permanent and universal regulatory relief previously granted to specific parties through ELOS findings and exemptions. Manufacturers are now allowed to produce aircraft with “No Smoking” signs that can be illuminated continuously, and operators are allowed to operate them without petitioning the FAA. For manufacturers, operators, and the FAA, this rulemaking eliminates unnecessary costs of time and paperwork associated with ELOS findings and exemptions.
The Regulatory Flexibility Act (RFA) of 1980, (5 U.S.C. 601-612), as amended by the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121) and the Small Business Jobs Act of 2010 (Pub. L. 111-240), requires Federal agencies to consider the effects of regulatory action on small business and other small entities and to minimize any significant economic impact. The term “small entities” comprises small businesses and not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000.
As described in the Regulatory Evaluation, this rule relieves aircraft manufacturers from the need to request ELOS findings from the FAA and operators from the need to petition the FAA to allow “No Smoking” signs to be continuously illuminated. Further, if an agency determines that a rulemaking will not result in a significant economic impact on a substantial number of small entities, the head of the agency may so certify under section 605(b) of the RFA. Therefore, based on the foregoing, the FAA Administrator certifies that this direct final rule will not have a significant economic impact on a substantial number of small entities.
The Trade Agreements Act of 1979 (Pub. L. 96-39), as amended by the Uruguay Round Agreements Act (Pub. L. 103-465), prohibits Federal agencies from establishing standards or engaging in related activities that create unnecessary obstacles to the foreign commerce of the United States. Pursuant to these Acts, the establishment of standards is not considered an unnecessary obstacle to the foreign commerce of the United States, so long as the standard has a legitimate domestic objective, such as the protection of safety, and does not operate in a manner that excludes imports that meet this objective. The statute also requires consideration of international standards and, where appropriate, that they be the basis for U.S. standards.
The FAA has assessed the potential effect of this direct final rule and determined that it ensures the safety of the American public and does not exclude imports that meet this objective. The rule relieves restrictions on “No Smoking” signs for both domestic and foreign manufacturers and operators and so does not create unnecessary obstacles to foreign commerce. As a result, this direct final rule is a safety rule consistent with the Trade Agreements Act.
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) governs the issuance of Federal regulations that require unfunded mandates. An unfunded mandate is a regulation that requires a State, local, or tribal governments, or the private sector to incur direct costs without the Federal government having first provided the funds to pay those costs. This rulemaking creates no new requirements and so imposes no direct costs. Therefore, the FAA has determined that the requirements of the Unfunded Mandates Reform Act do not apply.
The Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)) requires that the FAA consider the impact of paperwork and other information collection burdens imposed on the public. The FAA has determined that there will be no new requirement for information collection associated with this direct final rule.
In keeping with U.S. obligations under the Convention on International Civil Aviation, it is FAA policy to conform to International Civil Aviation Organization (ICAO) Standards and Recommended Practices to the maximum extent practicable. The FAA has reviewed the corresponding ICAO Standards and Recommended Practices and has identified no differences with these regulations.
FAA Order 1050.1F identifies FAA actions that are categorically excluded from preparation of an environmental assessment or environmental impact statement under the National Environmental Policy Act (NEPA) in the absence of extraordinary circumstances. The FAA has determined this rulemaking action qualifies for the categorical exclusion identified in paragraph 5-6.6f for regulations and involves no extraordinary circumstances.
The FAA has analyzed this direct final rule under the principles and criteria of Executive Order 13132, Federalism. The FAA has determined that this action will not have a substantial direct effect on the States, the relationship between the Federal Government and the States, or on the distribution of power and responsibilities among the various levels of government and, therefore, will not have federalism implications.
The FAA analyzed this direct final rule under Executive Order 13211, Actions Concerning Regulations that Significantly Affect Energy Supply, Distribution, or Use. The FAA has determined that it is not a “significant energy action” under the executive order and is not likely to have a significant adverse effect on the supply, distribution, or use of energy.
Executive Order 13609, Promoting International Regulatory Cooperation, promotes international regulatory cooperation to meet shared challenges involving health, safety, labor, security, environmental, and other issues and to reduce, eliminate, or prevent unnecessary differences in regulatory requirements. The FAA has analyzed this action under the policies and agency responsibilities of Executive Order 13609 and has determined that this action will have no effect on international regulatory cooperation.
The FAA invites interested persons to participate in this rulemaking by submitting written comments, data, or views. The most helpful comments reference a specific portion of the rule, explain the reason for any recommended change, and include supporting data. To ensure the docket does not contain duplicate comments, commenters should submit only one time if comments are filed electronically, or commenters should send only one copy of written comments if comments are filed in writing.
The FAA will file in the docket all comments it receives, as well as a report summarizing each substantive public contact with FAA personnel concerning this rulemaking. Before acting on this rulemaking, the FAA will consider all comments it receives on or before the closing date for comments. The FAA will consider comments filed after the comment period has closed if it is possible to do so without incurring expense or delay. The FAA may change this rule in light of the comments it receives.
Confidential Business Information (CBI) is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to this direct final rule contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to this direct final rule, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission containing CBI as “PROPIN.” The FAA will treat such marked submissions as confidential under the FOIA, and they will not be placed in the public docket of this direct final rule. Submissions containing CBI should be sent to the person in the
A copy of this direct final rule, all comments received, any confirmation document, and all background material may be viewed online at
Copies may also be obtained by sending a request to the Federal Aviation Administration, Office of Rulemaking, ARM-1, 800 Independence Avenue SW, Washington, DC 20591, or by calling (202) 267-9677. Commenters must identify the docket or amendment number of this rulemaking.
All documents the FAA considered in developing this direct final rule, including economic analyses and technical reports, may be accessed in the electronic docket for this rulemaking.
The Small Business Regulatory Enforcement Fairness Act (SBREFA) of 1996 requires the FAA to comply with small entity requests for information or advice about compliance with statutes and regulations within its jurisdiction. A small entity with questions regarding this document may contact its local FAA official or the person listed under the
Aircraft, Aviation safety.
Aircraft, Airmen, Aviation safety, Air carriers, Air taxis, Charter flights.
Air carriers, Aircraft, Airmen, Aviation safety, Charter flights, Safety.
Aircraft, Airmen, Aviation safety.
In consideration of the foregoing, the Federal Aviation Administration amends chapter I of title 14, Code of Federal Regulations as follows:
49 U.S.C. 106(f), 106(g), 40113, 44701, 44702 and 44704; Pub. L. 115-254, 132 Stat 3281 (49 U.S.C. 44903 note).
(a) Regarding “No Smoking” signs and placards:
(1) There must be at least one placard, or lighted sign, stating if smoking is prohibited. The placard or lighted sign must be legible to each person seated in the cabin.
(2) Lighted “No Smoking” signs must either be operable by a member of the flightcrew or be illuminated continuously during airplane operations. Illuminated signs must be legible under all probable conditions of cabin illumination to each person seated in the cabin.
49 U.S.C. 106(f), 106(g), 40101, 40103, 40105, 40113, 40120, 44101, 44111, 44701, 44704, 44709, 44711, 44712, 44715, 44716, 44717, 44722, 46306, 46315, 46316, 46504, 46506-46507, 47122, 47508, 47528-47531, 47534, Pub. L. 114-190, 130 Stat. 615
(a) Except as provided in paragraph (b) of this section, no person may operate an airplane carrying passengers unless it is equipped with signs that are visible to passengers and flight attendants to notify them when smoking is prohibited and when safety belts must be fastened.
(1) The signs that notify when safety belts must be fastened must be so constructed that the crew can turn them on and off.
(2) The signs that prohibit smoking and signs that notify when safety belts must be fastened must be illuminated during airplane movement on the surface, for each takeoff, for each landing, and when otherwise considered to be necessary by the pilot in command.
49 U.S.C. 106(f), 106(g), 40103, 40113, 40119, 41706, 42301 preceding note added by Pub. L. 112-95, sec. 412, 126 Stat. 89, 44101, 44701-44702, 44705, 44709-44711, 44713, 44716-44717, 44722, 44729, 44732; 46105; Pub. L. 111-216, 124 Stat. 2348 (49 U.S.C. 44701 note); Pub. L. 112-95, 126 Stat. 62 (49 U.S.C. 44732 note); Pub. L. 115-254, 132 Stat. 3186 (49 U.S.C. 44701 note).
(a) Except as provided in paragraph (l) of this section, no person may operate an airplane unless it is equipped with passenger information signs that meet the requirements of § 25.791 of this chapter.
49 U.S.C. 106(f), 106(g), 40113, 44701-44702, 44705, 44710-44711, 44713, 44716-44717, 44722.
(a) * * *
(3) Signs that meet the following requirements:
(i) Signs that are visible to all occupants to notify them when safety belts should be fastened. These signs must be so constructed that they can be turned on and off by a crewmember. They must be turned on for each takeoff and each landing and when otherwise considered to be necessary by the pilot in command.
(ii) Signs that are visible to all occupants to notify them when smoking is prohibited. These signs must be turned on for each takeoff and each landing and when otherwise considered to be necessary by the pilot in command.
(a) Except as provided in paragraph (b) of this section, no person may operate an airplane carrying passengers unless it is equipped with signs that meet the requirements of § 25.791 of this chapter and that are visible to passengers and flight attendants to notify them when smoking is prohibited and when safety belts must be fastened.
(1) The signs that notify when safety belts must be fastened must be so constructed that the crew can turn them on and off.
(2) The signs that prohibit smoking and signs that notify when safety belts must be fastened must be illuminated during airplane movement on the surface, for each takeoff, for each landing, and when otherwise considered to be necessary by the pilot in command.
Issued under authority provided by 49 U.S.C. 106(f), 44701(a), and 41706(e) in Washington, DC.
Office of National Marine Sanctuaries (ONMS), National Ocean Service (NOS), National Oceanic and Atmospheric Administration (NOAA), Department of Commerce (DOC).
Extension of temporary special use areas.
On July 27, 2024, the National Oceanic and Atmospheric Administration (NOAA) issued an interim final rule establishing three special use areas within Federal waters of the Florida Keys National Marine Sanctuary (FKNMS) from July 27, 2024 through August 26, 2024. This notice extends the temporary special use areas an additional 60 days. The special use areas prohibit all entry except for restoration activities under a valid Office of National Marine Sanctuaries (ONMS) permit, continuous transit without interruption, and for law enforcement purposes, from August 26, 2024 to October 25, 2024. This temporary rule is necessary to prevent or minimize destruction of, loss of, or injury to sanctuary resources, specifically to facilitate restoration activities to improve or repair living habitats through protecting coral nursery stock at this site from potential impacts caused by anchor damage and/or fishing gear. This extension is necessary to protect the corals in the temporary special use areas until water temperatures cool and all of the corals are moved back to the original in-shore permitted nursery site. This temporary special use area will expire within 120 days from the date it was established.
The effective period for the interim final rule, temporary emergency rule published July 27, 2024, at 89 FR 53483, is extended. This extension of this rule is effective August 26, 2024 through October 25, 2024.
Sarah Fangman, Superintendent, Florida Keys National Marine Sanctuary, 33 East Quay Road, Key West, FL 33040, 305-360-2713 phone, or by email at
Additional background materials can be found on the FKNMS website at
Sarah Fangman, Superintendent, Florida Keys National Marine Sanctuary, 33 East Quay Road, Key West, FL 33040, 305-360-2713 phone, or by email at
On July 27, 2024, NOAA issued an interim final rule, temporary emergency rule (RIN 0648-BN10) creating three temporary special use areas for the purpose of coral restoration within Federal waters of FKNMS for 60 days with the possibility of extending an additional 60 days following public notice (89 FR 53483). Section 15 CFR 922.164(e) of the FKNMS regulations allows the ONMS Director to set aside discrete areas of the Sanctuary as special use areas in order to provide for, among other uses, the restoration of degraded or otherwise injured sanctuary resources (15 CFR 922.164(e)(1)(i)). A special use area shall be no larger than the size the ONMS Director deems reasonably necessary to accomplish the applicable objective. No person may enter a special use area except to conduct restoration activities under a valid ONMS permit, continuous transit without interruption, or law enforcement purposes. Activities that are currently allowed in the area, including fishing, are prohibited.
These temporary special use areas were established to limit the potential for physical impact to coral nurseries that were temporarily relocated to deeper waters to protect the nursery corals from heat stress caused by the current on-going marine heat wave. Creation of these temporary special use areas limits the potential for physical impact to this sensitive coral nursery stock from anchoring, unintentional fouling of fishing gear, and bottom tending fishing gear including traps. The ONMS Director determined that the size of 0.07 square miles for each site is no larger than the size reasonably necessary to protect the coral nursery stock from physical damage. The original rule established these special use areas for 60 days, until August 26, 2024, with the possibility of one 60-day extension. NOAA has determined a 60-day extension is necessary to protect the corals in the temporary special use areas until water temperatures cool and all of the corals are moved back to the original in-shore permitted nursery sites.
NOAA will continue to provide notice of the location of these areas through sanctuary radio announcements, press releases, and with assistance from the U.S. Coast Guard and FKNMS staff. NOAA has requested the U.S. Coast Guard give an additional notification to vessels, via notice to mariners, to remain in continuous transit through this temporary area through October 25, 2024.
The establishment of the three temporary special use areas was taken in accordance with 15 CFR 922.165 of the FKNMS regulations (62 FR 32154, June 12, 1997). Section 922.165 provides that, where necessary to prevent or minimize the destruction of, loss of, or injury to a Sanctuary resource, any and all activities are subject to immediate temporary regulation, including prohibition, for up to 60 days, with one 60-day extension. This notification is for one 60-day extension to allow water temperatures to cool and complete the relocation of the corals from these off-shore temporary special use areas back to the original in-shore permitted nursery site.
The interim final rule was necessitated by anticipation of a marine heat wave this summer that would impact and likely kill coral reefs in the Florida Keys at an unprecedented rate and scale. These conditions are unsustainable for coral reef ecosystems, and those at most risk are the coral nursery stock because these are located in shallow, nearshore protected environments that heat up much more than offshore locations. There are currently 14 active coral nursery sites throughout the Florida Keys. These nursery sites are strategically located in close proximity to the sites where the nursery coral will be outplanted to promote coral restoration. Active coral restoration in the Florida Keys is necessary to facilitate coral restoration, as in the last 40 years, healthy coral cover in the Florida Keys reefs has declined by more than 90 percent.
NOAA and restoration partners identified these three deepwater locations because they maintain temperatures below the bleaching threshold, are not exposed to deleterious levels of ultraviolet (UV) radiation, and experience substantial water movement, all conditions more conducive to coral survival. A portion of the most valuable corals, including representative colonies of each species of boulder and branching corals, samples of elkhorn coral, staghorn coral, star corals (
This extension of NOAA's emergency action maintains the offshore temporary special use areas to continue to limit the potential for physical impact to this sensitive coral nursery stock until temperatures cool and corals may be relocated back to the original inshore permitted nursery sites. These sensitive corals are being grown to support critical sanctuary restoration efforts and could be impacted from anchoring, unintentional fouling of fishing gear, and bottom tending fishing gear including traps. The protections afforded by maintaining these special use areas need to be in place to avoid further damage to these sensitive nursery corals that have already experienced impact from heat stress. As such, a 60-day extension of these special use areas is necessary to prevent or minimize the destruction of, loss of, or injury to Sanctuary resources.
The 60-day extension of this interim final rule continues the applicability of three special use areas, approximately 0.07 square miles in size for each site, into which all entry will be prohibited except for conducting restoration activities under a valid ONMS permit, continuous transit without interruption, and law enforcement purposes. These special use areas were created for 60 days from July 27, 2024 until August 26, 2024. This action extends the temporary special use areas for an additional 60 days, until October 25, 2024.
The coordinates for this temporary special use area are included in Appendix VI to Subpart P of Part 922 and in the July 27, 2024
Effective from July 27, 2024 through October 25, 2024, all entry except for conducting restoration activities under a valid ONMS permit, continuous transit without interruption, and law enforcement purposes is prohibited within these temporary special use areas. The boundaries for the special use areas begin at Point 1 in each of the coordinates in Appendix VI to Subpart P of Part 922 and continue to each subsequent point in numerical order ending at Point 5. (Coordinates are unprojected (Geographic) and based on the North American Datum of 1983).
The first of these special use areas was created in 2023 with a final temporary rule (88 FR 60887, September
The second area is located within Federal open waters of the Atlantic Ocean, approximately four miles offshore from the City of Key Colony Beach/Marathon.
The third area is located within Federal open waters of the Atlantic Ocean, approximately 6.5 miles offshore from Summerland Key. Looe Key Special Use Area includes within its boundary one mooring buoy that is used by private individuals or diving and fishing charter operators, which is unavailable for these uses while the temporary special use area restrictions are in place. This is one of 47 total mooring buoys in the vicinity of Looe Key, representing 2% of the total mooring buoy availability in this area (or 0.22% of all mooring buoys available throughout the sanctuary). Currently within this area anchoring is prohibited on living coral other than hardbottom in water depths less than 40 feet when visibility is such that the seabed can be seen (15 CFR 922.163(a)(5)(ii)), and in Looe Key Sanctuary Preservation Area, anchoring is prohibited if a mooring buoy is available or if conducted anywhere other than a designated anchoring area when such areas have been designated and are available (15 CFR 922.164(d)(1)(vi)).
Pursuant to 16 U.S.C. 1437(d)(1) and 15 CFR 922.8(a), any person who violates this rule is subject to a civil penalty. The maximum civil monetary penalty authorized under the National Marine Sanctuaries Act (NMSA) has been adjusted for inflation over time and is currently $216,972 per violation per day.
This action is issued pursuant to the National Marine Sanctuaries Act, 16 U.S.C. 1431
In the interim final rule, 89 FR 53483, the Assistant Administrator of the National Ocean Service, NOAA, found good cause to waive notice and public comment pursuant to 5 U.S.C. 553(b)(3)(B) and make the rule immediately effective under 5 U.S.C. 553(d)(3), as it would be impracticable and contrary to the public interest to delay taking the emergency measure to protect corals that were relocated due to heat stress to deeper, cooler waters. NOAA invited comments for 30 days (until July 29, 2024) following publication of the interim final rule. The interim final rule authorized one 60-day extension of the special use area, which we hereby invoke.
16 U.S.C. 1431
Coast Guard, DHS.
Final rule.
The Coast Guard is establishing specific areas of the Hudson and East Rivers where safety zones will be enforced on the navigable waters beneath aerial drone shows. This action is necessary to protect personnel, vessels, and the marine environment from potential hazards created by aerial drone displays. This final rule would prohibit persons and vessels from being in the safety zone unless authorized by the Captain of the Port Sector New York or a designated representative.
This rule is effective September 23, 2024.
To view documents mentioned in this preamble as being available in the docket, go to
If you have questions about this rule, call or email MST1 Melanie Hughes, Sector New York Waterways Management Division, U.S. Coast Guard; 718-354-4352,
From November 2022 until June 2024, U.S. Coast Guard Sector New York received 13 requests for aerial drones displays within the Captain of The Port's (COTP) area of responsibility. Of those 13 requests, 10 have either taken place or were planned to take place in areas above the Hudson and East Rivers. In all cases, the sponsors of the drone displays requested safety zones beneath the drones' flight path. The request for safety zones is driven by Federal Aviation Administration (FAA) regulation that drones cannot safely fly over human beings. It is becoming increasingly more common to hold aerial drone displays over the water to reduce the number of occupants immediately below a drone show. In response, on May 24, 2024, the Coast Guard published a notice of proposed rulemaking (NPRM) titled Safety Zones; Aerial Drone Displays, Hudson and East Rivers, New York, NY (89 FR 45803). There we stated why we issued the NPRM and invited comments on our proposed regulatory action related to this rule. During the comment period that ended June 24, 2024, we received three comments.
The Coast Guard is issuing this rule under authority in 46 U.S.C. 70034. The COTP New York has determined the potential hazards associated with drone shows to be a safety concern for anyone directly underneath the flight path of aerial drone displays. The purpose of this rule is to ensure the safety of human life and vessels on the navigable waters of the Hudson and East Rivers
As noted above, we received three comments; one was submitted directly to the docket and the other two were emailed to the Coast Guard point of contact referenced in the
One commenter asked whether a barge would be allowed to remain in place while a safety zone is being enforced. The commenter stated that removing a barge would entail additional costs if it were required to move. The rule allows entry and occupancy in the designated safety zone by contacting the COTP or the COTP's Designated Representative via VHF-FM Marine Channel 16, or by contacting the Coast Guard Sector New York command center at 718-354-4356. Such requests as the commenter presents will be considered on a case-by-case basis with regards to the safety of the event and users of the waterway. Additionally, Zones 1 and 2 occur within areas monitored by the Coast Guard's Vessel Traffic Center, who will ensure adequate notice and predictability in the waters through coordination of vessel movements and dissemination of information.
One commenter inquired about a scenario where the City of New York would need to pass through a closed safety zone in order to inspect and/or repair a location that is deemed an emergency and whether they would be given special permission to do so. This rule allows all vessels, not just those operated by the City of New York, to seek permission to enter the zone if necessary. The COTP can grant access on a case-by-case basis into the regulated area. To seek access into a safety zone, you may contact the Sector New York Command Center at 718-354-4356 or use VHF channel 13 or 16. Additionally, the Coast Guard anticipates any enforcement of a regulated area to be of a short duration (while drones are in flight, typically between 10-20 minutes at a time) and impact a small, designated area of the waterway. In many cases, vessels can safely transit around the safety zone. The areas designated as Zone 1 (Hudson River) and Zone 2 (East River) will not be enforced in their entirety, rather, a smaller portion of the zone will be enforced to cover all waters beneath the drone's flight path. The Coast Guard anticipates, on average, that these safety zones would only cover the waters within a 200-yard radius of the aerial drone display. However, safety zones could be established up to a radius of 500-yards from the aerial drone display.
One commenter requested to know if Pier 89 and Pier 90, near the Intrepid Museum (Pier 86), on the Hudson River were included in Zone 1 (Hudson River). Zone 1 (Hudson River) covers all waters of the Hudson River extending from lower Manhattan (Staten Island Ferry, Whitehall terminal) north to Pier 99.
This rule establishes designated zones on the Hudson and East Rivers in which a safety zone radius up to 500-yards will be established for aerial drone displays. The establishment of a safety zone within a designated zone requires the coordinates defining the center of the safety zone to be within the boundaries of one of the zones.
We developed this rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive orders, and we discuss First Amendment rights of protestors.
Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. This rule has not been designated a “significant regulatory action,” under section 3(f) of Executive Order 12866, as amended by Executive Order 14094 (Modernizing Regulatory Review). Accordingly, this rule has not been reviewed by the Office of Management and Budget (OMB).
This regulatory action determination is based on the ability of other waterway users to safely transit around the safety zones in many cases, and the size and duration of the safety zones will impact a small, designated area of the waterway for a relatively short period of time. Moreover, the Coast Guard will notify mariners of the enforcement via marine broadcasts, local notice to mariners, local news media, distribution in leaflet form, or by an on-scene oral notice as appropriate. The rule will also allow vessels to seek permission to enter the zone if necessary.
The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard received no comments from the Small Business Administration on this rulemaking. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.
While some owners or operators of vessels intending to transit the safety zone may be small entities, for the reasons stated in section V.A above, this rule will not have a significant economic impact on any vessel owner or operator.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please call or email the person listed in the
Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.
This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct
Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
We have analyzed this rule under Department of Homeland Security Directive 023-01, Rev. 1, associated implementing instructions, and Environmental Planning COMDTINST 5090.1 (series), which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves designating areas on the Hudson and East Rivers where safety zones can be established underneath drone shows. It is categorically excluded from further review under paragraph L60a of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1. A Record of Environmental Consideration supporting this determination is available in the docket. For instructions on locating the docket, see the
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to call or email the person listed in the
Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:
46 U.S.C. 70034, 70051, 70124; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security Delegation No. 00170.1, Revision No. 01.3.
(a)
(1)
(2)
(b)
(c)
(2) To seek permission to enter the designated safety zone, contact the COTP or the COTP's Designated Representative via VHF-FM Marine Channel 16, or by contacting the Coast Guard Sector New York command center at 718-354-4356. Those in the safety zone must comply with all lawful orders or directions given to them by the COTP or the COTP's designated representative.
(d)
Coast Guard, DHS.
Notification of enforcement of regulation.
The Coast Guard will enforce the Lake Michigan at Chicago Harbor and Burnham Park Harbor safety and security zone on a portion of Lake Michigan in Chicago, IL. This action is intended to protect spectators and dignitaries associated with the Democratic National Convention. During the enforcement period listed below, entry into, transiting, or anchoring within the safety and security zone is prohibited unless authorized by the Captain of the Port Lake Michigan or a designated Coast Guard or U.S. Secret Service representative.
The regulations in 33 Code of Federal Regulations (CFR) 165.904 will be enforced from 12 p.m. on August 18, 2024 through 12 p.m. on August 23, 2024.
If you have questions about this notice of enforcement, call or email LT James Fortin, Waterways Management Division, Marine Safety Unit Chicago, U.S. Coast Guard; telephone: (630) 986-2155, email:
The Coast Guard will enforce the Lake Michigan at Chicago Harbor and Burnham Park Harbor safety and security zone listed in 33 CFR 165.904 from 12 p.m. on August 18, 2024 through 12 p.m. on August 23, 2024. This safety and security zone encompasses all waters of Lake Michigan within Burnham Park Harbor shoreward of a line across the entrance of the harbor connecting coordinates 41°51′09″ N, 087°36′36″ W and 41°51′11″ N, 087°36′22″ W.
Pursuant to 33 CFR 165.904, all vessels must obtain permission from the Captain of the Port Lake Michigan, or his or her designated on-scene representative to enter, move within, or exit this safety zone during the enforcement times listed in this notice of enforcement. The designation of the Captain of the Port Lake Michigan's on-scene representative need not be in writing. Requests must be made in advance and approved by the Captain of the Port or a designated on-scene representative before transits will be authorized. Approvals will be granted on a case-by-case basis. Vessels and persons granted permission to enter the safety and security zone shall obey all lawful orders or directions of the Captain of the Port Lake Michigan or U.S. Secret Service official.
This notice of enforcement is issued under authority of 33 CFR 165.904, Lake Michigan at Chicago Harbor & Burnham Park Harbor—Safety and Security Zone and 5 U.S.C. 552(a). In addition to this notification of enforcement in the
Coast Guard, DHS.
Temporary final rule.
The Coast Guard will establish a Security Zone on the Chicago River (Main Branch) between mile marker 325.6 (point at which the Chicago River connects to the South Branch Chicago River) and 100 yards extending past the end of the Chicago River covering the area of the Federal channel within Chicago Harbor and the North Branch Chicago River between mile marker 325.6 (point at which the North Branch Chicago River connects to the Chicago River-Main Branch and the South Branch Chicago River) and mile marker 331.4 (end of navigation channel). This action is intended to protect spectators and dignitaries associated with the Democratic National Convention. During the enforcement period listed below, entry into, transiting, or anchoring within the Security Zone if prohibited unless authorized by the Captain of the Port Lake Michigan or a designated Coast Guard or U.S. Secret Service Representative.
For the purposes of enforcement, actual notice will be used from August 18, 2024, until August 23, 2024. This rule is effective without actual notice from August 23, 2024, through August 23, 2024.
To view documents mentioned in this preamble as being available in the docket, go to
If you have questions about this Temporary Final Rule, call or email LT James Fortin, Waterways Management Division, Marine Safety Unit Chicago, U.S. Coast Guard; telephone: (630) 986-2155, email:
The Coast Guard is issuing this temporary rule under authority in 5 U.S.C. 553(b)(B). This statutory provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” The Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule due to it being impracticable and contrary to the public interest. Due to the sensitive security issues related to the Democratic National Convention, providing a public notice and comment period would be contrary to the security zone's intended objective of protecting VIPs and the public because we cannot share the sensitive security information details prior to the rule being published.
Also, under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the
The Coast Guard may issue security zone regulations under authority in 46
The Democratic National Convention will take place in Chicago, IL from August 18, 2024, until August 23, 2024. The Coast Guard will enforce a Security Zone on the Chicago River (Main Branch) between mile marker 325.6 (point at which the Chicago River connects to the South Branch Chicago River) and 100 yards extending past the end of the Chicago River covering the area of the Federal channel within Chicago Harbor and the North Branch Chicago River between mile marker 325.6 (point at which the North Branch Chicago River connects to the Chicago River-Main Branch and the South Branch Chicago River) and mile marker 331.4 (end of navigation channel). The regulations in 33 Code of Federal Regulations (CFR) 165.T09-0749 will be enforced intermittently from 12 p.m. on August 18, 2024, through 12 p.m. on August 23, 2024.
All vessels must obtain permission from the Captain of the Port Lake Michigan, or his or her designated on-scene representative to enter, move within, or exit this security zone during the enforcement times listed in this temporary final rule. The designation of the Captain of the Port Lake Michigan's on-scene representative need not be in writing. Requests must be made in advance and approved by the Captain of the Port or a designated on-scene representative before transits will be authorized. Approvals will be granted on a case-by-case basis. Vessels and persons granted permission to enter the security zone shall obey all lawful orders or directions of the Captain of the Port Lake Michigan or a designated on-scene representative.
This temporary final rule is issued under the authority of 46 U.S.C. 70051, 46 U.S.C. 70124, and 5 U.S.C. 552(a). In addition to this temporary final rule in the
We developed this rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive orders, and we discuss First Amendment rights of protestors.
Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. This rule has not been designated a “significant regulatory action,” under section 3(f) of Executive Order 12866, as amended by Executive Order 14094 (Modernizing Regulatory Review). Accordingly, this rule has not been reviewed by the Office of Management and Budget (OMB).
This regulatory action determination is based on the size, location, duration, and time of year of the security zone. The security zone will impact a small, designated area and will be enforced only during the event and event-related activities. The security zone will be in a location where commercial vessel traffic is expected to be significant during enforcement; commercial and recreational vessel traffic will not be authorized to transit the security zone to the extent compatible with public safety and security. Persons and vessels will be able to operate in the surrounding area adjacent to the security zone during the enforcement period. Moreover, the Coast Guard will issue Broadcast Notice to Mariners via VHF-FM marine channel 16 identifying the continuously and intermittently security zone location, maritime restrictions, and enforcement dates.
The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.
While some owners or operators of vessels intending to transit the near or adjacent the security zone may be small entities, for the reasons stated in section V.A above, this rule will not have a significant economic impact on any vessel owner or operator.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please call or email the person listed in the
This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.
Also, this rule does not have Tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian Tribes, on the relationship between the Federal Government and Indian Tribes, or on the distribution of power and responsibilities between the Federal Government and Indian Tribes.
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or Tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
We have analyzed this rule under Department of Homeland Security Directive 023-01, Rev. 1, associated implementing instructions, and Environmental Planning COMDTINST 5090.1 (series), which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves one security zone which will be enforced for a span of multiples days during the timeframe stated above and will prohibit entry within certain waters of the Chicago River. It is categorically excluded from further review under paragraph L60(c) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1. A Record of Environmental Consideration supporting this determination is available in the docket. For instructions on locating the docket, see the
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to call or email the person listed in the
Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR 165 as follows:
46 U.S.C. 70034, 70051, 70124; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security Delegation No. 00170.1, Revision No. 01.3.
(a)
(1)
(2)
(3)
(b)
(c)
(1) No person or vessel may enter or remain in a security zone without the permissions of the Captain of the Port.
(2) Each person and vessel in a security zone shall obey any direction or order of the Captain of the Port;
(3) The Captain of the Port may take possession and control of any vessel in the security zone;
(4) The Captain of the Port may remove any person, vessel, article, or thing from a security zone;
(5) No person may board, or take or place any article or thing on board, any vessel in a security zone without the permission of the Captain of the Port; and
(5) No person may take or place any article or thing upon any waterfront facility in a security zone without the permission of the Captain of the Port.
(d)
Postal Service
Final rule.
On July 12, 2024, the Postal Service
Dale Kennedy at 202-268-6592 or Kathy Frigo at 202-268-4178.
On July 5, 2024, in PRC Docket No. MC2024-413, the Postal Service filed a request to remove International Money Transfer
As stated in the PRC's Order No. 7352 issued in Docket No. MC2024-413 on August 9, 2024, the PRC favorably reviewed the request to remove International Money Transfer Service—Outbound, which has an effective date of October 1, 2024, and the request to remove International Money Transfer Service—Inbound, which has an effective date of October 1, 2025. The order is available on the PRC's website at
The Postal Service is eliminating the competitive international extra service for International Money Transfer Service known as International Postal Money Orders. This elimination will occur in two phases as follows:
• Effective October 1, 2024, the foreign posts for the following countries will stop selling international postal money orders destined for the United States:
○ Belize.
○ Peru.
Likewise, effective October 1, 2024, the Postal Service will stop selling international postal money orders destined to the countries listed below:
○ Albania.
○ Belize.
○ Bolivia.
○ Cape Verde.
○ Dominican Republic.
○ Ecuador.
○ El Salvador.
○ Guinea.
○ Guyana.
○ Honduras.
○ Mali.
○ Peru.
○ Sierra Leone.
• Effective October 1, 2025, the foreign posts for the following countries will stop cashing international postal money orders issued by the Postal Service:
○ Albania.
○ Belize.
○ Bolivia.
○ Cape Verde.
○ Dominican Republic.
○ Ecuador.
○ El Salvador.
○ Guinea.
○ Guyana.
○ Honduras.
○ Mali.
○ Peru.
○ Sierra Leone.
Likewise, effective October 1, 2025, the Postal Service will stop cashing international postal money orders issued by the countries listed below:
○ Belize.
○ Peru.
A customer who is in possession of an international postal money order issued by the U.S. Postal Service® may redeem it at a U.S. Post Office
The Postal Service hereby adopts the following changes to
We will publish an appropriate amendment to 39 CFR part 20 to reflect these changes.
Foreign relations, International postal services.
Accordingly, the Postal Service amends
5 U.S.C. 552(a); 13 U.S.C. 301-307; 18 U.S.C. 1692-1737; 39 U.S.C. 101, 401, 403, 404, 407, 414, 416, 3001-3011, 3201-3219, 3403-3406, 3621, 3622, 3626, 3632, 3633, and 5001.
International postal money order service is a service used to transfer funds to individuals or firms in countries that have entered into agreements with the United States Postal Service for the exchange of international postal money orders.
Effective October 1, 2024, the United States Postal Service no longer offers customers the ability to purchase international postal money orders. Exhibit 371.2 lists the countries that accept international postal money orders purchased
Effective October 1, 2025, the postal operators of the countries listed in Exhibit 371.2 will stop cashing international postal money orders issued by the U.S. Postal Service that are destined for those countries. Likewise, effective October 1, 2025, the Postal Service will stop cashing international postal money orders issued by the postal operators of the two countries marked with asterisks in Exhibit 371.2 (Belize and Peru) that are destined for the United States.
Valid international postal money orders issued by the postal operators of the two countries marked with asterisks in Exhibit 371.2 (Belize and Peru) will be paid in accordance with the procedures for cashing domestic money orders (see DMM 509.3). However, no international postal money order will be paid after the expiration of the validity date on the international money order or after September 30, 2025, whichever comes first.
Use PS Form 6401,
Environmental Protection Agency (EPA).
Final rule.
This regulation establishes an exemption from the requirement of a tolerance for residues of oxirane, phenyl-, polymer with oxirane, mono(dihydrogen phosphate), decyl ether, minimum number average molecular weight 1300 Daltons (CAS Reg. No. 308336-53-0) when used as an inert ingredient in a pesticide chemical formulation. Evonik Corporation, submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of oxirane, phenyl-, polymer with oxirane, mono(dihydrogen phosphate), decyl ether on food or feed commodities when used in accordance with these exemptions.
This regulation is effective August 23, 2024. Objections and requests for hearings must be received on or before October 22, 2024 and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2024-0153, is available at
Charles Smith, Registration Division (7505T), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone number: (202) 566-1030; email address:
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).
• Pesticide manufacturing (NAICS code 32532).
You may access a frequently updated electronic version of 40 CFR part 180 through the Office of the Federal Register's e-CFR site at
Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2024-0153 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing and must be received by the Hearing Clerk on or before October 22, 2024.
EPA's Office of Administrative Law Judges (OALJ), where the Hearing Clerk is housed, urges parties to file and serve documents by electronic means only, notwithstanding any other particular requirements set forth in other procedural rules governing those proceedings. See “Revised Order Urging Electronic Service and Filing”, dated June 22, 2023, which can be found at
In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please
•
•
•
Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at
In the
Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the exemption is “safe.” Section 408(c)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and use in residential settings but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing an exemption from the requirement of a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue . . .” and specifies factors EPA is to consider in establishing an exemption.
EPA establishes exemptions from the requirement of a tolerance only in those cases where it can be shown that the risks from aggregate exposure to pesticide chemical residues under reasonably foreseeable circumstances will pose no appreciable risks to human health. In order to determine the risks from aggregate exposure to pesticide inert ingredients, the Agency considers the toxicity of the inert in conjunction with possible exposure to residues of the inert ingredient through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. If EPA is able to determine that a finite tolerance is not necessary to ensure that there is a reasonable certainty that no harm will result from aggregate exposure to the inert ingredient, an exemption from the requirement of a tolerance may be established.
Consistent with FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action and considered its validity, completeness and reliability and the relationship of this information to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. In the case of certain chemical substances that are defined as polymers, the Agency has established a set of criteria to identify categories of polymers expected to present minimal or no risk. The definition of a polymer is given in 40 CFR 723.250(b) and the exclusion criteria for identifying these low-risk polymers are described in 40 CFR 723.250(d). Oxirane, phenyl-, polymer with oxirane, mono(dihydrogen phosphate), decyl ether conforms to the definition of a polymer given in 40 CFR 723.250(b) and meets the following criteria that are used to identify low-risk polymers.
1. The polymer is not a cationic polymer nor is it reasonably anticipated to become a cationic polymer in a natural aquatic environment.
2. The polymer does contain as an integral part of its composition at least two of the atomic elements carbon, hydrogen, nitrogen, oxygen, silicon, and sulfur.
3. The polymer does not contain as an integral part of its composition, except as impurities, any element other than those listed in 40 CFR 723.250(d)(2)(ii).
4. The polymer is neither designed nor can it be reasonably anticipated to substantially degrade, decompose, or depolymerize. An available biodegradation study supports that oxirane, phenyl-, polymer with oxirane, mono (dihydrogen phosphate), decylethers, is not readily biodegradable (MRID 52270301).
5. The polymer is manufactured or imported from monomers and/or reactants that are already included on the TSCA Chemical Substance Inventory or manufactured under an applicable TSCA section 5 exemption.
6. The polymer is not a water absorbing polymer with a number average molecular weight (MW) greater than or equal to 10,000 Daltons.
7. The polymer does not contain certain perfluoroalkyl moieties consisting of a CF3- or longer chain length as listed in 40 CFR 723.250(d)(6).
Additionally, the polymer also meets as required the following exemption criteria: specified in 40 CFR 723.250(e):
The polymer's number average MW of 1300 Daltons is greater than 1,000 and less than 10,000 Daltons. The polymer contains less than 10% oligomeric material below MW 500 and less than 25% oligomeric material below MW 1,000, and the polymer does not contain any reactive functional groups.
Thus, oxirane, phenyl-, polymer with oxirane, mono (dihydrogen phosphate), decyl ether, meets the criteria for a polymer to be considered low risk under 40 CFR 723.250. Based on its conformance to the criteria in this unit, no mammalian toxicity is anticipated from dietary, inhalation, or dermal exposure to oxirane, phenyl-, polymer with oxirane, mono (dihydrogen phosphate), decyl ether.
For the purposes of assessing potential exposure under this exemption, EPA considered that oxirane, phenyl-, polymer with oxirane, mono (dihydrogen phosphate), decyl
Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.”
EPA has not found oxirane, phenyl-, polymer with oxirane, mono (dihydrogen phosphate), decyl ether, to share a common mechanism of toxicity with any other substances, and oxirane, phenyl-, polymer with oxirane, mono (dihydrogen phosphate), decyl ether, does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance exemption, therefore, EPA has assumed that oxirane, phenyl-, polymer with oxirane, mono (dihydrogen phosphate), decyl ether, does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's website at
Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. Due to the expected low toxicity of oxirane, phenyl-, polymer with oxirane, mono (dihydrogen phosphate), decyl ether, EPA has not used a safety factor analysis to assess the risk. For the same reasons no additional safety factor is needed for assessing risk to infants and children.
Based on the conformance to the criteria used to identify a low-risk polymer, EPA concludes that there is a reasonable certainty of no harm to the U.S. population, including infants and children, from aggregate exposure to residues of oxirane, phenyl-, polymer with oxirane, mono (dihydrogen phosphate), decyl ether.
An analytical method is not required for enforcement purposes since the Agency is establishing an exemption from the requirement of a tolerance without any numerical limitation.
Accordingly, EPA finds that exempting residues of oxirane, phenyl-, polymer with oxirane, mono (dihydrogen phosphate), decyl ether, from the requirement of a tolerance will be safe.
This action establishes a tolerance exemption under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501
Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance exemption in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601
This action directly regulates growers, food processors, food handlers, and food retailers, not States or Tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or Tribal governments, on the relationship between the National Government and the States or Tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999), and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000), do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501
Pursuant to the Congressional Review Act (5 U.S.C. 801
Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.
Therefore, for the reasons stated in the preamble, EPA is amending 40 CFR chapter I as follows:
21 U.S.C. 321(q), 346a and 371.
Environmental Protection Agency (EPA).
Final rule.
This regulation establishes an exemption from the requirement of a tolerance for residues of
This regulation is effective August 23, 2024. Objections and requests for hearings must be received on or before October 22, 2024 and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2023-0146, is available at
Madison H. Le, Biopesticides and Pollution Prevention Division (7511M), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone number: (202) 566-1400; email address:
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).
• Pesticide manufacturing (NAICS code 32532).
You may access a frequently updated electronic version of 40 CFR part 180 through the Office of the Federal Register's e-CFR site at
Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2023-0146, in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing and must be received by the Hearing Clerk on or before October 22, 2024.
The EPA's Office of Administrative Law Judges (OALJ), in which the Hearing Clerk is housed, urges parties to file and serve documents by electronic means only, notwithstanding any other particular requirements set forth in other procedural rules governing those proceedings.
In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2023-0146, by one of the following methods:
•
•
•
Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at
In the
Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement of a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the exemption is “safe.” Section 408(c)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings but does not include occupational exposure. Pursuant to FFDCA section 408(c)(2)(B), in establishing or maintaining in effect an exemption from the requirement of a tolerance, EPA must take into account the factors set forth in FFDCA section 408(b)(2)(C), which require EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance or tolerance exemption and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .” Additionally, FFDCA section 408(b)(2)(D) requires that EPA consider “available information concerning the cumulative effects of [a particular pesticide's] . . . residues and other substances that have a common mechanism of toxicity.”
EPA evaluated the available toxicological and exposure data on
The available data and information demonstrated that, with regard to humans,
Based upon its evaluation in the
An analytical method is not required for
Therefore, an exemption from the requirement of a tolerance is established for residues of
This action establishes a tolerance exemption under FFDCA section 408(d) in response to a petition submitted to EPA. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is
Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance exemption in this action, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (5 U.S.C. 601
This action directly regulates growers, food processors, food handlers, and food retailers, not States or Tribes. As a result, this action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, EPA has determined that this action will not have a substantial direct effect on States or Tribal governments, on the relationship between the National Government and the States or Tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian Tribes. Thus, EPA has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999), and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000), do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (2 U.S.C. 1501
This action does not involve any technical standards that would require EPA's consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (15 U.S.C. 272 note).
Pursuant to the Congressional Review Act (5 U.S.C. 801
Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.
Therefore, for the reasons stated in the preamble, EPA is amending 40 CFR part 180 as follows:
21 U.S.C. 321(q), 346a and 371.
An exemption from the requirement of a tolerance is established for residues of
Environmental Protection Agency (EPA).
Final rule.
This regulation establishes a tolerance for residues of ethaboxam in or on leaf petiole vegetable subgroup 22B. The Interregional Project Number 4 (IR-4) requested this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA).
This regulation is effective August 23, 2024. Objections and requests for hearings must be received on or before October 22, 2024, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2023-0259, is available at
Charles Smith, Director, Registration Division (7505T), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone number: (202) 566-1030; email address:
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).
• Pesticide manufacturing (NAICS code 32532).
You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Office of the Federal Register's e-CFR site at
Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file an
EPA's Office of Administrative Law Judges (OALJ), in which the Hearing Clerk is housed, urges parties to file and serve documents by electronic means only, notwithstanding any other particular requirements set forth in other procedural rules governing those proceedings. See “Revised Order Urging Electronic Service and Filing”, dated June 22, 2023, which can be found at
In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2023-0259, by one of the following methods:
•
•
•
Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at
In the
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue . . . .”
Consistent with FFDCA section 408(b)(2)(D), and the factors specified therein, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for ethaboxam including exposure resulting from the tolerance established by this action. EPA's assessment of exposures and risks associated with ethaboxam follows.
In an effort to streamline its publications in the
EPA has previously published a number of tolerance rulemakings for ethaboxam in which EPA concluded, based on the available information, that there is a reasonable certainty that no harm would result from aggregate exposure to ethaboxam and established a tolerance for residues of that chemical. EPA is incorporating previously published sections from those rulemakings as described further in this rulemaking, as they remain unchanged.
EPA's dietary exposure assessments have been updated to include the additional exposure from the new use of ethaboxam in or on leaf petiole vegetable subgroup 22B in greenhouses and the exposures assessed in rulemakings since 2017. An acute endpoint attributable to a single dose
An acute endpoint attributable to a single dose exposure was not identified; therefore, an acute dietary risk assessment is not necessary. Chronic dietary risks are below the Agency's level of concern of 100% of the cPAD; they are 39% of the cPAD for children 1 to 2 years old, the population group with the highest estimated exposure. There is no short- or intermediate-term residential exposure expected since there are no proposed or previously registered residential uses of ethaboxam. Therefore, the chronic aggregate risks consist only of the dietary risks from food and water and, as stated above, are below the Agency's level of concern.
Ethaboxam is classified as showing “suggestive evidence of carcinogenic potential” based on increased incidence of benign Leydig cell tumors in males. The Agency determined that quantification of cancer risk using a nonlinear approach would adequately account for all chronic toxicity, including carcinogenicity, that could result from exposure to ethaboxam. Therefore, the noncancer chronic reference dose is protective of cancer dietary risk and is not of concern.
Therefore, based on the risk assessments and information described above, EPA concludes there is a reasonable certainty that no harm will result to the general population, or to infants and children, from aggregate exposure to ethaboxam residues, including its metabolites and degradates. More detailed information about the Agency's analysis can be found at
For a discussion of the available analytical enforcement method, see Unit IV.A. of the August 3, 2017, rulemaking.
In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4).
Codex does not have established MRLs for ethaboxam in commodities that are members of the leaf petiole vegetable subgroup 22B.
Therefore, a tolerance is established for residues of ethaboxam, including its metabolites and degradates, in or on leaf petiole vegetable subgroup 22B at 0.15 ppm.
This action establishes tolerances under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001), or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501
Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601
This action directly regulates growers, food processors, food handlers, and food retailers, not States or Tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not
This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).
Pursuant to the Congressional Review Act (5 U.S.C. 801
Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.
Therefore, for the reasons stated in the preamble, EPA is amending 40 CFR part 180 as follows:
21 U.S.C. 321(q), 346a and 371.
(a) * * *
Federal Communications Commission.
Final rule; announcement of effective date.
In this document, the Commission announces that the Office of Management and Budget has approved revisions to the information collection requirements under OMB Control Numbers 3060-0686, 3060-0944 and 3060-1163, as associated with rules and procedures that improve the timeliness and transparency of the process by which it seeks the review of executive branch agencies for certain applications with foreign ownership. IB Docket No. 16-155; FCC 20-133.
The amendments to 47 CFR 1.767, 1.5001, 1.40001(a)(2) and (3), 1.40003, 63.12, 63.18 and 63.24, published at 85 FR 76360 on November 27, 2020, are effective on August 19, 2024.
Cathy Williams, Office of the Managing Director, Federal Communications Commission, at (202) 418-2918 or
This document announces that the Office of Management and Budget (OMB) approved the information collection requirements in 47 CFR 1.767, 1.5001, 1.40001(a)(2) and (3), 1.40003, 63.12, 63.18 and 63.24 on May 9, 2024 and May 29, 2024. These rule sections were adopted in the Process Reform for Executive Branch Review of Certain FCC Applications and Petitions Involving Foreign Ownership, FCC 20-133. The Commission publishes this document as an announcement of the effective date for these amended rules.
If you have any comments on the burden estimates listed below, or how the Commission can improve the collections and reduce any burdens caused thereby, please contact Cathy Williams, Federal Communications Commission, Room 3.317, 45 L Street NE, Washington, DC 20554, regarding OMB Control Numbers 3060-0686, 3060-0944 and 3060-1163. Please include the OMB Control Number in your correspondence. The Commission will also accept your comments via email at
To request materials in accessible formats for people with disabilities (Braille, large print, electronic files, audio format), send an email to
As required by the Paperwork Reduction Act of 1995 (44 U.S.C. 3507), the Commission is notifying the public that it received final OMB approval on May 9, 2024 and May 29, 2024 for the information collection requirements contained in 47 CFR 1.767, 1.5001, 1.40001(a)(2) and (3), 1.40003, 63.12, 63.18 and 63.24. Under 5 CFR part 1320, an agency may not conduct or sponsor a collection of information unless it displays a current, valid OMB Control Number.
No person shall be subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act that does not display a current, valid OMB Control Number. The OMB Control Numbers for the information collection requirements in 47 CFR 1.767, 1.5001, 1.40001(a)(2) and (3), 1.40003, 63.12, 63.18 and 63.24 are 3060-0686, 3060-0944 and 3060-1163.
The foregoing notice is required by the Paperwork Reduction Act of 1995, Public Law 104-13, October 1, 1995, and 44 U.S.C. 3507.
The total annual reporting burdens and costs for the respondents are as follows:
In the 2020 Executive Branch Review Order, the Commission adopted rules and procedures to facilitate a more streamlined and transparent review process for coordinating applications with the Executive Branch agencies. The Commission also established firm time frames for the Executive Branch agencies to complete their review consistent with Executive Order 13913, which established the Committee for the Assessment of Foreign Participation in the United States Telecommunications Services Sector (the Committee). Specifically, under the new rules, the Committee has 120 days for initial review, plus an additional 90 days for secondary assessment if the Committee determines that the risk to national security or law enforcement interests cannot be mitigated with standard mitigation measures. The Commission also adopted and codified five categories of information for which applicants must provide detailed and comprehensive information to the Committee.
In the 2021 Executive Branch Second Order, the Commission adopted the Standard Questions—a baseline set of national security and law enforcement questions covering the five categories of information described above. The responses to the Standard Questions will replace the information that applicants currently provide to the Committee on an individualized basis. The Standard Questions consist of six separate questionnaires (based on subject matter) and a supplement for the provision of personally identifiable information (PII). Two of these questionnaires and the PII supplement are applicable to international section 214s. International section 214 applicants with reportable foreign ownership will be required to answer the questions, and file their responses, as well as a copy of the FCC application, directly with the Committee.
In the 2020 Executive Branch Review Order, the Commission adopted rules and procedures to facilitate a more streamlined and transparent review process for coordinating applications with the Executive Branch agencies. The Commission also established firm time frames for the Executive Branch agencies to complete their review consistent with Executive Order 13913, which established the Committee for the Assessment of Foreign Participation in the United States Telecommunications Services Sector (the Committee). Specifically, under the new rules, the Committee has 120 days for initial review, plus an additional 90 days for secondary assessment if the Committee determines that the risk to national security or law enforcement interests cannot be mitigated with standard mitigation measures. The Commission also adopted and codified five categories of information for which applicants must provide detailed and comprehensive information to the Committee.
In the 2021 Executive Branch Second Order, the Commission adopted the Standard Questions—a baseline set of national security and law enforcement questions covering the five categories of information described above. The responses to the Standard Questions will replace the information that applicants currently provide to the Committee on an individualized basis. The Standard Questions consist of six separate questionnaires (based on subject matter) and a supplement for the provision of personally identifiable information (PII). Two of these questionnaires and the PII supplement are applicable to submarine cables. Submarine cable applicants with reportable foreign ownership will be required to answer the questions and file their responses as well as a copy of the FCC application, directly with the Committee.
In the 2020 Executive Branch Review Order, the Commission adopted rules and procedures to facilitate a more streamlined and transparent review process for coordinating applications with the Executive Branch agencies. The Commission also established firm time frames for the Executive Branch agencies to complete their review consistent with Executive Order 13913, which established the Committee for the Assessment of Foreign Participation in the United States Telecommunications Services Sector (the Committee). Specifically, under the new rules, the Committee has 120 days for initial review, plus an additional 90 days for secondary assessment if the Committee determines that the risk to national security or law enforcement interests cannot be mitigated with standard mitigation measures. The Commission also adopted and codified five categories of information for which applicants must provide detailed and comprehensive information to the Committee.
In the 2021 Executive Branch Second Order, the Commission adopted the Standard Questions—a baseline set of national security and law enforcement questions covering the five categories of information described above. The responses to the Standard Questions will replace the information that applicants currently provide to the Committee on an individualized basis. The Standard Questions consist of six separate questionnaires (based on subject matter) and a supplement for the provision of personally identifiable information (PII). Petitioners will be required to submit their responses to the Standard Questions and a copy of the section 310(b) petition, directly with the Committee. Broadcast petitioners will be required to answer Standard Questions specific to broadcast licensees and common carrier wireless petitioners will be required to answer Standard Questions specific to common carrier licenses as well as a general PII supplement applicable to all respondents to the Standard Questions.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Temporary rule; closure.
NMFS closes the General category fishery for Atlantic bluefin tuna (BFT) for the remainder of the June through August time period. The General category may only retain, possess, or land large medium and giant (
Effective 11:30 p.m., local time, August 22, 2024, through August 31, 2024.
Larry Redd, Jr.,
Atlantic BFT fisheries are managed under the 2006 Consolidated HMS Fishery Management Plan (FMP) and its amendments, pursuant to the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act; 16 U.S.C. 1801
Under § 635.28(a)(1), NMFS files a closure action with the Office of the Federal Register for publication when a BFT quota (or subquota) is reached or is projected to be reached. Retaining, possessing, or landing BFT under that quota category is prohibited on or after the effective date and time of a closure action for that category until the opening of the relevant subsequent quota period or until such date as specified.
As described in § 635.27(a), the current baseline U.S. BFT quota is 1,316.14 metric tons (mt) (not including the 25 mt ICCAT allocated to the United States to account for bycatch of BFT in pelagic longline fisheries in the Northeast Distant Gear Restricted Area per § 635.27(a)(3)). The General category baseline quota is 710.7 mt. The General category baseline quota is suballocated to time periods. Relevant to this action, the baseline subquota for the June through August time period is 355.4 mt.
To date, reported landings for the BFT General category June through August time period total 316.1 mt. Based on these landings data, as well as average catch rates and anticipated fishing conditions, NMFS has determined that the adjusted June through August time period subquota of 355.4 mt is projected to be reached and exceeded shortly. Therefore, retaining, possessing, or landing large medium or giant (
On May 31, 2024 (89 FR 47095), NMFS published a final rule, which among other things, implemented RFDs every Sunday, Tuesday, Friday, and Saturday from July 1 through November 30, 2024. Since the fishery will be closed for the remainder of the June through August time period, NMFS has decided to waive the previously-scheduled RFDs for the remainder of that time period. Previously-scheduled RFDs (
With the RFDs waived during a closure, consistent with § 635.23(a)(7) fishermen aboard General category permitted vessels and HMS Charter/Headboat permitted vessels may tag and release BFT of all sizes, subject to the requirements of the catch-and-release and tag-and-release programs at § 635.26. All BFT that are released must be handled in a manner that will maximize their survival, and without removing the fish from the water, consistent with requirements at § 635.21(a)(1). For additional information on safe handling, see the “Careful Catch and Release” brochure available at
NMFS will continue to monitor the BFT fisheries closely. Per § 635.5(b)(2)(i)(A), dealers are required to submit landing reports within 24 hours of a dealer receiving BFT. Late reporting by dealers compromises NMFS' ability to timely implement actions such as quota and retention limit adjustments, as well as closures, and may result in enforcement actions. Additionally, and separate from the dealer reporting requirement, General and HMS Charter/Headboat category vessel owners are required per § 635.5(a)(4) to report their own catch of all BFT retained or discarded dead within 24 hours of the landing(s) or end of each trip, by accessing
After the fishery reopens on September 1, depending on the level of fishing effort and catch rates of BFT, NMFS may determine that additional adjustments are necessary to ensure available subquotas are not exceeded or to enhance scientific data collection from, and fishing opportunities in, all geographic areas as specified under § 635.27(a)(7). If needed, subsequent adjustments will be published in the
NMFS issues this action pursuant to section 305(d) of the Magnuson-Stevens Act (16 U.S.C. 1855(d)) and regulations at 50 CFR part 635 and this action is exempt from review under Executive Order 12866.
The Assistant Administrator for NMFS (AA) finds that pursuant to 5 U.S.C. 553(b)(B), it is impracticable and contrary to the public interest to provide prior notice of, and an opportunity for public comment on this action, for the following reasons. Specifically, the regulations implementing the 2006 Consolidated HMS FMP and amendments provide for inseason retention limit adjustments and fishery closures to respond to the unpredictable nature of BFT availability on the fishing grounds, the migratory nature of this species, and the regional variations in the BFT fishery. Providing for prior notice and an opportunity to comment is impracticable and contrary to the public interest as this fishery is currently underway and, based on the most recent landings information, the available time period subquota is projected to be reached shortly. Delaying this action could result in BFT landings that exceed the June through August time period subquota, which may result in future potential quota reductions for other BFT categories, depending on the magnitude of a potential overharvest. Taking this action does not raise conservation and management concerns and would support effective management of the BFT fishery. NMFS notes that the public had an opportunity to comment on the underlying rulemakings that established the U.S. BFT quota and the inseason adjustment and closure criteria.
For all of the above reasons, the AA also finds that pursuant to 5 U.S.C. 553(d), there is good cause to waive the 30-day delay in effective date.
16 U.S.C. 971
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Temporary rule; closure.
NMFS is prohibiting retention of Pacific cod by catcher/processors using trawl gear in the Central Regulatory Area of the Gulf of Alaska (GOA). This action is necessary because the 2024 total allowable catch of Pacific cod allocated to catcher/processors using trawl gear in the Central Regulatory Area of the GOA has been reached.
Effective 1200 hours, Alaska local time (A.l.t.), August 20, 2024, through 2400 hours, A.l.t., December 31, 2024.
Krista Milani, 907-581-2062.
NMFS manages the groundfish fishery in the GOA exclusive economic zone according to the Fishery Management Plan for Groundfish of the Gulf of Alaska (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act). Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR parts 600 and 679.
The 2024 total allowable catch (TAC) of Pacific cod allocated to catcher/processors using trawl gear in the Central Regulatory Area of the GOA is 635 metric tons as established by the final 2024 and 2025 harvest specifications for groundfish of the GOA (89 FR 15484, March 4, 2024).
In accordance with § 679.20(d)(2), the Administrator, Alaska Region, NMFS
NMFS issues this action pursuant to section 305(d) of the Magnuson-Stevens Act. This action is required by 50 CFR part 679, which was issued pursuant to section 304(b), and is exempt from review under Executive Order 12866.
Pursuant to 5 U.S.C. 553(b)(B), there is good cause to waive prior notice and an opportunity for public comment on this action, as notice and comment would be impracticable and contrary to the public interest, as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay prohibiting the retention of Pacific cod by catcher/processors using trawl gear in the Central Regulatory Area of the GOA. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of August 19, 2024.
The Assistant Administrator for Fisheries, NOAA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.
16 U.S.C. 1801
Coast Guard, DHS.
Notice of proposed rulemaking.
The Coast Guard is proposing to establish a temporary safety zone for certain waters of the Cuyahoga River. This action is necessary to provide for the safety of life on these navigable waters from position 41-29.716′ N, 081-42.137′ W to position 41-29.927′ N, 081-42.356′ W during the Cleveland Dragon Boat Festival on or about September 21, 2024. This rulemaking would prohibit persons and vessels from being in the safety zone unless authorized by the Captain of the Port Eastern Great Lakes or a designated representative. We invite your comments on this proposed rulemaking.
Comments and related material must be received by the Coast Guard on or before September 9, 2024.
You may submit comments identified by docket number USCG-2024-0746 using the Federal Decision-Making Portal at
If you have questions about this rule, call or email Cody Mayrer at Marine Safety Unit Cleveland's Waterways Management Division, U.S. Coast Guard; telephone 216-937-0111, email
The Cleveland Dragon Boat Festival has occurred annually for over a decade on the Cuyahoga River. However, the past two years events were relocated to the Black River. For 2024, the festival will return to the Cuyahoga River. The Captain of the Port Eastern Great Lakes (COTP) initiated a rulemaking in 2015 (80 FR 51943) to protect spectators, participants, and vessels from the hazards associated with the rowing event.
The Cleveland Dragon Boat Association notified the Coast Guard that it will be conducting a dragon boat festival from 7 a.m. through 4 p.m. on September 21, 2024. Typically, the event occurs on or about the third Saturday of September between the hours of 7 a.m. through 4 p.m. The exact date may differ based on local environmental conditions. The safety zone will cover all navigable waters of the Cuyahoga River from position 41-29.716′ N, 081-42.137′ W to position 41-29-927′ N, 081-42.356′ W in Cleveland, Ohio. Hazards from the event include, but are not limited to, sponsor operated vessels needing to transit the area during the festival. These vessels are expected to accompany the vessels competing in the rowboat style races. The COTP has determined that potential hazards associated with the festival would be a safety concern for anyone within this portion of the Cuyahoga River.
The purpose of this rulemaking is to ensure the safety of vessels and the navigable waters within this portion of the Cuyahoga River before, during, and after the scheduled event. The Coast Guard is proposing this rulemaking under authority in 46 U.S.C. 70034 (previously 33 U.S.C. 1231).
The COTP is proposing to establish a safety zone from 6:30 a.m. to 4:30 p.m. on or about September 21, 2024. The Dragon Boat Festival is scheduled to occur on September 21, 2024, but may occur on or about that date due to local environmental conditions. The safety zone would cover all navigable waters adjacent to Settler's Landing to north of the Cleveland Memorial Shoreway in Cleveland, Ohio, from position 41-29.716′ N, 081-42.137′ W to position 41-29-927′ N, 081-42.356′ W. The duration of the zone is intended to ensure the safety of vessels and these navigable waters before, during, and after the scheduled dragon boat festival. No vessel or person would be permitted to enter the safety zone without obtaining permission from the COTP or a designated representative. The regulatory text we are proposing appears at the end of this document.
We developed this proposed rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive orders, and we discuss First Amendment rights of protestors.
Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. This NPRM has not been designated a “significant regulatory action,” under section 3(f) of Executive Order 12866, as amended by Executive Order 14094 (Modernizing Regulatory Review). Accordingly, the NPRM has not been reviewed by the Office of Management and Budget (OMB).
This regulatory action determination is based on size, location, and duration of the proposed rule. This Safety Zone would restrict navigation on and through this small, designated portion of the Cuyahoga River for ten hours on one day.
The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and
While some owners or operators of vessels intending to transit the safety zone may be small entities, for the reasons stated in section IV.A above, this proposed rule would not have a significant economic impact on any vessel owner or operator.
If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this proposed rule would have a significant economic impact on it, please submit a comment (see
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this proposed rule. If the proposed rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please call or email the person listed in the
This proposed rule would not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under Executive Order 13132 (Federalism), if it has a substantial direct effect on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this proposed rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.
Also, this proposed rule does not have tribal implications under Executive Order 13175 (Consultation and Coordination with Indian Tribal Governments) because it would not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this proposed rule has implications for federalism or Indian tribes, please call or email the person listed in the
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this proposed rule would not result in such an expenditure, we do discuss the potential effects of this proposed rule elsewhere in this preamble.
We have analyzed this proposed rule under Department of Homeland Security Directive 023-01, Rev. 1, associated implementing instructions, and Environmental Planning COMDTINST 5090.1 (series), which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have made a preliminary determination that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This proposed rule involves a safety zone that will cover all navigable waters of the Cuyahoga River from position 41-29.716′ N, 081-42.137′ W to position 41-29-927′ N, 081-42.356′ W in Cleveland, Ohio. Normally, such actions are categorically excluded from further review under paragraph L63(a) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1. A preliminary Record of Environmental Consideration supporting this determination is available in the docket. For instructions on locating the docket, see the
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to call or email the person listed in the
We view public participation as essential to effective rulemaking and will consider all comments and material received during the comment period. Your comment can help shape the outcome of this rulemaking. If you submit a comment, please include the docket number for this rulemaking, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation.
We review all comments received, but we will only post comments that address the topic of the proposed rule. We may choose not to post off-topic, inappropriate, or duplicate comments that we receive.
Marine safety, Navigation (water), Reporting and recordkeeping
For the reasons discussed in the preamble, the Coast Guard is proposing to amend 33 CFR part 165 as follows:
46 U.S.C. 70034, 70051, 70124; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5, Department of Homeland Security Delegation No. 00170.1, Revision No. 01.3.
(a)
(b)
(c)
(d)
(1) The Coast Guard may patrol the event area under the direction of a designated Coast Guard Patrol Commander. The Patrol Commander may be contacted on Channel 16 VHF-FM (156.8 MHz) by the call sign “PATCOM.”
(2) All persons and vessels not registered with the sponsor as participants or official patrol vessels are considered spectators. The “official patrol vessels” consist of any Coast Guard, state or local law enforcement and sponsor provided vessels designated or assigned by the Captain of the Port Eastern Great Lakes, to patrol the event.
(3) Spectator vessels desiring to transit the regulated area may do so only with prior approval of the Patrol Commander and when so directed by that officer and will be operated at a no wake speed in a manner which will not endanger participants in the event or any other craft.
(4) No spectator shall anchor, block, loiter, or impede the through transit of official patrol vessels in the regulated area during the effective dates and times, unless cleared for entry by or through an official patrol vessel.
(5) The Patrol Commander may forbid and control the movement of all vessels in the regulated area. When hailed or signaled by an official patrol vessel, a vessel shall come to an immediate stop and comply with the directions given. Failure to do so may result in expulsion from the area, citation for failure to comply, or both.
(6) Any spectator vessel may anchor outside the regulated areas specified in this chapter, but may not anchor in, block, or loiter in a navigable channel.
(7) The Patrol Commander may terminate the event or the operation of any vessel at any time it is deemed necessary for the protection of life or property.
(8) The Patrol Commander will terminate enforcement of the special regulations at the conclusion of the event.
Federal Communications Commission.
Proposed rule; correction.
The Federal Communications Commission (Commission) published a proposed rule document in the
August 23, 2024.
Federal Communications Commission, 45 L Street NE, Washington, DC 20554.
Joshua Mendelsohn, Disability Rights Office, Consumer and Governmental Affairs Bureau, at 202-559-7304, or
In the
Farm Service Agency, USDA.
Notice.
The Farm Service Agency (FSA) is issuing this notice to announce the actions it is taking to comply with a preliminary injunction related to payment calculations for ERP 2022.
Kathy Sayers; telephone: (202) 720-6825; email:
FSA announced ERP 2022 in a notice published in the
(1) American Indians or Alaskan Natives;
(2) Asians or Asian-Americans;
(3) Blacks or African Americans;
(4) Hispanics or Hispanic Americans;
(5) Native Hawaiians or other Pacific Islanders; and
(6) Women.
“Underserved farmer or rancher” means a beginning farmer or rancher, limited resource farmer or rancher, socially disadvantaged farmer or rancher, or veteran farmer or rancher.
The Notice of Funds Availability includes the following provisions related to the payment calculations that were applicable only to underserved farmers or ranchers:
• For Track 1, the payment calculation provides a refund of an underserved farmer or rancher's share of the premium and fee for crop insurance or Noninsured Crop Disaster Assistance Program coverage; and
• For Track 2, the payment calculation provides an increase to an underserved farmer or rancher's payment that is equal to 15 percent of the gross Track 2 payment after progressive factoring, not to exceed the calculated Track 2 payment before progressive factoring.
Upon issuance of the preliminary injunction, and in order to comply with the preliminary injunction, FSA took action to immediately halt ERP 2022 payments while FSA evaluated the scope of changes that would be required. This notice announces that FSA is resuming issuance of ERP 2022 payments; however, consistent with the preliminary injunction, payments to socially disadvantaged farmers or ranchers will be subject to a modified payment calculation that does not include the refund of premiums and fees under Track 1 or the 15 percent increase under Track 2 described above. If the preliminary injunction is lifted, with available funds, FSA will make or update payments to affected and eligible socially disadvantaged producers consistent with the terms of the Notice of Funds Availability.
Some ERP 2022 payments may continue to be delayed due to the need to modify payment software to accommodate these changes, but FSA intends to begin issuing payments again in late August to eligible producers.
Federal Crop Insurance Corporation, USDA.
Renewal and Revision of the Currently Approved Information Collection.
In accordance with the Paperwork Reduction Act of 1995, the Farm Service Agency (FSA) and Risk Management Agency (RMA) are requesting comments from all interested individuals and organizations on a revision of a currently approved paperwork package associated with the Acreage and Crop Reporting Streamlining Initiative (ACRSI).
Written comments on this notice will be accepted until close of business October 22, 2024.
We invite you to submit comments on this information collection request. In your comments, include the date, volume, and page number of this issue of the
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All comments received, including those received by mail, will be posted without change and publicly available on
Fritz Matetzschk, United States Department of Agriculture, FSA, DAFP,PDD, Washington, DC 20250-0570, (202) 690-2031; or David Zanoni, RMA, United States Department of Agriculture, P.O. Box 419205, Kansas City, MO 64133-6205, (816) 507-9302.
RMA is continuing to improve the existing Office of Management and Budget (OMB) approved information collections for RMA, 0563-0053, Multiple Peril Crop Insurance, acreage information, generally collected from the respondent during a personal visit to the FSA Service Center and again from the respondent during a personal visit with the insurance agent.
The forms are still available to accommodate respondents with no internet access and those who wish to continue to personally visit the FSA Service Center and insurance agent to report this common information.
Information reported to the common data collection and reporting capability (otherwise known as the Clearinghouse) are shared by both FSA and Approved Insurance Providers (AIPs) via RMA. With continued ACRSI process enhancements, some or all of the commodity and acreage information in the existing approved information collections are reported through this solution. Furthermore, the information collected are the same as the information currently approved. Additionally, the respondent will continue to report their common information one time through a single source thereby reducing the respondent's burden of reporting such common information and eliminating the duplicate reporting that may be currently required. The information collected will continue to be the same as the information currently approved and are used in the same manner it would be used if reported separately to each agency. The producers are continuing to use their precision-ag systems, farm management information systems, or download data files to directly report certain commodity and acreage information needed to participate in USDA programs.
The information being collected may consist of, but not be limited to: Producer name, customer/tax ID, state, county, commodity name, commodity type or variety, intended use, date planted, planted acreage, and land location (which may include legal description, FSA farm number, FSA tract number, FSA field number, geospatial as-planted field boundaries, Resource Land Unit, etc.).
FSA and RMA continues to enhance the ACRSI process. The effectiveness and lessons learned from each phase informed changes and expansions in subsequent phases. The first phase was initiated in the fall of 2011 in Dickenson, Marion, McPherson, and Saline Counties in Kansas, and only for the collection of information from producers regarding winter wheat. The second phase was implemented in the spring of 2015 in 30 counties of Illinois and Iowa covering 9 crops. The third phase was implemented in the fall of 2015 in all counties of 15 states covering 9 crops. The fourth phase was implemented in the spring of 2016 in all counties nationwide covering 13 crops and about 90 percent of reported acreage. The fifth phase was implemented in the fall of 2016 expanding nationwide coverage to 16 crops and about 93 percent of reported acreage. The sixth phase was implemented in the fall of 2017 expanding nationwide coverage to 25 crops and about 94 percent of reported acreage. Since that time, ACRSI has continuously added more crops and types that now covers over 97 percent of insurable acreage. The program will continue to add crops and types over time to stay current; however, there are no crops left to cross walk that have major acreage impacts.
RMA and FSA additionally piloted a process to allow external providers to submit required data from precision agriculture or farm management information systems. This 2018 Pilot used planting data from Nebraska producers that was disseminated to the Agencies through the ACRSI Clearinghouse process. Beginning in 2024, FSA now processes geospatial data from third parties or AIPs with the Geospatial Review Application. This allows FSA staff to process more efficiently the submitted data and reduce the time and effort spent by producers when reporting detailed precision data to FSA.
However, the existing approved information collection will be updated, modified or eliminated, as applicable, to reflect the reduction in burden on the respondents as the ACRSI process is enhanced.
We are requesting comments on all aspects of this information collection to help us to:
(1) Evaluate whether the collection of information is necessary for the proper performance of the functions of the agencies, including whether the information will have practical utility;
(2) Evaluate the accuracy of the agency's estimate of burden including the validity of the methodology and assumptions used;
(3) Enhance the quality, utility and clarity of the information to be collected;
(4) Minimize the burden of the collection of information on those who are to respond through use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms to technology.
All comments in response to this notice, including names and addresses when provided, will be a matter of
Food and Nutrition Service (FNS), USDA.
Notice of reestablished matching program.
In accordance with the Privacy Act of 1974, as amended, USDA FNS is providing notice of a reestablished computer matching program between FNS and the State agencies that administer the Supplemental Nutrition Assistance Program (SNAP). The matching program allows State agencies access to the Electronic Disqualified Recipient System (eDRS), a national database operated by FNS. The system maintains records of SNAP disqualifications imposed by State agencies on individuals who have been found to have committed an intentional program violation (IPV).
The deadline for comments on this notice is September 23, 2024.
The re-established matching program will become effective not sooner than 30 days after publication of this notice, provided no comments are received that warrant a change to this notice. The matching program will be conducted for an initial term of 18 months and may be renewed for up to one additional year if the parties make no change to the matching program and certify that the program has been conducted in compliance with the matching agreement.
Interested parties may submit written comments by one of the following methods:
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For general questions, please contact the above individual, Maribelle Balbes, Branch Chief, SAB, SNAP, FNS at
The Privacy Act of 1974, as amended, 5 U.S.C. 552a, provides certain protections for individuals applying for and receiving federal benefits. The law governs the use of computer matching by federal agencies when records in a system of records, which contains information about individuals that are retrieved by name or other personal identifier, are matched with records of other Federal, State, or local government records. The Privacy Act requires agencies involved in a matching program to:
• Obtain approval of a Computer Matching Agreement, prepared in accordance with the Privacy Act, by the Data Integrity Board of any Federal agency participating in a matching program.
• Enter into a written Computer Matching Agreement.
• Provide a report of the matching program to Congress and the Office of Management and Budget (OMB), and make it available to the public, as required by 5 U.S.C. 552a(o), (u)(3)(A), and (u)(4).
• Publish a notice of the matching program in the
• Notify the individuals whose information will be used in the matching program that the information they provide is subject to verification through matching, as required by 5 U.S.C. 552a(o)(1)(D).
• Verify match findings before suspending, terminating, reducing, or making a final denial of an individual's benefits or payments or taking other adverse action against the individual, as required by 5 U.S.C. 552a(p).
This matching program meets these requirements.
FNS and the State agencies that administer SNAP to include all 50 States, the District of Columbia, and the territories of Guam and the U.S. Virgin Islands.
The Food and Nutrition Act of 2008 (the Act), as amended, 7 U.S.C. 2015(b), provides the legal authority for conducting the matching program. Section 6(b) of the Act prescribes mandatory periods of ineligibility for persons found to have committed an IPV such as fraud, misrepresentation, or other violation of statute or regulation in connection with SNAP. Section 6(b)(4) prescribes regulations to ensure that appropriate State and Federal entities forward information concerning determinations arising out of such proscribed activity by a specific individual.
The eDRS matching program maintains program integrity and reduces payment errors by providing information to assist State agencies with establishing or verifying the eligibility of individuals for SNAP benefits and determining the appropriate disqualification period to be imposed for a new IPV as required in regulations at 7 CFR 273.16, Disqualification for intentional Program violation. Each State agency must submit information about individuals who have been disqualified from SNAP within their State to eDRS. As a participant in this matching program, each State agency has access to this national system to both submit the required information for their State and perform the required matches against information provided by all State agencies.
SNAP applicants and new household members are matched against eDRS as part of the eligibility determination process to ensure the individual is not currently disqualified from receiving benefits due to an IPV. Individuals who are being disqualified by a State agency due to a new IPV finding are matched against eDRS to assist the State agency in determining the appropriate duration of the new disqualification
The data elements in eDRS provide information about individuals who have been disqualified, the disqualification details, and the agency that imposed the disqualification. State agencies submit this information about disqualifications imposed in their State and this information is then available to all participating State agencies with access to eDRS. State agencies use personally identifying information to search eDRS for the individual being matched.
The system of records for this data exchange comprising eDRS is USDA/FNS-5, Information on Persons Disqualified from the Supplemental Nutrition Assistance Program, 75 FR 81205 (Dec. 27, 2010). This data exchange is authorized under routine uses.
Food and Nutrition Service (FNS), USDA.
Notice.
In accordance with the Paperwork Reduction Act of 1995, this notice invites the general public and other public agencies to comment on the proposed information collection. This is a revision of an existing information collection to conduct demonstration pilot projects to test the redemption of SNAP benefits through mobile payment technologies.
Written comments must be received on or before October 22, 2024.
Comments may be sent via the following methods:
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All responses to this notice will be summarized and included in the request for Office of Management and Budget (OMB) approval. All comments will be a matter of public record.
Requests for additional information or copies of this information collection should be directed to Eden Temple, at (703) 457-7734 or via email to
Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions that were used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on those who are to respond, including use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
The information collected in the pilot evaluation (to be submitted for OMB approval under a separate information collection request) will help FNS determine the success of and best practices for the use of mobile payment technologies to redeem SNAP benefits. This information will inform Program design, standards, rulemaking, and guidance for approval of SNAP mobile payment technologies as well as Departmental decisions and recommendations to Congress with respect to requiring all State EBT systems to accept mobile payment technologies in the future.
To achieve these objectives, FNS seeks OMB approval only for implementation of MPP by State agencies. Under the Paperwork Reduction Act, FNS will seek a separate OMB approval to evaluate the results of completed MPPs under a separate 60-day
In 2022, FNS issued a request for volunteers for participate in the MPP. FNS received 12 proposals and selected 5 States to participate. Because the request for volunteers (RFV) process has already occurred and its burden was covered in the initial 2022 information collection request, FNS is removing the hours associated with the RFV process from this renewal. Because pilot projects are still being designed, it is impossible for FNS to know in advance the design and structure of pilots that may be proposed or the specific activities each State and associated partners will undertake while conducting a MPP. Therefore, we have provided general estimates based on an assumed pilot model. Actual pilots may vary widely from this model and include a variety of potential stakeholders; this information collection does not intend to establish a standard model; this model will be used throughout this notice simply for ease of estimation.
If there are substantive changes to this data collection request, the agency will seek OMB approval to revise this information collection request following
The pilot period will last a total of eighteen (18) months, and Pilot Participants (State agencies and associated business partner organizations) will join on a rolling basis with the condition that they must each participate for a minimum of nine (9) months. Per the requirement in Section 4006(e) of the Agricultural Act of 2018 (Pub. L. 115-334) FNS has selected 5 MPPs. FNS estimates that, based on the assumed model in this notice, each State agency may require 80 hours to conduct the following activities during each month of implementation of an MPP (as applicable). These activities include:
1. Design of mobile payment integration and changes to EBT systems and functionality to accommodate mobile payments,
2. Testing of EBT systems to ensure compatibility,
3. Provision of technical assistance and support to SNAP households that participate in an MPP, and/or
4. Coordination with EBT processors, SNAP retailers, and mobile payment contractors.
FNS estimates that, based on the assumed model in this notice, each of the 5 State agencies may issue 1 recruitment notice for the MPP to 5,000 individuals who are members of SNAP households in each State for a total of 25,000 individuals. These notices may be issued to SNAP households electronically or via mail, depending on the State. Generation and issuance of each notice by the State agency is expected to take approximately 3 minutes (0.05 hours). FNS also estimates that each of the 25,000 individual household members will require up to 3 minutes (0.05 hours) to read the recruitment notice for participation in the pilot. FNS estimates that approximately 5,000 of the recruited participants will opt to participate in the pilot (1,000 per State) and that each of the 5,000 participants will require 15 minutes to enroll in an MPP. Potential enrollment activities for SNAP household respondents are based on the assumed model in this information collection may include calling or emailing the State agency to indicate interest, reviewing instructions, downloading an application (as known as app), technical assistance, and/or enrolling in the app.
Because the RFV process has already occurred and its burden was covered in the 2022 information collection request, FNS is removing the hours associated with the RFV process from this renewal. This results in a decrease of 23,510 burden hours.
There is no recordkeeping or third-party reporting burden associated with this information collection.
Rural Business-Cooperative Service, USDA.
Notice.
The Rural Business-Cooperative Service (RBCS or Agency), a Rural Development (RD) agency of the United States Department of Agriculture (USDA), invites applications for loans and grants under the Rural Economic Development Loan and Grant Programs (REDLG or Programs) for fiscal year (FY) 2025, subject to the availability of funding. This notice is being issued prior to the passage of a FY 25 Consolidated Appropriations Act, which may or may not provide funding for this program, to allow applicants sufficient time to leverage financing, prepare and submit their applications, and give the Agency time to process applications within FY 2025. Based on FY 2024 appropriated funding and current budget situation, the Agency estimates that approximately $50,000,000 will be available for FY 2025. Successful applications will be selected by the Agency for funding and subsequently awarded to the extent that funding may ultimately be made available through appropriations. All applicants are responsible for any expenses incurred in developing their applications.
The deadlines for completed applications to be received in the RD State Office for quarterly funding competitions are no later than 4:30 p.m. (local time) on: First Quarter, September 30, 2024; Second Quarter, December 31, 2024; Third Quarter, March 31, 2025, and Fourth Quarter, June 30, 2025. The Agency will not consider any application received after the deadline for funding competition in that fiscal quarter.
Applications must be submitted in paper or electronically to the RD State Office for the state where the project is located. A list of the RD State Office contacts can be found at:
Cindy Mason at
• Addressing Climate Change and Environmental Justice; Reducing climate pollution and increasing resilience to the impacts of climate change through economic support to rural communities.
• Advancing Racial Justice, Place-Based Equity, and Opportunity; Ensuring all rural residents have equitable access to RD programs and benefits from RD funded projects.
• Creating More and Better Market Opportunities; Assisting rural communities recover economically through more and better market opportunities and through improved infrastructure.
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The Consolidated Appropriations Act, 2024, (Pub. L. 118-42, Division B, Title VII), Section 736 designates funding for projects in persistent poverty counties. Persistent poverty counties is “any county that has had 20 percent or more of its population living in poverty over the past 30 years, as measured by the 1990 and 2000 decennial censuses, and 2007-2011 American Community Survey 5-year average, or any territory or possession of the United States”. Section 736 expands the eligible population in persistent poverty counties to include any county seat of such a persistent poverty county that has a population that does not exceed the authorized population limit by more than 10 percent, expanding the current 50,000 population limit to 55,000 for only county seats located in persistent poverty counties. Therefore, assuming the Appropriations Act for 2025 has similar language, applicants and/or beneficiaries located in persistent poverty county seats with populations up to 55,000 (per the 2010 Census) are eligible.
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(a) There are no “responsiveness” or “threshold” eligibility criteria for these loans and grants. There is no limit on the number of applications an applicant may submit under this announcement.
(b) None of the funds made available by this or any other Act may be used to enter into a contract, memorandum of understanding, or cooperative agreement with, make a grant to, or provide a loan or loan guarantee to any corporation that:
(i) 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 where the awarding agency is aware of the unpaid tax liability, unless a Federal agency has considered suspension or debarment of the corporation and has made a determination that this further action is not necessary to protect the interests of the Government.
(ii) Was convicted of a felony criminal violation under any Federal law within the preceding 24 months, where the awarding agency is aware of the conviction, unless a Federal agency has considered suspension or debarment of the corporation and has made a determination that this further action is not necessary to protect the interests of the Government.
(c) Applications will not be considered for funding if they do not provide sufficient information to determine eligibility or are missing required elements.
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(a) At the time of application, each applicant must have an active registration in the System for Award Management (SAM) before submitting its application in accordance with 2 CFR part 25. In order to register in SAM, entities will be required to obtain a Unique Entity Identifier (UEI). Instructions for obtaining the UEI are available at
(b) Applicants must maintain an active SAM registration, with current, accurate and complete information, at all times during which it has an active Federal award or an application under consideration by a Federal awarding agency.
(c) Applicants must ensure they complete the Financial Assistance General Certifications and Representations in SAM.
(d) Applicants must provide a valid UEI in its application, unless determined exempt under 2 CFR 25.110.
(e) The Agency will not make an award until the applicant has complied with all SAM requirements including providing the UEI. If an applicant has not fully complied with the requirements by the time the Agency is ready to make an award, the Agency may determine that the applicant is not qualified to receive a Federal award and use that determination as a basis for making a Federal award to another applicant.
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The Agency will not solicit or consider new scoring or eligibility information that is submitted after the application deadline. The Agency also reserves the right to ask applicants for clarifying information and additional verification of assertations in the application.
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(a) There are no specific limitations on the number of pages, font size and type face, margins, paper size, number of copies, and the sequence or assembly requirements.
(b) The component pieces of this application should contain original signatures on the original application. Any form that requires an original signature but is signed electronically in the application submission, must be signed in ink by the authorized person prior to the disbursement of funds.
(c) An original copy of the application package must be filed with the RD State Office for the State where the intermediary is located.
(d) Applicants may submit applications in hard copy or electronic format as previously indicated in the Application and Submission Information section of this notice. If the applicant wishes to hand deliver their application, the addresses for these deliveries can be located in the
Applicants intending to mail applications must allow sufficient time to permit delivery on or before the closing deadline date and time. Acceptance by the United States Postal Service or private mailer does not constitute delivery. Facsimile (FAX) or postage due applications will not be accepted.
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(a) Assisting rural communities recover economically through more and better market opportunities and through improved infrastructure. Applicant would receive priority points if the project is located in or serving a rural community whose economic well-being ranks in the most distressed tier (distress score of 80 or higher) of the Distressed Communities Index using the Distressed Communities Look-Up Map available at
(b) Ensuring all rural residents have equitable access to RD programs and benefits from RD funded projects. Using the Social Vulnerability Index (SVI) Look-Up Map (available at
• Is located in or serving a community with score 0.75 or above on the SVI;
• Is a Federally recognized Tribe, including Tribal instrumentalities and entities that are wholly owned by Tribes; or
• Is a project where at least 50 percent of the project beneficiaries are members of Federally recognized Tribes and non-Tribal applicants include a Tribal Resolution of Consent from the Tribe or Tribes that the applicant is proposing to serve.
• Is an application from or benefiting a Rural Partner's Network's (RPN) community network (rural.gov). Currently, RPN Networks exist in
(c) Reducing climate pollution and increasing resilience to the impacts of climate change through economic support to rural communities. Using the Disadvantaged Community and Energy Community Look-Up Map (available at
• If the project is located in or serves a
• If the project is located in or serves an
• If applicants can demonstrate through a written narrative how the proposed climate-impact projects will improve the livelihoods of community residents and meet pollution mitigation or clean energy goals.
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The following additional requirements apply to intermediaries or grantees selected for these Programs:
(i) Form RD 4280-2, “Rural Business-Cooperative Service Financial Assistance Agreement.”
(ii) Letter of Conditions.
(iii) Form RD 1940-1, “Request for Obligation of Funds.”
(iv) Form RD 1942-46, “Letter of Intent to Meet Conditions.”
(v) SF LLL, “Disclosure of Lobbying Activities,” if applicable.
(vi) Form SF 270, “Request for Advance or Reimbursement.”
(vii) Form RD 400-4, “Assurance Agreement” must be completed by the applicant and each prospective ultimate recipient.
(viii) Intermediaries or grantees must collect and maintain data provided by ultimate recipients on race, sex, and national origin and ensure ultimate recipients collect and maintain this data. Race and ethnicity data will be collected in accordance with OMB
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3. Reporting.
(a) A financial status report and a project performance activity report will be required of all grantees on a quarterly basis until initial funds are expended and yearly thereafter, if applicable, based on the Federal FY. The grantee will complete the project within the total time available to it in accordance with the scope of work and any necessary modifications thereof prepared by the grantee and approved by the Agency. A final project performance report will be required with the final financial status report. The final report may serve as the last quarterly report. The final report must provide complete information regarding the jobs created and supported as a result of the grant if applicable. Grantees must continuously monitor performance to ensure that time schedules are being met, projected work by time periods is being accomplished, and other performance objectives are being achieved. Grantees must submit an original of each report to the Agency no later than 30 days after the end of the quarter. The project performance reports must include, but not be limited to, the following:
(i) A comparison of actual accomplishments to the objectives established for that period;
(ii) Problems, delays, or adverse conditions, if any, which have affected or will affect attainment of overall project objectives, prevent meeting time schedules or objectives, or preclude the attainment of particular project work elements during established time periods. This disclosure shall be accompanied by a statement of the action taken or planned to resolve the situation;
(iii) Objectives and timetable established for the next reporting period;
(iv) Any special reporting requirements, such as jobs supported and created, businesses assisted, or economic development which results in improvements in median household
(v) Within 90 days after the conclusion of the project, the intermediary will provide a final project evaluation report. The last quarterly payment will be withheld until the final report is received and approved by the Agency. Even though the intermediary may request reimbursement on a monthly basis, the last 3 months of reimbursements will be withheld until a final report, project performance, and financial status report are received and approved by the Agency.
(b) In addition to any reports required by 2 CFR part 200 and 2 CFR 400.1 to 400.2 and 2 CFR part 415 to 422, the intermediary or grantee must provide reports as required by 7 CFR part 4280, subpart A.
For general questions about this announcement, please contact your RD State Office provided in the
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(a) Faith-based organizations may apply for this award on the same basis as any other organization, as set forth at, and subject to the protections and requirements of, this part and any applicable constitutional and statutory requirements, including 42 U.S.C. 2000bb
(b) A faith-based organization that participates in this program will retain its independence from the Government and may continue to carry out its mission consistent with religious freedom and conscience protections in Federal law. Religious accommodations may also be sought under many of these religious freedom and conscience protection laws.
(c) A faith-based organization may not use direct Federal financial assistance from USDA to support or engage in any explicitly religious activities except when consistent with the Establishment Clause of the First Amendment and any other applicable requirements. An organization receiving Federal financial assistance also may not, in providing services funded by USDA, or in their outreach activities related to such services, discriminate against a program beneficiary or prospective program beneficiary on the basis of religion, a religious belief, a refusal to hold a religious belief, or a refusal to attend or participate in a religious practice.
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Program information may be made available in languages other than English. Persons with disabilities who require alternative means of communication to obtain program information (
To file a program discrimination complaint, a complainant should complete a Form AD-3027, USDA Program Discrimination Complaint Form, which can be obtained online at
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USDA is an equal opportunity provider, employer, and lender.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The U.S. Department of Commerce (Commerce) preliminarily determines that one of the exporters subject to this antidumping duty administrative review made sales of subject merchandise at less than normal value, one of the exporters subject to this antidumping duty administrative review did not make sales of subject merchandise at less than normal value, and that two companies, Shanghai Smart Chemicals Co. Ltd. (Shanghai Smart), and Deosen Biochemical Ltd., had no shipments of subject merchandise during the period of review (POR) July 1, 2022, through June 30, 2023. In addition, we are rescinding this review, in part, with respect to five companies. Interested parties are invited to comment on these preliminary results.
Applicable August 23, 2024.
Reginald Anadio, AD/CVD Operations, Office IV, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-3166.
On July 3, 2023, Commerce published in the
For a complete description of the events that occurred following the initiation of the review,
The product covered by the
Between September and October 2023, Meihua Group International Trading (Hong Kong) Limited/Langfang Meihua Biotechnology Co., Ltd./Xinjiang Meihua Amino Acid Co., Ltd. (collectively, Meihua), Shanghai Smart, and Deosen Biochemical Ltd. filed timely certifications that they had no exports, shipments, sales, or entries of subject merchandise to the United States during the POR.
Consistent with Commerce's practice in non-market economy (NME) cases, we are not rescinding this administrative review with respect to Deosen Biochemical Ltd. and Shanghai Smart but intend to complete the review and issue appropriate instructions to CBP based on the final results of the review.
Pursuant to 19 CFR 351.213(d)(1), Commerce will rescind an administrative review, in whole or in part, if all parties that requested a review withdraw their requests within 90 days of the publication date of the notice of initiation of the requested review in the
Commerce is conducting this review in accordance with section 751(a)(1)(B) of the Tariff Act of 1930, as amended (the Act). We calculated constructed export price in accordance with section 772 of the Act. Because China is an NME country within the meaning of section 771(18) of the Act, we calculated normal value in accordance with section 773(c) of the Act. For a full description of the methodology underlying these preliminary results,
Commerce preliminarily determines that two non-individually examined companies are eligible for separate rates in this administrative review.
Under Commerce's policy regarding the conditional review of the China-wide entity,
Aside from Deosen Biochemical Ltd. and Shanghai Smart, for which we preliminarily find no shipments, and Henan Sinowin, Meihua, Qingdao Yalai, and Foodchem Biotech Co., Ltd. and Shanghai Cy-Everlasting, for which this review is being rescinded, Commerce considers all other companies for which a review was requested and did not demonstrate separate rate eligibility to be part of the China-wide entity.
We preliminarily determine that the following weighted-average dumping margins exist for the POR July 1, 2022, through June 30, 2023:
Commerce intends to disclose its calculations performed to interested parties for these preliminary results within five days of any public announcement or, if there is no public announcement, within five days of the date of publication of this notice in accordance with 19 CFR 351.224(b).
As provided in section 782(i)(3) of the Act, because Commerce has received a timely request to conduct verification by an interested party and has not made a verification in the two immediately preceding reviews, Commerce intends to verify certain information reported by Deosen Biochemical (Ordos) Ltd. and Neimenggu Fufeng Biotechnologies Co., Ltd. (aka Inner Mongolia Fufeng Biotechnologies Co., Ltd.)/Shandong Fufeng Fermentation Co., Ltd./Xinjiang Fufeng Biotechnologies Co., Ltd.
As provided under 19 CFR 351.309(c)(2) and (d)(2), in prior proceedings we have encouraged interested parties to provide an executive summary of their brief that should be limited to five pages total, including footnotes. In this review, we instead request that interested parties provide at the beginning of their briefs a public, executive summary for each issue raised in their briefs.
Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing must submit a written request to the Assistant Secretary for Enforcement and Compliance, filed electronically via ACCESS. Requests should contain: (1) the party's name, address, and telephone number; (2) the number of participants; and (3) a list of issues to be discussed. Issues raised in the hearing will be limited to those raised in the respective case briefs. An electronically filed hearing request must be received successfully in its entirety by Commerce's electronic records system, ACCESS, by 5 p.m. Eastern Time within 30 days after the date of publication of this notice.
Unless otherwise extended, Commerce intends to issue the final results of this administrative review, which will include the results of its analysis of issues raised in any briefs, within 120 days of publication of these preliminary results of review in the
Upon issuance of the final results of review, Commerce will determine, and CBP shall assess, antidumping duties on all appropriate entries covered by this review.
We will calculate importer/customer-specific assessment rates equal to the ratio of the total amount of dumping calculated for examined sales to a particular importer/customer to the total entered value of those sales, in accordance with 19 CFR 351.212(b)(1).
For respondents not individually examined in this administrative review that qualified for a separate rate, the assessment rate will be equal to the weighted-average dumping margin assigned to the respondent in the final results of this review.
Pursuant to Commerce's refinement to its practice, for sales that were not reported in the U.S. sales database submitted by a respondent individually examined during this review, Commerce will instruct CBP to liquidate the entry of such merchandise at the dumping margin assigned to the China-wide entity (
In accordance with section 751(a)(2)(C) of the Act, the final results of this review shall be the basis for the assessment of antidumping duties on entries of merchandise covered by the final results of this review and for future deposits of estimated antidumping duties, where applicable.
The following cash deposit requirements will be effective for all shipments of xanthan gum from China entered, or withdrawn from warehouse, for consumption on or after the date of publication of the notice of the final results of this administrative review in the
This notice also serves as a preliminary reminder to importers of their responsibility under 19 CFR 351.402(f) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in the Commerce's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of double antidumping duties.
Commerce is issuing and publishing these preliminary results in accordance with sections 751(a)(1) and 777(i)(1) of the Act, and 19 CFR 351.213(d)(4) and 351.221(b)(4).
International Trade Administration, Department of Commerce.
The United States Department of Commerce, International Trade Administration (ITA), is announcing the postponement of the Sub-Saharan Africa Rail and Port (SSARP) Trade Mission to South Africa and Angola, announced in the Notice published in the
The Department of Commerce is postponing the Sub-Saharan Africa Rail and Port Trade Mission to South Africa and Angola announced May 03, 2024 (89 FR 36756) as scheduled for August 19-24, 2024. The Sub-Saharan Africa Rail and Port Trade Mission to South Africa and Angola has been postponed to 2025 with the specific dates to be confirmed. ITA will publish another announcement with the dates once confirmed.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of public meeting.
The New England Fishery Management Council (Council) is scheduling a joint public meeting of its Monkfish Committee and Advisory Panel via webinar to consider actions affecting New England fisheries in the exclusive economic zone (EEZ). Recommendations from this group will be brought to the full Council for formal consideration and action, if appropriate.
This webinar will be held on Monday, September 9, 2024, at 1 p.m.
Cate O'Keefe, Executive Director, New England Fishery Management Council; telephone: (978) 465-0492.
The Monkfish Committee and Advisory panel will meet to review and discuss the 2024 Monkfish Fishery Performance draft report. They will review the non-regulatory improvements made to the Monkfish Research Set-Aside (RSA) program to date, based on recommendations of the 2023 Monkfish RSA Working Group. The group will receive an update from the 2023-2024 Monkfish RSA project participants including an overview of work to date and an opportunity to provide feedback to the project participants. The Committee and Advisory Panel will also discuss the possibility of recommending a pause to the Monkfish RSA RFP solicitation until the program's underlying economic and programmatic issues are addressed. Other business may be discussed, as necessary.
Although non-emergency issues not contained on the agenda may come before this Council for discussion, those issues may not be the subject of formal action during this meeting. Council action will be restricted to those issues specifically listed in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Act, provided the public has been notified of the Council's intent to take final action to address the emergency. The public also should be aware that the meeting will be recorded. Consistent with 16 U.S.C. 1852, a copy of the recording is available upon request.
This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Cate O'Keefe, Executive Director, at (978) 465-0492, at least 5 days prior to the meeting date.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of issuance of letter of authorization.
In accordance with the Marine Mammal Protection Act (MMPA), as amended, its implementing regulations, and NMFS' MMPA Regulations for Taking Marine Mammals Incidental to Geophysical Surveys Related to Oil and Gas Activities in the Gulf of Mexico, notification is hereby given that a Letter of Authorization (LOA) has been issued to CCG for the take of marine mammals incidental to geophysical survey activity in the Gulf of Mexico (GOM).
The LOA is effective from August 15, 2024 through July 31, 2025.
The LOA, LOA request, and supporting documentation are available online at:
Jenna Harlacher, Office of Protected Resources, NMFS, (301) 427-8401.
Sections 101(a)(5)(A) and (D) of the MMPA (16 U.S.C. 1361
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 GOM 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 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
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” (LPAI) standard of the MMPA.
CGG plans to conduct a three-dimensional (3D) ocean bottom node (OBN) survey over 1,840 lease blocks in the Garden Banks and Keathley Canyon areas, with water depths ranging from approximately 1,000 to 3,200 meters (m). See section F of the LOA application for a map of the area.
CGG anticipates using two dual-source vessels, and would preferentially use the low-frequency tuned pulse source (TPS). Alternatively, CGG may use conventional airgun array sources consisting of 42 elements with a total volume of 5,220 cubic inches (in
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 the 32 element, 5,110 in
Consistent with the preamble to the final rule, the survey effort proposed by CGG 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
No 3D OBN surveys were included in the modeled survey types, and use of existing proxies (
The survey will take place over approximately 115 days with 65 days of sound source operation, with 40 days planned in Zone 5 and 25 days planned in Zone 6. The monthly distribution of survey days is not known in advance, though we assume that the planned 65 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 solely on the modeling yielded results that are not realistically likely to occur when considered in light of other relevant information available during the rulemaking process regarding marine mammal occurrence in the GOM. The approach used in the acoustic exposure modeling, in which seven modeling zones were defined over the U.S. GOM, necessarily averages fine-scale information about marine mammal distribution over the large area of each modeling zone. Thus, although the modeling conducted for the rule is a natural starting point for estimating take, the rule acknowledged that other information could be considered (see,
NMFS' 2024 final rule provided detailed discussion regarding Rice's whale habitat (see,
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. CGG's planned activities will
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 GOM 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;
Based on the analysis contained herein of CGG's proposed survey activity described in its LOA application and the anticipated take of marine mammals, NMFS finds that small numbers of marine mammals will be taken relative to the affected species or stock sizes (
NMFS has determined that the level of taking for this LOA request is consistent with the findings made for the total taking allowable under the incidental take regulations and that the amount of take authorized under the LOA is of no more than small numbers. Accordingly, we have issued an LOA to CGG authorizing the take of marine mammals incidental to its geophysical survey activity, as described above.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of hybrid meeting.
The North Pacific Fishery Management Council (Council) Crab Plan Team will meet September 9, 2024, through September 12, 2024.
The meeting will be held on Monday, September 9, 2024, through Wednesday, September 11, 2024, from 9 a.m. to 4 p.m., and Thursday, September 12, 2024, from 9 a.m. to 12:30 p.m., Pacific Standard Time.
The meetings will be a hybrid meeting. The in-person component of the meeting will be held at the Alaska Fishery Science Center in the Traynor Room 2076, 7600 Sand Point Way NE, Building 4, Seattle, WA 98115. If you plan to attend in person, you need to notify Diana Stram (
Instructions for attending the meeting via video conference are given under
Diana Stram, Council staff; phone: (907) 271-2809; email:
The agenda will include: (a) summer trawl survey results; (b) Fishery summary 2023/2024; (c) Ecosystem Status reports; (d) SMKC SAFE report; (e) BBRKC SAFE report and risk table; (f) Snow crab SAFE report and risk table; (g) BBRKC and snow crab report cards; (h) Tanner crab SAFE report and risk table; (i) NSRKC proposed models; (j) Overfishing status updates; (k) BSFRF update; and (l) additional topics. The agenda is subject to change, and the latest version will be posted at
You can attend the meeting online using a computer, tablet, or smart phone, or by phone only. Connection information will be posted online at:
Public comment letters will be accepted and should be submitted electronically to
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of public meeting.
The Pacific Fishery Management Council's (Pacific Council) Ad Hoc Ecosystem Workgroup (EWG) is holding an online meeting, which is open to the public.
The online meeting will be held Monday to Wednesday, September 9-11, 2024, from 10 a.m. to 3 p.m. on Monday, September 9 and 9 a.m. to 2 p.m. on Tuesday and Wednesday, September 10 and 11. The meeting may extend beyond the noticed end time on each day, if necessary, to conclude the day's business.
This meeting will be held online. Specific meeting information, including directions on how to join the meeting and system requirements will be provided in the meeting announcement on the Pacific Council's website (see
Kit Dahl, Staff Officer, Pacific Council; telephone: (503) 820-2422.
The purpose of this online meeting is for the EWG to discuss and draft reports for items on the September 2024 Pacific Council meeting agenda. The EWG may also discuss other items related to the Pacific Council's Fishery Ecosystem Plan. An agenda for the webinar will be posted on the Pacific Council website in advance of the webinar.
Although non-emergency issues not contained in the meeting agenda may be discussed, those issues may not be the subject of formal action during this meeting. Action will be restricted to those issues specifically listed in this document and any issues arising after publication of this document that require emergency action under section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the intent to take final action to address the emergency.
Requests for sign language interpretation or other auxiliary aids should be directed to Mr. Kris Kleinschmidt (
The Department of Commerce will submit the following information collection request to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995, on or after the date of publication of this notice. We invite the general public and other Federal agencies to comment on proposed, and continuing information collections, which helps us assess the impact of our information collection requirements and minimize the public's reporting burden. Public comments were previously requested via the
This information collection request may be viewed at
Written comments and recommendations for the proposed information collection should be submitted within 30 days of the publication of this notice on the following website
Committee for Purchase From People Who Are Blind or Severely Disabled.
Deletions from the Procurement List.
This action deletes product(s) and service(s) from the Procurement List that were furnished by nonprofit agencies employing persons who are blind or have other severe disabilities.
For further information or to submit comments contact: Michael R. Jurkowski, Telephone: (703) 489-1322 or email
This notice is published pursuant to 41 U.S.C. 8503(a)(2) and 41 CFR 51-2.3. Its purpose is to provide interested persons an opportunity to submit comments on the proposed actions.
On July 19, 2024 (89 FR 58723), the Committee for Purchase From People Who Are Blind or Severely Disabled published notice of proposed deletions from the Procurement List. This notice is published pursuant to 41 U.S.C. 8503(a)(2) and 41 CFR 51-2.3.
After consideration of the relevant matter presented, the Committee has determined that the product(s) and service(s) listed below are no longer suitable for procurement by the Federal Government under 41 U.S.C. 8501-8506 and 41 CFR 51-2.4.
I certify that the following action will not have a significant impact on a substantial number of small entities. The major factors considered for this certification were:
1. The action will not result in additional reporting, recordkeeping or other compliance requirements for small entities.
2. The action may result in authorizing small entities to furnish the product(s) and service(s) to the Government.
3. There are no known regulatory alternatives which would accomplish the objectives of the Javits-Wagner-O'Day Act (41 U.S.C. 8501-8506) in connection with the product(s) and service(s) deleted from the Procurement List.
Accordingly, the following product(s) and service(s) are deleted from the Procurement List:
Committee for Purchase From People Who Are Blind or Severely Disabled.
Proposed additions to and deletions from the Procurement List.
The Committee is proposing to add service(s) to the Procurement List that will be furnished by nonprofit agencies employing persons who are blind or have other severe disabilities and deletes product(s) and service(s) previously furnished by such agencies.
Committee for Purchase From People Who Are Blind or Severely Disabled, 355 E Street SW, Washington, DC 20024.
For further information or to submit comments contact: Michael R. Jurkowski, Telephone: (703) 489-1322 or email
This notice is published pursuant to 41 U.S.C. 8503 (a)(2) and 41 CFR 51-2.3. Its purpose is to provide interested persons an opportunity to submit comments on the proposed actions.
On 5/31/2024 (89 FR 47135), the Committee for Purchase From People Who Are Blind or Severely Disabled (operating as the U.S. AbilityOne Commission) stated that a service proposed for addition to the Procurement List at Fort Liberty, NC, was a Base Operations Services requirement. This statement was in error. The service type is Base Operation Support, Sustainment, Restoration, and Modernization (SRM) (Barracks only), which is hereby corrected by publishing this Notice. Because the prior Notice fully complied with 41 CFR 51-2.3 by allowing for 30 days of public comment, additional public comments to this correction must be received by 9/1/2024 to meet contracting activity award timing. The Committee will consider public comments previously received under 89 FR 47135 together with any public comments received pursuant to this correction.
The following service(s) are proposed for addition to the Procurement List for production by the nonprofit agencies listed:
The following service(s) are proposed for deletion from the Procurement List:
Office of Career, Technical, and Adult Education, Department of Education.
Notice.
The Secretary of Education invites publishers to submit tests for review and approval for use in the National Reporting System for Adult Education (NRS) and announces the date by which publishers must submit these tests. This notice relates to the approved information collection under OMB control number 1830-0567.
Submit your application by email to
John LeMaster, U.S. Department of Education, 400 Maryland Avenue SW, Washington, DC 20202-7240. Telephone: (202) 987-0903. Email:
If you are deaf, hard of hearing, or have a speech disability and wish to access telecommunications relay services, please dial 7-1-1.
The Department's regulations for Measuring Educational Gain in the National Reporting System for Adult Education, 34 CFR part 462 (NRS regulations), include the procedures for determining the suitability of tests for use in the NRS.
There is a review process that will begin on October 1, 2024. Only tests submitted from publishers by the due date will be reviewed in that review cycle, 34 CFR 462.10. If a publisher submits a test after October 1, 2024, the test will not be reviewed until the review cycle that begins on October 1, 2025.
(a) In preparing your application, you must comply with the requirements in 34 CFR 462.11.
(b) In accordance with 34 CFR 462.10, the deadline for transmittal of applications in this fiscal year is October 1, 2024.
(c) Applications are due by 11:59 p.m. Eastern Time on October 1, 2024. You must retain a copy of your sent email message and the email attachments as proof that you timely submitted your application.
(d) We do not consider applications submitted after the application deadline date to be timely for the October 1, 2024, review cycle. If an application is submitted after the October 1, 2024, deadline date, the application will be considered timely for the October 1, 2025, deadline date.
You may also access Department documents published in the
President's Board of Advisors on Historically Black Colleges and Universities, Office of the Secretary, U.S. Department of Education.
Announcement of an open meeting.
This notice sets forth the agenda for the fall 2024 meeting of the President's Board of Advisors on Historically Black Colleges and Universities (Board) and provides information to members of the public about how to attend the meeting, request to make oral comments at the meeting, and submit written comments pertaining to the work of the Board.
On Thursday, September 19, 2024, the Board will hold a hybrid meeting from 10:30 a.m. to 3:30 p.m. E.D.T. in the Liberty Ballroom of the Philadelphia Marriott Downtown located at 1201 Market Street, Philadelphia, PA 19107.
Sedika Franklin, Associate Director/Designated Federal Official, U.S. Department of Education, White House Initiative on Historically Black Colleges and Universities, 400 Maryland Avenue SW, Washington, DC 20202 or by email at
The Board advises the President in the following areas: (i) improving the identity, visibility, and distinctive capabilities and overall competitiveness of HBCUs; (ii) engaging the philanthropic, business, government, military, homeland-security, and education communities in a national dialogue regarding new HBCU programs and initiatives; (iii) improving the
To virtually join the meeting, please click on the appropriate link, enter your name, email address, and organization, and follow the prompts to connect to the meeting audio by computer or telephone. Members of the public may virtually join the meeting 5 minutes prior to its start time. Members of the public joining by phone will be automatically placed in listen only mode.
Members of the public may also join in person. The meeting will take place in the Liberty Ballroom of the Philadelphia Marriott Downtown located at 1201 Market Street, Philadelphia, PA 19107. There will be signs in the building directing you to the meeting space.
You may also access documents of the Department published in the
Office of the Elementary and Secondary Education (OESE), Department of Education (ED).
Notice.
In accordance with the Paperwork Reduction Act (PRA) of 1995, the Department is proposing an extension without change of a currently approved information collection request (ICR).
Interested persons are invited to submit comments on or before September 23, 2024.
Written comments and recommendations for proposed information collection requests should be submitted within 30 days of publication of this notice. Click on this link
For specific questions related to collection activities, please contact Andrew Brake, 202-453-6136.
The Department is especially interested in public comment addressing the following issues: (1) is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.
White House Initiative on Advancing Educational Equity, Excellence, and Economic Opportunity for Black Americans, Office of the Secretary, Department of Education.
Announcement of an open meeting.
This notice sets forth the agenda for the September 10, 2024, open meeting of the Presidential Advisory Commission on Advancing Educational Equity, Excellence, and Economic Opportunity for Black Americans (PAC) and provides information to members of the public about how to attend the meeting and submit written comments related to the work of the PAC.
The PAC will meet on September 10, 2024, from 10:00 a.m. to 2:00 p.m. E.D.T.
The meeting will occur at the U.S. Capitol Visitor Center located at First St. SE, Washington, DC 20515. Only PAC members will participate in the meeting at this address. Members of the public are invited to join the meeting virtually.
Monique Toussaint, Designated Federal Official, U.S. Department of Education, White House Initiative on Advancing Educational Equity, Excellence, and Economic Opportunity for Black Americans, 400 Maryland Avenue SW, Washington, DC 20202; email
The PAC advises the President in the following areas: (i) what is needed for the development, implementation, and coordination of educational programs and initiatives at the Department and other agencies to improve educational opportunities and outcomes for Black Americans; (ii) how to promote career pathways for in-demand jobs for Black students, including registered apprenticeships, internships, fellowships, mentorships, and work-based learning initiatives; (iii) how to increase public awareness of and generate solutions for the educational and training challenges and equity disparities that Black Americans face and the causes of these challenges; and (iv) approaches to establish local and national partnerships with public, private, philanthropic, and nonprofit stakeholders to advance the mission and objectives of Executive Order 14050, consistent with applicable law. Notice of the meeting is required by 5 U.S.C. chapter 10 and is intended to notify the public of its opportunity to attend.
You may also access documents of the Department published in the
Take notice that on August 12, 2024, Texas Connector Pipeline, LLC (Texas Connector), 1500 Post Oak Blvd., Houston, Texas 77056, filed an application under section 7(c) of the Natural Gas Act (NGA), and Part 157 of the Commission's regulations to amend its authorization granted by the Commission in Docket Nos. CP17-20-000, et al. on April 18, 2019 for the Texas Connector Project (Project), located in Jefferson and Orange Counties, Texas and Calcasieu Parish, Louisiana. The proposed amendment: (1) eliminates the southern compressor station; (2) changes the number and size of compressor units at the northern compressor station (Orangefield Compressor Station), increasing the compression at that station by 45,984 horsepower; (3) decreases the overall amount of pipeline by 3.2 miles; (4) eliminates one meter station and associated lateral; and (5) revises Texas Connector's initial rates. The estimated cost of the activities proposed in this amendment increases the cost of the Texas Connector Project by $322,287,118, all as more fully set forth in the application which is on file with the Commission and open for public inspection.
In addition to publishing the full text of this document in the
User assistance is available for eLibrary and the Commission's website during normal business hours from FERC Online Support at (202) 502-6652 (toll free at 1-866-208-3676) or email at
Any questions regarding the proposed project should be directed to Jerrod L. Harrison, Sempra Infrastructure, Assistant General Counsel, 488 8th Avenue, San Diego, California 92101, by phone at (619) 696-2987, or by email at
Pursuant to section 157.9 of the Commission's Rules of Practice and Procedure,
Texas Connector stated that a water quality certificate under section 401 of the Clean Water Act is required for the Project from the Railroad Commission of Texas. When available, Texas Connector should submit to the Commission a copy of the request for certification for the Commission authorization, including the date of the request was submitted to the certifying agency and either (1) a copy of the certifying agency's decision or (2) evidence of waiver of water quality certification.
There are three ways to become involved in the Commission's review of this project: you can file comments on the project, you can protest the filing, and you can file a motion to intervene in the proceeding. There is no fee or cost for filing comments or intervening. The deadline for filing a motion to intervene is 5:00 p.m. Eastern Time on September 6, 2024. How to file protests, motions to intervene, and comments is explained below.
The Commission's Office of Public Participation (OPP) supports meaningful public engagement and participation in
Any person wishing to comment on the project may do so. Comments may include statements of support or objections, to the project as a whole or specific aspects of the project. The more specific your comments, the more useful they will be.
Pursuant to sections 157.10(a)(4)
To ensure that your comments or protests are timely and properly recorded, please submit your comments on or before September 6, 2024.
There are three methods you can use to submit your comments or protests to the Commission. In all instances, please reference the Project docket number CP24-512-000 in your submission.
(1) You may file your comments electronically by using the eComment feature, which is located on the Commission's website at
(2) You may file your comments or protests electronically by using the eFiling feature, which is located on the Commission's website (
(3) You can file a paper copy of your comments or protests by mailing them to the following address below. Your written comments must reference the Project docket number (CP24-512-000).
The Commission encourages electronic filing of comments (options 1 and 2 above) and has eFiling staff available to assist you at (202) 502-8258 or
Persons who comment on the environmental review of this project will be placed on the Commission's environmental mailing list, and will receive notification when the environmental documents (EA or EIS) are issued for this project and will be notified of meetings associated with the Commission's environmental review process.
The Commission considers all comments received about the project in determining the appropriate action to be taken.
Any person, which includes individuals, organizations, businesses, municipalities, and other entities,
To intervene, you must submit a motion to intervene to the Commission in accordance with Rule 214 of the Commission's Rules of Practice and Procedure
There are two ways to submit your motion to intervene. In both instances, please reference the Project docket number CP24-512-000 in your submission.
(1) You may file your motion to intervene by using the Commission's eFiling feature, which is located on the Commission's website (
(2) You can file a paper copy of your motion to intervene, along with three copies, by mailing the documents to the address below. Your motion to intervene must reference the Project docket number CP24-512-000.
The Commission encourages electronic filing of motions to intervene (option 1 above) and has eFiling staff available to assist you at (202) 502-8258 or
Protests and motions to intervene must be served on the applicant either by mail or email at: Jerrod L. Harrison, Sempra Infrastructure, Assistant General Counsel, 488 8th Avenue, San Diego, California 92101 or by email at
All timely, unopposed
Throughout the proceeding, additional information about the project will be available from the Commission's Office of External Affairs, at (866) 208-FERC, or on the FERC website at
In addition, the Commission offers a free service called eSubscription which allows you to keep track of all formal issuances and submittals in specific dockets. This can reduce the amount of time you spend researching proceedings by automatically providing you with notification of these filings, document summaries, and direct links to the documents. For more information and to register, go to
As announced in the August 2, 2024 Notice in this proceeding, the Federal Energy Regulatory Commission (Commission) will convene a Commissioner-led technical conference in the above-referenced proceeding. The technical conference will take place on November 1, 2024, from 10:00 a.m. to 3:00 p.m. Eastern Time. The technical conference will be held in-person at the Commission's headquarters at 888 First Street NE, Washington, DC 20426 in the Commission Meeting Room. The purpose of this technical conference is to discuss generic issues related to the co-location of large loads at generating facilities. The Commission does not intend to discuss at this technical conference any specific proceeding before the Commission. Broadly, issues to be explored at the technical conference may include whether co-located loads require the provision of wholesale transmission or ancillary services, related cost allocation issues, and potential resource adequacy, reliability, affordability, market, and customer impacts. Our next supplemental notice will include details on panels and a self-nomination process.
The technical conference will be open to the public. Advance registration is not required, and there is no fee for attendance. Information will also be posted on the Calendar of Events on the Commission's website,
The technical conference will be transcribed and webcast. Transcripts will be available for a fee from Ace Reporting (202-347-3700). A link to the webcast of this event will be available in the Commission Calendar of Events at
Commission technical conferences are accessible under section 508 of the Rehabilitation Act of 1973. For accessibility accommodations, please send an email to
For more information about this technical conference, please contact Keatley Adams at
Commission staff coordinated with the staff of the North American Electric Reliability Corporation (NERC) to conduct the annual oversight of the Find, Fix, Track and Report (FFT) program, as outlined in the March 15, 2012, Order,
Commission staff reviewed a sample of 32 of 173 FFTs and 30 of 889 CEs submitted by NERC between October 2022 and September 2023.
Commission staff found that the FFT and CE programs are meeting expectations. All 62 FFTs and CEs have been adequately remediated and the root cause of each noncompliance was clearly identified. Commission staff also reviewed the supporting information for these FFTs or CEs and agreed with the final risk determinations for all 62 noncompliances, which clearly identified the factors affecting the risk prior to mitigation (such as potential and actual risk) and actual harm. Further, no FFTs or CEs sampled contained any material misrepresentations by the registered entities. Commission staff found that the Regional Entities appropriately identified all 62 of the sampled noncompliances as appropriate to be processed as FFTs and CEs.
Take notice that the Commission received the following exempt wholesale generator filings:
Take notice that the Commission received the following electric rate filings:
The filings are accessible in the Commission's eLibrary system (
Any person desiring to intervene, to protest, or to answer a complaint in any of the above proceedings must file in accordance with Rules 211, 214, or 206 of the Commission's Regulations (18 CFR 385.211, 385.214, or 385.206) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
The Commission's Office of Public Participation (OPP) supports meaningful public engagement and participation in Commission proceedings. OPP can help members of the public, including landowners, environmental justice communities, Tribal members and others, access publicly available information and navigate Commission processes. For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, the public is encouraged to contact OPP at (202) 502-6595 or
This is a supplemental notice in the above-referenced proceeding of Agway Energy Services, LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is September 5, 2024.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically may mail similar pleadings to the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426. Hand delivered submissions in docketed proceedings should be delivered to Health and Human Services, 12225 Wilkins Avenue, Rockville, Maryland 20852.
In addition to publishing the full text of this document in the
User assistance is available for eLibrary and the Commission's website during normal business hours from FERC Online Support at 202-502-6652 (toll free at 1-866-208-3676) or email at
The Commission's Office of Public Participation (OPP) supports meaningful public engagement and participation in Commission proceedings. OPP can help members of the public, including landowners, environmental justice communities, Tribal members and others, access publicly available information and navigate Commission processes. For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, the public is encouraged to contact OPP at (202) 502-6595 or
Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:
Any person desiring to intervene, to protest, or to answer a complaint in any of the above proceedings must file in accordance with Rules 211, 214, or 206 of the Commission's Regulations (18 CFR 385.211, 385.214, or 385.206) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
The filings are accessible in the Commission's eLibrary system (
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
The Commission's Office of Public Participation (OPP) supports meaningful public engagement and participation in Commission proceedings. OPP can help members of the public, including landowners, environmental justice communities, Tribal members and others, access publicly available information and navigate Commission processes. For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, the public is encouraged to contact OPP at (202) 502-6595 or
Take notice that on August 2, 2024, Rover Pipeline LLC (Rover), 1300 Main
In addition to publishing the full text of this document in the
User assistance is available for eLibrary and the Commission's website during normal business hours from FERC Online Support at (202) 502-6652 (toll free at 1-866-208-3676) or email at
Any questions regarding the proposed project should be directed to Mr. Blair Lichtenwalter, Senior Director, Regulatory Affairs, Rover Pipeline LLC, 1300 Main Street, Houston, Texas 77002, by phone at (713) 989-2605, or by email at
Pursuant to section 157.9 of the Commission's Rules of Practice and Procedure,
There are three ways to become involved in the Commission's review of this project: you can file comments on the project, you can protest the filing, and you can file a motion to intervene in the proceeding. There is no fee or cost for filing comments or intervening. The deadline for filing a motion to intervene is 5:00 p.m. Eastern Time on September 6, 2024. How to file protests, motions to intervene, and comments is explained below.
The Commission's Office of Public Participation (OPP) supports meaningful public engagement and participation in Commission proceedings. OPP can help members of the public, including landowners, environmental justice communities, Tribal members and others, access publicly available information and navigate Commission processes. For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, the public is encouraged to contact OPP at (202) 502-6595 or
Any person wishing to comment on the project may do so. Comments may include statements of support or objections, to the project as a whole or specific aspects of the project. The more specific your comments, the more useful they will be.
Pursuant to sections 157.10(a)(4)
To ensure that your comments or protests are timely and properly recorded, please submit your comments on or before September 6, 2024.
There are three methods you can use to submit your comments or protests to the Commission. In all instances, please reference the Project docket number CP24-508-000 in your submission.
(1) You may file your comments electronically by using the eComment feature, which is located on the Commission's website at
(2) You may file your comments or protests electronically by using the eFiling feature, which is located on the Commission's website (
(3) You can file a paper copy of your comments or protests by mailing them to the following address below. Your written comments must reference the Project docket number (CP24-508-000).
The Commission encourages electronic filing of comments (options 1 and 2 above) and has eFiling staff available to assist you at (202) 502-8258 or
Persons who comment on the environmental review of this project will be placed on the Commission's environmental mailing list, and will receive notification when the environmental documents (EA or EIS) are issued for this project and will be notified of meetings associated with the Commission's environmental review process.
The Commission considers all comments received about the project in
Any person, which includes individuals, organizations, businesses, municipalities, and other entities,
To intervene, you must submit a motion to intervene to the Commission in accordance with Rule 214 of the Commission's Rules of Practice and Procedure
There are two ways to submit your motion to intervene. In both instances, please reference the Project docket number CP24-508-000 in your submission.
(1) You may file your motion to intervene by using the Commission's eFiling feature, which is located on the Commission's website (
(2) You can file a paper copy of your motion to intervene, along with three copies, by mailing the documents to the address below. Your motion to intervene must reference the Project docket number CP24-508-000.
The Commission encourages electronic filing of motions to intervene (option 1 above) and has eFiling staff available to assist you at (202) 502-8258 or
Protests and motions to intervene must be served on the applicant either by mail or email at: Mr. Blair Lichtenwalter, Senior Director, Regulatory Affairs, Rover Pipeline LLC, 1300 Main Street, Houston, Texas 77002 or at
All timely, unopposed
Throughout the proceeding, additional information about the project will be available from the Commission's Office of External Affairs, at (866) 208-FERC, or on the FERC website at
In addition, the Commission offers a free service called eSubscription which allows you to keep track of all formal issuances and submittals in specific dockets. This can reduce the amount of time you spend researching proceedings by automatically providing you with notification of these filings, document summaries, and direct links to the documents. For more information and to register, go to
Environmental Protection Agency (EPA).
Notice.
EPA has received applications to register pesticide products containing active ingredients not included in any currently registered pesticide products. Pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), EPA is hereby providing notice of receipt and opportunity to comment on these applications.
Comments must be received on or before September 23, 2024.
Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2024-0058, through the
Madison H. Le, Biopesticides and Pollution Prevention Division (BPPD) (7511M), main telephone number: (202) 566-1400, email address:
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).
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EPA has received applications to register pesticide products containing active ingredients not included in any currently registered pesticide products. Pursuant to the provisions of FIFRA section 3(c)(4) (7 U.S.C. 136a(c)(4)), EPA is hereby providing notice of receipt and opportunity to comment on these applications. Notice of receipt of these applications does not imply a decision by the Agency on these applications. For actions being evaluated under EPA's public participation process for registration actions, there will be an additional opportunity for public comment on the proposed decisions. Please see EPA's public participation website for additional information on this process (
Environmental Protection Agency (EPA).
Notice.
EPA has received applications to register new uses for pesticide products containing currently registered active ingredients. Pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), EPA is hereby providing notice of receipt and opportunity to comment on these applications.
Comments must be received on or before September 23, 2024.
Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2024-0061, through the Federal eRulemaking Portal at
Dan Rosenblatt, Registration Division (RD) (7505T), main telephone number: (202) 566-2875, email address:
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).
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EPA has received applications to register new uses for pesticide products containing currently registered active ingredients. Pursuant to the provisions of FIFRA section 3(c)(4) (7 U.S.C. 136a(c)(4)), EPA is hereby providing notice of receipt and opportunity to comment on these applications. Notice of receipt of these applications does not imply a decision by the Agency on these applications.
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Export-Import Bank of the United States.
Notice.
This Notice is to inform the public the Export-Import Bank of the United States (“EXIM”) has received an application for final commitment for a long-term loan or financial guarantee in excess of $100 million. Comments received within the comment period specified below will be presented to the EXIM Board of Directors prior to final action on this Transaction.
Comments must be received on or before September 17, 2024 to be assured of consideration before final consideration of the transaction by the Board of Directors of EXIM.
Comments may be submitted through
Brief description of the purpose of the transaction: The financing request is in support of the Obligor's acquisition of goods and services, to be utilized in the deployment of a nationwide 5G telecommunications network in India. EXIM's support is to be made pursuant to the EXIM co-financing agreement with Finnvera PLC, the Finnish export credit agency.
Brief non-proprietary description of the anticipated use of the items being exported: The 5G equipment and services will be used for deployment of the nation-wide 5G network in India.
Federal Maritime Commission.
Notice and request for comment.
The Federal Maritime Commission (Commission) is giving public notice that the agency has submitted to the Office of Management and Budget (OMB) for approval an extension, without change, of an existing information collection related to controlled carriers. The public is invited to comment on the information collection pursuant to the Paperwork Reduction Act of 1995.
Written comments must be submitted on or before October 22, 2024.
The Commission is accepting comments using the Federal eRulemaking Portal at
Lucille L. Marvin, Managing Director, (202) 523-5800,
The Commission invites the general public and other Federal agencies to comment on any aspect of the continuing information collection listed in this notice, as required by the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Comments submitted in response to this notice will be included or summarized in our request for Office of Management and Budget (OMB) approval of the relevant information collection. All comments are part of the public record and subject to disclosure. Please do not include any confidential or inappropriate material in your comments.
Federal Acquisition Service (Q), General Services Administration (GSA).
Meeting notice.
As stipulated by the Federal Advisory Committee Act (FACA), as amended, GSA is hereby giving notice of two (2) open public meetings of the Federal Secure Cloud Advisory Committee (FSCAC). Information on attending and providing public comment is under the
The open public meetings will be held virtually on Thursday, September 12, 2024, from 12:00 p.m. to 4:00 p.m., Eastern Time (ET), and Thursday, October 10, 2024, from 12:00 p.m. to 3:00 p.m., Eastern Time (ET). The meeting materials, registration information, and agendas for the meetings will be made available prior to the meetings online at
The meetings will be accessible via webcast. Separate registration is required for each meeting and will be made available prior to the meetings online at
Michelle White, Designated Federal Officer (DFO), FSCAC, GSA, 703-489-4160,
GSA, in compliance with the FedRAMP Authorization Act of 2022 (the Act), established the FSCAC, a statutory advisory committee in accordance with the provisions of FACA, as amended (5 U.S.C. 10). The Federal Risk and Authorization Management Program (FedRAMP) within GSA is responsible for providing a standardized, reusable approach to security assessment and authorization for cloud computing products and services that process unclassified information used by agencies.
The FSCAC will provide advice and recommendations to the Administrator of GSA, the FedRAMP Board, and agencies on technical, financial, programmatic, and operational matters regarding the secure adoption of cloud computing products and services. The FSCAC will ensure effective and ongoing coordination of agency adoption, use, authorization, monitoring, acquisition, and security of cloud computing products and services to enable agency mission and administrative priorities. The purposes of the Committee are:
• To examine the operations of FedRAMP and determine ways that authorization processes can continuously be improved, including the following:
○ Measures to increase agency reuse of FedRAMP authorizations.
○ Proposed actions that can be adopted to reduce the burden, confusion, and cost associated with FedRAMP authorizations for cloud service providers.
○ Measures to increase the number of FedRAMP authorizations for cloud computing products and services offered by small businesses concerns (as defined by section 3(a) of the Small Business Act (15 U.S.C. 632(a)).
○ Proposed actions that can be adopted to reduce the burden and cost of FedRAMP authorizations for agencies.
• Collect information and feedback on agency compliance with, and implementation of, FedRAMP requirements.
• Serve as a forum that facilitates communication and collaboration among the FedRAMP stakeholder community.
The FSCAC will meet no fewer than three (3) times a calendar year. Meetings shall occur as frequently as needed, called, and approved by the DFO.
The September 12, 2024 public meeting will be dedicated to providing the Committee with additional information pertinent to their new initiatives. Presentations may be held on the Office of Management and Budget's (OMB) Memorandum titled “Modernizing the Federal Risk Authorization Management Program (FedRAMP)” (OMB Memo), and several panel discussions by both industry and agencies will be held for the Committee to better understand both stakeholder groups' challenges. Members of the public will have the opportunity to provide oral public comments during this meeting, and may also submit public comments in writing prior to this meeting by completing the public comment form on our website,
The October 10, 2024 public meeting will be dedicated to deliberations in order to develop an initial draft of recommendations to the GSA Administrator on their initial two (2) priority initiatives of (1) identifying and documenting top challenges and proposing solutions around the barrier
Both of these virtual meetings are open to the public. The meeting materials, registration information, and agendas for the meetings will be made available prior to the meetings online at
For information on services for individuals with disabilities, or to request accommodation for a disability, please email the FSCAC staff at
Members of the public attending will have the opportunity to provide oral public comment during the FSCAC meeting. Written public comments can be submitted at any time by completing the public comment form on our website,
Administration for Community Living, HHS.
Notice.
The President's Committee for People with Intellectual Disabilities (PCPID) will host a meeting for its members to discuss the 2024 PCPID Report focused on Home and Community Based Services (HCBS) and discuss emerging issues facing people with intellectual disabilities. All the PCPID meetings, in any format, are open to the public. Members of the public can join in person or virtually. This meeting will be conducted in presentation and discussion format.
The meeting will take place on Septmber 26, 2024 from 9:00 a.m. to 4:00 p.m. (EST) and September 27, 2024 from 9:00 a.m. to 3:00 p.m. (EST).
Comments received by September 13, 2024 will be shared with the PCPID at the September 26-27, 2024 meeting.
Mr. David Jones, Director, Office of Intellectual Developmental Disabilities, 330 C Street SW, Switzer Building, Room 1126, Washington, DC 20201. Telephone: 202-795-7367. Fax: 202-795-7334. Email:
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft product-specific guidances. The draft guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the
Submit either electronic or written comments on the draft guidance by October 22, 2024 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
You may submit comments on any guidance at any time as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).
Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the
Joseph Kotsybar, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 3623A, Silver Spring, MD 20993-0002, 240-402-1062,
In the
As described in that guidance, FDA adopted this process to develop and disseminate product-specific guidances and provide a meaningful opportunity for the public to consider and comment on those guidances. Under that process, draft guidances are posted on FDA's website and announced periodically in
FDA is announcing the availability of new draft product-specific guidances for industry for drug products containing the following active ingredients:
FDA is announcing the availability of revised draft product-specific guidances for industry for drug products containing the following active ingredients:
For a complete history of previously published
These draft guidances are being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). These draft guidances, when finalized, will represent the current thinking of FDA on, among other things, the product-specific design of BE studies to support ANDAs. They do not establish any rights for any person and are not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.
While these guidances contain no collection of information, they do refer to previously approved FDA collections of information. The previously approved collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections of information in 21 CFR part 312 for investigational new drugs have been approved under 0910-0014. The collections of information in 21 CFR part 314 for applications for FDA approval to market a new drug and in 21 CFR part 320 for bioavailability and bioequivalence requirements have been approved under OMB control number 0910-0001.
Persons with access to the internet may obtain the draft guidance at
Food and Drug Administration, HHS.
Notice; establishment of a public docket; request for comments.
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Oncologic Drugs Advisory Committee (the Committee). The general function of the Committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
The meeting will be held on September 26, 2024, from 8 a.m. to 6:15 p.m. Eastern Time.
The public may attend the meeting at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-0002. The public will also have the option to participate, and the advisory committee meeting will be heard, viewed, captioned, and recorded through an online teleconferencing and/or video conferencing platform.
Answers to commonly asked questions about FDA advisory committee meetings, including information regarding special accommodations due to a disability, visitor parking, and transportation, may be accessed at:
FDA is establishing a docket for public comment on this meeting. The docket number is FDA-2024-N-3647. The docket will close on September 25, 2024. Please note that late, untimely filed comments will not be considered. The
Comments received on or before September 12, 2024, will be provided to the Committee. Comments received after that date will be taken into consideration by FDA. In the event that the meeting is cancelled, FDA will continue to evaluate any relevant applications or information, and consider any comments submitted to the docket, as appropriate.
You may submit comments as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” FDA will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Joyce Frimpong, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-796-7973, email:
• adequacy of PD-L1 expression as a predictive biomarker for patient selection in this patient population;
• differing risk-benefit assessments in different subpopulations defined by PD-L1 expression; and
• adequacy of the cumulative data to restrict the approvals of immune checkpoint inhibitors based on PD-L1 expression.
The Committee will discuss the existing supplemental biologics license applications (sBLA) which were approved for patients with previously untreated HER2-negative unresectable or metastatic gastric or gastroesophageal adenocarcinoma:
• sBLA 125554/S-091 for OPDIVO (nivolumab) injection, submitted by Bristol Myers-Squibb Co.; and
• sBLA 125514/S-143 for KEYTRUDA (pembrolizumab) injection, submitted by Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc.
The Committee will also discuss BLA 761417 for tislelizumab injection, submitted by BeiGene USA, Inc., for the same proposed indication.
During the afternoon session, the Committee will discuss the use of immune checkpoint inhibitors in patients with metastatic or unresectable esophageal squamous cell carcinoma. The current labeling for approved checkpoint inhibitors in this indication reflects broad approvals in the intent to treat patient populations agnostic of PD-L1 expression. Cumulative data has shown that PD-L1 expression appears to be a predictive biomarker of treatment efficacy in this patient population; however, clinical trials have used different approaches to assess PD-L1 expression and different thresholds to define PD-L1 positivity. FDA would like the Committee's opinion on the following:
• adequacy of PD-L1 expression as a predictive biomarker for patient selection in this patient population;
• differing risk-benefit assessments in different subpopulations defined by PD-L1 expression; and
• adequacy of the cumulative data to restrict the approvals of immune checkpoint inhibitors based on PD-L1 expression.
The Committee will discuss the existing sBLAs which were approved for patients with previously untreated
• sBLA 125514/S-096 for KEYTRUDA (pembrolizumab) injection, submitted by Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc.;
• sBLAs 125554/S-105 and S-106 for OPDIVO (nivolumab) injection, submitted by Bristol Myers-Squibb Co.; and
• sBLA 125377/S-122 for YERVOY (ipilimumab) injection, submitted by Bristol Myers-Squibb Co.
The Committee will also discuss the new BLA 761380 for tislelizumab, submitted by BeiGene USA, Inc., for the same proposed indication.
FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available on FDA's website at the time of the advisory committee meeting. Background material and the link to the online teleconference and/or video conference meeting will be available at the location of the advisory committee meeting and at
For press inquiries, please contact the Office of Media Affairs at
FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Joyce Frimpong (see
FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our website at
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. 1001
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled “Electronic Submission Template for Medical Device De Novo Requests.” FDA is issuing this guidance to introduce submitters of De Novo requests to the Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER) to the current resources and associated content developed and made publicly available to support De Novo electronic submissions to FDA. This guidance is intended to represent one of several steps in meeting FDA's commitment to the development of electronic submission templates to serve as guided submission preparation tools for industry to improve submission consistency and enhance efficiency in the review process.
The announcement of the guidance is published in the
You may submit either electronic or written comments on Agency guidances at any time as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
You may submit comments on any guidance at any time (see § 10.115 (21 CFR 10.115(g)(5))).
An electronic copy of the guidance document is available for download from the internet. See the
Lisa Lim, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1108, Silver Spring, MD 20993-0002, 301-796-6443; or James Myers, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993, 240-402-7911.
FDA is issuing this guidance document to introduce submitters of De Novo requests
FDA's guidance document “Providing Regulatory Submissions for Medical Devices in Electronic Format—Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act”
A notice of availability of the draft guidance appeared in the
In section 745A(b) of the FD&C Act, Congress granted explicit statutory authorization to FDA to specify in guidance the statutory requirement for electronic submissions solely in electronic format by providing standards, a timetable, and criteria for waivers and exemptions. To the extent that this guidance provides such
To the extent that this guidance describes recommendations that are not standards, timetable, criteria for waivers of, or exemptions under section 745A(b)(3) of the FD&C Act, it is being issued consistent with FDA's good guidance practices regulation (§ 10.115). The guidance represents the current thinking of FDA on Electronic Submission Template for Medical Device De Novo Requests. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance contains both binding and nonbinding provisions.
Persons interested in obtaining a copy of the guidance may do so by downloading an electronic copy from the internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at
While this guidance contains no new collection of information, it does refer to previously approved FDA collections of information. The previously approved collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information in the following table have been approved by OMB:
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) refusing to approve a new drug application (NDA) submitted by Intarcia Therapeutics, Inc., an i2o Therapeutics Business Unit, (Intarcia) for ITCA 650 (exenatide in DUROS device). FDA has determined that the approval criteria in the FD&C Act have not been met because Intarcia has failed to demonstrate that ITCA 650 is safe for its intended conditions of use.
This notice is applicable August 23, 2024.
Rachael Vieder Linowes, Office of Scientific Integrity, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4206, Silver Spring, MD 20993, 240-402-5931.
ITCA 650 (exenatide in DUROS device) is a novel drug-device combination product for human patients intended to deliver the active ingredient, exenatide, a glucagon-like peptide-1 receptor agonist (GLP-1 RA). Intarcia proposed that ITCA 650 be indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ITCA 650 is intended to provide continuous dosing of exenatide from an osmotic mini-pump implanted in the subdermal space of the abdomen for 3 months for initiation of therapy and every 6 months afterwards for maintenance therapy. ITCA 650 must be inserted and removed by a healthcare provider trained on the included placement tool and guide. ITCA 650 is proposed in two dosage strengths: 20 micrograms (mcg)/day for 3 months and 60 mcg/day for 6 months. The drug formulation used in ITCA 650 is a viscous, non-aqueous suspension. Each mini-pump of ITCA 650—20 mcg/day for 3 months and 60 mcg/day for 6 months—nominally contains 2.56 milligrams (mg) and 14.05 mg of synthetic exenatide, respectively.
On November 21, 2016, Intarcia submitted NDA 209053 for ITCA 650. In support of its NDA, Intarcia included three phase 3 clinical trials to establish substantial evidence of safety and effectiveness—CLP-103, CLP-105, and CLP-107. CLP-107, also known as FREEDOM, was a cardiovascular outcome trial (CVOT). On September 21, 2017, the Center for Drug Evaluation and Research (CDER) issued a complete response (CR) letter to Intarcia stating that the NDA could not be approved in its present form. On September 19, 2019, Intarcia resubmitted the NDA, and on March 9, 2020, CDER issued a second CR letter stating that the NDA could not be approved in its present form, describing specific deficiencies and, where deemed possible, recommending ways that Intarcia might remedy those deficiencies.
On March 16, 2021, after pursuing formal dispute resolution, Intarcia submitted a request under 21 CFR 314.110(b)(3) for an opportunity for a hearing on whether there are grounds under section 505(d) of the FD&C Act (21 U.S.C. 355(d)) for refusing to approve the NDA for ITCA 650. CDER subsequently published a notice of opportunity for a hearing (NOOH) regarding a proposal to refuse to approve the NDA (86 FR 49334
CDER's second deficiency noted that the cardiovascular risk assessment failed to provide sufficient assurances that ITCA 650 is not associated with excess cardiovascular risk. In particular, CDER stated that “the clinical trial data suggested that ITCA 650 may be associated with an increased risk for major adverse cardiovascular events (MACE), defined as myocardial infarction, nonfatal stroke, and cardiovascular death.” (86 FR 49334 at 49336). The other deficiencies related to concerns regarding the in vitro dose delivery performance data and drug-release specifications, delivery performance data and variability in daily in vitro drug-release (IVR) data, inadequate support of sterility assurance, and deficiencies regarding certain manufacturing practices. Key aspects of those deficiencies included that “the in vitro device performance data demonstrated inconsistent day-to-day drug delivery and did not support that weekly and biweekly in vitro drug-release testing is adequate to ensure controlled in vivo drug release by the device constituent of ITCA 650,” and that “failure rate data was inadequate to support the safety and effectiveness of the device constituent of ITCA 650” (86 FR 49334 at 49336).
Intarcia, through counsel, timely requested a hearing and subsequently submitted data, information, and analyses in support of that hearing request. Intarcia further argued that the risks identified by CDER are in line with the risks of the product class, as opposed to unique to ITCA 650, and that, provided there are appropriate restrictions included in ITCA 650's labeling, the safety profile for ITCA 650 falls in line with the product class. Intarcia stated that ITCA 650's benefits, including the new dosage form for patients, outweighs its risks and allows for a positive benefit-risk ratio that supports approval.
More specifically, Intarcia disputed CDER's determination that ITCA 650 led to higher AKI events in a controlled clinical setting compared to other products in its class. In support of its contention, Intarcia submitted an analysis of publicly available clinical review documents for Wegovy, an approved drug with a similar active ingredient,
Regarding the cardiovascular risk, Intarcia stated that CDER previously acknowledged that, “due to the limited size and duration of the preapproval CVOT, the hazard ratio for cardiovascular risk was not definitive and would not constitute sufficient grounds for denial of the NDA, as long as a postmarketing CVOT would be completed.” Intarcia stated that, because CDER overstated the AKI risk for ITCA 650 and admitted that the cardiovascular risk is not grounds for denial, ITCA 650 should be approved.
In accordance with 21 CFR 314.200, CDER then submitted a proposed order denying Intarcia's hearing request on the proposal to refuse to approve ITCA 650. In the proposed order, CDER provided findings that Intarcia had not raised a genuine and substantial issue of fact justifying a hearing regarding CDER's proposal to refuse to approve NDA 209053 in its present form. The proposed order found that the data and other evidence submitted in support of the NDA for ITCA 650 does not show the product to be safe under section 505(d)(2) of the FD&C Act:
Intarcia's NDA fails to demonstrate that the novel combination of the DUROS pump device and exenatide (ITCA 650) is safe for use, in part because the IVR data do not demonstrate that ITCA is reliable and do not validate the limits of the dose delivery specifications for the device, the proposed acceptance criteria are too wide and would allow drug release that is not sufficiently controlled by the device to meet clinical needs, and the device hazards associated with failure modes have not been sufficiently addressed by new risk control measures.
The proposed order further described how the inaccurate dosing “raises significant safety concerns because marked increases in [ ] exenatide increase the risk of gastrointestinal intolerability, AKI, and potentially MACE.” In the proposed order, CDER noted how Intarcia's acceptance criteria for its dosing is “unacceptably wide,” indicating that the drug release is not well controlled and that, therefore, ITCA 650 is not safe for use under the proposed conditions.
Regarding the AKI events, the proposed order included analysis of Intarcia's clinical trials and concomitant findings that serious adverse events of AKI occurred in 14 study participants (0.5 percent) who received ITCA 650 (all requiring hospitalization) and 4 (0.2 percent) who received placebo. The proposed order found that this imbalance “leads to an unfavorable benefit-risk assessment for ITCA 650 based on the data and information contained in the NDA in its present form.” According to the proposed order, even a reanalysis of the data in a manner that would be most favorable to Intarcia would still raise a concern regarding the number AKI events for ITCA 650, leading to an unfavorable benefit-risk balance, which would preclude approval. CDER's proposed order accounted for Intarcia's Wegovy discussion and concluded that “the numeric imbalance in serious AKI adverse events in [FREEDOM] suggests that ITCA 650 causes AKI to a greater extent than other members of the GLP-1 RA class, which did not show numeric imbalances in large, randomized clinical trials, and that the available data set ITCA 650 apart from the class with regard to AKI risk.” The proposed order further included a conclusion that the AKI risk indicated by the data offered in support of approval cannot be adequately mitigated with post-approval measures because the AKI events occurred in patients who did not have known risk factors and they occurred in both the initial and maintenance dosing.
CDER's proposed order also addressed the cardiovascular risk, stating that the CVOT for ITCA 650, which was conducted in the population “most
On October 10, 2022, Intarcia responded to CDER's proposed order. By letter dated February 7, 2023, the Office of the Commissioner (OC) provided Intarcia with an opportunity, pursuant to § 12.32 (21 CFR 12.32), to request a hearing under part 14 (21 CFR part 14) in lieu of a formal evidentiary hearing under part 12 (21 CFR part 12) and indicated that the Agency would conduct any such hearing before the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC). On February 20, 2023, Intarcia requested a public hearing before the EMDAC in lieu of a formal evidentiary hearing. On March 24, 2023, OC granted Intarcia's request and explained that, under § 12.32(f)(1), OC would treat the votes and discussion of the issues by the EMDAC as an initial decision under 21 CFR 12.120 and that both CDER and Intarcia could file exceptions to those votes and discussion pursuant to 21 CFR 12.125. OC further indicated that it would render a final decision for the Agency based on the public record.
On August 24, 2023, FDA published the notice of hearing before the EMDAC on the proposal to refuse to approve ITCA 650 and summarized the issues to be considered and addressed (88 FR 57958). CDER conducted the hearing before the EMDAC on September 21, 2023. After the EMDAC heard presentations from CDER, Intarcia, and the public participants, the EMDAC voted unanimously that, based on the available evidence, Intarcia had not demonstrated that the benefits of ITCA 650 outweigh its risks for the treatment of T2DM. The EMDAC members explained the reasoning behind their votes, which is summarized below. After the EMDAC meeting, Intarcia submitted timely exceptions to the EMDAC's votes and advice, and CDER responded to Intarcia's exceptions. Therefore, this matter is before the Principal Deputy Commissioner (PDC) on appeal under 21 CFR 12.130.
Pursuant to section 503(g) of the FD&C Act (21 U.S.C. 353(g)), for a combination product containing a drug and a device with a primary mode of action of a drug, Intarcia submitted an NDA for ITCA 650. Under section 505(d) of the FD&C Act, FDA may approve an NDA only if it contains, among other things, a demonstration of the safety and effectiveness of the product for the conditions prescribed, recommended, or suggested in the proposed labeling. FDA must deny approval if the evidence does not show that the drug is safe for use under the proposed conditions (section 505(d)(2) of the FD&C Act) or if there is insufficient information about the drug to determine whether it is safe for use under such conditions (section 505(d)(4) of the FD&C Act). In making these assessments, FDA “implement[s] a structured risk-benefit assessment framework . . . to facilitate the balanced consideration of benefits and risks” (section 505(d) of the FD&C Act).
At the hearing under part 14, both CDER and Intarcia made presentations consistent with their previous submissions in this matter with respect to CDER's proposal to refuse approval of ITCA 650. At the close of the hearing, in light of those presentations and the presentations by public participants, the EMDAC then considered two discussion questions and voted on whether, based on the available data, Intarcia had demonstrated that the benefits of ITCA 650 outweigh its risks for treating T2DM. The discussion questions focused on the safety profile of ITCA 650 with respect to AKI, “cardiovascular safety” and “overall safety” and the benefit-risk “balance of ITCA 650 for the indication to improve glycemic control in patients with T2DM.”
With respect to the discussion question regarding ITCA 650's safety profile, including the risk of AKIs and cardiovascular events, the EMDAC Chair summarized the views expressed by the committee as follows:
[R]egarding whether the safety profile of [ ] ITCA 650 has been adequately characterized based on available data with respect to the AKI safety signal, what I heard is that panel members expressed concerns about the imbalance in AKI. Although some panel members also noted the low incidence, there were concerns expressed about this risk being increased while on metformin, or ACE [angiotensin-converting enzyme] inhibitors, or ARBs [angiotensin receptor blockers], which are therapies that patients with [T2DM] are likely to be taking. * * * Regarding cardiovascular safety, there were a lot of comments about this, and I think, in general, the panel expressed a lot of concerns about the point estimate of cardiovascular risk being above 1 and felt that the cardiovascular safety signal needs to be further investigated before consideration for approval. * * * Then lastly, in terms of overall safety, the panel did have concerns. Some of the concerns expressed were related to, really again, AKI cardiovascular risk[,] but also all-cause mortality was mentioned. A few panel members expressed concerns about lack of information about glycemic excursions and rate of hyper- and hypoglycemia with concerns about variability in the release of the drug.
A review of the transcript confirms the accuracy of this summary. Of note, multiple EMDAC members expressed concerns about the AKIs and cardiovascular risks given how little is known about the drug delivery and the variability of the delivery levels. In general, the EMDAC expressed a need for more data related to AKIs, cardiovascular risks, and overall safety to assess whether ITCA 650 is sufficiently safe for the indicated population.
With respect to the discussion question regarding the benefit-risk balance of ITCA 650, the EMDAC Chair summarized the committee's stated views as follows:
Regarding the panel's assessment of the benefit-risk balance of ITCA 650 for the indication to improve glycemic control in patients with [T2DM], what I heard was that, in general, panel members felt that the benefits of ITCA 650 didn't outweigh the risks. Panel members commented on the moving testimonies during the open public hearing. [T2DM] is a devastating disorder to live with. We need to do better with available therapies and other treatments, but right now there are other options for [T2DM] treatment, and several of them reduce cardiovascular risk and risk for kidney outcomes. * * * Furthermore, I heard the panel members talk about adherence being a very complex problem, and the management of [T2DM] is not just about taking a single medication; there are many other factors. Right now, we really don't have evidence for improved adherence or adequate data to alleviate the safety concerns. The benefit of [ ] lowering [blood sugar levels] is not enough for a [T2DM] medication necessarily now; we need to also be looking at cardiovascular benefits, heart failure, and kidney outcomes, among others.
A review of the transcript again confirms the accuracy of the Chair's summary. Of additional note, several EMDAC members expressed concerns that variability in drug delivery by ITCA 650, as suggested by the data, could lead to patients receiving less reliable dosages of the drug on a regular basis than they would if they were using an
The hearing concluded with the EMDAC's consideration of a voting question: “Based on the available data has the [sponsor] demonstrated that the benefits of the ITCA 650 drug-device combination product outweigh its risks for the treatment of T2DM?” As noted above, the EMDAC members voted unanimously—by a vote of 19 to 0—that Intarcia had failed to make such a showing, and each provided a rationale for their vote. The Chair summarized the EMDAC members' stated rationales as follows:
As you heard, none of the panel members voted yes[,] and all 19 panel members voted no. What I heard is that panel members mentioned the uncertainty about AKI and cardiovascular safety, as well as the variability in drug delivery being the greatest concerns, and then whether or not this is the best version of the device was questioned. * * * I think, overall, the panel acknowledged the work that has gone into ITCA 650 and this innovative approach[ ] but felt that it would be a disservice to our patients to recommend approval with the safety and drug delivery concerns that exist, and panel members voiced their understanding of the negative impact of [T2DM] and the hope that the applicant can do [ ] additional safety studies because of the great potential for this device.
Of note, the EMDAC consistently voiced safety concerns about ITCA 650 based on the data presented at the hearing, including the potential for cardiovascular complications and AKIs and the variability of the dosages provided by the device component of the product. Several EMDAC members also observed that resolving these safety concerns before approval of ITCA 650 would be essential and that post-approval studies would be inadequate to ensure the safety of the product for patients.
On appeal, Intarcia's arguments regarding the procedural aspects of the EMDAC hearing generally question the overall fairness of the proceeding. In general, Intarcia presented concerns related to the scope of the meeting and the voting question, specifically that the EMDAC did not focus solely on the issues identified in CDER's NOOH and that the considerations before the EMDAC were “unjustly expanded” beyond the scope of the NOOH. Furthermore, Intarcia states that the EMDAC Chair did not let Intarcia address certain “inaccurate statements” made by CDER and the EMDAC regarding: (1) the death narratives for certain subjects in the clinical studies of ITCA 650 and (2) a comparison of AKI events in the clinical data for ITCA 650 in relation to the clinical data for other products in the same class that received FDA approval. Intarcia also argues that CDER's presentation approach “did not allow the EMDAC to engage in a fact-based and evidence-based deliberation and voting discussion that was supported to address the comparative GLP-1 safety assertions in CDER's proposed order under dispute.” Where procedural objections and factual objections intertwine, the PDC addresses the core of the factual disputes below. Here, the analysis focuses on the overall fairness of the hearing.
After considering Intarcia's procedural objections, the PDC finds that they are unfounded. When Intarcia requested the part 14 hearing in lieu of a formal evidentiary hearing under part 12, the PDC did not limit the scope of what would be reviewed by the EMDAC. CDER appears to have followed its standard processes for advisory committee meetings and presented its full assessment of Intarcia's NDA to enable the EMDAC to render an initial decision on whether the data offered in support of the NDA show that the benefits of ITCA 650 outweigh its risks. Intarcia received proper notice of the issues before the EMDAC, including the voting question. As was borne out at the EMDAC meeting itself, Intarcia had the opportunity to shape the issues for the advisory committee meeting through its briefing materials and presentation.
As to Intarcia's contentions regarding the EMDAC Chair's meeting facilitation the PDC does not find any evidence of unfairness or prejudice against Intarcia after reviewing the EMDAC transcript. Both CDER and Intarcia had opportunities to present their views on the issues, ask clarifying questions of the other, and answer questions posed by the EMDAC. Intarcia argues that there were instances when the EMDAC Chair did not allow it to properly rebut certain assertions by CDER or the EMDAC members and when the EMDAC Chair made allegedly inaccurate statements. The PDC does not find that the inability to further respond to certain issues created an unfair hearing or any prejudice in this instance. The statements that Intarcia claims it was unable to rebut or challenge, namely statements regarding the death narratives for certain clinical study subjects and AKI rate reflected in the clinical data for ITCA 650 compared to the data for other products in the same class, were addressed in both CDER and Intarcia's presentations, as well as in the EMDAC's briefing documents. Intarcia had ample opportunity throughout the hearing to address both topics. Therefore, the EMDAC Chair's decision not to give Intarcia an additional opportunity to address either matter does not persuade me that the hearing was unfair. Further, as the PDC will explain in more detail below—after considering the additional information Intarcia presented on appeal, including statements on the death narratives and examples of what Intarcia states were “inaccuracies”—the PDC does not believe that any of the procedural issues to which Intarcia points prejudiced it in a meaningful way or materially affected the advice and recommendations provided by the EMDAC. Perhaps more importantly, the PDC concludes that any alleged deficiency in the hearing process before the EMDAC would not affect her judgment with respect to the substantive issues discussed next.
Intarcia's factual challenges center on three areas: the AKI discussion and conclusions, the necessity of a post-approval CVOT, and the IVR data and performance. Intarcia disputes numerous assertions and findings related to AKI events in the clinical data offered in support of approval, including: (1) whether the number of serious adverse events (SAEs) in the clinical studies cited by CDER was accurate, (2) whether the AKI events are a product-class issue, as opposed to an issue specific to ITCA 650, and (3) whether the GI-related events are also a drug-class issue related to the AKI events. Intarcia further disputes the EMDAC's findings on the necessity of another pre-approval CVOT, largely by suggesting that CDER's presentation on the issue was incomplete or misleading. Intarcia states that CDER misrepresented conclusions related to the necessity of another CVOT and that CDER presented conclusions conflicting with statements from its own dispute resolution process. Intarcia also asserts that there were multiple areas where CDER either did not provide proper context or provided false information regarding ITCA 650 and other products in the drug class. Regarding ITCA 650's device performance and dose variability, Intarcia claims that CDER's presentation was misleading in that it relied on hypotheticals while discussing the device.
Beyond these specific challenges, Intarcia generally argues that the data provided in ITCA 650's NDA shows that the combination product would have a
Before addressing the specific factual challenges, the PDC first addresses the allegations that CDER made misrepresentations of facts and presented materially false and misleading information. In support of this position, Intarcia points to alleged inconsistencies in CDER's position during the review process and in its presentation to the EMDAC. For example, Intarcia states that CDER made misrepresentations related to the MACE data and the intersection of that data with the AKI imbalance by citing what it claims are differences in CDER's position in the formal dispute resolution process and the current process. In both the proposed order and its presentation to the EMDAC, CDER has consistently described its concerns with the MACE data and maintained that, taken together with its other concerns with ITCA 650, the data do not support approval because the benefit-risk profile presented by the clinical data offered in support of the NDA does not support approval. The documents associated with the prior dispute resolution process are not part of the record before the PDC in this proceeding. Nevertheless, even if Intarcia's allegations of inconsistency are accurate, a mere evolution in thinking by CDER, including statements in previous decisions by specific officials within CDER, would not establish that CDER misled the EMDAC.
In support of its position that CDER misled the EMDAC, Intarcia also includes a list of allegedly inaccurate claims that misled the EMDAC, including but not limited to the number of AKI-related deaths, the AKI imbalance calculation, and hypothetical device graphs used during CDER's discussion of the IVR concerns. Intarcia's disagreement with CDER's assessments do not even approach establishing that CDER made an effort to mislead the EMDAC, and a review of Intarcia's arguments and the underlying record bears out that Intarcia merely disagrees with CDER's interpretation of the evidence in many instances.
Regarding the AKI disputes, the differences in interpretation of the data regarding AKI events were central to the presentations by Intarcia and CDER, and their divergent views do not establish an effort by CDER to mislead the EMDAC. The PDC addresses the disputes regarding AKI events in the clinical data in detail below but finds nothing in the record before her to indicate that CDER misled the EMDAC or included inaccurate information in its briefing materials for or its presentation to the EMDAC. As to the IVR dispute, CDER affirmatively disclosed that its presentation used hypothetical graphs, negating the argument that the data used in those hypothetical graphs were inaccurate or misleading. CDER appears to have presented those graphs to demonstrate the effect of inconsistent dose delivery in hypothetical devices as a means of providing context and enabling a fuller understanding of the clinical data presented. While the PDC does not explicitly address each aspect of Intarcia's claims that CDER misled or misrepresented the evidence or data to the EMDAC, the record before her establishes that Intarcia's arguments along those lines reflect disagreement with CDER's interpretation of the data and do not show that the CDER's presentation to the EMDAC or its briefing materials were misleading or inaccurate. Further, as previously discussed, Intarcia had ample opportunity to challenge CDER's interpretation of the data and frame the scientific issues for the EMDAC.
After reviewing the information presented by Intarcia on appeal and documents contained in the public record, the PDC finds that CDER's presentation, while at odds with Intarcia's own interpretation of the underlying data, contained appropriate conclusions. As to the allegedly inaccurate statements by the EMDAC Chair, a review of the evidence and the meeting transcript supports that the EMDAC's overall assessment was amply reasoned and supported based on the underlying record. In short, the PDC finds that the data presented and evaluated by the EMDAC regarding the safety of ITCA 650 precludes a finding that the drug is safe for use under the proposed conditions.
Intarcia urges FDA to consider ITCA 650's NDA based on a comparison to approved drug products, rather than on its own standalone merits. The PDC finds that the benefit-risk profile of ITCA 650, as reflected in the data and other information presented at the hearing, is inadequate to support approval. In so finding, the PDC is aligned with the conclusions of the EMDAC, whose stated views on the safety of ITCA did not, to any meaningful degree, hinge on comparisons to the benefit-risk profile of other therapies. The evidence presented to the EMDAC highlights serious safety concerns that have not been adequately addressed by the information contained in ITCA 650's NDA. Based on the multiple safety concerns addressed below, the NDA in its present form does not support a determination that ITCA 650 is safe within the meaning of section 505(d)(2) of the FD&C Act. As discussed in more detail below the PDC has further concluded, based on the data, information, and arguments presented to the EMDAC, that Intarcia has failed to show that the benefit-risk profile of ITCA 650 compares favorably to drug products currently on the market.
The PDC now addresses each area of concern identified by Intarcia with respect to EMDAC's conclusions regarding the clinical data offered to support approval of ITCA 650, namely issues related to concerns expressed by CDER with respect to AKI and cardiovascular events and variability in the dosing provided by the product.
As described above, the EMDAC highlighted concerns related to AKI events reflected in the data, including the number of AKI events observed in the clinical data and the likelihood that the AKI risk would increase if the patient were also taking common T2DM therapies while using ITCA 650. The EMDAC also expressed concerns about the number of reported AKI events in the clinical data even with a low proportion of participants with significant chronic kidney disease. The EMDAC expressed concerns about how the AKI rates would translate in a real world setting when the indicated population would likely have higher, or more serious, rates of chronic kidney disease.
CDER has stated that, based on the evidence included in the NDA, clinical trial subjects who received ITCA 650 had more AKI events than the control group. CDER, relying on individual and pooled analyses of the three ITCA 650 phase 3 clinical trials and the resulting analyses, found a numeric imbalance in serious AKI events:
Baseline eGFR category was coded as mild renal impairment (baseline eGFR 60 to 89 mL/min/1.73m2) for 9 subjects and moderate renal impairment (baseline eGFR 30 to 59 mL/min/1.73m2) for 5 subjects who had AKI SAEs in the ITCA 650 treatment arm. As shown in Table 30 (Section 5.2) among these 5 subjects categorized as 48 moderately renally impaired at baseline, two subjects had baseline eGFRs of 57 and 58 mL/min/1.73m2, respectively, and no subject had baseline eGFR. . . . Only a limited number of subjects with chronic kidney disease (CKD) stage 3 or worse were enrolled in any of the trials, including FREEDOM: as previously noted, only one subject in CLP-103 had a baseline eGFR under 60 mL/min/1.73m2, fewer than 5% of subjects in CLP-105 had a baseline eGFR under 60 mL/min/1.73m2, and fewer than 10% of subjects in CLP-107 had a baseline eGFR under 60 mL/min/1.73m2 at baseline. The AKI signal in FREEDOM was observed in a population less susceptible to AKI I, whereas no AKI signal was observed in the other [GLP-1 RA] CVOTs which studied populations more susceptible to AKI . . . further indicating that the risk of AKI associated with use of ITCA 650 is greater than the risk of AKI associated with currently marketed [GLP-1 RAs].
The crux of Intarcia's argument related to the AKI events reflected in the clinical data for ITCA 650 is that AKI concerns expressed by both CDER and the EMDAC are a drug-class risk and no worse for ITCA 650. Intarcia points to data from various other drug products to support its assertions. Intarcia also disputes the number of AKI events presented by CDER, claiming that there are 11 AKI events instead of the 14 counted by CDER.
In its presentation to the EMDAC, CDER discussed a key concern contained within the data—namely, an increase in AKI events in trial subjects who received the drug, particularly in Intarcia's largest study, FREEDOM, which had a relatively low proportion of subjects with significant chronic kidney disease:
All but one serious AKI event and all but 4 nonserious AKI events occurred in Study CLP-107 (FREEDOM), the largest study with the longest median follow up time. Baseline eGFR is associated with risk of AKI events (Grams et al. 2010);
The EMDAC appears to have agreed with this analysis.
Having a low proportion of participants with significant chronic kidney disease would lead to the expectation that there is a lower baseline risk for AKI events. Renal impairment is common for those with T2DM. Therefore, if an AKI safety concern is present for those who do not have significant renal concerns, it raises serious questions regarding the potential AKI risk to those in the patient population for ITCA 650 that Intarcia has proposed. The indicated population would generally have underlying renal impairment concerns. The higher risk observed in the clinical data for ITCA 650 raises issues about the potentially greater risk in the postapproval setting. In the monitored setting of a clinical trial, some AKI events may be prevented or mitigated, but doing so is more difficult in the real world. As explained in CDER's proposed order, “sufficient risk mitigation approaches could not be identified for the AKI risk, particularly because serious AKI events occurred in participants who did not have known risk factors, could occur at unpredictable times, and were observed with both the initial (20 mcg/day) and maintenance dose (60 mcg/day) of ITCA 650”:
[T]here is no evidence to support Intarcia's assertion that the AKI events occurred in “well-defined windows” of treatment initiation and dose escalation. Although some of the AKI events in the treatment group occurred proximate to implantation and dose escalation, others occurred at unpredictable time points thereafter. The unpredictable timing of these events makes it impossible to adequately warn providers as to when patients may be most likely to experience serious AKI. Accordingly, the clinical trial data support CDER's conclusion that the AKI risk cannot be adequately mitigated through labeling.
The PDC further finds that, if serious AKI events are occurring in individuals without significant renal concerns and at variable times, there is insufficient reason to believe that the potential for AKI events stemming from ITCA 650 can be addressed through risk mitigation measures, such as labeling or patient monitoring, because healthcare providers would not have adequate information to identify patients requiring additional monitoring or education.
Additionally, throughout the process, CDER also responded to Intarcia's contentions that the increase in AKI events was observed in those in the study who were also using metformin. As CDER and the EMDAC correctly noted, metformin usage is a first line treatment for patients with T2DM, and therefore this signal would apply to the majority of the intended patient population for ITCA 650. Given that metformin is not believed to be associated with an increased AKI risk, the increase in AKI events for ITCA 650 for those patients being treated with metformin simply reinforces the conclusion that ITCA 650 poses an increased AKI risk, especially for those in the intended patient population. Indeed, as CDER explained in its briefing materials for the EMDAC, study subjects in both the control and test groups were often taking metformin:
Study CLP-105 was a multicenter, randomized, double-blind (subjects randomized to ITCA 650 and placebo pill or to sitagliptin and placebo ITCA 650 device), active comparator trial that compared efficacy, safety, and tolerability of ITCA 650 to sitagliptin, both as add-on to metformin.
Regardless of the AKI risk associated with approved products whose active ingredient is a GLP-1 RA, the evidence underlying the NDA for ITCA 650 highlights a concerning AKI risk arising in subjects that did not have significant renal impairment. The PDC notes that neither in its recommendations nor its underlying reasoning, did the EMDAC
Additionally, even if the PDC was to view Intarcia's arguments regarding the number of AKI events in its favor and find that there were only 11 AKI events for subjects being treated with ITCA 650, it would still not address the overriding concern of the AKI risk appearing in a subject population with low significant chronic kidney disease. Regardless of which count is used, although the number of AKI events in the ITCA 650 Phase 3 trials was small, there is an overall, and serious, increase in AKI events for ITCA 650.
Separately, despite the concerns just described, were the PDC to consider Intarcia's arguments regarding ITCA 650's risk relative to the risk of similar products with an analogous indication, the evidence presented to the EMDAC supports that ITCA 650 in fact presents a higher risk than approved drug products containing GLP-1 RA as an active ingredient. After analyzing the CVOTs for other products in the class, CDER summarized its findings in its EMDAC briefing materials:
CDER interrogated the CVOTs of the approved [GLP-1 RA] products with the same censoring schemes, [standardized MedDRA queries] (SMQs), and [FDA MedDRA queries] (FMQs) as were applied to FREEDOM. . . . CDER notes that the imbalance in AKI seen in FREEDOM (labeled ITCA in Figure 12) was not observed in other CVOTs in the [GLP-1 RA] class. This imbalance in AKI was observed despite FREEDOM enrolling a lower proportion of subjects with baseline moderate-to-severe renal impairment compared with other CVOTs in the [GLP-1 RA] drug class, such that the FREEDOM population would be expected to have lower baseline risk for AKI events (Table 21).
CDER concluded:
The higher risk observed in the preapproval database for ITCA 650 raises concern about the potentially greater risk versus other [GLP-1 RA] products in the postapproval setting: in the monitored setting of a clinical trial, some AKI may be prevented or mitigated, while this may not consistently occur in clinical practice. Moreover, the number of patients exposed to the ITCA 650 product would be much higher postapproval, and both of these factors differentiate the preapproval from the postapproval setting.
CDER reiterated in its presentation to the EMDAC that “no approved [GLP-1 RA-containing] product had an AKI imbalance in their premarket or postmarket clinical trials.” In response, Intarcia points to the AKI warning included in Wegovy's labeling, which it claims refutes the notion that no AKI imbalances occurred in the clinical trials for GLP-1 RA products. Intarcia's argument conflates AKI occurrence with an AKI imbalance. CDER does not claim that AKI events never occurred in GLP 1- RA related clinical trials, but rather that the number of events that occurred in FREEDOM led to an imbalance that was not seen for any other GLP-1 RA products in a randomized clinical trial. The relative number that occurred in FREEDOM distinguishes ITCA 650 from the other clinical trials for approved products containing a similar active ingredient, which may have had instances of AKI events but in a smaller proportion than ITCA 650 in the preapproval setting.
Intarcia specifically points to Wegovy as an example of another GLP-1 RA product that had an AKI imbalance in its randomized clinical trials and still received approval; however, that argument is not borne out by the data. As explained in CDER's proposed order:
Intarcia asserts that there was an imbalance in serious AKI events during titration in both Wegovy arms (1.0 mg and 2.4 mg) in Trial 4374 (STEP 2). Intarcia states that the percentage of participants with serious AKI for each arm in STEP 2, and in STEP 2 overall, was “identical” to the percentage of treatment-emergent serious AKI in [FREEDOM]. The STEP 2 trial demonstrated a rate of serious AKI adverse events of 0.5% for both the 2.4 mg and 1 mg arms (2 participants with serious AKI events per arm), and 0.2% for the placebo arm (1 participant with serious AKI events). Although Intarcia claims these percentages are comparable to the AKI risk demonstrated in [FREEDOM], there are too few events (
The PDC agrees with CDER's analysis. Indeed, considering that ITCA 650 showed an AKI imbalance in a preapproval trial, where no others in the class presented similar concerns, the PDC finds that ITCA 650 presents a higher risk than approved products containing a GLP-1 RA.
CDER described the connection between GI events to AKI occurrence in its briefing materials, stating that “CDER's review of the narratives of serious AKI events that occurred in the ITCA 650 treatment arms revealed 11of 14 events described GI symptoms (
Both CDER, and later the EMDAC, expressed concerns regarding cardiovascular safety. Specifically, the EMDAC felt that, after looking at the various data analyses, the CVOT did not adequately exclude the possibility that ITCA 650 is associated with an excess risk of cardiovascular harm. The EMDAC disagreed with Intarcia's view that, because its CVOT met the primary end point requirements and conformed to FDA guidance, those findings are sufficient alone to support approval of ITCA 650. The EMDAC concluded that,
On appeal, Intarcia contests both the need for another pre-approval CVOT, stating that its original pre-approval CVOT meta-analysis met CDER's primary end point requirements, and the comparison of its CVOT results to post-approval CVOTs for other products. Intarcia also contends that CDER's current analysis conflicts with previous statements. Lastly, Intarcia states that a “larger, longer,
Intarcia does not, however, dispute that the CVOT showed an HR estimate of 1.12, with a 95 percent confidence interval. Moreover, Intarcia does not challenge the number of MACE incidents or contend that collecting additional CVOT data is warranted. But the fundamental question is whether the data submitted with the NDA show a benefit-risk profile sufficient to establish the safety of ITCA 650 for approval. Whether, if ITCA 650 were approved, FDA would require a postmarketing CVOT is a separate issue. In the PDC's view, the cardiovascular data for ITCA 650 are troubling and do not characterize the risks associated with the product, including the cardiovascular risk, in a manner adequate to support the finding of safety necessary for approval.
Additionally, were the PDC to consider Intarcia's CVOT comparisons to other GLP-1 RA products, the PDC still finds that the ITCA 650 data does not adequately characterize the cardiovascular risks associated with ITCA 650. CDER analyzed FREEDOM in its EMDAC briefing materials and summarized its findings:
Notably, Table 21 [,which compared baseline subject characteristics across CVOTs in the GLP-1 RA class,] demonstrates that at baseline, a smaller proportion of subjects enrolled in FREEDOM had moderate or severe renal impairment than the trial populations of any other CVOT in the class, and the proportion of subjects with baseline [cardiovascular] disease was lower relative to most of the other [GLP-1 RA] CVOTs. This observation is reflected in the lower incidence of MACE in the placebo arm of the trial compared to the placebo arms of the other trials (Table 22). As noted above, imbalances in MACE events unfavorable to ITCA 650 were most pronounced in susceptible subgroups (
CDER concluded:
The primary and secondary endpoint analyses and all other prespecified analyses of CV risk, regardless of pooling or censoring strategy utilized, support the same conclusion: the results of FREEDOM, a dedicated CVOT which enrolled patients with T2DM at high CV risk, do not adequately exclude the possibility that ITCA 650 is associated with excess risk of CV harm.
On appeal, Intarcia merely dismisses CDER's analyses as scientifically unsound and reiterates that a postapproval CVOT is warranted because the preapproval CVOT met the primary endpoint requirements. However, the PDC agrees with CDER's analysis regarding comparisons between the preapproval clinical data offered in support of approved GLP-1 RA products and the data presented in support of ITCA 650 in this proceeding.
Diabetes is associated with an elevated risk of cardiovascular disease. The PDC finds that, while the original CVOT met the primary end point requirements, the PDC agrees with CDER's and EMDAC's concerns that the HR, especially in light of the other findings, does not provide adequate assurance that ITCA 650 is not associated with an increase in cardiovascular risk. Contrary to Intarcia's assertions, meeting the primary endpoints in the original CVOT is not sufficient, standing alone, to show that the existing clinical data adequately characterizes the cardiovascular risks associated with ITCA 650 to conclude that the product is safe. Meeting the primary endpoints is merely one data point in the overall assessment of the overall benefit-risk assessment of a medical product. As described by CDER in the briefing materials to the EMDAC and highlighted through tables 20-22 in those materials, the primary and secondary endpoint analyses, regardless of pooling strategy, supports that the data generated by FREEDOM, the only CVOT conducted thus far, do not adequately exclude the possibility that ITCA 650 is associated with excess risk of cardiovascular harm. As described in CDER's briefing materials to the EMDAC, “imbalances in MACE events unfavorable to ITCA 650 were most pronounced in susceptible subgroups (
Finally, in considering whether the benefits outweigh the risks for ITCA 650, the EMDAC also expressed concerns about the variability in drug delivery and the device itself. CDER's review of the data found that the IVR ranges for ITCA 650 are unacceptably wide, leading to concerns with dose accuracy. On appeal, Intarcia's states that its daily IVR testing meets the acceptance criteria and necessary confidence intervals and offers comparisons to other products on pharmacokinetic variability. Focusing on the issue of variability, the PDC finds that Intarcia has not presented adequate information to ensure that ITCA 650 would be safe for the proposed indication.
In its previous submissions, and in its appeal, Intarcia lists its proposed IVR range for each dosage target: for the 20 mcg/day device, from days 0 to 14, the proposed IVR range is 2 to 40 mcg/day, which represents 10 percent to 200 percent of the target dose. From days 14 to 91, the IVR range is 10 to 36 mcg/day, which represents 50 percent to 180 percent of the target dose. For the 60 mcg/day device, the IVR range for days 0 to 28 is 2 to 120 mcg/day, which represents 3.3 percent to 200 percent of the target dose. The IVR range for days 28 to 182 is 25 to 110 mcg/day, which represents 50 percent to 180 percent of the target dose. Intarcia states that these ranges are within a 95 percent confidence interval with 80-90 percent reliability, but they nonetheless reflect very wide acceptance criteria. For both the 20 mcg/day device and the 60 mcg/day device, after day 14, a patient could receive anywhere from 50 percent to 180 percent of the exenatide dose, which could also result in rapid shifts
Such wide acceptance criteria would allow for daily exenatide release that is not controlled sufficiently by the ITCA 650 device to safely meet clinical needs for the proposed indication. For example, because in steady state both ITCA 650 devices can deliver on a daily basis anywhere from 50% to 180% of the target dose of exenatide, rapid shifts in exenatide exposure could result. Increasing exposures to exenatide are known to result in gastrointestinal adverse reactions such as vomiting and diarrhea leading to dehydration, decreased intravascular volume, and AKI.
Intarcia argues that the GI concerns lessen after dose titration and escalation, but such a wide dosing range undermines that position. If patients are never assured of how much exenatide they are receiving, if they receive too little or too much, there is always an elevated risk of GI events with ITCA 650 in its present form.
In general, applicants propose acceptance criteria, and FDA may agree or disagree with the proposal, depending on the data. The data submitted by Intarcia are intended to show that the device meets the proposed acceptance criteria to a specific confidence interval. Even if the specific ITCA 650 performance data submitted are within a tighter range than the acceptance criteria proposed by Intarcia, those acceptance criteria are inappropriate because they would allow for manufacture of the device with unacceptably wide criteria. As stated in CDER's proposed order, “[t]he wide acceptance criteria specifications for both the 20 mcg/day and the 60 mcg/day devices would allow for drug release that is unreliable and not controlled sufficiently by the device to meet clinical needs.” The IVR acceptance criteria proposed by Intarcia are very wide and thus indicate that drug release is not well controlled by the device.
Additionally, given that the IVR ranges are so wide, the confidence interval and reliability percentages are low for ITCA 650. As CDER described in its proposed order,
CDER typically recommends that dose accuracy requirements are met with 95% confidence and 95% reliability. In this context, reliability is the probability that the device will perform satisfactorily for a specified period of time for the intended use. Because ITCA 650 is an implantable device that does not communicate device failures to the end user (
It is even more imperative that ITCA 650 doses reliably because it does not communicate device failures to the user. As explained by CDER in its briefing materials,
A patient may only discover that a device failure occurred during use due to the onset of symptoms related to the device failure. This lack of user awareness regarding the status of drug delivery necessitates a high degree of device reliability to ensure that use of the device is safe in patients.
Intarcia's analysis does not support its claims related to dose accuracy, given the low reliability percentages as well as the wide IVR specification ranges. The wide acceptance criteria specifications for both the 20 mcg/day and the 60 mcg/day devices would allow for drug release that is unreliable and not controlled sufficiently by the device to meet clinical needs. Given the rates of adverse events in the clinical trials for ITCA 650, as discussed above, it is reasonable to interpret those safety signals as potentially flowing from dosing variability. In short, the data do not support that the intended patient population would receive an accurate dose of exenatide each day, thereby leading to adverse health events.
Intarcia on appeal compares ITCA 650's IVR data to other products' data. The PDC does not find Intarcia's arguments regarding such comparisons to be persuasive. On appeal, Intarcia references another exenatide product, Byetta, which it says, “is known to have large swings in pharmacokinetic variability.” As noted in the proposed order, however, “Byetta is not an implanted device. Byetta (exenatide) is a twice daily injection indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.” CDER, in the proposed order, further explained, “The timing of the injections is specific and clearly outlined in the prescribing information. In contrast, as discussed in detail above, Intarcia's proposed IVR acceptance criteria are very wide and as such would allow for drug release that is not sufficiently controlled by the device.” Similarly, Bydureon, which Intarcia points to as an example of an exenatide product with comparable pharmacokinetic variability, is also not an implantable device but instead is a weekly injectable. CDER compared ITCA 650 and Bydureon's variability in its briefing materials and summarized the findings:
Quantification and comparison of within-subject variability (WSV) in pharmacokinetics is challenging for a few reasons. First, clinical trials do not typically collect frequent pharmacokinetic samples, particularly in time periods relevant to detect rapid concentration excursions. Secondly, the estimate of variability is sensitive to the nature of the chosen time window (duration of window, time between samples). Lastly, even if ideal data were available, within-subject variability does not quantify infrequent but dramatic spikes, but rather average variability (
Even if the PDC was to consider these other products, which are not implantable devices like ITCA 650, the PDC agrees with CDER and the EMDAC that the evidence and data presented in this proceeding suggests that ITCA 650 raises concerns with drug delivery variability that compare unfavorably to approved products with a similar or identical active ingredient.
The studies supporting ITCA 650's NDA, which were conducted in a controlled environment to measure drug delivery rates, demonstrated that the ITCA 650 does not provide an accurate and predictable release of exenatide. Given the information discussed above, the PDC finds that Intarcia's IVR data does not support the safety of the product given the wide IVR acceptance ranges and lower reliability percentages.
Having already addressed the safety-related concerns, the PDC will turn briefly to the benefits of ITCA 650. Intarcia states that the benefits of ITCA 650 include (1) an extended maintenance therapy option, (2) a dosing option with “unequivocal sustained efficacy with 6-month dosing,” and (3) safety in-line with other GLP-1s. Intarcia presented a letter signed by 12 experts in support of its arguments related to the benefits of ITCA 650.
The main benefits that Intarcia highlights relate to its position that ITCA 650 is a valuable new dosing option because it may increase medication adherence. Intarcia has not provided data in support of its argument but instead bases this assertion on the fact that ITCA-650 is an implantable device that lasts for 3 or 6 months. However, the evidence offered in support of approval undermines Intarcia's position. As previously discussed, ITCA 650 has dose reliability and variability issues. As previously outlined in the EMDAC discussion summary, multiple EMDAC members expressed concern that the drug delivery variability issue could lead to patients receiving less reliable drug doses than if they were using an analogous drug regimen that was not delivered via an implanted osmotic pump. Therefore, if ITCA 650 does not provide the proper dose, a patient would become nonadherent to their medication, regardless of the patient's intentions. The PDC therefore disagrees with Intarcia and its experts that the mode of drug delivery inherently equates to medication adherence. Furthermore, as found by CDER in its proposed order, “Intarcia has provided no evidence that demonstrates patients prescribed ITCA 650 are more likely to continue the treatment than patients prescribed other approved treatments for type 2 diabetes.” Given the lack of concrete information to support its theoretical argument, the PDC gives little weight to this benefit in the overall assessment of whether the benefit-risk assessment supports approval of ITCA 650 in its present form.
While Intarcia correctly points out in its appeal that more therapies are needed for patients with T2DM, FDA will only approve NDAs when the data shows that the benefits outweigh the risks. After reviewing the information contained in the public record, the PDC finds that the benefits of ITCA 650 do not outweigh its risks. The PDC agrees with the EMDAC's conclusions and find that there are too many unanswered questions regarding risks associated with ITCA 650 to find that it has a positive benefit-risk profile and is safe under section 505(d)(2) of the FD&C Act. For the reasons described above, Intarcia has not presented adequate evidence to show that the drug is safe for use under the proposed conditions; therefore, the PDC cannot approve the NDA for ITCA 650.
For the reasons described above, FDA finds that the record shows that the approval criteria set forth in section 505(d)(2) of the FD&C Act have not been met, as ITCA 650's risks outweigh its benefits; therefore, Intarcia has not demonstrated that ITCA 650 is safe for its intended use. Therefore, under section 505(d) of the FD&C Act, FDA hereby denies approval to Intarcia's NDA in its current form.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or Agency) is announcing the issuance of Emergency Use Authorizations (EUAs) (the Authorizations) for certain medical devices related to Coronavirus Disease 2019 (COVID-19). FDA has issued the Authorizations listed in this document under the Federal Food, Drug, and Cosmetic Act (FD&C Act). These Authorizations contain, among other things, conditions on the emergency use of the authorized products. The Authorization follows the February 4, 2020, determination by the Secretary of Health and Human Services (HHS), as amended on March 15, 2023, that there is a public health emergency, or a significant potential for a public health emergency, that affects, or has a significant potential to affect, national security or the health and security of U.S. citizens living abroad and that involves the virus that causes COVID-19, and the subsequent declarations on February 4, 2020, March 2, 2020, and March 24, 2020, that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of the virus that causes COVID-19, personal respiratory protective devices, and medical devices, including alternative products used as medical devices, respectively, subject to the terms of any authorization issued under the FD&C Act. These Authorizations, which include an explanation of the reasons for issuance, are listed in this document, and can be accessed on FDA's website from the links indicated.
These Authorizations are effective on their date of issuance.
Submit written requests for single copies of an EUA to the Office of Policy, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request or include a fax number to which the Authorization may be sent. See the
Kim Sapsford-Medintz, Office of Product Evaluation and Quality, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3216, Silver Spring, MD 20993-0002, 301-796-0311 (this is not a toll-free number).
Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) allows FDA to strengthen the public health protections against biological, chemical, radiological, or nuclear agent or agents. Among other things, section 564 of the FD&C Act allows FDA to authorize the use of an unapproved medical product or an unapproved use of an approved medical product in certain situations. With this EUA authority, FDA can help ensure that medical countermeasures may be used in emergencies to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by a biological, chemical, radiological, or nuclear agent or agents when there are no adequate, approved, and available alternatives.
Section 564(b)(1) of the FD&C Act provides that, before an EUA may be issued, the Secretary of HHS must declare that circumstances exist justifying the authorization based on one of the following grounds: (1) a determination by the Secretary of Homeland Security that there is a domestic emergency, or a significant potential for a domestic emergency, involving a heightened risk of attack with a biological, chemical, radiological, or nuclear agent or agents; (2) a determination by the Secretary of Defense that there is a military emergency, or a significant potential for
Once the Secretary of HHS has declared that circumstances exist justifying an authorization under section 564 of the FD&C Act, FDA may authorize the emergency use of a drug, device, or biological product if the Agency concludes that the statutory criteria are satisfied. Under section 564(h)(1) of the FD&C Act, FDA is required to publish in the
An electronic version of this document and the full text of the Authorizations are available on the internet and can be accessed from
Having concluded that the criteria for the issuance of the following Authorizations under section 564(c) of the FD&C Act are met, FDA has authorized the emergency use of the following products for diagnosing, treating, or preventing COVID-19 subject to the terms of each Authorization. The Authorizations in their entirety, including any authorized fact sheets and other written materials, can be accessed from FDA's web page entitled “Emergency Use Authorization,” available at
FDA is hereby announcing the following Authorizations for multianalyte tests:
• Nano-Ditech Corporation's Nano-Check Influenza+COVID-19 Dual Test, issued on July 08, 2024.
• ACON Laboratories, Inc.'s Flowflex Plus COVID-19 and Flu A/B Home Test, issued on July 23, 2024.
Department of Health and Human Services (HHS), Office of the Assistant Secretary for Health (OASH), Office of Disease Prevention and Health Promotion; Department of Agriculture (USDA), Food, Nutrition, and Consumer Services (FNCS).
Notice.
The Departments of Health and Human Services and Agriculture announce the sixth meeting of the 2025 Dietary Guidelines Advisory Committee (Committee). This meeting will be open to the public virtually.
The sixth Committee meeting will be held on September 25, 2024, from 9:00 a.m. to 4:30 p.m. Eastern Time and on September 26, 2024, from 8:30 a.m. to 3:00 p.m. Eastern Time. Registration is required for the livestream and opens to the public on August 26, 2024, at
The meeting will be accessible online via livestream and recorded for later viewing. Registrants will receive the livestream information prior to the meeting.
Designated Federal Officer, 2025 Dietary Guidelines Advisory Committee, Janet M. de Jesus, MS, RD; Office of Disease Prevention and Health Promotion, 1101 Wootton Parkway, Suite 420, Rockville, MD 20852; Phone: 240-453-8266; Email
Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the Advisory Committee to the Deputy Director for Intramural Research, National Institutes of Health.
The meeting will be held as a virtual meeting and will be open to the public as indicated below. Individuals who plan to view the virtual meeting and need special assistance or other reasonable accommodations to view the meeting, should notify the Contact Person listed below in advance of the meeting.
Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person.
Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 1009 of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
United States Coast Guard, Department of Homeland Security.
Notice of open Federal advisory committee meetings.
The National Offshore Safety Advisory Committee (Committee) will meet in-person along with the SEACOR POWER and Dynamic Positioning subcommittees over two days in Spring, Texas to discuss matters relating to activities directly involved with, or in support of, the exploration of offshore mineral and non-mineral energy resources, to the extent that such matters are within the jurisdiction of the United States Coast Guard. These three meetings will be open to the public.
The full Committee will meet on Wednesday, September 18, 2024, from 8 a.m. to 5:30 p.m. (CDT). Please note these meetings may end early if the subcommittees or the full Committee have completed their business.
The three meetings will be held at American Bureau of Shipping Global Headquarters, 1701 City Place Drive, Spring, TX 77389.
The National Offshore Safety Advisory Committee is committed to ensuring all participants have equal access regardless of disability status. If you require reasonable accommodations due to a disability to fully participate, please email Mr. Patrick Clark at
Additionally, if you go to the online docket and sign-up for email alerts, you will be notified when comments are posted.
Mr. Patrick W. Clark, Designated Federal Officer of the National Offshore Safety Advisory Committee, telephone 571-607-8236 or email
Notice of these three meetings is given pursuant to the
The Committee operates under the provisions of the
Two subcommittees will meet to discuss the following task statements.
(1) Task Statement 01-2023: SEACOR POWER—Review National Transportation Safety Board (NTSB) report concerning the capsizing of the U.S. flagged liftboat SEACOR POWER.
(2) Task Statement 01-2024: Dynamic Positioning—Review the industry standards that may enhance safety of Dynamic Positioning vessels and operations on the Outer Continental Shelf (OCS).
The task statements and other subcommittee information are located at
The agenda of each subcommittee meeting will include the following:
(1) Call to order by subcommittee Chair.
(2) Introduction and review subcommittee task statement.
Subcommittee discussion and preparation of draft recommendations for the full Committee meeting on September 18, 2024.
(3) Public comment period.
(4) Subcommittee members approve final draft recommendations to send to the full
Committee.
(5) Adjournment of meeting.
The agenda for the September 18, 2024 Committee meeting is as follows:
(1) Call to order.
(2) Roll call and determination of quorum.
(3) Adoption of previous meeting minutes and agenda.
(4) Opening remarks.
(5) SEACOR POWER Subcommittee Chair briefs the Final Draft Report to the Committee.
(6) Committee deliberation.
(7) Committee voting.
(8) Update from the Dynamic Positioning subcommittee.
(9) New business—Issuance of three task statements on Sexual Assault and Sexual
Harassment.
(10) Public comment period.
(11) Closing remarks and plans for next meeting.
(12) Adjournment of meeting.
A copy of all pre-meeting documentation will be available at:
Federal Emergency Management Agency, Department of Homeland Security.
Notice.
New or modified Base (1-percent annual chance) Flood
Each LOMR was finalized as in the table below.
Each LOMR is available for inspection at both the respective Community Map Repository address listed in the table below and online through the FEMA Map Service Center at
Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance and Mitigation Administration, FEMA, 400 C Street SW, Washington, DC 20472, (202) 646-7659, or (email)
The Federal Emergency Management Agency (FEMA) makes the final flood hazard determinations as shown in the LOMRs for each community listed in the table below. Notice of these modified flood hazard determinations has been published in newspapers of local circulation and 90 days have elapsed since that publication. The Deputy Associate Administrator for Insurance and Mitigation has resolved any appeals resulting from this notification.
The modified flood hazard determinations are made pursuant to section 206 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4105, and are in accordance with the National Flood Insurance Act of 1968, 42 U.S.C. 4001
The new or modified flood hazard information is the basis for the floodplain management measures that the community is required either to adopt or to show evidence of being already in effect in order to remain qualified for participation in the National Flood Insurance Program (NFIP).
This new or modified flood hazard information, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own or pursuant to policies established by other Federal, State, or regional entities.
This new or modified flood hazard determinations are used to meet the floodplain management requirements of the NFIP. The changes in flood hazard determinations are in accordance with 44 CFR 65.4.
Interested lessees and owners of real property are encouraged to review the final flood hazard information available at the address cited below for each community or online through the FEMA Map Service Center at
Transportation Security Administration, DHS.
30-Day notice.
This notice announces that the Transportation Security Administration (TSA) has forwarded the Information Collection Request (ICR), Office of Management and Budget (OMB) control number 1652-0059, abstracted below to OMB for review and approval of a revision of the currently approved collection under the Paperwork Reduction Act (PRA). The ICR describes the nature of the information collection and its expected burden. The collection involves the submission of biographic and biometric information by individuals seeking to enroll in the TSA PreCheck® (also known as TSA Pre✓®) Application Program, as well as optional surveys related to customer service and enrollment processes.
Send your comments by September 23, 2024. A comment to OMB is most effective if OMB receives it within 30 days of publication.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Christina A. Walsh, TSA PRA Officer, Information Technology (IT), TSA-11, Transportation Security Administration, 6595 Springfield Center Drive, VA 22150; telephone (571) 227-2062; email
TSA published a
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
(1) Evaluate whether the proposed information requirement is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2) Evaluate the accuracy of the agency's estimate of the burden;
(3) Enhance the quality, utility, and clarity of the information to be collected; and
(4) Minimize the burden of the collection of information on those who are to respond, including using appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
Although participation in the TSA PreCheck® Application Program is voluntary, individuals must submit biographic, biometric,
As part of this process, TSA sends the applicants' fingerprints and associated information to the Federal Bureau of Investigation (FBI) for the purpose of comparing their fingerprints to other fingerprints in the FBI's Next Generation Identification (NGI) system or its successor systems including civil, criminal, and latent fingerprint repositories. The FBI may retain applicants' fingerprints and associated information in NGI after the completion of their application and, while retained, their fingerprints may continue to be compared against other fingerprints submitted to or retained by NGI as part of the FBI's Rap Back program.
TSA uses the STA results to decide if an individual poses a low risk to transportation or national security. TSA issues approved applicants a known traveler number (KTN) that they may use when making travel reservations. Airline passengers who submit a KTN when making airline reservations are eligible for expedited screening on flights originating from U.S. airports and select international locations including Nassau, Bahamas.
When the STA is complete, TSA makes a final determination on eligibility for the TSA PreCheck® Application Program and notifies applicants of its decision. Most applicants generally should expect to receive notification from TSA within three to five days and up to 60 days from the submission of their completed applications. If initially deemed ineligible by TSA, applicants will have an opportunity to correct cases of misidentification or inaccurate criminal records. Applicants must submit a correction of any information they believe to be inaccurate within 60 days of issuance of TSA's letter. If a corrected record is not received by TSA within the specified amount of time, the agency may make a final determination to deny eligibility. Individuals who TSA determines are ineligible for the TSA PreCheck® Application Program will undergo standard or other screening at airport security checkpoints.
The TSA PreCheck® Application Program enhances aviation security by permitting TSA to better focus its limited security resources on passengers who are unknown to TSA and whose level of risk is undetermined, while also facilitating and improving the commercial aviation travel experience for the public. Travelers who choose not to enroll in this initiative are not subject to any limitations on their travel because of their choice; they will be processed through normal TSA screening before entering the sterile areas of airports. TSA also retains the authority to perform standard or other screening on a random basis on TSA PreCheck® Application Program participants and any other travelers authorized to receive expedited physical screening.
The introduction of additional enrollment providers, as discussed in the previous ICR revision, allows enrollment providers to offer multiple price points for TSA PreCheck® enrollment and renewal as well as additional enrollment locations, which will allow the public to select the best option for their needs. TSA plans to explore new enrollment capabilities to include remote proctored enrollment
Inter-American Foundation.
Notice of information collection; request for comment.
Under the provisions of the Paperwork Reduction Act, agencies are required to publish a Notice in the
Comments must be received by September 23, 2024.
Comments and requests for copies of the subject information collection may be sent by any of the following methods:
•
•
Associate General Counsel: Nicole Stinson, (202) 683-7117.
The agency received a comment in response to the sixty (60) day notice published in
Geological Survey, Department of the Interior.
Notice of information collection; request for comment.
In accordance with the Paperwork Reduction Act of 1995 (PRA), the U.S. Geological Survey (USGS) National Wildlife Health Center (NWHC) is proposing a new information collection in use without OMB approval.
Interested persons are invited to submit comments on or before September 23, 2024.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
To request additional information about this information collection request (ICR), contact Katherine Richgels by email at
In accordance with the PRA (44 U.S.C. 3501
A
As part of our continuing effort to reduce paperwork and respondent burdens, we are again soliciting comments from the public and other Federal agencies on the proposed ICR that is described below. We are especially interested in public comment addressing the following:
(1) Whether or not the collection of information is necessary for the proper performance of the functions of the agency, including whether or not the information will have practical utility;
(2) The accuracy of our estimate of the burden for this collection of information, including the validity of the methodology and assumptions used;
(3) Ways to enhance the quality, utility, and clarity of the information to be collected; and
(4) How the agency might minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
Comments that you submit in response to this notice are a matter of public record. We will include or summarize each comment in our request to OMB to approve this ICR. Before including your address, phone number, email address, or other personally identifiable information (PII) in your comment, you should be aware that your entire comment—including your PII—may be made publicly available at any time. While you can ask us in your comment to withhold your PII from public review, we cannot guarantee that we will be able to do so.
Wildlife health information is shared in international health monitoring efforts through the NWHC's role (along with the Canadian Wildlife Health Cooperative) as a Collaborating Centre for Research, Diagnosis, and Surveillance of Wildlife Pathogens within the World Organization for Animal Health. The NWHC is also a Reference Center for Wildlife Health and Wildlife Disease, a member of the U.S. Department of Agriculture National Animal Health Laboratory Network, and a Food and Agriculture Organization of the United Nations Reference Center for Wildlife Health and Wildlife Disease Diagnostics.
An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.
The authority for this action is the PRA of 1995 (44 U.S.C. 3501
Bureau of Land Management, Interior.
Notice of public meeting.
In accordance with the Federal Land Policy and Management Act of 1976 and the Federal Advisory Committee Act of 1972, the U.S. Department of the Interior, Bureau of Land Management's (BLM) Western Montana Resource Advisory Council (RAC) will meet as follows.
The RAC will hold a meeting on September 24, 2024, from 9 a.m. to 4 p.m. Mountain Time (MT). A virtual participation option will be available to the public. Individuals who want to participate virtually must register at least 1 week in advance of the meeting to allow the BLM time to plan for the number of individuals who wish to participate.
The meeting will be held at the BLM Butte Field Office, 106 North Parkmont, Butte, MT 59701. The final agenda and virtual participation instructions will be confirmed for the public via BLM online announcement, social media, on the RAC's web page at
Written comments for the RAC may be sent electronically in advance of the scheduled meeting to Ann Boucher,
Ann Boucher, BLM Montana/Dakotas State Office, telephone: (406) 896-5255, email:
Please make requests in advance for sign language interpreter services, language translation services, assistive listening devices, or other reasonable accommodations. We ask that you contact the person listed above at least 14 business days prior to the meeting to give the Department of the Interior sufficient time to process your request. All reasonable accommodation requests are managed on a case-by-case basis.
The RAC provides recommendations to the Secretary of the Interior concerning the planning and management of the public land resources located within the BLM's Western Montana District. Agenda topics for the September 24, 2024, meeting include a discussion about the Madison River Fee Proposal, updates from field managers, and other resource management issues the RAC may raise. While the meeting is scheduled to conclude at 4 p.m. MT, it may end earlier or later depending on the needs of RAC members. Therefore, members of the public interested in a specific agenda item or discussion should schedule their arrival accordingly.
The meeting is open to the public and a 30-minute public comment period will be offered at 3:30 p.m. MT. Depending on the number of persons wishing to speak and the time available, the amount of time for oral comments may be limited. Before including your address, phone number, email address, or other personal identifying information in written comments, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
Detailed minutes for RAC meetings are maintained in the BLM Western Montana District Office. Minutes will also be posted to the RAC's web page at:
Bureau of Land Management.
Notice of availability.
In compliance with the National Environmental Policy Act of 1969, as amended (NEPA), and the Federal Land Policy and Management Act of 1976, as amended (FLPMA), the Bureau of Land Management (BLM) has prepared a Proposed Resource Management Plan (RMP) and Final Environmental Impact Statement (EIS) for the Rock Springs Field Office and by this notice is announcing the start of a 30-day protest period of the Proposed RMP.
This notice announces a 30-day protest period to the BLM on the Proposed RMP beginning with the date of the Environmental Protection Agency's (EPA) publication of its Notice of Availability (NOA) of the Proposed RMP/Final EIS in the
The Proposed RMP and Final EIS is available on the BLM ePlanning project website at
Instructions for filing a protest with the BLM for the Rock Springs Field Office RMP Revision can be found at:
Kimberlee Foster, Field Manager, telephone 307-352-0201; address 280 HWY 191 N, Rock Springs, WY 82901; email
The planning area is located in portions of Lincoln, Sweetwater, Uinta, Sublette, and Fremont counties in southwestern Wyoming and encompasses approximately 3.6 million acres of public land.
Resources on lands administered by the BLM within the planning area are currently managed under the Green River RMP (1997) and Jack Morrow Hills Coordinated Activity Plan (2006), as amended. The Green River RMP encompasses multiple Areas of Critical Environmental Concern, Special Management Areas, and Wilderness Study Areas.
This Final EIS documents the comprehensive analysis of alternatives for the planning and management of public lands and resources administered by the Rock Springs Field Office. The Field Office administers various programs, including mineral exploration and development, renewable energy, wildlife habitat, outdoor recreation, wild horses, livestock grazing, and historic trails. The Final EIS provides analysis of potential management direction for important resource values and resource uses within the planning area and allocates the use of public lands for multiple uses. The Final EIS also provides management direction for the protection of certain resources while allowing for leasing and development of mineral resources, livestock grazing, and other activities at appropriate levels.
The Proposed RMP was developed in response to public comment on the Draft EIS (published in August 2023) and is a mix of the other four alternatives analyzed. The Proposed RMP alternative provides for conservation of resource values with appropriate constraints on other resource uses, while addressing public concerns regarding flexibility for development, especially in areas most likely to yield energy and mineral resources.
The Proposed RMP provides for the improvement and protection of habitat for wildlife and sensitive plant and animal species, improvement of riparian areas, and implementation of management actions that improve water quality and enhance protection of cultural resources, as well as ensuring opportunities for recreation and responsible energy development.
The BLM planning regulations state that any person who participated in the preparation of the RMP and has an interest that will or might be adversely affected by approval of the Proposed RMP may protest its approval to the BLM Director. Protest of the Proposed RMP constitutes the final opportunity for administrative review of the proposed land use planning decisions prior to the BLM adopting an approved RMP. Instructions for filing a protest regarding the Proposed RMP with the BLM Director may be found online at
National Park Service, Interior.
Notice.
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the California Department of Parks and Recreation intends to repatriate certain cultural items that meet the definition of objects of cultural patrimony and that have a cultural affiliation with the Indian Tribes or Native Hawaiian organizations in this notice.
Repatriation of the cultural items in this notice may occur on or after September 23, 2024.
Dr. Leslie L. Hartzell, NAGPRA Coordinator, California Department of Parks and Recreation, P.O. Box 942896, Sacramento, CA 94296-0001, telephone (916) 653-5910, email
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of the California Department of Parks and Recreation, and additional information on the determinations in this notice, including the results of consultation, can be found in the summary or related records. The National Park Service is not responsible for the determinations in this notice.
A total of 54 lots of cultural items have been requested for repatriation. The objects of cultural patrimony are modified bone, modified shell, modified stone, and unmodified bone.
In 1975-76, one lot of an object of cultural patrimony was removed from CA-PLA-158 (ACCN.P159), Placer County, CA. The object was removed as part of a surface survey to determine the feasibility and impact of day-use facilities. This survey was overseen by the California Department of Parks and Recreation. The object of cultural patrimony is modified stone.
In 1977, 22 lots of cultural items were removed from CA-PLA-243 and CA-PLA-244 (ACCN.P228), Placer County,
In 1977, one lot of cultural items was removed from CA-PLA-254 (ACCN.P228) Placer County, CA. The California Department of Parks and Recreation removed the objects during a surface survey. The items of cultural patrimony are modified stone.
In 1977, two lots of cultural items was removed from CA-PLA-259 (ACCN.P228), Placer County, CA. The California Department of Parks and Recreation removed the objects during a surface survey. The items of cultural patrimony are modified stone.
The 23 lots of cultural items were removed from CA-SUT-57 (ACCN.P388), Sutter County, CA, which was accessioned into California Department of Parks and Recreation in or before 1982. The objects of cultural patrimony are modified bone, modified shell, modified stone, and unmodified bone.
From 2004-05, two lots of objects of cultural patrimony were removed from CA-SUT-167/H (ACCN.P1420) Sutter County, CA. The objects were found during a surface survey. The object of cultural patrimony is modified stone.
From 2004-05, one lot of an object of cultural patrimony was removed from Sutter County, CA. The object was found during a surface survey. The cultural items are modified stone.
From 2004-05, one lot of an object of cultural patrimony was removed from SUT-ISO (ACCN.1420), Sutter County, CA. The object was found during a surface survey. The cultural items are modified stone.
In December 1959, one lot of cultural items was removed from CA-YUB-13 (ACCN.230), Yuba County, CA. The excavation was directed by the California Department of State Parks. The objects of cultural patrimony are unmodified bone.
The California Department of Parks and Recreation has determined that:
• The 54 lots of objects of cultural patrimony described in this notice have ongoing historical, traditional, or cultural importance central to the Native American group, including any constituent sub-group (such as a band, clan, lineage, ceremonial society, or other subdivision), according to the Native American traditional knowledge of an Indian Tribe or Native Hawaiian organization.
• There is a reasonable connection between the cultural items described in this notice and the Cachil DeHe Band of Wintun Indians of the Colusa Indian Community of the Colusa Rancheria, California; Enterprise Rancheria of Maidu Indians of California; Ione Band of Miwok Indians of California; Mooretown Rancheria of Maidu Indians of California; Shingle Springs Band of Miwok Indians, Shingle Springs Rancheria (Verona Tract), California; United Auburn Indian Community of the Auburn Rancheria of California; Wilton Rancheria, California; and the Yocha DeHe Wintun Nation, California.
Additional, written requests for repatriation of the cultural items in this notice must be sent to the authorized representative identified in this notice under
Repatriation of the cultural items in this notice to a requestor may occur on or after September 23, 2024. If competing requests for repatriation are received, the California Department of Parks and Recreation must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the cultural items are considered a single request and not competing requests. The California Department of Parks and Recreation is responsible for sending a copy of this notice to the Indian Tribes and Native Hawaiian organizations identified in this notice and to any other consulting parties.
National Park Service, Interior.
Notice.
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the San Francisco State University (SF State) NAGPRA Program intends to repatriate certain cultural items that meet the definition of objects of cultural patrimony and that have a cultural affiliation with the Indian Tribes or Native Hawaiian organizations in this notice.
Repatriation of the cultural items in this notice may occur on or after September 23, 2024.
Elise Green, San Francisco State University NAGPRA Program, 1600 Holloway Avenue, San Francisco, CA 94132, telephone (415) 338-1381, email
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of the SF State NAGPRA Program and additional information on the determinations in this notice, including the results of consultation, can be found in the summary or related records. The National Park Service is not responsible for the determinations in this notice.
A total of three cultural items have been requested for repatriation. The three objects of cultural patrimony are a grass bundle coiled flat basket, a coiled basket, and a fiber sandal. Two baskets were donated to the Treganza Anthropology Museum (TAM) at San Francisco State University in the 1960s and 1970s. When the TAM closed in 2012, all the Native American items were transferred to the SF State NAGPRA Program. Both baskets are from the Southwest Collection and there are no records of the donors at SF State. The site where the fiber sandal was discovered (Kingman, AZ) is located on the aboriginal lands of the Hualapai Tribe. The fiber sandal was found by SF State Professor Gary Paul and brought back to campus.
It was once common practice by museums to use chemicals on cultural
The SF State NAGPRA Program has determined that:
• The three objects of cultural patrimony described in this notice have ongoing historical, traditional, or cultural importance central to the Native American group, including any constituent sub-group (such as a band, clan, lineage, ceremonial society, or other subdivision), according to the Native American traditional knowledge of an Indian Tribe or Native Hawaiian organization.
• There is a reasonable connection between the cultural items described in this notice and the Hualapai Indian Tribe of the Hualapai Indian Reservation, Arizona.
Additional, written requests for repatriation of the cultural items in this notice must be sent to the authorized representative identified in this notice under
Repatriation of the cultural items in this notice to a requestor may occur on or after September 23, 2024. If competing requests for repatriation are received, the SF State NAGPRA Program must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the cultural items are considered a single request and not competing requests. The SF State NAGPRA Program is responsible for sending a copy of this notice to the Indian Tribes and Native Hawaiian organizations identified in this notice and to any other consulting parties.
National Park Service, Interior.
Notice.
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the American Museum of Natural History (AMNH) intends to repatriate certain cultural items that meet the definition of objects of cultural patrimony and that have a cultural affiliation with the Indian Tribe in this notice.
Repatriation of the cultural items in this notice may occur on or after September 23, 2024.
Nell Murphy, American Museum of Natural History, Central Park West at 79th Street, New York, NY 10024, telephone (212) 769-5837, email
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of the AMNH, and additional information on the determinations in this notice, including the results of consultation, can be found in the summary or related records. The National Park Service is not responsible for the determinations in this notice.
A total of 66 cultural items have been requested for repatriation. The 66 objects of cultural patrimony comprise a Thunder Medicine Pipe Bundle. The cultural items were accessioned by the Museum in 1904 and 1905 and were acquired from Dr. Clark Wissler through a Museum expedition to the Blackfeet community in Montana.
The American Museum of Natural History has determined that:
• The 66 objects of cultural patrimony described in this notice are objects that have ongoing historical, traditional, or cultural importance central to a Native American group, including any constituent sub-group (such as a band, clan, lineage, ceremonial society, or other subdivision), according to the Native American traditional knowledge of an Indian Tribe or Native Hawaiian organization.
• There is a reasonable connection between the cultural items described in this notice and the Blackfeet Tribe of the Blackfeet Indian Reservation of Montana.
Additional, written requests for repatriation of the cultural items in this notice must be sent to the authorized representative identified in this notice under
Repatriation of the cultural items in this notice to a requestor may occur on or after September 23, 2024. If competing requests for repatriation are received, the AMNH must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the cultural items are considered a single request and not competing requests. The AMNH is responsible for sending a copy of this notice to the Indian Tribes identified in this notice.
National Park Service, Interior.
Notice.
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the Allen Memorial Art Museum at Oberlin
Repatriation of the cultural item in this notice may occur on or after September 23, 2024.
Dr. Amy Margaris, Oberlin College, Department of Anthropology, King Building, 10 N Professor Street, Oberlin, OH 44074, telephone (440) 775-5173, email
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of Oberlin College, and additional information on the determinations in this notice, including the results of consultation, can be found in the summary or related records. The National Park Service is not responsible for the determinations in this notice.
A total of one cultural item has been requested for repatriation. The one unassociated funerary object is a ceramic vessel. The vessel (object number 1920.8, “Water Bottle in the Shape of a Bird”) is housed in the Allen Memorial Art Museum (AMAM) on the campus of Oberlin College and was attributed in some AMAM records as Peruvian (Chimú) in origin. However, other AMAM records describe it as “American Indian, 1100-1400, Gift of Mrs. H.H. Wright, 1920” which accords with a paper label on the vessel bottom that reads “This Water Jar was taken from a [. . .] grave in Prehistoric gravey [. . ., presumably “graveyard”] S of Nashville—Aug. 1885. H.” [. . ., presumably H.H. Wright]. Herbert H. Wright was an 1873 graduate of Oberlin College who served as professor of mathematics and music at Fisk University in Nashville, TN, and is described in
Oberlin College has determined that:
• The one unassociated funerary object described in this notice is reasonably believed to have been placed intentionally with or near human remains, and is connected, either at the time of death or later as part of the death rite or ceremony of a Native American culture according to the Native American traditional knowledge of an Indian Tribe. The unassociated funerary object has been identified by a preponderance of the evidence as removed from a specific burial site with cultural affiliation to an Indian Tribe.
• There is a reasonable connection between the cultural item described in this notice and the Cherokee Nation; Eastern Band of Cherokee Indians; and the United Keetoowah Band of Cherokee Indians in Oklahoma.
Additional, written requests for repatriation of the cultural items in this notice must be sent to the authorized representative identified in this notice under
Repatriation of the cultural items in this notice to a requestor may occur on or after September 23, 2024. If competing requests for repatriation are received, Oberlin College must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the cultural items are considered a single request and not competing requests. Oberlin College is responsible for sending a copy of this notice to the Indian Tribes and Native Hawaiian organizations identified in this notice and to any other consulting parties.
National Park Service, Interior.
Notice.
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the Culver-Stockton College intends to repatriate certain cultural items that meet the definition of objects of cultural patrimony and that have a cultural affiliation with the Indian Tribes or Native Hawaiian organizations in this notice.
Repatriation of the cultural items in this notice may occur on or after September 23, 2024.
C. Patrick Hotle, Culver-Stockton College, No. 1 College Hill, Canton, MO 63435, telephone (217) 592-2300, email
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of Culver-Stockton College, and additional information on the determinations in this notice, including the results of consultation, can be found in the summary or related records. The National Park Service is not responsible for the determinations in this notice.
A total of two cultural items have been requested for repatriation. The two objects of cultural patrimony are ceremonial clubs. The first object, part of the Paul Corey collection given to the college in 1977, is a ceremonial club from Skamania Co. Washington. It is fourteen by five inches long, of grayish brown color. The geographical location is written on a label attached to the club. Nothing more is known about the object. The second ceremonial club is also from the Paul Corey collection given to the college in 1977. It is from Sherman Co., Oregon. It is eleven and one-half by three and one-half inches and grayish brown in color. The geographical location is written on a label attached to the club. Nothing more is known about the object.
The Culver-Stockton College has determined that:
• The two objects of cultural patrimony described in this notice have ongoing historical, traditional, or cultural importance central to the Native American group, including any constituent sub-group (such as a band, clan, lineage, ceremonial society, or other subdivision), according to the Native American traditional knowledge of an Indian Tribe or Native Hawaiian organization.
• There is a reasonable connection between the cultural items described in this notice and the Confederated Tribes and Bands of the Yakama Nation; Confederated Tribes of the Umatilla Indian Reservation; and the Confederated Tribes of the Warm Springs Reservation of Oregon.
Additional, written requests for repatriation of the cultural items in this notice must be sent to the authorized representative identified in this notice under
Repatriation of the cultural items in this notice to a requestor may occur on or after September 23, 2024. If competing requests for repatriation are received, the Culver-Stockton College must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the cultural items are considered a single request and not competing requests. The Culver-Stockton College is responsible for sending a copy of this notice to the Indian Tribes and Native Hawaiian organizations identified in this notice and to any other consulting parties.
National Park Service, Interior.
Notice.
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the Stamford Museum & Nature Center intends to repatriate certain cultural items that meet the definition of unassociated funerary objects and that have a cultural affiliation with the Indian Tribes or Native Hawaiian organizations in this notice.
Repatriation of the cultural items in this notice may occur on or after September 23, 2024.
Roanne Wilcox, Stamford Museum & Nature Center, 39 Scofieldtown Road, Stamford, CT 06903, telephone (203) 977-6543, email
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of the Stamford Museum & Nature Center, and additional information on the determinations in this notice, including the results of consultation, can be found in the summary or related records. The National Park Service is not responsible for the determinations in this notice.
A total of two cultural items have been requested for repatriation. The two unassociated funerary objects are clay elbow pipes. One pipe is labeled “Grave,” Miss.”, the other pipe is labeled “Grave, Jefferson Co., Ark. 1938.”
The Stamford Museum & Nature Center has determined that:
• The two unassociated funerary objects described in this notice are reasonably believed to have been placed intentionally with or near human remains, and are connected, either at the time of death or later as part of the death rite or ceremony of a Native American culture according to the Native American traditional knowledge of a lineal descendant, Indian Tribe, or Native Hawaiian organization. The unassociated funerary objects have been identified by a preponderance of the evidence as related to human remains, specific individuals, or families, or removed from a specific burial site or burial area of an individual or individuals with cultural affiliation to an Indian Tribe or Native Hawaiian organization.
• There is a reasonable connection between the cultural items described in this notice and The Osage Nation.
Additional, written requests for repatriation of the cultural items in this notice must be sent to the authorized representative identified in this notice under
Repatriation of the cultural items in this notice to a requestor may occur on or after September 23, 2024. If competing requests for repatriation are received, the Stamford Museum & Nature Center must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the cultural items are considered a single request and not competing requests. The Stamford Museum & Nature Center is responsible for sending a copy of this notice to the Indian Tribes and Native Hawaiian organizations identified in this notice and to any other consulting parties.
National Park Service, Interior.
Notice.
In accordance with the Native American Graves Protection and
Repatriation of the cultural item in this notice may occur on or after September 23, 2024.
Dr. Lara Noldner, Office of the State Archaeologist Bioarchaeology Program, University of Iowa, 700 S Clinton Street, Iowa City, IA 52242, telephone (319) 384-0740, email
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of the OSA-BP, and additional information on the determinations in this notice, including the results of consultation, can be found in the summary or related records. The National Park Service is not responsible for the determinations in this notice.
A total of one cultural item has been requested for repatriation. The sacred object is an elkhorn beaded necklace. This item was acquired by James West at an unknown time; a note with the necklace indicates it originated from an estate sale in southwestern Minnesota with “L. Sioux” in parentheses. The necklace was donated along with several other unprovenienced artifacts to the University of Iowa Office of the State Archaeologist (OSA Catalogue # 2021-3-1) by James' wife Jeanne in October of 2021. In consultation with the representatives of the Flandreau Santee Sioux Tribe of South Dakota, Upper Sioux Community, Minnesota, and Wahpekute Dakota the necklace was identified as belonging to lineal descendants of Inyangmani. No potentially hazardous materials are present on the item.
The OSA-BP has determined that:
• The one sacred object described in this notice is a specific ceremonial object needed by a traditional Native American religious leader for present-day adherents to practice traditional Native American religion, according to the Native American traditional knowledge of a lineal descendant, Indian Tribe, or Native Hawaiian organization.
• Dr. Chris Mato Nunpa, Dr. Waziyatawin, Inyan Mani Hoksida (“Running Walker Boy”, John Roberts), Annie Roberts Adams, Eliza Roberts Cavender, Elsie Two Bear Cavendar, and Carrie Cavender Schommer are connected to the cultural item described in this notice.
Additional, written requests for repatriation of the cultural item in this notice must be sent to the authorized representative identified in this notice under
Repatriation of the cultural item in this notice to a requestor may occur on or after September 23, 2024. If competing requests for repatriation are received, the OSA-BP must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the cultural item are considered a single request and not competing requests. The OSA-BP is responsible for sending a copy of this notice to the Indian Tribes and Native Hawaiian organizations identified in this notice and to any other consulting parties.
National Park Service, Interior.
Notice.
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), Western Washington University (WWU) has completed an inventory of human remains and associated funerary objects and has determined that there is a cultural affiliation between the human remains and associated funerary objects and Indian Tribes or Native Hawaiian organizations in this notice. The human remains and associated funerary objects were removed from 45-SJ-215, San Juan County, WA.
Repatriation of the human remains and associated funerary objects in this notice may occur on or after September 23, 2024.
Dr. Judith Pine, Western Washington University, Department of Anthropology, Arntzen Hall 340, 516 High Street, Bellingham, WA 98225, telephone (360) 650-4783, email
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of the WWU, and additional information on the determinations in this notice, including the results of consultation, can be found in its inventory or related records. The National Park Service is not responsible for the determinations in this notice.
Human remains representing, at minimum, two individuals were removed from 45-SJ-215, Hunter Bay, Lopez Island in San Juan County, WA. Associated with the human remains, are 15 newly identified funerary objects, consisting of stone, bone and antler tools and a modified clay concretion.
In August of 1952, Dr. Herbert Taylor excavated in the Hunter Bay area with the Western Washington State College (now WWU) field school. In the field notes it was referred to as “The Village Site.” No Smithsonian trinomial was provided at the time, but subsequent research indicates the collection is from 45-SJ-215.
The description provided in the original WWU NAGPRA Inventory has been updated to include an MNI, as well as the Smithsonian trinomial. In addition, no Associated Funerary Objects were reported in the original WWU NAGPRA Inventory, however, during the WWU 2018-2020 Repatriation and Rehousing Project, 15 items were identified as associated funerary objects by Lummi Cultural Specialist, R. Tom. No known individuals were identified. No hazardous chemicals are known to have been used to treat the human remains or associated funerary objects while in the custody of WWU.
The human remains and associated funerary objects in this notice are connected to one or more identifiable earlier groups, tribes, peoples, or cultures. There is a relationship of
Based on the information available and the results of consultation, cultural affiliation is clearly identified by the information available about the human remains and associated funerary objects described in this notice.
The WWU has determined that:
• The human remains described in this notice represent the physical remains of at least two individuals of Native American ancestry.
• The 15 objects described in this notice are reasonably believed to have been placed intentionally with or near individual human remains at the time of death or later as part of the death rite or ceremony.
• There is a connection between the human remains and associated funerary objects described in this notice and the Lummi Tribe of the Lummi Reservation; Samish Indian Nation; and the Swinomish Indian Tribal Community.
Written requests for repatriation of the human remains and associated funerary objects in this notice must be sent to the authorized representative identified in this notice under
1. Any one or more of the Indian Tribes or Native Hawaiian organizations identified in this notice.
2. Any lineal descendant, Indian Tribe, or Native Hawaiian organization not identified in this notice who shows, by a preponderance of the evidence, that the requestor is a lineal descendant or an Indian Tribe or Native Hawaiian organization with cultural affiliation.
Repatriation of the human remains and associated funerary objects described in this notice to a requestor may occur on or after September 23, 2024. If competing requests for repatriation are received, the WWU must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the human remains and associated funerary objects are considered a single request and not competing requests. The WWU is responsible for sending a copy of this notice to the Indian Tribes and Native Hawaiian organizations identified in this notice.
National Park Service, Interior.
Notice.
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), Museum of the Rockies has completed an inventory of associated funerary objects and has determined that there is a cultural affiliation between the associated funerary objects and Indian Tribes or Native Hawaiian organizations in this notice.
Repatriation of the associated funerary objects in this notice may occur on or after September 23, 2024.
Eric Metz, Paleontology Collections Manager-Registrar, Museum of the Rockies, P.O. Box 172720, 600 W Kagy Boulevard, Bozeman, MT 59717, telephone (406) 994-6578, email
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of the Museum of the Rockies, and additional information on the determinations in this notice, including the results of consultation, can be found in its inventory or related records. The National Park Service is not responsible for the determinations in this notice.
Six associated funerary objects have been identified. The six associated funerary objects are six lithics including one point blank, four diagnostic points, and one broken obsidian point. In 1951, human remains representing, at minimum, one individual were removed from a mesa in Carbon County, MT, by Joseph L. Cramer. The mesa, located 1.5 miles southeast of Joliet Town, is the divide between Rock Creek & Elbow Creek. In 1991, Cramer donated these human remains and associated funerary objects to Museum of the Rockies. The human remains associated with these objects have been listed in a Notice of Inventory Completion published in the
Based on the information available and the results of consultation, cultural affiliation is clearly identified by the information available about the associated funerary objects described in this notice.
The Museum of the Rockies has determined that:
• The six objects described in this notice are reasonably believed to have been placed intentionally with or near individual human remains at the time of death or later as part of the death rite or ceremony.
• There is a connection between the human remains and associated funerary objects described in this notice and the Crow Tribe of Montana.
Written requests for repatriation of the associated funerary objects in this notice must be sent to the authorized representative identified in this notice under
1. Any one or more of the Indian Tribes or Native Hawaiian organizations identified in this notice.
2. Any lineal descendant, Indian Tribe, or Native Hawaiian organization not identified in this notice who shows, by a preponderance of the evidence, that the requestor is a lineal descendant or an Indian Tribe or Native Hawaiian organization with cultural affiliation.
Repatriation of the associated funerary objects described in this notice to a requestor may occur on or after September 23, 2024. If competing requests for repatriation are received, the Museum of the Rockies must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the associated funerary objects are considered a single request and not competing requests. The Museum of the Rockies is responsible for sending a copy of this notice to the Indian Tribes and Native Hawaiian organizations identified in this notice.
National Park Service, Interior.
Notice.
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the U.S. Department of the Interior, Bureau of Indian Affairs (BIA), and the University of Tennessee, Knoxville, Department of Anthropology (UTK), have completed an inventory of human remains and associated funerary objects and have determined that there is a cultural affiliation between the human remains and associated funerary objects and Indian Tribes or Native Hawaiian organizations in this notice.
Repatriation of the human remains and associated funerary objects in this notice may occur on or after September 23, 2024.
Tamara Billie, U.S. Department of the Interior, Bureau of Indian Affairs, 1001 Indian School Road NW, Mailbox 44, Albuquerque, NM 87104, telephone (505) 879-9711, email
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of the BIA, and additional information on the determinations in this notice, including the results of consultation, can be found in its inventory or related records. The National Park Service is not responsible for the determinations in this notice.
Human remains representing, at least, four individuals have been reasonably identified. The 10 associated funerary objects are three lots of lithics, four lots of ceramics, and three lots of faunal remains.
These remains and objects were removed from 25RH1, the Leary site, in Richardson County, Nebraska. There have been numerous excavations of this site, but these remains and objects were likely removed in 1968, under the direction of Alfred E. Johnson of the University of Kansas (KU). Bulldozer cutting along the terrace of the Nemaha River exposed burials which were “salvaged” by Johnson in 1968. Based on the information available, it is highly likely that William Bass brought these remains and two of the funerary objects (one lot of ceramics and one lot of faunal remains) from KU to UTK when he began working in the Department of Anthropology in 1971. However, some of the associated funerary objects remained at KU, including three lots of lithics, three lots of ceramics, and two lots of faunal remains. Some of the human remains appear to have been treated with an unknown preservative and some have glue present.
25RH1 has been documented as an Oneota culture site. This is supported by anthropological, archeological, linguistic, oral tradition, and other relevant information or expert opinion, including Native American traditional knowledge. The Iowa Tribe of Kansas and Nebraska is among the present-day representatives of the Oneota culture. This site is also located on the Iowa Tribe of Kansas and Nebraska's reservation.
Based on the information available and the results of consultation, cultural affiliation is clearly identified by the information available about the human remains and associated funerary objects described in this notice.
BIA has determined that:
• The human remains described in this notice represent the physical remains of four individuals of Native American ancestry.
• The 10 objects described in this notice are reasonably believed to have been placed intentionally with or near individual human remains at the time of death or later as part of the death rite or ceremony.
• There is a connection between the human remains and associated funerary objects described in this notice and the Iowa Tribe of Kansas and Nebraska.
Written requests for repatriation of the human remains and associated funerary objects in this notice must be sent to the authorized representative identified in this notice under
1. Any one or more of the Indian Tribes or Native Hawaiian organizations identified in this notice.
2. Any lineal descendant, Indian Tribe, or Native Hawaiian organization not identified in this notice who shows, by a preponderance of the evidence, that the requestor is a lineal descendant or an Indian Tribe or Native Hawaiian organization with cultural affiliation.
Repatriation of the human remains and associated funerary objects in this notice to a requestor may occur on or after September 23, 2024. If competing requests for repatriation are received, the BIA must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the human remains and associated funerary objects are considered a single request and not competing requests. The BIA is responsible for sending a copy of this notice to the Indian Tribes and Native Hawaiian organizations identified in this notice.
National Park Service, Interior.
Notification of boundary revision.
The boundary of Indiana Dunes National Park (Park) is modified to include 32.24 acres of donated land located in Porter County, Indiana, immediately adjoining the Park boundary. The National Park Service (NPS) has accepted the land donation from Canonie IDNL Acquisition, LLC, an Indiana Limited Liability Company, in care of the National Park Trust, a nonprofit organization dedicated to preserving parks.
The effective date of this boundary revision is August 23, 2024.
The map depicting this boundary revision is available for inspection at the following locations: National Park Service, Land Resources
Acting Chief Eric Giusti,
Notice is hereby given that, pursuant to 16 U.S.C. 460u through 460u-26, the boundary of Indiana Dunes National Park is modified to include an adjoining tract identified as Tract 116-01, containing 32.24 acres. The boundary revision is depicted on Map No. 626/122887, dated August 2015.
16 U.S.C. 460u-19 specifically provides that, after notifying the House Committee on Natural Resources and the Senate Committee on Energy and Natural Resources, the Secretary of the Interior is authorized to accept the donation of Tract 116-01 and revise the Park boundary to include the tract upon publication of Notice in the
National Park Service, Interior.
Notice of Intended Disposition.
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the U.S. Department of the Interior, Bureau of Land Management, Arizona State Office, Tucson Field Office, intends to carry out the disposition of human remains removed from Federal or Tribal lands to the lineal descendants or Indian Tribe with priority for disposition in this notice.
Disposition of the human remains in this notice may occur on or after September 23, 2024. If no claim for disposition is received by May 15, 2025, the human remains in this notice will become unclaimed human remains or cultural items.
Colleen J. Dingman, Field Manager, Bureau of Land Management, Tucson Field Office, 3201 E Universal Way, Tucson, AZ 85756, telephone (520) 258-7200, email
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of the Bureau of Land Management, Arizona State Office, Tucson Field Office, and additional information on the human remains or cultural items in this notice, including the results of consultation, can be found in the related records. The National Park Service is not responsible for the identifications in this notice.
Based on the information available, human remains representing at least one individual have been reasonably identified. No associated funerary objects are present. The discovery reported to the Tucson Field Office on January 30, 2023, consisted of approximately 50+/−cremated bone fragments averaging two centimeters in size. These remains were discovered in Cochise County, AZ.
The Bureau of Land Management, Arizona State Office, Tucson Field Office, has determined that:
• The human remains described in this notice represent the physical remains of one individual of Native American ancestry.
• The Tohono O'odham Nation of Arizona has priority for disposition of the human remains described in this notice.
Written claims for disposition of the human remains in this notice must be sent to the appropriate official identified in this notice under
1. Any lineal descendant or Indian Tribe identified in this notice.
2. Any lineal descendant or Indian Tribe not identified in this notice who shows, by a preponderance of the evidence, that they have priority for disposition.
Disposition of the human remains in this notice may occur on or after September 23, 2024. If competing claims for disposition are received, the Bureau of Land Management, Arizona State Office, Tucson Field Office, must determine the most appropriate claimant prior to disposition. Requests for joint disposition of the human remains are considered a single request and not competing requests. The Bureau of Land Management, Arizona State Office, Tucson Field Office, is responsible for sending a copy of this notice to the lineal descendants and Indian Tribes identified in this notice and to any other consulting parties.
National Park Service, Interior.
Notice.
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), Mercyhurst University has completed an inventory of human remains and has determined that there is a cultural affiliation between the human remains and Indian Tribes or Native Hawaiian organizations in this notice.
Repatriation of the human remains in this notice may occur on or after September 23, 2024.
Anne Marjenin, Mercyhurst University, 501 E 38th Street, Erie, PA 16546, telephone (814) 824-2012, email
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of Mercyhurst University, and additional information
Based on the information available, human remains representing, at least, one individual have been reasonably identified. No associated funerary objects are present. On an unknown date, the individual (IN-CL/PR-TIN-0001) was removed from a location likely near Clarksville, Clark County, Indiana, in proximity to Silver Creek and its confluence with the Ohio River. On an unknown date, the individual was obtained by Raymond C. Vietzen (1907-1995). Vietzen, an avocational archaeologist, collector, and author, established the Indian Ridge Museum in Elyria, Ohio, and the Archaeological Society of Ohio (formerly the Ohio Indian Relic Collectors Society). The Indian Ridge Museum, founded in the 1930s, served as Vietzen's laboratory and repository, and it remained in operation until the mid-1990s. After Vietzen's death, the facility fell into disrepair, and most of the items he had acquired and housed at the museum were sold. In 1998, the Ohio Historical Society (presently the Ohio History Connection) removed ancestral human remains and some of the remaining items from the facility and temporarily housed them at the Ohio Historical Society. In October of 2003, these remains were transferred from the Ohio Historical Society to Mercyhurst College (presently Mercyhurst University).
There is no record regarding potentially hazardous substances having been used to treat the human remains.
Based on the information available and the results of consultation, cultural affiliation is reasonably identified by the geographical location or acquisition history of the human remains described in this notice.
Mercyhurst University has determined that:
• The human remains described in this notice represent the physical remains of one individual of Native American ancestry.
• There is a reasonable connection between the human remains described in this notice and the Absentee-Shawnee Tribe of Indians of Oklahoma; Bad River Band of the Lake Superior Tribe of Chippewa Indians of the Bad River Reservation, Wisconsin; Bay Mills Indian Community, Michigan; Cayuga Nation; Chippewa Cree Indians of the Rocky Boy's Reservation, Montana; Citizen Potawatomi Nation, Oklahoma; Delaware Nation, Oklahoma; Delaware Tribe of Indians; Eastern Shawnee Tribe of Oklahoma; Forest County Potawatomi Community, Wisconsin; Grand Traverse Band of Ottawa and Chippewa Indians, Michigan; Hannahville Indian Community, Michigan; Keweenaw Bay Indian Community, Michigan; Kickapoo Traditional Tribe of Texas; Kickapoo Tribe of Indians of the Kickapoo Reservation in Kansas; Kickapoo Tribe of Oklahoma; Lac Courte Oreilles Band of Lake Superior Chippewa Indians of Wisconsin; Lac du Flambeau Band of Lake Superior Chippewa Indians of the Lac du Flambeau Reservation of Wisconsin; Lac Vieux Desert Band of Lake Superior Chippewa Indians of Michigan; Little River Band of Ottawa Indians, Michigan; Little Shell Tribe of Chippewa Indians of Montana; Little Traverse Bay Bands of Odawa Indians, Michigan; Match-e-be-nash-she-wish Band of Pottawatomi Indians of Michigan; Miami Tribe of Oklahoma; Minnesota Chippewa Tribe, Minnesota (Six component reservations: Bois Forte Band (Nett Lake); Fond du Lac Band; Grand Portage Band; Leech Lake Band; Mille Lacs Band; White Earth Band); Nottawaseppi Huron Band of the Potawatomi, Michigan; Oneida Indian Nation; Oneida Nation; Onondaga Nation; Ottawa Tribe of Oklahoma; Peoria Tribe of Indians of Oklahoma; Pokagon Band of Potawatomi Indians, Michigan and Indiana; Prairie Band Potawatomi Nation; Red Cliff Band of Lake Superior Chippewa Indians of Wisconsin; Red Lake Band of Chippewa Indians, Minnesota; Saginaw Chippewa Indian Tribe of Michigan; Saint Regis Mohawk Tribe; Sault Ste. Marie Tribe of Chippewa Indians, Michigan; Seneca Nation of Indians; Seneca-Cayuga Nation; Shawnee Tribe; Sokaogon Chippewa Community, Wisconsin; St. Croix Chippewa Indians of Wisconsin; The Osage Nation; Tonawanda Band of Seneca; Turtle Mountain Band of Chippewa Indians of North Dakota; Tuscarora Nation; United Keetoowah Band of Cherokee Indians in Oklahoma; and the Wyandotte Nation.
Written requests for repatriation of the human remains in this notice must be sent to the authorized representative identified in this notice under
1. Any one or more of the Indian Tribes or Native Hawaiian organizations identified in this notice.
2. Any lineal descendant, Indian Tribe, or Native Hawaiian organization not identified in this notice who shows, by a preponderance of the evidence, that the requestor is a lineal descendant or a culturally affiliated Indian Tribe or Native Hawaiian organization.
Repatriation of the human remains in this notice to a requestor may occur on or after September 23, 2024. If competing requests for repatriation are received, Mercyhurst University must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the human remains are considered a single request and not competing requests. Mercyhurst University is responsible for sending a copy of this notice to the Indian Tribes and Native Hawaiian organizations identified in this notice.
National Park Service, Interior.
Notice.
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), Kansas State University has completed an inventory of human remains and associated funerary objects and has determined that there is a cultural affiliation between the human remains and associated funerary objects and Indian Tribes or Native Hawaiian organizations in this notice.
Repatriation of the human remains and associated funerary objects in this notice may occur on or after September 23, 2024.
Megan Williamson, Department of Sociology, Anthropology, and Social Work, Kansas State University, 204 Waters Hall, 1603 Old Claflin Place, Manhattan, KS 66506-4003, telephone (785) 532-6005, email
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of Kansas State University, and additional information on the determinations in this notice, including the results of consultation, can be found in its inventory or related records. The National Park Service is not responsible for the determinations in this notice.
Human remains representing, at least, one individual have been identified. The 42 associated funerary objects are one unmodified shell, two ceramic body sherds, five unmodified stones, and 34 chipped stone debris. This assemblage was transferred to Kansas State University from University of Kansas in the early 1970s. No known provenience or known background other than a note stating `Liberal' is with the remains. Liberal, Kansas is in Seward County, Kansas. There are no known potentially hazardous substances used to treat any of the human remains or associated funerary objects.
Human remains representing, at least, one individual has been identified. There are no associated funerary objects present. The human remains in this Notice were transferred to Kansas State University from a physician in Hill City, KS in the 1970s. The name of the physician is unknown however a site number 14GH601 had been assigned. No Hazardous materials have been used in the treatment of the human remain.
Based on the information available and the results of consultation, cultural affiliation is reasonably identified by the geographical location or acquisition history of the human remains and associated funerary objects described in this notice.
Kansas State University has determined that:
• The human remains described in this notice represent the physical remains of two individuals of Native American ancestry.
• The 42 objects described in this notice are reasonably believed to have been placed intentionally with or near individual human remains at the time of death or later as part of the death rite or ceremony.
• There is a connection between the human remains and associated funerary objects described in this notice and the Cheyenne and Arapaho Tribes, Oklahoma.
Written requests for repatriation of the human remains and associated funerary objects in this notice must be sent to the authorized representative identified in this notice under
1. Any one or more of the Indian Tribes or Native Hawaiian organizations identified in this notice.
2. Any lineal descendant, Indian Tribe, or Native Hawaiian organization not identified in this notice who shows, by a preponderance of the evidence, that the requestor is a lineal descendant or an Indian Tribe or Native Hawaiian organization with cultural affiliation.
Repatriation of the human remains and associated funerary objects described in this notice to a requestor may occur on or after September 23, 2024. If competing requests for repatriation are received, Kansas State University must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the human remains and associated funerary objects are considered a single request and not competing requests. Kansas State University is responsible for sending a copy of this notice to the Indian Tribes and Native Hawaiian organizations identified in this notice.
National Park Service, Interior.
Request for nominations.
The National Park Service (NPS), U.S. Department of the Interior, is requesting nominations for qualified persons to serve as members on the Cedar Creek and Belle Grove National Historical Park Advisory Commission (Commission).
Written nominations must be received by September 23, 2024.
Nominations or requests for further information should be sent to Karen Beck-Herzog, Site Manager, Cedar Creek and Belle Grove National Historical Park, P.O. Box 700, Middletown, Virginia 22645, or via email
Karen Beck-Herzog, via telephone (540) 868-0938.
The Commission was established in accordance with the Cedar Creek and Belle Grove National Historical Park Act of 2002 (16 U.S.C. 410iii-7). The Commission was designated by Congress to provide advice to the Secretary of the Interior on the preparation and implementation of the park's general management plan and in the identification of sites of significance outside the park boundary.
The Commission consists of 15 members appointed by the Secretary, as follows:
(a) 1 representative from the Commonwealth of Virginia; (b) 1 representative each from the local governments of Strasburg, Middletown, Frederick County, Shenandoah County, and Warren County; (c) 2 representatives of private landowners within the Park; (d) 1 representative from a citizen interest group; (e) 1 representative from the Cedar Creek Battlefield Foundation; (f) 1 representative from the Belle Grove, Incorporated;
(g) 1 representative from the National Trust for Historic Preservation; (h) 1 representative from the Shenandoah Valley Battlefields Foundation; (i) 1 ex-officio representative from the National Park Service; and (j) 1 ex-officio representative from the United States Forest Service. Alternate members may be appointed to the Commission.
We are currently seeking primary and alternate members to represent Belle Grove, Inc., the Cedar Creek Battlefield Foundation, the Shenandoah Valley Battlefields Foundation, the Town of Strasburg, and Warren County.
Each member shall be appointed for a term of three years and may be reappointed for not more than two successive terms. A member may serve after the expiration of that member's term until a successor has been appointed. The Chairperson of the Commission shall be elected by the members to serve a term of one-year renewable for one additional year.
Nominations should be typed and should include a resume providing an adequate description of the nominee's
Members of the Commission serve without compensation. However, while away from their homes or regular places of business in the performance of services for the Commission as approved by the NPS, members may be allowed travel expenses, including per diem in lieu of subsistence, in the same manner as persons employed intermittently in Government service are allowed such expenses under 5 U.S.C. 5703.
National Park Service, Interior.
Notice.
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), San Bernardino County Museum has completed an inventory of human remains and associated funerary objects and has determined that there is a cultural affiliation between the human remains and associated funerary objects and Indian Tribes or Native Hawaiian organizations in this notice.
Repatriation of the human remains and associated funerary objects in this notice may occur on or after September 23, 2024.
Tamara Serrao-Leiva, San Bernardino County Museum, 2024 Orange Tree Lane, Redlands, CA 92374, telephone (909) 435-5359, email
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of the San Bernardino County Museum, and additional information on the determinations in this notice, including the results of consultation, can be found in the inventory or related records. The National Park Service is not responsible for the determinations in this notice.
Based on the information available, human remains representing, at least, one individual have been reasonably identified. The eight associated funerary objects are petrified wood, flaked stone, shell, plant material, ground stone, historic objects, ceramics, and faunal. On November 19, 1939, land surveyor Benjamin McCown collected items from Pinyon Wash in Davis Valley and Dry Lake, Imperial County, California. These were brought to San Bernardino County Museum once Archaeological Survey Association of Southern California disbanded in 2008.
Based on the information available and the results of consultation, cultural affiliation is reasonably identified by the geographical location or acquisition history of the human remains and associated funerary objects described in this notice.
The San Bernardino County Museum has determined that:
• The human remains described in this notice represent the physical remains of one individuals of Native American ancestry.
• The eight lots of objects described in this notice are reasonably believed to have been placed intentionally with or near individual human remains at the time of death or later as part of the death rite or ceremony.
• There is a reasonable connection between the human remains and associated funerary objects described in this notice and the Campo Band of Diegueno Mission Indians of the Campo Indian Reservation, California; Capitan Grande Band of Diegueno Mission Indians of California (Barona Group of Capitan Grande Band of Mission Indians of the Barona Reservation, California; Viejas (Baron Long) Group of Capitan Grande Band of Mission Indians of the Viejas Reservation, California); Ewiiaapaayp Band of Kumeyaay Indians, California; Inaja Band of Diegueno Mission Indians of the Inaja and Cosmit Reservation, California; Jamul Indian Village of California; La Posta Band of Diegueno Mission Indians of the La Posta Indian Reservation, California; Manzanita Band of Diegueno Mission Indians of the Manzanita Reservation, California; Mesa Grande Band of Diegueno Mission Indians of the Mesa Grande Reservation, California.
Written requests for repatriation of the human remains and associated funerary objects in this notice must be sent to the authorized representative identified in this notice under
1. Any one or more of the Indian Tribes or Native Hawaiian organizations identified in this notice.
2. Any lineal descendant, Indian Tribe, or Native Hawaiian organization not identified in this notice who shows, by a preponderance of the evidence, that the requestor is a lineal descendant or a culturally affiliated Indian Tribe or Native Hawaiian organization.
Repatriation of the human remains and associated funerary objects in this notice to a requestor may occur on or after September 23, 2024. If competing requests for repatriation are received, San Bernardino County Museum must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the human remains and associated funerary objects are considered a single request and not competing requests. The San Bernardino County Museum is responsible for sending a copy of this notice to the Indian Tribes and Native Hawaiian organizations identified in this notice.
National Park Service, Interior.
Notice.
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the U.S. Department of the Interior, Bureau of Land Management, Alaska State Office (BLM Alaska) has completed an inventory of human remains and has determined that there is a cultural
Repatriation of the human remains in this notice may occur on or after September 23, 2024.
Robin O. Mills, Bureau of Land Management, 222 W 7th Avenue #13, Anchorage, AK 99513, telephone (907) 474-2359, email
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of the BLM Alaska, and additional information on the determinations in this notice, including the results of consultation, can be found in the inventory or related records. The National Park Service is not responsible for the determinations in this notice.
Based on the information available, human remains representing at least four individuals have been reasonably identified. No associated funerary objects are present. The human remains include 15 skeletal elements representing minimally four individuals, secured during the 1958-1961 archaeological excavations at Cape Krusenstern, Alaska, by Louis Giddings. Previous repatriations from this site and others nearby occurred in 2000 to the Tribe identified in this notice. The new identified remains were discovered by specifically searching for human remains in excavation bags containing animal faunal elements, in August-November 2023. The new remains were found from three archaeological proveniences: (1) 10 ribs (MNI one individual; adult) from House 8, (2) two vertebrae & one metacarpal (MNI one individual; adult) from a seal fauna feature near House 30, and (3) one metatarsal and one clavicle (MNI two individuals; one teenager, one child) from House 41.
Based on the information available and the results of consultation, cultural affiliation is reasonably identified by the geographical location or acquisition history of the human remains described in this notice.
The BLM Alaska has determined that:
• The human remains described in this notice represent the physical remains of four individuals of Native American ancestry.
• There is a reasonable connection between the human remains in this notice and the Native Village of Kotzebue.
Written requests for repatriation of the human remains in this notice must be sent to the authorized representative identified in this notice under
1. Any one or more of the Indian Tribes or Native Hawaiian organizations identified in this notice.
2. Any lineal descendant, Indian Tribe, or Native Hawaiian organization not identified in this notice who shows, by a preponderance of the evidence, that the requestor is a lineal descendant or a culturally affiliated Indian Tribe or Native Hawaiian organization.
Repatriation of the human remains in this notice to a requestor may occur on or after September 23, 2024. If competing requests for repatriation are received, the BLM Alaska must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the human remains are considered a single request and not competing requests. The BLM Alaska is responsible for sending a copy of this notice to the Indian Tribes and Native Hawaiian organizations identified in this notice.
National Park Service, Interior.
Notice.
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), Mercyhurst University has completed an inventory of human remains and has determined that there is a cultural affiliation between the human remains and Indian Tribes or Native Hawaiian organizations in this notice.
Repatriation of the human remains in this notice may occur on or after September 23, 2024.
Anne Marjenin, Mercyhurst University, 501 E 38th Street, Erie, PA 16546, telephone (814) 824-2012, email
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of Mercyhurst University, and additional information on the determinations in this notice, including the results of consultation, can be found in the inventory or related records. The National Park Service is not responsible for the determinations in this notice.
Based on the information available, human remains representing, at least, one individual have been reasonably identified. No associated funerary objects are present. On an unknown date, the individual (IN-zUNK-TIN-0001) was removed from an unknown geographic location in Indiana. On an unknown date, the individual was obtained by Raymond C. Vietzen (1907-1995). Vietzen, an avocational archaeologist, collector, and author, established the Indian Ridge Museum in Elyria, Ohio, and the Archaeological Society of Ohio (formerly the Ohio Indian Relic Collectors Society). The Indian Ridge Museum, founded in the 1930s, served as Vietzen's laboratory and repository, and it remained in operation until the mid-1990s. After Vietzen's death, the facility fell into disrepair, and most of the items he had acquired and housed at the museum were sold. In 1998, the Ohio Historical Society (presently the Ohio History Connection) removed ancestral human remains and some of the remaining items from the facility and temporarily housed them at the Ohio Historical Society. In October of 2003, these remains were transferred from the Ohio Historical Society to Mercyhurst College (presently Mercyhurst University).
While there is no record regarding potentially hazardous substances having been used to treat the human remains, an unidentified adhesive or lacquer is present. It is unknown when the substance was applied.
Based on the information available and the results of consultation, cultural affiliation is reasonably identified by the geographical location or acquisition history of the human remains described in this notice.
Mercyhurst University has determined that:
• The human remains described in this notice represent the physical remains of one individual of Native American ancestry.
• There is a reasonable connection between the human remains described in this notice and the Absentee-Shawnee Tribe of Indians of Oklahoma; Bad River Band of the Lake Superior Tribe of Chippewa Indians of the Bad River Reservation, Wisconsin; Bay Mills Indian Community, Michigan; Cayuga Nation; Chippewa Cree Indians of the Rocky Boy's Reservation, Montana; Citizen Potawatomi Nation, Oklahoma; Crow Creek Sioux Tribe of the Crow Creek Reservation, South Dakota; Delaware Nation, Oklahoma; Delaware Tribe of Indians; Eastern Shawnee Tribe of Oklahoma; Flandreau Santee Sioux Tribe of South Dakota; Forest County Potawatomi Community, Wisconsin; Grand Traverse Band of Ottawa and Chippewa Indians, Michigan; Hannahville Indian Community, Michigan; Kaw Nation, Oklahoma; Keweenaw Bay Indian Community, Michigan; Kickapoo Traditional Tribe of Texas; Kickapoo Tribe of Indians of the Kickapoo Reservation in Kansas; Kickapoo Tribe of Oklahoma; Lac Courte Oreilles Band of Lake Superior Chippewa Indians of Wisconsin; Lac du Flambeau Band of Lake Superior Chippewa Indians of the Lac du Flambeau Reservation of Wisconsin; Lac Vieux Desert Band of Lake Superior Chippewa Indians of Michigan; Little River Band of Ottawa Indians, Michigan; Little Shell Tribe of Chippewa Indians of Montana; Little Traverse Bay Bands of Odawa Indians, Michigan; Lower Sioux Indian Community in the State of Minnesota; Match-e-be-nash-she-wish Band of Pottawatomi Indians of Michigan; Miami Tribe of Oklahoma; Minnesota Chippewa Tribe, Minnesota (Six component reservations: Bois Forte Band (Nett Lake); Fond du Lac Band; Grand Portage Band; Leech Lake Band; Mille Lacs Band; White Earth Band); Nottawaseppi Huron Band of the Potawatomi, Michigan; Omaha Tribe of Nebraska; Oneida Indian Nation; Oneida Nation; Onondaga Nation; Ottawa Tribe of Oklahoma; Peoria Tribe of Indians of Oklahoma; Pokagon Band of Potawatomi Indians, Michigan and Indiana; Ponca Tribe of Indians of Oklahoma; Ponca Tribe of Nebraska; Prairie Band Potawatomi Nation; Prairie Island Indian Community in the State of Minnesota; Quapaw Nation; Red Cliff Band of Lake Superior Chippewa Indians of Wisconsin; Red Lake Band of Chippewa Indians, Minnesota; Saginaw Chippewa Indian Tribe of Michigan; Saint Regis Mohawk Tribe; Santee Sioux Nation, Nebraska; Sault Ste. Marie Tribe of Chippewa Indians, Michigan; Seneca Nation of Indians; Seneca-Cayuga Nation; Shakopee Mdewakanton Sioux Community of Minnesota; Shawnee Tribe; Sokaogon Chippewa Community, Wisconsin; St. Croix Chippewa Indians of Wisconsin; Stockbridge Munsee Community, Wisconsin; The Osage Nation; Tonawanda Band of Seneca; Turtle Mountain Band of Chippewa Indians of North Dakota; Tuscarora Nation; United Keetoowah Band of Cherokee Indians in Oklahoma; Upper Sioux Community, Minnesota; Wyandotte Nation; and the Yankton Sioux Tribe of South Dakota.
Written requests for repatriation of the human remains in this notice must be sent to the authorized representative identified in this notice under
1. Any one or more of the Indian Tribes or Native Hawaiian organizations identified in this notice.
2. Any lineal descendant, Indian Tribe, or Native Hawaiian organization not identified in this notice who shows, by a preponderance of the evidence, that the requestor is a lineal descendant or a culturally affiliated Indian Tribe or Native Hawaiian organization.
Repatriation of the human remains in this notice to a requestor may occur on or after September 23, 2024. If competing requests for repatriation are received, Mercyhurst University must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the human remains are considered a single request and not competing requests. Mercyhurst University is responsible for sending a copy of this notice to the Indian Tribes and Native Hawaiian organizations identified in this notice.
National Park Service, Interior.
Notice.
In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the U.S. Department of the Interior, Bureau of Land Management, Alaska State Office (BLM Alaska) intends to repatriate certain cultural items that meet the definition of unassociated funerary objects and that have a cultural affiliation with the Indian Tribes or Native Hawaiian organizations in this notice.
Repatriation of the cultural items in this notice may occur on or after September 23, 2024.
Robin O. Mills, Bureau of Land Management, 222 W 7th Avenue #13, Anchorage, AK 99513, telephone (907) 474-2359, email
This notice is published as part of the National Park Service's administrative responsibilities under NAGPRA. The determinations in this notice are the sole responsibility of the BLM Alaska, and additional information on the determinations in this notice, including the results of consultation, can be found in the summary or related records. The National Park Service is not responsible for the determinations in this notice.
A total of 69 unassociated funerary objects have been requested for repatriation. The 69 unassociated funerary objects are lance and arrow blades and shafts, game pieces, different types of projectile points, other hunting tools and accessories, wood shavings, dolls, stone tools, a carving, an effigy, bowls, dishes, cups, and scoop pieces, and wrapping material.
Based on the information available, Native American unassociated funerary objects have been identified at the University of Pennsylvania Museum of Archaeology and Anthropology (Penn Museum). These objects were collected by William Van Valin when he was hired by the Penn Museum to lead the John Wanamaker Expedition to Alaska, in 1917-1919. The 69 unassociated funerary objects derive from the
The BLM Alaska has determined that:
• The 69 unassociated funerary objects described above are reasonably believed to have been placed intentionally with or near individual human remains, and are connected, either at the time of death or later as part of the death rite or ceremony and are believed, by a preponderance of the evidence, to have been removed from a specific burial site of an individual or individuals with cultural affiliation to an Indian Tribe or Native Hawaiian organization.
• There is a reasonable connection between the human remains and funerary objects described in this notice and the Native Village of Barrow Inupiat Traditional Government.
Additional, written requests for repatriation of the cultural items in this notice must be sent to the authorized representative identified in this notice under
Repatriation of the cultural items in this notice to a requestor may occur on or after September 23, 2024. If competing requests for repatriation are received, the BLM Alaska must determine the most appropriate requestor prior to repatriation. Requests for joint repatriation of the cultural items are considered a single request and not competing requests. The BLM Alaska is responsible for sending a copy of this notice to the Indian Tribes and Native Hawaiian organizations identified in this notice and to any other consulting parties.
International Trade Commission.
Notice.
The Commission hereby gives notice of the scheduling of expedited reviews pursuant to the Tariff Act of 1930 (“the Act”) to determine whether revocation of the antidumping duty order and countervailing duty order on cast iron soil pipe from China would be likely to lead to continuation or recurrence of material injury within a reasonably foreseeable time.
July 5, 2024.
Alexis Yim (202-708-1446), Office of Investigations, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436. Hearing-impaired persons can obtain information on this matter by contacting the Commission's TDD terminal on 202-205-1810. Persons with mobility impairments who will need special assistance in gaining access to the Commission should contact the Office of the Secretary at 202-205-2000. General information concerning the Commission may also be obtained by accessing its internet server (
For further information concerning the conduct of these reviews and rules of general application, consult the Commission's Rules of Practice and Procedure, part 201, subparts A and B (19 CFR part 201), and part 207, subparts A, D, E, and F (19 CFR part 207).
In accordance with §§ 201.16(c) and 207.3 of the rules, each document filed
By order of the Commission.
International Trade Commission.
Notice.
Notice is hereby given that on August 16, 2024, the presiding administrative law judge (“ALJ”) issued an Initial Determination (“ID”) Granting Complainant's Motion for Summary Determination of Violation of the General Exclusion Order (“GEO”), combined with a Recommended Determination (“RD”) to issue cease and desist orders (“CDOs”) against four defaulting enforcement respondents. The Commission is soliciting submissions on public interest issues raised by the recommended relief should the Commission find a violation of the GEO. This notice is soliciting comments from the public and interested government agencies only.
Paul Lall, Office of the General Counsel, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436, telephone (202) 205-2043. Copies of non-confidential documents filed in connection with this investigation may be viewed on the Commission's electronic docket (EDIS) at
On November 9, 2023, the Commission determined to institute an enforcement proceeding under Commission Rule 210.75 on behalf of complainant Meenaxi Enterprise Inc. (“Meenaxi”) to investigate alleged violations of the GEO by four respondents: (1) Bharat Bazar Inc. of Union City, California (“Bharat Bazaar”); (2) Coconut Hill Inc. d/b/a Coconut Hill of Sunnyvale, California (“Coconut Hill”); (3) Organic Ingredients Inc. d/b/a Namaste Plaza Indian Super Market (“Organic Ingredients”) of San Diego, California; and (4) New India Bazar Inc. d/b/a New India Bazar of San Jose, California (“New India”) (collectively the “Enforcement Respondents”).
On January 10, 2024, the presiding ALJ issued an order directing the Enforcement Respondents to show cause why they should not be found in default and why judgment should not be rendered against them for failing to respond to the enforcement complaint and notice of investigation.
On March 14, 2024, the Commission determined that the four Enforcement Respondents are in default.
Section 337 of the Tariff Act of 1930 provides that, if the Commission finds a violation, it shall exclude the articles concerned from the United States unless, after considering the effect of such exclusion upon the public health and welfare, competitive conditions in the United States economy, the production of like or directly competitive articles in the United States, and United States consumers, it finds that such articles should not be excluded from entry. (19 U.S.C. 1337(d)(1)). A similar provision applies to cease and desist orders. (19 U.S.C. 1337(f)(1)).
The Commission is soliciting submissions on public interest issues raised by the recommended relief should the Commission find a violation of the GEO, specifically: CDOs against the four Enforcement Respondents: (1) Bharat Bazaar; (2) Coconut Hill; (3) Organic Ingredients; and (4) New India. Parties are to file public interest submissions pursuant to 19 CFR 210.50(a)(4).
The Commission is interested in further development of the record on the public interest in this investigation. Accordingly, members of the public and interested government agencies are invited to file submissions of no more than five (5) pages, inclusive of attachments, concerning the public interest in light of the ALJ's Recommended Determination. Comments should address whether issuance of the recommended CDOs in this investigation, should the Commission find a violation of the GEO, would affect the public health and welfare in the United States, competitive conditions in the United States economy, the production of like or directly competitive articles in the United States, or United States consumers.
In particular, the Commission is interested in comments that:
(i) explain how the articles potentially subject to the recommended CDOs are used in the United States;
(ii) identify any public health, safety, or welfare concerns in the United States relating to the recommended CDOs;
(iii) identify like or directly competitive articles that complainant, its licensees, or third parties make in the United States which could replace the subject articles if they are subject to CDOs;
(iv) indicate whether complainant, complainant's licensees, and/or third-party suppliers have the capacity to replace the volume of articles potentially subject to the recommended CDOs within a commercially reasonable time; and
(v) explain how the recommended CDOs would impact consumers in the United States.
Written submissions must be filed no later than by close of business on September 9, 2024.
Persons filing written submissions must file the original document
Any person desiring to submit a document to the Commission in confidence must request confidential treatment by marking each document with a header indicating that the document contains confidential information. This marking will be deemed to satisfy the request procedure set forth in Rules 201.6(b) and 210.5(e)(2) (19 CFR 201.6(b) & 210.5(e)(2)). Documents for which confidential treatment by the Commission is properly sought will be treated accordingly. Any non-party wishing to submit comments containing confidential information must serve those comments on the parties to the investigation pursuant to the applicable Administrative Protective Order. A redacted non-confidential version of the document must also be filed simultaneously with any confidential filing and must be served in accordance with Commission Rule 210.4(f)(7)(ii)(A) (19 CFR 210.4(f)(7)(ii)(A)). All information, including confidential business information and documents for which confidential treatment is properly sought, submitted to the Commission for purposes of this investigation may be disclosed to and used: (i) by the Commission, its employees and Offices, and contract personnel (a) for developing or maintaining the records of this or a related proceeding, or (b) in internal investigations, audits, reviews, and evaluations relating to the programs, personnel, and operations of the Commission including under 5 U.S.C. Appendix 3; or (ii) by U.S. government employees and contract personnel, solely for cybersecurity purposes. All contract personnel will sign appropriate nondisclosure agreements. All nonconfidential written submissions will be available for public inspection on EDIS.
This action is taken under the authority of section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and in Part 210 of the Commission's Rules of Practice and Procedure (19 CFR part 210).
By order of the Commission.
Office on Violence Against Women, Department of Justice.
60-Day notice.
The Department of Justice (DOJ), Office on Violence Against Women will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995.
Comments are encouraged and will be accepted for 60 days until October 22, 2024.
If you have additional comments especially on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact Catherine Poston, Office on Violence Against Women, at 202-514-5430 or
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:
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Drug Enforcement Administration, Department of Justice.
60-Day notice.
The Drug Enforcement Administration (DEA), Department of Justice (DOJ), will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995.
Comments are encouraged and will be accepted for 60 days until October 22, 2024.
If you have additional comments especially on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact Scott A Brinks, Regulatory Drafting and Policy Support Section, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152; Telephone: (571) 362-3261; Email:
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:
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If additional information is required contact: Darwin Arceo, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street NE, 4W-218, Washington, DC 20530.
Office on Violence Against Women, Department of Justice.
60-Day notice.
The Department of Justice (DOJ), Office on Violence Against Women will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995.
Comments are encouraged and will be accepted for 60 days until October 22, 2024.
If you have additional comments especially on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact Cathy Poston, Office on Violence Against Women, at 202-514-5430 or
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:
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If additional information is required contact: Darwin Arceo, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street NE, 4W-218, Washington, DC 20530.
Office on Violence Against Women, Department of Justice.
60-Day notice.
The Department of Justice (DOJ), Office on Violence Against Women will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995.
Comments are encouraged and will be accepted for 60 days until October 22, 2024.
If you have additional comments especially on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact Cathy Poston, Office on Violence Against Women, at 202-514-5430 or
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:
This is a request to consolidate existing previously approved information collections under a new collection—a new consolidated OMB number. This collection is currently covered by a series of approved collections with different OMB numbers that correspond to grant program-specific progress reporting forms. The purpose of obtaining a new, omnibus OMB number for OVW's performance reporting data catalog is to align approval for this information collection with the mechanism through which OVW plans to collect the data,
The information obtained through this collection is used in reports to Congress on the effectiveness and use of grant funding, monitoring grant funded activities, and to assess the extent to which grant program goals are being achieved. There are three sets of respondents: formula grant program state administrators, formula program subgrantees, and discretionary program grantees.
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If additional information is required contact: Darwin Arceo, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street NE, 4W-218, Washington, DC 20530.
Notice of availability; request for comments.
The Department of Labor (DOL) is submitting this Occupational Safety & Health Administration (OSHA)-sponsored information collection request (ICR) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995 (PRA). Public comments on the ICR are invited.
The OMB will consider all written comments that the agency receives on or before September 23, 2024.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Nicole Bouchet by telephone at 202-693-0213, or by email at
The purpose of the requirement is to reduce workers' risk of death or serious injury by ensuring that restraining devices used by them during the servicing of multi-piece rim wheels are in safe operating condition. For additional substantive information about this ICR, see the related notice published in the
This information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless the OMB approves it and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information that does not display a valid OMB Control Number.
DOL seeks PRA authorization for this information collection for three (3) years. OMB authorization for an ICR cannot be for more than three (3) years without renewal. The DOL notes that information collection requirements submitted to the OMB for existing ICRs receive a month-to-month extension while they undergo review.
Mine Safety and Health Administration (MSHA), Labor.
Notice.
The Federal Mine Safety and Health Act of 1977 governs the application, processing, and disposition of petitions for modification of mandatory safety standards. Any mine operator or representative of miners may petition for an alternative method of complying with an existing safety standard. MSHA reviews the content of each submitted petition, assesses the mine in question, and ultimately issues a decision on the petition. This notice includes a list of petitions for modification that were granted after MSHA's review and investigation,
Copies of the final decisions are posted on MSHA's website at
S. Aromie Noe, Director, Office of Standards, Regulations, and Variances at 202-693-9440 (voice),
Under section 101(c) of the Federal Mine Safety and Health Act of 1977, any mine operator or representative of miners may petition to use an alternative approach to comply with a mandatory safety standard. In response, the Secretary of Labor (Secretary) or his or her designee may modify the application of a mandatory safety standard to that mine if the Secretary determines that: (1) An alternative method exists that will guarantee no less protection for the miners affected than that provided by the standard; or (2) the application of the standard will result in a diminution of safety to the affected miners.
MSHA bases the final decision on the petitioner's statements, any comments and information submitted by interested persons, and a field investigation of the conditions at the mine. In some instances, MSHA may approve a petition for modification on the condition that the mine operator complies with other requirements noted in the decision. In other instances, MSHA may deny, dismiss, or revoke a petition for modification. In accordance with 30 CFR 44.5, MSHA publishes every final action granting a petition for modification.
On the basis of the findings of MSHA's investigation, and as designee of the Secretary, MSHA granted or partially granted the petitions for modification below. Since the previous
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National Aeronautics and Space Administration (NASA).
Notice of a reinstatement of information collection.
NASA, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995 (PRA).
Comments are due by October 22, 2024.
Written comments and recommendations for this information collection should be sent within 60 days of publication of this notice at
Requests for additional information or copies of the information collection instrument(s) and instructions should be directed to NASA PRA Clearance Officer, Stayce Hoult, NASA Headquarters, 300 E Street SW, JC0000, Washington, DC 20546, phone 256-714-8575, or email
Information collection is for reports, other than financial, property, or patent, data or copyrights reports (covered under separate OMB Control numbers), required for effective management and administration of contracts with an estimated value of more than $500,000, in support of NASA's mission.
NASA is committed to effectively performing the Agency's communication function in accordance with the Space Act Section 203 (a)(3) to “provide for the widest practicable and appropriate dissemination of information concerning its activities and the results thereof,” and to enhance public understanding of, and participation in, the nation's aeronautical and space program in accordance with the NASA Strategic Plan.
NASA collects this information electronically where feasible. NASA encourages recipients to use the latest computer technology in preparing documentation, but information may also be collected by mail or fax.
Comments are invited on: (1) Whether the proposed collection of information is necessary for the proper performance of the functions of NASA, including whether the information collected has practical utility; (2) the accuracy of NASA's estimate of the burden (including hours and cost) of the
Comments submitted in response to this notice will be summarized and included in the request for OMB approval of this information collection. They will also become a matter of public record.
National Aeronautics and Space Administration (NASA).
Notice of information collection.
NASA, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995 (PRA).
Comments are due by September 23, 2024.
Written comments and recommendations for this information collection should be sent within 30 days of publication of this notice at
Requests for additional information or copies of the information collection instrument(s) and instructions should be directed to NASA PRA Clearance Officer, Stayce Hoult, NASA Headquarters, 300 E Street SW, JC0000, Washington, DC 20546, phone 256-714-8575, or email
NASA is committed to effectively performing the Agency's communication function in accordance with the Space Act Section 203 (a)(3) to “provide for the widest practicable and appropriate dissemination of information concerning its activities and the results thereof,” and to enhance public understanding of, and participation in, the nation's aeronautical and space program in accordance with the NASA Strategic Plan. The NASA Office of STEM Engagement (OSTEM) administers the agency's national stem engagement and education activities in support of the Space Act, including the performance assessment and evaluation of OSTEM projects, programs and NASA STEM engagement investments. This generic clearance will allow the NASA OSTEM to continue to test and pilot with subject matter experts, secondary students, higher education students, educators, and interested parties new and existing information collection forms and assessment instruments for the purposes of improvement and establishing validity and reliability characteristics of the forms and instruments. Existing information collections include the NASA Student STEM Inventory (Grades 4-12), NASA OSTEM Educator Professional Development (EPD) Pre- and Post-Workshop Learning Assessment (Surveys), NASA Internship Program Evaluation (Internship Retrospective Survey, Internship Experience Survey, and Semi-Structured Focus Group Protocol), NASA CONNECTS Evaluation Survey and Focus Group Protocol, MUREP Outcome Student Participant and Principal Investigator Focus Group Protocols. Forms and instruments to be tested include program application forms, customer satisfaction questionnaires, focus group protocols, and project activity survey instruments. Methodological testing will include focus group discussions, pilot surveys to test new individual question items as well as the complete form and instrument. In addition, test-retest and similar protocols will be used to determine reliability characteristics of the forms and instruments. Methodological testing will assure that forms and instruments accurately and consistently collect and measure what they are intended to measure and that data collection items are interpreted precisely and consistently, all towards the goal of accurate Agency reporting while improving the execution of NASA STEM Engagement activities.
Electronic, paper, and focus group interviews.
Comments are invited on: (1) Whether the proposed collection of information is necessary for the proper performance of the functions of NASA, including whether the information collected has practical utility; (2) the accuracy of NASA's estimate of the burden (including hours and cost) of the proposed collection of information; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including automated collection techniques or the use of other forms of information technology.
Comments submitted in response to this notice will be summarized and included in the request for OMB approval of this information collection. They will also become a matter of public record.
National Archives and Records Administration (NARA).
Notice of availability of proposed records schedules; request for comments.
The National Archives and Records Administration (NARA)
We must receive responses on the schedules listed in this notice by October 8, 2024.
To view a records schedule in this notice, or submit a comment on one, use the following address:
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If you are unable to comment via
Eddie Germino, Strategy and Performance Division, by email at
We are publishing notice of records schedules in which agencies propose to dispose of records they no longer need to conduct agency business. We invite public comments on these records schedules, as required by 44 U.S.C. 3303a(a) and list the schedules at the end of this notice by agency and subdivision requesting disposition authority.
In addition, this notice lists the organizational unit(s) accumulating the records or states that the schedule has agency-wide applicability. It also provides the control number assigned to each schedule, which you will need if you submit comments on that schedule.
We have uploaded the records schedules and accompanying appraisal memoranda to the
We will post comments, including any personal information and attachments, to the public docket unchanged. Because comments are public, you are responsible for ensuring that you do not include any confidential or other information that you or a third party may not wish to be publicly posted. If you want to submit a comment with confidential information or cannot otherwise use the
We will consider all comments submitted by the posted deadline and consult as needed with the Federal agency seeking the disposition authority. After considering comments, we may or may not make changes to the proposed records schedule. The schedule is then sent for final approval by the Archivist of the United States. After the schedule is approved, we will post on
We will post schedules on our website in the Records Control Schedule (RCS) Repository, at
Each year, Federal agencies create billions of records. To control this accumulation, agency records managers prepare schedules proposing retention periods for records and submit these schedules for NARA's approval. Once approved by NARA, records schedules provide mandatory instructions on what happens to records when no longer needed for current Government business. The records schedules authorize agencies to preserve records of continuing value in the National Archives or to destroy, after a specified period, records lacking continuing administrative, legal, research, or other value. Some schedules are comprehensive and cover all the records of an agency or one of its major subdivisions. Most schedules, however, cover records of only one office or program or a few series of records. Many of these update previously approved schedules, and some include records proposed as permanent.
Agencies may not destroy Federal records without the approval of the Archivist of the United States. The Archivist grants this approval only after thorough consideration of the records' administrative use by the agency of origin, the rights of the Government and of private people directly affected by the Government's activities, and whether or not the records have historical or other value. Public review and comment on these records schedules is part of the Archivist's consideration process.
1. Department of Agriculture, Animal and Plant Health Inspection Service, Records of the Diagnostic Services Section (DAA-0463-2024-0004).
2. Department of Agriculture, Animal and Plant Health Inspection Service, Records of the Proficiency and Validation Services Section (DAA-0463-2024-0003).
3. Department of Agriculture, Animal and Plant Health Inspection Service, Records of the Reagents and Vaccine Services Section (DAA-0463-2024-0002).
4. Department of Agriculture, Animal and Plant Health Inspection Service, Records of the Scientific Liaison Services Section (DAA-0463-2024-0001).
5. Department of Health and Human Services, Administration for Strategic Preparedness and Response, ASPR Technical Resources, Assistance Center, and Information Exchange System (DAA-0611-2023-0012).
6. Department of Health and Human Services, Health Resources and Services
7. Department of Health and Human Services, Records of the Office of Investigations (OI) of the Inspector General (IG) of Health and Human Services (DAA-0468-2024-0004).
8. Department of Justice, Federal Bureau of Investigation, Safeguard Assessment Records (DAA-0065-2024-0001).
9. Department of Transportation, Federal Aviation Administration, Aviation Safety Records (DAA-0237-2023-0017).
10. Consumer Product Safety Commission, Agency-wide, Small Business Ombudsman (DAA-0424-2022-0001).
11. Federal Energy Regulatory Commission, Agency-wide, MG Dockets (DAA-0138-2024-0012).
12. Library of Congress, Agency-wide, Congressional Relations—2024 updates (DAA-0297-2024-0012).
13. Library of Congress, Agency-wide, Facilities and Safety—2024 updates (DAA-0297-2024-0006).
14. Pretrial Services Agency for the District of Columbia, Agency-wide, Disclosure of Relationship and or Association with a Supervised Person (DAA-0562-2024-0003).
15. Social Security Administration, Agency-wide, Leadership Records (DAA-0047-2024-0001).
16. Social Security Administration, Agency-wide, Legal Records (DAA-0047-2022-0003).
1:00 p.m., Tuesday, August 27, 2024.
Board Room, 7th Floor, Room 7B, 1775 Duke Street (All visitors must use Diagonal Road Entrance), Alexandria, VA 22314-3428.
Closed.
1. Board Appeal. Closed pursuant to Exemption (8).
Melane Conyers-Ausbrooks, Secretary of the Board, Telephone: 703-518-6304.
Weeks of August 26, and September 2, 9, 16, 23, and 30 2024. The schedule for Commission meetings is subject to change on short notice. The NRC Commission Meeting Schedule can be found on the internet at:
The NRC provides reasonable accommodation to individuals with disabilities where appropriate. If you need a reasonable accommodation to participate in these public meetings or need this meeting notice or the transcript or other information from the public meetings in another format (
Public.
Members of the public may request to receive the information in these notices electronically. If you would like to be added to the distribution, please contact the Nuclear Regulatory Commission, Office of the Secretary, Washington, DC 20555, at 301-415-1969, or by email at
There are no meetings scheduled for the week of August 26, 2024.
There are no meetings scheduled for the week of September 9, 2024.
There are no meetings scheduled for the week of September 16, 2024.
There are no meetings scheduled for the week of September 23, 2024
There are no meetings scheduled for the week of August 19, 2024.
For more information or to verify the status of meetings, contact Sarah Turner at 301-287-9058 or via email at
The NRC is holding the meetings under the authority of the Government in the Sunshine Act, 5 U.S.C. 552b.
For the Nuclear Regulatory Commission.
Peace Corps.
30-Day notice and request for comments.
The Peace Corps will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval. The purpose of this notice is to allow 30 days for public comment in the
Submit comments on or before September 23, 2024.
Comments should be addressed to James Olin, FOIA/Privacy Act Officer. James Olin can be contacted by email at
James Olin, Peace Corps, at
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Peace Corps.
30-Day notice and request for comments.
The Peace Corps will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval. The purpose of this notice is to allow 30 days for public comment in the
Submit comments on or before September 23, 2024.
Comments should be addressed to James Olin, FOIA/Privacy Act Officer. James Olin can be contacted by email at
James Olin, Peace Corps, at
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Peace Corps.
30-Day notice and request for comments.
The Peace Corps will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval. The purpose of this notice is to allow 30 days for public comment in the
Submit comments on or before September 23, 2024.
Comments should be addressed to James Olin, FOIA/Privacy Act Officer. James Olin can be contacted by email at
James Olin, Peace Corps, at
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Peace Corps.
30-Day notice and request for comments.
The Peace Corps will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval. The purpose of this notice is to allow 30 days for public comment in the
Submit comments on or before September 23, 2024.
Comments should be addressed to James Olin, FOIA/Privacy Act Officer. James Olin can be contacted by email at
James Olin, Peace Corps, at
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Office of Personnel Management.
Notice.
According to the provisions of section 10 of the Federal Advisory Committee Act, notice is hereby given that a virtual meeting of the Federal Prevailing Rate Advisory Committee will be held on Thursday, September 19, 2024. There will be no in-person gathering for this meeting.
The virtual meeting will be held on September 19, 2024, beginning at 10:00 a.m. (ET).
The meeting will convene virtually.
Ana Paunoiu, 202-606-2858, or email
The Federal Prevailing Rate Advisory Committee is composed of a Chair, five representatives from labor unions holding exclusive bargaining rights for Federal prevailing rate employees, and five representatives from Federal agencies. Entitlement to membership on the Committee is provided for in 5 U.S.C. 5347.
The Committee's primary responsibility is to review the Prevailing Rate System and other matters pertinent to establishing prevailing rates under subchapter IV, chapter 53, 5 U.S.C., as amended, and from time to time advise the Office of Personnel Management.
Annually, the Chair compiles a report of pay issues discussed and concluded recommendations. These reports are available to the public. Reports for calendar years 2008 to 2023 are posted at
The public is invited to submit material in writing to the Chair on Federal Wage System pay matters felt to be deserving of the Committee's attention. Additional information on
This meeting is open to the public, with an audio option for listening. This notice sets forth the participation guidelines for the meeting.
The following information must be provided when registering:
• Name.
• Agency and duty station.
• Email address.
• Your topic of interest.
Members of the press, in addition to registering for this event, must also RSVP to
A confirmation email will be sent upon receipt of the registration. Audio teleconference information for participation will be sent to registrants the morning of the virtual meeting. Office of Personnel Management.
Notice is hereby given that pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Rule 17Ad-4(b) & (c) (17 CFR 240.17Ad-4) is used to document when transfer agents are exempt, or no longer exempt, from the minimum performance standards and certain recordkeeping provisions of the Commission's transfer agent rules. Pursuant to Rule 17Ad-4(b), if the Commission or the Office of the Comptroller of the Currency (“OCC”) is the appropriate regulatory authority (“ARA”) for an exempt transfer agent, that transfer agent is required to prepare and maintain in its possession a notice certifying that it is exempt from certain performance standards and recordkeeping and record retention provisions of the Commission's transfer agent rules. This notice need not be filed with the Commission or OCC. If the Board of Governors of the Federal Reserve System (“Fed”) or the Federal Deposit Insurance Corporation (“FDIC”) is the transfer agent's ARA, that transfer agent must prepare a notice and file it with the Fed or FDIC.
Rule 17Ad-4(c) sets forth the conditions under which a registered transfer agent loses its exempt status. Once the conditions for exemption no longer exist, the transfer agent, to keep the appropriate ARA apprised of its current status, must prepare, and file if the ARA for the transfer agent is the Fed or the FDIC, a notice of loss of exempt status under paragraph (c). The transfer agent then cannot claim exempt status under Rule 17Ad-4(b) again until it remains subject to the minimum performance standards for non-exempt transfer agents for six consecutive months.
ARAs use the information contained in the notices required by Rules 17Ad-4(b) and 17Ad-4(c) to determine whether a registered transfer agent qualifies for the exemption, to determine when a registered transfer agent no longer qualifies for the exemption, and to determine the extent to which that transfer agent is subject to regulation.
The Commission estimates that approximately 10 registered transfer agents each year prepare or file notices in compliance with Rules 17Ad-4(b) and 17Ad-4(c). The Commission estimates that each such registered transfer agent spends approximately 1.5 hours to prepare or file such notices for an aggregate total annual burden of 15 hours (based on approximately 1.5 burden hours per year for the approximately 10 transfer agents). The Commission also estimates the aggregate annual internal cost of compliance for the 10 registered transfer agents is approximately $4.785 (based on 1.5 hours annual burden × $319 hourly wage × 10 respondents). This reflects an increase in aggregate annual internal cost of compliance of $540 due to the increase in the hourly wage of transfer agents from $283 to $319.
Written comments are invited on: (a) whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; (b) the accuracy of the Commission's estimates of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information on respondents; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted by October 22, 2024.
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information under the PRA unless it displays a currently valid OMB control number.
Please direct your written comments to: Austin Gerig, Director/Chief Information Officer, Securities and Exchange Commission, c/o Oluwaseun Ajayi, 100 F Street NE, Washington, DC 20549, or send an email to:
On May 24, 2024, the Public Company Accounting Oversight Board (the “Board” or the “PCAOB”) filed with the Securities and Exchange Commission (the “Commission”), pursuant to Section 107(b)
On May 13, 2024, the Board unanimously adopted the Amendments.
Among other things, the Amendments enhance the existing general principles and responsibilities of an auditor by:
• Including introductory language that reaffirms the auditor's fundamental obligation to protect investors through the preparation and issuance of independent auditor's reports;
• Including objectives related to the audit of the effectiveness of a company's internal control over financial reporting;
• Retaining and clarifying the general principles and responsibilities that are foundational for an audit, including reasonable assurance,
• Aligning the engagement partner's supervisory responsibilities under AS 1201,
• Retaining the requirement for the auditor to be independent but expressing the obligation more directly by referring to PCAOB independence rules and standards and SEC independence rules and regulations;
• Describing the auditor's obligations to (i) comply with ethics requirements,
• Expressing the auditor's responsibilities by using the terms set forth in PCAOB Rule 3101,
• Removing language that is outdated, inconsistent, and not relevant to audits conducted under the standards of the PCAOB.
The Amendments also improve other PCAOB auditing standards that address responsibilities fundamental to the conduct of an audit, including by:
• Clarifying the engagement partner's existing responsibilities for supervision and review by providing more specificity related to such activities;
• Clarifying the requirements for audit documentation in AS 1215 to identify who performed the work, who reviewed the work, and the date of such review;
• Accelerating the period in AS 1215 to assemble a complete and final set of audit documentation for retention from 45 days to 14 days (“documentation completion date”);
• Updating
The Amendments will be effective for audits of financial statements for fiscal years beginning on or after December 15, 2024, except that, for registered public accounting firms that provide audit opinions for 100 or fewer issuers during the calendar year ending December 31, 2024, the amendment relating to the documentation completion date will take effect for audits of financial statements for fiscal years beginning on or after December 15, 2025. The PCAOB has proposed application of the Amendments to include audits of emerging growth companies (“EGCs”),
As noted above, to date the Commission has received eleven (11) comment letters on the Amendments.
Some commenters suggested that the Commission encourage the PCAOB to provide implementation support and to undertake a post-implementation review of the Amendments to assess whether they have met their stated objectives.
Some commenters stated that because the Amendments extend the concept of due professional care, specifically professional skepticism, beyond a critical assessment of audit evidence to a critical assessment of other information related to the audit, the Amendments will result in increased focus on the preparation of Form AP,
The same commenters observed that the effective date of the Amendments related to the 14-day documentation completion date requirement does not reference interim reviews or stub periods and requested clarification.
SOX requires us to determine whether the Amendments are consistent with the requirements of Title I of SOX and the rules and regulations thereunder or are necessary or appropriate in the public interest or for the protection of investors.
In the Notice of Filing of Proposed Rules, the Board recommended that the Commission determine that the Amendments apply to audits of EGCs.
Section 103(a)(3)(C) further provides that “[a]ny additional rules” adopted by the PCAOB do not apply to audits of EGCs “unless the Commission determines that the application of such additional requirements is necessary or appropriate in the public interest, after considering the protection of investors and whether the action will promote efficiency, competition, and capital formation.” The Amendments fall within this category. Having considered those statutory factors, we find that applying the Amendments to the audits of EGCs is necessary or appropriate in the public interest.
With respect to the Commission's determination of whether the Amendments will apply to audits of EGCs, the PCAOB explained why it believes the Amendments should apply to audits of EGCs. The Board sought public input on the application of the Amendments to the audits of EGCs, and those that responded to the Board generally agreed the Amendments should apply to the audits of EGCs.
We agree with the Board's assessment and believe that applying the
The PCAOB explained how associated costs may be relatively higher for EGC audits in large part due to the amendment accelerating the documentation completion date.
We also concur with the PCAOB's conclusion that while the costs to update references within firm methodologies and related guidance for the amendments made to the general principles and responsibilities of the auditor could also be relatively higher for firms which are more likely to serve as EGC auditors, in general, the alternative of not applying the same standard and related amendments to audits of EGCs and non-EGCs creates the potential for confusion, or even potential additional costs and inefficiencies to maintain separate methodologies.
As the PCAOB explained in its analysis, the amendment to accelerate the documentation completion date could improve efficiency and capital formation for EGCs to the extent that the amendment reduces uncertainty about the reliability of an EGC's financial statements via enhanced audit quality.
Accordingly, after considering the protection of investors and whether the action will promote efficiency, competition, and capital formation, we believe there is a sufficient basis to determine that applying the Amendments to the audits of EGCs is necessary or appropriate in the public interest.
The Commission has reviewed and considered the Amendments, the information submitted therewith by the PCAOB, and the comment letters received, and the recommendation of the Commission's staff. The Commission concludes that the determinations made by the PCAOB as described in the Adopting Release are reasonable. The Amendments will reaffirm and modernize the foundational audit standards, clarify engagement partner responsibilities, and accelerate the documentation completion date, which should improve audit quality. In particular, the Amendments make the following important changes, among others, to the existing standards, which will advance the Board's investor protection mandate under SOX: reaffirm the auditor's fundamental obligation to protect investors;
A. The Commission finds that the Amendments are consistent with the requirements of Title I of SOX and the rules and regulations thereunder and are necessary or appropriate in the public interest or for the protection of investors; and
B. Separately, the Commission finds that the application of the Amendments to the audits of EGCs is necessary or appropriate in the public interest, after considering the protection of investors and whether the action will promote efficiency, competition, and capital formation.
By the Commission.
On June 20, 2024, the Public Company Accounting Oversight Board (the “Board” or the “PCAOB”) filed
On June 12, 2024, the Board unanimously adopted the Amendments.
The Amendments are principles-based in how they further specify and clarify certain existing auditor responsibilities and are therefore intended to be adaptable to the evolving nature of the use of technology in the audit. In particular, the Amendments:
• Clarify the description of what constitutes a
• Specify auditor responsibilities when identifying items that require further investigation when performing tests of details;
• Specify that if the auditor uses an audit procedure for more than one purpose (
• Specify auditor responsibilities for evaluating the reliability of external information provided by the company under audit;
• Emphasize the importance of controls over information technology;
• Emphasize the importance of appropriate disaggregation or detail of information to the relevance of audit evidence;
• Make conforming changes to AS 2501.
The Amendments will be effective for audits of financial statements for fiscal years beginning on or after December 15, 2025. The PCAOB has proposed application of the Amendments to include audits of emerging growth companies (“EGCs”),
As noted above, to date the Commission has received six (6) comment letters in response to the Notice of Filing of Proposed Rules.
A number of commenters identified the requirements in new paragraph .10A(b) of AS 1105 as requiring further clarity or modification.
All commenters stated that either interpretive or other implementation guidance was warranted to facilitate implementation of the Amendments. One commenter recommended the Commission delay the effective date of the Amendments to align with the effective date of the recently proposed amendments to AS 2305.
As discussed above, a number of commenters were of the view that new paragraph AS1105.10A(b) requires the auditor, in all circumstances, to test whether each piece of information provided to the auditor by the company, which the company received from external sources, has been modified by the company. Although we understand the concerns raised by such commenters, we believe these concerns may be misplaced, particularly in light of the guidance provided by the Board in the Adopting Release. For example, in the Adopting Release, the Board stated that “[it was] not prescribing the nature, timing, or extent of the auditor's procedures to evaluate the reliability of the external information.”
Regarding commenter concerns about the availability of source records, we do not believe that having source records only available in electronic form would inhibit procedures to compare information to source records. Source records are not defined in the PCAOB's auditing standards and may exist in many forms, including in electronic form. We note that, when considering the reliability of such a record, AS 1105.10A and AS 1105.09 require the auditor to consider, among other things, the means by which it was obtained, including any processing by the company and whether there are indications that it may not be authentic.
We also do not believe that the Amendments would require management to establish new controls solely for purposes of satisfying the requirements of the auditor as raised by commenters. The PCAOB addressed this concern in the Adopting Release by explicitly stating that the Amendments do not require testing of controls to establish reliability.
One commenter stated that aspects of revised AS 2301.48 “impact auditors' ability to consistently determine whether a particular audit procedure qualifies as a test of details.”
Regarding the comment recommending the Commission delay the effective date to align with the Substantive Analytical Procedures Proposal, the effective date was addressed by the Board in the Adopting Release, and the Board specifically highlighted that they considered “the effective dates for other Board rulemaking projects.”
We acknowledge commenters' concerns about the need for implementation guidance and we note that the Board has a historical practice of performing a post-implementation review
In the Notice of Filing of Proposed Rules, the Board recommended that the Commission determine that the Amendments apply to audits of EGCs.
Section 103(a)(3)(C) further provides that “[a]ny additional rules” adopted by the PCAOB do not apply to audits of EGCs “unless the Commission determines that the application of such additional requirements is necessary or appropriate in the public interest, after considering the protection of investors and whether the action will promote efficiency, competition, and capital formation.” The Amendments fall within this category. Having considered those statutory factors, we find that applying the Amendments to the audits of EGCs is necessary or appropriate in the public interest.
With respect to the Commission's determination of whether the Amendments will apply to audits of EGCs, the PCAOB provided information, including data and analysis of EGCs that sets forth its views as to why it believes the Amendments should apply to audits of EGCs.
The Board indicated in its assessment that for all audits performed pursuant to PCAOB standards, including audits of EGCs, the Amendments may lead to higher audit quality, more efficient audits, lower audit fees, or some combination of the three.
The Board noted that the Amendments could impact the ability of EGCs to compete if the costs of the Amendments to audited companies (as a result of any increase in costs to their auditors) disproportionately impact EGCs relative to their competitors.
We agree with the Board's findings and further emphasize the benefits of the Amendments for EGCs. The Amendments may promote higher audit quality for EGC audits employing technology-assisted analysis, and thus a higher reliability of financial reporting for the affected EGCs. An increased reliability of financial reporting may enhance investor protection and lead to an improved efficiency of capital allocation and enhanced capital formation with respect to EGCs. These benefits may be moderated relative to the effects on other issuers, because, for example, the auditors of EGCs are currently less likely to employ technology-assisted analysis. However, any potential costs passed down to EGCs may be similarly moderated.
We note that the Amendments could also impact competition for capital or in product markets in which EGCs compete. For example, if non-EGCs are more likely to be the subject of audits using technology-assisted analysis, these issuers may experience greater improvements in the reliability of their financial reporting and thereby attract more capital than EGCs. Alternatively, if any incremental costs or savings passed down to audited companies by auditors as a result of the Amendments are disproportionately directed to either EGCs or their competitors, competition may be affected. However, given that the direct benefits and costs of the rule (including effects on audit quality and audit fees) are expected to be relatively modest, any resulting impact on competition is likely to be relatively limited. While there may be additional effects if the Amendments result in a larger number of auditors newly incorporating or expanding the use of technology-assisted analysis in their audits, and it is difficult to predict which auditors and which engagements would most likely be the subject of such changes, it is not clear that such effects would disproportionately favor the competitors of EGCs. Further, many of the potential effects on competition are unlikely to be mitigated by applying the Amendments only to audits of non-EGCs.
Accordingly, after considering the protection of investors and whether the action will promote efficiency, competition, and capital formation, we believe there is a sufficient basis to determine that applying the Amendments to the audits of EGCs is necessary or appropriate in the public interest.
The Commission has reviewed and considered the Amendments, the information submitted therewith by the PCAOB, the comment letters received, and the recommendation of the Commission's staff. The Commission concludes that the determinations made by the PCAOB as described in the Adopting Release are reasonable. In particular, the Amendments address challenges with the rapidly evolving use of technology-based analytical tools that may not be sufficiently addressed under current professional audit standards. Addressing these challenges will advance the Board's investor protection mandate under SOX given that (1) the use of technology-based analytical tools is substantially increasing and is expected to continue to do so; (2) technology-based analytical tools have the potential to enhance the effectiveness of audit procedures by, for example, increasing the amount of data an auditor is able to analyze or
A. The Commission finds that the Amendments are consistent with the requirements of Title I of SOX and the rules and regulations thereunder and are necessary or appropriate in the public interest or for the protection of investors; and
B. Separately, the Commission finds that the application of the Amendments to the audits of EGCs is necessary or appropriate in the public interest, after considering the protection of investors and whether the action will promote efficiency, competition, and capital formation.
By the Commission.
On June 20, 2024, the Public Company Accounting Oversight Board (the “Board” or the “PCAOB”) filed with the Securities and Exchange Commission (the “Commission”), pursuant to section 107(b)
Existing PCAOB Rule 3502 codifies associated persons' ethical obligation not to contribute to a registered firm's violations of the laws, rules, and standards that the Board is charged with enforcing.
Following notice and comment, and based on its experience with Rule 3502 since the Commission approved the ethics rule in 2006,
The PCAOB determined that under the current formulation of Rule 3502, an incongruity exists between the respective requisite mental states for liability of a registered firm resulting from an associated person's conduct and for liability of the associated person. Specifically, a firm, which acts through its associated persons, can commit a primary violation of certain laws, rules, or standards by acting
The PCAOB also determined that the current version of Rule 3502 prevents the Board from executing its investor-protection mandate to the fullest extent that Congress authorized in SOX. According to the PCAOB, in the instances in which the Board has instituted proceedings against firms for negligence-based violations, the Board has not been able to charge individuals who negligently, directly, and substantially contributed to the firms' violations. The Amendment would allow the Board to do so.
The Amendment will be effective 60 days from the date of this order.
The comment period on the Amendment ended on July 23, 2024. The Commission received one comment letter.
We have considered the concerns raised by the commenter, all of which were considered by the Board prior to finalizing the Amendment, and believe that the Amendment is consistent with the requirements of Title I of SOX and the rules and regulations thereunder and necessary or appropriate in the public interest or for the protection of investors.
With respect to the Board's authority, in its 2006 order approving Rule 3502, the Commission stated that “the rule is within the scope of the PCAOB's authority, particularly its authority to establish ethical standards.”
In addition, section 105 of SOX permits the Board to impose liability for single acts of negligence. Specifically, section 105(c)(4) authorizes the Board to impose an array of sanctions—listed in subparagraphs (A) through (G)—upon finding that a registered firm or associated person engaged in violative conduct, without reference to the level of culpability required but “subject to applicable limitations” in section 105(c)(5). Section 105(c)(5), in turn, provides that “[t]he sanctions and penalties described in subparagraphs (A) through (C) and (D)(ii) of [Section 105(c)(4)] shall only apply to [ ] intentional or knowing conduct, including reckless conduct,” or “repeated instances of negligent conduct each resulting in a violation of the applicable statutory, regulatory, or professional standard.” Section 105(c)(5) thus does not restrict the Board's authority to impose for single acts of negligence certain sanctions—those in subparagraphs (D)(i) and (E) through (G) of section 105(c)(4).
With respect to the Amendment's potential adverse effects, we acknowledge (as the PCAOB did) that the Amendment could result in some incremental legal costs and operational adjustments for firms, individuals, and issuers. However, for the reasons discussed below, we agree with the Board's conclusion that any unintended consequences of the Amendments are likely to be limited and that, on balance, the Amendment will enhance audit quality, not diminish it, for the benefit of investors.
As a threshold matter, the Amendment does not establish a novel burden on individuals to refrain from acting negligently and thereby contributing to a firm's violation: the Commission already has the ability to bring cases against associated persons for negligently contributing to registered firms' violations of numerous laws and rules governing the preparation and issuance of audit reports.
SOX requires us to determine whether the Amendment is consistent with the requirements of Title I of SOX and the rules and regulations thereunder and is necessary or appropriate in the public interest or for the protection of investors. In making this determination, we have considered the comments received, as well as the feedback received and modifications made by the PCAOB throughout its rulemaking process.
Section 103(a)(3)(C) of SOX, as amended by section 104 of the Jumpstart Our Business Startups Act of 2012, requires that any rules of the Board requiring mandatory audit firm rotation or a supplement to the auditor's report in which the auditor would be required to provide additional information about the audit and the financial statements of the issuer (auditor discussion and analysis) shall not apply to an audit of an emerging growth company (“EGC”).
The Board expressed its view that section 103(a)(3)(C) does not apply to the Amendment because the provisions of the Amendment do not fall into those categories and do not impose additional requirements on the audits of EGCs.
With respect to the Commission's determination of whether the Amendment will apply to audits of EGCs, the PCAOB provided information, including data and analysis of EGCs, that sets forth its views as to why it believes the Amendment should apply to audits of EGCs.
We agree with the Board's assessment and believe that applying the Amendment to the audits of EGCs is necessary or appropriate in the public interest, after considering the protection of investors and whether the Amendment will promote efficiency, competition, and capital formation. Specifically, by applying the Amendment to all associated persons of registered public accounting firms engaged in the audits of issuers and registered broker-dealers, including audits of EGCs, investors will benefit from higher standards of audit quality and enhancements to investor protection brought about by the Amendment. Because EGCs are likely to be newer public companies, investors may place greater importance on external audits' adherence to applicable audit standards, in order to enhance and test the credibility of management disclosures, including whether financial statements are free from material misstatement due to error or fraud. Therefore, all else equal, the benefits of the higher audit quality resulting from the Amendment may be more significant for EGCs than for non-EGCs, including improved efficiency of capital allocation, lower cost of capital, and enhanced capital formation. Because investors who lack confidence in a company's financial statements may require a larger risk premium that increases the cost of capital to companies, the improved audit quality resulting from applying the Amendment to associated persons engaged in EGC audits could reduce the cost of capital to those EGCs.
Also, given the Commission's existing authority to sanction associated persons of accounting firms for single acts of contributory negligence, the costs to EGCs associated with the Amendment are expected to be small. Therefore, the Amendment's impact on competition, if any, is expected to be limited.
Accordingly, after considering the protection of investors and whether the action will promote efficiency, competition, and capital formation, we believe that the application of the Amendment to associated persons engaged in the audits of EGCs is necessary or appropriate in the public interest.
The Commission has reviewed and considered the Amendment, the information submitted therewith by the PCAOB, the comment letter received, and the recommendation of the Commission's staff. The Commission concludes that the determinations made by the PCAOB as described in the Adopting Release are reasonable. In particular, the Amendment will make Rule 3502 both a more effective deterrent against unethical contributory conduct by associated persons and a more effective enforcement tool. The Amendment also should prompt individuals to exercise the appropriate level of care in their audit work and lead firms to allocate resources more efficiently, which will raise audit quality. In doing so, the Amendment will advance the Board's investor protection mandate under SOX. Therefore, in connection with the PCAOB's filing and the Commission's review:
A. The Commission finds that the Amendment is consistent with the requirements of Title I of SOX and the rules and regulations thereunder and is necessary or appropriate in the public interest or for the protection of investors; and
B. Separately, the Commission finds that the application of the Amendment to associated persons engaged in the audits of EGCs is necessary or appropriate in the public interest, after considering the protection of investors and whether the action will promote efficiency, competition, and capital formation.
By the Commission.
Notice is hereby given that pursuant to the Paperwork Reduction Act of 1995 (“PRA”) (44 U.S.C. 3501
Rule 17a-5(c) generally requires broker-dealers who carry customer accounts to provide statements of the broker-dealer's financial condition to their customers. Paragraph (c)(5) of Rule 17a-5 provides a conditional exemption from this requirement. A broker-dealer that elects to take advantage of the exemption must publish its statements on its website in a prescribed manner, and must maintain a toll-free number that customers can call to request a copy of the statements.
The purpose of the Rule is to ensure that customers of broker-dealers are provided with information concerning the financial condition of the firm that may be holding the customers' cash and securities. The Commission, when adopting the Rule in 1972, stated that the goal was to “directly” send a customer essential information so that the customer could “judge whether his broker or dealer is financially sound.” The Commission adopted the Rule in response to the failure of several broker-dealers holding customer funds and securities in the period between 1968 and 1971.
The Commission estimates that approximately 153 broker-dealer respondents carrying approximately 272 million public customer accounts incur a burden of approximately 327,444 hours per year to comply with the Rule.
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information under the PRA unless it displays a currently valid OMB control number.
Please direct your written comments to: Austin Gerig, Director/Chief Data Officer, Securities and Exchange Commission, c/o Oluwaseun Ajayi, 100 F Street NE, Washington, DC 20549, or send an email to:
Notice is hereby given that pursuant to the Paperwork Reduction Act of 1995 (“PRA”) (44 U.S.C. 3501
Rule 17f-2(a) (Fingerprinting Requirements for Securities Professionals) requires that securities professionals be fingerprinted. This requirement serves to identify security-risk personnel, to allow an employer to make fully informed employment decisions, and to deter possible wrongdoers from seeking employment in the securities industry. Partners, directors, officers, and employees of exchanges, brokers, dealers, transfer agents, and clearing agencies are included.
The Commission staff estimates that approximately 4,480 respondents will submit an aggregate total of 289,780 new fingerprint cards each year or approximately 65 fingerprint cards per year per registrant. The staff estimates that the average number of hours necessary to complete a fingerprint card is one-half hour. Thus, the total estimated annual burden is 144,890 hours for all respondents (289,780 times one-half hour). The average internal cost of compliance per hour is approximately $310. Therefore, the total estimated annual internal cost of compliance for all respondents is $44,915,900 (144,890 times $310).
This rule does not involve the collection of confidential information.
Written comments are invited on: (a) whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; (b) the accuracy of the Commission's estimates of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted by October 22, 2024.
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information under the PRA unless it displays a currently valid OMB control number.
Please direct your written comments to: Austin Gerig, Director/Chief Data Officer, Securities and Exchange Commission, c/o Oluwaseun Ajayi, 100 F Street NE, Washington, DC 20549, or send an email to:
On January 10, 2024, NYSE Arca, Inc. (“NYSE Arca” or “Exchange”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The Proposal was published for comment in the
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Notice is hereby given that pursuant to the Paperwork Reduction Act of 1995 (“PRA”) (44 U.S.C. 3501
On February 12, 1935, the Commission adopted Rule 12d2-1
Any such suspension may be continued until such time as the Commission may determine that the suspension is designed to evade the provisions of Section 12(d) of the Act and Rule 12d2-2 thereunder.
The trading suspension notices serve a number of purposes. First, they inform the Commission that an exchange has suspended from trading a listed security or reintroduced trading in a previously suspended security. They also provide the Commission with information necessary for it to determine that the suspension has been accomplished in accordance with the rules of the exchange, and to verify that the exchange has not evaded the requirements of Section 12(d) of the Act and Rule 12d2-2 thereunder by improperly employing a trading suspension. Without Rule 12d2-1, the Commission would be unable to fully implement these statutory responsibilities.
There are 24 national securities exchanges
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information under the PRA unless it displays a currently valid OMB control number.
Please direct your written comments to: Austin Gerig, Director/Chief Data Officer, Securities and Exchange Commission, c/o Oluwaseun Ajayi, 100 F Street NE, Washington, DC 20549, or send an email to:
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to modify the delisting process for securities that fail to regain compliance with the bid price requirement following a second compliance period and for securities that have had a reverse stock split over the prior one-year period.
The text of the proposed rule change is available on the Exchange's website at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
Nasdaq is proposing to amend Listing Rules 5810 and 5815 to provide that a company will be suspended from trading on Nasdaq if the company has been non-compliant with the $1.00 bid price requirement for more than 360 days. In addition, Nasdaq is proposing to modify the listing standards such that Nasdaq will immediately send a Delisting Determination, as defined in Rule 5805(h), without any compliance period, to any company that becomes non-compliant with the $1.00 minimum bid price requirement if the company effected a reverse stock split within the prior one-year period.
Nasdaq listing standards require a company's equity securities listed on the Nasdaq Global Select, Global and Capital Markets to maintain a closing bid price that is no less than one dollar per share (the “Bid Price Requirement”).
The bid price rules truncate these compliance periods in two circumstances. First, Listing Rule 5810(c)(3)(A)(iii) provides that if a company's security has a closing bid price of $0.10 or less for 10 consecutive trading days, Nasdaq must issue a Delisting Determination with respect to that security, notwithstanding any otherwise available compliance period. Second, Listing Rule 5810(c)(3)(A)(iv) provides that if a company's security fails to meet the continued listing requirement for minimum bid price and the company has effected one or more reverse stock splits over the prior two-year period with a cumulative ratio of 250 shares or more to one, then the company is not eligible for any compliance periods and Nasdaq must issue a Delisting Determination with respect to that security.
Based on Nasdaq's experience with the rules, Nasdaq is proposing two changes to the bid price requirements for listed companies to better protect investors.
Nasdaq has observed that some companies do not regain compliance during the second 180-day compliance period notwithstanding the company's notification to Nasdaq of its intent to do so. In these circumstances, Nasdaq issues a Delisting Determination; however, as described above, the company could continue its listing by appealing that decision to a Hearings Panel, which has the discretion to
Nasdaq believes that two consecutive compliance periods for a total of 360 days is a sufficient period of time for a company to regain compliance with the Bid Price Requirement, even if the company is required to obtain stockholder approval to effect a reverse stock split by the jurisdiction where the company is incorporated. Nasdaq provides a company with a second bid price compliance period only if the company reviewed its circumstances and notified Nasdaq that it intends to cure the bid price deficiency by effecting a reverse stock split within the second 180-day compliance period. As such, Nasdaq believes that it is not appropriate for a company in these circumstances to continue trading on Nasdaq during the pendency of the Hearings Panel review process. Instead, Nasdaq proposes to amend Rule 5815 to remove the stay provision in these situations so that the company's securities will be suspended from trading on Nasdaq during the pendency of the Hearings Panel's review.
Specifically, Nasdaq proposes to adopt Listing Rule 5815(a)(1)(B)(ii)d. to provide that notwithstanding the general rule that a timely request for a hearing shall ordinarily stay the suspension and delisting action pending the issuance of a written panel decision, a request for a hearing shall not stay the suspension of the securities from trading where the matter relates to a request made by a company that was afforded the second 180-day compliance period described in Rule 5810(c)(3)(A)(ii) and that failed to regain compliance with the minimum bid price requirement during that period. For clarity, Nasdaq proposes to note that pursuant to Rule 5810(c)(3)(A), a company achieves compliance with the minimum bid price requirement by meeting the applicable standard for a minimum of 10 consecutive business days, unless Staff exercises its discretion to extend this 10 day period as discussed in Rule 5810(c)(3)(H).
A company that is suspended under the proposed rule could appeal the Delisting Determination to a Hearings Panel, but its securities would trade in the over-the-counter (OTC) market while that appeal is pending. Pursuant to Listing Rule 5815(c)(1)(A) the Hearings Panel will continue to have discretion, where it deems appropriate, to provide an exception for up to 180 days from the Delisting Determination date for the company to regain compliance with the Bid Price Requirement. Pursuant to Listing Rule 5815(c)(1)(E) the Hearings Panel will also continue to have the authority to find the company in compliance with all applicable listing standards and reinstate the trading of the company's securities on Nasdaq (
As described above, upon a company's failure to satisfy the applicable Bid Price Requirement, Rule 5810(c)(3)(A) provides for an automatic compliance period of 180 calendar days for the company to achieve compliance with the Bid Price Requirement. The process of providing an automatic 180-day compliance period is designed to allow adequate time for a company facing temporary business issues, a temporary decrease in the market value of its securities, or temporary market conditions to regain compliance with the Bid Price Requirement. However, Nasdaq has observed that some companies, typically those in financial distress or experiencing a prolonged operational downturn, engage in a pattern of repeated reverse stock splits.
Nasdaq believes that such behavior is often indicative of deep financial or operational distress within such companies rendering them inappropriate for trading on Nasdaq for investor protection reasons. In these situations, Nasdaq has observed that the challenges facing such companies, generally, are not temporary and may be so severe that the company is not likely to regain compliance within the prescribed compliance period and will continue oscillating between compliance and non-compliance with the Bid Price Requirement. Moreover, a pattern of recurring bid price non-compliance can be a leading indicator of other listing compliance concerns. As a result, these companies often become subject to delisting for other reasons during the compliance periods.
In 2020, Nasdaq amended the rules to require the issuance of a Delisting Determination if a company falls out of compliance with the Bid Price Requirement after completing one or more reverse stock splits resulting in a cumulative ratio of 250 shares or more to one over the two-year period before such non-compliance (the “2020 Rule”).
Accordingly, Nasdaq proposes to further enhance investor protections by immediately initiating the delisting process (rather than providing a 180-day compliance period) for any company's security that becomes non-compliant with the Bid Price Requirement if, in the prior one-year period, the company conducted a reverse stock split (regardless of the ratio). The company could appeal that delisting notification to the Hearings Panel, where it could receive up to 180 days to regain compliance, as described above. Specifically, Nasdaq proposes to amend Listing Rule 5810(c)(3)(A)(iv) to provide that if a company's security fails to meet the continued listing requirement for minimum bid price and the company has effected a reverse stock split over the prior one-year period then the company shall not be eligible for any compliance period specified in Rule 5810(c)(3)(A) and the Listing Qualifications Department shall issue a Delisting Determination under Rule 5810 with respect to that security.
The cumulative impact of the proposed rule change and the 2020 Rule would be as follows:
• A company that effected a reverse stock split of any ratio will be subject to delisting if it falls out of compliance with the Bid Price Requirement within one year of the previous reverse stock split.
• A company that effected one or more reverse stock split with a cumulative ratio of 1-for-250 or higher will be subject to delisting if it falls out of compliance with the Bid Price Requirement within two years of the reverse stock split(s).
The Exchange believes that its proposal is consistent with Section 6(b) of the Act,
While listed, these securities are exempt from the “Penny Stock Rules,”
Nasdaq also believes that the proposal to amend Listing Rule 5815(a)(1)(B)(ii) to provide that a hearing request shall not stay the suspension of the securities from trading when the matter relates to a request made by a company that was afforded the second 180-day compliance period described in Rule 5810(c)(3)(A)(ii) and that failed to regain compliance with the minimum bid price requirement during that period is designed to protect investors and the public interest. In particular, this change will prevent continued trading in such company's securities until an independent Hearings Panel reviews the Delisting Determination and determines that continued trading on Nasdaq is appropriate.
Finally, Nasdaq believes the proposed rule change furthers the objectives of Section 6(b)(7) of the Act in that it continues to provide a fair procedure for companies subject to these enhanced listing requirements. These companies can seek review of a Delisting Determination from a Hearings Panel, which can afford the company additional time to regain compliance, and can appeal the Hearings Panel decision to the Nasdaq Listing and Hearing Review Council.
The Exchange does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act. While Nasdaq does not believe there will be any impact on competition from the proposed change, any impact on competition that does arise will be necessary to better protect investors, in furtherance of a central purpose of the Act.
No written comments were either solicited or received.
Within 45 days of the date of publication of this notice in the
Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Notice is hereby given that pursuant to the Paperwork Reduction Act of 1995 (“PRA”) (44 U.S.C. 3501
Regulation AC requires that research reports published, circulated, or provided by a broker or dealer or covered person contain a statement attesting that the views expressed in each research report accurately reflect the analyst's personal views and whether or not the research analyst received or will receive any compensation in connection with the views or recommendations expressed in the research report. Regulation AC also requires broker-dealers to, on a quarterly basis, make, keep, and maintain records of research analyst statements regarding whether the views expressed in public appearances accurately reflected the analyst's personal views, and whether any part of the analyst's compensation is related to the specific recommendations or views expressed in the public appearance. Regulation AC also requires that research prepared by foreign persons be presented to U.S. persons pursuant to Securities Exchange Act Rule 15a-6 and that broker-dealers notify associated persons if they would be covered by the regulation. Regulation AC excludes the news media from its coverage.
The Commission estimates that Regulation AC imposes an aggregate annual time burden of approximately 41,384 hours. The Commission estimates that the total annual internal cost of compliance for the 41,384 hours is approximately $22,891,896.
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information under the PRA unless it displays a currently valid OMB control number.
Small Business Administration.
Amendment 7.
This is an amendment of the Presidential declaration of a major disaster for the State of Iowa (FEMA-4796-DR), dated 06/24/2024.
Issued on 08/16/2024.
Alan Escobar, Office of Disaster Recovery & Resilience, U.S. Small Business Administration, 409 3rd Street SW, Suite 6050, Washington, DC 20416, (202) 205-6734.
The notice of the President's major disaster declaration for the State of Iowa, dated 06/24/2024, is hereby amended to extend the deadline for filing applications for physical damages as a result of this disaster to 10/22/2024.
All other information in the original declaration remains unchanged.
U.S. Small Business Administration.
Amendment 3.
This is an amendment of the Presidential declaration of a major disaster for the State of New Mexico (FEMA-4795-DR), dated 06/20/2024.
Issued on 08/15/2024.
Vanessa Morgan, Office of Disaster Recovery & Resilience, U.S. Small Business Administration, 409 3rd Street SW, Suite 6050, Washington, DC 20416, (202) 205-6734.
The notice of the President's major disaster
All other information in the original declaration remains unchanged.
Social Security Administration (SSA).
Notice of updated schedule of standard administrative fees.
On August 22, 2012, we announced in the
The changes described above are applicable for requests we receive on or after October 1, 2024.
Stephen Hull, Social Security Administration, Office of Finance, 6401 Security Boulevard, Baltimore, MD 21235-6401, (410) 966-1890. For information on eligibility or filing for benefits, visit our website,
Section 1106 of the Act and the Privacy Act
A requester can obtain certified and non-certified detailed yearly Social Security earnings information by completing Form SSA-7050,
We will continue to evaluate all standard fees at least every two years to ensure we capture the full costs associated with providing information for non-program-related purposes. We require nonrefundable advance payment by check, money order, or credit card. We do not accept cash. We will accept only one form of payment in the full amount of the standard fee for each request and will not divide the fee amount between more than one form of payment. If we revise any of the standard fees, we will publish another notice in the
Additional information is available on our Business Services website at
The Commissioner of SSA, Martin O'Malley, having reviewed and approved this document, is delegating the authority to electronically sign this document to Faye Lipsky, who is a Federal Register Liaison for SSA, for
Great Lakes Terminal Railroad, LLC (GLTRR), a Class III carrier, has filed a verified notice of exemption pursuant to 49 CFR 1150.41 to lease and operate 14,215 feet (2.69 miles) of trackage in Chicago, Ill. (the Line), following the acquisition of the Line by Norfolk Southern Railway Company (NSR) from GLTRR's affiliated company, Great Lakes Terminal, LLC (GLT). According to the verified notice, the Line does not have mileposts. GLTRR has operated over the Line since 2018 pursuant to a lease agreement with GLT.
According to the verified notice, GLT has reached an agreement with NSR to sell NSR the Line on or after September 6, 2024. GLTRR states it has entered into a lease agreement with NSR to continue to operate the Line following the close of the sale. GLTRR states that the lease agreement will be effective on or after the effective date of the notice.
GLTRR certifies that its projected annual revenues are less than $5 million and are not expected to exceed those that would qualify it as a Class III carrier. GLTRR states that the transaction does not involve any provision or agreement that may limit future interchange with a third-party connecting carrier, nor is the Line currently subject to any agreement that imposes such an interchange commitment.
The transaction may be consummated on or after September 8, 2024, the effective date of the exemption (30 days after the verified notice was filed).
If the verified notice contains false or misleading information, the exemption is void ab initio. Petitions to revoke the exemption under 49 U.S.C. 10502(d) may be filed at any time. The filing of a petition to revoke will not automatically stay the effectiveness of the exemption. Petitions for stay must be filed no later than August 30, 2024 (at least seven days before the exemption becomes effective).
All pleadings, referring to Docket No. FD 36801, must be filed with the Surface Transportation Board either via e-filing on the Board's website or in writing addressed to 395 E Street SW, Washington, DC 20423-0001. In addition, a copy of each pleading must be served on GLTRR's representative, Crystal M. Zorbaugh, Mullins Law Group PLLC, 2001 L Street NW, Suite 720, Washington, DC 20036.
According to GLTRR, this action is categorically excluded from environmental review under 49 CFR 1105.6(c) and from historic preservation reporting requirements under 49 CFR 1105.8(b).
Board decisions and notices are available at
By the Board, Scott M. Zimmerman, Acting Director, Office of Proceedings.
Surface Transportation Board.
Notice of filing schedule; opportunity for submissions by non-parties.
The Surface Transportation Board (Board) has issued a decision in its investigation of the causes of substandard on-time performance of Amtrak's Sunset Limited that, among other things, establishes a procedural schedule for the filing of pleadings and provides guidance on subjects to be addressed in those pleadings. Under the procedural schedule, non-parties will be permitted to submit replies to the opening briefs filed by Amtrak and railroad parties' replies.
Amtrak's opening statement is due by October 7, 2024. Railroad party replies to Amtrak's opening statement are due by December 23, 2024. Non-party replies are due January 22, 2025. Railroad party rebuttals to non-party replies are due February 21, 2025. Amtrak's rebuttal to all replies is due by February 21, 2025.
All filings must be filed with the Surface Transportation Board either via e-filing on the Board's website or in writing addressed to 395 E Street SW, Washington, DC 20423-0001. Parties and non-parties submitting filings must reference Docket No. NOR 42175 and comply with the Board's service requirements set forth at 49 CFR 1104.12. Information on the Board's service requirements can be viewed on the Board's website at
Brian O'Boyle (202) 245-0364. If you require an accommodation under the Americans with Disabilities Act, please call (202) 245-0245.
Additional information is contained in the Board's decision served on August 19, 2024, which is available at
By the Board, Board Members Fuchs, Hedlund, Primus, and Schultz.
Surface Transportation Board.
Notice Tentatively Approving and Authorizing Finance Transaction.
On June 21, 2024, Bus Company Holdings Topco LP (Topco) and Bus Company Holdings US LLC (Holdings US) (collectively, Bus Company Holdings), both noncarriers, along with certain of their subsidiaries (collectively, Applicants), filed an application for control over the assets of certain interstate passenger motor carriers controlled by Coach USA, Inc. (Coach USA). The Board is tentatively approving and authorizing the transaction subject to the Renco Group,
Renco's filing to join the application must be filed by September 6, 2024. Comments must be filed by October 7, 2024. If any comments are filed, Applicants may file a reply by October 22, 2024. If no opposing comments are filed by October 7, 2024, this notice shall be effective on October 8, 2024.
Comments, referring to Docket No. MCF 21117, may be filed with the Board either via e-filing on the Board's website or in writing addressed to: Surface Transportation Board, 395 E Street SW, Washington, DC 20423-0001. In addition, send one copy of comments to Applicants' representative: Joshua H. Runyan, Steptoe LLP, 1330 Connecticut Avenue NW, Washington, DC 20036.
Sarah Fancher at (202) 740-5507. If you require an accommodation under the Americans With Disabilities Act, please call (202) 245-0245.
According to the application,
On June 11, 2024, Coach USA, on behalf of itself, affiliates, and subsidiaries, filed a voluntary petition for relief under Chapter 11 of the Bankruptcy Code in the United States Bankruptcy Court for the District of Delaware. (Appl. 3 (citing
The transaction underlying the application contemplates that the assets and goodwill of certain Coach USA subsidiaries—Rockland Coaches, Inc. (Rockland Coaches); Hudson Transit Lines, Inc. (Hudson); Chenango Valley Bus Lines, Inc. (Chenango); Sam Van Galder, Inc. (Sam Van Galder); Wisconsin Coach Lines, Inc. (Wisconsin Coach Lines); Suburban Transit Corp.; Dillon's Bus Service, Inc. (Dillon's Bus Service); Olympia Trails Bus Company Inc. (Olympia Trails); Elko, Inc.; Trentway-Wagar, Inc. (Trentway-Wagar); and Community Bus Lines, Inc. (Community Bus Lines) (collectively, Coach USA Subsidiaries)—will be purchased separately by the Acquisition Companies. (
The specific acquisitions of control that are contemplated by the transaction are as follows: Rockland Bus Lines will acquire the assets of Rockland Coaches; Shortline Transit will acquire the assets of Hudson and Chenango; Wisconsin Transit will acquire the assets of Sam Van Galder and Wisconsin Coach; Suburban Transit Lines will acquire the assets of Suburban Transit Corp.; Dillion's Bus Lines will acquire the assets of Dillon's Bus Service; OBC Lines will acquire the assets of Olympia Trails; Elko Bus Lines will acquire the assets of Elko, Inc.; Newcan Coach will acquire the assets of Trentway-Wagar (
The Acquisition Companies are described in the application as follows:
• Rockland Bus Lines is a limited liability company organized under the laws of, and headquartered in, New Jersey. (Appl. at 5.)
• Shortline Transit is a limited liability company organized under the laws of, and headquartered in, New York. (
• Wisconsin Transit is a limited liability company organized under the laws of, and headquartered in, Wisconsin. (
• Suburban Transit Lines is a limited liability company organized under the laws of, and headquartered in, New Jersey. (
• Dillion's Bus Lines is a limited liability company organized under the laws of, and headquartered in, Maryland. (
• OBC Lines LLC is a limited liability company organized under the laws of, and headquartered in, New Jersey. (
• Elko Bus Lines is a limited liability company organized under the laws of Wyoming and headquartered in Nevada. (
• Community Transport Lines is a limited liability company organized under the laws of, and headquartered in, New Jersey. (
• Newcan Coach is a Canadian unlimited liability company organized under the laws of, and headquartered in, Ontario, Canada. (
The application describes the Coach USA Subsidiaries
• Rockland Coaches employs approximately 88 employees, including 63 drivers, and operates approximately 99 buses. (Appl. 7.) It focuses its operations on commuter routes to and from New York City. (
• Together, Hudson and Chenango employ approximately 213 employees, including 127 drivers, and operate approximately 209 buses. (
• Sam Van Galder employs approximately 214 employees, including 141 drivers, and operates approximately 94 buses. (
• Wisconsin Coach Lines employs approximately 89 employees, including 49 drivers, and operates approximately 94 buses. (
• Suburban Transit Corp. employs approximately 260 employees, including 186 drivers, and operates approximately 149 buses. (
• Dillon's Bus Service employs approximately 193 employees, including 134 drivers, and operates approximately 169 buses. (
• Olympia Trails employs approximately 49 employees, including 12 drivers and operates approximately 17 buses. (
• Elko, Inc. employs approximately 203 employees, including 133 drivers, and operates approximately 146 buses. (
• Community Bus Lines employs approximately 244 employees, including 187 drivers, and operates approximately 143 buses. (Appl. 10.) It focuses its operations on contracted transit bus services at the Brooklyn Navy Yard, N.Y. (
• Trentway-Wagar employs approximately 300 employees, including 150 drivers, and operates approximately 135 buses. (
Under 49 U.S.C. 14303(b), the Board must approve and authorize a transaction that it finds consistent with the public interest, taking into consideration at least (1) the effect of the proposed transaction on the adequacy of transportation to the public, (2) the total fixed charges that result from the proposed transaction, and (3) the interest of affected carrier employees. Applicants have submitted the information required by 49 CFR 1182.2, including information to demonstrate that the proposed transaction is consistent with the public interest under 49 U.S.C. 14303(b),
Applicants assert that granting the application would be consistent with the public interest. (Appl. 12.) According to Applicants, the transaction will preserve the value of the Coach USA Subsidiaries' assets and ensure continued efficient and adequate service to the public. (
Applicants assert that the proposed transaction will have no material adverse impact on the fixed charges of the Coach USA Subsidiaries and that interest charges should decline as a result of the transaction. (
Applicants state that Renco “does not believe that it should be an applicant” because it “will not . . . direct or oversee control of any day-to-day bus operations or services of the Acquisition Companies,” and “[a]ny `control' is solely incidental to Renco's direct or indirect ownership interest, like any other sole or majority owner of an entity.” (Suppl. 2, July 12, 2024; Suppl. 2, July 24, 2024.) “Control,” however, is not limited to “actual control,” but also encompasses “legal control” and the “power to exercise control,” including through or by a holding or investment company. 49 U.S.C. 13102(5);
Based on Applicants' representations, the Board finds that the acquisition as proposed in the application is consistent with the public interest. In the interest of expedition—particularly in light of the ongoing bankruptcy proceeding—the application will be tentatively approved and authorized, subject to Renco submitting a complete filing, as described above, that is consistent with the Board's public interest finding by September 6, 2024. If any opposing comments are timely filed, these findings will be deemed vacated, and, unless a final decision can be made on the record as developed, a procedural schedule will be adopted to reconsider the application.
This action is categorically excluded from environmental review under 49 CFR 1105.6(c).
Board decisions and notices are available at
1. The proposed transaction is approved and authorized, subject to Renco submitting a satisfactory filing to join the application by September 6, 2024, and the filing of opposing comments.
2. If opposing comments are timely filed, the findings made in this notice will be deemed vacated.
3. This notice will be effective October 8, 2024, unless the Board finds Renco's submission unsatisfactory or opposing comments are filed by October 7, 2024. If any comments are filed, Applicants may file a reply by October 22, 2024.
4. A copy of this notice will be served on: (1) the U.S. Department of Transportation, Federal Motor Carrier Safety Administration, 1200 New Jersey Avenue SE, Washington, DC 20590; (2) the U.S. Department of Justice, Antitrust Division, 10th Street & Pennsylvania Avenue NW, Washington, DC 20530; and (3) the U.S. Department of Transportation, Office of the General Counsel, 1200 New Jersey Avenue SE, Washington, DC 20590.
By the Board, Board Members Fuchs, Hedlund, Primus, and Schultz.
9:00 a.m. CT on August 22, 2024.
Marriott Shoals Conference Center, 10 Hightower Place, Florence, Alabama.
Open.
The TVA Board of Directors will hold a public meeting on August 22 at the Marriott Shoals Conference Center, 10 Hightower Place, Florence, Alabama. The meeting will be called to order at 9:00 a.m. CT to consider the agenda items listed below. TVA management will answer questions from the news media following the Board meeting.
On August 21, at the Marriott Shoals Conference Center, the public may comment on any agenda item or subject at a Board-hosted public listening session which begins at 2:00 p.m. CT and will last until 4:00 p.m. Preregistration is required to address the Board.
For more information: Please call TVA Media Relations at (865) 632-6000, Knoxville, Tennessee. Anyone who wishes to comment on any of the agenda in writing may send their comments to: TVA Board of Directors, Board Agenda Comments, 400 West Summit Hill Drive, Knoxville, Tennessee 37902.
Department of Transportation, Federal Aviation Administration (FAA).
Notice of submission deadline.
Under this notice, the FAA announces the submission deadline of October 10, 2024, for Summer 2025 flight schedules at Chicago O'Hare International Airport (ORD), John F. Kennedy International Airport (JFK),
Schedules should be submitted by October 10, 2024.
Schedules may be submitted to the Slot Administration Office by email to:
Al Meilus, Manager, Slot Administration and Capacity Analysis, AJR-G, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591; telephone (202) 267-2822; email
This document provides routine notice to carriers serving capacity-constrained airports in the United States, including ORD, JFK, LAX, EWR, and SFO. In particular, this notice announces the deadline for carriers to submit schedules for the Summer 2025 scheduling season.
The FAA has designated JFK as an IATA Level 3 airport consistent with the Worldwide Slot Guidelines (WSG).
The FAA has designated EWR, LAX, ORD, and SFO as IATA Level 2 airports
The FAA is primarily concerned about scheduled and other regularly conducted commercial operations during designated hours, but carriers may submit schedule plans for the entire day. The designated hours for the Summer 2025 scheduling season are: at EWR and JFK from 0600 to 2300 Eastern Time (1000 to 0300 UTC), at LAX and SFO from 0600 to 2300 Pacific Time (1300 to 0600 UTC), and at ORD from 0600 to 2100 Central Time (1100 to 0200 UTC). These hours are unchanged from previous scheduling seasons.
Carriers should submit schedule information in sufficient detail including, at minimum, the marketing or operating carrier, flight number, scheduled time of operation, frequency, aircraft equipment, and effective dates. IATA standard schedule information format and data elements for communications at Level 2 and Level 3 airports in the IATA Standard Schedules Information Manual (SSIM) Chapter 6 may be used. The WSG provides additional information on schedule submissions at Level 2 and Level 3 airports. Some carriers at JFK manage and track slots through FAA-assigned Slot ID numbers corresponding to an arrival or departure slot in a particular half-hour on a particular day of week and date. The FAA has a similar voluntary process for tracking schedules at EWR with Reference IDs, and certain carriers are managing their schedules accordingly. The primary users of IDs are United States and Canadian carriers that have the highest frequencies and considerable schedule changes throughout the season and can benefit from a simplified exchange of information not dependent on full flight details. Carriers are encouraged to submit schedule requests at those airports using Slot or Reference IDs.
As stated in the WSG, schedule facilitation at a Level 2 airport is based on the following: (1) Schedule adjustments are mutually agreed upon between the carriers and the facilitator; (2) the intent is to avoid exceeding the airport's coordination parameters; (3) the concepts of historic precedence and series of slots do not apply at Level 2 airports, although WSG recommends giving priority to approved services that plan to operate unchanged from the previous equivalent season at Level 2 airports; and (4) the facilitator should adjust the smallest number of flights by the least amount of time necessary to avoid exceeding the airport's coordination parameters. Consistent with the WSG, the success of Level 2 in the United States depends on the voluntary cooperation of carriers.
The FAA considers several factors and priorities that are consistent with the WSG as it reviews schedule and slot requests at Level 2 and Level 3 airports, including (1) historic slots or services from the previous equivalent season over new demand for the same timings; (2) services that are unchanged over services that plan to change time or other capacity relevant parameters; (3) introduction of year-round services; (4) effective period of operation; (5) regularly planned operations over
The FAA seeks to maintain close communications with carriers and terminal schedule facilitators on potential runway schedule issues or terminal and gate issues that may affect the runway times. In addition to applying these priorities from the WSG, the U.S. Government has adopted a number of measures and procedures to promote competition and new entry at U.S. slot-controlled and schedule-facilitated airports.
Slot management in the United States differs in some respect from procedures in other countries. In the United States, the FAA is responsible for facilitation and coordination of runway access for takeoffs and landings at Level 2 and Level 3 airports; however, the airport authority or its designee is responsible for facilitation and coordination of terminal/gate/airport facility access. The process with the individual airports for terminal access and other airport services is separate from, and in addition to, the FAA schedule review based on runway capacity.
Generally, the FAA uses average hourly runway capacity throughput for airports and performance metrics in conducting its schedule review at Level 2 airports and determining the scheduling limits at Level 3 airports included in FAA rules or orders.
Finally, the FAA notes that the schedule information submitted by carriers to the FAA may be subject to disclosure under the Freedom of Information Act (FOIA). The WSG also provides for release of information at certain stages of slot coordination and
Consistent with the WSG, carriers are asked for their voluntary cooperation to adjust schedules to meet the targeted scheduling limits in order to minimize potential congestion and delay. For the Summer 2025 scheduling season, the voluntary, targeted hourly scheduling limits remain at 77 operations and 41 operations per half-hour.
Carriers are reminded that FAA approval for runway times is separate from the approval process for gates or other airport infrastructure and both are essential for the success of Level 2 at EWR. Schedule facilitation at Level 2 airports is designed to engender collaboration and gain mutual agreement between the carriers and the FAA regarding schedules and potential adjustments to stay within the performance goals and capacity limits of the airport and to mitigate delays and congestion that would result in the need for Level 3 slot controls. The FAA expects that all carriers operating at EWR will respect the targeted scheduling limits and work cooperatively with the FAA in order to avoid unacceptable delays and other adverse operational impacts at the airport.
The FAA is aware of runway construction planned at EWR for 2025. At this time, the FAA is evaluating the impact on EWR's runway capacity throughout the projected construction period in 2025. If the FAA concludes that scheduling relief is needed, a separate policy will be issued.
National Highway Traffic Safety Administration (NHTSA), Department of Transportation (DOT).
Notice of a public meeting.
The National Highway Traffic Safety Administration (NHTSA) will hold a public meeting from October 28 to October 30, 2024, as a joint effort between the Agency's Vehicle Safety Research and Behavioral Safety Research offices to share information on activities within the Agency's research programs. The meeting will be held in a virtual format with representatives from across the two research offices presenting the information in panels.
Questions from the audience will be addressed following presentations. Each presentation will include visual slides that will be available in a public docket after the public meeting. A recording of the panels will also be available on the NHTSA website.
NHTSA will hold the public meeting on October 28 to October 30, 2024, with times to be established as the agenda is further refined. The meeting will be held virtually, via Zoom. Registration to attend the meeting must be received no later than October 23, 2024. There is no cost to register. Registration can be completed at
The meeting will be held virtually via Zoom. The virtual meeting's online access link(s) will be available upon registration. Details regarding the agenda and speakers will be added to the Public Meeting website,
If you have questions about the public meeting, please contact Jennifer Oxenham at 202-366-2827 or by email at
For reference, NHTSA's previous Safety Research Portfolio public meeting, held in Fall 2022, is available for viewing at
Registration is recommended for all attendees. Attendees should register at
NHTSA is committed to providing equal access to this event for all participants. People with disabilities can submit an accommodation request, and people with limited English proficiency can submit a language access request. Please submit any request to Jennifer Oxenham at 202-366-2827 or via email at
Should it be necessary to cancel or reschedule the meeting due to an unforeseen circumstance, NHTSA will take all available measures to notify registered participants as soon as possible. NHTSA will conduct the public meeting informally, and
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This public meeting is intended to provide public and stakeholder outreach regarding research activities at NHTSA for both vehicle and behavioral safety, including expected near-term deliverables. NHTSA technical research staff will discuss projects recently concluded or underway and may also introduce early-stage projects. As time allows, there will be an opportunity for session attendees to submit questions via the chat feature in the broadcast medium.
Presentations will be displayed during the panel sessions and will be posted to the docket (
Discussion of research projects will occur in the form of technical panel presentations. Participants will be able to register for any or all of the days and be able to join the Zoom webinar in parts or for full sessions throughout each day.
The Agency invites comments on the information presented as well as on the Agency's research priorities, research goals, and additional research gaps/needs the public may believe NHTSA should be addressing. Select project work may be posted to the docket for which comments are also welcome. Slides presented at the public meeting will be posted to the docket subsequently for public access and a recording of the meeting will be made available after the event for offline viewing.
Notice of open meeting.
This notice announces an open meeting of the Community Development Advisory Board (the Advisory Board), which provides advice to the Director of the Community Development Financial Institutions Fund (CDFI Fund). The meeting will be open to the public who may either attend the meeting in-person or view it as a live webcast. The meeting will be held at the U.S. Department of the Treasury in a room that will accommodate up to 50 members of the public on a first-come, first-served basis. The Advisory Board page on the CDFI Fund website is located at
The meeting will be held from 9:30 a.m. to 4:00 p.m. Eastern Time on Thursday, September 19, 2024.
The Advisory Board meeting will be held in the Cash Room at the U.S. Department of the Treasury located at 1500 Pennsylvania Avenue NW, Washington, DC 20220.
In general, the CDFI Fund will make all statements available in their original format, including any business or personal information provided such as
Bill Luecht, Senior Advisor, Office of Legislative and External Affairs, CDFI Fund; (202) 653-0322 (this is not a toll-free number); or
Section 104(d) of the Riegle Community Development and Regulatory Improvement Act of 1994 (Pub. L. 103-325), which created the CDFI Fund, established the Advisory Board. The charter for the Advisory Board has been filed in accordance with the Federal Advisory Committee Act, as amended (5 U.S.C. 1001
The function of the Advisory Board is to advise the Director of the CDFI Fund (who has been delegated the authority to administer the CDFI Fund) on the policies regarding the activities of the CDFI Fund. The Advisory Board is not a governing board, and it does not advise the CDFI Fund on approving or declining any particular application for monetary or non-monetary awards.
In accordance with section 10(a) of the Federal Advisory Committee Act, 5 U.S.C. 1009 and the regulations thereunder, Bill Luecht, Designated Federal Officer of the Advisory Board, has ordered publication of this notice that the Advisory Board will convene an open meeting, which will be held in the Cash Room at the U.S. Department of the Treasury located at 1500 Pennsylvania Avenue NW, Washington, DC 20220, from 9:30 a.m. to 4:00 p.m. Eastern Time on Thursday. September 19, 2024. The room will accommodate up to 50 members of the public on a first-come, first-served basis.
Because the meeting will be held in a secure federal building, members of the public who wish to attend the meeting must register in advance. The link to the online registration system is also posted under the date of the meeting at
Members of the public who wish to view the live webcast can access the link which will be posted under the date of the meeting at
The Advisory Board meeting will include a report from the CDFI Fund Director on the activities of the CDFI Fund and panel discussions related to the Advisory Board's subcommittees. This meeting is being convened to commemorate the 30th anniversary of the establishment of the CDFI Fund.
Office of the Comptroller of the Currency (OCC), Treasury.
Notice and request for comment.
The OCC, as part of its continuing effort to reduce paperwork and respondent burden, invites comment on a continuing information collection, as required by the Paperwork Reduction Act of 1995 (PRA). In accordance with the requirements of the PRA, the OCC may not conduct or sponsor, and the respondent is not required to respond to, an information collection unless it displays a currently valid Office of Management and Budget (OMB) control number. The OCC is soliciting comment concerning the renewal of its information collection titled, “International Regulation—Part 28.”
Comments must be received by October 22, 2024.
Commenters are encouraged to submit comments by email, if possible. You may submit comments by any of the following methods:
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Following the close of this notice's 60-day comment period, the OCC will publish a second notice with a 30-day comment period. You may review comments and other related materials that pertain to this information collection beginning on the date of publication of the second notice for this collection by the method set forth in the next bullet.
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Shaquita Merritt, Clearance Officer, (202) 649-5490, Chief Counsel's Office, Office of the Comptroller of the Currency, 400 7th Street SW, Washington, DC 20219. If you are deaf, hard of hearing, or have a speech disability, please dial 7-1-1 to access telecommunications relay services.
Under the PRA (44 U.S.C. 3501
A national bank shall notify the OCC when it (1) files an application, notice, or report with the Board of Governors of the Federal Reserve System (FRB) to establish or open a foreign branch; or acquire or divest of an interest in, or close, an Edge corporation, Agreement corporation, foreign bank, or other foreign organization; or (2) opens a foreign branch, and no application or notice is required by the FRB for such transaction. Pursuant to § 28.3(c), the OCC also has required additional information in the form of an application from a national bank seeking to join a foreign exchange, clearinghouse, or similar type of organization. In lieu of a notice, the OCC may accept a copy of an application, notice, or report submitted to another Federal agency that covers the proposed action and contains substantially the same information required by the OCC. A national bank shall furnish the OCC with any additional information the OCC may require in connection with the national bank's foreign operations.
A foreign bank shall aggregate business transacted by all Federal branches and agencies with the business transacted by all state branches and agencies controlled by the foreign bank in determining its compliance with limitations based upon the capital of the foreign bank. A foreign bank shall designate one Federal branch or agency office in the United States to maintain consolidated information so that the OCC can monitor compliance.
A foreign bank should require its depository bank to segregate its capital equivalency deposits (CED) on the depository bank's books and records. The instruments making up the CED that are placed in safekeeping at a depository bank to satisfy a foreign bank's CED requirement must be maintained pursuant to an agreement prescribed by the OCC that shall be a written agreement entered into with the OCC. Each Federal branch or agency shall maintain a capital equivalency account and keep records of the amount of liabilities requiring capital equivalency coverage in a manner and form prescribed by the OCC. A foreign bank's CED may not be reduced in value below the minimum required for that branch or agency without the prior approval of the OCC, but in no event may the value fall below the statutory minimum.
A foreign bank may apply to the OCC for an exemption to permit an uninsured Federal branch to accept or maintain deposit accounts that are not listed in § 28.16(b). The request should describe the types, sources, and estimated amount of such deposits and explain why the OCC should grant an exemption, and how the exemption maintains and furthers the policies described in § 28.16(a).
A foreign bank that has more than one Federal branch in the same state may aggregate deposits in all of its Federal branches in that state, but exclude deposits of other branches, agencies, or wholly owned subsidiaries of the bank. The Federal branch shall compute the average amount by using the sum of deposits as of the close of business of the last 30 calendar days ending with, and including, the last day of the calendar quarter, divided by 30. The Federal branch shall maintain records of the calculation until its next examination by the OCC.
Each Federal branch or agency shall maintain a set of accounts and records reflecting its transactions that are separate from those of the foreign bank and any other branch or agency. The Federal branch or agency shall keep a set of accounts and records in English sufficient to permit the OCC to examine the condition of the Federal branch or agency and its compliance with applicable laws and regulations.
The OCC may require a foreign bank to hold certain assets in the state in which its Federal branch or agency is located.
The Federal branch or agency shall send the OCC certification that all of its Reports of Examination have been destroyed or return its Reports of Examination to the OCC.
Comments submitted in response to this notice will be summarized and included in the request for OMB approval. All comments will become a matter of public record. Comments are invited on:
(a) Whether the collection of information is necessary for the proper performance of the functions of the OCC, including whether the information has practical utility;
(b) The accuracy of the OCC's estimate of the burden of the collection of information;
(c) Ways to enhance the quality, utility, and clarity of the information to be collected;
(d) Ways to minimize the burden of the collection on respondents, including through the use of automated collection techniques or other forms of information technology; and
(e) Estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information.
Veterans Benefits Administration, Department of Veterans Affairs.
Notice.
In compliance with the Paperwork Reduction Act (PRA) of 1995, this notice announces that the Veterans Benefits Administration, Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden, and it includes the actual data collection instrument.
Comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice by clicking on the following link
An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. The
Department of Veterans Affairs (VA) gives notice under the Federal Advisory Committee Act, 5 U.S.C. Ch. 10, that the Veterans' Advisory Committee on Rehabilitation (hereinafter the Committee) will meet on Monday, September 16, 2024 and Tuesday, September 17, 2024. The meeting sessions will begin and end as follows:
Sessions are open to the public, except when the Committee is conducting a tour of VA facilities. Tours of VA facilities are closed to protect Veterans' privacy and personal information, by 5 U.S.C. 552b(c)(6).
The purpose of the Committee is to advise the Secretary of VA on the rehabilitation needs of Veterans with disabilities and the administration of VA's rehabilitation programs.
During the open sessions, the Committee will receive briefings on various Veterans Health Administration and Veterans Benefits Administration (VBA) programs designed to enhance the rehabilitative potential of Veterans with disabilities. In the closed session, the Committee will tour the Seattle VA Medical Center located at 1660 S. Columbian Way, Seattle, WA 98108.
Members of the public may submit written statements until Wednesday, September 11, 2024, for the Committee's review to Ms. Latrese Thompson, Designated Federal Officer, VBA (28), 1800 G Street NW, Washington, DC 20006, or at
Members of the public may attend in person or virtually using the following Microsoft Teams link by computer or mobile app:
Federal Deposit Insurance Corporation.
Notice of proposed rulemaking.
The Federal Deposit Insurance Corporation (FDIC) is inviting comment on proposed revisions to its regulations relating to the brokered deposits restrictions that apply to less than well-capitalized insured depository institutions. The proposed rule would revise the “deposit broker” definition and would amend the analysis of the “primary purpose” exception to the “deposit broker” definition. The proposed rule would also amend two of the designated business relationships under the primary purpose exception and make changes to the notice and application process for the primary purpose exception. In addition, the proposed rule would clarify when an insured depository institution can regain status as an “agent institution” under the limited exception for a capped amount of reciprocal deposits.
Comments must be received by the FDIC no later than October 22, 2024.
You may submit comments on this document using any of the following methods:
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The FDIC's mission is to maintain stability and public confidence in the nation's financial system by, among other things, overseeing financial institutions for safety and soundness and insuring deposits. Since the enactment of section 29 of the Federal Deposit Insurance Act (FDI Act),
The FDIC has found significant reliance on brokered deposits increases an institution's risk profile, particularly as its financial condition weakens. The FDIC's statistical analyses and other studies have found that an IDI's use of brokered deposits in general is correlated with a higher probability of failure and higher losses to the DIF upon failure.
On December 15, 2020, the FDIC Board adopted a final rule that established a new framework for analyzing whether certain deposit arrangements qualify as brokered deposits (the 2020 Final Rule).
This is because, in large part, the changes made by the 2020 Final Rule have narrowed the types of deposit-related activities that are considered brokered; in the FDIC's view, this narrowing is problematic because these deposits continue to present the same risks as before the 2020 Final Rule. The 2020 Final Rule also expanded the types of business relationships that are eligible to be excepted from the “deposit broker” definition. For instance, the 2020 Final Rule excluded certain factors, such as the payment of fees, from the “deposit broker” definition that had historically been viewed as relevant to whether a deposit is brokered. The 2020 Final Rule also expanded the scope of the primary purpose exception to the deposit broker definition, which has allowed for a
Based on the FDIC's experience, the decline in reported brokered deposits is also due, in part, to some IDIs misunderstanding and misreporting deposits under the 2020 Final Rule. Despite the FDIC's efforts in conducting industry outreach and providing clarifying information,
If left unchanged, this underreporting of brokered deposits could have serious consequences for IDIs and the DIF, which is used to protect depositors of insured banks and to resolve failed banks, as such underreporting impedes the ability to evaluate the extent of reliance on brokered deposits and the effects on an IDI's risk profile for supervisory and deposit insurance pricing purposes. Moreover, the FDIC is concerned that these issues expose IDIs individually and the banking system more broadly to the type of risk the brokered deposit restrictions are intended to address—namely that a less than well-capitalized institution could rely on less stable third-party deposits for rapid growth that may weaken the safety and soundness of IDIs and the banking system and expose the FDIC to increased losses.
Additionally, experiences since the 2020 Final Rule have shown that some of the underlying reasons to narrow the coverage of the rule have proved to be problematic. For example, First Republic Bank,
To address these concerns and challenges, the FDIC is proposing amendments that would (1) simplify certain definitions of the 2020 Final Rule to reduce operational challenges and reporting burdens on IDIs; (2) help ensure uniform and consistent reporting of brokered deposits by IDIs; and (3) strengthen the safety and soundness of the banking system by ensuring that less than well-capitalized institutions are restricted from relying on brokered deposits to support risky, rapid growth.
Brokered and high-rate deposits became a concern among bank regulators and Congress before any statutory restrictions were enacted. This concern arose because (1) such deposits could facilitate a bank's rapid growth in risky assets without adequate controls; (2) once problems arose, a problem bank could use such deposits to fund additional risky assets to attempt to “grow out” of its problems, a strategy that ultimately increased the losses to the DIF when the institution failed; and (3) brokered and high-rate deposits were sometimes considered less stable because at that time, deposit brokers (on behalf of customers), or the customers themselves, were often drawn to high rates and prone to leave the bank quickly to obtain a better rate or if they became aware of problems at the bank.
The FDIC has recognized that “historically, most institutions that use brokered deposits have done so in a prudent manner and appropriately measure, monitor, and control risks associated with brokered
As early as the 1970s, the FDIC noted concerns about brokered deposits, as stated in the FDIC's Division of Bank Supervision Manual: “The use of brokered deposits has been responsible for abuses in banking and has contributed to some bank failures, with consequent losses to the larger depositors, other creditors, and shareholders.”
The FDIC and the DIF were significantly affected by the financial crisis between 2007 and 2017. During this time, excluding Washington Mutual, Inc., 530 IDIs failed and were placed in FDIC receivership and, as of March 31, 2024, the estimated loss to the DIF for these institutions is $71.9 billion.
Based on Call and Thrift Financial Report data, 47 institutions that failed relied heavily on brokered deposits and each caused an estimated loss to the DIF
Another example is ANB Financial National Association (ANB Financial), which failed on May 9, 2008. As of March 31, 2024, the estimated loss to the DIF for ANB Financial was $1.0 billion, representing 54 percent of the institution's $1.9 billion in total assets at failure. In its Call Report filed prior to failure,
In the aftermath of the financial crisis of 2008 and 2009, section 1506 of the Dodd-Frank Wall Street Reform and Consumer Protection Act directed the FDIC to conduct a study of core and brokered deposits, which the FDIC completed in 2011. In the FDIC's
In December 2017, the FDIC published
Moreover, the Inspectors General of the Federal banking agencies have prepared reports detailing how brokered deposits were sometimes used by failed banks between 2007 and 2017.
In 2019, the FDIC updated its analysis in the 2011 Study on Core Deposits and Brokered Deposits with data through the end of 2017.
Section 29 of the FDI Act,
Under section 29, a “deposit broker” includes any person engaged in the business of placing third-party deposits, or facilitating the placement of third-party deposits, with IDIs or the business of placing deposits with IDIs for the purpose of selling interests in those deposits to third parties.
The “deposit broker” definition is subject to the following nine statutory exceptions:
1. An insured depository institution, with respect to funds placed with that depository institution;
2. An employee of an insured depository institution, with respect to funds placed with the employing depository institution;
3. A trust department of an insured depository institution, if the trust in question has not been established for the primary purpose of placing funds with insured depository institutions;
4. The trustee of a pension or other employee benefit plan, with respect to funds of the plan;
5. A person acting as a plan administrator or an investment adviser in connection with a pension plan or other employee benefit plan provided that that person is performing managerial functions with respect to the plan;
6. The trustee of a testamentary account;
7. The trustee of an irrevocable trust (other than one described in 12 U.S.C. 1831f(g)(1)(B)), as long as the trust in question has not been established for the primary purpose of placing funds with insured depository institutions;
8. A trustee or custodian of a pension or profit-sharing plan qualified under section 401(d) or 403(a) of the Internal Revenue Code of 1986; or
9. An agent or nominee whose primary purpose is not the placement of funds with depository institutions (the “primary purpose exception”).
Section 337.6 includes the statutory exceptions to the “deposit broker” definition plus a tenth exception for an IDI acting as an intermediary or agent of a U.S. Government department or agency for a government sponsored minority or women-owned depository institution program.
In the 2020 Final Rule, the FDIC amended the brokered deposit regulation to further define circumstances under which a third party is a “deposit broker.” More specifically, the 2020 Final Rule provides a person is engaged in the business of placing deposits if that person receives third-party funds and deposits those funds at more than one IDI.
• The person has legal authority, contractual or otherwise, to close the account or move the third party's funds to another IDI;
• The person is involved in negotiating or setting rates, fees, terms, or conditions for the deposit account; or
• The person engages in matchmaking activities.
A person is engaged in “matchmaking activities” if the person proposes deposit allocations at, or between, more than one IDI based upon both the particular deposit objectives of a specific depositor or depositor's agent, and the particular deposit objectives of specific IDIs.
• A depositor or depositor's agent when the person has access to specific financial information of the depositor or
• An IDI when the person has access to the target deposit-balance objectives of specific IDIs and the proposed deposit allocation is based upon this information.
The “matchmaking activities” definition, however, excludes deposits placed by a depositor's agent with an IDI affiliated with the depositor's agent.
As noted above, the 2020 Final Rule provides that a person is engaged in the business of placing deposits or facilitating the placement of deposits of third parties if that person receives third-party funds and deposits those funds at more than one IDI or if that person is engaged in certain activities with respect to deposits placed at more than one IDI.
The 2020 Final Rule provides that the primary purpose exception applies when, with respect to a particular business line, the primary purpose of the agent's or nominee's business relationship with its customers is not the placement of funds with depository institutions.
1. Less than 25 percent of the total assets that the agent or nominee has under administration for its customers is placed at depository institutions (25 percent test);
2. 100 percent of depositors' funds that the agent or nominee places, or assists in placing, at depository institutions are placed into transactional accounts that do not pay any fees, interest, or other remuneration to the depositor (enabling transactions test);
3. A property management firm places, or assists in placing, customer funds into deposit accounts for the primary purpose of providing property management services;
4. The agent or nominee places, or assists in placing, customer funds into deposit accounts for the primary purpose of providing cross-border clearing services to its customers;
5. The agent or nominee places, or assists in placing, customer funds into deposit accounts for the primary purpose of providing mortgage servicing;
6. A title company places, or assists in placing, customer funds into deposit accounts for the primary purpose of facilitating real estate transactions;
7. A qualified intermediary places, or assists in placing, customer funds into deposit accounts for the primary purpose of facilitating exchanges of properties under section 1031 of the Internal Revenue Code;
8. A broker dealer or futures commission merchant places, or assists in placing, customer funds into deposit accounts in compliance with 17 CFR 240.15c3 through 3(e) or 17 CFR 1.20(a);
9. The agent or nominee places, or assists in placing, customer funds into deposit accounts for the primary purpose of posting collateral for customers to secure credit-card loans;
10. The agent or nominee places, or assists in placing, customer funds into deposit accounts for the primary purpose of paying for or reimbursing qualified medical expenses under section 223 of the Internal Revenue Code;
11. The agent or nominee places, or assists in placing, customer funds into deposit accounts for the primary purpose of investing in qualified tuition programs under section 529 of the Internal Revenue Code;
12. The agent or nominee places, or assists in placing, customer funds into deposit accounts to enable participation in the following tax-advantaged programs: Individual retirement accounts under section 408(a) of the Internal Revenue Code, Simple individual retirement accounts under section 408(p) of the Internal Revenue Code, or Roth individual retirement accounts under section 408A of the Internal Revenue Code;
13. A Federal, State, or local agency places, or assists in placing, customer funds into deposit accounts to deliver funds to the beneficiaries of government programs; and
14. The agent or nominee places, or assists in placing, customer funds into deposit accounts pursuant to such other relationships as the FDIC specifically identifies as a designated business relationship that meets the primary purpose exception.
As noted, the 2020 Final Rule allows the FDIC to identify additional relationships as designated business exceptions to the primary purpose exception.
For the 25 percent and enabling transactions test exceptions, a third party or an IDI on behalf of a third party must file a notice with the FDIC for a particular business line.
For agents or nominees that do not meet one of the designated business exceptions, such third parties, or an IDI on behalf of a third party, may apply for a primary purpose exception in accordance with the requirements contained in § 303.243(b).
In 2018, section 29 of the FDI Act was amended as part of the Economic Growth, Regulatory Relief, and Consumer Protection Act (EGRRCPA), to allow “agent institutions” to except a capped amount of “reciprocal deposits”
Reciprocal deposits are defined by statute to mean deposits received by an agent institution through a deposit placement network with the same maturity (if any) and in the same aggregate amount as covered deposits placed by the agent institution in other network member banks.
On December 18, 2018, the FDIC adopted a final rule (the 2018 Reciprocal Deposits Rule), to amend its regulations that implement brokered deposits and interest rate restrictions to conform with the changes to section 29 by EGRRCPA.
• As of its most recent annual examination under 12 U.S.C. 1820(d), was found to have a composite condition of outstanding or good and is well capitalized;
• Has obtained a brokered deposit waiver from the FDIC;
• Does not receive an amount of reciprocal deposits that causes the total amount of reciprocal deposits held by the agent institution to be greater than the average of the total amount of reciprocal deposits held by the agent institution on the last day of each of the four calendar quarters preceding the calendar quarter in which the agent institution was found not to have a composite condition of outstanding or good or was determined to be not well capitalized.
Under the 2018 Reciprocal Deposits Rule, an “agent institution” can except reciprocal deposits from being classified as brokered deposits up to its applicable statutory caps—the “general cap” or “special cap.” Under the “general cap,” an agent institution may except reciprocal deposits up to the lesser of the following amounts from being classified as brokered deposits: $5 billion or an amount equal to 20 percent of the agent institution's total liabilities. Reciprocal deposits in excess of the general cap, as well as those reciprocal deposits that do not meet section 29's limited exception, may not take advantage of the limited exception and are to be reported as brokered deposits. The “special cap” applies if the IDI either was found to not have a composite condition of outstanding or good when most recently examined under section 10(d) of the FDI Act or is not well capitalized and has not received a waiver from the brokered deposit restrictions under section 29(c). In this case, the IDI may still meet the “agent institution” definition if the IDI does not receive reciprocal deposits that result in its total reciprocal deposits to be in excess of the “special cap.” The “special cap” is the average amount of reciprocal deposits held at the IDI on the last day of each of the four calendar quarters preceding the calendar quarter in which the agent institution was found not to have a composite condition of outstanding or good or was determined to be not well capitalized. If, after the IDI becomes subject to the “special cap,” an IDI receives reciprocal deposits that result in its total reciprocal deposits to be in excess of its special cap, it is no longer an agent institution. If an IDI is not an agent institution, it is not eligible to use the limited exception, and all of its reciprocal deposits should be reported as brokered deposits.
As such, the amount of reciprocal deposits excepted from being considered brokered turns on whether the IDI qualifies as an agent institution and if so, whether the IDI is subject to the special cap.
As stated above, following the April 1, 2021, effective date of the 2020 Final Rule, IDIs reported a significant decrease in brokered deposits in their Call Report filings. As illustrated in chart 1, from March 31, 2021, to June 30, 2021, brokered deposits declined by nearly $350 billion, or 31.8 percent, the largest decline since brokered deposit reporting began in 1983. Brokered deposit balances continued to decline through March 31, 2022, following the extended compliance date of January 1, 2022. The FDIC notes, however, that as of the fourth quarter of 2023, brokered deposits at all IDIs are 22.5 percent higher than the quarter before the 2020 Final Rule took effect (first quarter 2021), despite the considerable amount of deposits that are no longer considered brokered based on the 2020 Final Rule changes. This increase in reported brokered deposits is due to increases in insured brokered deposit balances, including brokered reciprocal deposits. These increases may be driven in part by higher interest rates, which have exacerbated competition for deposit funding, and depositors seeking additional deposit insurance coverage, particularly following the failures that occurred in the first half of 2023.
Since the April 1, 2021, effective date of the 2020 Final Rule, the FDIC has observed the continued expansion of IDI arrangements with third parties to deliver deposit products (particularly those with transactional features) for a variety of IDI objectives, including to expand geographic reach, offer innovative products, and raise deposits. In these arrangements, an IDI typically makes deposit products or services available through an arrangement in which a third party, rather than the IDI, markets, distributes, or otherwise provides access to or assists in the placement of customer deposits at particular IDIs. Depending on the services provided by the third party, and the availability of regulatory exceptions to the “deposit broker” definition (
Recent events, however, underscore the precarious nature of these funding arrangements as they can be highly unstable, with either the third party or the underlying customers moving funds based on market conditions or other factors. These arrangements can also be prone to other forms of disruption such as the potential or actual insolvency of the third party, as recently demonstrated by the bankruptcy of Synapse Financial Technologies, Inc. (Synapse).
In certain circumstances, these arrangements are excluded from the brokered deposit definition pursuant to changes implemented by the 2020 Final Rule, even though the arrangements exhibit the same risks as brokered deposits. An example is the failure of Voyager, which was exempted from the brokered deposit definition by virtue of the exclusive deposit placement arrangement exception. Where less than well-capitalized institutions may be able to continue to grow with such deposits, because they are not currently treated as brokered deposits, the FDIC believes that these arrangements have the potential to undermine the safety and soundness of such institutions individually, and financial stability more broadly.
Under the current regulations, less than well-capitalized IDIs have unrestricted access to third-party deposits that are excluded from being classified as brokered because certain provisions in the current rule do not fully consider important safety and soundness considerations. This in turn raises the risk that less than well-capitalized IDIs may rely on less stable third-party deposits for rapid growth that could ultimately expose the DIF to increased losses.
In addition, as discussed above, many IDIs do not correctly apply the definitions in the rule, particularly with respect to the involvement of additional third parties within a deposit placement arrangement. This issue has led to a number of IDIs misreporting brokered deposits as nonbrokered. This is particularly concerning because all IDIs, even well-capitalized IDIs, have an obligation to file Call Reports accurately
With respect to the 2018 Reciprocal Deposits Rule, the rule states how an IDI may meet the “agent institution”
To address the issues raised above, the FDIC is proposing a rule that would strengthen its brokered deposit regulations by revising certain provisions to further support the statutory language and purpose of the brokered deposit restrictions, as well as simplifying certain provisions that pose operational challenges. To achieve these objectives, and as discussed in more detail below, the proposed rule would:
• Revise certain provisions of the “deposit broker” definition, including removing the “matchmaking activities” prong and replacing it with a deposit allocation provision;
• Eliminate the exclusive deposit placement arrangement exception to restore the regulations' applicability to a third party that otherwise meets the definition of a “deposit broker,” when that third party is involved with deposits placed at one or more IDIs;
• Amend the analysis underlying the “primary purpose” exception to the “deposit broker” definition, including revising the 25 percent test designated exception and eliminating the enabling transactions designated exception; and
• Update the application and notice processes for the primary purpose exception and limit such processes to IDIs.
As part of the proposal, IDIs relying on an existing approved primary purpose exception application, a 25 percent test designated exception notice, or an enabling transactions designated exception notice or application, would no longer be able to rely on such exceptions. Such IDIs would need to submit a new primary purpose exception application based upon updated criteria or, if applicable, rely upon a new designated business exception that meets the primary purpose exception based upon the proposed changes discussed below. If a deposit placement activity, however, meets one of the designated exceptions that are preserved under the proposal, the IDI may continue to rely upon the primary purpose exception without further action.
Finally, as part of this release, the FDIC is also proposing to clarify when an IDI that has lost “agent status” because it no longer qualifies for the reciprocal deposit exception, can regain status as an “agent institution”.
The FDIC invites comments on all aspects of this proposal, as well comments in response to specific questions in section VII of this document.
The proposed rule would amend the “deposit broker” definition by revising the “engaged in the business of placing deposits” (“placing”) and “engaged in the business of facilitating the placement of deposits” (“facilitating”) prongs. The revised “deposit broker” definition would (1) combine the “placing” and “facilitating” prongs, (2) remove the term “matchmaking activities” and replace it with a deposit allocation provision, and (3) add a new factor related to fees. Specifically, the proposed rule would provide that a person is engaged in the business of placing or facilitating the placement of deposits of third parties if that person engages in one or more of the following activities:
• The person receives third-party funds and deposits those funds at one or more IDIs;
• The person has legal authority, contractual or otherwise, to close the account or move the third party's funds to another IDI;
• The person is involved in negotiating or setting rates, fees, terms, or conditions for the deposit account;
• The person proposes or determines deposit allocations at one or more IDIs (including through operating or using an algorithm, or any other program or technology that is functionally similar); or
• The person has a relationship or arrangement with an IDI or customer where the IDI, or the customer, pays the person a fee or provides other remuneration in exchange for or related to the placement of deposits.
Under the 2020 Final Rule, the “placing” and “facilitating” prongs are currently separate provisions under the “deposit broker” definition. Under section 29, a “deposit broker” includes “any person engaged in the business of placing deposits, or facilitating the placement of deposits, of third parties.”
The proposal would retain the first two prongs of the current facilitation definition;
The FDIC has observed a number of IDIs and other stakeholders incorrectly determining that a third-party deposit allocator is not a “deposit broker” by misapplying the current “matchmaking activities” definition. The FDIC provided clarifications through the issuance of
As such, the FDIC believes eliminating the current “matchmaking activities” definition and replacing it with the proposed deposit allocation
Moreover, unlike the “matchmaking activities” definition under the 2020 Final Rule, the proposed prong related to deposit allocation services would not exclude third parties that provide these services between affiliated entities. As discussed in the preamble to the 2020 Final Rule, the matchmaking activities prong would not include persons that engage in activities that would otherwise satisfy the matchmaking prong if the activities are conducted between an IDI and an affiliated party.
Finally, the proposed rule would add that a person is “engaged in the business of placing, or facilitating the placement of, deposits of third parties” if that person has a relationship or arrangement with an IDI or customer where the IDI, or the customer, pays the person a fee or provides other remuneration in exchange for, or related to, the placement of deposits. The statutory definition of “deposit broker” includes any third party that is engaged in the business of placing deposits, or facilitating the placement of deposits, on behalf of third parties (
Moreover, the FDIC had, for the more than 30 years since enactment of section 29 up until the adoption of the 2020 Final Rule, considered fees in analyzing deposit broker relationships, including whether a person receives fees from IDIs based upon the number of accounts opened or the volume of deposits placed. In the past, FDIC generally found that the amount, nature, and purpose of fees paid for the placement of third-party deposits were relevant to the analysis of the relationship among the IDI, depositor, and third-party intermediary. This was because fees paid to a third-party intermediary reflected whether the involvement of the third-party intermediary was to earn fees (engaged in the business) through placing or facilitating the placement of third-party deposits to the IDI. For example, the FDIC often found that fees paid to a third-party intermediary would play a key role in incentivizing referral volume of third-party deposits to the IDI. Since the 2020 Final Rule took effect, the FDIC has continued to observe that third-party intermediaries receive fees or other remuneration in exchange for, or related to, the placement of third-party deposits, including volume-based fees, but may not be defined as a “deposit broker” under the current regulations. Without a consideration of fees or other remuneration, and assuming the third party does not meet one of the other parts of the “deposit broker” definition, a less than well-capitalized IDI could accept third-party deposits that share characteristics with deposits the FDIC has historically observed as constituting a brokered deposit. For example, such third-party deposits may be more likely to leave the IDI if another IDI were to offer more favorable terms or pay a higher fee, putting stress on the IDI to replace the withdrawn funds on reasonable terms in a timely manner.
Accordingly, the FDIC believes that fees and other remuneration are important considerations when determining whether a person is a “deposit broker” and explicitly including this factor within the definition would be appropriate to further align the regulation with section 29's statutory purpose of restricting less than well-capitalized IDIs' access to brokered deposits.
Under the FDI Act, the term “deposit broker” is defined, in relevant part, to include “any person engaged in the business of placing deposits, or facilitating the placement of deposits, of third parties
The 2020 Final Rule amended the FDIC's regulations so that the brokered deposit restrictions do not apply where a third party that otherwise meets the definition of deposit broker has an exclusive deposit placement arrangement at only one IDI.
Under this change, an IDI can rely for 100 percent of its deposits on an unaffiliated third party without any of those deposits considered brokered. The IDI can fall below well capitalized and still rely on those third-party placed deposits for 100 percent of its funding without any of those deposits being considered brokered, which provides an avenue for less than well-capitalized IDIs to obtain and retain brokered deposits that appears to conflict with intent of the statutory prohibition. An IDI can form multiple “exclusive” third party relationships to fund itself without any of those deposits considered brokered. Thus, the current regulation exposes the banking system to the kind of risk the brokered deposit restrictions were intended to address.
Further, there has never been any dispute that the brokered deposit restrictions are intended to apply to brokered certificates of deposit (CDs). While the 2020 Final Rule makes clear that a brokered CD is not eligible for a primary purpose exception, a market participant has pointed out to the FDIC that, because of the exclusion, the plain meaning of the definitions of “engaged in the business of placing deposits” and “engaged in the business of facilitating the placement of deposits” could be read to exclude a third party that arranges the issuance of a brokered CD for only one IDI.
For these reasons, and to mitigate any unintended effects of the interpretation as related to the statute's purpose and its application to brokered CDs, the FDIC is proposing to revise the brokered deposit regulations to restore their applicability to any third party that meets the definition of deposit broker, including those involved in placing deposits at only one IDI.
The proposed rule would revise the analysis for determining when an agent or nominee meets the primary purpose exception to the “deposit broker” definition. Currently, the statute and regulation state that the term “deposit broker” does not include an agent or nominee whose primary purpose is not the placement of funds with IDIs.
Accordingly, the current regulation focuses the primary purpose exception analysis on the third party's business relationship with its customers. While that is an important part of analyzing the exception, the FDIC believes that the relationship between the IDI and third party is also important in determining the purpose motivating the placement of third-party deposits and if the primary purpose is or is not the placement of funds with IDIs.
The statutory definition of the “primary purpose exception” excludes an agent or nominee whose primary purpose is not the placement of third-party funds with IDIs from being considered a “deposit broker.”
For example, a third party that meets the primary purpose exception under the current rule may also be steering its customers to particular IDIs in an effort to maximize its own fees for the placement of customer deposits. The current rule, however, does not consider this latter purpose in analyzing whether the third party meets the primary purpose exception.
Accordingly, the proposal provides that the primary purpose exception to the “deposit broker” definition would apply when an agent or nominee whose primary purpose in placing customer deposits at IDIs is for a substantial purpose other than to provide a deposit-placement service or FDIC deposit insurance with respect to particular business lines.
The proposed interpretation of the primary purpose exception would be similar to how the FDIC historically interpreted the exception before 2020. Prior to the 2020 Final Rule, the FDIC through long-standing staff advisory opinions and published FAQs interpreted the primary purpose exception to apply when the intent of the third party, in placing deposits or facilitating the placement of deposits, was to promote some other goal (
The FDIC believes that restoring this aspect of the primary purpose exception analysis is necessary to fully consider the intent driving the placement of third-party deposits at an IDI. As detailed below, the proposal would provide additional factors to consider, including fees and other remuneration provided to the third party, in determining whether the intent of the third party in placing deposits at an IDI is for a substantial purpose other than to provide a deposit-placement service or FDIC deposit insurance.
The proposed rule would also update the primary purpose application process under § 303.243(b). The 2020 Final Rule allows a third party or an IDI on behalf of a third party to submit a primary purpose exception application. From the FDIC's experience, some third parties have provided insufficient information for the FDIC to process an application, such as failing to provide required information on all parties within a deposit arrangement, including the receiving IDIs. Moreover, the FDIC has observed some IDIs misunderstand the primary purpose exception application approvals provided to third-party applicants, as the IDI was not the applicant and the approval does not apply to its particular deposit placement activity with the third party; these misunderstandings have contributed to problems with IDIs filing accurate Call Reports.
For these reasons, the FDIC proposes to no longer allow third parties to apply for a primary purpose exception. As proposed, each IDI wishing to rely on a primary purpose exception would be required to submit an application for the specific deposit placement arrangement that it has with the third party involved. This would provide the FDIC the opportunity to review the specific facts and circumstances surrounding the deposit placement activity between the individual IDI applicant and the third party in determining whether a primary purpose exception should be approved.
Under the 2020 Final Rule, applicants that seek a primary purpose exception, other than applications for primary purpose exception to enable transactions with fees, interest, or other remuneration, must include, to the extent applicable, the following information:
• A description of the deposit placement arrangements between the third party and IDIs for the particular business line, including the services provided by any relevant third parties;
• A description of the particular business line;
• A description of the primary purpose of the particular business line;
• The total amount of customer assets under management by the third party, with respect to the particular business line;
• The total amount of deposits placed by the third party at all IDIs, including the amounts placed with the applicant, if the applicant is an IDI, with respect to the particular business line;
• Revenue generated from the third party's activities related to the placement, or facilitating the placement, of deposits, with respect to the particular business line;
• Revenue generated from the third party's activities not related to the placement, or facilitating the placement, of deposits, with respect to the particular business line;
• A description of the marketing activities provided by the third party, with respect to the particular business line;
• The reasons the third party meets the primary purpose exception;
• Any other information the applicant deems relevant; and
• Any other information that the FDIC requires to initiate its review and render the application complete.
The proposed rule would add new factors to be considered as part of the primary purpose exception application. Specifically, the proposed rule would amend § 303.243(b)(4)(ii) to include consideration of whether:
• The IDI, or customer, pays fees or other remuneration to the agent or nominee for deposits placed with the IDI and the amount of such fees or other remuneration, including how the amount of fees or other remuneration is calculated;
• The agent or nominee has discretion to choose the IDI(s) at which customer deposits are or will be placed; and
• The agent or nominee is mandated by law to disburse funds to customer deposit accounts.
The proposed rule would also require IDIs to provide copies of contracts relating to the deposit placement arrangement, including all third-party contracts, to supplement the IDI's description of the deposit placement arrangement that is currently required under the 2020 Final Rule. These new factors would supplement the factors that were provided under the 2020 Final Rule.
Accordingly, the FDIC believes consideration of these proposed factors, in conjunction with the existing application factors,
The proposed rule would amend the 25 percent test and eliminate the enabling transactions test designated exception. In contrast to the other designated business exceptions, based on the FDIC's experience, these exceptions are overly broad and cover a variety of different business lines rather than a narrow set of business lines intended by the FDIC's bright-line designated exceptions. Further, the FDIC would likely find that the current 25 percent and enabling transactions tests would not meet the primary purpose exception under the proposed analysis in that the primary purpose of these arrangements in placing customer deposits at IDIs would often not be for a substantial purpose other than to provide a deposit-placement service or FDIC deposit insurance. Moreover, the current notice process does not allow the FDIC to review submissions before an entity can invoke the exception, and many of the submissions have been incomplete, inaccurate, or vague. For these reasons, and as discussed in more detail below, the FDIC is amending the 25 percent test and eliminating the enabling transactions test in a manner that aligns with the proposed updated analysis of the primary purpose exception.
The 2020 Final Rule provides that the primary purpose of an agent's or nominee's business relationship with its customers will not be considered to be the placement of funds at a depository institution, if less than 25 percent of the total assets that the agent or nominee has under administration for its customers, in a particular business line, is placed at IDIs.
Before 2005, all sweeps from broker-dealers were defined as brokered deposits because the broker-dealer was placing third-party (customer) funds at IDIs. Between 2005 and 2020, FDIC staff interpreted the primary purpose exception to apply to a broker-dealer that swept customer funds to an affiliated IDI if the activity was conducted within certain parameters. Among the parameters were that (1) swept deposits did not exceed 10 percent of the affiliate's assets and (2) related fees paid by the IDI to the broker-dealer were “flat” fees (
Under the 2020 Final Rule, a broker-dealer that sweeps customer funds to IDIs meets the “deposit broker” definition but is eligible for the primary purpose exception where less than 25 percent of that broker-dealer's total assets under administration for its customers is placed at IDIs.
Since the implementation of the 2020 Final Rule, the FDIC has encountered a number of challenges with notice filings submitted under the 25 percent test and with reporting associated with sweep deposits. The challenges became more apparent since the new reporting items related to sweep deposits were added to the Call Report shortly after the 2020 Final Rule became effective.
The proposed rule would revise the current “25 percent test” designated exception and its notice process to (1) align with the proposed analysis of the primary purpose exception and (2) ensure that the FDIC and the IDI can properly determine whether any additional third parties meet the “deposit broker” definition before the exception can be invoked. In order to more clearly describe the business arrangements intended to qualify for this primary purpose exception, the proposed rule would revise the “25 percent test” and rename it as the “Broker-Dealer Sweep Exception” (BDSE).
As proposed, subject to the additional conditions below, the BDSE would be available only to a broker-dealer or investment adviser registered with the Securities and Exchange Commission and only if less than 10 percent of the total assets that the broker-dealer or investment adviser, as agent or nominee, has under management for its customers, in a particular business line, is placed into non-maturity accounts at
The FDIC is proposing the BDSE because a third party that places less than 25 percent of its customer's assets under administration in a bank account does not, by itself, demonstrate that the deposit-placement activity is for a goal other than to provide deposit insurance or a deposit placement service. Rather, placing less than 10 percent of customer funds at IDIs would be more indicative that the primary purpose for broker dealers and investment advisers in placing customer funds at IDIs is to temporarily safe-keep customer free cash balances (
In addition, the proposal would amend one of the key measures used as part of this designated exception from “customer assets under administration” to “customer assets under management.” From the FDIC's experience with the 2020 Final Rule, “customer assets under administration” is a more appropriate measure when including a broader group of business relationships and business lines, whereas “assets under management” would be appropriate under the proposed rule to accurately reflect the scope of the types of services provided by broker dealers and investment advisers. The proposed rule would define “assets under management” to mean securities portfolios and cash balances with respect to which an investment adviser or broker-dealer provides continuous and regular supervisory or management services.
Under the proposed rule, an IDI would be required to provide a written notice with the following information:
• A description of the deposit placement arrangement between the IDI and the broker-dealer or investment adviser for the particular business line;
• The registration and contact information for the broker-dealer or investment adviser;
• The total amount of customer assets under management by the broker-dealer or investment adviser;
• The total amount of deposits placed by the broker-dealer or investment adviser on behalf of its customers at all IDIs; and
• A certification that no additional third parties are involved in the deposit placement arrangement.
IDIs would be able to rely on the BDSE if the FDIC has not provided a written disapproval within 90 days from submission. The FDIC, within its discretion, could extend the time period for an additional 90 days to provide a written notice of disapproval to the IDI. Further, the FDIC would be able to request additional information at any time after receipt of a written notice. Submissions that fail to include the required information would be considered incomplete and disapproved. Moreover, notice filers with an effective notice would be required to provide quarterly updates within 30 days of the quarter end, with monthly figures for the quarter, to demonstrate continuous compliance with the exception. Lastly, the proposed rule provides that the FDIC would be able to revoke an effective BDSE notice within 15 days of providing the IDI written notice if:
• The broker-dealer or investment adviser no longer meets the criteria to rely on the BDSE;
• An additional third party is involved in the business line;
• The notice or subsequent reporting is inaccurate; or
• The notice filer fails to submit one or more required reports.
The FDIC believes the BDSE notice requirement would be helpful in ensuring the parties who meet the exception can rely on it. The FDIC also believes this notice process would be more operationally workable than the current 25 percent test notice process as the required information would be tailored to specific information to which the receiving IDI should have access or be able to obtain from the broker-dealer or investment adviser.
The proposed rule would amend § 303.243(b) to describe a new primary purpose exception application process for sweep arrangements that use additional third parties. Specifically, an IDI, on behalf of a broker dealer or investment adviser that places less than 10 percent of customer funds under management into IDIs through the use of an additional third party, would be required to provide the following as part of an application:
• A description of the deposit placement arrangement between the IDI, the broker-dealer or investment adviser, and the additional third party, including the services provided by the additional third party, for the particular business line, and copies of contracts relating to the deposit placement arrangement, including all third party contracts;
• The total amount of customer assets under management by the broker-dealer or investment adviser;
• The total amount of deposits placed by the broker-dealer or investment adviser on behalf of its customers at all IDIs;
• Information on whether the additional third party places or facilitates the placement of deposits at IDIs;
• Information on whether the additional third party has legal authority, contractual or otherwise, to close the account or move the third party's funds to another IDI;
• Information on fees and the amount of fees paid from any source to the additional third party with respect to its services provided as part of the deposit placement arrangement;
• Information on whether the additional third party has discretion to choose the IDIs at which customer deposits are or will be placed; and
• Any other information that the FDIC requires to initiate its review and render the application complete.
Moreover, the FDIC would be able to request additional information from the applicant at any time during processing of the application.
The proposed rule provides that within 120 days of receiving a complete application, the FDIC would issue a written determination, but the FDIC could extend its review by 120 additional days, with notice. If necessary, the FDIC could further extend its review period, which is more likely when an application involves complex or novel arrangements or issues. If the FDIC receives an incomplete application, the FDIC would, as soon as possible, notify the applicant and explain what is needed to render the application complete. The FDIC would also be able to request additional information at any time during the processing of the filing.
The FDIC would approve an application under this provision if the FDIC finds that the applicant demonstrates that, with respect to the IDI and the particular business line, the (1) broker-dealer or investment adviser meets the criteria for the BDSE and (2) the additional third party involved in the deposit placement arrangement is not a “deposit broker” as defined under the proposed rule.
Prior to the 2020 Final Rule, the FDIC did not distinguish between acting with the purpose of placing deposits for other parties and acting with the purpose of enabling other parties to use deposits to make purchases. The 2020 Final Rule distinguished these two purposes and created a primary purpose exception for third parties that place deposits to allow their customers to enable transactions. IDIs receiving deposits from deposit brokers relying on this exception do not report these deposits as brokered; however, as described below, many of these deposits would not satisfy the proposed primary purpose exception analysis.
A third party qualifies for the current enabling transactions primary purpose exception by either submitting an application or submitting a notice. In a deposit placement arrangement where interest, fees, or other remunerations are provided to the depositor, the agent or nominee must receive prior approval before relying on the enabling transactions primary purpose exception by submitting an application to the FDIC.
The current enabling transactions test would not satisfy the proposed primary purpose exception because placing deposits into accounts with transactional features would not, by itself, prove that the substantial purpose of the deposit placement arrangement is for a purpose other than providing deposit insurance or a deposit-placement service. The FDIC believes that there is no relevant difference between an agent or nominee's purpose in placing deposits to enable transactions and placing deposits to access a deposit account and deposit insurance.
For these reasons, the FDIC is proposing to eliminate the enabling transactions test and the corresponding notice process. As proposed, IDIs that currently rely on a primary purpose of enabling transactions under the notice process could file an application under the general primary purpose exception application process under current § 303.243(b)(4)(ii) (subject to the amendments under the proposed rule), if they believe that the primary purpose in placing customer deposits at IDIs is for a substantial purpose other than to provide a deposit-placement service or FDIC deposit insurance with respect to the particular business line. As discussed above, only IDIs would be permitted to file an application under the proposed rule.
The proposed rule would also eliminate the application process for the enabling transactions exception where interest, fees, or other remuneration is provided to depositors under § 303.243(b)(4)(i). Applications previously approved under this provision would be rescinded. IDIs would be able to submit a new application to seek a primary purpose exception if they believe that the business line may be eligible for the general primary purpose exception.
Under the 2020 Final Rule, the FDIC identified other designated business exceptions that meet the primary purpose exception in addition to the 25 percent and enabling transactions tests discussed above. The proposed rule would retain the remaining designated business exceptions listed in the 2020 Final Rule, as well as the additional designated exception for non-discretionary custodians engaged in the placement of deposits. While the primary purpose interpretation under the proposed rule differs from the interpretation contained in the 2020 Final Rule, the outcome of whether these specific arrangements meet the primary purpose exception would not necessarily change if evaluated under the proposed revised interpretation based on the FDIC's current understanding of these specific arrangements.
The FDIC believes the remaining existing designated business exceptions are narrowly tailored to address specific business lines or functions and would satisfy the proposed primary purpose exception analysis in that the primary purpose of these arrangements in placing customer deposits at IDIs is for a substantial purpose other than to provide a deposit-placement service or FDIC deposit insurance. However, the FDIC will continue to monitor these specific arrangements, and if any changes indicate that the primary purpose of any of these arrangements is to provide a deposit-placement service or FDIC deposit insurance, the FDIC would revise the designated exceptions through the notice and comment process.
As discussed above, the amount of reciprocal deposits an IDI can except from being considered brokered under the limited exception turns on whether the IDI qualifies as an agent institution and if so, whether the IDI is subject to the special cap. An IDI that meets the agent institution definition can lose its agent institution status due to no longer meeting the qualifying provisions under section 29 and the 2018 Reciprocal Deposits Rule. Section 29 and the 2018 Reciprocal Deposits Rule do not clarify
An IDI that is an agent institution may lose that status, and thereby lose the ability to use the exception. For example, if a well-capitalized IDI with a composite condition of outstanding or good has its CAMELS composite condition downgraded below outstanding or good at its most recent examination conducted under section 10(d) for the FDI Act, it becomes subject to a special cap. If the IDI subsequently receives reciprocal deposits that results in its total reciprocal deposits exceeding its special cap, it is no longer an agent institution. Thus, the IDI no longer qualifies for the limited exception and must report all its reciprocal deposits as brokered deposits.
In response to questions raised, and in recognition that the current statute and regulation do not provide clarity on this issue, the FDIC proposes to add a new § 337.6(e)(3) to provide a path for an IDI to regain agent institution status. An IDI that lost its agent institution status would be eligible to regain its agent institution status as follows:
• If the IDI is well capitalized, the date the IDI is notified that its CAMELS composite condition is rated outstanding or good at its most recent examination under 12 U.S.C. 1820(d);
• If the IDI is well-rated, the date the IDI is notified, or is deemed to have notice, that it is well capitalized under regulations implementing section 38 of the FDI Act issued by the appropriate Federal banking agency for that institution;
• The date the FDIC grants a brokered deposit waiver; or
• On the last day of the third consecutive calendar quarter during which the IDI did not at any time receive reciprocal deposits that caused its total reciprocal deposits to exceed its special cap.
To illustrate, if as the result of an examination, a well-capitalized IDI that had had a CAMELS composite rating of “3” receives written notice, including, for example, a transmittal letter, informing it that it had received an upgrade to a composite rating of “2” the IDI would regain its agent institution status as of the date of the written notice under the proposal. If the FDIC grants a brokered deposit waiver to an adequately capitalized IDI, the IDI would regain agent institution status on the date the FDIC grants the waiver. If the IDI does not fit into either of these categories and lost its agent institution status during the fourth quarter of 2024 but can demonstrate that it did not receive any reciprocal deposits that caused its total reciprocal deposits to exceed its special cap at any time during the first, second, or third quarters of 2025, it would regain agent institution status on the last day of the third quarter of 2025.
As part of this proposal, the FDIC is also inviting comment on the following alternatives that are under consideration.
As discussed above, the proposed rule would provide a BDSE that would be available to a broker-dealer or investment adviser that places or facilitates the placement of less than 10 percent of the total assets that it has under management for its customers at one or more IDIs, and no additional third parties are involved in the deposit placement arrangement. Further the proposed rule would provide a specific application process for sweep arrangements that involve an additional third party.
The FDIC is considering whether a designated business exception for sweep deposits should instead be rescinded. Under this alternative, IDIs would be required to report all sweep deposits as brokered because the broker-deal or investment adviser would meet the “deposit broker” definition since it would be placing or facilitating the placement of the third-party deposits. IDIs receiving sweep deposits, however, could apply for the general primary purpose exception. Whether a broker-dealer or an investment adviser would meet the primary purpose exception under this alternative would not be based on a de-minimis amount of customer funds placed at one or more IDIs. Rather, an IDI would be required to submit the required information listed under the general primary purpose exception application process as described in the proposed rule to demonstrate that the deposit-placement activity of the sweep arrangement, including those with an additional third party, is for a substantial purpose other than to provide deposit insurance or a deposit placement service.
The FDIC is also considering whether instead to change the BDSE to apply to a broker-dealer or investment adviser that sweeps customer funds to an affiliated IDI and meets other certain parameters. Under this alternative, a broker-dealer or investment adviser would meet the designated business exception if:
• The broker-dealer or investment adviser places or facilitates the placement of swept funds into non-maturity accounts at an affiliated IDI, and the amount of swept funds are less than 10 percent of the total assets that the broker-dealer or investment adviser has under management for its customers; and
• The related fees paid by the IDI to the broker-dealer or investment adviser are “flat fees” (
This alternative would be similar to the FDIC's treatment of affiliated sweep deposit arrangements prior to the 2020 Final Rule. Under this alternative, the exception would not apply to deposit arrangements where swept funds are placed at unaffiliated IDIs.
As previously stated, the proposed rule would strengthen the FDIC's brokered deposit regulations by revising certain provisions to further support the statutory language and purpose of the brokered deposit restrictions, and clarifying and streamlining provisions that the FDIC observes have posed interpretive challenges. In summary, the proposed rule would (1) streamline and update certain provisions of the “deposit broker” definition; (2) eliminate the exclusive placement arrangement exception and restore the regulations' applicability to cases where a third party, that otherwise meets the definition of deposit broker, is involved with placing deposits at one or more IDIs; (3) amend the “primary purpose” exception to the “deposit broker” definition, including revising the “25 percent test” designated exception to a 10 percent test exception (and narrowing the scope of firms to which the exception may apply) and eliminating the “enabling transactions” designated exception; (4) update the primary purpose exception application and notice processes and make it so that only IDIs may submit an application and/or a notice on behalf of a third party; and (5) clarify how an IDI that loses its “agent institution” status regains that status.
The proposed rule would apply to all IDIs and affect any IDI that currently holds brokered deposits, or holds deposits that could be reclassified as brokered under the proposed rule, including IDIs that are less than well capitalized. As of March 31, 2024, there are 4,577 FDIC-insured depository
One likely aggregate effect of the proposed changes is that some deposits currently not reported as brokered would be reported as brokered deposits if the proposal is adopted. This may potentially affect IDIs, consumers, and nonbank firms that may be considered “deposit brokers” under the proposal.
The proposed rule would revise the “deposit broker” definition and would amend the analysis of the “primary purpose” exception to the “deposit broker” definition. The FDIC believes that under the proposed rule fewer entities are likely to be exempt from the definition of deposit broker than is the case currently. Additionally, to the extent such entities continue to place funds at IDIs, the amount of deposits at IDIs considered brokered under the proposed rule is likely to increase. The FDIC does not have the data necessary to estimate the amount of deposits that would be reclassified as brokered under the proposed rule. However, at the end of the first quarter during which the 2020 Final Rule was in effect—April through June of 2021—IDIs reported almost $350 billion fewer brokered deposits than in the previous quarter, a reduction in reported brokered deposits of more than 30 percent.
The remainder of this subsection considers first the proposed rule's potential effects on less than well-capitalized IDIs specifically, then discusses costs to IDIs more broadly (including those that may be less than well capitalized), and an overview of the proposed rule's expected effects on the number of applications and notices (collectively, filings) sent to the FDIC. This subsection concludes with a discussion of the proposed rule's potential benefits. The subsection “Reporting Compliance Costs” of this document provides more detailed estimates on the expected effects of the proposed rule on the number of filings sent to the FDIC, and the expected dollar cost associated with those filings.
The acceptance of brokered deposits is subject to statutory and regulatory restrictions for banks that are not well capitalized. Adequately capitalized banks may not accept brokered deposits without an approved waiver from the FDIC, and banks that are less than adequately capitalized may not accept them at all. As a result, adequately capitalized and undercapitalized banks generally hold fewer brokered deposits. To the extent less than well-capitalized IDIs are able to rely on deposits that share the characteristics of brokered deposits (such as volatility) but are not currently reported as brokered, such IDIs can operate using a riskier liability structure than one reliant on more stable funding sources, thereby potentially increasing the risk of loss to the DIF. By generally increasing the scope of deposits that are considered brokered, the proposed rule limits the ability of less than well-capitalized banks to rely on potentially less stable third-party deposits that are currently reported as nonbrokered but would be reported as brokered under the proposed rule.
Based on IDIs' reported capital ratios as of March 31, 2024, there are seven less than well-capitalized IDIs, one of which reports holding some volume of brokered deposits.
As mentioned above, adequately capitalized banks may not accept brokered deposits without an approved waiver from the FDIC, and because the FDIC believes the proposed rule is likely to increase the amount of deposits considered brokered, it may increase the number of waiver applications the FDIC receives from adequately capitalized IDIs. This potential effect of the proposed rule is difficult to estimate because, as mentioned above, not only does the FDIC not possess the data necessary to estimate the amount of deposits that would be reclassified as brokered at specific banks under the proposed rule, but also the number of adequately capitalized banks depends on other factors, such as economic conditions and asset quality.
The FDIC believes that if the proposed rule was adopted affected IDIs, including well-capitalized and less than well-capitalized IDIs, may incur some costs. First, the proposed rule may lead some IDIs to restructure their liabilities. Second, the proposed rule may affect certain regulatory ratios required to be calculated by some large IDIs. Third, affected IDIs may be incentivized to make changes to their organizational structure. Fourth, affected IDIs may need to make changes to internal systems, policies, or procedures that pertain to brokered deposits. Fifth, the proposed rule is expected to affect the number of filings that IDIs send to the FDIC. Finally, the proposed rule may affect some IDIs' FDIC deposit insurance assessments. Each of these potential costs is discussed below in turn.
IDIs affected by the proposed rule may incur costs associated with making changes to the structure of their liabilities. As discussed above, there was a drop in reported brokered deposits immediately after the effective date of the 2020 Final Rule. The FDIC believes that the changes in the proposed rule are likely to result in a greater proportion of nonbrokered deposits being reclassified as brokered. To the extent affected IDIs are currently operating at their desired ratios of brokered deposits to total liabilities and the proposed rule increases the amount of deposits considered brokered, some affected IDIs may find that, at least initially, the proposed rule may cause them to have a greater than desired share of brokered deposits to liabilities. The FDIC does not have the data to
For some large IDIs, brokered deposits can affect the calculation of certain regulatory ratios, such as the Liquidity Coverage Ratio (LCR) and Net Stable Funding Ratio (NSFR). The FDIC does not have the data to estimate the amount of deposits that would be reclassified as brokered by the proposed rule at individual IDIs, and thus cannot estimate how many IDIs, if any, may incur costs associated with maintaining compliance with, or maintaining management buffers relative to, these regulatory ratios because of the proposed rule.
It is possible that some IDIs may choose to make changes to the organizational structure of their institutions if the proposed rule is adopted. In particular, IDIs that rely on the current exclusive placement exception to obtain nonbrokered deposits from affiliates may be incentivized to stop using these deposits or perhaps change their organizational structure as a result of the proposed rule. The FDIC does not have the information to estimate any such changes or attendant costs.
The FDIC believes that if the proposed rule was adopted, IDIs affected may incur some costs associated with making changes to their internal systems, policies, and procedures associated with deposit brokering activities and arrangements (especially those involving third parties). The FDIC does not have the data to be able to reliably estimate the costs associated with these changes, but expects that they are likely to be modest. Further, the FDIC believes that some of these costs may be ameliorated because the proposed rule is similar to the regulatory framework that existed prior to the 2020 Final Rule, therefore some affected entities may have experience with some of those policies and procedures.
Several aspects of the proposed rule may impact the number of filings that IDIs submit to the FDIC. First, as mentioned previously, the proposed rule may increase the number of brokered deposit waiver applications the FDIC receives from adequately capitalized IDIs. Second, the proposed rule eliminates the “enabling transactions” exception (including its attendant notice), and the FDIC believes that many entities that currently rely on this exception may work with IDIs to file PPE applications. Third, the proposed rule replaces the current “25 percent test” notice exception with two similar but distinct exceptions: the BDSE requiring a notice, for arrangements involving only an IDI and broker-dealer, and the BDSE requiring an application, for arrangements involving an IDI, broker-dealer, and additional third-party. The FDIC believes the BDSE notice will be more operationally workable than the current “25 percent test” notice process, as the information required to complete the BDSE notice would be tailored to specific information the receiving IDI should have access to or be able to obtain from the broker-dealer. Finally, concurrent with the finalization of the proposed rule, the FDIC would rescind notices and applications approved under the 2020 Final Rule, and would eliminate the ability of non-IDIs to file applications or notices. Therefore, the FDIC expects that the proposed rule could result in a significant increase in PPE applications from IDIs, especially in the period immediately following the effective date if the proposed rule were adopted. IDIs may incur costs associated with such submissions, including costs associated with gathering more information from third parties as part of the application process. See the “Reporting Compliance Costs” subsection of this document for a more detailed discussion of the potential effects of the proposed rule on the number and types of filings sent to the FDIC.
The proposed rule could also affect FDIC deposit insurance assessments. Under the FDIC's assessment regulations, IDIs with a significant concentration of brokered deposits may pay higher quarterly assessments, depending on other factors.
The FDIC believes that the proposed rule would pose two primary benefits. First, the proposed rule would clarify certain concepts for affected IDIs. Second, the FDIC believes the proposed rule would improve the safety and soundness of the banking system. The benefits of improved safety and soundness are difficult to quantify, but such benefits are likely to accrue to the public and to all IDIs, not just those that are less than well capitalized. The FDIC discusses these potential benefits below in turn.
The FDIC believes that the proposed rule would improve the safety and soundness of the banking system, as well as covered IDIs. To the extent the proposed rule's changes would better identify deposits that are currently not reported as brokered but share the risk characteristics of brokered deposits, the FDIC believes that the proposal would enhance the ability of the FDIC to ensure the safety and soundness of the banking system. In particular, the rule would limit the ability for a less than well-capitalized institution to rely on a risky funding source and improve clarity so that reliance on brokered deposits, regardless of capitalization, would be correctly reflected in an institution's regulatory reporting, deposit insurance assessments, and regulatory ratios.
As discussed above, the FDIC has found significant reliance on brokered deposits increases an institution's risk profile, particularly as its financial condition weakens. The FDIC's statistical analyses and other studies have found that the use of brokered deposits by IDIs in general is associated with a higher probability of failure and higher losses to the DIF upon failure. The use of brokered deposits by IDIs is correlated with (1) higher levels of asset growth, (2) higher levels of nonperforming loans, and (3) a lower proportion of core deposit
The FDIC also believes that the proposed rule would benefit covered IDIs by clarifying certain practices and concepts. For example, the proposed rule includes a provision to clarify how an IDI may regain its “agent institution” status after losing it. The FDIC also believes that the proposed rule would benefit IDIs by promoting accurate reporting and understanding of the regulation and how the involvement of third parties within a deposit placement arrangement may, or may not, result in the deposits being brokered. Based on the FDIC's experience, the initial decline in brokered deposits following the effective date of the 2020 Final Rule was due, in part, to some IDIs misunderstanding and misreporting a significant amount of deposits as nonbrokered. The FDIC believes that increased clarity should reduce costs for affected IDIs and ensure more accurate reporting.
The proposed rule may affect consumers that utilize brokered deposits, deposit placement services or arrangements. To the extent that consumers utilize deposits currently, or in future periods, which are not classified as brokered, but would be as a result of the adoption of the proposed rule, they might experience changes in interest rates on those funds, or costs associated with placing those funds with different entities. The FDIC does not have the information necessary to estimate such changes, and therefore, discusses these effects qualitatively.
If adopted, the proposed rule may pose costs or benefits to consumers by incentivizing them to place their funds with different entities. To the extent that some entities cease offering, or change the terms of, certain services because of a desire to avoid the placement of deposits considered brokered under the proposal, or because IDIs would prefer not to accept deposits considered brokered under the proposal, certain deposit placement arrangements may change. In particular, consumers may change their relationships with certain third-party providers or third-party providers may change their relationships with certain IDIs. Further, to the extent that consumers consider other fund management options, such as money market mutual funds, as substitutes for certain brokered deposits, consumers may change fund placement arrangements. Finally, consumers considering using deposit placement services may also benefit from the increased clarity in the proposed rule on what is and is not considered brokered.
The proposed rule may affect third parties directly or indirectly involved in the provision of brokered deposit products. To the extent that third parties are involved in the provision of deposits currently not designated as brokered, but would be if the proposed rule was adopted, such third parties may incur costs associated with making changes to systems, policies, and procedures. To the extent that third parties may have previously relied on exceptions that existed under 2020 Final Rule but no longer will exist under the proposed rule—such as the “enabling transactions” exception—they may experience costs associated with transitioning their business models (including potentially revising fees, changing revenue structures, etc.) to reflect the new rule.
Third parties may also incur costs associated with the submission of filings to the FDIC by affiliated IDIs on their behalf for deposit placement arrangements. As mentioned previously, the proposed rule rescinds existing primary purpose exceptions and notices granted under the 2020 Final Rule and restricts the application and notice process to IDIs. Therefore, to the extent that third parties who previously applied and received approval for a primary purpose exception wish to continue offering their services to covered IDIs, they may incur costs associated with providing information to those IDIs to support applications and notices to the FDIC. Finally, as the proposed rule's criteria for determining whether an entity is exempt from being considered a deposit broker are generally stricter than the criteria in the 2020 Final Rule, more third parties are likely to be considered deposit brokers under the proposed rule.
The FDIC believes the proposed rule, if adopted, would likely affect the number of applications and notices (collectively, filings) that IDIs submit to the FDIC for a number of reasons. First, the FDIC believes that the proposed rule may increase the share of filings made up of applications because the proposed rule would eliminate the “enabling transactions” notice exception. Based on the FDIC's supervisory experience, many “enabling transactions” notice filers will file PPE applications through IDIs, therefore the proposed rule may result in an increase in filings overall as more deposits are likely to be considered brokered under the proposed rule. Second, the proposed rule would replace the current “25 percent test” notice exception with two similar but distinct exceptions: the BDSE requiring a notice, for arrangements involving only an IDI and broker-dealer, and the BDSE requiring an application, for arrangements involving an IDI, broker-dealer, and an additional third party. Third, the FDIC believes that the proposed rule is likely to result in an increase in filings, at least initially, because the proposed rule would rescind approved applications and notices filed under the 2020 Final Rule. Finally, because the FDIC believes the proposed rule is likely to increase the amount of deposits classified as brokered, the FDIC believes the proposed rule may increase the likelihood that an adequately capitalized IDI submits a waiver application to accept brokered deposits to the FDIC. The FDIC does not have the information necessary to quantify the potential changes in filings that are likely to occur if the proposed rule was adopted. Therefore, to quantify the effect of the proposed rule on filing activity, the FDIC made certain assumptions it deemed reasonable based on its experience with administering the 2020 Final Rule, described below, and relied on the number of filings it received under the 2020 Final Rule as proxies for the number of filings it would receive under the proposed rule.
The proposed rule would likely increase the number of PPE applications received by the FDIC. As mentioned above, the proposed rule would eliminate the “enabling transactions” exception and the FDIC believes that many entities that relied on that exception may work with IDIs that file PPE applications. Thus, in addition to the 12 PPE applications that the FDIC received in the roughly three years since the effective date of the 2020 Final Rule (April 1, 2021, to March 15, 2024),
The proposed rule would likely change the number of notices received by the FDIC. As mentioned previously, the proposed rule would eliminate the “enabling transactions” exception and its attendant notice if adopted. Further, the proposed rule would replace the “25 percent test” exception by the BDSE. When only an IDI and broker-dealer are involved, the BDSE requires a notice. The FDIC believes a reasonable proxy for the number of BDSE notices under the proposed rule is the number of “25 percent test” exception notices the FDIC received under the 2020 Final Rule for which it did not identify a potential third party,
The proposed rule would adopt a new application process for arrangements between an IDI and a broker-dealer in which a third party is involved in the sweep of funds from the broker-dealer to the IDI (BDSE application). The FDIC believes a reasonable proxy for the number of BDSE applications is the number of “25 percent test” exception notices the FDIC received over the roughly three-year period since the effective date of the 2020 Final Rule for which the FDIC believed a third party may be involved, as such arrangements are not eligible for the BDSE notice. The FDIC received 33 “25 percent test” exception notices from 29 unique notificants that it identified as potentially involving a third party over the roughly three-year period since the effective date of the 2020 Final Rule,
Based on the discussion above, the FDIC estimates that the proposed rule would impose 503 labor hours per year associated with reporting requirements if adopted; 434 labor hours to complete applications and notices and 69 labor hours of to satisfy reporting obligations associated with approved applications and notices.
The Regulatory Flexibility Act (RFA) generally requires an agency, in connection with a proposed rule, to prepare and make available for public comment an initial regulatory flexibility analysis that describes the impact of the proposed rule on small entities. However, an initial regulatory flexibility analysis is not required if the agency certifies that the proposed rule will not, if promulgated, have a significant economic impact on a substantial
The FDIC does not believe that the rule would have a significant economic effect on a substantial number of small entities. However, some expected effects of the rule are difficult to assess or accurately quantify given current information. Therefore, the FDIC has included an initial regulatory flexibility analysis in this section.
As stated previously, the FDIC has found significant reliance on brokered deposits increases an institution's risk profile, particularly as its financial condition weakens. Adoption of the 2020 Final Rule led to certain deposit arrangements that were viewed as brokered prior to the 2020 Final Rule as no longer being classified as brokered, even though the FDIC believes such deposits present similar risks as brokered deposits and could pose serious consequences for IDIs and the DIF. Additionally, the FDIC has observed a number of challenges with entities understanding certain provisions of the 2020 Final Rule, which has resulted in inaccurate and inconsistent application of the rule. Finally, the FDIC wishes to better align certain of its brokered deposit regulations with the statutory language and purpose of section 29 of the FDI Act.
As mentioned above, the FDIC's proposal would clarify and revise certain of its brokered deposit regulations to better support the statutory language and purpose of the brokered deposit restrictions. Additionally, the FDIC seeks to revise the notice and application processes for certain primary purpose exceptions, and eliminate certain existing exceptions, with the objective of increasing industry safety and soundness and decreasing the frequency of misreporting of brokered deposits as nonbrokered. For further discussion of the policy objectives of the proposed rule please refer to section I of this document.
The FDIC is proposing to adopt this rule under authorities granted by section 29 of the FDI Act. The law defines key terms such as “deposit broker” and, among other things, restricts adequately capitalized IDIs from accepting funds obtained, directly or indirectly, by or through any deposit broker for deposit into one or more deposit accounts (referred to as brokered deposits) without a waiver, and prohibits less than adequately capitalized banks from obtaining such funds altogether. For a more detailed discussion of the proposed rule's legal basis please refer to sections II and III of this document.
In summary, the proposed rule would (1) streamline and update certain provisions of the “deposit broker” definition; (2) eliminate the exclusive placement arrangement exception and restore the regulations' applicability to cases where a third party, that otherwise meets the definition of deposit broker, is involved with placing deposits at one or more IDIs; (3) amend the “primary purpose” exception to the “deposit broker” definition, including revising the 25 percent test designated exception to a 10 percent test exception (and narrowing the scope of firms to which the exception may apply) and eliminating the enabling transactions designated exception; (4) update the primary purpose exception application and notice processes and make it so that only IDIs may submit an application and/or a notice on behalf of a third party; and (5) clarify how an IDI that loses its “agent institution” status regains that status. For a more detailed description of the proposed rule, please refer to section III of this document.
As of the quarter ending March 31, 2024, the FDIC insures 4,577 depository institutions; of these, 3,259 are “small entities” by the terms of the RFA.
There are five categories of effects of the proposed rule on small, FDIC-insured institutions: effects applicable to potentially any small IDI; effects applicable to small, less than well-capitalized institutions; effects applicable to nonbank subsidiaries or affiliates of small institutions that may or may not be deemed deposit brokers under the proposed rule; effects applicable to third parties that may or may not be deemed deposit brokers under the proposed rule; and reporting requirements for small, covered IDIs. Also, the proposed rule may affect certain consumers; however, “natural persons” are not small entities for purposes of the RFA. Therefore, these potential effects are not discussed in this initial regulatory flexibility analysis.
If adopted, the proposed rule could directly affect the 1,237 small IDIs that currently report positive amounts of brokered deposits. In addition, the proposed rule could affect all 3,259 small IDIs regarding the types of deposits they choose to accept in the future. The proposed rule would revise the “deposit broker” definition and
The remainder of the discussion in this subsection is divided into potential costs to small IDIs associated with the proposed rule, followed by potential benefits to small IDIs.
Small IDIs affected by the proposed rule may incur costs if they choose to alter the composition of their liabilities as a result of the proposed rule. As discussed above, adoption of the 2020 Final Rule led to certain deposit arrangements that were viewed as brokered prior to the 2020 Final Rule as no longer being classified as brokered. The FDIC believes that the changes in the proposed rule are likely to result in a greater proportion of nonbrokered deposits being reclassified as brokered. To the extent affected IDIs are currently operating at their desired ratios of brokered deposits to total liabilities and the proposed rule increases the amount of deposits considered brokered, some affected IDIs may find that the proposed rule causes them to have a greater than desired share of brokered deposits to liabilities. The FDIC does not have the data to be able to estimate how many institutions might choose to change the composition of their liabilities because of the proposed rule or by how much, in part because the FDIC does not possess the information necessary to estimate for particular banks the amount of deposits, if any, that would be reclassified as brokered by the proposed rule.
If the proposed rule is adopted, it is possible that some small IDIs may choose to make changes to the organizational structure of their institutions. In particular, small IDIs that rely on the current exclusive placement exception to obtain nonbrokered deposits from affiliates may be incentivized to stop using such deposits and perhaps change their organizational structure as a result of the proposed rule.
Small IDIs affected by the proposed rule may also incur some costs associated with changes to their internal systems, policies, and procedures associated with deposit brokering activities and deposit placement arrangements (especially those involving third parties). However, the FDIC believes that some of these costs may be ameliorated because the proposed rule is very similar to the regulatory framework that existed prior to the 2020 Final Rule; therefore, some affected entities may have experience with some of those policies and procedures.
The FDIC also believes the proposed rule may affect the number of applications and notices (collectively, filings) that small IDIs may submit to the FDIC. The effect of the proposed rule on filings submitted by small IDIs is discussed below in the “Reporting Compliance Costs” section of this RFA analysis.
Finally, the proposed rule could also affect FDIC deposit insurance assessments at certain small IDIs. Under the FDIC's assessment regulations, IDIs with a significant concentration of brokered deposits may pay higher quarterly assessments, depending on other factors.
The FDIC believes a primary benefit of the proposed rule is that it would improve the safety and soundness of the banking system, including covered IDIs. As discussed in more detail in section II.A. of this document, “Brokered Deposits—A History of Concerns and Related Research,” and in the “Expected Effects” analysis in section V of this document, the FDIC's own analyses as well as other studies have found that IDI use of brokered deposits in general is associated with a higher probability of failure and higher losses to the DIF upon failure. IDI use of brokered deposits is correlated with (1) higher levels of asset growth, (2) higher levels of nonperforming loans, and (3) a lower proportion of core deposit
Another potential benefit to small IDIs of the proposed rule is the clarification of certain concepts and practices, and by promoting accurate reporting and understanding of the regulation and how the involvement of third parties within a deposit placement arrangement may, or may not, result in the deposits being brokered. For example, the proposed rule includes a provision to clarify how an IDI may regain its “agent institution” status after losing it. The FDIC believes that increased clarity should reduce costs for covered small IDIs and ensure more accurate reporting. As previously described, based on the FDIC's experience, the initial decline in brokered deposits following the effective date of the 2020 Final Rule was due, in part, to some IDIs
The acceptance of brokered deposits is subject to statutory and regulatory restrictions for banks that are not well capitalized. Adequately capitalized banks may not accept brokered deposits without a waiver from the FDIC, and banks that are less than adequately capitalized may not accept them at all. As a result, adequately capitalized and undercapitalized banks generally hold fewer brokered deposits. To the extent less than well-capitalized IDIs are able to rely on deposits that share the characteristics of brokered deposits (such as volatility) but are not currently reported as brokered, such IDIs can operate using a riskier liability structure than one reliant on more stable funding sources, thereby potentially increasing the risk of loss to the DIF. By generally increasing the scope of deposits that are considered brokered, the proposed rule would limit the ability of less than well-capitalized small banks to rely on potentially less stable third-party deposits that are currently reported as nonbrokered but would be reported as brokered under the proposed rule.
Based on IDIs' reported capital ratios as of March 31, 2024, there are six small, less than well-capitalized IDIs, none of which report holding any brokered deposits.
As mentioned above, adequately capitalized banks may not accept brokered deposits without a waiver from the FDIC, and the proposed rule would generally increase the scope of deposits that are considered brokered. Thus, one potential effect of the proposed rule may be to increase the number of brokered deposit waiver applications submitted to the FDIC by adequately capitalized small banks. This potential effect of the proposed rule is difficult to estimate because, as mentioned above, not only does the FDIC not possess the data necessary to estimate the amount of deposits that would be reclassified as brokered at specific small banks under the proposed rule, but also the number of adequately capitalized small banks depends on other factors, such as economic conditions.
The proposed rule could affect nonbank subsidiaries of small IDIs, in particular, nonbank subsidiaries of small IDIs that may not be considered deposit brokers under the 2020 Final Rule, but may be considered deposit brokers under the proposed rule. Additionally, under the 2020 Final Rule nonbanks may avail themselves of the notice or application process in order to seek certain primary purpose exceptions. However, under the proposed rule only IDIs may submit notices or applications with respect to primary purpose exceptions. In addition, to the extent a nonbank subsidiary of a small bank relies on the 2020 Final Rule's exclusive placement arrangement exception to place deposits solely at its parent IDI, the proposed removal of this exception could affect the subsidiary and its parent IDI.
As discussed in “Expected Effects,” section V of this document, the proposed rule may affect third parties directly or indirectly involved with the provision of deposit products. The FDIC does not have information on the number or size of potentially affected third parties; however, the FDIC believes it is likely that some affected third parties may be small entities.
First, concurrent with the finalization of the proposed rule, the FDIC would rescind existing primary purpose exceptions and notices granted under the 2020 Final Rule, and the proposed rule would restrict the application and notice process to IDIs. Therefore, to the extent that small third parties who previously applied and received approval for a primary purpose exception wish to continue offering their services to IDIs, they may incur costs associated with providing information to those IDIs to support applications and notices to the FDIC.
Second, to the extent that small third parties are directly or indirectly involved with the provision of deposits not currently designated as brokered deposits, but that would be if the proposed rule were adopted, such small third parties may incur costs associated with complying with the requirements in the proposed rule. Such costs would include, but would not be limited to (1) costs associated with making changes to systems, policies, and procedures involved in the provision of brokered deposits; (2) costs associated with the submission of filings to the FDIC by affiliated IDIs on their deposit placement arrangements; and (3) other costs associated with transitioning their business models to incorporate the provision of brokered deposits (including potential changes to fees, revenue structures, etc.).
Third, small third parties who are engaged in the provision of deposits that are considered brokered may incur costs associated with making changes to systems, policies, and procedures to comply with the requirements in the proposed rule. Also, such small third parties may experience changes to fee and revenue structures as a result of the requirements in the proposed rule.
Finally, as the proposed rule's criteria for determining whether an entity is a deposit broker are generally stricter than the criteria in the 2020 Final Rule, more small third parties could be considered deposit brokers under the proposed rule.
The FDIC believes the proposed rule would likely affect the number of applications and notices (collectively, filings) that IDIs submit to the FDIC for the reasons discussed in the “Reporting Compliance Costs” section of the “Expected Effects” analysis in section V of this document, above. Briefly, the FDIC believes the proposed rule would likely affect the number of filings because it eliminates the “enabling transactions” exception, and the FDIC's supervisory experience suggests many “enabling transactions” notice filers would file PPE applications through IDIs. Second, the proposed rule would replace the current “25 percent test” notice exception with two similar but distinct exceptions: the BDSE requiring a notice, for arrangements involving only an IDI and broker-dealer, and the BDSE requiring an application, for arrangements involving an IDI, broker-dealer, and an additional third party. Third, the FDIC believes that the proposed rule would likely result in an increase in filings, at least initially, because the proposed rule would rescind approved applications and notices filed under the 2020 Final Rule. Finally, because the FDIC believes the proposed rule would likely increase the amount of deposits classified as brokered, the FDIC believes the
While the FDIC does not have the information necessary to quantify the potential changes in filings by small IDIs that are likely to occur if the proposed rule is adopted, based on the number of filings received during the roughly three-year period since the 2020 Final Rule became effective, the FDIC believes the effect is likely to be modest. During the aforementioned period, five small IDIs (out of 29 total IDIs and 46 other entities) submitted a total of only six filings out of 147.
The FDIC has not identified any likely duplication, overlap, and/or potential conflict between this proposed rule and any other Federal rule.
The FDIC invites comments on all aspects of the supporting information provided in this RFA section. In particular, would this proposed rule have any significant effects on small entities that the FDIC has not identified?
Certain provisions of the proposed rule contain “collections of information” within the meaning of the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501 through 3521). In accordance with the requirements of the PRA, the FDIC may not conduct or sponsor, and the respondent is not required to respond to, an information collection unless it displays a currently valid Office of Management and Budget (OMB) control number. The information collections contained in the proposed rule have been submitted to OMB for review and approval by the FDIC under section 3507(d) of the PRA (44 U.S.C. 3507(d)) and § 1320.11 of OMB's implementing regulations (5 CFR part 1320). The FDIC proposes to extend for three years, with revision, the following information collection:
The total estimated annual burden for OMB No. 3064-0099 is 545 hours, an increase of 168 hours from the most recent PRA renewal.
Comments on aspects of this document that may affect reporting, recordkeeping, or disclosure requirements and burden estimates should be sent to the address listed in the
Section 722 of the Gramm-Leach-Bliley Act requires the agencies to use plain language in all proposed and final rules published after January 1, 2000. The FDIC invites comment on how to make this proposed rule easier to understand.
For example:
• Have the agencies organized the material to inform your needs? If not, how could the agencies present the proposed rule more clearly?
• Are the requirements in the proposed rule clearly stated? If not, how could the proposal be more clearly stated?
• Does the proposed regulation contain technical language or jargon that is not clear? If so, which language requires clarification?
• Would a different format (grouping and order of sections, use of headings, paragraphing) make the proposed regulation easier to understand? If so, what changes would achieve that?
• Is this section format adequate? If not, which of the sections should be changed and how?
• What other changes can the agencies incorporate to make the proposed regulation easier to understand?
Pursuant to section 302(a) of the Riegle Community Development and Regulatory Improvement Act of 1994
The FDIC invites comment from all members of the public regarding all aspects of the proposal. In particular, the FDIC seeks feedback on the scope of the proposed rule and its requirements, and responses to the following specific questions:
1. Does the FDIC's proposed amendment to the “deposit broker” definition align more closely with the statutory language and purpose of section 29 of the FDI Act? Why or why not?
2. Is the FDIC's proposed change to remove “matchmaking activities” from the “deposit broker” definition and proposal to add a deposit allocation provision appropriate? Why or why not?
3. Is the consideration of fees appropriate when determining whether a person is a “deposit broker”? Are there any additional factors the FDIC should consider adding to the “deposit broker” definition? Please explain and provide data to support your views.
4. Is the proposed updated primary purpose exception analysis appropriate? Why or why not?
5. Are the proposed changes to the primary purpose exception application process appropriate? Is it appropriate to limit the application process to IDIs? Is the proposed process sufficiently clear to allow IDIs to obtain the required information on all third parties within a deposit placement arrangement?
6. Are there any additional factors the primary purpose exception application process should consider?
7. Should previously approved primary purpose exceptions be added to the regulatory list of “designated exceptions” as meeting the primary purpose exception under the proposed rule if they satisfy the proposed primary purpose exception?
8. Should any of the designated exceptions be removed, or new ones added? Please explain.
9. Should the enabling transactions designated exception be amended to include only non-reloadable prepaid card programs, such as gift cards? Please explain.
10. For the proposed BSDE, is the use of “assets under management” appropriate? Is the definition of “assets under management” sufficiently clear under the proposed rule? Is it appropriate to request the total amount of deposits placed by the broker-dealer or investment adviser on behalf of its customers at all IDIs and the total amount of customer assets under management as of the last quarter and as of the date of the notice filing?
11. Given that the limited reciprocal deposits exception is intended for IDIs that are in good condition and well managed, should there be any ability for an IDI to regain “agent status” absent a return to being a well-rated and well-capitalized IDI?
12. Can allowance of regaining “agent status” potentially run counter to the goals of having an IDI focus on addressing its problems because the exception would potentially allow an IDI that is less than well-capitalized and not well-rated to grow its deposits through this avenue?
13. If an IDI could regain “agent status” absent a return to being a well-rated and well-capitalized IDI, is it appropriate to allow the IDI to regain
14. Would rescinding a designated exception for sweep deposits be appropriate? Why or why not?
15. Would limiting the BDSE to sweep deposits placed at affiliated IDIs be appropriate? Why or why not?
16. Are there any additional alternatives the FDIC should consider?
Administrative practice and procedure, Bank deposit insurance, Banks, Banking, Reporting and recordkeeping requirements, Savings associations.
Banks, Banking, Reporting and recordkeeping requirements, Savings associations, Securities.
For the reasons stated in the preamble, the FDIC proposes to amend 12 CFR parts 303 and 337 as follows:
12 U.S.C. 378, 1463, 1467a, 1813, 1815, 1817, 1818, 1819(a) (Seventh and Tenth), 1820, 1823, 1828, 1831i, 1831e, 1831o, 1831p-1, 1831w, 1831z, 1835a, 1843(l), 3104, 3105, 3108, 3207, 5412; 15 U.S.C. 1601-1607.
(b)
(2)
(3)
(i)
(A) A description of the deposit placement arrangement between the insured depository institution and the broker-dealer or investment adviser for the particular business line;
(B) The registration and contact information for the broker-dealer or investment adviser;
(C) The total amount of customer assets under management (as defined in § 337.6(a)(11) of this chapter) by the broker-dealer or investment adviser as of the last quarter and as of the date of the filing;
(D) The total amount of deposits placed by the broker-dealer or investment adviser on behalf of its customers at all depository institutions as of the last quarter and as of the date of the filing; and
(E) A certification that no additional third parties are involved in the deposit placement arrangement.
(ii)
(iii)
(iv)
(v)
(vi)
(vii) Ongoing
(viii)
(A) The broker dealer or investment adviser no longer meets the criteria to rely on the designated exception;
(B) The notice or subsequent reporting is inaccurate; or
(C) The notice filer fails to submit one or more required reports.
(4)
(i)
(A) A description of the deposit placement arrangement between the insured depository institution, the broker-dealer or investment adviser, and the additional third party, including the services provided by the additional third party, for the particular business line, and copies of contracts relating to the deposit placement arrangement, including all third-party contracts;
(B) The total amount of customer assets under management by the broker-dealer or investment adviser;
(C) The total amount of deposits placed by the broker-dealer or investment adviser on behalf of its customers at all depository institutions;
(D) Information on whether the additional third party places or facilitates the placement of deposits at insured depository institutions, including through operating or using an algorithm, or any other program or technology that is functionally similar;
(E) Information on whether the additional third party has legal authority, contractual or otherwise, to close the account or move the third party's funds to another insured depository institution, including through operating or using an algorithm, or any other program or technology that is functionally similar;
(F) Information on the amount of fees paid to the additional third party from any source with respect to its services provided as part of the deposit placement arrangement;
(G) Information on whether the additional third party has discretion to choose the insured depository institution(s) at which customer deposits are or will be placed; and
(H) Any other information that the FDIC requires to initiate its review and render the application complete.
(ii)
(A) A description of the deposit placement arrangements between the third party and insured depository institutions for the particular business line, including the services provided by any additional third parties, and copies of contracts relating to the deposit placement arrangement, including all third-party contracts;
(B) A description of the particular business line;
(C) A description of the primary purpose of the particular business line;
(D) The total amount of customer assets under management by the third party, with respect to the particular business line;
(E) The total amount of deposits placed by the third party at all insured depository institutions, including the amounts placed with the applicant, with respect to the particular business line. This includes the total amount of term deposits and transactional deposits placed by the third party, but should be exclusive of the amount of brokered CDs, as defined in § 337.6(a)(5)(iv)(I)(
(F) Information on whether the insured depository institution or customer pays fees or other remuneration to the agent or nominee for deposits placed with the insured depository institution and the amount of such fees or other remuneration, including how the amount of fees or other remuneration is calculated;
(G) Information on whether the agent or nominee has discretion to choose the insured depository institution(s) at which customer deposits are or will be placed;
(H) Information on whether the agent or nominee is mandated by law to disburse funds to customer deposit accounts;
(I) A description of the marketing activities provided by the third party, with respect to the particular business line;
(J) The reasons the third party meets the primary purpose exception;
(K) Any other information the applicant deems relevant; and
(L) Any other information that the FDIC requires to initiate its review and render the application complete.
(iii)
(iv)
(B) If an application is submitted that is not complete, the FDIC will notify the applicant and explain what is needed to render the application complete.
(C) The FDIC may extend the 120-day timeframe to complete its review of a complete application, if necessary, with notice to the applicant, for 120 additional days. If necessary, the FDIC may further extend its review period.
(v)
(A) Submitted under paragraph (b)(4)(i) of this section if the FDIC finds that the applicant demonstrates that, with respect to the particular business line, the additional third party involved in the deposit placement arrangement is not a
(B) Submitted under paragraph (b)(4)(ii) of this section if the FDIC finds that the applicant demonstrates that, with respect to the particular business line under which the third party places or facilitates the placement of deposits, the primary purpose of the third party's business relationship with the insured depository institution is for a substantial purpose other than to provide a deposit-placement service or FDIC deposit insurance for customer funds placed at the insured depository institution.
(vi)
(B) Applicants that receive a written approval for the primary purpose exception, will provide reporting to the FDIC and to its primary Federal regulator, if required under this section.
(vii)
(A) Require additional information from an applicant to ensure that the approval is still appropriate, or for purposes of verifying the accuracy and correctness of the information submitted to the FDIC as part of the application under this section;
(B) Require the applicant to reapply for approval;
(C) Impose additional conditions on an approval; or
(D) Withdraw an approval.
12 U.S.C. 375a(4), 375b, 1463, 1464, 1468, 1816, 1818(a), 1818(b), 1819, 1820(d), 1821(f), 1828(j)(2), 1831, 1831f, 1831g, 5412.
(a) * * *
(5)
(i)
(A) Any person engaged in the business of placing or facilitating the placement of deposits of third parties with insured depository institutions;
(B) Any person engaged in the business of placing deposits with insured depository institutions for the purpose of selling those deposits or interests in those deposits to third parties; and
(C) An agent or trustee who establishes a deposit account to facilitate a business arrangement with an insured depository institution to use the proceeds of the account to fund a prearranged loan.
(ii)
(A) The person receives third-party funds and deposits those funds at one or more insured depository institutions;
(B) The person has legal authority, contractual or otherwise, to close the account or move funds of the third party to another insured depository institution;
(C) The person is involved in negotiating or setting rates, fees, terms, or conditions for the deposit account;
(D) The person proposes or determines deposit allocations at one or more insured depository institutions (including through operating or using an algorithm, or any other program or technology that is functionally similar); or
(E) The person has a relationship or arrangement with an insured depository institution or customer where the insured depository institution or the customer pays the person a fee or provides other remuneration in exchange for deposits being placed at one or more insured depository institution.
(iii)
(iv)
(A) An insured depository institution, with respect to funds placed with that depository institution.
(B) An employee of an insured depository institution, with respect to funds placed with the employing depository institution.
(C) A trust department of an insured depository institution, if the trust or other fiduciary relationship in question has not been established for the primary purpose of placing funds with insured depository institutions.
(D) The trustee of a pension or other employee benefit plan, with respect to funds of the plan.
(E) A person acting as a plan administrator or an investment adviser in connection with a pension plan or other employee benefit plan provided that person is performing managerial functions with respect to the plan.
(F) The trustee of a testamentary account.
(G) The trustee of an irrevocable trust (other than one described in paragraph (a)(5)(i)(B) of this section), as long as the trust in question has not been established for the primary purpose of placing funds with insured depository institutions.
(H) A trustee or custodian of a pension or profit-sharing plan qualified under section 401(d) or 403(a) of the Internal Revenue Code of 1986 (26 U.S.C. 401(d) or 403(a)).
(I) An agent or nominee whose primary purpose in placing customer deposits at insured depository institutions is for a substantial purpose other than to provide a deposit-placement service or to obtain FDIC deposit insurance with respect to particular business lines between the individual insured depository institutions and the agent or nominee.
(
(
(
(
(
(
(
(
(
(
(
(
(
(
(
(
(
(
(J) An insured depository institution acting as an intermediary or agent of a U.S. Government department or agency for a government sponsored minority or women-owned depository institution deposit program.
(v)
(9)
(10)
(11)
(e) * * *
(3)
(i)(A) When most recently examined under section 10(d) of the Federal Deposit Insurance Act (12 U.S.C. 1820(d)) was found to have a composite condition of outstanding or good; and
(B) Is well capitalized;
(ii)(A) As of the date the insured depository institution is notified, or is deemed to have notice, that it is well capitalized under regulations implementing section 38 of the FDI Act issued by the appropriate Federal banking agency for that institution; and
(B) Is well-rated;
(iii) Has obtained a waiver pursuant to paragraph (c) of this section; or
(iv)(A) Does not receive an amount of reciprocal deposits that causes the total amount of reciprocal deposits held by the agent institution to be greater than the average of the total amount of reciprocal deposits held by the agent institution on the last day of each of the four calendar quarters preceding the calendar quarter in which the agent institution was found not to have a composite condition of outstanding or good or was determined to be not well capitalized; and
(B) An insured depository institution that is not in compliance with paragraph (e)(2)(i)(C) of this section may regain its status as an agent institution after complying with paragraph (e)(3)(iv)(A) of this section continuously for two successive reporting quarters.
By order of the Board of Directors.
U.S. Small Business Administration.
Proposed rule.
The U.S. Small Business Administration (SBA or Agency) proposes to amend its regulations governing the Historically Underutilized Business Zone (HUBZone) Program to clarify certain policies. In 2019, SBA published a comprehensive revision to the HUBZone Program regulations, which implemented changes intended to make the HUBZone Program more efficient and effective. This proposed rule is intended to clarify and improve policies surrounding some of those changes. In particular, the rule proposes to require any certified HUBZone small business to be eligible as of the date of offer for any HUBZone contract. SBA also proposes to make several changes to SBA's size and 8(a) Business Development (BD) regulations, as well as some technical changes to the Women-Owned Small Business (WOSB) and Veteran Small Business Certification (VetCert) programs. Of note, the proposed rule would delete the program specific recertification requirements contained separately in SBA's size, 8(a) BD, HUBZone, WOSB, and VetCert and move them to a new section that would cover all size and status recertification requirements. This should ensure that the size and status requirements will be uniformly applied.
Comments must be received on or before October 7, 2024.
You may submit comments, identified by Docket No. SBA-2024-0007 or RIN 3245-AH68, by any of the following methods:
•
•
Laura Maas, Deputy Director, Office of HUBZone, (202) 205-7341,
On November 26, 2019, SBA published the first comprehensive revision of the HUBZone Program regulations since the program's implementation more than 20 years ago. 84 FR 65222. The revisions were intended to clarify current HUBZone Program policies and procedures and implement changes to make the HUBZone Program more efficient and effective. This proposed rule would make additional clarifications to the program regulations to reflect SBA policies established in response to feedback received in the time since the publication of the comprehensive revision.
SBA also made a number of revisions to the HUBZone regulations as part of its implementation of section 1701 of the National Defense Authorization Act for Fiscal Year 2018 (NDAA 2018), Public Law 115-91, Dec. 12, 2017. Included within that rulemaking were revisions freezing the HUBZone map until the results of the 2020 census were released; authorizing “legacy HUBZone employees”; requiring annual recertification; implementing one-year certification and requiring HUBZone firms to be eligible on each anniversary of their HUBZone certification date; and requiring HUBZone firms to be HUBZone-certified at the time of offer for any HUBZone contract, with eligibility relating back to their certification anniversary date and removing the requirement for HUBZone small businesses to be eligible at the time of award of a HUBZone contract.
In the time since SBA published the comprehensive revision, the Office of the HUBZone Program has received questions and information that prompted refinement and clarification of policies contained in that revision, which SBA published in “Frequently Asked Questions” in February 2020 and in subsequent updates. This proposed rule would incorporate some of those clarifications and make other refinements in the HUBZone regulations, including requiring HUBZone firms to be eligible on the date of offer for a HUBZone contract and relieving the burden of annual recertification by moving to a triennial recertification requirement. In addition, this proposed rule would clarify policies related to “Governor-designated covered areas,” which were authorized by the NDAA 2018 and implemented through a direct final rule published by SBA on November 15, 2019. 84 FR 62447.
Further, in response to concerns related to potential fraud and abuse in the program, SBA is proposing to amend the definition of the term “employee” by raising the minimum number of work hours necessary for an individual to count as an employee for HUBZone program purposes.
The proposed rule would also make several changes to SBA's size and 8(a) business development (BD) regulations, as well as some technical changes to the women-owned small business (WOSB) and the Veteran Small Business Certification (VetCert) programs. Of note, the proposed rule would delete the program specific recertification requirements contained separately in SBA's size, 8(a) BD, HUBZone, WOSB, and VetCert and move them to a new section that would cover all size and status recertification requirements. Currently, there is some language contained in the program specific recertification rules that is not identical in each of the programs. This has caused some confusion as to whether SBA intended the rules to be different in certain cases. That was not SBA's intent. Moving all size and recertification to new § 125.12 should alleviate any confusion between the different programs and ensure that the size and status requirements will be uniformly applied.
SBA proposes to amend its rules on affiliation in the size regulations and control in the 8(a) BD, WOSB and VetCert program regulations regarding negative control. Specifically, this proposed rule would make the negative-control rules consistent across SBA's various programs. The negative control provision states that a concern may be deemed controlled by, and therefore affiliated with, a minority shareholder that has the ability to prevent a quorum or otherwise block action by the board of directors or shareholders. The rule does not include any specific exceptions, though some have
This proposed rule would first amend § 121.103(a)(3) by adding language currently contained in the VetCert rules that developed from OHA case law to clarify that there are certain “extraordinary circumstances” under which a minority shareholder may have some decision-making authority without a finding of negative control. Specifically, SBA will not find that a lack of control exists where a qualifying individual or business does not have the unilateral power and authority to make decisions regarding: (1) adding a new equity stakeholder; (2) dissolution of the company; (3) sale of the company or all assets of the company; (4) the merger of the company; (5) the company declaring bankruptcy; and (g) amendment of the company's governance documents to remove the shareholder's authority to block any of (1) through (5). These exceptions to negative control are being implemented to promote consistency with other SBA contracting programs (
This rule proposes to add the same language to a new § 124.106(h) for the 8(a) BD program and to § 127.202(h) for the WOSB program. Finally, since the current VetCert regulations have only the first five exceptions for control and this rule would add six to the size, 8(a) BD and WOSB regulations, the proposed rule would add that same sixth exception to the VetCert regulations also. That addition would be a new § 128.203(j)(6). Through this proposed rule, SBA would add explicit exceptions to the negative-control provision for all programs for which control is an eligibility element. This would permit all small businesses to seek equity funding without becoming affiliated with the investors solely because of a broad interpretation of the negative-control rule. SBA specifically requests comments as to whether the six identified exceptions are sufficient or whether one or more additional exceptions should also be included in the regulations.
Section 121.103(h)(3) sets forth SBA's “ostensible subcontractor” rule, which may find a prime contractor ineligible for the award of any small business contract or order where a subcontractor that is not similarly situated (as that term is defined in § 125.1) performs primary and vital requirements of a contract, order, or agreement, or where the prime contractor is unusually reliant on such a subcontractor. The current regulatory text provides that a contractor and its ostensible subcontractor are treated as joint venturers for size determination purposes, and as long as each concern is small under the size standard corresponding to the relevant North American Industry Classification System (NAICS) code or the prime contractor is small and the subcontractor is its SBA-approved mentor, the arrangement will qualify as a small business. That language has caused some confusion. In the context of a subcontractor that is an SBA-approved mentor of the prime contractor, in treating the relationship “as a joint venture”, SBA intended to allow the relationship to qualify as a small business only if all the joint venture requirements were met. That would mean that the protégé and mentor have an underlying joint venture agreement that meets the requirements of § 125.8(b), the protégé will direct and have ultimate responsibility for the contract, and the performance of work requirements set forth in § 125.8(c) will be met. In a prime-subcontractor relationship, those requirements are not present and SBA would aggregate the revenues/employees of such “joint ventures” in determining size. Unfortunately, without clearly specifying SBA's intent, the current regulation could be read to allow mentors to be found to be ostensible subcontractors while not meeting the normal joint venture requirements. That was not SBA's intent. This proposed rule would simplify § 121.103(h) by eliminating the reference to a joint venture and instead specify that an offeror is ineligible as a small business concern, an 8(a) small business concern, a certified HUBZone small business concern, a WOSB/EDWOSB, or a VO/SDVO small business concern where SBA determines there to be an ostensible subcontractor relationship.
This proposed rule would also make a corresponding change to § 121.702(c)(7) for the SBIR program. That change would provide that a concern with an other than small ostensible subcontractor cannot be considered a small business concern for SBIR and STTR awards.
Section 121.104 defines the term annual receipts to mean all revenue in whatever form received or accrued from whatever source, including from the sales of products or services, interest, dividends, rents, royalties, fees, or commissions, reduced by returns and allowances. It goes on to state that generally, receipts are considered “total income” plus “cost of goods sold” as these terms are defined and reported on Internal Revenue Service (IRS) tax return forms. The section also provides that Federal income tax must be used to determine the size status of a concern. There has been some confusion as to whether SBA is restricted in all circumstances to examining only a concern's tax returns or whether SBA may look at other information if it appears or there is other information suggesting that the tax returns do not adequately capture a concern's total revenue. The proposed rule clarifies that SBA will always consider a concern's tax returns, but may also consider other relevant information in appropriate circumstances in determining whether the concern qualifies as small.
SBA proposes to simplify and reorganize § 121.404, which addresses the date used to determine size for size certifications and determinations. The proposed changes would not alter the substance of SBA's rules regarding the date to determine size, but rather seek to clarify the current rules and make them easier to understand and apply. In addition to these clarifications, SBA is proposing substantive changes to the rules regarding size recertification and proposes to remove paragraph (g) on size recertification and relocate that paragraph to new section 125.12, which addresses size and small business program status recertification.
Generally, a concern (including its affiliates) must qualify as small under the NAICS code assigned to a contract as of the date the concern submits a self-certification that it is small to the procuring activity as part of its initial offer or response which includes price. Once awarded a contract as a small business, a concern is generally considered to be a small business throughout the life of that contract. For orders and agreements issued under multiple award contracts, the date that size is determined depends on whether the underlying multiple award contract was awarded on an unrestricted basis or whether it was set aside or reserved for small business (
Where an order or agreement is to be set aside for small business under an unrestricted multiple award contract, size is determined as of the date of initial offer (or other formal response to a solicitation), including price, for each
Where the underlying multiple award contract was set aside or reserved for small business, size status will generally flow down from the underlying contract to the order or agreement, unless recertification is requested by a contracting officer with respect to an agreement or order. As such, size status for an order or agreement under a multiple award contract that itself was set aside or reserved for small business is determined as of the date of initial offer, including price, for the multiple award contract, unless size recertification is requested by the contracting officer in connection with a specific order or agreement.
This rule proposes to also clarify that where a contracting officer requests size recertification with respect to a specific order or agreement, size is determined as of the date of initial offer (or other formal response to a solicitation), including price, for that specific order or agreement only. The requirement to recertify applies only to the order or agreement for which a contracting officer requested recertification. The recertification does not apply to the underlying contract. Where an initially-small contract holder has naturally grown to be other than small and could not recertify as small for a specific order or agreement for which a contracting officer requested recertification, it may continue to qualify as small for other orders or agreements where a contracting officer does not request recertification.
If size recertification is triggered by a merger, sale, or acquisition; or because it is a long-term contract in the fifth year of performance, size will be determined as of the date of the merger, sale, or acquisition occurred, or the date of the size recertification in the case of a recertification in the fifth year of a long-term contract. The impact of a disqualifying recertification, the events that require recertification, and the timing of recertification, are discussed in detail in 125.12, which is a new proposed section of SBA's regulations.
To summarize and clarify, there are three, narrow exceptions to the general rule that the date on which size is determined for an order or agreement against a multiple award contract is dependent on whether the underlying multiple award contract was set aside for small business or unrestricted. The first exception is for set-aside orders or agreements to be placed against GSA's Federal Supply Schedule (FSS) Multiple Award Schedule (MAS) contracts, which is an unrestricted vehicle. Unlike set-side and reserved orders issued under unrestricted multiple award contracts where size status is determined at the date of the offer for the order, for FSS orders size status is determined as of the date of offer for the underlying FSS contract. This exception does not apply when any trigger for size recertification occurs under § 125.12, including when a contracting officer requests a size recertification with the offer for a specific order or agreement that is set-aside for small businesses against the FSS MAS.
SBA provides this clarification in response to a recent decision of the Government Accountability Office (GAO) in
The second exception is for 8(a) sole source awards issued against multiple award contracts, regardless of whether the underlying multiple award contract is unrestricted, set-aside (even if the underlying multiple award contract itself was set-aside or reserved as an 8(a) award), or under the GSA's FSS MAS contracts. SBA has always required an 8(a) Participant to qualify as eligible (to still be an active Participant in the 8(a) program, qualify as small, and meet all other eligibility criteria) at the time of any 8(a) sole source award. In terms of size for a specific 8(a) sole source order or agreement under a multiple award contract, including GSA's FSS MAS contracts, the concern must qualify as small for the size standard corresponding to the NAICS code assigned to the order or agreement on the date of initial offer for and award of the order or agreement.
The third exception applies when size recertification is triggered pursuant to any scenario outlined in new § 125.12, including when a contracting officer requests recertification of size for a particular order or agreement against a multiple award contract. To be clear, when a recertification of size is triggered, the date to determine size is outlined in new section 125.12, and is typically the date of the triggering event, but may be the date of initial offer for a particular order or agreement if a contracting officer requested recertification with the offer. Size recertification is an essential tool that ensures small business awards continue to be entered into with entities that are small at the time of offer for a particular award. As such, when the requirement for recertification is triggered, the date to determine size shifts to a date that coincides with either the triggering event or the date of initial offer for a particular award (except for sole source 8(a) awards as noted above).
Section 121.1001 identifies who may initiate a size protest or request a formal size determination in different instances. Paragraph 121.1001(b)(2)(ii) identifies who may request a formal size determination where SBA cannot verify that an 8(a) Participant is small for a specific sole source or competitive 8(a) contract. There have been a few cases where SBA initially determined that a Participant qualified as small for a sole source 8(a) contract, but later received information that questioned that determination. Under a strict reading of § 121.1001(b)(2)(ii), SBA could not then request a formal size determination because the wording of § 121.1001(b)(2)(ii) authorized such a request only where SBA “cannot verify the eligibility of the apparent successful offeror because SBA finds the concern to be other than small.” Since verification, albeit initial verification only, had already occurred, some have questioned whether SBA could request a formal size determination at all in that
This rule also proposes to add a new § 121.1001(b)(12) to specifically authorize requests for formal size determinations relating to size recertifications required by § 125.12. Section 125.12 requires a concern to recertify its size when there is a merger, acquisition, or sale and prior to the sixth year and every option thereafter of a long-term contract. Although SBA and the relevant contracting officer may file a size protest before or after the award of a contract (
SBA is also considering allowing a size protest in connection with the award of an order issued under a multi-agency multiple award contract where the protest relates to the ostensible subcontractor rule. Whether a large business subcontractor will perform primary and vital requirements or whether a small business prime contractor will be unduly reliant on a large business subcontractor will not be an issue at the time of award of an underlying small business multiple award contract. It is at the order level where undue reliance may become an issue. SBA requests comments regarding whether SBA should implement a regulatory provision authorizing such a protest.
Section 121.1010 explains how a concern can become recertified as a small business after receiving an adverse size determination. This proposed rule would make slight wording changes to § 121.1010(b) to make clear that size recertification is not required and the prohibition against future self-certification does not apply if the adverse SBA size determination is based solely on a finding of affiliation limited to a particular Government procurement or property sale, such as an ostensible subcontracting relationship or non-compliance with the nonmanufacturer rule.
Section 124.3 sets forth the definitions that are important in the 8(a) BD program. Included within this section is the definition of the term Community Development Corporation or CDC. In 1981, Congress enacted the Omnibus Reconciliation Act. Included within Title VI of this Act was § 626(a)(2), codified at 42 U.S.C. 9815(a)(2), which required SBA to “promulgate regulations to ensure the availability to community development corporations of such programs as shall further the purposes of this subchapter, including programs under section 8(a) of the Small Business Act.” Pursuant to 42 U.S.C. 9802, a CDC is defined as a non-profit organization responsible to the residents of the area it serves which is receiving financial assistance under 42 U.S.C. 9805,
Sections 124.105(b) (for the 8(a) BD program), 127.202(d) (for the WOSB program), and 128.202(c) (for VetCert program) set forth ownership requirements pertaining to partnerships. The language of the three sections is not consistent. SBA seeks to harmonize the provisions so that a firm simultaneously applying to be certified in more than one program must meet the same requirements. SBA does not want possible contradictory determinations based on the same facts. In other words, SBA believes that it would be
Section 124.105 sets forth the ownership requirements that an applicant to or Participant in the 8(a) BD program must meet in order to be and remain eligible for the program. Paragraph 124.105(h) provides certain ownership restrictions that are applicable to non-disadvantaged individuals and concerns that seek to have an ownership interest in an applicant or Participant. The regulation currently provides that a non-disadvantaged individual or another business concern in the same or similar line of business generally cannot own more than a 10 percent interest in a Participant that is in the developmental stage or more than a 20 percent interest in a Participant in the transitional stage of the program. The proposed rule would increase the allowable ownership percentages for non-disadvantaged individuals and business concerns in the same or similar line of business from 10 and 20 percent to 20 and 30 percent. By changing 10 percent to 20 percent, the proposed rule would make this ownership restriction consistent with that contained in § 124.108(a)(4). It then follows that the current 20 percent ownership restriction for the transitional stage would also be correspondingly increased, which is why the proposed rule would raise that restriction to 30 percent.
Paragraph (i) sets forth the requirements relating to changes of ownership. Generally, a Participant may change its ownership or business structure so long as one or more disadvantaged individuals own and control it after the change and SBA approves the transaction in writing prior to the change. Paragraph 124.105(i)(2) authorizes three exceptions as to when prior SBA approval of a change of ownership is not needed and provides four examples implementing the change of ownership requirements, one showing when prior SBA approval is required and three showing when it is not. Prior SBA approval is not needed where all non-disadvantaged individual (or entity) owners involved in the change of ownership own no more than a 20 percent interest in the concern both before and after the transaction. To be consistent with the proposed change to § 124.105(h) above, the proposed rule would require prior approval only where a non-disadvantaged individual owns more than a 30 percent interest in the 8(a) Participant either before or after the transaction. The proposed rule would also add a fourth exception as to when prior SBA approval is not required. Specifically, the proposed rule would specify that prior SBA approval is not required where the 8(a) Participant has never received an 8(a) contract. The rule would then clarify that where prior approval is not required, the Participant must notify SBA within 60 days of such a change in ownership, or before it submits an offer for an 8(a) contract, whichever occurs first. SBA must be able to determine the continued eligibility of the Participant before it accepts a sole source 8(a) procurement on behalf of or authorizes the award of a competitive 8(a) award to the Participant. Finally, the rule would make changes to the examples set forth in § 124.105(i)(2) to reflect the change from 20 percent to 30 percent and would add a fifth example highlighting that prior SBA approval is not required where a Participant has never received an 8(a) contract.
Paragraph 124.105(k) currently provides generally that SBA considers applicable state community property laws in determining ownership interests when an owner resides in a community property state. Under that provision, a transfer or relinquishment of interest by the non-disadvantaged spouse may be necessary in some cases to establish eligibility for the 8(a) BD program. SBA initially promulgated this provision in order to comply with the statutory requirement that an 8(a) concern must be at least 51 percent “unconditionally” owned one or more socially and economically disadvantaged individuals. Upon reexamination, SBA believes that it may not be necessary to consider community property laws when determining that a specific individual does in fact “unconditionally” own an applicant or Participant. In order to align the 8(a) BD ownership requirements with those applicable in the WOSB and VetCert programs, SBA proposes to eliminate § 124.105(k). SBA requests comments as to whether not considering community property laws complies with the unconditional ownership requirement and whether previously required transmutation agreements (
The proposed rule would add a new § 124.105(k) to allow a right of first refusal granting a non-disadvantaged individual the contractual right to purchase the ownership interests of a disadvantaged individual without affecting the unconditional nature of ownership, if the terms follow normal commercial practices. This would align 8(a) ownership requirements with those set forth in the VetCert program. Of course, if those rights are exercised by a non-disadvantaged individual after certification that result in disadvantaged individuals owning less than 51% of the concern, SBA will initiate termination proceedings. This same provision would be added to § 127.201(b) to conform the WOSB unconditional ownership requirements as well.
The proposed rule would also align the language in § 124.105(f)(1) (for the 8(a) BD program), § 127. (for the WOSB program), and § 128.202(g) (for the VetCert program) regarding the distribution of profits. There was a slight wording difference in the 8(a) BD and VetCert regulations and the proposed rule would make the wording consistent. The same provision would also be added to the WOSB regulations.
Sections 124.106(e) (for the 8(a) BD program), 127.202(g) (for the WOSB program), and 128.203(h) (for VetCert program) address limitations on the involvement of non-qualifying individuals that can affect a business concern's eligibility for participation in the 8(a) BD, WOSB, and VetCert programs based on a qualifying individual's lack of control. Basically, each of these provisions generally prohibit a non-qualifying individual from unduly influencing the day-to-day management and control of qualifying individuals. The language of the three provisions, however, is not entirely consistent. This has led to questions as to whether SBA intended different application of the control requirements for different programs. In order to clear up any confusion, this rule proposes to change the wording of the three provisions to bring them more in line with each other to ensure that the control requirement is consistently applied. For example, the WOSB regulations did not previously contain a provision that generally required a qualifying woman to be the highest compensated individual in the business concern unless the concern demonstrates that the compensation to be received by a non-qualifying woman is commercially reasonable or that the qualifying woman has elected to take
Section 124.107(a) currently provides that an applicant's income tax returns for each of the two previous tax years must show operating revenues in the primary industry in which the applicant is seeking 8(a) BD certification. The proposed rule would revise this provision to require merely that an applicant's income tax returns for each of the two previous tax years must show operating revenues. Revenue on an income tax return may not be aligned by industry or NAICS code and SBA does not seek to deny entry to the 8(a) program to a firm that has performed work in its projected primary industry but that work may not have been properly captured on its tax return.
Section 124.107(e) requires that, as a condition to show an 8(a) applicant's potential for success, the applicant or individuals employed by the applicant must hold all requisite licenses if the concern is engaged in an industry requiring professional licensing (
Section 124.108 sets forth other eligibility requirements that apply to 8(a) applicants and Participants. One of those requirements is that SBA must determine that an applicant or Participant and all of its principals possess good character. The 8(a) BD program is one of several certification programs to help small businesses win federal contracting awards, but the scope of the 8(a) BD program is different. For the WOSB and VetCert programs, SBA only determines whether a small business applicant is owned and controlled by one or more qualifying individuals. SBA does not look at character or business integrity in determining whether a small business is owned and controlled by qualifying individuals. Similarly, for the HUBZone program, SBA only determines whether the small business applicant is located in and employs residents of a historically underutilized business zone. SBA certification of these qualifications allows the certified small businesses to compete for certain federal contracts. These are not business development programs. Although SBA determines whether an 8(a) small business applicant is owned and controlled by one or more qualifying individuals, the program is not limited to this certification. Its scope is broader and includes a multi-year business development program with eligibility for specific management and technical assistance from SBA to support the business's successful competition in the marketplace. SBA requires “good character” to be admitted to this development program.
The proposed rule would limit the grounds that would serve as an automatic, mandatory bar from participation in the 8(a) BD program based on good character (
SBA will continue to conduct internal checks related to an applicant's business integrity that includes the applicant's criminal history, and consider all factors in evaluating whether an applicant would be a good candidate to participate in the 8(a) BD program. SBA will consider each application individually. The proposed rule does not change business integrity requirements of procuring agency contracting officers or any business integrity evaluations done by them. Procuring agency contracting officers evaluate offerors' responsibility to perform federal contracts prior to award, a process that can include an evaluation of business integrity.
Where fraudulent activity occurs after a firm is admitted to the 8(a) BD program, whether that activity results in an indictment, conviction, civil judgment or not, SBA may immediately move to protect the Government's interests. This could be through suspension/termination from the 8(a) BD program or through a Government-wide suspension/debarment action. The existence of a cause for suspension, termination or debarment, however, does not necessarily require that the Participant be suspended, terminated or debarred. SBA will consider the seriousness of the Participant's acts or omissions and any remedial measures or mitigating factors made by the Participant.
Sections 124.108(e) (for the 8(a) BD program) and 128.201(b) (for the VetCert program) provide generally that a small business concern is ineligible for certification if the concern or any of its principals has failed to pay significant financial obligations owed to the Federal Government. A similar provision is not currently contained in the WOSB or HUBZone eligibility requirements. This rule proposes to apply that restriction to the WOSB and HUBZone programs as well. To ensure consistency among the programs, the rule would also revise the language in §§ 124.108(e) and 128.201(b) so that the regulatory language applying to all four programs is the same.
Sections 124.204(d) (for the 8(a) BD program), 126.306(d) (for the HUBZone program), 127.304(d) (for the WOSB program), and 128.302 (for the VetCert program) set forth the date at which at applicant must be eligible for each certification program. The wording of the regulations is not consistent. Section 124.204(d) specifies that an applicant must be eligible as of the date SBA issues a decision. Section 126.306(d) specifies that an applicant must be eligible as of the date it submitted its application and at the time SBA issues a decision. Section 127.304(d) specifies that an applicant must be eligible as of the date it submitted its application and up until the time SBA issues a decision. Section 128.302 details how SBA processes applications for VOSB and SDVOSB certification, but does not specifically address the point at which eligibility is determined. SBA is in the process of establishing a uniform application processing system. That system will allow a firm to simultaneously apply for multiple certifications for which it believes it is eligible. SBA believes that it is critical that eligibility be determined at the same point in time for all certification programs. If, for example, a firm amends a corporate document to come into compliance with a specific control requirement after initially submitting its application for the 8(a) BD program and the WOSB program, the current regulations would support a finding that a qualifying individual did control the applicant for 8(a) BD purposes but did not control the applicant for WOSB purposes. SBA believes that would be an inappropriate result. Therefore, this proposed rule amends each of these sections to require consistent wording that an applicant must be eligible as of the date SBA issues a decision. Although the proposed rule would specify that an applicant must be eligible as of the date SBA issues a decision, implicitly a small business must believe that it is eligible at the time it applies for certification for any program. For purposes of applying for HUBZone certification, an applicant must submit payroll records for the four-week period immediately prior to its application date. It would be impossible to require payroll records for some unknown future date. After submitting an application for any program, a concern must immediately notify SBA of any changes that could affect its eligibility and provide information and documents to verify the changes.
The proposed rule would add a new provision to § 124.303(c) (for the 8(a) BD program), to § 126.503 (for the HUBZone program), to § 127.405(f) (for the WOSB program), and to § 128.310(g) (for the VetCert program) providing that a firm that is decertified or terminated from one SBA certification program due to the submission of false or misleading information may be removed from SBA's other small business contracting programs. In addition, the proposed rule would provide that SBA may require the firm to enter into an administrative agreement as a condition of admission or re-admission to one of the SBA certification programs. SBA believes that a firm that submits false information to obtain a certification in one program is more likely to submit false information to other SBA programs, and SBA needs a mechanism by which to investigate whether this has occurred and remove non-responsible firms from its programs expeditiously.
Section 124.207 provides that a concern which has been declined for 8(a) BD program participation may submit a new application for admission to the program at any time after 90 days from the date of the Agency's final decision to decline. It also provides that a concern that has been declined three times within 18 months of the date of the first final Agency decision finding the concern ineligible cannot submit a new application for admission to the program until 12 months from the date of the third final Agency decision to decline. The proposed rule would remove that second provision. No other program has such a restriction and SBA does not seek to thwart firms who have made legitimate attempts to overcome deficiencies from again applying to the 8(a) BD program.
Section 124.503 addresses how SBA will accept a procurement offered for award through the 8(a) BD program. An agency may offer a sole source procurement to SBA nominating a particular 8(a) Participant for performance based on the firm's self-
Section 303 of the Business Opportunity Development Reform Act of 1988 (BODRA), Public Law No. 100-656, tit. III, § 303, 102 Stat. 3865 (1988), adopted and expanded SBA's sole source contract acceptance procedures, mandating that SBA shall award a sole source 8(a) contract to the 8(a) firm nominated by the offering agency, provided the following three statutory criteria are met: (i) the Program Participant is determined to be a responsible contractor with respect to performance of such contract opportunity; (ii) the award of such contract would be consistent with the Program Participant's business plan; and (iii) the award of the contract would not result in the Program Participant exceeding its 8(a) competitive business mix. This mandate is codified in Section 8(a)(16)(A) of the Small Business Act, 15 U.S.C. 637(a)(16)(A). BODRA also directed SBA to promote—to the maximum extent practicable—the equitable geographic distribution of sole source 8(a) contracts. In response to BODRA, SBA promulgated a rule stating that it would consider, among other things, equitable geographic distribution for open 8(a) sole source contracts offered to the 8(a) BD program. This policy is currently set forth in paragraph 124.503(d)(3).
There has been some confusion as to whether SBA considers equitable contract distribution for a follow-on to an 8(a) procurement offered to SBA on behalf of a specific 8(a) Participant. In SBA's view, the imperative statutory command of Section 8(a)(16)(A) restricts its authority to affirmatively deny a contract offering made on behalf of a specific Participant based on considerations related to the equitable distribution of sole source 8(a) contracts, irrespective of whether the procurement is a “new” or repetitive 8(a) requirement. The proposed rule would clarify this position by providing that § 124.503(g)(1)(iii) applies only to open sole source 8(a) offerings.
Section 124.504 identifies several reasons why SBA will not accept a particular requirement for award through the 8(a) BD program. One of those reasons is where the procuring activity issued a solicitation for or otherwise expressed publicly a clear intent to award a contract as a small business set-aside, or to use the HUBZone, VetCert, or WOSB programs prior to offering the requirement to SBA for award as an 8(a) contract. This rule proposes to authorize SBA to accept a requirement for the 8(a) program where the AA/BD determines that there is a reasonable basis to cancel the initial solicitation or, if a solicitation had not yet been issued, a reasonable basis for the procuring agency to change its initial clear expression of intent to procure outside the 8(a) BD program. This would happen, for example, where the procuring agency's needs have changed since the initial solicitation was issued such that the solicitation no longer represents its current need, or where appropriations are no longer available for the requirement as anticipated, and the solicitation must be cancelled until a following fiscal year where funds are available. A change in strategy only (
Section 124.509 establishes non-8(a) business activity targets (BATs) to ensure that Participants do not develop an unreasonable reliance on 8(a) awards. The reason for requiring a certain percentage of non-8(a) revenue during a Participant's last five years in the 8(a) BD program is to strengthen the Participant's ability to prosper once it exits the program. Congress believed that firms that were totally reliant on the 8(a) BD program for their revenues would be ill prepared to survive as on-going business concerns after leaving the program. As such, Congress required a certain percentage of non-8(a) revenue during the transitional stage of program participation to bolster Participants' continued viability. SBA amended § 124.509 as part of a comprehensive final rule in October 2020.
Section 124.514 provides guidance regarding the exercise of 8(a) options and modifications. Paragraph 124.514(a)(1) currently states that if a concern has graduated or been terminated from the 8(a) BD program or is no longer small under the size standard corresponding to the NAICS code for the requirement, negotiations to price the option cannot be entered into and the option cannot be exercised. Because the regulatory language specifies graduation and termination from the program, SBA has received a few inquiries as to whether this provision applies to firms that have voluntarily exited the program. SBA has always intended this provision to apply to all firms that are no longer active Participants in the program. The proposed rule would merely make that intent clear by specifically providing that this provision applies to all firms whose term of participation in the 8(a) BD program has ended or who have otherwise exited the program through any means.
Section 124.518(c) provides that SBA may authorize another Participant to complete performance of an 8(a) contract and, in conjunction with the procuring activity, permit novation of that contract without invoking the termination for convenience or waiver provisions of § 124.515 where SBA determines that substitution would serve the business development needs of both 8(a) Participants. SBA has seen several instances where a joint venture between an 8(a) Participant and a non-8(a) business concern was awarded an 8(a) contract and for whatever reason the two firms seek to terminate the joint venture and novate the 8(a) contract individually to the 8(a) Participant that was the lead partner of the joint venture. If novation would occur, performance of the 8(a) contract would remain with an 8(a) Participant (
Section 124.602 sets forth the kind of annual financial statement an 8(a) BD Participant submits to SBA, depending upon its gross annual receipts. Currently, Participants with gross annual receipts of more than $10 million must submit to SBA audited annual financial statements prepared by a licensed independent public accountant; Participants with gross annual receipts between $2 million and $10 million must submit to SBA reviewed annual financial statements prepared by a licensed independent public accountant; and Participants with gross annual receipts of less than $2 million must submit to SBA an annual statement prepared in-house or a compilation statement prepared by a licensed independent public accountant. SBA believes that with the value of federal contracts greatly increasing over the last few years, the top dollar threshold of $10 million is being met by most Participants far more frequently. Recognizing that requiring an audited financial statement can be a significant cost to many small businesses, this rule proposes to require audited financial statements for those Participants exceeding $20 million, reviewed financial statements for those Participants with gross annual receipts between $5 million and $20 million, and in-house financial statements for those Participants with less than $5 million in annual receipts.
SBA's regulations currently make clear that a contracting activity cannot conduct a competition requiring multiple socioeconomic certifications. In this regard, § 124.501(b) prohibits a contracting activity from restricting an 8(a) competition to Participants that are also certified HUBZone small businesses, certified WOSBs or certified SDVO small businesses. There is a similar restriction for the HUBZone program in § 126.609, for the WOSB program in § 127.503(e), and for the VetCert program in § 128.404(d). However, there is no similar specific restriction for small business set-asides and reserves. Where a contracting activity seeks to require 8(a), HUBZone, WOSB or SDVO certification in addition to status as a small business, in essence the contracting activity would be soliciting as an 8(a), HUBZone, WOSB or SDVO small business contract. That is permissible. Similarly, current § 125.2(e)(6) specifies that a contracting officer may set aside orders for eligible 8(a) Participants, certified HUBZone small business concerns, SDVO small business concerns, WOSBs, and EDWOSBs against total small business set-aside multiple award contracts. As such, there should be no doubt that there can be an order or agreement set-aside or reserved for a specific type of small business (
Section 125.3 governs subcontracting plans and reporting of subcontracting achievements. SBA proposes to extend the due dates for subcontracting reports by 15 days, from 30 days to 45 days. SBA also would extend the time period for reviewing such reports by 15 days, from 60 days to 75 days. These extended time periods recognize that prime contractors are under increased reporting burdens because of order-level subcontract reporting.
Section 125.6 sets forth the limitations on subcontracting that apply to a small business prime contractor. A small business prime contractor, together with any similarly situated entity, must perform a certain specified
Additionally, there has been some confusion as to how work performed by leased employees is considered in determining compliance with the applicable limitation on subcontracting. Paragraph 125.6(d)(3) explains that work performed by an independent contractor shall be considered a subcontract and will therefore count against the prime contractor's limitation on subcontracting unless the independent contractor qualifies as a similarly situated entity. Unlike independent contractors, employees obtained from a temporary employee agency, professional employee organization, or leasing concern perform work under the primary direction and control of the recipient concern. For this reason, such individuals are treated as employees of the recipient concern for purposes of determining that concern's employee count under Section 121.106(a). SBA believes the same logic should apply when determining a recipient prime contractor's compliance with the limitations on subcontracting. Work performed by employees leased to the small business prime contractor shall be considered the prime contractor's self performance, and therefore will not count against the prime contractor's limitation on subcontracting. The proposed rule would clarify this position in § 125.6(d)(3).
Section 125.8(e) covers how agencies evaluate the capabilities, past performance, and experience of joint ventures, including SBA mentor-protégé joint ventures. For SBA mentor-protégé joint ventures, section 125.8(e) provides that a procuring activity may not require the protégé firm to individually meet the same evaluation or responsibility criteria as that required of other offerors generally. This provision recognizes that protégés may be less experienced when submitting an offer but, if they win the award, will gain experience and capabilities while performing with the mentor. SBA does not require, however, that every contract competition include special evaluation criteria for protégés.
A recent decision by the Court of Federal Claims has caused some confusion as to what past performance a procuring activity can require of a protégé joint venture partner and how that past performance should be evaluated.
Where a joint venture is the apparent successful offeror for a contract set aside or reserved for small business, § 125.8(f) currently authorizes the procuring activity to execute a contract in the name of the joint venture entity or a small business partner to the joint venture. There has been some confusion as to whether a procuring activity can choose to either execute the contract in the name of the joint venture entity or to a small business partner to the joint venture. SBA did not intend such discretion. SBA's joint venture rules set forth in § 121.103(h)(1) provide that a joint venture may be in the form of a formal or informal partnership or exist as a separate limited liability company or other separate legal entity. Where a joint venture exists as a separate legal entity, SBA intended a contract to be executed in the name of the joint venture. SBA intended to allow contracts successfully won by a joint venture to be awarded in the name of the small business partner only where the joint venture was not a separate legal entity, but rather an informal arrangement that had a written joint venture agreement that complied with SBA's regulations. The proposed rule would clarify SBA's intent.
Section 125.9 sets forth the requirements relating to SBA's mentor-protégé program. Paragraph 125.9(b) specifies rules pertaining to firms seeking to become mentors and to firms which have been approved as mentors in the program. The introductory language to that paragraph provides that any concern that demonstrates a commitment and the ability to assist small business concerns may act as a mentor, including other than small businesses. There has been some confusion as to whether no-profit
Paragraph 125.9(b)(3)(ii)(B) authorizes a mentor to purchase another business entity that is also an SBA-approved mentor of one or more protégé small business concerns where the purchasing mentor commits to honoring the obligations under the seller's mentor-protégé agreement. Paragraph 125.9(b)(3)(i) provides that a mentor that has more than one protégé cannot submit competing offers in response to a solicitation for a specific procurement through separate joint ventures with different protégés. However, it is possible that the initial or selling mentor may be a contract holder as a joint venture with a protégé on the same multiple award contract where the acquiring mentor is also a contract holder as a joint venture with its protégé. In such a case, after the purchase and the purchasing mentor committing to fulfill the obligations of the selling mentor's mentor-protégé agreement, the purchasing mentor could then have two different joint ventures as contract holders on the same multiple award contract. This could allow the mentor to dictate which joint venture could compete for any specific order under the multiple award contract. SBA does not believe that the mentor should be able to choose one protégé over another to compete for an order. In order to clarify SBA's intent, the proposed rule would provide that where a mentor purchases another business entity that is also an SBA-approved mentor that is a contract holder as a joint venture with a protégé small business and the mentor is also a contract holder with a protégé small business on that same multiple award contract, the mentor must exit one of those joint venture relationships. SBA understands that this could adversely affect one of the protégé firms involved in a joint venture. To alleviate any harm to a protégé, the proposed rule would also permit the protégé firm connected to the joint venture from which the mentor exits to seek to acquire the new mentor's interest in the underlying multiple award contract or reserve and work with the contracting officer to determine whether novation of such contract or reserve to itself only may be appropriate where it is consistent with 41 U.S.C. 6305 and FAR 42.1204. The protégé may also seek to replace the new mentor with another business in the joint venture such that the revised joint venture continues to qualify as small. Similarly, the proposed rule would also add a new § 125.9(d)(1)(iv) which would give a protégé firm a right of first refusal to purchase a mentor's interest in a mentor-protégé joint venture where the mentor seeks to sell its interest in the joint venture.
The proposed rule would also redesignate current § 125.9(e)(6) as § 125.9(c)(4). This provision relates to rules affecting protégé firms and SBA believes it should more appropriately be located in § 125.9(c), which has a heading entitled “Proteges.” The proposed rule would add clarifying language to redesignated § 125.9(c)(4)(iv) to make clear that a concern cannot be a protégé for a total of more than 12 years. There has been some confusion that if a protégé elects to extend its mentor-protégé relationship with the same mentor for an additional six-year period that the protégé could somehow be able to participate in the mentor-protégé program as a protégé for more than 12 years. SBA believes that the current regulations clearly restrict such participation to a total of 12 years. Nevertheless, in order to dispel any possible contrary interpretation, the proposed rule would specify that a firm could be a protégé for up to 12 years, whether the concern has a mentor-protégé relationship with two different mentors or the same mentor for second six-year period.
Finally, the proposed rule would add a new § 125.9(c)(5). Within the provisions relating to mentors in § 125.9(b), the current regulations authorize a firm to purchase another firm that is currently an approved mentor in SBA's mentor-protégé program and to continue that mentor-protégé relationship if the purchasing firm commits to honoring the obligations under the seller's mentor-protégé agreement. The regulations do not, however, currently address any rights a protégé may have where such a sale occurs. There are times that the former mentor-protégé agreement would not be a good fit with the purchasing business concern. The purchasing concern may have different capabilities than the selling concern and may not be the best business concern to carry out the previous mentor's commitments. Where the purchasing concern is not able to fulfill the requirements of the existing mentor-protégé agreements as written, SBA believes that the protégé firm should be able to either negotiate a revised mentor-protégé agreement with the buying concern or terminate the mentor-protégé agreement if the protégé believes the buying concern is not a good fit for it. This right of the protégé would be limited to where the new mentor would not fulfill the former mentor-protégé agreement. SBA would have to approve any revised mentor-protégé agreement. If the mentor-protégé agreement is terminated, the protégé firm could seek another business concern to enter a mentor-protégé relationship for a duration not to exceed six years minus the length of the mentor-protégé relationship with the former mentor.
SBA proposes to relocate size recertification and small business program status recertification to new § 125.12. Historically, size and status recertification have been separately addressed in parts 121 (for size), 124 (for 8(a) BD), 126 (for HUBZone), 127 (for WOSB), and 128 (for service-disabled veteran-owned small business or SDVOSB) of SBA's regulations. Differences in the regulatory text are an unintended result of placing the size and status recertification rules across multiple sections of title 13. SBA believes that the rules regarding recertification should be the same for size and status, across all SBA small business government contracting and business development programs. The consolidation of the rules into one section that is cross-referenced in each small business program regulation would simplify the text and ensure easier, more consistent interpretation and application of the regulations. The requirements for recertification currently contained in § 121.404(g) (for size), § 126.619 (for HUBZone status), § 127.504(h) (for WOSB/EDWOSB status), and § 128.401(e) (for SDVOSB status) would be amended to reference the provisions contained in § 125.12. This change would ensure that all recertification requirements pertaining to size and status would be identical.
Size and status recertification is a complex area of SBA's regulations that requires simplification and clarity, especially in the context of exceptions to recertification and the impact of recertification. SBA's proposed
Similarly, for a single award small business contract or any unrestricted contract, a concern that recertified as other than small or other than the required small business program status remains eligible to receive options. The procuring agency cannot count the option period as an award to a small business or small business program participant for goaling purposes. Such a concern may recertify as small or as the required small business program status for a subsequent option period if it meets the applicable size standard or becomes a certified small business program participant at that time. Conversely, for a multiple award small business set-aside or reserve, a concern that recertified as other than small or other than the required small business program would be ineligible to receive options.
The proposed rule would also clarify SBA's intent as to the effect of a disqualifying recertification that occurs after an offer is submitted but prior to award. For an award set aside or reserved for small business, a concern must recertify its size and, where appropriate, status if a merger, sale or acquisition occurs after an offer is submitted but prior to award. If the concern submits a disqualifying recertification, it may or may not be eligible for the award depending on when the sale, merger or acquisition occurred. If the merger, sale, or acquisition occurs within 180 days of offer submission and before award, the concern is ineligible for the award. If the merger, sale, or acquisition occurs after 180 days of its offer and before award, the concern would continue to be eligible for the award.
These proposed changes are needed to overcome several recent decisions from the GAO and SBA's Office of Hearings and Appeals (OHA). SBA believes that GAO and OHA adopted incorrect interpretations in these cases, resulting in the misapplication of SBA's size recertification regulations. SBA provides clarification through this preamble and proposed changes to the regulatory text to avoid confusion from courts or administrative venues regarding the proper and reasonable interpretation of SBA's size recertification rules.
In 2021, OHA issued a decision in Size Appeal of
SBA filed comments in response to the appeal that distinguished between size recertifications requested by a contracting officer and recertifications following a merger, sale, or acquisition, only as that distinction relates to timeliness for size protests. Over the years, the distinction was misinterpreted to be broader than SBA intended and to impact eligibility for future set-aside orders against unrestricted multiple award contracts. SBA's OHA has issued several subsequent decisions to the
Any disqualifying size or status recertification precipitated by § 125.12(a) or § 125.12(b) (except for the 180-day rule discussed above), renders a concern ineligible for future set-aside or reserved awards, including awards of set-aside or reserved orders against pre-existing unrestricted or set-aside multiple award contracts. Additionally, in support of this interpretation, SBA proposes to allow requests for size determinations following any size recertification made in §§ 125.12(a) and (b) as well as those is requested by a contracting officer as set forth in § 125.12(c).
SBA notes that the requirement for size recertification has always been interpreted by SBA to apply to Blanket Purchase Agreements in addition to all other small business set-aside or reserved awards, whether those awards are executed in the form of task orders, contracts, or any other type of procurement mechanism. Following a 2022 bid protest decision from GAO, SBA explicitly added the word “agreement” at 13 CFR 121.404(g)(2)(iii).
The proposed rule would add a new § 125.13 explaining the restrictions on fees for representatives of applicants to and participants in the 8(a) BD, HUBZone, WOSB, and VetCert programs. These restrictions are currently contained in § 124.4 for the 8(a) BD program. The proposed rule takes the language currently contained in § 124.4 for the 8(a) BD program and adds it to a new § 125.13 that would be applicable to the 8(a) BD, HUBZone, WOSB and VetCert programs. SBA considered making revisions to part 126, 127 and 128 of this title adopting the same language contained in § 124.4 for the WOSB, HUBZone and VetCert programs. Instead, SBA believes that it would be more expedient to add a new § 125.13 that would apply to all of SBA's certification programs than it would be to repeat the same language in each of the specific program area's regulations.
The proposed rule would revise the definitions for the following terms: “Certify”, “Contracting Officer (CO)”, “Decertify”, “Dynamic Small Business Search (DSBS)”, “Employee”, “HUBZone Small Business Concern”, “Indian Tribal Government”, “Interested party”, “Principal office”, “Qualified Disaster Area”, “Redesignated Area”, “Reside”, and
The proposed rule would clarify that “Certification” and “Certify” both mean the process by which SBA determines that a concern is qualified for the HUBZone program and eligible to be designated by SBA as a certified HUBZone small business concern in DSBS (or successor system).
The proposed rule would add a new definition for the term “Certification”.
The proposed rule would amend the definition of “Contracting Officer” to correct an outdated citation.
The proposed rule would amend the definition of “decertify” to clarify that a firm may voluntarily withdraw from the program without SBA needing to approve such withdrawal.
The proposed rule would amend the definition of “Dynamic Small Business Search (DSBS)” to reference “SAM, as defined in this section” rather than “the System for Award Management (SAM)”. SBA proposes to remove the words “the Dynamic Small Business Search (DSBS)” wherever they appear and add in their place the acronym “DSBS”.
The proposed rule would amend the definition of “employee” to prevent abuse and strengthen the integrity of the program. The HUBZone program was intended to provide meaningful work experiences to individuals who reside in some of the nation's most economically distressed communities to help them gain valuable skills, on-the-job experience, and upward mobility. In 2021, SBA HUBZone analysts identified a pattern in which firms put on their payroll HUBZone residents who did not perform work for those companies in order to claim them as employees and appear to qualify for the program. This has never been permitted under the HUBZone regulations because allowing this practice would undermine the purpose of the HUBZone program.
In response to the discovery of this practice and to prevent fraud and abuse in the program, this proposed rule would increase the number of hours that an individual must work to be considered an employee for HUBZone purposes to 80 hours per month. Under SBA's current regulations, an employee is defined as an individual “employed on a full-time, part-time, or other basis, so long as that individual works a minimum of 40 hours during the four-week period immediately prior to the relevant date of review . . .” 13 CFR 126.103. SBA believes that the minimum 40 hours per month is not sufficient to promote the purpose of the program. Furthermore, under the current 40 hour per month requirement, an individual could work 40 hours in one week and be off the remaining three weeks of the month. If all HUBZone employees did the same, the “principal office” could be empty and closed for the remaining three weeks of the month. SBA believes that there needs to be a legitimate presence in the HUBZone, and this includes occupying the principal office and requiring that office to be open during normal business hours, and requiring employees to work significantly at that office. SBA does not believe that a firm that can close its “principal office” three weeks every month meets that legitimate presence, but rather that there should be a consistent presence at the principal office. SBA also notes that an 80 hour per month requirement would be consistent with how the 8(a) BD program treats employees establishing a bona fide place of business. In that context, § 124.3 defines the term bona fide place of business for 8(a) construction contracts to mean a location where an 8(a) BD Participant regularly maintains an office within the appropriate geographical boundary which employs at least one individual who works at least 20 hours per week at that location. The 80 hours per month requirement in this proposed rule would be in line with that 20 hours per week requirement. SBA requests comments on whether 80 hours per month is an appropriate threshold and whether there should be a minimum number of hours per week. SBA also seeks comments on whether there should be an exception to the 80 hours per month threshold for a limited number (or percentage) of individuals where such individuals are working at least 40 hours per month.
In addition, the proposed rule would clarify the existing requirement that an individual must be performing work for the concern in order to be considered an employee for HUBZone purposes. This proposed rule would provide that in order to ensure that an individual is performing work for the business concern, SBA may request a combination of job descriptions, resumes, detailed timesheets, sample work product and other relevant documentation.
The proposed rule also would delete the provision providing that individuals who receive in-kind compensation may be considered employees. The current regulations provide that someone receiving in-kind compensation may be considered an employee, where the compensation is commensurate with the work performed by the individual and provides a demonstrable financial value to the individual, and where the arrangement is compliant with all relevant federal and state laws, such as federal tax laws. SBA is proposing to eliminate this provision because SBA has found that little to no firms are able to meet these requirements. The process of requesting and reviewing documentation that is ultimately insufficient has only served to slow down application processing.
Finally, SBA is requesting comments on when reservists should be considered employees for HUBZone purposes. When reservists are called up for active duty, companies may be required to hold their positions for them, which may mean those individuals appear on the company's payroll with zero hours listed. SBA requests feedback on whether there are scenarios when such individuals should be treated as employees for HUBZone purposes.
The proposed rule would provide that individuals who are obtained “from a concern
The proposed rule would add a new definition for the term “HUBZone Certification Date” providing that this is the date on which SBA approves a concern's application for HUBZone certification and is the date specified in the concern's certification letter. The proposed definition would provide that if a concern leaves the HUBZone program and reapplies for certification, their HUBZone certification date is the date SBA approves the concern's most recent application.
The proposed rule would add a new definition for the term “HUBZone Map” providing that the HUBZone Map is a
The proposed rule would add a new definition for the term “HUBZone Resident Employee” providing that this means an individual who meets the definition of an employee and who SBA has determined resides in a HUBZone.”
The proposed rule would amend the definition of the term “HUBZone small business concern” by deleting the last sentence, which provides: “A concern that was a certified HUBZone small business concern as of December 12, 2017, and that had its principal office located in a Redesignated Area set to expire prior to January 1, 2020, shall remain a certified HUBZone small business concern until June 30, 2023, so long as all other HUBZone eligibility requirements are met.” This is a reference to the previous map freeze, and since the map freeze ended on June 30, 2023, this language is no longer a necessary.
The proposed rule would amend the definition of “Indian Tribal Government” to make it consistent with the definition of the term “Indian tribe” in the 8(a) BD Program regulations at § 124.3 of this chapter. Specifically, the proposed rule revises the definition to explicitly allow participation by State-recognized tribes.
The proposed rule would amend the definition of “interested party” to prevent non-HUBZone firms from filing a HUBZone protest on a HUBZone set-aside procurement. Currently, an interested party is defined as any concern that submits an offer for a specific HUBZone set-aside contract or order, or any concern that submitted an offer in full and open competition and its opportunity for award will be affected by a price evaluation preference given a qualified HUBZone small business concern. In the context of a HUBZone set-aside contract, SBA does not believe that a firm that is not itself a qualified HUBZone small business concern should be able to submit a protest. In other words, a large business or a small business which is not a qualified HUBZone small business should not be able to protest the HUBZone status of the apparent successful offeror on a HUBZone set aside contract merely because it submitted an offer for that contract or order. The large business or small business which is not a qualified HUBZone small business is not harmed by an award to the apparent successful offeror since it has no right itself to that award. It is ineligible for that award. Only firms that are capable of winning the HUBZone set-aside contract or order should be able to protest the HUBZone status of an apparent successful offeror. SBA has seen situations where a non-eligible firm has submitted an offer and then protested the HUBZone status of the apparent successful offeror. SBA believes this is not the intent of the protest process and causes unnecessary delays. If such a “protest” raises a genuine concern, SBA can always adopt it as an SBA-initiated protest. However, often this is a delay tactic used by an incumbent contractor protesting the apparent successful offeror in order to continue to perform the underlying work while the protest is resolved. This change would not affect the ability of a large business to protest the HUBZone status of an apparent successful offeror where the apparent successful offeror received the benefit of the HUBZone price evaluation preference in an unrestricted competition and the large business submitted an offer for that contract. In such a case, a large business could otherwise be eligible for the award of the contract. SBA is proposing a similar change to the WOSB regulations through a separate rulemaking.
The proposed rule would amend the definition of “principal office” to make several changes and clarifications. First, the proposed rule would require firms to provide a lease that commenced at least 30 days prior to the date of SBA's review and ends at least 60 days after the date of SBA's review. Second, the proposed rule would clarify the requirement that a firm must conduct business from the location identified as the firm's principal office and may be required to demonstrate that it is doing so by providing documentation such as photos and/or providing a live or virtual walk-through of the space. The proposed rule would also provide that for shared working spaces (or “coworking” spaces), firms will need to provide evidence that the firm has dedicated space within any shared location, and that such dedicated space contains sufficient work surface area, furniture, and equipment to accommodate the number of employees claimed to work from this location. The proposed rule would specify that a virtual office (or other location where a firm only receives mail and/or occasionally performs business) does not qualify as a principal office. Third, the proposed rule would add a provision stating that if 100% of a firm's employees telework (
The proposed rule would revise the definition of “Qualified Disaster Area” to provide that a census tract or non-metropolitan county shall be considered to be a Qualified Disaster Area for the period of time starting on the date on which the President declared the major disaster for the area in which the census tract or non-metropolitan county, as applicable, is located (or in the case of a catastrophic incident, on the date on which the catastrophic incident occurred in the area in which the census tract or non-metropolitan county, as applicable, is located) and ending on the date when SBA next updates the HUBZone Map in accordance with § 126.104(a). This is SBA's current interpretation of the statutory definition of “Qualified Disaster Area” and the proposed rule would only make that interpretation clearer.
The proposed rule would amend the definition of “Redesignated Area” to delete the last sentence, which currently reads: “However, an area that was a redesignated area on or after December 12, 2017, shall remain a redesignated area until June 30, 2023.” This is a reference to the previous map freeze, and since the map freeze ended on June 30, 2023, this language is no longer necessary.
The proposed rule would revise the definition of “reside” to provide that to
The proposed rule would amend the definition of “Small business concern (SBC)” to make it consistent with the definition contained in § 126.200(b)(1). In order to be eligible for the HUBZone program, SBA previously required that a concern qualify as small for the size standard corresponding to its primary industry. That requirement was contained both in § 126.103 and § 126.200(b)(1). SBA amended § 126.200(b)(1) to require that a concern must qualify as small under the size standard corresponding to any NAICS code listed in its profile in the System for Award Management. 88 FR 26164, 26212 (Apr. 27, 2023). SBA inadvertently did not make a corresponding change to the definition of small business concern contained in § 126.103. The proposed rule would adjust § 126.103 to be consistent with § 126.200(b)(1).
The proposed rule would define “System for Award Management (SAM)” as having the same meaning as that which is in FAR 2.101. SBA also proposes to remove the words “System for Award Management (
Finally, SBA proposes to remove the word “SBC” wherever it appears in this part and add in its place the phrase “small business concern”.
The proposed rule would make several amendments to § 126.104, which explains how Governor-designated covered areas become designated. First, the proposed rule would insert language providing that a State Governor may annually submit a petition to the SBA Office of the HUBZone Program requesting that certain covered areas be designated as Governor-designated covered areas. This is not a change from current policy, but rather a restatement of that policy in a more clear and direct way. Second, the proposed rule also would clarify that a petition need not seek SBA approval for those covered areas previously designated as Governor-designated covered areas. Third, the proposed rule would provide that a Governor-designated covered area will be treated as a HUBZone until SBA next updates the HUBZone Map in accordance with § 126.104(a), or one year after the petition is approved, whichever is later. Fourth, the proposed rule would authorize the Associate Administrator for Government Contracting and Business Development or designee, instead of the SBA Administrator, to approve specific covered areas to be considered as Governor-designated covered areas. SBA believes that this will reduce the amount of time to approve a petition, which will allow small businesses located in such areas the opportunity to participate more expeditiously in the HUBZone Program.
Finally, the proposed rule would remove the term “urbanized area” in the definition of “covered area” in § 126.104(d)(1). The HUBZone statute and the current regulations provide that only certain areas are eligible to become Governor-Designated Covered Areas. Such areas are referred to as “covered areas.” A “covered area” is defined in the statute and regulations as “an area in a State . . . (i) [t]hat is located outside of an urbanized area, as determined by the Bureau of the Census; (ii) [w]ith a population of not more than 50,000; and (iii) [f]or which the average unemployment rate is not less than 120 percent of the average unemployment rate of the United States or of the State in which the covered area is located, whichever is less, based on the most recent data available from the American Community Survey conducted by the Bureau of the Census.” 15 U.S.C. 657a(b)(3)(F)(v)(I); 13 CFR 126.104(d)(1). Thus, the statute and implementing regulations provide that “covered areas” must be located outside of “urbanized areas.” At the time this provision was implemented, the Census Bureau defined “urbanized areas” as “urban areas” with populations of 50,000 or more. In addition, the Census Bureau defined “urban clusters” as “urban areas” with populations of more than 2,500 and less than 50,000. Given these definitions, SBA interpreted the statute to mean that areas located in “urban clusters” could be eligible for Governor's designation if they also met the unemployment requirement. In addition, SBA interpreted “area” to mean either a census tract or a county.
Following the 2020 census, the Census Bureau changed the definition of “urban area” in several ways, including by removing the distinction between “urbanized areas” and “urban clusters” and discontinuing the use of those terms. As a result, areas that previously were known as urbanized areas or urban clusters are both now simply designated as urban areas. In a
The proposed rule would add a new § 126.105, explaining when the HUBZone Map will be updated in accordance with statutory requirements. Proposed § 126.105 would provide that Qualified Census Tracts and Qualified Non-Metropolitan Counties will be updated every 5 years. This is consistent with the statutory requirement for SBA to update these designations on a 5-year cycle. The proposed rule would provide that Redesignated Areas will be added to the HUBZone Map when areas cease to be designated as Qualified Census Tracts or Qualified Non-Metropolitan Counties, in accordance with the 5-year cycle, and will expire after 3 years. The proposed rule would provide that Qualified Base Closure Areas will be added to the HUBZone Map after SBA receives information that the Department of Defense has created a new base closure area and will expire after 8 years. The proposed rule would provide that Qualified Disaster Areas generally will be added to the HUBZone Map on a monthly basis, based on data received by SBA from the Federal Emergency Management Agency (FEMA), and generally will expire on the effective date of the 5-year HUBZone Map update following the declaration. Finally, the proposed rule would provide that Governor-designated covered areas will be added to the HUBZone Map after SBA approves a petition in accordance with § 126.104 and will expire on the effective date of the 5-year HUBZone Map update
Section 126.200 sets forth the requirements a concern must meet to be eligible as a certified HUBZone small business concern. Pursuant to § 126.200(b)(1), a concern, together with its affiliates, must qualify as a small business concern under the size standard corresponding to any NAICS code listed in its profile in SAM. This paragraph does not, however, explain how SBA will determine whether a business concern qualifies as small. Some have questioned whether SBA performs a formal size determination with respect to each application. That is not the case. In determining whether a concern seeking to be a certified HUBZone small business qualifies as small under the size standard corresponding to a specific NAICS code, SBA will accept the concern's size representation in SAM, unless there is evidence to the contrary. SBA will request a formal size determination pursuant to § 121.1001(b)(8) of this chapter where any information it possesses calls into question the concern's SAM size representation. The proposed rule would clarify SBA's intent in this regard. The proposed rule would also provide the same guidance for WOSB/EDWOSB certifications by adding a new § 127.200(e) and to VOSB/SDVOSB certifications by revising § 128.204(a).
The proposed rule would revise § 126.200(c)(1) to incorporate policy updates to the “long-term investment” provision, which was implemented through SBA's final rule published on November 26, 2019 (84 FR 65222). This provision incentivizes firms to make long-term investments in qualifying HUBZones by allowing them to maintain their principal office for up to 10 years and continue to be considered to meet the principal office requirement even if the area loses its HUBZone designation.
First, the proposed rule would provide that the 10-year “clock” starts to run on the firm's HUBZone certification date (if the investment was made prior to the firm's certification) or on the firm's recertification date that follows the execution of the lease or deed (if the investment was made after the firm's certification). For example, if a firm was certified on May 1, 2020, and purchased a building on December 1, 2020, the 10-year clock would start when the firm recertifies prior to May 1, 2023.
Second, the proposed rule would clarify SBA's current policy that a firm is not eligible to take advantage of the long-term investment provision if its principal office is in a Redesignated Area or a Qualified Disaster Area at the time of the investment. Redesignated Areas and Qualified Disaster Areas are areas that have already lost their designation as Qualified Census Tracts or Qualified Non-Metropolitan Counties because the income, poverty, and/or unemployment levels of those tracts/counties have improved beyond the statutory levels necessary to qualify as HUBZones. SBA does not believe it would be in line with the purpose of the HUBZone program—to encourage investment in low-income and high-unemployment areas—to encourage firms to invest in areas that have already surpassed the HUBZone thresholds for these socioeconomic indicators. SBA notes that if a firm's principal office is in a location that falls within both a qualifying area (
Third, the proposed rule would provide that a firm is not eligible for this provision if its principal office is owner-occupied (
The proposed rule would revise § 126.200(d)(1) to clarify that if a firm has one employee, that employee must reside in a HUBZone for the firm to be eligible for HUBZone certification. That has always been SBA's interpretation of the HUBZone requirements, and the proposed rule merely makes that explicit.
The proposed rule would revise § 126.200(d)(3), which addresses “Legacy HUBZone Employees” to: clarify the amount of time an individual must reside in a HUBZone in order to qualify as a Legacy HUBZone Employee; specify that residence in a Redesignated Area does not qualify someone for this provision; and to implement limits on the number of Legacy HUBZone Employees a firm may have.
First, the proposed rule would provide that a Legacy HUBZone Employee is an individual who: (a) resided in a HUBZone (other than a Redesignated Area) for at least 90 days preceding, and 180 days following, the concern's HUBZone certification date or most recent recertification date, and (b) remains an employee at the time of the concern's current recertification date.
Second, the proposed rule would clarify that an individual cannot reside in a Redesignated Area and qualify as a Legacy HUBZone Employee. This does not mean to imply that an individual who resided in a HUBZone when a firm was first certified as a HUBZone eligible firm and continued to live at that same location while the area transitioned to a Redesignated Area cannot be considered a Legacy HUBZone Employee if that individual moves to a non-HUBZone area. The proposed rule intends to clarify that an individual who qualifies as a HUBZone employee for the first time while living in a Redesignated Area cannot later be deemed a Legacy HUBZone Employee.
Third, the proposed rule would provide that a certified HUBZone small business may only have one legacy HUBZone employee at a given time. SBA supports the growth of individual HUBZone employees and allowing such employees to improve their personal residential situation. However, SBA is concerned that the Legacy HUBZone Employee concept could be abused. Without a limit on the number of Legacy HUBZone Employees permitted by SBA, a firm could potentially move all individuals into a HUBZone for a one-year period and qualify all of those individuals as Legacy HUBZone Employees without those individuals ever intending to live long-term in the HUBZone area. SBA seeks comments on what the limit on Legacy HUBZone Employees should be and whether there should be any other limitations. Specifically, SBA requests comments on the following: whether SBA should limit the duration of Legacy HUBZone employee status to a certain number of years, and if so, how many years would be appropriate; whether individuals who were students when they resided in a HUBZone should be eligible for treatment as Legacy HUBZone Employees; whether Legacy Employees should be limited to full-time employees only; and whether an owner of the concern should be able to qualify as a Legacy HUBZone Employee. SBA is concerned that not imposing some
The proposed rule would revise § 126.200(e), which addresses the “attempt to maintain” requirement. The proposed rule would clarify when HUBZone firms must certify that they will attempt to maintain compliance with the 35% HUBZone residency requirement during the performance of a HUBZone contract. The rule would provide that firms must make this certification when they apply for HUBZone certification, at the time they complete their recertification, and at the time of offer for any HUBZone contract.
Similarly, the proposed rule would amend § 126.200(f) to provide that HUBZone firms must certify that they will comply with the applicable limitations on subcontracting requirements when they apply for HUBZone certification, and at the time they complete their annual recertification. Certified HUBZone small business concerns also agree to comply with the limitations on subcontracting requirements under FAR clause 52.219-14, Limitations on Subcontracting, by submitting an offeror for and executing a HUBZone contract.
Finally, the proposed rule would revise § 126.200(g) to clarify that neither a concern nor any of its owners may have an active exclusion in SAM at the time of application or at any time while the concern is HUBZone-certified.
The proposed rule would amend § 126.201 by rephrasing the language explaining the ownership requirements for HUBZone small business concerns. The current regulations provide: “An owner of a SBC seeking HUBZone certification or a qualified HUBZone SBC is a person who owns any legal or equitable interest in such SBC.” The proposed rule would rephrase this sentence to read: “For purposes of qualifying for HUBZone certification, SBA considers any person who owns any legal or equitable interest in a concern to be an owner of the concern.” This change is intended only to make this section clearer and easier to read, without changing the meaning or intent of the provision.
The proposed rule would revise § 126.204(a) to specify that a HUBZone firm can have affiliates, so long as the firm and its affiliates in the aggregate qualify as small in at least one NAICS code listed in the HUBZone firm's SAM profile. This clarification is necessary because the current regulation says only that the firm and its affiliates in the aggregate must be small—without specifying that the firms, together, must be small in at least one NAICS code listed in the HUBZone-certified firm's SAM profile.
The proposed rule would amend § 126.204(c) to clarify that SBA reviews the “totality of circumstances” when determining whether to aggregate the employees of affiliated companies for purposes of calculating a firm's compliance with the 35% HUBZone residency and principal office requirements. In addition, the proposed rule would add a new paragraph (c)(4) clarifying SBA's current policy that if firms are not considered affiliated for size purposes, their employees generally will not be aggregated for HUBZone purposes.
Sections 126.302 and 126.303 provide general guidance on applying to SBA to be certified as a HUBZone small business concern. Section 124.203 provides similar guidance for applying to the 8(a) BD program; sections 127.301 and 127.302 do so for the WOSB program and section 128.301 does the same for applying to the VetCert program. The current regulations for the 8(a) BD, HUBZone and WOSB programs require that an application must be electronically signed by a specified individual (by each individual claiming social and economic disadvantage status for the 8(a) BD program and by an officer of the concern who is authorized to represent the concern for the HUBZone and WOSB programs). This proposed rule would change that language to provide instead that the individual(s) upon whom eligibility is based take responsibility for the accuracy of all information submitted on behalf of the applicant. The proposed rule would also add similar language to § 128.301 for the VetCert program.
The proposed rule would amend § 126.304(e) to clarify the records that HUBZone participants must maintain to ensure continued eligibility. Specifically, the proposed rule would provide that HUBZone small business concerns must retain documentation related to any “Legacy HUBZone employees” in order to demonstrate that individuals being claimed as Legacy HUBZone employees meet the requirements (
The proposed rule would amend § 126.306 by adding a new paragraph (h) to make clear that the D/HUB's decision to approve or deny an application to the HUBZone program is the final agency decision. This has been SBA's long-standing policy. There is no reconsideration or appeal process because declined applicants are permitted to reapply to the HUBZone program 90 days after receiving the decline decision.
The proposed rule would revise § 126.309, which describes when a declined or decertified firm can re-apply for HUBZone certification. The proposed rule would keep the 90-day wait period for firms whose application has been declined, but would eliminate that wait period for firms that have been decertified. When the HUBZone regulations were first implemented, declined or decertified firms were required to wait one year to reapply to the HUBZone program. At that time, SBA chose the one-year period to give small businesses a reasonable period of time within which to make the changes or modifications that are necessary to enable them to qualify for the HUBZone program, and at the same time to allow SBA to administer the HUBZone program effectively with available resources. However, SBA found that in many cases, a small business only had to hire a few additional HUBZone residents to come back into compliance. SBA also found that after the 2010 census, many small businesses had principal offices in HUBZone areas that were expiring and some such businesses may be planning to move to newly-designated HUBZone areas. SBA found that it would not serve the purposes of the program to make such small businesses wait one year to reapply. Thus, in 2011, SBA reduced the wait period to ninety (90) calendar days, to encourage businesses to move into newly designated HUBZones and hire HUBZone residents, which are the two purposes of the statute. SBA also believed that it would create an incentive for small businesses that no longer meet the HUBZone program
At the present time, the HUBZone portfolio is once again being significantly impacted by changes to the HUBZone Map caused by the decennial census. When the HUBZone Map was updated on July 1, 2023, many Redesignated Areas lost their HUBZone status, and thus many small businesses with principal offices in those Redesignated Areas have faced (or are facing) the decision to either relocate their principal office or withdraw from the program. Given how many small businesses are being affected by the expiration of the Redesignated Areas—whether as a result of its principal office no longer being located in a HUBZone or employees no longer residing in a HUBZone—SBA believes it is best to eliminate the waiting period that currently applies after decertification.
This rule proposes a corresponding change to § 126.803, to provide that a firm that is decertified for any reason (including based on a protest or due to voluntarily withdrawing) can reapply immediately after the decertification is effective.
In order to promote consistency across SBA's programs, the proposed rule would make similar changes in § 127.305 for the WOSB program and in § 128.305 for the VetCert program to eliminate the 90-day wait time to reapply for certification in those programs after it has been decertified.
The proposed rule would revise § 126.401, which explains what program examinations are. The proposed rule would provide that a program examination is an investigation by SBA officials, which verifies the accuracy of any certification made or information provided as part of the HUBZone application process, as part of the recertification process, or in connection with a HUBZone contract. The current regulation does not specify that program examinations may be conducted to verify the accuracy of certifications made in connection with HUBZone contracts. This proposed change would be necessary if SBA implemented the proposed changes requiring a HUBZone small business concern to meet the 35% HUBZone residency and principal office requirements on the date it submits an offer for a HUBZone contract. In light of this proposed requirement, proposed § 126.401 would provide that during a program examination, SBA “may verify that the concern met the program's eligibility requirements at the time of its application for certification, at the time of any recertification, or at the time of its offer for a HUBZone contract.”
The proposed rule would amend § 126.403(a) to clarify that a program examination may include a site visit. The current regulations describing program examinations provide that “SBA may conduct a program examination, or parts of an examination, at one or more of the concern's offices.” It is true that SBA may conduct a site visit to one or more of a HUBZone concern's offices as part of a program examination. However, site visits are just one potential facet of a program examination and not all program examinations include site visits.
The proposed rule would amend § 126.404 to clarify that where a firm is found ineligible pursuant to a program examination, SBA will decertify the firm by removing the firm's certification in DSBS for a period of 30 calendar days, during which time the firm is ineligible to submit offers for or be awarded HUBZone contracts. SBA may also identify such decertification actions on its website to ensure that relevant contracting officers are aware of any such decertification. Decertification in this instance is a statutory requirement under section 31(d)(6) of the Small Business Act. Prior to this rule, SBA has not formally removed firms' HUBZone status in DSBS during this 30-day period. However, SBA has determined that in order for the statutory requirement to be enforceable, SBA must remove a firm's certification in DSBS during the 30-day suspension period. In addition, the proposed rule would provide that the firm must provide written notice of the concern's ineligibility to the contracting officer for any pending HUBZone award. During this 30-day period, the firm may submit documentation showing that it was in fact eligible on its recertification date. If the concern failed to submit documentation sufficient to demonstrate its eligibility by the last day of the 30-day period, the concern would remain decertified. If SBA overturned its determination, SBA would reverse the firm's decertification and reinstate its certification.
The proposed rule would revise §§ 126.500 and 126.601 to eliminate the one-year certification rule and instead require firms to be eligible on the date of offer for HUBZone contracts and only recertify once every three years. Currently, the HUBZone rules require firms to annually recertify their HUBZone status to SBA. Under the current rules, once a firm annually recertifies its HUBZone status, it generally can submit offers for HUBZone contracts for one year without being required to meet the 35% HUBZone residency and principal office requirements at the time of offer. Thus, SBA's current regulations set one point in time—the date of certification or the certification anniversary date—as the time at which a firm must be eligible for a HUBZone contract. Under the current regulations, if a firm is eligible as of its certification or certification anniversary date, it remains eligible for HUBZone contracts for a period of one year from that date regardless of whether the firm falls out of compliance with the HUBZone eligibility requirements throughout the year. SBA believes that the current process can permit abuses that were not intended for the program. A firm could hire one or more individuals who reside in a HUBZone for four weeks prior to its application for certification and immediately dismiss those individuals from its employ after becoming certified and be eligible throughout the year for HUBZone contracts. Similarly, a firm could again re-hire one or more individuals who reside in a HUBZone for four weeks prior to its certification anniversary date and immediately release those individuals after the certification anniversary date and be eligible for additional HUBZone contracts for another year. SBA believes that that was not the intent of the program. Thus, proposed § 126.601(a) would require a firm to be both a certified HUBZone small business and one that continues to be eligible as of the date of its offer for a HUBZone contract.
In light of this change, the rule also proposes to amend § 126.500 to require firms to recertify to SBA every three years, rather than annually. SBA believes annual recertification is not necessary, and would impose undue burdens on HUBZone small businesses, if firms are also required to be eligible at the time they submit offers on any HUBZone contracts. Moreover, SBA believes that uniformity among its contracting programs is an important goal, and SBA's WOSB and VetCert programs require firms to be eligible at the time of offer for contracts and to recertify to SBA every three years. Thus, returning to triennial recertification, combined with the change to require HUBZone firms to be eligible on the date of offer for HUBZone contracts, would bring the HUBZone program
The proposed rule would clarify that an offeror on a competitively awarded HUBZone contract need not be eligible on the date of award of such contract. Prior to 2020, SBA's regulations required eligibility for a competitively awarded HUBZone contract both at time of offer and time of award. That caused problems with the procurement process where a HUBZone employee that was counted on for HUBZone eligibility left the firm in the time between the firm's offer and the date of award. The firm could be in the process of hiring a new employee from a HUBZone but if it had not done so by the date of award the firm would be ineligible for award. SBA continues to believe that determining such a firm ineligible for award is inappropriate. There must be certainty to eligibility when a firm submits an offer. The proposed rule, however, would provide that certainty. As long as a firm is eligible as of the date of its offer for a competitively awarded HUBZone contract, it will be eligible for award. This is similar to the size requirement where a firm must also be small on the date of its offer but may grow to be other than small between the date of its offer and the date of award. However, the proposed rule would specify that there is an exception to this rule for HUBZone sole source awards, for which a firm must be HUBZone-certified at the time of award. SBA believes that sole source procurements require stricter eligibility rules. In order to be eligible for a sole source HUBZone award, a procuring activity must conclude that the firm receiving the award is the only certified HUBZone small business concern that is capable of performing the contract. That by itself is very restrictive, and SBA believes that eligibility should also be restrictive. SBA does not believe that Congress intended to allow a firm that no longer qualifies as a HUBZone small business concern prior to award to be elevated to a status as the only certified HUBZone small business concern that is capable of performing the contract. In addition, this change would align HUBZone sole source awards with how SBA treats sole source awards in the 8(a) BD program.
The proposed rule would clarify that an offeror under a competitive HUBZone contract must be identified as HUBZone-certified in DSBS when it submits its initial offer. SBA proposes to add this to clarify that for the HUBZone program, unlike the WOSB Program, a firm cannot submit an offer on HUBZone contract while its application is still pending. That is, a concern is only eligible to submit offers for HUBZone contracts after SBA has formally approved its application and updated DSBS (or successor system) showing that the concern is a certified HUBZone small business concern. In addition, the proposed rule would clarify that for a multiple award contract, where concerns are not required to submit price as part of the offer for the contract, an offeror must be identified as a certified HUBZone small business concern in DSBS (or successor system) and meet the HUBZone requirements in § 126.200 on the date of initial offer, which may not include price. This is consistent with SBA's size regulations at § 121.404(a)(1)(iv).
SBA has also found that the HUBZone Program goals are not sufficiently fulfilled by how the “attempt to maintain” requirement is currently being implemented. Under the current rules, a HUBZone firm can have less than 35% HUBZone residents at the time of its annual recertification if the firm is performing a HUBZone contract. This means that a firm being awarded HUBZone contracts in essence never has to demonstrate that it is employing at least 35% HUBZone residents. SBA believes this is contrary to the purpose of the HUBZone Program. SBA believes it would make more sense to give firms a specific “grace period” after they are awarded a HUBZone contract during which time they can take the necessary steps to hire enough HUBZone residents to get back up to 35% HUBZone residency. If a firm's recertification falls within this grace period, then such firm's recertification would require the firm to represent that it is “attempting to maintain” compliance with the 35% HUBZone residency requirement. After the grace period, then such firm would have to be back up to 35% HUBZone residency at the time of any recertification. This rule proposes that the grace period be 12 months following the award of a HUBZone contract. To implement this proposed change, proposed § 126.500(a)(1)(i) would provide that, in order to recertify, a HUBZone firm that did not receive a HUBZone contract during the year preceding its recertification date must represent that, at the time of its recertification, at least 35% of its employees reside in HUBZones and the concern's principal office is located in a HUBZone. Proposed § 126.500(a)(1)(ii), on the other hand, would provide that a HUBZone firm that was awarded a HUBZone contract during the year preceding its recertification date would have to represent that, at the time of its recertification, it is attempting to maintain compliance with the 35% HUBZone residency requirement and the concern's principal office is located in a HUBZone.
Proposed § 126.500(a)(2) would provide that a concern's recertification must be submitted within 90 calendar days before the triennial anniversary of its HUBZone certification date. This 90-day window mirrors the VetCert regulations and thus creates additional uniformity among SBA's programs.
Proposed § 126.500(a)(3) would provide that a firm that fails to recertify will be proposed for decertification. However, SBA is seeking comments on whether such firms should be decertified automatically within a certain timeframe (such as 30 days) of failing to recertify.
Proposed § 126.500(b) would explain that SBA will conduct a program examination of each certified HUBZone small business concern at least once every three years to ensure continued program eligibility, using a risk-based analysis. The proposed rule would further provide that SBA may conduct more frequent program examinations using a risk-based analysis to select which concerns are examined. This is SBA's current policy, and this rule would make these policies clearer.
The proposed rule would revise § 126.501 in its entirety. The proposed section would address a certified HUBZone small business concern's ongoing obligations to SBA (which is what this section addressed prior to the 2019 rule change). First, the proposed rule would provide that a certified HUBZone small business concern that acquires, is acquired by, or merges with another business entity must provide evidence to SBA, within 30 calendar days of the transaction becoming final, that the concern continues to meet the HUBZone eligibility requirements. The proposed section would provide that a concern that no longer meets the requirements may voluntarily withdraw from the program or it will be removed by SBA pursuant to program decertification procedures. This is SBA's current policy, but the current regulations only require a firm to notify SBA via email where it is involved in a merger or acquisition and do not explain what happens after such notification.
Second, proposed § 126.501(b) would provide that a certified HUBZone small business concern that is performing a HUBZone contract and fails to “attempt to maintain” the minimum employee HUBZone residency requirement must notify SBA notify SBA via email to
The proposed rule would add a new paragraph (d) to § 126.503, clarifying that SBA will decertify a HUBZone small business concern that is debarred from federal contracting without first proposing the firm for decertification. This is merely a clarification of an existing policy. Once a firm has been debarred, it is ineligible for all federal contracts and subcontracts and thus there is no benefit to being HUBZone-certified.
The proposed rule would amend § 126.504(a) to add that SBA will remove a firm's HUBZone designation if the firm has been debarred from government contracting pursuant to the procedures in FAR 9.4. This change would be consistent with the addition of a new paragraph (d) to § 126.503, discussed above.
The proposed rule would revise § 126.504(c) by renumbering the introductory language as paragraph (c)(1), changing paragraph (c)(1) to paragraph (c)(2), and eliminating current paragraph (c)(2) as unnecessary. The proposed rule would then amend renumbered § 126.504(c)(1) by clarifying that a firm is ineligible to submit offers for HUBZone contracts at the time SBA decertifies the firm. The current regulations provide that a firm is ineligible when it is “removed as a certified HUBZone small business concern in DSBS.” However, there are occasional lags between SBA's decertification action and updates to DSBS, as well as potential errors in updates to DSBS. SBA may identify such decertification actions on its website to address the occasional lags.
The proposed rule would amend renumbered § 126.504(c)(2) by clarifying that a firm must be HUBZone-certified at the time of its initial offer for a HUBZone contract, and it must be able to demonstrate its compliance with the HUBZone requirements (
The proposed rule would amend § 126.600 to clarify that qualifying joint ventures may be considered HUBZone small business concerns for HUBZone contracts and to clarify that the rules in Part 126 apply to HUBZone prime contracts, not subcontracts awarded to HUBZone small businesses. The proposed rule would add a new paragraph (e) clarifying that orders awarded to certified HUBZone small business concerns under set-aside Multiple Award Contracts are HUBZone contracts.
The proposed rule would amend the requirements relating to how a certified HUBZone small business concern “attempts to maintain” having at least 35% of its employees reside in a HUBZone during the performance of a HUBZone contract. Specifically, the proposed rule would revise § 126.602 to provide that a certified HUBZone small business concern that has received a HUBZone contract must be “attempting to maintain” the 35% HUBZone residency requirement (including by having at least 20% of its employees reside in a HUBZone) on the first certification anniversary date after being awarded a HUBZone contract and at least 35% of its employees reside in a HUBZone on each certification anniversary date thereafter. SBA does not believe that the 35% HUBZone residency requirement should be watered down to as low as 20% over the course of a firm's participation in the HUBZone program merely because a HUBZone small business concern received one or more HUBZone contracts. However, SBA also believes that it must give some meaning to the “attempt to maintain” statutory language, which is why allowing a firm to drop below the 35% residency requirement (but no lower than 20%) for a year makes sense to SBA. SBA believes that giving a firm an additional year to come back into compliance with the 35% residency requirement after being awarded a HUBZone contract is a good balance between the two statutory requirements. However, SBA requests comments on how to implement this requirement where a HUBZone firm receives multiple HUBZone awards in successive years.
The proposed rule would amend § 126.605 to clarify that this section describes circumstances under which a contracting officer is prohibited from soliciting a requirement as a HUBZone contract. The proposed rule changes the words “may not” to “shall not” to clarify that a contracting officer does not have discretion to award a HUBZone contract in those specified instances.
The proposed rule would amend § 126.612 by adding a new paragraph (f) providing that the awardee of a HUBZone sole source contract must be a certified HUBZone small business concern on the date of award. This has always been the policy for the 8(a) Business Development program (
The proposed rule would amend § 126.613, which addresses the HUBZone price evaluation preference (PEP), to clarify how the HUBZone PEP should be applied. The proposed rule would revise paragraph (a) and the examples. The proposed rule would provide that to apply the HUBZone PEP, a contracting officer must add 10% to the offer of the otherwise successful large business offeror. Then, if the certified HUBZone small business concern's offer is lower than that of the large business after the HUBZone PEP is applied, the certified HUBZone small business concern must be deemed the lowest-priced offeror. The proposed rule would add a sentence specifying that the HUBZone price evaluation preference does not apply where the initial lowest responsive and responsible offeror is a small business concern.
The proposed rule would add clarifying language to Example 1 explaining that a non-HUBZone small business concern is not affected by the application of the HUBZone PEP where such non-HUBZone small business is not the lowest offeror prior to the application of the preference. This is because the HUBZone PEP is intended neither to harm nor to benefit a non-HUBZone small business.
The proposed rule would amend Example 2 by specifying that, in the example, after the application of the HUBZone PEP, the HUBZone small business concern's offer is not lower than the offer of the large business (
The proposed rule would amend Example 3 to clarify that a contracting officer should not apply the HUBZone PEP where the lowest, responsive, responsible offeror is a small business concern, even if a large business concern submitted an offer.
In addition, the proposed rule would clarify how the PEP should be applied to a procurement using trade off procedures. The proposed rule would provide that for a procurement using trade off procedures, the CO must first apply the 10% price preference to the offers of any large businesses and then determine which offeror represents the best value to the Government, in accordance with the terms of the solicitation. Where, after considering the price adjustment, the total evaluation points received by a certified HUBZone small business concern is equal to or greater than the total evaluation points received by a large business, award shall be made to the certified HUBZone small business concern.
The proposed rule would amend § 126.615 by adding a reference to § 125.9, to clarify that large businesses may participate in HUBZone procurements by serving as SBA-approved mentors under SBA's mentor-protégé program, and by correcting the cross-reference to the limitations on subcontracting.
The proposed rule would amend § 126.616, which describes the circumstances under which a joint venture can be awarded a HUBZone contract. The proposed rule would delete language from current § 126.616(a)(1) stating that a “joint venture itself need not be a certified HUBZone small business concern.” SBA proposes to delete this language because it implies that a joint venture could be HUBZone-certified, when in fact the HUBZone program does not certify joint ventures under any circumstances. Instead, proposed § 126.616(a)(1) would clarify that SBA does not certify HUBZone joint ventures, but provide that a joint venture should be designated as a HUBZone joint venture in SAM (or successor system), with the HUBZone-certified joint venture partner identified. The proposed rule would add a new paragraph (k) to provide that a procuring agency may only receive HUBZone credit for an award to a HUBZone joint venture where the joint venture complies with the requirements in § 126.616.
As noted above, this rule proposes to move recertification requirements for size and socioeconomic status to a new § 125.12. A revised § 126.12 would refer to the requirements set forth in§ 125.12 as applying to recertifications of HUBZone status.
The proposed rule would amend § 126.701 by removing the words “these subcontracting percentages” in the section heading and adding in their place the words “the limitations on subcontracting” to clarify the content of the section.
The proposed rule would amend § 126.800 by removing the paragraph subheadings and incorporating them into the text of the regulation, to make the section more readable. In addition, the proposed rule would clarify that interested parties may protest a HUBZone joint venture offeror's eligibility for award of a HUBZone contract. Finally, the proposed rule would add a new paragraph (c) providing that for contracts other than HUBZone contracts, SBA may protest an apparent successful offeror's status as a certified HUBZone small business concern. SBA believes that where there is evidence that the prospective awardee does not meet the HUBZone requirements, the agency needs to be able to protest a firm's HUBZone status, even for a non-HUBZone award. This would prevent an agency from receiving HUBZone credit where the awardee is not eligible for the program.
In response to the change made to § 126.601(a) requiring a HUBZone small business to be eligible for a HUBZone contract as of the date of its initial offer including price, the proposed rule would first align the protest procedures to recognize that the date of offer would be the relevant date for protesting a HUBZone small business concern's eligibility for award of a HUBZone contract.
SBA proposes to amend § 126.803 by revising paragraph (a), which explains the date that will be used to determine a firm's HUBZone eligibility if it is the subject of a HUBZone status protest. As explained above, this proposed rule would require HUBZone firms to be eligible at the time of offer for competitively awarded HUBZone contracts. Consistent with this proposed change, proposed § 126.803(a) would provide that for all HUBZone contracts other than HUBZone sole source awards, SBA shall determine a protested firm's HUBZone eligibility as of the date of its initial offer that includes price. For HUBZone sole source awards, SBA would determine a protested firm's HUBZone eligibility as of the date of award.
SBA also proposes to redesignate paragraphs (c), (d), and (e) as paragraphs (d), (e), and (f), and to add a new paragraph (c) to § 126.803. Proposed § 126.803(c) would provide that the burden of proof to demonstrate eligibility is on the protested concern. The section would explain that if a concern does not provide information requested by SBA within the allotted time provided, or if it submits incomplete information, SBA may draw an adverse inference and presume that the information that the applicant failed to provide would demonstrate ineligibility and sustain the protest on that basis. These policies are explained in SBA's protest notification letters, and SBA believes it makes sense to add them to the protest regulations.
The proposed rule would amend § 126.900 by adding a new paragraph (e)(4) providing that if SBA discovers that false or misleading information has been knowingly submitted by a certified small business concern in order to obtain or maintain HUBZone certification, the D/HUB will propose the firm for decertification.
In order to be eligible for the 8(a) BD program, SBA requires socially and economically disadvantaged individuals to reside in the United States.
Section 127.400 provides guidance as to how a concern can maintain its WOSB or EDWOSB certification. Current § 127.400(b) specifies that a concern must either request a program examination from SBA or notify SBA that it has requested a program examination from a third-party certifier no later than 30 days prior to its certification anniversary. In order to provide consistency between the programs, the proposed rule would state that a concern must either recertify with SBA or notify SBA that it has completed a program examination from a third party certifier in the 90 calendar days prior to its certification anniversary. The
Section 134.1104 sets forth the time limits a VOSB or SDVOSB must appeal an adverse determination finding it ineligible for the VetCert program to SBA's Office of Hearings and Appeals (OHA). Currently, § 134.1104 requires an appeal to be filed within 10 business days of receipt of the denial. When an application for the 8(a) BD program is denied, a firm has 45 days from the date it receives the Agency decision to file an appeal with OHA.
Executive Order 12866, “Regulatory Planning and Review,” directs agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563, “Improving Regulation and Regulatory Review,” emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. Executive Order 14094, “Modernizing Regulatory Review,” amends section 3(f) of Executive Order 12866 and supplements and reaffirms the principles, structures and definitions governing contemporary regulatory review established in Executive Order 12866 and Executive Order 13563. The OMB Office of Information and Regulatory Affairs (OIRA) has determined that this rule is a significant regulatory action and, therefore, it was reviewed under subsection 6(b) of E.O. 12866.
This regulatory action clarifies and streamlines SBA's regulations governing the HUBZone Program and other contracting assistance programs. In 2019, SBA published a comprehensive revision to the HUBZone Program regulations, which implemented changes intended to make these regulations easier to understand and implement. This proposed rule is intended to further clarify and improve policies surrounding some of those changes to ensure that the HUBZone program fulfills its statutory purpose. In addition, SBA has heard from small businesses of a desire for consistency among its contracting assistance programs in order to relieve burdens associated with compliance with multiple programs. As a result, the proposed rule would make several improvements to create uniformity among the programs, including deleting the program-specific recertification requirements contained separately in SBA's size, 8(a) BD, HUBZone, WOSB, and VetCert and moving them to a new section that would cover all size and status recertification requirements.
The proposed rule benefits program participants by reducing burdens and increasing consistency with other contracting programs while changing or adding some compliance requirements that strengthen the program's impact and reduce the potential for business policies and practices that are contrary to the goals of the HUBZone program. The reduction of burdens includes the decrease in the time of proof of residence for employees, removal of the 90-day wait period for reapplication after decertification, revisions to the part of the rule that addresses Governor-designated covered areas, a change in the negative-control rule in SBA's affiliation rule, deletion of program-specific requirements for certification, and triennial instead of annual recertification. Additionally, the proposed rule adds a telework provision. Proposed compliance requirements include limits on the number of Legacy Employees, revised requirements for the use of the “attempt to maintain” statutory language, possible minimum thresholds for number of hours worked, and proof of eligibility at the time of offer of a HUBZone contract. These proposed compliance measures are consistent with the program's goal of promotion of growth and impact of small businesses in historically underutilized areas and SBA believes, as outlined below, that they are not substantial burdens.
The decrease from 180 days to 90 days for proof of employees' residency allows for firms to enter the HUBZone program more quickly and increases opportunities for newly-hired employees. Both of these results increase accessibility of the program's opportunities. Removal of the 90-day wait period for decertified firms also promotes the program's accessibility because SBA has found that a shorter wait period is consistent with firms' ability to qualify or return to compliance by hiring HUBZone residents or by moving to a newly-designated HUBZone.
The restatement of § 126.104 clarifies existing policy on Governor-designated covered areas, including the condition for annual petitions and a statement of no need for SBA's approval of previously designated covered areas. This restatement decreases uncertainty for firms that participate or plan to participate in the program. The restatement also authorizes the Associate Administrator for Government Contracting and Business Development, or designee, instead of the Administrator to approve covered areas, which SBA believes would reduce time to approve a petition and facilitate entry into the program.
Amendments to regulations on affiliation will remove inconsistencies with other programs' regulations. The benefit of the amendments is more certainty on measures that minority-share investors can include to protect their investments without a finding of control. This proposed rule further reduces uncertainty in this matter by applying the same language to the 8(a) BD, WOSB and VetCert programs. SBA expects the changes in regulations on affiliation and control and increased consistency among programs to improve the environment for access to capital for small businesses in contracting assistance programs.
The proposed rule returns the HUBZone program to triennial recertification and deletes program-specific recertification requirements. Both of these changes alleviate the burden associated with recertification.
The proposed rule recognizes the increased importance of telework and allows small businesses with 100 percent of its employees to participate in the HUBZone program but with the condition that at least 51 percent of the employees work from HUBZone locations. This provision enables program participants to use the benefits of telework for recruitment and flexibility while addressing the program's goals of stimulating economic activity in HUBZone areas.
The proposed rule revises § 126.200(d)(3) to allow HUBZone firms to retain employees who have move out of a HUBZone but proposes a limitation on the number of these Legacy HUBZone Employees. This is an attempt to balance the needs of employees who move for personal reasons or for professional development with the aims of the program to promote business activity in specific areas. The limitation is a potential source of burden on small business entities and SBA is seeking comments on aspects of limiting the number of Legacy Employees.
SBA is also adjusting the threshold of 20 percent of employees for “attempt to maintain” currently in § 126.500(a)(2) with 35 percent. This increased threshold is a stronger standard but the procedures for demonstrating compliance are not different. Any resulting costs should be balanced against SBA's assessment that HUBZone goals are not sufficiently fulfilled by implementation of the current requirement of 20 percent.
Currently, § 126.103 specifies that an individual who works 40 hours in a four-week period is an employee. SBA proposes to increase the number of hours worked to 80 but seeks comments on whether this level is appropriate. This proposal is a revised and stricter compliance requirement but is one that SBA believes better promotes the purpose of the program and the need for a firm's legitimate presence in the HUBZone area. SBA expects that the increase in hours of gainful employment would be matched with increased output and therefore the additional hours would not impose a burden on employers. Recognizing some employers' and employees' needs for fewer hours per period, SBA seeks comments on a minimum number of hours for some individuals.
This rule proposes to require any certified HUBZone small business to be eligible as of the date of offer for any HUBZone contract. In Federal Procurement Data System (FPDS) data from previous years, approximately 2,100 new HUBZone contracts were awarded in a fiscal year. SBA estimates it takes approximately 1 hour for a firm to gather proof that it is eligible at the time of offer. Thus, this proposed rule will increase the burden on HUBZone small business concerns by approximately 2,100 hours for an estimated annual cost of $278,166.
The proposed changes clarify and streamline regulations and increase consistency with other contracting programs. Many of the benefits are not quantifiable, but SBA estimates annual savings of about $408,639 from reduced frequency of recertification. Benefits from the proposed changes regarding affiliation and control reduce uncertainty for investors and may therefore have a significant impact on access to capital. The rule contains measures that introduce or strengthen some compliance requirements but these are balanced by the need to maintain the goals and integrity of the program. The one quantifiable burden noted in these proposed compliance measures is proof of eligibility at the time of offer and this is a cost only when the benefit of the offer is present.
SBA considered alternatives to each of the significant changes made by this rule. Instead of requiring HUBZone firms to recertify every three years and be eligible at the time of offer, SBA considered maintaining the current requirement where annual recertification allows a concern to seek and be eligible for HUBZone contracts for a year. However, SBA has found that the annual recertification requirement does not fulfill the purposes of the HUBZone program as effectively as requiring firms to be eligible at the time of offer for HUBZone contracts. Moreover, SBA believes that uniformity among its contracting programs is an important goal, and returning to triennial recertification and eligibility determinations based on the date of offer would bring the HUBZone program much more in line with SBA's other small business and socioeconomic contracting programs.
This regulatory action is needed to clarify and improve SBA's regulations governing the HUBZone Program and SBA's other socioeconomic contracting programs. In 2019, SBA published a
For the purposes of Executive Order 13132, Federalism, SBA has determined that this rule would not have substantial, direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, for the purpose of Executive Order 13132, Federalism, SBA has determined that this rule has no federalism implications warranting preparation of a federalism assessment.
This rule does not impose additional reporting or recordkeeping requirements under the Paperwork Reduction Act, 44 U.S.C. Chapter 35.
In 2019, SBA revised its regulations to give contracting officers discretion to request information demonstrating compliance with the limitations on subcontracting requirements.
According to the Regulatory Flexibility Act (RFA), 5 U.S.C. 601, when an agency issues a rulemaking, it must prepare a regulatory flexibility analysis to address the impact of the rule on small entities. However, section 605 of the RFA allows an agency to certify a rule, in lieu of preparing an analysis, if the rulemaking is not expected to have a significant economic impact on a substantial number of small entities. The RFA defines “small entity” to include “small businesses,” “small organizations,” and “small governmental jurisdictions.” This proposed rule concerns various aspects of SBA's HUBZone program, as well as its size, 8(a) BD, WOSB, and VetCert programs. As such, the rule relates to small businesses but would not affect “small organizations” or “small governmental jurisdictions.”
The proposed changes clarify and streamline regulations and increase consistency with other contracting programs. Many of the benefits are not quantifiable, but SBA estimates annual savings of about $408,639 from reduced frequency of HUBZone recertification. There are approximately 5,000 small businesses that are listed as certified HUBZone small businesses in DSBS, and under the proposed rule, these firms would only need to recertify every three years, rather than every year. Benefits from the proposed changes regarding affiliation and control reduce uncertainty for investors and may therefore improve access to capital. The rule contains measures that introduce or strengthen some compliance requirements, but these are balanced by the need to maintain the goals and integrity of the program. The one quantifiable burden noted in these proposed compliance measures is proof of HUBZone eligibility at the time of offer and this is a cost only when the benefit of the offer is present. Moreover, this burden is counterweighed by the benefit of making the HUBZone program more consistent with SBA's other socioeconomic contracting programs, which decreases the amount of regulations that small businesses must learn and understand in order to participate in SBA's programs. The other changes that make the programs more consistent, such as consolidating the regulations related to recertification of size and status, only serve to benefit the small businesses that participate in these programs. Based on the foregoing, SBA does not believe that the proposed amendments would have a disparate impact on small businesses or would impose any additional significant costs. For the reasons discussed, SBA certifies that this proposed rule would not have a significant economic impact on a substantial number of small entities.
Administrative practice and procedure, Government procurement, Government property, Grant programs—business, Individuals with disabilities, Loan programs—business, Small businesses.
Administrative practice and procedure, Government procurement, Government property, Small businesses.
Government contracts, Government procurement, Reporting and recordkeeping requirements, Small businesses, Technical assistance.
Administrative practice and procedure, Government procurement, Penalties, Reporting and recordkeeping requirements, Small businesses.
Government contracts, Reporting and recordkeeping requirements, Small businesses.
Government contracts, Government procurement, Reporting and recordkeeping requirements, Small businesses Technical assistance, Veterans.
Administrative practice and procedure; Claims Confidential business information; Equal access to justice; Equal employment opportunity; Lawyers; Organization and function (Government agencies).
Accordingly, for the reasons stated in the preamble, SBA proposes to amend 13 CFR parts 121, 124, 125, 126, 127, 128, and 134 as follows:
15 U.S.C. 632, 634(b)(6), 636(a)(36), 662, and 694a(9).
(a) * * *
(3) Control may be affirmative or negative. Negative control includes, but is not limited to, instances where a minority shareholder has the ability, under the concern's charter, by-laws, or shareholder's agreement, to prevent a quorum or otherwise block action by the board of directors or shareholders. However, SBA will not find that a minority shareholder has negative control where such minority shareholder has the authority to block action by the board of directors or shareholders regarding the following extraordinary circumstances:
(i) Adding a new equity stakeholder;
(ii) Dissolution of the company;
(iii) Sale of the company or all assets of the company;
(iv) The merger of the company;
(v) The company declaring bankruptcy; and
(vi) Amendment of the company's corporate governance documents to remove the shareholder's authority to block any of (1) through (5).
(h) * * *
(3)
(v) A joint venture offeror is ineligible as a small business concern, an 8(a) small business concern, a certified HUBZone small business concern, a WOSB/EDWOSB concern, or a VO/SDVO small business concern where SBA determines that the managing joint venture partner will not perform 40% of the work to be performed by the joint venture, where a joint venture partner that is not similarly situated to the managing venturer performs primary and vital requirements of a contract, or of an order, or where the managing venturer is unusually reliant on such a joint venture partner.
(a) * * *
(1) SBA will consider a concern's Federal income tax return and any amendments filed with the IRS on or before the date of self-certification to determine the size status of the concern. SBA may also consider other relevant information where it appears that the tax return does not properly capture a concern's total revenue.
(a)
(b)
(2) When multiple NAICS codes are assigned to a multiple award contract as set forth in § 121.402(c)(1)(ii), SBA determines size status for the underlying multiple award contract for each discrete category for which an offer is submitted, by applying the size standard corresponding to each discrete category, as of the date a business concern submits its initial offer which includes price for the contract.
(3) Where concerns are not required to submit price as part of the initial offer for a multiple award contract, SBA determines size status for the underlying multiple award contract as of the date a business concern submits its initial offer for the contract, which may not include price.
(c)
(2)
(i) Where a contracting officer requests size recertification with respect to a specific order, size is determined as of the date the business concern submits its initial offer (or other formal response to a solicitation), which includes price, for the order.
(ii) Where a contracting officer requests size recertification with respect to a specific order, size is determined only with respect to that order. Where a contract holder has grown to be other than small and cannot recertify as small for a specific order for which a contracting officer requested recertification, it may continue to qualify as small for other orders issued under the contract where a contracting officer does not request recertification.
(3)
(4)
(ii) For 8(a) sole source orders issued under a multiple award contract, size is determined in accordance with § 124.503(i)(1)(iv) of this chapter, as of the date the order is offered to the 8(a) BD program, regardless of whether the multiple award contract is unrestricted, set-aside, or the GSA FSS MAS contract.
(iii) Size is determined on the date of recertification when a recertification is required pursuant to §§ 125.12(a) and (b) of this chapter, or on the date of initial offer which includes price if requested by a contracting officer pursuant to § 125.12(c). This exception applies to all provisions of paragraphs 121.404(a), (b), (c), and (d).
(d)
(e)
(f)
(g)
(h)
(i)
(j)
(c) * * *
(7)
(i) All aspects of the relationship between the concern and the subcontractor are considered, including, but not limited to, the terms of the proposal (such as management, technical responsibilities, and the percentage of subcontracted work) and agreements between the concern and subcontractor or subgrantee (such as bonding assistance or the teaming agreement).
(ii) To determine whether a subcontractor performs primary and vital requirements of a funding agreement, SBA will also consider whether the concern's proposal complies with the performance requirements of the SBIR or STTR program.
(iii) The prime and any small business ostensible subcontractor both must comply individually with the ownership and control requirements in paragraphs (a) and (b) of this section, as applicable.
The revision and additions read as follows:
(b) * * *
(2) * * *
(iii) Where SBA initially verified the eligibility of an 8(a) Participant for the award of an 8(a) contract but subsequently receives specific information that the Participant may be other than small and consequently ineligible, the Associate Administrator for Business Development or the Associate General Counsel for Procurement Law may request a formal size determination.
(12) In connection with a size recertification relating to a contract required by § 125.12 of this chapter, the contracting officer, the SBA program manager relating to the contract at issue (
(13) In connection with a size recertification relating to a multiple award contract required by § 125.12 of this chapter, any contract holder on that multiple award contract may also request a formal size determination concerning a recertifying concern's status as a small business.
(i) A request for a formal size determination made by another contract
(ii) SBA will dismiss as not sufficiently specific any request for a formal size determination alleging merely that the recertifying concern is not small or is affiliated with unnamed other concerns.
(b) Recertification will not be required nor will the prohibition against future self-certification apply if the adverse SBA size determination is based solely on a finding of affiliation limited to a particular Government procurement or property sale, such as an ostensible subcontracting relationship or non-compliance with the nonmanufacturer rule.
15 U.S.C. 634(b)(6), 636(j), 637(a), 637(d), 644, 42 U.S.C. 9815; and Pub. L. 99-661, 100 Stat. 3816; Sec. 1207, Pub. L. 100-656, 102 Stat. 3853; Pub. L. 101-37, 103 Stat. 70; Pub. L. 101-574, 104 Stat. 2814; Sec. 8021, Pub. L. 108-87, 117 Stat. 1054; and Sec. 330, Pub. L. 116-260.
(a) * * *
(1) * * * In determining whether a concern applying to be certified for the 8(a) BD program qualifies as a small business concern under the size standard corresponding to its primary industry classification, SBA will accept the concern's size representation in the System for Award Management (
The revisions read as follows:
(b)
(f) * * *
(1) At least 51 percent of any distribution of profits paid to the owners of a corporation, partnership, or limited liability company concern, and a disadvantaged individual's ability to share in the profits of the concern must be commensurate with the extent of his or her ownership interest in that concern;
(h) * * *
(2) A non-Participant business concern in the same or similar line of business or a principal of such concern may generally not own more than a 20 percent interest in an 8(a) Participant that is in the developmental stage or more than a 30 percent interest in an 8(a) Participant in the transitional stage of the program, except that a business concern approved by SBA to be a mentor pursuant to § 125.9 of this chapter may own up to 40 percent of its 8(a) Participant protégé as set forth in § 125.9(d)(2), whether or not that concern is in the same or similar line of business as the Participant.
(i) * * *
(2) (i) Prior approval by the AA/BD is not needed where:
(A) All non-disadvantaged individual (or entity) owners involved in the change of ownership own no more than a 30 percent interest in the concern both before and after the transaction;
(B) The transfer results from the death or incapacity due to a serious, long-term illness or injury of a disadvantaged principal;
(C) The disadvantaged individual or entity in control of the Participant will increase the percentage of its ownership interest; or
(D) The Participant has never received an 8(a) contract.
(ii) In determining whether a non-disadvantaged individual involved in a change of ownership has more than a 30 percent interest in the concern, SBA will aggregate the interests of all immediate family members as set forth in § 124.3, as well as any individuals who are affiliated based on an identity of interest under § 121.103(f).
(iii) Where prior approval is not required, the concern must notify SBA within 60 days of such a change in ownership, or before it submits an offer for an 8(a) contract, whichever occurs first.
(k)
The revision and addition to read as follows:
(e) * * *
(3) Receive compensation from the applicant or Participant in any form as a director, officer or employee, that exceeds the compensation to be received by the highest ranking officer (usually CEO or President), unless the concern demonstrates that the compensation to be received by the non-disadvantaged individual is commercially reasonable or that the highest-ranking officer has elected to take lower compensation to benefit the applicant or Participant. A Participant must notify SBA within 30 calendar days if the compensation paid to the highest-ranking officer of the Participant falls below that paid to a non-disadvantaged individual. In such a case, SBA must determine that that the compensation to be received by the non-disadvantaged individual is commercially reasonable or that the highest-ranking officer has elected to take lower compensation to benefit the Participant before SBA may determine that the Participant is eligible for an 8(a) award.
(h)
(1) Adding a new equity stakeholder;
(2) Dissolution of the company;
(3) Sale of the company or all assets of the company;
(4) The merger of the company;
(5) The company declaring bankruptcy; and
(6) Amendment of the company's corporate governance documents to remove the shareholder's authority to block any of (1) through (5).
The revisions read as follows:
SBA must determine that with contract, financial, technical, and management support from the 8(a) BD program, from contractors or from others assisting with business operations, the applicant concern is able to perform 8(a) contracts and possess reasonable prospects for success in competing in the private sector. * * *
(a) Income tax returns for each of the two previous tax years must show operating revenues.
The revision to read as follows:
(a) * * *
(3) An applicant is ineligible for admission to the 8(a) BD program if the applicant concern or a proprietor, partner, limited liability member, director, officer, or holder of at least 20 percent of its stock, or another person (including key employees) with significant authority over the concern lacks business integrity as demonstrated by conduct that could be grounds for suspension or debarment;
(e)
* * * The majority socially and economically disadvantaged owner
(d) An applicant must be eligible as of the date SBA issues a decision. An applicant's eligibility will be based on the totality of circumstances, including facts set forth in the application, supporting documentation, any information received in response to any SBA request for clarification, and any changed circumstances.
A concern which has been declined for 8(a) BD program participation may submit a new application for admission to the program at any time after 90 calendar days from the date of the Agency's final decision to decline.
(c)
(2) A firm that is decertified from the HUBZone Program, the WOSB Program, or the VetCert Program due to the submission of false or misleading information may be terminated from the 8(a) BD Program.
(3) SBA may require a firm that is decertified from the HUBZone Program, the WOSB Program, or the VetCert Program due to the submission of false or misleading information to enter into an administrative agreement with SBA as a condition of admission to the 8(a) BD program.
(g) * * *
(1) * * *
(iii) For open requirements, the effect that contract would have on the equitable distribution of 8(a) contracts; and
(a)
The addition to read as follows:
(d) * * *
(1) * * *
(ii) In determining the projected revenue SBA should consider in determining whether one or more unsuccessful offers submitted by the Participant would have given the Participant sufficient revenues to achieve the applicable non-8(a) business activity target under paragraph (d)(1)(i)(A) of this section, SBA will consider:
(A) Only procurements for which the Participant had reasonable prospects of success; and
(B) Only the base year of the procurement at issue and not the projected full value of the procurement.
(a) * * *
(1) If a firm's term of participation in the 8(a) BD program has ended (or the firm has otherwise exited the program) or is no longer small under the size standard corresponding to the NAICS code for the requirement, negotiations to price the option cannot be entered into and the option cannot be exercised.
(d)
15 U.S.C. 632(p), (q), 634(b)(6), 637, 644, 657f, 657q, 657r, and 657s; 38 U.S.C. 501 and 8127.
(c) * * *
(6)
The additions read as follows:
(a) * * *
(4) For subcontracting purposes, a concern must qualify as a small business concern and a socioeconomic small business concern as of the date that it certifies that it is small or that it qualifies as a socioeconomic small business concern for the subcontract.
(b) * * *
(4) Except for HUBZone and SDVO small business subcontractors, a prime contractor may rely on the socioeconomic self-certification of a subcontractor provided the prime contractor does not have a reason to doubt the subcontractor's self-certification.
(d) * * * However, for a multi-agency set aside contract where more than one agency can issue orders under the contract, the ordering agency must use the period of performance for each order to determine compliance and monitor compliance with the limitations on subcontracting for that specific order. At the end of performance of the order, the ordering contracting officer should then inform the contracting officer for the underlying multi-agency contract if the ordering contracting officer knows that the contractor has failed to meet the applicable limitations on subcontracting requirement. * * *
(3) * * * Work performed by an employee obtained from a temporary employee agency, professional employee organization, or leasing concern shall be treated as the recipient concern's self-performance. The work performed by employees leased to the small business prime contractor will therefore not count against the applicable limitation on subcontracting.
The additions and revision read as follows:
(e) * * * A procuring activity has discretion whether to require a protégé member of a joint venture to demonstrate some level of past performance and/or experience. Where it does so, the procuring activity may not require a protégé firm to individually meet all the same evaluation or responsibility criteria as that required of other offerors generally. * * *
(f)
The revisions and additions read as follows:
(b)
(2) (i) SBA will decline an application if SBA determines that the mentor does not possess good character or a favorable financial position, employs or otherwise controls the managers or key employees of the protégé, or is otherwise affiliated with the protégé.
(ii) SBA may terminate the mentor-protégé agreement if:
(A) SBA determines that the mentor does not possess good character or a favorable financial position;
(B) SBA determines that the mentor was affiliated with the protégé at the time of application or becomes affiliated with the protégé for reasons other than the mentor-protégé agreement or assistance provided under the agreement; or
(C) Key managers or personnel become employees of both the mentor and protégé firms at the same time.
(4) A mentor cannot be a contract holder through joint ventures with two protégé small business concerns on the same small business multiple award contract or small business reserve on a multiple award contract at the same time.
(i) Where a mentor purchases another business entity that is also an SBA-approved mentor that is a contract holder as a joint venture with a protégé small business and the mentor is also a contract holder with a protégé small business on that same multiple award contract, the mentor must exit one of those joint venture relationships.
(ii) The protégé firm connected to the joint venture from which the mentor exits may seek to:
(A) Acquire the new mentor's interest in the small business multiple award contract or reserve and, where necessary and appropriate, novate such contract or reserve to itself only pursuant to FAR 42.1204; or
(B) Replace the new mentor with another business in the joint venture such that the revised joint venture continues to qualify as small, and, where necessary and appropriate, novate such contract or reserve pursuant to FAR 42.1204.
(c) * * *
(4) * * *
(iv) Instead of having a six-year mentor-protégé relationship with two separate mentors, a protégé may seek to extend or renew a mentor-protégé relationship with the same mentor for a second six-year term. In order for SBA to approve an extension or renewal of a mentor-protégé relationship with the same mentor, the mentor must commit to providing additional business development assistance to the protégé. Whether a protégé has a mentor-protégé relationship with two different mentors or the same mentor for a second six-year period, a concern cannot be a protégé for a total of more than 12 years.
(5) Where a business concern purchases another business concern that is currently the mentor of a protégé firm, that business concern can become the new mentor of the protégé if it commits to honoring the obligations under the seller's mentor-protégé agreement or the purchasing business concern and the protégé negotiate a new mentor-protégé agreement that SBA approves. Where that occurs, that new mentor-protégé relationship will be effective for no longer than six years minus the length of the mentor-protégé relationship with the seller mentor.
(i) If the purchasing business concern and the protégé firm cannot agree on either continuing with the previous mentor-protégé agreement or negotiating a new mentor-protégé agreement that is acceptable to SBA, the protégé firm can terminate its mentor-protégé relationship.
(ii) Where a mentor-protégé relationship is terminated, the protégé firm may seek another business concern to enter a mentor-protégé relationship for a duration not to exceed six years minus the length of the mentor-protégé relationship with the former mentor.
(d) * * *
(1) * * *
(iv) Where a mentor seeks to sell its interest in a mentor-protégé joint venture, the protégé firm shall have a right of first refusal to purchase that interest.
(a)
(1) A concern and the acquiring concern must recertify if each has received an award as a small business or small business program participant.
(2) In the context of a joint venture, recertification is required from any partner to the joint venture that has merged or is party to the sale or acquisition.
(3) Recertification does not change the terms and conditions of the award. The limitations on subcontracting, non-manufacturer and subcontracting plan requirements in effect at the time of award remain in effect throughout the life of the award regardless of whether a recertification is qualifying or disqualifying. However, a contracting officer may require a subcontracting plan if a prime contractor's size status changes from small to other than small as a result of a size recertification.
(4) A size re-certification shall relate to the size standard in effect at the time of re-certification that corresponds to the NAICS code that was initially assigned to the award.
(b)
(c)
(d)
(e)
(1)
(2)
(i)
(ii)
(A)
(B)
(iii)
(A) For a single award small business set-aside or reserve award or any unrestricted award, a concern that submits a disqualifying recertification remains eligible to receive options. The procuring agency cannot count the option period as an award to a small business or small business program participant for goaling purposes. Such a concern may make a qualifying recertification for a subsequent option period if it meets the applicable size standard or becomes a certified small business program participant.
(B) For a multiple award small business set-aside or reserve award, a concern that submits a disqualifying
(f)
(a) The compensation received by any packager, agent, or representative of a concern applying for 8(a) BD, HUBZone, WOSB/EDWOSB, or VOSB/SDVOSB certification in exchange for assisting the applicant in obtaining such certification must be reasonable in light of the service(s) performed by the packager, agent, or representative.
(b) The compensation received by any packager, agent, or representative of a certified 8(a) BD, HUBZone small business concern, WOSB/EDWOSB, or VOSB/SDVOSB in exchange for assisting the concern in obtaining any small business contracts, orders, BPAs, BAs, or BOAs must be reasonable in light of the service(s) performed by the packager, agent, or representative, and cannot be a fee that is a percentage of the gross value of the contract, order, BPA, BA or BOA.
(c) For good cause, SBA may initiate proceedings to suspend or revoke a packager's, agent's, or representative's privilege to assist applicants obtain SBA certification and assist certified small business concerns obtain contracts, orders, or any other assistance to support participation in the 8(a) BD, HUBZone, WOSB or VetCert programs. Good cause is defined in § 103.4 of this chapter.
(1) SBA may send a “show cause” letter requesting the agent or representative to demonstrate why the agent or representative should not be suspended or proposed for revocation, or may immediately send a written notice suspending or proposing revocation, depending upon the evidence in the administrative record. The notice will include a discussion of the relevant facts and the reason(s) why SBA believes that good cause exists.
(2) Unless SBA specifies a different time in the notice, the agent or representative must respond to the notice within 30 calendar days of the date of the notice with any facts or arguments showing why good cause does not exist. The agent or representative may request additional time to respond, which SBA may grant in its discretion.
(3) After considering the agent's or representative's response, SBA will issue a final determination, setting forth the reasons for this decision and, if a suspension continues to be effective or a revocation is implemented, the term of the suspension or revocation.
(d) The relevant SBA program office may refer a packager, agent, or other representative to SBA's Suspension and Debarment Official for possible Government-wide suspension or debarment where appropriate, including where it appears that the packager, agent, or representative assisted an applicant or certified small business concern to submit information to SBA that the packager, agent, or representative knew to be false or materially misleading.
15 U.S.C. 632(a), 632(j), 632(p), 644 and 657a.
The revisions and additions read as follows:
(1) To determine the number of hours worked by each individual employed by the firm, SBA will review a concern's payroll records for the most recently completed pay periods that account for the four-week period immediately prior to the relevant date of review. To determine if an individual is an employee, SBA reviews the totality of circumstances, including criteria used by the Internal Revenue Service (IRS) for Federal income tax purposes and the factors set forth in SBA's Size Policy Statement No. 1 (51 FR 6099, February 20, 1986).
(2) In general, the following are considered employees:
(i) Individuals obtained from a temporary employee agency, from a concern primarily engaged in leasing employees, or through a union agreement, or co-employed pursuant to a Professional Employer Organization agreement;
(ii) An individual who has an ownership interest in the concern and who works for the concern 80 hours or more during the four-week period immediately prior to the relevant date of review, whether or not the individual receives compensation;
(iii) An owner who works less than 80 hours during the four-week period immediately prior to the relevant date of review, where another individual has not been hired to manage and direct the actions of the concern's employee(s).
(3) In general, the following are not considered employees:
(i) Individuals who are not owners and receive no compensation (including no in-kind compensation) for work performed;
(ii) Individuals who receive deferred compensation for work performed;
(iii) Independent contractors to whom payments are reported via IRS Form 1099 and who are not otherwise considered employees under SBA's Size Policy Statement No. 1; and
(iv) Subcontractors.
(3) Employees of an affiliate may be considered employees, if the totality of the circumstances shows that there is no clear line of fracture between the HUBZone applicant (or certified HUBZone small business concern) and its affiliate(s) (
(4) An individual must perform work for the concern to be considered an employee for HUBZone purposes. SBA may require evidence that an individual is performing work, including but not limited to the following: a job description; the individual's resume; timesheets; proof of onboarding and/or training; evidence of regular communication assigning work to the individual and responses to such communication; examples of work product commensurate with hours worked; documentation demonstrating the individual's participation in online or telephonic meetings with supervisors or colleagues, such as meeting invitations, notes from meetings, post-meeting questions or assignments; written attestations; and other relevant documentation.
(1) In order for a location to be considered the principal office, the concern must provide a deed or an active lease that includes a start date that was at least 30 calendar days prior to the relevant date of review, and an end date that is at least 60 calendar days after the relevant date of review, as well as any other documentation requested by SBA;
(2) In order for a location to be considered the principal office, the concern must conduct business at this location. The concern may be required to demonstrate that it is doing so by submitting evidence including but not limited to the following:
(i) Photos and/or a live or virtual walk-through of the space; and
(ii) For shared working spaces, evidence that the firm has dedicated space within any shared location, and that such dedicated space contains sufficient work surface area, furniture, and equipment to accommodate the number of employees claimed to work from this location;
(3) If an employee works at multiple locations, then the employee will be deemed to work at the location where the employee spends more than 50% of his or her time. If an employee does not spend more than 50% of his or her time at any one location and at least one of those locations is a non-HUBZone location, then the employee will be deemed to work at a non-HUBZone location.
(4) If 100% of a firm's employees telework, at least 51% of its employees must work from HUBZone locations to meet the principal office requirement.
(5) For those concerns whose “primary industry classification” is services or construction (see § 121.201 of this chapter), the determination of principal office excludes the concern's employees who perform more than 50% of their work at job-site locations to fulfill specific contract obligations. If all of a concern's employees perform more than 50% of their work at job sites, the concern does not comply with the principal office requirement.
(i)
(ii)
(iii)
(2) A census tract or non-metropolitan county shall be considered to be a Qualified Disaster Area for the period of time starting on the date on which the President declared the major disaster for the area in which the census tract or non-metropolitan county, as applicable, is located (or in the case of a catastrophic incident, on the date on which the catastrophic incident occurred in the area in which the census tract or non-metropolitan county, as applicable, is located) and ending on the date when SBA next updates the HUBZone Map in accordance with § 126.104(a).
(1) To determine residence, SBA will first look to an individual's address identified on his or her driver's license or other government-issued identification card.
(i) Where such documentation is not available (or where the address on the individual's driver's license it outdated), SBA will require other specific proof of residency, such as deeds, leases, and/or utility bills, as well as a signed statement explaining why a driver's license is unavailable and attesting to an individual's dates of residency.
(ii) Where such documentation does not demonstrate 90 days of residency, SBA will require a signed statement attesting to an individual's dates of residency.
(2) For HUBZone purposes, SBA will consider individuals temporarily residing overseas in connection with the performance of a contract to reside at their U.S. residence.
(i)
(ii)
(iii)
(a)
(1) A Governor may submit not more than 1 petition described in this section per calendar year.
(2) The petition described in this section shall include all covered areas in a State for which the Governor seeks designation as a Governor-designated covered area. The total number of covered areas included in such petition may not exceed 10 percent of the total number of covered areas in the State.
(3)(i) The total number of covered areas in a State shall be calculated by aggregating the number of census tracts and counties that qualify as covered areas as described in (d) of this section.
(ii) A petition need not seek SBA approval for those covered areas previously designated as Governor-designated covered areas.
(b)
(1) The potential for job creation and investment in the covered area;
(2) The demonstrated interest of small business concerns in the covered area to be designated as a Governor-designated covered area;
(3) How State and local government officials have incorporated the covered area into an economic development strategy; and
(4) If the covered area was a HUBZone before becoming the subject of the petition, the impact on the covered area if the Administrator did not approve the petition.
(c)
(d)
(e)
(1) The term “covered area” means a census tract or county in a State—
(i) That is located outside of an urban area, as determined by the Bureau of the Census, with a population of not more than 50,000; and
(ii) For which the average unemployment rate is at least 120 percent of the average unemployment rate of the United States or of the State in which the covered area is located, whichever is less, based on the most recent data available from the American Community Survey conducted by the Bureau of the Census.
(2) The term “Governor” means the chief executive of a State.
(3) The term “State” means each of the States of the United States, the District of Columbia, the Commonwealth of Puerto Rico, the United States Virgin Islands, Guam, the Commonwealth of the Northern Mariana Islands, or American Samoa.
The HUBZone Map will be updated as follows:
(a) Qualified Census Tracts and Qualified Non-Metropolitan Counties will be updated every 5 years.
(b) Redesignated Areas will be added to the HUBZone Map when areas cease to be designated as Qualified Census Tracts or Qualified Non-Metropolitan Counties, in accordance with the 5-year cycle described in paragraph (a), and will be removed after 3 years.
(c) Qualified Base Closure Areas will be added to the HUBZone Map after SBA receives information from the Department of Defense that a new base closure area has been created and will be removed after 8 years.
(d) Qualified Disaster Areas generally will be added to the HUBZone Map on a monthly basis, based on data received by SBA from the Federal Emergency Management Agency (FEMA), and generally will be removed on the effective date of the 5-year HUBZone Map update following the declaration.
(e) Governor-Designated Covered Areas will be added to the HUBZone Map after SBA approves a petition in accordance with § 126.104 and will be removed on the effective date of the 5-year HUBZone Map update following the approval, or one year after the petition is approved, whichever is later.
The revisions and additions read as follows:
(b) * * *
(1) * * * In determining whether a concern qualifies as small under the size standard corresponding to a specific NAICS code, SBA will accept the concern's size representation in SAM, or successor system, unless there is evidence indicating that the concern is other than small. SBA will request a formal size determination pursuant to § 121.1001(b)(8) of this chapter where any information it possesses calls into question the concern's
(c) * * *
(1)
(ii)
(iii)
(A) An office located in a Redesignated Area at the time of initial HUBZone certification;
(B) An office that is shared with one or more other concerns or individuals;
(C) Any location being used as a personal residence; or
(D) An investment made within 180 calendar days of the expiration of an area's designation as a Qualified Census Tract, Qualified Non-Metropolitan County, Governor-Designated Covered Area, or Qualified Base Closure Area.
(2)
(d)
(2)
(3)
(A) Continues to live in a HUBZone for at least 180 calendar days immediately after the firm's HUBZone certification date (or recertification date); and
(B) Continues to meet the definition of “employee” in § 126.103 continuously and without interruption.
(ii) An individual who initially qualified as a HUBZone Resident Employee by living in a Redesignated Area or a Qualified Disaster Area will not qualify as a Legacy HUBZone Employee.
(iii) A certified HUBZone small business concern may have up to one Legacy HUBZone Employee at a given time.
(iv) The certified HUBZone small business concern must maintain records of the Legacy HUBZone Employee's original HUBZone address, as well as records of any HUBZone other address in which the individual resided, as well as records of the individual's continuous and uninterrupted employment by the HUBZone small business concern, for the duration of the concern's participation in the HUBZone program. In order to demonstrate that an individual resided in a HUBZone for 180 days after certification (or recertification), the concern must submit to SBA copies of leases, utility bills, or property tax records.
(v) The certification date or recertification date being used to establish the HUBZone residency of the employee must be after December 26, 2019.
(e)
(2) If the concern is owned in whole or in part by one or more Indian Tribal Governments (or by a corporation that is wholly owned by one or more Indian Tribal Governments), the concern must certify at the time of application and at each recertification that it will “attempt to maintain” (see § 126.103) the applicable employment percentage described in paragraph (c)(2) of this section during the performance of any HUBZone contract it receives.
(3) At the time of offer for a HUBZone contract, a concern must certify that it will “attempt to maintain” compliance with the 35% HUBZone residency requirement.
(f)
(ii) In connection with a HUBZone contract, certified HUBZone small business concerns also agree to comply with the limitations on subcontracting requirements under FAR clause 52.219-14 by submitting an offeror for and executing a HUBZone contract.
(g)
(h)
For purposes of qualifying for HUBZone certification, SBA considers any person who owns any legal or equitable interest in a concern to be an owner of the concern. * * *
The revisions and addition read as follows:
(a) A HUBZone small business concern may have affiliates, provided that the HUBZone small business concern, together with its affiliates, qualifies as a small business concern as defined in part 121 of this chapter under the size standard corresponding to any NAICS code listed in its profile in SAM.
(c) * * *
(3) Minimal business activity between the concern and its affiliate alone will not result in an affiliate's employees being counted as employees of the HUBZone applicant or HUBZone small business concern.
(4) SBA will not treat the employees of one company as employees of another for HUBZone program purposes if the two firms would not be considered affiliated for size purposes under Part 121 of this chapter.
A concern seeking certification as a HUBZone small business concern must submit an electronic application to SBA's HUBZone Program Office via SBA's web page at
(e)
(2) HUBZone small business concerns must retain documentation related to “Legacy HUBZone employees,” as described in § 126.200(d)(3).
The revision and addition read as follows:
(d) An applicant must be eligible as of the date SBA issues a decision.
(h) The D/HUB's decision is the final agency decision.
(a) A concern that SBA has declined may apply for certification after ninety (90) calendar days from the date of decline if it believes that it has overcome all reasons for decline through changed circumstances and is currently eligible.
(b) A concern that SBA has decertified may apply for certification immediately after the date of decertification, if it believes that it has overcome all reasons for decertification through changed circumstances and is currently eligible.
(c) A concern that voluntarily withdraws from the HUBZone program may immediately re-apply for certification, if it believes that it is currently eligible.
A program examination is an investigation by SBA officials, which verifies the accuracy of any certification made or information provided as part of the HUBZone application process, as part of the recertification process, or in connection with a HUBZone contract.
(a) SBA will determine the scope of a program examination and may review any information related to the concern's HUBZone eligibility including, but not limited to, documentation related to the concern's size, principal office, ownership, compliance with the 35% HUBZone residency requirement, and compliance with the “attempt to maintain” (
(b) SBA may require that a HUBZone small business concern submit additional information as part of the program examination. If SBA requests additional information, SBA will presume that written notice of the request was provided when SBA sends such request to the concern at an email address provided in the concern's profile in DSBS or
(b) If the D/HUB (or designee) determines that the concern is eligible, SBA will send a written notice to the HUBZone small business concern and continue to designate the concern as a certified HUBZone small business concern in DSBS (or successor system).
(c) If the D/HUB (or designee) determines that the concern is not eligible, the firm will be suspended from the HUBZone program. The concern will have 30 calendar days to submit sufficient documentation showing that it was in fact eligible on the date of review. During the suspension period, such concern may not compete for or be awarded a HUBZone contract and must provide written notice of the concern's ineligibility to the contracting officer for any pending HUBZone award. If such concern fails to submit documentation sufficient to demonstrate its eligibility, the concern will be decertified. If SBA overturns its determination, SBA will reverse the firm's decertification and reinstate its certification.
(a)
(i) A certified HUBZone small business concern that was not awarded a HUBZone contract during the 12-month period preceding its recertification must represent that, at the time of its recertification, at least 35% of its employees reside in HUBZones and the concern's principal office is located in a HUBZone.
(ii) A certified HUBZone small business concern that was awarded a HUBZone contract during the 12-month period preceding its recertification must represent that, at the time of its recertification, it is attempting to maintain compliance with the 35% HUBZone residency requirement and the concern's principal office is located in a HUBZone.
(2) The concern's recertification must be submitted in the 90 calendar days before the triennial anniversary of its HUBZone certification date.
(3) If a concern fails to recertify, SBA will propose the concern for decertification pursuant to § 126.503.
(b)
(a) A certified HUBZone small business concern that acquires, is acquired by, or merges with another business entity must provide evidence to SBA, within 30 calendar days of the transaction becoming final, that the concern continues to meet the HUBZone eligibility requirements. A concern that no longer meets the requirements may voluntarily withdraw from the program or it will be removed by SBA pursuant to program decertification procedures.
(b) A certified HUBZone small business concern that is performing a HUBZone contract and fails to “attempt to maintain” the minimum employee HUBZone residency requirement (
The revisions and addition read as follows:
(a)
(1)
(2)
(3)
(4)
(i) If SBA finds that the concern is not eligible, the D/HUB will decertify the concern and remove its designation as a certified HUBZone small business concern in DSBS (or successor system).
(ii) If SBA finds that the concern is eligible, the concern will continue to be designated as a certified HUBZone small business concern in DSBS (or successor system).
(c)
(2) A firm that is decertified from the HUBZone program due to the submission of false or misleading information may be removed from SBA's other small business contracting programs, including the 8(a) Business Development Program, the Women-Owned Small Business (WOSB) Program, the Veteran Small Business Certification (VetCert) Program, and SBA's Mentor-Protégé Program.
(3) A firm that is decertified or terminated from the 8(a) BD Program, the WOSB Program, or the VetCert Program due to the submission of false or misleading information may be decertified from the HUBZone Program.
(4) SBA may require a firm that is decertified or terminated from the HUBZone Program, 8(a) BD Program, the WOSB Program, or the VetCert Program due to the submission of false or misleading information to enter into an administrative agreement with SBA as a condition of admission or re-admission to the HUBZone program.
(d)
The additions and revisions read as follows:
(a) * * *
(3) Been debarred pursuant to the procedures in FAR 9.4; or
(c)(1) After a concern has been decertified by SBA, it is ineligible for the HUBZone program and may not submit an offer for a HUBZone contract.
(2) As long as a concern was a certified HUBZone small business and met the HUBZone requirements as of the date of its initial offer for a HUBZone contract, it may be awarded a HUBZone contract even if it no longer appears as a certified HUBZone small business concern on DSBS or no longer qualifies as an eligible HUBZone small business on the date of award.
HUBZone contracts are prime contracts awarded to a certified HUBZone small business concern (or a HUBZone joint venture that complies with the requirements of § 126.616), regardless of the place of performance, through any of the following procurement methods:
(a) Sole source awards awarded pursuant to § 126.612 to certified HUBZone small business concerns (or HUBZone joint ventures that comply with the requirements of § 126.616);
(b) Set-aside awards (including partial set-asides and set-aside multiple award contracts) based on competition restricted to certified HUBZone small business concerns;
(c) Awards to certified HUBZone small business concerns (or HUBZone joint ventures that comply with the requirements of § 126.616) through full and open competition after the HUBZone price evaluation preference is applied to an other than small business in favor of a certified HUBZone small business concern (or a HUBZone joint venture that complies with the requirements of § 126.616);
(d) Awards based on a reserve for certified HUBZone small business concerns (or HUBZone joint ventures that comply with the requirements of § 126.616) in an unrestricted solicitation;
(e) Orders awarded to certified HUBZone small business concerns (or HUBZone joint ventures that comply with the requirements of § 126.616) under a multiple award contract that was set-aside for certified HUBZone small business concerns; or
(f) Orders set-aside for certified HUBZone small business concerns (or HUBZone joint ventures that comply with the requirements of § 126.616) under a multiple award contract that was awarded in full and open competition.
(a) Only certified HUBZone small business concerns are eligible to submit offers for a HUBZone contract or to receive a price evaluation preference under § 126.613.
(i) An offeror on a HUBZone contract must be identified as a certified HUBZone small business concern in DSBS (or successor system) and meet the HUBZone requirements in § 126.200 as of the date it submits its initial offer that includes price.
(ii) For a multiple award contract, where concerns are not required to submit price as part of the offer for the contract, an offeror must be identified as a certified HUBZone small business concern in DSBS (or successor system) and meet the HUBZone requirements in § 126.200 as of the date it submits its initial offer, which may not include price.
(iii) A HUBZone joint venture must have its joint venture agreement in place that complies with the requirements in § 126.616 as of its final offer.
(b) * * *
(1) Is a certified HUBZone small business concern in DSBS (or successor system) and meets the HUBZone requirements in § 126.200, including having 35% of its employees residing in HUBZones and having its principal office located in a HUBZone;
(f) In general, an offeror on a HUBZone contract is not required to be HUBZone-certified on the date the contract is awarded. However, for HUBZone sole source contracts, the concern must be a certified HUBZone small business concern and meet the requirements in § 126.200 at the time of award and must qualify as small as of that date under the size standard corresponding to the NAICS code assigned to the procurement.
(a) A certified HUBZone small business concern that has been awarded a HUBZone contract must “attempt to maintain” (
(b) For orders under indefinite delivery, indefinite quantity contracts (including orders under multiple award contracts), a certified HUBZone small business concern must “attempt to maintain” the HUBZone residency requirement during the performance of each order that is set aside for HUBZone small business concerns.
(c) A certified HUBZone small business concern that is tribally-owned, and made the certification in § 126.200(c)(2)(ii) at the time of its HUBZone certification (or at the time of its most recent recertification), must have at least 35% of its employees engaged in performing a HUBZone contract residing within any Indian reservation governed by one or more of the concern's Indian Tribal Government owners, or residing within any HUBZone adjoining any such Indian reservation.
(d) A certified HUBZone small business concern that has less than 20% of its total employees residing in a HUBZone during the performance of a HUBZone contract has failed to attempt to maintain the HUBZone residency requirement. Such failure will result in proposed decertification pursuant to § 126.503.
The addition to read as follows:
(f) The intended awardee is a certified HUBZone small business concern at the time of its initial offer and on the date of award.
The revisions and additions read as follows:
(a)
(2) The HUBZone price evaluation preference does not apply where the initial lowest responsive and responsible offeror is a small business concern.
(3) The HUBZone price evaluation preference does not apply if the certified HUBZone small business concern will receive the contract as part of a reserve for certified HUBZone small business concerns.
(4) To apply the HUBZone price evaluation preference, the CO must add 10% to the offer of the otherwise successful large business offeror. If the certified HUBZone small business concern's offer is lower than that of the large business after the preference is applied, the certified HUBZone small business concern must be deemed the lowest-priced offeror. For a best value procurement, the CO must first apply the 10% price preference to the offers of any large businesses and then determine which offeror represents the best value to the Government, in accordance with the terms of the solicitation. Where, after considering the price evaluation adjustment, the price offered by a certified HUBZone small business concern is equal to the price offered by a large business (or, in a best value procurement, the total evaluation points received by a certified HUBZone small business concern is equal to or greater than the total evaluation points received by a large business), award shall be made to the certified HUBZone small business concern.
(b)
Except as provided in §§ 126.618 and 125.9, a large business may not participate as a prime contractor on a HUBZone award but may participate as a subcontractor to a certified HUBZone small business concern, subject to the limitations on subcontracting set forth in § 125.6.
(a) * * *
(1) SBA does not certify HUBZone joint ventures, but the joint venture should be designated as a HUBZone joint venture in
(e) * * *
(1) * * *
(i) It is a certified HUBZone small business concern that appears in DSBS (or successor system) as a certified HUBZone small business concern and it meets the eligibility requirements in § 126.200;
(l) For a procuring agency to receive HUBZone credit for goaling purposes, the joint venture awardee must comply with the requirements of this section and § 125.8.
A prime contractor that receives an award as a certified HUBZone small business concern must comply with the recertification requirements set forth in § 125.12 of this chapter regarding its status as a certified HUBZone small business.
(a) For a HUBZone sole source procurement, SBA or the contracting officer may protest the intended awardee's status as a certified HUBZone small business concern.
(b) For HUBZone contracts other than sole source procurements, including multiple award contracts (
(c) For contracts other than HUBZone contracts, SBA may protest an apparent successful offeror's status as a certified HUBZone small business concern.
The revisions and additions read as follows:
(a)
(2) For protests filed against a HUBZone joint venture alleging that the joint venture does not comply with the requirements in § 126.616, SBA will determine the eligibility of the joint venture as of its final offer for the procurement.
(3) For protests alleging undue reliance on one or more non-HUBZone subcontractors or alleging that such subcontractor(s) will perform the primary and vital requirements of the contract, SBA will determine the HUBZone small business concern's eligibility as of the date of its final offer for the procurement.
(c)
(f) * * *
(3) A concern found to be ineligible may apply for HUBZone certification immediately after its decline if it believes that it has overcome all reasons for ineligibility through changed circumstances and is currently eligible.
The addition reads as follows:
(e) * * *
(4) If SBA discovers that false or misleading information has been knowingly submitted by a certified small business concern in order to obtain or maintain HUBZone certification, the D/HUB will propose the firm for decertification.
15 U.S.C. 632, 634(b)(6), 637(m), 644 and 657r.
The revisions and additions read as follows:
(a) * * *
(2) Not less than 51 percent unconditionally and directly owned and controlled by one or more economically disadvantaged women who are citizens of and reside in the United States.
(b) * * *
(2) Not less than 51 percent unconditionally and directly owned and controlled by one or more women who
(d)
(e)
(b)
(1) The pledge or encumbrance of stock or other ownership interest as collateral, including seller-financed transactions, does not affect the unconditional nature of ownership if the terms follow normal commercial practices and the owner retains control absent violations of the terms.
(2) In determining unconditional ownership, SBA will disregard any unexercised stock options or similar agreements held by qualifying women. However, any unexercised stock options or similar agreements (including rights to convert non-voting stock or debentures into voting stock) held by men or other entities will be treated as exercised, except for any ownership interests which are held by investment companies licensed under 15 U.S.C. 681
(3) A right of first refusal granting a man or other entity the contractual right to purchase the ownership interests of the qualifying woman, does not affect the unconditional nature of ownership, if the terms follow normal commercial practices. If those rights are exercised by a man or other entity after certification, the WOSB/EDWOSB must notify SBA. If the exercise of those rights results in qualifying women owning less than 51% of the concern, SBA will initiate decertification pursuant to § 127.405.
(g)
(1) At least 51 percent of any distribution of profits paid to the owners of a corporation, partnership, or limited liability company concern, and a qualifying woman's ability to share in the profits of the concern must be commensurate with the extent of her ownership interest in that concern;
(2) 100 percent of the value of each share of stock owned by them in the event that the stock is sold; and
(3) At least 51 percent of the retained earnings of the concern and 100 percent of the unencumbered value of each share of stock or member interest owned in the event of dissolution of the corporation, partnership, or limited liability company.
(d)
(g)
(1) Exercise actual control or have the power to control the concern;
(2) Have business relationships that cause such dependence that the qualifying woman cannot exercise independent business judgment without great economic risk;
(3) Control the concern through loan arrangements (which does not include providing a loan guaranty on commercially reasonable terms);
(4) Provide critical financial or bonding support or a critical license to the concern, which directly or indirectly allows the male or other entity to significantly influence business decisions of the qualifying woman.
(5) Be a former employer, or a principal of a former employer, of any qualifying woman, unless the concern demonstrates that the relationship between the former employer or principal and the qualifying woman does not give the former employer actual control or the potential to control the concern and such relationship is in the best interests of the concern; or
(6) Receive compensation from the concern in any form as a director, officer, or employee, that exceeds the compensation to be received by the qualifying woman who holds the highest officer position (usually Chief Executive Officer or President), unless the concern demonstrates that the compensation to be received by non-qualifying woman is commercially reasonable or that the qualifying woman has elected to take lower compensation to benefit the concern.
(h)
(1) Adding a new equity stakeholder;
(2) Dissolution of the company;
(3) Sale of the company or all assets of the company;
(4) The merger of the company;
(5) The company declaring bankruptcy; and
(6) Amendment of the company's corporate governance documents to remove the shareholder's authority to block any of (1) through (5).
A concern seeking certification as a WOSB or EDWOSB must submit an
(d) An applicant must be eligible as of the date SBA issues a decision. An applicant's eligibility will be based on the totality of circumstances, including facts set forth in the application, supporting documentation, any information received in response to any SBA request for clarification, and any changed circumstances.
(a) A concern that SBA or a third-party certifier has declined may apply for certification after ninety (90) calendar days from the date of decline if it believes that it has overcome all of the reasons for decline and is currently eligible. A concern that has been declined may seek certification by any of the certification options listed in § 127.300.
(b) A concern that SBA has decertified may apply for certification immediately after the date of decertification, if it believes that it has overcome all reasons for decertification through changed circumstances and is currently eligible.
(c) A concern that voluntarily withdraws from the WOSB program may immediately apply for certification, if it believes that it is currently eligible.
(b) The concern must either recertify with SBA or notify SBA that it has completed a program examination from a third party certifier in the 90 calendar days prior to its certification anniversary. Failure to do so will result in the concern being decertified.
(f)
(2) A firm that is decertified or terminated from the 8(a) BD Program, the HUBZone Program, or the VetCert Program due to the submission of false or misleading information may be decertified from the WOSB Program.
(3) SBA may require a firm that is decertified or terminated from the WOSB Program, 8(a) BD Program, the HUBZone Program, or the VetCert Program due to the submission of false or misleading information to enter into an administrative agreement with SBA as a condition of admission or re-admission to the WOSB program.
The revisions read as follows:
(a)
(1) Qualify as a small business concern under the size standard corresponding to the NAICS code assigned to the contract;
(2) Meet the eligibility requirements of an EDWOSB or WOSB in § 127.200; and
(3) Either be a certified EDWOSB or WOSB pursuant to § 127.300, or represent that the concern has submitted a complete application for WOSB or EDWOSB certification to SBA or a third-party certifier and has not received a negative determination regarding that application from SBA or the third party certifier.
(i) If a concern becomes the apparent successful offeror while its application for WOSB or EDWOSB certification is pending, either at SBA or a third-party certifier, the contracting officer for the particular contract must immediately inform SBA's D/GC. SBA will then prioritize the concern's WOSB or EDWOSB application and make a determination regarding the firm's status as a WOSB or EDWOSB within 15 calendar days from the date that SBA received the contracting officer's notification. Where the application is pending with a third-party certifier, SBA will immediately contact the third-party certifier to require the third-party certifier to complete its determination within 15 calendar days.
(ii) If the contracting officer does not receive an SBA or third-party certifier determination within 15 calendar days after the SBA's receipt of the notification, the contracting officer may presume that the apparently successful offeror is not an eligible WOSB or EDWOSB and may make award accordingly, unless the contracting officer grants an extension to the 15-day response period.
(h)
15 U.S.C. 632(q), 634(b)(6), 644, 645, 657f, 657f-1.
(a) * * *
(2) Not less than 51 percent owned and controlled by one or more veterans who reside in the United States.
(b) * * *
(2) Not less than 51 percent owned and controlled by one or more service-disabled veterans who reside in the United States or, in the case of a veteran with a disability that is rated by the Secretary of Veterans Affairs as a permanent and total disability who are unable to manage the daily business operations of such concern, the spouse or permanent caregiver of such veteran who resides in the United States.
(b)
(c)
The revision and addition read as follows:
(g)
(h)
(1) Exercise actual control or have the power to control the concern;
(2) Have business relationships that cause such dependence that the qualifying veteran cannot exercise independent business judgment without great economic risk;
(3) Control the concern through loan arrangements (which does not include providing a loan guaranty on commercially reasonable terms);
(4) Provide critical financial or bonding support or a critical license to the concern, which directly or indirectly allows the non-qualifying veteran to significantly influence business decisions of the qualifying veteran.
(5) Be a former employer, or a principal of a former employer, of any qualifying veteran, unless the concern demonstrates that the relationship between the former employer or principal and the qualifying veteran does not give the former employer actual control or the potential to control the concern and such relationship is in the best interests of the concern; or
(6) Receive compensation from the concern in any form as a director, officer, or employee, that exceeds the compensation to be received by the qualifying veteran who holds the highest officer position (usually Chief Executive Officer or President), unless the concern demonstrates that the compensation to be received by non-qualifying veteran is commercially reasonable or that the qualifying veteran has elected to take lower compensation to benefit the concern.
(j) * * *
(6) Amendment of the company's corporate governance documents to remove the shareholder's authority to block any of (1) through (5).
(a)
An application for certification as a VOSB or SDVOSB must be electronically filed according to the instructions on SBA's website at
The addition reads as follows:
(a) * * * An applicant must be eligible as of the date SBA issues a decision.
(a) A concern that SBA has declined may apply for certification after ninety (90) calendar days from the date of decline, if it believes that it has overcome all of the reasons for decline and is currently eligible.
(b) A concern that SBA has decertified may apply for certification immediately after the date of decertification, if it believes that it has overcome all reasons for decertification through changed circumstances and is currently eligible.
(c) A concern that voluntarily withdraws from the VetCert program may immediately apply for certification, if it believes that it is currently eligible.
(g)
(2) A firm that is decertified or terminated from the 8(a) BD Program, the HUBZone Program, or the WOSB Program due to the submission of false or misleading information may be decertified from the VetCert Program.
(3) SBA may require a firm that is decertified or terminated from the VetCert Program, the 8(a) BD Program, the HUBZone Program, or the WOSB Program due to the submission of false or misleading information to enter into an administrative agreement with SBA as a condition of admission or re-admission to the VetCert program.
The revisions read as follows:
(a)
(e)
(a) * * * SBA does not certify VOSB or SDVOSB joint ventures, but the joint venture should be designated as a VOSB or SDVOSB joint venture in
(k) For a procuring agency to receive VOSB or SDVOSB credit for goaling purposes, the joint venture awardee must comply with the requirements of this section and § 125.8.
5 U.S.C. 504; 15 U.S.C. 632, 634(b)(6), 634(i), 637(a), 648(l), 656(i), 657t and 687(c); E.O. 12549, 51 FR 6370, 3 CFR, 1986 Comp., p. 189.
Subpart J issued under 15 U.S.C. 657f.
Subpart K issued under 15 U.S.C. 657f.
Subpart L issued under 15 U.S.C. 636(a)(36); Pub. L. 116-136, 134 Stat. 281; Pub. L. 116-139, 134 Stat. 620; Pub. L. 116-142, 134 Stat. 641; and Pub. L. 116-147, 134 Stat. 660.
Subpart M issued under 15 U.S.C. 657a; Pub. L. 117-81, 135 Stat. 1541.
(e) * * *
(1) If the VOSB or SDVOSB status protest pertains to a procurement, the Judge will determine a protested concern's eligibility as a VOSB or SDVOSB as of the date of its initial offer or response which includes price for a competitively awarded VOSB/SDVOSB contract, order, or agreement, and as of the date of award for any sole source VOSB or SDVOSB award. * * *